Overview
- TickerCVKD on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersPonte Vedra, Florida1
- Incorporated inDE2
- Business address822 A1A North, Suite 306, Ponte Vedra, Fl 320822
- Filer category, Emerging growth company2
- Legal formCorporation
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4-((2-Hydroxy-3-MethoxyBenzyl)Amino) Benzenesulfonamide Derivatives as 12-Lipoxygenase Inhibitors.3 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.6
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| General and administrative expenses | $9.4M | $6.8M |
| Research and development expenses | $4.1M | $4.2M |
| Depreciation expense | $6.9K | $1.9K |
| Total operating expenses | $13.5M | $11.0M |
| Loss from operations | -$13.5M | -$11.0M |
| Interest and dividend income | $223.8K | $309.3K |
| Total other income | $223.8K | $309.3K |
| Net loss and comprehensive loss | -$13.2M | -$10.7M |
| Net loss per common share, basic (in Dollars per share) | -$6.64 | -$8.73 |
| Net loss per common share, Diluted (in Dollars per share) | -$6.64 | -$8.73 |
| Weighted average number of common shares used in computing net loss per common share, basic (in Shares) | 2.0M shares | 1.2M shares |
| Weighted average number of common shares used in computing net loss per common share, Diluted (in Shares) | 2.0M shares | 1.2M 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.6
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $4.0M | $10.0M | |
| Interest receivable | $5.1K | $38.2K | |
| Prepaid expenses and other current assets | $200.1K | $42.3K | |
| Deferred offering costs | $106.3K | $14.4K | |
| Total current assets | $4.3M | $10.1M | |
| Property, plant and equipment, net | $5.2K | $6.9K | |
| Other assets | $2.2K | $3.8K | |
| Total assets | $4.3M | $10.1M | |
| Accounts payable | $650.7K | $1.5M | |
| Accrued liabilities | $937.3K | $1.2M | |
| Total current liabilities | $1.6M | $2.7M | |
| Total liabilities | $1.6M | $2.7M | |
| Common stock, $0.001 par value; 75,000,000 shares authorized, 2,338,127 shares issued and outstanding as of December 31, 2025; 1,782,486 shares issued and outstanding as of December 31, 2024 | $2.3K | $1.8K | |
| Additional paid-in capital | $41.7M | $33.2M | |
| Accumulated deficit | -$39.0M | -$25.7M | |
| Total stockholders equity | $2.7M | $7.4M | $7.7M |
| Total liabilities and stockholders equity | $4.3M | $10.1M | |
| Preferred stock par value (in Dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized (in Shares) | 7.5M shares | 7.5M shares | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 75.0M shares | 75.0M shares | |
| Common stock, shares issued (in Shares) | 2.3M shares | 1.8M shares | |
| Common stock, shares outstanding (in Shares) | 2.3M shares | 1.8M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $4.0M | $10.0M | |
| Interest receivable | $5.1K | $38.2K | |
| Prepaid expenses and other current assets | $200.1K | $42.3K | |
| Deferred offering costs | $106.3K | $14.4K | |
| Total current assets | $4.3M | $10.1M | |
| Property, plant and equipment, net | $5.2K | $6.9K | |
| Other assets | $2.2K | $3.8K | |
| Total assets | $4.3M | $10.1M | |
| Accounts payable | $650.7K | $1.5M | |
| Accrued liabilities | $937.3K | $1.2M | |
| Total current liabilities | $1.6M | $2.7M | |
| Total liabilities | $1.6M | $2.7M | |
| Common stock, $0.001 par value; 75,000,000 shares authorized, 2,338,127 shares issued and outstanding as of December 31, 2025; 1,782,486 shares issued and outstanding as of December 31, 2024 | $2.3K | $1.8K | |
| Additional paid-in capital | $41.7M | $33.2M | |
| Accumulated deficit | -$39.0M | -$25.7M | |
| Total stockholders equity | $2.7M | $7.4M | $7.7M |
| Total liabilities and stockholders equity | $4.3M | $10.1M | |
| Preferred stock par value (in Dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized (in Shares) | 7.5M shares | 7.5M shares | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 75.0M shares | 75.0M shares | |
| Common stock, shares issued (in Shares) | 2.3M shares | 1.8M shares | |
| Common stock, shares outstanding (in Shares) | 2.3M shares | 1.8M 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.6
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$13.2M | -$10.7M |
| Depreciation expense | $6.9K | $1.9K |
| Equity-based compensation | $1.9M | $1.4M |
| Non-cash lease expense | -$352 | |
| Interest receivable | $33.1K | -$905 |
| Prepaid expenses | -$157.9K | $10.2K |
| Deferred offering costs | -$91.9K | -$14.4K |
| Other assets | $1.6K | |
| Accounts payable | -$851.8K | $1.3M |
| Accrued liabilities | -$244.2K | $543.3K |
| Net cash used in operating activities | -$12.6M | -$7.4M |
| Investment in property and equipment | -$5.1K | -$6.5K |
| Net cash used in investing activities | -$5.1K | -$6.5K |
| Proceeds from warrant inducements | $4.7M | |
| Issuance costs from warrant inducement | -$541.0K | |
| Proceeds from sale of common stock under ATM | $4.9M | $5.1M |
| Issuance costs for sale of common stock under ATM | -$271.2K | -$337.6K |
| Proceeds from the sale of common stock and warrants | $2.3M | |
| Issuance costs for the sale of common stock and warrants | -$291.9K | |
| Proceeds from exercise of warrants | $298 | |
| Proceeds from exercise of stock options | $48.0K | |
| Net cash provided by financing activities | $6.6M | $9.0M |
| Net change in cash and cash equivalents | -$6.0M | $1.6M |
No quarter-by-quarter statement was filed.
Corporate structure
Cadrenal Therapeutics, 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 Cadrenal Therapeutics, Inc.
- PNC Financial Services Filed SCHEDULE 13G on Cadrenal Therapeutics, Inc., latest Aug 7, 2026
- 648 A.s. Havlickova Filed SCHEDULE 13G/A on Cadrenal Therapeutics, Inc., latest Feb 12, 2025 (2 filings since Oct 4, 2024)
- Quang X. Pham Filed SCHEDULE 13D on Cadrenal Therapeutics, Inc., latest Jan 29, 2025 (2 filings since Feb 12, 2024)
- John Raymond Murphy Filed SCHEDULE 13G/A on Cadrenal Therapeutics, Inc., latest Jan 15, 2025 (3 filings since Mar 27, 2023)
- ARMISTICE CAPITAL, LLC Filed SC 13G/A on Cadrenal Therapeutics, Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2024)
- Cadrenal Therapeutics, Inc. Ponte Vedra, Florida
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Cadrenal Therapeutics, 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 |
|---|---|---|---|
| Property and equipment, net | $5.2K6 Dec 31, 2025 | $6.9K6 Dec 31, 2024 | −25.5% |
Investments
Properties, in its own words
Our corporate headquarters are located at 822 A1A North, Suite 306, Ponte Vedra, Florida 32082, which are leased pursuant to a Lease Agreement, originally dated October 15, 2022 with Veranda III Partners, Ltd. (the “Lease Agreement”), as subsequently amended. The Lease Agreement, as most recently amended by an addendum dated October 14, 2025, has a term of 12 months commencing on November 1, 2025. The monthly rent is $2,346. We believe that these headquarters are adequate for our current operations and needs.
Item 2 of the 10-K filed Mar 31, 2026.3
Leadership
Who has led Cadrenal Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerQuang X. Pham Jan 19, 2023 to now9
- ChairQuang X. Pham Jan 19, 2023 to now9
- Chief financial officerQuang X. Pham Jun 10, 2026 to now10
- Chief financial officerMatthew K. Szot Jan 19, 2023 to Jun 10, 202611
- Chief operating officerJeffrey Scott Cole Apr 3, 2024 to now12
Board members and other officers (7)
- Chief Medical OfficerJames J. Ferguson Iii. Feb 6, 2025 to now13
- Chief Medical OfficerDouglas W. Losordo Jan 19, 2023 to Jan 19, 202414
- Board memberLee Scott Golden Dec 3, 2025 to now15
- Board memberQuang X. Pham Jan 19, 2024 to Jan 19, 202416
- Board memberGlynn Wilson Jan 19, 2023 to now17
- Board memberSteven Zelenkofske Jan 19, 2023 to now18
- Board memberRobert Lisicki Jul 24, 2023 to now19
Named in SEC Form D filings
People the company listed in its private-offering notices.
Timeline
- Oct 7, 20268-K Regulation FD disclosure; Other events21
- Sep 29, 20268-K Executive or director change; Shareholder vote22
- Aug 31, 20268-K Regulation FD disclosure; Other events23
- Aug 13, 20268-K Results of operations24
- Jul 21, 20268-K Regulation FD disclosure; Other events25
- Jul 17, 20268-K Executive or director change26
- Jul 10, 20268-K Executive or director change27
- Jul 1, 20268-K Entered a material agreement; Unregistered sale of shares; Other events28
- Jun 29, 20268-K Executive or director change29
- Jun 18, 20268-K Regulation FD disclosure; Other events30
- Jun 3, 20268-K Executive or director change31
- May 7, 20268-K Results of operations32
- Jan 19, 2023New chief executive Quang X. Pham becomes CEO9
Calendar
Coming up
- Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.31) a share, on Nov 10, 2025.33
When it reported results
- Aug 13, 2026Reported quarterly or annual results24
- May 7, 2026Reported quarterly or annual results32
- Mar 31, 2026Reported quarterly or annual results34
- Nov 10, 2025Reported quarterly or annual results35
- Aug 11, 2025Reported quarterly or annual results36
- May 8, 2025Reported quarterly or annual results37
- Mar 13, 2025Reported quarterly or annual results38
- Nov 7, 2024Reported quarterly or annual results39
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
277 filings to the SEC since October 2021: 4 annual reports, 11 quarterly reports, 62 major events, 69 insider forms, 10 large holders, 7 private raises, 114 other. The latest 20:
- Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
- Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
- Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
- Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
- Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
- Oct 8, 2026S-8 REGISTRATION STATEMENT EDGAR
- Oct 7, 20268-K CURRENT REPORT EDGAR
- Sep 29, 20268-K CURRENT REPORT EDGAR
- Sep 3, 2026S-8 REGISTRATION STATEMENT EDGAR
- Aug 31, 20268-K CURRENT REPORT. EDGAR
- Aug 13, 202610-Q QUARTERLY REPORT EDGAR
- Aug 13, 20268-K CURRENT REPORT EDGAR
- Aug 7, 2026SCHEDULE 13G EDGAR
- Aug 3, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Aug 3, 2026ARS EDGAR
- Aug 3, 2026DEF 14A PROXY STATEMENT EDGAR
- Jul 23, 2026PRE 14A PROXY STATEMENT EDGAR
- Jul 21, 20268-K CURRENT REPORT EDGAR
- Jul 20, 2026EFFECT EDGAR
- Jul 20, 2026424B3 PROSPECTUS EDGAR
The 277 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
51 open-market trades by officers, directors and large owners since October 2021: 6 buys and 45 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jun 29, 2026 | Pham Quang XChairman and CEO | Sale | 7,400 | $3.03 | $22.4K | Form 4 |
| Jun 26, 2026 | Pham Quang XChairman and CEO | Sale | 9,029 | $3.05 | $27.5K | Form 4 |
| Jun 25, 2026 | Pham Quang XChairman and CEO | Sale | 2,127 | $3.00 | $6.4K | Form 4 |
| Jun 23, 2026 | Pham Quang XChairman and CEO | Sale | 2,277 | $3.20 | $7.3K | Form 4 |
| Jun 22, 2026 | Pham Quang XChairman and CEO | Sale | 9,167 | $3.55 | $32.5K | Form 4 |
| Jun 17, 2026 | Pham Quang XChairman and CEO | Sale | 513 | $3.16 | $1.6K | Form 4 |
| Jun 16, 2026 | Pham Quang XChairman and CEO | Sale | 3,613 | $3.18 | $11.5K | Form 4 |
| Jun 15, 2026 | Pham Quang XChairman and CEO | Sale | 3,666 | $3.58 | $13.1K | Form 4 |
| Jun 12, 2026 | Pham Quang XChairman and CEO | Sale | 12,996 | $3.94 | $51.2K | Form 4 |
| Jun 11, 2026 | Pham Quang XChairman and CEO | Sale | 1,462 | $4.12 | $6.0K | Form 4 |
| Jun 10, 2026 | Pham Quang XChairman and CEO | Sale | 3,500 | $4.21 | $14.7K | Form 4 |
| Jun 9, 2026 | Pham Quang XChairman and CEO | Sale | 12,992 | $4.06 | $52.7K | Form 4 |
| Jun 8, 2026 | Pham Quang XChairman and CEO | Sale | 5,893 | $4.38 | $25.8K | Form 4 |
| Jun 5, 2026 | Pham Quang XChairman and CEO | Sale | 2,064 | $4.42 | $9.1K | Form 4 |
| Jun 4, 2026 | Pham Quang XChairman and CEO | Sale | 3,898 | $4.41 | $17.2K | Form 4 |
| Jun 3, 2026 | Pham Quang XChairman and CEO | Sale | 2,323 | $4.26 | $9.9K | Form 4 |
| Jun 2, 2026 | Pham Quang XChairman and CEO | Sale | 349 | $4.46 | $1.6K | Form 4 |
| May 29, 2026 | Pham Quang XChairman and CEO | Sale | 303 | $5.01 | $1.5K | Form 4 |
| May 28, 2026 | Pham Quang XChairman and CEO | Sale | 2,989 | $4.93 | $14.7K | Form 4 |
| May 22, 2026 | Pham Quang XChairman and CEO | Sale | 1,165 | $5.69 | $6.6K | Form 4 |
All 51 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.
- PNC Financial ServicesSCHEDULE 13G, 1 filing Aug 7, 202640
- 648 A.s. HavlickovaSCHEDULE 13G/A, 2 filings Oct 4, 2024 to Feb 12, 202541
- Quang X. PhamSCHEDULE 13D, 2 filings Feb 12, 2024 to Jan 29, 202542
- John Raymond MurphySCHEDULE 13G/A, 3 filings Mar 27, 2023 to Jan 15, 202543
- ARMISTICE CAPITAL, LLCSC 13G/A, 2 filings Feb 14, 2024 to Nov 14, 202444
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 | Quang X. Pham | 61 | $751.3K | $1.9M45 |
| 2025 | James J. Ferguson | 72 | $457.4K | $1.4M45 |
| 2025 | Matthew Szot | $459.7K | $1.3M45 | |
| 2024 | Chief Executive Officer | $708.8K | $1.2M45 | |
| 2024 | Former Chief Financial Officer | $435.9K | $868.3K45 |
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- Private raises (Form D) $38.5M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2026 | $16.8M | $16.8M |
| 2025 | $4.4M | $4.4M |
| 2024 | $9.4M | $9.4M |
| 2023 | $7.5M | $7.5M |
| 2022 | $400.0K | $400.0K |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
- Jun 30, 2026Raised $8.8 million in a private offering of securities20 Form D: 1 investor so far Form D
- Apr 1, 2026Raised $7.9 million in a private offering of securities46 Form D: 1 investor so far Form D
- Dec 16, 2025Raised $4.4 million in a private offering of securities47 Form D: 4 investors so far Form D
- Nov 1, 2024Raised $9.4 million in a private offering of securities48 Form D: 5 investors so far Form D
- Jul 14, 2023Raised $7.5 million in a private offering of securities49 Form D: 1 investor so far Form D
- Nov 30, 2022Raised $250,000 in a private offering of debt50 Form D: $1 million offered in all Form D
- Jul 12, 2022Raised $150,000 in a private offering of debt51 Form D: $2 million offered in all 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 |
|---|---|---|---|---|
| Vanguard Capital Management LLC | 50,137 | $167.5K | 0.0% | +4,936 |
| Geode Capital Management, LLC | 19,024 | $63.5K | 0.0% | −2,602 |
| Vanguard Fiduciary Trust Co | 8,311 | $27.8K | 0.0% | No change |
| Tower Research Capital LLC (TRC) | 1,282 | $4.3K | 0.0% | +889 |
| UBS Group AG | 1,112 | $3.7K | 0.0% | +1,109 |
| Grove Bank & Trust | 1,000 | $3.3K | 0.0% | New |
| Morgan Stanley | 706 | $2.4K | 0.0% | +606 |
| Clearstead Advisors, LLC | 650 | $2.2K | 0.0% | New |
| Quest 10 Wealth Builders, Inc. | 380 | $1.3K | 0.0% | New |
| Osaic Holdings, Inc. | 300 | $1.0K | 0.0% | No change |
| Rockefeller Capital Management L.P. | 150 | $501 | 0.0% | No change |
| Wells Fargo & Company/mn | 99 | $331 | 0.0% | No change |
| Barclays PLC | 93 | $311 | 0.0% | New |
| Integrated Wealth Concepts LLC | 86 | $287 | 0.0% | New |
| Archer Investment Corp | 70 | $234 | 0.0% | +35 |
| IFP Advisors, Inc | 30 | $100 | 0.0% | No change |
| Hrt Financial LP | 29,055 | $97 | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Cadrenal Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARCadrenal Therapeutics, Inc.1
- CIK0001937993
- Employer ID (EIN)88-08607463
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address822 A1A North, Suite 306, Ponte Vedra, FL 320821
- Phone904-300-07011
- Shares outstanding3,567,592 as of Aug 13, 20268
- Public float$24.9M as of Jun 30, 20253
- AuditorWithumSmith+Brown, PC, East Brunswick, New Jersey PCAOB ID 100; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceJul 15, 20221
- Filings277 in all: 8-K (61), 4 (57), 144 (25), 10-Q (11), 3 (10), CORRESP (10), UPLOAD (9), 424B5 (8)1
All 37 form types
EFFECT (8), D (7), 424B3 (6), S-1/A (6), S-8 (6), DEFA14A (5), 10-K (4), ARS (4), DEF 14A (4), S-3 (4), SC 13G (4), S-1 (3), 144/A (2), 424B4 (2), DRS/A (2), DRSLTR (2), PRE 14A (2), SC 13G/A (2), SCHEDULE 13G/A (2), SEC STAFF LETTER (2), 3/A (1), 4/A (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), POS AM (1), SCHEDULE 13D (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Mar 31, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) Aug 3, 2026
Latest 8-K (8-K) Oct 7, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.001 per share | CVKD | Nasdaq |
From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Cadrenal Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 76 risks under these headings, as written.3
- Because of the following factors, as well as other factors affecting our financial condition and operating results, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.
- Investors should carefully consider the risks described below before deciding whether to invest in our securities. If any of the following risks actually occur, our business, financial condition or results of operations could be adversely affected. In such case, the trading price of our Common Stock could decline and you could lose all or part of your investment. Our actual results could differ materially from those anticipated in the forward-looking statements made throughout this Annual Report a result of different factors, including the risks we face described below.
- Risks Related to Our Financial Position and Need for Capital
- Our financial statements have been prepared assuming that we will continue as a going concern.
- Any shutdown of the U.S. federal government may adversely affect our business.
- We are a clinical development biopharmaceutical company with a limited operating history.
- We have a limited operating history upon which to evaluate our ability to commercialize our product candidate.
- We have a history of operating losses and expect to continue to incur substantial losses for the foreseeable future. We may never become profitable or, if achieved, be able to sustain profitability.
- Our cash and the proceeds from our completed financings will only fund our operations for a limited time, and we will need to raise additional capital to fund our planned clinical trials and to support our development and commercialization efforts for our product candidates.
- We will also need to raise additional capital to expand our business to meet our long-term business objectives.
- Our need for future financing may result in the issuance of additional securities, which will cause investors to experience dilution.
- Risks Related to Product Development, Regulatory Approval, Manufacturing, and Commercialization
The other 65 risks
- Our future success depends heavily on FDA review of our Phase 3 trial protocol and commencement of our Phase 3 clinical trial.
- The 12-LOX platform of assets is subject to significant clinical risks that could impede our ability to advance CAD-1005 or our second-generation oral candidates.
- Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ staffing and operations, 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.
- Our business is dependent upon the success of our lead investigational product candidate, CAD-1005, which require additional clinical testing before we can seek regulatory approval and potentially launch commercial sales.
- Our business is dependent on the Old Dominion License Agreement, and the termination, non-renewal or failure to maintain that agreement could materially and adversely affect our business, financial condition and prospects.
- All of our current data for our product candidates are the results of clinical trials conducted by third parties and do not necessarily provide sufficient evidence that our products are viable as potential pharmaceutical products or that we can successfully conduct clinical trials.
- As all of the clinical trials for our product candidates to date were conducted by third parties, we cannot be assured that such clinical trials were in compliance with applicable laws, rules and regulations.
- Our efforts to develop our product candidate may not generate data sufficient to support an application for regulatory approval.
- Even if we successfully complete our clinical trials, we may not receive regulatory approval for our product candidates, and we may not be able to commercialize our product candidates and our ability to generate revenue will be limited.
- Orphan drug designation does not translate to approval and, even if we obtain FDA approval, we may not enjoy marketing exclusivity or other expected benefits.
- Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidate.
- Even if we obtain regulatory approval, we will still face ongoing regulatory requirements and our product candidates may face future development and regulatory difficulties.
- Clinical trials are very expensive, time-consuming and difficult to design and implement.
- Delays or difficulty in the enrollment of patients in any or all of our clinical trials could increase our development costs and delay completion of our clinical trials and associated regulatory submissions.
- Even if approved, our product candidates may not have labeling that allows us to successfully commercialize it.
- If any of our product candidates is approved, our success depends on our commercialization efforts, which may not be achieved. If we are unable to commercialize our product candidate, or experience significant delays in doing so, our business could be materially harmed.
- Our product candidates may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
- We have never submitted an NDA to the FDA or comparable applications to other regulatory authorities and we may not be successful in achieving approval of our product candidates.
- After approval of a product candidate, it will remain subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional risk and expense.
- After approval, our products could be subject to labeling and other restrictions and we may be required to withdraw from the market or be subject to penalties if we fail to comply with regulatory requirements.
- We are subject, directly or indirectly, to federal and state obligations and regulations applicable to our marketing practices. If we are unable to comply, or have not complied, with such laws, we could face substantial penalties.
- We currently do not have any long-term supply agreements or commercialization partnerships with third-party manufacturers for the production and distribution of our product candidates and intend to rely upon third parties to produce and distribute them.
- If the manufacturer upon which we rely fails to comply with stringent regulations, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates and may lose potential revenues.
- We face substantial competition, which may result in others discovering, developing or commercializing competing products more successfully than we do, or, perhaps obtaining approval before our product and, potentially delaying our approval.
- If serious adverse effects are identified with respect to any of our product candidates or any of our approved products, we may need to modify or abandon our development of that product candidate, discontinue sale of an approved product, or change our labeling to reflect new safety risks.
- Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and to commercialize our product candidates and affect the prices we may obtain.
- If we market any of our products in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal penalties.
- Our ability to generate product revenues will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.
- The impact of recent healthcare reform legislation, other changes in the healthcare industry, and in healthcare spending is currently unknown and may adversely affect our business model.
- We will rely on third parties and consultants to conduct all of our clinical trials. If these third parties or consultants do not successfully carry out their contractual duties, comply with regulatory requirements, or meet expected deadlines, we may be unable to obtain regulatory approval for any future product candidates.
- We currently do not have any distribution, marketing, support and sales capabilities and plan to rely on third-party distribution partners for the distribution, marketing, support and sales of our products which could delay or limit our ability to generate revenue.
- Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- We intend to establish a sales force to market our product candidates. If we are not successful in doing so, our ability to generate sales and profits will be limited.
- We plan to rely on collaborations and license arrangements with third parties to commercialize, market and promote our marketed products which may limit our ability to generate revenue and adversely affect our profitability.
- Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
- Global health crises may adversely affect our planned operations.
- Compliance with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization of our products.
- General Company-Related Risks
- If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop our current product candidates or any future product candidates, conduct our clinical trials and commercialize our product candidates or any future products we develop.
- We will need to increase the size of our organization, and we may experience difficulties in managing this growth.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit the commercialization of any future products we develop.
- Our business and operations would suffer in the event of computer system failures.
- We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.
- Any failure to maintain the security of information relating to our patients, customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise, could expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm our reputation.
- Use of artificial intelligence in research, development, and commercial activities presents operational, regulatory, ethical, and reputational risks that could adversely affect our business.
- We may acquire other businesses or form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
- Changes in general economic or business conditions, including tariff and customs regulations, may have a negative impact on our business.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain sufficient exclusivity and/or patent protection for our product candidates, or if the scope of the exclusivity or patent protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to commercialize our product candidates successfully may be adversely affected.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming, and unsuccessful.
- If we are sued for infringing the intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
- Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
- We may not be able to enforce our intellectual property rights throughout the world.
- All of our issued U.S. and foreign patents with respect to tecarfarin expired in 2024 and, therefore, we no longer have patent protection for tecarfarin.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- Risks Related to Ownership of Our Common Stock
- An active public trading market for our Common Stock may not be maintained.
- We cannot be assured that we will be able to maintain our listing on the Nasdaq Capital Market.
- Our stock price has fluctuated in the past, has recently been volatile and may be volatile in the future, and as a result, investors in our Common Stock could incur substantial losses.
- Even if our product candidates receive FDA approval, there is no guarantee that the trading price of our Common Stock will increase following approval, and in the past, some companies have not necessarily experienced such an increase.
- If financial or industry analysts do not publish research or reports about our business or if they issue inaccurate or unfavorable commentary or downgrade our Common Stock, our stock price and trading volume could decline.
- Our officers and directors exercise significant control over our Company and may be able to control our management and operations, acting in their best interests and not necessarily those of other stockholders.
- Future sales and issuances of our Common Stock or rights to purchase Common Stock, including pursuant to our equity incentive plans and outstanding warrants, could result in additional dilution of the percentage ownership of our stockholders and could depress the market price of our Common Stock.
- Anti-takeover provisions in our charter documents, and under Delaware law, could make an acquisition of our company, which may be beneficial to our stockholders, more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our Common Stock.
- Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware or the federal district court for the District of Delaware is the exclusive forum for certain disputes between us and our stockholders, which could result in increased costs for our stockholders to bring a claim and could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
- We do not intend to pay dividends in the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the price of our Common Stock.
Legal proceedings
We are not currently a party to any material legal proceedings. We may, however, in the ordinary course of business face various claims brought by third parties, and we may, from time to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating to employment matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation. If this were to happen, the payment of any such awards could have a material adverse effect on our business, financial condition and results of operations. Additionally, any such claims, whether or not successful, could damage our reputation and business.
The opening of Item 3, Legal Proceedings.3
Sources
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- 15SEC EDGARLee Scott Golden, Board member
- 16SEC EDGARQuang X. Pham, Board member
- 17SEC EDGARGlynn Wilson, Board member
- 18SEC EDGARSteven Zelenkofske, Board member
- 19SEC EDGARRobert Lisicki, Board member
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