| · |
|---|
| | | Page |
|---|
| PART I | | |
|---|
| ITEM 1. | Business | 1 |
|---|
| ITEM 1A. | Risk Factors | 25 |
|---|
| ITEM 1B. | Unresolved Staff Comments | 69 |
|---|
| ITEM 1C. | Cybersecurity | 69 |
|---|
| ITEM 2. | Properties | 69 |
|---|
| ITEM 3. | Legal Proceedings | 70 |
|---|
| ITEM 4. | Mine Safety Disclosures | 70 |
|---|
| PART II | | |
|---|
| ITEM 5. | Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities | 70 |
|---|
| ITEM 6. | [Reserved] | 71 |
|---|
| ITEM 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 72 |
|---|
| ITEM 7A. | Quantitative and Qualitative Disclosures About Market Risk | 81 |
|---|
| ITEM 8. | Financial Statements and Supplementary Data | 81 |
|---|
| ITEM 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 111 |
|---|
| ITEM 9A. | Controls and Procedures | 111 |
|---|
| ITEM 9B. | Other Information | 112 |
|---|
| ITEM 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 113 |
|---|
| PART III | | |
|---|
| ITEM 10. | Directors, Executive Officers of the Registrant and Corporate Governance Matters | 113 |
|---|
| ITEM 11. | Executive Compensation | 113 |
|---|
| ITEM 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 113 |
|---|
| ITEM 13. | Certain Relationships and Related Transactions, and Director Independence | 113 |
|---|
| ITEM 14. | Principal Accountant Fees and Services | 113 |
|---|
| PART IV | | |
|---|
| ITEM 15. | Exhibits and Financial Statement Schedules | 114 |
|---|
| | Signatures | 118 |
|---|
i
Forward-Looking Statements
This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential” or “continue” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
| ● | our expectations and beliefs regarding the potential benefits of our product candidates; |
| ● | our expectations regarding the clinical effectiveness of our product candidates and utility of our biomarker data; |
| ● | the anticipated timing, costs and conduct of our ongoing and planned clinical trials for soquelitinib (formerly CPI-818), ciforadenant and mupadolimab and planned preclinical studies and clinical trials for other product candidates in our development programs, including the anticipated timing of data from such trials and related reports; |
| ● | the scope and design of our planned clinical trials, including but not limited to target patient enrollment numbers; |
| ● | our ability to develop, acquire and advance product candidates into, and successfully complete, clinical trials; |
| ● | the timing of the completion of our ongoing and planned clinical trials of soquelitinib, ciforadenant and mupadolimab and the timing and availability of clinical data from such clinical trials; |
| ● | clinical and regulatory development plans with respect to soquelitinib, ciforadenant and mupadolimab, and our other product candidates; |
| ● | our strategy to protect, establish and maintain our proprietary technology and intellectual property rights covering our product candidates, including the projected terms of patent protection; |
| ● | the potential benefits of strategic collaborations, including our collaboration with Angel Pharmaceuticals, our ongoing business development efforts and our ability to enter into strategic arrangements; |
| ● | developments and projections relating to our competitors and our industry, including competing therapies and our beliefs regarding our competitive advantage; |
| ● | our estimates regarding the effect of changes in the tax code as a result of recent federal tax legislation and uncertainty as to how some of those changes may be applied; and |
| ● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, including our forecast of the period of time through which our financial resources will be adequate to support our operations. |
Any forward-looking statements in this Annual Report on Form 10-K reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part I, Item 1A. Risk Factors and discussed elsewhere in this Annual Report on Form 10-K. Given these uncertainties, you should not place
ii
undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
This Annual Report on Form 10-K also contains estimates, projections and other information concerning our industry, our business and the markets for certain drugs, including data regarding the estimated size of those markets, their projected growth rates and the incidence of certain medical conditions. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.
Except where the context otherwise requires, in this Annual Report on Form 10-K, “we,” “us,” “our” and the “Company” refer to Corvus Pharmaceuticals, Inc.
Trademarks
This Annual Report on Form 10-K includes trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included in this Annual Report on Form 10-K are the property of their respective owners.
iii
Risk Factor Summary
Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the Securities and Exchange Commission (SEC) before making investment decisions regarding our common stock.
| ● | We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it. |
| ● | We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, other operations or commercialization efforts. |
| ● | Our product candidates are in various stages of development and may fail or suffer delays that materially and adversely affect their commercial viability. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize such product candidates, or experience significant delays in doing so, our business will be materially harmed. |
| ● | Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results. Any product candidate we or any of our existing or potential future collaborators advance into clinical trials, including soquelitinib, ciforadenant and mupadolimab, may not have favorable results in later clinical trials, if any, or receive regulatory approval. |
| ● | Any termination or suspension of, or delays in the commencement or completion of, our planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects. |
| ● | Our product candidates are subject to extensive regulation, compliance with which is costly and time consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates. |
| ● | We are conducting and plan to conduct clinical trials for soquelitinib, ciforadenant and mupadolimab, and we and Angel Pharmaceuticals may in the future, conduct additional clinical trials of product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in foreign locations. |
| ● | If we encounter difficulties enrolling subjects in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. |
iv
| ● | The occurrence of serious complications or side effects in connection with use of our product candidates, either in clinical trials or post-approval, could lead to discontinuation of our clinical development programs, refusal of regulatory authorities to approve our product candidates or, post-approval, revocation of marketing authorizations or refusal to approve new indications, which could severely harm our business, prospects, operating results and financial condition. |
| ● | We may not be successful in our efforts to identify or discover additional product candidates. |
| ● | We rely, and expect to continue to rely, on third parties to conduct our clinical trials. If these third parties do not meet our deadlines or otherwise conduct the trials as required, our clinical development programs could be delayed or unsuccessful and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected, or at all. |
| ● | We rely on third parties to conduct some or all aspects of our manufacturing, research and preclinical and clinical testing, and these third parties may not perform satisfactorily. |
| ● | We, or our third-party manufacturers, may be unable to successfully scale-up manufacturing of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing our product candidates and commercializing approved products, if any. |
| ● | If we are unable to commercialize our product candidates or if we experience significant delays in obtaining regulatory approval for, or commercializing, any or all of our product candidates, our business will be materially and adversely affected. |
| ● | If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline. |
| ● | We face competition from entities that have developed or may develop product candidates for cancer, including companies developing novel treatments and technology platforms. If these companies develop technologies or product candidates more rapidly than we do or their technologies are more effective, our ability to develop and successfully commercialize product candidates may be adversely affected. |
| ● | An active, liquid and orderly market for our common stock may not be sustained. |
| ● | The trading price of the shares of our common stock could be highly volatile, and investors in our common stock could incur substantial losses. |
v
