Private company

SpringWorks Therapeutics, Inc.

In its 2025 annual report the company says: “We are a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. We have a differentiated portfolio of small molecule targeted oncology assets, including two approved products and several clinical and preclinical candidates at various stages of development, and are advancing programs in rare tumor types as well as highly prevalent, genetically defined cancers.”3 It is headquartered in Stamford, Connecticut.1

Last updated Oct 20, 2026.

Overview

  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersStamford, Connecticut1
  • Incorporated inDE2
  • Business address100 Washington Boulevard, Stamford, Ct 069022
  • Filer categoryLarge accelerated filer2

We are a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. We have a differentiated portfolio of small molecule targeted oncology assets, including two approved products and several clinical and preclinical candidates at various stages of development, and are advancing programs in rare tumor types as well as highly prevalent, genetically defined cancers. Our strategic approach and operational excellence across research, translational science, and clinical development have enabled us to successfully launch two products, investigate additional product candidates across various clinical trials, and enter into multiple shared-value partnerships with industry leaders to expand our portfolio. From this foundation, we …3 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 2024

-145.2%Operating margin4
-134.7%Net margin4
3417.3%Revenue growth, 20244
-53.7%Return on equity4
-$180.1MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Cost of revenue3¢$12.6M
  • Research and development43¢$200.5M
  • Selling, general and admin55¢$256.7M

Out of $191.6M in revenue.4 The company lost money this year.

Financial statements

Revenue5674$191.6M in 2024
0$50.0M$100.0M$150.0M$200.0M2019: $0$020192020: $35.0M$35.0M20202021: $0$020212022: $0$020222023: $5.4M$5.4M20232024: $191.6M$191.6M2024+3417%
Operating income85674-$278.1M in 2024+1404% since 2018
-$400.0M-$300.0M-$200.0M-$100.0M02018: -$18.5M-$18.5M20182019: -$59.2M-$59.2M2019+220%2020: -$46.3M-$46.3M2020−22%2021: -$173.5M-$173.5M2021+274%2022: -$280.7M-$280.7M2022+62%2023: -$343.0M-$343.0M2023+22%2024: -$278.1M-$278.1M2024−19%
Net income85674-$258.1M in 2024+1349% since 2018
-$400.0M-$300.0M-$200.0M-$100.0M02018: -$17.8M-$17.8M20182019: -$58.3M-$58.3M2019+227%2020: -$45.6M-$45.6M2020−22%2021: -$173.9M-$173.9M2021+282%2022: -$277.4M-$277.4M2022+60%2023: -$325.1M-$325.1M2023+17%2024: -$258.1M-$258.1M2024−21%
Fiscal year2018201920202021202220232024
Revenue$05$35.0M6$07$04$5.4M4$191.6M4
Cost of revenue$07$04$422.0K4$12.6M4
Research and development$9.9M8$42.5M5$51.9M6$101.7M7$146.1M4$150.5M4$200.5M4
Selling, general and admin$71.8M7$134.6M4$197.6M4$256.7M4
Operating expenses$173.5M6$280.7M6$348.5M4$469.7M4
Operating income-$18.5M8-$59.2M5-$46.3M6-$173.5M7-$280.7M4-$343.0M4-$278.1M4
Net income-$17.8M8-$58.3M5-$45.6M6-$173.9M7-$277.4M4-$325.1M4-$258.1M4
Earnings per share-$1.056-$3.597-$5.214-$5.154-$3.484
Earnings per share (diluted)-$1.056-$3.597-$5.214-$5.154-$3.484
Shares (weighted, basic)48.5M shares753.3M shares463.1M shares474.1M shares4
Shares (weighted, diluted)48.5M shares753.3M shares463.1M shares474.1M shares4

Compare SpringWorks Therapeutics, Inc. with another company

Corporate structure

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

Major holders of SpringWorks Therapeutics, Inc.

  • Goldman Sachs Filed SCHEDULE 13G/A on SpringWorks Therapeutics, Inc., latest Nov 12, 2025
  • Hudson Bay Capital Management LP Filed SCHEDULE 13G on SpringWorks Therapeutics, Inc., latest Aug 8, 2025
  • GLAZER CAPITAL, LLC Filed SCHEDULE 13G on SpringWorks Therapeutics, Inc., latest Jul 7, 2025
  • FMR LLC Filed SCHEDULE 13G/A on SpringWorks Therapeutics, Inc., latest May 7, 2025 (5 filings since Feb 9, 2022)
  • Deep Track Capital, LP Filed SCHEDULE 13G/A on SpringWorks Therapeutics, Inc., latest Feb 14, 2025 (3 filings since Apr 14, 2023)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on SpringWorks Therapeutics, Inc., latest Jan 31, 2025 (4 filings since Feb 10, 2022)
  • Boxer Capital Management, LLC Filed SC 13G/A on SpringWorks Therapeutics, Inc., latest Oct 25, 2024
  • EcoR1 Capital, LLC Filed SC 13G/A on SpringWorks Therapeutics, Inc., latest Feb 14, 2024 (2 filings since Sep 16, 2022)
  • State Street Corporation Filed SC 13G/A on SpringWorks Therapeutics, Inc., latest Jan 23, 2024 (2 filings since Feb 10, 2023)
  • ORBIMED ADVISORS LLC Filed SC 13D/A on SpringWorks Therapeutics, Inc., latest Dec 6, 2023 (4 filings since Sep 14, 2022)
  • BC SW, LP Filed SC 13D/A on SpringWorks Therapeutics, Inc., latest Mar 20, 2023 (2 filings since Sep 13, 2022)
  • PERCEPTIVE ADVISORS LLC Filed SC 13G/A on SpringWorks Therapeutics, Inc., latest Feb 14, 2023 (2 filings since Feb 15, 2022)
  • SpringWorks Therapeutics, Inc. Stamford, Connecticut

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

What it owns

What SpringWorks Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$25.1M4 Dec 31, 2024$20.6M4 Dec 31, 2023+21.7%
Accumulated depreciation$5.4M4 Dec 31, 2024$2.7M4 Dec 31, 2023+102.9%
Property and equipment, net$19.7M4 Dec 31, 2024$17.9M4 Dec 31, 2023+9.7%
Operating-lease assets (leased space)$7.0M4 Dec 31, 2024$6.1M4 Dec 31, 2023+13.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$69.8M4 Dec 31, 2024$176.1M4 Dec 31, 2023−60.4%
Marketable securities, non-current$153.9M4 Dec 31, 2024$183.4M4 Dec 31, 2023−16.1%
Debt securities available for sale$392.2M4 Dec 31, 2024$486.5M4 Dec 31, 2023−19.4%
Stakes in other companies (equity method)$4.2M4 Dec 31, 2024$2.0M4 Dec 31, 2023+114.3%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, gross$16.2M4 Dec 31, 2024$11.2M4 Dec 31, 2023+44.4%
Accumulated amortization$694.0K4 Dec 31, 2024$50.0K4 Dec 31, 2023+1288.0%
Finite-lived intangibles, net$15.6M4 Dec 31, 2024$11.2M4 Dec 31, 2023+38.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$10.2M4 Dec 31, 2024$3.1M4 Dec 31, 2023+229.1%

Properties, in its own words

Our headquarters are located in Stamford, Connecticut, where we have leased approximately 24,000 square feet of office space under a lease that expires in April 2028, with two five-year renewal options or one ten-year renewal option. Various corporate functions including clinical development operations, our discovery lab and translational operations are based in Research Triangle Park in Durham, North Carolina, where we have leased approximately 22,352 square feet of office space under a lease that expires in 2029, with two five-year renewal options. We believe that our current and planned facilities are adequate to meet our needs for the foreseeable future, and that, should it be needed, suitable additional space will be available to accommodate any such expansion of our operations.

Item 2 of the 10-K filed Feb 20, 2025.3

Leadership

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

Chief executive

  1. Saqib Islam2019–now

Chief financial officer

  1. Perier I. Francis Jr.2019–now

Chief operating officer

  1. Badreddin Edris2021–now
20202025
Board members and other officers (18)

Timeline

  1. Jul 1, 20258-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights33
  2. Jun 26, 20258-K Shareholder vote34
  3. Jun 16, 20258-K Other events35
  4. May 14, 20258-K Shareholder vote36
  5. Apr 28, 20258-K Entered a material agreement; Regulation FD disclosure37
  6. Feb 20, 20258-K Results of operations38
  7. Feb 12, 20258-K Regulation FD disclosure; Other events39
  8. Jan 13, 20258-K Results of operations; Regulation FD disclosure40
  9. Nov 12, 20248-K Results of operations41
  10. Aug 7, 20248-K Results of operations42
  11. Jul 30, 20248-K Executive or director change43
  12. Jun 7, 20248-K Ended a material agreement44
  13. Sep 12, 2019New chief executive Saqib Islam becomes CEO13

Calendar

When it reported results

  1. Feb 20, 2025Reported quarterly or annual results38
  2. Jan 13, 2025Reported quarterly or annual results40
  3. Nov 12, 2024Reported quarterly or annual results41
  4. Aug 7, 2024Reported quarterly or annual results42
  5. May 2, 2024Reported quarterly or annual results45
  6. Feb 27, 2024Reported quarterly or annual results46
  7. Nov 2, 2023Reported quarterly or annual results47
  8. Aug 2, 2023Reported quarterly or annual results48

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

Filings

302 filings to the SEC since October 2021: 4 annual reports, 11 quarterly reports, 42 major events, 159 insider forms, 30 large holders, 56 other. The latest 20:

  1. Nov 12, 2025SCHEDULE 13G/A EDGAR
  2. Aug 8, 2025SCHEDULE 13G EDGAR
  3. Jul 11, 202515-12G EDGAR
  4. Jul 7, 2025SCHEDULE 13G EDGAR
  5. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  6. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  7. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  8. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  9. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  10. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  11. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  12. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  13. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  14. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  15. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  16. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  17. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  18. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  19. Jul 2, 20254 OWNERSHIP DOCUMENT EDGAR
  20. Jul 1, 2025S-8 POS EDGAR

The 302 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

35 open-market trades by officers, directors and large owners since October 2021: 0 buys and 35 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Mar 3, 2025Edris BadreddinChief Operating OfficerSale20,000$54.23$1.1MForm 4
Mar 3, 2025Islam SaqibChief Executive OfficerSale49,000$54.24$2.7MForm 4
Feb 20, 2025Islam SaqibChief Executive OfficerSale29,328$60.30$1.8MForm 4
Feb 20, 2025Ashar BhaveshChief Commercial OfficerSale1,016$61.19$62.2KForm 4
Feb 20, 2025LYNCH DANIELDirectorSale47,600$60.22$2.9MForm 4
Feb 14, 2025Islam SaqibChief Executive OfficerSale10,672$59.92$639.5KForm 4
Feb 14, 2025LYNCH DANIELDirectorSale400$60.00$24.0KForm 4
Feb 10, 2025Pichl DanielChief People OfficerSale29,750$54.36$1.6MForm 4
Feb 10, 2025LYNCH DANIELDirectorSale175,000$54.46$9.5MForm 4
Feb 10, 2025Islam SaqibChief Executive OfficerSale48,000$53.30$2.6MForm 4
Feb 10, 2025Hambleton JulieDirectorSale13,774$53.01$730.2KForm 4
Feb 10, 2025Edris BadreddinChief Operating OfficerSale30,000$53.13$1.6MForm 4
Dec 3, 2024Edris BadreddinChief Operating OfficerSale20,000$41.96$839.3KForm 4
Dec 2, 2024Islam SaqibChief Executive OfficerSale49,000$41.37$2.0MForm 4
Sep 3, 2024Islam SaqibChief Executive OfficerSale49,000$40.57$2.0MForm 4
Sep 3, 2024Edris BadreddinChief Operating OfficerSale20,000$40.65$812.9KForm 4
Jun 3, 2024Islam SaqibChief Executive OfficerSale49,000$39.90$2.0MForm 4
Jun 3, 2024Hambleton JulieDirectorSale4,648$40.03$186.0KForm 4
Jun 3, 2024Edris BadreddinChief Operating OfficerSale20,000$40.07$801.4KForm 4
Feb 16, 2024Pichl DanielChief People OfficerSale15,000$50.10$751.5KForm 4

All 35 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
2024Saqib Islam, J.D.Chief Executive Officer55$760.0K$16.2M63
2024Badreddin Edris, Ph.D.Chief Operating Officer38$620.0K$5.9M63
2024James Cassidy, M.D., Ph.D.Chief Medical Officer66$525.0K$4.1M63
2024Bhavesh Ashar, M.B.A.Chief Commercial Officer59$525.0K$3.9M63
2024Francis I. Perier, Jr., M.B.A.Chief Financial Officer65$510.0K$3.2M63
2023Saqib Islam, J.D.Chief Executive Officer55$725.0K$18.4M63
2023Badreddin Edris, Ph.D.Chief Operating Officer38$585.0K$6.6M63
2023James Cassidy, M.D., Ph.D.Chief Medical Officer66$500.0K$4.3M63
2023Francis I. Perier, Jr., M.B.A.Chief Financial Officer65$495.0K$3.7M63
2023Bhavesh Ashar, M.B.A.Chief Commercial Officer59$500.0K$2.8M63
2022Saqib Islam, J.D.Chief Executive Officer55$680.0K$15.3M63
2022Badreddin Edris, Ph.D.Chief Operating Officer38$550.0K$5.7M63
2022Bhavesh Ashar, M.B.A.Chief Commercial Officer59$475.0K$4.9M63
2022Francis I. Perier, Jr., M.B.A.Chief Financial Officer65$475.0K$4.1M63
2022James Cassidy, M.D., Ph.D.Chief Medical Officer66$460.0K$2.8M63

SEC filer profile

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

  • Name on EDGARSpringWorks Therapeutics, Inc.1
  • CIK0001773427
  • Employer ID (EIN)83-40668273
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address100 Washington Boulevard, Stamford, CT 069021
  • Phone203-883-94901
  • Shares outstanding75,322,696 as of May 2, 202511
  • Public float$2.7B as of Jun 30, 20243
  • AuditorErnst & Young LLP, Hartford, Connecticut PCAOB ID 42; it also attests to the company’s internal control over financial reporting3
  • On EDGAR sinceApr 12, 20191
  • Filings461 in all: 4 (208), 8-K (57), 3 (25), SC 13G/A (19), 144 (18), 10-Q (17), SC 13D/A (11), SC 13G (10)1
    All 41 form types

    DEFA14A (9), 4/A (7), CORRESP (7), S-8 (7), S-8 POS (7), 10-K (6), 424B5 (6), DEF 14A (6), UPLOAD (6), SCHEDULE 13G/A (4), ARS (3), SCHEDULE 13G (3), S-1/A (2), S-3ASR (2), SC 13D (2), SEC STAFF LETTER (2), 15-12G (1), 25-NSE (1), 424B3 (1), 424B4 (1), 5 (1), 8-A12B (1), 8-K/A (1), CERT (1), D (1), DEFM14A (1), DRS (1), DRS/A (1), DRSLTR (1), EFFECT (1), POSASR (1), PREM14A (1), S-1 (1)

  • Latest filingsAnnual report (10-K) Feb 20, 2025
    Quarterly report (10-Q) May 9, 2025
    Proxy statement (DEF 14A) Apr 4, 2025
    Latest 8-K (8-K) Jul 1, 2025

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 Par Value per ShareSWTXThe Nasdaq Global Select Market

From the cover page of the 10-K filed Feb 20, 2025 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks SpringWorks Therapeutics, Inc. names in Item 1A of its 10-K filed Feb 20, 2025: 70 risks under these headings, as written.3

  • •Our business depends heavily on our ability to successfully commercialize OGSIVEO and GOMEKLI in the United States and in other jurisdictions where we may obtain marketing approval, including Europe. There is no assurance that our commercialization efforts with respect to OGSIVEO or GOMEKLI will be successful or that we will be able to generate revenues at the levels or on the timing we expect, or at levels or on the timing necessary to support our goals.
  • •We have limited experience as a commercial company and the sales, marketing, and distribution of OGSIVEO, GOMEKLI, or any future approved products may be unsuccessful or less successful than anticipated.
  • •Our business is highly dependent on the successful commercialization of OGSIVEO and GOMEKLI and development of our current product candidates. If we are unable to successfully commercialize OGSIVEO or GOMEKLI or successfully complete clinical development of, obtain regulatory approval for, or commercialize, our product candidates, or if we experience delays in doing so, our business will be materially harmed.
  • •We were not involved in the early development of our lead products or in the development of third-party agents being developed in combination with our product candidates; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials for our products and product candidates.
  • •If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates.
  • •Interim “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available, are not necessarily predictive of the final results of the completed study or the results of other ongoing or future studies and are subject to audit and verification procedures that could result in material changes.
  • •We expect to develop nirogacestat and mirdametinib, and potentially future product candidates, in combination with other therapies, and safety or supply issues with combination use products may delay or prevent development and approval of such product candidates.
  • •If we encounter difficulties enrolling patients in any of our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • •The target patient populations of OGSIVEO for the treatment of desmoid tumors and GOMEKLI for the treatment of NF1-PN are small and have not been definitively determined, and if our estimates of the number of treatable patients is lower than expected, our potential revenues from sales of OGSIVEO or of GOMEKLI and our ability to achieve profitability would be compromised.
  • •Even if our product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payers, or others in the medical community necessary for commercial success.
  • •We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for, or commercialize, any potential product candidates.
  • •Because we rely on third-party manufacturing and supply partners, our supply of preclinical and clinical development materials and commercial product may become limited or interrupted or may not be of satisfactory quantity or quality, which could delay, prevent or impair our development or commercialization efforts.
The other 58 risks
  • •We are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on a limited number of qualified active ingredient manufacturers for the commercial supply of OGSIVEO, GOMEKLI and each of our other product candidates.
  • •Our existing and future collaborations are important to our business. If we are unable to maintain our existing collaborations or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected. In addition, our collaborators have broad discretion in many aspects of their performance of collaboration activities and they may take actions with which we do not agree.
  • •We depend on intellectual property licensed from third parties, including from Pfizer for our lead product candidates, and termination of any of these licenses could result in the loss of significant rights, which would harm our business.
  • •If we fail to comply with our obligations under our patent licenses with third parties, we could lose license rights that are important to our business.
  • •We have been granted Orphan Drug designation for nirogacestat and mirdametinib and may seek Orphan Drug designation for other product candidates, but we may be unable to obtain or maintain such designation, or the benefits associated with such designation, including the potential for market exclusivity, which may negatively impact our financial performance.
  • •A portion of our manufacturing of our lead products takes place in China, with additional capacity sourced from India, through third-party manufacturers. A significant disruption in the operation of those manufacturers, a trade war or political unrest could materially adversely affect our business, financial condition and results of operations.
  • •The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
  • •We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • •We are still developing the internal research capabilities required to independently discover new product candidates, and we plan to execute our growth strategy, in part by identifying and in-licensing or acquiring additional product candidates that have been discovered and initially developed by others. We may not be successful in executing our growth strategy or such growth strategy may not deliver the anticipated results.
  • •Our current operations are concentrated in two locations, and we or the third parties upon whom we depend may be adversely affected by natural disasters, including those that may be related to climate change, or other unforeseeable or uncontrollable events, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • •We have incurred significant net losses since our inception and anticipate that we will continue to incur net losses until we reach profitability, which we currently anticipate to be in the first half of 2026. We may not be able to reach profitability in the first half of 2026 if we cannot continue to effectively commercialize OGSIVEO or effectively commercialize GOMEKLI.
  • •We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.
  • •We may require additional capital to fund our operations and if we fail to obtain necessary capital, we will not be able to complete the development and commercialization of our product candidates.
  • •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.
  • •We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • •Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • •Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • •Our bylaws designate certain specified courts as the sole and exclusive forums 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.
  • Company-specific material risk factors
  • Risks related to our research and development and commercialization
  • Our business depends heavily on our ability to successfully commercialize OGSIVEO and GOMEKLI in the United States and in other jurisdictions where we may obtain marketing approval, including Europe. There is no assurance that our commercialization efforts with respect to OGSIVEO or GOMEKLI will be successful or that we will be able to generate revenues at the levels or on the timing we expect, or at levels or on the timing necessary to support our goals.
  • We have limited experience as a commercial company and the sales, marketing, and distribution of OGSIVEO, GOMEKLI, or any future approved products may be unsuccessful or less successful than anticipated.
  • Our business is highly dependent on the successful commercialization of OGSIVEO and GOMEKLI and development of our current product candidates. If we are unable to successfully commercialize OGSIVEO or GOMEKLI or successfully complete clinical development of, obtain regulatory approval for, or commercialize, our product candidates, or if we experience delays in doing so, our business will be materially harmed.
  • We were not involved in the early development of our lead products or in the development of third-party agents being developed in combination with our product candidates; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials for our products and product candidates.
  • If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates.
  • Interim “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available, are not necessarily predictive of the final results of the completed study or the results of other ongoing or future studies and are subject to audit and verification procedures that could result in material changes.
  • We expect to develop nirogacestat and mirdametinib, and potentially future product candidates, in combination with other therapies, and safety or supply issues with combination use products may delay or prevent development and approval of such product candidates.
  • If we encounter difficulties enrolling patients in any of our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • The target patient populations of OGSIVEO for the treatment of desmoid tumors and GOMEKLI for the treatment of NF1-PN are small and have not been definitively determined, and if our estimates of the number of treatable patients is lower than expected, our potential revenues from sales of OGSIVEO or of GOMEKLI and our ability to achieve profitability would be compromised.
  • Even if our product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payers, or others in the medical community necessary for commercial success.
  • Risks related to our reliance on third parties
  • We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for, or commercialize, any potential product candidates.
  • Because we rely on third-party manufacturing and supply partners, our supply of preclinical and clinical development materials and commercial product may become limited or interrupted or may not be of satisfactory quantity or quality, which could delay, prevent or impair our development or commercialization efforts.
  • We are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on a limited number of qualified active ingredient manufacturers for the commercial supply of OGSIVEO, GOMEKLI and each of our lead product candidates.
  • Our existing and future collaborations are important to our business. If we are unable to maintain our existing collaborations or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected. In addition, our collaborators have broad discretion in many aspects of their performance of collaboration activities and they may take actions with which we do not agree.
  • Risks related to our intellectual property
  • We depend on intellectual property licensed from third parties, including from Pfizer for our lead product candidates, and termination of any of these licenses could result in the loss of significant rights, which would harm our business.
  • If we fail to comply with our obligations under our patent licenses with third parties, we could lose license rights that are important to our business.
  • We have been granted Orphan Drug designation for nirogacestat and mirdametinib and may seek Orphan Drug designation for other product candidates, but we may be unable to obtain or maintain such designation, or the benefits associated with such designation, including the potential for market exclusivity, which may negatively impact our financial performance.
  • A portion of our manufacturing of our lead products takes place in China, with additional capacity sourced from India, through third-party manufacturers. A significant disruption in the operation of those manufacturers, a trade war or political unrest could materially adversely affect our business, financial condition and results of operations.
  • The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
  • Risks related to managing our business and operations
  • We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • We are still developing the internal research capabilities required to independently discover new product candidates, and we plan to execute our growth strategy, in part by identifying and in-licensing or acquiring additional product candidates that have been discovered and initially developed by others. We may not be successful in executing our growth strategy or such growth strategy may not deliver the anticipated results.
  • Our current operations are concentrated in two locations, and we or the third parties upon whom we depend may be adversely affected by natural disasters, including those that may be related to climate change, or other unforeseeable or uncontrollable events, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Risks related to our financial position and need for additional capital
  • We have incurred significant net losses since our inception and anticipate that we will continue to incur net losses until we reach profitability, which we currently anticipate to be in the first half of 2026. We may not be able to reach profitability in the first half of 2026 if we cannot continue to effectively commercialize OGSIVEO or effectively commercialize GOMEKLI.
  • We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.
  • We may require additional capital to fund our operations and if we fail to obtain necessary capital, we will not be able to complete the development and commercialization of our product candidates.
  • 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.
  • Risks related to our common stock
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • Our bylaws designate certain specified courts as the sole and exclusive forums 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.
  • General risk factors
  • Risks related to research and development and the biopharmaceutical industry
  • Clinical development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • The successful development of biopharmaceuticals is highly uncertain.
  • Due to our limited resources and access to additional capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business.
  • Our future clinical trials or those of our future collaborators may reveal significant adverse events not seen in prior preclinical studies or clinical trials and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates.
  • Increasing demand for compassionate use of our product candidates could negatively affect our reputation and harm our business.
  • We face significant competition from other biopharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
  • 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 the Company’s current and projected business operations and its financial condition and results of operations.
  • Risks related to intellectual property
  • Our success depends in part on our ability to protect our intellectual property, and patent terms may be inadequate to protect our competitive position. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.

Legal proceedings

We are not currently a party to any material legal proceedings.

The opening of Item 3, Legal Proceedings.3

Sources

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