Overview
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- TickerGTBP on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersSan Francisco, California1
- Incorporated inDE2
- Business address505 Montgomery Street, 10Th Floor, San Francisco, Ca 941112
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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2 weeks on and two weeks off (to prevent NK cell exhaustion) for at least 2 cycles of therapy, as agreed on with the FDA.3 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years (annual) or 2 quarters (quarterly), latest first.8
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $3.5M | $5.8M |
| Selling, general and administrative (including $432,000 and $230,000 of stock compensation during the years ended December 31, 2025 and 2024, respectively) | $8.9M | $8.6M |
| Loss from Operations | -$12.4M | -$14.4M |
| Interest income | $123.0K | $402.0K |
| Interest expense | -$127.0K | |
| Loss on initial recognition of Greenshoe Rights liability | -$28.7M | |
| Change in fair value of Greenshoe Rights liability | $11.4M | |
| Change in fair value of warrant liability | $241.0K | $800.0K |
| Gain on settlement of vendor payable | $998.0K | |
| Other | $156.0K | |
| Total Other Income (Expense), Net | -$15.9M | $1.2M |
| Net Loss | -$28.4M | -$13.2M |
| Dividend on Series L Preferred Stock | -$320.0K | |
| Deemed dividend | -$5.8M | |
| Net Loss attributable to common stockholders | -$34.4M | -$13.2M |
| Net Loss Per Share - Basic | -$6.68 | -$6.94 |
| Net Loss Per Share - Diluted | -$6.68 | -$6.94 |
| Weighted average common shares outstanding - basic | 5.5M shares | 1.9M shares |
| Weighted average common shares outstanding - diluted | 5.5M shares | 1.9M shares |
| Period ending | 2025-09-30 | 2025-06-30 |
|---|---|---|
| Loss from Operations | -$3.4M | -$1.5M |
| Loss on initial recognition of Greenshoe Rights liability | -$28.7M | |
| Change in fair value of Greenshoe Rights liability | -$11.4M | |
| Total Other Income (Expense), Net | $11.7M | -$28.7M |
| Net Loss | $8.3M | -$30.2M |
| Dividend on Series L Preferred Stock | -$144.0K | -$85.0K |
| Deemed dividend | -$4.1M | |
| Net Loss attributable to common stockholders | $4.1M | -$30.3M |
| Net Loss Per Share - Basic | $1.04 | -$10.92 |
| Net Loss Per Share - Diluted | $1.04 | -$10.92 |
| Weighted average common shares outstanding - basic | 3.9M shares | 2.8M shares |
| Weighted average common shares outstanding - diluted | 3.9M shares | 2.8M shares |
Every line of the balance sheet as filed: the last 5 fiscal years (annual) or 6 quarters (quarterly), latest first.8
| Period ending | 2025-12-31 | 2025-11-30 | 2025-09-30 | 2025-06-30 | 2024-12-31 |
|---|---|---|---|---|---|
| Cash and cash equivalents | $6.8M | $4.0M | |||
| Restricted cash | $94.0K | $93.0K | |||
| Deferred offering costs | $634.0K | ||||
| Prepaid expenses and other current assets | $567.0K | $188.0K | |||
| Total Current Assets | $8.1M | $4.2M | |||
| TOTAL ASSETS | $8.1M | $4.3M | $7.1M | $4.2M | |
| Accounts payable | $748.0K | $3.9M | |||
| Accrued expenses | $1.6M | $1.8M | |||
| Warrant liability | $11.0K | $252.0K | |||
| Total Current Liabilities | $2.3M | $5.9M | |||
| Preferred stock value | $1.0K | $1.0K | |||
| Common stock, par value $0.001, 250,000,000 shares authorized, 25,534,173 and 2,234,328 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $26.0K | $3.0K | $3.0K | $2.0K | |
| Additional paid in capital | $729.7M | $721.1M | $700.4M | $693.6M | |
| Accumulated deficit | -$723.9M | -$718.1M | -$726.3M | -$695.2M | |
| Total Stockholders Equity (Deficit) | $5.8M | $3.0M | -$25.9M | -$1.7M | |
| TOTAL LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) | $8.1M | $4.3M | $7.1M | $4.2M | |
| Preferred stock, par value | $0.01 | $0.01 | |||
| Preferred stock, shares authorized | 15.0M shares | 15.0M shares | |||
| Common stock, par value | $0.00 | $0.00 | $0.00 | ||
| Common stock, shares authorized | 250.0M shares | 250.0M shares | |||
| Common stock, shares issued | 25.5M shares | 2.2M shares | |||
| Common stock, shares outstanding | 25.5M shares | 2.2M shares |
| Period ending | 2025-12-31 | 2025-11-30 | 2025-09-30 | 2025-06-30 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|---|---|
| Cash and cash equivalents | $6.8M | $4.0M | ||||
| Restricted cash | $94.0K | $93.0K | ||||
| Deferred offering costs | $634.0K | |||||
| Prepaid expenses and other current assets | $567.0K | $188.0K | ||||
| Total Current Assets | $8.1M | $4.2M | ||||
| TOTAL ASSETS | $8.1M | $4.3M | $7.1M | $4.2M | ||
| Accounts payable | $748.0K | $3.9M | ||||
| Accrued expenses | $1.6M | $1.8M | ||||
| Warrant liability | $11.0K | $252.0K | ||||
| Total Current Liabilities | $2.3M | $5.9M | ||||
| Preferred stock value | $1.0K | $1.0K | ||||
| Common stock, par value $0.001, 250,000,000 shares authorized, 25,534,173 and 2,234,328 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $26.0K | $3.0K | $3.0K | $2.0K | ||
| Additional paid in capital | $729.7M | $721.1M | $700.4M | $693.6M | ||
| Accumulated deficit | -$723.9M | -$718.1M | -$726.3M | -$695.2M | ||
| Total Stockholders Equity (Deficit) | $5.8M | $3.0M | -$25.9M | -$1.7M | $7.5M | |
| TOTAL LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) | $8.1M | $4.3M | $7.1M | $4.2M | ||
| Preferred stock, par value | $0.01 | $0.01 | ||||
| Preferred stock, shares authorized | 15.0M shares | 15.0M shares | ||||
| Common stock, par value | $0.00 | $0.00 | $0.00 | |||
| Common stock, shares authorized | 250.0M shares | 250.0M shares | ||||
| Common stock, shares issued | 25.5M shares | 2.2M shares | ||||
| Common stock, shares outstanding | 25.5M shares | 2.2M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.8
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$28.4M | -$13.2M |
| Stock based compensation | $432.0K | $230.0K |
| Loss on initial recognition of Greenshoe Rights liability | $28.7M | |
| Change in fair value of Greenshoe Rights liability | -$11.4M | |
| Change in fair value of warrant liability | -$241.0K | -$800.0K |
| Gain on settlement of debt | -$998.0K | |
| Issuance of warrants for VRT waiver | $44.0K | |
| Gain on extinguishment of debt | -$200.0K | |
| (Increase) Decrease in prepaid expenses and deferred offering costs | $377.0K | -$104.0K |
| Decrease in operating lease right-of-use assets | $53.0K | |
| Increase (Decrease) in accounts payable and accrued expenses | -$1.3M | $937.0K |
| (Decrease) in operating lease liability | -$58.0K | |
| Net Cash Used in Operating Activities | -$12.9M | -$12.9M |
| Sale of short-term investments | $12.9M | |
| Net Cash Provided by Investing Activities | $12.9M | |
| Exercise of warrants and issuance of inducement warrants for cash, net | $5.5M | |
| Proceeds from issuance of common stock and warrants, net | $3.0M | |
| Proceeds from issuance of Series L Preferred Stock and warrants, net | $10.5M | |
| Payment of dividend on Series L Preferred Stock | -$229.0K | |
| Net Cash Provided by Financing Activities | $15.8M | $3.0M |
| Net Increase in Cash and Cash Equivalents and Restricted Cash | $2.9M | $3.0M |
| Fair value of prefunded warrants issued for Committed Equity Facility fee | $672.0K | |
| Fair value of common stock and warrants issued for services | $718.0K | |
| Fair value of prefunded warrant and common stock to settle vendor payable | $847.0K | $810.0K |
| Fair value of common stock issued for dividends | $91.0K |
No quarter-by-quarter statement was filed.
Corporate structure
GT Biopharma, 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 GT Biopharma, Inc.
- RainForest Partners, LLC Filed SCHEDULE 13G on GT Biopharma, Inc., latest Sep 15, 2026
- BRISTOL INVESTMENT FUND LTD Filed SCHEDULE 13G/A on GT Biopharma, Inc., latest Jun 2, 2025 (3 filings since Mar 3, 2022)
- Five Narrow Lane LP Filed SCHEDULE 13G on GT Biopharma, Inc., latest May 14, 2025
- CYTOVANCE BIOLOGICS INC Filed SCHEDULE 13G/A on GT Biopharma, Inc., latest Oct 17, 2024 (2 filings since Sep 19, 2023)
- ARMISTICE CAPITAL, LLC Filed SC 13G/A on GT Biopharma, Inc., latest Feb 14, 2024 (2 filings since Feb 14, 2023)
- BIGGER CAPITAL FUND L P Filed SC 13G/A on GT Biopharma, Inc., latest Jan 28, 2022
- ALPHA CAPITAL ANSTALT Filed SC 13G/A on GT Biopharma, Inc., latest Jan 18, 2022
- GT Biopharma, Inc. San Francisco, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What GT Biopharma, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Investments
Properties, in its own words
Effective as of July 1, 2024, the Company became a fully remote company. We operate in a virtual environment and do not have a physical office space or headquarters.
Item 2 of the 10-K filed Mar 2, 2026.3
Leadership
Who has led GT Biopharma, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerMichael Martin Breen Jul 19, 2022 to now11
- Chief executive officerRaymond W. Urbanski Mar 19, 2019 to Mar 19, 201912
- Chief executive officerShawn Cross Mar 16, 2018 to Mar 16, 201813
- Chief executive officerKathleen Clarence-Smith Dec 1, 2017 to Dec 1, 201714
- Chief executive officerDavid Saloff Sep 1, 2011 to May 30, 201215
- Chief executive officerMarvin S. Hausman Md. Oct 16, 2006 to Feb 8, 200816
- ChairMichael Martin Breen Jul 19, 2022 to Aug 15, 202311
- ChairDavid Saloff May 30, 2012 to May 30, 201217
- PresidentBernard Landes Mar 22, 2010 to Mar 22, 201018
- PresidentMarvin S. Hausman Md. Oct 16, 2006 to Feb 8, 200816
- Chief financial officerAlan Louis Urban Jun 13, 2024 to now19
- Chief financial officerGavin Choy Feb 14, 2022 to Feb 14, 202220
- Chief financial officerManu Ohri Feb 18, 2022 to Aug 15, 202321
- Chief financial officerSteven W. Weldon Feb 12, 2016 to May 14, 202022
- Chief financial officerMichael D. Handelman Mar 22, 2010 to Mar 22, 201023
- Chief financial officerMichael D. Centron Jan 10, 2006 to Aug 2, 200624
- Chief operating officerGary M. Post Nov 13, 2007 to Nov 13, 200725
Board members and other officers (26)
- Pres. of R&D, CMOGregory Berk Jul 19, 2022 to Jul 19, 202226
- Chief Medical OfficerRaymond W. Urbanski Dec 1, 2017 to Dec 1, 201727
- SecretaryGary M. Post Jul 12, 2010 to Jul 12, 201028
- SecretarySydney Colin Neill Nov 8, 2006 to Nov 8, 200629
- Board memberAndrew J. Ritter May 29, 2025 to now30
- Board memberHilary Kramer Jun 3, 2025 to now31
- Board memberDavid C. Mun-Gavin Jul 30, 2025 to now32
- Board memberCharles J. Casamento May 4, 2023 to now33
- Board memberGregory Berk Feb 14, 2022 to Feb 14, 202234
- Board memberRajesh C. Shrotriya Md. Feb 14, 2022 to Feb 1, 202335
- Board memberAlan Louis Urban Jun 14, 2022 to Jul 19, 202236
- Board memberBruce Wendel Oct 7, 2021 to Feb 1, 202337
- Board memberMichael Martin Breen Nov 12, 2021 to now38
- Board memberRaymond W. Urbanski Mar 19, 2019 to Mar 19, 201912
- Board memberShawn Cross Mar 16, 2018 to Mar 16, 201813
- Board memberKathleen Clarence-Smith Dec 1, 2017 to Dec 1, 201714
- Board memberSteven W. Weldon Feb 12, 2016 to May 14, 202022
- Board memberThomas W. Hoog Feb 8, 2011 to Feb 8, 201139
- Board memberKenneth Haynes Eaton Jul 7, 2011 to Jul 7, 201140
- Board memberDavid Saloff Jul 11, 2011 to Sep 1, 201141
- Board memberAnshuman Dube Mar 25, 2010 to May 24, 201142
- Board memberMatthew R. Spolar Jan 19, 2007 to Nov 13, 200743
- Board memberGary M. Post Mar 23, 2006 to Jul 12, 201044
- Board memberJohn E. Repine Aug 2, 2006 to Nov 13, 200745
- Board memberMarvin S. Hausman Md. Aug 2, 2006 to Feb 8, 200846
- Board memberSydney Colin Neill Aug 2, 2006 to Nov 13, 200747
Former names
- OXIS INTERNATIONAL INCJun 8, 1995 to Jul 25, 20172
Timeline
- Sep 25, 20268-K Other events48
- Sep 21, 20268-K Entered a material agreement; Unregistered sale of shares; Change to shareholders' rights49
- Sep 15, 20268-K Entered a material agreement; Unregistered sale of shares; Change to shareholders' rights50
- Sep 3, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events51
- Aug 14, 20268-K Shareholder vote52
- Jun 12, 20268-K Bylaws or fiscal year changed53
- May 22, 20268-K Listing notice or transfer54
- Apr 7, 20268-K Entered a material agreement55
- Mar 2, 20268-K Earlier financial statements no longer reliable56
- Nov 26, 20258-K Listing notice or transfer57
- Nov 14, 20258-K Results of operations58
- Sep 26, 20258-K Change to shareholders' rights59
- Jul 19, 2022New chief executive Michael Martin Breen becomes CEO11
- Mar 19, 2019New chief executive Raymond W. Urbanski becomes CEO12
- Mar 16, 2018New chief executive Shawn Cross becomes CEO13
- Dec 1, 2017New chief executive Kathleen Clarence-Smith becomes CEO14
- Sep 1, 2011New chief executive David Saloff becomes CEO15
- Oct 16, 2006New chief executive Marvin S. Hausman Md. becomes CEO16
Calendar
Coming up
- Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($20.75) a share, on Nov 14, 2025.60
When it reported results
- Nov 14, 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
200 filings to the SEC since October 2021: 6 annual reports, 18 quarterly reports, 53 major events, 38 insider forms, 11 large holders, 4 private raises, 70 other. The latest 20:
- Oct 13, 2026DEF 14A EDGAR
- Oct 9, 2026S-1 EDGAR
- Oct 2, 2026PRE 14A EDGAR
- Sep 29, 2026D EDGAR
- Sep 25, 20268-K EDGAR
- Sep 21, 20268-K EDGAR
- Sep 15, 20268-K EDGAR
- Sep 15, 2026SCHEDULE 13G EDGAR
- Sep 3, 20268-K EDGAR
- Aug 14, 20268-K EDGAR
- Aug 14, 202610-Q EDGAR
- Jul 2, 2026DEF 14A EDGAR
- Jun 18, 2026PRE 14A EDGAR
- Jun 12, 20268-K EDGAR
- May 22, 20268-K EDGAR
- May 15, 202610-Q EDGAR
- May 13, 2026EFFECT EDGAR
- May 13, 2026424B3 EDGAR
- May 11, 2026CORRESP EDGAR
- May 6, 2026UPLOAD EDGAR
The 200 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
2 open-market trades by officers, directors and large owners since October 2021: 2 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Apr 11, 2023 | Breen Michael MartinCEO and Director | Buy | 50,000 | $0.50 | $25.0K | Form 4 |
| Apr 6, 2023 | Ohri ManuCFO & Secretary | Buy | 50,000 | $0.50 | $25.0K | 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.
- RainForest Partners, LLCSCHEDULE 13G, 1 filing Sep 15, 202661
- BRISTOL INVESTMENT FUND LTDSCHEDULE 13G/A, 3 filings Mar 3, 2022 to Jun 2, 202562
- Five Narrow Lane LPSCHEDULE 13G, 1 filing May 14, 202563
- CYTOVANCE BIOLOGICS INCSCHEDULE 13G/A, 2 filings Sep 19, 2023 to Oct 17, 202464
- ARMISTICE CAPITAL, LLCSC 13G/A, 2 filings Feb 14, 2023 to Feb 14, 202465
- BIGGER CAPITAL FUND L PSC 13G/A, 1 filing Jan 28, 202266
- ALPHA CAPITAL ANSTALTSC 13G/A, 1 filing Jan 18, 202267
Money raised
Private offerings the company reported to the SEC on Form D.
- Sep 14, 2026Raised $7.8 million in a private offering of equity Form D: $39 million offered in all Form D
- May 14, 2025Filed a private offering of equity Form D: $20 million offered in all Form D
- May 12, 2025Raised $6 million in a private offering of equity Form D: 9 investors so far Form D
- Feb 25, 2025Raised $1.3 million in a private offering of equity Form D: 6 investors so far Form D
SEC filer profile
How GT Biopharma, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARGT Biopharma, Inc.1
- CIK0000109657
- Employer ID (EIN)94-16204073
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address505 Montgomery Street, 10Th Floor, San Francisco, CA 941111
- Phone(800) 304-98881
- Shares outstanding45,109,497 as of Aug 10, 20267
- Public float$8.6M as of Jun 30, 20253
- AuditorWeinberg & Company, P.A, Los Angeles, California PCAOB ID 572; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceMay 12, 19951
- Filings881 in all: 8-K (223), 4 (102), 10-Q (75), 424B3 (48), 3 (43), SC 13G/A (31), UPLOAD (27), CORRESP (26)1
All 57 form types
10-K (23), DEF 14A (21), 10QSB (20), EFFECT (19), S-1/A (15), S-1 (13), SC 13G (13), 4/A (12), D (11), NT 10-Q (11), PRE 14A (10), S-3 (10), S-3/A (10), 10-Q/A (9), DEFA14A (8), S-8 (8), 10KSB (7), 8-K/A (7), 10-K/A (6), NT 10-K (6), SB-2/A (6), DEF 14C (4), POS AM (4), PRE 14C (4), REGDEX (4), SC 13D (4), SC 13D/A (4), PRER14A (3), PRER14C (3), 10-C (2), 10KSB/A (2), 10QSB/A (2), 3/A (2), 424B5 (2), ARS (2), DEFR14A (2), RW (2), SB-2 (2), SCHEDULE 13G (2), SCHEDULE 13G/A (2), 10-K405 (1), 424B4 (1), 5 (1), 8-A12B (1), CERT (1), D/A (1), NT 10-K/A (1), S-1MEF (1), SC 14F1 (1)
- Latest filingsAnnual report (10-K) Mar 2, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Oct 13, 2026
Latest 8-K (8-K) Sep 25, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.001 Par Value | GTBP | Nasdaq |
From the cover page of the 10-K filed Mar 2, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks GT Biopharma, Inc. names in Item 1A of its 10-K filed Mar 2, 2026: 61 risks under these headings, as written.3
- Risks Related to Our Financial Condition and Capital Requirements
- Our financial condition raises substantial doubt as to our ability to continue as a going concern.
- Our business is at an early stage of development and we may not develop therapeutic products that can be commercialized.
- We have a history of operating losses and we expect to continue to incur losses for the foreseeable future and we may never generate revenue or achieve profitability.
- We will need additional capital to conduct our operations and develop our products, and our ability to obtain the necessary funding is uncertain.
- Our research and development costs could exceed our projections requiring us to significantly modify our planned operations.
- Risks Related to Clinical Development and Potential Regulatory Approval
- We have limited clinical testing and regulatory capabilities, and human clinical trials are subject to extensive regulatory requirements, which are very expensive, time-consuming and difficult to design and implement. Our products may fail to achieve necessary safety and efficacy endpoints during clinical trials, which may limit our ability to generate revenues from therapeutic products.
- Clinical drug development is costly, time-consuming and uncertain, and we may suffer setbacks in our clinical development program that could harm our business.
- It may take longer to complete our clinical trials than we project, or we may not be able to complete them at all.
- If we experience delays or difficulties in the enrollment of patients in clinical trials, those clinical trials could take longer than expected to complete and our receipt of necessary regulatory approvals could be delayed or prevented.
- We are subject to extensive regulation, which can be costly and time consuming and can subject us to unanticipated delays. Even if we obtain regulatory approval for some of our products, those products may still face regulatory difficulties.
The other 51 risks
- Obtaining regulatory approval even after clinical trials that are believed to be successful is an uncertain process.
- We will continue to be subject to extensive FDA regulation following any product approvals, and if we fail to comply with these regulations, we may suffer a significant setback in our business.
- Risks Related to Our Intellectual Property
- Our intellectual property may be compromised.
- If our efforts to protect the proprietary nature of the intellectual property related to our future product candidates and proprietary technologies are not adequate, we may not be able to compete effectively in our market and our business would be harmed.
- Claims that we infringe the intellectual property rights of others may prevent or delay our drug discovery and development efforts.
- We may desire, or be forced, to seek additional licenses to use intellectual property owned by third parties, and such licenses may not be available on commercially reasonable terms or at all.
- The patent protection covering some of our product candidates may be dependent on third parties, who may not effectively maintain that protection.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
- If we are unsuccessful in obtaining or maintaining patent protection for intellectual property in development, our business and competitive position would be harmed.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- If we fail to meet our obligations under our license agreements, we may lose our rights to key technologies on which our business depends.
- Risks Related to Our Business Operations and Industry
- If we lose key personnel, or if we cannot recruit qualified additional employees to carry on our business operations, we may not be able to implement our business strategy.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause our business to suffer.
- Our reliance on the activities of our non-employee consultants, research institutions and scientific contractors, whose activities are not wholly within our control, may lead to delays in development of our proposed products.
- Many of our business practices are subject to scrutiny and potential investigation by regulatory and government enforcement authorities, as well as to lawsuits brought by private citizens under federal and state laws. We could become subject to investigations, and our failure to comply with applicable law or an adverse decision in lawsuits may result in adverse consequences to us. If we fail to comply with U.S. healthcare laws, we could face substantial penalties and financial exposure, and our business, operations and financial condition could be adversely affected.
- Laws impacting the U.S. healthcare system are subject to a great deal of uncertainty, which may result in adverse consequences to our business.
- We may not be successful in our efforts to build a pipeline of product candidates.
- 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 marketing approval, if any.
- We may expend our limited resources to pursue a particular product candidate or indication that does not produce any commercially viable products and may fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- Our products may be expensive to manufacture, and they may not be profitable if we are unable to control the costs to manufacture them.
- The interruption of the flow of raw materials could disrupt the supply chain and our ability to manufacture our products.
- We currently lack manufacturing capabilities to produce our therapeutic product candidates at commercial-scale quantities and do not have an alternate manufacturing supply, which could negatively impact our ability to meet any future demand for the product.
- To be successful, our proposed products must be accepted by the healthcare community, which can be very slow to adopt or unreceptive to new technologies and products.
- Our business is based on novel technologies that are inherently expensive and risky and may not be understood by or accepted in the marketplace, which could adversely affect our future value.
- Our competition includes fully integrated biotechnology and pharmaceutical companies that have significant advantages over us.
- If competitors develop and market products that are more effective, safer or less expensive than our product candidates or offer other advantages, our commercial prospects will be limited.
- If we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably.
- We may not be able to obtain third-party patient reimbursement or favorable product pricing, which would reduce our ability to operate profitably.
- We may be subject to litigation that will be costly to defend or pursue and uncertain in its outcome.
- We are exposed to the risk of liability claims, for which we may not have adequate insurance.
- We could be subject to product liability lawsuits based on the use of our product candidates in clinical testing or, if obtained, following marketing approval and commercialization. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to cease clinical testing or limit commercialization of our product candidates.
- We rely on third parties to conduct preclinical and clinical trials of our product candidates. 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 and our business could be substantially harmed.
- We contract with third parties for the supply of product candidates for clinical testing and expect to contract with third parties for the manufacturing of our product candidates for large-scale testing and commercial supply. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- We currently have no marketing and sales force. If we are unable to establish effective marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to effectively market and sell our product candidates, if approved, or generate product revenues.
- Our business and operations would suffer in the event of system failures.
- We face risks associated with security breaches or cyber-attacks.
- Our operations are vulnerable to interruption by natural disasters, power loss, terrorist activity and other events beyond our control, the occurrence of which could materially harm our business.
- Epidemic or pandemic outbreaks such as COVID-19 (coronavirus), natural disasters, whether or not caused by climate change, unusual weather conditions, terrorist acts and political events, could disrupt business and result in halting our clinical trials and otherwise adversely affect our financial performance.
- Risks Related to Our Common Stock
- Our common stock may be at risk for delisting from Nasdaq in the future if we do not regain or maintain compliance with Nasdaq’s continued listing requirements. Delisting could adversely affect the liquidity of our common stock and the market price of our common stock could decrease.
- We may issue additional shares of common stock or preferred stock, which would dilute the interest of our stockholders and could cause the price of our common stock to decline.
- There has been a limited public market for our common stock, and we do not know whether one will develop to provide adequate liquidity. Furthermore, the trading price for our common stock, should an active trading market develop, may be volatile and could be subject to wide fluctuations in per-share price.
- Our outstanding warrants and options may affect the market price of our common stock.
- Because our common stock may be deemed a low-priced “penny” stock, an investment in our common stock should be considered high-risk and subject to marketability restrictions.
- Financial Industry Regulatory Authority (“FINRA”) sales practice requirements may also limit a stockholder’s ability to buy and sell our common stock, which could depress the price of our common stock.
- 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.
- We are subject to state and federal securities laws, the terms of the Charter, Amended and Restated Bylaws (the “Bylaws”) and the terms of complex contracts; a failure to comply with current and future laws, regulations or standards, or the terms of our Charter, Bylaws or contractual arrangements, could have an adverse effect on our business.
- Anti-takeover provisions may limit the ability of another party to acquire us, which could cause our stock price to decline.
- We do not currently or for the foreseeable future intend to pay dividends on our common stock.
- We are subject to ongoing regulatory burdens resulting from our public listing.
- If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
Legal proceedings
Ohri Matter
On July 22, 2024, the Company filed an AAA Arbitration Demand against Manu Ohri, its former Chief Financial Officer. In the demand, the Company asserts claims against Mr. Ohri for breach of his fiduciary duties and breach of contract and seeks a declaratory judgment providing that the Company may characterize Mr. Ohri’s termination as “for cause” under his employment agreement, and that the Company may revoke the separation agreement entered into between the Company and Mr. Ohri prior to the Company learning of Mr. Ohri’s breaches. In addition to the declaratory judgment, the Company seeks damages arising from Mr. Ohri’s violations, and attorneys’ fees and any forum and arbitration fees. On September 3, 2024, Mr. Ohri filed both a general denial of the Company’s claims against him and counterclaims for breach of his employment agreement and separation agreement. The final hearing date, originally scheduled for June 10, 2025, has been postponed indefinitely in order to allow the parties to mediate the dispute. Mediation is scheduled for March 31, 2026. Should mediation be unsuccessful, the case will proceed to a final hearing in October 2026. At this stage in the proceedings the Company is not able to determine the probability of the outcome of this matter or a range of reasonably expected losses, if any. The Company believes it has recorded an appropriate accrual for the matter.
TWF Global Matter
The opening of Item 3, Legal Proceedings.3
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 13SEC EDGARShawn Cross, Chief executive officer
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- 17SEC EDGARDavid Saloff, Chair
- 18SEC EDGARBernard Landes, President
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- 20SEC EDGARGavin Choy, Chief financial officer
- 21SEC EDGARManu Ohri, Chief financial officer
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- 26SEC EDGARGregory Berk, Pres. of R&D, CMO
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- 28SEC EDGARGary M. Post, Secretary
- 29SEC EDGARSydney Colin Neill, Secretary
- 30SEC EDGARAndrew J. Ritter, Board member
- 31SEC EDGARHilary Kramer, Board member
- 32SEC EDGARDavid C. Mun-Gavin, Board member
- 33SEC EDGARCharles J. Casamento, Board member
- 34SEC EDGARGregory Berk, Board member
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- 36SEC EDGARAlan Louis Urban, Board member
- 37SEC EDGARBruce Wendel, Board member
- 38SEC EDGARMichael Martin Breen, Board member
- 39SEC EDGARThomas W. Hoog, Board member
- 40SEC EDGARKenneth Haynes Eaton, Board member
- 41SEC EDGARDavid Saloff, Board member
- 42SEC EDGARAnshuman Dube, Board member
- 43SEC EDGARMatthew R. Spolar, Board member
- 44SEC EDGARGary M. Post, Board member
- 45SEC EDGARJohn E. Repine, Board member
- 46SEC EDGARMarvin S. Hausman Md., Board member
- 47SEC EDGARSydney Colin Neill, Board member
- 48SEC EDGAROther events
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- 52SEC EDGARShareholder vote
- 53SEC EDGARBylaws or fiscal year changed
- 54SEC EDGARListing notice or transfer
- 55SEC EDGAREntered a material agreement
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- 57SEC EDGARListing notice or transfer
- 58SEC EDGARResults of operations
- 59SEC EDGARChange to shareholders' rights
- 60NasdaqNasdaq calendar
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