QUARTERLY 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 | ||||
Emerging growth company |
1 | ||||
3 | ||||
3 | ||||
5 | ||||
5 | ||||
17 | ||||
24 | ||||
24 | ||||
26 | ||||
26 | ||||
26 | ||||
67 |
• | 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 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 Jumpstart Our Business Startups 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 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.” |
• | “Business Combination” means the Merger and the other transactions described in the Merger Agreement. |
• | “Lock-up Agreement” means those certain Resale Lock-up Agreements, dated December 23, 2020, by and between us and each Legacy Holder and each person or entity who acquired shares of our common stock in connection with the dissolution of the Sponsor. |
• | “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. |
• | “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. |
• | “Sponsor” means LifeSci Investments, LLC, LSAC’s sponsor and an entity affiliated with LifeSci Capital LLC, which was dissolved effective January 28, 2021. |
• | “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 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 and clinical development plans and timelines and supply chain could 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 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 new chemical entity payload that has to date been approved by the U.S. Food and Drug Administration, or 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. |
• | We are a “controlled company” within the meaning of the Nasdaq listing rules and as such are exempt from certain corporate governance requirements. |
ITEM 1. |
Financial Statements. |
June 30, 2021 |
December 31, 2020 |
|||||||
(Unaudited) |
||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Prepaid expenses |
||||||||
Other current assets |
— | |||||||
Total current assets |
||||||||
Right-of-use |
— | |||||||
Property , plant and equipment |
— | |||||||
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 5 |
||||||||
Stockholders’ equity |
||||||||
Preferred stock, $ June 30 , 2021 and December 31, 2020 |
||||||||
Common stock, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Total stockholders’ equity |
||||||||
Total liabilities and stockholders’ equity |
$ |
$ |
||||||
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
Operating expenses: |
||||||||||||||||
General and administrative |
$ | $ | $ | $ | ||||||||||||
Research and development |
— | — | ||||||||||||||
Total operating expenses |
||||||||||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other income |
||||||||||||||||
Change in fair value of warrant liabilities |
— | — | ||||||||||||||
Total other income |
— | — | ||||||||||||||
Net loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||
Net loss per common share, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Weighted average common shares outstanding, basic and diluted |
||||||||||||||||
For the Three Months Ended June 30, 2021 |
||||||||||||||||||||||||
Common Stock |
Subscription Receivable |
Additional Paid-in Capital |
Accumulated Deficit |
Total Stockholders’ Equity |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
Balance as of April 1, 2021 |
$ |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||
Issuance of common stock from warrant exercises |
— |
— |
||||||||||||||||||||||
Reclassification of warrant liabilities to equity due to warrant exercises for cash |
— |
— |
— |
— |
||||||||||||||||||||
Stock-based compensation |
— |
— |
— |
— |
||||||||||||||||||||
Net loss |
— |
— |
— |
— |
( |
) |
( |
) | ||||||||||||||||
Balance as of June 30, 2021 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
For the Six Months Ended June 30, 2021 |
||||||||||||||||||||
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Total Stockholders’ Equity |
|||||||||||||||||
Shares |
Amount |
|||||||||||||||||||
Balance as of January 1, 2021 |
$ |
$ |
$ |
( |
) |
$ |
||||||||||||||
Issuance of common stock from warrant exercises |
— |
— |
||||||||||||||||||
Reclassification of warrant liabilities to equity due to warrant exercises for cash |
— |
— |
— |
|||||||||||||||||
Stock-based compensation |
— |
— |
— |
|||||||||||||||||
Net loss |
— |
— |
— |
( |
) |
( |
) | |||||||||||||
Balance as of June 30, 2021 |
$ |
$ |
$ |
( |
) |
$ |
||||||||||||||
For the Three Months Ended June 30, 2020 |
||||||||||||||||||||||||
Common Stock |
Subscription Receivable |
Additional Paid-in Capital |
Accumulated Deficit |
Total Stockholders’ Deficit |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
Balance as of April 1, 2020 |
$ |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
( |
) | |||||||||||||
Issuance of restricted stock |
— | ( |
) | — | — | |||||||||||||||||||
Stock-based compensation related to restricted stock |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
Balance as of June 30, 2020 |
$ |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
( |
) | |||||||||||||
For the Six Months Ended June 30, 2020 |
||||||||||||||||||||||||
Common Stock |
Subscription Receivable |
Additional Paid-in Capital |
Accumulated Deficit |
Total Stockholders’ Deficit |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
Balance as of January 1, 2020 |
$ |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
( |
) | |||||||||||||
Issuance of restricted stock |
— | ( |
) | — | — | |||||||||||||||||||
Stock-based compensation related to restricted stock |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
Balance as of June 30, 2020 |
$ |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
( |
) | |||||||||||||
For the Six Months Ended June 30, |
||||||||
2021 |
2020 |
|||||||
Cash flows from operating activities |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Stock-based compensation |
||||||||
Amortization of right-of-use |
( |
) | — | |||||
Change in fair value of warrant liabilities |
( |
) | — | |||||
Changes in operating assets and liabilities: |
||||||||
Prepaid and other current assets |
— | |||||||
Other assets |
( |
) | — | |||||
Accounts payable |
||||||||
Accrued expenses |
— | |||||||
Due to related parties |
( |
) | ||||||
Lease liabilities |
— | |||||||
|
|
|
|
|||||
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: |
||||||||
Proceeds from warrants exercised for cash |
— | |||||||
|
|
|
|
|||||
Net cash provided by financing activities |
— | |||||||
Net increase in cash and cash equivalents |
— | |||||||
Cash and cash equivalents at the beginning of the period |
— | |||||||
|
|
|
|
|||||
Cash and cash equivalents at the end of the period |
$ |
$ |
— |
|||||
|
|
|
|
|||||
Supplemental disclosure of cash flow information: |
||||||||
Cash paid for income taxes |
$ | $ | — | |||||
Cash paid for interest |
$ | $ | — | |||||
Supplemental schedule of non-cash investing and financing activities: |
||||||||
Issuance of restricted stock not yet paid |
$ | — | $ | |||||
Reclassification of warrant liabilities to equity due to warrant exercises for cash |
$ | $ | — | |||||
Right-of-use assets obtained in exchange for operating lease liabilities |
|
$ |
|
|
|
$ |
— |
|
Fair Value Measured as of June 30, 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 – January 1, 2021 |
$ |
|||
Reclassification of warrant liabilities due to warrant exercises |
( |
) | ||
Change in fair value |
( |
) | ||
|
|
|||
Balance – June 30, 2021 |
$ |
|||
|
|
As of June 30, 2021 |
As of December 31, 2020 |
|||||||
Stock price |
|
$ |
|
|
|
$ |
|
|
Exercise price |
$ | $ | ||||||
Option term (years) |
||||||||
Volatility (annual) |
% | % | ||||||
Risk-free rate |
% | % | ||||||
Dividend yield (per share) |
% | % |
For the Six Months ended June 30, 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 (years) |
||||
Weighted-average discount rate – operating leases |
% |
Remaining period ended December 31, 2021 |
$ | |||
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 Condensed Consolidated Balance Sheet at June 30, 2021 |
$ | |||
Number of Shares |
Weighted Average Grant Date Fair Value |
|||||||
Nonvested at January 1, 2021 |
$ |
|||||||
Vested |
( |
) | ||||||
Nonvested at June 30, 2021 |
$ |
|||||||
Stock Options |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Life (in years) |
Aggregate Intrinsic Value |
|||||||||||||
Outstanding at January 1, 2021 |
$ | $ | — | |||||||||||||
Options granted |
— | |||||||||||||||
Outstanding at June 30, 2021 |
$ | $ | ||||||||||||||
Options vested and exercisable at June 30, 2021 |
$ | $ | — | |||||||||||||
For the six months ended June 30, 2021 |
||||
Exercise price |
$ | |||
Expected term (years) |
||||
Volatility (annual) |
% | |||
Risk-free rate |
% | |||
Dividend yield (per share) |
% |
For the three months ended June 30, 2021 |
For the six months ended June 30, 2021 |
|||||||
Research and development |
$ | $ | ||||||
General and administrative |
||||||||
Total stock-based compensation expense |
$ |
$ |
||||||
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Numerator: |
||||||||||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Denominator: |
||||||||||||||||
Weighted average common shares outstanding, basic and diluted |
||||||||||||||||
Net loss per common share, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
For the three and six months endedJune 30, |
||||||||
2021 | 2020 | |||||||
Options outstanding |
||||||||
Warrants |
||||||||
Total |
— | |||||||
ITEM 2. |
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 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 three months ended June 30, |
||||||||||||
2021 | 2020 | Amount Change | ||||||||||
Operating expenses: |
||||||||||||
General and administrative |
$ | 6,695 | $ | 33 | $ | 6,662 | ||||||
Research and development |
10,698 | — | 10,698 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
17,393 | 33 | 17,360 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(17,393 | ) | (33 | ) | (17,360 | ) | ||||||
|
|
|
|
|
|
|||||||
Other income |
||||||||||||
Change in fair value of warrant liabilities |
15,359 | — | 15,359 | |||||||||
|
|
|
|
|
|
|||||||
Total other income |
15,359 | — | 15,359 | |||||||||
|
|
|
|
|
|
|||||||
Net loss |
$ |
(2,034 |
) |
$ |
(33 |
) |
$ |
(2,001 |
) | |||
|
|
|
|
|
|
For the six months ended June 30 |
||||||||||||
2021 | 2020 | Amount Change | ||||||||||
Operating expenses: |
||||||||||||
General and administrative |
$ | 11,486 | $ | 37 | $ | 11,449 | ||||||
Research and development |
15,532 | — | 15,532 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
27,018 | 37 | 26,981 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(27,018 | ) | (37 | ) | (26,981 | ) | ||||||
|
|
|
|
|
|
|||||||
Other income |
— | — | ||||||||||
Change in fair value of warrant liabilities |
18,708 | — | 18,708 | |||||||||
|
|
|
|
|
|
|||||||
Total other income |
18,708 | — | 18,708 | |||||||||
|
|
|
|
|
|
|||||||
Net loss |
$ |
(8,310 |
) |
$ |
(37 |
) |
$ |
(8,273 |
) | |||
|
|
|
|
|
|
• | 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 six months ended June 30, |
||||||||
2021 | 2020 | |||||||
Net cash used in operating activities |
$ | (11,612 | ) | $ | — | |||
Net cash used in investing activities |
$ | (5,228 | ) | $ | — | |||
Net cash provided by financing activities |
$ | 40,671 | $ | — |
ITEM 3. |
Quantitative and Qualitative Disclosures About Market Risk. |
ITEM 4. |
Controls and Procedures. Evaluation of Disclosure Controls and Procedures |
ITEM 1. |
Legal Proceedings. |
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, for example neutropenia is an on-target toxicity of VIP152 and additional drug-related adverse effects are likely to be identified as more patients are treated; |
• | achieving 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 and manufacturers; |
• | 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, KSPi warhead, or SMDC delivering an SN38 derived 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 or 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 may or may not be related to incompletely explored pharmacokinetic and pharmacodynamics behaviors; |
• | 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; |
• | 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 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 2. |
Exhibits. |
† | 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 report 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. |
VINCERX PHARMA, INC. | ||
Date: August 12, 2021 | /s/ Dr. Ahmed M. Hamdy | |
Dr. Ahmed M. Hamdy Chief Executive Officer | ||
Date: August 12, 2021 | /s/ Alexander A. Seelenberger | |
Alexander A. Seelenberger Chief Financial Officer |
Exhibit 31.1
Certification of Principal Executive Officer Pursuant to Exchange Act Rule 13a-14(a)/15d-14(a) as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Dr. Ahmed M. Hamdy, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Vincerx Pharma, 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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(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: August 12, 2021
/s/ Dr. Ahmed M. Hamdy |
Dr. Ahmed M. Hamdy |
Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
Certification of Principal Financial Officer Pursuant to Exchange Act Rule 13a-14(a)/15d-14(a) as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Alexander A. Seelenberger, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Vincerx Pharma, 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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(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: August 12, 2021
/s/ Alexander A. Seelenberger |
Alexander A. Seelenberger |
Chief Financial Officer (Principal Financial Officer) |
Exhibit 32.1
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350 as Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Dr. Ahmed M. Hamdy, the Chief Executive Officer (Principal Executive Officer) of Vincera Pharma, Inc. (the Company), hereby certify, that, to my knowledge:
1. The Quarterly Report on Form 10-Q for the period ended June 30, 2021 (the Report) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 12, 2021
/s/ Dr. Ahmed M. Hamdy |
Dr. Ahmed M. Hamdy |
Chief Executive Officer (Principal Executive Officer) |
This certification shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Exhibit 32.2
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350 as Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Alexander A. Seelenberger, the Chief Financial Officer (Principal Financial Officer) of Vincera Pharma, Inc. (the Company), hereby certify, that, to my knowledge:
1. The Quarterly Report on Form 10-Q for the period ended June 30, 2021 (the Report) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 12, 2021
/s/ Alexander A. Seelenberger |
Alexander A. Seelenberger |
Chief Financial Officer (Principal Financial Officer) |
This certification shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Jun. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Preferred stock par value | $ 0.0001 | $ 0.0001 |
Preferred stock shares authorized | 30,000,000 | 30,000,000 |
Preferred stock shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Common stock par value | $ 0.0001 | $ 0.0001 |
Common stock shares authorized | 120,000,000 | 120,000,000 |
Common stock shares issued | 17,521,075 | 13,984,441 |
Common stock shares outstanding | 17,521,075 | 13,984,441 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2021 |
Jun. 30, 2020 |
Jun. 30, 2021 |
Jun. 30, 2020 |
|
Operating expenses: | ||||
General and administrative | $ 6,695 | $ 33 | $ 11,486 | $ 37 |
Research and development | 10,698 | 15,532 | ||
Total operating expenses | 17,393 | 33 | 27,018 | 37 |
Loss from operations | (17,393) | (33) | (27,018) | (37) |
Other income | ||||
Change in fair value of warrant liabilities | 15,359 | 18,708 | ||
Total other income | 15,359 | 18,708 | ||
Net loss | $ (2,034) | $ (33) | $ (8,310) | $ (37) |
Net loss per common share, basic and diluted | $ (0.12) | $ (0.01) | $ (0.55) | $ (0.01) |
Weighted average common shares outstanding, basic and diluted | 16,350 | 5,009 | 15,050 | 4,988 |
Nature of Business |
6 Months Ended |
---|---|
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | NOTE 1. NATURE OF BUSINESS LSAC was initially formed on December 19, 2018 as a Delaware corporation for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. In December 2020, the Merger Sub merged with and into Legacy Vincera Pharma, with Legacy Vincera Pharma surviving the Merger as a wholly- owned subsidiary of LSAC. In connection with the Business Combination, LSAC changed its name to Vincera Pharma, Inc., and subsequently in January 2021, changed its name to Vincerx Pharma, Inc. (together with its consolidated subsidiaries, the “Company”). The Company is a clinical-stage biopharmaceutical company focused on leveraging its extensive development and oncology expertise to advance new therapies intended to address unmet medical needs for the treatment of cancer. The Company’s current pipeline is entirely derived from the Bayer License Agreement (see Note 3), pursuant to which the Company has been granted an exclusive, royalty-bearing, worldwide license under certain Bayer patents and know-how to develop, use, manufacture, commercialize, sublicense and distribute a clinical-stage and follow-on small molecule drug program and a preclinical stage bioconjugation platform, which includes next-generation antibody-drug conjugates and small molecule drug conjugates. The Company intends to use these product candidates to treat various cancers in a patient-specific, targeted approach. During the early months of 2020, COVID-19 emerged and has subsequently spread world-wide. The World Health Organization has declared COVID-19 a pandemic resulting in federal, state and local governments and private entities mediating various restrictions, including travel restrictions, restrictions on public gatherings, stay at home orders, and advisories and quarantining people who may have been exposed to the virus. Management continues to evaluate the impact of the COVID-19 pandemic on its current operations and future plans and takes appropriate measures to address any such impact, but there can be no assurance that these efforts will be successful and that the pandemic will not have negative effect on the Company’s financial position and results of its operations. |
Summary of Significant Accounting Policies |
6 Months Ended |
---|---|
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X of the rules and regulations of the SEC. They include the accounts of Vincerx and its wholly-owned subsidiaries VNRX Corp and Vincerx Pharma GmbH. All intercompany accounts and transactions have been eliminated. Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2020 as filed with the SEC on May 14, 2021, which contains the audited financial statements and notes thereto. The financial information as of December 31, 2020 is derived from the audited financial statements presented in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2020. The interim results for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any future periods. The Business Combination is accounted for as a reverse recapitalization, with no goodwill or other intangible assets recorded, in accordance with GAAP. Under this method of accounting, LSAC is treated as the “acquired” company for financial reporting purposes. Accordingly, for accounting purposes, the Business Combination is treated as the equivalent of Legacy Vincera Pharma issuing stock for the net assets of LSAC, accompanied by a recapitalization. As a result, references to the “Company” herein may refer to Legacy Vincera Pharma prior to the consummation of the Business Combination. The acquired net assets of LSAC are stated at historical cost, with no goodwill or other intangible assets recorded. Use of Estimates The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of commitments and contingencies at the date of the financial statements as well as reported amounts of expenses during the reporting periods. Estimates made by the Company include, but are not limited to, those related to the valuation of common stock prior to the Business Combination, common stock warrant liabilities and stock-based compensation. The Company bases these estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying amounts of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the Company’s Annual Report on Form 10-K/A other than the additions below. Leases Effective January 1, 2021, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 842, Leases Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use Operating lease liabilities and their corresponding right-of-use right-of-use In accordance with ASC 842, components of a lease should be allocated between lease components (e.g., land, building, etc.) and non-lease components (e.g., common area maintenance, consumables, etc.). The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. Recent Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02 , Leases (Topic 842 2018-11, Leases (Topic 842): Targeted Improvements right-of-use assets and lease liabilities of approximately$ 3.3 million, which represents the discounted cash flows of the Company’s operating lease prior to the April 2021 lease amendment. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes 2019-12 removes certain exceptions to the general principles in ASC 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. On January 1, 2021, the Company adopted this standard without any material impact on its condensed consolidated financial statements. In August 2020, the FASB issued ASU
2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity |
Bayer License |
6 Months Ended |
---|---|
Jun. 30, 2021 | |
Bayer License [Abstract] | |
Bayer License | NOTE 3. BAYER LICENSE On October 7, 2020, the Company entered into the Bayer License Agreement, which became effective on December 23, 2020 upon the closing of the Business Combination. Pursuant to the Bayer License Agreement, the Company has an exclusive, worldwide, royalty-bearing license under certain Bayer patents and know-how to develop, use, manufacture, commercialize, sublicense and distribute (i) a clinical-stage small molecule drug platform, including a PTEFb inhibitor compound, and (ii) a preclinical stage bioconjugation platform, which includes next-generation antibody-drug conjugates and small molecule drug conjugates. Following the closing of the Business Combination, the Company paid Bayer a $5.0 million upfront license fee on January 5, 2021. If the Company achieves all of the development and commercial sales milestones for license products under the Bayer License Agreement for each of the countries and disease indications, the Company would be obligated to pay milestone payments that range from $110.0 million to up to $318.0 million per licensed product, and upon successful commercialization of at least five licensed products, the Company could be required to pay aggregate milestone payments in excess of $1 billion. In addition to milestone payments, the Company is also required to pay Bayer under the Bayer License Agreement ongoing royalties in the single digit to low double-digit percentage range on net commercial sales of licensed products. As of June 30, 2021, no development and commercial sales milestones under the Bayer License Agreement have been met . |
Fair Value Measurements |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | NOTE 4. FAIR VALUE MEASUREMENT The Company’s financial liabilities subject to fair value measurements on a recurring basis and the level of inputs used for such measurements were as follows (amounts in thousands):
The Company performs procedures such as comparing prices obtained from independent sources to ensure that appropriate fair values are recorded. Because the transfer of certain private warrants to anyone outside of a small group of individuals constituting the sponsors of LSAC would result in these private warrants having similar terms as the public warrants, management determined that the fair value of each of these private warrants is approximately double that of a public warrant, with a modest adjustment for short-term marketability restrictions. Accordingly, these private warrants are classified as Level 3 financial instruments. The estimated fair value of the private warrants is determined with Level 3 inputs using Black-Scholes and Monte Carlo simulations. There were no transfers between Level 1, 2 or 3 during the three- and six-month periods ended June 30, 2021. The following table presents changes in Level 3 liabilities measured at fair value for the six-month period ended June 30, 2021. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long-dated volatilities) inputs (in thousands).
A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities that are categorized within Level 3 of the fair value hierarchy as of June 30, 2021 and December 31, 2020 is as follows:
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Commitments and Contingencies |
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Commitments and Contingencies | NOTE 5. COMMITMENTS AND CONTINGENCIES Leases On December 23. 2020, the Company entered into a 5-year term lease agreement which commenced on January 1, 2021. On April 1, 2021, the lease was amended to include additional space. The annual rent expense is approximately $1.1 million. At June 30, 2021, the Company had operating lease liabilities of approximately $4.2 million and right of use assets of approximately $4.2 million, which were included in the condensed consolidated balance sheets. The following summarizes quantitative information about the Company’s operating leases (amounts in thousands):
As of June 30, 2021, future minimum payments during the next five years and thereafter are as follows (in thousands):
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Stockholders' Equity |
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Stockholders' Equity | NOTE 6. STOCKHOLDERS’ EQUITY The Company’s Certificate of Incorporation authorizes the issuance of 120,000,000 shares of common stock, $0.0001 par value per share and 30,000,000 shares of undesignated preferred stock, $0.0001 par value per share. As of June 30, 2021, and December 31, 2020, there were 17,521,075 shares of common stock and 13,984,441 shares of common stock (which include 2,744,586 shares of common stock constituting part of the units), outstanding, respectively, and no shares of preferred stock outstanding. On April 5, 2021, the Company announced that it would redeem all of its outstanding public warrants to purchase shares of the Company’s common stock that were issued under the Warrant Agreement, dated March 5, 2020, by and between the Company and Continental Stock Transfer & Trust Company, as warrant agent, as part of the units sold in the Company’s initial public offering, that remained outstanding and unexercised on May 5, 2021, the redemption date, at a redemption price of $0.01 per public warrant. In addition to the $6.1 million of cash received on April 1, 2021 from the exercise of public warrants in March 2021, prior to the redemption notice, the Company received additional proceeds of approximately $31.4 million from the exercise of additional public warrants during the redemption period. Prior to the redemption date, the units were each separated into one share of common stock and one public warrant. Pursuant to the redemption, a total of 40,491 public warrants were unexercised as of the redemption date and redeemed by the Company at the redemption price of $0.01 per public warrant. During the six months ended June 30, 2021, 275,000 private warrants were exercised for cash. The Company issued 275,000 shares of common stock and subsequently received approximately $ 3.2 million cash in April 2021. Restricted Shares A summary of restricted stock activity for the six months ended June 30, 2021 is presented below:
As of June 30, 2021, there was approximately $10,919 of unrecognized stock-based compensation related to restricted stock that will be amortized in 3.0 years. Warrants As of June 30, 2021, there were 3,295,000 private warrants to purchase common stock outstanding. After the redemption described above, no public warrants remained outstanding at June 30, 2021. Each public warrant entitled the registered holder to purchase one-half (1/2) of a share of common stock at a price of $11.50 per whole share of common stock, subject to adjustment as discussed below, at any time commencing on the later of one year after the closing of the initial public offering of LSAC or the consummation of a business combination. Prior to the redemption described above, the warrants would have expired at 5:00 p.m., New York City time, on December 23, 2025 (five years from the closing of the Company’s initial business combination). The private warrants are identical to the previously outstanding public warrants except that (i) each private warrant is exercisable for one share of common stock at an exercise price of $11.50 per share and (ii) such private warrants will be exercisable for cash (even if a registration statement covering the shares of common stock issuable upon exercise of such private warrants is not effective) or on a cashless basis, at the holder’s option (except with respect to 500,000 of the private warrants held by Rosedale Park, LLC and 500,000 of the private warrants held by LifeSci Holdings LLC, which were amended to remove the cashless exercise provision), and will not be redeemable by the Company (except with respect to 500,000 of the private warrants held by Rosedale Park, LLC and 500,000 of the private warrants held by LifeSci Holdings LLC, which were amended to include a redemption provision substantially identical to that of the public warrants; provided, however, that such redemption rights may not be exercised during the first 12 months following the closing of the Business Combination unless the last sales price of the Company’s common stock has been equal to or greater than $20.00 per share for any 20 trading days within a 30 trading day period ending on the third business day prior to the date on which notice of redemption is given), in each case so long as they are still held by the initial purchasers or their affiliates. The private warrants purchased by Rosedale Park, LLC, will expire on March 5, 2025, provided that once the private warrants are not beneficially owned by Chardan Capital Markets, LLC or any of its related persons anymore, the private warrants may not be exercised five years following the completion of the Company’s initial business combination. The previously outstanding public warrants and the private warrants issued to LifeSci Holdings LLC that were amended as described above were determined to be equity classified in accordance with ASC 815, Derivatives and Hedging. The remaining private warrants were determined to be liability classified in accordance with ASC 815, Derivatives and Hedging (see note 4). |
Equity Incentive Plans |
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Share-based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity Incentive Plans | NOTE 7. EQUITY INCENTIVE PLANS In connection with the Business Combination, the stockholders approved the Vincerx Pharma, Inc. 2020 Stock Incentive Plan (the “2020 Plan”), which became effective upon the closing of the Business Combination on December 23, 2020. As of June 30, 2021, the Company had 3,490,046 shares of common stock reserved for issuance under the 2020 Plan. The 2020 Plan allows for the grant of stock options and rights to acquire restricted stock to employees, directors and consultants of the Company. The terms and conditions of specific awards are set at the discretion of the Company’s board of directors. Options granted under the 2020 Plan expire no later than 10 years from the date of grant. Unvested common shares obtained upon early exercise of options are subject to repurchase by the Company at the original issue price. Stock option activity under the 2020 Plan is as follows (amounts in thousands, except per share amount):
Stock-based compensation expense is based on the grant-date fair value. The Company recognizes compensation expense for all stock-based awards on a straight-line basis over the requisite service period of the awards, which is generally the option vesting term of three years. The Company recognized stock-based compensation of approximately $6.6 million and $11.4 million during the three- and six- months ended June 30, 2021, respectively. The Company recorded a de minimus value of stock-based compensation for the comparable periods in 2020. As of June 30, 2021, the Company had stock-based compensation of approximately $23.0 million related to unvested stock options not yet recognized that are expected to be recognized over an estimated weighted average period of 2.8 years. The following weighted average assumptions were used as inputs to the Black-Scholes option valuation model in determining the estimated grant-date fair value of the Company’s stock options granted during the six months ended June 30, 2021:
Total stock-based compensation expense recognized in the three- and six- months ended June 30, 2021 was as follows (amounts in thousands):
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Net Loss per Share Applicable to Common Stockholders |
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Net Loss per Share Applicable to Common Stockholders | NOTE 8. NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share is computed similarly to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. The following table sets forth the computation of loss per share for the three- and six-months ended June 30, 2021 and 2020 (amounts in thousands, except per share number):
The following table presents the potential common stock outstanding that was excluded from the computation of diluted net loss per share of common stock as of the periods presented because including them would have been antidilutive (amount in thousands):
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Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X of the rules and regulations of the SEC. They include the accounts of Vincerx and its wholly-owned subsidiaries VNRX Corp and Vincerx Pharma GmbH. All intercompany accounts and transactions have been eliminated. Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2020 as filed with the SEC on May 14, 2021, which contains the audited financial statements and notes thereto. The financial information as of December 31, 2020 is derived from the audited financial statements presented in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2020. The interim results for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any future periods. The Business Combination is accounted for as a reverse recapitalization, with no goodwill or other intangible assets recorded, in accordance with GAAP. Under this method of accounting, LSAC is treated as the “acquired” company for financial reporting purposes. Accordingly, for accounting purposes, the Business Combination is treated as the equivalent of Legacy Vincera Pharma issuing stock for the net assets of LSAC, accompanied by a recapitalization. As a result, references to the “Company” herein may refer to Legacy Vincera Pharma prior to the consummation of the Business Combination. The acquired net assets of LSAC are stated at historical cost, with no goodwill or other intangible assets recorded. |
Use of Estimates | Use of Estimates The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of commitments and contingencies at the date of the financial statements as well as reported amounts of expenses during the reporting periods. Estimates made by the Company include, but are not limited to, those related to the valuation of common stock prior to the Business Combination, common stock warrant liabilities and stock-based compensation. The Company bases these estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying amounts of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. |
Significant Accounting Policies | Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the Company’s Annual Report on Form
10-K/A other than the additions below. |
Leases | Leases Effective January 1, 2021, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 842, Leases Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use Operating lease liabilities and their corresponding right-of-use right-of-use In accordance with ASC 842, components of a lease should be allocated between lease components (e.g., land, building, etc.) and
non-lease components (e.g., common area maintenance, consumables, etc.). The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02 , Leases (Topic 842 2018-11, Leases (Topic 842): Targeted Improvements right-of-use assets and lease liabilities of approximately$ 3.3 million, which represents the discounted cash flows of the Company’s operating lease prior to the April 2021 lease amendment. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes 2019-12 removes certain exceptions to the general principles in ASC 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. On January 1, 2021, the Company adopted this standard without any material impact on its condensed consolidated financial statements. In August 2020, the FASB issued ASU
2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity |
Fair Value Measurements (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Liabilities Measurement on Fair Value Recurring Basis | The Company’s financial liabilities subject to fair value measurements on a recurring basis and the level of inputs used for such measurements were as follows (amounts in thousands):
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Summary of Changes in Fair Value Liabilities Attributable to Both Observable and Unobservable | The following table presents changes in Level 3 liabilities measured at fair value for the six-month period ended June 30, 2021. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long-dated volatilities) inputs (in thousands).
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Summary of Weighted Average Significant Unobservable Inputs Level 3 Inputs Used in Measuring The Company's Warrant Liabilities | A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities that are categorized within Level 3 of the fair value hierarchy as of June 30, 2021 and December 31, 2020 is as follows:
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Summary of Quantitative Information About the Company's Operating Leases | The following summarizes quantitative information about the Company’s operating leases (amounts in thousands):
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Summary of Future Minimum Lease Payments | As of June 30, 2021, future minimum payments during the next five years and thereafter are as follows (in thousands):
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Equity [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Restricted Stock Activity | A summary of restricted stock activity for the six months ended June 30, 2021 is presented below:
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Equity Incentive Plans (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Stock Option Activity | Stock option activity under the 2020 Plan is as follows (amounts in thousands, except per share amount):
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Summary of Weighted-Average Assumptions Used to Estimate Fair Value of Stock Options and Restricted Stock Awards using Black-Scholes Option Valuation Model | The following weighted average assumptions were used as inputs to the Black-Scholes option valuation model in determining the estimated grant-date fair value of the Company’s stock options granted during the six months ended June 30, 2021:
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Summary of Stock Based Compensation Expense | Total stock-based compensation expense recognized in the three- and six- months ended June 30, 2021 was as follows (amounts in thousands):
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Net Loss per Share Applicable to Common Stockholders (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Earnings Per Share, Basic and Diluted | The following table sets forth the computation of loss per share for the three- and six-months ended June 30, 2021 and 2020 (amounts in thousands, except per share number):
|
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Summary of Potential Common Stock Outstanding that was excluded from the Computation of Diluted Net Loss Per Share of Common Stock | The following table presents the potential common stock outstanding that was excluded from the computation of diluted net loss per share of common stock as of the periods presented because including them would have been antidilutive (amount in thousands):
|
Nature of Business - Additional Information (Details) |
6 Months Ended |
---|---|
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Incorporation date | Dec. 19, 2018 |
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands |
Jun. 30, 2021 |
Mar. 31, 2021 |
---|---|---|
Summary Of Significant Accounting Policies [Line Items] | ||
Lease term | 12 months | |
Amount of right-of-use asset expected to be recorded after adoption of ASU 2016-02 | $ 4,217 | |
Accounting Standards Update 2016-02 [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Amount of right-of-use asset expected to be recorded after adoption of ASU 2016-02 | $ 3,300 | |
Amount of lease liability expected to be recorded of ASU 2016-02 | $ 3,300 |
Bayer License - Additional Information (Details) - USD ($) $ in Millions |
6 Months Ended | |
---|---|---|
Jan. 05, 2021 |
Jun. 30, 2021 |
|
Bayer License [Line Items] | ||
Date of licence agreement with Bayer | Oct. 07, 2020 | |
Licence fee paid to Bayer | $ 5.0 | |
Aggregate milestone payments Payable to Bayer | $ 1,000.0 | |
Minimum [Member] | ||
Bayer License [Line Items] | ||
Milestone payments payables per licenced product to Bayer | 110.0 | |
Maximum [Member] | ||
Bayer License [Line Items] | ||
Milestone payments payables per licenced product to Bayer | $ 318.0 |
Fair Value Measurement - Summary of Liabilities Measurement on Fair Value Recurring Basis (Details) - USD ($) $ in Thousands |
Jun. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Liabilities: | ||
Common stock warrant liabilities | $ 11,097 | $ 32,308 |
Total fair value | 11,097 | 32,308 |
Level 3 [Member] | ||
Liabilities: | ||
Common stock warrant liabilities | 11,097 | 32,308 |
Total fair value | $ 11,097 | $ 32,308 |
Fair Value Measurement - Summary of Changes in Fair Value Liabilities Attributable to Both Observable and Unobservable (Details) $ in Thousands |
6 Months Ended |
---|---|
Jun. 30, 2021
USD ($)
| |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Beginning balance | $ 32,308 |
Reclassification of warrant liabilities due to warrant exercises | (2,503) |
Change in fair value | (18,708) |
Ending balance | $ 11,097 |
Fair Value Measurement - Summary of Weighted Average Significant Unobservable Inputs Level 3 Inputs Used in Measuring The Company's Warrant Liabilities (Details) - Level 3 [Member] |
Jun. 30, 2021
yr
$ / shares
|
Dec. 31, 2020
yr
$ / shares
|
---|---|---|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant liabilities | 0 | 0 |
Exercise price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant liabilities | 11.50 | 11.50 |
Option term [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant liabilities | yr | 4.5 | 5.0 |
Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant liabilities | 29.4 | 29.4 |
Risk-free rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant liabilities | 0.8 | 0.4 |
Stock price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant liabilities | 12.99 | 20.91 |
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands |
6 Months Ended | |
---|---|---|
Dec. 23, 2020 |
Jun. 30, 2021 |
|
Loss Contingencies [Line Items] | ||
Duration of lease agreement | 5 years | |
Date of lease Commencement | Jan. 01, 2021 | |
Annual lease rent | $ 1,100 | $ 83 |
Operating lease liabilities | 4,218 | |
Operating Right of Use Assets | $ 4,217 |
Commitments and Contingencies - Summary of Quantitative Information About the Company's Operating Leases (Details) - USD ($) $ in Thousands |
6 Months Ended | |
---|---|---|
Dec. 23, 2020 |
Jun. 30, 2021 |
|
Lease cost | ||
Operating lease cost | $ 83 | |
Variable lease cost | 0 | |
Total operating lease expense | $ 1,100 | 83 |
Operating cash flows from operating leases | 70 | |
Right-of-use assets obtained in exchange for operating lease liabilities | $ 4,166 | |
Weighted-average remaining lease term – operating leases (years) | 4 years 6 months | |
Weighted-average discount rate – operating leases | 8.00% |
Commitments and Contingencies - Summary of Future Minimum Lease Payments (Details) $ in Thousands |
Jun. 30, 2021
USD ($)
|
---|---|
Contractual Obligation, Fiscal Year Maturity [Abstract] | |
Remaining period ended December 31, 2021 | $ 266 |
Year ended December 31, 2022 | 1,015 |
Year ended December 31, 2023 | 1,236 |
Year ended December 31, 2024 | 1,284 |
Year ended December 31, 2025 | 1,336 |
Total | 5,137 |
Less present value discount | (919) |
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at June 30, 2021 | $ 4,218 |
Stockholders' Equity - Schedule of Restricted Stock Activity (Details) - Restricted Stock |
6 Months Ended |
---|---|
Jun. 30, 2021
$ / shares
shares
| |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Beginning balance, Shares | shares | 361,168 |
Vested, Shares | shares | (89,241) |
Ending balance, Shares | shares | 271,927 |
Beginning balance, Weighted Average | $ / shares | $ 0.036 |
Vested, Weighted Average | $ / shares | 0 |
Ending balance, Weighted Average | $ / shares | $ 0.041 |
Equity Incentive Plans - Additional Information (Details) - USD ($) |
3 Months Ended | 6 Months Ended | |
---|---|---|---|
Jun. 30, 2021 |
Jun. 30, 2021 |
Jun. 30, 2020 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized stock based compensation | $ 23.0 | $ 23.0 | |
Amotization period of unrecognized stock based compensation | 2 years 9 months 18 days | ||
Stock based compensation expense | $ 11,352,000 | $ 1,000 | |
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized stock based compensation | 10,919 | $ 10,919 | |
Amotization period of unrecognized stock based compensation | 3 years | ||
Stock based compensation expense | $ 6,600,000 | $ 11,400,000 | |
Twenty Thousand Twenty Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares of common stock reserved for issuance | 3,490,046 | 3,490,046 |
Equity Incentive Plans - Schedule of Weighted-Average Assumptions Used to Estimate Fair Value of Stock Options and Restricted Stock Awards using Black-Scholes Option Valuation Model (Details) |
6 Months Ended |
---|---|
Jun. 30, 2021
$ / shares
| |
Share-based Payment Arrangement [Abstract] | |
Exercise price | $ 19.02 |
Expected term (years) | 5 years 10 months 24 days |
Volatility (annual) | 75.50% |
Risk-free rate | 0.90% |
Dividend yield (per share) | 0.00% |
Equity Incentive Plans - Schedule of Employee Service Share Based Compensation Allocation of Recognized Period Costs (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended |
---|---|---|
Jun. 30, 2021 |
Jun. 30, 2021 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Payment Arrangement, Expense | $ 6,637 | $ 11,352 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Payment Arrangement, Expense | 4,401 | 7,078 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Payment Arrangement, Expense | $ 2,236 | $ 4,274 |
Net Loss per Share Applicable to Common Stockholders - Schedule of Earnings Per Share Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2021 |
Jun. 30, 2020 |
Jun. 30, 2021 |
Jun. 30, 2020 |
|
Earnings Per Share [Abstract] | ||||
Net loss | $ (2,034) | $ (33) | $ (8,310) | $ (37) |
Denominator: | ||||
Weighted average common shares outstanding, basic and diluted | 16,350 | 5,009 | 15,050 | 4,988 |
Net loss per common share, basic and diluted | $ (0.12) | $ (0.01) | $ (0.55) | $ (0.01) |
Net Loss per Share Applicable to Common Stockholders - Schedule of Potential Common Stock Outstanding that was excluded from the Computation of Diluted Net Loss Per Share of Common Stock (Details) - shares shares in Thousands |
3 Months Ended | 6 Months Ended | |
---|---|---|---|
Jun. 30, 2021 |
Jun. 30, 2020 |
Jun. 30, 2020 |
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 6,467 | ||
Option Outstanding [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,172 | ||
Warrant [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,295 |
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