RISK FACTORS

You should carefully review and consider the following risk factors and the other information contained in this proxy statement/prospectus, including the financial statements and notes to the financial statements included herein, in evaluating the Business Combination and the proposals to be voted on at the Special Meeting. The following risk factors related to ZyVersa apply to the business and operations of ZyVersa and will also apply to the business and operations of the post-combination company following the completion of the Business Combination. The occurrence of one or more of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may adversely affect the ability to complete or realize the anticipated benefits of the Business Combination, and may have an adverse effect on the business, cash flows, financial condition and results of operations of the post-combination company. You should also carefully consider the following risk factors in addition to the other information included in this proxy statement/prospectus, including matters addressed in the section entitled “Cautionary Note Regarding Forward-Looking Statements.” The following discussion should be read in conjunction with the financial statements and notes to the financial statements included herein. Unless the context otherwise requires, all references in this section to “ZyVersa,” “we,” “us” or “our” refer to the business of ZyVersa Therapeutics, Inc., a Delaware corporation, and its subsidiary prior to the consummation of the Business Combination, which will be the business of the post-combination company and its subsidiary following the consummation of the Business Combination.

Risks Related to Our Financial Position and Need for Capital

We are a development stage company with a limited operating history and no revenues, and there are a number of factors that may affect our prospects.

We are a development stage pharmaceutical company with a limited operating history and no revenues. The likelihood of success of our business plan must be considered in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered in connection with developing and expanding early-stage businesses and the regulatory and competitive environment in which we operate. Pharmaceutical and biopharmaceutical product development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by development stage pharmaceutical companies such as our Company, and note that we cannot assure you that we will be able to successfully address these risks.

Our operations to date have been primarily limited to our organizational and capital-raising activities, negotiating our license agreements, and conducting development activities for VAR 200 and IC 100. We have not demonstrated our ability to successfully complete large-scale, pivotal clinical trials, obtain regulatory approvals, manufacture a commercial scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Because of our limited operating history, we have limited insight into trends that may emerge and affect our business, and errors may be made in developing an approach to address those trends and the other challenges faced by development stage pharmaceutical companies such as our Company. Failure to adequately respond to such trends and challenges could cause our business, results of operations and financial condition to suffer or fail. Further, our limited operating history may make it difficult for our stockholders to make any predictions about our likelihood of future success or viability.

Factors relating to our business that may affect our prospects may include other such as:

•        our ability to obtain additional funding to develop and commercialize our product candidates;

•        any delays in regulatory review and approval for implementation of our development plans;

•        delays in the commencement, enrollment and timing of clinical trials;

•        the success of our preclinical and clinical trials through all phases of preclinical and clinical development;

•        any delays in regulatory review and approval of our product candidates;

•        our ability to obtain and maintain regulatory approval for our product candidates that we seek to develop in the United States and foreign jurisdictions;

•        potential side effects of our product candidates that could delay or prevent commercialization, limit the indications for our product candidates, if approved, require the establishment of Risk Evaluation and Mitigation Strategies (“REMS”), cause an approved drug to be taken off the market or subject us to fines and penalties and third-party claims;

•        market acceptance of our product candidates, if approved for marketing;

•        our dependence on third parties to manufacture and supply our product candidates;

•        our dependence on clinical research organizations (“CROs”) to conduct our clinical trials;

•        our dependence on contract manufacturing organizations (“CMOs”) to produce our products for clinical purposes and commercialization;

•        our ability to establish or maintain collaborations, licensing or other arrangements;

•        our ability to identify, acquire and incorporate other businesses, products and/or technologies;

•        our ability to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations;

•        competition from existing products or new products that may emerge;

•        the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our product candidates;

•        our ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important to our business;

•        our ability to leverage our partners’ proprietary technology platform to discover and develop additional product candidates;

•        our ability to attract and retain key personnel to manage our business effectively;

•        our ability to build our finance infrastructure and improve our accounting systems and controls;

•        potential product liability claims;

•        potential liabilities associated with hazardous materials; and

•        our ability to obtain and maintain adequate insurance policies.

We have never been profitable. To date, we do not have data to support regulatory approval of any of our drug products, we have no products approved for commercial sale in any jurisdiction, and we have not generated any Revenue from product sales. As a result, our ability to curtail our losses and reach profitability is unproven, and we may never achieve or sustain profitability.

We have never been profitable and do not expect to be profitable for the foreseeable future. As of December 31, 2021, our accumulated net loss was approximately ($53,824,569) million. We have devoted most of our financial resources to our organizational and capital-raising activities and negotiating our license agreements, and other strategic partnerships and collaborations. We have not completed development of any product candidate through the receipt of marketing approval, and we have therefore not generated any revenues from product sales. Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. We expect to incur increased expenses as we continue the clinical development of VAR 200 and preclinical development of IC 100 and other product candidates that we may seek to develop and for which we may seek marketing approval in the United States and elsewhere. We also expect an increase in our expenses associated with creating additional infrastructure (including hiring additional personnel) to commence clinical trials and continue the development and commercialization of VAR 200 and IC 100 and other product candidates that we may seek to develop. As a result, we expect to continue to incur net losses and negative cash flows for the foreseeable future. These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.

To date, we have financed our operations through the sale of our equity securities. The amount of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. If we are unable to develop and commercialize VAR 200, IC 100, or any other product candidates that we may seek to develop, either alone or with collaborators, or if revenues from any product candidate that receives marketing approval are insufficient, we will not achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability.

We may be unable to continue as a going concern.

We are a development stage pharmaceutical company with no commercial products. Our primary product candidates are in the process of being developed, and will require significant additional preclinical and clinical development and investment before they could potentially be commercialized. As a result, we have not generated any Revenue from operations since inception, and we have incurred substantial net losses to date. Moreover, our cash position is vastly inadequate to support our business plans and substantial additional funding will be needed in order to pursue those plans, which include research and development of our primary product candidates, seeking regulatory approval for those product candidates, and pursuing their commercialization in the United States and other markets. Those circumstances raise substantial doubt about our ability to continue as a going concern. In particular, we believe that our current cash and cash equivalents on hand will only be sufficient to meet our anticipated cash requirements through the third quarter of 2022. If we are unable to continue as a going concern, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. In addition, our lack of cash resources and our potential inability to continue as a going concern may materially adversely affect the value of our capital stock and our ability to raise new capital or to enter into critical contractual relations with third parties.

We will need additional capital to develop and commercialize our product candidates. If we are unable to raise sufficient capital, we would be forced to delay, reduce or eliminate our product development programs.

Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. We expect our research and development expenses to increase in connection with our ongoing activities, particularly as we start clinical trials for VAR 200 and conduct preclinical development of IC 100. We have no commitments or arrangements for any additional financing to fund our development and commercialization efforts for VAR 200, IC 100, or any other product candidate that we may seek to develop. We will need to raise substantial additional capital to develop and commercialize VAR 200, IC 100, and any other product candidate that we may seek to develop. Because successful development of VAR 200 or IC 100 is uncertain, we are unable to estimate the actual funds required to complete their development and commercialization.

Until we can generate a sufficient amount of Revenue from VAR 200, IC 100, or any other product candidate that we may seek to develop, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaborations and licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or curtail, our operations. To the extent that we raise additional funds by issuing equity securities, or securities convertible into equity securities, the ownership of our then existing stockholders may be diluted, which dilution could be significant depending on the price at which we may be able to sell our securities. Also, if we raise additional capital through the incurrence of indebtedness, we may become subject to additional covenants restricting our business activities, the holders of debt instruments may have rights and privileges senior to those of our equity investors, and servicing the interest and principal repayment obligations under such debt instruments could divert funds that would otherwise be available to support research and development, clinical or commercialization activities. Corresponding, we may not be able to enter into collaborations that we seek to establish. To the extent that we raise additional funds through collaborations and licensing arrangements, it may be necessary to relinquish some rights to our technologies or our product candidates or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.

Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

•        the initiation, progress, timing, costs and results of preclinical and clinical trials for our product candidates;

•        whether the FDA requires that we perform additional studies for our product candidates that we seek to develop beyond those that we anticipate;

•        the terms and timing of any future collaboration, licensing or other arrangements that we may establish;

•        the outcome, timing and cost of regulatory approvals;

•        the effect of competing technological and market developments;

•        the cost and timing of establishing commercial-scale outsourced manufacturing capabilities;

•        market acceptance of our product candidates, if we receive regulatory approval;

•        the cost of establishing sales, marketing and distribution capabilities for our product candidates, if we receive regulatory approval; and

•        the extent to which we acquire, license or invest in businesses, products or technologies.

We are subject to various U.S. anti-corruption laws and other anti-bribery and anti-kickback laws and regulations.

ZyVersa is subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, and other anticorruption, anti-bribery, and anti-money laundering laws in the jurisdictions in which it does business. These laws generally prohibit ZyVersa and ZyVersa’s employees from improperly influencing government officials or commercial parties in order to obtain or retain business, direct business to any person, or gain any improper advantage. The FCPA and other applicable anti-bribery and anti-corruption laws also may hold ZyVersa liable for acts of corruption and bribery committed by ZyVersa’s third-party business partners, representatives, and agents who are acting on ZyVersa’s behalf. ZyVersa and its third-party business partners, representatives, and agents may have direct or indirect interactions with officials and employees of government agencies or state-owned or affiliated entities and it may be held liable for the corrupt or other illegal activities of these third-party business partners and intermediaries and its employees, representatives, contractors, and agents, even if it does not explicitly authorize such activities. These laws also require that ZyVersa keeps accurate books and records and maintain internal controls and compliance procedures designed to prevent any such actions. While ZyVersa has policies and procedures to address compliance with such laws, it cannot assure that its employees and agents will not take actions in violation of its policies or applicable law, for which it may be ultimately held responsible and its exposure for violating these laws increases as its international presence expands and as it increases sales and operations in foreign jurisdictions. Any violation of the FCPA or other applicable anti-bribery, anti-corruption, and anti-money laundering laws could result in whistleblower complaints, adverse media coverage, investigations, imposition of significant legal fees, loss of export privileges, severe criminal or civil sanctions, or suspension or debarment from U.S. government contracts, substantial diversion of management’s attention, a drop in the Combined Entity’s stock price, or overall adverse consequences to ZyVersa’s business, all of which may have an adverse effect on ZyVersa’s reputation, business, financial condition, and operating results.

Risks Related to Development, Regulatory Approval and Commercialization

A pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19 could cause a disruption to the development of our product candidates.

Public health crises such as pandemics or similar outbreaks could adversely impact our business. In December 2019, a novel strain of a virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes COVID-19, surfaced in Wuhan, China and has since spread worldwide. The coronavirus pandemic is evolving, and to date has led to the implementation of various responses, including government-imposed quarantines, travel restrictions and other public health safety measures. The extent to which the coronavirus impacts our operations or those of our third-party partners, including our preclinical studies or clinical trial operations, will also depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information that will emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. The continued spread of COVID-19 globally could adversely impact our preclinical or clinical trial operations in the U.S. and abroad, including our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have

heightened exposure to COVID-19. For example, similar to other biopharmaceutical companies, we may experience delays in enrolling our current and/or planned clinical trials. COVID-19 may also affect employees of third-party CROs located in affected geographies that we rely upon to carry out our clinical trials. In addition, the patient populations that our lead and other core product candidates target may be particularly susceptible to COVID-19, which may make it more difficult for us to identify patients able to enroll in our future clinical trials and may impact the ability of enrolled patients to complete any such trials. Any negative impact COVID-19 has to patient enrollment or treatment or the execution of our product candidates could cause costly delays to clinical trial activities, which could adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses, and have a material adverse effect on our financial results.

Additionally, timely enrollment in planned clinical trials is dependent upon clinical trial sites which could be adversely affected by global health matters, such as pandemics. We plan to conduct clinical trials for our product candidates in geographies which are currently being affected by the coronavirus. Some factors from the coronavirus outbreak that will delay or otherwise adversely affect enrollment in the clinical trials of our product candidates, as well as our business generally, include:

•        the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, including the attention of physicians serving as our clinical trial investigators, hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our prospective clinical trials;

•        limitations on travel that could interrupt key trial and business activities, such as clinical trial site initiations and monitoring, domestic and international travel by employees, contractors or patients to clinical trial sites, including any government-imposed travel restrictions or quarantines that will impact the ability or willingness of patients, employees or contractors to travel to our clinical trial sites or secure visas or entry permissions, a loss of face-to-face meetings and other interactions with potential partners, any of which could delay or adversely impact the conduct or progress of our prospective clinical trials;

•        the potential negative effect on the operations of our third-party manufacturers;

•        interruption in global shipping, affecting the transport of raw materials for our products, clinical trial materials, such as patient samples, investigational drug product and conditioning drugs and other supplies used in our prospective clinical trials; and

•        business disruptions caused by potential workplace, laboratory and office closures and an increased reliance on employees working from home, disruptions to or delays in ongoing laboratory experiments and operations, staffing shortages, travel limitations or mass transit disruptions, any of which could adversely impact our business operations or delay necessary interactions with local regulators, ethics committees and other important agencies and contractors.

We have taken temporary precautionary measures intended to help minimize the risk of the virus to our employees, including having all of our employees to work remotely, suspending all non-essential travel worldwide for our employees and discouraging employee attendance at industry events and in-person work-related meetings, which could negatively affect our business. We cannot presently predict the scope and severity of the planned and potential shutdowns or disruptions of businesses and government agencies, such as the SEC or FDA.

Our business is dependent on the successful development, regulatory approval and commercialization of our product candidates, in particular VAR 200 and IC 100.

The success of our business, including our ability to finance our company and generate any Revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization or partnering of our product candidates. In the future, we may also become dependent on just one of our product candidates or any future product candidates that we may in-license, acquire or develop. The preclinical and clinical and commercial success of our product candidates will depend on a number of factors, including the following:

•        the ability to raise additional capital on acceptable terms, or at all;

•        timely completion of our clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors;

•        whether we are required by the FDA, or similar foreign regulatory agencies to conduct additional preclinical or clinical trials beyond those planned to support the approval and commercialization of our product candidates or any future product candidates;

•        acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities;

•        our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities, the safety and efficacy of our product candidates or any future product candidates;

•        our ability to identify an active compound within the drug product that can be detected in a pharmacokinetics study;

•        the prevalence, duration and severity of potential side effects experienced in connection with our product candidates or future approved products, if any;

•        the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;

•        achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or approved products, if any;

•        the ability of third parties with whom we contract to manufacture clinical trial and commercial supplies of our product candidates or any future product candidates, remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices, or cGMP, or good agricultural and collection practices, or GACP;

•        a continued acceptable safety profile during preclinical and clinical development and following approval of our product candidates or any future product candidates;

•        our ability to successfully commercialize our product candidates or any future product candidates in the United States and internationally, if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration with others;

•        acceptance by physicians, patients and payors of the benefits, safety and efficacy of our product candidates or any future product candidates, if approved, including relative to alternative and competing treatments;

•        our ability to comply with numerous post-approval regulatory requirements;

•        our and our partners’ ability to establish and enforce intellectual property rights in and to our product candidates or any future product candidates;

•        our and our partners’ ability to avoid third-party patent interference or intellectual property infringement claims; and

•        our ability to in-license or acquire additional product candidates or commercial-stage products that we believe we can successfully develop and commercialize.

VAR 200 may not obtain an FDA designation as an Orphan Drug for FSGS. A request for Orphan Drug Designation was submitted by ZyVersa and received by the FDA on September 17, 2018. Orphan Drug Designation was unable to be granted because (1) the FSGS preclinical model used to support the request reflected prevention rather than treatment of FSGS, which was the proposed indication for VAR 200, and (2) FDA felt that the prevalence estimate provided was underestimated based on the assumptions and calculations used. ZyVersa plans to reapply for Orphan Drug Designation when clinical data are available for VAR 200, using additional information to support the prevalence rate of FSGS.

If we are unable to achieve one or more of the above factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays and increased costs or an inability to obtain regulatory approvals or commercialize our product candidates. Even if regulatory approvals are obtained, we may never be able

to successfully commercialize any of our product candidates. Accordingly, we cannot assure you that we will be able to generate sufficient Revenue through the sale of our product candidates or any future product candidates to continue operations.

Preclinical drug development for our product candidate IC 100 is very expensive, time-consuming and uncertain. Our preclinical trials may fail to adequately demonstrate pharmacologic activity in therapeutic areas of interest; cause unintended short- or long-term effects in other bodily systems; or produce unexpected toxicity that may alter or risk benefit assessment. The class of compounds reflective of IC 100 has not entered into clinical trials, and the effects of the pharmacologic class are unknown. These and other factors could prevent or delay further development.

The scientific discoveries that form the basis for ZyVersa’s efforts to generate and develop its product candidates are relatively recent. The scientific evidence to support the feasibility of developing agents based on ZyVersa’s approach is both preliminary and limited. IC 100 represents a novel therapeutic modality and the successful development may require additional studies and efforts to optimize its therapeutic potential. IC 100 may not demonstrate in patients the therapeutic properties ascribed to it in the laboratory or preclinical studies, and may interact with human biological systems in unforeseen, ineffective or even harmful ways. If ZyVersa is not able to successfully develop and commercialize IC 100 it may never become profitable and the value of its capital stock may decline.

IC 100 is a relatively novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all.

ZyVersa has concentrated its research and development efforts on a limited number of initial targeted disease indications. There can be no assurance that ZyVersa will not experience problems or delays in developing its current or future indications and that such problems or delays will not cause unanticipated costs, or that any such development problems can be solved. Preclinical data generated on IC 100 along with a proposed clinical development plan requires review and allowance by the FDA under an Investigational New Drug Application. ZyVersa has not generated the data to support such an application, and the results of preclinical studies will require FDA review prior to the initiation of clinical studies which may not be granted.

ZyVersa may not be successful in its efforts to use and expand its development platform to build a pipeline of product candidates.

A key element of ZyVersa’s strategy for IC 100 is to use its experienced management and scientific team to evaluate IC 100 in broad range of human disease in order to build a pipeline of product candidates. Although ZyVersa’s research and development efforts to date have resulted in potential product candidates, ZyVersa may not be able to continue to identify and develop additional product candidates. Even if ZyVersa is successful in continuing to build its pipeline, the potential product candidates that ZyVersa identifies may not be suitable for clinical development. For example, these potential product candidates may be shown to have harmful side effects or other characteristics that indicate that they are unlikely to receive marketing approval and achieve market acceptance. If ZyVersa does not successfully develop and commercialize product candidates based upon its approach, ZyVersa will not be able to obtain product Revenue in future periods, which likely would result in significant harm to its financial position. There is no assurance that ZyVersa will be successful in its preclinical and clinical development, and the process of obtaining regulatory approvals will, in any event, require the expenditure of substantial time and financial resources.

Clinical drug development for our product candidates is very expensive, time-consuming and uncertain. Our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization.

Clinical drug development for our product candidates is very expensive, time-consuming, difficult to design and implement and its outcome is inherently uncertain. Before obtaining regulatory approval for the commercial sale of a product candidate, we must demonstrate through clinical trials that a product candidate is both safe and effective for use in the target indication, which is impossible to predict. Most product candidates that commence clinical trials are never approved by regulatory authorities for commercialization. Our product candidates are in various stages of development and a failure of one more clinical trial can occur at any stage of testing or at any time during the trial process. We expect that clinical trials for these product candidates will continue for several years, but may take significantly longer than expected to complete. Not all of our product candidates have been tested in humans and the first use in humans may reveal unexpected effects. We have not completed all clinical trials for the approval of any of our product candidates.

We may experience delays in ongoing and future clinical trials for our product candidates and do not know if future clinical trials, if any, will begin on time, need to be redesigned, enroll adequate number of patients on time or be completed on schedule, if at all. In addition, we, any partner with which we currently or may in the future collaborate, the FDA, an IRB or other regulatory authorities, including state and local agencies and counterpart agencies in foreign countries, may suspend, delay, require modifications to or terminate our clinical trials at any time, for various reasons, including:

•        discovery of safety or tolerability concerns, such as serious or unexpected toxicities or side effects or exposure to otherwise unacceptable health risks, experienced by study participants or other safety issues;

•        lack of effectiveness of any product candidate during clinical trials or the failure of our product candidates to meet specified endpoints;

•        slower than expected rates of subject recruitment and enrollment rates or inability to enroll a sufficient number of patients in clinical trials resulting from numerous factors, including the prevalence of other companies’ clinical trials for their product candidates for the same indication, or clinical trials for indications for which patients do not as commonly seek treatment;

•        delays or difficulties in our clinical trials due to quarantines or other restrictions resulting from the COVID-19 pandemic;

•        difficulty in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;

•        difficulty in obtaining IRB approval for studies to be conducted at each clinical trial site;

•        delays in manufacturing or obtaining, or inability to manufacture or obtain, sufficient quantities of materials for use in clinical trials;

•        inadequacy of or changes in our manufacturing process or the product formulation or method of delivery;

•        changes in applicable laws, regulations and regulatory policies;

•        delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective CROs, clinical trial sites and other third-party contractors;

•        inability to add a sufficient number of clinical trial sites;

•        uncertainty regarding proper formulation and dosing;

•        failure by us, our employees, our CROs or their employees or other third-party contractors to comply with contractual and applicable regulatory requirements or to perform their services in a timely or acceptable manner;

•        failure by us, our employees, our CROs or their employees or any partner with which we may collaborate or their employees to comply with applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security and recordkeeping for drug and biologic products;

•        scheduling conflicts with participating clinicians and clinical institutions;

•        failure to design appropriate clinical trial protocols;

•        insufficient data to support regulatory approval;

•        inability or unwillingness of medical investigators to follow our clinical protocols; or

•        difficulty in maintaining contact with subjects during or after treatment, which may result in incomplete data.

We or any partner with which we may collaborate may suffer significant setbacks in our clinical trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials. In the event that we or our potential partners abandon or are delayed in the clinical development efforts related to our product candidates, we may not be able to execute on our business plan effectively and our business, financial condition, operating results and prospects would be harmed.

Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

As product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. Such changes may also require additional testing, FDA notification or FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials.

We may be unable to obtain regulatory approval for VAR 200 or IC 100, our early-stage product candidates under applicable regulatory requirements. The FDA and foreign regulatory bodies have substantial discretion in the approval process, including the ability to delay, limit or deny approval of product candidates. The delay, limitation or denial of any regulatory approval would adversely impact commercialization, our potential to generate Revenue, our business and our operating results.

We currently have no products approved for sale, and we may never obtain regulatory approval to commercialize any of our current or future product candidates. The research, testing, manufacturing, safety surveillance, efficacy, quality control, recordkeeping, labeling, packaging, storage, approval, sale, marketing, distribution, import, export, and reporting of safety and other post-market information related to our drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and in foreign countries, and such regulations differ from country to country. We are not permitted to market any of our current product candidates in the United States until we receive approval of a NDA, BLA, or other applicable regulatory filing from the FDA. We are also not permitted to market any of our current product candidates in any foreign countries until we or our partners receive the requisite approval from the applicable regulatory authorities of such countries. To gain approval to market a new drug such as VAR 200 or IC 100, the FDA and/or foreign regulatory authorities must receive, among other things, preclinical and clinical data that adequately demonstrate the safety, purity, potency, efficacy, and compliant manufacturing of the drug product for the intended indication applied for in a NDA, BLA or other applicable regulatory filing. The development and approval of new drug products involves a long, expensive and uncertain process, and delay or failure can occur at any stage. A number of companies in the pharmaceutical and biopharmaceutical industry have suffered significant setbacks in nonclinical development, clinical trials, including in Phase 3 clinical development, even after promising results in earlier preclinical studies or clinical trials. These setbacks have been caused by, among other things, findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unreported adverse events. Success in clinical trials does not ensure that later clinical trials will be successful, or that nonclinical studies will be successful. The results of clinical trials by other parties may not be indicative of the results in trials we or our partners may conduct.

The FDA and foreign regulatory bodies have substantial discretion in the drug development and approval process, including the ability to delay, limit drug development or limit or deny approval of product candidates for many reasons. The FDA or the applicable foreign regulatory body may:

•        disagree with the design or implementation of one or more clinical trials;

•        not deem a product candidate safe and effective for its proposed indication, or may deem a product candidate’s safety or other perceived risks to outweigh its clinical or other benefits;

•        not find the data from preclinical studies and clinical trials sufficient to support approval, or the results of clinical trials may not meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory body for approval;

•        disagree with our interpretation of data from preclinical studies or clinical trials performed by us or third parties, or with the interpretation of any partner with which we may collaborate;

•        determine the data collected from preclinical or clinical trials may not be sufficient to support the submission of an IND or NDA, or other applicable regulatory filing;

•        require additional preclinical studies or clinical trials;

•        identify deficiencies in the formulation, quality control, labeling or specifications of our current or future product candidates;

•        require clinical trials in pediatric patients in order to establish pharmacokinetics or safety for this more drug-sensitive population;

•        grant approval contingent on the performance of costly additional post-approval clinical trials;

•        approve our current or any future product candidates for a more limited indication or a narrower patient population than we originally requested or with strong warnings that may affect marketability;

•        not approve the labeling that we believe is necessary or desirable for the successful commercialization of our product candidates;

•        not approve of the manufacturing processes, controls or facilities of third-party manufacturers or testing labs with which we contract;

•        consider our products a device instead of a drug requiring a different approval process and manufacturing needs;

•        consider one of our products a combination product instead of a singular drug requiring additional clinical trials or increased number of patients per study, or

•        change its approval policies or adopt new regulations in a manner rendering our clinical data or regulatory filings insufficient for approval.

Any delay, limitation or denial in any applicable regulatory approval for any of our product candidates would delay or adversely impact commercialization of our product candidates and would harm our business, financial condition, operating results and prospects.

Even if our current product candidates or any future product candidates obtain regulatory approval, they may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.

The commercial success of any of our current or future product candidates, if approved, will depend significantly on the broad adoption and use of the resulting product by physicians, patients and payors for approved indications, and may not be commercially successful. The degree and rate of adoption of our current or future product candidates, if approved, will depend on a number of factors, including:

•        the clinical indications for which the product is approved and patient demand for approved products that treat those indications;

•        the effectiveness of our product as compared to other available therapies;

•        the availability of coverage and adequate reimbursement from managed care plans and other healthcare payors for any of our product candidates that may be approved;

•        the cost of treatment with our product candidates in relation to alternative treatments and willingness to pay for the product, if approved, on the part of patients;

•        acceptance by physicians, major operators of clinics and patients of the product as a safe and effective treatment;

•        physician and patient willingness to adopt a new therapy over other available therapies to treat approved indications;

•        overcoming any biases physicians or patients may have toward particular therapies for the treatment of approved indications;

•        proper training and administration of our product candidates by physicians and medical staff;

•        patient satisfaction with the results and administration of our product candidates and overall treatment experience;

•        the Revenue and profitability that our product candidate may offer a physician as compared to alternative therapies;

•        the prevalence and severity of side effects;

•        limitations or warnings contained in the FDA-approved labeling for our product candidates;

•        any FDA requirement to undertake a risk evaluation and mitigation strategy, or REMS;

•        the effectiveness of our sales, marketing and distribution efforts;

•        our ability to maintain sufficient quantities of supply to meet demand;

•        adverse publicity about our product candidates or favorable publicity about competitive products; and

•        potential product liability claims.

If any of our current or future product candidates are approved for use but fail to achieve the broad degree of physician and patient adoption necessary for commercial success, our operating results and financial condition will be adversely affected, which may delay, prevent or limit our ability to generate Revenue and continue our business.

Our product candidates, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration.

The pharmaceutical industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis on developing proprietary therapeutics. Numerous pharmaceutical companies, generic drug companies, biotechnology companies, and academic and research institutions are engaged in the development, patenting, manufacturing, and marketing of health care products competitive with those that we are developing, including Travere, Pfizer, Goldfinch Bio, Boehringer Ingelheim, Astra Zeneca, Sanofi, Novartis, Roche, and others. Many of our competitors have greater financial resources, marketing capabilities, sales forces, manufacturing capabilities, research and development capabilities, clinical trial expertise, intellectual property portfolios, experience in obtaining patents and regulatory approvals for product candidates and other resources than us. Some of the companies that offer competing products also have a broad range of other product offerings, large direct sales forces and long-term customer relationships with our target physicians, which could inhibit our market penetration efforts. In addition, certain of our product candidates, if approved, may compete with a share of some patients’ discretionary budgets and for physicians’ attention within their clinical practices.

We anticipate that, if we obtain regulatory approval of our product candidates, we will face significant competition from other approved therapies. If approved, our product candidates may also compete with unregulated, unapproved, off-label, and over the counter treatments. Certain of our product candidates, if approved, will present novel therapeutic approaches for the approved indications and will have to compete with existing therapies, some of which are widely known and accepted by physicians and patients. To compete successfully in this market, we will have to demonstrate that the relative cost, safety and efficacy of our approved products, if any, provide an attractive alternative to existing and other new therapies. Such competition could lead to reduced market share for our product candidates and contribute to downward pressure on the pricing of our product candidates, which could harm our business, financial condition, operating results and prospects.

We expect to face generic or similar type of product competition for our product candidates, which could adversely affect our business, financial condition, operating results and prospects.

Upon the expiration or loss of any patent protection for any of our product candidates that are approved, or upon the “at-risk” launch, despite pending patent infringement litigation against the generic product or its equivalent, by a generic competitor of a generic version of any of our product candidates that are approved, which may be sold

at significantly lower prices than our approved product candidates, we could lose a significant portion of sales of that product in a short period of time, which would adversely affect our business, financial condition, operating results and prospects.

Any product candidates that we commercialize, or that any partner with which we may collaborate commercializes, will be subject to ongoing and continued regulatory review.

Even after we or our partners achieve U.S. regulatory approval for a product candidate, if any, we or our partners will be subject to continued regulatory review and compliance obligations. For example, with respect to our product candidates, the FDA may impose significant restrictions on the approved indicated uses for which the product may be marketed or on the conditions of approval. A product candidate’s approval may contain requirements for potentially costly post-approval studies and surveillance, including Phase 4 clinical trials or a REMS, to monitor the safety and efficacy of the product. We will also be subject to ongoing FDA obligations and continued regulatory review with respect to, among other things, the manufacturing, processing, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for our product candidates. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP requirements, with the FDA’s good clinical practice, or GCP, or good agricultural and collections practices, or GACP, requirements and good laboratory practice, or GLP, requirements, which are regulations and guidelines enforced by the FDA for all of our product candidates in clinical and preclinical development, and for any clinical trials that we conduct post-approval. To the extent that a product candidate is approved for sale in other countries, we may be subject to similar restrictions and requirements imposed by laws and government regulators in those countries.

If we, our partners, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:

•        impose restrictions on the marketing or manufacturing of the product, suspend or withdraw product approvals or revoke necessary licenses;

•        mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners;

•        require us or our partners to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;

•        issue warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available;

•        commence criminal investigations and prosecutions;

•        impose injunctions, suspensions or revocations of necessary approvals or other licenses;

•        impose other civil or criminal penalties;

•        suspend any ongoing clinical trials;

•        delay or refuse to approve pending applications or supplements to approved applications filed by us or our potential partners;

•        refuse to permit drugs or precursor chemicals to be imported or exported to or from the United States;

•        suspend or impose restrictions on operations, including costly new manufacturing requirements; or

•        seize or detain products or require us or our partners to initiate a product recall.

The regulations, policies or guidance of the FDA and other applicable government agencies may change and new or additional statutes or government regulations may be enacted that could prevent or delay regulatory approval of our product candidates or further restrict or regulate post-approval activities. We cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are not able to achieve and maintain regulatory compliance, we may not be permitted to market our product candidates, which would adversely affect our ability to generate Revenue and achieve or maintain profitability.

We may in the future conduct clinical trials for our product candidates outside the United States and the FDA and applicable foreign regulatory authorities may not accept data from such trials.

We may in the future choose to conduct one or more of our clinical trials outside the United States, including in Canada, Europe and South America. Although the FDA or applicable foreign regulatory authority may accept data from clinical trials conducted outside the United States or the applicable jurisdiction, acceptance of such study data by the FDA or applicable foreign regulatory authority may be subject to certain conditions. Where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will not approve the application on the basis of foreign data alone unless those data are applicable to the U.S. population and U.S. medical practice; the studies were performed by clinical investigators of recognized competence; and the data are considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Many foreign regulatory bodies have similar requirements. In addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions where the studies are conducted. There can be no assurance the FDA or applicable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or applicable foreign regulatory authority does not accept such data, it would likely result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan.

Our product candidates may cause undesirable side effects or have other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in post-approval regulatory action.

Unforeseen side effects from any of our product candidates could arise either during clinical development or, if approved, after the approved product has been marketed. Undesirable side effects caused by product candidates could cause us, any partners with which we may collaborate or regulatory authorities to interrupt, modify, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable foreign authorities. Results of clinical trials could reveal a high and unacceptable severity and prevalence of side effects. In such an event, trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us, or our potential partners, to cease further development of or deny approval of product candidates for any or all targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in product liability claims. Any of these occurrences may harm our business, financial condition, operating results and prospects.

Additionally, if we or others identify undesirable side effects, or other previously unknown problems, caused by our product candidates after obtaining U.S. or foreign regulatory approval or other products with the same or related active ingredients, a number of potentially negative consequences could result, including:

•        regulatory authorities may withdraw their approval of the product;

•        regulatory authorities may require a recall of the product or we or our potential partners may voluntarily recall a product;

•        regulatory authorities may require the addition of warnings or contraindications in the product labeling, narrowing of the indication in the product label or field alerts to physicians and pharmacies;

•        we may be required to create a medication guide outlining the risks of such side effects for distribution to patients or institute a REMS;

•        we may have limitations on how we promote the product;

•        we may be required to change the way the product is administered or modify the product in some other way; the FDA or applicable foreign regulatory authority may require additional clinical trials or costly post-marketing testing and surveillance to monitor the safety or efficacy of the product;

•        the FDA or applicable foreign regulatory authority may require additional clinical trials or costly post-marketing testing and surveillance to monitor the safety or efficacy of the product

•        sales of the product may decrease significantly;

•        we could be sued and held liable for harm caused to patients; and

•        our brand and reputation may suffer.

Any of the above events resulting from undesirable side effects or other previously unknown problems could prevent us or our potential partners from achieving or maintaining market acceptance of the affected product candidate and could substantially increase the costs of commercializing our product candidates.

We may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if we commercialize any products. This risk exists even if a product is approved for commercial sale by the FDA and manufactured in facilities licensed and regulated by the FDA or an applicable foreign regulatory authority. Our products and product candidates are designed to affect important bodily functions and processes. Any side effects, manufacturing defects, misuse or abuse associated with our product candidates could result in injury to a patient or even death. We cannot offer any assurance that we will not face product liability suits in the future, nor can we assure you that our insurance coverage will be sufficient to cover our liability under any such cases.

In addition, a liability claim may be brought against us even if our product candidates merely appear to have caused an injury. Product liability claims may be brought against us by consumers, health care providers, pharmaceutical companies or others selling or otherwise coming into contact with our product candidates, among others. If we cannot successfully defend ourselves against product liability claims we will incur substantial liabilities and reputational harm. In addition, regardless of merit or eventual outcome, product liability claims may result in:

•        withdrawal of clinical trial participants;

•        termination of clinical trial sites or entire trial programs;

•        inability to gain regulatory approval of our product candidates;

•        the inability to commercialize our product candidates;

•        decreased demand for our product candidates;

•        impairment of our business reputation;

•        product recall or withdrawal from the market or labeling, marketing or promotional restrictions;

•        substantial costs of any related litigation or similar disputes;

•        distraction of management’s attention and other resources from our primary business;

•        substantial monetary awards to patients or other claimants against us that may not be covered by insurance; or

•        loss of revenue.

We currently maintain product liability insurance coverage, which may not be sufficient to cover all of our product liability related expenses or losses and may not cover us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost, in sufficient amounts or upon adequate terms to protect us against losses due to product liability. We will need to increase our product liability coverage if any of our product candidates receive regulatory approval, which will be costly, and we may be unable to obtain this increased product liability insurance on commercially reasonable terms, or at all. A successful product liability claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could decrease our cash and could harm our business, financial condition, operating results and prospects.

If any of our product candidates are approved for marketing and we are found to have improperly promoted off-label uses, or if physicians misuse our products or use our products off-label, we may become subject to prohibitions on the sale or marketing of our products, product liability claims and significant fines, penalties and sanctions, and our brand and reputation could be harmed.

The FDA and other regulatory agencies strictly regulate the marketing and promotional claims that are made about drug and biologic products. In particular, a product may not be promoted for uses or indications that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling and comparative safety or efficacy claims cannot be made without direct comparative clinical data. If we are found to have promoted off-label uses of any of our product candidates, we may receive warning or untitled letters and become subject to significant liability, which would materially harm our business. Both federal and state governments have levied large civil and criminal fines against companies for alleged improper promotion and have enjoined several companies from engaging in off-label promotion. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would materially harm our business. In addition, management’s attention could be diverted from our business operations, significant legal expenses could be incurred and our brand and reputation could be damaged. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we are deemed by the FDA to have engaged in the promotion of our products for off-label use, we could be subject to FDA regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our business activities constitute promotion of an off-label use, which could result in significant penalties, including criminal, civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment or restructuring of our operations.

We cannot, however, prevent a physician from using our product candidates outside of those indications for use when in the physician’s independent professional medical judgment he or she deems appropriate. Physicians may also misuse our product candidates or use improper techniques, potentially leading to adverse results, side effects or injury, which may lead to product liability claims. If our product candidates are misused or used with improper technique, we may become subject to costly litigation by physicians or their patients. Furthermore, the use of our product candidates for indications other than those cleared by the FDA may not effectively treat such conditions, which could harm our reputation among physicians and patients.

We may choose not to continue developing or commercializing any of our product candidates at any time during development or after approval, which would reduce or eliminate our potential return on investment for those product candidates.

At any time, we may decide to discontinue the development of any of our product candidates or not to continue commercializing one or more of our approved product candidates for a variety of reasons, including the appearance of new technologies that make our product obsolete, competition from a competing product or changes in or failure to comply with applicable regulatory requirements. If we terminate a program in which we have invested significant resources, we will not receive any return on our investment and we will have missed the opportunity to have allocated those resources to potentially more productive uses.

We or our current and prospective partners may be subject to product recalls in the future that could harm our brand and reputation and could negatively affect our business.

We or our current and prospective partners may be subject to product recalls, withdrawals or seizures if any of our product candidates, if approved for marketing, fail to meet specifications or are believed to cause injury or illness or if we are alleged to have violated governmental regulations including those related to the manufacture, labeling, promotion, sale or distribution. Any recall, withdrawal or seizure in the future could materially and adversely affect consumer confidence in our brands and lead to decreased demand for our approved products. In addition, a recall, withdrawal or seizure of any of our approved products would require significant management attention, would likely result in substantial and unexpected expenditures and would harm our business, financial condition and operating results.

If we or any partners with which we may collaborate are unable to achieve and maintain coverage and adequate levels of reimbursement for any of our product candidates for which we receive regulatory approval, or any future products we may seek to commercialize, their commercial success may be severely hindered.

For any of our product candidates that become available only by prescription, successful sales by us or by any partners with which we may collaborate depend on the availability of coverage and adequate reimbursement from third-party payors. Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. The availability of coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and private third-party payors is critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. If any of our product candidates do not demonstrate attractive efficacy profiles, they may not qualify for coverage and reimbursement. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate or may require co-payments that patients find unacceptably high. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products.

In addition, the market for our product candidates will depend significantly on access to third-party payors’ drug formularies or lists of medications for which third-party payors provide coverage and reimbursement. The industry competition to be included in such formularies often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payors may refuse to include a particular branded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or another alternative is available.

Further, third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, in the United States, although private third-party payors tend to follow Medicare, no uniform policy of coverage and reimbursement for drug products exists among third-party payors. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

Further, we believe that future coverage and reimbursement will likely be subject to increased restrictions both in the United States and in international markets. Third-party coverage and reimbursement for any of our product candidates for which we may receive regulatory approval may not be available or adequate in either the United States or international markets, which could harm our business, financial condition, operating results and prospects.

Healthcare legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative impact on our business and results of operations.

In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.

Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. For example, in the United States, the Patient Protection and Affordable Care Act of 2010, or the ACA, substantially changed the way health care is financed by both governmental and private insurers and significantly affects the pharmaceutical industry. Many provisions of the ACA impact the biopharmaceutical industry, including that in order for a biopharmaceutical product to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to U.S. government agencies, the manufacturer must extend discounts to entities eligible to participate in the drug pricing program under the Public Health Services Act, or PHS. Since its enactment, there have been judicial and Congressional challenges and amendments to certain aspects of the ACA. There is continued uncertainty about the implementation of the ACA, including the potential for further amendments to the ACA and legal challenges to or efforts to repeal the ACA.

Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, the now-departed Trump administration proposed numerous prescription drug cost control measures. Similarly, the new Biden administration has made lowering prescription drug prices one of its priorities. The Biden administration has not yet proposed any specific plans, but we expect that these will be forthcoming in the near term. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Other examples of proposed changes include, but are not limited to, expanding post-approval requirements, changing the Orphan Drug Act, and restricting sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether government regulations, guidance or interpretations will be changed, or what the impact of such changes would be on the marketing approvals, sales, pricing, or reimbursement of our drug candidates or products, if any, may be. We expect that these and other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved drug. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate Revenue, attain profitability, or commercialize our drugs.

In addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may impose additional costs or lengthen FDA review times for DMT310 or any future product candidates. We cannot determine how changes in regulations, statutes, policies, or interpretations when and if issued, enacted or adopted, may affect our business in the future. Such changes could, among other things, require:

•        additional clinical trials to be conducted prior to obtaining approval;

•        changes to manufacturing methods;

•        recalls, replacements, or discontinuance of one or more of our products; and

•        additional recordkeeping.

Such changes would likely require substantial time and impose significant costs, or could reduce the potential commercial value of our product candidates. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any other products would harm our business, financial condition, and results of operations.

We may also be subject to healthcare laws, regulation and enforcement and our failure to comply with those laws could adversely affect our business, operations and financial condition.

Certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. We are subject to regulation by both the federal government and the states in which we or our partners conduct our business. The laws and regulations that may affect our ability to operate include:

•        the federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs;

•        federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the federal civil False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

•        the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

•        HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

•        the federal physician sunshine requirements under the Affordable Care Act, which require manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members; and

•        state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation has strengthened these laws. For example, the recently enacted Affordable Care Act, among other things, amended the intent requirement of the federal Anti-Kickback Statute and certain criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the Affordable Care Act provided that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

Achieving and sustaining compliance with these laws may prove costly. In addition, any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of the laws described above or any other governmental laws or regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment or the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.

Our business involves the use of hazardous materials and we and our third-party suppliers and manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.

The manufacturing activities of our third-party suppliers and manufacturers involve the controlled storage, use and disposal of hazardous materials owned by us, including the components of our product candidates and other hazardous compounds. We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling, and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at our suppliers’ or manufacturers’ facilities pending use and disposal. We and our suppliers and manufacturers cannot completely eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, injury to our service providers and others and environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized by our third-party suppliers and manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources. We do not currently carry biological or hazardous waste insurance coverage.

Our employees, independent contractors, principal investigators, consultants, vendors, CROs and any partners with which we may collaborate may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk that our employees, independent contractors, principal investigators, consultants, vendors, CROs and any partners with which we may collaborate may engage in fraudulent or other illegal activity. Misconduct by these persons could include intentional, reckless or negligent conduct or unauthorized activity that violates: laws or regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA or foreign regulatory authorities; manufacturing standards; federal, state and foreign healthcare fraud and abuse laws and data privacy; or laws that require the true, complete and accurate reporting of financial information or data. In particular, sales, marketing and other business arrangements in the healthcare industry are subject to extensive laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws may restrict or prohibit a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials, or illegal misappropriation of drug product, which could result in regulatory sanctions or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations, and serious harm to our reputation. In addition, federal procurement laws impose substantial penalties for misconduct in connection with government contracts and require certain contractors to maintain a code of business ethics and conduct. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our operating results.

Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.

Our future profitability will depend, in part, on our ability to commercialize our product candidates in foreign markets for which we intend to rely on collaborations with third parties. If we commercialize VAR 200 or IC 100 or our other product candidates in foreign markets, we would be subject to additional risks and uncertainties, including:

•        our customers’ ability to obtain market access and appropriate reimbursement for our product candidates in foreign markets;

•        our inability to directly control commercial activities because we are relying on third parties;

•        the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements;

•        different medical practices and customs in foreign countries affecting acceptance in the marketplace

•        import or export licensing requirements;

•        longer accounts receivable collection times;

•        longer lead times for shipping;

•        language barriers for technical training;

•        reduced protection of intellectual property rights in some foreign countries;

•        foreign currency exchange rate fluctuations; and

•        the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.

Foreign sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs, any of which may adversely affect our results of operations.

Risks Related to Our Dependence on Third Parties

We have in the past relied and expect to continue to rely on third-party CROs and other third parties to conduct and oversee our clinical trials and other aspects of product development. If these third parties do not meet our requirements or otherwise conduct the trials as required, we may not be able to satisfy our contractual obligations or obtain regulatory approval for, or commercialize, our product candidates when expected or at all.

We have in the past relied and expect to continue to rely on third-party CROs to conduct and oversee our clinical trials and other aspects of product development. We also rely upon various medical institutions, clinical investigators and contract laboratories to conduct our trials in accordance with our clinical protocols and all applicable regulatory requirements, including the FDA’s regulations and GCPs, which are an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors, and state regulations governing the handling, storage, security and recordkeeping for drug and biologic products. These CROs and other third parties play a significant role in the conduct of these trials and the subsequent collection and analysis of data from the clinical trials. We rely heavily on these parties for the execution of our clinical trials and preclinical studies, and control only certain aspects of their activities. We and our CROs and other third-party contractors are required to comply with GCP, GLP, and GACP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for products in clinical development. Regulatory authorities enforce these GCP, GLP and GACP requirements through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of these third parties fail to comply with applicable GCP, GLP and GACP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other regulatory authority may require us to perform additional clinical trials before approving our or our partners’ marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical or preclinical trials complies with applicable GCP and GLP requirements. In addition, our clinical trials must generally be conducted with product produced under cGMP regulations. Our failure to comply with these regulations and policies may require us to repeat clinical trials, which would delay the regulatory approval process.

Our CROs are not our employees, and we do not control whether or not they devote sufficient time and resources to our clinical trials. Our CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials, or other drug development activities, which could harm our competitive position. We face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs, which may reduce our trade secret protection and allow our potential competitors to access and exploit our proprietary technology. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for any other reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize any product candidate that we develop. As a result, our financial results and the commercial prospects for any product candidate that we develop would be harmed, our costs could increase, and our ability to generate Revenue could be delayed.

If any of our CROs or clinical trial sites terminate their involvement in one of our clinical trials for any reason, we may not be able to enter into arrangements with alternative CROs or clinical trial sites, or do so on commercially reasonable terms. In addition, if our relationship with clinical trial sites is terminated, we may experience the loss of follow-up information on patients enrolled in our ongoing clinical trials unless we are able to transfer the care of those patients to another qualified clinical trial site. In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and could receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site may be questioned by the FDA.

We rely completely on third-party contractors to supply, manufacture and distribute clinical drug supplies for our product candidates, including certain sole-source suppliers and manufacturers, we intend to rely on third parties for commercial supply, manufacturing and distribution if any of our product candidates receive regulatory approval and we expect to rely on third parties for supply, manufacturing and distribution of preclinical, clinical and commercial supplies of any future product candidates.

We do not currently have, nor do we plan to acquire, the infrastructure or capability to supply, manufacture or distribute preclinical, clinical or commercial quantities of drug substances or products. Our ability to develop our product candidates depends and our ability to commercially supply our products will depend, in part, on our ability to successfully obtain the raw materials and APIs and other substances and materials used in our product candidates from third parties and to have finished products manufactured by third parties in accordance with regulatory requirements and in sufficient quantities for preclinical and clinical testing and commercialization. If we fail to develop and maintain supply relationships with these third parties, we may be unable to continue to develop or commercialize our product candidates.

We rely and will continue to rely on certain third parties as the sole source of the materials they supply or the finished products they manufacture. Any of our existing suppliers or manufacturers may:

•        fail to supply us with product on a timely basis or in the requested amount due to unexpected damage to or destruction of facilities or equipment or otherwise;

•        fail to increase manufacturing capacity and produce drug product and components in larger quantities and at higher yields in a timely or cost-effective manner, or at all, to sufficiently meet our commercial needs;

•        be unable to meet our production demands due to issues related to their reliance on sole-source suppliers and manufacturers;

•        supply us with product that fails to meet regulatory requirements;

•        become unavailable through business interruption or financial insolvency;

•        lose regulatory status as an approved source;

•        be unable or unwilling to renew current supply agreements when such agreements expire on a timely basis, on acceptable terms or at all; or

•        discontinue production or manufacturing of necessary drug substances or products.

In the event of any of the foregoing, if we do not have an alternative supplier or manufacturer in place, we would be required to expend substantial management time and expense to identify, qualify and transfer processes to alternative suppliers or manufacturers. Transferring technology to other sites may require additional processes, technologies and validation studies, which are costly, may take considerable amounts of time, may not be successful and, in most cases, require review and approval by the FDA. Any need to find and qualify new suppliers or manufacturers could significantly delay production of our product candidates, adversely impact our ability to market our product candidates and adversely affect our business. Replacements may not be available to us on a timely basis, on acceptable terms or at all. Additionally, we and our manufacturers do not currently maintain significant inventory of drug substances and other materials. Any interruption in the supply of a drug substance or other material or in the manufacture of our product candidates could have a material adverse effect on our business, financial condition, operating results and prospects.

We do not have direct control over the ability of our contract suppliers and manufacturers to maintain adequate capacity and capabilities to serve our needs, including quality control, quality assurance and qualified personnel. Although we are ultimately responsible for ensuring compliance with regulatory requirements such as cGMPs and GACP, we are dependent on our contract suppliers and manufacturers for day-to-day compliance with cGMPs or GACP for production of raw materials, APIs, and finished products. Facilities used by our contract suppliers and manufacturers to produce the APIs and other substances and materials or finished products for commercial sale must pass inspection and be approved by the FDA and other relevant regulatory authorities. Our contract suppliers and manufacturers must comply with cGMP and GACP requirements enforced by the FDA through its facilities inspection program and review of submitted technical information. If the safety of any product or product candidate or component is compromised due to a failure to adhere to applicable laws or for other reasons, we may not be able to successfully commercialize or obtain regulatory approval for the affected product or product candidate, and we may be held liable for injuries sustained as a result. Any of these factors could cause a delay or termination of preclinical studies, clinical trials or regulatory submissions or approvals of our product candidates, and could entail higher costs or result in our being unable to effectively commercialize our approved products on a timely basis, or at all.

In addition, these contract manufacturers are engaged with other companies to supply and manufacture materials or products for such companies, which also exposes our suppliers and manufacturers to regulatory risks for the production of such materials and products. As a result, failure to meet the regulatory requirements for the production of those materials and products may also affect the regulatory clearance of a contract supplier’s or manufacturer’s facility. If the FDA or a comparable foreign regulatory agency does not approve these facilities for the supply or manufacture of our product candidates, or if it withdraws its approval in the future, we may need to find alternative supply or manufacturing facilities, which would negatively impact our ability to develop, obtain regulatory approval of or market our product candidates, if approved.

Our reliance on contract manufacturers and suppliers further exposes us to the possibility that they, or third parties with access to their facilities, will have access to and may misappropriate our trade secrets or other proprietary information.

In addition, the manufacturing facilities of certain of our suppliers, including our supplier of Spongilla lacustris, are located outside of the United States. This may give rise to difficulties in importing our products or product candidates or their components into the United States or other countries as a result of, among other things, regulatory agency approval requirements or import inspections, incomplete or inaccurate import documentation or defective packaging.

If we are not able to establish and maintain collaborations, we may have to alter our development and commercialization plans.

The development and potential commercialization of our product candidates will require substantial additional cash to fund expenses. In order to fund further development of our product candidates, we may collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of those product candidates. We face significant competition in seeking appropriate partners. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the partner’s resources and experience, the terms and conditions of the proposed collaboration and the proposed partner’s evaluation of a number of factors. Those factors may include the design or results of clinical trials; the likelihood of approval by the FDA or other regulatory authorities; the potential market for the subject product candidate; the costs and complexities of manufacturing and delivering such product candidate to patients; the potential of competing products; any uncertainty with respect to our ownership of our intellectual property; and industry and market conditions generally. The partner may also consider alternative product candidates or technologies for similar indications that may be available for collaboration and whether such a collaboration could be more attractive than the one with us for our product candidate. We may also be restricted under future license agreements from entering into agreements on certain terms with potential partners. Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future partners.

Future collaborations we may enter into may involve the following risks:

•        collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations;

•        collaborators may not perform their obligations as expected;

•        changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, may divert resources or create competing priorities;

•        collaborators may delay discovery and preclinical development, provide insufficient funding for product development of targets selected by us, stop or abandon discovery and preclinical development for a product candidate, repeat or conduct new discovery and preclinical development for a product candidate;

•        collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed than ours;

•        product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the development of our product candidates;

•        disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the discovery, preclinical development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

•        collaborators may not properly maintain or defend our intellectual property rights or intellectual property rights licensed to us or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

•        collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and

•        collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.

Collaborations typically impose detailed obligations on each party. If we were to breach our obligations, we may face substantial consequences, including potential termination of the collaboration, and our rights to our partners’ product candidates, in which we have invested substantial time and money, would be lost.

We may not be able to negotiate collaborations on a timely basis, on acceptable terms or at all. If we are unable to do so, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product Revenue.

Risks Related to Managing Our Growth, Our Employees and Our Operations

We will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing any growth.

Our management, personnel, systems and facilities currently in place are not adequate to support our business plan and near-term future growth. We will need to further expand our chemistry and manufacturing team, clinical team, managerial, operational, financial, and other resources to support our planned research, development and commercialization activities.

To manage our operations, growth and various projects effectively requires that we:

•        continue to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;

•        attract and retain sufficient numbers of talented employees;

•        develop a marketing, sales and distribution capability;

•        manage our commercialization activities for our product candidates effectively and in a cost-effective manner;

•        establish and maintain relationships with development and commercialization partners;

•        manage our preclinical and clinical trials effectively;

•        manage our third-party supply and manufacturing operations effectively and in a cost-effective manner, while increasing production capabilities for our current product candidates to commercial levels; and

•        manage our development efforts effectively while carrying out our contractual obligations to partners and other third parties.

In addition, historically, we have utilized and continue to utilize the services of part-time outside consultants to perform a number of tasks for us, including tasks related to preclinical and clinical testing. Our growth strategy may also entail expanding our use of consultants to implement these and other tasks going forward. We rely on consultants for certain functions of our business and will need to effectively manage these consultants to ensure that they successfully carry out their contractual obligations and meet expected deadlines. There can be no assurance that we will be able to manage our existing consultants or find other competent outside consultants, as needed, on economically reasonable terms, or at all. If we are not able to effectively manage our growth and expand our organization by hiring new employees and expanding our use of consultants, we might be unable to implement successfully the tasks necessary to execute effectively on our planned research, development and commercialization activities and, accordingly, might not achieve our research, development and commercialization goals.

If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan.

Our ability to compete in the highly competitive pharmaceuticals industry depends upon our ability to attract and retain highly qualified managerial, scientific, medical, sales and marketing and other personnel. We are highly dependent on our management, including: Stephen Glover, Peter Wolfe, Nick A. Labella, Jr. and Karen A. Cashmere. The loss of the services of any of these individuals could impede, delay or prevent the successful development of our product pipeline, completion of our planned clinical trials, commercialization of our product candidates or in-licensing or acquisition of new assets and could negatively impact our ability to successfully implement our business plan. If we lose the services of any of these individuals, we might not be able to find suitable replacements on a timely basis or at all, and our business could be harmed as a result. We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees. In order to retain valuable employees at our company, in addition to salary and cash incentives, we provide stock options that vest over time. The value to employees of stock options that vest over time will be significantly affected by movements in our stock price that are beyond our control, and may at any time be insufficient to counteract offers from other companies.

We might not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses, particularly in the Weston, FL area where the Combined Entity will be headquartered. We could have difficulty attracting experienced personnel to our company and may be required to expend significant financial resources in our employee recruitment and retention efforts. Many of the other pharmaceutical companies with whom we compete for qualified personnel have greater financial and other resources, different risk profiles and longer histories in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that will harm our ability to implement our business strategy and achieve our business objectives.

In addition, we have scientific and clinical advisors who assist us in formulating our development and clinical strategies. These advisors are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us. In addition, our advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with ours.

We currently have limited marketing capabilities and no sales organization. If we are unable to establish sales and marketing capabilities on our own or through third parties, we will be unable to successfully commercialize our product candidates, if approved, or generate product Revenue.

We currently have limited marketing capabilities and no sales organization. To commercialize our product candidates, if approved, in the United States, Canada, the European Union and other jurisdictions we seek to enter, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. Although our management team has experience in the marketing, sale and distribution of pharmaceutical products from prior employment at other companies, we as a company have no prior experience in the marketing, sale and distribution of pharmaceutical products and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of these products. We may choose to collaborate with additional third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our product candidates. If we are unable to successfully commercialize our product candidates, either on our own or through collaborations with one or more third parties, our business, financial condition, operating results and prospects would suffer.

Our failure to successfully in-license, acquire, develop, and market additional product candidates or approved products would impair our ability to grow our business.

We intend to in-license, acquire, develop and market additional products and product candidates and we may in-license or acquire commercial-stage products or engage in other strategic transactions. Because our internal research and development capabilities are limited, we may be dependent upon pharmaceutical companies, academic scientists and other researchers to sell or license products or technology to us. The success of this strategy depends partly upon our ability to identify and select promising pharmaceutical product candidates and products, negotiate licensing or acquisition agreements with their current owners and finance these arrangements.

The process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and complex. Other companies, including some with substantially greater financial, marketing, sales and other resources, may compete with us for the license or acquisition of product candidates and approved products. We have limited resources to identify and execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure. Moreover, we may devote resources to potential acquisitions or licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates on terms that we find acceptable, or at all.

Further, any product candidate that we acquire may require additional development efforts prior to commercial sale, including preclinical or clinical testing and approval by the FDA and applicable foreign regulatory authorities. All product candidates are prone to risks of failure typical of pharmaceutical product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot provide assurance that any approved products that we acquire will be manufactured or sold profitably or achieve market acceptance.

Additional potential transactions that we may consider include a variety of different business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments. Any such transaction may require us to incur non-recurring or other charges, may increase our near- and

long-term expenditures and may pose significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial results. For example, these transactions entail numerous potential operational and financial risks, including:

•        exposure to unknown liabilities;

•        disruption of our business and diversion of our management’s time and attention in order to develop acquired products, product candidates or technologies;

•        incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions;

•        substantial acquisition and integration costs;

•        write-downs of assets or impairment charges;

•        increased amortization expenses;

•        difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;

•        impairment of relationships with key suppliers, partners or customers of any acquired businesses due to changes in management and ownership; and

•        inability to retain our key employees or those of any acquired businesses.

Accordingly, there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, and any transaction that we do complete could harm our business, financial condition, operating results and prospects.

Manufacturing and supply of the APIs and other substances and materials used in our product candidates is a complex and technically challenging undertaking, and there is potential for failure at many points in the manufacturing, testing, quality assurance and distribution supply chain, as well as the potential for latent defects after products have been manufactured and distributed.

Manufacturing and supply of APIs, other substances and materials and finished drug products is technically challenging. Changes beyond our direct control can impact the quality, volume, price and successful delivery of our product candidates and can impede, delay, limit or prevent the successful development and commercialization of our product candidates. Mistakes and mishandling are not uncommon and can affect successful production and supply. Some of these risks include:

•        failure of our manufacturers to follow cGMP or GACP requirements or mishandling of product while in production or in preparation for transit;

•        inability of our contract suppliers and manufacturers to efficiently and cost-effectively increase and maintain high yields and batch quality, consistency and stability;

•        our inability to develop an FDA approved bioassay for release of any future product;

•        difficulty in establishing optimal drug delivery substances and techniques, production and storage methods and packaging and shipment processes;

•        transportation and import/export risk, particularly given the global nature of our supply chain;

•        delays in analytical results or failure of analytical techniques that we depend on for quality control and release of any future product;

•        natural disasters, pandemics, labor disputes, financial distress, lack of raw material supply, issues with facilities and equipment or other forms of disruption to business operations of our contract manufacturers and suppliers; and

•        latent defects that may become apparent after the product has been released and which may result in recall and destruction of product.

Any of these factors could result in delays or higher costs in connection with our clinical trials, regulatory submissions, required approvals or commercialization of our product candidates, which could harm our business, financial condition, operating results and prospects.

Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.

Our operations to date have been primarily limited to researching and developing our product candidates and undertaking preclinical studies and clinical trials of our product candidates. We have not yet obtained regulatory approvals for any of our product candidates. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history or approved products on the market. Furthermore, our operating results may fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult to predict, including the following:

•        delays in the commencement, enrollment and the timing of clinical testing for our product candidates;

•        the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;

•        any delays in regulatory review and approval of product candidates in clinical development;

•        the timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may change from time to time;

•        the cost of manufacturing our product candidates, which may vary depending on FDA guidelines and requirements, and the quantity of production;

•        our ability to obtain additional funding to develop our product candidates;

•        expenditures that we will or may incur to acquire or develop additional product candidates and technologies;

•        the level of demand for our product candidates, should they receive approval, which may vary significantly;

•        potential side effects of our product candidates that could delay or prevent commercialization or cause an approved drug to be taken off the market;

•        the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our product candidates, if approved;

•        our dependency on third-party manufacturers to supply or manufacture our product candidates;

•        our ability to establish an effective sales, marketing and distribution infrastructure in a timely manner;

•        market acceptance of our product candidates, if approved, and our ability to forecast demand for those product candidates;

•        our ability to receive approval and commercialize our product candidates outside of the United States;

•        our ability to establish and maintain collaborations, licensing or other arrangements;

•        our ability and third parties’ abilities to protect intellectual property rights;

•        costs related to and outcomes of potential litigation or other disputes;

•        our ability to adequately support future growth;

•        our ability to attract and retain key personnel to manage our business effectively;

•        potential liabilities associated with hazardous materials;

•        our ability to maintain adequate insurance policies; and

•        future accounting pronouncements or changes in our accounting policies.

Our operating results and liquidity needs could be negatively affected by market fluctuations and economic downturn.

Our operating results and liquidity could be negatively affected by economic conditions generally, both in the United States and elsewhere around the world. The market for discretionary medical products and procedures may be particularly vulnerable to unfavorable economic conditions. Some patients may consider certain of our product candidates to be discretionary, and if full reimbursement for such products is not available, demand for these products may be tied to the discretionary spending levels of our targeted patient populations. Domestic and international equity and debt markets have experienced and may continue to experience heightened volatility and turmoil based on domestic and international economic conditions and concerns. In the event these economic conditions and concerns continue or worsen and the markets continue to remain volatile, our operating results and liquidity could be adversely affected by those factors in many ways, including weakening demand for certain of our products and making it more difficult for us to raise funds if necessary, and our stock price may decline. Additionally, although we plan to market our products primarily in the United States, we could in the future have partners with extensive global operations, indirectly exposing us to risk.

Our business and operations would suffer in the event of failures in our internal computer systems.

Despite the implementation of security measures, our computer systems and those of our current and any future partners, contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced any such material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our manufacturing activities, development programs and our business operations. For example, the loss of manufacturing records or clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further commercialization and development of our products and product candidates could be delayed.

We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.

Significant disruptions to our information technology systems or breaches of information security could adversely affect our business. In the ordinary course of business, we collect, store and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. The size and complexity of our information technology systems, and those of our third-party vendors with whom we contract, make such systems potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our employees, partners or vendors, from attacks by malicious third parties, or from intentional or accidental physical damage to our systems infrastructure maintained by us or by third parties. Maintaining the secrecy of this confidential, proprietary, or trade secret information is important to our competitive business position. While we have taken steps to protect such information and invested in information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential information that could adversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive information. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud, trickery or other forms of deception, or for any other reason, could enable others to produce competing products, use our proprietary technology or information, or adversely affect our business or financial condition. Further, any such interruption, security breach, loss or disclosure of confidential information, could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on our business, financial position, results of operations or cash flow.

Risks Related to Our Intellectual Property

Failure to adequately protect Our intellectual property could adversely affect Our business, financial condition, and operating results.

Our business depends on its intellectual property and proprietary technology, the protection of which is crucial to the success of its business. We rely on a combination of trademark, copyright, and trade secret laws, license agreements, intellectual property assignment agreements, and confidentiality procedures to protect its intellectual property. Additionally, we rely on proprietary information (such as trade secrets, know-how and confidential information) to protect intellectual property that may not be patentable, or that we believe is best protected by means that do not require public disclosure. We generally attempt to protect our intellectual property, technology, and confidential information by requiring our employees and consultants who develop intellectual property on our behalf to enter into confidentiality and invention assignment agreements and third parties we share information with to enter into nondisclosure agreements. These agreements may not effectively prevent unauthorized use or disclosure of our confidential information, intellectual property, or technology and may not provide an adequate remedy in the event of unauthorized use or disclosure of our confidential information or technology, or infringement of our intellectual property. For example, we may fail to enter into the necessary agreements, and even if entered into, these agreements may be willfully breached or may otherwise fail to prevent disclosure, third-party infringement or misappropriation of our proprietary information, may be limited as to their term and may not provide an adequate remedy in the event of unauthorized disclosure or use of proprietary information. In addition, our proprietary information may otherwise become known or be independently developed by our competitors or other third parties. To the extent that our employees, consultants, contractors, and other third parties use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our intellectual property rights and other proprietary rights, and failure to obtain or maintain protection for our proprietary information could adversely affect our competitive business position.

Despite our efforts to protect our proprietary rights, other parties may unintentionally or willfully disclose, obtain or use our technologies or systems, which may allow unauthorized parties to copy aspects of our platform or other software, technology, and functionality or obtain and use information that we consider proprietary. In addition, unauthorized parties may also attempt, or successfully endeavor, to obtain our intellectual property, confidential information and trade secrets through various methods, including through scraping of public data or other content from our website or mobile applications, cybersecurity attacks, and legal or other methods of protecting this data may be inadequate. Monitoring unauthorized use and disclosures of our intellectual property, proprietary technology, or confidential information can be difficult and expensive and we cannot be sure that the steps we have taken will prevent misappropriation or infringement of our intellectual property or proprietary rights.

We have registered domain names for websites that we use in our business, such as www.zyversa.com and other variations. The inclusion of the website address in this proxy statement/prospectus does not include or incorporate by reference the information on the ZyVersa website into this proxy statement/prospectus.

Competitors have and may continue to adopt service names similar to ours, thereby harming our ability to build brand identity and possibly leading to user confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks that are similar to our trademarks. For additional information see other risk factors in this section titled, “Risk Factors — Risks Related to Our Intellectual Property.” Further, litigation or proceedings before the U.S. Patent and Trademark Office or other governmental authorities and administrative bodies in the United States and abroad may be necessary in the future to enforce our intellectual property rights and to determine the validity and scope of the proprietary rights of others. Any litigation initiated by ZyVersa concerning the violation by third parties of its intellectual property rights is likely to be expensive and time-consuming and could lead to the invalidation of, or render unenforceable, its intellectual property, or could otherwise have negative consequences for ZyVersa. Even when ZyVersa sues other parties for such infringement, that suit may have adverse consequences for our business. In addition, ZyVersa may not timely or successfully apply for a patent or register its trademarks or otherwise secure its intellectual property, which could result in negative effects to our market share, financial condition and results of operations. our efforts to protect, maintain, or enforce its proprietary rights may not be respected in the future or may be invalidated, circumvented, or challenged. and could result in substantial costs and diversion of resources, which could adversely affect its business, financial condition, and operating results.

We may be unable to continue to use the domain names that we use in our business or prevent third parties from acquiring and using domain names that infringe on, are similar to, or otherwise decrease the value of our brand, trademarks, or service marks.

We have registered domain names that we use in, or are related to, its business. If we lose the ability to use a domain name, whether due to trademark claims, failure to renew the applicable registration, or any other cause, we may be forced to market our offerings under a new domain name, which could cause us substantial harm, or to incur significant expense in order to purchase rights to the domain name in question. We may not be able to obtain preferred domain names outside the United States due to a variety of reasons, including because they are already held by others. In addition, our competitors and others could attempt to capitalize on our brand recognition by using domain names similar to our domain names. We may be unable to prevent third parties from acquiring and using domain names that infringe on, are similar to, or otherwise decrease the value of our brand or our trademarks or service marks. Protecting, maintaining, and enforcing our rights in our domain names may require litigation, which could result in substantial costs and diversion of resources, which could in turn adversely affect our business, financial condition, and operating results.

Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our future patents.

Our ability to obtain patents is highly uncertain because, to date, some legal principles remain unresolved, there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States and the specific content of patents and patent applications that are necessary to support and interpret patent claims is highly uncertain due to the complex nature of the relevant legal, scientific, and factual issues. Changes in either patent laws or interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property or narrow the scope of our patent protection.

For example, on September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. The United States Patent and Trademark Office, or USPTO, has developed new and untested regulations and procedures to govern the full implementation of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, only became effective in March 2013. The Leahy-Smith Act has also introduced procedures making it easier for third parties to challenge issued patents, as well as to intervene in the prosecution of patent applications. Finally, the Leahy-Smith Act contains new statutory provisions that require the USPTO to issue new regulations for their implementation, and it may take the courts years to interpret the provisions of the new statute. It is too early to tell what, if any, impact the Leahy-Smith Act will have on the operation of our business and the protection and enforcement of our intellectual property. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our future patents. Further, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have owned or licensed or that we might obtain in the future. An inability to obtain, enforce, and defend patents covering our proprietary technologies would materially and adversely affect our business prospects and financial condition.

Similarly, changes in patent laws and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we may obtain in the future. Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. For example, if the issuance to us, in a given country, of a patent covering an invention is not followed by the issuance, in other countries, of patents covering the same invention, or if any judicial interpretation of the validity, enforceability, or scope of the claims, or the written description or enablement, in a patent issued in one country is not similar to the interpretation given

to the corresponding patent issued in another country, our ability to protect our intellectual property in those countries may be limited. Changes in either patent laws or in interpretations of patent laws in the United States and other countries may materially diminish the value of our intellectual property or narrow the scope of our patent protection.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive. The requirements for patentability may differ in certain countries, particularly developing countries. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement on infringing activities is inadequate. These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. In addition, certain countries in Europe and certain developing countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we may have limited remedies if our patents are infringed or if we are compelled to grant a license to our patents to a third party, which could materially diminish the value of those patents. This could limit our potential Revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license. Finally, our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual property laws.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and annuity fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we or our licensors fail to maintain the patents and patent applications covering our product candidates, our competitors might be able to enter the market, which would have an adverse effect on our business.

If we fail to comply with our obligations under our intellectual property license agreements, we could lose license rights that are important to our business.

We are a party to certain license agreements that impose various diligence, milestone, royalty, insurance and other obligations on us. If we fail to comply with these obligations, the respective licensors may have the right to terminate the license, in which event we may not be able to develop or market the affected product candidate.

The loss of such rights could materially adversely affect our business, financial condition, operating results and prospects. For more information about these license arrangements, see “Business-Collaborations and License Agreements.”

If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming, and an unfavorable outcome in that litigation could have a material adverse effect on our business.

Our commercial success depends upon our ability to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. We cannot guarantee that marketing and selling such candidates and using such technologies will not infringe existing or future patents. Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the fields relating to our product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that others may assert that our product candidates, technologies or methods of delivery or use infringe their patent rights. Moreover, it is not always clear to industry participants, including us, which patents cover various drugs, biologics, drug delivery systems or their methods of use, and which of these patents may be valid and enforceable. Thus, because of the large number of patents issued and patent applications filed in our fields, there may be a risk that third parties may allege they have patent rights encompassing our product candidates, technologies or methods.

In addition, there may be issued patents of third parties that are infringed or are alleged to be infringed by our product candidates or proprietary technologies. Because some patent applications in the United States may be maintained in secrecy until the patents are issued, because patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing and because publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our own and in-licensed issued patents or our pending applications. Our competitors may have filed, and may in the future file, patent applications covering our product candidates or technology similar to ours. Any such patent application may have priority over our own and in-licensed patent applications or patents, which could further require us to obtain rights to issued patents covering such technologies. If another party has filed a U.S. patent application on inventions similar to those owned or in-licensed to us, we or, in the case of in-licensed technology, the licensor may have to participate, in the United States, in an interference proceeding to determine priority of invention.

We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights alleging that our product candidates or proprietary technologies infringe such third parties’ intellectual property rights, including litigation resulting from filing under Paragraph IV of the Hatch-Waxman Act. These lawsuits could claim that there are existing patent rights for such drug and this type of litigation can be costly and could adversely affect our operating results and divert the attention of managerial and technical personnel, even if we do not infringe such patents or the patents asserted against us are ultimately established as invalid. There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In addition, there is a risk that a court will order us to pay the other party damages for having violated the other party’s patents.

As a result of patent infringement claims, or to avoid potential claims, we may choose or be required to seek licenses from third parties. These licenses may not be available on commercially acceptable terms, or at all. Even if we are able to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectual property, or such rights might be restrictive and limit our present and future activities. Ultimately, we or a licensee could be prevented from commercializing a product, or forced to cease some aspect of our business operations, if, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms.

In addition to possible infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference, derivation, re-examination or other post-grant proceedings declared or granted by the USPTO, and similar proceedings in foreign countries, regarding intellectual property rights with respect to our current or of our other products.

There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries generally. To date, no litigation asserting infringement claims has ever been brought against us. If a third-party claims that we infringe its intellectual property rights, we may face a number of issues, including:

•        infringement and other intellectual property claims which, regardless of merit, may be expensive and time-consuming to litigate and may divert our management’s attention from our core business;

•        substantial damages for infringement, which we may have to pay if a court decides that the product or technology at issue infringes or violates the third party’s rights, and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees;

•        a court prohibiting us from selling or licensing the product or using the technology unless the third party licenses its intellectual property rights to us, which it is not required to do;

•        if a license is available from a third party, we may have to pay substantial royalties or upfront fees or grant cross-licenses to intellectual property rights for our products or technologies; and

•        redesigning our products or processes so they do not infringe, which may not be possible or may require substantial monetary expenditures and time.

Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could harm our ability to raise additional funds or otherwise adversely affect our business, financial condition, operating results and prospects.

Because we rely on certain third-party licensors and partners, and will continue to do so in the future, if one of our licensors or partners is sued for infringing a third party’s intellectual property rights, our business, financial condition, operating results and prospects could suffer in the same manner as if we were sued directly. In addition to facing litigation risks, we have agreed to indemnify certain third-party licensors and partners against claims of infringement caused by our proprietary technologies, and we have entered or may enter into cost-sharing agreements with some our licensors and partners that could require us to pay some of the costs of patent litigation brought against those third parties whether or not the alleged infringement is caused by our proprietary technologies. In certain instances, these cost-sharing agreements could also require us to assume greater responsibility for infringement damages than would be assumed just on the basis of our technology.

The occurrence of any of the foregoing could adversely affect our business, financial condition or operating results.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property or the patents of our licensors, which could be expensive and time-consuming.

Competitors may infringe our intellectual property, including our patents or the patents of our licensors. As a result, we may be required to file infringement claims to stop third-party infringement or unauthorized use. This can be expensive and time-consuming, particularly for a company of our size. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patent claims do not cover its technology or that the factors necessary to grant an injunction against an infringer are not satisfied. An adverse determination of any litigation or other proceedings could put one or more of our patents at risk of being invalidated, interpreted narrowly or amended such that they do not cover our product candidates. Moreover, such adverse determinations could put our patent applications at risk of not issuing, or issuing with limited and potentially inadequate scope to cover our product candidates or to prevent others from marketing similar products.

Interference, derivation or other proceedings brought at the USPTO may be necessary to determine the priority or patentability of inventions with respect to our patent applications or those of our licensors or potential partners. Litigation or USPTO proceedings brought by us may fail or may be invoked against us by third parties. Even if we are successful, domestic or foreign litigation or USPTO or foreign patent office proceedings may result in substantial

costs and distraction to our management. We may not be able, alone or with our licensors or potential partners, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other proceedings, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings. In addition, during the course of this kind of litigation or proceedings, there could be public announcements of the results of hearings, motions or other interim proceedings or developments or public access to related documents. If investors perceive these results to be negative, the market price for our common stock or warrants could be significantly harmed.

Our reliance on third parties requires us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.

We consider proprietary trade secrets or confidential know-how and unpatented know-how to be important to our business. We may rely on trade secrets or confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value.

To protect this type of information against disclosure or appropriation by competitors, our policy is to require our employees, consultants, collaborators, contractors and advisors to enter into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with us prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. However, current or former employees, consultants, collaborators, contractors and advisors may unintentionally or willfully disclose our confidential information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. The need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations. Enforcing a claim that a third party obtained illegally and is using trade secrets or confidential know-how is expensive, time consuming and unpredictable. The enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction.

In addition, these agreements typically restrict the ability of our employees, consultants, collaborators, contractors and advisors to publish data potentially relating to our trade secrets, although our agreements may contain certain limited publication rights. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication of information by any of our third-party collaborators. A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed to us alleged trade secrets of their former employers or their former or current customers.

As is common in the biotechnology and pharmaceutical industries, certain of our employees were formerly employed by other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Moreover, we engage the services of consultants to assist us in the development of our products and product candidates, many of whom were previously employed at or may have previously been or are currently providing consulting services to, other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that these employees and consultants or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers or their former or current customers. Although we have no knowledge of any such claims being alleged to date, if such claims were to arise, litigation may be necessary to defend against any such claims. Even if we are successful in defending against any such claims, any such litigation could be protracted, expensive, a distraction to our management team, not viewed favorably by investors and other third parties and may potentially result in an unfavorable outcome.

If our patent term expires before or soon after our products are approved, or if manufacturers of generic or biosimilar drugs successfully challenge our patents, our business may be materially harmed.

Patents have a limited duration. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates, their manufacture, or use are obtained, once the patent life has expired, we may be open to competition from competitive medications, including generic or biosimilar medications.

Depending upon the timing, duration and conditions of FDA marketing approval of our product candidates, one or more of our United States patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act, and similar legislation in the European Union. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. The patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one patent applicable to an approved drug may be extended. However, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that product will be shortened and our competitors may obtain approval to market competing products sooner than we expect. Also, the scope of our right to exclude during any patent term extension period may be limited or may not cover a competitor’s product or product use. As a result, our Revenue from applicable products could be reduced, possibly materially.

Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such drug candidates might expire before or shortly after such drug candidates are commercialized. As a result, our patents and patent applications may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

Manufacturers of generic or biosimilar drugs may challenge the scope, validity, or enforceability of our patents in court or before a patent office, and we may not be successful in enforcing or defending those intellectual property rights and, as a result, may not be able to develop or market the relevant product exclusively, which would have a material adverse effect on any potential sales of that product. Upon the expiration of our issued patents or patents that may issue from our pending patent applications, we will not be able to assert such patent rights against potential competitors and our business and results of operations may be adversely affected.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential collaborators or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our unregistered trademarks or trade names. Over the long term, if we are unable to successfully register our trademarks and trade names and establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our financial condition or results of operations.

Our proprietary information may be lost, or we may suffer security breaches.

In the ordinary course of our business, we collect and store sensitive data, including intellectual property, clinical trial data, proprietary business information, personal data and personally identifiable information of our clinical trial subjects and employees, in our data centers and on our networks. The secure processing, maintenance and transmission of this information is critical to our operations. Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Although, to our knowledge, we have not experienced any such material security breach to date, any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, significant regulatory penalties, disrupt our operations, damage our reputation and cause a loss of confidence in us and our ability to conduct clinical trials, which could adversely affect our reputation and delay our clinical development of our product candidates.

Risks Related to Ownership of Combined Entity Common Stock and this Business Combination

Larkspur may redeem your unexpired public warrants prior to their exercise at a time that is disadvantageous to you, thereby making your public warrants worthless.

Larkspur will have the ability to redeem outstanding public warrants at any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant, provided that the last reported sales price of Larkspur Common Stock equals or exceeds $18.00 per share (as may be adjusted) on each of twenty (20) trading days within any thirty (30) trading day period commencing after the public warrants become exercisable and ending on the third trading day prior to the date on which Larkspur sends the notice of redemption to public warrant holders and provided certain other conditions are met. Neither current nor recent stock prices meet or exceed the threshold that would allow Larkspur to redeem public warrants. In the event Larkspur elects to redeem all of the public warrants that are subject to redemption, Larkspur shall fix a date for the redemption (the “Redemption Date”). Notice of redemption shall be mailed by first class mail, postage prepaid, by Larkspur not less than thirty (30) days prior to the Redemption Date to the registered holders of the public warrants to be redeemed at their last addresses as they shall appear on the registration books. Any notice mailed in the manner herein provided shall be conclusively presumed to have been duly given whether or not the registered holder received such notice. If and when the public warrants become redeemable by Larkspur, Larkspur may not exercise its redemption right if it is unable to register or qualify the underlying securities for sale under all applicable state securities laws.

Redemption of the outstanding public warrants could force you (i) to exercise your public warrants and pay the exercise price therefor at a time when it may be disadvantageous for you to do so, (ii) to sell your public warrants at the then-current market price when you might otherwise wish to hold your public warrants or (iii) to accept the nominal redemption price which, at the time the outstanding public warrants are called for redemption, may be substantially less than the market value of your public warrants. None of the private warrants will be redeemable by Larkspur.

The Combined Entity will be an emerging growth company and any decision to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies could make the Combined Entity’s common stock less attractive to investors.

Larkspur currently is, and following the Business Combination, the Combined Entity will be, an “emerging growth company,” as defined in the JOBS Act. For as long as it continues to be an emerging growth company, the Combined Entity may choose to take advantage of exemptions from various reporting requirements applicable to other public companies but not to “emerging growth companies,” including:

•        not being required to have independent registered public accounting firm audit the Combined Entity’s internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act;

•        reduced disclosure obligations regarding executive compensation in the Combined Entity’s periodic reports and annual report on Form 10-K; and

•        exemptions from the requirements of holding non-binding advisory votes on executive compensation and stockholder approval of any golden parachute payments not previously approved.

As a result, the stockholders may not have access to certain information that they may deem important. The Combined Entity’s status as an emerging growth company will end as soon as any of the following takes place:

•        the last day of the fiscal year in which the Combined Entity has at least $1.07 billion in annual revenue;

•        the date the Combined Entity qualifies as a “large accelerated filer,” with at least $700.0 million of equity securities held by non-affiliates;

•        the date on which the Combined Entity has issued, in any three-year period, more than $1.0 billion in non-convertible debt securities; or

•        the last day of the fiscal year ending after the fifth anniversary of the Larkspur IPO.

Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies. The Combined Entity may elect to take advantage of this extended transition period and as a result, its financial statements may not be comparable with similarly situated public companies.

The Combined Entity cannot predict if investors will find the Combined Entity’s common stock less attractive if it chooses to rely on any of the exemptions afforded emerging growth companies. If some investors find the Combined Entity’s common stock less attractive because the Combined Entity relies on any of these exemptions, there may be a less active trading market for the Combined Entity’s common stock and the market price of the Combined Entity’s common stock may be more volatile and may decline.

If the Combined Entity fails to maintain an effective system of disclosure controls and internal control over financial reporting, the Combined Entity’s ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired, which may adversely affect investor confidence in the Combined Entity and, as a result, the market price of Combined Entity common stock.

As a public company, the Combined Entity will be required to comply with the requirements of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, including, among other things, that the Combined Entity maintain effective disclosure controls and procedures and internal control over financial reporting. ZyVersa continues to develop and refine its disclosure controls and other procedures that are designed to ensure that information the Combined Entity is required to disclose in the reports that the Combined Entity will file with the SEC is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms and that information required to be disclosed in reports under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is accumulated and communicated to the Combined Entity’s management, including the Combined Entity’s principal executive and financial officers.

ZyVersa must continue to improve its internal control over financial reporting. The Combined Entity will be required to make a formal assessment of the effectiveness of its internal control over financial reporting and once the Combined Entity ceases to be an emerging growth company, the Combined Entity will be required to include an attestation report on internal control over financial reporting issued by the Combined Entity’s independent registered public accounting firm. To achieve compliance with these requirements within the prescribed time period, the Combined Entity will be engaging in a process to document and evaluate the Combined Entity’s internal control over financial reporting, which is both costly and challenging. In this regard, the Combined Entity will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of the Combined Entity’s internal control over financial reporting, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. There is a risk that the Combined Entity will not be able to conclude, within the prescribed time period or at all, that the Combined Entity’s internal control over financial reporting is effective as required by Section 404 of the Sarbanes-Oxley Act. Moreover, the Combined Entity’s testing, or the subsequent testing by the Combined Entity’s independent registered public accounting firm, may reveal additional deficiencies in the Combined Entity’s internal control over financial reporting that are deemed to be material weaknesses.

Any failure to implement and maintain effective disclosure controls and procedures and internal control over financial reporting, including the identification of one or more material weaknesses, could cause investors to lose confidence in the accuracy and completeness of the Combined Entity’s financial statements and reports, which

would likely adversely affect the market price of the Combined Entity’s common stock. In addition, the Combined Entity could be subject to sanctions or investigations by the stock exchange on which the Combined Entity’s common stock is listed, the SEC and other regulatory authorities.

If the perceived benefits of the Business Combination do not meet the expectations of investors or securities analysts, the market price of Larkspur’s securities prior to the Closing may decline. The market values of the Combined Entity’s securities at the time of the Business Combination may vary significantly from their prices on the date the Business Combination Agreement was executed, the date of this proxy statement/prospectus, or the date on which Larkspur’s stockholders vote on the Business Combination Proposal and the other proposals presented to them.

Following the Business Combination, fluctuations in the price of the Combined Entity’s securities could contribute to the loss of all or part of your investment. Prior to the Business Combination, there has not been a public market for ZyVersa’s Capital Stock. Accordingly, the valuation Larkspur has ascribed to ZyVersa in the Business Combination may not be indicative of the price that will be implied in the trading market for the Combined Entity’s securities following the Business Combination. If an active market for the Combined Entity’s securities develops and continues after the Business Combination, the trading price of such securities could be volatile and subject to wide fluctuations in response to various factors, some of which are beyond the Combined Entity’s control. Any of the factors listed below could have a material adverse effect on your investment in the Combined Entity’s securities and the Combined Entity’s securities may trade at prices significantly below the price you paid for them or that were implied by the conversion of ZyVersa Capital Stock you owned into the Combined Entity’s securities as a result of the Business Combination. In such circumstances, the trading price of the Combined Entity’s securities may not recover and may experience a further decline.

Factors affecting the trading price of the Combined Entity’s securities may include:

•        the impact of the ongoing COVID-19 pandemic on the Combined Entity’s business;

•        general economic and political conditions;

•        actual or anticipated changes or fluctuations in the Combined Entity’s operating results, changes in the market’s expectations about the Combined Entity’s operating results; or failure to meet the expectation of securities analysts or investors in a particular period;

•        announcements by the Combined Entity or its competitors of new technology, features, or services;

•        competitors’ performance;

•        developments or disputes concerning the Combined Entity’s intellectual property or other proprietary rights;

•        actual or perceived data security breaches or other data security incidents;

•        announced or completed acquisitions of businesses by the Combined Entity or its competitors;

•        actual or anticipated fluctuations in the Combined Entity’s quarterly financial results or the quarterly financial results of companies perceived to be similar to it;

•        any actual or anticipated changes in the financial projections the Combined Entity may provide to the public or the Combined Entity’s failure to meet those projections

•        any major change in the Combined Entity’s Board or management;

•        changes in laws and regulations affecting the Combined Entity’s business actual or anticipated developments in the Combined Entity’s business, its competitors’ businesses, or the competitive landscape generally and any related market speculation;

•        litigation involving the Combined Entity, its industry or both;

•        governmental or regulatory actions or audits;

•        regulatory or legal developments in the United States;

•        announcement or expectation of additional financing efforts;

•        changes in accounting standards, policies, guidelines, interpretations, or principles;

•        the Combined Entity’s ability to meet compliance requirements;

•        the public’s reaction to the Combined Entity’s press releases, other public announcements, and filings with the SEC;

•        operating and share price performance of other companies that investors deem comparable to the Combined Entity;

•        price and volume fluctuations in the overall stock market from time to time;

•        changes in operating performance and stock market trading volumes and trading prices of other technology companies generally, or those in the pharmaceutical industry in particular;

•        changes in financial estimates and recommendations by securities analysts concerning the Combined Entity or the pharmaceutical industry in general;

•        changes in the Combined Entity’s capital structure, such as future issuances of securities or the incurrence of additional debt;

•        the volume of shares of the Combined Entity’s common stock available for public sale;

•        sales of shares of the Combined Entity’s common stock by the Combined Entity or its stockholders;

•        expiration of market stand-off or lock-up agreements;

•        sales of substantial amounts of shares of the Combined Entity’s common stock by the Combined Entity’s directors, executive officers, or significant stockholders or the perception that such sales could occur;

•        failure of securities analysts to maintain coverage of the Combined Entity; and

•        the other risk factors under “Risk Factors”.

Broad market and industry factors may materially harm the market price of the Combined Entity’s securities irrespective of the Combined Entity’s operating performance. The stock markets in general, have experienced price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the particular companies affected. The trading prices and valuations of these stocks and of the Combined Entity’s securities, may not be predictable. A loss of investor confidence in the market for retail stocks or the stocks of other companies which investors perceive to be similar to the Combined Entity could depress the Combined Entity’s share price regardless of the Combined Entity’s business, prospects, financial conditions, or results of operations. A decline in the market price of the Combined Entity’s securities also could adversely affect the Combined Entity’s ability to issue additional securities and the Combined Entity’s ability to obtain additional financing in the future.

Insiders will continue to have substantial influence over the Combined Entity after the Closing, which could limit your ability to affect the outcome of key transactions, including a change of control.

Upon the Closing, the Combined Entity’s executive officers, directors, and their affiliates will beneficially own approximately [            ]% of the Combined Entity’s common stock outstanding, assuming maximum redemptions, representing [            ]% of the vote.

As a result, these stockholders, if they act together, will be able to influence the Combined Entity’s management and affairs and all matters requiring stockholder approval, including the election of directors, amendments of the Combined Entity’s organizational documents, and approval of significant corporate transactions. They may also have interests that differ from yours and may vote in a way with which you disagree and which may be adverse to your interests. This concentration of ownership may have the effect of delaying, preventing, or deterring a change in control of the Combined Entity and might affect the market price of the Combined Entity’s common stock. In addition, the Sponsor will hold the right to designate a director to the Combined Entity’s Board following the Closing. This control could have the effect of delaying or preventing a change of control of the Combined Entity or changes in its management and will make the approval of certain transactions difficult or impossible without the support of these stockholders and their votes.

The numbers of shares and percentage interests set forth above are based on a number of assumptions, including: (1) the maximum number of redemptions; (2) that Larkspur does not issue any additional equity securities prior to the Business Combination, other than with respect to the PIPE Investment; and (3) that there are no future exercises of the Larkspur Warrants. If the actual facts differ from these assumptions, the numbers of shares and percentage interests set forth above will be different.

If securities or industry analysts either do not publish research about the Combined Entity or publish inaccurate or unfavorable research about the Combined Entity, the Combined Entity’s business or the Combined Entity’s market, or if they adversely change their recommendations regarding the Combined Entity’s common stock, the trading price or trading volume of the Combined Entity’s common stock could decline.

The trading market for the Combined Entity’s common stock will be influenced in part by the research and reports that securities or industry analysts may publish about us, the Combined Entity’s business, the Combined Entity’s market, or the Combined Entity’s competitors. If one or more securities analysts initiate research with an unfavorable rating or downgrade the Combined Entity’s Common Stock, provide a more favorable recommendation about the Combined Entity’s competitors or publish inaccurate or unfavorable research about the Combined Entity’s business, the Combined Entity’s Common Stock price would likely decline. If few securities analysts commence coverage of us, or if one or more of these analysts cease coverage of the Combined Entity, or fail to publish reports on the Combined Entity regularly, the Combined Entity could lose visibility in the financial markets and demand for the Combined Entity’s securities could decrease, which in turn could cause the price and trading volume of the Combined Entity’s common stock to decline.

A significant portion of the Combined Entity’s total outstanding shares is restricted from immediate resale but may be sold into the market in the near future, which could cause the market price of the Combined Entity’s common stock to decline significantly, even if the Combined Entity’s business is doing well.

The market price of the Combined Entity’s common stock could decline as a result of sales of a large number of shares of the Combined Entity’s common stock in the market after the Closing, or the perception that these sales could occur. Following the Closing, based on the number of shares of ZyVersa’s Capital Stock outstanding as of            , 2022, the Combined Entity will have a total of            shares of the Combined Entity’s common stock outstanding. At any time after the expiration of a lock-up to which such shares are subject, certain stockholders will be entitled, under the Combined Entity’s Amended and Restated Registration Rights Agreement, to certain rights with respect to the registration of the offer and sale of those shares under the Securities Act, including requesting the Combined Entity file a registration statement to register the offer and sale of their shares.

In addition, the Combined Entity intends to file a registration statement to register shares reserved for future issuance under the Combined Entity’s equity compensation plans. Upon effectiveness of that registration statement, subject to the satisfaction of applicable vesting restrictions and the expiration or waiver of the market standoff agreements and lock-up agreements referred to above, the shares issued upon exercise of outstanding stock options, restricted stock unit awards, and warrants or the vesting of other equity awards granted under such plans will be available for immediate resale in the public market.

Sales of the Combined Entity’s common stock as restrictions end or pursuant to registration rights may make it more difficult for the Combined Entity to sell equity securities in the future at a time and at a price that the Combined Entity deems appropriate. These sales also could cause the trading price of the Combined Entity’s common stock to fall and make it more difficult for you to sell shares of the Combined Entity’s common stock at a time and price that you deem appropriate.

Larkspur’s Sponsor, directors, officers, advisors or their affiliates may enter into certain transactions, including purchasing shares or warrants from the public, which may influence the outcome of the Business Combination and reduce the public “float” of the shares of common stock of Larkspur.

Larkspur’s Sponsor, directors, officers, advisors or their affiliates may purchase public shares or public warrants or a combination thereof in privately negotiated transactions or in the open market either prior to or following the Closing, although they are under no obligation to do so. Such a purchase may include a contractual acknowledgement that such stockholder, although still the record holder of Larkspur’s shares, is no longer the beneficial owner thereof and therefore agrees not to exercise his, her or its Redemption Rights. If Larkspur’s

Sponsor, directors, officers, advisors or their affiliates purchase shares in privately negotiated transactions from public stockholders who have already elected to exercise their Redemption Rights, such selling stockholders would be required to revoke their prior elections to redeem their shares. Additionally, at any time at or prior to the Business Combination, subject to applicable securities laws (including with respect to material nonpublic information),

Larkspur’s Sponsor, directors, officers, advisors or their affiliates may enter into transactions with investors and others to provide them with incentives to acquire public shares, vote their public shares in favor of the Business Combination or not redeem their public shares. However, they have no current commitments, plans, or intentions to engage in such transactions and have not formulated any terms or conditions for any such transactions. The purpose of any such transaction could be to: (1) vote such shares in favor of the Business Combination and thereby increase the likelihood of obtaining stockholder approval of the Business Combination; or (2) reduce the number of Larkspur warrants outstanding. This may result in the Closing that may not otherwise have been possible.

In addition, if such purchases are made, the public “float” of shares of common stock of Larkspur or Larkspur warrants and the number of beneficial holders of Larkspur’s securities may be reduced, possibly making it difficult to obtain or maintain the quotation, listing, or trading of Larkspur’s securities on a national securities exchange.

Because there are no current plans to pay cash dividends on the Combined Entity common stock for the foreseeable future, you may not receive any return on investment unless you sell your Combined Entity common stock at a price greater than what you paid for it.

The Combined Entity intends to retain future earnings, if any, for future operations, expansion, and debt repayment and there are no current plans to pay any cash dividends for the foreseeable future. The declaration, amount and payment of any future dividends on shares of the Combined Entity’s common stock will be at the sole discretion of the Combined Entity’s Board. The Combined Entity’s Board may take into account general and economic conditions, the Combined Entity’s financial condition and results of operations, the Combined Entity’s available cash and current and anticipated cash needs, capital requirements, contractual, legal, tax and regulatory restrictions, implications of the payment of dividends by the Combined Entity to its stockholders or by its subsidiaries to it, and such other factors as the Combined Entity’s Board may deem relevant. As a result, you may not receive any return on an investment in the Combined Entity’s common stock unless you sell your Combined Entity common stock for a price greater than that which you paid for it.

The Combined Entity stockholders may experience dilution in the future.

The percentage of shares of Combined Entity common stock owned by current stockholders may be diluted in the future because of equity issuances for acquisitions, capital market transactions, or otherwise, including, without limitation, equity awards that the Combined Entity may grant to its directors, officers, and employees, exercise of the Combined Entity warrants.

The Proposed Charter will provide, subject to limited exceptions, that the Court of Chancery will be the sole and exclusive forum for certain stockholder litigation matters, which could limit the Combined Entity’s stockholders’ ability to obtain a chosen judicial forum for disputes with the Combined Entity or its directors, officers, employees or stockholders.

The Proposed Charter will require, to the fullest extent permitted by law, that derivative actions brought in the Combined Entity’s name, actions against directors, officers and employees for breach of fiduciary duty and other similar actions may be brought in the Court of Chancery or, if that court lacks subject matter jurisdiction, another federal or state court situated in the State of Delaware. Any person or entity purchasing or otherwise acquiring any interest in shares of the Combined Entity’s capital stock shall be deemed to have notice of and consented to the forum provisions in the Proposed Charter. In addition, the Proposed Charter and amended and restated bylaws will provide that the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action under the Securities Act and the Exchange Act. While the exclusive forum provision does not restrict the ability of shareholders to bring claims under the Securities Act, it may limit shareholders’ ability to bring a claim in the judicial forum that they find favorable and may increase certain litigation costs on the shareholders, which may discourage the filing of claims under the Securities Act against the Combined Entity, its directors and officers.

In March 2020, the Delaware Supreme Court issued a decision in Salzburg et al. v. Sciabacucchi, which found that an exclusive forum provision providing for claims under the Securities Act to be brought in federal court is facially valid under Delaware law. It is unclear whether this decision will be appealed, or what the final outcome of this case will be. The Combined Entity intends to enforce this provision, but it does not know whether courts in other jurisdictions will agree with this decision or enforce it.

This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the Combined Entity or any of its directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims. Alternatively, if a court were to find the choice of forum provision contained in the Proposed Certificate of Incorporation to be inapplicable or unenforceable in an action, the Combined Entity may incur additional costs associated with resolving such action in other jurisdictions, which could harm its business, operating results and financial condition.

Additionally, it is uncertain whether this choice of forum provision is enforceable. Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. In light of this uncertainty, investors bringing a claim may face certain additional risks, including increased costs and uncertainty of litigation outcomes.

Anti-takeover provisions in the Proposed Organizational Documents could delay or prevent a change of control.

Certain provisions of the Proposed Charter and the Proposed Bylaws to become effective upon the consummation of the Business Combination may have an anti-takeover effect and may delay, defer or prevent a merger, acquisition, tender offer, takeover attempt or other change of control transaction that a stockholder might consider in its best interest, including those attempts that might result in a premium over the market price for the shares held by the Combined Entity’s stockholders.

These provisions provide for, among other things:

•        the ability of the Combined Entity’s board of directors to issue one or more series of preferred stock;

•        a classified board;

•        advance notice for nominations of directors by stockholders and for stockholders to include matters to be considered at the Combined Entity’s annual meetings;

•        certain limitations on convening special stockholder meetings;

•        limiting the persons who may call special meetings of stockholders;

•        limiting the ability of stockholders to act by written consent; and

•        the Combined Entity’s board of directors have the express authority to make, alter or repeal the Combined Entity’s amended and restated bylaws.

These anti-takeover provisions could make it more difficult or frustrate or prevent a third party from acquiring the Combined Entity, even if the third party’s offer may be considered beneficial by many of the Combined Entity’s stockholders. Additionally, the provisions may frustrate or prevent any attempts by the Combined Entity stockholders to replace or remove its current management by making it more difficult for stockholders to replace members of the Combined Entity’s board of directors, which is responsible for appointing the members of its management. As a result, the Combined Entity’s stockholders may be limited in their ability to obtain a premium for their shares. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing and to cause the Combined Entity to take other corporate actions you desire. See “Description of the Combined Entity’s Securities.”

Claims for indemnification by the Combined Entity’s directors and officers may reduce the Combined Entity’s available funds to satisfy successful third-party claims against the Combined Entity and may reduce the amount of money available to the Combined Entity.

The Proposed Organizational Documents will provide that the Combined Entity will indemnify its directors and officers, in each case to the fullest extent permitted by Delaware law.

In addition, as permitted by Section 145 of the DGCL, the amended and restated bylaws and its indemnification agreements that it will enter into with its directors and officers will provide that:

•        the Combined Entity will indemnify its directors and officers for serving the Combined Entity in those capacities or for serving other business enterprises at its request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful;

•        the Combined Entity may, in its discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law;

•        the Combined Entity will be required to advance expenses, as incurred, to its directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification;

•        the Combined Entity will not be obligated pursuant to its amended and restated bylaws to indemnify a person with respect to proceedings initiated by that person against the Combined Entity or its other indemnitees, except with respect to proceedings authorized by its board of directors or brought to enforce a right to indemnification;

•        the rights conferred in the amended and restated bylaws are not exclusive, and the Combined Entity is authorized to enter into indemnification agreements with its directors, officers, employees and agents and to obtain insurance to indemnify such persons; and

•        the Combined Entity may not retroactively amend its bylaw provisions to reduce its indemnification obligations to directors, officers, employees and agents.

Risks Related to Being a Public Company

Our management team has limited experience managing a public company and may not successfully manage our transition to public company status.

Most members of our management team have limited experience managing a publicly-traded company, interacting with public company investors and complying with the increasingly complex laws pertaining to public companies. Our management team may not successfully or efficiently manage the transition to being a public company that is subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of securities analysts and investors. These new obligations and constituents will require significant attention from our senior management and could divert their attention away from the day-to-day management of our business, which could harm our business, results of operations and financial condition.

Following the Closing, the Combined Entity will incur significant increased expenses and administrative burdens as a public company, which could have an adverse effect on its business, financial condition, and operating results.

Following the Closing, the Combined Entity will face increased legal, accounting, administrative, and other costs and expenses as a public company that ZyVersa does not incur as a private company and these expenses may increase even more after the Combined Entity is no longer an “emerging growth company.” The Sarbanes-Oxley Act, including the requirements of Section 404, as well as rules and regulations subsequently implemented by the SEC, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 and the rules and regulations promulgated and to be promulgated thereunder, the PCAOB and the securities exchanges and the listing standards of the Nasdaq, impose additional reporting and other obligations on public companies.

Compliance with public company requirements will increase costs and make certain activities more time-consuming. A number of those requirements will require the Combined Entity to carry out activities ZyVersa has not done previously. For example, the Combined Entity will create new board committees, enter into new

insurance policies, and adopt new internal controls and disclosure controls and procedures. In addition, expenses associated with SEC reporting requirements will be incurred. Furthermore, if any issues in complying with those requirements are identified (for example, if management or the Combined Entity’s independent registered public accounting firm identifies material weaknesses in the internal control over financial reporting), the Combined Entity could incur additional costs rectifying those issues, the existence of those issues could adversely affect the Combined Entity’s reputation or investor perceptions of it and it may be more expensive to obtain director and officer liability insurance. Risks associated with the Combined Entity’s status as a public company may make it more difficult to attract and retain qualified persons to serve on the Combined Entity’s Board or as executive officers. In addition, as a public company, the Combined Entity may be subject to stockholder activism, which can lead to substantial costs, distract management, and impact the manner in which the Combined Entity operates the Combined Entity’s business in ways the Combined Entity does not currently anticipate. As a result of disclosure of information in this proxy statement/prospectus and in filings required of a public company, the Combined Entity’s business and financial condition will become more visible, which may result in threatened or actual litigation, including by competitors and other third parties. If such claims are successful, the Combined Entity’s business and results of operations could be materially adversely affected and even if the claims do not result in litigation or are resolved in the Combined Entity’s favor, these claims and the time and resources necessary to resolve them, could divert the resources of the Combined Entity’s management and adversely affect the Combined Entity’s business and results of operations. The additional reporting and other obligations imposed by these rules and regulations will increase legal and financial compliance costs and the costs of related legal, accounting, and administrative activities. These increased costs will require the Combined Entity to divert a significant amount of money that could otherwise be used to expand the business and achieve strategic objectives. Advocacy efforts by stockholders and third parties may also prompt additional changes in governance and reporting requirements, which could further increase costs.

The requirements of being a public company may strain our resources, divert management’s attention and affect its ability to attract and retain qualified board members.

After the completion of the Business Combination, we will be subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the Sarbanes-Oxley Act and any rules promulgated thereunder, as well as the rules of Nasdaq. The requirements of these rules and regulations increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly, and increase demand on our systems and resources. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal controls for financial reporting. In order to maintain and, if required, improve our disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management oversight will be required and, as a result, management’s attention may be diverted from other business concerns. These rules and regulations can also make it more difficult for us to attract and retain qualified independent members of our board of directors. Additionally, these rules and regulations make it more difficult and more expensive for us to obtain director and officer liability insurance. We may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. The increased costs of compliance with public company reporting requirements and our potential failure to satisfy these requirements can have a material adverse effect on our operations, business, financial condition or results of operations.

In order to satisfy our obligations as a public company, we will need to hire qualified accounting and financial personnel with appropriate public company experience.

As a newly public company, we will need to establish and maintain effective disclosure and financial controls and make changes in our corporate governance practices. We may need to hire additional accounting and financial personnel with appropriate public company experience and technical accounting knowledge, and it may be difficult to recruit and retain such personnel. Even if we are able to hire appropriate personnel, our existing operating expenses and operations will be impacted by the direct costs of their employment and the indirect consequences related to the diversion of management resources from research and development efforts.

ZyVersa may be subject to securities litigation, which is expensive and could divert management attention.

Following the Business Combination, the per share price of the common stock may be volatile and, in the past, companies that have experienced volatility in the market price of their stock have been subject to securities litigation, including class action litigation. Litigation of this type could result in substantial costs and diversion

of management’s attention and resources, which could have a material adverse effect on our business, financial condition, and results of operations. Any adverse determination in litigation could also subject the Company to significant liabilities.

Because ZyVersa will become a publicly traded company by means other than a traditional underwritten initial public offering, ZyVersa’s stockholders may face additional risks and uncertainties.

Because ZyVersa will become a publicly traded company by means of consummating the Business Combination rather than by means of a traditional underwritten initial public offering, there is no independent third-party underwriter selling the shares of ZyVersa’s common stock, and, accordingly, ZyVersa’s stockholders will not have the benefit of an independent review and investigation of the type normally performed by an unaffiliated, independent underwriter in a public securities offering. Due diligence reviews typically include an independent investigation of the background of the company, any advisors and their respective affiliates, review of the offering documents and independent analysis of the plan of business and any underlying financial assumptions.

Although Larkspur performed a due diligence review and investigation of ZyVersa in connection with the Business Combination, the lack of an independent due diligence review and investigation increases the risk of investment in ZyVersa because Larkspur’s due diligence review and investigation may not have uncovered facts that would be important to a potential investor.

In addition, because ZyVersa will not become a publicly traded company by means of a traditional underwritten initial public offering, security or industry analysts may not provide, or be less likely to provide, coverage of ZyVersa. Investment banks may also be less likely to agree to underwrite secondary offerings on behalf of ZyVersa than they might otherwise be if ZyVersa became a publicly traded company by means of a traditional underwritten initial public offering because they may be less familiar with ZyVersa as a result of more limited coverage by analysts and the media. The failure to receive research coverage or support in the market for ZyVersa’s common stock could have an adverse effect on ZyVersa’s ability to develop a liquid market for ZyVersa’s common stock.

Risks Related to the Business Combination and Larkspur

Changes to SEC Rules Regarding SPACs Could Have an Adverse Effect on Larkspur or its Ability to Consummate the Business Combination

On March 30, 2022, the SEC issued proposed rules relating to, among other items, enhancing disclosures in business combination transactions involving SPACs and private operating companies; amending the financial statement requirements applicable to transactions involving shell companies; effectively limiting the use of projections in SEC filings in connection with proposed business combination transactions; increasing the potential liability of certain participants in proposed business combination transactions; and the extent to which SPACs could become subject to regulation under the Investment Company Act of 1940, as amended. These rules, if adopted, whether in the form proposed or in revised form, may materially adversely affect the Larkspur’s ability to negotiate and complete the Business Combination and may increase the costs and time related thereto.

The consummation of the Business Combination is subject to a number of conditions and if those conditions are not satisfied or waived, the Business Combination Agreement may be terminated in accordance with its terms and the Business Combination may not be completed.

The Business Combination Agreement conditions Closing of the Business Combination to a number of conditions, including approval of the Business Combination Agreement by ZyVersa stockholders, approval of the proposals required to effect the Business Combination by Larkspur stockholders, receipt of certain regulatory approvals, effectiveness of the registration statement of which this proxy statement/prospectus is a part, approval of the shares of the Combined Entity common stock to be issued to ZyVersa stockholders for listing on Nasdaq, the accuracy of the representations and warranties by both parties (subject to the materiality standards set forth in the Business Combination Agreement), and the performance by both parties of their covenants and agreements (subject to the materiality standards set forth in the Business Combination Agreement). These Closing conditions may not be fulfilled in a timely manner or at all, and, accordingly, the Business Combination may not be completed. In addition, the parties can mutually decide to terminate the Business Combination Agreement at any time, before or after stockholder approvals, or Larkspur or ZyVersa may elect to terminate the Business Combination Agreement in certain other circumstances.

Some of Larkspur’s officers and directors may have conflicts of interest that may influence or have influenced them to support or approve the Business Combination without regard to your interests or in determining whether the ZyVersa is appropriate for Larkspur’s initial business combination.

The personal and financial interests of Larkspur’s Sponsor, officers and directors may influence or have influenced their motivation in identifying and selecting a target for the Business Combination, their support for completing the Business Combination and the operation of the Combined Entity following the Business Combination.

Larkspur’s Sponsor owns 1,941,790 shares of Class B common stock, which were initially acquired prior to Larkspur’s IPO for a purchase price of $0.013 per share, and Larkspur’s officers have pecuniary interests in such shares of common stock through indirect ownership interests in the Sponsor. Such shares had an aggregate market value of approximately $            based on the last sale price of $            per share on Nasdaq on            , the record date. In addition, the Sponsor purchased an aggregate of 320,272 private placement units for a purchase price of $3,202,720, or $10.00 per warrant. Each private placement unit consists of one share of Class A common stock and three-fourths of one redeemable private warrant. Each whole private warrant is exercisable to purchase one share of common stock of Larkspur at $11.50 per share. Larkspur’s Amended and Restated Certificate of Incorporation require Larkspur to complete an initial business combination (which will be the Business Combination should it occur) within 12 months from the closing of the initial public offering (unless such date is extended in accordance with the Existing Organizational Documents) (the “Combination Period”). If the Business Combination is not completed and Larkspur is forced to wind up, dissolve and liquidate in accordance with the Amended and Restated Certificate of Incorporation, the 1,425,190 shares of common stock currently held by Larkspur’s Sponsor and independent directors, respectively, and the private placement units held by the Sponsor will be worthless (as the holders have waived liquidation rights with respect to such shares of common stock and warrants).

Larkspur’s Sponsor, directors and officers, and their respective affiliates have incurred significant out-of-pocket expenses in connection with performing due diligence on suitable targets for business combinations and the negotiation of the Business Combination. At the Closing of the Business Combination, Larkspur’s Sponsor, directors and officers, and their respective affiliates, will be reimbursed for any out-of-pocket expenses incurred in connection with activities on Larkspur’s behalf such as identifying potential target businesses and performing due diligence on suitable targets for business combinations. On May 7, 2021, Larkspur issued unsecured promissory notes to the Sponsor’s investors, which were amended and restated on October 7, 2021 (the “Promissory Notes”), pursuant to which Larkspur may borrow up to an aggregate principal amount of $750,000. The Promissory Notes are non-interest bearing and payable on the earlier of (i) December 31, 2021 or (ii) the consummation of the Initial Public Offering. As of December 31, 2021, there was no amount outstanding under the Promissory Notes.

The exercise of Larkspur’s directors’ and executive officers’ discretion in agreeing to changes or waivers in the terms of the Business Combination may result in a conflict of interest when determining whether changes to the terms of the Business Combination or waivers of conditions are appropriate and in Larkspur’s stockholders’ best interest.

In the period leading up to the Closing of the Business Combination, events may occur that, pursuant to the Business Combination Agreement, may require Larkspur to agree to amend the Business Combination Agreement, to consent to certain actions taken by ZyVersa or to waive rights that Larkspur is entitled to under the Business Combination Agreement. Such events could arise because of changes in the course of ZyVersa’s business, a request by ZyVersa to undertake actions that would otherwise be prohibited by the terms of the Business Combination Agreement or the occurrence of other events that would have a material adverse effect on ZyVersa’s business and would entitle Larkspur to terminate the Business Combination Agreement. In any of such circumstances, it would be at Larkspur’s discretion, acting through its board of directors, to grant its consent or waive those rights. The existence of financial and personal interests of one or more of the directors described in the preceding risk factors may result in a conflict of interest on the part of such director(s) between what he or they may believe is best for Larkspur and its stockholders and what he or they may believe is best for himself or themselves in determining whether or not to take the requested action. As of the date of this proxy statement/prospectus, Larkspur does not believe there will be any changes or waivers that Larkspur’s directors and executive officers would be likely to make after stockholder approval of the Business Combination Proposal has been obtained. While certain changes could be made without further stockholder approval, Larkspur will circulate a new or amended proxy statement/prospectus and resolicit Larkspur’s stockholders if changes to the terms of the transaction that would have a material impact on its stockholders are required prior to the vote on the Business Combination Proposal.

A portion of our total outstanding shares are restricted from immediate resale but may be sold into the market in the near future. This could cause the market price of our common stock to drop significantly, even if the Combined Entity’s business is doing well.

Sales of a substantial number of shares of the common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of the common stock. While the Sponsor has agreed, and will continue to be subject, to certain restrictions regarding the transfer of the common stock, these shares may be sold after the expiration of the applicable restrictions. The Combined Entity may file one or more registration statements prior to or shortly after the Closing of the Business Combination to provide for the resale of such shares from time to time. As restrictions on resale end and the registration statements are available for use, the market price of the common stock could decline if the holders of currently restricted shares sell them or are perceived by the market as intending to sell them.

If the sale of some or all of the PIPE Investment fails to close and sufficient stockholders exercise their Redemption Rights in connection with the Business Combination, Larkspur may lack sufficient funds to consummate the Business Combination.

In connection with the Business Combination Agreement, Larkspur entered into the PIPE Subscription Agreement with the PIPE Investors, which provides for the purchase of an aggregate of up to 12,500 shares of convertible preferred stock and warrants in an amount equal to 100% of the shares of common stock issuable upon conversion of such preferred stock (the “PIPE Securities”) immediately prior to the Closing in a private placement to close concurrently with, and contingent upon, the Closing of the Business Combination, for a purchase price of $1,000 per share of preferred stock, or an aggregate of up to $12,500,000. In addition, prior to giving effect to the exercise of any Redemption Rights, the Trust Account has approximately $78.6 million, plus accrued interest since the completion of the Larkspur IPO.

However, if the sale of the PIPE Securities does not close by reason of the failure by some or all of the PIPE Investors to fund the purchase price for their PIPE Securities, for example, and a sufficient number of holders of shares of common stock exercise their Redemption Rights in connection with the Business Combination, we may lack sufficient funds to consummate the Business Combination. Additionally, the PIPE Investors’ obligations to purchase the PIPE Securities are subject to termination prior to the closing of the sale of the PIPE Securities by mutual written consent of Larkspur, ZyVersa and the PIPE Investors, if the Business Combination is not consummated on or before December 15, 2022. The PIPE Investors’ obligations to purchase the PIPE Securities are subject to fulfilment of customary Closing conditions, including that the Business Combination must be consummated substantially concurrently with, and immediately following, the purchase of the PIPE Securities. In the event of any such failure to fund, any termination of such obligation, or if any such condition is not satisfied and not waived, we may not be able to obtain additional funds to account for such shortfall on terms favorable to us or at all. Any such shortfall would also reduce the amount of funds that we have available for working capital of the Combined Entity. While the PIPE Investors represented to us that it has sufficient funds to satisfy its obligations under the PIPE Subscription Agreement, we have not obligated the PIPE Investors to reserve funds for such obligations.

For information on the consequences if the Business Combination is not completed or must be restructured, please see the section of this proxy statement/prospectus entitled “Risk Factors — Risks Related to the Business Combination and Larkspur.”

Subsequent to the completion of the Business Combination, ZyVersa may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on its financial condition and its share price, which could cause you to lose some or all of your investment.

Larkspur cannot assure you that the due diligence Larkspur has conducted on ZyVersa will reveal all material issues that may be present with regard to ZyVersa, or that factors outside of Larkspur’s or ZyVersa’s control will not later arise. As a result of unidentified issues or factors outside of Larkspur’s or ZyVersa’s control, the Combined Entity may be forced to later write-down or write-off assets, restructure operations, or incur impairment or other charges that could result in reporting losses. Even if Larkspur’s due diligence successfully identifies certain risks, unexpected risks may arise and previously known risks may materialize in a manner not consistent with the preliminary risk analysis conducted by Larkspur. Even though these charges may be non-cash items that would not have an immediate impact on the Combined Entity’s liquidity, the fact that the Combined Entity reports charges of

this nature could contribute to negative market perceptions about the Combined Entity or its securities. In addition, charges of this nature may cause the Combined Entity to violate leverage or other covenants to which it may be subject. Accordingly, any stockholders who choose to remain stockholders following the Business Combination could suffer a reduction in the value of their shares from any such write-down or write-downs.

Larkspur’s public stockholders will experience dilution due to the issuance to ZyVersa’s existing equityholders of securities entitling them to a significant voting stake in the Combined Entity.

Based upon the assumptions described under the section entitled “Unaudited Pro Forma Condensed Combined Financial Information,” Larkspur’s non-redeeming public stockholders, the PIPE Investor and the Sponsor would hold in the aggregate approximately [            ]%, [            ]% and [            ]%, respectively, of the outstanding economic interests in the Combined Entity following the consummation of the Business Combination. Without limiting the other assumptions described under the section entitled “Unaudited Pro Forma Condensed Combined Financial Information,” these ownership percentages do not take into account:

•        any warrants or options to purchase the common stock, including the public warrants and the private placement warrants, that will be outstanding following the Business Combination; and

•        any equity awards that may be issued by the Combined Entity.

If any shares of common stock are redeemed in connection with the Business Combination, the percentage of the Combined Entity’s outstanding voting stock held by the current holders of Larkspur will decrease relative to the percentage held if none of the shares of common stock are redeemed. To the extent that any of the outstanding public warrants and private placement warrants are exercised for shares of common stock, Larkspur’s existing stockholders may experience substantial dilution.

Larkspur public stockholders who do not redeem their shares of common stock will have a reduced ownership and voting interest after the Business Combination and will exercise less influence over management of the Combined Entity.

Upon the issuance of Larkspur common stock in connection with the Business Combination, the percentage ownership of public stockholders who do not redeem their shares of common stock will be diluted. The percentage of the Combined Entity’s common stock that will be owned by public stockholders as a group will vary based on the number of shares of common stock for which the holders thereof request redemption in connection with the Business Combination. To illustrate the potential ownership percentages of public stockholders under different redemption levels, based on the number of issued and outstanding shares of common stock on December 31, 2021, and based on the Larkspur shares of common stock expected to be issued in the Business Combination and the common stock expected to be issued as part of the PIPE Investment, non-redeeming public stockholders, as a group, will own:

•        if there are no redemptions of public shares, [            ]% of the Combined Entity’s common stock expected to be outstanding immediately after the Business Combination; or

•        if there are maximum redemptions, [            ]% of the Combined Entity’s common stock expected to be outstanding immediately after the Business Combination.

Because of this, public stockholders, as a group, will have less influence on the board of directors, management and policies of the Combined Entity than they now have on the board of directors, management and policies of Larkspur. For further discussion of the assumptions underlying the no redemption and maximum redemptions scenarios set forth above, please see “Unaudited Pro Forma Condensed Combined Financial Information.”

The ownership percentage with respect to the Combined Entity following the Business Combination does not take into account the following potential issuances of securities, which will result in further dilution to public stockholders who do not redeem their public shares:

•        the issuance of up to 7,767,159 shares upon exercise of the public warrants at a price of $11.50 per share;

•        the issuance of up to 238,200 shares upon exercise of the private placement warrants held by the Sponsor at a price of $11.50 per share; and

•        the issuance of shares under the Omnibus Incentive Plan.

If all such shares were issued immediately after the Business Combination, based on the number of issued and outstanding shares of common stock of Larkspur, and based on the common stock expected to be issued in the Business Combination and the common stock expected to be issued as part of the PIPE Investment, non-redeeming public stockholders, as a group, would own:

•        if there are no redemptions of public shares, [            ]% of the Combined Entity’s common stock outstanding assuming all such shares were issued immediately after the Business Combination; or

•        if there are maximum redemptions of the outstanding public shares, [            ]% of the Combined Entity’s common stock outstanding assuming all such shares were issued immediately after the Business Combination.

Larkspur has no operating history and is subject to a mandatory liquidation and subsequent dissolution requirement. As such, there is a risk that Larkspur will be unable to continue as a going concern if it does not consummate an initial business combination by December 23, 2022 (unless such date is extended in accordance with the Existing Organizational Documents). If Larkspur is unable to effect an initial business combination by such date, Larkspur will be forced to liquidate and its warrants will expire worthless.

Larkspur is a blank check company, and as it has no operating history and is subject to a mandatory liquidation and subsequent dissolution requirement, there is a risk that Larkspur will be unable to continue as a going concern if it does not consummate an initial business combination by December 23, 2022. Unless Larkspur amends its Existing Organizational Documents (which would require the affirmative vote of the holders of 65% of all then outstanding shares of common stock) and certain other agreements into which Larkspur has entered to expand the life of Larkspur, if Larkspur does not complete an initial business combination by December 23, 2022, Larkspur will: (i) cease all operations except for the purpose of winding up; (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the public shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account, including interest earned on the funds held in the Trust Account and not previously released to Larkspur to pay its income taxes, if any (less up to $100,000 of interest earned to pay dissolution expenses) divided by the number of the then-outstanding public shares, which redemption will completely extinguish public stockholders’ rights as stockholders (including the right to receive further liquidation distributions, if any); and (iii) as promptly as reasonably possible following such redemption, subject to the approval of Larkspur’s remaining stockholders and its board of directors, liquidate and dissolve, subject in each case to its obligations under Delaware General Corporation Law to provide for claims of creditors and the requirements of other applicable law. There will be no Redemption Rights or liquidating distributions with respect to Larkspur’s warrants, which will expire and be worthless if Larkspur fails to consummate an initial business combination within 12 months from the closing of the initial public offering (unless such date is extended in accordance with the Existing Organizational Documents).

Larkspur’s Amended and Restated Certificate of Incorporation provide that, if it winds up for any other reason prior to the consummation of the initial business combination, Larkspur will follow the foregoing procedures with respect to the liquidation of the Trust Account as promptly as reasonably possible but not more than ten business days thereafter, subject to applicable Delaware General Corporation Law. In such case, based on the amount of funds on deposit in the Trust Account as of the record date, Larkspur’s public stockholders would receive only approximately $10.10 per public share upon the redemption of their shares and their warrants would expire worthless.

Because the market price of shares of the Combined Entity Common Stock will fluctuate, ZyVersa’s stockholders cannot be certain of the value of the merger consideration they will receive until the Closing of the Business Combination.

Upon completion of the Business Combination, each share of ZyVersa common stock and ZyVersa preferred stock will be converted into the right to receive shares of Combined Entity common stock. The stock component of the merger consideration that ZyVersa stockholders will receive is a fixed number of shares of Combined Entity common stock; it is not a number of shares with a particular fixed market value. The market price of Combined Entity common stock at the Effective Time of the Business Combination may vary significantly from its price on the date the Business Combination Agreement was executed or on other dates, including the date on which ZyVersa stockholders provide written consent to the adoption of the Business Combination Agreement and the transactions

contemplated thereby. Stock price changes may result from a variety of factors, including changes in the business, operations, or prospects of Larkspur, regulatory considerations, and general business, market, industry, or economic conditions. Many of these factors are outside of the control of Larkspur and ZyVersa.

Larkspur has a limited ability to assess the management of ZyVersa’s business and, as a result, cannot assure you that ZyVersa’s management has all the skills, qualifications, or abilities to manage a public company.

Larkspur’s ability to assess ZyVersa’s management may be limited due to a lack of time, resources, or information. Larkspur’s assessment of the capabilities of ZyVersa’s management, therefore, may prove to be incorrect, and ZyVersa management may lack the skills, qualifications, or abilities that Larkspur believed ZyVersa management had. Should ZyVersa’s management not possess the skills, qualifications, or abilities necessary to manage a public company, the operations and profitability of the Combined Entity post-Business Combination may be negatively impacted.

Larkspur stockholders will have a reduced ownership and voting interest after the Business Combination and will exercise less influence over management.

Upon the issuance of the shares of the Combined Entity common stock to ZyVersa stockholders, the percentage ownership of current Larkspur stockholders will be diluted. Additionally, of the expected seven members of the Combined Entity’s Board after the completion of the Business Combination, one will be appointed by joint agreement between ZyVersa and Larkspur, and if no agreement can be reached, then by Larkspur, and the rest will be current ZyVersa directors or appointed by current ZyVersa stockholders. Because of this, current Larkspur stockholders, as a group, will have less influence on the directors, management, and policies of the Combine Entity than they now have on the board of directors, management, and policies of Larkspur.

The market price of shares of the Combined Entity’s common stock after the Business Combination may be affected by factors different from those currently affecting the prices of Larkspur’s shares of common stock.

Upon completion of the Business Combination, holders of shares of ZyVersa common stock and preferred stock will become holders of shares of Combined Entity common stock. Prior to the Business Combination, Larkspur has had limited operations. Upon completion of the Business Combination, the Combined Entity’s results of operations will depend upon the performance of the Combined Entity’s businesses, which are affected by factors that are different from those currently affecting the results of operations of Larkspur.

If the Adjournment Proposal is not approved, and an insufficient number of votes have been obtained to authorize the consummation of the Business Combination, the Larkspur Board will not have the ability to adjourn the Special Meeting in order to solicit further votes, and, therefore, the Business Combination will not be approved.

The Larkspur Board is seeking approval to adjourn the Special Meeting if at the Special Meeting there are insufficient votes to approve consummation of the Business Combination. If the Adjournment Proposal is not approved, the Larkspur Board will not have the ability to adjourn the Special Meeting to a later date and, therefore, will not have sufficient time to solicit votes to approve consummation of the Business Combination, which would not be completed.

The unaudited pro forma condensed combined financial information included in this proxy statement/prospectus is for illustrative purposes only and the actual financial condition and results of operations after the Business Combination may differ materially.

The unaudited pro forma financial information included herein is presented for illustrative purposes only and is not necessarily indicative of what the Combined Entity’s actual financial position or results of operations would have been had the Business Combination been completed on the date(s) indicated. The preparation of the pro forma financial information is based upon available information and certain assumptions and estimates that Larkspur and ZyVersa currently believe are reasonable. The unaudited pro forma condensed combined financial information for the Combined Entity following the Business Combination in this proxy statement/prospectus is presented for illustrative purposes only and is not necessarily indicative of what our actual financial position or results of operations would have been had the Business Combination been completed on the dates indicated. See “Unaudited Pro Forma Condensed Combined Financial Information” for more information.

In addition, the assumptions used in preparing the pro forma financial information may not prove to be accurate and other factors may affect the Combined Entity’s financial condition or results of operations following the Closing. Any potential decline in the Combined Entity’s financial condition or results of operations may cause significant variations in the stock price of the Combined Entity.

We cannot assure you that the Combined Entity’s common stock will be approved for listing on Nasdaq or that the Combined Entity will be able to comply with the continued listing standards of Nasdaq.

In connection with the Closing, Larkspur intends to list the Combined Entity’s common stock and warrants on Nasdaq under the symbols “ZVSA” and “ZVSAW”, respectively. The Combined Entity’s continued eligibility for listing may depend on the number of shares of common stock of Larkspur that are redeemed. If, after the Business Combination, Nasdaq delists the Combined Entity’s common stock from trading on its exchange for failure to meet the listing standards and the Combined Entity is not able to list such securities on another national securities exchange, the Combined Entity expects such securities could be quoted on an over-the-counter market. If this were to occur, the Combined Entity and its stockholders could face significant material adverse consequences including:

•        a limited availability of market quotations for the Combined Entity’s securities;

•        reduced liquidity for the Combined Entity’s securities;

•        a determination that the Combined Entity’s common stock is a “penny stock”, which will require brokers trading the Combined Entity’s common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of the Combined Entity’s common stock;

•        a limited amount of news and analyst coverage; and

•        a decreased ability to issue additional securities or obtain additional financing in the future.

Larkspur and ZyVersa will be subject to business uncertainties while the Business Combination is pending.

Uncertainty about the Closing or effect of the Business Combination may affect the relationship between Larkspur and ZyVersa and their respective suppliers, users, distributors, licensors, and licensees during the pendency of the Business Combination. Any such impact may have an adverse effect on Larkspur or ZyVersa, and consequently on the Combined Entity. These uncertainties may cause parties that deal with Larkspur or ZyVersa to seek to change existing business relationships with them and to delay or defer decisions concerning Larkspur or ZyVersa. Changes to existing business relationships, including termination or modification, could negatively affect each of Larkspur’s and ZyVersa’s Revenue, earnings and cash flow, as well as the market price of Larkspur’s shares of common stock. Adverse effects arising from the pendency of the Business Combination could be exacerbated by any delays in Closing of the Business Combination or termination of the Business Combination Agreement.

Additionally, the attention of Larkspur’s and ZyVersa’s management may be directed towards the completion of the Business Combination, including obtaining regulatory approvals and other transaction-related considerations, and may be diverted from the day-to-day business operations of Larkspur and ZyVersa, as applicable, and matters related to the Business Combination may require commitments of time and resources that could otherwise have been devoted to other opportunities that might have been beneficial to Larkspur and ZyVersa, as applicable. Further, the Business Combination may give rise to potential liabilities, including as a result of pending and future stockholder lawsuits relating to the Business Combination. Any of these matters could adversely affect the businesses, financial condition, or results of operations of Larkspur and ZyVersa.

Third parties may terminate or alter existing contracts or relationships with Larkspur or ZyVersa.

Larkspur and ZyVersa have contracts with distributors, affiliates, landlords, licensors, and other business partners that may require Larkspur or ZyVersa, as applicable, to obtain consent from these other parties in connection with the Business Combination. If these consents cannot be obtained, the counterparties to these contracts and other third parties with which Larkspur or ZyVersa currently have relationships may have the ability to terminate, reduce the scope of, or otherwise materially adversely alter their relationships with either or both parties in anticipation of the Business Combination, or with the Combined Entity following the Business Combination. The pursuit of such rights may result in Larkspur, ZyVersa, or the Combined Entity suffering a loss of potential future

revenue or incurring liabilities in connection with a breach of such agreements and losing rights that are material to its business. Any such disruptions could limit the Combined Entity’s ability to achieve the anticipated benefits of the Business Combination. The adverse effect of such disruptions could also be exacerbated by a delay in the Closing of the Business Combination or the termination of the Business Combination Agreement.

Larkspur and ZyVersa will incur substantial transaction fees and costs in connection with the Business Combination and the integration of their businesses.

Larkspur and ZyVersa have incurred and expect to incur additional material non-recurring expenses in connection with the Business Combination and the completion of the transactions contemplated by the Business Combination Agreement and related transaction agreements. While both Larkspur and ZyVersa have assumed that a certain level of expenses would be incurred in connection with the Business Combination, there are many factors beyond their control that could affect the total amount of, or the timing of, anticipated expenses with respect to the integration and implementation of the combined businesses. Additional unanticipated costs may be incurred in the course of conducting the business of the Combined Entity after the completion of the Business Combination.

Termination of the Business Combination Agreement could negatively impact Larkspur and ZyVersa.

If the Business Combination is not completed for any reason, including as a result of ZyVersa stockholders declining to adopt the Business Combination Agreement and related proposals or Larkspur stockholders declining to approve the proposals required to effect the Business Combination, the ongoing businesses of ZyVersa and Larkspur may be adversely impacted and, without realizing any of the anticipated benefits of completing the Business Combination, ZyVersa and Larkspur would be subject to a number of risks, including the following:

•        ZyVersa or Larkspur may experience negative reactions from the financial markets, and Larkspur may experience a negative reaction to its stock price (including to the extent that current market prices reflect a market assumption that the Business Combination will be completed);

•        ZyVersa may experience negative reactions from its users, vendors, and employees;

•        ZyVersa and Larkspur will have incurred substantial expenses and will be required to pay certain costs relating to the Business Combination, whether or not the Business Combination is completed; and

•        since the Business Combination Agreement restricts the conduct of ZyVersa’s and Larkspur’s businesses prior to the completion of the Business Combination, each of ZyVersa and Larkspur may not have been able to take certain actions during the pendency of the Business Combination that would have benefitted it as an independent company, and the opportunity to take such actions may no longer be available. See “The Business Combination Agreement — Representations, Warranties and Covenants”.

If the Business Combination Agreement is terminated and the ZyVersa Board seeks another business combination, ZyVersa stockholders cannot be certain that ZyVersa will be able to find a party willing to offer equivalent or more attractive consideration than the consideration Larkspur has agreed to provide in the Business Combination or that such other merger or business combination is completed. If the Business Combination Agreement is terminated and the Larkspur Board seeks another merger or business combination, Larkspur stockholders cannot be certain that Larkspur will be able to find another acquisition target that would constitute a business combination or that such other merger or business combination will be completed. See “The Business Combination Agreement — Termination”.

ZyVersa directors and officers may have interests in the Business Combination different from the interests of ZyVersa stockholders.

The executive officers of ZyVersa negotiated the terms of the Business Combination Agreement with the executive officers of Larkspur, and the ZyVersa Board determined that entering into the Business Combination Agreement was in the best interests of ZyVersa and its stockholders, declared the Business Combination Agreement advisable, and recommended that ZyVersa stockholders adopt the Business Combination Agreement. In considering these facts and the other information contained in this proxy statement/prospectus, you should be aware that ZyVersa executive officers and directors may have financial interests in the Business Combination that may be different from, or in addition to, the interests of ZyVersa stockholders. The ZyVersa Board was aware

of and considered these interests, among other matters, in reaching the determination to approve the terms of the Business Combination and in recommending to ZyVersa stockholders that they vote to approve the Business Combination. See “The Business Combination Agreement — Interests of ZyVersa’s Directors and Officers in the Business Combination”.

Larkspur directors and officers may have interests in the Business Combination different from the interests of Larkspur stockholders.

Executive officers of Larkspur negotiated the terms of the Business Combination Agreement with their counterparts at ZyVersa, and the Larkspur Board determined that entering into the Business Combination Agreement was in the best interests of Larkspur and its stockholders, declared the Business Combination Agreement advisable, and recommended that Larkspur stockholders approve the proposals required to effect the Business Combination. In considering these facts and the other information contained in this proxy statement/prospectus, you should be aware that Larkspur executive officers and directors may have financial interests in the Business Combination that may be different from, or in addition to, the interests of Larkspur stockholders. The Larkspur Board was aware of and considered these interests, among other matters, in reaching the determination to approve the terms of the Business Combination and in recommending to Larkspur stockholders that they vote to approve the Business Combination. See “The Business Combination — Interests of Larkspur’s Directors and Officers in the Business Combination”.

Larkspur and ZyVersa may be materially adversely affected by negative publicity related to the proposed Business Combination and in connection with other matters.

From time to time, political and public sentiment in connection with the Business Combination and in connection with other matters could result in a significant amount of adverse press coverage and other adverse public statements affecting Larkspur and ZyVersa. Adverse press coverage and other negative publicity, whether or not driven by political or public sentiment, may also result in investigations by regulators, legislators and law enforcement officials or ultimately in legal claims. Responding to these investigations and lawsuits, regardless of the ultimate outcome of the proceeding, can divert the time and effort of senior management from the management of Larkspur’s and ZyVersa’s respective businesses. Addressing any adverse publicity, governmental scrutiny, or enforcement or other legal proceedings is time consuming and expensive and, regardless of the factual basis for the assertions being made, can have a negative impact on the reputation of Larkspur and ZyVersa, on the morale and performance of their employees, and on their relationships with regulators. It may also have an adverse impact on their ability to take timely advantage of various business and market opportunities. The direct and indirect effects of negative publicity, and the demands of responding to and addressing it, may have a material adverse effect on Larkspur’s and ZyVersa’s respective businesses, financial condition, and results of operations.

The Business Combination Agreement and Stockholder Support Agreement contains provisions that may discourage other companies from attempting to acquire ZyVersa for greater merger consideration.

The Business Combination Agreement contains provisions that may discourage a third party from submitting a business combination proposal to ZyVersa that might result in greater value to ZyVersa stockholders than the Business Combination with Larkspur or may result in a potential competing acquirer proposing to pay a lower per share price to acquire ZyVersa than it might otherwise have proposed to pay absent such provisions. These provisions include a general prohibition on ZyVersa from soliciting, or, subject to certain exceptions relating to the exercise of fiduciary duties by the ZyVersa Board, entering into discussions with any third party regarding any acquisition proposal or offers for competing transactions, and a commitment by certain holders of ZyVersa Capital Stock to vote in favor of the transactions contemplated by the Business Combination Agreement.

The Business Combination Agreement contains provisions that may discourage Larkspur from seeking an alternative business combination.

The Business Combination Agreement and Shareholder Support Agreement contains provisions that prohibit Larkspur, subject to certain exceptions relating to the exercise of fiduciary duties by the Larkspur Board, from seeking alternative business combinations during the pendency of the Business Combination. Further, if Larkspur is unable to obtain the requisite approval of its stockholders, either party may terminate the Business Combination Agreement.

During the pendency of the Business Combination, Larkspur will not be able to solicit, initiate or take any action to facilitate or encourage any inquiries or the making, submission or announcement of, or enter into a business combination with another party because of restrictions in the Business Combination Agreement.

During the pendency of the Business Combination, Larkspur will not be able to enter into a business combination with another party because of non-solicitation provisions in the Business Combination Agreement which prohibit Larkspur from soliciting other business combinations. If the Business Combination is not completed, these non-solicitation provisions will make it more difficult to complete an alternative business combination following the termination of the Business Combination Agreement due to the passage of time during which these provisions remain in effect.

The Combined Entity’s business and operations could be negatively affected if it becomes subject to any securities litigation or stockholder activism, which could cause the Combined Entity to incur significant expense, hinder execution of business and growth strategy and impact its stock price.

In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been brought against that company. Stockholder activism, which could take many forms or arise in a variety of situations, has been increasing recently. Volatility in the stock price of the Combined Entity’s common stock or other reasons may in the future cause it to become the target of securities litigation or stockholder activism. Securities litigation and stockholder activism, including potential proxy contests, could result in substantial costs and divert management’s and the board of directors’ attention and resources from the Combined Entity’s business. Additionally, such securities litigation and stockholder activism could give rise to perceived uncertainties as to the Combined Entity’s future, adversely affect its relationships with service providers and make it more difficult to attract and retain qualified personnel. Also, the Combined Entity may be required to incur significant legal fees and other expenses related to any securities litigation and activist stockholder matters. Further, its stock price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and stockholder activism.

In connection with the Business Combination, the Sponsor, and Larkspur’s directors, executive officers, advisors and their affiliates may elect to purchase shares or public warrants from public stockholders, which may influence a vote on a proposed business combination and reduce the public “float” of our shares of common stock.

In connection with the Business Combination, the Sponsor and the directors, executive officers, advisors or their affiliates may purchase shares or public warrants in privately negotiated transactions or in the open market either prior to or following the completion of our initial business combination, although they are under no obligation to do so. However, other than as expressly stated herein, they have no current commitments, plans or intentions to engage in such transactions and have not formulated any terms or conditions for any such transactions. None of the funds in the Trust Account will be used to purchase shares or public warrants in such transactions.

In the event that the Sponsor and the directors, executive officers, advisors or their affiliates purchase shares in privately negotiated transactions from public stockholders who have already elected to exercise their Redemption Rights, such selling stockholders would be required to revoke their prior elections to redeem their shares. The purpose of any such purchases of shares would be to vote such shares in favor of the Business Combination and thereby increase the likelihood of obtaining stockholder approval of the Business Combination, where it appears that such requirement would otherwise not be met. The purpose of any such purchases of public warrants would be to reduce the number of public warrants outstanding or to vote such warrants on any matters submitted to the warrant holders for approval in connection with our initial business combination. Any such purchases of our securities may result in the completion of our initial business combination that may not otherwise have been possible. Any such purchases will be reported pursuant to Section 13 and Section 16 of the Exchange Act to the extent such purchasers are subject to such reporting requirements.

In addition, if such purchases are made, the public “float” of our shares of common stock or public warrants and the number of beneficial holders of our securities may be reduced, possibly making it difficult to maintain or obtain the quotation, listing or trading of our securities on a national securities exchange.

There is no guarantee that a Larkspur public stockholder’s decision whether to redeem its shares of Larkspur’s common stock for a pro rata portion of the Trust Account will put such stockholder in a better future economic position.

We cannot assure you as to the price at which a public stockholder may be able to sell the shares of the Combined Entity’s common stock in the future following the completion of the Business Combination. Certain events following the consummation of any business combination, including the Business Combination, may cause an increase in the Combined Entity’s stock price, and may result in a lower value realized now than a Larkspur stockholder might realize in the future had the stockholder not elected to redeem such stockholder’s public shares. Similarly, if a Larkspur public stockholder does not redeem his, her, or its shares, such stockholder will bear the risk of ownership of the Combined Entity’s common stock after the consummation of the Business Combination, and there can be no assurance that a stockholder can sell his, her, or its shares of the Combined Entity’s common stock in the future for a greater amount than the redemption price set forth in this proxy statement/prospectus. A Larkspur public stockholder should consult his, her, or its own tax or financial advisor for assistance on how this may affect its individual situation.

If Larkspur public stockholders fail to comply with the redemption requirements specified in this proxy statement/prospectus, they will not be entitled to redeem their public shares for a pro rata portion of the funds held in the Trust Account.

Larkspur intends to comply with the U.S. federal proxy rules when conducting redemptions in connection with the Business Combination. However, despite Larkspur’s compliance with these rules, if a Larkspur stockholder fails to receive Larkspur’s proxy materials, such stockholder may not become aware of the opportunity to redeem its shares of common stock of Larkspur. In addition, the proxy materials that Larkspur will furnish to holders of public shares in connection with the Business Combination will describe the various procedures that must be complied with in order to validly tender or redeem public shares. In the event that a public stockholder fails to comply with these or any other procedures, its public shares may not be redeemed.

In order to exercise their Redemption Rights, public stockholders are required to deliver their public shares, either physically or electronically using the Depository Trust Company’s DWAC System, to Larkspur’s Transfer Agent prior to the vote at the Special Meeting. If a public stockholder properly seeks redemption as described in this proxy statement/prospectus and the Business Combination with ZyVersa is consummated, Larkspur will redeem these public shares for a pro rata portion of the funds deposited in the Trust Account and the public stockholder will no longer own such public shares following the Business Combination. See the section entitled “Special Meeting of Stockholders — Redemption Rights” for additional information on how to exercise your Redemption Rights.

If you or a “group” of stockholders are deemed to hold in excess of 15% of our shares of common stock, you will lose the ability to redeem all such shares in excess of 15% of our shares of common stock.

The Amended and Restated Certificate of Incorporation of Larkspur provides that a public stockholder, together with any affiliate of such stockholder or any other person with whom such stockholder is acting in concert or as a “group” (as defined under Section 13 of the Exchange Act), will be restricted from seeking Redemption Rights with respect to more than an aggregate of 15% of the shares sold in the IPO without our prior consent, which we refer to as the “Excess Shares.” However, we would not be restricting our stockholders’ ability to vote all of their shares (including Excess Shares) for or against the Business Combination. Your inability to redeem the Excess Shares will reduce your influence over our ability to complete the Business Combination and you could suffer a material loss on your investment in us if you sell Excess Shares in open market transactions. Additionally, you will not receive redemption distributions with respect to the Excess Shares if we complete the Business Combination. As a result, you will continue to hold that number of shares exceeding 15% and, in order to dispose of such shares, would be required to sell your shares in open market transactions, potentially at a loss.

ZyVersa stockholders will have their rights as stockholders governed by the organizational documents of the Combined Entity.

As a result of the completion of the Business Combination, holders of shares of ZyVersa common stock and preferred stock will become holders of shares of the Combined Entity’s common stock, which will be governed by the organizational documents of the Combined Entity. As a result, there will be differences between the rights currently enjoyed by ZyVersa stockholders and the rights of those stockholders who become the Combined Entity’s stockholders. See “Comparison of Stockholders’ Rights”.

If third parties bring claims against Larkspur, the proceeds held in the Trust Account could be reduced and the per-share redemption amount received by Larkspur stockholders may be less than $10.10 per share.

The deposit of funds in the Trust Account by Larkspur may not protect those funds from third-party claims against Larkspur. Although Larkspur has sought to have all vendors, service providers, prospective target businesses, and other entities with which it does business execute agreements with Larkspur waiving any right, title, interest, or claim of any kind in or to any monies held in the Trust Account for the benefit of the Larkspur public stockholders, such parties may not execute such agreements, or even if they execute such agreements they may not be prevented from bringing claims against the Trust Account, including, but not limited to, fraudulent inducement, breach of fiduciary responsibility, or other similar claims, as well as claims challenging the enforceability of the waiver, in each case in order to gain an advantage with respect to a claim against Larkspur’s assets, including the funds held in the Trust Account. If any third-party refuses to execute an agreement waiving such claims to the monies held in the Trust Account, Larkspur’s management will perform an analysis of the alternatives available to it and will only enter into an agreement with a third party that has not executed a waiver if management believes that such third party’s engagement would be significantly more beneficial to Larkspur than any alternative. Making such a request of potential target businesses may make Larkspur’s acquisition proposal less attractive to them and, to the extent prospective target businesses refuse to execute such a waiver, it may limit the field of potential target businesses that Larkspur might pursue.

Examples of possible instances where Larkspur may engage a third party that refuses to execute a waiver include the engagement of a third-party consultant whose particular expertise or skills are believed by management to be significantly superior to those of other consultants that would agree to execute a waiver or in cases where management is unable to find a service provider willing to execute a waiver. In addition, there is no guarantee that such entities will agree to waive any claims they may have in the future as a result of, or arising out of, any negotiations, contracts, or agreements with Larkspur and will not seek recourse against the Trust Account for any reason.

The Sponsor has agreed that it will be liable to Larkspur for any claims by a third party for services rendered or products sold to Larkspur, or by a prospective target business with which Larkspur has discussed entering into a transaction agreement, reduce the amount of funds in the Trust Account to below (i) $10.10 per share or (ii) such lesser amount per share held in the Trust Account as of the date of the liquidation of the Trust Account resulting from reductions in the value of the trust assets, in each case, net of the amount of interest that may be withdrawn to pay taxes. This liability will not apply to claims by a third party that executed a waiver of any and all rights to seek access to the funds in the Trust Account and except as to any claims under Larkspur’s indemnity of the underwriters of the Larkspur IPO against certain liabilities, including liabilities under the Securities Act. Moreover, if an executed waiver is deemed to be unenforceable against a third party, then the Sponsor will not be responsible to the extent of any liability for such third-party claims. Larkspur has not independently verified whether the Sponsor, which is a newly formed entity, has sufficient funds to satisfy its indemnity obligations and believes that the Sponsor’s only assets are securities of Larkspur. Larkspur has not asked the Sponsor to reserve for such indemnification obligations.

Therefore, Larkspur cannot assure you that the Sponsor would be able to comply with those obligations. As a result, if any such claims were successfully made against the Trust Account, the funds available for Larkspur’s initial business combination and redemptions could be reduced to less than $10.10 per public share. In such event, Larkspur may not be able to complete its initial business combination, and Larkspur stockholders would receive such lesser amount per public share in connection with any redemption of their public shares. None of Larkspur’s officers will indemnify Larkspur for claims by third parties, including, without limitation, claims by vendors and prospective target businesses.

Our directors may decide not to enforce the indemnification obligations of the Sponsor, resulting in a reduction in the amount of funds in the Trust Account available for distribution to our public stockholders.

In the event that the proceeds in the Trust Account are reduced below the lesser of (i) $10.10 per share and (ii) the actual amount per share held in the Trust Account as of the date of the liquidation of the Trust Account if less than $10.10 per share due to reductions in the value of the trust assets, in each case less taxes payable, and the Sponsor asserts that it is unable to satisfy its obligations or that it has no indemnification obligations related to a particular claim, our independent directors would determine whether to take legal action against the Sponsor to enforce its indemnification obligations. While we currently expect that our independent directors would take legal action on our behalf against the Sponsor to enforce its indemnification obligations to us, it is possible that our independent directors

in exercising their business judgment and subject to their fiduciary duties may choose not to do so in any particular instance. If our independent directors choose not to enforce these indemnification obligations, the amount of funds in the Trust Account available for distribution to our public stockholders may be reduced below $10.10 per share.

We may not have sufficient funds to satisfy indemnification claims of our directors and executive officers.

We agreed to indemnify our officers and directors to the fullest extent permitted by law. However, our officers and directors agreed to waive any right, title, interest or claim of any kind in or to any monies in the Trust Account and to not seek recourse against the Trust Account for any reason whatsoever (except to the extent they are entitled to funds from the Trust Account due to their ownership of public shares).

Accordingly, any indemnification provided will be able to be satisfied by us only if (i) we have sufficient funds outside of the Trust Account or (ii) we consummate an initial business combination (which shall be the Business Combination should it occur). Our obligation to indemnify our officers and directors may discourage stockholders from bringing a lawsuit against our officers or directors for breach of their fiduciary duty. These provisions also may have the effect of reducing the likelihood of derivative litigation against our officers and directors, even though such an action, if successful, might otherwise benefit us and our stockholders. Furthermore, a stockholder’s investment may be adversely affected to the extent we pay the costs of settlement and damage awards against our officers and directors pursuant to these indemnification provisions.

If, after we distribute the proceeds in the Trust Account to our public stockholders, we file a bankruptcy or winding-up petition or an involuntary or winding-up bankruptcy petition is filed against us that is not dismissed, a bankruptcy court may seek to recover such proceeds, and the members of our board of directors may be viewed as having breached their fiduciary duties to our creditors, thereby exposing the members of our board of directors and us to claims of punitive damages.

If, after we distribute the proceeds in the Trust Account to our public stockholders, we file a bankruptcy or winding-up petition or an involuntary bankruptcy or winding-up petition is filed against us that is not dismissed, any distributions received by stockholders could be viewed under applicable debtor/creditor and/or bankruptcy or insolvency laws as either a “preferential transfer” or a “fraudulent conveyance.” As a result, a bankruptcy court could seek to recover some or all amounts received by our stockholders. In addition, our board of directors may be viewed as having breached its fiduciary duty to our creditors and/or having acted in bad faith, thereby exposing itself and us to claims of punitive damages, by paying public stockholders from the Trust Account prior to addressing the claims of creditors.

If, before distributing the proceeds in the Trust Account to our public stockholders, we file a bankruptcy or winding-up petition or an involuntary or winding-up bankruptcy petition is filed against us that is not dismissed, the claims of creditors in such proceeding may have priority over the claims of our stockholders and the per-share amount that would otherwise be received by our stockholders in connection with our liquidation may be reduced.

If, before distributing the proceeds in the Trust Account to our public stockholders, we file a bankruptcy or winding-up petition or an involuntary bankruptcy or winding-up petition is filed against us that is not dismissed, the proceeds held in the Trust Account could be subject to applicable bankruptcy law, and may be included in our bankruptcy estate and subject to the claims of third parties with priority over the claims of our stockholders. To the extent any bankruptcy or insolvency claims deplete the Trust Account, the per-share amount that would otherwise be received by our stockholders in connection with our liquidation may be reduced.

You may only be able to exercise your public warrants on a “cashless basis” under certain circumstances, and if you do so, you will receive fewer common stock from such exercise than if you were to exercise such warrants for cash.

The warrant agreement provides that in the following circumstances holders of warrants who seek to exercise their warrants will not be permitted to do so for cash and will, instead, be required to do so on a cashless basis in accordance with Section 3(a)(9) of the Securities Act: (i) if the common stock issuable upon exercise of the warrants are not registered under the Securities Act in accordance with the terms of the warrant agreement; (ii) if we have so elected and the common stock are at the time of any exercise of a warrant not listed on a national securities exchange such that they satisfy the definition of “covered securities” under Section 18(b)(1) of the Securities Act; and (iii) if we have so elected and we call the public warrants for redemption. If you exercise your public warrants on a cashless

INFORMATION ABOUT THE PARTIES TO THE BUSINESS COMBINATION

Larkspur Health Acquisition Corp. (“Larkspur”)

Larkspur is a blank check company incorporated as a Delaware corporation for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. For more information regarding Larkspur, see the section entitled “Information About Larkspur.”

Larkspur Merger Sub, Inc. (“Merger Sub”)

Merger Sub is a Delaware corporation and a wholly owned subsidiary of Larkspur. Merger Sub does not own any material assets or operate any business.

ZyVersa Therapeutics, Inc. (“ZyVersa”)

ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop drugs for patients with chronic renal or inflammatory diseases with high unmet medical needs. ZyVersa’s mission is to develop drugs that optimize health outcomes and improve patients’ quality of life. ZyVersa has two proprietary globally licensed drug development platforms, each of which was discovered by research scientists at the University of Miami, Miller School of Medicine (the “University of Miami” or “University”). These development platforms are:

•        VAR 200 (2-hydroxypropyl-beta-cyclodextrin or “2HPβCD”), an injectable cholesterol efflux mediator in clinical development for treatment of renal diseases with IND authorization from the FDA to conduct a Phase 2a study in patients with FSGS that has not yet been implemented; and

•        IC 100, a monoclonal antibody inflammasome ASC inhibitor in preclinical development for treatment of inflammatory conditions. ZyVersa believes that each of its product candidates has the potential to treat numerous indications in their respective therapeutic areas. ZyVersa’s strategy is to focus on indication expansion to maximize commercial potential.

ZyVersa licensed from L&F Research LLC exclusive, worldwide rights to intellectual property related to use of 2HPβCD (VAR 200) for the treatment of kidney disease in humans, and they licensed from InflamaCORE, LLC exclusive worldwide rights to intellectual property related to a monoclonal antibody inflammasome ASC inhibitor (IC 100) for all inflammatory conditions).

ZyVersa’s principal executive office is located at 2200 North Commerce Parkway, Suite 208, Weston, Florida 33326. Its telephone number is 754-231-1688. ZyVersa’s website can be found at https://www.zyversa.com. ZyVersa’s website and information contained on, or that can be accessed through, the website is not deemed to be incorporated by reference in, and is not considered part of, this Proxy Statement/Prospectus. For more information regarding ZyVersa, see the section entitled “Information About ZyVersa.”

THE BUSINESS COMBINATION AGREEMENT

This section describes the material provisions of the Business Combination Agreement and certain additional agreements entered into or to be entered into at Closing pursuant to the Business Combination Agreement (the “Related Agreements”) but does not purport to describe all of the terms thereof or include all of the additional agreements entered into or to be entered into pursuant to the Business Combination Agreement. The following summary is qualified in its entirety by reference to the complete text of the Business Combination Agreement and each of the Related Agreements. Stockholders and other interested parties are urged to read the Business Combination Agreement and such Related Agreements in their entirety.

Capitalized terms used but not defined herein shall have the meanings ascribed to such terms in the Business Combination Agreement.

Explanatory Note Regarding the Business Combination Agreement

The Business Combination Agreement and this summary are included to provide you with information regarding the terms of the Business Combination Agreement. The Business Combination Agreement contains representations and warranties by Larkspur and ZyVersa. The representations, warranties and covenants made in the Business Combination Agreement by Larkspur and ZyVersa were qualified and subject to important limitations agreed to by Larkspur and ZyVersa in connection with negotiating the terms of the Business Combination Agreement. In particular, in your review of the representations and warranties contained in the Business Combination Agreement and described in this summary, it is important to bear in mind that the representations and warranties were negotiated with the principal purpose of establishing circumstances in which a party to the Business Combination Agreement may have the right not to consummate the Business Combination if the representations and warranties of the other party were to be untrue due to a change in circumstance or otherwise, and allocating risk between the parties to the Business Combination Agreement, rather than establishing or attempting to set forth matters as facts. The representations and warranties also may be subject to a contractual standard of materiality different from that generally applicable to stockholders and reports and documents filed with the SEC and some representations, warranties and covenants were qualified by the matters contained in the confidential disclosure letters that Larkspur and ZyVersa each delivered in connection with the Business Combination Agreement and certain documents filed with the SEC. Moreover, information concerning the subject matter of the representations and warranties, which do not purport to be accurate as of the date of this proxy statement/prospectus, may have changed since the date of the Business Combination Agreement.

For the foregoing reasons, the representations and warranties or any descriptions of those provisions should not be read alone or relied upon as presenting the actual state of facts or condition of Larkspur or ZyVersa, or any of their respective subsidiaries or affiliates. Instead, such provisions or descriptions should be read only in conjunction with the other information provided elsewhere in this document or incorporated by reference into this proxy statement/prospectus. Please see the section entitled “Where You Can Find More Information.”

Larkspur will provide additional disclosures in its public reports to the extent it is aware of the existence of any material facts that are required to be disclosed under federal securities laws and that might otherwise contradict the terms and information contained in the Business Combination Agreement and will update such disclosure as required by federal securities laws.

Ownership of the Combined Entity

The following table shows the anticipated beneficial ownership of various holders of the Combined Entity’s common stock upon Closing of the Business Combination in the no redemption and maximum redemption scenarios and is based on the following assumptions: (i) there are no other issuances of equity interests of Larkspur or ZyVersa, (ii) neither the Sponsor nor any of ZyVersa’s current stockholders purchase Larkspur public shares in the open market, (iii) no Larkspur or Combined Entity warrants are exercised, (iv) the PIPE Investors do not purchase shares in the open market between the date of the PIPE Subscription Agreement and the close of business on the third trading day prior to the Special Meeting of Larkspur’s stockholders called in connection with the Business

Combination, and (v) the conversion price for the shares of preferred stock issued to the PIPE Investors is $10.00 and the exercise price for the warrants issued to the PIPE Investors is $11.50. The residual equity value owned by non-redeeming stockholders will remain $10.00 per share as illustrated in the sensitivity table below.

Percentage Beneficial Ownership in the Combined Entity		No Redemptions				Maximum Redemptions
Larkspur Public Stockholders			[    ]	%			[    ]	%
ZyVersa Stockholders			[    ]	%			[    ]	%
PIPE Investors			[    ]	%			[    ]	%
Sponsor			[    ]	%			[    ]	%
			[    ]	%			[    ]	%
Value of the Shares Owned by Non-Redeeming Stockholders
Total Shares Outstanding Excluding Warrants			[    ]				[    ]
Total Equity Value Post-Redemptions		$	[    ]			$	[    ]
Per Share Value		$				$

____________

(1)      Assumes that Larkspur’s public stockholders exercise Redemption Rights with respect to [            ] public shares, which represents redemption of 100% of Larkspur public shares, for an aggregate redemption payment of $[            ] million.

(2)      The Sponsor and its Affiliates will hold up to 1,941,790 shares of common stock, which will be cancelled and exchanged on a one-for-one basis for the Combined Entity’s common stock upon consummation of the proposed Business Combination. The Sponsor paid approximately $0.01 per founder share. Assuming a value of $10.00 per share of the Combined Entity’s common stock, based on the deemed value of $10.00 per share of the Combined Entity’s common stock in the proposed Business Combination, this represents an appreciation in value of approximately $9.99 per share of the Combined Entity’s common stock. Assuming a value of $            per share of the Combined Entity’s common stock, the Closing price of a shares of common stock of Larkspur on            , 2022, this represents an appreciation in value of approximately $            per share of the Combined Entity’s common stock.

Background of the Business Combination

The terms of the Business Combination Agreement are the result of negotiations between the representatives of Larkspur and ZyVersa. The following chronology summarizes the key meetings and events that led to the signing of the Business Combination Agreement. This chronology does not purport to catalogue every conversation or correspondence among representatives of Larkspur, ZyVersa, their respective representatives or any other party.

Larkspur is a blank check company incorporated on March 17, 2021 as a Delaware corporation for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. Larkspur focused its search on the technology industry, specifically within the biotechnology sector in the United States, which complements the expertise of its officers, directors, and advisors.

On December 23, 2021, Larkspur consummated its IPO of 7,767,159 units, including 267,159 units issued pursuant to the partial exercise by the underwriters of their over-allotment option. Each unit consists of one share of Class A common stock and three-fourths of one redeemable warrant. Each whole warrant entitles the holder thereof to purchase one ordinary share at a price of $11.50 per share (subject to adjustment). The units were sold at an offering price of $10.00 per unit, resulting in gross proceeds of $77,671,590. Concurrently, with the completion of Larkspur’s initial public offering, Larkspur consummated a private placement of an aggregate of 317,600 units, each at a purchase price of $10.00 per unit, generating total proceeds of $3,176,000. Of the proceeds received from the consummation of the IPO, the sale of the private placement units and the exercise of the over-allotment option on January 6, 2022, $78,451,910 was placed in Larkspur’s Trust Account.

Prior to the consummation of the IPO, neither Larkspur, nor anyone on its behalf, had any substantive discussions, formal or otherwise, with respect to a potential business combination transaction with Larkspur.

As discussed herein, after the completion of Larkspur’s IPO, Larkspur’s management began to seek potential candidates for a business combination. In addition, Larkspur was contacted by a number of individuals and entities with respect to potential business combination opportunities. During the course of this search process,

representatives of Larkspur regularly updated and received input from members of Larkspur’s board of directors, certain of whom were regular participants in the ongoing meetings and discussions with representatives of several potential target opportunities, on the status of the search process.

Larkspur’s management team was led by Daniel J. O’Connor, our Chairman of the Board and Chief Executive Officer, and David S. Briones, our Chief Financial Officer, Treasurer, Secretary, and Director. The Larkspur team was formed to be a collective team experienced in capital market and buy-side investments, with significant operational experience across the biotechnology sector. Messrs. O’Connor and Briones believed that a team that had capital markets experience and significant biotech operational experience, including but not limited to science and drug development operational experience, would both differentiate Larkspur and optimize the opportunity for its success. This cross-functional operational experience was important to them as they built out the Larkspur team and they believed the team’s combination of experiences would be an important strategic advantage in the market. Additionally, they felt their sizing of sub-$100 million would be an advantage as many SPACs over the past two years had raised significantly more capital, but offered more dilution for SPAC targets.

In evaluating potential business combination opportunities, the Larkspur team focused on a number of attributes. The management team sought out biopharmaceutical companies that had some or all of the following: (i) compelling technology; (ii) validating data with respect to the technology, (iii) a compelling underlying value proposition(s), (iv) the potential of technology value accretion via the infusion of capital/access to the capital markets, (v) technology that would be attractive to other larger pharma companies/acquirors/licensees, (vi) a competitive advantage of some level, (vii) a scalable platform with public company readiness, (vii) a highly driven and experienced management team, (viii) public market reception, (ix) barriers to entry, and (x) competitive advantages. These criteria are not intended to be exhaustive.

Larkspur interacted with and/or received information from over twenty (20) biopharmaceutical companies, several of which were introduced to Larkspur and represented by bankers. Larkspur held several teleconferences (either via Zoom or Teams) with fourteen (14) of these target companies and subsequently entered into confidentiality agreements with nine (9). Exclusive of meetings held with ZyVersa (further described below), the Larkspur management team conducted over seventeen (17) teleconference meetings with target companies, including numerous calls with the banking representatives of several of these companies and well as several calls with the management of three targets.

In January, 2022, Larkspur entered into a confidentiality agreement, reviewed and met with a clinical stage biotech company developing novel oncology product candidates. While the technology was attractive, this potential target was organized outside the U.S., which Larkspur considered suboptimal. This target opportunity was also in advanced discussions with another SPAC, which eventually resulted in a discontinuation of discussions.

Another target biopharmaceutical company Larkspur reviewed and met with in January, 2022, was a pre-clinical stage company possessing an experimental COVID-19 treatment technology developed by renowned scientist. However, Larkspur’s management determined that the potential target company’s product candidate was too focused on a specific niche area of the market and the potential target company’s focus had become crowded industry was too small for the public markets.

In January, 2022, Larkspur entered into a confidentiality agreement and representatives of Larkspur met via teleconference on several occasions with representatives of a clinical-stage biopharmaceutical company developing immunomodulatory vaccines and cell-based immunotherapies for cancer and other diseases. While the potential target business was novel and compelling and its management was interested in going public to continue growing their portfolio of brands, the Larkspur team passed on the opportunity because it lacked audited financial statements sufficient to achieve Larkspur’s timelines and also because it was largely organized outside the U.S.

In January, 2022, Larkspur entered into a confidentiality agreement and representatives of Larkspur reviewed and had several teleconferences with representatives of a scientific research and development biopharmaceutical company developing in therapeutics, including proprietary cannabinoid formulations and protein-based therapeutics focused on a developing a safer, more effective alternative to current pain management therapies (including opioids) for chronic pain and neuropathic pain. The Larkspur management team felt that while the target market was attractive, the business may not be well-received in the market as there already exist several cannabinoid focused companies.

In January, 2022, Larkspur entered into a confidentiality agreement and representatives of Larkspur reviewed and had several teleconferences with the management of a spinoff biopharmaceutical company from a large, successful private company. The Larkspur team was interested in the overall opportunity but felt that the majority stake that the large private company maintained in the spinoff may not be attractive in the public markets.

In January, 2022, representatives of Larkspur reviewed and had a teleconference with representatives of a spinoff biopharmaceutical company from a successful private company, seeking to reposition and repurpose existing drugs to address unmet medical needs. Larkspur’s representatives were impressed with the background and experience of the potential target company’s management and management’s focus and the operating results from the parent business; however, the target business decided not to pursue the public markets at this time.

In January, 2022, Larkspur entered into a confidentiality agreement and representatives of Larkspur met with representatives of a clinical-stage biopharmaceutical company developing a platform designed to develop safe and effective product candidates to promote immune tolerance. The potential target business was novel and compelling, and its management was interested in going public to continue growing their product candidate pipeline.

The Larkspur management team had teleconferences and several calls with the business leaders and focused on a deeper understanding of the potential target company’s overall business. Members of Larkspur’s Board participated on some of these teleconferences and calls. While both the target company and the Larkspur team were interested in potentially entering into a term sheet and Larkspur subsequently shared with the potential target company an initial draft of a term sheet Larkspur had created with its legal team; ultimately, Larkspur’s management did not finalize the term sheet or sign an exclusivity agreement as the target company decided to delay its pursuit of entry into the public markets.

Another target biopharmaceutical company Larkspur reviewed and met with in late January, 2022, was a clinical stage company developing gene therapy programs targeting severe CNS disorders. The Larkspur management team felt that while the technology was attractive, the target company had a pre-existing broad relationship with a major pharmaceutical company that may affect its ability to partner with others.

In February, 2022, Larkspur entered into a confidentiality agreement, reviewed and met with a clinical stage biotech leveraging new uses for existing therapies and technologies, potentially resulting in accelerated development and a streamlined regulatory process such new uses. The Larkspur team appreciated the strategy; however, this target opportunity was also in advanced discussions with another SPAC, which eventually resulted in a discontinuation of discussions.

In May, 2022, Larkspur entered into a confidentiality agreement and representatives of Larkspur reviewed and had teleconferences with representatives of a biopharmaceutical company developing proprietary cannabinoid therapeutics to treat various diseases. The Larkspur management had several calls with the business leaders and focused on a deeper understanding of the potential target company’s overall business. While both the target company and the Larkspur team were interested in potentially entering into a term sheet, and Larkspur subsequently shared with the potential target company an initial draft of a term sheet; ultimately, Larkspur’s management did not finalize the term sheet or sign an exclusivity agreement. The Larkspur management team reasoned that, while the company had existing resources which potentially obviated the need for additional financing, the business may not be well-received in the market as there already exist several cannabinoid focused companies.

In June, 2022, Larkspur entered into a confidentiality agreement and representatives of Larkspur reviewed and had several teleconferences with representatives of a developer, producer and marketer of food extracts that could potentially ameliorate health issues related to obesity. The Larkspur management team felt that while the target market was attractive, the business was largely located outside the United States and was in an industry not directly related to the biopharmaceutical industry.

During the week of January 3, 2022, representatives of BTIG, LLC (“BTIG”) and Noble Capital Markets (Noble), in their capacity as financial advisor to ZyVersa (the “ZyVersa Advisors”), introduced ZyVersa’s business to Larkspur management shortly thereafter ZyVersa Advisors felt that Larkspur management’s understanding of the markets and operator-led team would be a good match for ZyVersa.

Larkspur executed a confidentiality agreement with ZyVersa dated January 5, 2022, to facilitate due diligence review of confidential materials. The first call between Larkspur’s and ZyVersa’s respective management teams took place on January 5, 2022. The Larkspur management team was impressed with ZyVersa’s management track record of prior success, the future potential of the company’s two product candidates, VAR 200 and IC 100 and the market reception that they felt ZyVersa’s business could receive if ZyVersa went public.

Throughout January and February 2022, teleconferences were held between the management team and Board members of Larkspur and ZyVersa. Generally, during this time, the Larkspur team was conducting a review of ZyVersa’s business model and its future opportunities. Among several other topics, during these meetings the Larkspur team focused on the history of the business, current operational status, mechanism of action with respect to VAR 200 and IC 100, pre-clinical data, IP, manufacturing status, staffing, key opinion leaders, as well as potential risks and issues.

On January 19, 2022, the Larkspur team were granted access to ZyVersa’s digital data room that included confidential information regarding the business and operations of ZyVersa (the “Data Room”).

During the month of January, 2022, Larkspur held several teleconferences and calls internally to discuss ZyVersa’s overall business, valuation and future outlook. Larkspur worked with A.G.P./Alliance Global Partners, the underwriter in Larkspur’s initial public offering, to get their understanding of ZyVersa. In addition to serving as Larkspur’s underwriter, A.G.P./Alliance Global Partners served in an advisory capacity in connection with the Business Combination and also served as the Larkspur’s placement agent in connection with the PIPE Investment. AGP assisted the Larkspur in structuring and negotiating the Business Combination Agreement, introduced the Larkspur to potential investors to purchase Larkspur’s securities in connection with the Business Combination, assisted Larkspur with preparing press releases related to the Business Combination, and organized and participated in agenda driven conference calls.

On January 12, 2022, the Larkspur team traveled to ZyVersa’s offices in Fort Lauderdale, Florida, for an all-day face-to-face meeting with the management of ZyVersa and several of their KOL’s. Messrs. O’Connor and Briones attended in person, Drs. Mehra and Twitty, members of the Larkspur board of directors, attended via teleconference.

On January 13, 2022, a face-to-face meeting was held at the offices of ZyVersa’s advisors, Nobel, to discuss the furtherance of due diligence. Present were members of management teams from Larkspur and ZyVersa, as well as attorneys from their respective counsels. The aspects of ZyVersa’s business that were among the most significant to Larkspur were the perceived competitive advantages of IC 100, combined with the interest, activity and the potential for collaborations with major pharmaceutical companies. Additionally, with respect to VAR 200, management teams discussed the proof of concept and pre-clinical data (FSGS, Alport syndrome, diabetic kidney disease), combined with the fact that 2HPßCD (VAR-200) had been used as excipients in other approved drugs.

In late January and early February, 2022, the Larkspur management team and ZyVersa Advisors held several phone calls whereby they discussed the term sheet proposal and challenges that Larkspur’s management and board of directors identified regarding ZyVersa. ZyVersa Advisors communicated that there were multiple SPACs considering a potential business combination with ZyVersa but ZyVersa’s management and board of directors were most interested in the Larkspur team. On these calls, Larkspur’s and ZyVersa Advisors’ representatives discussed the valuation and thoughts around the total cash Larkspur would aim to raise in a PIPE Investment.

Throughout the month of January, 2022, and thereafter, the Larkspur team continued to conduct diligence on ZyVersa’s pre-clinical data and have discussions with its Board members on ZyVersa’s pipeline. During this time, Larkspur’s Board and its management team evaluated and discussed the potential transaction with ZyVersa, including the pros and cons of the opportunity. Larkspur management asked the Board members to review the company presentation and share any questions. Larkspur Board member, Dr. Mehra, had a one-on-one teleconference with ZyVersa CEO, Stephen Glover, wherein Mr. Glover and Dr. Mehra discuss ZyVersa and its product candidates. Messrs. O’Connor and Briones discussed with members of the Board their positive views on the opportunity and valuation based on their experience in the biotechnology industry. Larkspur’s management believed that the potential transaction with ZyVersa presented a compelling opportunity and recommended that Larkspur sign a 30-day exclusivity letter with ZyVersa. In late January, the Larkspur team worked on an initial draft of a non-binding term sheet to submit to ZyVersa’s management team and the ZyVersa Advisors, which was then forwarded to ZyVersa’s management.

On February 3, 2022, Larkspur and ZyVersa executed a confidential non-binding term sheet (the “Term Sheet”), which included the financial terms of the transaction, the anticipated pro forma ownership of New ZyVersa, transaction consideration of $130 million, and the agreed framework with respect to post-Closing governance of New ZyVersa. The Term Sheet also included a binding mutual exclusivity provision through March 4, 2022.

Around February 6, 2022, in order to enable Larkspur to further conduct its due diligence review, Larkspur and certain of its advisors, including Larkspur’s counsel, McDermott Will & Emery LLP (“MWE”), were granted access to the Data Room. Larkspur conducted due diligence in traditional functional areas, including but not limited to, corporate structure and organization, capitalization, employee benefits, labor and employment matters, material contracts, regulatory and other healthcare matters, data privacy and cybersecurity, intellectual property, real property, pre-clinical data, pre-reviewed publications, clinical development plans, drug supply, and manufacturing.

On March 11, 2022, without members of the ZyVersa management team present, members of the Larkspur team had a teleconference with Alessia Fornoni, MD, PhD, Professor of Medicine and Chief, Katz Family Division of Nephrology and Hypertension, University of Miami Miller School of Medicine and the inventor of VAR 200 (described below) to discuss the VAR 200 program. Dr. Fornoni is a tenured Professor of Medicine and Molecular and Cellular Pharmacology at the University of Miami Miller School of Medicine. She is the Chief of the Katz Family Division of Nephrology and Hypertension and serves as and Director and Chair of the Peggy and Harold Katz Drug Discovery Center.

On March 11, 2022, without members of the ZyVersa management team present, members of the Larkspur team had a teleconference Drs. Juan Pablo De Rivero Vaccari, PhD, Research Assistant Professor in the Department of Neurological Surgery & The Miami Project to Cure Paralysis at the University of Miami, Miller School of Medicine, and Robert Keane, Professor, Physiology and Biophysics, Neurological Surgery and Microbiology, and Immunology, University of Miami Miller School of Medicine to discuss the IC 100 program with the co-inventors of IC 100 (described below). Dr. de Rivero Vaccari is an Assistant Professor in the Department of Neurological Surgery & The Miami Project to Cure Paralysis, and a Distinguished Faculty Member of the Center for Cognitive Neuroscience & Aging at the University of Miami Miller School of Medicine. He has studied the innate immune response for over 17 years and was the first to show the involvement of the inflammasome in the Central Nervous System. Dr. Keane is Professor of Physiology and Biophysics, Neurological Surgery and Microbiology and Immunology at the University of Miami, Miller School of Medicine. Over the last 30 years his research has focused on understanding the innate immune response in the central nervous system. Dr. Keane is the discoverer of inflammasomes in neurons after central nervous system injury.

On or about February 15, 2022, representatives of MWE provided Lowenstein Sandler LLP (“Lowenstein”), counsel to ZyVersa, with an initial draft of the Business Combination Agreement and an initial draft of the Form S-4.

On February 21, 2022, representatives of MWE submitted an initial due diligence request list to representatives of ZyVersa. Representatives of MWE, Lowenstein, Larkspur, ZyVersa and certain other advisors also met telephonically to discuss issues presented by the draft of the Business Combination Agreement and certain proposed terms of the ancillary agreements thereto.

On February 18, 2022, MWE sent an initial draft of a business combination agreement to Lowenstein, who in turn sent comments back to MWE on February 24, 2022.

On February 24, 2022, representatives of MWE met telephonically with representatives of ZyVersa and representatives of Lowenstein as part of Larkspur’s due diligence review of ZyVersa. Representatives of MWE discussed questions regarding general corporate and organizational matters, financing, material contracts and arrangements, data privacy and cybersecurity, litigation matters, intellectual property regulatory, labor and employment, employee benefits, environmental, and insurance matters.

On February 25, 2022, MWE and Lowenstein completed a conference call to discuss open items and structural terms of the Business Combination Agreement.

On March 3, 2022, Larkspur and ZyVersa agreed to extend the term of the binding mutual exclusivity until April 6, 2022.

On March 7, 2022, representatives of MWE also submitted a revised draft of its due diligence request list to representatives of ZyVersa.

On March 9, 2022, Larkspur engaged Cassel Salpeter & Co., LLC (“Cassel Salpeter”) to evaluate the proposed transaction and render to the Larkspur Board an opinion as to whether the consideration to be paid or issued by Larkspur in the transaction is fair, from a financial point of view to Larkspur. The Larkspur Board determined to seek this opinion in order to obtain a view from a third party with experience in de-SPAC transactions regarding the fairness, from a financial point of view, to Larkspur of the consideration paid by Larkspur to ZyVersa pursuant to the Business Combination Agreement.

On March 14, 2022, representatives of MWE met telephonically with representatives of ZyVersa as part of Larkspur’s due diligence review of ZyVersa. Representatives of MWE discussed questions regarding intellectual property and regulatory matters.

On March 15, 2022, representatives of Lowenstein sent a further revised markup of the Business Combination Agreement to MWE.

On March 17, 2022, Lowenstein and MWE completed a conference call to discuss certain securities and structural issues regarding the Business Combination and to negotiate certain terms of the Business Combination Agreement.

On March 25, 2022, representatives of MWE sent a markup of the Business Combination Agreement to Lowenstein.

On April 1, 2022, Larkspur engaged Alston & Bird LLP (“A&B”) as counsel and thereafter provided access to the ZyVersa data room.

On April 5, 2022, representatives of Lowenstein sent a markup of the Business Combination Agreement to Larkspur, which Larkspur then forwarded to A&B on April 14, 2022.

On May 3, 2022, A&B provided to Lowenstein a request for certain diligence items.

During the week of May 9, 2022, ZyVersa advisors and ZyVersa prepared materials for a financing and, thereafter during May, June and July, ZyVersa advisors and ZyVersa to begin meeting with investors with respect to a bridge financing.

On May 3, representatives of A&B sent a revised draft of the Business Combination Agreement to Lowenstein.

On May 3, representatives of A&B submitted a revised draft of the supplemental diligence request list to representatives of ZyVersa.

On May 5, representatives of A&B sent a revised draft of the PIPE Subscription Agreement reflecting revised business terms to Lowenstein. Representatives of Lowenstein sent revised drafts of the Lock-Up Agreement, the Stockholder Support Agreement, and Larkspur Founders Stock Letter to A&B. The parties also finalized drafts of the Proposed Organizational Documents.

On May 11, representatives of A&B, Larkspur, Alliance Global Partners (“AGP”), Lowenstein and ZyVersa completed a conference call to discuss open items regarding the PIPE financing terms, the Business Combination Agreement and the drafting process with respect to the proxy/registration statement.

On May 18, representatives of A&B sent a further revised draft of the PIPE Subscription Agreement to Lowenstein.

On May 18, representatives of A&B submitted a revised draft of the supplemental diligence request list to representatives of ZyVersa. Representatives of Lowenstein sent a markup of the PIPE and Backstop Subscription Agreement to A&B.

On May 20, representatives of A&B sent a revised draft of the Amended and Restated Registration Rights Agreement to Lowenstein. Representatives of Lowenstein also sent revised drafts of the Lock-Up Agreement and the Stockholder Support Agreement to A&B.

On May 20, representatives of A&B sent a revised draft of the PIPE and Backstop Subscription Agreement to Lowenstein.

On May 21, representatives of Lowenstein sent a revised draft of the Amended and Restated Registration Rights Agreement to A&B.

On May 21, representatives of ZyVersa provided written diligence responses to A&B’s supplemental due diligence request list.

On May 22, representatives of Lowenstein sent a revised draft of the Business Combination Agreement to A&B.

On May 23, representatives from the Company, A&B, AGP, and Cassel Salpeter discussed market conditions.

On May 24, representatives of A&B and Lowenstein met telephonically to discuss issues presented by the draft of the Business Combination Agreement. Representatives of Lowenstein also sent a revised draft of the Amended and Restated Registration Rights Agreement to MWE. Representatives of ZyVersa provided written diligence responses to A&B’s supplemental due diligence request list. Representatives of MWE also sent revised drafts of the Lock-Up Agreement, the Stockholder Support Agreement, and Larkspur Founders Stock Letter to Lowenstein.

On May 25, representatives of A&B also sent a revised draft of the Business Combination Agreement to Lowenstein.

On May 25, representatives of Lowenstein and A&B exchanged drafts of the Business Combination Agreement, the Larkspur Founders Stock Letter, the Amended and Restated Registration Rights Agreement, the Lock-Up Agreement and the Stockholder Support Agreement. The parties finalized the Larkspur Founders Stock Letter, the Amended and Restated Registration Rights Agreement, the Lock-Up Agreement and the Stockholder Support Agreement.

In June 2022, A.G.P. provided feedback that the $130 million valuation, which was based upon market conditions in February 2022, was disconnected from then-current market conditions. Specifically, the XBI biotech index was down approximately 30% from February 2022, and the small cap biotech valuations also experienced significant decreases from the February 2022 valuation. These factors led to a corresponding decrease of approximately 35% in transaction consideration from $130 million to $85 million. Following this change, the Business Combination Agreement was revised accordingly.

On June 30, 2022, A&B and Lowenstein completed a conference call to discuss updated terms of the Business Combination Agreement and the PIPE Investment documents.

During May, June and July 2022, AGP led a PIPE Investment process where its representatives went out to investors to raise capital in connection with the potential Business Combination.

In July 2022, seven funds extended offers to invest in ZyVersa via a PIPE relating to a Business Combination. The offers were well-received by ZyVersa and Larkspur’s management and board of directors. ZyVersa, Larkspur, and the respective law firms started to work towards announcing a transaction that would include PIPE financing.

On July 1, 2022, representatives of A&B, Larkspur, AGP, ZyVersa and Lowenstein completed a conference call with an updated framework and timeline for completing the definitive documents regarding the Business Combination and the PIPE financing and for announcing the signing of such documents. Certain changes to the terms regarding the PIPE financing were summarized by AGP.

On July 12, 2022, a quorum of the Larkspur Board convened via videoconference with all Board members present and with representatives of A&B in attendance, as well as representatives from AGP in attendance for an initial portion of the meeting and thereafter dismissed from the meeting. During the meeting, the Larkspur Board received an update of the current status of transaction negotiations and copies of the proposed Business Combination Agreement and other agreements and documents to be reviewed by the Larkspur Board in connection with the proposed Business Combination. Following a review and discussion among the directors of the Business Combination Agreement, PIPE, press release, and related documents and agreements, the Larkspur Board agreed adjourn the meeting and reconvene on July 14, 2022 following their review of the materials provided.

On July 13, 2022, representatives of A&B, Lowenstein, Larkspur, ZyVersa and AGP met telephonically to discuss issues presented by the draft of the Business Combination Agreement and the PIPE Subscription Agreement. Representatives of Lowenstein also sent revised drafts of the Placement Agent Agreement and Lock-Up Agreement. Representatives of AGP circulated a draft press release to be reviewed by all parties. A&B and Lowenstein circulated multiple revised drafts of the Business Combination Agreement.

On July 14, 2022, a quorum of the Larkspur Board convened again via videoconference with all Board members present and with representatives of A&B in attendance, as well as representatives from AGP and CS, and Mr. Glover, in attendance for a portion of the meeting to answer any questions the Larkspur Board may have. The representatives from AGP and Cassel Salpeter, and Mr. Glover, were thereafter dismissed from the meeting. Prior to his dismissal, Mr. Salpeter, from Cassel Salpeter, provided to the Larkspur Board its opinion to the effect that the Merger Shares to be issued by Larkspur in the Business Combination pursuant to the Business Combination Agreement was fair to Larkspur from a financial point of view. Following a review and discussion among the directors of the Business Combination Agreement, the PIPE, the press release, the Cassel Salpeter fairness opinion and related documents and agreements, the Larkspur Board unanimously approved that Larkspur Management enter into the Business Combination Agreement, PIPE and related agreements.

On July 20, 2022, the Business Combination Agreement, PIPE and related agreements were signed in connection with the Business Combination Agreement and a joint press release announcing the Business Combination and corresponding PIPE financing was issued.

Recommendation of the Larkspur Health Acquisition Corp. Board and Reasons for the Business Combination

The Larkspur Health Acquisition Corp. management and Board, in evaluating the Business Combination, reviewed a number of materials, including the investor presentation and analyses therein, the transaction documentation, and certain due diligence summary materials prepared by Larkspur’s management team, and consulted with Larkspur’s management team and legal advisors. In reaching its resolution (i) that the Business Combination Agreement and the transactions contemplated thereby are advisable and in the best interests of Larkspur and its shareholders and (ii) to recommend that Larkspur public shareholders adopt the Business Combination Agreement and approve the Business Combination and the transactions contemplated thereby, the Larkspur Board considered a range of factors, including, but not limited to, the factors discussed below.

In light of the number and wide variety of factors considered in connection with its evaluation of the Business Combination, the Larkspur Board did not consider it practicable to, and did not attempt to, quantify or otherwise assign relative weights to the specific factors that it considered in reaching its determination and supporting its decision. The Larkspur Board viewed its decision as being based on all of the information available and the factors presented to and considered by it. In addition, individual directors may have given different weight to different factors. This explanation of Larkspur’s reasons for the Business Combination and all other information presented in this section is forward-looking in nature and, therefore, should be read in light of the factors discussed under “Cautionary Note Regarding Forward-Looking Statements.”

In approving the Business Combination, the Larkspur Board obtained a fairness opinion. The officers and directors of Larkspur have substantial experience in evaluating the operating and financial merits of companies from a wide range of industries and concluded that their experience and background enabled them to make the necessary analyses and determinations regarding the Business Combination.

In addition, Larkspur’s officers, directors and advisors have substantial experience with mergers and acquisitions across a variety of different industries.

In evaluating the Business Combination, the Larkspur Board considered the criteria and guidelines to evaluate prospective business opportunities set by the Larkspur management team in the Larkspur IPO prospectus:, including, but not limited to these general guidelines:

•        Compelling proprietary technology supported by validating data;

•        Compelling underlying value proposition(s) and a compelling risk/reward proposition;

•        Addressing unmet medical need;

•        Potential of technology value accretion via the infusion of capital/access to the capital markets;

•        Attractiveness of the technology to other larger pharma companies/acquirors/licensees;

•        Scalable platform with public company readiness;

•        Multiple assets with the ability to create value, diversifying risk, looking for multiple shots on goal;

•        Premier scientific and clinical leadership;

•        Highly driven and experienced management team with experience in the public market;

•        Significant growth potential;

•        Public market reception;

•        Barriers to entry;

•        Competitive advantages;

•        Leveraging Larkspur’s management team’s experiences; and

•        Other criteria.

The criteria above were not intended to be exhaustive. Any evaluation relating to the merits of a particular initial business combination may be based, to the extent relevant, on these general guidelines as well as other considerations, factors and criteria that Larkspur’s management and the Larkspur Board deemed relevant.

The Larkspur Board determined that ZyVersa meets many of the above criteria following a presentation from Larkspur’s management team which noted, among other things, that:

•        Transformative Market Opportunity.    The Larkspur Board considered the fact that ZyVersa has two proprietary globally licensed product candidate platforms (IC 100 and VAR 200) invented by top tier research scientists at University of Miami Miller School of Medicine with highly differentiated mechanisms of action which address numerous unmet medical needs, including orphan indications, in renal disease and diseases caused by excessive inflammation. ZyVersa’s advantages with respect to both product platforms puts it in a position to be a preferred licensing partner to larger biopharmaceutical companies. Further, ZyVersa is positioned to be a long-term leader in the renal disease and inflammasome space because of the relationships ZyVersa has established with two entities founded by such inventors and researchers at University of Miami Miller School of Medicine to discover, in-license, develop, and commercialize therapeutics to treat diverse disease states with these product platforms, including (i) InflamaCore, LLC in the case of our IC 100 platform; and (ii) L&F Research LLC in the case of our VAR 200 platform. For additional information about the agreements with InflamaCore, LLC and the L&F License Agreement, see the section entitled “Information about ZyVersa — Strategic Alliances and Arrangements”.

•        Product Pipeline.    The Larkspur Board considered the fact that ZyVersa has a deep pipeline with IC 100 and VAR 200 product candidates, both having the potential to improve care across a wide range of therapeutic areas. Specifically, ZyVersa has created two product platforms to treat both renal and inflammatory diseases.

•        IC 100, is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 is subject to a License Agreement with InflamaCORE, LLC, pursuant to which InflamaCORE, LLC granted ZyVersa an exclusive, worldwide license for the development and commercialization of IC 100.

•        VAR 200 (2-Hydroxypropyl-Beta-Cyclodextrin or 2HPβCD) is a cholesterol efflux mediator designed to alleviate excess cholesterol in podocytes that contributes to the pathology of various glomerular diseases. VAR 200 is subject to a License Agreement with L&F Research LLC, pursuant to which L&F Research LLC granted ZyVersa an exclusive, worldwide license for the development and commercialization of VAR 200.

•        Inflammasome Discovery, Research Focus and IC 100.    The Larkspur Board considered that the discovery of a macromolecular complex, termed the “inflammasome,” that senses ‘danger’ and initiates the inflammatory response contributed to a resurgence of interest in the fields of innate immunity and cell death. Subsequent research linking inflammasomes to hereditary and metabolic diseases has led to creation of a new class of therapeutics targeting inflammasomes.

Broadly defined, inflammasomes regulate the innate immune response going from detection of external threats to the mounting of a counterattack. Inflammasomes are multiprotein complexes involved in the activation of caspase-1 and the processing of the pro-inflammatory cytokines, interleukin (IL)-1b and IL-18 as well as the cell death mechanism of pyroptosis. Specifically, inflammasomes are molecular protein complexes comprised of three main elements: i) a “sensor” molecule including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin (NLR pyrin domain-containing 3 or NLRP3 is the best known); ii) an adapter protein known as “apoptosis-associated speck-like protein containing a caspase recruitment domain” (“ASC”); and iii) pro-caspase/caspase-1. Each of the sensor molecules (e.g., NLRP3) respond to different pathogens or danger signals, forming unique inflammasomes. ASC recruits pro-caspase 1 into the inflammasome and subsequently caspase-1 activates the cytokine IL-1β, triggering a pro-inflammatory immune response. Following activation, inflammasomes oligomerize to produce

massive cytokine signaling platforms termed ASC specks. Importantly, ASC is involved with not only the formation of the NLRP3 inflammasome, but also eleven or more other types of inflammasomes, each associated with a unique sensor molecule (generally, inflammasomes are named by their associated sensor molecule, e.g., “NLRP3 inflammasome”). ASC specks are released into the extracellular space or into tissue fluids causing excessive inflammation leading to cellular and tissue damage.

Previous attempts to inhibit inflammasome initiated inflammation focused on downstream blockade of cytokines (immune inflammation signaling proteins) produced by inflammasome activation. This has led to mixed results (Strategies for Targeting the NLRP3 Inflammasome in the Clinical and Preclinical Space, Journal of Medicinal Chemistry, J. Med. Chem. 2021, 64, 101−122). Recent attempts to inhibit the NLRP3 inflammasome focuses on compounds to bind or inhibit NLRP3 or perturb its function. (J. Med. Chem. 2021, 64, 101−122). Targeting the NLRP3 inflammasome has been characterized as “an exploding field of research.” (J. Med. Chem. 2021, 64, 101−122). IC 100 is a monoclonal antibody (mAb) targeting the ASC protein component of inflammasomes. IC 100 inhibits intracellular ASC to block inflammasome formation, and it also inhibits both intracellular and extracellular ASC in ASC specks (ASC assembles into a large protein complex, which is termed “speck”), thereby disrupting its (ASC speck) structure and function by preventing the recruitment of pro-caspase 1 and the subsequent activation of the cytokine IL-1β to trigger an immune response. Thus, in doing so, IC 100 inhibits initiation and perpetuation of damaging inflammation contributing to inflammatory diseases.

•        Compelling Value Proposition with IC 100.    The Larkspur Board considered that IC 100 represents a so-called “pipeline within a product” because one product candidate (IC 100) offers a significant opportunity to improve care across a wide range of therapeutic areas because chronic inflammation associated with overactivation of inflammasomes underlies a large number of diverse inflammatory diseases, to include:

•        Autoimmune diseases — multiple sclerosis, systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis and colitis;

•        Metabolic diseases diabetes — atherosclerosis, non-alcoholic fatty liver disease and gout;

•        Neurodegenerative diseases — Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis; and

•        Injuries — spinal cord injury, traumatic brain injury and stroke.

•        Attractiveness of Inflammasome Technology to Pharma Companies/Acquirors/Licensees — Major Inflammasome Acquisitions.    The Larkspur Board considered that as therapeutics targeting inflammasomes has become an area of high research interest, it has also become highly attractive to biopharmaceutical companies. This is evidenced by the acquisition of several start-up companies focusing on NLRP3 sensor molecules by large pharmaceutical companies at an early stage of development.

•        Since 2016, several small pharmaceutical companies have developed targeted NLRP3 inhibitors, and over the past twenty-four months large pharmaceutical companies have acquired several of those smaller companies in significant deals or have started developing inhibitors of their own. (“Pharma Looks to Inflammasome Inhibitors as All-Around Therapies” The Scientist, April 2021).

•        Beginning in late 2017 and continuing to September 2020, M&A activity with respect to preclinical/Phase 1 inflammasome product candidates included the following:

•        BMS acquisition of IMF Therapeutics, Inc. (NLRP3 and STING Inhibitors), September, 2017, for $300mm upfront and $1.01 billion in milestone payments;

•        Roche acquisition of Jecure Therapeutics, Inc. (NLRP3), November, 2019, for undisclosed amounts;

•        Novartis acquisition of IMF Tre (NLRP3), April, 2019, $310mm upfront and undisclosed milestone payments; and

•        Roche acquisition of Inflazome (NLRP3), September, 2020, $450mm upfront and $1.265 billion in milestone payments.

•        Recent Attractiveness of Inflammasome Technology to Institutional Investors — The Larkspur Board considered that as therapeutics targeting inflammasomes has become an area of high research interest, it has also become highly attractive to health care focused institutional investors. This is evidenced by the two private companies focusing on NLRP3 sensor molecules at an early stage of development.

•        NodThera, Inc., a private company developing NLRP3 inhibitors, has received approximately $95mm from well-known healthcare focused investors, including Sofinnova Partners, Nova Holdings and Sanofi Ventures; and

•        Ventus Therapeutics, a private company developing NLRP3 inhibitors, has received approximately $300mm from well-known healthcare focused investors, including SoftBank Vision Fund 2 and RA Capital Management.

•        Competitive Advantages of IC 100.    The Larkspur Board considered the fact that ZyVersa’s IC 100 has several distinct proprietary competitive advantages, including the following:

•        The inventors of IC 100 discovered that certain critical amino acids in one domain of the ASC protein were involved in inflammasome and ASC speck formation. Based on this discovery, they designed a blocking mAb against those specific amino acids. As such, IC 100 has a highly differentiated mechanism of action (MOA) because it inhibits ASC, which is a common component among several different types of inflammasomes.

•        IC 100 is differentiated from other inflammasome inhibitor product candidates in development because it targets adaptor ASC with a mAb, whereas other inflammasome inhibitors in development target only specific sensor proteins (primarily NLRP3) with a small molecule.

•        Of the three potential target components of the inflammasome described above, i) sensor molecules (e.g. NLRP3), ii) adaptor ASC, and iii) pro-caspase/caspase-1, IC 100’s target, ASC, has potential to be the most effective target because:

•        Inhibition of sensor molecules (e.g. NLRP3) blocks only intracellular inflammasome formation, whereas inhibition of ASC both blocks intracellular inflammasome formation and disrupts structure and subsequent function of intracellular and extracellular ASC Specks to block perpetuation of the inflammatory response; and

•        Sensor molecules (e.g. NLRP3) are each associated with only one type of inflammasome, whereas the adaptor protein ASC, a common component of inflammasomes, is associated with numerous different types of inflammasomes.

Figure 1: ASC, a common component of inflammasomes, is associated with several different types of inflammasomes.

Unlike NLRP3 inflammasome inhibitors, the Larkspur Board considered it a key differentiating feature that IC 100 targets more than one type of inflammasome via ASC inhibition as multiple types of inflammasomes are implicated in a given disease or condition and that such inhibition may be critical to achieve a meaningful anti-inflammatory therapeutic effect in a broad range of inflammatory conditions associated with activation of more than one type of inflammasome.

Disease/Condition		Inflammasomes Implicated		Reference
Multiple Sclerosis		AIM2, NLRP1, NLRP3, NLRC4		Soulika 2009; Maver 2017; Freeman 2017; Noroozi 2017; Soares 2019
Lupus Nephritis		AIM2, NLRP3		Choubey and Panchanathan 2017; Zhu 2021; Fu 2019
Diabetic Nephropathy		AIM2, NLRP3, NLRC4		Komada 2018; Hutton 2016; Yuan 2016
CNS Injury		AIM2, NLRP1, NLRP2, NLRP3		de Rivero Vaccari 2008, 2009, 2012; Abulafia 2009; Liu 2013; Bartolotti 2018; Ducza 2021
Alzheimer’s Disease		AIM2, NLRP1, NLRP3		Ahmed 2017; Venegas 2017; White 2017; Wu 2017; Lang 2018
Rheumatoid Arthritis		AIM2, NLRP1, NLRP3, NLRP6		Goh 2017; Addobbatti 2018; Li 2016; Sode 2015; Wang 2014; Ghimire 2020
Inflammatory Bowel Disease		AIM2, NLRP1, NLRP3, NLRP6, NLRC4		Vanhove 2015; Ratsimandresy 2017; Lazaridis 2017; Kanneganti 2017; Normand 2011; Levy 2015; Seregin 2017; Tye 2018; Williams 2018; Opipari and Franchi, 2015

Figure 2: Multiple types of inflammasomes implicated in several different disease types.

•        Targeting caspase-1 may be inadequate to achieve a therapeutic effect since it is associated with only one of the two inflammasome pathways, the canonical pathway (the non-canonical pathway is associated with caspase-4 and 5). In the absence of caspase 1, caspase 4 and 5 can still activate cytokines. Additionally, safety may be a concern with caspase-1 inhibitors, such as VX-740 (Pralnacasan) (analog is VX-765), which demonstrated liver toxicity in clinical trials for rheumatoid arthritis requiring suspension of the trial.

•        Targeting IL-1β, which is activated by caspase-1, may be inadequate to achieve a therapeutic effect since inhibition of IL-1β will not address inflammation associated with IL-18 or IL-1β-independent pyroptosis, which also releases cytokines, ASC specks, and alarmins into the extracellular space, heightening and perpetuating the damaging inflammatory response in neighboring cells and tissues.

•        Targeting ASC with IC 100 has further competitive advantages because, intracellularly, ASC polymerizes into long ASC filaments (ASC specks) that are crucial for inflammasome activation. ASC specks are released into the extracellular space following pyroptosis (cell death) with continued activation of pro-IL-1β, heightening and perpetuating the inflammatory response in neighboring cells and tissues. As such, IC 100 has potential to attenuate both initiation and perpetuation of inflammation.

•        Significant Preclinical Data for IC 100.    The Larkspur Board considered that ZyVersa has IND-enabling preclinical proof-of-concept data for MS and ARDS, and non-GLP toxicology and safety data in mice and non-human primates demonstrating no adverse safety signals at very high doses. Specifically, preclinical data demonstrated potential for the clinical development of IC 100 across multiple indications (multiple sclerosis (“MS”), acute respiratory distress syndrome (“ARDS”), spinal cord injury, and traumatic brain injury. Initial preclinical toxicology studies in rodents and non-human primates showed no significant safety issues at doses up to 300 mg/kg.

•        Significant Intellectual Property (“IP”) Protection for IC 100.    The Larkspur Board considered that ZyVersa has exclusive worldwide rights to an IP portfolio for IC 100 and a cell line technology licensed from InflamaCore, LLC (founded by IC 100 inventors/researchers at the University of Miami Miller School of Medicine, who licensed the IP from the University and Selexis SA, a cell line development company in Switzerland). The IP portfolio for IC 100 covers both therapeutics and diagnostics. There are currently five patent families covering composition of matter, biomarkers, and method-of-use patents. There are six issued patents in the US, EP, CA and JP and 36 patent applications pending world-wide. A Notice of Allowance has been received for a composition-of-matter patent, which is valid at least until December 28, 2037. ZyVersa has the potential to continue to actively file patents related to formulations in development, dosing regimens, administration routes, and new indications.

•        VAR 200 Supported by Favorable Macro Trends.    The Larkspur Board considered the recent trends in public health initiatives to improve identification of populations at risk and those in early stages of kidney disease, which indicate a need for VAR 200. Specifically, the HHS’ Advancing American Kidney Health Initiative (2019) is a program with three goals: to reduce the number of patients developing renal failure through better diagnosis, treatment, and preventative care; to maximize the provision of home dialysis care; and to expand the pool of kidneys available for transplant. The Larkspur Board considered that VAR 200 potentially addresses the first of these goals.

Another trend is the increasingly sophisticated diagnostics that are carving out niches with smaller, yet significant, renal indications. These niches include FSGS (focal segmental glomerulosclerosis) and Alport Syndrome, both of which are a focus of ZyVersa’s VAR 200.

Lastly, no disease-modifying drugs (i.e., treatments or interventions that affect the underlying pathophysiology of the disease and have a beneficial outcome on its course) that substantially slow progression of CKD to end-stage disease are currently available.

Given these healthcare trends and initiatives, the Larkspur Board considered that renal therapies will likely come into increasing focus in coming quarters, and that VAR 200 will be well-positioned to capitalize on these developments.

•        Compelling Value Proposition with VAR 200.    The Larkspur Board considered the following contributed to create a compelling value proposition with respect to VAR 200;

•        A large body of clinical and experimental studies support that altered lipid metabolism may contribute to the pathogenesis and progression of kidney disease and that accumulation of renal lipids has been observed in several conditions of genetic and nongenetic origins, linking local fat to the pathogenesis of kidney disease. (Excess intracellular glomerular lipids accumulation contributes to kidney damage and disfunction, Am J Physiol Renal Physiol. 2016 Mar 15; 310(6): F433 — F445).

•        Pre-clinical data in three different animal models of kidney disease (FSGS, Alport syndrome, diabetic kidney disease) has shown that VAR 200 has the potential to extract excess intracellular renal lipids for metabolism and excretion. As such, VAR 200 has a strong value proposition since it has the potential to be the first kidney disease-modifying drug that inhibits pathogenic glomerular lipid accumulation to mediate progression of glomerular injury, reduce proteinuria, and thereby delay kidney disease progression.

•        The clinical program was both accelerated and de-risked via the U.S. Food and Drug Administration (“FDA”) concurrence that, based upon the preclinical data and the human safety data of 2HPβCD as an excipient ZyVersa did not need to conduct a Phase 1 clinical study and could move directly into a Phase 2a evaluation.

•        An IND for VAR 200 is active, and initiation of an Investigator Initiated Trial (IIT) dosing patients with renal disease is expected to begin in 2022. As a cholesterol efflux mediator, VAR 200 offers potential for indication expansion beyond ZyVersa’s initial focus on orphan indications of FSGS and Alport syndrome, into a range of larger non-orphan kidney disease indications, including diabetic kidney disease and other forms of chronic kidney diseases.

•        Competitive Advantages of VAR 200.    The Larkspur Board considered the fact that ZyVersa’s VAR 200 has several distinct proprietary competitive advantages.

•        VAR 200 has a highly differentiated MOA in that it is the only product in development that mediates the removal of excess renal intracellular lipids that contribute to kidney damage and dysfunction. Intracellular podocyte lipid accumulation from reduced cholesterol efflux causes podocyte injury and flattened foot processes leading to proteinuria (elevated protein in the urine). Proteinuria is strongly associated with kidney disease progression, and it is predictive of a poor prognosis.

•        Because 2HPβCD has a demonstrated safety profile from decades of use as an excipient in marketed drugs, VAR 200 received clearance from the U.S. Food and Drug Administration (FDA) to proceed to a Phase 2a study in adult as well as pediatric FSGS patients.

•        Significant Preclinical Data for VAR 200.    The Larkspur Board considered that VAR 200 has preclinical proof-of-concept data in 3 different animal models of kidney disease (FSGS, Alport syndrome, diabetic kidney disease), supporting clinical trials for each indication.

•        Significant IP Protection for VAR 200.    The Larkspur Board considered that pursuant to the license agreement with L&F Research LLC (founded by VAR 200 inventors/researchers at the University of Miami Miller School of Medicine, who licensed the IP from the University), VAR 200 has potential for seven years of orphan drug exclusivity for FSGS and Alport Syndrome in the US, ten years in the EU, and an exclusive worldwide license to IP related to use of 2HPβCD for treatment of kidney diseases in humans, including FSGS, as described in certain method-of-use patents and pending applications filed in the United States and selected foreign countries (Canada, China, Europe, Japan, and Mexico). Current method of use patent terms are valid to 2031, 2032, and 2033. New patent applications are planned to expand the scope of protection throughout development of VAR 200 (e.g., related to new formulations, including SubQ formulations in development, dosing regimens and administration routes).

•        Financial Condition.    The Larkspur Board also considered factors such as ZyVersa’s historical financial results, outlook and expansion opportunities, and financial plan. In considering those factors, Larkspur’s Board reviewed ZyVersa’s historical finances and its current prospects for growth if ZyVersa achieves its business plan. In reviewing those factors, the Larkspur Board determined that ZyVersa is well-positioned for strong future growth.

•        Experienced and Proven Management Team.    The Larkspur Board considered the fact that ZyVersa was co-founded and is led by a CEO with a proven track record of successfully building biopharmaceutical companies and who has assembled a strong management team led by a mix of seasoned life science and technology employees. The senior management of ZyVersa intends to remain with ZyVersa in the capacity of officers and/or directors, providing helpful continuity in advancing ZyVersa’s strategic and growth goals.

•        Mr. Glover, Co-Founder, President and CEO of ZyVersa, has extensive experience building successful biopharmaceutical companies, with a focus on pharmaceutical business strategy, corporate development, product development, commercialization and business optimization. His experience spans Fortune 100, start-up and entrepreneurial environments and his transaction experience covers over 25 transactions totaling over $10 billion. His strategic and operational experience, which covers most therapeutic classes of biopharmaceuticals, includes strategic planning, corporate development, operations management, product development, clinical and regulatory, product marketing and sales management. Prior to co-founding ZyVersa, Mr. Glover was Co-Founder and Chief Business Officer of Coherus BioSciences, a late-stage commercial biologics platform Company focused on delivering biosimilar therapeutics which went public in 2014. Previously, he was President of Insmed Therapeutic Proteins and EVP and Chief Business Officer of Insmed Incorporated, where

he was responsible for the creation of its biosimilar business unit and sale of that business to Merck and led the strategic review process that resulted in the merger of Insmed and Transave. Prior to joining Insmed, Mr. Glover held senior-level positions in sales, marketing and operations at Andrx Corporation, Roche Laboratories, Amgen and IMS Health.

The Larkspur Board also considered a number of other factors pertaining to the Business Combination as generally supporting its decision to enter into the Business Combination Agreement and the transactions contemplated thereby, including, but not limited to, the following material factors:

•        Due Diligence.    Due diligence examinations of ZyVersa and discussions with ZyVersa’s management and Larkspur’s management team, business advisors and legal advisors concerning Larkspur’s due diligence examination of ZyVersa;

•        Negotiated Transaction.    The financial and other terms of the Business Combination Agreement and the fact that such terms and conditions are reasonable and were the product of arm’s-length negotiations between Larkspur and ZyVersa;

•        Lock-Up.    The ZyVersa founders and senior management of ZyVersa have agreed to be subject to a 180-day lock-up in respect of their New ZyVersa Common Stock subject to early release upon achievement of a specified price target for New ZyVersa Common Stock (see “The Business Combination Agreement — Related Agreements — Lock-Up Agreement” and “Description of New ZyVersa’s Securities”);

•        Fairness Opinion.    The financial analyses of Cassel Salpeter reviewed with the Board on July 14, 2022 and the opinion of Cassel Salpeter, dated as of July 14, 2022, as to the fairness, from a financial point of view, of the Merger Shares to be issued by the Company, in the aggregate, in the Business Combination pursuant to the Business Combination Agreement; and

•        Other Alternatives.    The Larkspur Board believes, after a thorough review of other business combination opportunities reasonably available to Larkspur, that the proposed Business Combination represents the best potential business combination for Larkspur and the most attractive opportunity for Larkspur’s management to accelerate its business plan based upon the process utilized to evaluate and assess other potential acquisition targets, and the Larkspur Board believes that such process has not presented a better alternative.

The Larkspur Board also considered a variety of uncertainties and risks and other potentially negative factors concerning the Business Combination, including, but not limited to, the following:

•        Early Stage Company and Limited Operating History.    The fact that ZyVersa is an early-stage company with a history of losses and a limited operating history, and previously had a material weakness in its internal control over financial reporting arising from an accumulation of significant deficiencies relating to, among other things, its limited accounting and financial reporting personnel and insufficient segregation of duties;

•        Growth Initiatives May Not be Achieved.    The risk that ZyVersa’s growth initiatives may not be fully achieved or may not be achieved within the expected timeframe.

•        Intellectual Property Risk.    The risk that ZyVersa may not have adequate intellectual property rights to carry out its business, may need to defend itself against patent, copyright, trademark, trade secret or other intellectual property infringement or misappropriation claims, and may need to enforce its intellectual property rights from unauthorized use by third parties;

•        Regulatory Risk.    The risk that are associated with ZyVersa operating in the highly-regulated healthcare industry. Failure to comply with regulations or laws could subject ZyVersa to significant regulatory risk, including the risk of litigation, regulatory actions and compliance issues that could subject ZyVersa to significant fines, penalties, judgments, remediation costs, negative publicity and requirements resulting in increased expenses;

•        Macroeconomic Risks.    Macroeconomic uncertainty, including the continuing impacts of the COVID-19 pandemic, and the effects it could have on the Post-Combination Company’s revenues.

•        Redemption Risk.    The potential that a significant number of Larkspur public shareholders elect to redeem their shares prior to the consummation of the Business Combination and pursuant to the Existing Organizational Documents, which would potentially make the Business Combination more difficult or impossible to complete;

•        Shareholder Vote.    The risk that Larkspur public shareholders may fail to provide the respective votes necessary to effect the Business Combination;

•        Closing Conditions.    The fact that the completion of the Business Combination is conditioned on the satisfaction of certain closing conditions that are not within Larkspur’s control;

•        Litigation.    The possibility of litigation challenging the Business Combination or that an adverse judgment granting permanent injunctive relief could indefinitely enjoin consummation of the Business Combination;

•        Listing Risks.    The challenges associated with preparing ZyVersa, a private entity, for the applicable disclosure and listing requirements to which New ZyVersa will be subject as a publicly traded company on Nasdaq;

•        Benefits May Not Be Achieved.    The risks that the potential benefits of the Business Combination may not be fully achieved or may not be achieved within the expected timeframe;

•        Liquidation of Larkspur.    The risks and costs to Larkspur if the Business Combination is not completed, including the risk of diverting management focus and resources from other business combination opportunities;

•        Costs Savings and Growth Initiatives May Not be Achieved.    The risk that the cost savings and growth initiatives may not be fully achieved or may not be achieved within the expected timeframe;

•        Larkspur Public Shareholders Receiving a Minority Position in New ZyVersa.    The risk that Larkspur public shareholders will hold a minority position in New ZyVersa;

•        Evolving Regulatory Regime Governing Special Purpose Acquisition Companies.    The risk that regulation of special purpose acquisition companies continues to evolve and the SEC, Nasdaq and other regulators may revisit and update their laws, regulations and policies; and

•        Fees and Expenses.    The fees and expenses that are associated with completing the Business Combination.

In addition to considering the factors described above, the Larkspur Board also considered other factors including, without limitation:

•        Interests of Certain Persons.    Some officers and directors of Larkspur may have interests in the Business Combination (see “— Interests of Larkspur’s Directors and Officers in the Business Combination” and “Risk Factors — Risks Related to the Business Combination and Larkspur — Some of Larkspur’s officers and directors may have conflicts of interest that may influence or have influenced them to support or approve the Business Combination without regard to your interests or in determining whether New ZyVersa is appropriate for Larkspur’s initial business combination.”); and

•        Other Risk Factors.    Various other risk factors associated with the business of ZyVersa, as described in the section entitled “Risk Factors” appearing elsewhere in this proxy statement/prospectus.

The Larkspur Board concluded that the potential benefits that it expects Larkspur and its shareholders to achieve as a result of the Business Combination outweighed the potentially negative and other factors associated with the Business Combination. The Larkspur Board also noted that Larkspur public shareholders would have a substantial economic interest in New ZyVersa (depending on the level of Larkspur public shareholders that sought redemption of their public shares for cash). Accordingly, the Larkspur Board determined that the Business Combination and the transactions contemplated by the Business Combination Agreement were advisable and in the best interests of Larkspur and its shareholders.

Opinion of Cassel Salpeter & Co., LLC

Opinion of Financial Advisor to the Larkspur Board

On July 14, 2022, Cassel Salpeter rendered its oral opinion to the Larkspur board (which was confirmed in writing by delivery of Cassel Salpeter’s written opinion dated such date), to the effect that, as of July 14, 2022, the shares of Larkspur common stock to be issued by Larkspur, in the aggregate (the “Aggregate Merger Shares”), in the Business Combination pursuant to the Business Combination Agreement was fair, from a financial point of view, to Larkspur.

The summary of the opinion in this proxy statement/prospectus is qualified in its entirety by reference to the full text of the written opinion, which is included as Annex G to this proxy statement/prospectus and sets forth the procedures followed, assumptions made, qualifications and limitations on the review undertaken and other matters considered by Cassel Salpeter in preparing its opinion. However, neither Cassel Salpeter’s written opinion nor the summary of its opinion and the related analyses set forth in this proxy statement/prospectus are intended to be, and do not constitute, advice or a recommendation to any stockholder as to how such stockholder should act or vote with respect to any matter relating to the proposed Business Combination or otherwise, including, without limitation, whether any such stockholder should redeem its shares or any party should participate in the PIPE.

The opinion was addressed to the Larkspur Board for the use and benefit of the members of the Larkspur Board (in their capacities as such) in connection with the Larkspur Board’s evaluation of the Business Combination. Cassel Salpeter’s opinion was just one of the several factors the Larkspur Board took into account in making its determination to approve the Business Combination, including those described elsewhere in this proxy statement/prospectus.

Cassel Salpeter’s opinion only addressed whether, as of the date of the opinion, the Aggregate Merger Shares to be issued in the Business Combination in the aggregate pursuant to the Business Combination Agreement was fair, from a financial point of view, to Larkspur. It did not address any other terms, aspects, or implications of the Business Combination, the Business Combination Agreement or any related or other transaction or agreement, including, without limitation, (i) other than assuming the consummation thereof, the PIPE Investment or the conversion of ZyVersa preferred stock into shares of ZyVersa common stock; (ii) the Shareholder Support Agreement, the Lock-Up Agreement, and the Amended and Restated Registration Rights Agreement to be entered into in connection with, and as described in, the Business Combination Agreement, (iii) any term or aspect of the Business Combination that is not susceptible to financial analysis, (iv) the fairness of the Business Combination, or all or any portion of the Aggregate Merger Shares, to any security holders of Larkspur, ZyVersa or any other person or any creditors or other constituencies of Larkspur, ZyVersa or any other person, (v) the appropriate capital structure of Larkspur or ZyVersa or whether Larkspur should be issuing debt or equity securities or a combination of both in the Business Combination, (vi) any capital raising or financing transaction contemplated by Larkspur or the Company, including, without limitation, the PIPE Investment, nor (vi) the fairness of the amount or nature, or any other aspect, of any compensation or consideration payable to or received by any officers, directors, or employees of any parties to the Business Combination, or any class of such persons, relative to the Aggregate Merger Shares, or otherwise. The opinion also did not address whether the Aggregate Merger Shares to be issued in the Business Combination in the aggregate pursuant to the Business Combination Agreement was fair, from a financial point of view, to the unaffiliated stockholders of Larkspur. Cassel Salpeter did not express any opinion as to what the value of shares of Larkspur Class A Stock, Larkspur Class B Stock or any other security of Larkspur actually will be when issued in the Business Combination or the prices at which shares of Larkspur Class A Stock, Larkspur Class B Stock, or any other securities of Larkspur or ZyVersa could trade, be purchased or sold at any time.

Cassel Salpeter’s opinion did not address the relative merits of the Business Combination as compared to any alternative transaction or business strategy that might have existed for Larkspur, or the merits of the underlying decision by the Larkspur Board or Larkspur to engage in or consummate the Business Combination. The financial and other terms of the Business Combination were determined pursuant to negotiations between the parties to the Business Combination Agreement and were not determined by or pursuant to any recommendation from Cassel Salpeter. In addition, Cassel Salpeter was not authorized to, and did not, solicit indications of interest from third parties regarding a potential transaction involving Larkspur.

Cassel Salpeter was not requested to, and did not, (a) initiate or participate in any discussions or negotiations with respect to the Acquisition Merger, the securities, assets, businesses or operations of Larkspur, ZyVersa or any other party, or any alternatives to the Acquisition Merger, (b) negotiate the terms of the Business Combination, or (c) advise the Larkspur Board, Larkspur or any other party with respect to alternatives to the Business Combination. Cassel Salpeter’s analyses and opinion were necessarily based upon market, economic, and other conditions as they existed on, and could be evaluated as of, the date of Cassel Salpeter’s opinion and upon certain assumptions regarding such financial, economic, market and other conditions, which were subject to unusual volatility and which, if different than assumed, could have a material impact on Cassel Salpeter’s analyses and opinion. Accordingly, although subsequent developments could arise that would otherwise affect its opinion, Cassel Salpeter did not assume any obligation to update, review, or reaffirm its opinion to Larkspur or any other person or otherwise to comment on or consider events occurring or coming to Cassel Salpeter’s attention after the date of its opinion.

In arriving at its opinion, Cassel Salpeter made such reviews, analyses, and inquiries as Cassel Salpeter deemed necessary and appropriate under the circumstances. Among other things, Cassel Salpeter:

Reviewed a draft, dated July 13, 2022, of the Business Combination Agreement.

Reviewed certain publicly available financial information and other data with respect to Larkspur and ZyVersa that Cassel Salpeter deemed relevant.

Reviewed certain other information and data with respect to Larkspur and ZyVersa made available to Cassel Salpeter by Larkspur and ZyVersa, including projections for the years ending December 31, 2022, 2023 and 2024 with respect to the future financial performance of ZyVersa prepared by management of ZyVersa (referred to in this section as the “Projections”) and other internal financial information furnished to Cassel Salpeter by or on behalf of Larkspur and ZyVersa.

Considered and compared the financial and operating performance of ZyVersa with that of companies with publicly traded equity securities that Cassel Salpeter deemed relevant.

Considered the publicly available financial terms of certain transactions that Cassel Salpeter deemed relevant.

Discussed the business, operations, and prospects of ZyVersa and the proposed Business Combination with Larkspur’s and ZyVersa’s managements and certain of Larkspur’s and ZyVersa’s representatives.

Conducted such other analyses and inquiries, and considered such other information and factors, as Cassel Salpeter deemed appropriate.

For purposes of its analyses and opinion, Cassel Salpeter, at Larkspur’s direction, assumed that (i) each share of SPAC Class A Stock had a value equal to $10.00 (with such $10.00 value being based on the approximate cash per outstanding share of SPAC Class A Stock (excluding, for the avoidance of doubt, the dilutive impact of outstanding shares of SPAC Class B Stock that were not issued in Larkspur’s initial public offering or any warrants to purchase SPAC Common Stock), and (ii) the Aggregate Merger Shares would consist of 8,500,000 shares of SPAC Class A Stock with an aggregate value of $85,000,000.

In arriving at its opinion, Cassel Salpeter, with Larkspur’s consent, relied upon and assumed, without independently verifying, the accuracy and completeness of all of the financial and other information that was supplied or otherwise made available to it or available from public sources, and Cassel Salpeter further relied upon the assurances of Larkspur’s and the Company’s management that they were not aware of any facts or circumstances that would have made any such information inaccurate or misleading. Cassel Salpeter also relied upon, without independent verification, the assessments of the management of Larkspur and ZyVersa as to the ZyVersa’s existing and future technology, products, projects, and services (including, without limitation, the development, testing, marketing, and life of such technology, products, projects, and services), and Cassel Salpeter assumed, at Larkspur’s direction, that there will be no developments with respect to any such matters that would adversely affect its analysis and opinion. Cassel Salpeter is not a legal, tax, accounting, environmental, regulatory, technology or science advisor, and Cassel Salpeter did not express any views or opinions as to any legal, tax, accounting, environmental, regulatory, technology or science matters relating to Larkspur, ZyVersa, the Business Combination, or otherwise. Cassel Salpeter understood and assumed that the Larkspur Board had obtained or would obtain such advice as it deemed necessary or appropriate from qualified legal, tax, accounting, environmental, regulatory, technology, science and other professionals, that such advice was sound and reasonable and that the Larkspur Board and Larkspur had acted or would act in accordance with such advice.

Larkspur advised Cassel Salpeter and Cassel Salpeter assumed that the Projections were reasonably prepared on a basis reflecting the best currently available estimates and judgments of the management of ZyVersa with respect to the future financial performance of ZyVersa, and Cassel Salpeter assumed, at Larkspur’s direction, that the Projections provided a reasonable basis upon which to analyze and evaluate ZyVersa and form an opinion. At Larkspur’s direction, Cassel Salpeter used and relied upon the Projections for purposes of its analyses and opinion. Cassel Salpeter expressed no view or opinion with respect to the Projections or the assumptions on which they were based. In reaching its conclusions hereunder, Cassel Salpeter did not perform a risk-adjusted net present value analysis of ZyVersa, because Larkspur advised Cassel Salpeter and Cassel Salpeter assumed, forecasts with respect to the future financial performance of ZyVersa reflecting the best currently available estimates and judgments of the management of ZyVersa or Larkspur were not available for the period beyond December 31, 2024 or for any period with sufficient detail to conduct a risk-adjusted net present value analysis. Cassel Salpeter did not evaluate the solvency or creditworthiness of Larkspur, ZyVersa or any other party to the Business Combination, the fair value of Larkspur, ZyVersa or any of their respective assets or liabilities, or whether Larkspur, ZyVersa or any other party to the Business Combination is paying or receiving reasonably equivalent value in the Business Combination under any applicable foreign, state, or federal laws relating to bankruptcy, insolvency, fraudulent transfer, or similar matters, nor did Cassel Salpeter evaluate, in any way, the ability of Larkspur, ZyVersa or any other party to the Business Combination to pay its obligations when they come due. Cassel Salpeter did not physically inspect Larkspur’s or ZyVersa’s properties or facilities and did not make or obtain any evaluations or appraisals of Larkspur’s or ZyVersa’s assets or liabilities (including any contingent, derivative, or off-balance-sheet assets and liabilities). Cassel Salpeter did not attempt to confirm whether Larkspur or ZyVersa had good title to their respective assets. Cassel Salpeter’s role in reviewing any information was limited solely to performing such reviews as it deemed necessary to support its own advice and analysis and was not on behalf of the Larkspur Board, Larkspur, or any other party.

Cassel Salpeter assumed, with Larkspur’s consent, that the Business Combination would be consummated in a manner that complies in all respects with applicable foreign, federal, state, and local laws, rules, and regulations and that, in the course of obtaining any regulatory or third party consents, approvals, or agreements in connection with the Business Combination, no delay, limitation, restriction, or condition would be imposed that would have an adverse effect on Larkspur, ZyVersa or the Business Combination. Cassel Salpeter also assumed, with Larkspur’s consent, that the final executed form of the Business Combination Agreement would not differ in any material respect from the draft Cassel Salpeter reviewed and that the Acquisition Merger would be consummated on the terms set forth in the Business Combination Agreement, without waiver, modification, or amendment of any term, condition, or agreement thereof that would be material to its analyses or opinion. Cassel Salpeter also assumed that the representations and warranties of the parties to the Business Combination Agreement contained therein were true and correct and that each such party would perform all of the covenants and agreements to be performed by it under the Business Combination Agreement. Cassel Salpeter offered no opinion as to the contractual terms of the Business Combination Agreement or the likelihood that the conditions to the consummation of the Business Combination set forth in the Business Combination Agreement would be satisfied. Larkspur also advised Cassel Salpeter, and Cassel Salpeter assumed, that for U.S. federal tax income purposes the Business Combination would qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended.

In connection with preparing its opinion, Cassel Salpeter performed a variety of financial analyses. The following is a summary of the material financial analyses performed by Cassel Salpeter in connection with the preparation of its opinion. It is not a complete description of all analyses underlying such opinion. The preparation of an opinion is a complex process involving various determinations as to the most appropriate and relevant methods of financial analysis and the application of those methods to the particular circumstances. As a consequence, neither Cassel Salpeter’s opinion nor the respective analyses underlying its opinion is readily susceptible to partial analysis or summary description. In arriving at its opinion, Cassel Salpeter assessed as a whole the results of all analyses undertaken by it with respect to the opinion. While it took into account the results of each analysis in reaching its overall conclusions, Cassel Salpeter did not make separate or quantifiable judgments regarding individual analyses and did not draw, in isolation, conclusions from or with regard to any individual analysis or factor. Therefore, Cassel Salpeter believes that the analyses underlying the opinion must be considered as a whole and that selecting portions of its analyses or the factors it considered, without considering all analyses and factors underlying the opinion collectively, could create a misleading or incomplete view of the analyses performed by Cassel Salpeter in preparing the opinion.

The implied valuation reference ranges indicated by Cassel Salpeter’s analyses are not necessarily indicative of actual values nor predictive of future results, which may be significantly more or less favorable than those suggested by such analyses. Much of the information used in, and accordingly the results of, Cassel Salpeter’s analyses are inherently subject to substantial uncertainty.

Summary of Material Financial Analyses.

The following summary of the material financial analyses performed by Cassel Salpeter in connection with the preparation of its opinion includes information presented in tabular format. The tables alone do not constitute a complete description of these analyses. Considering the data in the tables below without considering the full narrative description of the analyses, as well as the methodologies and assumptions underlying the analyses, could create a misleading or incomplete view of the financial analyses Cassel Salpeter performed.

For purposes of its analyses and opinion Cassel Salpeter, at Larkspur’s direction, assumed that (i) each share of SPAC Class A Stock had a value equal to $10.00 (with such $10.00 value being based on the approximate cash per outstanding share of SPAC Class A Stock (excluding, for the avoidance of doubt, the dilutive impact of outstanding shares of SPAC Class B Stock that were not issued in Larkspur’s initial public offering or any warrants to purchase SPAC Common Stock), and (ii) the Aggregate Merger Shares consisted of 8,500,000 shares of SPAC Class A Stock with an aggregate value of $85,000,000.

Share prices for the selected companies used in the selected companies analysis described below were as of July 12, 2022. Estimates of financial performance for the selected companies listed below were based on publicly available research analyst estimates for those companies. Estimates of financial performance for ZyVersa were based on the Projections.

Selected Companies Analysis.    Cassel Salpeter considered certain financial data for ZyVersa and selected companies with publicly traded equity securities Cassel Salpeter deemed relevant in its professional judgement due to among other things similarities, for purposes of its analyses, of the selected companies with ZyVersa in one or more respects. The financial and operating data reviewed included market value, total invested capital, cash as a percentage of total invested capital, estimated 2022 revenue and estimated 2023 revenue. The selected companies with publicly traded equity securities and the resulting high, low, mean and median financial data were:

•        ChemoCentryx, Inc.

•        Travere Therapeutics, Inc.

•        Reata Pharmaceuticals, Inc.

•        FibroGen, Inc.

•        Chinook Therapeutics, Inc.*

•        CinCor Pharma, Inc.*

•        Akebia Therapeutics, Inc.

•        Tricida, Inc.

•        DiaMedica Therapeutics Inc.*

•        Angion Biomedica Corp.*

•        Trevi Therapeutics, Inc.*

•        Regulus Therapeutics Inc.*

•        Unicycive Therapeutics, Inc.*

•        XORTX Therapeutics Inc.*

•        Immunic, Inc.*

•        MediciNova, Inc.*

•        NervGen Pharma Corp.*

•        Edesa Biotech, Inc.

____________

*        Companies with less than $10,000 2003E Revenue

(Dollars in Thousands)		Market Value			Total Invested Capital			Cash/Total Invested Capital			2023E Revenue			2024E Revenue
All Selected Companies
High		$	1,652,514		$	2,020,006		198.4	%		$	323,509		$	400,807
Mean			487,404			552,581		62.9	%			64,038			91,188
Median			121,350			137,727		44.0	%			2,518			17,589
Low			12,925			13,194		12.8	%			—			—
Selected Companies with Less Than $10,000 2023 E Revenue
High		$	1,111,081		$	1,154,123		198.4	%		$	4,550		$	27,106
Mean			225,557			232,007		78.7	%			1,001			6,498
Median			77,217			77,217		78.9	%			—			—
Low			12,925			13,194		12.8	%			—			—

The selected companies analysis indicated an implied value reference range for ZyVersa of $75,000,000 to $95,000,000 as compared to the assumed value of the Aggregate Merger Shares of $85,000,000.

None of the selected companies have characteristics identical to ZyVersa. An analysis of selected publicly traded companies is not mathematical; rather it involves complex consideration and judgments concerning differences in financial and operating characteristics of the selected companies and other factors that could affect the public trading values of the companies reviewed.

Selected Transactions Analysis.    Cassel Salpeter considered the financial terms of the following business transactions Cassel Salpeter deemed relevant in its professional judgement due to among other things similarities, for purposes of its analyses, of the target companies with ZyVersa in one or more respects. The financial data reviewed included the up front consideration, the announced milestone consideration and the sum of the up-front consideration and the announced milestone consideration (the “combined consideration”), in each case payable in the subject transaction. The selected transactions and the resulting high, low, mean and median financial data were:

Date		Target		Acquiror
15-Dec-20		Prevail Therapeutics Inc.		Eli Lilly and Company
15-Oct-20		Disarm Therapeutics, Inc.		Eli Lilly and Company
21-Sep-20		Inflazome Ltd.		Roche Holding AG (SWX:ROG)
7-Sep-20		Alkahest, Inc.		Grifols, S.A.
1-Apr-19		IFM Tre, Inc.		Novartis AG (SWX:NOVN)
14-Jan-19		inRegen/Twin City Bio, LLC		ProKidney LLC
9-Oct-18		Vector Neurosciences Inc.		MeiraGTx Holdings plc
11-Jul-18		Visterra, Inc.		Otsuka America, Inc.
28-Jun-18		Keryx Biopharmaceuticals, Inc.		Akebia Therapeutics, Inc.
3-Aug-17		IFM Therapeutics, LLC		Bristol-Myers Squibb Company (NYSE:BMY)
22-Nov-16		Chase Pharmaceuticals Corporation, Inc.		Allergan plc

(Dollars in Thousands)
Business Transactions		Up Front			Milestone			Total
High		$	782,690		$	2,020,000		$	2,320,000
Mean			318,395			506,732			825,127
Median			300,000			21,300			630,550
Low			2,680						23,980