☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware |
83-5112298 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) | |
One Broadway, 14 th FloorCambridge, |
02142 | |
(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Class A Common Stock, $0.0001 Par Value | NUVL | Nasdaq Global Select Market |
Large accelerated filer |
☐ |
Accelerated filer |
☐ | |||
Non-accelerated filer |
☒ |
Smaller reporting company |
☒ | |||
Emerging growth company |
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Page |
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PART I |
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Item 1. |
8 |
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Item 1A. |
79 |
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Item 1B. |
145 |
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Item 2. |
145 |
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Item 3. |
145 |
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Item 4. |
145 |
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PART II |
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Item 5. |
146 |
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Item 6. |
147 |
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Item 7. |
148 |
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Item 7A. |
157 |
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Item 8. |
158 |
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Item 9. |
178 |
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Item 9A. |
178 |
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Item 9B. |
179 |
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Item 9C. |
179 |
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PART III |
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Item 10. |
180 |
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Item 11. |
180 |
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Item 12. |
180 |
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Item 13. |
180 |
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Item 14. |
180 |
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PART IV |
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Item 15. |
181 |
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Item 16. |
181 |
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184 |
• | the initiation, timing, progress, results, and cost of NVL-520 and NVL-655, as well as our discovery programs and our current and future preclinical and clinical studies, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our current and future programs; |
• | the ability of our preclinical studies and clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; |
• | the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates; |
• | the timing, scope and likelihood of regulatory filings and approvals, including timing of Investigational New Drug applications (INDs) and final U.S. Food and Drug Administration (FDA) approval of our current product candidates or any future product candidates; |
• | the timing, scope or likelihood of foreign regulatory filings and approvals; |
• | our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop product candidates, including by applying learnings from one program to other programs and from one indication to our other indications; |
• | our estimates of the number of patients that we will enroll and our ability to initiate, recruit, and enroll patients in and conduct and successfully complete our clinical trials at the pace that we project; |
• | our ability to scale-up our manufacturing and processing approaches to appropriately address our anticipated commercial needs, which will require significant resources; |
• | our ability to maintain and further develop the specific shipping, storage, handling and administration of NVL-520 and NVL-655 at the clinical sites; |
• | our ability to obtain funding for our operations necessary to complete further development and commercialization of our product candidates; |
• | our ability to take advantage of accelerated regulatory pathways for our product candidates; |
• | our ability to obtain and maintain regulatory approval of our product candidates; |
• | our ability to commercialize our product candidates, if approved, including the geographic areas of focus and sales strategy; |
• | the pricing and reimbursement of our product candidates, if approved; |
• | the implementation of our business model, and strategic plans for our business, product candidates, and technology; |
• | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; |
• | estimates of our future expenses, revenues, capital requirements, and our needs for additional financing; |
• | the period over which we estimate our existing cash, cash equivalents and marketable securities will be sufficient to fund our future operating expenses and capital expenditure requirements; |
• | future agreements with third parties in connection with the development and commercialization of our product candidates; |
• | the size and growth potential of the markets for our product candidates, and our ability to serve those markets; |
• | our financial performance; |
• | the rate and degree of market acceptance of our product candidates; |
• | regulatory developments in the United States (the U.S.) and foreign countries; |
• | our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
• | our ability to produce our product candidates with advantages in turnaround times or manufacturing cost; |
• | our competitive position and the success of competing therapies that are or may become available; |
• | our need for and ability to attract and retain key scientific, management and other personnel; |
• | the impact of laws and regulations; |
• | our expectations regarding the period during which we will remain an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the JOBS Act); |
• | developments relating to our competitors and our industry; |
• | the effect of the COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations, including but not limited to our preclinical studies and future clinical trials; and |
• | other risks and uncertainties, including those listed under the section titled “Risk Factors.” |
• | We are very early in our development efforts, have a limited operating history, have not completed any clinical trials, have no products approved for commercial sale and have not generated any revenue, which may make it difficult for investors to evaluate our current business and likelihood of success and viability; |
• | We have incurred significant net losses in each period since our inception, and we expect to continue to incur significant net losses for the foreseeable future; |
• | We are very early in our development efforts and our future prospects are substantially dependent on NVL-520 and NVL-655; |
• | Our preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval and commercialization; |
• | Our discovery and preclinical development activities are focused on the development of targeted therapeutics for patients with cancer-associated genomic alterations, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may never lead to approved or marketable products; |
• | In addition to NVL-520 and NVL-655, our prospects depend in part upon discovering, developing and commercializing additional product candidates from our ALK IXDN, HER2 and other discovery programs, which may fail in development or suffer delays that adversely affect their commercial viability; |
• | Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to use and expand our approach to build a pipeline of product candidates with commercial value; |
• | We may not be able to submit INDs, clinical trial applications (CTAs) or comparable applications to commence clinical trials on the timelines we expect, and even if we are able to, regulatory authorities may not permit us to proceed; |
• | Our product candidates may cause undesirable adverse events when used alone or in combination with other products that may result in a safety profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences; |
• | If we experience delays or difficulties in the enrollment or maintenance of patients in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented; |
• | The effects of the ongoing COVID-19 pandemic could adversely impact our business, including our clinical trials and preclinical studies; |
• | We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do; |
• | If any of our third-party manufacturers encounter difficulties in production, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented; |
• | The market opportunities for any product candidates we develop, if approved, may be limited to certain smaller patient subsets and may be smaller than we estimate them to be; |
• | We may be unable to obtain U.S. or foreign regulatory approval and, as a result, may be unable to commercialize our product candidates; |
• | We have never commercialized a product candidate as a company before and currently lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; |
• | Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight; |
• | Where appropriate, we plan to secure approval through the use of accelerated registration pathways. If we are unable to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we are currently contemplating, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals; |
• | Our relationships with healthcare professionals, clinical investigators, contract research organizations (CROs) and third-party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws, which could expose us to significant losses; |
• | Our reliance on a limited number of employees who provide various administrative, research and development, and other services across our organization presents operational challenges that may adversely affect our business; |
• | If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval; |
• | If we are unable to obtain, maintain and enforce patent protection for our technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected; |
• | We may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful; |
• | Third parties may allege that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on our business; |
• | If we are unable to protect the confidentiality of our trade secrets and other proprietary information, our business and competitive position would be adversely affected; |
• | If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected; |
• | We rely on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research and studies; |
• | If we decide to establish collaborations, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans; |
• | Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance; |
• | Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval. Three of our directors are affiliated with our principal stockholders; and |
• | We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock. |
ITEM 1. BUSINESS |
• | Patient-driven focus. |
• | Deep expertise in chemistry and structure-based drug design to achieve precise selectivity (“Threading the needle”). pre-defined in our target product profiles. Leveraging our team’s deep expertise in chemistry and structure-based drug design, we ‘thread the needle’ to navigate competing molecular challenges and develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, optimize CNS activity, and drive more durable responses. |
• | Efficient drug discovery and development. |
• | Matthew Shair, Ph.D., head scientific advisor, Professor of Chemistry and Chemical Biology at Harvard University. Dr. Shair is the scientific founder of Nuvalent and is on our board of directors; |
• | Michael Meyers, M.D., Ph.D., clinical advisor, Chief Medical Officer at Syndax; |
• | Pasi Jänne, M.D., Ph.D., clinical advisor, Dana Farber Cancer Institute; |
• | Ross Camidge, M.D., Ph.D., clinical advisor, Professor at University of Colorado; |
• | Alexander Drilon, M.D., clinical advisor, Memorial Sloan Kettering; |
• | Aaron Hata, M.D., Ph.D., translational research advisor, Massachusetts General Hospital; and |
• | Nancy Kohl, Ph.D., translational research advisor, independent consultant. |
• | Patient Impact . |
• | Empowerment . |
• | Collaboration . |
• | Advance the ongoing clinical development of NVL-520, our first lead product candidate and a differentiated ROS1-selective inhibitor, in the Phase 1/2 ARROS-1 study designed to support potential regulatory approval. NVL-520 is positioned to be a differentiated inhibitor of ROS1 based on its activity against wild-type ROS1 fusions and key resistance mutations, selectivity over other kinases associated with adverse events and dose-limiting toxicities, and activity in the CNS to address brain metastases. We believe that these characteristics may position NVL-520 to deliver a favorable tolerability profile and more robust anti-tumor response than existing ROS1 inhibitors, which has the potential to drive more durable responses in patients. Clinical investigation of NVL-520 is ongoing in the Phase 1 portion of our ARROS-1 study, a first-in-human NVL-520 in advanced ROS1-positive NSCLC and other solid tumors. Pending supportive data, we plan to engage with regulators to discuss whether we may qualify for any expedited drug development pathways. |
• | Advance NVL-655, our second lead product candidate, a differentiated ALK-selective inhibitor, through clinical development and regulatory approval.NVL-655 to have a compelling product profile with activity against wild-type ALK fusions and drug-resistant mutations in ALK-driven tumors, selectivity over other kinases associated with adverse events and dose-limiting toxicities, and activity in the CNS to address brain metastases. We believe that these characteristics position NVL-655 to be a differentiated ALK inhibitor that may deliver a favorable tolerability profile and more robust anti-tumor response than existing therapies. We have submitted an IND for NVL-655 and the FDA has confirmed that clinical investigation of NVL-655 may proceed. We plan to initiate the Phase 1 portion of our planned ALKOVE-1 study, a first-in-human NVL-655 in advanced ALK-positive NSCLC and other solid tumors, in the second quarter of 2022. Pending supportive data, we plan to engage with regulators to discuss whether we may qualify for any expedited drug development pathways. |
• | Continue to partner with physician-scientists to characterize current and emerging medical needs for patients and the limitations of existing therapies. |
• | Progress our discovery stage programs, ALK IXDN and HER2 Exon 20 Insertions, while continuing to expand our pipeline of precisely targeted novel product candidates. |
• | Commercialize our product candidates in key geographies and opportunistically pursue strategic collaborations to maximize the full potential of our pipeline . precisely |
targets, product candidates, disease areas, or geographies, if we believe these collaborations could accelerate the development and commercialization of our product candidates and allow us to realize the full potential of our pipeline. |
• | Patient-driven focus. |
• | Deep expertise in chemistry and structure-based drug design to achieve precise selectivity (“Threading the needle”). |
• | Efficient drug discovery and development. |
1. | Resistance mutations. |
2. | Selectivity. off-target kinase inhibition, specifically TRK, have been observed with entrectinib, repotrectinib, and lorlatinib. Reported TRKB-related adverse events for these brain-penetrant TRK inhibitors include cognitive impairment, mood disorders, sleep disturbances, dizziness, ataxia, and weight gain. Figure 4 below highlights the various CNS-related safety implications associated with inhibition of TRK in the CNS. |
3. | Poor brain penetration. |
• | Activity against wild-type ROS1 fusions, an oncogenic driver. |
• | Activity against resistance mutations to address the medical need and enable more durable responses. |
• | Avoid inhibition of TRK (TRK sparing) to reduce CNS toxicity. |
• | Avoid inhibition of other off-target kinases to reduce toxicity. |
• | Optimized brain penetration to effectively treat patients with brain metastases. |
• | inhibits wild-type ROS1 fusions; |
• | remains active in tumors that have developed ROS1 resistance mutations, including G2032R; |
• | is selective for ROS1 over the structurally related TRK family, indicating the potential to minimize TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and drive more durable responses for patients with ROS1 resistance mutations; |
• | is selective for ROS1 over other off-target kinases; and |
• | is brain-penetrant in pharmacokinetic and pharmacology studies. |
1. | Resistance mutations. |
2. | Selectivity. off-target kinase inhibition, specifically attributed to TRKB, have been observed with lorlatinib. Reported TRKB-related adverse events for this brain-penetrant TRK inhibitor include cognitive impairment, mood disorders, sleep disturbances, dizziness, ataxia, and weight gain. |
• | Activity against wild-type ALK fusions, an oncogenic driver. ALK-positive cancers. |
• | Activity against resistance mutations to address the medical need and enable more durable responses. ALK-positive NSCLC patients. Moreover, by more effective coverage of known ALK mutation variants, this novel compound could limit the appearance of these resistance mutations and lead to more durable responses in earlier lines of therapy. |
• | Avoid inhibition of TRK (TRK sparing) to reduce CNS toxicity. |
• | Avoid inhibition of other off-target kinases to reduce toxicity. |
• | Optimized brain penetration to effectively treat patients with brain metastases. ALK-positive NSCLC patients have brain metastases at diagnosis, and incidence of brain metastases increases to more than 60% in later lines of therapy, highlighting the need for a brain-penetrant ALK-selective inhibitor that can avoid CNS adverse events. |
• | inhibits wild-type ALK fusions; |
• | remains active in tumors that have developed resistance to first-, second-, and third generation ALK inhibitors, including tumors with the solvent-front G1202R single mutation, G1202R+ compound mutations, or a non-G1202R mutation; |
• | is selective for ALK over the structurally related TRK family, indicating the potential to minimize TRK-related CNS adverse events seen with other ALK inhibitors and drive more durable responses for patients with ALK resistance mutations; |
• | is selective for ALK over other off-target kinases; and, |
• | is brain-penetrant in pharmacokinetic studies. |
• | completion of preclinical laboratory tests, animal studies and formulation studies according to good laboratory practices (GLP) regulations or other applicable regulations; |
• | design of a clinical protocol and submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated when certain changes are made; |
• | approval by an independent institutional review board (IRB) or ethics committee representing each clinical trial site before each clinical trial may be initiated; |
• | performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practices (GCPs) and other clinical-trial related regulations to evaluate the safety and efficacy of the investigational product for each proposed indication; |
• | preparation and submission to the FDA of an NDA requesting marketing approval for one or more proposed indications, including payment of application user fees; |
• | review of the NDA by an FDA advisory committee, where applicable; |
• | satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the drug is produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality, and purity; |
• | satisfactory completion of any FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data submitted in support of the NDA; and |
• | FDA review and approval of the NDA, which may be subject to additional post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (REMS), and any post-approval studies required by the FDA. |
• | Phase 1 |
• | Phase 2 |
• | Phase 3 |
• | Fast Track designation condition |
• | Breakthrough therapy designation. |
intensive involvement of senior managers and experienced staff on a proactive, collaborative and cross-disciplinary review and rolling review. |
• | Priority review. |
• | Accelerated approval. pre-approval of promotional materials. |
• | Regenerative advanced therapy. |
• | restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; |
• | safety alerts, Dear Healthcare Provider letters, press releases, or other communications containing warnings or other safety information about a product; |
• | mandated modification of promotional materials and labeling and issuance of corrective information; |
• | fines, warning letters, untitled letters, or other enforcement-related letters or clinical holds on post-approval clinical trials; |
• | refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product approvals; |
• | product seizure or detention, or refusal to permit the import or export of products; |
• | injunctions or the imposition of civil or criminal penalties; and |
• | consent decrees, corporate integrity agreements, debarment, or exclusion from federal health care programs. |
• | federal false claims, false statements, and civil monetary penalties laws prohibiting, among other things, any person from knowingly presenting, or causing to be presented, a false claim for payment of government funds or knowingly making, or causing to be made, a false statement to get a false claim paid; |
• | federal healthcare program anti-kickback law, which prohibits, among other things, persons from offering, soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual for, or the purchasing or ordering of, a good or service for which payment may be made under federal healthcare programs such as Medicare and Medicaid; |
• | the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; |
• | federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; |
• | federal Open Payments (or federal “sunshine” law), which requires pharmaceutical and medical device companies to monitor and report certain financial interactions with certain healthcare providers to the Center for Medicare & Medicaid Services (CMS) within the HHS for re-disclosure to the public, as well as ownership and investment interests held by certain healthcare providers and their immediate family members; |
• | federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; |
• | analogous state laws and regulations, including: state anti-kickback and false claims laws; state laws requiring pharmaceutical companies to comply with specific compliance standards, restrict financial interactions between pharmaceutical companies and healthcare providers or require pharmaceutical companies to report information related to payments to health care providers or marketing expenditures; and state laws governing privacy, security and breaches of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and |
• | laws and regulations prohibiting bribery and corruption such as the FCPA, which, among other things, prohibits U.S. companies and their employees and agents from authorizing, promising, offering, or providing, directly or indirectly, corrupt or improper payments or anything else of value to foreign government officials, employees of public international organizations or foreign government-owned or affiliated entities, candidates for foreign public office, and foreign political parties or officials thereof. |
• | Decentralized procedure |
• | Mutual recognition procedure |
Name |
Age |
Position | ||
James R. Porter, Ph.D. |
46 | Chief Executive Officer, President and Director | ||
Alexandra Balcom |
38 | Chief Financial Officer and Treasurer | ||
Deborah Miller, Ph.D., J.D. |
46 | Chief Legal Officer and Secretary | ||
Darlene Noci |
45 | SVP of Product Development & Regulatory Affairs | ||
Christopher D. Turner, M.D. |
54 | Chief Medical Officer |
• | successful and timely completion of preclinical and clinical development of NVL-520, NVL-655 and any future product candidates from our ALK IXDN, HER2 and other discovery programs, and any other future programs; |
• | establishing and maintaining relationships with CROs and clinical sites for the clinical development of NVL-520, NVL-655 and any future product candidates from our ALK IXDN, HER2 and other current or future discovery programs; |
• | timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development; |
• | developing an efficient and scalable manufacturing process for our product candidates, including the production of finished products that are appropriately packaged for sale if our product candidates obtain marketing approvals; |
• | establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for our product candidates, if approved; |
• | successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators; |
• | a continued acceptable safety profile following any marketing approval of our product candidates; |
• | commercial acceptance of our product candidates by patients, the medical community and third-party payors, including the willingness of physicians to use our product candidates, if approved, in lieu of (or as a second-line treatment in conjunction with) other approved therapies; |
• | satisfying any required post-marketing approval commitments to applicable regulatory authorities; |
• | identifying, assessing and developing new product candidates; |
• | obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the U.S. and internationally; |
• | defending against third-party interference or infringement claims, if any; |
• | entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; |
• | obtaining coverage and adequate reimbursement by third-party payors for our product candidates, if approved; |
• | addressing any competing therapies and technological and market developments; and |
• | attracting, hiring and retaining qualified personnel. |
• | successful and timely completion of preclinical studies; |
• | submission of INDs in the U.S. and CTAs and/or comparable applications outside the U.S. for regulatory authority review and agreement to proceed with our clinical trials; |
• | our ability to address any potential delays resulting from factors related to the COVID-19 pandemic; |
• | successful initiation and completion of clinical trials; |
• | successful and timely patient selection and enrollment in and completion of clinical trials; |
• | maintaining and establishing relationships with CROs and clinical sites for the clinical development of our product candidates both in the U.S. and internationally; |
• | maintaining and growing an organization of chemists, medical professionals and clinical development professionals who can develop and commercialize our product candidates; |
• | the frequency and severity of adverse events in clinical trials; |
• | obtaining positive data that support demonstration of efficacy, safety and tolerability profiles and durability of effect for our product candidates that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval; |
• | the timely receipt of marketing approvals from applicable regulatory authorities; |
• | the timely identification, development and approval of companion diagnostic tests, if required; |
• | the extent of any required post-marketing approval commitments to applicable regulatory authorities; |
• | the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of our product candidates; |
• | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the U.S. and internationally; |
• | the protection of our rights in our intellectual property portfolio; |
• | establishing sales, marketing and distribution capabilities and the successful launch of commercial sales of our product candidates if and when approved for marketing, whether alone or in collaboration with others; |
• | a continued acceptable safety profile following any marketing approval; |
• | commercial acceptance by patients, the medical community and third-party payors, including the willingness of physicians to use our product candidates, if approved, in lieu of (or as a second-line treatment in conjunction with) other approved therapies; and |
• | our ability to compete with other therapies. |
• | failure of our product candidates in preclinical studies or clinical trials to demonstrate safety and efficacy; |
• | receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials; |
• | negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain research, discovery and/or drug development programs; |
• | the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated, particularly if there are other trials enrolling the same or overlapping precisely targeted patient populations, or participants dropping out of these clinical trials at a higher rate than anticipated; |
• | third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• | the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable adverse events or other unexpected characteristics or risks; |
• | the cost of clinical trials of our product candidates being greater than anticipated; |
• | the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate; and |
• | regulators revising the requirements for approving our product candidates. |
• | generating sufficient data to support the initiation or continuation of preclinical studies and clinical trials; |
• | addressing any delays resulting from factors related to the ongoing COVID-19 pandemic; |
• | obtaining regulatory permission to initiate clinical trials; |
• | contracting with the necessary parties to conduct clinical trials; |
• | successful enrollment of patients in, and the completion of, clinical trials on a timely basis; |
• | the timely manufacture of sufficient quantities of a product candidate for use in clinical trials; and |
• | adverse events in clinical trials. |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; |
• | the FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, are only moderately effective or have undesirable or unintended adverse events, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; |
• | the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval; |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
• | the clinical data of the clinical trial may fail to meet the level of statistical significance required to obtain approval of our product candidates by the FDA, EMA or other comparable foreign regulatory authorities; |
• | we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable; |
• | the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; |
• | the FDA, EMA or other comparable regulatory authorities may fail to approve companion diagnostic tests required for our product candidates; |
• | we may not obtain or maintain adequate funding to complete the clinical trial in a manner that is satisfactory to the FDA, EMA or other comparable foreign regulatory authorities; and |
• | the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | size and nature of the patient population; |
• | severity of the disease under investigation; |
• | availability and efficacy of approved drugs for the disease under investigation; |
• | patient eligibility criteria for the trial in question as defined in the protocol, including biomarker-driven identification and/or certain highly-specific criteria related to stage of disease progression, which may limit the patient populations eligible for our clinical trials to a greater extent than competing clinical trials for the same indication that do not have a biomarker-driven patient eligibility criteria; |
• | perceived risks and benefits of the product candidate under study; |
• | clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved or other product candidates being investigated for the indications we are investigating; |
• | clinicians’ willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials; |
• | patient referral practices of physicians; |
• | the ability to monitor patients adequately during and after treatment; |
• | proximity and availability of clinical trial sites for prospective patients; and |
• | the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage cancer patients, will not survive the full terms of the clinical trials. |
• | delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
• | delays or difficulties in enrolling and retaining patients in any clinical trials, particularly elderly subjects, who are at a higher risk of severe illness or death from COVID-19; |
• | difficulties interpreting data from our clinical trials due to the possible effects of COVID-19 on patients; |
• | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of 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; |
• | interruption or delays in the operations of the FDA, EMA or other regulatory authorities, which may impact review and approval timelines; |
• | limitations in resources that would otherwise be focused on the conduct of our business, our preclinical studies or our clinical trials, including because of sickness or the desire to avoid contact with large groups of people or as a result of government-imposed “shelter in place” or similar working restrictions; |
• | interruptions, difficulties or delays arising in our existing operations and company culture as a result of the majority of our employees working remotely, including those hired during the COVID-19 pandemic; |
• | delays in receiving approval from regulatory authorities to initiate our clinical trials; |
• | delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials; |
• | interruptions in preclinical studies due to restricted or limited operations at the CROs conducting such studies; |
• | interruption in global freight and shipping that may affect the transport of clinical trial materials, such as investigational drug product to be used in our clinical trials; |
• | changes in regulations as part of a response to the ongoing COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted, or to discontinue the clinical trials altogether, or which may result in unexpected costs; |
• | 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 or contractor personnel; and |
• | refusal of the FDA, EMA or other regulatory authorities to accept data from clinical trials in affected geographies outside of their respective jurisdictions. |
• | the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments; |
• | the timing of market introduction of the product candidate as well as competitive products; |
• | the clinical indications for which a product candidate is approved; |
• | restrictions on the use of product candidates in the labelling approved by regulatory authorities, such as boxed warnings or contraindications in labelling, or a Risk Evaluation and Mitigation Strategy (REMS), if any, which may not be required of alternative treatments and competitor products; |
• | the potential and perceived advantages of our product candidates over alternative treatments; |
• | the cost of treatment in relation to alternative treatments; |
• | the availability of coverage and adequate reimbursement by third-party payors, including government authorities; |
• | willingness of physicians to use our product candidates, if approved, in lieu of (or as a second-line treatment in conjunction with) other approved therapies; |
• | the availability of an approved product candidate for use as a combination therapy; |
• | relative convenience and ease of administration; |
• | the willingness of the target patient population to try new therapies and undergo required diagnostic screening to determine treatment eligibility and of physicians to prescribe these therapies and diagnostic tests; |
• | the effectiveness of sales and marketing efforts; |
• | unfavorable publicity relating to our product candidates; and |
• | the approval of other new therapies for the same indications. |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; |
• | the FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective or have undesirable or unintended adverse events, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; |
• | the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval; |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
• | we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable; |
• | the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and |
• | the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | delays in or the rejection of product approvals; |
• | restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials; |
• | restrictions on the products, manufacturers or manufacturing process; |
• | warning or untitled letters; |
• | civil and criminal penalties; |
• | injunctions; |
• | suspension or withdrawal of regulatory approvals; |
• | product seizures, detentions or import bans; |
• | voluntary or mandatory product recalls and publicity requirements; |
• | total or partial suspension of production; |
• | imposition of restrictions on operations, including costly new manufacturing requirements; |
• | revisions to the labelling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings; |
• | imposition of a REMS, which may include distribution or use restrictions; and |
• | requirements to conduct additional post-market clinical trials to assess the safety of the product. |
• | Anti-Kickback Statute |
• | False Claims Laws. qui tam per-claim penalties. |
• | HIPAA. |
• | Transparency Requirements. |
to payments or transfers of value made to physicians, other healthcare providers and teaching hospitals, as well as information regarding ownership and investment interests held by physicians, other healthcare providers and their immediate family members. |
• | Analogous State and Foreign Laws. non-governmental third-party payors and are generally broad and are enforced by many different federal and state agencies as well as through private actions. |
• | identifying, recruiting, integrating, maintaining, retaining and motivating our current and additional employees; |
• | managing our internal development efforts effectively, including the preclinical, clinical, FDA, EMA and other comparable foreign regulatory authorities’ review process for NVL-520 and NVL-655 and our other programs, while complying with any contractual obligations to contractors and other third parties; |
• | managing increasing operational and managerial complexity; and |
• | improving our operational, financial and management controls, reporting systems and procedures. |
• | differing regulatory requirements and reimbursement regimes in foreign countries, such as the lack of pathways for accelerated drug approval, may result in foreign regulatory approvals taking longer and being more costly than obtaining approval in the U.S.; |
• | foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials or our interpretation of data from preclinical studies or clinical trials; |
• | approval policies or regulations of foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval; |
• | impact of the COVID-19 pandemic on our ability to produce our product candidates and conduct clinical trials in foreign countries; |
• | unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; |
• | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
• | compliance with legal requirements applicable to privacy, data protection, information security and other matters; |
• | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
• | foreign taxes, including withholding of payroll taxes; |
• | foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; |
• | difficulties staffing and managing foreign operations; |
• | complexities associated with managing multiple payor reimbursement regimes and government payors in foreign countries; |
• | workforce uncertainty in countries where labor unrest is more common than in the U.S.; |
• | potential liability under the FCPA or comparable foreign regulations; |
• | challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.; |
• | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
• | business interruptions resulting from geo-political actions, including war and terrorism, trade policies, treaties and tariffs. |
• | the scope of rights granted under the license agreement and other matters of contract interpretation; |
• | whether and the extent to which our technology and processes infringe the intellectual property rights of the licensor that are not subject to the licensing 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 rights without their authorization; |
• | our involvement in the prosecution of licensed patents and our licensors’ overall patent enforcement strategy; |
• | the amounts of royalties, milestones or other payments due under the license agreement; |
• | the sublicensing of patent and other rights under collaborative development relationships; |
• | our diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
• | the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and |
• | the priority of invention of patented technology. |
• | If we do not prevail in such disputes, we may lose any or all of our rights under such license agreements. |
• | the failure of the third party to manufacture our product candidates according to our schedule and specifications, or at all, including if our third-party contractors give greater priority to the supply of other |
products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them; |
• | the reduction or termination of production or deliveries by suppliers, or the raising or prices or renegotiation of terms; |
• | the termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is costly or inconvenient for us; |
• | the breach by the third-party contractors of our agreements with them; |
• | the failure of the third party to manufacture our product candidates according to our specifications; |
• | the failure of third-party contractors to comply with applicable regulatory requirements, including cGMPs; |
• | the mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified; |
• | clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and |
• | the misappropriation of our proprietary information, including our trade secrets and know-how. |
• | increased operating expenses and cash requirements; |
• | the assumption of additional indebtedness or contingent liabilities; |
• | the issuance of our equity securities; |
• | assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel; |
• | the diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic merger or acquisition; |
• | retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships; |
• | risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products, product candidates and marketing approvals; and |
• | our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs. |
• | collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected; |
• | collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as a result of a business combination or sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; |
• | collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; |
• | collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; |
• | a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products; |
• | we may grant exclusive rights to our collaborators that would prevent us from collaborating with others; |
• | collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings; |
• | disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources; |
• | collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; |
• | collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all; |
• | collaborators may not provide us with timely and accurate information regarding development progress and activities under the collaboration or may limit our ability to share such information, which could adversely impact our ability to report progress to our investors and otherwise plan our own development of our product candidates; |
• | collaborators may own or co-own intellectual property covering our products or product candidates that result from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and |
• | a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings. |
• | the timing and results of INDs, preclinical studies and clinical trials of our product candidates or those of our competitors; |
• | the success of competitive products or announcements by potential competitors of their product development efforts; |
• | regulatory actions with respect to our products or product candidates or our competitors’ products or product candidates; |
• | actual or anticipated changes in our growth rate relative to our competitors; |
• | regulatory or legal developments in the U.S. and other countries; |
• | developments or disputes concerning patent applications, issued patents or other proprietary rights; |
• | the recruitment or departure of key personnel; |
• | announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments; |
• | actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; |
• | fluctuations in the valuation of companies perceived by investors to be comparable to us; |
• | market conditions in the pharmaceutical and biotechnology sector; |
• | changes in the structure of healthcare payment systems; |
• | share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; |
• | announcement or expectation of additional financing efforts; |
• | sales of our common stock by us, our insiders or our other stockholders; |
• | expiration of market stand-off or lock-up agreements; |
• | the impact of any natural disasters or public health emergencies, such as the ongoing COVID-19 pandemic; and |
• | general economic, political, industry and market conditions. |
• | the timing and cost of, and level of investment in, research and development activities relating to our programs, which will change from time to time; |
• | our ability to enroll patients in clinical trials and the timing of enrollment; |
• | the cost of manufacturing our current product candidates and any future product candidates, which may vary depending on FDA, EMA or other comparable foreign regulatory authority guidelines and requirements, the quantity of production and the terms of our agreements with manufacturers; |
• | expenditures that we will or may incur to acquire or develop additional product candidates and technologies or other assets; |
• | the timing and outcomes of preclinical studies and clinical trials for NVL-520 and NVL-655, and any product candidates from our discovery programs, or competing product candidates; |
• | the need to conduct unanticipated clinical trials or trials that are larger or more complex than anticipated; |
• | competition from existing and potential future products that compete with NVL-520 or NVL-655 or any of our discovery programs, and changes in the competitive landscape of our industry, including consolidation among our competitors or partners; |
• | any delays in regulatory review or approval of NVL-520 and NVL-655 or product candidates from any of our discovery programs; |
• | the level of demand for any of our product candidates, if approved, which may fluctuate significantly and be difficult to predict; |
• | the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future products that compete with NVL-520 and NVL-655, or any of our discovery programs; |
• | our ability to commercialize NVL-520 or NVL-655, or product candidates from any of our discovery programs, if approved, inside and outside of the U.S., either independently or working with third parties; |
• | our ability to establish and maintain collaborations, licensing or other arrangements; |
• | our ability to adequately support future growth; |
• | potential unforeseen business disruptions that increase our costs or expenses; |
• | future accounting pronouncements or changes in our accounting policies; and |
• | the changing and volatile global economic and political environment. |
• | being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in our periodic reports; |
• | not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (the Sarbanes-Oxley Act); |
• | not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; |
• | reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and |
• | exemptions from the requirements of holding nonbinding advisory stockholder votes on executive compensation and stockholder approval of any golden parachute payments not previously approved. |
• | a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time; |
• | a prohibition on stockholder actions through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders; |
• | a requirement that special meetings of stockholders be called only by our board of directors acting pursuant to a resolution approved by the affirmative vote of a majority of the directors then in office; |
• | advance notice requirements for stockholder proposals and nominations for election to our board of directors; |
• | a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote in the election of directors; |
• | a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation; and |
• | the authority of our board of directors to issue preferred stock on terms determined by our board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock. |
ITEM 1B. |
UNRESOLVED STAFF COMMENTS |
ITEM 2. |
PROPERTIES |
ITEM 3. |
LEGAL PROCEEDINGS |
ITEM 4. |
MINE SAFETY DISCLOSURES |
ITEM 5. |
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER |
MATTERS |
AND ISSUER PURCHASES OF EQUITY SECURITIES |
ITEM 6. [RESERVED] |
ITEM 7. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND |
RESULTS |
OF OPERATIONS |
• | continue to advance our NVL-520 program in clinical development; |
• | advance our NVL-655 program from preclinical development into clinical development; |
• | advance the development of our discovery programs, including our ALK IXDN and HER2 programs; |
• | expand our pipeline of product candidates through our own product discovery and development efforts; |
• | seek to discover and develop additional product candidates; |
• | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
• | establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs; |
• | implement operational, financial and management systems; |
• | attract, hire and retain additional clinical, scientific, management and administrative personnel; |
• | maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; |
• | acquire or in-license other product candidates and technologies; and |
• | operate as a public company. |
• | personnel-related costs, including salaries, benefits and stock-based compensation expense, for employees engaged in research and development functions; |
• | expenses incurred in connection with our research programs, including under agreements with third parties, such as consultants and contractors and CROs; |
• | the cost of developing and scaling our manufacturing process and manufacturing drug substance and drug product for use in our research and preclinical and clinical studies, including under agreements with third parties, such as consultants and contractors and CMOs; and |
• | the cost of laboratory supplies and research materials. |
• | the timing and progress of development activities relating to NVL-520, NVL-655 and any future product candidates from our ALK IXDN, HER2 and other discovery programs, including any additional costs that may result from delays in enrollment or other factors; |
• | the number and scope of preclinical and clinical programs we decide to pursue; |
• | our ability to maintain our current research and development programs and to establish new ones; |
• | establishing an appropriate safety profile with IND-enabling toxicology studies; |
• | successful patient enrollment in, and the initiation and completion of, clinical trials; |
• | the number of trials required for regulatory approval; |
• | the countries in which the trials are conducted; |
• | the length of time required to enroll eligible subjects and initial clinical trials; |
• | the number of subjects that participate in the trials and per subject trial costs; |
• | potential additional safety monitoring requested by regulatory authorities; |
• | the duration of subject participation in the trials and follow-up; |
• | the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to applicable regulatory authorities; |
• | the receipt of regulatory approvals from applicable regulatory authorities; |
• | the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities; |
• | the extent to which we establish collaborations, strategic partnerships or other strategic arrangements with third parties, if any, and the performance of any such third party; |
• | establishing commercial manufacturing capabilities or making arrangements with CMOs; |
• | development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial launch; and |
• | obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights. |
Year Ended December 31, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Operating expenses: |
||||||||||||
Research and development |
$ | 35,559 | $ | 15,403 | $ | 20,156 | ||||||
General and administrative |
10,258 | 1,502 | 8,756 | |||||||||
Total operating expenses |
45,817 | 16,905 | 28,912 | |||||||||
Loss from operations |
(45,817 | ) | (16,905 | ) | (28,912 | ) | ||||||
Other income (expense): |
||||||||||||
Change in fair value of preferred stock tranche rights |
(635 | ) | 2,384 | (3,019 | ) | |||||||
Other income (expense), net |
114 | (35 | ) | 149 | ||||||||
Total other income (expense), net |
(521 | ) | 2,349 | (2,870 | ) | |||||||
Net loss |
$ | (46,338 | ) | $ | (14,556 | ) | $ | (31,782 | ) | |||
Year Ended December 31, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Direct research and development expenses by program: |
||||||||||||
NVL-520 |
$ | 11,411 | $ | 4,583 | $ | 6,828 | ||||||
NVL-655 |
7,302 | 2,948 | 4,354 | |||||||||
Discovery programs |
7,388 | 3,835 | 3,553 | |||||||||
Unallocated research and development expenses: |
||||||||||||
Personnel-related (including stock-based compensation) |
8,067 | 3,024 | 5,043 | |||||||||
Other |
1,391 | 1,013 | 378 | |||||||||
Total research and development expenses |
$ | 35,559 | $ | 15,403 | $ | 20,156 | ||||||
Year Ended December 31, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Personnel-related (including stock-based compensation) |
$ | 5,131 | $ | 797 | $ | 4,334 | ||||||
Professional and consultant fees |
3,095 | 525 | 2,570 | |||||||||
Other |
2,032 | 180 | 1,852 | |||||||||
Total general and administrative expenses |
$ | 10,258 | $ | 1,502 | $ | 8,756 | ||||||
Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
(in thousands) |
||||||||
Net cash used in operating activities |
$ | (40,000 | ) | $ | (14,949 | ) | ||
Net cash used in investing activities |
(220,028 | ) | — | |||||
Net cash provided by financing activities |
318,222 | 22,265 | ||||||
Net increase in cash and cash equivalents |
$ | 58,194 | $ | 7,316 | ||||
• | the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our discovery programs and product candidates, including the advancement of NVL-520 and planned advancement of NVL-655 throughout clinical development; |
• | the clinical development plans we establish for our product candidates; |
• | the number and characteristics of product candidates that we discover and develop through our product discovery and research efforts; |
• | the terms of any collaboration agreements we may choose to pursue; |
• | the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA and other comparable foreign regulatory authorities; |
• | the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights; |
• | the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us; |
• | the effect of competing technological and market developments; |
• | the cost and timing of completion of commercial-scale outsourced manufacturing activities; and |
• | the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own. |
• | vendors in connection with preclinical development activities; |
• | CROs in connection with preclinical and clinical studies and testing; and |
• | CMOs in connection with the process development and scale up activities and the production of materials. |
ITEM 7A. QUANTITATIVE |
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
ITEM 8. FINANCIAL |
STATEMENTS AND SUPPLEMENTARY DATA |
Page(s) |
||||
Report of Independent Registered Public Accounting Firm (KPMG LLP, Boston, MA, Auditor Firm ID: 185) | 159 | |||
160 | ||||
161 | ||||
162 | ||||
163 | ||||
164 |
December 31, |
||||||||
2021 |
2020 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 68,526 | $ | 10,332 | ||||
Marketable securities |
219,585 | — | ||||||
Prepaid expenses and other current assets |
2,517 | 314 | ||||||
|
|
|
|
|||||
Total current assets |
290,628 | 10,646 | ||||||
Other assets |
3,196 | — | ||||||
|
|
|
|
|||||
Total assets |
$ | 293,824 | $ | 10,646 | ||||
|
|
|
|
|||||
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,893 | $ | 1,252 | ||||
Accrued expenses |
5,894 | 1,171 | ||||||
Preferred stock tranche rights |
— | 1,957 | ||||||
|
|
|
|
|||||
Total current liabilities |
8,787 | 4,380 | ||||||
Notes payable and accrued interest to stockholder |
— | 2,235 | ||||||
|
|
|
|
|||||
Total liabilities |
8,787 | 6,615 | ||||||
|
|
|
|
|||||
Commitments and contingencies (Note 11) |
||||||||
Convertible preferred stock (Series A and B), $0.0001 par value; no shares and 112,431,508 shares authorized at December 31, 2021 and 2020, respectively; no shares and 89,945,206 shares issued and outstanding at December 31, 2021 and 2020, respectively; |
— | 35,354 | ||||||
|
|
|
|
|||||
Stockholders’ equity (deficit): |
||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares and no shares authorized at December 31, 2021 and 2020, respectively; no shares issued or outstanding |
— | — | ||||||
Class A common stock, $0.0001 par value; 140,000,000 shares and 160,000,000 shares authorized at December 31, 2021 and 2020, respectively; 42,862,175 shares and 3,129,384 shares issued and outstanding at December 31, 2021 and 2020, respectively |
4 | — | ||||||
Class B common stock, $0.0001 par value; 10,000,000 shares and no shares authorized at December 31, 2021 and 2020, respectively; 5,435,254 shares and no shares issued and outstanding at December 31, 2021 and 2020, respectively |
1 | — | ||||||
Additional paid-in capital |
363,483 | 842 | ||||||
Accumulated other comprehensive loss |
(228 | ) | — | |||||
Accumulated deficit |
(78,223 | ) | (31,885 | ) | ||||
Promissory note from stockholder |
— | (280 | ) | |||||
|
|
|
|
|
||||
Total stockholders’ equity (deficit) |
285,037 | (31,323 | ) | |||||
|
|
|
|
|
||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) |
$ | 293,824 | $ | 10,646 | ||||
|
|
|
|
Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
Operating expenses: |
||||||||
Research and development |
$ | 35,559 | $ | 15,403 | ||||
General and administrative |
10,258 | 1,502 | ||||||
|
|
|
|
|||||
Total operating expenses |
45,817 | 16,905 | ||||||
|
|
|
|
|||||
Loss from operations |
(45,817 | ) | (16,905 | ) | ||||
|
|
|
|
|||||
Other income (expense): |
||||||||
Change in fair value of preferred stock tranche rights |
(635 | ) | 2,384 | |||||
Other income (expense), net |
114 | (35 | ) | |||||
|
|
|
|
|||||
Total other income (expense), net |
(521 | ) | 2,349 | |||||
|
|
|
|
|||||
Net loss |
$ | (46,338 | ) | $ | (14,556 | ) | ||
|
|
|
|
|||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | (2.13 | ) | $ | (5.08 | ) | ||
|
|
|
|
|
||||
Weighted average shares of common stock outstanding, basic and diluted |
21,783,754 | 2,867,221 | ||||||
|
|
|
|
|
||||
Comprehensive loss: |
||||||||
Net loss |
$ | (46,338 | ) | $ | (14,556 | ) | ||
Other comprehensive loss: |
||||||||
Unrealized losses on marketable securities, net of tax of $0 |
(228 | ) | — | |||||
|
|
|
|
|||||
Comprehensive loss |
$ | (46,566 | ) | $ | (14,556 | ) | ||
|
|
|
|
Accumulated Other Comprehensive Loss |
Total Stockholders’ Equity (Deficit) |
|||||||||||||||||||||||||||||||||||||||||||
Convertible |
Class A |
Class B |
Additional Paid-in Capital |
Promissory Note from Stockholder |
||||||||||||||||||||||||||||||||||||||||
Preferred Stock |
Common Stock |
Common Stock |
Accumulated Deficit |
|||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||||||||||||
Balances at December 31, 2019 |
39,351,028 |
$ |
14,048 |
2,138,988 |
$ |
— |
— |
$ |
— |
$ |
98 |
$ |
— |
$ |
(17,329 |
) |
$ |
(25 |
) |
$ |
(17,256 |
) | ||||||||||||||||||||||
Issuance of Series A convertible preferred stock |
50,594,178 |
22,500 |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||
Issuance of common stock |
— |
— |
952,740 |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options |
— |
— |
37,656 |
— |
— |
— |
15 |
— |
— |
— |
15 |
|||||||||||||||||||||||||||||||||
Issuance of promissory note from related party stockholder |
— |
— |
— |
— |
— |
— |
— |
— |
— |
(250 |
) |
(250 |
) | |||||||||||||||||||||||||||||||
Interest on promissory note from related party stockholder |
— |
— |
— |
— |
— |
— |
— |
— |
— |
(5 |
) |
(5 |
) | |||||||||||||||||||||||||||||||
Stock-based compensation expense |
— |
— |
— |
— |
— |
— |
729 |
— |
— |
— |
729 |
|||||||||||||||||||||||||||||||||
Reclassification of preferred stock tranche rights upon settlement |
— |
(1,194 |
) |
— |
— |
— |
— |
— |
— |
— |
— |
— |
||||||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
— |
— |
— |
(14,556 |
) |
— |
(14,556 |
) | |||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Balances at December 31, 2020 |
89,945,206 |
35,354 |
3,129,384 |
— |
— |
— |
842 |
— |
(31,885 |
) |
(280 |
) |
(31,323 |
) | ||||||||||||||||||||||||||||||
Issuance of Series A convertible preferred stock |
22,486,302 |
10,000 |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||
Issuance of Series B convertible preferred stock, net of issuance costs of $348 |
65,223,679 |
134,652 |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||
Conversion of note payable and accrued interest to Series A convertible preferred stock |
5,025,604 |
2,815 |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||
Reclassification of preferred stock tranche rights upon settlement |
— |
2,592 |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||
Conversion of preferred stock to common stock upon initial public offering |
(182,680,791 |
) |
(185,413 |
) |
29,106,831 |
3 |
4,835,254 |
1 |
185,409 |
— |
— |
— |
185,413 |
|||||||||||||||||||||||||||||||
Issuance of common stock upon initial public offering, net of issuance costs of $3,020 |
— |
— |
10,612,500 |
1 |
600,000 |
— |
174,249 |
— |
— |
— |
174,250 |
|||||||||||||||||||||||||||||||||
Loss on extinguishment of debt |
— |
— |
— |
— |
— |
— |
(580 |
) |
— |
— |
— |
(580 |
) | |||||||||||||||||||||||||||||||
Interest on promissory note from related party stockholder |
— |
— |
— |
— |
— |
— |
— |
— |
— |
(4 |
) |
(4 |
) | |||||||||||||||||||||||||||||||
Repayment of promissory note from related stockholder party |
— |
— |
— |
— |
— |
— |
— |
— |
— |
284 |
284 |
|||||||||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options |
— |
— |
13,460 |
— |
— |
— |
12 |
— |
— |
— |
12 |
|||||||||||||||||||||||||||||||||
Unrealized losses on marketable securities |
— |
— |
— |
— |
— |
— |
— |
(228 |
) |
— |
— |
(228 |
) | |||||||||||||||||||||||||||||||
Stock-based compensation expense |
— |
— |
— |
— |
— |
— |
3,551 |
— |
— |
— |
3,551 |
|||||||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
— |
— |
— |
(46,338 |
) |
— |
(46,338 |
) | |||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Balances at December 31, 2021 |
— |
$ |
— |
42,862,175 |
$ |
4 |
5,435,254 |
$ |
1 |
$ |
363,483 |
$ |
(228 |
) |
$ |
(78,223 |
) |
$ |
— |
$ |
285,037 |
|||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (46,338 | ) | $ | (14,556 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Change in fair value of preferred stock tranche rights |
635 | (2,384 | ) | |||||
Stock-based compensation expense |
3,551 | 729 | ||||||
Non-cash interest income on promissory note |
(4 | ) | (5 | ) | ||||
Net amortization of premiums on marketable securities |
215 | — | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
(251 | ) | (14 | ) | ||||
Other assets |
(3,196 | ) | — | |||||
Accounts payable |
1,641 | 529 | ||||||
Accrued expenses |
3,747 | 752 | ||||||
|
|
|
|
|||||
Net cash used in operating activities |
(40,000 | ) | (14,949 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchases of marketable securities |
(221,043 | ) | — | |||||
Proceeds from sales and maturities of marketable securities |
1,015 | — | ||||||
|
|
|
|
|||||
Net cash used in investing activities |
(220,028 | ) | — | |||||
Cash flows from financing activities: |
||||||||
Proceeds from issuance of convertible preferred stock and preferred stock tranche rights, net of issuance costs |
144,652 | 22,500 | ||||||
Proceeds from initial public offering, net of underwriting discounts and commissions |
177,270 | — | ||||||
Issuance of promissory note to stockholder |
— | (250 | ) | |||||
Payments of insurance costs financed by a third-party |
(976 | ) | — | |||||
Proceeds from exercise of stock options |
12 | 15 | ||||||
Proceeds from repayment of promissory note to stockholder |
284 | — | ||||||
Payments of initial public offering costs |
(3,020 | ) | — | |||||
|
|
|
|
|||||
Net cash provided by financing activities |
318,222 | 22,265 | ||||||
|
|
|
|
|||||
Net increase in cash and cash equivalents |
58,194 | 7,316 | ||||||
Cash and cash equivalents at beginning of period |
10,332 | 3,016 | ||||||
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
$ | 68,526 | $ | 10,332 | ||||
|
|
|
|
|||||
Supplemental disclosure of noncash financing information: |
||||||||
Settlement of notes payable and accrued interest for preferred stock |
$ | 2,235 | $ | — | ||||
Conversion of convertible preferred stock to common stock upon initial public offering |
$ | 185,413 | $ | — | ||||
Insurance premium financed by a third-party |
$ | 1,952 | $ | — | ||||
Loss on extinguishment of debt |
$ | 580 | $ | — | ||||
Settlement of preferred stock tranche rights |
$ | 2,592 | $ | (1,194 | ) |
• |
Level 1—Quoted prices in active markets for identical assets or liabilities. |
• |
Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. |
• |
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. |
As of December 31, |
||||||||
2021 |
2020 |
|||||||
Convertible preferred stock (as converted to common stock) |
— |
16,711,823 |
||||||
Unvested restricted common stock |
21,129 |
45,561 |
||||||
Options to purchase common stock |
4,909,545 |
1,433,956 |
||||||
4,930,674 |
18,191,340 |
|||||||
December 31, 2021 |
||||||||||||||||
Amortized Cost |
Gross Unrealized Gains |
Gross Unrealized Losses |
Fair Value |
|||||||||||||
Commercial paper (due within one year) |
$ | 121,156 | $ | — | $ | (44 | ) | $ | 121,112 | |||||||
Corporate bonds (due within one year) |
43,756 | — | (60 | ) | 43,696 | |||||||||||
Government securities (due within one year) |
4,583 | — | (10 | ) | 4,573 | |||||||||||
U.S. treasury securities (due within one year) |
10,056 | — | (9 | ) | 10,047 | |||||||||||
Corporate bonds (due after one year through two years) |
36,218 | 1 | (99 | ) | 36,120 | |||||||||||
Government securities (due after one year through two years) |
4,045 | — | (8 | ) | 4,037 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | 219,814 | $ | 1 | $ | (230 | ) | $ | 219,585 | ||||||||
|
|
|
|
|
|
|
|
Preferred Stock Tranche Rights |
||||
Fair value at December 31, 2020 |
$ | 1,957 | ||
Change in fair value |
635 | |||
Settlement of preferred stock tranche rights |
(2,592 | ) | ||
|
|
|||
Fair value at December 31, 2021 |
$ | — | ||
|
|
December 31, |
|||||||||
2021 |
2020 |
||||||||
Accrued employee compensation and benefits |
$ |
2,730 | $ |
636 | |||||
Accrued external research and development expenses |
|
1,757 | |
405 | |||||
Accrued insurance |
|
976 | |
— | |||||
Other |
|
431 | |
130 | |||||
|
|
|
|
|
|||||
$ |
5,894 | $ |
1,171 | ||||||
|
|
|
|
|
Preferred Stock Authorized |
Preferred Stock Issued and Outstanding |
|
Carrying Value |
Liquidation Preference |
Common Stock Issuable Upon Conversion |
||||||||||||||||
(in thousands) |
(in thousands) |
||||||||||||||||||||
Series A Preferred Stock |
112,431,508 | 89,945,206 | $ |
35,354 | $ |
40,000 | 16,711,823 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
112,431,508 | 89,945,206 | $ |
35,354 | $ |
40,000 | 16,711,823 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
Risk-free interest rate |
0.8 | % | 0.4 | % | ||||
Expected volatility |
79.8 | % | 81.2 | % | ||||
Expected dividend yield |
— | — | ||||||
Expected term (in years) |
6.1 | 6.3 |
Number of Shares |
Weighted Average Exercise Price |
Weighted Average Contractual Term |
Aggregate Intrinsic Value |
|||||||||||||
(in years) |
(in thousands) |
|||||||||||||||
Outstanding as of December 31, 2020 |
1,433,956 | $ | 0.69 | 9.43 | $ | 255 | ||||||||||
Granted |
3,535,047 | 8.68 | ||||||||||||||
Exercised |
(13,460 | ) | 0.87 | |||||||||||||
Forfeited |
(45,998 | ) | 1.65 | |||||||||||||
Outstanding as of December 31, 2021 |
4,909,545 | $ | 6.44 | 9.09 | $ | 62,702 | ||||||||||
Vested and expected to vest as of December 31, 2021 |
4,909,545 | $ | 6.44 | 9.09 | $ | 62,702 | ||||||||||
Options exercisable as of December 31, 2021 |
670,299 | $ | 2.13 | 8.42 | $ | 11,330 |
Shares |
Weighted Average Grant Date Fair Value |
|||||||
Unvested restricted common stock as of December 31, 2020 |
45,561 | $ | 30 | |||||
Issued |
— | $ | — | |||||
Vested |
(24,432 | ) | $ | 8 | ||||
Forfeited |
— | $ | — | |||||
Unvested restricted common stock as of December 31, 2021 |
21,129 | $ | 22 | |||||
Year Ended December 31, |
|||||||||
2021 |
2020 |
||||||||
Research and development expenses |
$ |
1,349 | $ |
657 | |||||
General and administrative expenses |
2,202 | 72 | |||||||
$ |
3,551 | $ |
729 | ||||||
Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
Federal statutory income tax rate |
21.0 | % | 21.0 | % | ||||
State income taxes, net of federal benefit |
6.2 | 7.2 | ||||||
Permanent differences |
— | (1.9 | ) | |||||
Tax credits generated |
4.1 | 4.6 | ||||||
Change in deferred tax asset valuation allowance |
(29.5 | ) | (34.2 | ) | ||||
Series A tranche rights change in fair value |
(1.1 | ) | 3.4 | |||||
Stock-based compensation |
(0.7 | ) | (0.1 | ) | ||||
|
|
|
|
|||||
Effective income tax rate |
(0.0 | )% | (0.0 | )% | ||||
|
|
|
|
December 31, |
||||||||
2021 |
2020 |
|||||||
Deferred tax assets: |
||||||||
Net operating loss carryforwards |
$ | 19,951 | $ | 8,300 | ||||
Research and development tax credit carryforwards |
2,175 | 497 | ||||||
Intangible assets |
74 | 821 | ||||||
Stock-based compensation |
499 | — | ||||||
Other |
705 | 165 | ||||||
Total deferred tax assets |
23,404 | 9,783 | ||||||
Valuation allowance |
(23,400 | ) | (9,780 | ) | ||||
|
|
|
|
|||||
Net deferred tax assets |
4 | 3 | ||||||
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
||||||||
Other |
$ | (4 | ) | $ | (3 | ) | ||
|
|
|
|
|||||
Total deferred tax liabilities |
(4 | ) | (3 | ) | ||||
|
|
|
|
|||||
Net deferred tax assets |
$ | — | $ | — | ||||
|
|
|
|
Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
Valuation allowance as of beginning of year |
$ | 9,780 | $ | 4,796 | ||||
Increases recorded to income tax provision |
13,620 | 4,984 | ||||||
|
|
|
|
|||||
Valuation allowance as of end of year |
$ | 23,400 | $ | 9,780 | ||||
|
|
|
|
Exhibit Number |
Description of Exhibit |
Form |
File No. |
Exhibit |
Filing Date |
Filed Herewith | ||||||
3.1 | Third Amended and Restated Certificate of Incorporation of the Registrant | 8-K |
001-40671 |
3.1 | 8/2/2021 | |||||||
3.2 | Amended and Restated Bylaws of the Registrant | 8-K |
001-40671 |
3.2 | 8/2/2021 | |||||||
4.1 | Specimen Class A Common Stock Certificate | S-1 |
333-257730 |
4.1 | 7/7/2021 | |||||||
4.2 | Specimen Class B Common Stock Certificate | S-1 |
333-257730 |
4.2 | 7/7/2021 | |||||||
4.3 | Amended and Restated Investors’ Rights Agreement among the Registrant and certain of its stockholders, effective as of April 30, 2021 | S-1 |
333-257730 |
4.3 | 7/7/2021 | |||||||
4.4 | Description of Securities Registered Under Section 12 of the Exchange Act | X | ||||||||||
10.1# | 2021 Stock Option and Incentive Plan and forms of award agreements thereunder | S-1/A |
333-257730 |
10.2 | 7/26/2021 | |||||||
10.2# | 2021 Employee Stock Purchase Plan | S-1/A |
333-257730 |
10.3 | 7/26/2021 | |||||||
10.3# | Form of Indemnification Agreement between the Registrant and each of its directors | S-1 |
333-257730 |
10.4 | 7/7/2021 |
Exhibit Number |
Description of Exhibit |
Form |
File No. |
Exhibit |
Filing Date |
Filed Herewith | ||||||
101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document | |||||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | |||||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |||||||||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |||||||||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
# | Indicates a management contract or any compensatory plan, contract or arrangement. |
α | Nuvalent, Inc. has entered into an Executive Employment Agreement with each of Alexandra Balcom, Deborah Miller, Darlene Noci and Christopher D. Turner. |
† | Portions of this exhibit (indicated by asterisks) have been omitted in accordance with Item 601(b)(10) of Regulation S-K. |
+ | The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to be furnished with this Annual Report on Form 10-K and will not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. |
NUVALENT, INC. | ||||||||
Date: March 29, 2022 | By: | /s/ James R. Porter | ||||||
James R. Porter, Ph.D. | ||||||||
President and Chief Executive Officer |
Signature |
Title |
Date | ||
/s/ James R. Porter |
President, Chief Executive Officer and Director (Principal Executive Officer) |
March 29, 2022 | ||
James R. Porter, Ph.D. | ||||
/s/ Alexandra Balcom |
Chief Financial Officer (Principal Financial and Accounting Officer) |
March 29, 2022 | ||
Alexandra Balcom | ||||
/s/ Emily Drabant Conley |
Director | March 29, 2022 | ||
Emily Drabant Conley, Ph.D. | ||||
/s/ D. Gary Gilliland |
Director | March 29, 2022 | ||
D. Gary Gilliland, M.D., Ph.D. | ||||
/s/ Andrew A. F. Hack |
Director | March 29, 2022 | ||
Andrew A. F. Hack, M.D., Ph.D. | ||||
/s/ Robert Jackson |
Director | March 29, 2022 | ||
Robert Jackson, M.D. | ||||
/s/ Joseph Pearlberg |
Director | March 29, 2022 | ||
Joseph Pearlberg, M.D., Ph.D. | ||||
/s/ Matthew Shair |
Director | March 29, 2022 | ||
Matthew Shair, Ph.D. | ||||
/s/ Sapna Srivastava |
Director | March 29, 2022 | ||
Sapna Srivastava | ||||
/s/ Cameron A. Wheeler |
Director | March 29, 2022 | ||
Cameron A. Wheeler, Ph.D. |
Exhibit 4.4
DESCRIPTION OF SECURITIES REGISTERED
UNDER SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934
The following description of the Class A common stock, par value $0.0001 per share, of Nuvalent, Inc. (us, our, we or the Company), which is the only security of the Company registered under Section 12 of the Securities Exchange Act of 1934, as amended (the Exchange Act), summarizes certain information regarding our common stock in our third amended and restated certificate of incorporation (restated certificate of incorporation), our amended and restated bylaws and applicable provisions of the Delaware General Corporation Law (the DGCL), and is qualified by reference to our restated certificate of incorporation and amended and restated bylaws, which are incorporated by reference as Exhibit 3.1 and Exhibit 3.2, respectively, to the Annual Report on Form 10-K of which this Exhibit 4.4 is a part.
Authorized Capital Stock
Our authorized capital stock consists of 140,000,000 shares of Class A common stock, par value $0.0001 per share, 10,000,000 shares of Class B common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share, all of which shares of preferred stock are undesignated. Our Class A common stock is registered under Section 12(b) of the Exchange Act.
Common Stock
Voting Rights. The holders of our Class A common stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders. Except as otherwise expressly provided in our restated certificate of incorporation or as required by applicable law, on any matter that is submitted to a vote by our stockholders, holders of our Class B common stock are not entitled to any votes per share of Class B common stock, including for the election of directors. The holders of our common stock do not have any cumulative voting rights.
Dividends. Holders of our common stock are entitled to receive ratably any dividends declared by our board of directors out of funds legally available for that purpose, subject to any preferential dividend rights of any outstanding preferred stock.
Liquidation and Dissolution. In the event of our liquidation or dissolution, the holders of common stock are entitled to share ratably in all assets remaining after the payment of all debts and other liabilities and subject to the prior rights of any of our outstanding preferred stock.
Other Rights. Holders of our common stock have no preemptive, subscription, redemption or conversion rights or sinking fund provisions, except that holders of our Class B common stock have the right to convert each share of our Class B common stock into one share of Class A common stock at such holders election subject to the ownership limitations provided for in our restated certificate of incorporation that prohibit the conversion of our Class B common stock into shares of Class A common stock to the extent that, upon such conversion, such holder and any other persons with whom such holders beneficial ownership would be aggregated for purposes of Section 13(d) of the Exchange Act would beneficially own in excess of 4.9% or 9.9%, as applicable, based on the holders election, of any class of our securities registered under the Exchange Act. The rights, preferences and privileges of holders of common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of our preferred stock that we may designate and issue in the future.
Preferred Stock
Under the terms of our restated certificate of incorporation, our board of directors is authorized, without further action by our stockholders, to issue up 10,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof, including dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting, or the designation of, such series, any or all of which may be greater than the rights of common stock. The purpose of authorizing our board of directors to issue preferred stock and determine its rights and preferences is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions, future financings and other corporate purposes, could have the effect of making it more difficult for a third party to acquire, or could discourage a third party from seeking to acquire, a majority of our outstanding voting stock. In addition, the issuance of preferred stock could adversely affect the voting power of holders of our common stock and the likelihood that such holders will receive dividend payments and payments upon our liquidation.
Anti-Takeover Effects of Delaware Law and Our Restated Certificate of Incorporation and Amended and Restated Bylaws
Our restated certificate of incorporation and amended and restated bylaws include a number of provisions that may have the effect of delaying, deferring or preventing another party from acquiring control of us and encouraging persons considering unsolicited tender offers or other unilateral takeover proposals to negotiate with our board of directors rather than pursue non-negotiated takeover attempts. These provisions include the items described below.
Delaware Business Combination Statute. We are subject to Section 203 of the DGCL. Subject to certain exceptions, Section 203 prevents a publicly held Delaware corporation from engaging in a business combination with any interested stockholder for three years following the date that the person became an interested stockholder, unless either the interested stockholder attained such status with the approval of our board of directors, the business combination is approved by our board of directors and stockholders in a prescribed manner or the interested stockholder acquired at least 85% of our outstanding voting stock in the transaction in which it became an interested stockholder. A business combination includes, among other things, a merger or consolidation involving us and the interested stockholder and the sale of more than 10% of our assets. In general, an interested stockholder is any entity or person beneficially owning 15% or more of our outstanding voting stock and any entity or person affiliated with or controlling or controlled by such entity or person.
Staggered Board; Removal of Directors. Our restated certificate of incorporation divides our board of directors into three classes with staggered three-year terms. In addition, our restated certificate of incorporation provides that directors may be removed only for cause and then only by the affirmative vote of the holders of two-thirds or more of the shares then entitled to vote at an election of directors. Under our restated certificate of incorporation, any vacancy on our board of directors, however occurring, including a vacancy resulting from an increase in the size of our board of directors, may only be filled by the affirmative vote of a majority of our directors then in office even if less than a quorum. Furthermore, our restated certificate of incorporation provides that the authorized number of directors may be changed only by the resolution of our board of directors. The classification of our board of directors and the limitations on the ability of our stockholders to remove directors, change the authorized number of directors and fill vacancies could make it more difficult for stockholders to change the composition of our board of directors or for a third party to acquire, or discourage a third party from seeking to acquire, control of our company.
Stockholder Action; Special Meeting of Stockholders; Advance Notice Requirements for Stockholder Proposals and Director Nominations. Our restated certificate of incorporation provides that all
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stockholder actions are required to be taken by a vote of the stockholders at an annual or special meeting, and that stockholders may not take any action by written consent in lieu of a meeting. Our restated certificate of incorporation and amended and restated bylaws also provide that, except as required by statute, only a majority of the members of our board of directors then in office may call special meetings of stockholders and only those matters set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders. Our amended and restated bylaws limit the business that may be conducted at an annual meeting of stockholders to those matters properly brought before the meeting. In addition, our amended and restated bylaws establish advance notice procedures for stockholder proposals relating to the nomination of candidates for election as directors or new business to be brought before meetings of our stockholders. These procedures provide that notice of stockholder proposals must be timely given in writing to our corporate secretary prior to the meeting at which the action is to be taken. Generally, to be timely, notice must be received at our principal executive offices not less than 90 days nor more than 120 days prior to the first anniversary date of the annual meeting for the preceding year. Our amended and restated bylaws specify the requirements as to form and content of all stockholders notices. These provisions could have the effect of delaying until the next stockholder meeting stockholder actions that are favored by the holders of a majority of our outstanding voting securities. These provisions also could discourage a third party from making a tender offer for our common stock because even if the third party acquired a majority of our outstanding voting stock, it would be able to take action as a stockholder, such as electing new directors or approving a merger, only at a duly called stockholders meeting and not by written consent.
Super-majority Voting. The DGCL provides generally that the affirmative vote of a majority of the shares entitled to vote on any matter is required to amend a corporations certificate of incorporation or bylaws unless a corporations certificate of incorporation or bylaws, as the case may be, requires a greater percentage. Any amendment of our restated certificate of incorporation must first be approved by a majority of our board of directors, and if required by law or our restated certificate of incorporation, must thereafter be approved by a majority of the outstanding shares entitled to vote on the amendment and a majority of the outstanding shares of each class entitled to vote thereon as a class, except that the amendment of the provisions relating to stockholder action, board composition, and limitation of liability must be approved by not less than two-thirds of the outstanding shares entitled to vote on the amendment, and not less than two-thirds of the outstanding shares of each class entitled to vote thereon as a class. Our amended and restated bylaws may be amended by the affirmative vote of a majority of the directors then in office, subject to any limitations set forth in the amended and restated bylaws; and may also be amended by the affirmative vote of a majority of the outstanding shares entitled to vote on the amendment, voting together as a single class, except that the amendment of the provisions relating to notice of stockholder business and nominations and special meetings must be approved by not less than two-thirds of the outstanding shares entitled to vote on the amendment, and not less than two-thirds of the outstanding shares of each class entitled to vote thereon as a class, or, if our board of directors recommends that the stockholders approve the amendment, by the affirmative vote of the majority of the outstanding shares entitled to vote on the amendment, in each case voting together as a single class.
Exclusive Forum Selection. Our amended and restated bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for any state law claims for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of, or a claim based on, breach of a fiduciary duty owed by any of our current or former directors, officers, and employees to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL, our restated certificate of incorporation or our amended and restated bylaws (including the interpretation, application, validity or enforceability thereof), or (iv) any action asserting a claim that is governed by the internal affairs doctrine; provided, however, that the this provision shall not apply to any causes of action arising under the Securities Act of
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1933, as amended (the Securities Act), or the Exchange Act. In addition, our amended and restated bylaws provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States shall be the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. These choice of forum provisions will not apply to suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our restated certificate of incorporation. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.
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Exhibit 10.7
NUVALENT, INC.
NON-EMPLOYEE DIRECTOR COMPENSATION POLICY
The purpose of this Non-Employee Director Compensation Policy (the Policy) of Nuvalent, Inc. (the Company) is to provide a total compensation package that enables the Company to attract and retain, on a long-term basis, high-caliber directors who are not employees or officers of the Company or its subsidiaries (Outside Directors). This Policy will become effective as of December 3, 2021 (the Effective Date). In furtherance of the purpose stated above, all Outside Directors shall be paid compensation for services provided to the Company as set forth below:
Cash Retainers
Annual Retainer for Board Membership: $35,000 for general availability and participation in meetings and conference calls of our Board of Directors, to be paid quarterly in arrears, pro-rated based on the number of actual days served by the director during such calendar quarter. No additional compensation will be paid for attending individual meetings of the Board of Directors.
Additional Annual Retainer for Non-Executive Chair: |
$ | 30,000 | ||
Additional Annual Retainers for Committee Membership: |
||||
Audit Committee Chair: |
$ | 15,000 | ||
Audit Committee member: |
$ | 7,500 | ||
Compensation Committee Chair: |
$ | 10,000 | ||
Compensation Committee member: |
$ | 5,000 | ||
Nominating and Corporate Governance Committee Chair: |
$ | 8,000 | ||
Nominating and Corporate Governance Committee member: |
$ | 4,000 |
Chair and committee member retainers are in addition to retainers for members of the Board of Directors. No additional compensation will be paid for attending individual committee meetings of the Board of Directors.
Equity Retainers
Initial Award: An initial, one-time stock option award (the Initial Award) to purchase 40,000 Class A common shares will be granted to each new Outside Director upon his or her election to the Board of Directors, which shall vest in equal monthly installments over three years from the date of grant, provided, however, that all vesting shall cease if the director ceases to remain in service on the Board, unless the Board of Directors determines that the circumstances warrant continuation of vesting. The Initial Award shall expire ten years from the date of grant, and shall have a per share exercise price equal to the Fair Market Value (as defined in the Companys 2021 Stock Option and Incentive Plan) of the Companys Class A common
stock on the date of grant. This Initial Award applies only to Outside Directors who are first elected to the Board of Directors subsequent to the Effective Date.
Annual Award: On each date of each Annual Meeting of Stockholders of the Company following the Effective Date (the Annual Meeting), each continuing Outside Director, other than a director receiving an Initial Award, will receive an annual stock option award (the Annual Award) to purchase 20,000 Class A common shares, which shall vest in full upon the earlier of (i) the first anniversary of the date of grant or (ii) the date of the next Annual Meeting; provided, however, that all vesting shall cease if the directors service on the Board ceases, unless the Board of Directors determines that the circumstances warrant continuation of vesting. Such Annual Award shall expire ten years from the date of grant, and shall have a per share exercise price equal to the Fair Market Value of the Companys Class A common stock on the date of grant.
Sale Event Acceleration: All outstanding Initial Awards and Annual Awards held by an Outside Director shall become fully vested and exercisable upon a Sale Event (as defined in the Companys 2021 Stock Option and Incentive Plan).
Adjustment: The foregoing numbers of shares subject to Initial Awards and Annual Awards shall be automatically adjusted as provided in Section 3(b) of the Companys 2021 Stock Option and Incentive Plan related to changes in capitalization.
Expenses
The Company will reimburse all reasonable out-of-pocket expenses incurred by non-employee directors in attending meetings of the Board of Directors or any committee thereof.
Maximum Annual Compensation
The aggregate amount of compensation, including both equity compensation and cash compensation, paid by the Company to any Outside Director in a calendar year for services as an Outside Director period shall not exceed $750,000; provided, however, that such amount shall be $1,000,000 for the calendar year in which the applicable Outside Director is initially elected or appointed to the Board of Directors; (or such other limits as may be set forth in Section 3(b) of the Companys 2021 Stock Option and Incentive Plan or any similar provision of a successor plan). For this purpose, the amount of equity compensation paid in a calendar year shall be determined based on the grant date fair value thereof, as determined in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718 or its successor provision, but excluding the impact of estimated forfeitures related to service-based vesting conditions.
Exhibit 21.1
SUBSIDIARIES OF THE REGISTRANT
Name of subsidiary |
Jurisdiction of incorporation or organization | |
Nuvalent Securities Corporation |
Massachusetts |
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the registration statement (No. 333-258237) on Form S-8 of our report dated March 29, 2022, with respect to the consolidated financial statements of Nuvalent, Inc.
/s/ KPMG LLP
Boston, Massachusetts
March 29, 2022
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, James R. Porter, hereby certify that:
1. I have reviewed this Annual Report on Form 10-K of Nuvalent, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) (Paragraph omitted pursuant to SEC Release Nos. 33-8238/34-47986 and 33-8392/34-49313);
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: March 29, 2022
/s/ James R. Porter |
||
James R. Porter, Ph.D. | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Alexandra Balcom, hereby certify that:
1. I have reviewed this Annual Report on Form 10-K of Nuvalent, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) (Paragraph omitted pursuant to SEC Release Nos. 33-8238/34-47986 and 33-8392/34-49313);
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: March 29, 2022
/s/ Alexandra Balcom |
||
Alexandra Balcom | ||
Chief Financial Officer | ||
(Principal Financial and Accounting Officer) |
Exhibit 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, James R. Porter, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge, the Annual Report on Form 10-K of Nuvalent, Inc. for the fiscal year ended December 31, 2021 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and the information contained in such Form 10-K fairly presents, in all material respects, the financial condition and results of operations of Nuvalent, Inc.
/s/ James R. Porter |
||
James R. Porter, Ph.D. | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
March 29, 2022 |
Exhibit 32.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Alexandra Balcom, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge, the Annual Report on Form 10-K of Nuvalent, Inc. for the fiscal year ended December 31, 2021 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and the information contained in such Form 10-K fairly presents, in all material respects, the financial condition and results of operations of Nuvalent, Inc.
/s/ Alexandra Balcom |
||
Alexandra Balcom | ||
Chief Financial Officer | ||
(Principal Financial and Accounting Officer) | ||
March 29, 2022 |