SNDX on Nasdaq

Syndax Pharmaceuticals Inc

In its 2026 annual report the company says: “We are a commercial-stage biopharmaceutical company advancing innovative cancer therapies. We currently have two commercially approved medicines, Revuforj ® (revumenib) and Niktimvo™ (axatilimab-csfr), and a robust slate of clinical development programs designed to unlock the full potential of our first two products.”5 It is headquartered in Waltham, United States.2 Its shares trade on Nasdaq under the symbol SNDX.2

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Last updated Oct 21, 2026.

Overview

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  • TickerSNDX on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersWaltham, United States2
  • Incorporated inDE3
  • Business address730 Third Avenue, 9Th Floor, New York, Ny 100173
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation2
  • LEI529900OF94TRHKZVBS872
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o CORPORATION SERVICE COMPANY, 251 LITTLE FALLS DRIVE, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 40433762

We are a commercial-stage biopharmaceutical company advancing innovative cancer therapies. We currently have two commercially approved medicines, Revuforj ® (revumenib) and Niktimvo™ (axatilimab-csfr), and a robust slate of clinical development programs designed to unlock the full potential of our first two products.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

-158.4%Operating margin6
-165.6%Net margin6
627.8%Revenue growth, 20256
-441.6%Return on equity6
-$323.2MFree cash flow6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Net Product Revenues brought in 72% of the revenue Syndax Pharmaceuticals Inc broke down this way in fiscal 2025.

  1. Net Product Revenues$124.8M672%up 1526% from 2024
  2. Collaboration Revenue$42.4M625%
  3. Milestone Revenue$5.1M63%down 68% from 2024
Products and services by year
Products and services202320242025
Net Product Revenues$0$7.7M$124.8M
Collaboration Revenue$0$0$42.4M
Milestone Revenue$0$16.0M$5.1M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development59¢$258.8M
  • Selling, general and admin41¢$179.7M
  • Income tax0¢$433.0K

Out of $172.4M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$172.4M in 2025+11261% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $1.5M$1.5M20192020: $1.5M$1.5M2020+0%2021: $139.7M$139.7M2021+9110%2022: $0$020222023: $0$020232024: $23.7M$23.7M20242025: $172.4M$172.4M2025+628%
Operating income789106-$273.1M in 2025+375% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M0$100.0M2019: -$57.5M-$57.5M20192020: -$71.4M-$71.4M2020+24%2021: $26.2M$26.2M20212022: -$151.8M-$151.8M20222023: -$230.0M-$230.0M2023+52%2024: -$339.7M-$339.7M2024+48%2025: -$273.1M-$273.1M2025−20%
Net income789106-$285.4M in 2025+409% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M0$100.0M2019: -$56.0M-$56.0M20192020: -$73.2M-$73.2M2020+31%2021: $24.9M$24.9M20212022: -$149.3M-$149.3M20222023: -$209.4M-$209.4M2023+40%2024: -$318.8M-$318.8M2024+52%2025: -$285.4M-$285.4M2025−10%

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

Period ending2025-12-312024-12-312023-12-31
Total Revenue$172.4M$23.7M$0
Cost of product sales$7.0M$826.0K$0
Research and development expenses$258.8M$241.6M$163.0M
Selling, general and administrative$179.7M$120.9M$66.9M
Total operating expenses$445.4M$363.4M$230.0M
Loss from operations-$273.1M-$339.7M-$230.0M
Royalty interest expense-$33.8M-$4.9M$0
Other interest (expense) income-$6.0K$1.0K-$208.0K
Interest income$22.7M$26.1M$21.2M
Other expense, net-$1.3M-$247.0K-$361.0K
Total other income-$12.3M$20.9M$20.6M
Net income-$285.4M-$318.8M-$209.4M
Net loss attributable to common stockholders-$285.4M-$318.8M-$209.4M
Basic loss per share attributable to common stockholders-$3.29-$3.72-$2.98
Diluted loss per share attributable to common stockholders-$3.29-$3.72-$2.98
Basic loss per share attributable to common stockholders86.6M shares85.6M shares70.4M shares
Diluted loss per share attributable to common stockholders86.6M shares85.6M shares70.4M shares

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Corporate structure

Syndax Pharmaceuticals Inc sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Syndax Pharmaceuticals Inc

  • State Street Corporation Filed SCHEDULE 13G on Syndax Pharmaceuticals Inc, latest Aug 7, 2026 (5 filings since Feb 6, 2023)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Syndax Pharmaceuticals Inc, latest May 15, 2026 (6 filings since Oct 31, 2023)
  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Syndax Pharmaceuticals Inc, latest Apr 30, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Syndax Pharmaceuticals Inc, latest Mar 27, 2026 (3 filings since Feb 13, 2024)
  • Goldman Sachs Filed SCHEDULE 13G/A on Syndax Pharmaceuticals Inc, latest Aug 13, 2025 (3 filings since Feb 12, 2025)
  • Morgan Stanley Filed SCHEDULE 13G/A on Syndax Pharmaceuticals Inc, latest May 7, 2025 (2 filings since Feb 5, 2025)
  • BlackRock Filed SCHEDULE 13G/A on Syndax Pharmaceuticals Inc, latest Apr 17, 2025 (7 filings since Feb 7, 2022)
  • Wellington Management Company Filed SCHEDULE 13G/A on Syndax Pharmaceuticals Inc, latest Mar 7, 2025 (5 filings since Feb 4, 2022)
  • Kynam Capital Management, LP Filed SCHEDULE 13G/A on Syndax Pharmaceuticals Inc, latest Feb 14, 2025 (2 filings since Feb 14, 2024)
  • Avidity Partners Management LP Filed SC 13G/A on Syndax Pharmaceuticals Inc, latest Feb 13, 2024 (3 filings since Feb 14, 2022)
  • Frazier Life Sciences Public Fund, L.P. Filed SC 13G/A on Syndax Pharmaceuticals Inc, latest Oct 5, 2023 (3 filings since Dec 23, 2021)
  • BIOTECHNOLOGY VALUE FUND L P Filed SC 13G/A on Syndax Pharmaceuticals Inc, latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • Syndax Pharmaceuticals Inc Waltham, Massachusetts, United States
    • Syndax Europe B.V. Subsidiary · Netherlands

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 Syndax Pharmaceuticals 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$606.0K6 Dec 31, 2025$419.0K6 Dec 31, 2024+44.6%
Accumulated depreciation$425.0K6 Dec 31, 2025$419.0K6 Dec 31, 2024+1.4%
Property and equipment, net$181.0K6 Dec 31, 2025$06 Dec 31, 2024
Operating-lease assets (leased space)$1.3M6 Dec 31, 2025$2.0M6 Dec 31, 2024−33.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$134.9M6 Dec 31, 2025$154.1M6 Dec 31, 2024−12.4%
Marketable securities, current$259.1M6 Dec 31, 2025$418.8M6 Dec 31, 2024−38.1%
Debt securities available for sale$259.1M6 Dec 31, 2025$538.3M6 Dec 31, 2024−51.9%
Long-term investments$06 Dec 31, 2025$119.5M6 Dec 31, 2024−100.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$32.8M6 Dec 31, 2025$366.0K6 Dec 31, 2024+8849.2%
Raw materials$29.0M6 Dec 31, 2025$06 Dec 31, 2024
Work in process$2.1M6 Dec 31, 2025$330.0K6 Dec 31, 2024+540.0%
Finished goods$1.6M6 Dec 31, 2025$36.0K6 Dec 31, 2024+4386.1%

Properties, in its own words

Our principal office is located in New York, NY, where we lease approximately 12,000 square feet of office space pursuant to a lease that expires in August 2028. In February 2025, following the expiration of our lease, we closed our office in Waltham, MA and made New York our principal office location. In August 2025, following the expiration of our lease, we also closed approximately 4,000 square feet of additional office space in New York, NY. We believe that our existing facilities are sufficient for our foreseeable future needs. If we determine that additional or new facilities are needed in the future, we believe that appropriate alternative space would be available to us on commercially reasonable terms.

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

Leadership

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

Board members and other officers (22)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Syndax Europe B.V. Netherlands4

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

Timeline

  1. Aug 4, 20268-K Results of operations44
  2. Jul 14, 20268-K Other events45
  3. Jun 10, 20268-K Executive or director change; Shareholder vote46
  4. Jun 10, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares47
  5. Jun 4, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares48
  6. Apr 30, 20268-K Results of operations49
  7. Feb 26, 20268-K Results of operations50
  8. Jan 12, 20268-K Results of operations; Regulation FD disclosure51
  9. Dec 19, 20258-K Bylaws or fiscal year changed52
  10. Nov 3, 20258-K Results of operations53
  11. Oct 24, 20258-K Other events54
  12. Aug 4, 20258-K Results of operations55
  13. Feb 3, 2022New chief executive Michael A. Metzger becomes CEO14
  14. Mar 2, 2016New chief executive Briggs Morrison becomes CEO15

Calendar

Coming up

  1. Nov 2, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.70) a share, on Nov 3, 2025.56

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results44
  2. Apr 30, 2026Reported quarterly or annual results49
  3. Feb 26, 2026Reported quarterly or annual results50
  4. Jan 12, 2026Reported quarterly or annual results51
  5. Nov 3, 2025Reported quarterly or annual results53
  6. Aug 4, 2025Reported quarterly or annual results55
  7. May 5, 2025Reported quarterly or annual results57
  8. Mar 3, 2025Reported quarterly or annual results58

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

Filings

303 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 57 major events, 122 insider forms, 46 large holders, 58 other. The latest 20:

  1. Aug 7, 2026SCHEDULE 13G EDGAR
  2. Aug 4, 202610-Q EDGAR
  3. Aug 4, 20268-K EDGAR
  4. Jul 14, 20268-K EDGAR
  5. Jul 9, 20264 EDGAR
  6. Jul 8, 2026144 EDGAR
  7. Jun 12, 2026144 EDGAR
  8. Jun 12, 20264 EDGAR
  9. Jun 11, 2026144 EDGAR
  10. Jun 10, 20268-K EDGAR
  11. Jun 10, 20268-K EDGAR
  12. Jun 4, 2026DEFA14A EDGAR
  13. Jun 4, 20268-K EDGAR
  14. Jun 2, 20264 EDGAR
  15. Jun 2, 20264 EDGAR
  16. Jun 1, 2026144 EDGAR
  17. Jun 1, 2026144 EDGAR
  18. May 15, 2026SCHEDULE 13G/A EDGAR
  19. Apr 30, 2026SCHEDULE 13G EDGAR
  20. Apr 30, 2026ARS EDGAR

The 303 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

75 open-market trades by officers, directors and large owners since October 2021: 5 buys and 70 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 8, 2026Metzger Michael AChief Executive OfficerSale32,375$24.24$784.8KForm 4
Jun 12, 2026Botwood Nicholas A.J.Head of R&D, CMOSale31,235$18.14$566.6KForm 4
Jun 11, 2026Botwood Nicholas A.J.Head of R&D, CMOSale34,280$18.00$617.0KForm 4
Jun 1, 2026Goldan Keith A.Chief Financial OfficerSale1,177$18.99$22.4KForm 4
Jun 1, 2026Metzger Michael AChief Executive OfficerSale6,847$18.99$130.0KForm 4
Feb 9, 2026Metzger Michael AChief Executive OfficerSale17,159$21.03$360.9KForm 4
Feb 9, 2026Goldan Keith A.Chief Financial OfficerSale3,410$21.03$71.7KForm 4
Feb 6, 2026Metzger Michael AChief Executive OfficerSale7,412$20.62$152.8KForm 4
Feb 6, 2026Goldan Keith A.Chief Financial OfficerSale2,082$20.62$42.9KForm 4
Sep 8, 2025Metzger Michael AChief Executive OfficerSale157,307$16.41$2.6MForm 4
Aug 18, 2025Podlesak DennisDirectorSale19,200$15.84$304.1KForm 4
Aug 15, 2025Podlesak DennisDirectorSale19,200$15.54$298.4KForm 4
Aug 14, 2025Podlesak DennisDirectorSale19,200$14.19$272.4KForm 4
Jul 16, 2025Goldan Keith A.Chief Financial OfficerSale1,296$9.29$12.0KForm 4
Jul 16, 2025Metzger Michael AChief Executive OfficerSale7,534$9.29$70.0KForm 4
May 19, 2025Goldan Keith A.Chief Financial OfficerBuy3,000Form 4
May 19, 2025Huber Martin H. Jr.DirectorBuy5,000$8.99$45.0KForm 4
May 19, 2025Katkin KeithDirectorBuy10,000$9.11$91.1KForm 4
May 16, 2025Botwood Nicholas A.J.Head of R&D, CMOBuy11,765$9.00$105.9KForm 4
Mar 4, 2025Metzger Michael AChief Executive OfficerSale7,814$15.05$117.6KForm 4

All 75 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Michael A. Metzger$754.3K$7.1M74
2025Nick BotwoodM.B.B.S.58$345.7K$2.9M74
2025Keith A. Goldan55$516.9K$2.5M74
2025Luke J. Albrecht47$496.9K$2.3M74
2025Steve Closter57$485.3K$2.1M74
2024Chief Executive Officer$715.0K$7.7M74
2024Chief Commercial Officer$364.2K$3.6M74
2024Chief Financial Officer$497.0K$2.8M74
2024General Counsel and Secretary$471.0K$2.5M74
2023Chief Executive Officer$678.4K$9.1M74
2023Chief Financial Officer$470.3K$2.8M74
2023General Counsel and Secretary$442.1K$2.6M74

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
BlackRock, Inc.9,020,006$197.2M0.0%+765,580
Kynam Capital Management, LP8,050,959$176.0M9.7%No change
Goldman Sachs Group Inc5,861,265$128.1M0.0%+864,478
State Street Corp5,658,424$123.7M0.0%+1,228,348
Bank Of America Corp /de/4,045,094$88.4M0.0%−204,742
Vanguard Capital Management LLC3,927,892$85.9M0.0%+105,313
Deerfield Management Company, L.P.3,779,900$82.6M1.0%No change
Eversept Partners, LP2,798,210$61.2M3.3%−87,412
Geode Capital Management, LLC2,584,136$56.5M0.0%+427,078
Hood River Capital Management LLC2,564,279$56.1M0.4%+209,994
Kingdon Capital Management, L.l.c.2,500,000$54.6M7.4%No change
Franklin Resources Inc2,286,499$50.0M0.0%+136,420
Millennium Management LLC2,053,960$44.9M0.0%+1,854,436
Vanguard Portfolio Management LLC1,921,796$42.0M0.0%+184,655
UBS Group AG1,893,750$41.4M0.0%+740,088
Elmind Capital, LP1,855,000$40.6M10.2%No change
BNP PARIBAS ASSET MANAGEMENT Holding S.A.1,790,173$39.1M0.0%+57,632
Candriam S.C.A.1,696,040$37.0M0.2%+770,708
Soleus Capital Management, L.P.1,628,039$35.6M1.2%−98,869
Two Sigma Investments, LP1,578,125$34.5M0.0%−1,471
Orbimed Advisors LLC1,542,000$33.7M0.6%+579,700
Nuveen, LLC1,364,575$29.8M0.0%−130,070
Mpm Bioimpact LLC1,333,523$29.2M1.8%−7,210
Aisling Capital Management LP1,316,806$28.8M6.1%No change
Woodline Partners LP1,250,760$27.3M0.1%No change

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

SEC filer profile

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

  • Name on EDGARSyndax Pharmaceuticals Inc1
  • CIK0001395937
  • Employer ID (EIN)32-01625055
  • 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 address730 Third Avenue, 9Th Floor, New York, NY 100171
  • Phone781-419-14001
  • Shares outstanding89,297,086 as of Jul 31, 202612
  • Public float$799.2M as of Jun 30, 20255
  • AuditorDeloitte & Touche LLP, New York, New York PCAOB ID 34; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceApr 6, 20071
  • Filings653 in all: 4 (222), 8-K (114), SC 13G/A (50), 10-Q (32), 3 (32), 144 (24), SC 13G (20), 424B5 (19)1
    All 38 form types

    CT ORDER (11), S-8 (11), 10-K (10), DEF 14A (10), SCHEDULE 13G/A (10), D (9), DEFA14A (9), S-1/A (9), UPLOAD (8), CORRESP (7), SCHEDULE 13G (7), DRS/A (6), ARS (4), DRSLTR (3), EFFECT (3), S-3 (3), 10-K/A (2), 4/A (2), DRS (2), RW (2), S-1 (2), S-3ASR (2), 424B4 (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), PRE 14A (1), REGDEX (1), SC 13D (1), SC 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 4, 2026

Securities registered for trading

ClassSymbolExchange
Common StockSNDXThe Nasdaq Stock Market, LLC

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 Syndax Pharmaceuticals Inc names in Item 1A of its 10-K filed Feb 26, 2026: 54 risks under these headings, as written.5

  • Risks Related to Our Business and Industry
  • Our business depends heavily on our ability to successfully commercialize Revuforj and Niktimvo in the United States and in other jurisdictions where we may obtain marketing approval. There is no assurance that our commercialization efforts with respect to Revuforj or Niktimvo will be successful or that we will be able to generate revenues at the levels or on the timing we expect.
  • We have recently begun commercialization efforts and the sales, marketing, and distribution of Revuforj, Niktimvo, or any future approved products may be unsuccessful or less successful than anticipated.
  • If the market opportunities for our products are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • We are currently developing several product candidates. If we are unable to successfully complete clinical development of, obtain regulatory approval for, and commercialize our product candidates, our business prospects will be significantly harmed.
  • Interim top-line 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.
  • We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of any of our product candidates.
  • We are dependent upon our collaboration with Incyte to further develop and commercialize axatilimab. If we or Incyte fail to perform as expected the potential for us to generate future revenue under the collaboration could be significantly reduced, the development and/or commercialization of axatilimab may be terminated or substantially delayed, and our business could be adversely affected.
  • If we or our collaborators are unable to enroll patients in clinical trials, these clinical trials may not be completed on a timely basis or at all.
  • We may be required to relinquish important rights to and control over the development and commercialization of our product candidates to our current or future collaborators.
  • We may explore strategic collaborations that may never materialize or may fail.
The other 43 risks
  • Failure to comply with regulatory requirements or unanticipated problems with Revuforj or Niktimvo may result in various adverse actions, such as the suspension or withdrawal of either product, closure of a facility or enforcement of substantial penalties or fines.
  • The regulatory approval processes of the FDA and foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. Our inability to obtain regulatory approval for our product candidates would harm our business.
  • Disruptions at the FDA and other government agencies caused by layoffs, funding shortages or global health concerns could negatively impact our business.
  • Revuforj, Niktimvo and our future products may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community to be commercially successful.
  • We are in the process of building and maintaining our sales, marketing and distribution infrastructure.
  • The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for Revuforj, Niktimvo or any future products could limit our ability to market those products and decrease our ability to generate revenue.
  • We currently rely, and expect to continue to rely, on third-party contract manufacturers as well as Incyte for all of our required raw materials, active pharmaceutical ingredients and finished product for our preclinical research, clinical trials, and commercial manufacturing and distribution.
  • Our products and product candidates may face future development and regulatory difficulties.
  • Our products and product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial scope of their approved use, or result in significant negative consequences following any marketing approval.
  • Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States.
  • Certain of our product candidates may require companion diagnostics in certain indications. Failure to successfully develop, validate and obtain regulatory clearance or approval for such tests could harm our product development strategy or prevent us from realizing the full commercial potential of our investigational products.
  • We are dependent on UCB Biopharma Sprl, or UCB, to comply with the terms of our license agreement for axatilimab.
  • Our employees, consultants and collaborators may engage in misconduct or other improper activities, including insider trading and non-compliance with regulatory standards and requirements.
  • We must attract and retain additional highly skilled employees in order to succeed.
  • Current and future legislation may adversely impact our business, operations, and profitability including, among other things, increasing the difficulty and cost for us to commercialize Revuforj, Niktimvo, and other product candidates, preventing or delaying marketing approval of our product candidates and affecting the prices we may obtain.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates.
  • Our relationships with healthcare providers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations as well as privacy and data security laws and regulations, which could expose us to significant penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm, fines, exclusion from participation in government healthcare programs, curtailments or restrictions of our operations, administrative burdens and diminished profits and future earnings.
  • Off-label use or misuse of our products may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits.
  • If our information technology systems or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
  • Social media platforms present new risks and challenges to our business.
  • Risks Related to Our Financial Position and Capital Needs
  • We have incurred net losses since our inception, except 2021, and anticipate that we will continue to incur net losses for the near future.
  • While we have product revenue, we may never achieve or maintain profitability.
  • We may require additional capital to finance our planned operations, which may not be available to us on acceptable terms, or at all. As a result, we may not complete the development and commercialization of, or obtain regulatory approval for our existing product candidates or develop new product candidates.
  • Changes in tax laws or regulations could materially adversely affect our company.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Risks Related to Intellectual Property
  • If we are unable to obtain or protect intellectual property rights, we may not be able to compete effectively in our market.
  • We may not be able to protect our intellectual property rights throughout the world.
  • If we breach the UCB license agreement related to axatilimab or if the UCB license agreement is otherwise terminated, we could lose the ability to continue the development and commercialization of axatilimab.
  • If we breach the license agreement related to revumenib or if the license agreement is otherwise terminated, we could lose the ability to continue the development and commercialization of revumenib.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have an adverse effect on the success of our business and on our stock price.
  • Third parties may initiate legal proceedings against us alleging that we infringe their intellectual property rights or we may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, the outcome of which would be uncertain and could have an adverse effect on the success of our business.
  • We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • Our inability to protect our confidential information and trade secrets would harm our business and competitive position.
  • Risks Related to Ownership of Our Common Stock and Other General Matters
  • The market price of our stock may be volatile and you could lose all or part of your investment.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
  • We may sell additional equity or debt securities or enter into other arrangements to fund our operations, which may result in dilution to our stockholders and impose restrictions or limitations on our business.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence control over matters subject to stockholder approval.
  • We may be subject to securities litigation, which is expensive and could divert management attention.
  • If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
  • Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would benefit our stockholders and may prevent attempts by our stockholders to replace or remove our current management.

Legal proceedings

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

The opening of Item 3, Legal Proceedings.5

Sources

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