Overview
- TickerHEPA on OTC2
- IndustryPharmaceutical Preparations2
- HeadquartersNew York, United States2
- Incorporated inDE3
- Business address34 Shrewsbury Ave., Suite 1D, Red Bank, Nj 077013
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI5493004WF12U6NOV8U202
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O National Registered Agents, Inc., 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 53351172
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U.S. and foreign governments periodically propose and pass legislation designed to reduce the cost of healthcare and pharmaceutical products.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 2023
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $445.5K | $11.8M |
| General and administrative | $3.3M | $7.5M |
| Asset impairment loss | $402.7K | |
| Total operating expenses | $4.2M | $19.3M |
| Loss from operations | -$4.2M | -$19.3M |
| Interest expense, net | -$24.4K | -$1.2M |
| Write-off related party note receivable | -$600.0K | |
| Change in fair value of contingent consideration and derivative financial instruments | -$4.1M | $7.6M |
| Inducement expense | -$2.6M | |
| Loss before income taxes | -$8.3M | -$16.2M |
| Income tax benefit (expense) | $3.0M | |
| Net loss | -$8.3M | -$13.2M |
| Weighted-average common shares outstanding basic | 9.4M shares | 122.9K shares |
| Weighted-average common shares outstanding diluted | 9.4M shares | 122.9K shares |
| Net loss per common share basic | -$0.88 | -$107.35 |
| Net loss per common share diluted | -$0.88 | -$107.35 |
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.5
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash | $1.8M | $406.4K | |
| Prepaid expenses | $1.2M | $1.2M | |
| Total current assets | $3.1M | $1.6M | |
| Total assets | $3.1M | $1.6M | |
| Accounts payable | $167.8K | $220.2K | |
| Accrued expenses | $77.5K | $23.7K | |
| Notes payable, current | $54.1K | $2.9M | |
| Total current liabilities | $299.4K | $3.1M | |
| Derivative financial instrumentswarrants | $103.0K | $333.2K | |
| Total liabilities | $402.4K | $3.5M | |
| Common stock$0.0001 par value per share; 120,000,000 shares authorized, 11,620,317 and 139,168 shares issued and outstanding at December 31, 2025 and 2024, respectively. | $1.2K | $14 | |
| Additional paid-in capital | $247.1M | $234.3M | |
| Accumulated other comprehensive income (loss) | $8.3K | $8.3K | |
| Accumulated deficit | -$246.1M | -$237.8M | |
| Total stockholders equity | $2.7M | -$1.9M | $7.3M |
| Total liabilities and stockholders equity | $3.1M | $1.6M | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 120.0M shares | 120.0M shares | |
| Common stock, shares issued | 11.6M shares | 139.2K shares | |
| Common stock, shares outstanding | 11.6M shares | 139.2K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash | $1.8M | $406.4K | |
| Prepaid expenses | $1.2M | $1.2M | |
| Total current assets | $3.1M | $1.6M | |
| Total assets | $3.1M | $1.6M | |
| Accounts payable | $167.8K | $220.2K | |
| Accrued expenses | $77.5K | $23.7K | |
| Notes payable, current | $54.1K | $2.9M | |
| Total current liabilities | $299.4K | $3.1M | |
| Derivative financial instrumentswarrants | $103.0K | $333.2K | |
| Total liabilities | $402.4K | $3.5M | |
| Common stock$0.0001 par value per share; 120,000,000 shares authorized, 11,620,317 and 139,168 shares issued and outstanding at December 31, 2025 and 2024, respectively. | $1.2K | $14 | |
| Additional paid-in capital | $247.1M | $234.3M | |
| Accumulated other comprehensive income (loss) | $8.3K | $8.3K | |
| Accumulated deficit | -$246.1M | -$237.8M | |
| Total stockholders equity | $2.7M | -$1.9M | $7.3M |
| Total liabilities and stockholders equity | $3.1M | $1.6M | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 120.0M shares | 120.0M shares | |
| Common stock, shares issued | 11.6M shares | 139.2K shares | |
| Common stock, shares outstanding | 11.6M shares | 139.2K 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.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$8.3M | -$13.2M |
| Stock-based compensation | $20.8K | $791.6K |
| Asset impairment loss | $402.7K | |
| Depreciation | $30.8K | |
| Amortization of debt discount | $1.3M | |
| Inducement expense | $2.6M | |
| Write-off related party note receivable | $600.0K | |
| Change in fair value of derivative instrument-warrants | $4.1M | -$5.6M |
| Change in fair value of contingent consideration | -$2.0M | |
| Accounts payable and accrued expenses | $1.4K | -$4.5M |
| Right of use asset | $212.9K | |
| Operating lease liability | -$209.0K | |
| Prepaid expenses and other assets | $491.6K | $1.9M |
| Net cash used in operating activities | -$3.3M | -$18.2M |
| Investment in license agreement | -$132.1K | |
| Investment in related party receivable | -$600.0K | |
| Net cash used in investing activities | -$132.1K | -$600.0K |
| Proceeds from the issuance of common stock and warrants, net | $9.0M | $1.8M |
| Equity issuance costs | -$802.6K | |
| Proceeds from equity and debt issuance under SPA, net of discount | $2.5M | |
| Payments on notes payable | -$3.4M | |
| Net cash (used in) provided by financing activities | $4.8M | $4.3M |
| Effect of exchange rates on cash | $87.1K | |
| Net increase (decrease) in cash | $1.4M | -$14.4M |
| Cash paid for interest | $17.8K | |
| Issuance of Note Payable for payment of prepaid expense | $526.2K | |
| Inducement expense for issuance of Series B-1 and B-2 warrants | $2.8M | |
| Cashless Exercise of 2025 Series B Warrants | $10.4M | |
| Issuance of common stock in connection with license agreement | $270.6K |
No quarter-by-quarter statement was filed.
Corporate structure
Hepion Pharmaceuticals, 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 Hepion Pharmaceuticals, Inc.
- KI Holdings, Ltd. Filed SCHEDULE 13D/A on Hepion Pharmaceuticals, Inc., latest Sep 16, 2026
- Kenneth Rickel Filed SCHEDULE 13G on Hepion Pharmaceuticals, Inc., latest Sep 15, 2026
- Gary S. Stetz Filed SCHEDULE 13D on Hepion Pharmaceuticals, Inc., latest Aug 20, 2026
- Sireesh Appajosyula Filed SCHEDULE 13D on Hepion Pharmaceuticals, Inc., latest Aug 20, 2026
- Vincent S. Lopriore Filed SCHEDULE 13D/A on Hepion Pharmaceuticals, Inc., latest Aug 20, 2026 (2 filings since May 1, 2026)
- Black Global 5 LLC Filed SCHEDULE 13D on Hepion Pharmaceuticals, Inc., latest Aug 7, 2026
- Anson Funds Management LP Filed SCHEDULE 13G/A on Hepion Pharmaceuticals, Inc., latest Aug 14, 2025 (2 filings since May 15, 2025)
- S.H.N. Financial Investments Ltd. Filed SCHEDULE 13G/A on Hepion Pharmaceuticals, Inc., latest Aug 14, 2025 (2 filings since Jan 27, 2025)
- BIGGER CAPITAL FUND L P Filed SCHEDULE 13G on Hepion Pharmaceuticals, Inc., latest Jan 24, 2025
- ARMISTICE CAPITAL, LLC Filed SC 13G/A on Hepion Pharmaceuticals, Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2024)
- Altium Capital Management LLC Filed SC 13G/A on Hepion Pharmaceuticals, Inc., latest Feb 14, 2022
- VANGUARD GROUP INC Filed SC 13G/A on Hepion Pharmaceuticals, Inc., latest Feb 10, 2022
- Hepion Pharmaceuticals, Inc. New York, New York, 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 Hepion Pharmaceuticals, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Accumulated depreciation | $420.7K6 Dec 31, 2024 | $379.5K6 Dec 31, 2023 | +10.9% |
| Operating-lease assets (leased space) | $05 Dec 31, 2025 | $212.9K6 Dec 31, 2023 | −100.0% |
Properties, in its own words
Our corporate headquarters are located at 55 Madison Ave, Suite 400- PMB #462, Morristown, New Jersey, 07960.
Item 2 of the 10-K filed Mar 12, 2026.4
Leadership
Who has led Hepion Pharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerGary S. Stetz Mar 18, 2026 to now14
- Chief executive officerRobert T. Foster Jul 25, 2019 to Sep 19, 202315
- Chief executive officerJames Sapirstein Mar 20, 2014 to Jan 5, 201816
- Chief executive officerGary S. Jacob Oct 7, 2013 to Feb 20, 201417
- ChairVincent S. Lopriore Mar 18, 2026 to now18
- ChairJohn P. Brancaccio Feb 21, 2024 to Feb 21, 202419
- PresidentGary S. Jacob Oct 7, 2013 to Feb 20, 201417
- Chief financial officerJohn T. Cavan Apr 20, 2016 to May 20, 202120
- Chief financial officerWilliam Karl Hornung Jun 26, 2014 to Jun 8, 201521
- Chief financial officerBernard Denoyer Oct 7, 2013 to Apr 4, 201422
- Chief operating officerSireesh Appajosyula Aug 12, 2026 to now23
Board members and other officers (21)
- VP, Corp. Dev.Chase Lopriore Aug 21, 2026 to now24
- Chief Medical OfficerJohn Z. Sullivan-Bolyai Mar 2, 2016 to Jul 7, 201725
- Chief Scientific OfficerRobert T. Foster Jun 16, 2016 to Jan 5, 201826
- Board memberGary S. Stetz Mar 18, 2026 to now14
- Board memberSireesh Appajosyula Mar 18, 2026 to now27
- Board memberChase Lopriore May 26, 2026 to now28
- Board memberDanina Fisher Jul 8, 2026 to now29
- Board memberJames Gordon Liddy Aug 21, 2026 to now30
- Board memberMichael J. Purcell Mar 6, 2024 to now31
- Board memberAnand Reddi Jul 5, 2022 to Jul 5, 202232
- Board memberKaouthar Lbiati Jul 20, 2022 to Feb 21, 202433
- Board memberPeter Wijngaard Jun 25, 2020 to Nov 28, 202334
- Board memberRobert T. Foster Jul 25, 2019 to Sep 19, 202315
- Board memberTamar D. Howson Dec 15, 2016 to Apr 11, 201735
- Board memberArnold Lippa Dec 3, 2015 to May 20, 202136
- Board memberBernard Denoyer Jan 28, 2014 to Jan 28, 201437
- Board memberJames Sapirstein Mar 20, 2014 to Jan 5, 201816
- Board memberChristopher McGuigan Oct 7, 2013 to Dec 4, 201438
- Board memberGary S. Jacob Oct 7, 2013 to Feb 21, 202417
- Board memberJohn P. Brancaccio Oct 7, 2013 to May 20, 202139
- Board memberTimothy M. Block Dec 5, 2013 to Feb 21, 202440
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
- ContraVir Pharmaceuticals, Inc.Aug 8, 2013 to Jul 23, 20193
Timeline
- Oct 9, 20268-K Entered a material agreement; Completed an acquisition or sale; Unregistered sale of shares44
- Oct 2, 20268-K Bylaws or fiscal year changed45
- Sep 28, 20268-K Change of auditor46
- Sep 8, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares47
- Aug 27, 20268-K Entered a material agreement; Unregistered sale of shares48
- Aug 20, 20268-K Executive or director change49
- Aug 4, 20268-K Entered a material agreement; Unregistered sale of shares50
- Jul 2, 20268-K Executive or director change51
- Jun 17, 20268-K Shareholder vote52
- Apr 22, 20268-K Entered a material agreement; Unregistered sale of shares53
- Apr 14, 20268-K Entered a material agreement; Executive or director change54
- Mar 18, 2026New chief executive Gary S. Stetz becomes CEO14
- Mar 18, 20268-K Executive or director change55
- Jul 25, 2019New chief executive Robert T. Foster becomes CEO15
- Mar 20, 2014New chief executive James Sapirstein becomes CEO16
- Oct 7, 2013New chief executive Gary S. Jacob becomes CEO17
- May 15, 2013Founded Hepion Pharmaceuticals, Inc. is founded2
Filings
217 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 62 major events, 40 insider forms, 18 large holders, 5 private raises, 70 other. The latest 20:
- Oct 14, 2026S-8 EDGAR
- Oct 9, 20268-K EDGAR
- Oct 2, 20264 EDGAR
- Oct 2, 20268-K EDGAR
- Sep 28, 20268-K EDGAR
- Sep 16, 20263 EDGAR
- Sep 16, 2026SCHEDULE 13D/A EDGAR
- Sep 15, 2026SCHEDULE 13G EDGAR
- Sep 14, 20264 EDGAR
- Sep 10, 2026DEF 14C EDGAR
- Sep 10, 20264 EDGAR
- Sep 8, 20268-K EDGAR
- Aug 31, 2026PRE 14C EDGAR
- Aug 27, 20268-K EDGAR
- Aug 21, 20264 EDGAR
- Aug 21, 20264 EDGAR
- Aug 21, 20264 EDGAR
- Aug 21, 20264 EDGAR
- Aug 21, 20264 EDGAR
- Aug 21, 20264 EDGAR
The 217 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
15 open-market trades by officers, directors and large owners since October 2021: 15 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 3, 2026 | Stetz Gary S. IIDirector | Buy | 500,000 | $0.05 | $25.0K | Form 4 |
| Aug 3, 2026 | Stetz Gary S.Interim CEO | Buy | 2,000,000 | $0.05 | $100.0K | Form 4 |
| Aug 3, 2026 | Purcell Michael J.Director | Buy | 2,000,000 | $0.05 | $100.0K | Form 4 |
| Aug 3, 2026 | Appajosyula SireeshChief Operating Officer | Buy | 2,000,000 | $0.05 | $100.0K | Form 4 |
| Aug 3, 2026 | LoPriore Vincent SExecutive Chairman | Buy | 10,000,000 | $0.05 | $500.0K | Form 4 |
| Apr 21, 2026 | Purcell Michael J.Director | Buy | 1,250,000 | $0.04 | $50.0K | Form 4 |
| Apr 21, 2026 | LoPriore Vincent SExecutive Chairman | Buy | 6,250,000 | $0.04 | $250.0K | Form 4 |
| Apr 21, 2026 | Appajosyula SireeshChief Operating Officer | Buy | 1,250,000 | $0.04 | $50.0K | Form 4 |
| Apr 21, 2026 | Stetz Gary S.Interim CEO | Buy | 1,250,000 | $0.04 | $50.0K | Form 4 |
| Nov 27, 2023 | Wijngaard PeterDirector | Buy | 2,500 | $3.05 | $7.6K | Form 4 |
| Nov 24, 2023 | Wijngaard PeterDirector | Buy | 2,500 | $3.09 | $7.7K | Form 4 |
| Sep 19, 2023 | Wijngaard PeterDirector | Buy | 1,000 | $5.64 | $5.6K | Form 4 |
| Sep 18, 2023 | Foster Robert TCEO and Director | Buy | 1,600 | $5.60 | $9.0K | Form 4 |
| Sep 15, 2023 | Wijngaard PeterDirector | Buy | 2,000 | $5.60 | $11.2K | Form 4 |
| Sep 15, 2023 | Foster Robert TCEO and Director | Buy | 1,600 | $5.40 | $8.6K | 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.
- KI Holdings, Ltd.SCHEDULE 13D/A, 1 filing Sep 16, 202656
- Kenneth RickelSCHEDULE 13G, 1 filing Sep 15, 202657
- Gary S. StetzSCHEDULE 13D, 1 filing Aug 20, 202658
- Sireesh AppajosyulaSCHEDULE 13D, 1 filing Aug 20, 202659
- Vincent S. LoprioreSCHEDULE 13D/A, 2 filings May 1, 2026 to Aug 20, 202660
- Black Global 5 LLCSCHEDULE 13D, 1 filing Aug 7, 202661
- Anson Funds Management LPSCHEDULE 13G/A, 2 filings May 15, 2025 to Aug 14, 202562
- S.H.N. Financial Investments Ltd.SCHEDULE 13G/A, 2 filings Jan 27, 2025 to Aug 14, 202563
- BIGGER CAPITAL FUND L PSCHEDULE 13G, 1 filing Jan 24, 202564
- ARMISTICE CAPITAL, LLCSC 13G/A, 2 filings Feb 14, 2024 to Nov 14, 202465
- Altium Capital Management LLCSC 13G/A, 1 filing Feb 14, 202266
- VANGUARD GROUP INCSC 13G/A, 1 filing Feb 10, 202267
- Empery Asset Management, LPSC 13G/A, 1 filing Jan 19, 202268
- SABBY MANAGEMENT, LLCSC 13G/A, 1 filing Jan 4, 202269
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 | John Brancaccio | $232.5K | $232.5K70 | |
| 2025 | Former ChiefExecutive Officer | $198.0K | $198.0K70 | |
| 2024 | Former Interim ChiefExecutive Officer and Chief Financial Officer | $313.9K | $502.3K70 |
Money raised
Private offerings the company reported to the SEC on Form D.
- Jul 31, 2026Raised $3.1 million in a private offering of equity Form D: 33 investors so far Form D
- Apr 21, 2026Raised $700,000 in a private offering of equity Form D: 11 investors so far Form D
- Jul 19, 2024Raised $2.9 million in a private offering of securities Form D: 7 investors so far Form D
- Sep 28, 2023Raised $5 million in a private offering of equity Form D: 1 investor so far Form D
- Nov 4, 2022Raised $20 million in a private offering of equity Form D: 8 investors so far Form D
SEC filer profile
How Hepion Pharmaceuticals, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARHepion Pharmaceuticals, Inc.1
- CIK0001583771
- Employer ID (EIN)46-27838064
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; 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 address34 Shrewsbury Ave., Suite 1D, Red Bank, NJ 077011
- Phone732-902-40001
- Shares outstanding90,219,317 as of Aug 10, 202612
- Public float$900.0K as of Jun 30, 20254
- AuditorGrassi & Co., CPAs, P.C, Jericho, New York PCAOB ID 606; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceAug 8, 20131
- Filings712 in all: 8-K (261), 4 (120), 10-Q (39), 3 (29), CORRESP (22), DEFA14A (18), SC 13G (18), UPLOAD (18)1
All 50 form types
DEF 14A (16), SC 13G/A (14), 10-K (12), 424B5 (12), S-1/A (11), EFFECT (10), D (9), PRE 14A (9), S-1 (8), S-8 (7), 10-12G/A (5), 10-K/A (5), 424B4 (5), 425 (4), ARS (4), FWP (4), NT 10-K (4), SCHEDULE 13D (4), SCHEDULE 13G (4), 8-K/A (3), CT ORDER (3), NT 10-Q (3), PRER14A (3), S-3 (3), 424B3 (2), RW (2), S-1MEF (2), S-3/A (2), SC 13D (2), SCHEDULE 13D/A (2), SCHEDULE 13G/A (2), 10-12G (1), 10-KT (1), 10-Q/A (1), 25-NSE (1), 8-A12B (1), ARS/A (1), CERTNAS (1), DEF 14C (1), PRE 14C (1), RW WD (1), SC 13D/A (1)
- Latest filingsAnnual report (10-K) Mar 12, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) Apr 28, 2026
Latest 8-K (8-K) Oct 9, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | HEPA |
From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Hepion Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 60 risks under these headings, as written.4
- Risks Related to Our Business
- We have incurred losses since inception, anticipate that we will incur continued losses for the foreseeable future indicating the possibility that we may not be able to operate in the future.
- We expect future product candidates to be in the early stages of development and commercial viability remains subject to the successful outcome of current and future preclinical studies, clinical trials, regulatory approvals and the risks generally inherent in the development of a pharmaceutical product candidate. If we are unable to successfully advance or develop our product candidates, our business will be materially harmed.
- If the results of preclinical studies or clinical trials for our product candidates, including those that are subject to existing or future license or collaboration agreements, are unfavorable or delayed, we could be delayed or precluded from the further development or commercialization of our product candidate, which could materially harm our business.
- If third party vendors upon whom we intend to rely on to conduct our preclinical studies or clinical trials do not perform or fail to comply with strict regulations, these studies or trials of our product candidates may be delayed, terminated, or fail, or we could incur significant additional expenses, which could materially harm our business.
- We have limited capacity for recruiting and managing clinical trials, which could impair our timing to initiate or complete clinical trials of our product candidates and materially harm our business.
- We, and our collaborators, must comply with extensive government regulations in order to advance our product candidates through the development process and ultimately obtain and maintain marketing approval for our products in the U.S. and abroad.
- We will require substantial additional funding which may not be available to us on acceptable terms, or at all. If we fail to raise the necessary additional capital, we may be unable to complete the development and commercialization of our product candidates or continue our development programs.
- The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidate, our business will be substantially harmed.
- We may be required to suspend or discontinue clinical trials due to unexpected side effects or other safety risks that could preclude approval of our product candidates.
- If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.
- If we are unable to satisfy regulatory requirements, we may not be able to commercialize our product candidates.
The other 49 risks
- We currently have no sales and marketing organization. If we are unable to establish a direct sales force in the United States to promote our products, the commercial opportunity for our products may be diminished.
- We may need others to market and commercialize our product candidate in international markets.
- We may not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our product candidates.
- Materials necessary to manufacture our product candidates may not be available on commercially reasonable terms, or at all, which may delay the development and commercialization of our product candidates.
- Our product candidates, if approved for sale, may not gain acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenues.
- Guidelines and recommendations published by various organizations can impact the use of our product.
- If third-party contract manufacturers upon whom we intend to rely on to formulate and manufacture our product candidates do not perform, fail to manufacture according to our specifications or fail to comply with strict regulations, our preclinical studies or clinical trials could be adversely affected and the development of our product candidates could be delayed or terminated or we could incur significant additional expenses.
- In the event that we need to change our third-party contract manufacturers, our preclinical studies, clinical trials or the commercialization of our product candidate could be delayed, adversely affected or terminated, or such a change may result in significantly higher costs.
- If a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial damage awards that could materially harm our business.
- If our use of hazardous materials results in contamination or injury, we could suffer significant financial loss.
- Our operations could be disrupted if our information systems fail, if we are unsuccessful in implementing necessary upgrades or if we are subject to cyber-attacks.
- Business disruptions could seriously harm future revenue and financial condition and increase our costs and expenses.
- Risks Relating to the Commercialization of our Product Candidate.
- We may delay or terminate the development of our product candidates at any time if we believe the perceived market or commercial opportunity does not justify further investment, which could materially harm our business.
- If we fail to enter into or maintain collaborations or other sales, marketing and distribution arrangements with third parties to commercialize our product candidates, or otherwise fail to establish marketing and sales capabilities, we may not be able to successfully commercialize our products.
- If government and third-party payers fail to provide adequate reimbursement or coverage for our products or those we develop through collaborations, our revenues and potential for profitability will be harmed.
- If any product candidate that we develop independently or through collaborations is approved but does not gain meaningful acceptance in its intended market, we are not likely to generate significant revenues or become profitable.
- Even if we or a collaborator achieve market acceptance for our product, we may experience downward pricing pressure on the price of our product due to social or political pressure to lower the cost of drugs, which would reduce our revenue and future profitability.
- We may be unable to successfully develop a product candidate that is the subject of collaboration if our collaborator does not perform, terminates our agreement, or delays the development of our product candidate.
- Risks Related to Our Intellectual Property
- If we are unable to adequately protect or expand our intellectual property related to our future product candidates, our business prospects could be harmed.
- If a third party claims we are infringing on its intellectual property rights, we could incur significant expenses, or be prevented from further developing or commercializing our product candidates.
- Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information and may not adequately protect our intellectual property.
- Our failure to successfully discover, acquire, develop and market additional product candidates or approved products would impair our ability to grow.
- Risks Related to Government Regulation
- We conduct our business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, reduce our revenue, adversely affect our results of operations and financial condition and harm our business.
- The insurance coverage and reimbursement status of newly approved products, in a new category of diagnostics and therapeutics, is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for current or future products could limit our ability, and that of our collaborators, to fully commercialize our products and decrease our ability to generate revenue.
- Changes in law relating to health insurance coverage and payment may adversely affect our business.
- Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- We must maintain compliance with marketing authorization requirements of the FDA and equivalent foreign and state regulatory authorities for our products and services whose sale is subject to their authority and failure to maintain compliance with FDA requirements may prevent or delay the marketing of our products and services.
- For each product we are developing that requires FDA premarket review or equivalent regulatory approval, the FDA or other regulatory authority may not grant clearance, authorization or premarket approval and failure to obtain necessary approvals for our future products and services would adversely affect our ability to grow our business.
- Modifications to our products with FDA clearance may require new FDA clearances, authorizations or approvals, or may require us to cease marketing or recall the modified clinical diagnostic products or future clinical products until clearances are obtained.
- Our employees, consultants and collaborators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
- Future Medicare payment rates are uncertain.
- Our products, and those jointly developed with our collaborators, may in the future be subject to product or service recalls. A recall of products or services, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our or our collaborators’ products or services, could have a significant adverse impact on us.
- Any additional commercialized products or any future products that obtain regulatory clearance, authorization, approval, accreditation or licensure will remain subject to regulatory scrutiny and our failure to maintain our regulatory clearances, authorizations, approvals, accreditations or licensures could adversely affect our reputation, business and results of operations.
- If any of our diagnostic products or services cause or contribute to a death or serious injury, or malfunction in certain ways, we will be required to report such death, serious injury or malfunction under applicable medical device reporting regulations, and such events can result in voluntary corrective actions or agency enforcement actions.
- We are subject to various laws and regulations, such as healthcare fraud and abuse laws, false claim laws and health information privacy and security laws, among others, and failure to comply with these laws and regulations may have an adverse effect on our business.
- We will need to increase the size of our organization.
- Risks Related to Our Common Stock
- Our common stock is a “penny stock,” which may make it more difficult for investors to sell their shares of common stock due to suitability requirements.
- Our common stock is currently traded on the OTC QB Market, which may have an unfavorable impact on our stock price and liquidity.
- 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.
- Since our common stock is currently quoted on the OTC QB Markets our stockholders may face significant restrictions on the resale of our common stock due to state “blue sky” laws and the sale of common stock in this offering is subject to state “blue sky” laws.
- If we fail to comply with the rules under the Sarbanes-Oxley Act of 2002 related to accounting controls and procedures in the future, or, if we discover additional material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.
- The market price of our common stock may be volatile and adversely affected by several factors.
- U.S. federal income tax reform could adversely affect us.
- Certain provisions in our certificate of incorporation and by-laws, and of Delaware law, may prevent or delay an acquisition of our company, which could decrease the trading price of our common stock.
- Future sales and issuances of our common stock or rights to purchase common stock pursuant to our equity incentive plan could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.
- We may be at risk of securities class action litigation.
- If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
- We presently do not intend to pay cash dividends on our common stock.
Legal proceedings
From time to time, we may become a party to various legal actions and complaints arising in the ordinary course of business. In addition to commitments and obligations in the ordinary course of business, we are subject to various claims, pending and potential legal actions for damages, investigations relating to governmental laws and regulations and other matters arising out of the normal conduct of our business. It is possible that cash flows or results of operations could be materially affected in any particular period by the unfavorable resolution of one or more of these contingencies.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 18SEC EDGARVincent S. Lopriore, Chair
- 19SEC EDGARJohn P. Brancaccio, Chair
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- 24SEC EDGARChase Lopriore, VP, Corp. Dev.
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- 27SEC EDGARSireesh Appajosyula, Board member
- 28SEC EDGARChase Lopriore, Board member
- 29SEC EDGARDanina Fisher, Board member
- 30SEC EDGARJames Gordon Liddy, Board member
- 31SEC EDGARMichael J. Purcell, Board member
- 32SEC EDGARAnand Reddi, Board member
- 33SEC EDGARKaouthar Lbiati, Board member
- 34SEC EDGARPeter Wijngaard, Board member
- 35SEC EDGARTamar D. Howson, Board member
- 36SEC EDGARArnold Lippa, Board member
- 37SEC EDGARBernard Denoyer, Board member
- 38SEC EDGARChristopher McGuigan, Board member
- 39SEC EDGARJohn P. Brancaccio, Board member
- 40SEC EDGARTimothy M. Block, Board member
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- 45SEC EDGARBylaws or fiscal year changed
- 46SEC EDGARChange of auditor
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- 49SEC EDGARExecutive or director change
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- 51SEC EDGARExecutive or director change
- 52SEC EDGARShareholder vote
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