•        If we receive approval for a product candidate that is not subject to our distribution agreement with Fresenius Medical Care, and we are unable to establish our own marketing, sales and distribution capabilities or are unable to enter into agreements with third parties do so, we may not be able to generate product revenue and will have to alter our development and commercialization plans.

•        The outbreak of COVID-19 may continue to adversely impact our business, including our manufacturing efforts, and our preclinical studies and clinical trials.

•        The manufacture of our product candidates is complex, we have not manufactured commercial product, and we may encounter difficulties in production. If we or any third-party manufacturer encounter such difficulties, our ability to supply our product candidates for clinical trials or, if approved, for commercial sale could be delayed or halted entirely.

•        We may be unable to demonstrate comparability between HAVs manufactured using the AURA system and HAVs manufactured using the LUNA200 system. Failure to demonstrate such comparability could adversely affect our ability to secure regulatory approval for our product candidates.

•        We rely on third parties to conduct and support our clinical trials, and those third parties may not perform satisfactorily, including by failing to adhere to regulatory requirements or our stated protocols or to meet deadlines for the completion of such trials.

•        We rely on third-party suppliers, including sole source suppliers, to provide certain components for our product candidates. Any failure by a third-party supplier to supply these components for manufacture may delay or impair our ability to complete our clinical trials and to commercialize our product candidates.

•        We intend to rely on our strategic, global partnership with Fresenius Medical Care to undertake, or assist with, the marketing, sale and distribution of certain of our product candidates if we receive marketing approval from relevant regulatory authorities. Disruption of this arrangement could materially adversely affect our business, prospects, operating results and financial condition.

•        Our ability to successfully commercialize our products may be impaired if we are unable to obtain and maintain effective intellectual property rights for our proprietary scientific technology platform and product candidates.

Risks Related to the Business Combination

•        The opinion of Lake Street, AHAC’s financial advisor, does not reflect changes in circumstances between February 16, 2021, the date Lake Street issued the opinion, and the Closing.

•        The exercise of AHAC’s directors’ and 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 such changes to the terms of the Business Combination or waivers of conditions are appropriate and in the best interests of AHAC’s stockholders.

•        If AHAC is unable to complete the Business Combination with Humacyte or another business combination by September 22, 2022 (or such later date as may be approved by AHAC’s stockholders), AHAC will cease all operations except for the purpose of winding up, redeeming 100% of the outstanding Public Shares for cash and, subject to the approval of its remaining stockholders and its Board, dissolving and liquidating. In such event, third parties may bring claims against AHAC and, as a result, the proceeds held in the Trust Account could be reduced and the per-share liquidation price received by stockholders could be less than $10.00 per share.

•        There is no guarantee that a Public Stockholder’s decision whether to redeem their Public Shares for a pro rata portion of the Trust Account will put the stockholder in a better future economic position.

•        Subsequent to the Closing, New Humacyte 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, results of operations and stock price, which could cause you to lose some or all of your investment.

Risks Related to Humacyte’s Business and Industry

Risks Related to the Development and Commercialization of Our Product Candidates

If our clinical trials fail to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States or do not otherwise produce favorable results, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates. If we experience significant delays or significant additional costs, our business will be materially harmed.

As with all regulated biologics, before obtaining marketing approval for any of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive and time-consuming, and its outcomes are uncertain. We believe the novelty of our research and development efforts, which are focused on the development of bioengineered human, acellular, tissue-based vessels for use across a wide spectrum of applications in vascular surgery, augments this uncertainty. The scientific discoveries that form the basis for our efforts to develop our product candidates are relatively new, and the scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. At this time, no products based on HAVs have been approved in the United States or in Europe. The clinical trial requirements of the FDA and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential product, and we may not succeed in obtaining marketing approval even if we view our clinical trials as successful. Data obtained from preclinical and clinical activities, and manufacturing comparability studies, are also subject to varying interpretations, which may delay, limit or prevent marketing approval. In such circumstances, we could experience significant delays, or be prevented from, developing or commercializing our HAVs, and our business, prospects, operating results and financial condition could be materially harmed.

Our V006 trial did not meet its primary endpoint, and if we fail to achieve the primary endpoint of our other ongoing or future clinical trials, or if safety issues arise, or if our comparability demonstration between our former and new manufacturing process fails or is not accepted by the FDA, or if the results from our clinical trials are otherwise inadequate to support regulatory approval of our product candidates, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

Even if we receive FDA approval for our HAVs, we may face a number of difficulties if the results of our clinical trials are unfavorable, inconclusive, or only modestly favorable or if there are safety concerns, such as adverse events (“AEs”) or serious adverse events (“SAEs”), which could include clotting, mechanical failure, immunological rejection, or infection, that could outweigh potential benefits associated with such product candidates. This could result in:

•        obtaining approval for indications or patient populations that are not as broad as intended or desired;

•        obtaining approval with, or later becoming subject to, labelling that includes significant use or distribution restrictions or significant safety warnings;

•        being subject to a Risk Evaluation and Mitigation Strategy (“REMS”) or equivalent requirement from a comparable foreign regulatory agency, to ensure that the benefits of a biological product outweigh its risks or to change the way the product is used;

•        being required to perform additional clinical trials to support approval or comparability or being subject to additional post-marketing testing requirements;

•        having regulatory authorities withdraw their approval of the product;

•        being sued; or

•        suffering damage to our reputation.

Any of these events could cause us to incur significant additional costs, significant delays and prevent us from achieving or maintaining market acceptance of or commercializing one or more of our product candidates.

If we experience failures or delays in our preclinical and clinical programs, we would be prevented from developing and commercializing our product candidates in a timely matter, if at all.

A number of factors impact the timing of our preclinical and clinical programs and the development and commercialization of our product candidates. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. Events that prevent successful or timely completion of the development of our product candidates beyond unfavorable or inconclusive clinical trial results include, among others, the following:

•        delays in the testing, validation, manufacturing or delivery of our product candidates to the clinical sites;

•        delays in reaching — or inability to reach — agreement with the FDA or other regulatory agencies on trial design, including final confirmation from the FDA as to the parameters of our V005 trial;

•        delays in reaching agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical trial sites;

•        delays in obtaining required Institutional Review Board (“IRB”) approval at each clinical trial site;

•        delays in recruiting suitable patients in sufficient volume to participate in our clinical trials and in having those patients complete participation in our clinical trials or return for follow-up, including delays related to the ongoing COVID-19 pandemic;

•        the occurrence of SAEs associated with any of our product candidates that are viewed to outweigh their potential benefits;

•        imposition of a clinical hold by regulatory agencies, including after an inspection of our clinical trial sites;

•        failure by CROs, other third parties or us to adhere to clinical trial requirements;

•        failure to perform in accordance with the FDA’s good clinical practices (“GCP”) or current good tissue practices (“cGTP”), or applicable regulatory guidelines in other countries;

•        clinical trial sites dropping out of, or being removed from, a trial; or

•        changes in regulatory requirements and guidance that require amending or submitting new clinical protocols or data.

Any inability to successfully complete development of our product candidates would likely result in significant additional costs to us and impair our ability to generate revenue. Clinical trial delays could also allow our competitors to bring products to market before we do, which could materially impair our ability to successfully commercialize our product candidates and may harm our business and prospects.

Our progress in early stage clinical trials may not be indicative of long-term efficacy in late stage clinical trials, and our progress in trials for one product candidate may not be indicative of progress in trials for another product candidate.

The product candidates in our pipeline are at various stages of development. Trial designs and results from previous studies are not necessarily predictive of our future clinical trial designs or results, and initial results of ongoing trials may not be confirmed upon full analysis of the complete trial data. A number of companies in the biotechnology industry have suffered significant setbacks in late-stage clinical trials even after achieving promising results in earlier stage clinical trials, and we may experience similar setbacks. Favorable results in clinical trials for one of our product candidates also do not necessarily indicate that we will obtain positive results in clinical trials related to other product candidates. The novelty of our proprietary scientific technology platform adds another layer of risk that early-stage clinical trials may not be indicative of long-term efficacy in our late-stage clinical trials. If we are unable to demonstrate favorable results in future clinical trials for our various product candidates, we expect that our business, prospects, operating results and financial condition will be materially adversely affected.

Additionally, several of our past, planned and ongoing clinical trials utilize an “open-label” trial design. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate. Some open-label clinical trials test only the investigational product candidate without

a comparator. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The results from an open-label trial may not be predictive of future clinical trial results with any of our product candidates when studied in an environment with an active control.

Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose preliminary or topline data from our clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, although we may not have received or had the opportunity to fully and carefully evaluate all data at the time such preliminary or topline results are released. As a result, the topline or preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available, or as patients from our clinical trials continue other treatments for their disease. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

If the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition. In addition, the information we choose to publicly disclose regarding a particular clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure.

If SAEs occur or other unacceptable side effects are identified in our HAVs we may need to delay, abandon or limit development and marketing of our product candidates.

Our HAVs may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude us from obtaining marketing approval. The most frequently reported SAEs related to the HAV for hemodialysis access were vascular graft thrombosis, vascular graft complications, and venous stenosis, and the most frequently reported SAEs related to the HAV for PAD were vascular graft complication and graft thrombosis. If our HAVs are associated with undesirable side effects in clinical trials or have negative characteristics that are unexpected, we may need to perform additional clinical trials, abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Even if one of our product candidates is approved, the FDA and other regulatory authorities may take action to withdraw it from the market if serious safety concerns emerge. Any of these events could cause us to delay, abandon or limit the development and, if approved, marketing of our product candidates.

We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals.

We are currently enrolling patients in several clinical trials, including in our V005 trial, which is a Phase II/III clinical trial of our 6 millimeter HAV in traumatic vascular repair and our V007 trial, which is a Phase III clinical trial comparing the safety and efficacy of our 6 millimeter HAV to AV fistula for hemodialysis access. Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends in part on the rate at which we can recruit patients to participate in such trials. Additionally,

the COVID-19 pandemic has had and may continue to have a sustained impact on our ability to recruit and follow up with patients. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA and other regulatory authorities, and as such our product candidates could be delayed or otherwise adversely affected. Patient enrollment and trial completion is affected by many factors including the:

•        size of the patient population and process for identifying subjects;

•        availability of clinical trial research resources at clinical sites in the era of the COVID-19 pandemic;

•        availability of persons to provide or obtain patient consent for trial participation due to COVID-19 restrictions;

•        design of the trial protocol;

•        inclusion and exclusion criteria;

•        safety profile, to date, of the product candidate under study;

•        perceived risks and benefits of the product candidate under study;

•        availability of competing therapies and clinical trials;

•        severity of the disease under investigation;

•        degree of progression of the subject’s disease at the time of enrollment;

•        proximity and availability of clinical trial sites for prospective subjects;

•        the impact of the COVID-19 pandemic or future pandemics or similar events on patients’ willingness and ability to participate in clinical trials or on study site policies;

•        ability to obtain and maintain subject consent;

•        risk that enrolled subjects will drop out before completion of the trial;

•        patient referral practices of physicians; and

•        ability to monitor subjects adequately during and after treatment.

If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business, financial condition, results of operations and prospects.

Lack of experience by investigators and surgeons with our HAVs can lead to incorrect implantation or follow-up procedures which could harm the results of our clinical trials and market acceptance of our HAVs, if approved.

Our HAVs are currently in various stages of preclinical and clinical testing and have not been widely used. We do not have the personnel capacity to directly conduct or manage all of the clinical trials that are necessary for the development of our HAVs. Therefore, we rely, and will continue to rely, on third parties to assist us in managing, monitoring and conducting our clinical trials. Some of the investigators in our clinical trials have not been, and, if our HAVs receive marketing approval, surgeons may not be, previously exposed to the implantation and follow-up procedures related to their use. As a result, our HAVs may be, and have been in the past, incorrectly implanted and follow-up procedures may be performed incorrectly, resulting in violations of our trial protocols, increased interventions or failure of the HAV. Our efforts to educate investigators, surgeons and interventionalists regarding the proper techniques for use of our HAVs both during clinical trials and following potential commercialization may be costly, prove unsuccessful and could materially harm our ability to continue the clinical trials or marketing of our HAVs. Regulatory authorities may also seek to impose restrictive labeling or proactive communication obligations on any marketing approval granted for use of our HAVs as a result, which could reduce market acceptance of any of our HAVs that receive marketing approval.

Our near-term prospects are dependent on the success of our 6 millimeter HAV, and if we are unable to successfully develop and commercialize it, our business, operating results and financial condition will be materially harmed.

We currently have no products approved for sale and, while we are developing a number of product candidates, we have invested and continue to invest a substantial portion of our efforts and financial resources in the development of our 6 millimeter HAV. None of our remaining product geometries and modifications have advanced beyond preclinical development. As a result, in the near term we are dependent on the success of our 6 millimeter HAV, and if we are unable to successfully develop, obtain marketing approval for, and commercialize it, our business, along with our operating results and financial condition, will be materially harmed. Even if we succeed with the development of our 6 millimeter HAV, our ability to generate product revenue and become profitable from our 6 millimeter HAV depends on our assumptions regarding the relevant market opportunity, for which our estimates may prove inaccurate, and market acceptance in any approved indication, which may never occur.

We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates.

A key element of our strategy is to use our proprietary scientific technology platform to expand our pipeline of HAVs and to progress other product candidates into and through clinical development. We may not be able to identify or develop future product candidates that are safe and effective. Even if we are successful in building our pipeline, the potential product candidates that we identify may not be suitable for clinical development, including if they have harmful side effects or other characteristics that render them unlikely to receive marketing approval or achieve market acceptance. Research programs to identify new product candidates require substantial technical, financial and human resources, and we may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful. If we do not successfully develop and commercialize additional product candidates based upon our technology, we may have difficulty generating product revenue in the future, which could result in significant harm to our business, prospects, operating results and financial condition and adversely affect our stock price.

Even if our HAVs receive marketing approval in the future for one or more of our product candidates, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

Even with the requisite approvals from the FDA in the United States, the European Commission in the European Union (the “EU”) and other regulatory authorities internationally, the commercial success of our HAVs will depend, in part, on the acceptance of physicians, patients and health care payors, as medically necessary, cost-effective and safe. Any product that we commercialize may not gain acceptance by physicians, patients, health care payors and others in the medical community due to ethical, social, medical and legal concerns. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable.

The degree of market acceptance of any of our product candidates that receives marketing approval will depend on a number of factors, including:

•        the efficacy and potential advantages of our product candidates compared with alternative products or methods, including convenience and ease of administration;

•        the prices we charge for our products, if approved;

•        the availability of third-party coverage and adequate reimbursement;

•        the willingness of the target patient population to try new products and methods and of physicians to use these products and methods;

•        the quality of our relationships with patient advocacy groups;

•        the strength of marketing and distribution support;

•        the availability of the product and our ability to meet market demand;

•        the prevalence and severity of any side effects; and

•        any restrictions on the use of our products, if approved.

The sizes of the market opportunities for our product candidates have not been established with precision and are estimates that management believes to be reasonable. If these market opportunities are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the relevant patient population, our revenue and ability to achieve profitability might be materially and adversely affected.

Our estimates of the market opportunity for certain of our product candidates, as set forth in this proxy statement/prospectus, are based on a number of internal and third-party estimates. While we believe our assumptions and the data underlying these estimates are reasonable, they may be inaccurate or based on imprecise data; in addition, the assumptions and conditions underlying the estimates may change at any time. For example, the number of patients who ultimately use our product candidates, if approved by regulatory authorities, and our total market opportunities for such product candidates, will depend on, among other things, pricing and reimbursement, market acceptance of those product candidates and patient access, and may be lower than we estimate. Additionally, any approval we receive for our product candidates may be based on a narrower definition of the relevant patient population than we have estimated. Either of these circumstances could materially harm our business, financial condition, results of operations and prospects.

We face and will continue to face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do, which may adversely affect our ability to successfully market or commercialize our HAVs.

The development and commercialization of new biological products is highly competitive and subject to rapid change and technological advancements. If approved, we expect our HAVs would compete with the use of a patient’s own blood vessels, as well as a variety of marketed products, such as conventional synthetic grafts, xenografts, and allografts, as well as developing technologies.

We expect to face competition with respect to any additional product candidates that we may seek to develop or commercialize in the future from a variety of sources, including major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies, hospital product-focused companies, as well as public and private universities and research organizations.

Many of our existing or potential competitors, either alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining marketing approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than the products that we develop. Our competitors also may obtain FDA or other marketing approval for their products more rapidly than we may obtain the same approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

We plan to seek marketing approval for our HAVs in the United States as a biologic and in the EU as a medicinal product. In both the United States and the EU, our competitors may try to market vascular conduits similar to our product candidates as medical devices. Such competitive products could have comparable characteristics and could function similarly in the body (and could even be protein-based like our product candidates). Companies may be able to obtain marketing approval for such products on the basis of less data than the data required for a BLA and marketing similar products as devices could permit our competitors to circumvent regulatory exclusivity for biologics in the United States and medicinal products in the EU.

Our distribution agreement with Fresenius Medical Care imposes obligations on us that may restrict our ability to operate our business in ways we believe to be in our long-term best interest.

We expect to rely on our strategic, global relationship with Fresenius Medical Care for the development and commercialization of certain of our product candidates. As discussed in more detail in the section of the proxy statement/prospectus titled “Information about Humacyte — Business — Distribution — Distribution Agreement with

Fresenius Medical Care,” Fresenius Medical Care will have the exclusive right to develop outside of the United States and EU and commercialize outside of the United States, among other things, our 6 millimeter x 42cm HAV and all improvements thereto, and modifications and derivatives thereof (including any changes to the length, diameter, or configuration of the foregoing), which we refer to as the distribution product, for use in vascular creation, repair, replacement or construction (including renal replacement therapy for dialysis access, the treatment of vascular trauma, and the treatment of PAD, but excluding coronary artery bypass graft, pediatric heart surgery, or adhering pancreatic islet cells onto the outer surface of the distribution product for use in diabetic patients). We refer to these indications wherein Fresenius Medical Care has rights to develop and commercialize Humacyte’s products as the field. The distribution agreement also imposes a number of restrictions on our business. For instance, outside the United States, the distribution agreement restricts our ability to engage a distributor for the distribution product outside the field or for HAV products other than the distribution product: we have granted Fresenius Medical Care (i) an exclusive right of first negotiation for exclusive distribution rights outside the United States for the distribution product for use outside the field, and (ii) an exclusive right of first negotiation for exclusive distribution rights outside the United States for our other HAV products, if any, subject, in each case, to certain conditions. These and other obligations may restrict our ability to operate our business in ways we believe are in our long-term best interest, which could harm our business and our prospects.

If we receive approval for a product candidate that is not subject to our distribution agreement with Fresenius Medical Care, and we are unable to establish our own marketing, sales and distribution capabilities or are unable to enter into agreements with third parties do so, we may not be able to generate product revenue and will have to alter our development and commercialization plans.

We currently have limited internal marketing, sales or distribution capabilities, and our management team has limited experience commercializing products following marketing approval. If one of our product candidates that is not subject to the distribution agreement with Fresenius Medical Care receives marketing approval, we will be required either to develop these capabilities internally or to make arrangements with third parties for the marketing, sales and distribution of the relevant product candidate. The establishment and development of our own marketing, sales and distribution functions will be expensive and time-consuming and may delay any product launch, and we may ultimately be unable to successfully develop the product candidate. In addition, or in the alternative, we could seek one or more partners to handle some or all of the marketing, sales and distribution activities associated with any such product candidate. However, we may face significant competition in seeking appropriate strategic partners, and the negotiation process is time consuming and complex. Therefore, we may not be able to enter into arrangements with third parties to do so on favorable terms or at all. In the event we are unable to develop our own marketing, sales and distribution functions or collaborate with a third-party organization for this purpose, we may not be able to successfully commercialize a product candidate that is not subject to the distribution agreement with Fresenius Medical Care, which would adversely affect our ability to generate revenue. Further, whether we commercialize any such product candidate on our own or rely on a third party to do so, our ability to generate revenue will be dependent on the effectiveness of the organization performing these functions.

Even if we receive marketing approval for our HAVs, there is uncertainty with respect to third-party coverage and reimbursement of our HAVs. They may also be subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, any of which could harm our business, prospects, operating results and financial condition.

There is uncertainty around third-party coverage and reimbursement of newly approved regenerative medicine type products, even those with the RMAT designation from FDA, such as our 6 millimeter HAV for AV access for performing hemodialysis, which received the RMAT designation in 2017. In the United States, third-party payors, including government payors such as the Medicare and Medicaid programs, play an important role in determining the extent to which medical products and biologics will be covered and reimbursed. The Medicare and Medicaid programs increasingly are used as models for how private payors and government payors develop their coverage and reimbursement policies. Currently, no RMAT tissue engineered product has established coverage and reimbursement by the Centers for Medicare and Medicaid Services (“CMS”). Even if our HAVs receive approval from regulatory

authorities, it is difficult to predict what CMS or any comparable foreign regulatory agency will decide with respect to coverage and reimbursement for novel products such as ours, as there is no body of established practices and precedents for these types of products.

The healthcare industry is acutely focused on cost containment, both in the United States and elsewhere. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement. These payors may not view our products, if any, as cost-effective, and coverage and reimbursement may not be available to our customers or may not be sufficient to allow our products, if any, to be marketed on a competitive basis. Cost-control initiatives could also cause us to decrease any price we might establish for products, which could result in lower than anticipated product revenue. Moreover, eligibility for reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our costs, including our costs related to research, development, manufacture, sale and distribution. Reimbursement rates may vary, by way of example, according to the use of the product and the clinical setting in which it is used. If the prices for our products, if any, decrease or if governmental and other third-party payors do not provide adequate coverage or reimbursement, our business, prospects, operating results and financial condition will suffer, perhaps materially.

In some countries, particularly in Europe, the pricing of our product may be subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products, if approved, is unavailable or more limited in scope or amount than we anticipate, or if pricing is set at even lower levels than we anticipate, our business could be harmed, possibly materially.

Product liability lawsuits against us could cause us to incur substantial liabilities that may not be covered by our limited product liability insurance and may limit development, approval and commercialization of our HAVs and any other product candidates that we develop in the future.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk, if and when we commercially sell our HAVs and any other product candidates that we may develop. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, product liability claims may result in:

•        decreased demand for any product candidates or products that we develop or sell, leading to loss of revenue;

•        injury to our reputation and significant negative media attention;

•        withdrawal, or slower enrollment, of clinical trial participants;

•        significant costs to defend the related litigation and reduced resources of our management to pursue our business strategy;

•        substantial monetary awards to trial participants or patients; and

•        inability to further develop or commercialize our product candidates.

We currently hold limited product liability insurance coverage, and it may not be adequate to cover all liabilities that we may incur. We also may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

The outbreak of COVID-19 may continue to adversely impact our business, including our manufacturing efforts, and our preclinical studies and clinical trials.

The ongoing COVID-19 pandemic has impacted our business and we expect it to continue to do so. In response to the spread of COVID-19, we limited entry into our facilities for non-essential personnel, and instituted daily health checks and weekly COVID-19 screenings for employees who entered the facility. In addition, we have experienced

delays in the ongoing enrollment of our clinical trials as a result of COVID-19. If COVID-19 continues to spread in the United States and elsewhere, we may experience disruptions that could severely impact our business, preclinical studies and clinical trials, including:

•        further delays or difficulties in enrolling patients in our clinical trials;

•        delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

•        delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials, including interruption in global shipping that may affect the transport of clinical trial materials;

•        changes in hospital or research institution policies or local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

•        diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals and clinics serving as our clinical trial sites and hospital and clinic staff supporting the conduct of our clinical trials;

•        interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, or the closing of clinical trial sites due to the virus, the occurrence of which could affect the integrity of clinical trial data;

•        interruption in global shipping affecting the transport of clinical trial materials, such as our HAVs and other supplies used in our clinical trials;

•        interruption in supply of raw materials required to manufacture our product candidates;

•        risk that participants enrolled in our clinical trials will acquire COVID-19 while the clinical trial is ongoing, or will withdraw from the clinical trial due to concerns over COVID-19, which could impact the results of the clinical trial, including by increasing the number of observed adverse events, or reducing the statistical power of the clinical trials;

•        interruptions or delays in preclinical studies, including delays in obtaining and housing experimental animals and in performing surgical interventions on animals to test our products;

•        delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;

•        delays in receiving feedback or responses from the FDA regarding regulatory submissions;

•        delays in obtaining meetings with FDA reviewers regarding manufacturing and clinical trials;

•        limitations in employee resources that would otherwise be focused on the conduct of our clinical trials or the manufacture of our product candidates, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

•        changes to the clinical endpoints, statistical analysis plan, or enrollment plans for ongoing clinical trials due to limitations in patients, resources, or sites, including due to COVID-19;

•        unanticipated deaths of clinical trial patients due to COVID-19 or due to lack of healthcare resources and follow-up as a consequence of COVID-19;

•        interruption or delays to our sourced discovery and clinical activities; and

•        impacts from prolonged remote work arrangements, such as increased cybersecurity risks and strains on our business continuity plans.

Three vaccines for COVID-19 were granted Emergency Use Authorization by the FDA in late 2020 and early 2021, and more may be authorized in the coming months. The resultant demand for vaccines and potential for manufacturing facilities and materials to be commandeered under the Defense Production Act of 1950, or equivalent foreign legislation, may make it more difficult to obtain materials for the products needed for our clinical trials, which could lead to delays in these trials. In addition, the competition for bioprocessing, quality control, manufacturing and logistics personnel due to ramping up of COVID-19 vaccine production in the North Carolina region may make it difficult to recruit and retain necessary employees. The extent to which the COVID-19 pandemic impacts our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence.

Risks Related to Manufacturing Our Product Candidates

The manufacture of our product candidates is complex, we have not manufactured commercial product, and we may encounter difficulties in production. If we or any third-party manufacturer encounter such difficulties, our ability to supply our product candidates for clinical trials or, if approved, for commercial sale could be delayed or halted entirely.

The process of manufacturing our HAVs is complex, highly regulated and subject to multiple risks. The manufacture of biologics such as our HAVs is susceptible to product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, inconsistency in yields, variability in product characteristics and difficulties in scaling the production process. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination, which would harm our business, operating results and financial condition as well as our reputation.

We currently manufacturing the 6 millimeter HAVs for our clinical trials at our manufacturing facility in Durham, North Carolina, where we have created a scalable modular manufacturing process, which we refer to as the LUNA200 system, that we believe will enable us to manufacture our HAVs, if approved, in commercial quantities in compliance with current good manufacturing practices (“cGMPs”). Our efforts to scale out our manufacturing operations may not succeed. Scaling out a biologic manufacturing process is a difficult task, as there are risks including, among others, cost overruns, process reproducibility, stability issues, lot consistency and timely availability of raw materials. Prior to the establishment of our internal manufacturing facility, we employed a contract manufacturer who produced our HAVs using a smaller-production system known as the AURA system. We have limited experience manufacturing our HAVs in-house with the LUNA200 system, and no experience manufacturing the volume that we anticipate will be required to supply all of our clinical trials or to achieve planned levels of commercial sales following marketing approval, if received. Additionally, our manufacturing process has evolved over time and we may not have the experience, resources, or facility capacity to handle adoption of future changes or expansion of capacity. The forecasts of demand we plan to use to determine order quantities and lead times for components from outside suppliers may be incorrect, and we may be unable to obtain such components when needed and at a reasonable cost. In addition, we may not be able to develop and implement efficient manufacturing capabilities and processes to manufacture our HAVs in sufficient volumes that also satisfy the legal, regulatory, quality, price, durability, engineering, design and production standards required to commercialize our HAVs successfully.

If we are unable to produce sufficient quantities of our HAVs for our clinical trial needs or commercialization due to production system limitations, we may need to make additional changes to our manufacturing processes and procedures. Such changes to our manufacturing platform could trigger the need to conduct additional bridging studies between our prior clinical supply and that of any new manufacturing processes and procedures. Should we experience delays or be unable to produce sufficient quantities of our HAVs utilizing our current or a modified version of our manufacturing system, we expect that our development and commercialization efforts would be impaired as a result, which would likely materially adversely affect our business, prospects, operating results and financial condition.

We may be unable to demonstrate comparability between HAVs manufactured using the AURA system and HAVs manufactured using the LUNA200 system. Failure to demonstrate such comparability could adversely affect our ability to secure regulatory approval for our product candidates.

To date, most of the patients who have been treated in clinical trials involving our product candidates were treated with HAVs manufactured at third-party manufacturing facilities using the AURA system. We may experience a supply shortage of HAVs manufactured using the AURA system prior to the completion of our ongoing clinical trials and are planning to seek amendment of our existing Investigational New Drug applications (“INDs”) to allow for the utilization HAVs manufactured at our facility using the LUNA200 system for our ongoing and future clinical trials. In order to do so, we will need to demonstrate comparability between HAVs produced using the AURA system and HAVs produced using the LUNA200 system and have completed a comparability clinical study. We cannot be assured that the FDA will not require us to conduct additional analytical comparability analyses, preclinical studies and/or clinical trials before allowing us to use the HAVs manufactured using the LUNA200 system. Failure to demonstrate such comparability, or if we are required to conduct additional testing or additional clinical trials to demonstrate comparability, may delay or prevent our ability to continue our clinical trials or delay our ability to submit a BLA for marketing authorization, which would materially and adversely affect our business, prospects, operating results and financial condition.

Manufacturing facilities are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals.

Our manufacturing facility is subject to ongoing regulation and periodic inspection by the FDA and other regulatory authorities to ensure compliance with cGMPs. Failure to follow and document adherence to such regulations or other regulatory requirements may (i) lead to significant delays in the availability of product for our clinical trials, (ii) result in the termination of or a hold being placed on one or more of our clinical trials, or (iii) delay or prevent filing or approval of marketing applications for our HAVs.

To monitor compliance with applicable regulations, the FDA routinely conducts inspections of facilities and may identify potential deficiencies. For example, the FDA issues what are referred to as “Form 483s” that set forth observations and concerns that are identified during its inspections. Failure to satisfactorily address the concerns or potential deficiencies identified in a Form 483 could result in the issuance of a warning letter, which is a notice of the issues that the FDA believes to be significant regulatory violations requiring prompt corrective actions. Failure to respond adequately to a warning letter, or to otherwise fail to comply with applicable regulatory requirements could result in enforcement, remedial or punitive actions by the FDA or other regulatory authorities.

Risks Related to Our Reliance on Third Parties

We rely on third parties to conduct and support our clinical trials, and those third parties may not perform satisfactorily, including by failing to adhere to regulatory requirements or our stated protocols or to meet deadlines for the completion of such trials.

We do not independently conduct clinical trials for our product candidates and instead rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to perform various functions, including implanting our HAVs and monitoring patients. The FDA and other regulatory authorities require us and these third parties to comply with GCP and, where applicable, GTP for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of patients in clinical trials are protected; ultimately, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and trial protocol. Failure by us or these third parties to do so could require us to enroll additional trial subjects beyond those we anticipate, could require us to modify our protocol, which may cause us to lose previously established Special Protocol Assessment agreements with the FDA or similar agreements with other regulatory authorities concerning whether the design and size of our clinical trial adequately addresses scientific and regulatory requirements to support marketing approval, or could materially harm our ability to complete our clinical trials, including as a result of the need to remove trial sites and participants from the trial. We have in the past and may in the future need to terminate trial sites due to failure to conduct a trial in accordance with its protocol, applicable regulations, and generally accepted research standards.

The performance of the sites for our clinical trials may also be adversely affected by various other issues, including familiarity with the properties of our HAVs, intervention rates, insufficient training of personnel, variances in medical infrastructure, lack of familiarity with conducting clinical trials in accordance with international regulatory standards, communication difficulties or changes in local regulations. If these third parties do not successfully conduct our clinical trials in accordance with regulatory requirements or our stated protocols, carry out their contractual duties, or meet expected deadlines, we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and may not be able to, or may be delayed in our efforts to, successfully commercialize our products if approved by regulatory authorities.

We rely on third-party suppliers, including sole source suppliers, to provide certain components for our product candidates. Any failure by a third-party supplier to supply these components for manufacture may delay or impair our ability to complete our clinical trials and to commercialize our product candidates.

We currently rely, and expect to continue to rely, on third parties for the supply of certain components necessary for our product candidates, such as donor tissue, other biologically derived substances, the PGA polymer mesh and the bioreactor bags in which our HAVs are grown. Our suppliers for certain of these materials, including SeraCare Life Sciences, Inc. (“SeraCare”) for the supply of human plasma and Confluent Medical Technologies, Inc. (“Confluent”) for the supply of polymer mesh, are sole source suppliers. Failure of one or more of our suppliers, including these sole source suppliers, to deliver components necessary for the production of our HAVs in a timely and sufficient manner, whether due to shortages of such materials, difficulties in scaling up supply to satisfy our clinical trial and commercial needs, contamination, recall, the COVID-19 pandemic or otherwise, or to source or manufacture such components in accordance with cGMPs and cGTPs, as applicable, could delay our ability to complete our clinical trials, obtain marketing approval and commercialize our product candidates. Establishing additional or replacement suppliers for these components could take a substantial amount of time and it may be difficult to establish replacement suppliers who meet regulatory requirements. In addition, as part of the FDA’s approval of our product candidates, the FDA must review and approve the individual components of our production process, which includes raw materials, the manufacturing processes and facilities of our suppliers. Some of our current suppliers have not undergone this process nor have they had any components included in any product approved by the FDA. If our suppliers fail to comply with applicable regulations, and if we do not qualify alternate suppliers, the clinical development, marketing approval or commercialization of our product candidates could be delayed, thereby increasing our costs to complete clinical development and to obtain marketing approval and depriving us of potential product revenue.

We intend to rely on our strategic, global relationship with Fresenius Medical Care to undertake, or assist with, the development and commercialization of certain of our product candidates if we receive marketing approval from relevant regulatory authorities. Disruption of this arrangement could materially adversely affect our business, prospects, operating results and financial condition.

Under the distribution agreement, Fresenius Medical Care has the exclusive right to sell and distribute the distribution product in the field outside of the United States. In addition, under the terms of the distribution agreement, Fresenius Medical Care will collaborate with Humacyte in its commercialization of the distribution product in the field in the United States, including adoption of the distribution product as a standard of care in patients for which such use is supported by clinical results and health economic analyses. As a result of our arrangement with Fresenius Medical Care, we expect to be reliant on Fresenius Medical Care to undertake or assist with the development and commercialization, as well as, in some cases, obtaining and maintaining regulatory approval, of the distribution product in the field and for Fresenius Medical Care to do so in a manner consistent with applicable law and regulatory requirements outside of the United States. If Fresenius Medical Care otherwise fails to undertake or assist with the development or commercialization, or obtaining or maintaining regulatory approvals, of the distribution product in accordance with the terms of the distribution agreement, our business, prospects, operating results and financial condition would be adversely affected, perhaps materially.

Fresenius Medical Care also maintains certain discretionary termination rights on a country-by-country basis with respect to any country outside of the United States under the distribution agreement, as discussed in more detail in the section of this prospectus titled “Information about Humacyte — Business — Distribution — Distribution Agreement with Fresenius Medical Care.” If the distribution agreement is terminated, we may not be able to secure an alternative distributor in the applicable country on a timely basis or at all, in which case our ability to generate revenues from the distribution product in such country would be harmed.

In addition, if Fresenius Medical Care fails to undertake or assist with the development or commercialization, or obtaining or maintaining regulatory approval, as applicable, of the distribution product in a manner consistent with applicable law and regulatory requirements, patient access to, and demand for, the distribution product could be reduced, our reputation could be damaged, and, under certain circumstances, we could be exposed to potential liability. Furthermore, while Fresenius Medical Care has certain commercialization diligence obligations, Fresenius Medical Care is not restricted from offering its own products and services or the products and services of other companies that compete with the distribution product, and may not undertake or assist with the development or commercialization of the distribution product effectively.

Risks Related to Our Financial Position and Need for Additional Funding

We have never generated product revenue and have incurred significant losses to date. We expect to continue to incur losses for the foreseeable future and may never generate product revenue or be profitable.

Since inception, we have generated no product revenue, and prior to receipt of marketing approval from regulatory authorities, we will be unable to do so. We incurred net losses of $66.5 million and $85.4 million for the years ended December 31, 2020 and 2019, respectively, and $17.7 million and $20.3 million for the three months ended March 31, 2020 and 2021, respectively. As of December 31, 2020 and March 31, 2021, we had an accumulated deficit of $388.1 million and $408.4 million, respectively. To date, we have financed our operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through grants from governmental agencies. We have devoted substantially all of our financial resources and efforts to research and development, including preclinical studies and clinical trials and development of our manufacturing technology, and we anticipate that our expenses will continue to increase over the next several years as we continue these activities. Our V005 and V007 trials are currently enrolling, and we currently intend to submit a BLA to the FDA relating to vascular trauma in 2022 and a supplement for AV access for hemodialysis in 2022. We also intend to continue scaling out our manufacturing facility to satisfy potential demand if the FDA approves our BLA, advancing preclinical and clinical development of additional clinical applications for our HAVs and funding our operations. Accordingly, we expect to continue to incur substantial operating losses for the foreseeable future, which may fluctuate significantly from quarter-to-quarter and year-to-year.

To become and remain profitable, we must succeed in obtaining marketing approval for our HAVs in the United States, in commercializing our HAVs, and in developing and commercializing additional product candidates that generate significant revenue. We may never succeed in these activities and, even if we do, may never generate revenue that is sufficient to achieve profitability.

Even if we do achieve profitability, we may not be able to sustain or increase profitability. Our failure to become and remain profitable would depress the value of our company and could impair our ability to maintain our research and development efforts, expand our business, diversify our product offerings or even continue our operations. A decline in the value of the Combined Company could also cause you to lose all or part of your investment.

Our recurring losses from operations and financial condition raise substantial doubt about our ability to continue as a going concern.

Without giving effect to the anticipated net proceeds from the Business Combination and PIPE Investment, we do not believe our existing cash and cash equivalents will be sufficient to fund our anticipated operating expenses, including clinical trial expenses, and capital expenditure requirements into 2022. In our audited financial statements as of and for the year ended December 31, 2020, we concluded that this circumstance raised substantial doubt about our ability to continue as a going concern within one year from the original issuance date of such financial statements. Similarly, in its report on such financial statements, our independent registered public accounting firm included an explanatory paragraph stating that as we have generated no product revenue and have incurred net losses and negative cash flows from operations since inception there is substantial doubt about our ability to continue as a going concern. Until such time, if ever, as we are able to successfully develop and commercialize one or more of our product candidates, we expect to fund our operations through the sale of equity, debt, borrowing under credit facilities or through potential collaborations with other companies, other strategic transactions or government contracts and grants.

We will need to raise additional capital to finance our operations, which we may not be able to do on acceptable terms or at all. If we are unable to raise additional capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. After the consummation of the Business Combination, in our own required quarterly assessments, we may continue to conclude that there is substantial doubt about our ability to continue as a going concern, and future reports from our independent registered public accounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.

We may need to raise additional funding, which may not be available on acceptable terms, or at all, and any failure to obtain capital when needed may force us to delay, limit or terminate our product development or commercialization efforts.

We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) scale out our manufacturing facility to satisfy potential demand if our HAVs receive marketing approval in the United States, (ii) continue our preclinical and clinical development efforts, including the ongoing clinical trials, and (iii) obtain marketing approval for our 6 millimeter HAV, and, if marketing approval is obtained, to commercialize our HAVs for one or more approved indications. We will need additional funding in connection with these activities. Our future capital requirements will depend on many factors, including:

•        the progress and results of our clinical trials and interpretation of those results by the FDA and other regulatory authorities;

•        the cost, timing and outcome of regulatory review of our product candidates, particularly for approval of our HAVs in the United States;

•        the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our additional product candidates;

•        the cost and timing of our future commercialization activities, including product manufacturing, marketing and distribution for our HAVs if approved by the FDA, and any other product candidate for which we receive marketing approval in the future;

•        the amount and timing of revenues, if any, that we receive from commercial sales of any product candidates for which we receive marketing approval; and

•        the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims.

Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition.

Pursuant to the terms of its outstanding indebtedness, Humacyte may be limited in its ability to incur future debt.

In March 2021, Humacyte entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., which provides a term loan facility of up to $50.0 million with a maturity date of March 1, 2025. Humacyte’s obligations under the Loan Agreement are secured by substantially all of its assets, except for its intellectual property.

Pursuant to the terms of the Loan Agreement, we are limited in our ability to incur additional indebtedness. In addition, a failure to comply with the covenants under the Loan Agreement could result in an event of default and an acceleration of amounts due. If an event of default occurs that is not waived by the lenders, and the lenders accelerate any amounts due, we may not be able to make accelerated payments, and the lenders could seek to enforce their security interests in the collateral securing such indebtedness, which could have a material adverse effect on our business and results of operations. Our payment obligations under the Loan Agreement reduce cash available to

fund working capital, capital expenditures, research and development and other corporate purposes, and limit our ability to obtain additional financing for working capital, capital expenditures, expansion plans and other investments, which may in turn limit our ability to implement our business strategy, heighten our vulnerability to downturns in our business, the industry, or in the general economy, limit our flexibility in planning for, or reacting to, changes in our business and the industry and prevent us from taking advantage of business opportunities as they arise. If market rates increase, we will have to pay additional interest on this indebtedness, which would further reduce cash available for our other business needs.

We cannot assure you that our business will generate sufficient cash flow from operations or that future financing will be available to us in amounts sufficient to enable us to make required and timely payments on our indebtedness, or to fund our operations.

To date, we have not requested or obtained marketing approval for, or commercialized, any of our product candidates, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

We are a development-stage company. Our operations to date, with respect to the development of our product candidates, have been limited to organizing and staffing our company, business planning, raising capital, identifying markets for our product candidates, undertaking preclinical studies and clinical trials of our product candidates for various potential indications and establishing research and development, manufacturing and distributing collaborations. We have not yet demonstrated the ability to obtain marketing approval for a product, to manufacture an approved product at commercial scale or to successfully commercialize an approved product. Consequently, any predictions you make about our financial prospects may not be as accurate as they could be if we had received marketing approval and begun commercializing a product.

Risks Related to Government Regulation

We may not obtain marketing approval from the FDA for any of our product candidates even if we successfully complete our clinical trials, which failure would materially harm our business, prospects, operating results and financial condition.

Prior to commercialization, biologics, like our HAVs, require the submission of a BLA to, and approval of the BLA by, the FDA. A BLA must be supported by extensive preclinical and clinical data, as well as extensive information regarding chemistry, manufacturing and controls (“CMC”), sufficient to demonstrate the safety, purity, potency and effectiveness of the applicable product candidate to the satisfaction of the FDA. We have never submitted a BLA for approval or otherwise obtained FDA approval for any of our product candidates.

The BLA approval process is expensive and uncertain, it may take several years to complete, and we may not be successful in obtaining such approval. The FDA has substantial discretion in the approval process. The number and types of preclinical studies and clinical trials that will be required for BLA approval varies depending on the product candidate, the disease or the condition that the product candidate is designed to target and the regulations applicable to any particular product candidate. The FDA could delay, limit or deny approval of our product candidates for many reasons, including because it:

•        may not deem the product candidate to be adequately safe or effective;

•        may not find the data from preclinical studies, clinical trials or CMC data sufficient to support approval;

•        may not approve the manufacturing processes or facilities associated with the product candidate;

•        may conclude that the long-term integrity of the product candidate for which approval is being sought has not been sufficiently demonstrated;

•        may change approval policies or adopt new regulations; or

•        may not accept a submission due to, among other reasons, the content or formatting of the submission.

Even for product candidates where the FDA agrees in an end-of-Phase II meeting that predefined efficacy and safety endpoints in Phase III trials can support marketing approval, the FDA may later modify its perspective if there is a significant scientific development before the trials are complete and the BLA is reviewed. Similarly, while the

FDA may agree to a special protocol assessment for a clinical trial, when it determines that the trial is adequately designed to provide necessary data to support a license application, the FDA may subsequently abandon the special protocol assessment if a substantial scientific issue essential to determining the safety or effectiveness of the product candidate has been identified after the testing has begun. In addition, if a company alters the protocol for a trial, the end-of-Phase II agreement or special protocol assessment may no longer apply. Further, the results of pivotal clinical trials are always subject to thorough FDA review. Even highly significant clinical trial results are no guarantee of approval.

We currently intend to submit a BLA to the FDA relating to vascular trauma in 2022 and a supplement for AV access in hemodialysis in 2022 based on the results of our V005 and V007 trials. The FDA may decline to approve our 6 millimeter HAV on the basis of these or other trial results.

Even if we obtain and maintain approval for our HAVs from the FDA, we may never obtain approval for our HAVs outside of the United States, where the regulatory process is also complex and subject to significant uncertainty. Failure to do so would limit our market opportunities and adversely affect our business.

Even if we receive FDA approval to market any biologic in the United States, we must comply with the numerous and varying regulatory and compliance related requirements of other countries, including the submission of extensive preclinical and clinical data, manufacturing and quality information regarding the process and facility, scientific data characterizing the relevant product candidate and other supporting data in order to establish safety and effectiveness. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods, including obtaining reimbursement and pricing approval in select markets. The time required to obtain approval in other countries might differ from that required to obtain FDA approval. The marketing approval process in other countries may include all of the risks associated with FDA approval as well as additional, presently unanticipated, risks. Marketing approval in one country does not ensure marketing approval in another, but a failure or delay in obtaining marketing approval in one country may negatively impact the regulatory process in others, including the risk that our product candidates may not be approved for all indications requested and that such approval may be subject to limitations on the indicated uses for which the product candidate may be marketed.

We may in the future seek orphan drug designation for the use of our HAVs to treat congenital pediatric heart defects. We may be unable to obtain such designation or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced.

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population of 200,000 or more in the United States when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. Orphan drug designation must be requested before submitting a BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug or biologic and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. Even if one of our product candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease. Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture sufficient supply of our product.

The review time for a BLA for our product candidates may be longer and more expensive than for other products because of the novelty and complexity of our product candidates, even if we seek “rolling review” or priority review, which would delay our ability to begin commercialization and earn product revenues.

The marketing approval process for novel product candidates such as ours may take longer to complete and be more expensive than the process for other, better known or extensively studied pharmaceutical or other product candidates. We may employ a “rolling review” of a BLA, which means we may submit completed modules of a BLA rather than waiting until every module of the BLA is completed before submitting the full BLA for FDA review. Such “rolling review” is common for indications that are part of one of FDA’s expedited programs, such as our 6 millimeter HAV, which has received Fast Track and RMAT designations for AV access in hemodialysis. The FDA may also

designate one or more of our product candidates for priority review after we submit a BLA. Under priority review, the FDA’s goal is to review an application within six months of the 60-day filing date, compared to ten months for a standard review. Even if we utilize a “rolling review” or the FDA designates one or more of our product candidates for priority review, it may not lead to a shorter review period. The FDA could also decide to consult an advisory committee as part of our BLA review process, which often leads to a longer review time. We are not permitted to commercialize our product candidates in the United States until they have been approved by the FDA, and if we experience a lengthier review period than expected, our ability to generate product revenues would be materially harmed.

Inadequate funding for the FDA and other government agencies, including from government shut downs, global health concerns or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, policy changes, and the risk of slowdowns and shutdowns due to the COVID-19 pandemic. Average review times at the FDA have fluctuated in recent years as a result. Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which could adversely affect our business. In addition, government funding of other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory agency policy during the period of product development, clinical trials and the review process. As of June 23, 2020, the FDA noted it was continuing to ensure timely reviews of applications for medical products during the COVID-19 pandemic in line with its user fee performance goals and conducting mission critical domestic inspections to ensure compliance of manufacturing facilities with FDA quality standards. However, the FDA may not be able to maintain this pace and delays or setbacks are possible in the future, including where a pre-approval inspection or an inspection of clinical sites is required and due to the COVID-19 pandemic and travel restrictions FDA is unable to complete such required inspections during the review period. On March 18, 2020, the FDA announced its intention to temporarily postpone routine surveillance inspections of domestic manufacturing facilities and provided guidance regarding the conduct of clinical trials which the FDA continues to update. As of July 2020, FDA began utilizing a risk-based prioritization system to assist in determining when and where it is safest to conduct such inspections based on data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. In August 2020, FDA published guidance outlining its approach to facility inspections during the COVID-19 pandemic. According to the guidance, FDA intends to, on a case-by-case basis, conduct only mission critical inspections, or, where possible to do so safely, resume prioritized domestic inspections, which generally include pre-approval inspections. FDA plans to use similar criteria for both domestic and foreign inspections to determine whether an inspection is mission critical. According to the guidance, should FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, FDA has stated that it generally intends to issue a complete response letter. Further, if there is inadequate information to make a determination on the acceptability of a facility, FDA intends to defer action on the application until an inspection can be completed. In 2020, several companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications. Additionally, regulatory authorities outside the U.S. may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic and may experience delays in their regulatory activities. If a prolonged government shutdown or other disruption occurs, it could significantly impact the ability of the FDA to

timely review and process our regulatory submissions, which could have a material adverse effect on our business. Future shutdowns or other disruptions could also affect other government agencies such as the SEC, which may also impact our business by delaying review of our public filings, to the extent such review is necessary, and our ability to access the public markets.

Even if we receive marketing approval for a product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to significant penalties if we fail to comply with applicable regulatory requirements.

If we obtain marketing approval for any of our product candidates, the approved product will be subject to ongoing regulatory requirements from the FDA and, if applicable, non-U.S. regulatory authorities. Any marketing approval that we receive for our product candidates may be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for potentially costly post-marketing follow-up trials to monitor the safety and efficacy of the product. In addition, if the FDA and non-U.S. regulatory authorities approve any of our product candidates, we will be subject to extensive and ongoing regulatory requirements by the FDA and other regulatory authorities with regard to the labelling, packaging, AE reporting, storage, advertising, promotion and recordkeeping for our products. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with regulatory requirements of the FDA and, if relevant, other non-U.S. regulatory authorities, we could be subject to administrative or judicially imposed sanctions, including the following:

•        issuance of warning letters or untitled letters by regulatory authorities asserting that we are in violation of the law;

•        imposition of injunctions or significant civil monetary penalties or pursuit by regulatory authorities of civil or criminal prosecutions and fines against us or our responsible officers;

•        suspension or withdrawal of marketing approval;

•        suspension of any ongoing clinical trials or refusal by regulatory authorities to approve pending marketing applications or supplements to approved applications;

•        seizure of products or refusal to allow us to enter into supply contracts, including government contracts, or to import or export products;

•        voluntary or mandatory product recalls and publicity requirements; and

•        restrictions on operations, including marketing efforts, or restrictions that mandate costly new manufacturing requirements.

Any of these events could reduce market acceptance of any or our product candidates that had received marketing approval, substantially reduce our revenue, increase the costs of operating our business, and cause us significant reputational damage, among other consequences. If we ultimately receive approval for any product candidates in jurisdictions outside the U.S., we expect to be subject to similar ongoing regulatory oversight by the relevant foreign regulatory authorities.

Our products may be subject to product recalls that could harm our reputation and could materially and adversely affect our business, financial condition, operating results, cash flows and prospects. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, if approved. In particular, while the FDA permits the dissemination of truthful and non-misleading information about an approved product, a manufacturer may not promote a product for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. The misuse or off-label use of our product may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory authorities if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.

We could also face product liability suits or regulatory delays due to defects in our products, which could be expensive and time-consuming and result in substantial damages payable by us and increases in our insurance rates.

Designation of our product candidates for expedited programs, such as Fast Track designation, Breakthrough Therapy Designation, or RMAT designation, or accelerated approval by the FDA, or priority designation by the Department of Defense, may not lead to a faster development or regulatory review or approval process, and even if granted, will not increase the likelihood that our product candidates will receive marketing approval.

In 2014, the FDA granted Fast Track designation for our 6 millimeter HAV for use in the creation of AV access for hemodialysis, and, in 2017, the FDA granted RMAT designation for our 6 millimeter HAV for the creation of vascular access for performing hemodialysis. We have not received designations pursuant to any of the FDA’s expedited programs for vascular trauma, peripheral arterial disease or our other indications, although we may in the future seek such designations if such product candidates meet the criteria for that designation. As a result, even if we submit a BLA for vascular repair, reconstruction and replacement, including in AV access in hemodialysis, our Fast Track and RMAT designations, and their attendant benefits, may not apply to this broader requested indication. In addition, even with one or more of these designations, we may not experience a faster development process, or faster review or approval, for our product candidates compared to product candidates that are not part of the expedited programs. Further, the FDA may withdraw a designation if it believes that the designation is no longer supported by data from our clinical development program. In addition, a product candidate may no longer demonstrate a potential to address unmet medical need if, for example, a new product is approved that addresses the same need, which could lead to loss of a designation. The loss of a designation under an expedited program, including a Fast Track designation, Breakthrough Therapy Designation, or RMAT designation, could significantly increase the costs of development and length of time required before we could seek marketing approval of such a product candidate.

We may seek accelerated approval for our HAV relating to vascular trauma. A product candidate may be eligible for accelerated approval if it treats a serious or life-threatening condition, generally provides a meaningful advantage over available therapies, and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. As a condition of accelerated approval, the FDA may require that a sponsor of a product receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. These confirmatory trials must be completed with due diligence. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product. Even if we do receive accelerated approval, we may not experience a faster development or regulatory review or approval process, and receiving accelerated approval does not provide assurance of ultimate full FDA approval. Accelerated approval may also be withdrawn if, among other things, a confirmatory trial required to verify the predicted clinical benefit of the product fails to verify such benefit or if such trial is not conducted with due diligence.

In addition, in 2018, our HAV product candidate was assigned a priority designation by the Secretary of Defense under Public Law 115-92. Similar to the designations described above that FDA may grant, a priority designation by the Department of Defense does not change the standards for approval but may expedite the development or approval process.

Healthcare reform measures could hinder or prevent our product candidates’ commercial success.

Our industry is highly regulated, and changes in or revisions to laws and regulations that make gaining reimbursement and pricing of our product candidates more difficult or subject to different criteria and standards may adversely impact our business, prospects, operating results and financial condition. In the United States, there have been and we expect there will continue to be a number of legislative, regulatory and other changes to the healthcare system to contain or reduce healthcare costs that may adversely affect our ability to set a price we believe is fair for our product candidates, our ability to generate revenues and achieve or maintain profitability, and the availability of capital.

Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, the Patient Protection and Affordable Care Act (the “ACA”), enacted in 2010 and amended by the Health Care and Education Reconciliation Act, contains a number of provisions that were intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies for fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry, and impose additional health policy reforms. The Bipartisan Budget Act of 2018, among other

things, amended the ACA to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole,” in part by requiring greater discounts from manufacturers. Various members of Congress have expressed a desire to repeal all or portions of the ACA, and in December 2017, portions of the ACA dealing with the individual mandate insurance requirement were effectively repealed by the Tax Cuts and Jobs Act of 2017. In December 2018, a federal district court judge in Texas found the ACA to be unconstitutional and therefore the entire law to be invalid. In December 2019, the U.S. Court of Appeals for the Fifth Circuit affirmed the ruling regarding the individual mandate but remanded the case to the district court for additional analysis of the question of severability and whether portions of the law remain valid. The case is currently under consideration by the U.S. Supreme Court and a decision is expected by the summer of 2021. Additionally, in December 2018, CMS published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the ACA risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment. Since then, the ACA risk adjustment program payment parameters have been updated annually. In addition, CMS published a final rule that gave states greater flexibility, starting in 2020, in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces. At this time, it remains unclear whether there will be further changes made to the ACA. The ACA, as currently enacted or as amended in the future, may adversely affect our business and operating results, and we do not know how future federal or state legislative or administrative changes relating to healthcare reform will affect our business.

Other legislative changes that have been adopted since enactment of the ACA could also affect potential pricing and utilization of our product candidates. For instance, the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction, created across-the-board reductions of 2% in Medicare payments to providers that will stay in effect through fiscal year 2030 unless additional congressional action is taken; however, pursuant to the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) and subsequent legislation, these Medicare sequester reductions are suspended from May 1, 2020 through March 31, 2021 due to the COVID-19 pandemic. Further, the American Taxpayer Relief Act of 2012, among other things, increased the statute of limitations for the government to recover overpayments to providers from three to five years.

In addition, the Secretary of Health and Human Services, various members of Congress and CMS have made statements and issued proposals regarding containment of drug prices through various means, including enabling CMS to negotiate U.S. drug pricing to align with foreign drug pricing, pricing transparency measures, reform of drug rebate programs, and conditioning coverage and reimbursement of certain drugs upon the prior failure or inadequacy of less expensive therapies, sometimes referred to as “step therapy.” Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. At the federal level, the former Trump administration’s budget proposal for fiscal year 2021 includes a $135 billion allowance to support legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs. On March 10, 2020, the former Trump administration sent “principles” for drug pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases. Further, the former Trump administration also previously released a “Blueprint”, or plan, to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers. The Department of Health and Human Services (“HHS”) has already started the process of soliciting feedback on some of these measures and, at the same, is immediately implementing others under its existing authority. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy, a type of utilization, for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that became effective January 1, 2019.

In addition, there have been several changes to the 340B drug pricing program, which imposes mandatory discounts for covered outpatient medications sold to certain health care facilities. On December 27, 2018, the District Court for the District of Columbia invalidated a reimbursement formula change under Medicare and CMS subsequently

altered the fiscal year 2019 and 2018 reimbursement formula on specified covered outpatient drugs (“SCODs”). A SCOD drug product may also be a covered outpatient drug under the 340B program, which allows 340B-participating hospitals to purchase the drug product at the 340B discounted rate and, when prescribing it to a Medicare patient, be reimbursed at the Medicare rate. Under the prior Medicare reimbursement rate, this created a significant, positive gap for 340B-participating health care facilities. CMS’s change in the Medicare reimbursement rate for SCODs significantly impacted, or eliminated, the positive gap for 340B-participating health care facilities. The court ruled this change was not an “adjustment” that was within the Secretary’s discretion to make but was instead a fundamental change in the reimbursement calculation. However, on July 31, 2020, the U.S. Court of Appeals for the District of Columbia Circuit overturned the district court’s decision and found that the changes were within the Secretary’s authority. On September 14, 2020, the plaintiffs-appellees filed a Petition for Rehearing En Banc (i.e., before the full court), but was denied on October 16, 2020. It is unlikely the Medicare rate litigation will impact 340B pricing for our approved products in the future, but it possible it could affect covered hospitals who might purchase our products.

Further, on July 24, 2020 and September 13, 2020, former President Trump signed several Executive Orders aimed at lowering drug pricing that seek to implement several of the administration’s proposals. The FDA also released a final rule on September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. Further, on November 20 2020 CMS issued an Interim Final Rule implementing the Most Favored Nation, or MFN, Model under which Medicare Part B reimbursement rates will be calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation and Development countries with a similar gross domestic product per capita. The MFN Model regulations mandate participation by identified Part B providers and will apply in all U.S. states and territories for a seven-year period beginning January 1, 2021, and ending December 31, 2027. On December 28, 2020, the United States District Court in Northern California issued a nationwide preliminary injunction against implementation of the interim final rule. Additionally, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. Although a number of these, and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, Congress has indicated that it will continue to seek new legislative measures to control drug costs

The ultimate content, timing, or effect of any healthcare reform legislation or executive order or the impact that the resulting changes may have on us is uncertain, but we expect there will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care.

If we fail to comply with healthcare regulations, we could face substantial penalties and our business, prospects, operating results and financial condition could be adversely affected.

Certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business even though we do not and will not control referrals of healthcare services. We could also be subject to patient privacy regulation by both the U.S. Government and the states in which we conduct our business. Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements. The regulations that may affect our ability to operate include, without limitation:

•        the federal Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs, even if the person does not have actual knowledge of the statute or specific intent to violate it;

•        the federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false claims, or knowingly using false statements, to obtain payment from the U.S. Government;

•        federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

•        the anti-inducement law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by a federal or state governmental program;

•        the federal transparency requirements under the ACA, including the provision commonly referred to as the Physician Payments Sunshine Act and its implementing regulations, which require applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the State Children’s Health Insurance Program to report annually to CMS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members. Effective January 1, 2022, these reporting obligations will extend to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners;

•        federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

•        federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

•        the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”), which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; 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.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participating in federal health care programs and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment, exclusion, or restructuring of our operations could adversely affect our ability to operate our business, prospects, operating results and financial condition. 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. Moreover, achieving and sustaining compliance with applicable federal and state privacy and fraud and abuse laws may prove costly.

Our business and operations, including our development programs, could be materially disrupted in the event of system failures, security breaches, violations of data protection laws or data loss or damage by us or third parties on which we rely, including our CROs or other contractors or consultants.

Our internal computer systems (including our LUNA200 manufacturing system) and those of third parties on which we rely, including our CROs and other contractors and consultants, are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. If such an event were to occur and cause interruptions in our operations, it could have a material adverse effect on our business operations, including a material disruption of our development program. Unauthorized disclosure of sensitive or confidential patient or employee data, including personally identifiable information, whether through breach of computer systems, systems failure, employee negligence, fraud or misappropriation, or otherwise, or unauthorized access to or through our information systems and networks, whether by our employees or third parties, could result in negative publicity, legal liability and damage to our reputation. Unauthorized disclosure of personally identifiable information could also expose us to sanctions for violations of data privacy laws and regulations around the world. To the extent that any disruption or security breach resulted 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 development

of our product candidates could be delayed. For example, the loss of or damage to clinical trial data, such as from completed or ongoing clinical trials, for any of our product candidates would likely result in delays in our marketing approval efforts and significantly increased costs in an effort to recover or reproduce the data.

We have previously been, and expect to remain, the target of cyber-attacks. As we become more dependent on information technologies to conduct our operations, cyber incidents, including deliberate attacks, such as ransomware attacks, and attempts to gain unauthorized access to computer systems (including our LUNA200 manufacturing system) and networks, may increase in frequency and sophistication. These incidents pose a risk to the security of our systems and networks, the confidentiality and the availability and integrity of our data and these risks apply both to us, and to third parties on whose systems we rely for the conduct of our business. While the effect of these incidents has not historically been material to our results of operations, financial condition or prospects, cyber threats are persistent and constantly evolving. Such threats have increased in frequency, scope and potential impact in recent years, which increase the difficulty of detecting and successfully defending against them. As cyber threats continue to evolve, we may be required to incur additional expenses in order to enhance our protective measures or to remediate any information security vulnerability. There can be no assurance that we or our third-party providers will be successful in preventing cyber-attacks or successfully mitigating their effects. Similarly, there can be no assurance that our collaborators, CROs, third-party logistics providers, distributors and other contractors and consultants will be successful in protecting our clinical and other data that is stored on their systems. Any cyber-attack or destruction or loss of data could have a material adverse effect on our business and prospects. In addition, we may suffer reputational harm or face litigation or adverse regulatory action as a result of cyber-attacks or destruction or loss of data and may incur significant additional expense to implement further data protection measures. It is also possible that unauthorized access to data may be obtained through inadequate use of security controls by our suppliers or other vendors. While we are not currently aware of any impact that the SolarWinds supply chain attack had on our business, this is a recent event, and the scope of the attack is yet unknown. Therefore, there is residual risk that we may experience a security breach arising from the SolarWinds supply chain attack.

Although we have general liability insurance coverage, our insurance may not cover all claims, continue to be available on reasonable terms or be sufficient in amount to cover one or more large claims; additionally, the insurer may disclaim coverage as to any claim. The successful assertion of one or more large claims against us that exceed or are not covered by our insurance coverage or changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements, could have a material adverse effect on our business, prospects, operating results and financial condition.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines and penalties or incur costs that could harm our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials and produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. In the event of contamination or injury resulting from our use or production of hazardous materials, we could be held liable for any resulting damages even if we contract with a third party for their disposal, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties resulting from contamination or injury from our use or production of hazardous materials. Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use or production of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous materials.

In addition, we may be required to incur substantial costs to comply with future environmental, health and safety laws and regulations. Compliance with such laws and regulations may divert resources away from our research, development and manufacturing efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

We are subject to anti-corruption and a variety of other laws governing our international operations. If we fail to comply with these laws, we could be subject to, among other things, civil or criminal penalties, other sanctions and remedial measures, and reputational damage, which could adversely affect our business, prospects, operating results and financial condition.

Our operations are subject to anti-corruption laws, including the U.S. Foreign Corrupt Practices Act (“FCPA”), the U.K. Bribery Act and other anti-corruption laws. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and partners from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. We are conducting certain of our other trials at a number of trial sites around the world. Certain of these jurisdictions pose a risk of potential FCPA violations, and we have relationships with third parties, including government-affiliated hospitals and universities, whose actions could potentially subject us to liability under the FCPA or local anti-corruption laws.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the U.S. Department of Commerce’s Bureau of Industry and Security, the U.S. Department of Treasury’s Office of Foreign Assets Control, and various non-U.S. government entities, including applicable economic sanctions on countries and persons, customs requirements, currency exchange regulations and transfer pricing regulations.

If we fail to comply with applicable anti-corruption laws and other legal requirements, we may become subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, including the loss of export or import privileges and debarment, and face substantial legal expenses. Likewise, even an investigation by U.S. or foreign authorities of potential violations of such laws could damage our reputation. In either case, our business, prospects, operating results and financial condition could be adversely affected. Under certain circumstances, we could also be held liable for the activities of our employees, contractors, and partners that violate anti-corruption laws, even if we do not explicitly authorize or have actual knowledge of such activities. Even allegations of such violations could potentially damage our reputation and harm our business.

Risks Related to Our Intellectual Property

Our ability to successfully commercialize our products may be impaired if we are unable to obtain and maintain effective intellectual property rights for our proprietary scientific technology platform and product candidates.

Our success depends in large part on our and our licensors’ ability to obtain and maintain patent and other intellectual property protection in the United States and in other countries with respect to our proprietary scientific technology platform and products. We have sought to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and product candidates that we and/or our licensors view as important to our business. This process is expensive and time-consuming, and we and our licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we and/or our licensors will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. In some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents or enforce the patents, covering technology or products that we license from third parties. Our existing patents and any future patents and the existing and any future licenses to third-party patents we obtain may not be sufficiently broad to prevent others from using our technologies or from developing competing products and technologies.

The patent position of biotechnology companies generally is highly uncertain and involves complex legal and factual questions for which legal principles remain unresolved. In recent years, patent rights have been the subject of significant litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our and our licensors’ patent rights are highly uncertain. Additionally, changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our owned or licensed patents or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States.

Even if our owned and licensed patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. We, or our licensors, may fail to identify patentable aspects of inventions made in the course

of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, we may miss potential opportunities to strengthen our patent position. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner. The issuance of a patent is not conclusive as to its scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop or prevent us from stopping others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Given the amount of time required for the development, testing and regulatory review of future product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours or otherwise provide us with a competitive advantage.

The patent protection we obtain for our product candidates may not be sufficient enough to provide us with any competitive advantage or our owned or licensed patents may be challenged.

In some instances, agreements through which we license patent rights may not give us control over patent prosecution or maintenance, so that we may not be able to control which claims or arguments are presented, how claims are amended, and may not be able to secure, maintain, or successfully enforce necessary or desirable patent protection from those patent rights. We have not had and do not have primary control over patent prosecution and maintenance for certain of the patents and patent applications we license and therefore cannot guarantee that these patents and applications will be prosecuted or maintained in a manner consistent with the best interests of our business. We cannot be certain that patent prosecution and maintenance activities by our licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents. Moreover, some of our in-licensed patents and patent applications are, and our future owned and licensed patents may be, co-owned with third parties. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in any future patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us.

It is possible that defects of form in the preparation or filing of our owned or licensed patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments or extensions. If we or our partners, collaborators, licensees, or licensors, whether current or future, fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If our partners, collaborators, licensees, or licensors, are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form, preparation, prosecution, or enforcement of our owned or licensed patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

Pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Assuming the other requirements for patentability are met, currently, the first to file a patent application is generally entitled to the patent. However, prior to March 16, 2013, in the United States, the first to invent was entitled to the patent. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions. Similarly, we cannot be certain that parties from whom we do or may license or purchase patent rights were the first to make relevant claimed inventions, or were the first to file for patent protection for them. If third parties have filed prior patent applications on inventions claimed in our owned or licensed patents or applications that were filed on or before March 15, 2013, an interference proceeding in the United States can be initiated by such third parties to determine who was the first to invent any of the subject matter covered by the patent claims of such owned or licensed patent applications. If third parties have filed such prior applications after March 15, 2013, a derivation proceeding in the United States can be initiated by such third parties to determine whether our owned or licensed invention was derived from theirs.

Moreover, because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, our owned and licensed patents or pending patent applications may be challenged in the courts or patent offices in the United States and abroad. There is no assurance that all of the potentially relevant prior art relating to our owned or licensed patents and patent applications has been found. If such prior art exists, it may be used to invalidate a patent, or may prevent a patent from issuing from a pending patent application. For example, such patent filings may be subject to a third-party submission of prior art to the U.S. Patent and Trademark Office (“USPTO”), or to other patent offices around the world. Alternately or additionally, we may become involved in post-grant review procedures, oppositions, derivation proceedings, ex parte reexaminations, inter partes review, supplemental examinations, or interference proceedings or challenges in district court, in the United States or in various foreign patent offices, including both national and regional, challenging patents or patent applications in which we have rights, including patents on which we rely to protect our business. An adverse determination in any such challenges may result in loss of the patent or in patent or patent application claims being narrowed, invalidated or held unenforceable, in whole or in part, or in denial of the patent application or loss or reduction in the scope of one or more claims of the patent or patent application, any of which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. In addition, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

Pending and future patent applications may not result in patents being issued that protect our business, in whole or in part, or which effectively prevent others from commercializing competitive products. Competitors may also be able to design around our owned or licensed patents. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our owned or licensed patents or narrow the scope of our patent protection. In addition, the laws of foreign countries may not protect our rights to the same extent or in the same manner as the laws of the United States. For example, patent laws in various jurisdictions, including significant commercial markets such as Europe, restrict the patentability of methods of treatment of the human body more than United States law does. If these developments were to occur, they could have a material adverse effect on our ability to generate revenue.

Issued patents that we have or may obtain or license may not provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner. Our competitors may also seek approval to market their own products similar to or otherwise competitive with our products. In these circumstances, we may need to defend or assert our owned or licensed patents, or both, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find our owned or licensed patents invalid or unenforceable, or that our competitors are competing in a non-infringing manner. Thus, even if we have valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe, misappropriate or violate our owned or licensed patents or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part. There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly and refuse to stop the other party from using the technology at issue on the grounds that our owned or licensed patents do not cover such technology. The standards that courts use to interpret patents are not always applied predictably or uniformly and can change, particularly as new technologies develop. As a result, we do not know how much protection, if any, will be given to our owned or licensed patents if we attempt to enforce them and they are challenged in court. An adverse result in any litigation proceeding could put one or more of our owned or licensed patents at risk of being invalidated or interpreted narrowly.

Inequitable conduct is frequently raised as a defense during intellectual property litigation. It is believed that all parties involved in the prosecution of our patent applications have complied with their duties of disclosure in the course of prosecuting our patent applications; however, it is possible that legal claims to the contrary could be asserted

if we were engaged in intellectual property litigation, and the results of any such legal claims are uncertain due to the inherent uncertainty of litigation. If a court determines that any party involved in the prosecution of our owned or licensed patents failed to comply with its duty of candor, the subject patent could be held to be unenforceable.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. Intellectual property litigation or other legal proceedings may cause us to incur significant expenses and may also absorb significant management time. Uncertainties resulting from our participation in patent litigation or other proceedings could have a material adverse effect on our business.

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could harm our business, prospects, operating results and financial condition.

Third parties may assert infringement, misappropriation or other claims against us, or other parties we have agreed to indemnify, based on existing third-party patents or patents that may be granted in the future as well as other intellectual property rights. There may be existing third-party patents or patent applications covering aspects of our technology. Furthermore, because patent applications are published sometime after filing, and because applications can take several years to issue, there may be additional currently pending third-party patent applications that are unknown to us, which may later result in issued patents. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. We may not have sufficient resources to bring these actions to a successful conclusion. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of the Combined Company’s common stock.

Because of the inevitable uncertainty in intellectual property litigation, we could lose a patent infringement or other action asserted against us regardless of our perception of the merits of the case. If we are found to infringe upon, misappropriate or otherwise violate a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and commercializing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the implicated technology or product. In addition, in any such proceeding or litigation, we could be found liable for monetary damages, which could be significant, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent. A finding of infringement, misappropriation or that we otherwise violated intellectual property rights could prevent us from commercializing our product candidates or force us to cease some or all of our business operations.

If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.

We are a party to intellectual property license agreements with third parties. For example, we have licenses with each of Duke University and Yale University, for patents associated with our proprietary technology, and may enter into additional license agreements in the future. Our existing license agreements impose, and we expect that our future license agreements will impose, various diligence, royalty payment, milestone payment, insurance and other obligations on us. If we fail to comply with these obligations or other obligations in our license agreements, our licensors may have the right to terminate these agreements, in which event we may not be able to develop and market any product or use any platform technology that is covered by these agreements. If our license agreements terminate, or we experience a reduction or elimination of licensed rights under these agreements, we may have to negotiate new or reinstated licenses with less favorable terms or we may not have sufficient intellectual property rights to operate our business. The occurrence of such events could materially harm our business.

Further, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. Accordingly, disputes may arise between us and our licensor, our licensor and its licensors, regarding intellectual property subject to a license agreement, including those relating to:

•        the scope of rights, if any, granted under the license agreement and other interpretation-related issues;

•        whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the license agreement;

•        whether our licensor or its licensor had the right to grant the license agreement;

•        whether third parties are entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property without their authorization;

•        our right to sublicense patent and other rights to third parties under collaborative development relationships;

•        whether we are complying with our obligations with respect to the use of the licensed technology in relation to our development and commercialization of product candidates;

•        our involvement in the prosecution of the licensed patents and our licensors’ overall patent enforcement strategy;

•        the allocation of ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and by us and our partners; and

•        the amounts of royalties, milestones or other payments due under the license agreement.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement. If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, or are insufficient to provide us the necessary rights to use the intellectual property, we may be unable to successfully develop and commercialize the affected product candidates. If we or any such licensors fail to adequately protect this intellectual property, our ability to commercialize our products could suffer. Any disputes with our licensors or any termination of the licenses on which we depend could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may not be successful in obtaining necessary intellectual property rights to product candidates for our development pipeline through acquisitions and in-licenses.

Although we intend to develop product candidates through our own internal research, we may need to obtain additional licenses from others to advance our research or allow commercialization of our product candidates. However, we may be unable to acquire or in-license intellectual property rights relating to, or necessary for, any such product candidates from third parties on commercially reasonable terms or at all. In that event, we may be unable to develop or commercialize such product candidates. We may also be unable to identify additional, future product candidates that we believe are an appropriate strategic fit for our company and intellectual property relating to, or necessary for, such product candidates.

The in-licensing and acquisition of third-party intellectual property is a competitive area, and a number of more established companies are also pursuing strategies to in-license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities. Furthermore, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. In addition, we expect that competition for the in-licensing or acquisition of third-party intellectual property rights for product candidates that are attractive to us may increase in the future, which may mean fewer suitable opportunities for us as well as higher acquisition or licensing costs. We may be unable to in-license or acquire the third-party intellectual property rights for product candidates on terms that would allow us to make an appropriate return on our investment. If we are unable to successfully obtain rights to suitable product candidates, our business, financial condition, results of operations and prospects for growth could suffer.

We may be unable to protect the confidentiality of our trade secrets, particularly in light of our reliance on third parties, which increases the possibility that such trade secrets will be disclosed or misappropriated, thus harming our business and competitive position.

In addition to our patented technology and products, we rely upon trade secrets, including unpatented know-how, technology and other proprietary information to develop and maintain our competitive position, particularly with respect to our manufacturing process. We seek to protect our trade secrets, in part, through confidentiality agreements with our employees, collaborators and consultants. We seek to have agreements with our employees and selected consultants that obligate them to assign any inventions created during their tenure with us. However, we may not obtain these agreements in all circumstances and the assignment of intellectual property under such agreements may not be self-executing. If the employees, collaborators or consultants that are parties to these agreements breach or violate their respective terms, we may not have adequate remedies for any such breach or violation. Our trade secrets could also be misappropriated by our competitors. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, time-consuming and potentially distracting, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent such a party from using that technology or information to compete with us. If our trade secrets are disclosed to or misappropriated or independently developed by a third party, it would harm our ability to protect our rights and could materially harm our business and competitive position.

Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.

We may employ individuals or engage consultants that previously worked with other organizations, including our competitors or potential competitors. Although we seek to ensure that such persons do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or they, or both, have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer or other third party. Litigation may be necessary to defend against these claims. If we fail in defending any such claims or settling those claims, we may lose valuable intellectual property rights or personnel in addition to paying monetary damages or a settlement. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Patent terms may be inadequate to protect our competitive position on our HAVs or our other product candidates for an adequate amount of time.

Patents have a limited lifespan. 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 HAVs are obtained, once the patent life has expired, we may face competition, including from other competing technologies. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

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

Filing, prosecuting, maintaining, defending and enforcing patents on our product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in countries outside the United States, or from selling or importing products made using our inventions in and into or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may also export infringing products to territories where we have patent protection, but enforcement rights are not as strong as those in the United States. These products may compete with our products, to the extent approved, and our owned or licensed patents or other intellectual property rights may not be effective or sufficient to prevent them from doing so.

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, trade secrets, and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our owned or licensed patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our owned or licensed 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 to us, if any, may not be commercially meaningful.

Many countries have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license 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 develop or license, which could adversely affect our business, financial condition, results of operations, and prospects.

Some of our internal intellectual property and most of our in-licensed intellectual property has been generated under U.S. Government grants and contracts that trigger certain obligations and U.S. Government rights and thus is subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.

Some of our internal intellectual property and most of our in-licensed intellectual property has been generated under U.S. Government grants and contracts that trigger certain obligations and U.S. Government rights under federal statutes and regulations, including the Bayh-Dole Act of 1980 and the Federal Technology Transfer Act of 1986. For example, the U.S. Government has a non-exclusive, non-transferable, irrevocable worldwide license to inventions conceived or first actually reduced to practice in the performance of a U.S. Government agreement. In addition, the U.S. Government has certain “march-in” rights to require us to grant exclusive, partially exclusive, or non-exclusive licenses to such inventions for the benefit of a third party if the U.S. Government determines that: (i) action is necessary to alleviate health or safety needs not reasonably met by us, our assignees, our licensees, or, in some cases, our licensors, (ii) action is necessary due to noncompliance with a U.S.-based manufacturing requirement applicable to exclusive licenses, (iii) action is necessary to meet requirements for public use specified by federal regulations and such requirements are not reasonably satisfied by us, our assignees, our licensees, and, in some cases, our licensors, and (iv) with respect to inventions made under funding agreements, adequate steps have not been taken to achieve practical application of the invention. The U.S. Government also has the right to take title to these inventions if we, or the applicable licensor, fails to disclose, elect title to, file or prosecute a patent application for, or defend or obtain a patent covering such inventions within time limits specified in particular funding agreements. The U.S. Government also has varying rights to use and disclose information, including copyrighted works, generated or delivered under a U.S. Government agreement depending on the terms of the agreement and the nature of the information. Intellectual property generated under a U.S. Government agreement is also subject to certain reporting requirements, compliance with which may require us or the applicable licensor to expend substantial resources. In addition, when inventions that are conceived or first actually reduced to practice under a U.S. Government funding agreement are exclusively licensed, products embodying or produced through the use of such inventions must be manufactured substantially in the United States. This U.S.-based manufacturing requirement may limit our ability to contract with non-U.S. companies to produce a covered product, although this requirement can be waived in certain circumstances. To the extent that any of our licensors’ current or future intellectual property is generated in the performance of U.S. Government grants or contracts, these requirements may apply to such intellectual property.

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

Our 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 or may be forced to stop using these names, which we need for name recognition by potential partners or customers in our

markets of interest. During trademark registration proceedings, we may receive rejections. Although we would be given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

•        others may be able to make products that are similar to any product candidates we may develop or utilize similar technology but that are not covered by the claims of the patents that we own or license or may own or license in the future;

•        we, or our current or future licensors might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or license or may own or license in the future;

•        we, or our current or future licensors might not have been the first to file patent applications covering certain of our or their inventions;

•        others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;

•        it is possible that our and our licensors’ pending owned or licensed patent applications or those that we may own or license in the future will not lead to issued patents;

•        issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

•        our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

•        we may not develop additional proprietary technologies that are patentable;

•        the patents of others may harm our business; and

•        we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they could harm our business, financial condition, results of operations, and prospects.

Risks Related to Employee Matters and Our Ability to Manage Growth

Our future success depends on our ability to retain our key employees, consultants and advisors and to attract, retain and motivate qualified personnel.

We are highly dependent on the research and development, clinical, regulatory, financial, commercial, and manufacturing expertise of the principal members of our management, scientific and clinical teams. The loss of the services of our executive officers or other key employees could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, losing or replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain marketing approval of and commercialize our product candidates. Competition

to hire from this limited pool is intense. We also experience competition for the hiring of scientific and clinical personnel from public and private universities and research institutions. In addition, we rely on consultants and advisors, including scientific, commercial and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may have commitments under employment, consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.

We expect to increase the size of our workforce in the future, and we may encounter difficulties in managing this growth, which could harm our operations.

As of March 15, 2021, we had 138 employees. As we move forward in our efforts to commercialize our HAVs, if approved, we expect to continue to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of development, regulatory affairs, manufacturing and quality and compliance and support functions. Due to our limited financial resources, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage this growth effectively could delay the execution of our business plans or harm our operations.

RISKS RELATED TO NEW HUMACYTE AND THE NEW HUMACYTE COMMON STOCK FOLLOWING THE BUSINESS COMBINATION

The price of New Humacyte common stock may be volatile.

The price of New Humacyte common stock may fluctuate due to a variety of factors, including:

•        actual or anticipated fluctuations in its quarterly and annual results and those of other public companies in industry;

•        mergers and strategic alliances in the industry in which it operates;

•        market prices and conditions in the industry in which it operates;

•        changes in government regulation;

•        the impact of the COVID-19 pandemic on New Humacyte’s business and operations;

•        potential or actual military conflicts or acts of terrorism;

•        announcements concerning New Humacyte or its competitors; and

•        the general state of the securities markets.

These market and industry factors may materially reduce the market price of New Humacyte common stock, regardless of New Humacyte’s operating performance.

Reports published by analysts, including projections in those reports that differ from New Humacyte’s actual results, could adversely affect the price and trading volume of New Humacyte common stock.

AHAC currently expects that securities research analysts will establish and publish their own periodic projections for the business of New Humacyte. These projections may vary widely and may not accurately predict the results New Humacyte actually achieves. New Humacyte’s stock price may decline if its actual results do not match the projections of these securities research analysts. Similarly, if one or more of the analysts who write reports on New Humacyte downgrades its stock or publishes inaccurate or unfavorable research about its business, New Humacyte’s stock price could decline. If one or more of these analysts ceases coverage of New Humacyte or fails to publish reports on New Humacyte regularly, its stock price or trading volume could decline. While AHAC expects research analyst coverage following the Business Combination, if no analysts commence coverage of New Humacyte, the trading price and volume for New Humacyte common stock could be adversely affected.

New Humacyte may issue additional shares of common stock or other equity securities without your approval, which would dilute your ownership interests and may depress the market price of New Humacyte common stock.

Upon consummation of the Business Combination, New Humacyte will have warrants outstanding to purchase up to an aggregate of              shares of New Humacyte common stock and former Humacyte options and warrants outstanding to purchase up to our aggregate of              shares of New Humacyte common stock, based on its outstanding options and warrants as of             . Under the 2021 Plan and ESPP, New Humacyte will also have the ability to issue a number of shares equal to 7.5% and 1%, respectively, of the shares of New Humacyte common stock issued and outstanding immediately after the Closing (assuming the 2021 Plan and ESPP are approved by AHAC stockholders at the Special Meeting). In addition, such aggregate number of shares under the 2021 Plan and the ESPP will automatically increase on January 1 of each year commencing January 1, 2022, in an amount equal to 5% and 1%, respectively, of the number of shares of New Humayte’s capital stock outstanding on December 31 of the preceding year, unless the New Humacyte Board acts prior to January 1 of a given year to provide that the increase for such year will be a lesser number. New Humacyte may also issue additional shares of common stock or other equity securities of equal or senior rank in the future in connection with, among other things, future acquisitions or repayment of outstanding indebtedness, without stockholder approval, in a number of circumstances.

New Humacyte’s issuance of additional shares of common stock or other equity securities of equal or senior rank would have the following effects:

•        AHAC’s existing stockholders’ proportionate ownership interest in New Humacyte will decrease;

•        the amount of cash available per share, including for payment of dividends in the future, may decrease;

•        the relative voting strength of each previously outstanding share of common stock may be diminished; and

•        the market price of New Humacyte’s shares of common stock may decline.

New Humacyte’s actual financial position and results of operations may differ materially from the unaudited pro forma condensed combined financial information included in this proxy statement/prospectus, which may not be indicative of what New Humacyte’s actual financial position or results of operations would have been.

The unaudited pro forma condensed combined financial information in this proxy statement/prospectus is presented for illustrative purposes only and is not necessarily indicative of what New Humacyte’s actual financial position or results of operations would have been had the Business Combination been completed on the dates indicated. See the section titled “Unaudited Pro Forma Condensed Combined Financial Information” for more information.

The obligations associated with being a public company will involve significant expenses and will require significant resources and management attention, which may divert from New Humacyte’s business operations.

As a public company, New Humacyte will become subject to the reporting requirements of the Exchange Act and the Sarbanes-Oxley Act. The Exchange Act requires the filing of annual, quarterly and current reports with respect to a public company’s business and financial condition. The Sarbanes-Oxley Act requires, among other things, that a public company establish and maintain effective internal control over financial reporting. As a result, New Humacyte will incur significant legal, accounting and other expenses that Humacyte did not previously incur. New Humacyte’s entire management team and many of its other employees will need to devote substantial time to compliance, and may not effectively or efficiently manage its transition into a public company.

These rules and regulations will result in New Humacyte incurring substantial legal and financial compliance costs and will make some activities more time-consuming and costly. For example, these rules and regulations will likely make it more difficult and more expensive for New Humacyte to obtain director and officer liability insurance, and it may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be difficult for New Humacyte to attract and retain qualified people to serve on its board of directors, its board committees or as executive officers.

New Humacyte will be an “emerging growth company” and it cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make the New Humacyte common stock less attractive to investors and may make it more difficult to compare performance with other public companies.

New Humacyte will be an emerging growth company as defined in the JOBS Act, and it intends to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Investors may find the New Humacyte common stock less attractive because New Humacyte will continue to rely on these exemptions. If some investors find the New Humacyte common stock less attractive as a result, there may be a less active trading market for their common stock, and the stock price may be more volatile.

An emerging growth company may elect to delay the adoption of new or revised accounting standards. With AHAC making this election, Section 102(b)(2) of the JOBS Act allows New Humacyte to delay adoption of new or revised accounting standards until those standards apply to non-public business entities. As a result, the financial statements contained in this proxy statement/prospectus and those that New Humacyte will file in the future may not be comparable to companies that comply with public business entities revised accounting standards effective dates.

If New Humacyte fails to maintain an effective system of internal control over financial reporting, it may not be able to accurately report its financial results or prevent fraud. As a result, stockholders could lose confidence in New Humacyte’s financial and other public reporting, which would harm its business and the trading price of the New Humacyte common stock.

Effective internal control over financial reporting is necessary for New Humacyte to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause New Humacyte to fail to meet its reporting obligations. In addition, any testing by New Humacyte conducted in connection with Section 404 of the Sarbanes-Oxley Act, or any subsequent testing by New Humacyte’s independent registered public accounting firm, may reveal deficiencies in New Humacyte’s internal control over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to New Humacyte’s financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in New Humacyte’s reported financial information, which could have a negative effect on the trading price of the New Humacyte common stock.

New Humacyte will be required to disclose changes made in its internal controls and procedures on a quarterly basis and its management will be required to assess the effectiveness of these controls annually. However, for as long as New Humacyte is an emerging growth company under the JOBS Act, its independent registered public accounting firm will not be required to attest to the effectiveness of its internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act. New Humacyte could be an emerging growth company for up to five years from the last day of the fiscal year of AHAC’s Initial Public Offering. An independent assessment of the effectiveness of New Humacyte’s internal control over financial reporting could detect problems that New Humacyte’s management’s assessment might not. Undetected material weaknesses in New Humacyte’s internal control over financial reporting could lead to financial statement restatements and require New Humacyte to incur the expense of remediation.

RISKS RELATED TO AHAC, THE BUSINESS COMBINATION AND REDEMPTIONS

The opinion of Lake Street, AHAC’s financial advisor, does not reflect changes in circumstances between February 16, 2021, the date Lake Street issued the opinion, and the Closing.

AHAC’s financial advisor, Lake Street, rendered an opinion dated February 16, 2021, to the Board that, as of such date, and subject to and based on the considerations referred to in its opinion, (i) the consideration to be paid by AHAC in the Business Combination pursuant to the Business Combination Agreement was fair to AHAC, from a financial point of view, and (ii) the fair market value of Humacyte implied by the various financial analyses Lake Street conducted in connection with its opinion equaled or exceeded 80% of the amount held by AHAC in trust for

the benefit of its Public Stockholders (excluding any deferred underwriters’ fees and taxes payable on the income earned on the Trust Account). The opinion was based on economic, market and other conditions in effect on, and the information made available to it as of, the date thereof.

Changes in the operations and prospects of Humacyte, general market and economic conditions and other factors on which Lake Street’s opinion was based, may significantly alter the value of Humacyte at the time the Business Combination is completed. The opinion does not speak as of the time the Business Combination will be completed or as of any date other than the date of such opinion. For a description of the opinion issued by Lake Street to the Board, please see “Proposal No. 1: The Business Combination Proposal — Opinion of AHAC’s Financial Advisor.”

AHAC and Humacyte will incur significant transaction and transition costs in connection with the Business Combination.

AHAC and Humacyte have both incurred and expect to incur significant, non-recurring costs in connection with consummating the Business Combination and operating as a public company following the consummation of the Business Combination. AHAC and Humacyte may also incur additional costs to retain key employees. Certain transaction expenses incurred in connection with the Business Combination, including all legal, accounting, consulting, investment banking and other fees, expenses and costs, will be paid by New Humacyte following the closing of the Business Combination.

AHAC will not have any right to make damage claims against Humacyte or Humacyte’s stockholders for the breach of any representation, warranty or covenant made by Humacyte in the Business Combination Agreement.

The Business Combination Agreement provides that all of the representations, warranties and covenants of the parties contained therein shall not survive the Closing, except for those covenants that by their terms apply or are to be performed in whole or in part after the Closing, and then only with respect to breaches occurring after Closing. Accordingly, there are no remedies available to the parties with respect to any breach of the representations, warranties, covenants or agreements of the parties to the Business Combination Agreement after the Closing of the Business Combination, except for covenants to be performed in whole or in part after the Closing. As a result, AHAC will have no remedy available to it if the Business Combination is consummated and it is later revealed that there was a breach of any of the representations, warranties and covenants made by Humacyte at the time of the Business Combination.

Subsequent to the Closing, New Humacyte 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, results of operations and stock price, which could cause you to lose some or all of your investment.

Although AHAC has conducted due diligence on Humacyte, AHAC cannot assure you that this diligence revealed all material issues that may be present in Humacyte’s business, that it would be possible to uncover all material issues through a customary amount of due diligence, or that factors outside of AHAC’s and Humacyte’s control will not later arise. As a result, after the Closing, New Humacyte may be forced to later write-down or write-off assets, restructure its operations, or incur impairment or other charges that could result in losses. Even if AHAC’s due diligence successfully identifies certain risks, unexpected risks may arise and previously known risks may materialize in a manner not consistent with AHAC’s preliminary risk analysis. Even though these charges may be non-cash items and may not have an immediate impact on New Humacyte’s liquidity, the fact that New Humacyte may charges of this nature could contribute to negative market perceptions about the Combined Company’s securities. In addition, charges of this nature may cause New Humacyte to be unable to obtain future financing on favorable terms or at all. Accordingly, any AHAC stockholder who chooses to remain a stockholder of the Combined Company following the Business Combination could suffer a reduction in the value of their shares. Such stockholders are unlikely to have a remedy for such reduction in value unless they are able to successfully claim that the reduction was due to the breach by AHAC’s officers or directors of a duty of care or other fiduciary duty owed to them, or if they are able to successfully bring a private claim under securities laws that the proxy solicitation relating to the Business Combination contained an actionable material misstatement or material omission.

The Sponsor and AHAC’s officers and directors own AHAC Common Stock and Warrants that will be worthless and have incurred reimbursable expenses that may not be reimbursed or repaid if the Business Combination is not approved. Such interests may have influenced their decision to approve the Business Combination with Humacyte.

The Sponsor and AHAC’s officers and directors and/or their affiliates beneficially own or have a pecuniary interest in Founder Shares and additional securities that they purchased in the Concurrent Private Placement. The holders have no redemption rights with respect to these securities in the event a business combination is not effected in the required time period. Therefore, if the Business Combination with Humacyte or another business combination is not approved within the required time period, such securities held by such persons will be worthless. Such securities had an aggregate market value of $            based upon the closing prices of the Class A Common Stock and Warrants on Nasdaq on the Record Date. Furthermore, the Sponsor and AHAC’s officers and directors and their affiliates are entitled to reimbursement of out-of-pocket expenses incurred by them in connection with certain activities on AHAC’s behalf, such as identifying and investigating possible business targets and business combinations. Any such expenses will be repaid upon completion of the Business Combination with Humacyte. As of June 10, 2021, no such reimbursable expenses have been incurred. If any such expenses are incurred, however, if AHAC fails to consummate the Business Combination, they will not have any claim against the Trust Account for repayment or reimbursement. Accordingly, AHAC may not be able to repay or reimburse these amounts if the Business Combination is not completed. See the section entitled “Proposal 1: The Business Combination Proposal — Interests of the Sponsor and AHAC’s Directors and Officers in the Business Combination.”

These financial interests may have influenced the decision of AHAC’s directors to approve the Business Combination with Humacyte and to continue to pursue such Business Combination. In considering the recommendations of AHAC’s Board to vote for the Business Combination Proposal and other proposals, AHAC’s stockholders should consider these interests.

The Public Stockholders will experience immediate dilution as a consequence of the issuance of New Humacyte common stock as consideration in the Business Combination and in the PIPE Investment.

In accordance with the terms and subject to the conditions of the Business Combination Agreement, at the Effective Time, (i) each outstanding share of Humacyte common stock will be cancelled and converted into the right to receive a number of shares of New Humacyte common stock equal to the Exchange Ratio; (ii) each outstanding share of Humacyte preferred stock will be cancelled and converted into the right to receive a number of shares of New Humacyte common stock equal to (A) the aggregate number of shares of Humacyte common stock that would be issued upon conversion of the shares of Humacyte preferred stock based on the applicable conversion ratio immediately prior to the Effective Time, multiplied by (B) the Exchange Ratio; and (iii) each outstanding Humacyte option or warrant will be converted into an option or warrant, as applicable, to purchase a number of shares of New Humacyte common stock equal to (A) the number of shares of Humacyte common stock subject to such option or warrant multiplied by (B) the Exchange Ratio at an exercise price per share equal to the current exercise price per share for such option or warrant divided by the Exchange Ratio; in each case, rounded down to the nearest whole share. In addition, holders of shares of Humacyte common stock and Humacyte preferred stock also will be eligible to receive Contingent Consideration of up to an aggregate of 15,000,000 shares of New Humacyte common stock based on the share price performance of the New Humacyte common stock or upon a change in control. Finally, in connection with the PIPE Investment, an aggregate of 17,500,000 shares of New Humacyte common stock will be issued. The issuance of additional New Humacyte common stock will significantly dilute the equity interests of existing holders of AHAC securities, and may adversely affect prevailing market prices for the New Humacyte common stock and/or New Humacyte warrants.

Warrants will become exercisable for New Humacyte common stock, which would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.

If the Business Combination is completed, outstanding Warrants will become exercisable for an aggregate of              shares of New Humacyte common stock in accordance with the terms of the warrant agreement governing those securities. These Warrants will become exercisable 30 days after the completion of the Business Combination. The exercise price of these Warrants will be $11.50 per share. To the extent such Warrants are exercised, additional shares of New Humacyte common stock will be issued, which will result in dilution to the holders of New Humacyte common stock and increase the number of shares eligible for resale in the public market. Sales of substantial numbers of such shares in the public market or the fact that such Warrants may be exercised could adversely affect the market

price of New Humacyte common stock. However, there is no guarantee that the Warrants will ever be in the money prior to their expiration, and as such, the Warrants may expire worthless. See “— Even if the Business Combination is consummated, the Public Warrants may never be in the money, and they may expire worthless, and the terms of the Public Warrants may be amended in a manner adverse to a holder if holders of at least 50% of the then outstanding Public Warrants approve of such amendment.”

Even if the Business Combination is consummated, the Public Warrants may never be in the money, and they may expire worthless, and the terms of the Public Warrants may be amended in a manner adverse to a holder if holders of at least 50% of the then outstanding Public Warrants approve of such amendment.

The Warrants were issued in registered form under a warrant agreement between Continental, as warrant agent, and AHAC. The warrant agreement provides that the terms of the Warrants may be amended without the consent of any holder to cure any ambiguity or correct any defective provision or correct any mistake, but requires the approval by the holders of at least 50% of the then-outstanding Public Warrants (as defined herein) to make any change that adversely affects the interests of the registered holders of Public Warrants. Accordingly, AHAC may amend the terms of the Public Warrants in a manner adverse to a holder if holders of at least 50% of the then-outstanding Public Warrants approve of such amendment and, solely with respect to any amendment to the terms of the Warrants sold as part of the Units in the Concurrent Private Placement (the “Private Placement Warrants”) or any provision of the warrant agreement with respect to the Private Placement Warrants, holders of at least 50% of the number of the then outstanding Private Placement Warrants. Although AHAC’s ability to amend the terms of the Public Warrants with the consent of at least 50% of the then-outstanding Public Warrants is unlimited, examples of such amendments could be amendments to, among other things, increase the exercise price of the Warrants, convert the Warrants into cash, shorten the exercise period or decrease the number of shares of New Humacyte common stock purchasable upon exercise of a Warrant.

AHAC may redeem your unexpired Public Warrants prior to their exercise at a time that is disadvantageous to you, thereby making your Public Warrants worthless.

AHAC has 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 the New Humacyte common stock equals or exceeds $18.00 per share (as adjusted for share subdivisions, share dividends, rights issuances, subdivisions, reorganizations, recapitalizations and the like) for any 20 trading days within a 30 trading-day period ending on the third trading day prior to the date AHAC sends the notice of redemption to the holders thereof. If and when the Public Warrants become redeemable by AHAC, AHAC may exercise its redemption right even if AHAC 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 to: (i) exercise your Public Warrants and pay the exercise price therefor at a time when it may be disadvantageous for you to do so; (ii) sell your Public Warrants at the then-current market price when you might otherwise wish to hold your Public Warrants; or (iii) accept the nominal redemption price which, at the time the outstanding Public Warrants are called for redemption, is likely to be substantially less than the market value of your Public Warrants.

The value received upon exercise of the Public Warrants (1) may be less than the value the holders would have received if they had exercised their Public Warrants at a later time where the underlying share price is higher and (2) may not compensate the holders for the value of the Public Warrants.

The Private Placement Warrants are not subject to the same risk of redemption as the Public Warrants as the Private Placement Warrants are not redeemable so long as they are held by the Sponsor, the underwriters or their permitted transferees. If the Private Placement Warrants are held by holders other than the Sponsor, the underwriters or their permitted transferees, the Private Placement Warrants will be redeemable by AHAC.

The exercise of AHAC’s directors’ and 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 such changes to the terms of the Business Combination or waivers of conditions are appropriate and in the best interests of AHAC’s stockholders.

In the period leading up to the Closing events may occur that, pursuant to the Business Combination Agreement, would require AHAC to agree to amend the Business Combination Agreement, to consent to certain actions taken by Humacyte or to waive rights that AHAC is entitled to under the Business Combination Agreement. Such events could arise because of changes in the course of Humacyte’s business, a request by Humacyte 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 Humacyte’s business and would entitle AHAC to terminate the Business Combination Agreement. In any of such circumstances, it would be at AHAC’s discretion, acting through its Board, to grant its consent or waive those rights. The existence of the financial and personal interests of the directors described in the preceding risk factors may result in a conflict of interest on the part of one or more of the directors between what he, she or they may believe is best for AHAC and what he, she or they may believe is best for himself, herself or themselves in determining whether or not to take the requested action. As of the date of this proxy statement/prospectus, AHAC does not believe there will be any material changes or waivers that AHAC’s directors and officers would be likely to make after the mailing of this proxy statement/prospectus. AHAC will circulate a supplemental or amended proxy statement/prospectus if changes to the terms of the Business Combination that would have a material impact on its stockholders are required prior to the vote on the Business Combination Proposal.

If AHAC is unable to complete the Business Combination with Humacyte or another business combination by September 22, 2022 (or such later date as may be approved by AHAC’s stockholders), AHAC will cease all operations except for the purpose of winding up, redeeming 100% of the outstanding Public Shares for cash and, subject to the approval of its remaining stockholders and its Board, dissolving and liquidating. In such event, third parties may bring claims against AHAC and, as a result, the proceeds held in the Trust Account could be reduced and the per-share liquidation price received by stockholders could be less than $10.00 per share.

Under the terms of the Current Charter AHAC must complete the Business Combination with Humacyte or another business combination by September 22, 2022 (or such later date as may be approved by AHAC stockholders in an amendment to its Current Charter), or AHAC must cease all operations except for the purpose of winding up, redeeming 100% of the outstanding Public Shares for cash and, subject to the approval of its remaining stockholders and its Board, dissolving and liquidating. In such event, third parties may bring claims against AHAC. Although AHAC seeks waiver agreements from certain vendors and service providers it has engaged and owes money to, and the prospective target businesses it has negotiated with, whereby such parties will waive any right, title, interest or claim of any kind they may have in or to any monies held in the Trust Account, there is no guarantee that vendors, regardless of whether they execute such waivers, will not seek recourse against the Trust Account notwithstanding such agreements. Furthermore, there is no guarantee that a court will uphold the validity of such agreements. Accordingly, the proceeds held in the Trust Account could be subject to claims which could take priority over those of the Public Stockholders. If AHAC is unable to complete a business combination within the required time period, the Sponsor has agreed that it will be liable under certain circumstances described herein to ensure that the proceeds in the Trust Account are not reduced by the claims of target businesses or claims of vendors or other entities that are owed money by AHAC for services rendered or contracted for or products sold to AHAC. However, the Sponsor may not be able to meet such obligation as its only assets are securities of AHAC. Therefore, the per-share distribution from the Trust Account in such a situation may be less than $10.00 due to such claims.

Additionally, if AHAC is forced to file a bankruptcy case or an involuntary bankruptcy case is filed against it which is not dismissed, or if AHAC otherwise enters compulsory or court supervised liquidation, the proceeds held in the Trust Account could be subject to applicable bankruptcy law, and may be included in its bankruptcy estate and subject to the claims of third parties with priority over the claims of AHAC’s stockholders. To the extent any bankruptcy claims deplete the Trust Account, AHAC may not be able to return to its Public Stockholders at least $10.00 per share of AHAC Common Stock.

AHAC’s stockholders may be held liable for claims by third parties against AHAC to the extent of distributions received by them.

If AHAC is unable to complete the Business Combination with Humacyte or another business combination within the required time period, AHAC 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 100% of the outstanding Public Shares for cash, which redemption will completely extinguish the Public Stockholders’ rights as stockholders (including the right to receive further liquidation distributions, if any), subject to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject to the approval of its remaining stockholders and its Board, dissolve and liquidate, subject (in the case of (ii) and (iii) above) to its obligations under Delaware law to provide for claims of creditors and the requirements of other applicable law. AHAC cannot assure you that it will properly assess all claims that may potentially be brought against AHAC. As such, AHAC’s stockholders could potentially be liable

for any claims to the extent of distributions received by them (but no more) and any liability of its stockholders may extend well beyond the third anniversary of the date of distribution. Accordingly, AHAC cannot assure you that third parties will not seek to recover from its stockholders amounts owed to them by AHAC.

If AHAC is forced to file a bankruptcy case or an involuntary bankruptcy case is filed against it which is not dismissed, any distributions received by stockholders could be viewed under applicable debtor, creditor and/or bankruptcy laws as either a “preferential transfer” or a “fraudulent conveyance.” As a result, a bankruptcy court could seek to recover all amounts received by AHAC’s stockholders. Furthermore, because AHAC intends to distribute the proceeds held in the Trust Account to its Public Stockholders promptly after the expiration of the time period to complete a business combination, this may be viewed or interpreted as giving preference to its Public Stockholders over any potential creditors with respect to access to or distributions from its assets. Furthermore, AHAC’s Board may be viewed as having breached its fiduciary duties to its creditors and/or may have acted in bad faith, thereby exposing itself and Humacyte to claims of punitive damages, by paying Public Stockholders from the Trust Account prior to addressing the claims of creditors. AHAC cannot assure you that claims will not be brought against it for these reasons.

Activities taken by existing AHAC stockholders to increase the likelihood of approval of the Business Combination Proposal and the other Proposals could have a depressive effect on AHAC Common Stock.

At any time prior to the Special Meeting, during a period when they are not then aware of any material nonpublic information regarding AHAC or its securities, the Sponsor, AHAC’s officers, directors and stockholders from prior to the Initial Public Offering, Humacyte or Humacyte’s stockholders and/or their respective affiliates may purchase shares from institutional and other investors who vote, or indicate an intention to vote, against the Business Combination Proposal, or execute agreements to purchase such shares from such investors in the future, or they may enter into transactions with such investors and others to provide them with incentives to acquire AHAC Common Stock or vote their shares in favor of the Business Combination Proposal. The purpose of such share purchases and other transactions would be to increase the likelihood of satisfaction of the requirements to consummate the Business Combination where it appears that such requirements would otherwise not be met. Entering into any such arrangements may have a depressive effect on AHAC Common Stock. For example, as a result of these arrangements, an investor or holder may have the ability to effectively purchase shares at a price lower than market and may therefore be more likely to sell the shares he, she or it owns, either prior to or immediately after the Special Meeting.

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 Board will not have the ability to adjourn the Special Meeting to a later date in order to solicit further votes, and, therefore, the Business Combination will not be approved.

There is no guarantee that a stockholder’s decision whether to redeem their shares of AHAC Common Stock for a pro rata portion of the Trust Account will put the stockholder in a better future economic position.

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

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

In order to exercise their redemption rights, Public Stockholders are required to submit a request in writing and deliver their stock to AHAC’s transfer agent at least two business days prior to the Special Meeting. Stockholders electing to redeem their shares will receive their pro rata portion of the Trust Account less income taxes payable, calculated as of two business days prior to the anticipated consummation of the Business Combination. See the section entitled “Special Meeting of AHAC Stockholders — Redemption Rights” for additional information on how to exercise your redemption rights.

Stockholders of AHAC who wish to redeem their shares for a pro rata portion of the Trust Account must comply with specific requirements for redemption that may make it more difficult for them to exercise their redemption rights prior to the deadline.

Public Stockholders who wish to redeem their shares for a pro rata portion of the Trust Account must, among other things, as fully described in the section entitled “Special Meeting of AHAC Stockholders — Redemption Rights,” deliver their shares (either physically or electronically) to Continental (or through DTC to Continental) prior to          , local time, on          , 2021.

In addition, holders of outstanding AHAC Units must separate the underlying shares of Class A Common Stock and Warrants prior to exercising redemption rights with respect to the Public Shares.

If a broker, dealer, commercial bank, trust company or other nominee holds your Units, you must instruct such nominee to separate your Units. Your nominee must send written instructions by facsimile or email to Continental. Such written instructions must include the number of Units to be split and the nominee holding such Units. Your nominee must also initiate electronically, using DTCC’s DWAC (deposit/withdrawal at custodian) system, a withdrawal of the relevant Units and a deposit of an equal number of shares of Class A Common Stock and Warrants. This must be completed far enough in advance to permit your nominee to exercise your redemption rights upon the separation of the Public Shares from the Units. While this is typically done electronically on the same business day, you should allow at least one full business day to accomplish the separation. If you fail to cause your Public Shares to be separated in a timely manner, you will likely not be able to exercise your redemption rights.

If you or a “group” of stockholders of which you are a part are deemed to hold an aggregate of more than 20% of AHAC Common Stock issued in the Initial Public Offering, you (or, if a member of such a group, all of the members of such group in the aggregate) will lose the ability to redeem all such shares in excess of 20% of common stock issued in the Initial Public Offering.

A Public Stockholder, together with any of his, her or its affiliates or any other person with whom he, she or it is acting in concert or as a “group” (as defined under Section 13 of the Exchange Act), will be restricted from redeeming in the aggregate his, her or its shares or, if part of such a group, the group’s shares, in an amount in excess of 20% of the Class A Common Stock included in the Units sold in the Initial Public Offering. In order to determine whether a stockholder is acting in concert or as a group with another stockholder, AHAC will require each Public Stockholder seeking to exercise redemption rights to certify to AHAC whether such stockholder is acting in concert or as a group with any other stockholder. Such certifications, together with other public information relating to stock ownership available to AHAC at that time, such as Section 13D, Section 13G and Section 16 filings under the Exchange Act, will be the sole basis on which AHAC makes the above-referenced determination. Your inability to redeem any such excess shares will reduce your influence over AHAC’s ability to consummate the Business Combination and you could suffer a material loss on your investment in AHAC if you sell such excess shares in open market transactions. Additionally, you will not receive redemption distributions with respect to such excess shares if AHAC consummates the Business Combination. As a result, you will continue to hold that number of shares aggregating to more than 20% of the shares sold in the Initial Public Offering and, in order to dispose of such excess shares, would be required to sell your stock in open market transactions, potentially at a loss. AHAC cannot assure you that the value of such excess shares will appreciate over time following the Business Combination or that the market price of New Humacyte common stock will exceed the per-share redemption price. Notwithstanding the foregoing, stockholders may challenge AHAC’s determination as to whether a stockholder is acting in concert or as a group with another stockholder in a court of competent jurisdiction.

Voting Your Shares

Each share of AHAC Common Stock that you own in your name entitles you to one vote. If you are a record owner of your shares, there are two ways to vote your shares of AHAC Common Stock at the Special Meeting:

•        You Can Vote By Signing and Returning the Enclosed Proxy Card.    If you vote by proxy card, your “proxy,” whose name is listed on the proxy card, will vote your shares as you instruct on the proxy card. If you sign and return the proxy card but do not give instructions on how to vote your shares, your shares will be voted as recommended by the Board “FOR” the Business Combination Proposal, the Charter Amendment Proposal, the Advisory Charter Amendment Proposals, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, the Incentive Plan Proposal, the ESPP Proposal and the Adjournment Proposal (if presented). Votes received after a matter has been voted upon at the Special Meeting will not be counted.

•        You Can Attend the Special Meeting and Vote Through the Internet.    You will be able to attend the Special Meeting online and vote during the meeting by visiting        and entering the control number included on your proxy card or on the instructions that accompanied your proxy materials, as applicable.

If your shares are held in “street name” or are in a margin or similar account, you should contact your broker to ensure that votes related to the shares you beneficially own are properly counted. If you wish to attend the meeting and vote online and your shares are held in “street name,” you must obtain a legal proxy from your broker, bank or nominee. That is the only way AHAC can be sure that the broker, bank or nominee has not already voted your shares.

Revoking Your Proxy

If you are a record owner of your shares and you give a proxy, you may change or revoke it at any time before it is exercised by doing any one of the following:

•        submit a new proxy card bearing a later date;

•        give written notice of your revocation to AHAC’s Secretary, which notice must be received by AHAC’s Secretary prior to the vote at the Special Meeting; or

•        vote electronically at the Special Meeting by visiting        and entering the control number found on your proxy card, voting instruction form or notice you previously received. Please note that your attendance at the Special Meeting will not alone serve to revoke your proxy.

If your shares are held in “street name” by your broker, bank or another nominee as of the close of business on the Record Date, you must follow the instructions of your broker, bank or other nominee to revoke or change your voting instructions.

Who Can Answer Your Questions About Voting Your Shares

If you are a stockholder and have any questions about how to vote or direct a vote in respect of your AHAC Common Stock, you may call       .

No Additional Matters May Be Presented at the Special Meeting

The Special Meeting has been called only to consider the approval of the Business Combination Proposal, the Charter Amendment Proposal, the Advisory Charter Amendment Proposals, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, the Incentive Plan Proposal, the ESPP Proposal and the Adjournment Proposal. Under the Bylaws, other than procedural matters incident to the conduct of the Special Meeting, no other matters may be considered at the Special Meeting if they are not included in this proxy statement/prospectus, which serves as the notice of the Special Meeting.

Redemption Rights

Pursuant to the Current Charter, any holders of Public Shares may demand that such shares be redeemed in exchange for a pro rata share of the aggregate amount on deposit in the Trust Account, less any owed but unpaid taxes on the funds in the Trust Account. If demand is properly made and the Business Combination is consummated, these

shares, immediately prior to the Business Combination, will cease to be outstanding and will represent only the right to receive a pro rata share of the aggregate amount on deposit in the Trust Account which holds the proceeds of the Initial Public Offering (including interest earned on the funds held in the Trust Account and not previously released to it to pay the Company’s franchise and income taxes). For illustrative purposes, based on funds in the Trust Account of approximately $              on the Record Date, the estimated per share redemption price would have been approximately $             .

In order to exercise your redemption rights, you must:

•        check the box on the enclosed proxy card to elect redemption;

•        provide, in the written request to redeem your Public Shares for cash to Continental, a “Stockholder Certification” if you are not acting in concert or as a “group” (as defined in Section 13d-3 of the Exchange Act) with any other stockholder with respect to shares of AHAC Common Stock;

•        prior to                (two business days before the Special Meeting), tender your shares physically or electronically and submit a request in writing that AHAC redeem your Public Shares for cash to Continental, AHAC’s transfer agent, at the following address:

Continental Stock Transfer & Trust Company
One State Street Plaza, 30th Floor
New York, New York 10004
Attn: Mark Zimkind
E-mail: mzimkind@continentalstock.com; or

•        deliver your Public Shares either physically or electronically through DTC to Continental at least two business days before the Special Meeting. Public Stockholders seeking to exercise their redemption rights and opting to deliver physical certificates should allot sufficient time to obtain physical certificates from Continental and time to effect delivery. It is AHAC’s understanding that stockholders should generally allot at least two weeks to obtain physical certificates from Continental. However, AHAC does not have any control over this process and it may take longer than two weeks. Stockholders who hold their shares in street name will have to coordinate with their bank, broker or other nominee to have the shares certificated or delivered electronically. If you do not submit a written request and deliver your Public Shares as described above, your shares will not be redeemed.

Any demand for redemption, once made, may be withdrawn at any time until the deadline for exercising redemption requests (and submitting shares to the transfer agent) and thereafter, with AHAC’s consent, until the closing of the Business Combination. If you delivered your shares for redemption to Continental and decide within the required timeframe not to exercise your redemption rights, you may request that Continental return the shares (physically or electronically). You may make such request by contacting AHAC’s transfer agent at        or at the address listed above.

Prior to exercising redemption rights, stockholders should verify the market price of Class A Common Stock as they may receive higher proceeds from the sale of their Class A Common Stock in the public market than from exercising their redemption rights if the market price per share is higher than the redemption price. We cannot assure you that you will be able to sell your shares of Class A Common Stock in the open market, even if the market price per share is higher than the redemption price stated above, as there may not be sufficient liquidity in AHAC Common Stock when you wish to sell your shares.

If you exercise your redemption rights, your shares of Class A Common Stock will cease to be outstanding immediately prior to the Business Combination and will only represent the right to receive a pro rata share of the aggregate amount on deposit in the Trust Account. You will no longer own those shares and will have no right to participate in, or have any interest in, the future growth of the Combined Company, if any. You will be entitled to receive cash for these shares only if you properly and timely demand redemption.

If the Business Combination is not approved or completed for any reason, then Public Stockholders who elected to exercise their redemption rights will not be entitled to redeem their shares. In such case AHAC will promptly return any Public Shares previously delivered by the Public Stockholders.

Dissenter Rights

AHAC stockholders do not have dissenter rights in connection with the Business Combination or the other Proposals.

Potential Purchases of Shares

In connection with the stockholder vote to approve the proposed Business Combination, the Sponsor, directors, officers or advisors or their respective affiliates may privately negotiate transactions to purchase AHAC Common Stock from stockholders who would have otherwise elected to have their shares redeemed in conjunction with a proxy solicitation pursuant to the proxy rules for a per-share pro rata portion of the Trust Account. None of AHAC’s Sponsor, directors, officers or advisors or their respective affiliates will make any such purchases when they are in possession of any material non-public information not disclosed to the seller or during a restricted period under Regulation M under the Exchange Act. Such a purchase would include a contractual acknowledgement that such stockholder, although still the record holder of AHAC Common Stock, is no longer the beneficial owner thereof and therefore agrees not to exercise its redemption rights, and could include a contractual provision that directs such stockholder to vote such shares in a manner directed by the purchaser. In the event that the Sponsor, directors, officers or 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. Any such privately negotiated purchases may be effected at purchase prices that are below or in excess of the per-share pro rata portion of the Trust Account.

Proxy Solicitation

AHAC is soliciting proxies on behalf of the Board. This solicitation is being made by mail but also may be made by telephone or in person. AHAC and its directors, officers and employees may also solicit proxies in person. AHAC will file with the SEC all scripts and other electronic communications that constitute proxy soliciting materials. AHAC will bear the cost of the solicitation.

AHAC has hired Morrow Sodali to assist in the proxy solicitation process. AHAC has agreed to pay Morrow Sodali approximately $       for proxy solicitation services.

AHAC will ask banks, brokers and other institutions, nominees and fiduciaries to forward the proxy materials to their principals and to obtain their authority to execute proxies and voting instructions. AHAC will reimburse them for their reasonable expenses.

Assistance

If you need assistance in completing your proxy card or have questions regarding the Special Meeting, please contact AHAC at (646) 494-3296 or Morrow Sodali (individuals call toll-free (800) 662-5200; banks and brokers call (203) 658-9400).

PROPOSAL 1: THE BUSINESS COMBINATION PROPOSAL

The discussion in this proxy statement/prospectus of the Business Combination and the principal terms of the Business Combination Agreement is subject to, and is qualified in its entirety by reference to, the Business Combination Agreement. A copy of the Business Combination Agreement is attached as Annex A to this proxy statement/prospectus. Unless the context otherwise requires, all references in this subsection to “we,” “us” or “our” refer to AHAC prior to the consummation of the Business Combination.

Headquarters; Trading Symbols

After completion of the transactions contemplated by the Business Combination Agreement:

•        the corporate headquarters and principal executive offices of New Humacyte will be located at 2525 East North Carolina Highway 54, Durham, North Carolina 27713; and

•        New Humacyte common stock and New Humacyte warrants are expected to be traded on Nasdaq under the symbols HUMA and HUMAW, respectively.

Background of the Business Combination

AHAC is a blank check company incorporated on July 1, 2020 as a Delaware corporation and formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. In conducting a targeted search for a business combination target, as described in greater detail below, AHAC utilized the global network and investing, industry and sector and transaction experience of Sponsor, AHAC’s management and the Board. The terms of the Business Combination Agreement and the related ancillary documents are the result of extensive negotiations among AHAC, Humacyte and their respective representatives and advisors. The following is a brief description of the background of these negotiations, the proposed Business Combination and related transactions.

On September 22, 2020, AHAC completed its Initial Public Offering of 10,000,000 Units at a price of $10.00 per Unit, generating gross proceeds of $100,000,000 before transaction costs (including deferred underwriting expenses to be paid upon completion of AHAC’s initial business combination). Each Unit consisted of one share of Class A Common Stock and one-half of one Warrant. Each whole Warrant entitles the holder thereof to purchase one share of Class A Common Stock for $11.50 per share, subject to certain adjustments. Simultaneous with the closing of the Initial Public Offering, AHAC completed the private sale of 355,000 Units at a price of $10.00 per Unit in the Concurrent Private Placement to Sponsor, Oppenheimer & Co. (“Oppenheimer”) and Northland Securities, Inc. (“Northland”). Prior to the consummation of the Initial Public Offering, neither AHAC, nor any authorized person on its behalf, initiated any substantive discussions, formal or otherwise, with respect to a business combination involving AHAC.

Following completion of the Initial Public Offering, AHAC’s officers and directors commenced an active, targeted search for an initial set of business combination targets, and considered a number of potential target businesses. Representatives of AHAC contacted, and were contacted by, a number of individuals and entities with respect to potential business combination opportunities, including financial advisors and companies in the life sciences and medical technology sectors. AHAC primarily considered businesses that it believed could benefit from the substantial expertise, experience and network of its management team, that AHAC determined have a scientific or other competitive advantage in the markets in which they operate and have attractive growth prospects. AHAC’s preliminary due diligence exercise included evaluations of various aspects of the potential target companies, including their product candidate pipelines and related scientific data, their market potential and financial information, in each case based on publicly available information and other market research available to the management team and its advisors.

AHAC also retained Lake Street following the completion of the Initial Public Offering, effective as of February 11, 2021, to deliver a fairness opinion to AHAC at the time of AHAC’s consideration of a business combination. Other than the delivery of such fairness opinion, Lake Street has not performed any services for Humacyte, and has not received any compensation from AHAC, in each case, in the two-year period preceding the date that AHAC and Humacyte entered into the Business Combination Agreement. Additionally, AHAC retained Piper Sandler & Co. (“Piper Sandler”) and Exos Securities LLC (“Exos”) to assist with identifying investors for any equity financing in connection with a possible business combination.

AHAC also engaged in substantial due diligence and detailed discussions with several business combination targets across subsectors of the life sciences and medical technology sectors throughout December 2020 that AHAC believed had attractive long-term growth potential, were well-positioned within their industry and would benefit from the substantial intellectual capital, operational experience and network of AHAC’s management team. AHAC ultimately determined to cease pursuit of each of its potential acquisition opportunities other than Humacyte either because (i) AHAC concluded that the target business would not be a suitable business combination opportunity for AHAC or (ii) the target pursued an alternative transaction or strategy.

In the process that led to identifying Humacyte as an attractive business combination opportunity, AHAC’s management team evaluated a number of different potential business combination targets. In the period between the closing of the Initial Public Offering on September 22, 2020 and the execution of the Business Combination Agreement on February 17, 2021, representatives of AHAC contacted and were contacted by representatives of 95 such potential combination targets to discuss the potential for a business combination transaction within the biotechnology and healthcare sectors. In connection with such evaluation, AHAC’s management team compiled a list of high priority potential targets and updated and supplemented such list from time to time. AHAC considered businesses that it believed had attractive long-term growth potential, were well positioned within their industry and would benefit from the operational experience and network of AHAC’s management team. This pipeline was periodically discussed with the AHAC Board.

All of the potential business combination targets that were considered operate in the life sciences industry, with the majority being clinical or pre-clinical stage therapeutics, digital health and medical device companies. AHAC entered into nondisclosure agreements with 16 such potential business combination targets (including Humacyte). The nondisclosure agreements that AHAC entered into with these potential business combination targets were mutual, relating to confidential information provided to AHAC before and after its execution, and contained, among other provisions, customary non-disclosure and non-use provisions and a customary trust account waiver pursuant to which the counterparty waived any right, title, interest or claim in AHAC’s Trust Account and agreed not to seek recourse against the Trust Account for any reason. None of these non-disclosure agreements had standstills or don’t ask don’t waive provisions. Following initial diligence, AHAC’s management discontinued discussions with 13 of the 16 business combination targets because AHAC’s management believed that pursuing a merger with these targets was not in the best interest of the AHAC’s stockholders for various reasons including early stage of research and development, quality of clinical data, size of potential market opportunity, and disagreement around merger terms including enterprise valuation.

One of the potential business combination targets (“Company A”), was a commercial stage digital health company. Representatives of AHAC conducted an introductory teleconference meeting with representatives of Company A on September 22, 2020 and AHAC entered into a nondisclosure agreement with Company A on September 23, 2020. Following initial diligence on Company A and preliminary discussions on terms of a potential business combination, AHAC’s management determined that a business combination with Company A was not in the best interests of AHAC shareholders because of disagreement around merger terms including enterprise valuation, and on October 8, 2020 AHAC and Company A mutually terminated discussions.

Another of the potential business combination targets (“Company B”), was a clinical stage biopharmaceutical company developing small molecule therapeutics for neurological diseases. Representatives of AHAC first met with representatives of Company B on September 23, 2020 and AHAC entered into a nondisclosure agreement with Company B on October 1, 2020. Following initial diligence on Company B, AHAC’s management considered Company B for the business combination. A written overview summarizing the investment case for Company B was shared with the AHAC Board on November 12, 2020 and December 11, 2020, AHAC performed fundamental diligence on Company B and AHAC and Company B negotiated terms of a potential business combination. AHAC’s management ultimately determined that a business combination with Company B was not in the best interests of AHAC shareholders because of disagreement around structure of proposed financing and valuation terms.

Negotiations with Humacyte

In November 2020, Peter Early, a representative from Exos, reached out to Rajiv Shukla, Chairman and Chief Executive Officer of AHAC, regarding Humacyte and provided non-confidential materials on Humacyte. Exos was assisting AHAC in identifying and evaluating potential blank-check merger candidates. On December 22, 2020, Mr. Shukla and Patrick Sturgeon, Chief Financial Officer, on behalf of AHAC, and Mr. Early on behalf of Exos, met

via video conference to discuss Humacyte and its business operations, including financial information, historic and projected revenues, views on competitive and positioning and market opportunity, and background on the Humacyte management team. At the meeting, the parties discussed Humacyte’s business and strategic prospects, as well as how a potential business combination with AHAC could be structured and the potential benefits of a business combination involving AHAC and Humacyte.

On December 24, 2020, representatives of AHAC and Humacyte executed a mutual non-disclosure agreement, relating to confidential information provided to AHAC before and after its execution, which contained, among other provisions, customary non-disclosure and non-use provisions and a customary trust account waiver pursuant to which Humacyte waived any right, title, interest or claim in AHAC’s Trust Account and agreed not to seek recourse against the Trust Account for any reason. On December 28, 2020, pursuant to that mutual non-disclosure agreement, Humacyte began to provide the representatives of AHAC with access to confidential data via a confidential online data room for purposes of AHAC conducting preliminary business and financial due diligence on Humacyte. On January 5, 2021, AHAC’s other advisors obtained access to the confidential online data room and Humacyte continued populating the confidential online data room with legal, operational, regulatory and tax information, documents and data.

Between December 28, 2020 and January 4, 2021, AHAC conducted preliminary business and financial due diligence with respect to Humacyte, which included research as to Humacyte’s markets and outlook, and having multiple conference calls and email exchanges with Brady Dougan, Chairman of Humacyte’s board of directors; Laura Niklason, M.D., Ph.D., President and Chief Executive Officer; Dale A. Sander, Chief Corporate and Commercial Development Officer; Jeffrey H. Lawson, M.D., Ph.D., Chief Surgical Officer; and Mr. Early regarding the potential merits of a potential business combination involving AHAC and Humacyte and the parties’ perspectives on the appropriate valuation framework for a potential transaction.

On December 30, 2020, AHAC submitted to Humacyte a draft non-binding term sheet setting forth certain proposed key terms with respect to a potential business combination between AHAC and Humacyte (the “Term Sheet”). The Term Sheet provided for, among other things, (i) a binding exclusivity period through January 30, 2021 (subject to certain exceptions), (ii) an implied Humacyte equity valuation of $800,000,000 (without taking into account the PIPE Investment or the funds held in the Trust Account to be utilized in the transaction), with no adjustment for Humacyte’s cash or debt, and (iii) contingent consideration payable to Humacyte stockholders consisting of 6,666,667 shares in the combined company if, after closing of the proposed business combination, the volume weighted average price of the shares of the combined company is greater than or equal to $15.00 over any 20 trading days within any 30 trading day period (the “$15 Price Target”), and an additional 5,000,000 shares if such volume weighted average price of such shares is greater than or equal to $20.00 over any 20 trading days within any 30 trading day period (the “$20 Price Target”). Pursuant to the Term Sheet, the total size of the PIPE Investment was anticipated to be $100 million, with the potential for additional PIPE Investment in the event of additional investor demand. Between December 30, 2020 and January 4, 2021, AHAC and Humacyte negotiated the terms of the Term Sheet. In connection with such negotiations, the contingent consideration payable to Humacyte stockholders was increased to 7,500,000 shares in the combined company, in the aggregate, in connection with the $15 Price Target and an additional 7,500,000 shares, in the aggregate, in connection with the $20 Price Target. On January 4, 2021, Humacyte’s board of directors authorized Humacyte’s entry into the Term Sheet and, on January 4, 2021, AHAC and Humacyte finalized and executed the Term Sheet.

Also on January 4, 2021, representatives of each of AHAC and Humacyte, together with AHAC’s advisors and Exos, conducted a telephonic meeting, where the parties discussed the potential timeline and steps to signing a definitive agreement for a business combination, and discussed and tentatively agreed to a work plan. Between the date of the initial telephonic meeting and February 16, 2021, representatives and advisors of each of AHAC and Humacyte conducted weekly telephonic meetings to further refine the transaction timeline, steps and related work plan.

Between January 4, 2021 and February 16, 2021, representatives of AHAC conducted further business and financial due diligence with respect to Humacyte and, over the same period of time, AHAC’s legal counsel at Goodwin & Procter LLP (“Goodwin”), tax advisor (Marcum LLP) and other advisors at Piper Sandler and Oppenheimer conducted due diligence with respect to Humacyte. Each of the advisors that conducted a due diligence review summarized for AHAC management its key findings with respect to its diligence review of Humacyte. Before reaching the determination that it was in the best interests of AHAC and its stockholders to approve the Business Combination, during the Board meeting to consider the approval of the Business Combination held on February 16, 2021 (as described below), the Board was provided with an overview of the due diligence process and key due diligence findings of AHAC’s officers’, Sponsor’s and their respective representatives’ and advisors’ due diligence.

The due diligence process included the following:

•        a comprehensive review of the materials provided in the confidential online data room after receiving access, which access was first provided to the various representatives and advisors of AHAC between December 28, 2020 and January 5, 2021;

•        requests for follow-up data and information from Humacyte, including Humacyte management responses to due diligence questions;

•        meetings, videoconferences and calls with Humacyte’s management team, including Dr. Niklason; Dr. Lawson; Douglas L. Blankenship, former Chief Financial Officer; William Tente, M.S., Chief Regulatory Officer; Sabrina Osborne, Executive Vice President, Strategy and People; Kiernan T. DeAngelis, Chief Medical Officer; and Heather Prichard, Ph.D., Chief Operating Officer, among others, regarding Humacyte’s business and product candidates, operations, projections and technical diligence matters, as well as tax and legal matters, including those related to intellectual property and information technology matters, regulatory matters and clinical operations, corporate matters (including material contracts, capitalization and other customary corporate matters), labor and employment matters, environmental matters and international trade matters;

•        review of publicly available industry data;

•        calls with leading U.S.-based surgeons with experience in organ transplants;

•        a summary by AHAC management to the Board with respect to their key findings with respect to their business, operational and financial due diligence, which report also included an overview of the legal due diligence findings by AHAC’s legal advisors;

•        review and analysis of certain financial information provided by Humacyte (see “— Certain Projected Financial Information”), which was incorporated into the fairness analysis prepared by Lake Street, and which fairness analysis also included an independent analysis of certain publicly traded companies and a discounted cash flow analysis based on the above-referenced financial information provided by Humacyte; and

•        review and analysis of Goodwin’s diligence findings and related analyses, which were provided to AHAC management on or around the weekend of February 14, 2021, and included in the materials provided to the Board in advance of the February 16, 2021 meeting of the Board (described below).

Between January 2021 and February 2021, representatives and advisors of AHAC and Humacyte held various calls and meetings to discuss Humacyte’s investor management presentation, including Humacyte management’s estimates for product launches over the next five years and estimated peak revenues from such products.

On January 11, 2021, Piper Sandler and Exos, on behalf of AHAC, commenced outreach to prospective investors regarding the PIPE Investment. Between January 11, 2021 and February 16, 2021, Piper Sandler and Exos held conversations with prospective investors with respect to the PIPE Investment and related terms. Due to additional investor demand, the PIPE Investment was increased from $100 million to $175 million by mutual agreement of AHAC and Humacyte.

On January 12, 2021, representatives of Goodwin, on behalf of AHAC, and representatives of Humacyte’s legal counsel at Covington & Burling LLP (“Covington”), on behalf of Humacyte, held a telephone conference call to discuss matters related to the form of Subscription Agreement and the PIPE Investment process. The parties continued to negotiate the terms of the Subscription Agreements until February 16, 2021, exchanging multiple drafts thereof. The principal terms being negotiated during such time related to, among other things, (i) the aggregate amount and allocation of the PIPE Investment among PIPE Investors and the identities of the PIPE Investors anticipated to sign the respective Subscription Agreements, (ii) whether and under what conditions the PIPE Investors would be able to refuse to consummate the transactions consummated by the Subscription Agreement and (iii) the terms and conditions of any registration rights to be granted to the PIPE Investors pursuant to the Subscription Agreements. The final version of the form of Subscription Agreement reflecting feedback from the prospective PIPE Investors was distributed on February 16, 2021.

On January 16, 2021, representatives of Lake Street held a call with representatives from AHAC management and discussed the potential timeline and steps to signing a definitive agreement for a business combination, and discussed and tentatively agreed to a work plan.

On January 18, 2021, AHAC and Humacyte mutually agreed to extend the exclusivity period, which pursuant to the Term Sheet would have expired on January 30, 2021, through February 26, 2021, to enable the parties and their respective advisors to have sufficient time to complete diligence and negotiate the definitive transaction documents.

On January 20 and 27, and February 12, 2021, representatives of Lake Street held meetings via teleconference with representatives from Humacyte management to conduct business and financial due diligence. On January 29, 2021, representatives of Lake Street held a meeting via teleconference with representatives from Piper Sandler and Humacyte management to discuss further business and financial due diligence questions with respect to Humacyte and the PIPE Investment.

On January 25, 2021, representatives of Goodwin, on behalf of AHAC, distributed to representatives of Humacyte Covington an initial draft of the Business Combination Agreement. The initial draft was based on the terms of the Term Sheet. The final documentation, including with respect to mechanics relating to the treatment in the Business Combination of certain of Humacyte’s outstanding securities (such as the Humacyte preferred stock, warrants, options and other equity-linked securities), restrictions on the conduct of AHAC’s and Humacyte’s respective businesses between signing and closing, obligations of the parties with respect to delivery of required approvals and preparation and submission of required filings, certain conditions to closing and termination rights of the parties and certain other terms of conditions, the details of which were not fully addressed in the Term Sheet, required additional negotiation by the parties.

On February 1, 2021, representatives of Goodwin distributed to representatives of Humacyte and Covington a revised version of the Business Combination Agreement and an initial draft of the Investor Rights and Lock-up Agreement.

On February 2, 2021, representatives of Covington, on behalf of Humacyte, distributed to representatives of AHAC and Goodwin a revised draft of the Business Combination Agreement and initial drafts of the Sponsor Support Agreement and Humacyte Support Agreement. The revised draft of the Business Combination Agreement included, among other changes, terms relating to the 2021 Plan and certain changes limiting Humacyte’s obligations with respect to the operation of its business in the ordinary course between signing and closing and other changes to the representations and warranties, covenants and to the conditions of each party’s obligations to consummate the Business Combination. The Sponsor Support Agreement provided, among other things, that the Sponsor and certain members of AHAC management would agree to vote in favor of the Business Combination and the transactions contemplated thereby and waive their respective redemption rights in connection with the consummation of the Business Combination with respect to any AHAC capital stock held by them. The Humacyte Support Agreement provided, among other things, that certain stockholders of Humacyte would agree to execute and deliver following effectiveness of the S-4 registration statement a written consent with respect to the outstanding shares of Humacyte capital stock held by them, adopting the Business Combination Agreement and related agreements and approving the Business Combination, pursuant to the terms and subject to the conditions set forth therein.

On February 4, 2021, representatives of Goodwin, on behalf of AHAC, distributed to representatives of Humacyte and Covington a revised draft of the Business Combination Agreement. The revised draft of the Business Combination Agreement included certain changes to the representations and warranties, covenants and to the conditions of each party’s obligations to consummate the Business Combination. Representatives of AHAC, Humacyte, Exos, Covington and Goodwin discussed the revised Business Combination Agreement via teleconference on February 4, 2021.

On February 5, 2021, representatives of Covington and Goodwin held a meeting via teleconference, on behalf of their respective clients, to further discuss the changes reflected in the most recent draft Business Combination Agreement circulated by Goodwin.

Between February 5, 2021 and February 16, 2021, representatives of Goodwin and Covington, on behalf of their respective clients, continued to negotiate the terms of the Business Combination Agreement and ancillary transaction documents, including those regarding, among other things, the 2021 Plan, Humacyte’s obligations with respect to the operation of its business between signing and closing, including its agreement to avoid taking certain corporate actions without the prior written consent of AHAC.

On February 8, 2021, representatives of Goodwin, on behalf of AHAC, sent representatives of Covington a revised draft of the Humacyte Support Agreement. Representatives of both Covington and Goodwin continued to negotiate the terms of the Humacyte Support Agreement over the course of that day, during which they reached substantive agreement, which is substantially reflected in the final version of the Humacyte Support Agreement executed by the parties thereto on February 17, 2021. See “— Related Agreements — Humacyte Support Agreement” for additional information.

On February 14, 2021, representatives of Goodwin, on behalf of AHAC, sent representatives of Covington a revised draft of the Sponsor Support Agreement. Representatives of both Covington and Goodwin continued to exchange drafts and negotiate the Sponsor Support Agreement until February 16, 2021, when they reached substantive agreement, which is substantially reflected in the final version of the Sponsor Support Agreement executed by the parties thereto on February 17, 2021. See “— Related Agreements — Sponsor Support Agreement” for additional information.

In the afternoon of February 16, 2021, the Board held a meeting via videoconference and representatives of Goodwin and Lake Street joined the meeting. At the meeting, the senior management of AHAC provided an overview of the proposed Business Combination and Humacyte as the proposed Business Combination target (including the rationale for the combined business) and updated the Board regarding the final negotiations of the proposed terms of the Business Combination. A representative of Goodwin gave a presentation to the Board on the fiduciary duties of directors under Delaware law in this context and on the terms of the final proposed Business Combination Agreement. Also at this meeting, Lake Street reviewed its financial analysis on Humacyte and the Business Combination, and rendered to the Board an oral opinion, which was subsequently confirmed by delivery of a written opinion as to (i) the fairness, from a financial point of view, to AHAC of the Merger Consideration to be paid and Contingency Consideration that may be payable by AHAC to the holders of Humacyte Shares under the Business Combination Agreement and (ii) whether Humacyte has a fair market value equal to at least 80% of the balance of funds in AHAC’s Trust Account (excluding deferred underwriting commissions and taxes payable). The Board, with the assistance of Goodwin and Lake Street, discussed the proposed terms of the Business Combination, including Humacyte as the proposed Business Combination target, the terms and conditions of the Business Combination Agreement and the key ancillary agreements (copies of all of which were provided to all of the members of the Board in advance of the meeting), the potential benefits of, and risks relating to the Business Combination and the reasons for entering into the Business Combination Agreement and the proposed timeline for finalizing the definitive transaction agreements and announcing the Business Combination. See “— AHAC Board of Directors’ Reasons for Approval of the Business Combination” for additional information related to the factors considered by the Board in approving the Business Combination. Following additional discussion on these and related matters, the Board unanimously determined, among other things, that the Business Combination Proposal is in the best interests of AHAC and its stockholders and recommended that its stockholders vote “FOR” the Business Combination Proposal.

On February 17, 2021, AHAC, Humacyte and Merger Sub executed the Business Combination Agreement. Concurrent with the execution of the Business Combination Agreement, AHAC also entered into (i) the Humacyte Support Agreement (along with the other parties thereto), (ii) the Sponsor Support Agreement (along with Humacyte and the other parties thereto), and (iii) each of the Subscription Agreements (with the other parties thereto) providing for binding subscriptions to purchase an aggregate of 17,500,000 shares of Class A Common Stock at a price of $10.00 per share. See “— Related Agreements” for additional information.

Also on February 17, 2021, AHAC and Humacyte issued a joint press release announcing the execution of the Business Combination Agreement and AHAC filed a Current Report on Form 8-K with the investor presentation providing information on Humacyte and used in connection with meetings with potential investors regarding Humacyte, the Business Combination and the PIPE Investment.

The Board’s Reasons for Approval of the Business Combination

AHAC was formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. AHAC sought to do this by utilizing the networks and industry experience of both its management team and the Board to identify, acquire and operate one or more businesses within or outside of the United States.

The Board met via videoconference on February 8, 2021 and February 16, 2021 to, among other things, discuss a potential business combination with Humacyte, and on February 16, 2021 unanimously approved the Business Combination and the Business Combination Agreement. Prior to reaching the decision to approve the Business Combination and the Business Combination Agreement, the Board consulted with our management, as well as with our legal and financial advisors. In making its determination with respect to the Transactions, the Board also considered the fairness analysis undertaken by Lake Street, financial advisor to AHAC in connection with the Business Combination. Lake Street rendered to the Board an oral opinion, which was subsequently confirmed by delivery of a written opinion, which we refer to as the Opinion, as to (i) the fairness, from a financial point of view, to AHAC of the Business Combination Consideration and the Contingent Consideration that may be payable by AHAC to the holders of Humacyte common stock and Humacyte preferred stock under the Business Combination Agreement and (ii) whether Humacyte has a fair market value equal to at least 80% of the balance of funds in Trust Account (excluding deferred underwriting commissions and taxes payable). See “— Opinion of AHAC’s Financial Advisor.”

In addition, the Board reviewed various industry and scientific data, including, but not limited to, Humacyte’s existing business model, Humacyte’s clinical trial progress and pipeline, and reviewed the results of management’s due diligence review of Humacyte which took place over a one-month period beginning in January of 2021 and continuing through the signing of the Business Combination Agreement on February 17, 2021, including extensive meetings and calls with Humacyte’s management team, leading surgeons with experience in organ transplants, and senior leadership at Fresenius Medical Care regarding clinical trials and pipeline, review of Humacyte’s material contracts, intellectual property matters, labor matters, operations, financing and accounting due diligence, tax due diligence, engaging and consulting financial advisors including, but not limited to, Piper Sandler, Oppenheimer, Exos, Lake Street and other legal due diligence with assistance from our legal counsel before determining that the Business Combination was in the best interest of AHAC. The Board also determined, after a thorough review of other business combination opportunities reasonably available, that the Business Combination represents the best potential business combination based upon the process utilized to evaluate and assess other potential acquisition targets.

The Board considered a wide variety of factors in connection with its evaluation of the Business Combination. In light of the complexity of those factors, the Board as a whole did not consider it practicable to, nor did it attempt to, quantify or otherwise assign relative weights to the specific factors it took into account in reaching its decision. Individual members of the Board may have given different weight to different factors. This explanation of AHAC’s reasons for the Board’s approval of 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 the section entitled “Forward-Looking Statements.”

In particular, the Board considered the following positive factors, although not weighted or in any order of significance:

•        Deep research & development pipeline targeting large markets, including dialysis AV access, PAD, trauma, diabetes and coronary bypass.    The Board considered Humacyte’s deep research & development pipeline that targets large markets with unmet needs. The Board further considered that Humacyte’s proprietary technology platform and extensive intellectual property portfolio, including 91 issued patents owned, co-owned or licensed by Humacyte and 28 pending patents owned, co-owned or licensed by Humacyte, will help Humacyte achieve its pipeline goals.

•        Regulatory considerations.    The Board considered the potential regulatory pathways for Humacyte’s product candidates, including the fact that Humacyte received Fast Track designation from the FDA for its 6 millimeter bioengineered HAV for use in the creation of AV access for hemodialysis, RMAT designation from the FDA for its 6 millimeter HAV for the creation of vascular access for performing hemodialysis, and a priority designation from the Secretary of Defense under Public Law 115-92 for one of its HAV product candidates. Although each of these designations may allow these product candidates to experience a faster development process, or faster review or approval, compared to product candidates that are not part of the expedited programs, such benefits may not be achieved for various reasons, and Humacyte may never obtain regulatory approval to market any product candidates.

•        Research & development aimed at the application of HAV for trauma, AV access and PAD.    The Board considered Humacyte’s development of its 6 millimeter HAV for use as a replacement vessel in patients who have experienced vascular trauma in either military or civilian environments and Humacyte’s

expectation that it will submit a BLA for its 6 millimeter HAV for vascular repair, reconstruction and replacement in the second half of 2022 or in 2023. The Board also considered Humacyte’s development of its 6 millimeter HAV for use as arteriovenous access for hemodialysis patients with end stage renal disease, and Humacyte’s Phase III pivotal trial and second Phase III trial in this area. Finally, the Board considered Humacyte’s development of its 6 millimeter HAV for use as a bypass conduit for patients with PAD and the status of its Phase II multi-center trial.

•        Pioneering vascular innovation in the field of bioengineered human tissue for use in implantation.    The Board believes that Humacyte has proven and experienced leadership, which is poised to execute on Humacyte’s unique approach to developing and manufacturing off-the-shelf, universally implantable, bioengineered human tissue.

•        Vast potential market opportunity for Humacyte’s vascular and non-vascular product candidates.    The Board considered that Humacyte’s vascular product candidates (coronary artery bypass graft, AV access, PAD and vascular trauma) and non-vascular product candidates (trachea, lung, esophagus, pancreas and urinary conduit) have the potential to serve large markets, which could be as large as $89.5 billion and $68.1 billion, respectively, in the aggregate.

•        Potential to address an area of high unmet medical need.    The Board considered the potential for use of Humacyte’s product candidates in vascular trauma cases (totaling approximately 75,000 per year in the United States), AV access for hemodialysis (totaling approximately 300,000 new cases per year in the U.S. and Europe) and PAD (totaling as many as 160,000 surgical procedures per year in the United States), which the Board believes has the potential to significantly improve the lives of patients.

•        Multiple pipeline opportunities led by a Phase III clinical stage program.    The Board considered that, as of January 26, 2021, Humacyte’s HAVs have been implanted in over 435 patients, and that Humacyte is currently conducting Phase III trials of its 6 millimeter HAV across two therapeutic indications, vascular trauma and arteriovenous access for hemodialysis, as well as continuing long term follow up of patients in its Phase II PAD studies. The Board also considered the potential timing of Humacyte’s anticipated submission of its BLA to the FDA for indications in vascular trauma in 2022 and arteriovenous access for hemodialysis in 2023.

•        Diversified risk profile from multimodality approach.    The Board considered that Humacyte’s pipeline and platform has several potential applications, including vascular trauma, AV access for hemodialysis, PAD, biovascular pancreas, coronary graft, pediatric heart surgery, trachea and lung applications. The Board believes that this multimodality approach would help Humacyte diversify its business risk.

•        Development of the commercial potential of product candidates, if approved.    The Board believes that, driven by its understanding of existing treatment paradigms and patient, physician and payor needs, Humacyte is in a strong position to build a focused and efficient medical affairs and commercial organization and commercialize its product candidates, if approved, in the United States and international markets.

•        Experienced management team.    The Board believes that Humacyte has a proven and experienced management team that will effectively lead the Combined Company after the Business Combination.

•        Backed by top-tier healthcare investors.    Humacyte’s existing investors include Fresenius Medical Care, among others, which the Board believes provides additional validation to Humacyte’s clinical and business strategies. The Board also considered the strong interest in the PIPE Investment from seasoned healthcare investors, including Fresenius Medical Care, OrbiMed, Monashee Investment Management, Alexandria Venture Investments, UBS O’Connor, Morgan Creek Capital, and a number of unnamed health care focused funds.

•        Opinion of Financial Advisor.    The Board considered the oral opinion of Lake Street rendered to the Board, which was subsequently confirmed by delivery of a written opinion that, as of such date and based upon and subject to the assumptions made, procedures followed, matters considered, and qualifications and limitations upon the review undertaken by Lake Street in preparing its opinion, (i) the consideration to be paid by AHAC to Humacyte equityholders in the Business Combination under the Business Combination Agreement is fair, from a financial point of view, to AHAC and (ii) Humacyte has a fair market value equal to at least 80% of the balance of funds in Trust Account (excluding deferred underwriting commissions

and taxes payable and subject to proportionate adjustments related to Nasdaq’s 80% test), as more fully described below under the heading titled “Proposal 1: The Business Combination Proposal — Opinion of AHAC’s Financial Advisor.”

•        Results of Due Diligence.    The Board considered the scope of the due diligence investigation carried out by AHAC’s management and outside advisors, and evaluated the results thereof and information available to it related to Humacyte, including (i) virtual meetings and calls with Humacyte’s management team regarding its operations, intellectual property, projections and the terms of the proposed transaction; (ii) review of financial and other business information made available by Humacyte in its virtual data room, including financial statements, material contracts, benefit plans and employee compensation matters, corporate governance, intellectual property, information technology, privacy and data regulation, litigation information, regulatory and compliance matters, and other legal and business diligence; and (iii) the fair market value analyses prepared by the independent financial advisor, all of which supported the conclusion that Humacyte was an attractive opportunity.

•        Investment by third parties.    The Board considered that certain third parties, including top-tier institutional investors, also committed to invest an additional $175.0 million in the combined company pursuant to the PIPE Investment at Closing. The Board determined the PIPE Investment to be a supporting indication of confidence in the business case for the Business Combination.

The Board also identified and considered the following factors and risks weighing negatively against pursuing the Business Combination, although not weighted or in any order of significance:

•        Clinical Risk.    While Humacyte has significant data from past clinical trials encompassing over 430 patients and over 800 patient years of data, there is no assurance that ongoing clinical trials will succeed. Patient years of data is calculated by multiplying the number of patients in the applicable clinical trials by the number of years such patients participated in the applicable clinical trials. Patient years normalize cumulative exposure across multiple trials, but do not represent long-term performance.

•        FDA Approval.    While Humacyte has received RMAT and Fast Track designations, the Board considered risks associated with the failure to receive FDA approval for Humacyte product candidates in late-stage clinical development in a timely matter, or at all, for the commercialization of its products.

•        Manufacturing.    While Humacyte has an existing facility for manufacturing HAVs, the Board considered the risks associated with scaling up production for commercial sales.

•        Commercialization.    While Humacyte has a commercialization partnership with Fresenius Medical Care, the Board considered the risk that Humacyte is unable to commercialize its product candidates in its pipeline, if approved and that Humacyte is subject to competition from other regenerative medicine companies.

•        Reimbursement.    The risk that Humacyte’s product candidates, if approved, do not become eligible for third-party coverage and/or approved for reimbursement.

•        Exclusivity.    The fact that the Business Combination Agreement includes an exclusivity provision that prohibits AHAC from soliciting other business combination proposals, which restricts AHAC’s ability, so long as the Business Combination Agreement is in effect, to consider other potential business combinations.

•        Other risks.    Various other risks associated with the Business Combination, the business of AHAC and the business of Humacyte described in the section entitled “Risk Factors,” including Humacyte’s need to raise additional capital to finance its operations.

Based on its review of the forgoing considerations, the Board concluded that the potentially negative factors associated with the Business Combination were outweighed by the potential benefits that it expects AHAC shareholders will receive as a result of the Business Combination. The Board noted that there can be no assurance about future results, including results considered or expected as disclosed in the foregoing reasons.

The preceding discussion of the information and factors considered by the Board is not intended to be exhaustive but includes the material factors considered by the Board. In view of the complexity and wide variety of factors considered by the Board in connection with its evaluation of the Business Combination, the Board did not consider

it practical to, nor did it attempt to, quantify, rank or otherwise assign relative weights to the different factors that it considered in reaching its decision. In addition, in considering the factors described above, individual members of the Board may have given different weight to different factors. The Board considered this information as a whole and overall considered the information and factors to be favorable to, and in support of, its determinations and recommendations.

This explanation of the Board’s reasons for its approval of 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 the section entitled “Forward-Looking Statements.”

Opinion of AHAC’s Financial Advisor

We retained Lake Street to act as our financial advisor in connection with the Business Combination. In selecting Lake Street, we considered, among other things, Lake Street’s qualifications, expertise, reputation, and knowledge of the business and affairs of Humacyte and the industry in which Humacyte operates.

On February 16, 2021, Lake Street rendered oral opinions to our Board, which were subsequently confirmed in a letter dated as of February 16, 2021, stating that, as of the date of the letter and subject to and based on the assumptions made, procedures followed, matters considered, limitations of the review undertaken and qualifications in such letter, (i) the Business Combination Consideration and the Contingent Consideration, is fair, from a financial point of view, to us and (ii) Humacyte has a fair market value equal to at least 80% of the balance of funds in our Trust Account (excluding deferred underwriting commissions and taxes payable and subject to proportionate adjustments related to Nasdaq’s 80% test).

The full text of Lake Street’s written opinion letter, dated as of February 16, 2021, is attached as Annex B. You should read Lake Street’s opinion letter carefully and in its entirety for a discussion of, among other things, the scope of the review undertaken and the assumptions made, procedures followed, matters considered and qualifications and limitations upon the review undertaken by Lake Street in connection with its opinions. This summary is qualified in its entirety by reference to the full text of the opinion letter. Lake Street’s opinion letter was directed to our Board, in its capacity as the Board of AHAC, and addressed only (i) the fairness from a financial point of view, as of the date of the opinion, to us of the Business Combination Consideration and the Contingent Consideration that may be payable in the Business Combination under the Business Combination Agreement and (ii) whether the fair market value of Humacyte exceeds 80% of the balance of funds in our Trust Account. The opinion letter does not constitute a recommendation as to how any stockholder should vote with respect to the merger or any other matter and does not in any manner address the price at which our securities will trade at any time.

In connection with rendering its opinions, Lake Street, among other things:

•        reviewed and analyzed the financial terms of the draft of the Business Combination Agreement dated February 10, 2021;

•        reviewed certain business and financial information relating to Humacyte it deemed relevant, and certain business, financial, and other information and data regarding Humacyte provided to Lake Street from books and records of Humacyte;

•        reviewed projected financials for Humacyte for the fiscal years ended December 31, 2020 through 2034 on a stand-alone basis prepared and furnished to Lake Street by Humacyte’s management, which financials included adjustments for probability of regulatory/technical success;

•        reviewed the Confidential Information Presentation dated January 2021 prepared by Humacyte’s management and its financial advisor for the PIPE Investment;

•        attended financial diligence calls with AHAC’s management and Humacyte’s management to discuss the financial projections and performance outlook for Humacyte, including total addressable markets, and Humacyte’s commercialization strategy;

•        reviewed AHAC’s Form 10-Q for the quarterly period ended September 30, 2020;

•        performed a discounted cash flow analysis based on financial projections prepared by Humacyte’s management solely for use in Lake Street’s financial analysis (see “— Certain Projected Financial Information”). The Lake Street fairness analysis was not shared with PIPE Investors and is disclosed herein solely to provide AHAC stockholders with this information made available to Lake Street in connection with its financial analysis;

•        analyzed public information regarding certain other companies in lines of business it believed to be comparable to Humacyte’s line of business, in whole or in part, including an analysis of public market prices and resulting valuation statistics; and

•        conducted such other analyses, examinations and inquiries and considered such other financial, economic and market criteria as Lake Street deemed necessary and appropriate in arriving at its opinions.

In its review and analysis and in arriving at its opinions, Lake Street assumed and relied on the accuracy and completeness of all of the financial and other information provided to or otherwise discussed with Lake Street or publicly available. Lake Street was not engaged to, and did not independently attempt to, verify any of such information. Lake Street also relied upon information provided by management of Humacyte as to the reasonableness and achievability of the financial and operating projections (and the assumptions and bases therefor) provided to Lake Street, and, with our consent, Lake Street assumed that the projections were reasonably prepared and reflect the best currently available estimates and judgments of Humacyte. Lake Street was not engaged to assess the reasonableness or achievability of the projections or the assumptions on which they were based, and Lake Street expressed no view as to such projections or assumptions. In addition, Lake Street did not conduct a physical inspection or appraisal of any of the assets, properties or facilities of Humacyte, and Lake Street was not furnished with any such evaluation or appraisal. Lake Street also assumed that all governmental, regulatory or other consents and approvals necessary for the consummation of the Business Combination would be obtained without any material adverse effect on Humacyte or the Business Combination.

Lake Street was not asked to, nor did Lake Street, offer any opinion as to the material terms of the Business Combination Agreement or the form of the Business Combination. In rendering its opinions, Lake Street assumed, with AHAC’s consent, that the final executed form of the Business Combination Agreement would not differ in any material respect from the draft that Lake Street examined, and that the conditions to the Business Combination in the Business Combination Agreement will be satisfied and that the Business Combination will be consummated on a timely basis in the manner contemplated by the Business Combination Agreement.

Lake Street’s opinions were based on economic and market conditions and other circumstances existing on, and information made available to Lake Street as of, February 16, 2021 and do not address any matters subsequent to such date. Lake Street’s opinions were limited to (i) the fairness from a financial point of view, as of the date of the opinion, to us of the Business Combination Consideration and the Contingent Consideration that may be payable in the Business Combination under the Business Combination Agreement and (ii) whether the fair market value of Humacyte exceeds 80% of the balance of funds in our Trust Account. They do not address Humacyte’s underlying business decision to effect the Business Combination or any other terms of the Business Combination. Although subsequent developments may affect Lake Street’s opinions, Lake Street does not have any obligation to update, revise, or reaffirm its opinions. Lake Street’s opinions were approved by a fairness committee of Lake Street.

The following is a summary of the material financial analyses performed by Lake Street in arriving at its opinions. Lake Street’s opinion letter was only one of many factors considered by the board of directors in evaluating the Business Combination. Neither Lake Street’s opinions nor its financial analyses were determinative of the Business Combination Consideration or Contingent Consideration or of the views of our Board or our management with respect to the Business Combination Consideration, the Contingent Consideration, or the Business Combination. None of the analyses performed by Lake Street were necessarily assigned a greater significance by Lake Street than any other, nor does the order of analyses described represent relative importance or weight given to those analyses by Lake Street. The summary text describing each financial analysis does not constitute a complete description of Lake Street’s financial analyses, including the methodologies and assumptions underlying the analyses, and if viewed in isolation could create a misleading or incomplete view of the financial analyses performed by Lake Street. The summary text set forth below does not represent and should not be viewed by anyone as constituting conclusions reached by Lake Street with respect to any of the analyses performed by it in connection with its opinions. Rather, Lake Street made its determination as to the fairness, from a financial point of view, to us of the Business Combination Consideration or

the Contingent Consideration that may be payable in the Business Combination pursuant to the Business Combination Agreement and as to the fair market value of Humacyte on the basis of its experience and professional judgment after considering the results of all of the analyses performed.

Discounted Cash Flow Analysis

Lake Street performed a discounted cash flow analysis of Humacyte, which was performed to derive an illustrative indication of the implied present value of Humacyte on an enterprise value. The illustrative discounted cash flow analysis of Humacyte was based on projections provided by Humacyte’s management and financial advisors for fiscal years 2020 through 2034, which projections included adjustments for probability of regulatory/technical success per Humacyte management. Lake Street calculated terminal values for Humacyte by using a perpetuity growth method employed to calculate terminal value utilizing a terminal growth rate of 1.5%, estimated working capital and capital expenditures as provided by Humacyte’s management, and a discount rate of 15.4% representing Humacyte’s estimated weighted average cost of capital (“WACC”). Humacyte’s guidance was for a terminal growth rate estimated at 3%. Lake Street used a range of 0% to 3% with a midpoint of 1.5% for the terminal growth rate to be conservative. Lake Street also noted that, per the World Bank, long-term GDP growth in the United States has averaged 3%. Lake Street arrived at a discount rate of 15.4% based on its analysis of Humacyte’s weighted average cost of capital using the capital asset pricing model and based on considerations that Lake Street deemed relevant in its professional judgment and experience, taking into account certain metrics including levered and unlevered betas for comparable companies and using a mid-year convention.

Lake Street performed a sensitivity analysis using discount rates ranging from 15.0% to 17.0%, and terminal growth rate range of 0.75% to 2.25%. This analysis indicated the following equity value reference range for Humacyte’s common shares:

Equity Value Reference Range
$1.991 billion to $2.828 billion

Although discounted cash flow analysis is a widely accepted and practiced valuation methodology, it relies on a number of assumptions, including growth rates, terminal multiples, and discount rates. The valuation derived from the discounted cash flow analysis is not necessarily indicative of Humacyte’s present or future value or results. Discounted cash flow analysis in isolation from other analyses is not an effective method of evaluating transactions.

Analysis of Comparable Publicly Traded Companies

Lake Street reviewed and compared certain publicly available financial data, ratios and trading multiples for comparable publicly traded companies that Lake Street determined, based on its professional judgment whose businesses, financial information, product mix, and operating profiles are reasonably comparable to those of the business of Humacyte for purposes of this analysis. Lake Street used comparable companies that met the following criteria:

•        Had a lead product focused on regenerative medicine therapies focused on damaged tissue regeneration;

•        Had a lead product in Phase II, Phase III, or Phase IV (post-marketing surveillance) clinical studies;

•        Had an enterprise value less than $3.3 billion; and

•        Had enterprise value to current year revenue data available for 2023 through 2026, which are Humacyte’s projected early product launch comparison years.

Lake Street did not exclude any comparable companies that met the selection criteria.

Financial data of the selected companies were based on publicly available information such as public filings and third-party equity research reports. Lake Street reviewed data, including Market Capitalization, Enterprise Value (“EV”), LTM Revenue, LTM EBITDA, EV as a multiple of projected revenue, of Humacyte and each of the following selected publicly traded companies, the operations of which Lake Street deemed similar for purposes of this analysis, based on its professional judgement and experience. The multiples for each of the selected companies were calculated using their respective closing prices on February 12, 2021 and were based on the most recent publicly available information and information from a third party data provider.

With respect to Humacyte’s comparable companies, the information Lake Street presented to our board of directors included multiples of EV to Revenue for projections for 2020, 2021, 2022, 2023 2024, 2025, and 2026, which were derived from a third party data provider based on revenue estimates from third-party equity research reports, which we refer to in the table below as “EV/CY Revenue.” For comparison purposes, Lake Street used the information regarding Humacyte’s projected 2023, 2024, 2025, and 2026 results, as provided to Lake Street by Humacyte’s management and can be found under “— Certain Projected Financial Information” on page 87.

The following table reflects the results of this analysis:

Based on its analysis and other considerations that Lake Street deemed relevant in its professional judgment and experience, Lake Street selected a reference range of Enterprise Values of less than $3.3 billion. In selecting this range of Enterprise Values, Lake Street made qualitative judgments based on its experience and professional judgment concerning differences between the business, financial and operating characteristics of Humacyte and the selected companies that could affect their public trading values in order to provide a context in which to consider the results of the quantitative analysis. Applying the reference range of Enterprise Value to the revenues estimated by Humacyte’s management, which revenues included adjustments for probability of regulatory/technical success, adjusting for $39.9 million in cash and $28.1 in indebtedness of Humacyte as of December 31, 2020, and using the 25th percentile, median, mean and 75th percentile and resulted in an implied equity value for Humacyte of approximately $553 million, $689 million, $882 million and $858 million, respectively, in 2023, $520 million, $803 million, $810 million and $999 million, respectively, in 2024, $403 million, $804 million, $898 million, and $1.221 billion, respectively, in 2025, and $310 million, $988 million, $938 million, and $1.451 billion, respectively, in 2026. The median implied equity values for each year ranged from $689 million to $988 million. The mean implied equity values for each year ranged from $810 million to $938 million. Lake Street then compared these ranges to the Business Combination Consideration and the Contingent Consideration that may be payable under the Business Combination Agreement.

No company used in the selected publicly traded companies analysis is identical to Humacyte. In evaluating selected publicly traded companies, Lake Street made judgments and assumptions with regard to industry performance, general business, economic, market and financial conditions and other matters which are beyond Humacyte’s control, such as the impact of competition on Humacyte and the industry generally, industry growth and the absence of any adverse material change in the financial conditions and prospects of Humacyte or the industry or the financial markets in general.

Miscellaneous

The preparation of a financial opinion is a complex analytical 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 and, therefore, a financial opinion is not readily susceptible to summary description. In arriving at its opinion, Lake Street did not draw, in isolation, conclusions from or with regard to any factor or analysis that it considered. Rather, Lake Street made its determination as to fairness on the basis of its experience and professional judgment after considering the results of all of the analyses.

In connection with Lake Street’s services as our financial advisor in connection with the Business Combination, we will pay Lake Street a fee of $200,000, which was payable upon the delivery of Lake Street’s opinion. In addition, we have agreed to reimburse Lake Street for certain of its expenses and to indemnify Lake Street and related persons against various potential liabilities, including certain liabilities that may arise in connection with Lake Street’s engagement.

Certain Projected Financial Information

In connection with the Board’s evaluation of the Business Combination and Lake Street’s financial analysis of Humacyte described in the subsection entitled “— Opinion of AHAC’s Financial Advisor”, Humacyte’s management provided to AHAC and Lake Street Humacyte’s non-public, internal financial forecasts prepared February 8, 2021 regarding Humacyte’s anticipated future operations for fiscal years 2021 through 2034, which incorporated the financial forecasts prepared by Humacyte management, as adjusted for customary regulatory success rates of pre-commercialization products. The summary information from such financial forecast is included in the table below because such information was considered by the Board for purposes of evaluating the Business Combination and by Lake Street for purposes of rendering its fairness opinion. Inclusion of summary information regarding the financial forecasts in this proxy statement/prospectus is not intended to influence your decision whether to vote for the Proposals.

The unaudited prospective financial information was not prepared with a view toward public disclosure, nor was it prepared with a view toward complying with published guidelines of the SEC, the guidelines established by the American Institute of Certified Public Accountants for the preparation and presentation of prospective financial information, or GAAP, but, in the view of Humacyte’s management, was prepared on a reasonable basis. However, this information is not fact and should not be relied upon as being necessarily indicative of future results, and readers of this document are cautioned not to place undue reliance on the prospective financial information. The unaudited prospective financial information does not take into account any circumstances or events occurring after the date it was prepared and should not be relied upon as being necessarily indicative of future results. New Humacyte will not refer back to this unaudited prospective financial information in future periodic reports filed under the Exchange Act.

The prospective financial information included in this proxy statement/prospectus has been prepared by, and is the responsibility of, Humacyte’s management. PricewaterhouseCoopers LLP has not audited, reviewed, examined, compiled nor applied agreed-upon procedures with respect to the accompanying prospective financial information and, accordingly, PricewaterhouseCoopers LLP does not express an opinion or any other form of assurance with respect thereto. The PricewaterhouseCoopers LLP report included in this document relates to Humacyte’s previously issued financial statements. It does not extend to the prospective financial information and should not be read to do so.

You are encouraged to review the financial statements of Humacyte included in this proxy statement/prospectus, as well as the financial information in the sections entitled “Information about Humacyte — Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Unaudited Pro Forma Condensed Combined Financial Information” in this proxy statement/prospectus, and to not rely on any single financial measure.

The unaudited prospective financial information involves certain assumptions, including, but not limited to:

•        The timing of the conduct and completion of ongoing and planned clinical trials, including trial size and other parameters, rate of trial enrollment, and impact of factors such as COVID-19.

•        The timing and rate of success in achieving FDA and international regulatory agency approval of product candidates, including the outcome of ongoing and planned clinical trials.

•        The timing and extent of the market acceptance and commercial results of any product candidates which achieve regulatory approval, including size of market, pricing, competition, and share of market achieved.

•        Other assumptions that are impacted by the reality that research, product development, regulatory approvals, launch timelines, and manufacturing and other operational execution are difficult to predict and many aspects of this progress will be impacted by circumstances that are out of Humacyte’s control.

While presented with numerical specificity, the unaudited prospective financial information reflects numerous estimates and assumptions made by Humacyte’s management with respect to industry performance, competition, general business, economic, market and financial conditions and matters specific to Humacyte’s business, all of which are difficult to predict and many of which are beyond Humacyte’s control.

The assumptions and estimates underlying the prospective financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the prospective financial information, including, among others, risks and uncertainties set forth under “Risk Factors” and “Forward-Looking Statements” contained elsewhere in this proxy statement/prospectus. Accordingly, there can be no assurance that the prospective results are indicative of the future performance of AHAC or Humacyte or that actual results will not differ materially from those presented in the prospective financial information. Inclusion of the prospective financial information in this proxy statement/prospectus should not be regarded as a representation by any person that the results contained in the prospective financial information will be achieved.

Considering that the Special Meeting will be held months after the date the prospective financial information referenced above was prepared, as well as the uncertainties inherent in any forecasted information, stockholders are cautioned not to place undue reliance on the prospective financial information. This information constitutes “forward-looking statements” and actual results likely will differ from it and the differences may be material. See the section entitled “Forward-Looking Statements.”

Neither AHAC nor Humacyte generally publishes its business plans and strategies or makes external disclosures of its anticipated financial condition or results of operations. AHAC and Humacyte have not updated, and do not intend to update or otherwise revise, the prospective financial information to reflect circumstances existing since its preparation, including any changes in general economic or industry conditions, or to reflect the occurrence of unanticipated events. Neither AHAC, Humacyte nor any of their respective representatives or advisers makes any representation to any person with regard to the ultimate performance of AHAC, Humacyte or the Combined Company.

A summary of the financial forecast information regarding Humacyte’s anticipated future operations for fiscal years 2021 through 2034 provided to Lake Street in connection with Lake Street’s opinion and related financial analyses is set forth below (dollar amounts presented below are in millions).

(1)      Probability adjusted for customary regulatory success rates of pre-commercialization products. The probability rate applied to the financial projections for each product candidate was dependent upon the stage of development and technological nature of the candidate. For product candidates in Phase III and Phase II development, each of which are vascular products, rates of 80% and 45%, respectively, were used. For product candidates in preclinical development, a rate of 27% was used for vascular product candidates due to the existing clinical experience with this class of product candidate, and a rate of 5% was used for non-vascular product candidates. In each case “E” represents projected results for the applicable fiscal year.

(2)      Revenue was projected by market and by geographical region based on estimates of current market size, projected market growth rates ranging from 3% to 5%, and projected market penetrations ranging from 10% to 20% for vascular product candidates and 1.0% to 1.5% for the non-vascular product candidate targeting diabetes, the results of which were then probability adjusted, as described in note (1) above.

(3)      Net income was projected by subtracting projected cost of goods sold, operating expenses, and income taxes from projected revenue to arrive at unlevered net income. Cost of goods sold projections were based on current production costs adjusted for expected reductions over time as production reaches higher scale and are projected to be within the range of industry standards for biologic products. Projected operating expenses are primarily comprised of research and development, sales and marketing, and general and administrative. Research and development expense projections are based on historic preclinical and clinical development costs applied to product candidates projected to be developed during the timeframe of the projections as well as other research programs. Projected sales and marketing expenses are based on similar sized specialty sales and marketing resources employed within the industry in similar-sized markets. General and administrative expenses were projected based on historic run rates increased to meet expected future requirements resulting from the transition to public status and the corporate growth reflected in the projections.

(4)      Projected free cash flow was calculated by adjusting projected unlevered net income by adding projected depreciation, subtracting projected capital expenditures, and subtracting projected working capital requirements. Future capital requirements were projected based on estimates of production capacity required to meet projected revenues, with the historic cost of acquiring Humacyte’s existing facilities and equipment used as a basis for estimated future capital costs. Working capital requirements were projected based on estimates of inventory, accounts receivable and accounts payable requirements to meet projected revenues and operations.

The prospective financial information above includes financial measures that were not calculated in accordance with GAAP, namely unlevered net income and free cash flow. Non-GAAP measures are not necessarily calculated the same way by different companies and should not be considered a substitute for or superior to GAAP results. Humacyte is not able to reconcile its forward-looking non-GAAP free cash flow measure because Humacyte cannot predict the timing and amounts of discrete items, which could significantly impact GAAP results.

Satisfaction of 80% Test

The Board concluded that Humacyte has a fair market value equal to at least 80% of the balance of the funds in the Trust Account (excluding the deferred underwriting commissions and taxes payable on the interest earned on the Trust Account) at the time of the execution of the Business Combination Agreement.

Interests of the Sponsor and AHAC’s Directors and Officers in the Business Combination

In considering the recommendation of the Board to vote in favor of approval of the Business Combination Proposal, the Charter Amendment Proposal and the other Proposals, AHAC stockholders should keep in mind that the Sponsor (which is affiliated with certain of AHAC’s officers and directors) and AHAC’s officers and directors have interests in such proposals that are different from, or in addition to, your interests as an AHAC stockholder or warrant holder. These interests include, among other things:

•        If the Business Combination with Humacyte or another business combination is not consummated by September 22, 2022 (or such later date as may be approved by AHAC’s stockholders), AHAC will cease all operations except for the purpose of winding up, redeeming 100% of the outstanding Public Shares for cash and, subject to the approval of its remaining stockholders and its Board, dissolving and liquidating. In such event, the (i) 2,500,000 Founder Shares held by the Sponsor and certain of AHAC’s officers and directors, which were acquired by the Sponsor for a purchase price of approximately $0.009 per share, or $25,000 in the aggregate, prior to the Initial Public Offering, and (ii) the 305,000 Units purchased by the Sponsor in the Concurrent Private Placement for a purchase price of $10.00 per Unit, or $3,050,000 in the aggregate, would be worthless because the holders are not entitled to participate in any redemption or distribution with respect to such securities. Such securities had an aggregate market value of approximately $             million based upon the closing price of $             per share on Nasdaq on the Record Date.

•        If AHAC is unable to complete a business combination within the required time period, the Sponsor will be personally liable under certain circumstances described herein to ensure that the proceeds in the Trust Account are not reduced by the claims of target businesses or claims of vendors or other entities that are owed money by AHAC for services rendered or contracted for or products sold to AHAC. If AHAC consummates a business combination, on the other hand, AHAC will be liable for all such claims.

•        The Business Combination Agreement provides for the continued indemnification of AHAC’s current directors and officers and the continuation of directors and officers liability insurance covering AHAC’s current directors and officers.

•        None of AHAC’s officers or directors will be required to commit his or her full time to the affairs of New Humacyte and, accordingly, may have conflicts of interest in allocating his or her time among various business activities.

•        In the course of their other business activities, AHAC’s officers and directors may become aware of investment and business opportunities which may be appropriate for presentation to New Humacyte as well as the other entities with which they are affiliated. AHAC’s management may have conflicts of interest in determining to which entity a particular business opportunity should be presented.

•        AHAC’s initial stockholders have agreed to waive their redemption rights with respect to any Founder Shares, Private Placement Shares and any Public Shares held by them in connection with the consummation of AHAC’s initial business combination. Additionally, initial stockholders have agreed to waive their redemption rights with respect to any Founder Shares and Private Placement Shares held by them if AHAC fails to consummate its initial business combination within 24 months after the closing of the Initial Public Offering. If AHAC does not complete its initial business combination within such applicable time period, the proceeds of the sale of the Units sold in the Concurrent Private Placement that are held in the Trust Account will be used to fund the redemption of its Public Shares, and the securities sold in the Concurrent Private Placement will expire worthless. The Founder Shares and the Units purchased in the Concurrent Private Placement held by AHAC’s initial stockholders had an aggregate market value of approximately $               million based upon the closing price of $               per share on Nasdaq on the Record Date. In addition, with certain limited exceptions, the Founder Shares will not be transferable or assignable by the Sponsor until the earlier to occur of: (A) one year after the completion of AHAC’s initial business combination and (B) subsequent to AHAC’s initial business combination, (x) if the reported last sale price of our Class A Common Stock equals or exceeds $12.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 trading days within any 30-trading day period commencing at least 150 days after AHAC’s initial business combination, or (y) the date on which AHAC completes a liquidation, merger, capital stock exchange, reorganization or other similar transaction that results in all of AHAC’s stockholders having the right to exchange their shares of common stock for cash, securities or other property. With certain limited exceptions, the Units sold in the Concurrent Private Placement, the Private Placement Warrants, the Class A Common Stock underlying the Private Placement Warrants and the Private Placement Shares will not be transferable, assignable or saleable by the Sponsor or its permitted transferees until 30 days after the completion of AHAC’s initial business combination. Since the Sponsor and AHAC’s officers and directors may directly or indirectly own AHAC Common Stock and Warrants following the Initial Public Offering, AHAC’s officers and directors may have a conflict of interest in determining whether a particular target business is an appropriate business with which to effectuate AHAC’s initial business combination.

•        AHAC’s officers and directors may have a conflict of interest with respect to evaluating a particular business combination if the retention or resignation of any such officers and directors was included by a target business as a condition to any agreement with respect to our initial business combination.

•        The Sponsor and AHAC’s officers or directors may have a conflict of interest with respect to evaluating a business combination and financing arrangements as AHAC may obtain loans from the Sponsor or an affiliate of the Sponsor or any of AHAC’s officers or directors to finance transaction costs in connection with an intended initial business combination. As of June 10, 2021, no such loans are outstanding. The terms of such loans, if any are made, have not been determined and no written agreements exist with respect to such loans. The loans would either be repaid upon consummation of a business combination, without interest, or, at the lender’s discretion, up to $1,500,000 of such loans may be converted into units of the post-business combination entity at a price of $10.00 per unit, and it is expected that the units issued upon conversion of such loans would be identical to the Units sold in the Initial Public Offering, except that such securities would not be redeemable given that such securities would be issued after completion of the initial business combination.

•        The Sponsor as well as Messrs. Carlson, Robertson, Springer and Xie, directors of AHAC, will be party to the Investors Rights and Lock-up Agreement, which will come into effect at the Effective Time.

Below is a table summarizing the entities to which our executive officers and directors currently have fiduciary duties or contractual obligations: