BMEA on Nasdaq

Biomea Fusion, Inc.

In its 2026 annual report the company says: “We are a clinical‑stage diabetes and obesity medicines company focused on the discovery and development of oral, small molecule drugs to treat and improve the lives of patients with diabetes, obesity, and other metabolic diseases.”3 It is headquartered in San Carlos, California.1 Its shares trade on Nasdaq under the symbol BMEA.1

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Last updated Oct 21, 2026.

Overview

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  • TickerBMEA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSan Carlos, California1
  • Incorporated inDE2
  • Business address1599 Industrial Road, San Carlos, Ca 940702
  • Filer category, Emerging growth company2

We are a clinical‑stage diabetes and obesity medicines company focused on the discovery and development of oral, small molecule drugs to treat and improve the lives of patients with diabetes, obesity, and other metabolic diseases.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 income45678-$83.5M in 2025+6888% since 2019
-$150.0M-$100.0M-$50.0M02019: -$1.2M-$1.2M20192020: -$5.3M-$5.3M2020+346%2021: -$41.7M-$41.7M2021+682%2022: -$83.6M-$83.6M2022+101%2023: -$126.1M-$126.1M2023+51%2024: -$144.1M-$144.1M2024+14%2025: -$83.5M-$83.5M2025−42%
Net income45678-$61.8M in 2025+5058% since 2019
-$150.0M-$100.0M-$50.0M02019: -$1.2M-$1.2M20192020: -$5.3M-$5.3M2020+344%2021: -$41.6M-$41.6M2021+681%2022: -$81.8M-$81.8M2022+97%2023: -$117.3M-$117.3M2023+43%2024: -$138.4M-$138.4M2024+18%2025: -$61.8M-$61.8M2025−55%

Every line of the income statement as filed: the last 3 fiscal years, latest first.8

Period ending2025-12-312024-12-312023-12-31
Research and development$62.0M$118.1M$102.5M
General and administrative$19.3M$26.0M$23.6M
Impairment of long-lived assets$2.2M$0$0
Total operating expenses$83.5M$144.1M$126.1M
Loss from operations-$83.5M-$144.1M-$126.1M
Change in fair value of common warrant liability$19.9M$0$0
Interest and other income, net$1.9M$5.6M$8.9M
Net loss-$61.8M-$138.4M-$117.3M
Unrealized gain on investments, net$1.0K
Comprehensive loss-$61.8M-$138.4M-$117.3M
Net loss per common share, basic-$1.18-$3.83-$3.44
Net loss per common share, diluted-$1.18-$3.83-$3.44
Weighted-average number of common shares used to compute basic net loss per common share52.2M shares36.1M shares34.1M shares
Weighted-average number of common shares used to compute diluted net loss per common share52.2M shares36.1M shares34.1M shares

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Corporate structure

Biomea Fusion, 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 Biomea Fusion, Inc.

  • CVI Investments, Inc. Filed SCHEDULE 13G/A on Biomea Fusion, Inc., latest Feb 17, 2026 (3 filings since Jun 25, 2025)
  • Blue Owl Capital Filed SCHEDULE 13G on Biomea Fusion, Inc., latest Feb 12, 2026 (3 filings since Aug 11, 2025)
  • Rainer M. Erdtmann Filed SCHEDULE 13G/A on Biomea Fusion, Inc., latest Feb 6, 2026 (5 filings since Feb 11, 2022)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G on Biomea Fusion, Inc., latest Dec 8, 2025 (4 filings since Feb 10, 2022)
  • Cormorant Asset Management, LP Filed SCHEDULE 13D/A on Biomea Fusion, Inc., latest Oct 24, 2025 (3 filings since Jul 22, 2025)
  • BlackRock Filed SCHEDULE 13G/A on Biomea Fusion, Inc., latest Jul 16, 2025 (4 filings since Feb 4, 2022)
  • BAKER BROS. ADVISORS LP Filed SCHEDULE 13G/A on Biomea Fusion, Inc., latest Feb 14, 2025 (3 filings since Feb 14, 2023)
  • Laurion Capital Management LP Filed SC 13G/A on Biomea Fusion, Inc., latest Nov 12, 2024 (2 filings since Feb 8, 2024)
  • State Street Corporation Filed SC 13G/A on Biomea Fusion, Inc., latest Jul 10, 2024 (2 filings since Apr 10, 2024)
  • Thomas Andrew Butler Filed SC 13G/A on Biomea Fusion, Inc., latest Feb 12, 2024 (3 filings since Feb 11, 2022)
  • FMR LLC Filed SC 13G/A on Biomea Fusion, Inc., latest Feb 9, 2024 (2 filings since May 10, 2023)
  • Cormorant Global Healthcare Master Fund, LP Filed SC 13D/A on Biomea Fusion, Inc., latest Apr 3, 2023
  • Biomea Fusion, Inc. San Carlos, California

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

What it owns

What Biomea Fusion, 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$1.2M8 Dec 31, 2025$7.9M8 Dec 31, 2024−85.4%
Accumulated depreciation$1.0M8 Dec 31, 2025$4.2M8 Dec 31, 2024−75.9%
Property and equipment, net$153.0K8 Dec 31, 2025$3.8M8 Dec 31, 2024−95.9%
Operating-lease assets (leased space)$08 Dec 31, 2025$6.9M8 Dec 31, 2024−100.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$55.8M8 Dec 31, 2025$58.3M8 Dec 31, 2024−4.2%
Debt securities available for sale$56.0M7 Dec 31, 2024$174.4M7 Dec 31, 2023−67.9%

Properties, in its own words

We currently lease approximately 18,796 square feet of office space in San Carlos, California under two leases which expire in January 2027. We believe these facilities are sufficient to meet our near-term needs and that any additional space we may require will be available on commercially reasonable terms.

Item 2 of the 10-K filed Mar 24, 2026.3

Leadership

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

Board members and other officers (12)

Timeline

  1. Oct 14, 20268-K Regulation FD disclosure; Other events25
  2. Sep 22, 20268-K Other events26
  3. Aug 5, 20268-K Financial statements and exhibits27
  4. Jun 11, 20268-K Shareholder vote28
  5. May 11, 20268-K Results of operations29
  6. Apr 28, 20268-K Regulation FD disclosure; Other events30
  7. Mar 24, 20268-K Results of operations31
  8. Feb 25, 20268-K Regulation FD disclosure32
  9. Jan 14, 20268-K Regulation FD disclosure; Other events33
  10. Nov 4, 20258-K Results of operations34
  11. Oct 7, 20258-K Entered a material agreement; Other events35
  12. Oct 6, 20258-K Other events36
  13. Mar 28, 2025New chief executive Michael J.m. Hitchcock becomes CEO11
  14. Apr 15, 2021New chief executive Thomas Andrew Butler becomes CEO12

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.27) a share, on Nov 4, 2025.37

When it reported results

  1. May 11, 2026Reported quarterly or annual results29
  2. Mar 24, 2026Reported quarterly or annual results31
  3. Nov 4, 2025Reported quarterly or annual results34
  4. Aug 5, 2025Reported quarterly or annual results38
  5. May 5, 2025Reported quarterly or annual results39
  6. Mar 31, 2025Reported quarterly or annual results40
  7. Oct 29, 2024Reported quarterly or annual results41
  8. Jul 31, 2024Reported 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

233 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 65 major events, 74 insider forms, 36 large holders, 38 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Sep 22, 2026424B5 EDGAR
  3. Sep 22, 20268-K EDGAR
  4. Aug 5, 202610-Q EDGAR
  5. Aug 5, 20268-K EDGAR
  6. Jun 12, 20264 EDGAR
  7. Jun 12, 20264 EDGAR
  8. Jun 12, 20264 EDGAR
  9. Jun 12, 20264 EDGAR
  10. Jun 11, 20268-K EDGAR
  11. May 11, 202610-Q EDGAR
  12. May 11, 20268-K EDGAR
  13. Apr 28, 20268-K EDGAR
  14. Apr 27, 2026DEF 14A EDGAR
  15. Apr 27, 2026ARS EDGAR
  16. Apr 3, 20264 EDGAR
  17. Apr 3, 20264 EDGAR
  18. Mar 24, 202610-K EDGAR
  19. Mar 24, 20268-K EDGAR
  20. Feb 25, 20268-K EDGAR

The 233 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

21 open-market trades by officers, directors and large owners since October 2021: 11 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 11, 2025Erdtmann Rainer MSee RemarksBuy30,000$1.43$42.9KForm 4
Dec 2, 2025Hitchcock Michael J.M.Interim CEOBuy100,000$0.99$99.0KForm 4
Dec 1, 2025Erdtmann Rainer MSee RemarksBuy10,000$1.05$10.5KForm 4
Nov 28, 2025Erdtmann Rainer MSee RemarksBuy40,000$1.10$44.0KForm 4
Sep 30, 2024Hitchcock Michael J.M.Interim CEOBuy10,000$10.06$100.6KForm 4
Jun 11, 2024Valle FrancoChief Financial OfficerBuy12,509$4.43$55.4KForm 4
Jun 1, 2023A2A Pharmaceuticals, Inc.10% ownerSale50,000$34.56$1.7MForm 4
May 31, 2023A2A Pharmaceuticals, Inc.10% ownerSale75,000$33.81$2.5MForm 4
May 12, 2023A2A Pharmaceuticals, Inc.10% ownerSale25,000$33.84$846.0KForm 4
May 9, 2023A2A Pharmaceuticals, Inc.10% ownerSale150,000$34.50$5.2MForm 4
May 8, 2023A2A Pharmaceuticals, Inc.10% ownerSale100,000$33.99$3.4MForm 4
Apr 20, 2023A2A Pharmaceuticals, Inc.10% ownerSale200,000$29.12$5.8MForm 4
Mar 31, 2023A2A Pharmaceuticals, Inc.10% ownerSale200,000$31.25$6.2MForm 4
Mar 31, 2023A2A Pharmaceuticals, Inc.10% ownerSale200,000$31.25$6.2MForm 4
Mar 30, 2023Cormorant Global Healthcare Master Fund, LPBuy400,000$30.00$12.0MForm 4
Nov 14, 2022Hitchcock Michael J.M.Interim CEOBuy5,000$7.93$39.6KForm 4
Nov 11, 2022Valle FrancoChief Financial OfficerBuy4,100$7.63$31.3KForm 4
Aug 16, 2022A2A Pharmaceuticals, Inc.10% ownerBuy30,684$13.87$425.6KForm 4
Jul 21, 2022A2A Pharmaceuticals, Inc.10% ownerSale34,658$11.21$388.5KForm 4
Jun 24, 2022A2A Pharmaceuticals, Inc.10% ownerSale34,658$11.76$407.6KForm 4

All 21 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
2025Michael J.M. Hitchcock, Ph.D.Interim Chief Executive Officer and Principal Executive Officer76$486.7K$2.6M56
2025Rainer (Ramses) ErdtmannChief Operating Officer, President, Principal Financial Officer and Principal Accounting Officer62$489.6K$2.2M56
2025Thomas ButlerFormer Chief Executive Officer and Former Chairman of the Board$662.0K56
2025Juan Pablo Frias, M.D.Former Chief Medical Officer$325.0K$549.0K56
2024Thomas ButlerFormer Chief Executive Officer and Former Chairman of the Board$633.6K$5.1M56
2024Rainer (Ramses) ErdtmannChief Operating Officer, President, Principal Financial Officer and Principal Accounting Officer62$489.6K$2.0M56

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 62. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Fmr LLC8,814,946$13.0M0.0%+1,587
Vanguard Capital Management LLC2,829,927$4.2M0.0%+232,627
Marshall Wace, Llp2,049,802$3.0M0.0%+851,251
Aisling Capital Management LP2,048,757$3.0M0.6%No change
Renaissance Technologies LLC1,455,474$2.1M0.0%+142,676
Fideuram - Intesa Sanpaolo Private Banking S.p.a.723,176$1.1M0.0%+166,140
BlackRock, Inc.715,445$1.1M0.0%+74,010
Geode Capital Management, LLC708,854$1.0M0.0%+160,668
Susquehanna International Group, Llp612,735$900.7K0.0%−17,130
Mariner, LLC594,726$874.2K0.0%−59,852
Jane Street Group, LLC458,289$673.7K0.0%+182,634
UBS Group AG444,728$653.8K0.0%−70,827
XTX Topco Ltd406,879$598.1K0.0%−123,663
Two Sigma Investments, LP384,459$565.2K0.0%−4,237
Morgan Stanley367,021$539.5K0.0%+20,279
Vanguard Fiduciary Trust Co338,345$497.4K0.0%+2,230
MAI Capital Management289,100$425.0K0.0%+200,000
State Street Corp257,315$378.3K0.0%+49,300
LMR Partners LLP200,000$261.0K0.0%No change
Northern Trust Corp128,526$188.9K0.0%−80,439
Headlands Technologies LLC111,349$163.7K0.0%+5,750
Marex Group Ltd100,000$147.0K0.0%No change
Goldman Sachs Group Inc93,757$137.8K0.0%+18,018
Bridgeway Capital Management, LLC84,600$124.4K0.0%No change
Jain Global LLC75,698$111.3K0.0%New

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

SEC filer profile

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

  • Name on EDGARBiomea Fusion, Inc.1
  • CIK0001840439
  • Employer ID (EIN)82-25201343
  • 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 address1599 Industrial Road, San Carlos, CA 940701
  • Phone(650) 980-90991
  • Shares outstanding72,483,852 as of Jul 31, 202610
  • Public float$93.6M as of Jun 30, 20253
  • AuditorDeloitte & Touche LLP, San Francisco, CA PCAOB ID 34; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJan 15, 20211
  • Filings290 in all: 4 (80), 8-K (73), 10-Q (17), 3 (14), SC 13G/A (12), SC 13G (11), 424B5 (8), CORRESP (8)1
    All 34 form types

    SCHEDULE 13G/A (7), UPLOAD (7), S-8 (6), 10-K (5), DEF 14A (5), ARS (4), SCHEDULE 13G (4), 144 (3), EFFECT (3), SCHEDULE 13D/A (3), 4/A (2), 5 (2), S-1/A (2), S-3 (2), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), D (1), DEFA14A (1), DRS (1), PRE 14A (1), S-1 (1), S-1MEF (1), SC 13D (1), SC 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 24, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par valueBMEAThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 24, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Biomea Fusion, Inc. names in Item 1A of its 10-K filed Mar 24, 2026: 75 risks under these headings, as written.3

  • Risks Related to Our Limited Operating History, Business, Financial Condition, Results of Operations, and Need for Additional Capital
  • We have a limited operating history, limited experience in conducting clinical trials, have not completed the clinical development of any product candidates, have no products approved for commercial sale, and have not generated any revenue, which may make it difficult for you 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 incur significant net losses for the foreseeable future.
  • We have not generated any revenue from our product candidates and may never generate revenue or be profitable. Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery and development of our product candidates.
  • Due to the significant resources required for the development of our product candidates, we must prioritize development of certain product candidates and/or certain indications. We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and product development programs or future commercialization efforts.
  • There is substantial doubt about our ability to continue as a going concern.
  • Volatility in capital markets and lower market prices for many securities may affect our ability to access new capital through sales of shares of our common stock or issuance of indebtedness, which may harm our liquidity, limit our ability to grow our business, pursue acquisitions or improve our operating infrastructure and restrict our ability to compete in our markets.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.
  • Risks Related to Product Development
  • Our discovery and development activities are focused on the development of novel small molecule therapies, initially targeted at menin, to treat patients with diabetes and obesity, and the approach we are taking to discover and develop such product candidates is novel, may never lead to marketable products and may not ultimately represent a significant market.
  • We are early in our development efforts and are substantially dependent on our product candidates, icovamenib and BMF-650. If we are unable to advance icovamenib, BMF-650 or any other product candidates through clinical development, obtain regulatory approval and ultimately commercialize icovamenib, BMF-650 or any other product candidates, or experience significant delays in doing so, our business, financial condition and results of operations will be materially adversely affected.
The other 64 risks
  • Preclinical and clinical drug development is a lengthy and expensive process, with an uncertain outcome. Our preclinical and clinical programs may experience delays or may never be initiated or completed, which would adversely affect our ability to obtain regulatory approvals or commercialize our product candidates on a timely basis or at all, which could have an adverse effect on our business.
  • The results of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or other comparable foreign regulatory authorities. Successful preclinical studies and clinical trials cannot provide assurance of successful commercialization.
  • We face risks related to global health emergencies such as a pandemic, epidemic, or outbreak of an infectious disease, which could materially adversely impact our business, results of operations, and financial condition, including our preclinical studies and clinical trials.
  • If we experience delays or difficulties in the enrollment and/or retention of eligible participants in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.
  • The market opportunities for our product candidates may be relatively small as it will be limited to those patients who are ineligible for or have failed prior treatments and our estimates of the prevalence of our target patient populations may be inaccurate.
  • The incidence and prevalence for target patient populations of icovamenib and BMF-650 are based on estimates and third-party sources. If the market opportunities for icovamenib and BMF-650 or any future product candidate we may develop, if and when approved, are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability might be materially and adversely affected.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • Our novel small molecule product candidates may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational product candidates that may result in a safety profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
  • Interim, “top-line”, and preliminary data from our clinical trials that we announce or publish from time to time may change as more participants data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, and others in the medical community.
  • Coverage and reimbursement of newly-approved products from third-party payors is uncertain. Our product candidates may become subject to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, either of which would adversely affect our business. 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.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities, which may not be sufficiently covered by insurance, and may be required to limit commercialization of our product candidates.
  • We have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators.
  • Risks Related to Regulatory Process and Other Legal Compliance Matters
  • The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
  • A condition or disease we are conducting or plan to conduct clinical trials for may not be a rare disease or condition that is eligible for orphan drug designation or we may not be able to obtain orphan drug designation or obtain or maintain the benefits associated with orphan drug designation, such as orphan drug exclusivity and, even if we do, that exclusivity may not prevent the FDA or other comparable foreign regulatory authorities, from approving competing products.
  • A Breakthrough Therapy designation or Fast Track designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development, regulatory review or approval process, and each designation does not increase the likelihood that any of our product candidates will receive regulatory approval in the United States.
  • Accelerated approval by the FDA, even if granted for our current or any other future product candidates, 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 regulatory approval.
  • We may seek priority review designation for one or more of our other product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Changes in funding or disruptions at the FDA, the SEC and other government agencies caused by reduction in staffing, funding shortages or global health concerns could hinder their ability to hire and retain 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, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Even if we receive regulatory approval of our product candidates, we will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Our employees, independent contractors, consultants, principal investigators, CROs, suppliers, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • We are or may become subject to stringent and changing laws, regulations, contractual obligations, and other obligations relating to privacy, data protection, and information security. The actual or perceived failure by us or our partners, customers, vendors, third-party payors or other related third parties to comply with such obligations could harm our reputation, subject us to significant fines and liability, or otherwise adversely affect our business.
  • Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.
  • Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.
  • Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business
  • We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Business disruptions could materially adversely affect our future revenue and financial condition and increase our costs and expenses.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be limited.
  • Changes in tax law may adversely affect us or our investors.
  • A portion of our chemistry-based product development and sourcing of certain manufacturing raw materials for our product candidates takes place outside the United States through third-party manufacturers. A significant disruption in the operation of those manufacturers, a trade war or political unrest in China could materially adversely affect our business, financial condition and results of operations.
  • Risks Related to Reliance on Third Parties
  • We currently rely, and plan to rely in the future, on third parties to conduct and support our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
  • We currently, and may in the future, depend on single-source suppliers for some of the ingredients, components and materials used in, and the manufacturing processes required to develop, our product candidates.
  • If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • We may, in the future, form or seek collaborations or strategic alliances or enter into licensing arrangements, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • Risks Related to Intellectual Property
  • If we are unable to obtain, maintain, enforce and adequately protect our patents and other intellectual property rights with respect to our technology and product candidates, or if the scope of our patents or other intellectual property rights are not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology or product candidates may be adversely affected.
  • Our success depends in part on our ability to protect our intellectual property rights. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to protect our intellectual property 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 governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements.
  • Any issued patents we may own covering our product candidates could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including the USPTO.
  • We may become involved in lawsuits or litigation at the USPTO to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our technology, products and product candidates.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • 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.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain. Defending against such lawsuits will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information or alleged trade secrets of third parties or competitors or are in breach of non-competition or non-solicitation agreements with our competitors or their former employers.
  • If we fail to comply with our obligations in any future agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with any licensors, we could lose license rights that are important to our business.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to Our Common Stock
  • The price of our stock has been and is likely to continue to be volatile, and you may not be able to resell shares of our common stock at or above the price you paid.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • A significant portion of our total outstanding shares may be sold into the market in the near future, which could cause the market price of our common stock to drop significantly.
  • Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans or upon the exercise of outstanding warrants, would result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our securities.
  • Our management and directors own our stock and may be able to exert influence over matters subject to stockholder approval.
  • We do not intend to pay dividends on our capital stock, so any returns will be limited to the value of our stock.
  • Provisions in our amended and restated certificate of incorporation and amended and restated bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our common stock.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide for an exclusive forum in the Court of Chancery of the State of Delaware for certain 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.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

Legal proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently a party to any material legal proceedings. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.

The opening of Item 3, Legal Proceedings.3

Sources

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