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Bicara Therapeutics Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. We have built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site.”3 It is headquartered in Boston, Massachusetts.1 Its shares trade on Nasdaq under the symbol BCAX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerBCAX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoston, Massachusetts1
  • Incorporated inDE2
  • Business address116 Huntington Avenue Suite 703, Boston, Ma 021162
  • Filer category, Emerging growth company2

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We are a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. We have built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This dual-targeting approach both enhances drug exposure within the tumor microenvironment, or TME, and limits systemic toxicity. This approach was deployed in the development of our lead program ficerafusp alfa, formerly BCA101, a bifunctional epidermal growth factor receptor-, or EGFR, directed monoclonal antibody bound to a human transforming growth factor beta, or TGF-β, ligand trap.3 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 income45-$155.6M in 2025+290% since 2023
-$200.0M-$150.0M-$100.0M-$50.0M02023: -$39.9M-$39.9M20232024: -$82.4M-$82.4M2024+107%2025: -$155.6M-$155.6M2025+89%
Net income45-$137.9M in 2025+165% since 2023
-$150.0M-$100.0M-$50.0M02023: -$52.0M-$52.0M20232024: -$68.0M-$68.0M2024+31%2025: -$137.9M-$137.9M2025+103%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
General and administrative$30.5M$18.8M
Total operating expenses$155.6M$82.4M
Loss from operations-$155.6M-$82.4M
Interest income$17.9M$14.6M
Total other income, net$17.9M$14.6M
Net loss before income taxes-$137.7M-$67.8M
Income tax expense-$217.0K-$187.0K
Net loss-$137.9M-$68.0M
Net Loss per share, basic (in usd per share)-$2.52-$4.05
Net Loss per share, diluted (in usd per share)-$2.52-$4.05
Weighted-average number common shares outstanding, basic (in shares)54.7B shares16.8B shares
Weighted-average number common shares outstanding, diluted (in shares)54.7B shares16.8B shares
Unrealized gain on marketable securities, net of tax$243.0K$0
Total other comprehensive income$243.0K$0
Total comprehensive loss-$137.7M-$68.0M

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Corporate structure

Bicara Therapeutics 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 Bicara Therapeutics Inc.

  • T. Rowe Price Investment Management, Inc. Filed SCHEDULE 13G/A on Bicara Therapeutics Inc., latest Oct 7, 2026 (3 filings since Feb 17, 2026)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Bicara Therapeutics Inc., latest Aug 13, 2026 (2 filings since May 15, 2026)
  • BlackRock Filed SCHEDULE 13G on Bicara Therapeutics Inc., latest Jul 27, 2026
  • Deep Track Capital, LP Filed SCHEDULE 13G/A on Bicara Therapeutics Inc., latest May 15, 2026 (2 filings since Feb 12, 2026)
  • Vestal Point Capital, LP Filed SCHEDULE 13G/A on Bicara Therapeutics Inc., latest May 15, 2026 (4 filings since May 15, 2025)
  • Red Tree GP, LLC Filed SCHEDULE 13G/A on Bicara Therapeutics Inc., latest May 8, 2026 (2 filings since Sep 26, 2024)
  • FMR LLC Filed SCHEDULE 13G/A on Bicara Therapeutics Inc., latest May 6, 2026 (8 filings since Sep 18, 2024)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13D/A on Bicara Therapeutics Inc., latest Mar 2, 2026 (2 filings since Sep 23, 2024)
  • Invus Global Management, LLC Filed SCHEDULE 13G/A on Bicara Therapeutics Inc., latest Jul 31, 2025 (2 filings since Sep 26, 2024)
  • TPG GP A, LLC Filed SC 13D on Bicara Therapeutics Inc., latest Sep 18, 2024
  • Bicara Therapeutics Inc. Boston, Massachusetts

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

What it owns

What Bicara Therapeutics 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, net$330.0K5 Dec 31, 2025$155.0K5 Dec 31, 2024+112.9%
Operating-lease assets (leased space)$1.7M5 Dec 31, 2025$690.0K5 Dec 31, 2024+146.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$96.7M5 Dec 31, 2025$489.7M5 Dec 31, 2024−80.3%
Marketable securities, current$318.1M5 Dec 31, 2025$05 Dec 31, 2024
Debt securities available for sale$318.1M5 Dec 31, 2025

Properties, in its own words

Our principal facilities consist of office space. Our corporate headquarters are currently located in Boston, Massachusetts, where we lease a total of 9,361 square feet at 116 Huntington Avenue pursuant to an Office Lease Agreement with Columbia REIT - 116 Huntington, LLC, dated August 16, 2023, as amended, or the Lease, for 9,361 square feet and a Sublease Agreement with J.W. Childs Associates, L.P., dated June 2, 2025, or the Sublease, for 9,682 square feet. The Lease and Sublease both expire on June 30, 2027, with an option to renew the Lease term for three (3) years. We believe that these facilities will be adequate for our near-term needs. If required, we believe that suitable additional or alternative space would be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 30, 2026.3

Leadership

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

Chief executive

  1. Claire Mazumdar2024–2026
  2. Ryan Cohlhepp2026–now

President

  1. Ryan Cohlhepp2024–now

Chief financial officer

  1. Ivan Hyep2024–2026
  2. Jennifer Larson2026–now

Chief operating officer

  1. Ryan Cohlhepp2024–now
2025
Board members and other officers (16)

Timeline

  1. Sep 10, 2026New chief executive Ryan Cohlhepp becomes CEO8
  2. Aug 25, 20268-K Entered a material agreement27
  3. Aug 11, 20268-K Results of operations28
  4. Jul 28, 20268-K Executive or director change; Regulation FD disclosure29
  5. Jun 10, 20268-K Shareholder vote30
  6. May 21, 20268-K Other events31
  7. May 11, 20268-K Results of operations32
  8. Mar 30, 20268-K Results of operations33
  9. Feb 26, 20268-K Entered a material agreement; Results of operations34
  10. Feb 19, 20268-K Other events35
  11. Jan 12, 20268-K Other events36
  12. Dec 8, 20258-K Regulation FD disclosure; Other events37
  13. Nov 10, 20258-K Results of operations38
  14. Sep 12, 2024New chief executive Claire Mazumdar becomes CEO9

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.67) a share, on Nov 10, 2025.39

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results28
  2. May 11, 2026Reported quarterly or annual results32
  3. Mar 30, 2026Reported quarterly or annual results33
  4. Feb 26, 2026Reported quarterly or annual results34
  5. Nov 10, 2025Reported quarterly or annual results38
  6. Aug 12, 2025Reported quarterly or annual results40
  7. May 13, 2025Reported quarterly or annual results41
  8. Mar 27, 2025Reported quarterly or annual results42

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

262 filings to the SEC since October 2021: 2 annual reports, 6 quarterly reports, 20 major events, 107 insider forms, 27 large holders, 100 other. The latest 20:

  1. Oct 7, 2026SCHEDULE 13G/A EDGAR
  2. Sep 10, 20264 EDGAR
  3. Sep 8, 2026144 EDGAR
  4. Sep 8, 2026144 EDGAR
  5. Aug 25, 20268-K EDGAR
  6. Aug 14, 20264 EDGAR
  7. Aug 14, 20263 EDGAR
  8. Aug 13, 2026SCHEDULE 13G/A EDGAR
  9. Aug 12, 20264 EDGAR
  10. Aug 12, 20264 EDGAR
  11. Aug 12, 20264 EDGAR
  12. Aug 11, 2026S-8 EDGAR
  13. Aug 11, 202610-Q EDGAR
  14. Aug 11, 20268-K EDGAR
  15. Aug 10, 2026144 EDGAR
  16. Aug 10, 2026144 EDGAR
  17. Aug 10, 2026144 EDGAR
  18. Jul 29, 20264 EDGAR
  19. Jul 29, 20264 EDGAR
  20. Jul 29, 20263 EDGAR

The 262 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

60 open-market trades by officers, directors and large owners since October 2021: 3 buys and 57 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 8, 2026Cohlhepp RyanPresident, COO & Interim CEOSale17,500$22.90$400.7KForm 4
Aug 10, 2026Hyep IvanChief Financial OfficerSale12,500$27.97$349.6KForm 4
Aug 10, 2026Mazumdar ClaireChief Executive OfficerSale10,000$27.98$279.8KForm 4
Aug 10, 2026Cohlhepp RyanPresident, COO & Interim CEOSale18,750$27.98$524.6KForm 4
Jul 10, 2026Mazumdar ClaireChief Executive OfficerSale10,000$28.42$284.2KForm 4
Jul 9, 2026Cohlhepp RyanPresident, COO & Interim CEOSale536$29.00$15.5KForm 4
Jul 8, 2026Cohlhepp RyanPresident, COO & Interim CEOSale28,214$28.98$817.6KForm 4
Jul 8, 2026Hyep IvanChief Financial OfficerSale28,000$28.84$807.6KForm 4
May 21, 2026Hyep IvanChief Financial OfficerSale9,200$20.42$187.9KForm 4
May 18, 2026Mazumdar ClaireChief Executive OfficerSale15,000$20.04$300.6KForm 4
May 15, 2026Cohlhepp RyanPresident, COO & Interim CEOSale12,500$20.29$253.6KForm 4
Apr 27, 2026Raben DavidChief Medical OfficerSale5,500$22.88$125.8KForm 4
Apr 21, 2026Hyep IvanChief Financial OfficerSale9,200$23.00$211.6KForm 4
Apr 20, 2026Mazumdar ClaireChief Executive OfficerSale15,000$23.61$354.1KForm 4
Apr 15, 2026Cohlhepp RyanPresident, COO & Interim CEOSale12,500$23.01$287.6KForm 4
Mar 25, 2026Raben DavidChief Medical OfficerSale5,500$18.95$104.2KForm 4
Mar 23, 2026Hyep IvanChief Financial OfficerSale9,200$18.52$170.4KForm 4
Mar 20, 2026Mazumdar ClaireChief Executive OfficerSale1,596$18.95$30.2KForm 4
Mar 19, 2026Mazumdar ClaireChief Executive OfficerSale6,905$18.78$129.7KForm 4
Mar 18, 2026Mazumdar ClaireChief Executive OfficerSale6,499$18.84$122.4KForm 4

All 60 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
2025Claire Mazumdar, Ph.D.Chief Executive Officer36$625.0K$927.7K53
2025Ryan Cohlhepp, Pharm.D.President and Chief Operating Officer49$588.0K$858.4K53
2025David Raben, M.D.Chief Medical Officer62$525.0K$709.2K53
2024Claire Mazumdar, Ph.D.Chief Executive Officer36$517.5K$8.9M53
2024Ryan Cohlhepp, Pharm.D.President and Chief Operating Officer49$517.5K$4.5M53

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.7,255,993$215.4M1.9%No change
Siren, L.L.C.5,602,970$166.4M3.4%−200,000
Vestal Point Capital, LP5,250,000$155.9M3.6%−175,000
Deep Track Capital, LP4,100,000$121.7M1.8%+37,500
BlackRock, Inc.3,848,090$114.2M0.0%+1,004,383
Jupiter Topco LLC3,171,015$94.0M0.0%New
Red Tree Management, LLC3,163,517$93.9M63.8%−6,992
Tpg Gp A, LLC3,010,425$89.4M1.8%No change
Vanguard Capital Management LLC2,216,639$65.8M0.0%+442,419
State Street Corp2,048,920$60.8M0.0%+629,532
Franklin Resources Inc1,951,892$58.0M0.0%+330,249
Fmr LLC1,893,070$56.2M0.0%−207,859
Omega Fund Management, LLC1,822,150$54.1M29.1%−570,000
Geode Capital Management, LLC1,162,635$34.5M0.0%+331,729
Jpmorgan Chase & Co1,015,965$29.8M0.0%+838,557
Jones Hill Capital LP892,621$26.5M5.6%−367,515
Acorn Capital Advisors, LLC643,381$19.1M5.2%−1
Aisling Capital Management LP568,919$16.9M3.6%No change
Palo Alto Investors LP550,408$16.3M2.3%No change
Rock Springs Capital Management LP535,286$15.9M0.8%+46,191
Goldman Sachs Group Inc520,567$15.5M0.0%−38,397
D. E. Shaw & Co., Inc.498,193$14.8M0.0%+221,250
Dimensional Fund Advisors LP461,724$13.7M0.0%+352,463
Nan Fung Trinity (hk) Ltd427,885$12.7M1.3%No change
Vanguard Portfolio Management LLC418,912$12.4M0.0%+127,973

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

SEC filer profile

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

  • Name on EDGARBicara Therapeutics Inc.1
  • CIK0002023658
  • Employer ID (EIN)83-29037453
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address116 Huntington Avenue Suite 703, Boston, MA 021161
  • Phone617-468-42191
  • Shares outstanding66,172,934 as of Aug 6, 20267
  • Public float$376.7M as of Jun 30, 20253
  • AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJun 10, 20241
  • Filings262 in all: 4 (84), 144 (61), 3 (23), 8-K (20), SCHEDULE 13G/A (14), SCHEDULE 13G (7), 10-Q (6), CORRESP (6)1
    All 31 form types

    S-8 (4), 424B5 (3), S-1/A (3), SC 13G (3), UPLOAD (3), 10-K (2), ARS (2), DEF 14A (2), DEFA14A (2), EFFECT (2), SC 13D (2), SEC STAFF LETTER (2), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), S-1 (1), S-1MEF (1), S-3 (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 30, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Aug 25, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001BCAXNasdaq Global Market

From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Bicara Therapeutics Inc. names in Item 1A of its 10-K filed Mar 30, 2026: 71 risks under these headings, as written.3

  • Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital
  • We are a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability. We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future.
  • If we are unable to raise capital when needed, or on acceptable terms, we may be unable to complete the development and commercialization of ficerafusp alfa or any future product candidates.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to ficerafusp alfa.
  • Risks Related to Our Business Operations and Industry
  • Our business is highly dependent on the success of ficerafusp alfa. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize ficerafusp alfa, or if we experience delays in doing so, our business will be materially harmed.
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • Due to the significant resources required for the development of our pipeline, and depending on our ability to access capital, we must prioritize the development of certain product candidates over others. Moreover, we may fail to expend our limited resources on product candidates or indications that may have been more profitable or for which there is a greater likelihood of success.
  • We may seek to grow our business through acquisitions or investments in new or complementary businesses, products or technologies, through the licensing of products or technologies from third parties or other strategic alliances. The failure to manage acquisitions, investments, licenses or other strategic alliances, or the failure to integrate them with our existing business, could have a material adverse effect on our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
  • Our employees, independent contractors, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We, our collaborators and our service providers are subject to a variety of privacy and data security laws, regulations and contractual obligations, which may require us to incur substantial compliance costs, and any failure or perceived failure by us to comply with them could expose us to significant fines and other penalties and otherwise harm our business and operations.
  • If we are unable to protect the confidentiality of our proprietary information, the value of ficerafusp alfa could be adversely affected.
The other 60 risks
  • The use of new and evolving technologies, such as artificial intelligence, or AI, in our operations may result in spending material resources and presents risks and challenges that can impact our business including by posing security and other risks to our confidential information, proprietary information and personal information, and as a result we may be exposed to reputational harm and liability.
  • Risks Related to the Discovery and Development of ficerafusp alfa or Future Product Candidates
  • Our business is dependent on our ability to advance ficerafusp alfa and future product candidates through clinical trials, obtain marketing approval and ultimately commercialize them.
  • Clinical development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays in developing and commercializing or be unable to develop or commercialize ficerafusp alfa and any future product candidates.
  • We are currently conducting, and may in the future conduct, clinical trials for ficerafusp alfa or any future product candidates outside the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • Positive results from preclinical studies and early-stage clinical trials may not be predictive of future results. Initial positive results in any of our clinical trials may not be indicative of results obtained when the trial is completed or in later stage trials.
  • Interim and preliminary results 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, validation and verification procedures that could result in material changes in the final data.
  • Ficerafusp alfa or any future product candidates may cause undesirable side effects or have other properties when used alone or in combination with other approved products or investigational new drugs that could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • Failure to adequately design a trial, or incorrect assumptions about the design of the trial, could adversely affect the ability to initiate the trial, enroll patients, complete the trial or obtain regulatory approval on the basis of the trial results, as well as lead to increased or unexpected costs and delayed timelines.
  • If we or our collaborators encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise be adversely affected.
  • Preclinical development is uncertain. Any preclinical programs we pursue may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all.
  • Failure to successfully develop and commercialize companion diagnostics with third party contractors for use with our product candidates could harm our ability to commercialize our product candidates.
  • Risks Related to Our Dependence On and Work with Third Parties
  • We rely, and expect to continue to rely, on third parties, including independent clinical investigators and CROs, to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates, and our business could be substantially harmed.
  • We currently and in the future may depend on other third-party collaborators for the discovery, development and commercialization of ficerafusp alfa and any of our future product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • We currently have established collaborations and may seek to establish future collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • The operations of our suppliers, many of which are located outside of the United States, are subject to additional risks that are beyond our control and that could harm our business, financial condition, results of operations and prospects.
  • If any third-party manufacturer of our product candidates is unable to increase the scale of its production of our product candidates or increase the product yield of its manufacturing, then our manufacturing costs may increase and commercialization may be delayed.
  • We may need to maintain licenses for drug substances from third parties to develop and commercialize some of our product candidates, which could increase our development costs and delay our ability to commercialize those product candidates.
  • Risks Related to Government Regulation
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be materially harmed.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy personnel, and substantial leadership, personnel and policy changes or otherwise, could prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
  • We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.
  • We intend to develop our product candidates in part in combination with other therapies and may develop our future product candidates in combination with other therapies, which exposes us to additional regulatory risks.
  • Even if we receive marketing approval of ficerafusp alfa, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. If we fail to comply or experience unanticipated problems with our products, we may be subject to administrative and judicial enforcement, including monetary penalties, for non-compliance and our approved products, if any, could be deemed misbranded or adulterated and prohibited from continued distribution.
  • While we intend to seek designations for our potential product candidates with the FDA and comparable foreign regulatory authorities that are intended to confer benefits such as a faster development process, there can be no assurance that we will successfully obtain such designations. In addition, even if one or more of our potential product candidates are granted such designations, we may not be able to realize the intended benefits of such designations.
  • We may not be able to obtain or maintain orphan drug designations for our product candidates, and we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • While we may seek accelerated approval for some of our product candidates, we may not be able to obtain it as the sufficiency of our clinical trial results for accelerated approval are subject to the FDA’s discretion.
  • Risks Related to Commercialization
  • The commercial success of ficerafusp alfa or any future 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.
  • The market opportunities for ficerafusp alfa or any future product candidate we develop, if approved, may prove to be smaller than we believe.
  • If approved, our product candidates that are regulated as biological products, or biologics, may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • Obtaining and maintaining marketing approval of ficerafusp alfa and any future product candidates in one jurisdiction does not mean that we will be successful in obtaining and maintaining marketing approval of ficerafusp alfa and any future product candidates in other jurisdictions.
  • We may enter into agreements with third parties to sell, distribute and/or market ficerafusp alfa, or any future product candidates, if we obtain regulatory approval, which may adversely affect our ability to generate revenues.
  • Off-label use or misuse of ficerafusp alfa may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits.
  • We are subject to export and import controls, economic sanctions and anti-corruption laws and regulations of the United States and other jurisdictions. We can face criminal liability and other serious consequences for violations of these laws and regulations, which can harm our business.
  • If we or any third-party manufacturer we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could have a material adverse effect on our business.
  • Risks Related to Our Intellectual Property
  • Our ability to compete may decline if we do not adequately protect our proprietary rights.
  • We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
  • Issued patents covering ficerafusp alfa and related technology could be found invalid or unenforceable if challenged in court or before a patent office. We are currently, and may in the future become, involved in lawsuits involving our intellectual property, including patents, to protect or enforce our patents, which could be expensive, time consuming and unsuccessful.
  • If we are unsuccessful in defending against any claims by competitors or others that we are infringing upon their intellectual property rights, our business could be materially harmed.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market our products.
  • If we fail to comply with our obligations under our intellectual property licenses with third parties, we could lose license rights that are important to our business.
  • We may be unsuccessful in licensing or acquiring third-party intellectual property that may be required to develop and commercialize ficerafusp alfa.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we do not obtain protection under the Hatch-Waxman Amendments and similar foreign legislation for extending the term of patents covering ficerafusp alfa, our business may be materially harmed.
  • We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • Risks Related to Healthcare, Insurance and Legal Matters
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of ficerafusp alfa.
  • The successful commercialization of ficerafusp alfa or any future 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 are subject to various U.S. 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 reputation, subject us to significant fines and liability or otherwise adversely affect our business.
  • Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to obtain coverage for and commercialize ficerafusp alfa, if approved, or any future product candidates and may adversely affect the prices we may set.
  • Failure to comply with laws and regulations related to the protection of research subjects could result in fines, penalties, and litigation, and have a material adverse effect upon our business.
  • Risks Related to Manufacturing of Our Product Candidates
  • Changes in methods of product candidate manufacturing may result in additional costs or delay.
  • We are subject to various manufacturing risks, any of which could substantially increase our costs and limit supply of ficerafusp alfa.
  • Risks Related to Employee Matters and Managing Growth
  • Our ability to develop product candidates, leverage our potential and our future growth depends on attracting, hiring and retaining our key personnel and recruiting additional qualified personnel. If we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. Additionally, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Risks Related to Ownership of Our Common Stock
  • The price of our stock may be volatile, and you could lose all or part of your investment.
  • 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.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • Our executive officers, directors, principal stockholders and their respective affiliates own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • Future sales or issuances of our common stock in the public market could cause our common stock price to fall.
  • Our issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.
  • 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 of the value of our common stock.

Legal proceedings

We are subject to various litigation, claims and other proceedings that arise from time to time in the ordinary course of business. On October 22, 2024, a complaint was filed in federal district court in the District of Massachusetts by Y-Trap, Inc., or Y-Trap, naming as defendants us and Biocon Ltd, or Biocon, captioned Y-Trap, Inc. v. Biocon Ltd and Bicara Therapeutics Inc., No. 24-cv-12678 (D. Mass.). The operative complaint alleges a claim against defendants for correction of inventorship of a number of patents, including patents alleged to be licensed to us relating to ficerafusp alfa. The complaint also alleges claims against defendants for unfair trade practices pursuant to Chapter 93A of the Massachusetts General Laws, unjust enrichment, and civil conspiracy. The complaint seeks, among other things, damages (including compensatory, enhanced, and punitive damages), an order correcting the inventorship of the patents at issue, costs and attorney’s fees, and other equitable and injunctive relief. On January 31, 2025, Y-Trap filed its operative amended complaint. On February 28, 2025, Biocon and Bicara moved to dismiss all of Y-Trap’s claims. On September 30, 2025, the court denied our motion. On October 30, 2025, we answered the operative complaint. We will continue to vigorously defend against this litigation.

The opening of Item 3, Legal Proceedings.3

Sources

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