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Private company

Nuvalent, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer. We leverage our team’s deep expertise in chemistry and structure-based drug design to develop innovative small molecules that are designed with the aim to overcome the limitations of existing therapies for clinically proven kinase targets.”5 It is headquartered in Wilmington, United States.2

Last updated Oct 21, 2026.

Overview

-$425.4MNet income, fiscal 20253
  • IndustryPharmaceutical Preparations2
  • HeadquartersWilmington, United States2
  • Incorporated inDE4
  • Business addressOne Broadway, 14Th Floor, Cambridge, Ma 021424
  • Filer categoryLarge accelerated filer4
  • Legal formCorporation2
  • LEI529900RZ62O2T6LNQS602
  • StatusActive2
  • LEI statusIssued and current2
  • Registered addressc/o THE CORPORATION TRUST COMPANY, CORPORATION TRUST CENTER 1209 ORANGE ST, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 62035742

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We are a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer. We leverage our team’s deep expertise in chemistry and structure-based drug design to develop innovative small molecules that are designed with the aim to overcome the limitations of existing therapies for clinically proven kinase targets.5 From its latest annual report

Financials

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

Key numbers, fiscal 2025

-34.1%Return on equity6

Financial statements

Operating income7896-$414.3M in 2025+2351% since 2020
-$600.0M-$400.0M-$200.0M02020: -$16.9M-$16.9M20202021: -$45.8M-$45.8M2021+171%2022: -$86.1M-$86.1M2022+88%2023: -$149.5M-$149.5M2023+74%2024: -$280.4M-$280.4M2024+88%2025: -$414.3M-$414.3M2025+48%
Net income78963-$425.4M in 2025+2823% since 2020
-$600.0M-$400.0M-$200.0M02020: -$14.6M-$14.6M20202021: -$46.3M-$46.3M2021+218%2022: -$81.9M-$81.9M2022+77%2023: -$126.2M-$126.2M2023+54%2024: -$260.8M-$260.8M2024+107%2025: -$425.4M-$425.4M2025+63%
Fiscal year2019202020212022202320242025
Research and development$15.4M7$35.6M8$63.7M9$113.2M6$217.8M6$307.0M6
Operating expenses$45.8M8$86.1M9$149.5M6$280.4M6$414.3M6
Operating income-$16.9M7-$45.8M8-$86.1M9-$149.5M6-$280.4M6-$414.3M6
Income before tax-$81.9M9-$126.2M6-$260.0M6-$424.8M6
Income tax$09$06$764.0K6$585.0K6
Net income-$14.6M7-$46.3M8-$81.9M9-$126.2M6-$260.8M6-$425.4M3
Earnings per share-$5.087-$2.138-$1.659-$2.176-$3.936-$5.856
Earnings per share (diluted)-$5.087-$2.138-$1.659-$2.176-$3.936-$5.856
Shares (weighted, basic)21.8M shares849.7M shares958.2M shares666.4M shares672.7M shares6
Shares (weighted, diluted)21.8M shares849.7M shares958.2M shares666.4M shares672.7M shares6

Compare Nuvalent, Inc. with another company

Corporate structure

Nuvalent, 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 Nuvalent, Inc.

  • James E. Flynn Filed SCHEDULE 13G/A on Nuvalent, Inc., latest Jul 17, 2026 (8 filings since Feb 11, 2022)
  • FMR LLC Filed SCHEDULE 13G/A on Nuvalent, Inc., latest Jul 8, 2026 (5 filings since Feb 9, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Nuvalent, Inc., latest Mar 27, 2026 (3 filings since Feb 13, 2024)
  • BlackRock Filed SCHEDULE 13G on Nuvalent, Inc., latest Jul 17, 2025 (4 filings since Oct 24, 2024)
  • PERCEPTIVE ADVISORS LLC Filed SC 13G/A on Nuvalent, Inc., latest Nov 14, 2024 (2 filings since Jan 2, 2024)
  • Paradigm Biocapital Advisors LP Filed SC 13G/A on Nuvalent, Inc., latest Nov 14, 2024 (3 filings since Oct 30, 2023)
  • Bain Capital Life Sciences Fund II, L.P. Filed SC 13D/A on Nuvalent, Inc., latest Mar 29, 2024 (3 filings since Nov 3, 2022)
  • Fairmount Funds Management LLC Filed SC 13G/A on Nuvalent, Inc., latest Feb 14, 2024 (3 filings since Nov 9, 2022)
  • Nuvalent, Inc. Wilmington, Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Nuvalent, 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.

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$261.7M6 Dec 31, 2025$145.7M6 Dec 31, 2024+79.7%
Marketable securities, current$1.1B6 Dec 31, 2025$972.6M6 Dec 31, 2024+14.1%
Debt securities available for sale$1.1B6 Dec 31, 2025$972.6M6 Dec 31, 2024+14.1%

Properties, in its own words

We lease office space for our corporate headquarters, which is located in Cambridge, Massachusetts. We believe our leased office space is adequate for our current needs and that suitable additional or alternative space will be available in the future on commercially reasonable terms, if required.

Item 2 of the 10-K filed Feb 26, 2026.5

Leadership

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

Chief financial officer

  1. Alexandra Balcom2021–now
2025
Board members and other officers (21)

Timeline

  1. Jul 15, 20268-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights34
  2. Jun 18, 20268-K Shareholder vote35
  3. Jun 9, 20268-K Entered a material agreement; Regulation FD disclosure36
  4. May 7, 20268-K Results of operations37
  5. Apr 7, 20268-K Other events38
  6. Feb 26, 20268-K Results of operations39
  7. Jan 14, 20268-K Results of operations40
  8. Dec 16, 20258-K Other events41
  9. Dec 10, 20258-K Executive or director change42
  10. Nov 20, 20258-K Entered a material agreement; Other events43
  11. Nov 17, 20258-K Other events44
  12. Oct 30, 20258-K Results of operations45
  13. Jan 25, 2017Founded Nuvalent, Inc. is founded2

Calendar

When it reported results

  1. May 7, 2026Reported quarterly or annual results37
  2. Feb 26, 2026Reported quarterly or annual results39
  3. Jan 14, 2026Reported quarterly or annual results40
  4. Oct 30, 2025Reported quarterly or annual results45
  5. Aug 7, 2025Reported quarterly or annual results46
  6. May 8, 2025Reported quarterly or annual results47
  7. Feb 27, 2025Reported quarterly or annual results48
  8. Nov 12, 2024Reported quarterly or annual results49

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

Filings

526 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 54 major events, 297 insider forms, 31 large holders, 125 other. The latest 20:

  1. Jul 27, 202615-12G EDGAR
  2. Jul 17, 2026SCHEDULE 13G/A EDGAR
  3. Jul 17, 20264 EDGAR
  4. Jul 15, 20264 EDGAR
  5. Jul 15, 20264 EDGAR
  6. Jul 15, 20264 EDGAR
  7. Jul 15, 20264 EDGAR
  8. Jul 15, 20264 EDGAR
  9. Jul 15, 20264 EDGAR
  10. Jul 15, 20264 EDGAR
  11. Jul 15, 20264 EDGAR
  12. Jul 15, 20264 EDGAR
  13. Jul 15, 20264 EDGAR
  14. Jul 15, 20264 EDGAR
  15. Jul 15, 20264 EDGAR
  16. Jul 15, 20264 EDGAR
  17. Jul 15, 20264 EDGAR
  18. Jul 15, 2026POSASR EDGAR
  19. Jul 15, 2026S-8 POS EDGAR
  20. Jul 15, 2026S-8 POS EDGAR

The 526 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

229 open-market trades by officers, directors and large owners since October 2021: 2 buys and 227 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 9, 2026Pelish Henry E.Chief Scientific OfficerSale2,111$123.81$261.4KForm 4
Jul 6, 2026Porter James RichardPresident and CEOSale30,000$123.72$3.7MForm 4
Jul 1, 2026Noci DarleneChief Development OfficerSale23,000$123.59$2.8MForm 4
Jul 1, 2026Balcom AlexandraChief Financial OfficerSale11,430$123.58$1.4MForm 4
Jun 29, 2026Noci DarleneChief Development OfficerSale5,500$123.51$679.3KForm 4
Jun 9, 2026Noci DarleneChief Development OfficerSale20,000$122.81$2.5MForm 4
Jun 8, 2026Porter James RichardPresident and CEOSale30,000$88.53$2.7MForm 4
Jun 1, 2026Balcom AlexandraChief Financial OfficerSale11,430$98.69$1.1MForm 4
May 28, 2026Miller Deborah AnnChief Legal OfficerSale5,500$107.84$593.1KForm 4
May 28, 2026Noci DarleneChief Development OfficerSale5,500$107.80$592.9KForm 4
May 4, 2026Porter James RichardPresident and CEOSale30,000$101.69$3.1MForm 4
May 1, 2026Balcom AlexandraChief Financial OfficerSale11,430$99.00$1.1MForm 4
Apr 30, 2026Miller Deborah AnnChief Legal OfficerSale5,500$99.22$545.7KForm 4
Apr 29, 2026Noci DarleneChief Development OfficerSale5,500$99.55$547.5KForm 4
Apr 9, 2026Pelish Henry E.Chief Scientific OfficerSale3,093$104.48$323.2KForm 4
Apr 6, 2026Porter James RichardPresident and CEOSale30,000$103.77$3.1MForm 4
Apr 1, 2026Balcom AlexandraChief Financial OfficerSale11,430$105.21$1.2MForm 4
Mar 30, 2026Noci DarleneChief Development OfficerSale5,500$97.81$537.9KForm 4
Mar 26, 2026Miller Deborah AnnChief Legal OfficerSale5,500$98.73$543.0KForm 4
Mar 25, 2026Balcom AlexandraChief Financial OfficerSale13,700$100.16$1.4MForm 4

All 229 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
2025James R. PorterPh.D.$652.1K$11.4M58
2025Christopher D. TurnerM.D.$520.1K$4.2M58
2025Alexandra BalcomMBA, CPA$475.5K$4.2M58
2025Darlene NociALM$467.4K$4.2M58
2025Deborah MillerPh.D., J.D.$467.0K$4.2M58
2024President and Chief Executive Officer$627.0K$17.3M58
2024Chief Medical Officer$500.1K$5.6M58
2024Chief Financial Officer and Treasurer$457.2K$5.5M58
2024Chief Legal Officer and Secretary$440.5K$5.5M58
2024Chief Development Officer$432.7K$5.4M58
2023President and Chief Executive Officer$602.8K$9.4M58
2023Chief Medical Officer$480.8K$3.6M58
2023Chief Financial Officer and Treasurer$440.3K$3.5M58

SEC filer profile

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

  • Name on EDGARNuvalent, Inc.1
  • CIK0001861560
  • Employer ID (EIN)81-51122985
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business addressOne Broadway, 14Th Floor, Cambridge, MA 021421
  • Phone508-446-22721
  • Shares outstanding73,181,747 Common Class A shares; 5,435,254 Common Class B shares as of Feb 19, 20265
  • Public float$3.6B as of Jun 30, 20255
  • AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceMay 12, 20211
  • Filings593 in all: 4 (299), 144 (84), 8-K (56), 3 (23), 10-Q (15), SC 13G/A (12), 424B5 (10), SC 13G (8)1
    All 42 form types

    SCHEDULE 13G/A (8), CORRESP (6), S-8 (6), S-8 POS (6), 10-K (5), DEF 14A (5), DEFA14A (5), ARS (4), SC TO-T/A (4), SC 13D/A (3), SC 14D9/A (3), SC TO-C (3), UPLOAD (3), EFFECT (2), S-1/A (2), S-3ASR (2), SEC STAFF LETTER (2), 15-12G (1), 25-NSE (1), 424B4 (1), 8-A12B (1), CERT (1), D (1), DRS (1), POSASR (1), PRE 14A (1), S-1 (1), S-1MEF (1), S-3 (1), SC 13D (1), SC 14D9 (1), SC TO-T (1), SC14D9C (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) May 7, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Jul 15, 2026

Securities registered for trading

ClassSymbolExchange
Class A Common Stock, $0.0001 par value per shareNUVLNasdaq Global Select Market

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Nuvalent, Inc. names in Item 1A of its 10-K filed Feb 26, 2026: 76 risks under these headings, as written.5

  • Risks related to our financial position and need for additional capital
  • We have a limited operating history, have no products approved for commercial sale and have not generated any revenue, 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 the discovery, development and commercialization of our product candidates.
  • We may require additional funding to finance our operations. If we are unable to obtain such funding when needed, or on acceptable terms, we may be forced to delay, reduce or eliminate one or more of our research and drug development programs, commercialization efforts, product development or other operations.
  • Risks related to the discovery, development and commercialization of our product candidates
  • Our future prospects are substantially dependent on zidesamtinib, neladalkib and NVL-330. If we are unable to advance these product candidates through development, obtain regulatory approval and ultimately commercialize such product candidates, or experience significant delays in doing so, our business will be materially harmed. Even if we obtain regulatory approval for such candidates, there is no assurance that our commercialization efforts will be successful or that we will be able to generate revenues or profits at the levels or on the timing we expect, if at all.
  • Our preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates, which would prevent or delay development, regulatory approval and commercialization.
  • Our discovery and development activities are focused on the development of targeted therapeutics for patients with cancer-associated genomic alterations, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may never lead to approved or marketable products.
  • Any delays in the commencement or completion, or termination or suspension, of our current, planned or future clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
  • The outcome of preclinical testing and early clinical trials may not be predictive of the success of later-stage clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities and we may not be able to commercialize our product candidates.
  • In addition to zidesamtinib, neladalkib and NVL-330, our prospects depend in part upon discovering, developing and commercializing additional product candidates from our discovery programs, which may fail in development or suffer delays that adversely affect their commercial viability.
The other 65 risks
  • The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval of our product candidates, we will be unable to generate product revenue and our business will be substantially harmed.
  • Our product candidates may cause significant adverse events, toxicities or other undesirable adverse events when used alone or in combination with other approved products or investigational new drugs 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, preliminary and topline data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • If we experience delays or difficulties in the enrollment or maintenance of patients in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.
  • We have never commercialized a product candidate as a company before and currently lack substantially all of the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators.
  • Even if one of our product candidates receives marketing approval, we or others may later discover that the product is less effective or tolerable than previously believed or causes undesirable side effects that were not previously identified, which could compromise our ability, or that of our collaborators, to market the product.
  • We have limited resources and are currently focusing our efforts on zidesamtinib, neladalkib and NVL-330 in particular indications and advancing our discovery programs. As a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.
  • We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • The manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
  • The market opportunities for any product candidates we develop, if approved, may be limited to certain smaller patient subsets and may be smaller than we estimate them to be.
  • Even if we are able to commercialize any of our product candidates, the drugs may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
  • Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inability could have an adverse effect on our business and financial condition.
  • Risks related to regulatory approval and other legal compliance matters
  • We may be unable to obtain U.S. or foreign regulatory approval and, as a result, may be unable to commercialize our product candidates.
  • We may develop our current or future product candidates in combination with other therapies, which would expose us to additional risks.
  • We have conducted and intend to continue conducting certain of our clinical trials globally. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
  • 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.
  • Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.
  • The FDA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • If we are required by the FDA, EMA or comparable regulatory authority to obtain clearance or approval of a companion diagnostic test in connection with approval of any of our product candidates or a group of therapeutic products, and we do not obtain or we face delays in obtaining clearance or approval of a diagnostic test, we may not be able to commercialize the product candidate and our ability to generate revenue may be materially impaired.
  • We may seek certain designations for our product candidates, including Breakthrough Therapy, Fast Track and Priority Review in the U.S., and PRIME (priority medicines) in the EU, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.
  • We may not be able to obtain orphan drug designation or obtain or maintain orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA, EMA or other comparable foreign regulatory authorities, from approving competing products.
  • Current and future legislation may increase the difficulty and cost for us to obtain reimbursement for our product candidates.
  • The prices of prescription pharmaceuticals in the U.S. and foreign jurisdictions are the subject of considerable legislative and executive actions and could impact the prices we obtain for our products, if and when licensed for marketing.
  • We are or may become subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development programs and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • If our product candidates are licensed for marketing and receive federal healthcare reimbursement, any relationships we may have with healthcare providers will be subject to applicable healthcare fraud and abuse laws and regulations, which could expose us to criminal and civil penalties and exclusion from participation in government healthcare programs.
  • Analogous State and Foreign Laws.
  • Processing of personal data is governed by restrictive laws and regulations in the jurisdictions in which we operate.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our business activities may be subject to the U.S. Foreign Corrupt Practices Act (FCPA) and similar anti-bribery and anti-corruption laws of other countries in which we operate, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • Risks related to employee matters, managing our growth and other risks related to our business
  • Our success is highly dependent on our ability to attract, hire and retain highly skilled executive officers and employees.
  • We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
  • Our internal computer systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or suffer actual or suspected security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations, and potentially significant delays in our delivery to market.
  • Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operations.
  • Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  • Our operations are vulnerable to interruption by flood, fire, earthquakes, power loss, telecommunications failure, terrorist activity, pandemics and other events beyond our control, which could harm our business.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data.
  • If we are unable to establish adequate sales, marketing and distribution capabilities or enter into agreements with third parties to sell, market or distribute our product candidates, we may not be able to successfully commercialize our product candidates that obtain regulatory approval.
  • A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
  • Changes in tax law could adversely affect our business and financial condition.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be limited.
  • Risks related to our intellectual property
  • Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
  • If we are unable to obtain, maintain and enforce patent protection for our technology and product candidates, or if the scope of the patent protection obtained is 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 and product candidates may be adversely affected.
  • Patent terms may not protect our competitive position for an adequate amount of time.
  • If we do not obtain patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation, which if granted could extend the term of our marketing exclusivity for any product candidates we may develop, our business may be materially and adversely affected.
  • Changes to patent laws in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • Third parties may allege that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on our business.
  • If we are unable to obtain licenses from third parties on commercially reasonable terms, our business could be adversely affected.
  • If we fail to comply with our obligations in any future intellectual property licenses with third parties that we may enter into, or otherwise experience disruptions to our business relationships with our future licensors, we could lose intellectual property rights that are important to our business.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • We may be subject to claims by third parties asserting that our employees, consultants or contractors have wrongfully used or disclosed confidential information of such third parties, or that they have wrongfully used or disclosed alleged trade secrets of their current or former employers, or that we have misappropriated their intellectual property, or that they own what we regard as our own intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets and other proprietary information, our business and competitive position would be adversely affected.
  • If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Risks related to our dependence on third parties
  • We rely on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research and studies.
  • We contract with third parties for the manufacture of our product candidates for preclinical studies and clinical trials, and expect to continue to do so for additional preclinical studies, clinical trials and ultimately for commercialization. This reliance on third parties increases the risk that we will not have sufficient quality and quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • Our manufacturing process needs to comply with FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals.
  • 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.
  • If our third-party manufacturers use hazardous materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • If we decide to establish collaborations, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.

Legal proceedings

As of December 31, 2025, we were not party to any material legal proceedings.

The opening of Item 3, Legal Proceedings.5

Sources

The numbers on this page point here. Each one links to the record it came from.

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  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
    SEC EDGAROther events
  39. 39
  40. 40
  41. 41
    SEC EDGAROther events
  42. 42
  43. 43
  44. 44
    SEC EDGAROther events
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58