Overview
Compare with BIO-PATH HOLDINGS, INC., Lyell Immunopharma, Inc. or AXIM BIOTECHNOLOGIES, INC., or pick any stock.
- TickerOGEN on NYSE2
- IndustryPharmaceutical Preparations2
- HeadquartersTampa, United States2
- Incorporated inFL3
- Business address9015 Town Center Parkway, Suite 143, Lakewood Ranch, Fl 342023
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300639MGD19K4ZW902
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O Catchur, Mark, Esq., 33602 Tampa, United States2
- Registered withFlorida Division of Corporations, P960000919492
See how the biggest companies compare on our leaderboards
Uses Thereof have been filed in the U.S. with the USPTO as utility patent applications.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 2023
Where the money goes
Where each dollar of revenue went, fiscal 2023
- Research and development100¢$15.5M
- Interest0¢$30.6K
Out of $37.7K in revenue.6 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.7
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $2.4M | $4.1M |
| General and administrative | $7.0M | $6.4M |
| Total operating expenses | $9.4M | $10.6M |
| Loss from operations | -$9.4M | -$10.6M |
| Interest income | $182.2K | $45.9K |
| Interest expense | -$785.9K | -$29.8K |
| Foreign currency exchange, net | -$13.2K | -$25.2K |
| Total other income (expense), net | -$616.9K | -$9.1K |
| Loss before income taxes | -$10.0M | -$10.6M |
| Income tax benefit | $136.9K | |
| Net loss | -$9.8M | -$10.6M |
| Basic net loss per share | -$4.56 | -$47.88 |
| Diluted net loss per share | -$4.56 | -$47.88 |
| Weight average shares outstanding, basic | 2.2M shares | 220.7K shares |
| Weight average shares outstanding, diluted | 2.2M shares | 220.7K shares |
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.7
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $4.4M | $864.8K | |
| Short-term investments | $4.0M | ||
| Interest receivable | $53.1K | ||
| Prepaid expenses and other current assets | $1.6M | $607.7K | |
| Total current assets | $10.1M | $1.5M | |
| Total assets | $10.1M | $1.5M | |
| Accounts payable and accrued expenses | $1.6M | $1.4M | |
| Short-term notes payable, net of debt issuance costs | $227.3K | $328.5K | |
| Total liabilities | $1.8M | $1.7M | |
| Common stock, $0.001 par value; 350,000,000 shares authorized; 4,271,529 and 419,003 shares issued and outstanding at December 31, 2025, and December 31, 2024, respectively | $4.3K | $419 | |
| Additional paid-in capital | $234.9M | $216.6M | |
| Accumulated deficit | -$226.6M | -$216.8M | |
| Total stockholders equity (deficit) | $8.3M | -$211.9K | $3.2M |
| Total liabilities and stockholders equity (deficit) | $10.1M | $1.5M | |
| Preferred stock, par value | $0 | $0 | |
| Preferred stock, shares authorized | 50.0M shares | 50.0M shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 350.0M shares | 350.0M shares | |
| Common stock, shares issued | 4.3M shares | 419.0K shares | |
| Common stock, shares outstanding | 4.3M shares | 419.0K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $4.4M | $864.8K | |
| Short-term investments | $4.0M | ||
| Interest receivable | $53.1K | ||
| Prepaid expenses and other current assets | $1.6M | $607.7K | |
| Total current assets | $10.1M | $1.5M | |
| Total assets | $10.1M | $1.5M | |
| Accounts payable and accrued expenses | $1.6M | $1.4M | |
| Short-term notes payable, net of debt issuance costs | $227.3K | $328.5K | |
| Total liabilities | $1.8M | $1.7M | |
| Common stock, $0.001 par value; 350,000,000 shares authorized; 4,271,529 and 419,003 shares issued and outstanding at December 31, 2025, and December 31, 2024, respectively | $4.3K | $419 | |
| Additional paid-in capital | $234.9M | $216.6M | |
| Accumulated deficit | -$226.6M | -$216.8M | |
| Total stockholders equity (deficit) | $8.3M | -$211.9K | $3.2M |
| Total liabilities and stockholders equity (deficit) | $10.1M | $1.5M | |
| Preferred stock, par value | $0 | $0 | |
| Preferred stock, shares authorized | 50.0M shares | 50.0M shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 350.0M shares | 350.0M shares | |
| Common stock, shares issued | 4.3M shares | 419.0K shares | |
| Common stock, shares outstanding | 4.3M shares | 419.0K 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.7
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$9.8M | -$10.6M |
| Amortization of debt discount and closing costs | $771.4K | |
| Stock-based compensation expense | $642.4K | $516.0K |
| Stock-based compensation recapture expense | -$86.6K | |
| Common stock for services rendered | $126.1K | |
| Other receivables | -$53.1K | |
| Prepaid expenses and other current assets | -$1.0M | $1.6M |
| Operating lease right of use assets | $9.8K | |
| Accounts payable and accrued expenses | $203.1K | -$119.8K |
| Change in operating lease liabilities | -$9.8K | |
| Net cash used in operating activities | -$9.2M | -$8.6M |
| Borrowings on short-term notes payable | $2.5M | |
| Payments on short-term notes payable | -$3.3M | -$693.1K |
| Net proceeds from issuance of preferred stock and warrants | $15.0M | |
| Net proceeds from issuance of common stock | $2.6M | $6.7M |
| Net cash provided by financing activities | $16.8M | $6.0M |
| Net increase (decrease) in cash and cash equivalents | $7.5M | -$2.6M |
| Interest paid | $22.4K | $29.8K |
No quarter-by-quarter statement was filed.
Corporate structure
ORAGENICS INC sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of ORAGENICS INC
- SABBY MANAGEMENT, LLC Filed SCHEDULE 13G on ORAGENICS INC, latest Jan 21, 2026
- Five Narrow Lane LP Filed SCHEDULE 13G on ORAGENICS INC, latest Jul 2, 2025
- Iroquois Capital Management, LLC Filed SC 13G/A on ORAGENICS INC, latest Nov 14, 2024 (2 filings since Sep 11, 2024)
- Lind Global Fund II LP Filed SC 13G/A on ORAGENICS INC, latest Nov 14, 2024 (2 filings since Mar 6, 2024)
- Odyssey Health, Inc. Filed SC 13D on ORAGENICS INC, latest Feb 12, 2024
- ORAGENICS INC Tampa, Florida, United States
- Oragenics Australia Pty Ltd Subsidiary · Australia
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What ORAGENICS 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $4.4M7 Dec 31, 2025 | $864.8K7 Dec 31, 2024 | +408.7% |
| Marketable securities, current | $4.0M7 Dec 31, 2025 |
Properties, in its own words
We lease office space located at 9015 Town Center Parkway, Suite 143, Lakewood Ranch, Florida, which serves as our principal executive offices. We believe that our current facilities are adequate for our present needs.
Item 2 of the 10-K filed Mar 16, 2026.5
Leadership
Who has led ORAGENICS INC, and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerJanet Huffman Dec 15, 2025 to now14
- Chief executive officerKimberly M. Murphy Jun 24, 2022 to Aug 10, 202315
- Chief executive officerAlan Joslyn Jun 8, 2016 to Feb 19, 202116
- Chief executive officerJohn N. Bonfiglio May 26, 2011 to Aug 13, 201417
- Chief executive officerRonald P. Evens Jan 29, 2008 to Jan 29, 200818
- Chief executive officerStanley Bruce Stein Apr 14, 2008 to Apr 14, 200819
- Chief executive officerRobert T. Zahradnik Sep 11, 2006 to Sep 26, 200620
- PresidentJ. Michael Redmond Jan 2, 2024 to Sep 20, 202421
- PresidentKimberly M. Murphy Jun 24, 2022 to Aug 10, 202315
- PresidentAlan Joslyn Jun 8, 2016 to Feb 19, 202116
- PresidentJohn N. Bonfiglio May 26, 2011 to Aug 13, 201417
- PresidentRonald P. Evens Jan 29, 2008 to Jan 29, 200818
- PresidentStanley Bruce Stein Apr 14, 2008 to Apr 14, 200819
- PresidentRobert T. Zahradnik Sep 11, 2006 to Sep 26, 200620
- Chief financial officerJanet Huffman Mar 8, 2023 to now22
- Chief financial officerMichael O'Keefe Sullivan Feb 14, 2012 to Aug 2, 202223
- Chief financial officerBrian John Bohunicky Jul 2, 2009 to Nov 16, 201124
- Chief financial officerDorothy Jean Delfino Jun 5, 2007 to May 23, 200825
- Chief operating officerRobert T. Zahradnik Mar 26, 2009 to Mar 26, 200926
Board members and other officers (23)
- OfficerMichael O'Keefe Sullivan Jun 26, 2018 to Jun 26, 201827
- OfficerAlan Joslyn Jun 26, 2017 to Mar 27, 201928
- Chief Scientific OfficerJeffrey D. Hillman Mar 8, 2006 to Oct 14, 201129
- PLEASE PROVIDERobert T. Zahradnik Mar 8, 2006 to Mar 8, 200630
- Board memberNatasha Giordano Sep 2, 2025 to now31
- Board memberBruce A. Cassidy Sr. Oct 6, 2023 to Sep 20, 202432
- Board memberKimberly M. Murphy May 4, 2020 to Sep 20, 202433
- Board memberAlan Joslyn Jun 8, 2016 to Feb 19, 202116
- Board memberAlan W. Dunton Apr 4, 2011 to now34
- Board memberJohn N. Bonfiglio May 26, 2011 to Aug 13, 201417
- Board memberCharles L. Pope Jun 8, 2010 to now35
- Board memberFred Telling Jun 8, 2010 to now36
- Board memberChristine L. Koski Jul 6, 2009 to Feb 17, 201637
- Board memberRobert C. Koski Jul 6, 2009 to now37
- Board memberDerek Hennecke Jan 4, 2008 to May 13, 200838
- Board memberRichard T. Welch Jan 4, 2008 to May 13, 200839
- Board memberStanley Bruce Stein Jan 23, 2008 to Apr 14, 200840
- Board memberKevin H. Sills Apr 16, 2008 to May 13, 200841
- Board memberRonald P. Evens Jun 20, 2007 to Jan 29, 200842
- Board memberDavid J. Gury Mar 8, 2006 to Feb 8, 200843
- Board memberGeorge T. Hawes Mar 8, 2006 to Mar 4, 200844
- Board memberJeffrey D. Hillman Mar 8, 2006 to Oct 14, 201129
- Board memberRobert T. Zahradnik Mar 8, 2006 to Sep 26, 200630
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- Oragenics Australia Pty Ltd Australia4
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Timeline
- Sep 16, 20268-K Regulation FD disclosure; Other events45
- Aug 28, 20268-K Listing notice or transfer; Other events46
- Jul 6, 20268-K Entered a material agreement; Executive or director change; Shareholder vote47
- May 19, 20268-K Regulation FD disclosure; Other events48
- May 7, 20268-K Other events49
- Apr 13, 20268-K Other events50
- Mar 31, 20268-K Director nominations51
- Mar 11, 20268-K Other events52
- Jan 22, 20268-K Entered a material agreement53
- Jan 20, 20268-K Regulation FD disclosure54
- Dec 15, 2025New chief executive Janet Huffman becomes CEO14
- Dec 15, 20258-K Executive or director change55
- Nov 12, 20258-K Other events56
- Jun 24, 2022New chief executive Kimberly M. Murphy becomes CEO15
- Jun 8, 2016New chief executive Alan Joslyn becomes CEO16
- May 26, 2011New chief executive John N. Bonfiglio becomes CEO17
- Apr 14, 2008New chief executive Stanley Bruce Stein becomes CEO19
- Jan 29, 2008New chief executive Ronald P. Evens becomes CEO18
- Sep 11, 2006New chief executive Robert T. Zahradnik becomes CEO20
- Nov 6, 1996Founded ORAGENICS INC is founded2
Calendar
Coming up
- Nov 6, 2026Reports results for the quarter ending Sep/202657
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
285 filings to the SEC since October 2021: 6 annual reports, 18 quarterly reports, 106 major events, 70 insider forms, 7 large holders, 1 private raises, 77 other. The latest 20:
- Sep 16, 20268-K EDGAR
- Aug 28, 20268-K EDGAR
- Aug 13, 202610-Q EDGAR
- Jul 7, 20264 PRIMARY DOCUMENT EDGAR
- Jul 7, 20263 PRIMARY DOCUMENT EDGAR
- Jul 6, 20268-K EDGAR
- May 20, 2026DEFA14A EDGAR
- May 20, 2026DEF 14A EDGAR
- May 19, 20268-K EDGAR
- May 8, 2026PRE 14A EDGAR
- May 8, 202610-Q EDGAR
- May 7, 20268-K EDGAR
- Apr 13, 20268-K EDGAR
- Mar 31, 20268-K EDGAR
- Mar 20, 2026EFFECT EDGAR
- Mar 19, 2026CORRESP EDGAR
- Mar 19, 2026S-3/A EDGAR
- Mar 16, 202610-K EDGAR
- Mar 11, 20268-K EDGAR
- Jan 27, 2026UPLOAD EDGAR
The 285 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
29 open-market trades by officers, directors and large owners since October 2021: 11 buys and 18 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Dec 12, 2025 | Telling FredDirector | Sale | 210 | $0.94 | $197 | Form 4 |
| Dec 12, 2025 | Telling FredDirector | Sale | 210 | $0.94 | $197 | Form 4 |
| Jun 18, 2025 | Odyssey Health, Inc.10% owner | Sale | 5,044 | $4.26 | $21.5K | Form 4 |
| Jun 17, 2025 | Odyssey Health, Inc.10% owner | Sale | 2,000 | $4.46 | $8.9K | Form 4 |
| Jun 16, 2025 | Odyssey Health, Inc.10% owner | Sale | 5,000 | $4.45 | $22.2K | Form 4 |
| Jun 13, 2025 | Odyssey Health, Inc.10% owner | Sale | 5,000 | $4.27 | $21.4K | Form 4 |
| Dec 6, 2024 | DUNTON ALAN WDirector | Sale | 66 | $0.36 | $24 | Form 4 |
| Dec 6, 2024 | Telling FredDirector | Sale | 3,597 | $0.36 | $1.3K | Form 4 |
| Nov 30, 2023 | Telling FredDirector | Sale | 3,500 | $3.57 | $12.5K | Form 4 |
| Dec 30, 2022 | KOSKI ROBERT CDirector | Sale | 42,357 | $0.11 | $4.7K | Form 4 |
| Dec 29, 2022 | KOSKI ROBERT CDirector | Sale | 36,648 | $0.11 | $4.0K | Form 4 |
| Dec 15, 2022 | KOSKI ROBERT CDirector | Sale | 140,497 | $0.18 | $25.3K | Form 4 |
| Dec 14, 2022 | KOSKI ROBERT CDirector | Sale | 25,000 | $0.18 | $4.5K | Form 4 |
| Dec 14, 2022 | KOSKI ROBERT CDirector | Sale | 4,503 | $0.18 | $811 | Form 4 |
| Dec 9, 2022 | KOSKI ROBERT CDirector | Sale | 48,795 | $0.20 | $9.8K | Form 4 |
| Dec 8, 2022 | KOSKI ROBERT CDirector | Sale | 13,036 | $0.20 | $2.6K | Form 4 |
| Nov 30, 2022 | KOSKI ROBERT CDirector | Sale | 200,000 | $0.19 | $38.0K | Form 4 |
| Nov 29, 2022 | KOSKI ROBERT CDirector | Sale | 200,000 | $0.19 | $38.0K | Form 4 |
| Jun 17, 2022 | Telling FredDirector | Buy | 10,084 | $0.29 | $2.9K | Form 4 |
| May 24, 2022 | Telling FredDirector | Buy | 78,673 | $0.29 | $22.8K | Form 4 |
All 29 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- SABBY MANAGEMENT, LLCSCHEDULE 13G, 1 filing Jan 21, 202658
- Five Narrow Lane LPSCHEDULE 13G, 1 filing Jul 2, 202559
- Iroquois Capital Management, LLCSC 13G/A, 2 filings Sep 11, 2024 to Nov 14, 202460
- Lind Global Fund II LPSC 13G/A, 2 filings Mar 6, 2024 to Nov 14, 202461
- Odyssey Health, Inc.SC 13D, 1 filing Feb 12, 202462
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.
Money raised
Private offerings the company reported to the SEC on Form D.
- Aug 4, 2023Raised $850,000 in a private offering of equity Form D: 2 investors so far Form D
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 |
|---|---|---|---|---|
| Geode Capital Management, LLC | 23,685 | $13.8K | 0.0% | −41,387 |
| 25 LLC | 23,160 | $13.4K | 0.0% | New |
| Jane Street Group, LLC | 12,771 | $7.4K | 0.0% | New |
| Tower Research Capital LLC (TRC) | 4,548 | $2.6K | 0.0% | No change |
| St. Johns Investment Management Company, LLC | 1,924 | $1.1K | 0.0% | +1,724 |
| BlackRock, Inc. | 703 | $408 | 0.0% | No change |
| UBS Group AG | 642 | $373 | 0.0% | −4,563 |
| Wells Fargo & Company/mn | 34 | $20 | 0.0% | No change |
| Harbour Investments, Inc. | 34 | $20 | 0.0% | No change |
| SBI Securities Co., Ltd. | 23 | $13 | 0.0% | +12 |
| Adkins Seale Capital Management LLC | 3 | $2 | 0.0% | No change |
| Johnson Financial Group, Inc. | 1 | $1 | 0.0% | No change |
| Bogart Wealth, LLC | 1 | $1 | 0.0% | No change |
| Strategic Wealth Partners, Ltd. | 1 | $1 | 0.0% | No change |
| Farther Finance Advisors, LLC | 1 | $1 | 0.0% | No change |
| Keating Financial Advisory Services, Inc. | 1 | $1 | 0.0% | No change |
| Fmr LLC | 0 | $0 | 0.0% | No change |
| Royal Bank Of Canada | 2 | $0 | 0.0% | +1 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How ORAGENICS INC is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARORAGENICS INC1
- CIK0001174940
- Employer ID (EIN)59-34105225
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company5
- Incorporated inFlorida5
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address9015 Town Center Parkway, Suite 143, Lakewood Ranch, FL 342021
- Phone81328679001
- Shares outstanding4,511,957 as of Aug 12, 202613
- Public float$3.1M as of Jun 30, 20255
- AuditorCherry Bekaert LLP, Tampa, Florida PCAOB ID 677; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceOct 16, 20021
- Filings1,144 in all: 8-K (337), 4 (317), 10-Q (57), 3 (35), SC 13D/A (27), CORRESP (25), DEF 14A (24), UPLOAD (23)1
All 56 form types
EFFECT (22), 424B5 (20), 10-K (18), 4/A (15), 424B3 (15), 10QSB (13), D (13), PRE 14A (12), S-8 (12), SC 13G/A (12), DEFA14A (11), POS AM (10), S-3 (10), S-1/A (9), SC 13G (9), SB-2/A (8), 10-K/A (7), S-1 (7), 5 (6), 8-K/A (6), 10KSB (5), 144 (5), DEF 14C (5), PRE 14C (5), SC 13D (5), CT ORDER (4), 10-Q/A (3), FWP (3), NT 10-K (3), 10KSB/A (2), 8-A12B (2), ARS (2), RW (2), S-3/A (2), SB-2 (2), SCHEDULE 13G (2), 10QSB/A (1), 25-NSE (1), 424B4 (1), 5/A (1), 8-A12G (1), CERTAMX (1), CERTNYS (1), DRS (1), DRSLTR (1), NT 10-Q (1), S-1MEF (1), S-3MEF (1)
- Latest filingsAnnual report (10-K) Mar 16, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) May 20, 2026
Latest 8-K (8-K) Sep 16, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock $0.001 par value per share | OGEN | NYSE |
From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks ORAGENICS INC names in Item 1A of its 10-K filed Mar 16, 2026: 67 risks under these headings, as written.5
- Risks Related to Our Business
- We have incurred significant losses since our inception and expect to continue to experience losses for the foreseeable future and may not be able to continue as a going concern.
- We will require additional capital to complete the development of ONP-002 and to operate our business, and we may not be able to obtain such capital on acceptable terms, or at all.
- There is substantial doubt regarding our ability to continue as a going concern, absent additional capital beyond our current operating horizon.
- The Certificate of Designation for our Series H Convertible Preferred Stock (the “Series H Preferred Stock”) contains anti-dilution provisions that may result in the reduction of the Conversion Price for the Series H Preferred Stock in the future. This feature may result in an indeterminate number of shares of Common Stock being issued upon conversion.
- We will need to raise additional capital in the future to complete the development and commercialization of our product candidates and operate our business.
- The market price of our Common Stock may never exceed the Conversion Price of the Series H Preferred Stock.
- The issuance of additional equity securities by us in the future would result in dilution to our existing common shareholders.
- Future sales of our Common Stock in the public market could cause our stock price to fall.
- We have limited concussion and neurology-specific research, development, manufacturing, testing, regulatory, commercialization, sales, distribution, and marketing experience, and we may need to invest significant financial and management resources to establish these capabilities. Despite such investments and our best efforts, our strategic acquisition of the ONP-002 and ONP-001 neurology drug assets may turn out to be unsuccessful.
- Our success with regard to the Neurology Assets depends on the viability of our business strategy with regard to those assets, which is unproven and may be unfeasible.
- There are substantial inherent risks in attempting to commercialize newly developed products, and, as a result, we may not be able to successfully develop any products.
The other 56 risks
- With limited resources we have paused our other product candidate research and development and now rely on the progress and success of ONP-002.
- We will need to achieve commercial acceptance of our products, if cleared or approved, to generate revenues and achieve profitability.
- The product candidates included in the Neurology Assets are still in development and we have not obtained authorization from any regulatory agency to commercially distribute such products in any country, and we may never obtain such authorizations.
- Our concussion drug product candidate is at the Phase 2 clinical stage and has not been approved for sale. We have not conducted substantial research and development for a concussion product candidate, and we may be unable to produce a concussion drug that successfully treats mild traumatic brain injury in a timely and economical manner, if at all.
- We are, and will continue to be, dependent in significant part on outside scientists and third-party research institutions for our research and development in order to be able to commercialize our product candidates.
- The third-party vendors upon whom we rely for the supply of ONP-002 are our sole source of supply, and the loss of these suppliers could significantly harm our business.
- The market opportunities for our concussion drug product candidate may be smaller than we believe them to be, or alternative drugs or technologies may be adopted, before our concussion drug achieve regulatory approval.
- If we are unable to successfully develop our product candidates, our operating results and competitive position could be harmed. Research and development involve a lengthy and complex process, and we may not be successful in our efforts to develop and commercialize our product candidates. The further development and ultimate commercialization of our Neurology Assets, as well as our other product candidates, are keys to our strategy.
- If we are successful in producing a treatment for mTBI (concussion), we may need to devote significant resources to its scale-up and development, including for use by the U.S. government or other foreign authorities. Moreover, government involvement may limit the commercial success of our concussion product candidate.
- Our product candidates, if approved, will face significant competition and our failure to compete effectively may prevent us from achieving significant market penetration.
- Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities.
- We may choose not to continue developing or commercializing any of our product candidates at any time during development or after approval, which would reduce or eliminate our potential return on investment for those product candidates.
- If any of our product candidates are shown to be ineffective or harmful in humans, we will be unable to generate revenues from these product candidates.
- We intend to seek licensing partners to cover a portion of the costs associated with obtaining regulatory approval for, and manufacturing and marketing of, our product candidates. If we are unable to obtain agreements with third parties to fund these costs, we will have to fund such costs ourselves or we may be unable to extract any value from these technologies.
- We are heavily dependent upon the ability and expertise of our management team and a very limited number of employees, and the loss of such individuals could have a material adverse effect on our business, operating results or financial condition.
- We need to hire and retain additional qualified scientists and other highly skilled personnel to maintain and grow our business.
- We might not be successful at acquiring, investing in or integrating businesses, entering into joint ventures or divesting businesses.
- We may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.
- We may be adversely affected by natural disasters, pandemics and other catastrophic events, and by man-made problems such as terrorism, that could disrupt our business operations, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
- Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited, each of which could harm our business.
- If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud.
- Risks Related to Our Intellectual Property and Data Security and Privacy
- Our limited resources and decision to pause the development of our COVID-19 vaccine candidate to focus on the development of ONP-002 may result in our breach of certain contracts.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- Changes in patent law or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- If we are unable to protect our trademarks or other intellectual property from infringement, our business prospects may be harmed.
- We may not be able to protect our intellectual property rights throughout the world.
- If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming and an unfavorable outcome in that litigation could have a material adverse effect on our business.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property or the patents of our licensors, which could be expensive and time consuming.
- If our intellectual property rights do not adequately protect our products or product candidates, or if third parties claim we are infringing their intellectual property rights, others could compete against us more directly or we could be subject to significant litigation. Such results could prevent us from marketing our products or product candidates and hurt our profitability.
- Our business and operations would suffer in the event of cybersecurity/information systems risk.
- Security breaches and other disruptions to our information technology systems or those of the vendors on whom we rely on could compromise our information and expose us to liability, reputational damage, or other costs.
- We may incur costs of addressing a cybersecurity incident.
- Risks Related to Government Regulations
- Our product candidates are subject to substantial government regulation, including the regulation of nonclinical testing and clinical trials. If we are unable to obtain regulatory approval for our product candidates, we will be unable to generate revenues.
- Clinical trials conducted outside of the United States, present additional risks.
- We may be unable to obtain regulatory approval for our concussion candidate, or other early-stage product candidates under applicable regulatory requirements. The FDA and foreign regulatory bodies have substantial discretion in the approval process, including the ability to delay, limit or deny approval of product candidates. The delay, limitation or denial of any regulatory approval would adversely impact commercialization, our potential to generate revenue, our business and our operating results.
- Delays or difficulties in the enrollment of patients in clinical trials may result in additional costs and delays in our ability to generate significant revenues and may delay or prevent our receipt of any regulatory approvals necessary to commercialize our planned and future products.
- Any product candidates that we commercialize will be subject to ongoing and continued regulatory review.
- Our product candidates may cause serious or undesirable side effects or possess other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of approved labeling or result in post-approval regulatory action.
- We may also be subject to healthcare laws, regulation and enforcement and our failure to comply with those laws could adversely affect our business, operations and financial condition.
- Our employees, independent contractors, principal investigators, consultants, vendors and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- Even if our current product candidates or any future product candidates obtain regulatory approval, they may fail to achieve the broad degree of health care payers, physician and patient adoption and use necessary for commercial success.
- If we are unable to achieve and maintain coverage and adequate levels of reimbursement for any of our product candidates for which we receive regulatory approval, or any future products we may seek to commercialize, their commercial success may be severely hindered.
- Risks Related to Our Common Stock
- We cannot assure you that we will continue to be listed on the NYSE American.
- Our financial results could vary significantly from quarter to quarter and are difficult to predict.
- The conversion of our Series F and Series H Preferred Stock, and the exercise of currently outstanding warrants could result in significant dilution to the holders of our common stock.
- Certain provisions of our articles of incorporation, bylaws, executive employment agreements and stock option plan may prevent a change of control of our company that a shareholder may consider favorable.
- The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial losses for shareholders.
- We may be subject to securities litigation, which is expensive and could divert management attention.
- Future sales or issuances of our common stock in the public markets, or the perception of such sales, could depress the trading price of our common stock.
- The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified members for our Board of Directors.
- If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our business and operating results and cause the trading price of our stock to decline.
- We will continue to incur significant costs as a result of and devote substantial management time to operating as a public company listed on the NYSE American.
- If securities or industry analysts publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
- We may issue debt or debt securities convertible into equity securities, any of which may be senior to our common stock as to distributions and in liquidation, which could negatively affect the value of our common stock.
- We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.
- We do not intend to pay cash dividends.
Legal proceedings
On December 7, 2022, the Company entered into an investment-banking engagement letter with Ladenburg Thalmann & Co. Inc. (“Ladenburg”), which was subsequently amended several times (collectively, the “Engagement Letter”). The Company terminated the Engagement Letter effective August 15, 2023. Following the termination, Ladenburg asserted that it was entitled to a fee in connection with the Company’s purchase of assets from Odyssey Health, Inc., and issued an invoice for $2,500,000 to the Company. The Company disputed that no such fee is owed. Related proceedings were also filed in the United States District Court for the Southern District of Florida. On October 16, 2025, the Company and Ladenburg executed a Settlement Agreement (the “Settlement Agreement”) resolving all claims between the parties. Under the terms of the Settlement Agreement, the Company agreed to pay $700,000, which was wired on October 17, 2025, in full satisfaction of the matter.
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.
- 1SEC EDGARORAGENICS INC filings on SEC EDGAR
- 2
- 3SEC EDGARORAGENICS INC filings on SEC EDGAR
- 4
- 5
- 6SEC EDGARORAGENICS INC 10-K for fiscal 2023
- 7SEC EDGARORAGENICS INC 10-K for fiscal 2023
- 8SEC EDGARORAGENICS INC 10-K for fiscal 2021
- 9SEC EDGARORAGENICS INC 10-K for fiscal 2022
- 10SEC EDGARORAGENICS INC 10-K for fiscal 2019
- 11SEC EDGARORAGENICS INC 10-K for fiscal 2020
- 12SEC EDGARORAGENICS INC 10-Q for fiscal 2026
- 13SEC EDGARORAGENICS INC 10-Q for fiscal 2026
- 14
- 15
- 16SEC EDGARAlan Joslyn, Chief executive officer
- 17
- 18
- 19
- 20
- 21SEC EDGARJ. Michael Redmond, President
- 22
- 23
- 24
- 25
- 26
- 27SEC EDGARMichael O'Keefe Sullivan, Officer
- 28SEC EDGARAlan Joslyn, Officer
- 29
- 30SEC EDGARRobert T. Zahradnik, PLEASE PROVIDE
- 31SEC EDGARNatasha Giordano, Board member
- 32SEC EDGARBruce A. Cassidy Sr., Board member
- 33SEC EDGARKimberly M. Murphy, Board member
- 34SEC EDGARAlan W. Dunton, Board member
- 35SEC EDGARCharles L. Pope, Board member
- 36SEC EDGARFred Telling, Board member
- 37SEC EDGARChristine L. Koski, Board member
- 38SEC EDGARDerek Hennecke, Board member
- 39SEC EDGARRichard T. Welch, Board member
- 40SEC EDGARStanley Bruce Stein, Board member
- 41SEC EDGARKevin H. Sills, Board member
- 42SEC EDGARRonald P. Evens, Board member
- 43SEC EDGARDavid J. Gury, Board member
- 44SEC EDGARGeorge T. Hawes, Board member
- 45
- 46
- 47
- 48
- 49SEC EDGAROther events
- 50SEC EDGAROther events
- 51SEC EDGARDirector nominations
- 52SEC EDGAROther events
- 53SEC EDGAREntered a material agreement
- 54SEC EDGARRegulation FD disclosure
- 55SEC EDGARExecutive or director change
- 56SEC EDGAROther events
- 57NasdaqNasdaq calendar
- 58
- 59
- 60
- 61
- 62
- 63