TRAW on Nasdaq
Traws Pharma, Inc.
American pharmaceutical preparations company based in Newtown2
In its 2026 annual report the company says: “Traws Pharma, Inc. is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. We are advancing novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health. Our product candidates are intended to be safe, with simple dosing regimens.”4
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Last updated Oct 21, 2026.
Overview
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- TickerTRAW on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersNewtown, United States2
- Incorporated inDE3
- Business address12 Penns Trail, Newtown, Pa 189403
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300BRAR7BTG2PIY512
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 29834832
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Traws Pharma, Inc. (“Traws,” “we,” or the “Company”) is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. We are advancing novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health. Our product candidates are intended to be safe, with simple dosing regimens. We strive to utilize accelerated clinical trial strategies with a commitment to patients who are especially vulnerable.4 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
Where the money goes
Financial statements
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Revenue | $2.2M6 | $231.0K7 | $226.0K8 | $226.0K9 | $226.0K10 | $226.0K5 | $2.8M5 |
| Research and development | $15.5M6 | $16.9M7 | $7.3M8 | $11.4M9 | $11.4M9 | ||
| Operating expenses | $16.7M8 | $19.9M9 | $20.5M10 | $142.6M5 | $20.7M5 | ||
| Operating income | -$21.7M6 | -$25.0M7 | -$16.5M8 | -$19.6M9 | -$20.3M10 | -$142.4M5 | -$17.9M5 |
| Interest | |||||||
| Income before tax | -$16.2M8 | -$19.0M9 | -$18.9M10 | -$166.5M5 | $9.2M5 | ||
| Income tax | $10.0K6 | $4.0K7 | |||||
| Net income | -$21.5M6 | -$25.2M7 | -$16.2M8 | -$19.0M9 | -$18.9M10 | -$166.5M5 | $9.2M5 |
| Earnings per share | -$2.177 | -$0.968 | -$0.919 | -$22.5710 | -$35.215 | $0.835 | |
| Earnings per share (diluted) | -$2.177 | -$0.968 | -$0.919 | -$22.5710 | -$35.215 | $0.825 | |
| Shares (weighted, basic) | 16.8M shares8 | 20.9M shares9 | 839.6K shares10 | 1.6M shares5 | 8.2M shares5 | ||
| Shares (weighted, diluted) | 16.8M shares8 | 20.9M shares9 | 839.6K shares10 | 1.6M shares5 | 8.4M shares5 |
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash | $22.7M7 | $19.0M8 | $55.1M9 | $38.5M8 | $20.6M9 | $21.3M5 | $3.8M5 |
| Current assets | $23.5M6 | $19.8M7 | $55.4M8 | $39.3M9 | $22.7M10 | $25.0M5 | $8.0M5 |
| Property, plant and equipment | $38.0K8 | $24.0K9 | $22.0K10 | $10.0K5 | $7.0K5 | ||
| Intangible assets | $2.5M5 | ||||||
| Total assets | $23.7M6 | $20.0M7 | $55.5M8 | $39.4M9 | $22.7M10 | $25.0M5 | $10.6M5 |
| Accounts payable | $2.8M8 | $3.9M9 | $5.6M10 | $8.2M5 | $5.7M5 | ||
| Current liabilities | $8.3M6 | $10.0M7 | $6.1M8 | $8.0M9 | $9.2M10 | $11.5M5 | $11.1M5 |
| Total liabilities | $12.1M6 | $13.8M7 | $9.4M8 | $11.1M9 | $12.0M10 | $56.6M5 | $11.2M5 |
| Retained earnings | -$444.7M8 | -$463.7M9 | -$482.6M10 | -$649.2M5 | -$640.0M5 | ||
| Shareholders’ equity | $11.6M13 | $6.2M8 | $46.1M9 | $28.3M10 | $10.7M5 | -$31.6M5 | -$629.0K5 |
| Shares outstanding | 111.2M shares6 | 12.4M shares7 | 20.9M shares8 | 20.9M shares9 | 840.3K shares10 | 3.7M shares5 | 9.1M shares5 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$20.8M6 | -$23.1M7 | -$19.5M8 | -$16.3M9 | -$17.9M10 | -$29.8M5 | -$18.2M5 |
| Depreciation and amortization | $14.0K8 | $14.0K9 | $16.0K10 | $12.0K5 | $61.0K5 | ||
| Stock-based compensation | $576.0K8 | $1.2M9 | $1.3M10 | $1.4M5 | $728.0K5 | ||
| Capital spending | $55.0K6 | $15.0K7 | $14.0K10 | ||||
| Free cash flow | -$20.9M | -$23.1M | -$17.9M | ||||
| Cash from investing | -$14.0K10 | -$3.6M5 | -$2.6M5 | ||||
| Cash from financing | $55.6M8 | $34.0M5 | $3.2M5 |
Corporate structure
Traws Pharma, 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 Traws Pharma, Inc.
- Ikarian Capital, LLC Filed SCHEDULE 13G/A on Traws Pharma, Inc., latest Aug 14, 2026 (4 filings since Feb 14, 2025)
- Sirenia Capital Management LP Filed SCHEDULE 13G on Traws Pharma, Inc., latest Aug 14, 2026
- Squadron Capital Management LLC Filed SCHEDULE 13G/A on Traws Pharma, Inc., latest Aug 14, 2026 (5 filings since Sep 19, 2025)
- Adage Capital Management, L.P. Filed SCHEDULE 13G/A on Traws Pharma, Inc., latest Aug 12, 2026 (4 filings since May 12, 2025)
- PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Traws Pharma, Inc., latest May 15, 2026 (4 filings since Jan 8, 2025)
- ORBIMED ADVISORS LLC Filed SCHEDULE 13D/A on Traws Pharma, Inc., latest May 5, 2026 (4 filings since Sep 23, 2024)
- Ayrton Capital LLC Filed SCHEDULE 13G/A on Traws Pharma, Inc., latest Feb 11, 2026 (2 filings since Feb 13, 2025)
- Jorey Chernett Filed SCHEDULE 13G on Traws Pharma, Inc., latest Jan 16, 2026
- Alyeska Investment Group, L.P. Filed SCHEDULE 13G on Traws Pharma, Inc., latest Feb 14, 2025
- Viriom, Inc. Filed SC 13D on Traws Pharma, Inc., latest Apr 8, 2024
- CVI Investments, Inc. Filed SC 13G/A on Traws Pharma, Inc., latest Feb 14, 2022 (2 filings since Oct 1, 2021)
- Traws Pharma, Inc. Newtown, Pennsylvania, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Traws Pharma, 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Machinery and equipment | $84.0K5 Dec 31, 2025 | $84.0K5 Dec 31, 2024 | 0% |
| Accumulated depreciation | $77.0K5 Dec 31, 2025 | $74.0K5 Dec 31, 2024 | +4.1% |
| Property and equipment, net | $7.0K5 Dec 31, 2025 | $10.0K5 Dec 31, 2024 | −30.0% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Finite-lived intangibles, gross | $2.6M5 Dec 31, 2025 | ||
| Accumulated amortization | $58.0K5 Dec 31, 2025 | ||
| Finite-lived intangibles, net | $2.5M5 Dec 31, 2025 |
Properties, in its own words
Our corporate headquarters is located in Newtown, Pennsylvania, where we lease short-term flexible office space. We believe that suitable additional or alternative space would be available on commercially reasonable terms if required in the future.
Item 2 of the 10-K filed Apr 15, 2026.4
Leadership
Who has led Traws Pharma, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chair
Chief financial officer
Chief operating officer
- Chief executive officerIain D. Dukes Oct 15, 2025 to now14
- Chief executive officerWerner Cautreels Apr 3, 2024 to Oct 15, 202515
- Chief executive officerSteven M. Fruchtman Nov 26, 2019 to Mar 15, 202416
- Chief executive officerRamesh Kumar Jul 24, 2013 to Jul 30, 201817
- ChairIain D. Dukes Apr 3, 2024 to Aug 7, 202418
- PresidentSteven M. Fruchtman Jul 30, 2018 to Mar 15, 202419
- PresidentRamesh Kumar Jul 24, 2013 to Feb 27, 201817
- PresidentThomas J. McKearn Jul 24, 2013 to Jan 28, 201620
- Chief financial officerCharles Nolan Parker Apr 8, 2026 to now21
- Chief financial officerNora Brennan Feb 7, 2025 to Apr 8, 202622
- Chief financial officerMark Patrick Guerin Sep 1, 2016 to Feb 7, 202523
- Chief financial officerAjay Bansal Jul 24, 2013 to Jan 28, 201624
- Chief operating officerNikolay Savchuk Apr 3, 2024 to now25
- Chief operating officerMark Patrick Guerin Jun 13, 2022 to Mar 15, 202426
Board members and other officers (26)
- Chief Science Officer VirologyCharles David Pauza Apr 3, 2024 to now27
- Acting Chief Medical OfficerRobert Redfield Apr 3, 2024 to now28
- CHIEF MEDICAL OFFICERVictor M. Moyo Oct 27, 2023 to Oct 27, 202329
- Chief Medical OfficerMark S. Gelder Md. Jun 17, 2021 to Mar 14, 202330
- Chief Medical OfficerRichard Charles Woodman Nov 7, 2018 to Jul 10, 202031
- VP Corp Dev & Gen CounselAbraham N. Oler Dec 14, 2018 to Feb 9, 202232
- Chief Medical OfficerSteven M. Fruchtman Jan 21, 2015 to Jan 5, 201833
- SVP - Product DevelopmentManoj Maniar May 21, 2015 to Jul 10, 202034
- Chief Accounting OfficerMark Patrick Guerin May 16, 2014 to Aug 10, 201635
- SVP, Finance & Corp. Develop.James Altland Jul 24, 2013 to Dec 24, 201336
- Board memberJohn Harold Leaman Oct 14, 2025 to now37
- Board memberIain D. Dukes Oct 15, 2025 to now14
- Board memberNikolay Savchuk Apr 3, 2024 to now25
- Board memberWerner Cautreels Apr 3, 2024 to now15
- Board memberLuba Greenwood Sep 17, 2024 to Sep 17, 202438
- Board memberPeter Atadja Dec 19, 2022 to Aug 14, 202339
- Board memberTrafford Clarke Dec 19, 2022 to now40
- Board memberMary Teresa Shoemaker Jun 8, 2020 to now41
- Board memberSteven M. Fruchtman Nov 26, 2019 to Mar 15, 202416
- Board memberJack E. Stover May 20, 2016 to now42
- Board memberJames J. Marino Jul 8, 2015 to Aug 14, 202343
- Board memberAnne Vanlent Jul 24, 2013 to Jun 17, 201544
- Board memberJerome Groopman Jul 24, 2013 to Aug 14, 202345
- Board memberMichael B. Hoffman Jul 24, 2013 to Aug 31, 202046
- Board memberRamesh Kumar Jul 24, 2013 to Jul 30, 201817
- Board memberViren Mehta Jul 24, 2013 to Aug 14, 202347
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
Timeline
- Aug 14, 20268-K Results of operations; Regulation FD disclosure49
- Jul 31, 20268-K Listing notice or transfer50
- Jul 10, 20268-K Other events51
- Jul 9, 20268-K Executive or director change; Shareholder vote52
- Jun 22, 20268-K Regulation FD disclosure53
- Jun 12, 20268-K Regulation FD disclosure54
- May 27, 20268-K Regulation FD disclosure55
- May 26, 20268-K Other events56
- May 15, 20268-K Results of operations; Regulation FD disclosure57
- Apr 15, 20268-K Entered a material agreement; Unregistered sale of shares; Other events58
- Apr 15, 20268-K Results of operations; Regulation FD disclosure59
- Feb 19, 20268-K Other events60
- Oct 15, 2025New chief executive Iain D. Dukes becomes CEO14
- Apr 3, 2024New chief executive Werner Cautreels becomes CEO15
- Nov 26, 2019New chief executive Steven M. Fruchtman becomes CEO16
- Jul 24, 2013New chief executive Ramesh Kumar becomes CEO17
- Dec 22, 1998Founded Traws Pharma, Inc. is founded2
Calendar
Coming up
- Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.34) a share, on Nov 13, 2025.61
When it reported results
- Aug 14, 2026Reported quarterly or annual results49
- May 15, 2026Reported quarterly or annual results57
- Apr 15, 2026Reported quarterly or annual results59
- Nov 13, 2025Reported quarterly or annual results62
- Aug 14, 2025Reported quarterly or annual results63
- May 15, 2025Reported quarterly or annual results64
- Mar 31, 2025Reported quarterly or annual results65
- Nov 14, 2024Reported quarterly or annual results66
Drug trials and FDA: coming up
- Nov 2026Phase 2 trial readout expected Phase 2 trial of TRX-100 and Influenza A/France/759/2021 (H1N1) virus in Influenza: primary completion expected Nov 2026 (ClinicalTrials.gov NCT07503405).67
- Dec 2026Phase 2 trial readout expected Phase 2 trial of TRX-100 and Standard of Care (SOC) in Influenza: primary completion expected Dec 2026 (ClinicalTrials.gov NCT07371650).68
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
318 filings to the SEC since October 2021: 10 annual reports, 15 quarterly reports, 82 major events, 120 insider forms, 29 large holders, 1 private raises, 61 other. The latest 20:
- Oct 8, 2026PRE 14A EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 14, 202610-Q EDGAR
- Aug 14, 20268-K EDGAR
- Aug 14, 2026SCHEDULE 13G EDGAR
- Aug 12, 2026SCHEDULE 13G/A EDGAR
- Jul 31, 20268-K EDGAR
- Jul 16, 20264 EDGAR
- Jul 15, 20264 EDGAR
- Jul 15, 20264 EDGAR
- Jul 14, 20264 EDGAR
- Jul 14, 20264 EDGAR
- Jul 14, 20264 EDGAR
- Jul 14, 20264 EDGAR
- Jul 14, 20264 EDGAR
- Jul 14, 20264 EDGAR
- Jul 14, 20264 EDGAR
- Jul 10, 20268-K EDGAR
- Jul 10, 2026424B5 EDGAR
The 318 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
6 open-market trades by officers, directors and large owners since October 2021: 6 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Apr 16, 2026 | OrbiMed Capital GP VIII LLC10% owner | Buy | 597,729 | $1.67 | $998.2K | Form 4 |
| Jan 28, 2022 | OLER ABRAHAM N.SVP Corp Dev & Gen Counsel | Buy | 1,500 | $1.67 | $2.5K | Form 4 |
| Jan 21, 2022 | OLER ABRAHAM N.SVP Corp Dev & Gen Counsel | Buy | 1,500 | $2.02 | $3.0K | Form 4 |
| Jan 14, 2022 | OLER ABRAHAM N.SVP Corp Dev & Gen Counsel | Buy | 1,500 | $2.20 | $3.3K | Form 4 |
| Jan 7, 2022 | OLER ABRAHAM N.SVP Corp Dev & Gen Counsel | Buy | 1,500 | $2.39 | $3.6K | Form 4 |
| Nov 19, 2021 | OLER ABRAHAM N.SVP Corp Dev & Gen Counsel | Buy | 1,000 | $3.16 | $3.2K | Form 4 |
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.
- Ikarian Capital, LLCSCHEDULE 13G/A, 4 filings Feb 14, 2025 to Aug 14, 202669
- Sirenia Capital Management LPSCHEDULE 13G, 1 filing Aug 14, 202670
- Squadron Capital Management LLCSCHEDULE 13G/A, 5 filings Sep 19, 2025 to Aug 14, 202671
- Adage Capital Management, L.P.SCHEDULE 13G/A, 4 filings May 12, 2025 to Aug 12, 202672
- PERCEPTIVE ADVISORS LLCSCHEDULE 13G/A, 4 filings Jan 8, 2025 to May 15, 202673
- ORBIMED ADVISORS LLCSCHEDULE 13D/A, 4 filings Sep 23, 2024 to May 5, 202674
- Ayrton Capital LLCSCHEDULE 13G/A, 2 filings Feb 13, 2025 to Feb 11, 202675
- Jorey ChernettSCHEDULE 13G, 1 filing Jan 16, 202676
- Alyeska Investment Group, L.P.SCHEDULE 13G, 1 filing Feb 14, 202577
- Viriom, Inc.SC 13D, 1 filing Apr 8, 202478
- CVI Investments, Inc.SC 13G/A, 2 filings Oct 1, 2021 to Feb 14, 202279
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.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Iain Dukes, D. Phil. Chief Executive Officer | 67 | $539.0K | $1.4M80 |
| 2025 | Charles Pauza Chief Science Officer | $500.0K | $1.0M80 | |
| 2025 | Nikolay Savchuk, Ph.D. Chief Operating Officer | 57 | $350.0K | $734.8K80 |
| 2025 | Werner Cautreels, Ph.D. Former Chief Executive Officer | 73 | $166.6K | $353.9K80 |
| 2024 | Werner Cautreels, Ph.D. Former Chief Executive Officer | 73 | $445.8K | $647.6K80 |
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- Private raises (Form D) $14.0M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2024 | $14.0M | $14.0M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 34. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Traws Pharma, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARTraws Pharma, Inc.1
- CIK0001130598
- Employer ID (EIN)22-36272524
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address12 Penns Trail, Newtown, PA 189401
- Phone267-759-36801
- Shares outstanding15,368,277 as of Aug 12, 202612
- Public float$9.8M as of Jun 30, 20254
- AuditorKPMG LLP, Philadelphia, Pennsylvania PCAOB ID 185; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceJan 8, 20031
- Filings984 in all: 4 (324), 8-K (223), 3 (42), 10-Q (40), CORRESP (29), DEFA14A (22), 424B5 (21), UPLOAD (20)1
All 49 form types
SC 13G (19), DEF 14A (18), SC 13G/A (18), EFFECT (16), S-1/A (15), 10-K (13), 424B3 (13), SCHEDULE 13G/A (13), S-8 (11), PRE 14A (10), S-3 (9), SCHEDULE 13G (9), D (8), SC 13D/A (8), 10-K/A (7), REGDEX/A (7), 424B4 (6), ARS (6), S-1 (6), 3/A (5), REGDEX (5), SC 13D (5), 144 (3), 8-K/A (3), D/A (3), FWP (3), S-3/A (3), 4/A (2), 8-A12B (2), CERTNAS (2), CT ORDER (2), POS AM (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 25-NSE (1), 424B2 (1), DRS (1), NT 10-K (1), NT 10-Q (1), PRER14A (1), S-1MEF (1)
- Latest filingsAnnual report (10-K) Apr 15, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) May 29, 2026
Latest 8-K (8-K) Aug 14, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $.01 per share | TRAW | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Apr 15, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Traws Pharma, Inc. names in Item 1A of its 10-K filed Apr 15, 2026: 47 risks under these headings, as written.4
- Risks Related to Our Financial Position and Capital Needs
- Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new financings.
- The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025 contains an explanatory paragraph relating to our ability to continue as a going concern.
- We need to obtain additional funding to execute our business plans; if we are unable to meet our needs for additional funding in the future, we will be required to limit, scale back or cease operations.
- We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future.
- We currently have no source of product revenue and may never become profitable.
- 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 maintain our cash at financial institutions, often in balances that exceed federally insured limits.
- We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability, including the ongoing military conflicts between Russia and Ukraine and Israel and Hamas and the recent military conflict in Iran. Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resulting from any such geopolitical tensions.
- International trade disputes have resulted in tariffs and other protectionist measures that could have a material adverse effect on our business, financial condition and results of operations.
- Changes in United States and China relations, as well as relations with other countries, and/or regulations may adversely impact our business, our operating results, our ability to raise capital and the market price of our shares.
- We may be adversely affected by the effects of inflation.
The other 36 risks
- Risks Related to Our Business and Industry
- Our product development efforts may not be successful.
- Our future success is dependent primarily on the regulatory approval and commercialization of our product candidates.
- The results of preclinical testing or earlier clinical studies are not necessarily predictive of future results. Any product candidate we advance into clinical trials may not have favorable results in later-stage clinical trials or receive regulatory approval.
- Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
- Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval.
- Failure to follow the FDA’s applicable regulatory requirements may result in enforcement action.
- Changes in product candidate manufacturing or formulation may result in additional costs or delay.
- We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our product candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign locations.
- Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations, government shutdowns or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
- Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
- We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
- If we breach our license agreements or fail to negotiate new agreements pertaining to our product candidates, we could lose the ability to continue the development and potential commercialization of these product candidates.
- Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
- We may engage in future business combinations or collaborations that could disrupt our business, cause dilution to our stockholders and harm our financial condition and operating results.
- We depend on information technology and computer systems to operate our business; our business and operations would suffer in the event of any failures or interruptions of our computer system, such as a data breach or cybersecurity incident.
- Climate change, environmental, social and governance and sustainability initiatives may result in regulatory or structural industry changes that could require significant operational changes and expenditures, reduce demand for the Company’s products and adversely affect our business, financial condition, and results of operations.
- Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses.
- Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.
- The widespread outbreak of a communicable disease, such as the recent COVID-19 pandemic, could adversely impact our business, including our clinical trials, drug manufacturing and nonclinical activities.
- Risks Related to Our Dependence on Third Parties
- We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates.
- If we lose our relationships with CROs, our drug development efforts could be delayed.
- We have limited experience manufacturing our product candidates on a large clinical or commercial scale and have no manufacturing facility. We are dependent on third-party manufacturers for the manufacture of our product candidates for clinical trials as well as on third parties for our supply chain, and if we experience problems with any third parties, the manufacturing of our product candidates or products could be delayed.
- We have entered into certain related party transactions and may continue to rely on related parties for certain development and support activities.
- Risks Related to Our Intellectual Property
- We could be required to incur significant expenses to perfect our intellectual property rights, and our intellectual property rights may be inadequate to protect our competitive position. If we are unable to protect our intellectual property rights, our competitive position could be harmed.
- We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.
- Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business.
- We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
- Risks Related to Ownership of Our Securities
- We may be required to raise additional financing by issuing new securities with terms or rights superior to those of our existing securityholders, which could adversely affect the market price of shares of common stock and our business.
- If we are unable to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock could be delisted, which could affect our common stock's market price and liquidity and reduce our ability to raise capital.
- We are obligated to develop and maintain proper and effective internal control over financial reporting. We have in the past identified, and in the future may identify, material weaknesses in our internal control over financial reporting. If we fail to develop and maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired.
- Future issuances of stock or other securities could dilute the holdings of stockholders and could materially affect the price of the shares of our common stock.
- Our share price and the liquidity of our stock may be volatile and result in substantial losses to our stockholders.
- We may be subject to securities litigation, which is expensive and could divert management attention.
- We do not anticipate paying any cash dividends on our capital stock in the foreseeable future. Accordingly, stockholders must rely on capital appreciation, if any, for any return on their investment.
- 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 be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management.
Legal proceedings
For a description of our material pending legal proceedings, please see Note 6, Commitments and Contingencies, to our consolidated financial statements included in Part IV in this Annual Report. We may, in the ordinary course of business, face various claims brought by third parties, and we may, from time to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating to employment matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation. If this were to happen, the payment of any such awards could have a material adverse effect on our business, financial condition and results of operations. Additionally, any such claims, whether or not successful, could damage our reputation and business.
The opening of Item 3, Legal Proceedings.4
Sources
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- 18SEC EDGARIain D. Dukes, Chair
- 19SEC EDGARSteven M. Fruchtman, President
- 20SEC EDGARThomas J. McKearn, President
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- 24SEC EDGARAjay Bansal, Chief financial officer
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- 37SEC EDGARJohn Harold Leaman, Board member
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- 39SEC EDGARPeter Atadja, Board member
- 40SEC EDGARTrafford Clarke, Board member
- 41SEC EDGARMary Teresa Shoemaker, Board member
- 42SEC EDGARJack E. Stover, Board member
- 43SEC EDGARJames J. Marino, Board member
- 44SEC EDGARAnne Vanlent, Board member
- 45SEC EDGARJerome Groopman, Board member
- 46SEC EDGARMichael B. Hoffman, Board member
- 47SEC EDGARViren Mehta, Board member
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- 50SEC EDGARListing notice or transfer
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- 53SEC EDGARRegulation FD disclosure
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