KYMR on Nasdaq

Kymera Therapeutics

Biopharmaceutical company based in Watertown1

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company dedicated to reinventing the treatment of human disease through the development of innovative, highly differentiated oral medicines that address significant health problems and meaningfully improve patients’ lives. We are committed to advancing novel technologies to address targets that have known disease-causing biology, but which have not been drugged, or have been inadequately drugged, often based on limitations of existing technologies.”5 Its shares trade on Nasdaq under the symbol KYMR.1

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Last updated Oct 21, 2026.

Overview

Compare with SANGAMO THERAPEUTICS, INC, Voyager Therapeutics (United States) or Editas Medicine, or pick any stock.

  • TickerKYMR on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersWatertown1
  • Websitewww.kymeratx.com
  • Incorporated inDE3
  • Business address500 North Beacon Street, 4Th Floor, Watertown, Ma 024723
  • Filer categoryLarge accelerated filer3

We are a clinical-stage biopharmaceutical company dedicated to reinventing the treatment of human disease through the development of innovative, highly differentiated oral medicines that address significant health problems and meaningfully improve patients’ lives. We are committed to advancing novel technologies to address targets that have known disease-causing biology, but which have not been drugged, or have been inadequately drugged, often based on limitations of existing technologies. Our approach is intended to discover and develop a new generation of medicines in a disease-agnostic manner.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

-891.1%Operating margin6
-794.0%Net margin6
-16.7%Revenue growth, 20256
-19.7%Return on equity6
-$234.3MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue11¢$39.2M
  • Research and development89¢$316.6M

Out of $39.2M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$39.2M in 2025+1236% since 2019
0$20.0M$40.0M$60.0M$80.0M2019: $2.9M$2.9M20192020: $34.0M$34.0M2020+1060%2021: $72.8M$72.8M2021+114%2022: $46.8M$46.8M2022−36%2023: $78.6M$78.6M2023+68%2024: $47.1M$47.1M2024−40%2025: $39.2M$39.2M2025−17%
Operating income789106-$349.4M in 2025+728% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$42.2M-$42.2M20192020: -$46.3M-$46.3M2020+10%2021: -$100.5M-$100.5M2021+117%2022: -$161.3M-$161.3M2022+60%2023: -$165.5M-$165.5M2023+3%2024: -$261.6M-$261.6M2024+58%2025: -$349.4M-$349.4M2025+34%
Net income789106-$311.4M in 2025+655% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$41.2M-$41.2M20192020: -$45.6M-$45.6M2020+11%2021: -$100.2M-$100.2M2021+120%2022: -$154.8M-$154.8M2022+54%2023: -$147.0M-$147.0M2023−5%2024: -$223.9M-$223.9M2024+52%2025: -$311.4M-$311.4M2025+39%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
Collaboration revenue$39.2M$47.1M$78.6M
Research and development$316.6M$240.2M$189.1M
General and administrative$68.2M$63.5M$55.0M
Impairment of long-lived assets$3.9M$4.9M$0
Total operating expenses$388.6M$308.7M$244.1M
Loss from operations-$349.4M-$261.6M-$165.5M
Interest and other income$38.4M$38.0M$18.8M
Interest and other expense-$370.0K-$249.0K-$196.0K
Total other income$38.0M$37.8M$18.6M
Net loss-$311.4M-$223.9M-$147.0M
Unrealized gain (loss) on marketable securities$3.3M-$933.0K$4.4M
Total comprehensive loss-$308.1M-$224.8M-$142.6M
Net loss attributable to common stockholders-$311.4M-$223.9M-$147.0M
Net loss per share, basic-$3.69-$2.98-$2.52
Net loss per share, diluted-$3.69-$2.98-$2.52
Total weighted average common stock outstanding, basic and diluted84.5M shares75.0M shares58.4M shares
Total weighted average common stock outstanding, basic and diluted84.5M shares75.0M shares58.4M shares

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Corporate structure

Kymera Therapeutics sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Kymera Therapeutics

  • Kymera Therapeutics Watertown
    • Kymera Securities Corporation Subsidiary · Massachusetts, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Kymera Therapeutics 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$65.3M6 Dec 31, 2025$66.5M6 Dec 31, 2024−1.8%
Accumulated depreciation$22.1M6 Dec 31, 2025$16.1M6 Dec 31, 2024+37.7%
Property and equipment, net$43.2M6 Dec 31, 2025$50.5M6 Dec 31, 2024−14.4%
Operating-lease assets (leased space)$42.4M6 Dec 31, 2025$47.4M6 Dec 31, 2024−10.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$357.0M6 Dec 31, 2025$120.3M6 Dec 31, 2024+196.9%
Marketable securities, current$491.3M6 Dec 31, 2025$368.5M6 Dec 31, 2024+33.3%
Marketable securities, non-current$771.2M6 Dec 31, 2025$362.2M6 Dec 31, 2024+112.9%
Debt securities available for sale$1.3B6 Dec 31, 2025$730.6M6 Dec 31, 2024+72.8%

Properties, in its own words

We currently occupy approximately 100,624 square feet of office and laboratory space in Watertown, Massachusetts under a lease that expires in March 2035. We have two options to extend the lease term, each for five additional years at then-market rates. Additionally, we currently lease approximately 34,522 rentable square feet of extra office and laboratory space in Watertown, Massachusetts under a lease that expires in March 2030 that we are not currently occupying. We intend to sublease and are actively marketing the original space to third parties. We believe that our office and laboratory space is sufficient to meet our current needs and that suitable additional space will be available as and when needed on commercially reasonable terms.

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

Leadership

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

Chief financial officer

  1. Bruce N. Jacobs2020–now

Chief operating officer

  1. Jeremy G. Chadwick2023–now
2025
Board members and other officers (23)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Kymera Securities Corporation Massachusetts4

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

Former names

  • Kymera Therapeutics, Inc.Jun 22, 2020 to Oct 1, 20263

Timeline

  1. Aug 5, 20268-K Results of operations37
  2. Jul 27, 20268-K Executive or director change; Regulation FD disclosure38
  3. Jun 25, 20268-K Regulation FD disclosure; Other events39
  4. Jun 24, 20268-K Shareholder vote40
  5. Jun 8, 20268-K Executive or director change41
  6. Apr 30, 20268-K Results of operations42
  7. Mar 27, 20268-K Bylaws or fiscal year changed43
  8. Feb 26, 20268-K Results of operations44
  9. Feb 26, 20268-K Entered a material agreement; Ended a material agreement; Other events45
  10. Jan 13, 20268-K Results of operations; Regulation FD disclosure46
  11. Dec 10, 20258-K Entered a material agreement; Other events47
  12. Dec 8, 20258-K Regulation FD disclosure; Other events48
  13. Aug 21, 2020Went public Listed on NASDAQ1
  14. Aug 20, 2020New chief executive Nello Mainolfi becomes CEO14

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.90) a share, on Nov 4, 2025.49

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results37
  2. Apr 30, 2026Reported quarterly or annual results42
  3. Feb 26, 2026Reported quarterly or annual results44
  4. Jan 13, 2026Reported quarterly or annual results46
  5. Nov 4, 2025Reported quarterly or annual results50
  6. Aug 11, 2025Reported quarterly or annual results51
  7. May 9, 2025Reported quarterly or annual results52
  8. Feb 27, 2025Reported quarterly or annual results53

Drug trials and FDA: coming up

  1. Jun 2027Phase 2 trial readout expected Phase 2 trial of KT-621 in Atopic Dermatitis: primary completion expected Jun 2027 (ClinicalTrials.gov NCT07217015).54

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

Filings

506 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 63 major events, 211 insider forms, 59 large holders, 153 other. The latest 20:

  1. Oct 1, 2026144 EDGAR
  2. Oct 1, 20264 EDGAR
  3. Sep 8, 2026SCHEDULE 13G/A EDGAR
  4. Sep 4, 20264 EDGAR
  5. Sep 4, 2026144 EDGAR
  6. Sep 2, 2026144 EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 13, 2026SCHEDULE 13G/A EDGAR
  9. Aug 5, 202610-Q EDGAR
  10. Aug 5, 20268-K EDGAR
  11. Jul 27, 20264 EDGAR
  12. Jul 27, 20263 EDGAR
  13. Jul 27, 20268-K EDGAR
  14. Jul 7, 2026144 EDGAR
  15. Jul 7, 20264 EDGAR
  16. Jul 2, 2026144 EDGAR
  17. Jul 2, 20264/A EDGAR
  18. Jul 2, 20264 EDGAR
  19. Jul 2, 20264 EDGAR
  20. Jul 2, 20264 EDGAR

The 506 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

149 open-market trades by officers, directors and large owners since October 2021: 17 buys and 132 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 4, 2026Adams BrianChief Legal OfficerSale6,371$116.83$744.3KForm 4
Jul 7, 2026Mainolfi NelloChief Executive OfficerSale50,000$119.00$6.0MForm 4
Jul 1, 2026Goodman NoahChief Business OfficerSale3,389$114.29$387.3KForm 4
Jul 1, 2026Mainolfi NelloChief Executive OfficerSale80,000$115.30$9.2MForm 4
Jun 30, 2026Jacobs Bruce N.Chief Financial OfficerSale77,109$114.97$8.9MForm 4
Jun 29, 2026Booth BruceDirectorSale76,650$108.05$8.3MForm 4
Jun 29, 2026Booth BruceDirectorSale31,283$109.48$3.4MForm 4
Jun 29, 2026Booth BruceDirectorSale45,367$107.06$4.9MForm 4
Jun 26, 2026Booth BruceDirectorSale467,878$110.29$51.6MForm 4
Jun 26, 2026BIOTECHNOLOGY VALUE FUND II LPDirectorSale1,630,658$106.50$173.7MForm 4
Jun 25, 2026Booth BruceDirectorSale285,684$121.86$34.8MForm 4
Jun 25, 2026Booth BruceDirectorSale262,637$115.39$30.3MForm 4
Jun 25, 2026Goodman NoahChief Business OfficerSale5,000$114.00$570.0KForm 4
Jun 24, 2026Booth BruceDirectorSale134,720$100.51$13.5MForm 4
Jun 23, 2026Booth BruceDirectorSale1,408$99.98$140.8KForm 4
Jun 22, 2026Booth BruceDirectorSale31,798$103.75$3.3MForm 4
Jun 22, 2026Booth BruceDirectorSale246,330$98.52$24.3MForm 4
Jun 22, 2026Goodman NoahChief Business OfficerSale2,500$99.00$247.5KForm 4
Jun 18, 2026Booth BruceDirectorSale115,056$91.01$10.5MForm 4
Jun 17, 2026Booth BruceDirectorSale116,812$90.34$10.6MForm 4

All 149 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
2025Nello MainolfiPh.D.$693.0K$8.5M68
2025Brian AdamsJ.D.52$145.2K$6.1M68
2025Noah GoodmanMBA$294.0K$3.2M68
2025Jared GollobM.D.62$507.1K$2.9M68
2025Bruce JacobsCFA, MBA$500.0K$2.9M68
2024FounderPresident and$670.0K$15.4M68
2024Chief Financial Officer$481.0K$7.1M68
2024Chief Medical Officer$490.0K$5.7M68
2023Chief Executive Officer$640.0K$9.7M68
2023Chief Financial Officer$470.0K$4.2M68
2023Chief Medical Officer$480.0K$3.5M68

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
Fmr LLC12,349,256$1.4B0.1%+649,306
Baker Bros. Advisors LP8,657,242$992.7M5.0%No change
Avoro Capital Advisors LLC7,474,747$857.1M7.7%No change
BlackRock, Inc.5,538,210$635.1M0.0%+477,334
Bvf Inc/il3,872,052$444.0M11.4%−1,630,658
Wellington Management Group Llp3,675,028$421.4M0.1%−214,659
Vanguard Portfolio Management LLC2,992,193$343.1M0.0%+118,137
Siren, L.L.C.2,935,830$336.7M6.8%−251,000
Vanguard Capital Management LLC2,932,378$336.3M0.0%+52,054
Atlas Venture Life Science Advisors, LLC2,847,541$326.5M37.1%−1,730,467
State Street Corp2,737,226$313.9M0.0%+347,459
Geode Capital Management, LLC1,816,331$208.3M0.0%+170,981
Capital Research Global Investors1,388,881$159.3M0.0%−284,394
Goldman Sachs Group Inc1,187,333$136.2M0.0%+298,924
UBS Group AG1,007,777$115.6M0.0%−16,075
Driehaus Capital Management LLC919,233$105.4M0.6%−124,350
Merck & Co., Inc.772,165$88.5M16.8%No change
Norges Bank757,246$86.8M0.0%New
Federated Hermes, Inc.749,398$85.9M0.1%+212,718
Dimensional Fund Advisors LP745,152$85.4M0.0%+152,273
Frontier Capital Management Co LLC740,866$85.0M0.8%−18,982
UBS AM, a distinct business unit of UBS ASSET MANAGEMENT AMERICAS LLC736,866$84.5M0.0%−139,006
Alliancebernstein L.P.981,521$81.8M0.0%+93,486
Holocene Advisors, LP636,579$73.0M0.2%−200,180
Northern Trust Corp581,907$66.7M0.0%+87,468

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

SEC filer profile

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

  • Name on EDGARKymera Therapeutics, Inc.2
  • CIK0001815442
  • Employer ID (EIN)81-29921665
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address500 North Beacon Street, 4Th Floor, Watertown, MA 024722
  • Phone857-285-53142
  • Shares outstanding83,150,618 as of Jul 31, 202612
  • Public float$2.3B as of Dec 31, 20255
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceJun 22, 20202
  • Filings644 in all: 4 (265), 144 (118), 8-K (76), 3 (28), SC 13G/A (23), 10-Q (18), SCHEDULE 13G/A (16), SC 13G (11)2
    All 32 form types

    424B5 (9), CORRESP (8), S-8 (7), 10-K (6), DEF 14A (6), DEFA14A (6), SC 13D/A (6), UPLOAD (5), ARS (4), SCHEDULE 13D/A (4), 4/A (3), S-1/A (3), SC 13D (3), 424B3 (2), 424B4 (2), DRS (2), EFFECT (2), S-1 (2), S-1MEF (2), S-3ASR (2), SEC STAFF LETTER (2), 8-A12B (1), CERT (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareKYMRThe Nasdaq Global 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 Kymera Therapeutics names in Item 1A of its 10-K filed Feb 26, 2026: 71 risks under these headings, as written.5

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We are a clinical stage company and that may make it difficult for our stockholders to evaluate the success of our business to date and to assess our future viability.
  • We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future.
  • We will need to raise substantial additional funding. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our product candidate development programs or future commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • We will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
  • 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 Drug Development and Regulatory Approval
  • We are very early in our development efforts and our STAT6 and IRF5 programs are in early clinical development with additional programs in preclinical development. If we are unable to advance our programs into and through the clinic for safety or efficacy reasons or commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • Our approach to the discovery and development of product candidates is novel and unproven, which makes it difficult to predict the time, cost of development and likelihood of successfully developing any products.
  • We may not be successful in our efforts to identify or discover additional product candidates or 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 depend heavily on the successful development of our lead programs. We cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, any of our current or future product candidates.
The other 61 risks
  • If we experience delays or difficulties in the initiation or enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Positive results from early preclinical studies and clinical trials of our current or future product candidates are not necessarily predictive of the results of later preclinical studies and clinical trials of our current or future product candidates. If we cannot replicate the positive results from our preclinical studies of our current or future product candidates in our future clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our current or future product candidates.
  • The incidence and prevalence for target patient populations of our product candidates have not been established with precision. If the market opportunities for our product candidates 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 will be adversely affected, possibly materially.
  • A pandemic, epidemic, or outbreak of an infectious disease may materially and adversely affect our business and our financial results and could cause a disruption to the development of our product candidates.
  • Our current or future product candidates may cause adverse or other undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • Manufacturing our current or future product candidates is complex and we may encounter difficulties in production. If we encounter such difficulties, our ability to provide supply of our current or future product candidates for preclinical studies and clinical trials or for commercial purposes could be delayed or stopped.
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our current or future product candidates, we will not be able to commercialize, or will be delayed in commercializing, our current or future product candidates, and our ability to generate revenue will be materially impaired.
  • We may seek Breakthrough Therapy Designation and/or Fast Track Designation for any of our current or future product candidates. These designations, even if granted by the FDA, may not lead to a faster development, regulatory review or approval process, and such designations do not increase the likelihood that any of our product candidates will receive marketing approval in the United States.
  • We or our collaborators may seek approval of KT-621, KT-579 or any other future product candidate, where applicable, under the FDA’s accelerated approval pathway. This pathway may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • We may seek Orphan Drug Designation for certain of our current or future product candidates, and we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity.
  • Even if we receive regulatory approval for any of our current or future product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our current or future product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates when and if any of them are approved.
  • Even if we receive marketing approval for our current or future product candidates in the U.S., we may never receive regulatory approval to market our current or future product candidates outside of the U.S.
  • Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that could materially adversely affect our business.
  • We may in the future conduct clinical trials for current or future product candidates outside the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • 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.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • Even if we are able to commercialize any current or future product candidates, such drugs may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.
  • Current and future healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
  • Our relationships with customers, health care providers, physicians, and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished future profits and earnings.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading laws.
  • Risks Related to Commercialization
  • Even if we receive marketing approval for our current or future product candidates, our current or future product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales.
  • We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any current or future product candidates that we may develop.
  • If, in the future, we are unable to establish sales and marketing and patient support capabilities or enter into agreements with third parties to sell and market our current or future product candidates, we may not be successful in commercializing our current or future product candidates if and when they are approved, and we may not be able to generate any revenue.
  • Risks Related to Our Dependence on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct our ongoing and planned preclinical studies and clinical trials for our current and future product candidates. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our current and potential future product candidates and our business could be substantially harmed.
  • The third parties upon whom we rely for the supply of the API, drug product, and starting materials used in our product candidates are limited in number, and the loss of any of these suppliers could significantly harm our business.
  • We may depend on collaborations with other third parties for the development and commercialization of our product candidates in the future. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • 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 preclinical and clinical programs and suspension or withdrawal of any regulatory approvals.
  • 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.
  • Risks Related to Intellectual Property
  • If we are unable to obtain and maintain patent and other intellectual property protection for our technology and product candidates or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs may be impaired, and we may not be able to compete effectively in our market.
  • If we fail to comply with our obligations in our current or any future agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • Intellectual property rights do not guarantee commercial success of current or future product candidates or other business activities. Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
  • Obtaining and maintaining our patent protection, including patent term, depends on compliance with various procedural, document submission, deadlines, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we miss a filing deadline for patent protection on these inventions or otherwise fail to comply with these requirements.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our current or future product candidates.
  • If our trademarks for our products or company name are not adequately protected in one or more countries where we intend to market our products, we may delay the launch of product brand names, use different or less effective trademarks or tradenames in different countries, or face other potentially adverse consequences or impediments to building our product brand recognition.
  • If we are unable to adequately protect and enforce our trade secrets, our business and competitive position would be harmed.
  • We may initiate, become a defendant in, or otherwise become party to lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to damages or settlement costs resulting from claims that we or our employees have violated the intellectual property rights of third parties, or are in breach of our agreements. We may be accused of, allege or otherwise become party to lawsuits or disputes alleging wrongful disclosure of third-party confidential information by us or by another party, including current or former employees, contractors or consultants. In addition to diverting attention and resources, such disputes could adversely impact our business reputation and/or protection of our proprietary technology.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement claims or adversely affect our ability to develop and market our current or future product candidates.
  • Risks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We will need to continue to develop and expand our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.
  • We or the third parties upon whom we depend may be adversely affected by unforeseen global events, natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • We intend to sublease our former space in Watertown, Massachusetts for occupancy now that we have moved to our new facility. If we are unable to sublease our space on favorable terms or if our subtenants are unable to meet their obligations under any sublease, we may be responsible for unexpected costs, which could impact our financial performance.
  • Our internal computer systems, or those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our current or future product candidates’ development programs.
  • We may be unable to adequately protect our information systems from cyberattacks, security incidents, or compromises, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure.
  • We, our collaborators and our service providers may be subject to a variety of privacy and data protection 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 fines or other penalties and otherwise harm our business and operations.
  • Issues relating to the use of artificial intelligence and machine learning could adversely affect our business and operating results.
  • Risks Related to Our Common Stock
  • The price of our common stock has been and may continue to be volatile and fluctuate substantially, and investors may lose all or part of their investment.
  • Unstable global economic and geopolitical conditions may have serious adverse consequences on our business, financial condition, stock price and results of operations.
  • If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
  • Our executive officers, directors, principal stockholders and their affiliates exercise significant influence over our company, which will limit your ability to influence corporate matters and could delay or prevent a change in corporate control.
  • We have issued a substantial number of warrants and equity awards from our equity plans which are exercisable into shares of our common stock which could result in substantial dilution to the ownership interests of our existing stockholders.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be investors’ sole source of gain.
  • We may be at an increased risk of securities class action litigation.
  • Risks Related to Tax
  • Changes in tax law may adversely affect us or our investors.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be subject to certain limitations, and, as a result, unavailable to reduce our future tax liability.
  • Risks Related to Our Controls and Reporting Requirements
  • If we fail to maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.5

Sources

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