Overview
- TickerADIL on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersCharlottesville, Virginia1
- Incorporated inDE2
- Business address1180 Seminole Trail, Suite 495, Charlottesville, Va 229012
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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Latvia, Bulgaria and Croatia). Approximately one-third of the total screened patients tested positive for the targeted genotypes.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 3 fiscal years, latest first.9
| Period ending | 2025-12-31 | 2025-09-30 | 2024-12-31 |
|---|---|---|---|
| Research and development | $2.6M | $3.2M | |
| General and administrative | $5.2M | $5.1M | |
| Total Operating Expenses | $7.8M | $8.3M | |
| Loss From Operations | -$7.8M | -$8.3M | |
| Interest income | $149.6K | $178.7K | |
| Inducement expense | -$4.5M | ||
| Loss on equity method investment | -$492.1K | $492.1K | -$552.2K |
| Other income (expense) | $164.9K | -$75.0K | |
| Total other Income (Expense) | -$177.7K | -$4.9M | |
| Net Loss | -$8.0M | -$13.2M | |
| Loss per share, basic (in Dollars per share) | -$11.93 | -$68.01 | |
| Loss per share, diluted (in Dollars per share) | -$11.93 | -$68.01 | |
| Weighted average shares, basic (in Shares) | 668.6K shares | 194.1K shares | |
| Weighted average shares, diluted (in Shares) | 668.6K shares | 194.1K 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.9
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $5.9M | $3.8M | |
| Prepaid expenses and other current assets | $299.7K | $308.2K | |
| Total Current Assets | $6.2M | $4.1M | |
| Intangible assets, net | $2.8K | $3.3K | |
| Equity method investment | $489.7K | $981.8K | |
| Total Assets | $6.7M | $5.0M | |
| Accounts payable | $655.2K | $250.1K | |
| Accrued expenses | $741.7K | $677.5K | |
| Total Current Liabilities | $1.4M | $975.9K | |
| Total Liabilities | $1.4M | $975.9K | |
| Common Stock, 100,000,000 shares authorized with a par value of $0.001 per share, 1,111,124 and 258,940 shares issued and outstanding at December 31, 2025 and 2024, respectively | $1.1K | $259 | |
| Additional paid in capital | $95.2M | $86.1M | |
| Accumulated deficit | -$90.0M | -$82.0M | |
| Total Stockholders Equity | $5.3M | $4.1M | $4.1M |
| Total Liabilities and Stockholders Equity | $6.7M | $5.0M | |
| Preferred stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized (in Shares) | 5.0M shares | 5.0M shares | |
| Preferred stock, shares outstanding (in Shares) | 0 shares | 0 shares | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares Outstanding (in Shares) | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 1.1M shares | 258.8K shares | |
| Common stock, shares Outstanding (in Shares) | 1.1M shares | 258.8K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $5.9M | $3.8M | |
| Prepaid expenses and other current assets | $299.7K | $308.2K | |
| Total Current Assets | $6.2M | $4.1M | |
| Intangible assets, net | $2.8K | $3.3K | |
| Equity method investment | $489.7K | $981.8K | |
| Total Assets | $6.7M | $5.0M | |
| Accounts payable | $655.2K | $250.1K | |
| Accrued expenses | $741.7K | $677.5K | |
| Total Current Liabilities | $1.4M | $975.9K | |
| Total Liabilities | $1.4M | $975.9K | |
| Common Stock, 100,000,000 shares authorized with a par value of $0.001 per share, 1,111,124 and 258,940 shares issued and outstanding at December 31, 2025 and 2024, respectively | $1.1K | $259 | |
| Additional paid in capital | $95.2M | $86.1M | |
| Accumulated deficit | -$90.0M | -$82.0M | |
| Total Stockholders Equity | $5.3M | $4.1M | $4.1M |
| Total Liabilities and Stockholders Equity | $6.7M | $5.0M | |
| Preferred stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized (in Shares) | 5.0M shares | 5.0M shares | |
| Preferred stock, shares outstanding (in Shares) | 0 shares | 0 shares | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares Outstanding (in Shares) | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 1.1M shares | 258.8K shares | |
| Common stock, shares Outstanding (in Shares) | 1.1M shares | 258.8K 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 3 fiscal years, latest first.9
| Period ending | 2025-12-31 | 2025-09-30 | 2024-12-31 |
|---|---|---|---|
| Loss from operations | -$8.0M | -$13.2M | |
| Stock-based compensation | $676.2K | $796.8K | |
| Amortization of intangible assets | $565 | $565 | |
| Inducement expense | $4.5M | ||
| Cost of commitment shares issued | $75.0K | ||
| Change in fair value contingent consideration | -$150.0K | ||
| Loss on equity method investment | $492.1K | -$492.1K | $552.2K |
| Prepaid expenses and other current assets | $8.6K | $63.4K | |
| Accrued expenses | $100.3K | $199.7K | |
| Accrued expenses, related party | -$47.9K | ||
| Accounts payable and other current liabilities | $405.1K | $146.8K | |
| Accounts payable, related party | -$48.3K | $24.2K | |
| Net cash used in operating activities | -$6.5M | -$6.9M | |
| Cash receipt from contingent consideration | $150.0K | ||
| Net cash provided by investing activities | $150.0K | ||
| Net proceeds from sale of common stock | $3.7M | $4.0M | |
| Proceeds from warrant exercise, net of expenses | $4.8M | $3.8M | |
| Net cash provided by financing activities | $8.5M | $7.8M | |
| NET INCREASE IN CASH AND CASH EQUIVALENTS | $2.1M | $923.4K | |
| Issuance of common stock to settle bonus accrual | $36.0K |
No quarter-by-quarter statement was filed.
Corporate structure
ADIAL 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 ADIAL PHARMACEUTICALS, INC.
- Coastlands Capital LP Filed SCHEDULE 13G/A on ADIAL PHARMACEUTICALS, INC., latest Jul 1, 2026 (2 filings since Jun 24, 2026)
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on ADIAL PHARMACEUTICALS, INC., latest May 15, 2026 (4 filings since Feb 14, 2024)
- INTRACOASTAL CAPITAL, LLC Filed SCHEDULE 13G on ADIAL PHARMACEUTICALS, INC., latest Jun 23, 2025
- Kevin Schuyler Filed SC 13D/A on ADIAL PHARMACEUTICALS, INC., latest Feb 18, 2022
- Mark Howard Peikin Filed SC 13G/A on ADIAL PHARMACEUTICALS, INC., latest Feb 14, 2022
- ADIAL PHARMACEUTICALS, INC. Charlottesville, Virginia
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What ADIAL 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.
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $5.9M9 Dec 31, 2025 | $3.8M9 Dec 31, 2024 | +56.8% |
| Stakes in other companies (equity method) | $489.7K9 Dec 31, 2025 | $981.8K9 Dec 31, 2024 | −50.1% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $2.8K9 Dec 31, 2025 | $3.3K9 Dec 31, 2024 | −16.8% |
Inventory
Properties, in its own words
We believe that we have adequate space for our anticipated needs and that suitable additional space will be available at commercially reasonable prices as needed.
Item 2 of the 10-K filed Mar 5, 2026.3
Leadership
Who has led ADIAL PHARMACEUTICALS, INC., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerCary J. Claiborne Aug 22, 2022 to now12
- Chief executive officerWilliam B. Stilley Iii. Jul 26, 2018 to Feb 25, 202213
- Chief financial officerVinay Shah Nov 18, 2024 to now14
- Chief financial officerJoseph Truluck Jul 26, 2018 to Mar 27, 202415
- Chief operating officerCary J. Claiborne Dec 8, 2021 to Feb 25, 202216
- Chief operating officerJoseph Truluck Jul 26, 2018 to Jul 26, 201815
Board members and other officers (13)
- Chief Development OfficerMatt Davidson Jun 16, 2026 to now17
- Chief Medical OfficerBankole A. Johnson Mar 26, 2019 to Feb 25, 202218
- Board memberMatt Davidson Jun 16, 2026 to now17
- Board memberWendy B. Young Jun 16, 2026 to now19
- Board memberCary J. Claiborne Nov 3, 2021 to now20
- Board memberJoseph Truluck Mar 5, 2020 to Mar 5, 202021
- Board memberJack W. Reich May 20, 2020 to May 20, 202022
- Board memberBankole A. Johnson Jul 26, 2018 to Jun 2, 202323
- Board memberJ. Kermit Anderson Jul 26, 2018 to now24
- Board memberJames W. Newman Jr. Jul 26, 2018 to now25
- Board memberKevin Schuyler Jul 26, 2018 to now26
- Board memberRobertson H. Gilliland Jul 26, 2018 to now27
- Board memberWilliam B. Stilley Iii. Jul 26, 2018 to May 25, 202313
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
- Adial Pharmaceuticals, L.L.C.May 12, 2017 to Sep 28, 20172
Timeline
- Oct 2, 20268-K Other events29
- Sep 18, 20268-K Executive or director change; Shareholder vote30
- Sep 16, 20268-K Entered a material agreement; Other events31
- Aug 25, 20268-K Unregistered sale of shares32
- Aug 21, 20268-K Listing notice or transfer33
- Aug 17, 20268-K Results of operations34
- Aug 13, 20268-K Executive or director change; Other events35
- Aug 11, 20268-K Financial statements and exhibits36
- Jun 11, 20268-K Entered a material agreement; Completed an acquisition or sale; New debt or obligation37
- May 11, 20268-K Results of operations38
- Apr 9, 20268-K Executive or director change39
- Mar 6, 20268-K Results of operations40
- Aug 22, 2022New chief executive Cary J. Claiborne becomes CEO12
- Jul 26, 2018New chief executive William B. Stilley Iii. becomes CEO13
Calendar
Coming up
- Nov 12, 2026Reports results for the quarter ending Sep/202641
When it reported results
- Aug 17, 2026Reported quarterly or annual results34
- May 11, 2026Reported quarterly or annual results38
- Mar 6, 2026Reported quarterly or annual results40
- Nov 14, 2025Reported quarterly or annual results42
- Aug 14, 2025Reported quarterly or annual results43
- May 15, 2025Reported quarterly or annual results44
- Mar 4, 2025Reported quarterly or annual results45
- Nov 14, 2023Reported quarterly or annual results46
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
305 filings to the SEC since October 2021: 5 annual reports, 16 quarterly reports, 99 major events, 64 insider forms, 9 large holders, 7 private raises, 105 other. The latest 20:
- Oct 5, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Oct 2, 20268-K CURRENT REPORT EDGAR
- Sep 21, 20264 EDGAR
- Sep 18, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Sep 18, 20268-K CURRENT REPORT EDGAR
- Sep 16, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Sep 16, 20268-K CURRENT REPORT EDGAR
- Aug 28, 2026S-3 REGISTRATION STATEMENT EDGAR
- Aug 28, 2026S-8 REGISTRATION STATEMENT EDGAR
- Aug 25, 20268-K CURRENT REPORT EDGAR
- Aug 24, 2026ARS EDGAR
- Aug 24, 2026DEF 14A PROXY STATEMENT EDGAR
- Aug 21, 20268-K CURRENT REPORT EDGAR
- Aug 17, 20268-K CURRENT REPORT EDGAR
- Aug 14, 202610-Q QUARTERLY REPORT EDGAR
- Aug 13, 20268-K CURRENT REPORT EDGAR
- Aug 11, 2026PRE 14A PROXY STATEMENT EDGAR
- Aug 11, 20268-K/A AMENDMENT NO. 1 TO FORM 8-K EDGAR
- Jul 16, 20264 OWNERSHIP DOCUMENT EDGAR
- Jul 13, 20264 OWNERSHIP DOCUMENT EDGAR
The 305 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
11 open-market trades by officers, directors and large owners since October 2021: 10 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jul 16, 2026 | Coastlands Capital LP10% owner | Buy | 1,233 | $2.75 | $3.4K | Form 4 |
| Jul 14, 2026 | Coastlands Capital LP10% owner | Buy | 2,000 | $2.65 | $5.3K | Form 4 |
| Jul 10, 2026 | Coastlands Capital LP10% owner | Buy | 1,700 | $2.70 | $4.6K | Form 4 |
| Jul 9, 2026 | Coastlands Capital LP10% owner | Buy | 10,053 | $2.79 | $28.0K | Form 4 |
| Jun 29, 2026 | Coastlands Capital LP10% owner | Buy | 25,000 | $2.60 | $65.0K | Form 4 |
| Sep 29, 2023 | Schuyler KevinDirector | Buy | 700 | $2.74 | $1.9K | Form 4 |
| Dec 30, 2021 | Newman James W. Jr.Director | Buy | 25,000 | $2.69 | $67.3K | Form 4 |
| Nov 30, 2021 | Stilley William B. IIIDirector | Buy | 10,600 | $2.75 | $29.1K | Form 4 |
| Nov 29, 2021 | Stilley William B. IIIDirector | Buy | 10,000 | $2.59 | $25.9K | Form 4 |
| Nov 26, 2021 | Newman James W. Jr.Director | Buy | 10,000 | $2.85 | $28.5K | Form 4 |
| Oct 4, 2021 | Johnson Bankole A.Director | Sale | 200,000 | 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.
- Coastlands Capital LPSCHEDULE 13G/A, 2 filings Jun 24, 2026 to Jul 1, 202647
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 4 filings Feb 14, 2024 to May 15, 202648
- INTRACOASTAL CAPITAL, LLCSCHEDULE 13G, 1 filing Jun 23, 202549
- Kevin SchuylerSC 13D/A, 1 filing Feb 18, 202250
- Mark Howard PeikinSC 13G/A, 1 filing Feb 14, 202251
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 | Cary Claiborne | $489.2K | $890.7K52 | |
| 2025 | Tony Goodman | $300.0K | $470.0K52 | |
| 2025 | Vinay Shah | $315.0K | $458.9K52 | |
| 2024 | Chief Executive Officer and Member of the Board of Directors | $485.7K | $1.2M52 | |
| 2024 | Chief Operating Officer | $298.5K | $376.2K52 | |
| 2024 | Chief Financial Officer | $39.4K | $91.2K52 |
Money raised
Private offerings the company reported to the SEC on Form D.
- Nov 28, 2025Raised $4.3 million in a private offering of securities Form D: 1 investor so far Form D
- May 2, 2025Raised $4.8 million in a private offering of securities Form D: 1 investor so far Form D
- Mar 6, 2024Raised $287,500 in a private offering of equity Form D: 1 investor so far Form D
- Oct 19, 2023Raised $4 million in a private offering of equity Form D: 1 investor so far Form D
- May 31, 2023Raised $52,500 in a private offering of equity Form D: $3.1 million offered in all Form D
- Feb 23, 2023Raised $61,603 in a private offering of securities Form D: 1 investor so far Form D
- Feb 11, 2022Raised $10 million in a private offering of securities Form D: 1 investor 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 |
|---|---|---|---|---|
| Jane Street Group, LLC | 32,119 | $82.2K | 0.0% | New |
| Citadel Advisors LLC | 29,547 | $75.6K | 0.0% | New |
| UBS Group AG | 19,147 | $49.0K | 0.0% | +18,605 |
| StoneX Group Inc. | 19,699 | $35.7K | 0.0% | New |
| Geode Capital Management, LLC | 12,393 | $31.7K | 0.0% | −11,856 |
| China Universal Asset Management Co., Ltd. | 8,000 | $20.5K | 0.0% | New |
| Vanguard Fiduciary Trust Co | 5,879 | $15.1K | 0.0% | No change |
| Vanguard Capital Management LLC | 5,831 | $14.9K | 0.0% | +5,470 |
| Manchester Capital Management LLC | 1,923 | $4.9K | 0.0% | No change |
| Tower Research Capital LLC (TRC) | 1,419 | $3.6K | 0.0% | +63 |
| BlackRock, Inc. | 304 | $778 | 0.0% | −806 |
| Raffa Wealth Management, LLC | 83 | $212 | 0.0% | No change |
| Morgan Stanley | 50 | $128 | 0.0% | No change |
| SBI Securities Co., Ltd. | 47 | $120 | 0.0% | No change |
| Wells Fargo & Company/mn | 6 | $15 | 0.0% | No change |
| Harbour Investments, Inc. | 3 | $8 | 0.0% | No change |
| Abound Wealth Management | 1 | $3 | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How ADIAL 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 EDGARADIAL PHARMACEUTICALS, INC.1
- CIK0001513525
- Employer ID (EIN)82-30746683
- Filer statusNon-accelerated filer not 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 address1180 Seminole Trail, Suite 495, Charlottesville, VA 229011
- Phone434-422-98001
- Shares outstanding2,625,890 as of Aug 12, 202611
- Public float$6.5M as of Jun 30, 20253
- AuditorCBIZ CPAs P.C, Marlton, New Jersey PCAOB ID 199; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceMar 16, 20111
- Filings562 in all: 8-K (151), 4 (98), CORRESP (36), EFFECT (26), 10-Q (25), UPLOAD (24), D (19), 424B3 (17)1
All 44 form types
3 (14), S-1/A (13), 424B5 (11), DEF 14A (11), S-3 (11), S-1 (10), S-8 (9), 10-K (8), DEFA14A (6), FWP (6), POS AM (6), SC 13D/A (6), PRE 14A (5), SC 13G (5), SC 13G/A (5), ARS (4), SC 13D (4), 8-K/A (3), DRS (3), DRSLTR (3), SCHEDULE 13G (3), 4/A (2), 424B4 (2), DEFR14A (2), DRS/A (2), SCHEDULE 13G/A (2), 10-Q/A (1), 25-NSE (1), 8-A12B (1), 8-A12B/A (1), CERT (1), NT 10-Q (1), NT 10-Q/A (1), PRER14A (1), RW (1), S-3/A (1)
- Latest filingsAnnual report (10-K) Mar 5, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Aug 24, 2026
Latest 8-K (8-K) Oct 2, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.001 per share | ADIL | Nasdaq |
From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks ADIAL PHARMACEUTICALS, INC. names in Item 1A of its 10-K filed Mar 5, 2026: 66 risks under these headings, as written.3
- Risks Relating to Our Company
- We have incurred net losses every year and quarter since our inception and anticipate that we will continue to incur net losses in the future.
- Our independent registered public accounting firm has expressed doubt about our ability to continue as a going concern.
- We currently have no product revenues and may not generate revenue at any time in the near future, if at all. Currently, we have no products approved for commercial sale.
- We have had limited operations to date and there can be no assurance that we will be able to execute on our business strategy.
- We will need to secure additional financing in order to support our operations and fund our current and future clinical trials. We can provide no assurances that any additional sources of financing will be available to us on favorable terms, if at all. Our forecast of the period of time through which our current financial resources will be adequate to support our operations and the costs to support our general and administrative, selling and marketing and research and development activities are forward-looking statements and involve risks and uncertainties.
- In the past we have identified material weaknesses in our internal controls, and we cannot provide assurances that additional material weaknesses will not occur in the future.
- We rely on a license to use various technologies that are material to our business and if the agreement were to be terminated or if other rights that may be necessary or we deem advisable for commercializing our intended products cannot be obtained, it would halt our ability to market our products and technology, as well as have an immediate material adverse effect on our business, operating results and financial condition.
- Our business is dependent upon the success of our lead product candidate, AD04, which requires significant additional clinical testing before we can seek regulatory approval and potentially launch commercial sales.
- The active ingredient of our product candidate, ondansetron, is currently available in generic form.
- Changes in general economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business and operating results.
- While there exists a large body of evidence supporting the safety of our primary API, ondansetron, under short-term use, there are currently no long-term use clinical safety data available.
The other 55 risks
- The current data for our lead product candidate, AD04 are the result of Phase 2 clinical trials conducted by third parties as well as data generated from the ONWARD trial we conducted and do not currently provide sufficient evidence that our products are viable as potential pharmaceutical products.
- The FDA and/or other global regulators may not accept our planned Phase 3 endpoints for final approval of AD04 and may determine additional clinical trials are required for approval of AD04.
- We will incur additional costs and our approvals could be delayed if the FDA or other global regulators requires additional clinical trials in patients that are negative for the genotypes targeted by AD04. In addition, clinical trials conducted with only genotype positive subjects will likely result in labeling restricted to treating patients that are genotype positive.
- Our use of the currently manufactured clinical trial material in the planned Phase 3 trial is dependent upon the review and approval of the relevant regulatory agencies and authorities.
- Our investigational product, AD04, is dependent on a successful development, approval, and commercialization of a genetic test, which is expected to be classified as a companion diagnostic.
- Our product candidate will require extensive clinical and other testing.
- Our clinical trials may fail to demonstrate adequately the safety and efficacy of AD04 or any future product candidates, which would likely prevent or delay regulatory approval and commercialization.
- If we experience delays in the enrollment of patients in our clinical trials our receipt of necessary regulatory approvals could be delayed or prevented.
- Our success will be dependent upon adoption by physicians and others.
- Rapid technological change and substantial competition may impair the business.
- Risks Relating to Our Business and Industry
- If we do not obtain the necessary regulatory approvals in the United States and/or other countries, we will not be able to sell our product candidates.
- Obtaining and maintaining regulatory approval of product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of product candidates in other jurisdictions.
- Clinical trials are very expensive, time-consuming and difficult to design and implement.
- AD04 and any future product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
- We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.
- There is uncertainty as to market acceptance of our technology and product candidates.
- Even if we are able to obtain regulatory approval for our product candidate or any product candidates we develop or acquire, we will continue to be subject to ongoing and extensive regulatory requirements, and our failure, or the failure of our contract manufacturers, to comply with these requirements could substantially harm our business.
- 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 have no experience selling, marketing or distributing products and have no internal capability to do so.
- We may not be successful in establishing and maintaining strategic partnerships or collaborations, which could adversely affect our ability to develop and commercialize products.
- No assurance can be given that a definitive agreement to implement the terms set forth in the collaboration framework agreement will be executed with Molteni.
- To the extent we elect to enter into licensing or collaboration agreements to partner AD04 or any future product candidates, our dependence on such relationships may adversely affect our business.
- We may face particular data protection, data security and privacy risks in connection with the European Union’s Global Data Protection Regulation and other privacy regulations.
- 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.
- We rely extensively on our information technology systems, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.
- Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or suffer security breaches.
- We have limited protection for our intellectual property. Our licensed patents and proprietary rights may not prevent us from infringing on the rights of others or prohibit potential competitors from commercializing products.
- The technology we license, our products or our development efforts may be found to infringe upon third-party intellectual property rights.
- We may be involved in lawsuits to protect or enforce the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Patents are subject to changing legal interpretation by the USPTO and the Courts.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- 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.
- If we are unable to obtain adequate coverage and reimbursement for our tests, it is unlikely that our tests will gain widespread acceptance.
- A variety of risks associated with marketing AD04 or any future product candidates internationally could materially adversely affect our business.
- We may not successfully effect our intended expansion.
- We rely on key executive officers and scientific, regulatory and medical advisors, and their knowledge of our business and technical expertise would be difficult to replace.
- Declining general economic or business conditions and changes to trade policy, including tariff and customs regulations, may have a negative impact on our business.
- Healthcare reform measures could hinder or prevent the commercial success of our product candidates.
- A shutdown of the U.S. federal government may adversely affect our business.
- 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.
- Risks Related to Our Securities and Investing in Our Securities
- Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.
- 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 cause our stock price to fall.
- We have additional securities available for issuance, which, if issued, could adversely affect the rights of the holders of our common stock.
- If we issue preferred stock with superior rights than our common stock, it could result in a decrease in the value of our common stock and delay or prevent a change in control of us.
- We have never paid dividends and have no plans to pay dividends in the future.
- We are a “smaller reporting company,” and we cannot be certain if the reduced SEC reporting requirements applicable to smaller reporting companies will make our common stock less attractive to investors.
- As a result of being a public company, we are subject to additional reporting and corporate governance requirements that will require additional management time, resources and expense.
- Our common stock has often been thinly traded, so you may be unable to sell at or near ask prices or at all if you need to sell your shares to raise money or otherwise desire to liquidate your shares.
- 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.
- Our need for future financing may result in the issuance of additional securities which will cause investors to experience dilution.
- The application of the “penny stock” rules to our common stock could limit the trading and liquidity of the common stock, adversely affect the market price of our common stock and increase your transaction costs to sell those shares.
- Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Our Certificate of Incorporation and our bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for certain types of state actions that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
- If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
Legal proceedings
We are subject to claims and legal actions that arise in the ordinary course of business from time to time. However, we are not currently subject to any claims or actions that we believe would have a material adverse effect on our financial position or results of operations.
The opening of Item 3, Legal Proceedings.3
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 14SEC EDGARVinay Shah, Chief financial officer
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- 19SEC EDGARWendy B. Young, Board member
- 20SEC EDGARCary J. Claiborne, Board member
- 21SEC EDGARJoseph Truluck, Board member
- 22SEC EDGARJack W. Reich, Board member
- 23SEC EDGARBankole A. Johnson, Board member
- 24SEC EDGARJ. Kermit Anderson, Board member
- 25SEC EDGARJames W. Newman Jr., Board member
- 26SEC EDGARKevin Schuyler, Board member
- 27SEC EDGARRobertson H. Gilliland, Board member
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- 29SEC EDGAROther events
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- 32SEC EDGARUnregistered sale of shares
- 33SEC EDGARListing notice or transfer
- 34SEC EDGARResults of operations
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- 36SEC EDGARFinancial statements and exhibits
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- 38SEC EDGARResults of operations
- 39SEC EDGARExecutive or director change
- 40SEC EDGARResults of operations
- 41NasdaqNasdaq calendar
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