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 |
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) | |
(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Large Accelerated Filer |
☐ |
Accelerated Filer |
☐ | |||
Non-Accelerated Filer |
☐ |
Smaller reporting company |
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Emerging growth company |
1 |
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4 |
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6 |
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ITEM 1. |
6 |
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ITEM 1A. |
42 |
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ITEM 1B. |
83 |
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ITEM 2. |
83 |
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ITEM 3. |
84 |
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ITEM 4. |
84 |
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85 |
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ITEM 5. |
85 |
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ITEM 6. |
85 |
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ITEM 7. |
86 |
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ITEM 7A. |
96 |
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ITEM 8. |
97 |
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ITEM 9. |
123 |
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ITEM 9A. |
123 |
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ITEM 9B. |
123 |
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ITEM 9C. |
123 |
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124 |
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ITEM 10. |
124 |
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ITEM 11. |
124 |
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ITEM 12. |
124 |
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ITEM 13. |
125 |
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ITEM 14. |
125 |
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125 |
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ITEM 15. |
125 |
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ITEM 16. |
128 |
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128 |
• | our future financial and business performance; |
• | strategic plans for our business and product candidates; |
• | our ability to develop or commercialize products; |
• | the expected results and timing of clinical trials and nonclinical studies; |
• | our ability to comply with the terms of the Bayer License Agreement; |
• | developments and projections relating to our competitors and industry; |
• | our expectations regarding our ability to obtain, develop and maintain intellectual property protection and not infringe on the rights of others; |
• | our ability to retain key scientific or management personnel; |
• | our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; |
• | our future capital requirements and the timing of those requirements and sources and uses of cash; |
• | our ability to obtain funding for our operations; |
• | the outcome of any known and unknown litigation and regulatory proceedings; |
• | our business, expansion plans and opportunities; and |
• | changes in applicable laws or regulations. |
• | risks associated with preclinical or clinical development and trials, including those conducted prior to our in-licensing; |
• | risks related to the rollout of our business and the timing of expected business milestones; |
• | changes in the assumptions underlying our expectations regarding our future business or business model; |
• | our ability to develop, manufacture and commercialize product candidates; |
• | general economic, financial, legal, political and business conditions and changes in domestic and foreign markets; |
• | changes in applicable laws or regulations; |
• | the impact of natural disasters, including climate change, and the impact of health epidemics, including the COVID-19 pandemic, on our business; |
• | the size and growth potential of the markets for our products, and our ability to serve those markets; |
• | market acceptance of our planned products; |
• | our ability to raise capital; |
• | the possibility that we may be adversely affected by other economic, business, and/or competitive factors; and |
• | other risks and uncertainties set forth in this report in the section entitled “Risk Factors.” |
• | “ADC” means antibody-drug conjugate. |
• | “Affordable Care Act” means the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act. |
• | “AML” means acute myeloid leukemia. |
• | “ANDA” means an abbreviated new drug application. |
• | “Bayer License Agreement” means that certain License Agreement, dated October 7, 2020, by and among Legacy Vincera Pharma, Bayer Aktiengesellschaft and Bayer Intellectual Property GmbH. |
• | “BLA” means a biologics license application. |
• | “BPCIA” means the Biologics Price Competition and Innovation Act of 2009. |
• | “Business Combination” means the Merger and the other transactions described in the Merger Agreement. |
• | “Bylaws” means our amended and restated bylaws. |
• | “Certificate of Incorporation” means our second amended and restated certificate of incorporation, as amended. |
• | “cGMP” means current Good Manufacturing Practice. |
• | “common stock” means our common stock, $0.0001 par value per share. |
• | “DLBCL” means diffuse large B-cell lymphoma. |
• | “Earnout Shares” means certain rights to common stock after the closing of the Business Combination that Legacy Holders may be entitled to receive pursuant to the Merger Agreement. |
• | “Exchange Act” means the Securities Exchange Act of 1934, as amended. |
• | “FDA” means the U.S. Food and Drug Administration. |
• | “FDCA” means the Federal Food, Drug and Cosmetic Act. |
• | “GAAP” means accounting principles generally accepted in the United States of America. |
• | “HIPAA” means the Health Insurance Portability and Accountability Act. |
• | “IL3RA” means Interleukin 3 receptor subunit alpha. |
• | “IND” means an investigational new drug application. |
• | “JOBS Act” means the Jumpstart Our Business Startups Act of 2012. |
• | “KSPi” means kinesin spindle protein inhibitor. |
• | “Legacy Holders” means the stockholders of Legacy Vincera Pharma immediately prior to the Business Combination. |
• | “Legacy Vincera Pharma” means Vincera Pharma, Inc. prior to the consummation of the Business Combination, which changed its name to VNRX Corp. following the Business Combination. |
• | “Legacy Vincera Pharma Common Stock” means Legacy Vincera Pharma common stock, par value $0.0001 per share. |
• | “Merger” means the merger of Merger Sub with and into Legacy Vincera Pharma, with Legacy Vincera Pharma surviving as the surviving company and as a wholly-owned subsidiary of LSAC, which occurred on December 23, 2020. |
• | “Merger Agreement” means that certain Merger Agreement, dated September 25, 2020, by and among LSAC, Merger Sub, Legacy Vincera Pharma and Raquel E. Izumi, as the representative of the Legacy Holders. |
• | “Merger Sub” means LifeSci Acquisition Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of LSAC at the time of the Business Combination. |
• | “MTD” means maximum tolerated dose. |
• | “mRNA” means messenger RNA. |
• | “NDA” means a new drug application. |
• | “public warrants” means warrants originally issued in the initial public offering of LSAC, which were redeemed in April 2021. |
• | “private warrants” means the warrants issued simultaneously with the closing of the initial public offering of LSAC in a private placement to LifeSci Holdings LLC and Rosedale Park, LLC and the warrants issued pursuant to Section 8.6 of the Merger Agreement. |
• | “PTEFb/CDK9” means positive transcription elongation factor beta/cyclin-dependent kinase 9. |
• | “Securities Act” means the Securities Act of 1933, as amended. |
• | “SMDC” means small molecule drug conjugate. |
• | “USPTO” means the United States Patent and Trademark Office. |
• | “Warrant Agreement” means that certain Warrant Agreement, dated March 5, 2020, between LSAC and the Continental Stock Transfer & Trust Company. |
• | We rely on the Bayer License Agreement to provide rights to the core intellectual property relating to all of our current product candidates, which agreement imposes significant payment and other obligations on us. Any failure by us to perform our obligations under the Bayer License Agreement could give Bayer AG (“Bayer”) the right to terminate or seek other remedies under the agreement, and any termination or loss of important rights under the Bayer License Agreement would significantly and adversely affect our ability to develop and commercialize VIP152, VIP943, VIP924, VIP236 and our other current product candidates, raise capital or continue our operations. |
• | We rely to a significant extent on the preclinical and clinical trial data provided by Bayer in assessing the viability of our product candidates, and such preclinical and clinical trial data has not been verified by us or any independent third parties. |
• | Our business, operations, clinical development plans, enrollment and timelines and supply chain has been, and could continue to be, adversely affected by the effects of epidemics, including the ongoing COVID-19 pandemic, on the manufacturing, clinical trial and other business activities performed by us or by third parties with whom we conduct business, including our contract manufacturers, contract research organizations, shippers, clinical trial sites and others. |
• | We are substantially dependent on the success of our lead product candidate, VIP152, which is currently in clinical trials. If we are unable to complete development of, obtain approval for and commercialize VIP152 in a timely manner, our business will be harmed. |
• | We are at an early stage in development efforts for our product candidates and we may not be able to successfully develop, manufacture and commercialize our product candidates on a timely basis or at all. |
• | There is currently no CDK9 inhibitor, ADC delivering a KSPi warhead or small molecule drug conjugate delivering a camptothecin payload that has to date been approved by the FDA, and the development of our product candidates may never lead to a marketable product. |
• | Our long-term prospects depend in part upon discovering, developing, manufacturing and commercializing additional product candidates, which may fail in development or suffer delays that adversely affect their commercial viability. |
• | Results from early-stage clinical trials may not be predictive of results from late-stage or other clinical trials. |
• | Interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. |
• | Even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success. |
• | If the market opportunity for any product candidate that we or our strategic partners develop is smaller than we believe, our revenue may be adversely affected and our business may suffer. |
• | We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted. |
• | We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success. |
• | Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inability could have an adverse effect on our business and financial condition. |
• | Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations. |
• | Clinical trials are expensive, time consuming, subject to delay and may be required to continue beyond our available funding, and we cannot be certain that we will be able to raise sufficient funds to complete the development and commercialize any of our product candidates currently in preclinical and clinical development, should they succeed. |
• | We are at an early stage of development as a company and our limited operating history may make it difficult to evaluate our ability to succeed. |
• | We have incurred net losses since inception, and we expect to continue to incur significant net losses for the foreseeable future. |
• | We require substantial capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts. |
• | The Bayer License Agreement obligates us to make significant milestone and royalty payments, some of which will be triggered prior to the commercialization of any of our other product candidates. |
• | We may be unable to obtain U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize our product candidates. |
• | Our current or future product candidates may cause adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could inhibit regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences. |
ITEM 1. |
Business. |
• | Continue the clinical development of our small molecule drug inhibitor (VIP152) as monotherapy and in combination with other anticancer agents in Phase 1, including expansions in patients with hematologic (e.g., double-hit DLBCL; transformed follicular lymphoma; Richter syndrome; chronic lymphocytic leukemia relapsed or refractory to any BTK inhibitors and venetoclax; and mantle cell lymphoma) and solid tumors (e.g., ovarian, triple negative breast cancer, and castration resistant prostate cancer) to obtain clinical proof-of-concept |
• | Begin clinical trials with our SMDC (VIP236) by late 2022 or early 2023. |
• | Begin clinical trials with at least one of our next-generation ADCs (VIP943 or VIP924) between the end of 2023 through early 2024. |
• | Durable disease control was observed in individual patients with pancreatic cancer and salivary gland cancer (9.5 and 16.8 months of treatment, respectively). |
• | Of 7 patients with double-hit DLBCL treated with VIP152 30 mg once weekly, 2 patients had complete metabolic remissions (CMR); both achieved CMR after 10 cycles. When treatment ended due to the COVID pandemic (i.e., patients had been in long remission and did not want to risk COVID infection at the hospital), both were still in CMR. One had been receiving treatment for 3.7 years and the other for 2.3 years. As of the end of 2021 both remained in remission nearly 1 year after stopping treatment with VIP152. |
• | Mode of Action |
• | Potential Indications |
• | Clinical Status |
• | Intellectual Property |
• | Discovery follow-on opportunity. |
• | VIP943 is an anti-IL3RA-KSPi ADC |
• | VIP924 is an anti-CXCR5-KSPi ADC |
• | Despite recent approvals, currently approved ADCs have a narrower than expected therapeutic index, which limits wider use (e.g., toxicity prevents reaching maximally efficacious dose or severe overlapping toxicities, such as neutropenia, with standard of care). |
• | Three key features of the KSPi-ADC platform were engineered to deliver on the promise of ADCs: |
• | Antibodies against overexpressed tumor antigens (i.e., anti-IL3RA for leukemias and anti-CXCR5 for B-cell malignancies); |
• | A nonpermeable and potent warhead (i.e., hydrophilic KSPi) to accumulate in tumor cells and prevent the killing of healthy cells (i.e., warhead accumulates in targeted cancer cells but cannot get into healthy cells); and |
• | A novel linker preferentially cleaved in tumor tissue vs normal cells (i.e., linker only cleaved by legumain, an enzyme over expressed in tumor tissue). |
• | Preclinical results for the KSPi-ADCs show efficacy without associated toxicity observed with the ADCs approved to date (e.g., monkey studies with the VIP943 showed no neutropenia, thrombocytopenia or liver toxicity). |
• | IND enabling studies for the KSPi-ADCs are in planning. |
• | completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices regulations; |
• | submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are made; |
• | approval by an Institutional Review Board or ethics committee at each clinical site before the trial is commenced; |
• | performance of adequate and well-controlled human clinical trials in accordance with applicable FDA regulations, good clinical practice requirements and other clinical trial-related regulations to establish the safety, purity and potency of the proposed drug product candidate for its intended purpose; |
• | preparation of and submission to the FDA of an NDA or BLA after completion of all pivotal clinical trials that includes substantial evidence of safety, purity and potency from results of nonclinical testing and clinical trials; satisfactory completion of an FDA Advisory Committee review, if applicable; |
• | a determination by the FDA within 60 days of its receipt of an NDA/BLA to file the application for review; |
• | satisfactory completion of one or more FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the drug product’s continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with good clinical practice requirements; and |
• | FDA review and approval, or licensure, of the NDA/BLA to permit commercial marketing of the product for particular indications for use in the United States. |
• | Phase 1 |
• | Phase 2 |
• | Phase 3 |
• | communicating expectations for dose-finding and dose optimization, through guidance, workshops and other public meetings; |
• | providing opportunities for and encouraging drug developers to meet with FDA Oncology Review Divisions early in their development programs, well before conducting trials intended for registration, to discuss dose-finding and dose optimization; and |
• | developing strategies for dose finding and dose optimization that leverage nonclinical and clinical data in dose selection, including randomized evaluations of a range of doses in trials. |
• | restrictions on the marketing or manufacturing of a product, mandated modification of promotional materials or issuance of corrective information, issuance by FDA or other regulatory authorities of safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product, or complete withdrawal of the product from the market or product recalls; |
• | fines, warning or untitled letters or holds on post-approval clinical studies; |
• | refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals; |
• | product seizure or detention, or refusal of the FDA to permit the import or export of products; or |
• | injunctions, consent decrees or the imposition of civil or criminal penalties. |
• | a covered benefit under its health plan; |
• | safe, effective and medically necessary; |
• | appropriate for the specific patient; |
• | cost-effective; and |
• | neither experimental nor investigational. |
ITEM 1A. |
Risk Factors. |
• | the efficacy of VIP152 at selectively targeting CDK9; |
• | the successful and timely completion of our ongoing clinical trials of VIP152; |
• | the initiation and successful patient enrollment and completion of additional clinical trials of VIP152 on a timely basis; |
• | establishing and maintaining relationships with contract research organizations and clinical sites for the clinical development of VIP152 in the United States and internationally; |
• | the frequency and severity of adverse events in the clinical trials and additional drug-related adverse events are likely to be identified as more patients are treated; |
• | achieving dose selection, efficacy, safety and tolerability profiles that are satisfactory to the FDA or any comparable foreign regulatory authority for marketing approval; |
• | establishing and maintaining supply arrangements with third party drug product suppliers, manufacturers and distributors; |
• | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; |
• | a continued acceptable safety profile following any marketing approval; and |
• | our ability to compete with other therapies. |
• | obtaining marketing approval, as the FDA or other regulatory authorities have never approved a CDK9 inhibitor, KSPi warhead, or SMDC delivering an optimized CPT payload; |
• | if any of these product candidates are approved, educating medical personnel regarding the potential efficacy and safety benefits, as well as the challenges, of incorporating such product candidates into existing treatment regimens, including in combination with other treatments for blood and solid cancers; and |
• | establishing the sales and marketing capabilities upon obtaining any marketing approvals necessary to gain market acceptance. |
• | generating sufficient data to support the initiation or continuation of clinical trials; |
• | 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 the product candidate for use in clinical trials; and |
• | adverse events in the clinical trials. |
• | timing of market introduction, number and clinical profile of competitive drugs; |
• | our ability to provide acceptable evidence of safety and efficacy; |
• | changing standards of medical care; |
• | relative convenience and ease of administration; |
• | restrictions on the use of our product candidates, such as boxed warnings or contraindications in labeling, or a Risk Evaluation and Mitigation Strategy, if any, which may not be required of alternative treatments and competitor products; |
• | pricing and cost-effectiveness, which may be subject to regulatory control; |
• | availability of coverage, reimbursement and adequate payment from health maintenance organizations and other third-party payors; and |
• | prevalence and severity of adverse side effects; and other potential advantages over alternative treatment methods. |
• | developing drug candidates; |
• | conducting preclinical and clinical trials; |
• | obtaining regulatory approvals; and |
• | commercializing product candidates. |
• | a covered benefit under its health plan; |
• | safe, effective and medically necessary; |
• | appropriate for the specific patient; |
• | cost-effective; and |
• | neither experimental nor investigational |
• | delays in securing clinical investigators and trial sites for our clinical trials; |
• | delays in obtaining Institutional Review Board, and regulatory approvals to commence a clinical trial; |
• | slower than anticipated rates of patient recruitment and enrollment, or not reaching the targeted number of patients because of competition for patients from other trials, or if there is limited or no availability of coverage, reimbursement and adequate payment from health maintenance organizations and other third-party payors for the use of agents used in our clinical trials or other reasons; |
• | unforeseen safety issues; |
• | uncertain dosing issues that could arise as a result of incompletely explored pharmacokinetic and pharmacodynamics behaviors or initiatives such as the FDA’s Project Optimus; |
• | approval and introduction of new therapies or changes in standards of practice or regulatory guidance that render our clinical trial endpoints or the targeting of our proposed indications less attractive; |
• | inability to monitor patients adequately during or after treatment or problems with investigator or patient compliance with the trial protocols; |
• | inability to replicate in large controlled studies safety and efficacy data obtained from a limited number of patients in uncontrolled trials; |
• | inability or unwillingness of medical investigators to follow our clinical protocols; and |
• | unavailability of clinical trial supplies. |
• | 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; and |
• | imposition of restrictions on operations, including costly new manufacturing requirements. |
• | we may not be able to control the amount and timing of resources that our collaborators may devote to the product candidates; |
• | our collaborators may experience financial difficulties; |
• | we may be required to relinquish important rights such as marketing and distribution rights; |
• | business combinations or significant changes in a collaborator’s business strategy may also adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement; |
• | a collaborator could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and |
• | collaborative arrangements are often terminated or allowed to expire, which would delay development and may increase the cost of developing our product candidates. |
• | the scope of rights granted under the license agreement and other interpretation-related issues; |
• | the extent to which our product candidates, technology, and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
• | the sublicensing of patent and other rights under our third-party 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. |
• | the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; |
• | patent applications may not result in any patents being issued; |
• | patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage; |
• | our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates; |
• | there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and |
• | countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates. |
• | result in costly litigation that may cause negative publicity; |
• | divert the time and attention of our technical personnel and management; |
• | cause development delays; |
• | prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law; |
• | require us to develop non-infringing technology, which may not be possible on a cost-effective basis; |
• | subject us to significant liability to third parties; or |
• | require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining access to the same technology. |
• | others may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license; |
• | we or our licensors or collaborators might not have been the first to make the inventions covered by the issued patents or patent application that we own or license; |
• | we or our licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; |
• | others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; |
• | it is possible that the pending patent applications we own or license will not lead to issued patents; |
• | issued patents that we own or license may be held invalid or unenforceable, as a result of legal challenges by our competitors; |
• | our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; |
• | we may not develop additional proprietary technologies that are patentable; |
• | the patents of others may have an adverse effect on our business; and |
• | we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property. |
• | actual or anticipated fluctuations in our financial results or the financial results of companies perceived to be similar; |
• | changes in the market’s expectations about our operating results; |
• | success of competitors; |
• | our operating results failing to meet the expectation of securities analysts or investors in a particular period; |
• | changes in financial estimates and recommendations by securities analysts concerning us or the oncology industry in general; |
• | operating and share price performance of other companies that investors deem comparable to us; |
• | our ability to develop or commercialize products; |
• | results of our clinical trials and nonclinical studies; |
• | changes in laws and regulations affecting our business; |
• | our ability to meet compliance requirements and obtain regulatory approvals; |
• | our ability to obtain and maintain proprietary protection for its current and future product candidates; |
• | commencement of, or involvement in, litigation involving us; |
• | our capital requirements and capital raising activities, such as issuances of securities or the incurrence of debt; |
• | the volume of shares of our common stock available for public sale; |
• | any major change in our board of directors or management; |
• | sales of shares of common stock by our directors, executive officers or significant stockholders, or the perception that such sales could occur; and |
• | general economic and political conditions such as recessions, interest rates, fuel prices, international currency fluctuations and acts of war or terrorism. |
• | a limited availability of market quotations for its securities; |
• | a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of our common stock; |
• | a limited amount of news and analyst coverage; and |
• | a decreased ability to issue additional securities or obtain additional financing in the future. |
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. |
• |
employee-related expenses, including salaries, bonuses, benefits, stock-based compensation and other related costs for those employees involved in research and development efforts; |
• |
external research and development expenses incurred under agreements with clinical research organizations, investigative sites and consultants to conduct our preclinical studies; |
• |
costs related to manufacturing material for preclinical studies and clinical trials, including fees paid to contract manufacturing organizations; |
• |
laboratory supplies and research materials; |
• |
costs related to compliance with regulatory requirements; and |
• |
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent, maintenance of facilities, insurance and equipment. |
• |
expenses incurred to conduct preclinical development and studies required to advance our product candidates into clinical trials; |
• |
per patient clinical trial costs, including based on the number of doses that patients receive; |
• |
the number of patients who enroll in each clinical trial; |
• |
the number of clinical trials required for approval; |
• |
the number of sites included in the clinical trials; |
• |
the countries in which the clinical trials are conducted; |
• |
the length of time required to enroll eligible patients; |
• |
the drop-out or discontinuation rates of patients; |
• |
potential additional safety monitoring requested by regulatory agencies; |
• |
the duration of patient participation in the clinical trials and follow-up; |
• |
the phase of development of the product candidate; |
• |
third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• |
the cost of insurance, including product liability insurance, in connection with clinical trials; |
• |
regulators or institutional review boards requiring that we or our investigators suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; and |
• |
the efficacy and safety profile of our product candidates. |
For the years ended December 31, |
||||||||||||
2021 |
2020 |
Amount Change |
||||||||||
Operating expenses: |
||||||||||||
General and administrative |
$ |
22,575 |
$ |
3,598 |
$ |
18,977 |
||||||
Research and development—license acquired |
— |
5,000 |
(5,000 |
) | ||||||||
Research and development |
40,081 |
2,116 |
37,965 |
|||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
62,656 |
10,714 |
51,942 |
|||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(62,656 |
) |
(10,714 |
) |
(51,942 |
) | ||||||
|
|
|
|
|
|
|||||||
Other income (expense) |
||||||||||||
Change in fair value of warrant liabilities |
23,358 |
(5,136 |
) |
28,494 |
||||||||
Financing costs—derivative warrant liabilities |
— |
(762 |
) |
762 |
||||||||
Other expense |
(8 |
) |
(8 |
) |
— |
|||||||
|
|
|
|
|
|
|||||||
Total other income (expense) |
23,350 |
(5,906 |
) |
29,256 |
||||||||
|
|
|
|
|
|
|||||||
Net loss |
$ |
(39,306 |
) |
$ |
(16,620 |
) |
$ |
(22,686 |
) | |||
|
|
|
|
|
|
• |
the extent to which we develop, in-license or acquire other product candidates and technologies in our product candidate pipeline; |
• |
the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs as we advance them through preclinical and clinical development; |
• |
the number and development requirements of product candidates that we may pursue; |
• |
the costs, timing and outcome of regulatory review of our product candidates; |
• |
the timing and amount of our milestone payments to Bayer under the Bayer License Agreement; |
• |
our headcount growth and associated costs as we expand our research and development capabilities and establish and expand our commercial infrastructure and operations; |
• |
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; |
• |
royalty payments to Bayer under the Bayer License Agreement; |
• |
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; |
• |
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; and |
• |
the costs of operating as a public company. |
For the years ended December 31, |
||||||||
2021 |
2020 |
|||||||
Net cash used in operating activities |
$ |
(33,402 |
) |
$ |
(2,279) |
|||
Net cash used in investing activities |
$ |
(5,258 |
) |
$ |
— |
|||
Net cash provided by financing activities |
$ |
88,453 |
$ |
64,071 |
• |
Expected Term |
• |
Expected Volatility |
• |
Expected Dividend Yield |
• |
Risk-Free Interest Rate Treasury zero-coupon issues with an equivalent remaining term equal to the expected life of the award. |
ITEM 7A. |
Quantitative and Qualitative Disclosures About Market Risk. |
ITEM 8. |
Financial Statements and Supplementary Data. |
98 |
||||
99 |
||||
100 |
||||
101 |
||||
102 |
||||
103 |
December 31, 2021 |
December 31, 2020 |
|||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash |
$ | |
$ | |||||
Restricted cash |
— | |||||||
Prepaid expenses |
||||||||
Other current assets |
||||||||
Total current assets |
||||||||
Right-of-use |
— | |||||||
Property, plant and equipment, net |
— | |||||||
Other assets |
||||||||
Total assets |
$ |
$ |
||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued expenses |
— | |||||||
Lease liability |
— | |||||||
License payable |
— | |||||||
Due to related parties |
— | |||||||
Common stock warrant liabilities |
||||||||
Total current liabilities |
||||||||
Lease liability, net of current portion |
— | |||||||
Total liabilities |
||||||||
Commitments and contingencies—Note 9 |
||||||||
Stockholders’ equity |
||||||||
Preferred stock, $ as of December 30, 2021 and 2020 |
||||||||
Common stock, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated other comprehensive loss |
( |
) | — | |||||
Accumulated deficit |
( |
) | ( |
) | ||||
Total stockholders’ equity |
||||||||
Total liabilities and stockholders’ equity |
$ |
$ |
||||||
For the years ended December 31, |
||||||||
2021 |
2020 |
|||||||
Operating expenses: |
||||||||
General and administrative |
$ | $ | ||||||
Research and development—license acquired |
— | |||||||
Research and development |
||||||||
|
|
|
|
|||||
Total operating expenses |
||||||||
|
|
|
|
|||||
Loss from operations |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Other income (expense) |
||||||||
Change in fair value of warrant liabilities |
( |
) | ||||||
Financing costs — derivative warrant liabilities |
— | ( |
) | |||||
Other expense |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total other income (expense) |
( |
) | ||||||
|
|
|
|
|||||
Net loss |
$ |
( |
) |
$ |
( |
) | ||
Other comprehensive loss: |
||||||||
Net foreign currency translation loss |
( |
) | — | |||||
|
|
|
|
|||||
Comprehensive loss |
$ |
( |
) |
$ |
( |
) | ||
|
|
|
|
|||||
Net loss per common share, basic and diluted |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
|||||
Weighted average common shares outstanding, basic and diluted |
||||||||
|
|
|
|
Common Stock |
Subscription Receivable |
Additional Paid-in Capital |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total Stockholders’ Equity |
|||||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||||||
Balance as of January 1, 2020 |
$ |
$ |
( |
) |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) | |||||||||||||||
Proceeds from reverse acquisition, net of transaction costs and warrant liabilities |
— |
— |
— |
— |
||||||||||||||||||||||||
Proceeds from Founders |
— |
— |
— |
— |
— |
|||||||||||||||||||||||
Issuance of restricted stock |
— |
— |
— |
— |
— |
— |
||||||||||||||||||||||
Stock-based compensation |
— |
— |
— |
— |
— |
|||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance as of December 31, 2020 |
— |
— |
( |
) |
||||||||||||||||||||||||
Issuance of common stock from private placement, net of transaction costs of $ |
— |
— |
— |
|||||||||||||||||||||||||
Issuance of common stock from warrant exercises |
— |
— |
— |
— |
||||||||||||||||||||||||
Issuance of common stock from employee stock plans |
— |
— |
— |
— |
||||||||||||||||||||||||
Reclassification of warrant liabilities to equity due to warrant exercises for cash |
— |
— |
— |
— |
— |
|||||||||||||||||||||||
Stock-based compensation |
— |
— |
— |
— |
— |
|||||||||||||||||||||||
Cumulative translation adjustment |
— |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance as of December 31, 2021 |
$ |
$ |
— |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, |
||||||||
2021 |
2020 |
|||||||
Cash flows from operating activities |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Amortization on debt discount |
— | |||||||
Depreciation and amortization |
— | |||||||
Stock-based compensation |
||||||||
Amortization of right-of-use |
— | |||||||
Change in fair value of warrant liabilities |
( |
) | ||||||
Financing costs—derivative warrant liabilities |
— | |||||||
Research and development-acquired license, expensed |
— | |||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid and other current assets |
( |
) | ||||||
Other assets |
( |
) | ( |
) | ||||
Accounts payable |
||||||||
Accrued expenses |
— | |||||||
Lease liability |
|
|
( |
) |
|
|
— |
|
Due to related parties |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
Cash Flows from Investing Activities: |
||||||||
Research and development-acquired license |
( |
) | — | |||||
Capital expenditures |
( |
) | — | |||||
|
|
|
|
|||||
Net cash used in investing activities |
( |
) | — | |||||
Cash Flows from Financing Activities: |
||||||||
Net proceeds from reverse acquisition |
||||||||
Proceeds from private placement, net of transaction costs |
— | |||||||
Proceeds from warrants exercised for cash, net of redemption cost |
— | |||||||
Proceeds from issuance of common stock from employee stock plans |
— | |||||||
Proceeds from Founders |
— | |||||||
Proceeds from issuance of notes payable to related parties |
— | |||||||
Repayment of notes payable to related parties |
— | ( |
) | |||||
|
|
|
|
|||||
Net cash provided by financing activities |
||||||||
Effect of exchange rate changes on cash and restricted cash |
( |
) | — | |||||
Net increase in cash and restricted cash |
||||||||
Cash and restricted cash at beginning of year |
— | |||||||
|
|
|
|
|||||
Cash and restricted cash at end of year |
$ |
$ |
||||||
|
|
|
|
|||||
Supplemental disclosure of cash flow information: |
||||||||
Cash paid for interest |
$ | $ | ||||||
Supplemental schedule of non-cash investing and financing activities: |
||||||||
Reclassification of warrant liabilities to equity due to warrant exercises for cash |
$ | $ | — | |||||
Right-of-use |
$ | $ | — |
Cash—LSAC trust |
$ | |||
Cash—LSAC cash assumed |
||||
Less: transaction costs and advisory fees |
( |
) | ||
Less: accrued transaction costs and advisory fees |
( |
) | ||
|
|
|||
Net cash contributions from Business Combination |
$ | |||
|
|
LSAC’s public stockholders |
||||
LSAC’s initial stockholders |
||||
Legacy Vincera Pharma stockholders |
||||
Other |
||||
|
|
|||
Total shares of common stock immediately after Business Combination |
||||
|
|
Fair Value Measured as of December 31, 2021 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Liabilities: |
||||||||||||||||
Common stock warrant liabilities |
$ |
$ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Fair Value Measured as of December 31, 2020 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Liabilities: |
||||||||||||||||
Common stock warrant liabilities |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
Warrant Liability |
||||
Balance – December 23, 2020 |
$ |
|||
Change in fair value |
||||
|
|
|||
Balance – December 31, 2020 |
||||
Reclassification of warrant liabilities due to warrant exercises |
( |
) | ||
Change in fair value |
( |
) | ||
|
|
|||
Balance – December 31, 2021 |
$ |
|||
|
|
As of December 31, 2021 |
As of December 31, 2020 |
|||||||
Exercise price |
$ | |
$ | |||||
Option term (years) |
||||||||
Volatility (annual) |
% | % | ||||||
Risk-free rate |
% | % | ||||||
Dividend yield (per s h are) |
% | % |
December 31, 2021 |
December 31, 2020 |
Estimated Useful Life |
||||||||||
Furniture and fixtures |
$ |
$ |
||||||||||
Computers |
||||||||||||
Total |
||||||||||||
Less: accumulated depreciation |
( |
) | ||||||||||
|
|
|
|
|||||||||
Total property, plant and equipment, net |
$ | $ | ||||||||||
|
|
|
|
December 31, 2021 |
December 31, 2020 |
|||||||
Accrued payroll |
$ | $ | ||||||
Accrued bonus |
||||||||
Accrued benefits |
||||||||
Accrued manufacturing, clinical trial and related |
||||||||
|
|
|
|
|||||
$ |
$ |
|||||||
|
|
|
|
For the years ended December 31, |
||||
2021 |
||||
Lease cost |
||||
Operating lease cost |
$ | |||
Variable lease cost |
||||
Total operating lease expense |
$ | |||
Other information |
||||
Operating cash flows from operating leases |
$ | |||
Right-of-use |
$ | |
||
Weighted-average remaining lease term – operating leases |
||||
Weighted-average discount rate – operating leases |
% |
Year ended December 31, 2022 |
$ | |||
Year ended December 31, 2023 |
||||
Year ended December 31, 2024 |
||||
Year ended December 31, 2025 |
||||
Total |
||||
Less present value discount |
( |
) | ||
Operating lease liabilities included in the Consolidated Balance Sheet at December 31, 2021 |
$ | |
||
Number of Shares |
Weighted Average Grant Date Fair Value per Share |
|||||||
Nonvested at January 1, 2020 |
$ |
|||||||
Restricted stock granted |
||||||||
Vested |
( |
) | ||||||
Nonvested at December 31, 2020 |
$ |
|||||||
Vested |
( |
) | ||||||
Nonvested at December 31, 2021 |
$ |
|||||||
Stock Options |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Life (in years) |
Aggregate Intrinsic Value |
|||||||||||||
Outstanding at January 1, 2020 |
— |
$ | — |
— |
$ | — |
||||||||||
Options granted |
— |
|||||||||||||||
Outstanding at December 31, 2020 |
— |
|||||||||||||||
Options granted |
— |
|||||||||||||||
Options cancelled |
( |
) | — |
— |
||||||||||||
Outstanding at December 31, 2021 |
$ | $ | ||||||||||||||
Options vested and exercisable at December 31, 2021 |
$ | $ | — |
|||||||||||||
For the years ended December 31, |
||||||||
2021 | 2020 | |||||||
Exercise price |
$ | $ | ||||||
Expected term (years) |
||||||||
Volatility (annual) |
% | % | ||||||
Risk-free rate |
% | % | ||||||
Dividend yield (per share) |
% | % |
For the years ended December 31, |
||||||||
2021 |
2020 |
|||||||
Research and development |
$ | $ | ||||||
General and administrative |
||||||||
Total stock-based compensation expense |
$ |
$ |
||||||
For the years ended December 31, |
||||||||
2021 |
2020 |
|||||||
Numerator: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Denominator: |
||||||||
Weighted average common shares outstanding, basic and diluted |
||||||||
Net loss per common share, basic and diluted |
$ | ( |
) | $ | ( |
) | ||
For the years ended December 31, |
||||||||
2021 |
2020 |
|||||||
Options outstanding |
||||||||
Warrants |
||||||||
Total |
||||||||
For the Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
Statutory federal income tax rate |
% | % | ||||||
State taxes, net of federal tax benefit |
( |
%) | % | |||||
Change in fair value of warrant liabilities |
% | ( |
%) | |||||
Research and development |
% | — | ||||||
Other |
( |
%) | ( |
%) | ||||
Change in valuation allowance |
( |
%) | ( |
%) | ||||
Income taxes provision (benefit) |
% | % | ||||||
As of December 31, |
||||||||
2021 |
2020 |
|||||||
Deferred tax assets: |
||||||||
Net operating loss |
$ | $ | ||||||
Stock-based compensation |
||||||||
Depreciation and amortization |
||||||||
Research and development credit |
||||||||
Accruals and reserves |
||||||||
Lease liability |
||||||||
Total deferred income tax assets |
||||||||
Less: Valuation allowances |
( |
) |
( |
) | ||||
Deferred tax assets, net of valuation allowances |
$ |
$ |
||||||
Deferred tax liabilities: Right of use asset |
( |
) | ||||||
Total deferred income tax liabilities |
$ |
( |
) | $ |
||||
Net deferred taxes |
$ |
$ |
||||||
Total |
||||
Balance as of December 31, 2019 |
$ | |||
Increase/decrease due to prior year positions |
||||
Increase/decrease due to current year positions |
||||
|
|
|||
Balance as of December 31, 2020 |
||||
Increase/decrease due to prior year positions |
||||
Increase/decrease due to current year positions |
||||
|
|
|||
Balance as of December 31, 2021 |
$ | |
||
|
|
ITEM 9. |
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. |
ITEM 9A. |
Controls and Procedures. |
ITEM 9B. |
Other Information. |
ITEM 9C. |
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. |
ITEM 10. |
Directors, Executive Officers and Corporate Governance. |
ITEM 11. |
Executive Compensation. |
ITEM 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. |
ITEM 13. |
Certain Relationships and Related Transactions, and Director Independence. |
ITEM 14. |
Principal Accountant Fees and Services. |
ITEM 15. |
Exhibit and Financial Statement Schedules. |
+ | The schedules and exhibits to this agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request. |
# | Indicates management contract or compensatory plan or arrangement. |
* | Portions of this exhibit have been omitted in accordance with Item 601(b)(10)(iv) of Regulation S-K. |
† | In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. 34-47986, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form 10-K and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or the “Exchange Act, or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933 except to the extent that the registrant specifically incorporates it by reference. |
ITEM 16. |
Form 10-K Summary. |
VINCERX PHARMA, INC. | ||
/s/ Dr. Ahmed M. Hamdy | ||
Name: | Dr. Ahmed M. Hamdy | |
Title: | Chief Executive Officer |
Signature |
Title |
Date | ||
/s/ Dr. Ahmed M. Hamdy Dr. Ahmed M. Hamdy |
Chief Executive Officer and Chairman (Principal Executive Officer) |
March 29, 2022 | ||
/s/ Alexander A. Seelenberger Alexander A. Seelenberger |
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
March 29, 2022 | ||
/s/ Laura I. Bushnell Laura I. Bushnell |
Director |
March 29, 2022 | ||
/s/ Dr. Brian J. Druker Dr. Brian J. Druker |
Director |
March 29, 2022 | ||
/s/ Dr. Raquel E. Izumi Dr. Raquel E. Izumi |
Director |
March 29, 2022 | ||
/s/ Dr. John H. Lee Dr. John H. Lee |
Director |
March 29, 2022 | ||
/s/ Christopher P. Lowe Christopher P. Lowe |
Director |
March 29, 2022 | ||
/s/ Dr. Andrew McDonald Dr. Andrew McDonald |
Director |
March 29, 2022 |
Signature |
Title |
Date | ||
/s/ Francisco D. Salva Francisco D. Salva |
Director |
March 29, 2022 | ||
/s/ Dr. Ruth E. Stevens Dr. Ruth E. Stevens |
Director |
March 29, 2022 |