Table of Contents
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 | ||||||
Table of Contents
TABLE OF CONTENTS
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 5 | ||||
| 5 | ||||
| ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
18 | |||
| ITEM 3. Quantitative and Qualitative Disclosures About Market Risk |
24 | |||
| 25 | ||||
| 26 | ||||
| 26 | ||||
| 26 | ||||
| 55 |
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Forward-Looking Statements
This report contains forward-looking statements that involve risks and uncertainties. These statements relate to future periods, future events or our future operating or financial plans or performance. When used in this report, the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “forecast,” “goal,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “seeks,” “suggests,” “scheduled,” “target,” or “will,” and similar expressions are intended to identify forward-looking statements, and include but are not limited to:
| • | our future financial and business performance; |
| • | strategic plans for our business and product candidates; |
| • | our ability to develop or commercialize products; |
| • | the expected results and timing of clinical trials and nonclinical studies; |
| • | our ability to comply with the terms of the Bayer License Agreement; |
| • | developments and projections relating to our competitors and industry; |
| • | our expectations regarding our ability to obtain, develop, and maintain intellectual property protection and not infringe on the rights of others; |
| • | our ability to retain key scientific or management personnel; |
| • | our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; |
| • | our future capital requirements and sufficiency of available cash, including our expected cash runway, and the timing of those requirements, and sources and uses of cash; |
| • | our ability to obtain funding for our operations; |
| • | the impact of our strategic prioritization and cost reduction measures; |
| • | the outcome of any known and unknown litigation and regulatory proceedings; |
| • | our business, expansion plans, and opportunities; and |
| • | changes in applicable laws or regulations. |
These statements are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those projected or otherwise implied by the forward-looking statements, including the following:
| • | risks associated with preclinical or clinical development and trials, including clinical trials conducted prior to our in-licensing; |
| • | risks related to the rollout of our business and the timing of expected business milestones; |
| • | changes in the assumptions underlying our expectations regarding our future business or business model; |
| • | our ability to develop, manufacture, and commercialize product candidates; |
| • | general economic, financial, legal, political, and business conditions and changes in domestic and foreign markets; |
| • | changes in applicable laws or regulations; |
| • | the impact of natural disasters, including climate change, and the impact of health pandemics and epidemics, including COVID-19, 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 our business may be adversely affected by other economic, business, political, or competitive factors, including the impact of inflation and the war in Ukraine; and |
| • | other risks and uncertainties set forth in this report in the section entitled “Risk Factors.” |
Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements.
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Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expected. These risks and uncertainties include, but are not limited to, those risks discussed in Item 1A of this report. These forward-looking statements made by us in this report speak only as of the date of this report. Except as required under the federal securities laws and rules and regulations of the Securities and Exchange Commission (the “SEC”), we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. You should, however, review additional disclosures we make in our definitive proxy statement for the 2023 Annual Meeting of Stockholders, Annual Report on Form 10-K for the year ended December 31, 2022, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the SEC.
You should read this report completely and with the understanding that our actual future results, levels of activity and performance as well as other events and circumstances may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
Frequently Used Terms
Unless the context indicates otherwise, references in this report to the “Company,” “Vincerx,” “we,” “us,” “our,” and similar terms refer to Vincerx Pharma, Inc. (f/k/a Vincera Pharma, Inc. f/k/a LifeSci Acquisition Corp.) and its consolidated subsidiaries. References to “LSAC” refer to LifeSci Acquisition Corp., our predecessor company prior to the consummation of the Business Combination (as defined below). Additional terms frequently used in this report include the following:
| • | “ADC” means antibody-drug conjugate. |
| • | “Affordable Care Act” means the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act. |
| • | “AML” means acute myeloid leukemia. |
| • | “ANDA” means an abbreviated new drug application. |
| • | “Bayer License Agreement” means that certain License Agreement, dated October 7, 2020, by and among Legacy Vincera Pharma, Bayer Aktiengesellschaft and Bayer Intellectual Property GmbH. |
| • | “BLA” means a biologics license application. |
| • | “BPCIA” means the Biologics Price Competition and Innovation Act of 2009. |
| • | “Business Combination” means the Merger and the other transactions described in the Merger Agreement. |
| • | “BTKi” means Bruton tyrosine kinase inhibitor. |
| • | “Bylaws” means our amended and restated bylaws. |
| • | “CDK” means cyclin-dependent kinase. |
| • | “Certificate of Incorporation” means our second amended and restated certificate of incorporation, as amended. |
| • | “cGMP” means current Good Manufacturing Practice. |
| • | “CLL” means chronic lymphocytic leukemia. |
| • | “common stock” means our common stock, $0.0001 par value per share. |
| • | “CPT” means camptothecin. |
| • | “DH-DLBCL” means double-hit diffuse large B-cell lymphoma (i.e., DLBCL characterized by translocations of MYC and BCL-2). |
| • | “Earnout Shares” means certain rights to common stock after the closing of the Business Combination that Legacy Holders may be entitled to receive pursuant to the Merger Agreement. |
| • | “Exchange Act” means the Securities Exchange Act of 1934, as amended. |
| • | “FDA” means the U.S. Food and Drug Administration. |
| • | “GAAP” means accounting principles generally accepted in the United States of America. |
| • | “IND” means an investigational new drug application. |
| • | “JOBS Act” means the Jumpstart Our Business Startups Act of 2012. |
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| • | “KSPi” means kinesin spindle protein inhibitor. |
| • | “Legacy Holders” means the stockholders of Legacy Vincera Pharma immediately prior to the Business Combination. |
| • | “Legacy Vincera Pharma” means Vincera Pharma, Inc. prior to the consummation of the Business Combination, which changed its name to VNRX Corp. following the Business Combination. |
| • | “MCL” means mantle cell lymphoma. |
| • | “MCL1” means a protein coding gene. |
| • | “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. |
| • | “mRNA” means messenger RNA. |
| • | “MYC” means a family of regulator genes and proto-oncogenes that code for transcription factors. |
| • | “NDA” means a new drug application. |
| • | “public warrants” means warrants originally issued in the initial public offering of LSAC, which were redeemed in April 2021. |
| • | “private warrants” means the warrants issued simultaneously with the closing of the initial public offering of LSAC in a private placement to LifeSci Holdings LLC and Rosedale Park, LLC and the warrants issued pursuant to Section 8.6 of the Merger Agreement. |
| • | “P-TEFb/CDK9” means positive transcription elongation factor beta/cyclin-dependent kinase 9. |
| • | “Securities Act” means the Securities Act of 1933, as amended. |
| • | “SMDC” means small molecule drug conjugate. |
| • | “USPTO” means the United States Patent and Trademark Office. |
| • | “Warrant Agreement” means that certain Warrant Agreement, dated March 5, 2020, between LSAC and the Continental Stock Transfer & Trust Company. |
Vincerx®, Vincerx Pharma®, the Vincerx Wings logo design and CellTrapper™ are our trademarks or registered trademarks. This report may also contain trademarks and trade names that are the property of their respective owners.
Summary Risk Factors
Our business is subject to numerous risks and uncertainties that could affect our ability to successfully implement our business strategy and affect our financial results. You should carefully consider all of the information in this report and, in particular, the following principal risks and all of the other specific factors described in Part II, Item 1A of this report, “Risk Factors,” before deciding whether to invest in our 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 VIP236, VIP943, VIP924, enitociclib (formerly VIP152), and our other current product candidates, raise capital or continue our operations. |
| • | We are substantially dependent on the success of VIP236, VIP943, and enitociclib, our lead product candidates. If we are unable to complete development of, obtain approval for, and commercialize these lead product candidates in a timely manner, our business will be harmed. |
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| • | We are at an early stage in development efforts for our product candidates, and we may not be able to successfully develop, manufacture, complete clinical trials, and commercialize our product candidates on a timely basis or at all. |
| • | 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. |
| • | Our preclinical development, clinical trials, manufacturing, supply chains and other operations and business activities, and the operations and business activities of third parties with whom we conduct business, including our contract manufacturers, contract research organizations, shippers, clinical trial sites and others, have been, and could continue to be, adversely affected by the effects of health pandemics and epidemics, including COVID-19. |
| • | 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, or eliminate one or more of our research and drug development programs or future commercialization efforts. |
| • | 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 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, target, or indication and fail to capitalize on product candidates, targets, or indications that may be more profitable or for which there is a greater likelihood of success. |
| • | Clinical trials are expensive, time consuming, subject to enrollment and other delays, 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 successfully complete the development, clinical trials and commercialization of any of our product candidates currently in preclinical and clinical development, should they succeed. |
| • | 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 prospects. |
| • | Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations, including those under the Inflation Reduction Act of 2022. |
| • | 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. |
| • | 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 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. |
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ITEM 1. |
Financial Statements. |
June 30, 2023 |
December 31, 2022 |
|||||||
(Unaudited) |
||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
||||||||
Short-term marketable securities |
||||||||
Prepaid expenses |
||||||||
Grant receivable |
||||||||
Other current assets |
||||||||
Total current assets |
||||||||
Right-of-use |
||||||||
Property, plant and equipment, net |
||||||||
Other assets |
||||||||
Total assets |
$ |
$ |
||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued expenses |
||||||||
Lease liability |
||||||||
Common stock warrant liabilities |
||||||||
Total current liabilities |
||||||||
Lease liability, net of current portion |
||||||||
Other noncurrent liabilities |
||||||||
Total liabilities |
||||||||
Commitments and contingencies - Note 6 |
||||||||
Stockholders’ equity |
||||||||
Preferred stock, $ |
||||||||
Common stock, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated other comprehensive income (loss) |
( |
) | ||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Total stockholders’ equity |
||||||||
Total liabilities and stockholders’ equity |
$ |
$ |
||||||
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
Operating expenses: |
||||||||||||||||
General and administrative |
$ | $ | $ | $ | ||||||||||||
Research and development |
||||||||||||||||
Restructuring |
||||||||||||||||
Total operating expenses |
||||||||||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other income (expense) |
||||||||||||||||
Change in fair value of warrant liabilities |
( |
) | ( |
) | ||||||||||||
Interest income |
||||||||||||||||
Other income (expense) |
( |
) | ||||||||||||||
Total other income (expense) |
||||||||||||||||
Net loss |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
Other comprehensive income: |
||||||||||||||||
Net foreign currency translation gain |
||||||||||||||||
Net unrealized gain on marketable securities |
||||||||||||||||
Comprehensive loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||
Net loss per common share, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Weighted average common shares outstanding, basic and diluted |
||||||||||||||||
For the Three Months Ended June 30, 2023 |
||||||||||||||||||||||||
Common Stock |
Additional Paid-in Capital |
Accumulated Other Comprehensive Income (Loss) |
Accumulated Deficit |
Total Stockholders’ Equity |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
| Balance as of April 1, 2023 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| Issuance of common stock from employee stock plans |
— | — | ||||||||||||||||||||||
| Stock-based compensation |
— | — | — | — | ||||||||||||||||||||
| Cumulative translation adjustment |
— | — | — | — | ||||||||||||||||||||
| Unrealized gain on marketable securities |
— | — | — | — | ||||||||||||||||||||
| Net loss |
— | — | — |
— | ( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Balance as of June 30, 2023 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
For the Six Months Ended June 30, 2023 |
||||||||||||||||||||||||
Common Stock |
Additional Paid-in Capital |
Accumulated Other Comprehensive Income (Loss) |
Accumulated Deficit |
Total Stockholders’ Equity |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
| Balance as of January 1, 2023 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||
| Issuance of common stock from employee stock plans |
— | — | ||||||||||||||||||||||
| Stock-based compensation |
— | — | — | — | ||||||||||||||||||||
| Cumulative translation adjustment |
— | — | — | — | ||||||||||||||||||||
| Unrealized gain on marketable securities |
— | — | — | — | ||||||||||||||||||||
| Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Balance as of June 30, 2023 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
For the Three Months Ended June 30, 2022 |
||||||||||||||||||||||||
Common Stock |
Additional Paid-in Capital |
Accumulated Other Comprehensive Income (Loss) |
Accumulated Deficit |
Total Stockholders’ Equity |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
| Balance as of April 1, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||
| Issuance of common stock from employee stock plans |
— | — | ||||||||||||||||||||||
| Stock-based compensation |
— | — | — | — | ||||||||||||||||||||
| Cumulative translation adjustment |
— | — | — | |||||||||||||||||||||
| Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Balance as of June 30, 2022 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
For the Six Months Ended June 30, 2022 |
||||||||||||||||||||||||
Common Stock |
Additional Paid-in Capital |
Accumulated Other Comprehensive Income (Loss) |
Accumulated Deficit |
Total Stockholders’ Equity |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
| Balance as of January 1, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||
| Issuance of common stock from employee stock plans |
— | — | ||||||||||||||||||||||
| Stock-based compensation |
— |
— |
— |
— |
||||||||||||||||||||
| Cumulative translation adjustment |
— |
— |
— |
— |
||||||||||||||||||||
| Net loss |
— |
— |
— |
— |
( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Balance as of June 30, 2022 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
For the six months ended June 30, |
||||||||
2023 |
2022 |
|||||||
Cash flows from operating activities |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation |
||||||||
Stock-based compensation |
||||||||
Amortization of right-of-use |
||||||||
Change in fair value of warrant liabilities |
( |
) | ||||||
Net amortization of discounts on marketable securities |
( |
) | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid and other current assets |
( |
) | ( |
) | ||||
Other assets |
( |
) | ||||||
Accounts payable |
( |
) | ||||||
Accrued expenses |
( |
) | ||||||
Lease liabilities |
( |
) | ( |
) | ||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
Cash Flows from Investing Activities: |
||||||||
Purchases of marketable securities |
( |
) | ||||||
Sales and maturities of marketable securities |
||||||||
Net cash provided by investing activities |
||||||||
Cash Flows from Financing Activities: |
||||||||
Proceeds from issuance of common stock from employee stock plans |
||||||||
Net cash provided by financing activities |
||||||||
Effect of exchange rate changes on cash, cash equivalents, and restricted cash |
||||||||
Net decrease in cash, cash equivalents, and restricted cash |
( |
) | ( |
) | ||||
Cash, cash equivalents, and restricted cash at beginning of the period |
||||||||
Cash, cash equivalents, and restricted cash at end of the period |
$ |
$ |
||||||
Supplemental disclosure of cash flow information: |
||||||||
Cash paid for interest |
$ | $ | ||||||
Cash paid for income taxes |
$ | $ | ||||||
Fair Value Measured as of June 30, 2023 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Assets: |
||||||||||||||||
Cash Equivalents: |
||||||||||||||||
Money market funds |
$ | $ | $ | $ | ||||||||||||
Short-term marketable securities: |
||||||||||||||||
Commercial paper |
||||||||||||||||
U.S. government treasuries |
||||||||||||||||
U.S. government agency securities |
||||||||||||||||
Corporate debt securities |
||||||||||||||||
Total cash equivalents and marketable securities |
$ | $ | $ | $ | ||||||||||||
Fair Value Measured as of December 31, 2022 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Assets: |
||||||||||||||||
Cash Equivalents: |
||||||||||||||||
Money market funds |
$ | $ | $ | $ | ||||||||||||
Commercial paper |
||||||||||||||||
Corporate debt securities |
||||||||||||||||
Short-term marketable securities: |
||||||||||||||||
Commercial paper |
||||||||||||||||
U.S. government treasuries |
||||||||||||||||
U.S. government agency securities |
||||||||||||||||
Corporate debt securities |
||||||||||||||||
Total cash equivalents and marketable securities |
$ | $ | $ | $ | ||||||||||||
Fair Value Measured as of June 30, 2023 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Liabilities: |
||||||||||||||||
Common stock warrant liabilities |
$ | $ | $ | $ | ||||||||||||
Total fair value |
$ | $ | $ | $ | ||||||||||||
Fair Value Measured as of December 31, 2022 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Liabilities: |
||||||||||||||||
Common stock warrant liabilities |
$ | $ | $ | $ | ||||||||||||
Total fair value |
$ | $ | $ | $ | ||||||||||||
Warrant Liability |
||||
Balance – January 1, 2023 |
$ |
|||
in fair value |
||||
Balance – June 30, 2023 |
$ |
|||
As of June 30, 2023 |
As of December 31, 2022 |
|||||||
Stock price |
$ | $ | ||||||
Exercise price |
$ | $ | ||||||
Option term (years) |
||||||||
Volatility (annual) |
% | % | ||||||
Risk-free rate |
% | % | ||||||
Dividend yield (per share) |
% | % | ||||||
June 30, 2023 |
||||||||||||||||
Amortized Cost |
Gross Unrealized Gain |
Gross Unrealized Loss |
Fair Value |
|||||||||||||
Assets: |
||||||||||||||||
Short-term marketable securities: |
||||||||||||||||
Commercial paper |
$ | $ | $ | ( |
) | $ | ||||||||||
U.S. government treasuries |
( |
) | ||||||||||||||
U.S. government agency securities |
( |
) | ||||||||||||||
Corporate debt securities |
||||||||||||||||
Total marketable securities |
$ | $ | $ | ( |
) | $ | ||||||||||
December 31, 2022 |
||||||||||||||||
Amortized Cost |
Gross Unrealized Gain |
Gross Unrealized Loss |
Fair Value |
|||||||||||||
Assets: |
||||||||||||||||
Short-term marketable securities: |
||||||||||||||||
Commercial paper |
$ | $ | $ | ( |
) | $ | ||||||||||
U.S. government treasuries |
( |
) | ||||||||||||||
U.S. government agency securities |
( |
) | ||||||||||||||
Corporate debt securities |
( |
) | ||||||||||||||
Total marketable securities |
$ | $ | $ | ( |
) | $ | ||||||||||
For the three months ended |
For the six months ended |
|||||||||||||||
June 30, 2023 |
June 30, 2022 |
June 30, 2023 |
June 30, 2022 |
|||||||||||||
Lease cost |
||||||||||||||||
Operating lease cost |
$ |
$ |
$ | $ | ||||||||||||
Variable lease cost |
||||||||||||||||
Total operating lease expense |
$ |
$ |
$ | $ | ||||||||||||
Other information |
||||||||||||||||
Operating cash flows from operating leases |
$ |
$ |
$ | $ | ||||||||||||
Right-of-use operating lease liabilities |
$ |
$ |
$ | $ | ||||||||||||
Weighted-average remaining lease term – operating leases |
||||||||||||||||
Weighted-average discount rate – operating leases |
% |
% |
% | % | ||||||||||||
Remaining period ended December 31, 2023 |
$ | |||
Year ended December 31, 2024 |
||||
Year ended December 31, 2025 |
||||
Year ended December 31, 2026 |
||||
Total |
||||
Less present value discount |
( |
) | ||
Operating lease liabilities included in the condensed consolidated balance sheet at June 30, 2023 |
$ | |||
Number of Shares |
Weighted Average Grant Date Fair Value per Share |
|||||||
Nonvested at January 1, 2023 |
$ |
|||||||
Vested |
( |
) | ||||||
Nonvested at March 31, 2023 |
$ |
|||||||
Vested |
( |
) | ||||||
Nonvested at June 30, 2023 |
$ |
|||||||
Number of Shares |
Weighted Average Grant Date Fair Value per Share |
|||||||
Nonvested at January 1, 2022 |
$ |
|||||||
Vested |
( |
) | ||||||
Nonvested at March 31, 2022 |
||||||||
Vested |
( |
) | ||||||
Nonvested at June 30, 2022 |
$ |
|||||||
Stock Options |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Life (in years) |
Aggregate Intrinsic Value |
|||||||||||||
Outstanding at January 1, 2023 |
$ | $ | ||||||||||||||
Options granted |
— | — | ||||||||||||||
Options exercised |
( |
) | — | — | ||||||||||||
Options cancelled |
( |
) | — | — | ||||||||||||
Outstanding at June 30, 2023 |
$ | $ | ||||||||||||||
Options vested and exercisable at June 30, 2023 |
$ | $ | ||||||||||||||
For the six months ended June 30, |
||||||||
2023 |
2022 |
|||||||
Exercise price |
$ | $ | ||||||
Expected term (years) |
||||||||
Volatility (annual) |
% | % | ||||||
Risk-free rate |
% | % | ||||||
Dividend yield (per share) |
% | % | ||||||
| For the three months ended | For the six months ended | |||||||||||||||
| June 30, 2023 | June 30, 2022 | June 30, 2023 | June 30, 2022 | |||||||||||||
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, |
|||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
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 ended June 30, |
||||||||
2023 |
2022 |
|||||||
Options outstanding |
||||||||
Warrants |
||||||||
Restricted stock |
||||||||
Total |
||||||||
Table of Contents
| ITEM 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
The below discussion should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations and the audited consolidated financial statements and notes thereto for the year ended December 31, 2022 included in our Annual Report on Form 10-K for the year ended December 31, 2022 and with the unaudited condensed consolidated financial statements and the notes thereto contained elsewhere in this report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.
Overview
We are a clinical-stage biopharmaceutical company focused on leveraging our extensive development and oncology expertise to advance new therapies intended to address unmet medical needs for the treatment of cancer. Our current pipeline is entirely derived from the Bayer License Agreement, pursuant to which we have been granted an exclusive, royalty-bearing, worldwide license under certain Bayer patents and know-how to develop, use, manufacture, commercialize, sublicense, and distribute (i) a bioconjugation platform, which includes next-generation antibody-drug conjugates and small molecule drug conjugates, and (ii) a small molecule drug program. We intend to use these product candidates to treat various cancers in a patient-specific, targeted approach. We believe that these product candidates are differentiated from current programs targeting similar cancer biology and, if approved, may improve clinical outcomes of patients with cancer.
Despite several decades of advances in targeted therapies, cancer continues to be the second leading cause of death in the United States population per the National Center for Health Statistics. Cancer is not a single disease but rather a constellation of maladies with each requiring a unique approach to vanquish it. Our vision is to address the unmet medical needs of patients with cancer with a diverse pipeline of targeted medicines. Our ADC platform includes VIP943 and VIP924, which are next-generation ADC compounds addressing known and novel oncology targets that we believe could deliver a greater safety and efficacy profile than current ADC compounds. Our bioconjugation program also includes VIP236, an SMDC for solid tumors. Our small molecule drug program includes enitociclib, which is a highly selective, clinical-stage P-TEFb/CDK9 inhibitor. In addition to our lead products, we acquired the rights to additional product candidates that are still in the preclinical stage.
License Agreement with Bayer
Following the closing of the Business Combination, we paid Bayer a $5.0 million upfront license fee under the Bayer License Agreement. In addition, we will be responsible for significant development and commercial milestone payments to Bayer as well as ongoing royalties on commercial sales. See the discussion below under “Liquidity and Capital Resources.”
Basis of Presentation
We currently conduct our business through one operating segment. As a pre-revenue company with no commercial operations, our activities to date have been limited and were conducted primarily in the United States. Our historical results are reported under GAAP and in U.S. dollars.
Components of Results of Operations
We are a research and development stage company, and our historical results may not be indicative of our future results for reasons that may be difficult to anticipate. Accordingly, the drivers of our future financial results, as well as the components of such results, may not be comparable to our historical results of operations.
Revenue
To date, we have not recognized any revenue from any sources, including from product sales, and we do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.
Research and Development Expense
Research and development expenses consist or will consist of preclinical development of our product candidates and discovery efforts (including conducting preclinical studies), manufacturing development efforts, preparing for and conducting clinical trials, and activities related to regulatory filings for our product candidates. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. Costs incurred in obtaining technology licenses through asset acquisitions are charged to research and
18
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development expense if the licensed technology has not reached technological feasibility and has no alternative future use. Research and development expenses include or could include:
| • | 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. |
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We anticipate that our research and development expenses will increase in the future as we continue to develop our product candidates and manufacturing processes and conduct discovery and research activities for our preclinical and clinical programs. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments, and our ongoing assessments as to each product candidate’s commercial potential. Our clinical development costs are expected to increase significantly as we commence, continue, and expand our clinical trials. Our future expenses may vary significantly each period based on factors such as:
| • | expenses incurred to conduct preclinical studies required to advance our product candidates into clinical trials, including the impact of factors such as inflation, the war in Ukraine, supply chain disruptions, and health pandemics and epidemics, including COVID-19; |
| • | per patient clinical trial costs, including based on the number of doses that patients receive and the cost of drug products for combination therapies; |
| • | 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. |
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Table of Contents
General and Administrative Expenses
General and administrative expenses consist or will consist principally of salaries and related costs for personnel in executive and administrative functions, including stock-based compensation, travel expenses, and recruiting expenses. Other general and administrative expenses include professional fees for legal, accounting, and tax-related services and insurance costs.
We anticipate that our general and administrative expenses will increase in the future as we expand our operations and infrastructure to support the initiation, continuation, and expansion of our preclinical studies and clinical trials for our product candidates. We also anticipate that our general and administrative expenses will increase as a result of payments for accounting, audit, legal, and consulting services, as well as costs associated with maintaining compliance with Nasdaq listing rules and SEC requirements, director and officer liability insurance, investor and public relations activities, and other expenses associated with operating as a public company.
Change in Fair Value of Warrant Liabilities
Certain of our private warrants are classified as liabilities pursuant to ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity. The change in fair value of warrant liabilities consists of the change in fair value of these private warrants.
Results of Operations
Comparison of the Three and Six Months Ended June 30, 2023 and 2022
The following tables set forth our historical operating results for the periods indicated (amounts in thousands):
| For the three months ended June 30 |
||||||||||||
| 2023 | 2022 | Amount Change | ||||||||||
| Operating expenses: |
||||||||||||
| General and administrative |
$ | 3,787 | $ | 4,722 | $ | (935 | ) | |||||
| Research and development |
7,873 | 13,742 | (5,869 | ) | ||||||||
| Restructuring |
— | 1,159 | (1,159 | ) | ||||||||
|
|
|
|
|
|
|
|||||||
| Total operating expenses |
11,660 | 19,623 | (7,963 | ) | ||||||||
|
|
|
|
|
|
|
|||||||
| Loss from operations |
(11,660 | ) | (19,623 | ) | 7,963 | |||||||
|
|
|
|
|
|
|
|||||||
| Other income (expense) |
||||||||||||
| Change in fair value of warrant liabilities |
(118 | ) | 1,202 | (1,320 | ) | |||||||
| Interest income |
327 | — | 327 | |||||||||
| Other income (expense) |
300 | — | 300 | |||||||||
|
|
|
|
|
|
|
|||||||
| Total other income (expense) |
509 | 1,202 | (693 | ) | ||||||||
|
|
|
|
|
|
|
|||||||
| Net loss |
$ | (11,151 | ) | $ | (18,421 | ) | $ | 7,270 | ||||
|
|
|
|
|
|
|
|||||||
| For the six months ended June 30 |
||||||||||||
| 2023 | 2022 | Amount Change | ||||||||||
| Operating expenses: |
||||||||||||
| General and administrative |
$ | 8,299 | $ | 10,378 | $ | (2,079 | ) | |||||
| Research and development |
18,460 | 29,713 | (11,253 | ) | ||||||||
| Restructuring |
— | 1,159 | (1,159 | ) | ||||||||
|
|
|
|
|
|
|
|||||||
| Total operating expenses |
26,759 | 41,250 | (14,491 | ) | ||||||||
|
|
|
|
|
|
|
|||||||
| Loss from operations |
(26,759 | ) | (41,250 | ) | 14,491 | |||||||
|
|
|
|
|
|
|
|||||||
| Other income (expense) |
||||||||||||
| Change in fair value of warrant liabilities |
(100 | ) | 6,413 | (6,513 | ) | |||||||
| Interest income |
793 | — | 793 | |||||||||
| Other income (expense) |
574 | (8 | ) | 582 | ||||||||
|
|
|
|
|
|
|
|||||||
| Total other income (expense) |
1,267 | 6,405 | (5,138 | ) | ||||||||
|
|
|
|
|
|
|
|||||||
| Net loss |
$ | (25,492 | ) | $ | (34,845 | ) | $ | 9,353 | ||||
|
|
|
|
|
|
|
|||||||
20
Table of Contents
Research and Development
Research and development expenses decreased by approximately $5.9 million and $11.3 million, respectively, for the three and six months ended June 30, 2023 compared to the three and six months ended June 30, 2022. The decrease for the three months ended June 30, 2023 compared with the same period in 2022 is primarily the result of decreases in stock-based compensation expense of approximately $2.0 million, payroll related costs of approximately $0.9 million as a result of our headcount reduction in June 2022, clinical services of approximately $1.1 million, and third party research and preclinical work of approximately $1.1 million. The decrease for the six months ended June 30, 2023 compared with the same period in 2022 is primarily the result of decreases in stock-based compensation expense of approximately $5.0 million, payroll related costs of approximately $2.1 million as a result of the headcount reduction, clinical services of approximately $1.8 million, and manufacturing services associated with our ADC program of approximately $1.4 million.
General and Administrative
General and administrative expenses decreased by approximately $1.0 million and $2.1 million, respectively, for the three and six months ended June 30, 2023 compared to the three and six months ended June 30, 2022. These decreases are primarily due to decreases in stock-based compensation expense of approximately $0.7 million and $1.8 million for the three and six months ended June 30, 2023, respectively.
Change in Fair Value of Warrant Liabilities
The change in fair value of warrant liabilities for the three and six months ended June 30, 2022 is primarily due to the decrease in the closing price of our common stock from $10.19 as of December 31, 2021 to $4.00 as of March 31, 2022, and to $1.32 as of June 30, 2022. For the three and six months ended June 30, 2023, the change in the stock price was insignificant.
Interest Income
Interest income is primarily comprised of interest income and gains or losses realized on cash, cash equivalents, and marketable securities. The increase in interest income to $0.3 million and $0.8 million for the three and six months ended June 30, 2023, respectively, is a result of rising interest rates within our portfolio of cash equivalents and short-term marketable securities.
Other Income (Expense)
Other income (expense) is primarily comprised of estimated grant income of approximately $0.3 million and $0.5 million for the three and six months ended June 30, 2023, respectively, earned in connection with our research activities conducted at our German subsidiary, partially offset by foreign currency transaction gains and losses related to certain transactions with European third-party vendors.
Liquidity and Capital Resources
To date, we have not generated any revenue from any source, including the commercial sale of approved drug products, and we do not expect to generate revenue in the foreseeable future. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval, our ability to generate future revenue will be adversely affected. We do not know when, or if, we will generate any revenue from our product candidates, and we do not expect to generate revenue unless and until we obtain regulatory approval of, and commercialize, our product candidates.
We expect our operating expenses to decrease over the next 12 months as we have completed significant portions of our manufacturing activities related to our lead programs, VIP236 and VIP943. We intend to prioritize resources towards advancing Phase I studies in these two lead programs and control spending, including discretionary spending, in other areas. We can adjust our operating plan spending levels based on the timing of future clinical trials, which are predicated upon adequate funding to complete the trials. We routinely evaluate the status of our clinical development programs as well as potential strategic options.
We will also be responsible for significant payments to Bayer under the Bayer License Agreement. We paid Bayer an upfront license fee of $5.0 million following the closing of the Business Combination. In addition, we will also be responsible to Bayer for significant future contingent payments under the Bayer License Agreement upon the achievement of certain development and commercial sales milestones as well as ongoing royalties on net commercial sales. The size and timing of these milestone payments will vary greatly depending on factors such as the particular licensed product, whether it involves a P-TEFb licensed product or a bioconjugation licensed product (and which bioconjugation program), the number of distinct disease indications, the number of different countries with respect to which the milestone is achieved and the level of net commercial sales, and it is therefore difficult to estimate the total payments that could become payable to Bayer and when those payments would be due. If we achieve all of the milestones for each of the countries and disease indications, we would be obligated to pay development and commercial milestone payments that range from $110.0 million to up to $318.0 million per licensed product, and upon successful commercialization of at
21
Table of Contents
least five licensed products, we could be required to pay aggregate milestone payments in excess of $1.0 billion. We will be required to pay certain of these milestone payments prior to the time at which we are able to generate sufficient revenue, if any, from commercial sales of any of our product candidates. In addition to milestone payments, we are 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.
We therefore anticipate that we will need substantial additional funding in connection with our continuing operations. At June 30, 2023, we had approximately $27.4 million in cash, cash equivalents, and marketable securities. We intend to devote our capital resources to the preclinical and clinical development of our product candidates, our public company compliance costs, and certain of the milestone payments under the Bayer License Agreement. In June 2022, our board of directors approved a strategic plan to prioritize, focus and realign our resources, including a 33% workforce reduction, to support our prioritized studies and programs and extend our estimated cash runway. Based on our current business plans and assumptions, we believe our existing cash will enable us to fund our operating expenses and capital requirements into late 2024. Our estimate as to how long we expect our capital to be able to fund our operating expenses and capital requirements is based on plans and assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could result in less cash available to us or cause us to consume capital significantly faster than we currently anticipate, and we may need or choose to seek additional funds sooner than planned.
Because of the numerous risks and uncertainties associated with research, development, manufacturing, clinical trials, and commercialization of our product candidates, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
| • | 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 research activities, clinical trials, 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 and associated costs; |
| • | 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. |
Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive, and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of product candidates that we do not expect to be commercially available in the near term, if at all.
Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Any future debt financing and equity financing, if available, may involve covenants limiting and restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, entering into profit-sharing or other arrangements, or declaring dividends. If we raise additional funds through collaborations, strategic alliances, or marketing, distribution, or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or to grant licenses on terms that may not be favorable to us, or at all, particularly in light of current economic or market conditions. We do not have any committed external source of funds. Market
22
Table of Contents
volatility resulting from pandemics or other epidemics, including COVID-19, inflation and other economic and market conditions, the war in Ukraine, and other factors, could also adversely impact our ability to access capital as and when needed. Our failure to raise capital as and when needed or on acceptable terms would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend, or eliminate one or more of our research-stage programs, clinical trials, or future commercialization efforts.
Our business operations, and those of third parties with whom we conduct business, have been, and could continue to be, adversely affected by health pandemics and epidemics, including COVID-19, and by economic, business, and political events, including inflation and the war in Ukraine. The extent to which these factors could continue to impact our business and operations will depend on future developments that are highly uncertain and cannot be predicted with confidence. Management continues to evaluate the impact of these factors on our current operations and future plans and intends to take appropriate measures to help alleviate their impact, but there can be no assurance that these efforts will be successful and that these factors will not have a negative effect on our financial position and results of its operations.
Cash Flows
The following table provides a summary of our cash flow data for the periods indicated (amounts in thousands):
| For the six months ended June, |
||||||||
| 2023 | 2022 | |||||||
| Net cash used in operating activities |
$ | (25,789 | ) | $ | (30,915 | ) | ||
| Net cash provided by investing activities |
$ | 20,689 | $ | — | ||||
| Net cash provided by financing activities |
$ | 96 | $ | 242 | ||||
Cash Flows from Operating Activities
Our cash flows used in operating activities to date have been primarily comprised of payroll and professional service fees related to research and development, clinical trials, and general and administrative activities. As we continue to expand clinical trials of, and seek marketing approval for, our product candidates, we expect our cash used in operating activities to increase, subject to additional funding, before we start to generate any material cash flows from our business.
Net cash used in operating activities was approximately $25.8 million for the six months ended June 30, 2023, consisting primarily of payments to clinical and manufacturing service providers, internal payroll costs, and third-party professional services as we operate as a public company and prepare for and conduct our clinical trials. Our net loss during the six months ended June 30, 2023 was approximately $25.5 million, which included approximately $1.8 million related to stock-based compensation.
23
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Cash Flows from Investing Activities
Net cash provided by investing activities for the six months ended June 30, 2023 consisted of sales and maturities of marketable securities of approximately $31.3 million, partially offset by purchases of marketable securities of approximately $10.6 million.
Cash Flows from Financing Activities
Net cash provided by financing activities consists solely of proceeds from issuance of common stock from employee stock plans.
Off-Balance Sheet Arrangements
We are not a party to any off-balance sheet arrangements, as defined under SEC rules.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect our reported amounts of assets, liabilities, revenues, and expenses.
On an ongoing basis, we evaluate our estimates and judgments, including those related to derivative liabilities, accrued expenses, and stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates based on the risks and uncertainties set forth in Part II, Item 1A of this report, “Risk Factors.”
Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2022. Other than described in Note 2 to our unaudited condensed consolidated financial statements in this report, our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022.
| ITEM 3. | Quantitative and Qualitative Disclosures About Market Risk. |
We are exposed to market risks in the ordinary course of our business, including the effects of interest rate changes and fluctuations in foreign currency exchange rates. Information on quantitative and qualitive disclosures about these market risks is set forth below.
Interest Rate Risk
Cash and restricted cash consist solely of cash held in depository accounts and as such are not affected by either an increase or decrease in interest rates. Furthermore, we consider all highly liquid investments as cash equivalents. As of June 30, 2023, we held cash equivalents and short-term marketable securities. The short-term nature of these investments are not significantly impacted by changes in the interest rates. Any interest-bearing instruments carry a degree of risk; however, we have not been exposed to, nor do we anticipate being exposed to, material risks due to changes in interest rates. A hypothetical 10% change in interest rates during any of the periods presented would not have had a material impact on our unaudited condensed consolidated financial statements.
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Foreign Currency Risk
Our operations are principally denominated by U.S. dollars, and we do not expect our future operating results to be significantly affected by foreign currency transaction risk. A hypothetical 10% change in foreign exchange rates during any of the periods presented would not have had a material impact on our unaudited condensed consolidated financial statements.
| ITEM 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Based on their evaluation as of the end of the period covered by this report, our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer) have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) for the three months ended June 30, 2023 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II
| ITEM 1. | Legal Proceedings. |
We are not currently a party to any legal proceedings, and are not aware of any pending or threatened legal proceedings against us that we believe could have a material adverse effect on our business, operating results or financial condition. We may from time to time become involved in legal proceedings arising in the ordinary course of business.
| ITEM 1A. | Risk Factors. |
Risks Related to the Discovery, Development and Commercialization of Our Product Candidates
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 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 VIP236, VIP943, VIP924, enitociclib, and our other current product candidates, raise capital or continue our operations.
We have licensed our current core patents and other intellectual property relating to VIP236, VIP943, VIP924, enitociclib, and our other current product candidates from Bayer on an exclusive, worldwide basis under the Bayer License Agreement. The Bayer License Agreement continues in effect on a country-by-country and licensed product-by-licensed product basis until there are no remaining royalty payment obligations in the relevant country and can be terminated earlier by Bayer in the event that we materially breach our material obligations, that bankruptcy or other insolvency proceedings are instituted against us or that we seek to revoke or challenge the validity of any licensed patents. If, for any reason, the Bayer License Agreement is terminated or we otherwise lose important rights, it would have a significant and adverse effect on our business and our ability to develop and commercialize our current product candidates, raise capital, or continue our operations.
The Bayer License Agreement imposes on us obligations relating to development, commercialization, funding, payment, diligence, intellectual property protection and other matters. We paid Bayer an upfront license fee of $5.0 million following the closing of the Business Combination. In addition, we are obligated to make significant future payments to Bayer upon the achievement of certain development and commercial sales milestones involving licensed products. The size and timing of these milestone payments will vary greatly depending on factors such as the particular licensed product, whether it involves a P-TEFb licensed product or a bioconjugation licensed product (and which bioconjugation program), the number of distinct disease indications, the number of different countries with respect to which the milestone is achieved and the level of net commercial sales, and it is therefore difficult to estimate the total payments that could become payable to Bayer and when those payments would be due. If we were to achieve all of the milestones for each of the countries and disease indications, we would be obligated to pay development and commercial 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, we could be required to pay aggregate milestone payments in excess of $1.0 billion. In addition to milestone payments, we are 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.
To the extent we are able to achieve any of these milestones, many of them would be achieved, and the related milestone payments owed, before we are able to generate sufficient revenues (or any revenues in the case of development milestones). Accordingly, we will need to obtain substantial additional funding or enter into strategic alliances in order to pay these milestones, and there can be no assurance that we will be able to obtain the necessary funding on acceptable terms or at all or that we will be able to enter into strategic alliances at levels sufficient to pay these milestones or at all. If we are unable to raise the necessary additional funding or enter into the necessary strategic alliances, or otherwise pay these milestones, we would be in breach of the Bayer License Agreement, which if not cured would give Bayer the right to terminate the agreement or seek other remedies, which would have a significant and adverse effect on our business and prospects and our ability to develop and commercialize our current product candidates, raise capital, or continue our operations.
We are substantially dependent on the success of VIP236, VIP943, and enitociclib, our lead product candidates. If we are unable to complete development of, obtain approval for, and commercialize these lead product candidates in a timely manner, our business will be harmed.
Our future success is substantially dependent on our ability to timely commence and complete clinical trials, obtain marketing approval for, and successfully commercialize VIP236, VIP943, and enitociclib, our lead product candidates. We are investing
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significant efforts and financial resources in the research and development of these lead product candidates, which will require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, marketing approval from government regulators, substantial investment, and significant marketing efforts before we can generate any revenues from product sales. We are not permitted to market or promote these or any other product candidates before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals.
The success of our lead product candidates will depend on several factors, including the following:
| • | the initiation, successful patient enrollment, and timely completion of clinical trials; |
| • | establishing and maintaining relationships with contract research organizations and clinical sites for clinical development in the United States and internationally; |
| • | the frequency and severity of adverse events in the clinical trials and additional drug-related adverse events; |
| • | achieving dose selection, efficacy, safety, and tolerability profiles that are satisfactory to the FDA or any comparable foreign regulatory authority for marketing approval; |
| • | establishing and maintaining supply arrangements with third-party drug product suppliers, manufacturers, and distributors; |
| • | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; |
| • | a continued acceptable safety profile following any marketing approval; and |
| • | our ability to compete with other therapies. |
We do not have control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights, and the manufacturing, marketing, distribution, and sales efforts of any future collaborator. If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize these lead product candidates, which would materially harm our business and prospects.
We are at an early stage in development efforts for our product candidates, and we may not be able to successfully develop, manufacture, complete clinical trials, and commercialize our product candidates on a timely basis or at all.
VIP236, VIP943, and VIP924 are part of a novel bioconjugation platform, and their potential therapeutic benefits are unproven, and we may never develop, successfully conduct or complete clinical trials, obtain marketing approval, and commercialize any of the product candidates in our bioconjugation platform. While several bioconjugation and ADC candidates are under development by other companies, there is currently no approved bioconjugation therapy using our proprietary cytotoxin (an optimized CPT payload derived from SN38, a well-known cytotoxic drug and active metabolite of irinotecan) or an ADC using KSPi and CellTrapper. We may uncover a previously unknown risk associated with KSPi or our optimized CPT payload, our CellTrapper technology may not be as impermeable as initial testing suggests, our linker technology may not be as effective as initial testing suggests, or other issues that may be more problematic than we currently believe, which may prolong the period of observation required for obtaining, or result in the failure to obtain, regulatory approval or may necessitate additional preclinical and clinical testing. While results from preclinical trials of VIP236, VIP943, and VIP924 have shown proof-of-concept for each, these product candidates may not demonstrate in patients any or all of the pharmacological benefits we believe they may possess. Positive results from preclinical trials are not necessarily predictive of the results of planned clinical trials of VIP236, VIP943, and VIP924. If the KSPi warhead or optimized CPT payload that we use is not safe in certain product candidates, we would be required to abandon or redesign all of our current lead ADC or SMDC product candidates. We have not yet succeeded and may never succeed in demonstrating efficacy and safety of VIP236, VIP943, and VIP924 in pivotal clinical trials or in obtaining marketing approval thereafter.
Enitociclib is a novel P-TEFb/CDK9 inhibitor and its potential therapeutic benefit is unproven. While several CDK9 inhibitor candidates are under development by other companies, there is currently no approved therapy inhibiting CDK9 for the treatment of cancers, and as a result, the regulatory pathway for enitociclib may present novel issues that could cause delays in development or approval. While results from preclinical data and early clinical trials of enitociclib have shown tolerable side effects and a reduction in MCL1 and MYC mRNA, enitociclib may not demonstrate in patients any or all of the pharmacological benefits we believe it may possess. Positive results from preclinical studies or early-stage clinical trials are not necessarily predictive of the results of planned clinical trials of enitociclib. In addition, we may not be able to replicate the positive results from Bayer’s Phase 1 clinical trials in our clinical trials. We have not yet succeeded and may never succeed in demonstrating efficacy and safety for enitociclib in pivotal clinical trials or in obtaining marketing approval thereafter.
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If we are unable to successfully develop, conduct or complete clinical trials, obtain marketing approval, and commercialize our product candidates, our business and prospects would be materially harmed.
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.
Our future operating results are dependent on our ability to successfully discover, develop, obtain regulatory approval for, manufacture, and commercialize product candidates beyond those we currently have in preclinical and clinical development. A product candidate can unexpectedly fail at any stage of manufacturing and preclinical and clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care, and other unpredictable variables. The results from preclinical testing or early clinical trials of a product candidate may not be predictive of the results that will be obtained in later stage clinical trials of the product candidate.
The success of other product candidates we may develop will depend on many factors, including the following:
| • | 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. |
Results from early-stage clinical trials may not be predictive of results from late-stage or other clinical trials.
Positive and promising results from preclinical studies and early-stage clinical trials may not be predictive of results from late-stage clinical trials or from clinical trials of the same product candidates for the treatment of other indications. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Late-stage clinical trials could differ in significant ways from early-stage clinical trials, including changes to inclusion and exclusion criteria, efficacy endpoints, dosing regimen, and statistical design. Moreover, success in clinical trials in a particular indication does not guarantee that a product candidate will be successful for the treatment of other indications. Many companies in the biotechnology industry have suffered significant setbacks in late-stage clinical trials after achieving encouraging or positive results in early-stage development. There can be no assurance that we will not face similar setbacks in our ongoing or planned late-stage clinical trials, and any subsequent or post-marketing confirmatory clinical trials. Therefore, despite positive results observed in early-stage clinical trials, our product candidates may fail to demonstrate sufficient efficacy in our pivotal or post-marketing confirmatory 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.
From time to time, we may publish preliminary interim or “top-line” data from clinical trials. Positive preliminary data may not be predictive of such trial’s subsequent or overall results. Preliminary data are subject to the risk that one or more of the outcomes may materially change as more data become available. Additionally, preliminary data are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Therefore, positive preliminary results in any ongoing clinical trial may not be predictive of such results in the completed trial. We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully evaluate all data. As a result, preliminary data that we report may differ from future results from the same clinical trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Preliminary data also remains subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, preliminary data should be viewed with caution until the final data are available. Material adverse changes in the final data compared to preliminary data could materially harm our business and prospects.
Our preclinical development, clinical trials, manufacturing, supply chains and other operations and business activities, and the operations and business activities of third parties with whom we conduct business, including our contract manufacturers, contract research organizations, shippers, clinical trial sites, and others, have been, and could continue to be, adversely affected by the effects of health pandemics and epidemics, including COVID-19.
Our business has been, and could continue to be, adversely affected by health pandemics and epidemics, including COVID-19, wherever we have clinical trial sites or other business operations. In addition, health pandemics and epidemics could cause significant
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disruption in the operations of third-party manufacturers, contract research organizations, shippers, clinical trial sites, and other third parties upon whom we rely. For example, COVID-19 presented a substantial public health and economic challenge around the world and affected, and could continue to affect, employees, patients, communities, and business operations, as well as the U.S. economy and financial markets. Many geographic regions, including those in which we and the third parties on whom we rely conduct operations, imposed, and in the future could again impose, “shelter-in-place,” quarantines, or similar orders or restrictions to control the spread of COVID-19. These measures negatively impacted our productivity, disrupted our business, delayed our preclinical and clinical programs and timelines and limited our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations, now or in the future, could negatively impact our business, operating results, and financial condition.
We are dependent on a worldwide supply chain for products to be used in our clinical trials and, if approved by the regulatory authorities, for commercialization. Quarantines, shelter-in-place, and similar government orders and restrictions, staffing shortages, and other disruptions in operations, whether related to COVID-19 or other health pandemics or epidemics, have impacted, and could continue to impact, personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials, which has impacted, and could continue to impact, our supply chain. For example, any manufacturing supply interruption of any product candidate could adversely affect our ability to conduct ongoing and future clinical trials of such product candidate. In addition, delays, closures, and other disruptions of transportation carriers and modal hubs could materially impact our clinical development and any future commercialization timelines.
If our relationships with our suppliers or other vendors are delayed, scaled back or terminated as a result of health pandemics or epidemics, including COVID-19, we may not be able to enter into arrangements with alternative suppliers or vendors or do so on commercially reasonable terms or in a timely manner. Switching or adding additional suppliers or vendors involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new supplier or vendor commences work. As a result, delays could generally occur, which could adversely impact our ability to meet our desired clinical development and any future commercialization timelines. See “Risks Related to Our Dependence on Third Parties.”
In addition, our clinical trials have been, and could continue to be, affected by COVID-19 or future health pandemics or epidemics. Clinical site initiation and patient enrollment have been, and could continue to be, delayed due to staffing shortages, prioritization of hospital resources toward the treatment and management of patients impacted by pandemics or epidemics, concerns among patients about participating in clinical trials during a pandemic or epidemic, or public health measures imposed by governmental authorities in the countries and regions in which the clinical sites are located. Some patients may have difficulty following certain aspects of clinical trial protocols if quarantines or other restrictive measures impede patient movement or interrupt healthcare services. Similarly, our inability to successfully recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure or experience additional restrictions by their institutions, city, or state governments could adversely impact our clinical trial operations.
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.
Even if our product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community. The degree of market acceptance of any of our approved product candidates will depend on a number of factors, including:
| • | timing of market introduction, number, clinical profile and potential advantages 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. |
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If any of our product candidates is approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors, and patients, we may not generate or derive sufficient revenue from that product candidate, and our financial results could be negatively impacted.
If the market opportunity for any product candidate that we develop is smaller than we believe, our revenue may be adversely affected, and our business may suffer.
We intend to focus our product candidate development on treatments for various oncology indications. Our projections of addressable patient populations that may benefit from treatment with our product candidates are based on our estimates. These estimates, which have been derived from a variety of sources, may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these cancers. Additionally, the potentially addressable patient population for our product candidates may not ultimately be amenable to treatment with our product candidates. Our market opportunity may also be limited by future competitor treatments that enter the market. If any of our estimates prove to be inaccurate, the market opportunity for any product candidate that we develop could be significantly diminished and have an adverse material impact on our business.
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.
Our competitors are developing a large number of drug candidates for the treatment of solid tumors, leukemia, B-cell malignancies, lymphomas, myelodysplastic syndrome, and other conditions. Any product candidates that we successfully develop and commercialize will compete with these drug candidates, existing therapies, and new therapies that may become available in the future. We believe that a significant number of products are currently under development, and may become commercially available in the future, for the treatment of conditions for which we may attempt to develop product candidates. Several pharmaceutical and biotechnology companies have CDK9 inhibitors, ADCs, immunotherapies, or other products on the market or in clinical trials which may be competitive to our product candidates in oncology indications.
Our competitors, either alone or together with collaborators, may have significantly greater financial, manufacturing, marketing, drug development, technical and human resources, and commercial expertise than we do and may have begun developing their drug candidates earlier than us. Our competitors may also have more experience:
| • | developing drug candidates; |
| • | conducting preclinical and clinical trials; |
| • | obtaining regulatory approvals; and |
| • | commercializing product candidates. |
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe adverse effects, are more convenient, have a broader label, are marketed more effectively, are reimbursed, or are less expensive than any products that we may develop. Our competitors also may obtain marketing approval from the FDA or other comparable foreign regulatory authorities for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. Technological advances or products developed by our competitors may render our technologies or product candidates obsolete, less competitive, or not economical. We anticipate that we will face increased competition in the future as new companies enter the markets and as scientific developments progress. If we are unable to compete effectively, our opportunity to generate revenue from the sale of our products we may develop, if approved, could be adversely affected.
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.
Because we have limited financial and managerial resources, we focus on development programs, therapeutic platforms, and product candidates that we identify for specific indications. As a result, we may forego or delay the pursuit of opportunities with other therapeutic platforms or product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs, therapeutic platforms, and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights.
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Clinical trials are expensive, time consuming, subject to enrollment and other delays, 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 successfully complete the development, clinical trials, and commercialization of any of our product candidates currently in preclinical and clinical development, should they succeed.
Clinical trials have uncertain outcomes and may be required to continue beyond our available funding. Failure can occur at any stage of the clinical trials, and we may experience numerous unforeseen events that could delay or prevent commercialization of our current or future product candidates, including, but not limited to:
| • | delays in securing clinical investigators and trial sites for our clinical trials; |
| • | delays in obtaining Institutional Review Board, and regulatory approvals to commence a clinical trial; |
| • | slower than anticipated rates of patient recruitment and enrollment, or not reaching the targeted number of patients, because of factors such as competition for patients from other trials, difficulty identifying patients with our proposed indications, the impact of COVID-19 or other health pandemics or epidemics, limited or no availability of coverage, reimbursement or adequate payment from health maintenance organizations, and other third-party payors; |
| • | unforeseen safety issues; |
| • | uncertain dosing issues that could arise as a result of incompletely explored pharmacokinetic and pharmacodynamics behaviors or initiatives such as the FDA’s Project Optimus; |
| • | approval and introduction of new therapies or changes in standards of practice or regulatory guidance that render our clinical trial endpoints or the targeting of our proposed indications less attractive; |
| • |