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CRVS on Nasdaq

Corvus Pharmaceuticals, Inc.

In its 2026 annual report the company says: “We are a clinical stage biopharmaceutical company developing product candidates that precisely target proteins that are critical to immune cell maturation and function. Our lead product candidate, soquelitinib (formerly CPI-818), is designed to bind specifically to a protein, interleukin 2 inducible T cell kinase (ITK), involved in T cell activation, T cell receptor signaling and T cell differentiation and function.”5 It is headquartered in Burlingame, United States.2 Its shares trade on Nasdaq under the symbol CRVS.2

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Last updated Oct 21, 2026.

Overview

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  • TickerCRVS on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersBurlingame, United States2
  • Incorporated inDE3
  • Business address901 Gateway Blvd, Third Floor, South San Francisco, Ca 940803
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300I3AVJ8F75NCX652
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 54539592

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We are a clinical stage biopharmaceutical company developing product candidates that precisely target proteins that are critical to immune cell maturation and function. We believe our proprietary product candidates have broad potential to address immune mediated diseases, inflammatory diseases and cancers.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Financial statements

Operating income678910-$43.0M in 2025−12% since 2019
-$60.0M-$40.0M-$20.0M02019: -$48.9M-$48.9M20192020: -$43.8M-$43.8M2020−10%2021: -$38.6M-$38.6M2021−12%2022: -$32.6M-$32.6M2022−16%2023: -$23.4M-$23.4M2023−28%2024: -$27.5M-$27.5M2024+18%2025: -$43.0M-$43.0M2025+56%
Net income678910-$15.3M in 2025−67% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$46.7M-$46.7M20192020: -$6.0M-$6.0M2020−87%2021: -$43.2M-$43.2M2021+621%2022: -$41.3M-$41.3M2022−4%2023: -$27.0M-$27.0M2023−35%2024: -$62.3M-$62.3M2024+130%2025: -$15.3M-$15.3M2025−75%

Every line of the income statement as filed: the last 3 fiscal years, latest first.10

Period ending2025-12-312024-12-312023-12-31
Research and development$33.7M$19.4M$16.5M
General and administrative$9.3M$8.2M$6.9M
Total operating expenses$43.0M$27.5M$23.4M
Loss from operations-$43.0M-$27.5M-$23.4M
Interest income and other expense, net$2.5M$1.8M$1.6M
Gain from sale of property and equipment$5.0K
Change in fair value of warrant liability$27.1M-$33.4M
Loss before equity method investment-$13.3M-$59.1M-$21.7M
Loss from equity method investment-$2.0M-$3.2M-$5.3M
Net loss-$15.3M-$62.3M-$27.0M
Net loss per share, basic-$0.19-$1.02-$0.56
Net loss per share, diluted-$0.53-$1.02-$0.56
Shares used to compute net loss per share, basic79.0M shares61.0M shares48.0M shares
Shares used to compute net loss per share, diluted79.7M shares61.0M shares48.0M shares
Unrealized gain (loss) on marketable securities-$17.0K$65.0K$66.0K
Cumulative foreign currency translation adjustment$409.0K-$386.0K-$470.0K
Comprehensive loss-$14.9M-$62.6M-$27.4M

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Corporate structure

Corvus Pharmaceuticals, Inc. sits at the top of its group. 3 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Corvus Pharmaceuticals, Inc.

  • State Street Corporation Filed SCHEDULE 13G on Corvus Pharmaceuticals, Inc., latest Aug 7, 2026
  • BlackRock Filed SCHEDULE 13G/A on Corvus Pharmaceuticals, Inc., latest Jul 27, 2026 (3 filings since Oct 17, 2025)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Corvus Pharmaceuticals, Inc., latest May 15, 2026 (2 filings since May 9, 2024)
  • Sirenia Capital Management LP Filed SCHEDULE 13G on Corvus Pharmaceuticals, Inc., latest May 15, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Corvus Pharmaceuticals, Inc., latest Mar 26, 2026 (2 filings since Jan 30, 2026)
  • Richard A. Miller Md. Filed SCHEDULE 13G/A on Corvus Pharmaceuticals, Inc., latest Feb 13, 2026 (5 filings since Feb 14, 2022)
  • ADAMS STREET PARTNERS LLC Filed SCHEDULE 13D/A on Corvus Pharmaceuticals, Inc., latest Feb 5, 2026
  • ORBIMED ADVISORS LLC Filed SCHEDULE 13D/A on Corvus Pharmaceuticals, Inc., latest Jan 27, 2026 (5 filings since Nov 3, 2021)
  • SAMLYN CAPITAL, LLC Filed SCHEDULE 13G/A on Corvus Pharmaceuticals, Inc., latest Aug 14, 2025 (6 filings since Feb 14, 2024)
  • TANG CAPITAL PARTNERS LP Filed SC 13G/A on Corvus Pharmaceuticals, Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • CHI Advisors LLC Filed SC 13G on Corvus Pharmaceuticals, Inc., latest Feb 13, 2023
  • INTEGRATED CORE STRATEGIES (US) LLC Filed SC 13G/A on Corvus Pharmaceuticals, Inc., latest Jan 30, 2023 (4 filings since Oct 22, 2021)
  • Corvus Pharmaceuticals, Inc. Burlingame, California, United States
    • Corvus Biopharmaceuticals, Ltd. Subsidiary · Cayman Islands
    • Corvus Hong Kong Limited Subsidiary · Hong Kong

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Corvus Pharmaceuticals, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$2.9M10 Dec 31, 2025$4.8M10 Dec 31, 2024−39.9%
Accumulated depreciation$2.6M10 Dec 31, 2025$4.6M10 Dec 31, 2024−42.7%
Property and equipment, net$220.0K10 Dec 31, 2025$151.0K10 Dec 31, 2024+45.7%
Operating-lease assets (leased space)$839.0K10 Dec 31, 2025$1.2M10 Dec 31, 2024−28.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$4.6M10 Dec 31, 2025$8.7M10 Dec 31, 2024−47.6%
Marketable securities, current$52.2M10 Dec 31, 2025$43.2M10 Dec 31, 2024+20.7%
Debt securities available for sale$43.2M9 Dec 31, 2024$14.5M9 Dec 31, 2023+197.5%
Stakes in other companies (equity method)$11.0M10 Dec 31, 2025$12.5M10 Dec 31, 2024−12.4%

Properties, in its own words

We currently lease approximately 20,916 square feet of office and research and development facilities in South San Francisco, California. This facility lease will expire in January 2028.

We previously leased approximately 27,280 square feet of office and research and development facilities in Burlingame, California. Approximately 7,585 square feet was subleased to Angel Pharmaceuticals through January 2023. This facility lease expired in January 2025.

Item 2 of the 10-K filed Mar 12, 2026.5

Leadership

Who has led Corvus Pharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Richard A. Miller Md.2016–now

President

  1. Richard A. Miller Md.2016–now

Chief financial officer

  1. Leiv Lea2016–now
20202025
Board members and other officers (17)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Corvus Biopharmaceuticals, Ltd. Cayman Islands4
  • Corvus Hong Kong Limited Hong Kong4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Aug 6, 20268-K Results of operations32
  2. Jul 22, 20268-K Executive or director change33
  3. Jun 12, 20268-K Shareholder vote34
  4. May 14, 20268-K Regulation FD disclosure; Other events35
  5. May 7, 20268-K Results of operations36
  6. Apr 23, 20268-K Executive or director change37
  7. Mar 13, 20268-K Entered a material agreement38
  8. Mar 12, 20268-K Results of operations39
  9. Jan 23, 20268-K Other events40
  10. Jan 20, 20268-K Regulation FD disclosure; Other events41
  11. Jan 20, 20268-K Other events42
  12. Nov 4, 20258-K Results of operations43
  13. Mar 22, 2016New chief executive Richard A. Miller Md. becomes CEO14
  14. Jan 27, 2014Founded Corvus Pharmaceuticals, Inc. is founded2

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.12) a share, on Nov 4, 2025.44

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results32
  2. May 7, 2026Reported quarterly or annual results36
  3. Mar 12, 2026Reported quarterly or annual results39
  4. Nov 4, 2025Reported quarterly or annual results43
  5. Aug 7, 2025Reported quarterly or annual results45
  6. May 8, 2025Reported quarterly or annual results46
  7. Mar 25, 2025Reported quarterly or annual results47
  8. Nov 12, 2024Reported quarterly or annual results48

Drug trials and FDA: coming up

  1. Jun 2027Phase 2 trial readout expected Phase 2 trial of Soquelitinib in Atopic Dermatitis: primary completion expected Jun 2027 (ClinicalTrials.gov NCT07441395).49

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

220 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 49 major events, 85 insider forms, 36 large holders, 30 other. The latest 20:

  1. Aug 7, 2026SCHEDULE 13G EDGAR
  2. Aug 6, 20268-K EDGAR
  3. Aug 6, 202610-Q EDGAR
  4. Jul 27, 2026SCHEDULE 13G/A EDGAR
  5. Jul 22, 20268-K EDGAR
  6. Jun 15, 20264 EDGAR
  7. Jun 15, 20264 EDGAR
  8. Jun 15, 20264 EDGAR
  9. Jun 15, 20264 EDGAR
  10. Jun 15, 20264 EDGAR
  11. Jun 12, 20268-K EDGAR
  12. May 20, 20264 EDGAR
  13. May 15, 2026SCHEDULE 13G/A EDGAR
  14. May 15, 2026SCHEDULE 13G EDGAR
  15. May 14, 20268-K EDGAR
  16. May 7, 20268-K EDGAR
  17. May 7, 2026S-8 EDGAR
  18. May 7, 202610-Q EDGAR
  19. Apr 27, 2026SCHEDULE 13G/A EDGAR
  20. Apr 27, 20264 EDGAR

The 220 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

24 open-market trades by officers, directors and large owners since October 2021: 21 buys and 3 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 11, 2026Moore David ScottDirectorBuy21,700$11.53$250.2KForm 4
May 18, 2026MILLER RICHARD A MDPresident and CEOBuy6,932$12.04$83.5KForm 4
Jun 27, 2025ORBIMED ADVISORS LLCDirectorSale1,176,332$4.16$4.9MForm 4
Jun 27, 2025Thompson Peter A.DirectorSale1,176,332$4.16$4.9MForm 4
May 6, 2024Jones William BentonSee RemarksBuy20,000$1.73$34.6KForm 4
May 6, 2024MILLER RICHARD A MDPresident and CEOBuy577,634$1.73$999.3KForm 4
May 15, 2023Grais LindaDirectorBuy10,000$2.45$24.5KForm 4
Dec 20, 2022Jones William BentonSee RemarksBuy20,000$0.79$15.8KForm 4
Dec 14, 2022LEA LEIVChief Financial OfficerBuy4,000$0.84$3.4KForm 4
Dec 14, 2022MILLER RICHARD A MDPresident and CEOBuy10,000$0.78$7.8KForm 4
Dec 13, 2022LEA LEIVChief Financial OfficerBuy30,000$0.74$22.2KForm 4
Dec 13, 2022MILLER RICHARD A MDPresident and CEOBuy50,000$0.74$37.0KForm 4
Sep 28, 2022MILLER RICHARD A MDPresident and CEOBuy25,000$0.76$19.0KForm 4
Sep 20, 2022MILLER RICHARD A MDPresident and CEOBuy20,000$0.81$16.3KForm 4
Jun 27, 2022MILLER RICHARD A MDPresident and CEOBuy5,000$1.00$5.0KForm 4
Jun 24, 2022MILLER RICHARD A MDPresident and CEOBuy5,000$1.03$5.2KForm 4
Jun 6, 2022MILLER RICHARD A MDPresident and CEOBuy890$1.01$899Form 4
Jun 2, 2022MILLER RICHARD A MDPresident and CEOBuy5,000$0.98$4.9KForm 4
Mar 31, 2022MILLER RICHARD A MDPresident and CEOBuy15,000$1.64$24.6KForm 4
Mar 17, 2022LEA LEIVChief Financial OfficerBuy13,878$1.65$22.9KForm 4

All 24 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Orbimed Advisors LLC7,165,006$107.0M2.0%No change
BlackRock, Inc.7,138,811$106.7M0.0%+978,389
State Street Corp4,474,091$66.8M0.0%+908,099
Vanguard Capital Management LLC3,292,710$49.2M0.0%+58,172
Adams Street Partners LLC3,275,616$48.9M11.1%No change
Vivo Capital, LLC2,805,816$41.9M3.8%No change
Wellington Management Group Llp2,731,632$40.8M0.0%+413,115
Perceptive Advisors LLC2,667,441$39.9M0.6%+375,000
Deep Track Capital, LP2,491,939$37.2M0.5%+400
Braidwell LP2,126,298$31.8M1.2%+373,500
Geode Capital Management, LLC1,853,659$27.7M0.0%+140,918
Foresite Capital Management VI LLC1,831,233$27.4M4.3%No change
Goldman Sachs Group Inc1,576,352$23.6M0.0%+35,543
Hood River Capital Management LLC1,571,805$23.5M0.2%+236,696
Morgan Stanley1,344,736$20.1M0.0%−1,154,089
Boxer Capital Management, LLC1,100,000$16.4M1.2%No change
Catalio Capital Management, LP1,080,888$16.1M3.0%+188,955
Millennium Management LLC1,047,985$15.7M0.0%+181,623
Vanguard Portfolio Management LLC814,750$12.2M0.0%+144,855
Two Sigma Investments, LP785,208$11.7M0.0%+245,339
Bank Of America Corp /de/757,798$11.3M0.0%+520,794
Adage Capital Partners Gp, L.l.c.750,000$11.2M0.0%No change
Eversept Partners, LP747,994$11.2M0.6%New
Emerald Advisers, LLC685,683$10.2M0.2%−533
DCF Advisers, LLC637,500$9.5M2.5%No change

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Corvus Pharmaceuticals, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARCorvus Pharmaceuticals, Inc.1
  • CIK0001626971
  • Employer ID (EIN)46-46708095
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address901 Gateway Blvd, Third Floor, South San Francisco, CA 940801
  • Phone(650) 900-45201
  • Shares outstanding84,120,944 as of Aug 6, 202612
  • Public float$251.9M as of Jun 30, 20255
  • AuditorPricewaterhouseCoopers LLP, San Jose, California PCAOB ID 238; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceDec 8, 20141
  • Filings581 in all: 4 (224), 8-K (124), 10-Q (32), SC 13G/A (29), 3 (25), SC 13G (13), SC 13D/A (12), 424B5 (11)1
    All 38 form types

    S-8 (11), 10-K (10), DEF 14A (10), DEFA14A (10), CORRESP (9), SCHEDULE 13G/A (9), UPLOAD (7), EFFECT (5), S-3 (4), SCHEDULE 13D/A (4), SCHEDULE 13G (4), SC 13D (3), 10-K/A (2), 424B4 (2), 5 (2), CT ORDER (2), D (2), S-1/A (2), SEC STAFF LETTER (2), 8-A12B (1), 8-K/A (1), CERTNAS (1), DRS (1), DRS/A (1), DRSLTR (1), PRE 14A (1), S-1 (1), S-3/A (1), S-3ASR (1), S-3MEF (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, Par Value $0.0001 per shareCRVSNasdaq Global Market

From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Corvus Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 73 risks under these headings, as written.5

  • Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital
  • 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.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • 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.
  • Interim “top-line” 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 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.
  • 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, results of operations and financial condition.
The other 62 risks
  • A Fast Track designation from the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive regulatory approval.
  • We may not be successful in our efforts to identify or discover additional product candidates.
  • Risks Related to Our Reliance on Third Parties
  • 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 and our contract manufacturers are subject to significant regulation with respect to manufacturing our products and the contract manufacturers on which we rely may not continue to meet regulatory requirements.
  • 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.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Commercialization of Our Product Candidates
  • 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.
  • Any approved products could be subject to restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
  • Disruptions at the FDA and other government agencies caused by funding shortages, staff reductions or policy changes could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Even if we receive regulatory approval we still may not be able to successfully commercialize soquelitinib, ciforadenant and mupadolimab or any other product candidate, and the revenue that we generate from sales, if any, could be limited.
  • Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product candidates and affect the prices we may obtain.
  • Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • We may fail to obtain orphan drug designations from the FDA for our product candidates, and even if we obtain such designations, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success.
  • We may form additional strategic alliances and collaborative partnerships in the future, and we may not realize the benefits of such alliances.
  • We face competition from entities that have developed or may develop product candidates for cancer and immune diseases, 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.
  • The market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small.
  • We have no sales, marketing or distribution capabilities, and we may have to invest significant resources to develop these capabilities.
  • Governments may impose price controls, which may adversely affect our future profitability.
  • Risks Related to Our Business Operations
  • Our results of operations may fluctuate significantly, which makes our future results of operations difficult to predict and could cause our results of operations to fall below expectations or any guidance we may provide.
  • We are dependent on the services of our President and Chief Executive Officer, Richard A. Miller, M.D., and other key executives, and if we are not able to retain these members of our management or recruit additional management, clinical and scientific personnel, our business will suffer.
  • We may encounter difficulties in managing our growth and expanding our operations successfully.
  • We are subject to various federal and state healthcare laws and regulations, and our failure to comply with these laws and regulations could harm our results of operations and financial condition.
  • We and our current and any existing or future collaborators, third-party manufacturers and suppliers will or may use biological materials and may use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of soquelitinib, ciforadenant and mupadolimab or our other product candidates.
  • We and any of our existing or potential future collaborators will be required to report to regulatory authorities if any products that may be approved in the future cause or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.
  • Our employees, independent contractors, principal investigators, CROs, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Risks Related to Our Intellectual Property
  • Our rights to develop and commercialize our product candidates are subject in part to the terms and conditions of licenses granted to us by other companies. The patent protection, prosecution and enforcement for some of our product candidates may be dependent on third parties.
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court.
  • Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
  • We may fail to comply with any of our obligations under existing agreements pursuant to which we license or have otherwise acquired intellectual property rights or technology, which could result in the loss of rights or technology that are material to our business.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Risks Related to Our Common Stock
  • 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.
  • If we fail to adhere to the listing requirements of the Nasdaq Global Market our common stock could be delisted.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • We do not currently intend to pay dividends on our common stock, and, consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation, if any, in the price of our common stock.
  • Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
  • We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely consolidated financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • General Risks
  • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Changes to applicable U.S. or foreign tax laws and regulations may have a material adverse effect on our business, financial condition and results of operations.
  • Our information technology systems, or those of any of our existing or potential future collaborators, CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • Changes in and failures to comply with U.S. and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance.
  • Our operations could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and pandemics, and other natural or manmade disasters or business interruptions, for which we are predominantly self-insured.
  • If any of our suppliers of the drug substance we use for the development of our product candidates are unable to provide such drug substance, our business could be disrupted and seriously harmed.
  • Our ability to use net operating loss carryforwards and other tax attributes may be limited.

Legal proceedings

We are not currently a party to any material litigation or legal proceedings; however, we may from time to time be involved in various legal proceedings incident to the ordinary course of our business.

The opening of Item 3, Legal Proceedings.5

Sources

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