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TYRA on Nasdaq

Tyra Biosciences, Inc.

Tyra Biosciences, Inc. is an American pharmaceutical preparations company based in Carlsbad.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTYRA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersCarlsbad, California1
  • Incorporated inDE2
  • Business address2656 State Street, Carlsbad, Ca 920082
  • Filer category, Emerging growth company2
  • Legal formCorporation

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Financials

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

Financial statements

Operating income34567-$132.8M in 2025+1328% since 2020
-$150.0M-$100.0M-$50.0M02020: -$9.3M-$9.3M20202021: -$26.3M-$26.3M2021+183%2022: -$58.9M-$58.9M2022+124%2023: -$79.9M-$79.9M2023+36%2024: -$104.2M-$104.2M2024+30%2025: -$132.8M-$132.8M2025+27%
Net income34567-$119.9M in 2025+1185% since 2020
-$150.0M-$100.0M-$50.0M02020: -$9.3M-$9.3M20202021: -$26.3M-$26.3M2021+182%2022: -$55.3M-$55.3M2022+110%2023: -$69.1M-$69.1M2023+25%2024: -$86.5M-$86.5M2024+25%2025: -$119.9M-$119.9M2025+39%

Every line of the income statement as filed: the last 2 fiscal years, latest first.7

Period ending2025-12-312024-12-31
Research and development$102.9M$80.1M
General and administrative$29.8M$24.1M
Total operating expenses$132.8M$104.2M
Loss from operations-$132.8M-$104.2M
Interest and other income, net$12.8M$17.7M
Total other income$12.8M$17.7M
Net loss-$119.9M-$86.5M
Unrealized gain (loss) on marketable securities available-for-sale, net-$377.0K$389.0K
Comprehensive loss-$120.3M-$86.1M
Net loss per share, basic-$2.01-$1.51
Net loss per share, diluted-$2.01-$1.51
Weighted-average shares used to compute net loss per share - basic59.6M shares57.2M shares
Weighted-average shares used to compute net loss per share - diluted59.6M shares57.2M shares

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Corporate structure

Tyra Biosciences, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Tyra Biosciences, Inc.

  • BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G on Tyra Biosciences, Inc., latest Sep 21, 2026 (6 filings since Mar 24, 2022)
  • Paradigm Biocapital Advisors LP Filed SCHEDULE 13G on Tyra Biosciences, Inc., latest Sep 17, 2026
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13D/A on Tyra Biosciences, Inc., latest Sep 17, 2026 (7 filings since Feb 6, 2024)
  • FARALLON CAPITAL MANAGEMENT, L.L.C. Filed SCHEDULE 13G/A on Tyra Biosciences, Inc., latest Aug 14, 2026
  • Vi Oncology Scsp Nextech Filed SCHEDULE 13G/A on Tyra Biosciences, Inc., latest Aug 14, 2026 (2 filings since Nov 14, 2024)
  • BlackRock Filed SCHEDULE 13G on Tyra Biosciences, Inc., latest Jul 30, 2026
  • Commodore Capital LP Filed SCHEDULE 13G/A on Tyra Biosciences, Inc., latest May 15, 2026 (3 filings since May 14, 2025)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Tyra Biosciences, Inc., latest May 15, 2026 (3 filings since May 14, 2025)
  • Todd Harris Filed SCHEDULE 13G/A on Tyra Biosciences, Inc., latest May 14, 2026 (2 filings since Feb 13, 2026)
  • Farallon Capital Partners, L.P. Filed SCHEDULE 13G/A on Tyra Biosciences, Inc., latest May 12, 2026 (2 filings since Feb 20, 2026)
  • Canaan XI L.P. Filed SCHEDULE 13G/A on Tyra Biosciences, Inc., latest Apr 24, 2026 (4 filings since Feb 8, 2022)
  • FMR LLC Filed SCHEDULE 13G on Tyra Biosciences, Inc., latest Apr 7, 2026 (7 filings since Feb 9, 2022)
  • Tyra Biosciences, Inc. Carlsbad, California

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Tyra Biosciences, 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$2.9M6 Dec 31, 2024$2.4M6 Dec 31, 2023+20.4%
Accumulated depreciation$1.3M6 Dec 31, 2024$807.0K6 Dec 31, 2023+58.7%
Property and equipment, net$1.3M7 Dec 31, 2025$1.7M7 Dec 31, 2024−20.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$77.4M7 Dec 31, 2025$92.0M7 Dec 31, 2024−15.9%
Debt securities available for sale$178.6M7 Dec 31, 2025$249.5M7 Dec 31, 2024−28.4%

Properties, in its own words

Our corporate headquarters are located in Carlsbad, California, where we lease approximately 13,065 square feet of laboratory and office space. Our headquarters consist of approximately 4,734 square feet of original space (the Original Space) and 8,331 square feet of space in an adjacent building (the Expansion Space). The lease for the Expansion Space commenced in November 2023. The lease for the Original Space and Expansion Space will end 120 months after the commencement date (November 2023) of the Expansion Space lease, subject to certain renewal options granted to us. We believe that our existing and planned expansion facilities are adequate for our current needs and that suitable additional or alternative space will be available in the future on commercially reasonable terms, if required.

For additional information, see Note 9, Leases, to the financial statements included in this Annual Report.

Item 2 of the 10-K filed Mar 2, 2026.10

Leadership

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

Chief executive

  1. Todd Harris2021–now

President

  1. Todd Harris2023–now

Chief financial officer

  1. Alan Fuhrman2023–now

Chief operating officer

  1. Daniel Bensen2021–2025
  2. Bhavesh Ashar2025–now
2025
Board members and other officers (24)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerHiroomi Tada, M.D., Ph.D. named Feb 13, 202438
  • Executive Officer, DirectorTodd Harris, Ph.D. named Feb 13, 202438
  • DirectorGilla Kaplan, Ph.D. named Feb 13, 202438
  • DirectorJake Simson, Ph.D. named Feb 13, 202438
  • DirectorMelissa McCracken, Ph.D. named Feb 13, 202438
  • DirectorSid Subramony, Ph.D. named Feb 13, 202438

Timeline

  1. Sep 15, 20268-K Other events39
  2. Sep 9, 20268-K Other events40
  3. Aug 4, 20268-K Results of operations41
  4. Jun 2, 20268-K Shareholder vote42
  5. May 13, 20268-K Results of operations43
  6. Apr 17, 20268-K Executive or director change44
  7. Apr 2, 20268-K Executive or director change45
  8. Mar 4, 20268-K Other events46
  9. Mar 2, 20268-K Results of operations47
  10. Dec 1, 20258-K Executive or director change48
  11. Nov 5, 20258-K Results of operations49
  12. Aug 22, 20258-K Other events50
  13. Sep 14, 2021New chief executive Todd Harris becomes CEO11

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.50) a share, on Nov 5, 2025.51

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results41
  2. May 13, 2026Reported quarterly or annual results43
  3. Mar 2, 2026Reported quarterly or annual results47
  4. Nov 5, 2025Reported quarterly or annual results49
  5. Aug 14, 2025Reported quarterly or annual results52
  6. May 8, 2025Reported quarterly or annual results53
  7. Mar 27, 2025Reported quarterly or annual results54
  8. Nov 7, 2024Reported quarterly or annual results55

Drug trials and FDA: coming up

  1. Nov 2026Phase 1/2 trial readout expected Phase 1/2 trial of TYRA-300 in Locally Advanced Urothelial Carcinoma: primary completion expected Nov 2026 (ClinicalTrials.gov NCT05544552).56

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

368 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 45 major events, 171 insider forms, 49 large holders, 1 private raises, 82 other. The latest 20:

  1. Sep 21, 2026SCHEDULE 13G EDGAR
  2. Sep 17, 2026SCHEDULE 13D/A EDGAR
  3. Sep 17, 20264 EDGAR
  4. Sep 17, 20264 EDGAR
  5. Sep 17, 20264 EDGAR
  6. Sep 17, 20264 EDGAR
  7. Sep 17, 2026SCHEDULE 13G EDGAR
  8. Sep 15, 20268-K EDGAR
  9. Sep 15, 2026424B5 EDGAR
  10. Sep 14, 2026FWP EDGAR
  11. Sep 14, 2026S-3ASR EDGAR
  12. Sep 11, 20264 EDGAR
  13. Sep 9, 20268-K EDGAR
  14. Aug 14, 2026SCHEDULE 13G/A EDGAR
  15. Aug 14, 2026SCHEDULE 13G/A EDGAR
  16. Aug 4, 2026424B5 EDGAR
  17. Aug 4, 202610-Q EDGAR
  18. Aug 4, 20268-K EDGAR
  19. Jul 30, 2026SCHEDULE 13G EDGAR
  20. Jun 26, 2026144 EDGAR

The 368 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

112 open-market trades by officers, directors and large owners since October 2021: 10 buys and 102 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 9, 2026Verjee RehanDirectorBuy972$20.58$20.0KForm 4
Mar 25, 2026KAPLAN GILLADirectorSale14,295$36.97$528.5KForm 4
Feb 12, 2026Bensen DanielChief Discovery OfficerSale8,000$32.87$263.0KForm 4
Jan 12, 2026Bensen DanielChief Discovery OfficerSale8,000$28.52$228.2KForm 4
Dec 19, 2025MORE ROBERT JDirectorSale10,000$25.00$250.0KForm 4
Dec 12, 2025Bensen DanielChief Discovery OfficerSale8,000$22.64$181.1KForm 4
Nov 21, 2025MORE ROBERT JDirectorSale246,871$20.25$5.0MForm 4
Nov 19, 2025Bensen DanielChief Discovery OfficerSale49,956$16.32$815.3KForm 4
Nov 18, 2025Bensen DanielChief Discovery OfficerSale75,633$16.07$1.2MForm 4
Nov 17, 2025Bensen DanielChief Discovery OfficerSale20,072$16.18$324.8KForm 4
Nov 14, 2025Bensen DanielChief Discovery OfficerSale110,228$16.02$1.8MForm 4
Nov 13, 2025Bensen DanielChief Discovery OfficerSale1,111$16.00$17.8KForm 4
Jun 18, 2025KAPLAN GILLADirectorSale9,568$9.78$93.6KForm 4
Jun 17, 2025KAPLAN GILLADirectorSale10$10.35$104Form 4
Jun 16, 2025RA CAPITAL MANAGEMENT, L.P.DirectorBuy11,813$10.13$119.7KForm 4
Jun 16, 2025KAPLAN GILLADirectorSale6,814$10.38$70.7KForm 4
Jun 13, 2025RA CAPITAL MANAGEMENT, L.P.DirectorBuy120,167$10.20$1.2MForm 4
Jun 13, 2025KAPLAN GILLADirectorSale15,000$10.31$154.7KForm 4
Jun 12, 2025RA CAPITAL MANAGEMENT, L.P.DirectorBuy31,307$10.20$319.3KForm 4
Jun 12, 2025KAPLAN GILLADirectorSale30,000$10.31$309.3KForm 4

All 112 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.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Todd HarrisPh.D.$658.0K$5.6M74
2025Bhavesh Ashar57$45.8K$4.7M74
2025Douglas WarnerM.D.54$551.2K$2.4M74
2024Chief Executive Officer$632.7K$7.6M74
2024Chief Medical Officer$165.6K$4.7M74

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$200.0M 2024–2024
Money received by yearMoney received by year, 2024–2024: $200.0M in all. Private raises (Form D) $200.0M.$0$50M$100M$150M$200M2024 · Private raises (Form D): $200.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$200.0M$200.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Feb 6, 2024Raised $200 million in a private offering of equity38 Form D: 21 investors so far Form D

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
Ra Capital Management, L.P.12,198,625$389.6M3.4%No change
Fmr LLC8,920,513$284.9M0.0%+1,172,865
Jupiter Topco LLC4,352,448$139.2M0.1%New
Alta Partners Management Company, L.P.3,823,425$122.1M95.9%No change
Nextech Invest Ltd.3,553,585$113.5M5.4%−502,276
TCG Crossover Management, LLC3,248,980$103.8M2.5%No change
BlackRock, Inc.3,031,972$96.8M0.0%+814,043
State Street Corp2,140,368$68.4M0.0%+924,290
Commodore Capital LP1,875,000$59.9M3.6%−600,000
Paradigm Biocapital Advisors LP1,828,607$58.4M1.1%−226,384
Vanguard Capital Management LLC1,508,447$48.2M0.0%+382,477
Bvf Inc/il1,476,196$47.1M1.2%−500,000
5AM Venture Management, LLC1,029,298$32.9M11.4%No change
Deerfield Management Company, L.P.1,017,000$32.5M0.4%+468,000
Hood River Capital Management LLC1,016,775$32.5M0.2%New
Geode Capital Management, LLC970,734$31.0M0.0%+312,252
Caligan Partners LP806,986$25.8M1.2%−469,982
Canaan Partners XI LLC750,000$24.0M18.8%No change
Siren, L.L.C.725,000$23.2M0.5%New
Sio Capital Management, LLC695,315$22.2M3.8%+89,876
Stempoint Capital LP632,754$20.2M3.5%+246,400
Marshall Wace, Llp583,133$18.6M0.0%+385,385
Goldman Sachs Group Inc463,477$14.8M0.0%−86,857
Jennison Associates LLC450,964$14.4M0.0%−181,468
Two Sigma Investments, LP449,808$14.4M0.0%+348,190

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

SEC filer profile

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

  • Name on EDGARTyra Biosciences, Inc.1
  • CIK0001863127
  • Employer ID (EIN)83-147634810
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company10
  • Incorporated inDelaware10
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address2656 State Street, Carlsbad, CA 920081
  • Phone(619) 728-47601
  • Shares outstanding59,676,939 as of Jul 31, 20269
  • Public float$297.3M as of Jun 30, 202510
  • AuditorErnst & Young LLP, San Diego, California PCAOB ID 42; no auditor attestation of internal control over financial reporting10
  • On EDGAR sinceMay 28, 20211
  • Filings425 in all: 4 (171), 144 (49), 8-K (46), 3 (31), 10-Q (15), SCHEDULE 13G/A (15), SC 13D/A (10), SCHEDULE 13G (10)1
    All 36 form types

    SC 13G/A (8), CORRESP (7), DEFA14A (6), 10-K (5), DEF 14A (5), SC 13G (5), UPLOAD (5), ARS (4), EFFECT (4), SCHEDULE 13D/A (4), S-3 (3), SC 13D (3), 424B5 (2), S-1/A (2), S-8 (2), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), D (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), PRE 14A (1), S-1 (1), S-1MEF (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Mar 2, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 17, 2026
    Latest 8-K (8-K) Sep 15, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareTYRAThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 2, 2026 (Section 12(b) of the Exchange Act).10

Risk factors and legal proceedings

The risks Tyra Biosciences, Inc. names in Item 1A of its 10-K filed Mar 2, 2026: 75 risks under these headings, as written.10

  • Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
  • We are early in our development efforts, have a limited operating history, have not completed any clinical trials, and have no products approved for commercial sale, which may make it difficult for investors to evaluate our current business and likelihood of success and viability.
  • We have incurred significant net losses in each period since our inception, and we expect to continue to incur significant net losses for the foreseeable future.
  • Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve our objectives relating to discovery, development and commercialization of our product candidates.
  • We will require substantial additional capital 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 development programs, commercialization efforts or other operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our portfolio of investments or bank deposits may be subject to market, interest and credit risk that may reduce their value and adversely affect our business, results of operations and financial condition.
  • Risks Related to the Discovery, Development and Marketing Approval of Our Product Candidates
  • We are early in our development efforts, with three product candidates in clinical development, and our other development programs in the preclinical or discovery stage. If we are unable to successfully develop, obtain marketing approval and ultimately commercialize product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • As an organization, we have never completed any clinical trials or submitted an application for marketing approval and may be unable to do so for any of our product candidates.
  • Clinical and preclinical 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. Our product candidates may not have favorable results in clinical trials, if any, or receive marketing approval on a timely basis, if at all.
  • In oncology, our discovery and preclinical development activities are focused on the development of targeted therapeutics for patients with genomically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and may never lead to approved products of commercial value.
The other 63 risks
  • Any difficulties or delays in the commencement or completion, or termination or suspension, of our clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
  • Our proprietary SNÅP platform is innovative and unproven, and we do not know whether we will be able to develop any product candidates that are successful in clinical development or products of commercial value.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Use of our product candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.
  • Our product candidates are subject to extensive regulation and compliance, 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.
  • If we are unable to successfully develop companion diagnostics for biomarkers that enable patient selection, or experience significant delays in doing so, we may not be able to commercialize the product candidate and our ability to generate revenue will be materially impaired.
  • We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We may not be able to obtain or maintain orphan drug designations for any of our product candidates, and we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • If we successfully develop our product candidates, we may seek Breakthrough Therapy designation or Fast Track designation by the FDA for one or more of our product candidates, but we may not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • We have obtained a rare pediatric disease designation for dabogratinib for the treatment of ACH, however, there is no guarantee that any FDA approval of dabogratinib will result in issuance of a priority review voucher.
  • We have conducted, and may continue to conduct, clinical trials for certain of our product candidates outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
  • Interim, topline and preliminary data from our preclinical studies and clinical trials that we may 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.
  • Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations 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.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third parties for the manufacture of our product candidates for preclinical and clinical development. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • Our reliance on third parties requires us to share our confidential information, which increases the possibility that confidential information will be misappropriated or disclosed.
  • We may seek to enter into collaborations, licenses and other similar arrangements and may not be successful in doing so, and even if we are, we may relinquish valuable rights and may not realize the benefits of such relationships.
  • We rely on third parties to conduct our clinical trials and some of our preclinical studies. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, our development programs and our ability to seek or obtain marketing approval for or commercialize our product candidates may be delayed.
  • Risks Related to Commercialization of Our Product Candidates
  • Even if we receive marketing approval for any product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions on marketing 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.
  • The commercial success of our product candidates will depend upon the degree of market acceptance of such product candidates by physicians, patients, healthcare payors and others in the medical community.
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
  • The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.
  • We face significant competition, and if our competitors develop technologies or product candidates more rapidly than we do or their technologies are more effective, our business and our ability to develop and successfully commercialize products may be adversely affected.
  • If the market opportunities for our product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
  • 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.
  • Risks Related to Our Business Operations and Industry
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
  • We will need to continue to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
  • We are subject to various federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our results of operations and financial condition.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
  • 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 may affect the prices we may set.
  • We and any of our third-party manufacturers or suppliers may use potent chemical agents and 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 our products.
  • Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities.
  • We and any of our potential future collaborators will be required to report to regulatory authorities if any of our product candidates or approved products in clinical trials cause or contribute to certain adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.
  • Our information technology systems, or those of any of our CROs, other contractors or consultants or potential future collaborators, may fail or suffer security breaches, which could result in a material disruption of our product development programs, harm our reputation, significant fines, penalties and liability and loss of customers or sales.
  • Our business could be affected by litigation, government investigations and enforcement actions.
  • Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may have serious adverse consequences on our business, financial condition and stock price.
  • Changes in tax law may materially adversely affect our financial condition, results of operations and cash flows.
  • Our ability to use net operating loss carryforwards and other tax attributes may be limited.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for our product candidates and other proprietary technologies we develop, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability
  • to successfully commercialize our product candidates and other proprietary technologies we may develop may be adversely affected.
  • Substantive examination is just beginning on our pending patent applications, which makes it difficult to forecast the extent of any future patent right.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Issued patents relating to our product candidates and other proprietary technologies we may develop could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may not be successful in obtaining necessary rights to any product candidate we may develop through acquisitions and in-licenses.
  • We may be subject to claims that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • Third-party claims of intellectual property infringement, misappropriation or other violations against us or our collaborators may prevent or delay the development and commercialization of our product candidates and other proprietary technologies we may develop.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming and unsuccessful.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • 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.
  • Intellectual property rights do not necessarily address all potential threats.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • Risks Related to Our Common Stock
  • The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses.
  • An active, liquid trading market for our common stock may not be maintained.

Legal proceedings

We are not currently subject to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.

The opening of Item 3, Legal Proceedings.10

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