Overview
- TickerPTIX on OTC2
- IndustryPharmaceutical Preparations2
- HeadquartersWilmington, United States2
- Incorporated inDE4
- Business address149 Fifth Avenue, Suite 500, New York, Ny 100104
- Filer categoryNon-accelerated filer, Smaller reporting company4
- Legal formCorporation2
- LEI549300KPBYAVJLPDKB702
- 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, 23755312
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Annual Report on Form 10-K. The below summary is qualified in its entirety by that more complete discussion of such risks and uncertainties.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 2026
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.3
| Period ending | 2026-03-31 | 2025-03-31 |
|---|---|---|
| Accounting and audit fees | $272.6K | $132.6K |
| Research and Development | $901.9K | $376.7K |
| Legal Fees | $874.4K | $183.1K |
| Consulting Fees | $939.2K | $667.6K |
| Salaries and wages | $764.6K | $132.8K |
| Bad debt expense | $1.0M | |
| General and administrative - other | $332.4K | $77.5K |
| Stock compensation | $418.6K | |
| TOTAL OPERATING EXPENSES | $4.5M | $2.6M |
| LOSS FROM OPERATIONS | -$4.5M | -$2.6M |
| Interest expenses | -$1.5M | -$1.0M |
| Derivative expense | -$343.4K | |
| Change in fair value of derivative liabilities | $1.5M | |
| Foreign currency exchange differences | $9.3K | $41.1K |
| Gain/loss on disposal of subsidiary | $7.3M | |
| Gain/loss on extinguishment of debt | -$1.1M | |
| TOTAL OTHER INCOME (EXPENSE) | $5.9M | -$998.3K |
| INCOME (LOSS) BEFORE INCOME TAXES | $1.4M | -$3.6M |
| Basic | $0.59 | -$0.67 |
| Diluted | $0.59 | -$0.67 |
| Basic | 2.3M shares | 5.4M shares |
| Diluted | 2.3M shares | 5.4M shares |
| Net income (loss) | $1.4M | -$3.6M |
| Unrealized foreign currency translation loss | -$202.1K | -$27.5K |
| Shares issued in connection with Phytanix Bio purchase | -$130.0K | |
| Comprehensive income (loss) | $1.0M | -$3.6M |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.3
| Period ending | 2026-03-31 | 2025-03-31 | 2024-03-31 |
|---|---|---|---|
| Cash in bank | $1.5M | $14.5K | |
| Prepaid expenses | $33.4K | ||
| VAT receivable | $73.5K | ||
| Inventories | $1.0K | ||
| Total current assets | $1.5M | $89.1K | |
| Fixed assets, net | $14.6K | ||
| Intangible assets, net | $2.1M | ||
| Total long-term assets | $2.1M | ||
| Total Assets | $3.7M | $89.1K | |
| Notes payable, net | $1.7M | ||
| Accounts payable | $949.5K | $961.1K | |
| Accrued liabilities | $82.0K | $249.1K | |
| Derivative liabilities | $1.4M | ||
| Loans payable, related parties | $779.2K | ||
| Total current liabilities | $1.0M | $5.0M | |
| Total liabilities | $1.0M | $5.0M | |
| Common stock, $0.0001 par value, respectively; 100,000,000 authorized; 1,810,208 and 5,800,000 shares issued outstanding | $182 | ||
| Additional paid in capital | $7.0M | $455.7K | |
| Accumulated deficit | -$4.0M | -$5.4M | |
| Foreign currency translation adjustment | -$343.1K | -$11.0K | |
| Total stockholders equity (deficit) | $2.6M | -$5.0M | -$1.8M |
| Total liabilities and stockholders equity (deficit) | $3.7M | $89.1K | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 2.0M shares | 2.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 1.8M shares | 5.8M shares | |
| Common stock, shares outstanding | 1.8M shares | 5.8M shares |
| Period ending | 2026-03-31 | 2025-03-31 | 2024-03-31 |
|---|---|---|---|
| Cash in bank | $1.5M | $14.5K | |
| Prepaid expenses | $33.4K | ||
| VAT receivable | $73.5K | ||
| Inventories | $1.0K | ||
| Total current assets | $1.5M | $89.1K | |
| Fixed assets, net | $14.6K | ||
| Intangible assets, net | $2.1M | ||
| Total long-term assets | $2.1M | ||
| Total Assets | $3.7M | $89.1K | |
| Notes payable, net | $1.7M | ||
| Accounts payable | $949.5K | $961.1K | |
| Accrued liabilities | $82.0K | $249.1K | |
| Derivative liabilities | $1.4M | ||
| Loans payable, related parties | $779.2K | ||
| Total current liabilities | $1.0M | $5.0M | |
| Total liabilities | $1.0M | $5.0M | |
| Common stock, $0.0001 par value, respectively; 100,000,000 authorized; 1,810,208 and 5,800,000 shares issued outstanding | $182 | ||
| Additional paid in capital | $7.0M | $455.7K | |
| Accumulated deficit | -$4.0M | -$5.4M | |
| Foreign currency translation adjustment | -$343.1K | -$11.0K | |
| Total stockholders equity (deficit) | $2.6M | -$5.0M | -$1.8M |
| Total liabilities and stockholders equity (deficit) | $3.7M | $89.1K | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 2.0M shares | 2.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 1.8M shares | 5.8M shares | |
| Common stock, shares outstanding | 1.8M shares | 5.8M 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.3
| Period ending | 2026-03-31 | 2025-03-31 |
|---|---|---|
| Net income (loss) | $1.4M | -$3.6M |
| Amortization of debt discount to interest expense | $1.6M | $598.8K |
| Stock based compensation | $418.6K | |
| Warrants and stock issued for services | $103.2K | |
| Bad debt expense | $773.2K | |
| Derivative expense | $343.4K | |
| Change in fair value of derivative liabilities | -$1.5M | |
| Depreciation expense | $49.2K | |
| Gain/loss on disposal of subsidiary | -$7.3M | |
| Gain/loss on extinguishment of debt | $1.1M | |
| Inventories | -$26 | -$29 |
| Prepaid expenses | $53.4K | |
| VAT receivable | $37.7K | -$40.4K |
| Accounts payable | $1.0M | $182.1K |
| Accrued liabilities | $17.4K | $206.0K |
| Net cash used in operating activities | -$2.8M | -$1.8M |
| Cash received in acquisition of Phytanix Bio | $943.2K | |
| Cash spent on unwind of Phytanix Bio acquisition | -$310.0K | |
| Purchase of fixed assets | -$3.3K | |
| Net cash provided by investing activities | $629.9K | |
| Increase in note payable for acquisition of Phytanix Bio | -$533.9K | |
| Net proceeds from notes payable | $1.6M | |
| Proceeds from sale of common stock | $395.5K | $200 |
| Proceeds from exercise of warrants | $3.9M | |
| Proceeds from related party loans | $62.3K | $187.1K |
| Net cash provided by financing activities | $3.9M | $1.8M |
| NET INCREASE IN CASH | $1.7M | $40.4K |
| Effect of exchange rate adjustments on cash | -$202.1K | -$27.5K |
| Bifurcation of warrants as derivative liabilities | $1.3M | |
| Debt extinguishment - related party parent reflected as capital contribution | $410.8K | |
| Net assets acquired of Phytanix Bio, net of cash paid | $1.4M | |
| Shares issued for warrant exercises | $3.9M |
No quarter-by-quarter statement was filed.
Compare Protagenic Therapeutics, Inc.\new with another company
Corporate structure
Protagenic Therapeutics, Inc.\new 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 Protagenic Therapeutics, Inc.\new
- BIGGER CAPITAL FUND L P Filed SCHEDULE 13G/A on Protagenic Therapeutics, Inc.\new, latest Aug 25, 2025 (2 filings since Jul 8, 2025)
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Protagenic Therapeutics, Inc.\new, latest Feb 14, 2025 (5 filings since Feb 15, 2022)
- Hudson Bay Capital Management LP Filed SC 13G/A on Protagenic Therapeutics, Inc.\new, latest Feb 4, 2022
- Protagenic Therapeutics, Inc.\new Wilmington, Delaware, 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 Protagenic Therapeutics, Inc.\new 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 |
|---|---|---|---|
| Property and equipment, before depreciation | $156.6K3 Mar 31, 2026 | ||
| Accumulated depreciation | $142.0K3 Mar 31, 2026 | $1.0K14 Jun 30, 2015 | +14102.9% |
| Property and equipment, net | $14.6K3 Mar 31, 2026 | $73.0K9 Dec 31, 2024 | −80.1% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $2.1M3 Mar 31, 2026 | ||
| Finite-lived intangibles, net | $2.1M3 Mar 31, 2026 |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $1.0K3 Mar 31, 2025 |
Properties, in its own words
The Company does not currently own any real property. The Company leases office space for its principal executive office located at 149 Fifth Avenue, Suite 500, New York, New York 10010.
Item 2 of the 10-K filed Aug 14, 2026.5
Leadership
Who has led Protagenic Therapeutics, Inc.\new, and when. Pick a name to see everywhere that person has worked.
Chief financial officer
Chief operating officer
- Chief executive officerBarrett Evans Oct 24, 2025 to now15
- Chief executive officerEdward J. Gildea Sep 12, 2014 to Sep 12, 201416
- Chief executive officerJeffrey A. Schwartz Jan 29, 2010 to Jan 29, 201017
- Chief executive officerBurton Katz Feb 22, 2007 to Jun 30, 200918
- ChairGaro H. Armen Oct 18, 2017 to now19
- PresidentRobert Ziroyan Feb 17, 2016 to Feb 17, 201620
- PresidentAndrew Stollman Feb 7, 2008 to Jun 30, 200921
- PresidentRaymond Musci Feb 22, 2007 to Feb 22, 200722
- Chief financial officerAlexander K. Arrow Feb 17, 2016 to Mar 29, 202423
- Chief financial officerDavid J. Horin Sep 12, 2014 to Sep 12, 201424
- Chief financial officerNathan Yu-Gai Fong Sep 20, 2011 to Sep 20, 201125
- Chief financial officerThomas Plotts Jan 6, 2010 to Jul 2, 201026
- Chief financial officerDaniel Harvey Feb 7, 2008 to Feb 7, 200827
- Chief financial officerAndrew Zaref Jul 29, 2008 to Jun 30, 200928
- Chief financial officerAllan Legator Feb 22, 2007 to Jan 31, 200829
- Chief financial officerRobert S. Ellin Nov 7, 2006 to Nov 7, 200630
- Chief operating officerRobert Ziroyan Feb 17, 2016 to Feb 17, 201620
- Chief operating officerSusan Swenson Aug 29, 2007 to Feb 13, 200831
- Chief operating officerRobert S. Ellin Nov 7, 2006 to Nov 7, 200630
Board members and other officers (29)
- OfficerGaro H. Armen Feb 17, 2016 to Aug 18, 201632
- Chief Marketing OfficerSharon Siegel Jun 7, 2011 to Jun 7, 201133
- Exec VP, Corporate DevelopmentRaymond Musci Dec 15, 2010 to Dec 17, 201034
- Chief Technology OfficerZachary Greenberger May 11, 2009 to Jun 30, 200935
- Chief Marketing OfficerScott Walker Feb 22, 2007 to Mar 12, 200736
- OfficerJay Wolf Nov 7, 2006 to Nov 7, 200630
- Board memberBarrett Evans Oct 24, 2025 to now15
- Board memberJennifer Buell Jul 21, 2020 to Mar 29, 202437
- Board memberBrian Corvese Oct 18, 2017 to Mar 29, 202438
- Board memberGaro H. Armen Feb 17, 2016 to Aug 18, 201632
- Board memberGregory Ekizian Feb 17, 2016 to Jun 22, 201639
- Board memberKhalil Barrage Feb 17, 2016 to Mar 29, 202440
- Board memberEdward J. Gildea Sep 12, 2014 to Sep 12, 201416
- Board memberJonathan Schechter Sep 12, 2014 to Sep 12, 201441
- Board memberStuart Goldfarb Jan 20, 2010 to Jan 20, 201042
- Board memberAndrew Stollman Feb 7, 2008 to Aug 7, 200821
- Board memberLawrence Burstein Feb 7, 2008 to Sep 30, 201043
- Board memberRobert Machinist Feb 7, 2008 to Feb 7, 200844
- Board memberJeffrey A. Schwartz Nov 20, 2008 to Jan 29, 201045
- Board memberMark Dyne Nov 21, 2008 to Sep 30, 201046
- Board memberBurton Katz Feb 22, 2007 to Jun 30, 200918
- Board memberDrew Larner Feb 22, 2007 to Mar 6, 200747
- Board memberRaymond Musci Feb 22, 2007 to Dec 17, 201022
- Board memberGil Klier Aug 15, 2007 to Sep 27, 200748
- Board memberIsaac Kier Oct 26, 2006 to Oct 26, 200649
- Board memberJerome A. Chazen Oct 27, 2006 to Sep 30, 201050
- Board memberBarry Regenstein Nov 7, 2006 to Mar 7, 200751
- Board memberJay Wolf Nov 7, 2006 to Nov 7, 200630
- Board memberRobert S. Ellin Nov 7, 2006 to Sep 30, 201030
Former names
Timeline
- Aug 20, 20268-K Regulation FD disclosure; Other events52
- Apr 7, 20268-K Executive or director change53
- Mar 3, 20268-K Executive or director change54
- Feb 24, 20268-K Entered a material agreement; Ended a material agreement; Completed an acquisition or sale55
- Jan 5, 20268-K Listing notice or transfer56
- Nov 26, 20258-K Listing notice or transfer; Regulation FD disclosure57
- Nov 5, 20258-K Executive or director change58
- Oct 31, 20258-K Other events59
- Oct 24, 2025New chief executive Barrett Evans becomes CEO15
- Sep 17, 20258-K Financial statements and exhibits60
- Aug 28, 20258-K Financial statements and exhibits61
- Aug 22, 20258-K Listing notice or transfer; Change of auditor; Regulation FD disclosure62
- Aug 13, 20258-K Exit or restructuring costs; Executive or director change; Bylaws or fiscal year changed63
- Sep 12, 2014New chief executive Edward J. Gildea becomes CEO16
- Jan 29, 2010New chief executive Jeffrey A. Schwartz becomes CEO17
- Feb 22, 2007New chief executive Burton Katz becomes CEO18
- Feb 3, 1994Founded Protagenic Therapeutics, Inc.\new is founded2
Filings
122 filings to the SEC since October 2021: 8 annual reports, 15 quarterly reports, 43 major events, 17 insider forms, 8 large holders, 31 other. The latest 20:
- Aug 24, 20264 EDGAR
- Aug 20, 20264 EDGAR
- Aug 20, 20268-K EDGAR
- Aug 20, 20264 EDGAR
- Aug 19, 202610-Q EDGAR
- Aug 14, 2026NT 10-Q EDGAR
- Aug 14, 202610-K EDGAR
- Aug 12, 20264 EDGAR
- Aug 10, 20264 EDGAR
- Aug 6, 20264 EDGAR
- Aug 3, 20264 EDGAR
- Jun 30, 2026NT 10-K EDGAR
- Apr 7, 20268-K EDGAR
- Mar 9, 202610-Q EDGAR
- Mar 3, 20268-K EDGAR
- Feb 24, 20268-K EDGAR
- Feb 18, 2026NT 10-Q EDGAR
- Jan 23, 202625-NSE EDGAR
- Jan 5, 20268-K EDGAR
- Dec 5, 2025DEF 14A EDGAR
The 122 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
10 open-market trades by officers, directors and large owners since October 2021: 10 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 21, 2026 | ARMEN GARO HEXEC. CHAIR & PRINCIPAL OFF | Buy | 20,000 | $0.65 | $13.0K | Form 4 |
| Aug 20, 2026 | ARMEN GARO HEXEC. CHAIR & PRINCIPAL OFF | Buy | 16,634 | $0.59 | $9.8K | Form 4 |
| Aug 19, 2026 | ARMEN GARO HEXEC. CHAIR & PRINCIPAL OFF | Buy | 2,700 | $0.35 | $945 | Form 4 |
| Aug 11, 2026 | ARMEN GARO HEXEC. CHAIR & PRINCIPAL OFF | Buy | 2,220 | $0.32 | $710 | Form 4 |
| Aug 6, 2026 | ARMEN GARO HEXEC. CHAIR & PRINCIPAL OFF | Buy | 685 | $0.22 | $151 | Form 4 |
| Aug 5, 2026 | ARMEN GARO HEXEC. CHAIR & PRINCIPAL OFF | Buy | 5,000 | $0.26 | $1.3K | Form 4 |
| Jul 30, 2026 | ARMEN GARO HEXEC. CHAIR & PRINCIPAL OFF | Buy | 26,291 | $0.18 | $4.7K | Form 4 |
| Oct 12, 2023 | Arrow Alexander K.Chief Financial Officer | Buy | 8,000 | $0.81 | $6.5K | Form 4 |
| May 18, 2022 | Arrow Alexander K.Chief Financial Officer | Buy | 8,000 | $0.72 | $5.8K | Form 4 |
| May 17, 2022 | Arrow Alexander K.Chief Financial Officer | Buy | 23,000 | $0.71 | $16.3K | 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.
- BIGGER CAPITAL FUND L PSCHEDULE 13G/A, 2 filings Jul 8, 2025 to Aug 25, 202564
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 5 filings Feb 15, 2022 to Feb 14, 202565
- Hudson Bay Capital Management LPSC 13G/A, 1 filing Feb 4, 202266
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| DRW Securities, LLC | 41,783 | $16.4K | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Protagenic Therapeutics, Inc.\new is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARProtagenic Therapeutics, Inc.\new1
- CIK0001022899
- Employer ID (EIN)06-13900255
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company5
- Incorporated inDelaware5
- Fiscal year endsMarch 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address149 Fifth Avenue, Suite 500, New York, NY 100101
- Phone(212) 994-82001
- Shares outstanding1,810,208 as of Aug 19, 202613
- Public float$6.6M as of Sep 30, 20255
- AuditorGreenGrowth CPAs, Los Angeles, California PCAOB ID 6580; it also attests to the company’s internal control over financial reporting5
- On EDGAR sinceOct 22, 19961
- Filings705 in all: 8-K (182), 4 (93), 10-Q (48), 3 (38), 10QSB (27), CORRESP (25), UPLOAD (20), DEF 14A (19)1
All 68 form types
SC 13D/A (17), 10-K (15), SC 13G (14), SC 13D (13), SC 13G/A (13), 425 (12), NT 10-Q (11), 10KSB (10), EFFECT (10), S-8 (10), 10-K/A (8), 8-K/A (8), DEFA14A (7), PRE 14A (7), S-1/A (7), 424B3 (5), 5 (5), NT 10-K (5), S-3/A (5), D/A (4), S-3 (4), 10KSB/A (3), 424B5 (3), 8-A12B (3), D (3), POS AM (3), S-1 (3), S-8 POS (3), SB-2/A (3), 10-12G/A (2), 10-Q/A (2), 25-NSE (2), 424B4 (2), NTN 10K (2), SB-2 (2), SC 14F1 (2), SCHEDULE 13G/A (2), 10-12G (1), 10-QT (1), 10SB12G (1), 10SB12G/A (1), 15-12B (1), 15-12G (1), 25 (1), 4/A (1), 424A (1), 424B1 (1), 8-A12B/A (1), CERT (1), CERTNAS (1), CT ORDER (1), DEF 14C (1), DEFR14A (1), POS EX (1), PRE 14C (1), RW (1), S-1MEF (1), S-4 (1), S-4/A (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Aug 14, 2026
Quarterly report (10-Q) Aug 19, 2026
Proxy statement (DEF 14A) Dec 5, 2025
Latest 8-K (8-K) Aug 20, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 | PTIX | |
| Common Stock Purchase Warrant | PTIXW |
From the cover page of the 10-K filed Aug 14, 2026 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks Protagenic Therapeutics, Inc.\new names in Item 1A of its 10-K filed Aug 14, 2026: 69 risks under these headings, as written.5
- Risks Related to Our Financial Condition and Capital Requirements
- The Company’s financial statements have been prepared on a going concern basis, and do not include adjustments that might be necessary if the Company is unable to continue as a going concern.
- We have a history of losses and expect that losses may continue in the future.
- We need to obtain financing to continue our operations.
- If we continue to incur operating losses and fail to obtain the capital necessary to fund our operations, we will be unable to advance our development programs, complete our clinical trials, or bring products to market, or may be forced to reduce or cease operations entirely. In addition, any capital obtained by us may be obtained on terms that are unfavorable to us, our investors, or both.
- We have a limited operating history, expect to incur significant operating losses, and have a high risk of never being profitable.
- Unstable market and economic conditions may have serious adverse consequences on our ability to raise funds, which may cause us to cease or delay our operations.
- Risks Related to Clinical Development and Regulatory Approval
- Our results to date provide no basis for predicting whether any of our product candidates will be safe or effective, or receive regulatory approval.
- We may not be able to initiate and complete preclinical studies and clinical trials for our product candidates which could adversely affect our business.
- The drug development and approval process is uncertain, time-consuming and expensive.
- The regulatory approval process is costly and lengthy and we may not be able to successfully obtain all required regulatory approvals.
The other 59 risks
- Even if we receive regulatory approvals for marketing our product candidates, if we fail to comply with continuing regulatory requirements, we could lose our regulatory approvals, and our business would be adversely affected.
- Even if we are able to obtain regulatory approvals for any of our product candidates, if they exhibit harmful side effects after approval, our regulatory approvals could be revoked or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims.
- If we experience delays or difficulties in the enrollment of subjects to our clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented, which could materially affect our financial condition.
- New federal laws or regulations on drug importation could make lower cost versions of our future products available, which could adversely affect our revenues, if any.
- Failure to obtain regulatory and pricing approvals in foreign jurisdictions could delay or prevent commercialization of our products abroad.
- It is uncertain whether product liability insurance will be adequate to address product liability claims, or that insurance against such claims will be affordable or available on acceptable terms in the future.
- If the market opportunities for our current and potential future drug candidates are smaller than we believe they are, our ability to generate product revenues will be adversely affected and our business may suffer.
- Risks Related to Our Reliance on Third Parties
- We may not be able to obtain and maintain the third-party relationships that are necessary to develop, commercialize and manufacture some or all our product candidates.
- We have no experience in sales, marketing and distribution and may have to enter into agreements with third parties to perform these functions, which could prevent us from successfully commercializing our product candidates.
- Data provided by collaborators and other parties upon which we rely, have not been independently verified and could turn out to be inaccurate, misleading, or incomplete.
- In certain cases, we may need to rely on a single supplier for a particular manufacturing material or service, and any interruption in or termination of service by such supplier could delay or disrupt the commercialization of our products.
- We rely on third parties to conduct our non-clinical studies and our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize our current product candidates or any future products, on a timely basis or at all, and our financial condition will be adversely affected.
- Risks Related to Commercialization of Our Product Candidates
- We have no experience as a company in commercializing any product. If we fail to obtain commercial expertise, upon product approval by regulatory agencies, our product launch and revenues could be delayed.
- We may not be able to gain market acceptance of our product candidates, which would prevent us from becoming profitable.
- We may not be able to manufacture our product candidates in clinical or commercial quantities, which would prevent us from commercializing our product candidates.
- Our products may not be accepted for reimbursement or properly reimbursed by third-party payers.
- New federal legislation may increase the pressure to reduce prices of pharmaceutical products paid for by Medicare, which could adversely affect our revenues, if any.
- Disputes under key agreements or conflicts of interest with our scientific advisors or clinical investigators could delay or prevent development or commercialization of our product candidates.
- Our competitors and potential competitors may develop products and technologies that make ours less attractive or obsolete.
- Competition in the biotechnology and pharmaceutical industries may result in competing products, superior marketing of other products and lower revenues or profits for us.
- Risks Related to Our Intellectual Property
- We may not be able to maintain our exclusive worldwide license to use and develop PT00114 which could materially affect our business plan.
- We have to sustain and further build our intellectual property rights.
- We must comply with our obligations in our intellectual property licenses with third parties.
- Patent litigation or other litigation in connection with our intellectual property rights may lead to publicity that may harm our reputation and the value of our common stock may decline.
- Protecting and defending against intellectual property claims may have a material adverse effect on our business.
- Intellectual property disputes could require us to spend time and money to address such disputes and could limit our intellectual property rights.
- We may not be able to enforce our intellectual property rights throughout the world.
- Changes to the patent law in the U.S. and other jurisdictions 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.
- If we fail to comply with our obligations under any license, collaboration or other intellectual property-related agreements, we may be required to pay damages and could lose intellectual property rights that may be necessary for developing, commercializing and protecting our current or future technologies or drug candidates or we could lose certain rights to grant sublicenses.
- Risks Related to Our Business Operations and Industry
- If we are not able to retain our current senior management team and our scientific advisors or continue to attract and retain qualified scientific, technical, and business personnel, our business will suffer.
- We may encounter difficulties in managing our growth, which could adversely affect our operations.
- Healthcare reform measures could adversely affect our business.
- Our business and operations are vulnerable to computer system failures, cyber-attacks or deficiencies in our cyber-security, which could increase our expenses, divert the attention of our management and key personnel away from our business operations and adversely affect our results of operations.
- Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
- If we, our CROs or our IT vendors experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of personal data, we may face costs, significant liabilities, harm to our brand and business disruption.
- If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
- Risks Associated to our Common Stock
- If we fail to comply with the continued minimum closing bid requirements of Nasdaq by April 28, 2025 or other requirements for continued listing, including stockholder equity requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
- Our common stock is a “Penny Stock” subject to specific rules governing its sale to investors that could impact its liquidity.
- The market price of our common stock may be volatile, and you could lose all or part of your investment.
- Compliance with the reporting requirements of federal securities laws can be expensive.
- Applicable regulatory requirements, including those contained in and issued under the Sarbanes-Oxley Act of 2002, may make it difficult for us to retain or attract qualified officers and directors, which could adversely affect the management of its business and its ability to obtain or retain listing of our common stock.
- If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or detect fraud. Consequently, investors could lose confidence in our financial reporting and this may decrease the trading price of our stock.
- The price of our common stock may become volatile, which could lead to losses by investors and costly securities litigation.
- Investors may experience dilution of their ownership interests because of the future issuance of additional shares of our common stock.
- Our common stock is controlled by insiders
- We do not intend to pay dividends for the foreseeable future and may never pay dividends.
- There can be no assurance that we will ever provide liquidity to our investors through a sale of our Company.
- Our certificate of incorporation allows our board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.
- Our common stock has been delisted from Nasdaq and now trades only in the over-the-counter market, which has substantially reduced the liquidity and may adversely affect the price of our common stock.
- There is no assurance that we will be able to relist our common stock on Nasdaq or any other national securities exchange.
- The application of “penny stock” rules to our common stock could further limit trading activity and the liquidity of our common stock.
- Delisting may reduce or eliminate analyst coverage and institutional ownership of our common stock.
- Our delisting impairs our access to the capital markets and could increase the cost and difficulty of raising capital.
- Our common stock may no longer constitute a “covered security,” which could subject offers and sales to additional state securities law requirements.
- Our common stock may be removed or otherwise excluded from stock market indices, resulting in forced selling.
- Our common stock may not be eligible for margin borrowing and could be subject to limitations on electronic clearing and settlement.
- Our delisting may harm our reputation and our relationships with customers, suppliers, employees, and other stakeholders.
- The market price of our common stock has been and may continue to be volatile, and the thinner over-the-counter market may make our common stock more susceptible to manipulation.
- Future sales or issuances of our common stock, including at depressed market prices, could result in substantial dilution and could further depress our stock price.
Legal proceedings
From time to time we may be named in claims arising in the ordinary course of business. As of March 31, 2026, no legal proceedings, government actions, administrative actions, investigations or claims are pending against us or involve us that, in the opinion of our management, could reasonably be expected to have a material adverse effect on our business, financial condition, and results of operations.
The opening of Item 3, Legal Proceedings.5
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 18SEC EDGARBurton Katz, Chief executive officer
- 19SEC EDGARGaro H. Armen, Chair
- 20SEC EDGARRobert Ziroyan, President
- 21SEC EDGARAndrew Stollman, President
- 22SEC EDGARRaymond Musci, President
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- 32SEC EDGARGaro H. Armen, Officer
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- 37SEC EDGARJennifer Buell, Board member
- 38SEC EDGARBrian Corvese, Board member
- 39SEC EDGARGregory Ekizian, Board member
- 40SEC EDGARKhalil Barrage, Board member
- 41SEC EDGARJonathan Schechter, Board member
- 42SEC EDGARStuart Goldfarb, Board member
- 43SEC EDGARLawrence Burstein, Board member
- 44SEC EDGARRobert Machinist, Board member
- 45SEC EDGARJeffrey A. Schwartz, Board member
- 46SEC EDGARMark Dyne, Board member
- 47SEC EDGARDrew Larner, Board member
- 48SEC EDGARGil Klier, Board member
- 49SEC EDGARIsaac Kier, Board member
- 50SEC EDGARJerome A. Chazen, Board member
- 51SEC EDGARBarry Regenstein, Board member
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- 53SEC EDGARExecutive or director change
- 54SEC EDGARExecutive or director change
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- 56SEC EDGARListing notice or transfer
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- 58SEC EDGARExecutive or director change
- 59SEC EDGAROther events
- 60SEC EDGARFinancial statements and exhibits
- 61SEC EDGARFinancial statements and exhibits
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