Overview
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- TickerPCSA on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersVero Beach, United States2
- Incorporated inDE3
- Business address601 21St Street, Suite 300, Vero Beach, Fl 329603
- Filer category, Emerging growth company3
- Legal formCorporation2
- LEI529900A51HZIE4XJB9602
- StatusActive2
- LEI statusIssued and current2
- Registered addressc/o National Registered Agents, Inc.,1209 Orange Street, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 49610942
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(“NGC”) small molecules, one of which is currently in a Phase 2 trial, while the other is in pre-clinical development.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 2022
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.13
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development expenses | $7.8M | $7.3M |
| General and administrative expenses | $6.2M | $4.8M |
| Operating Loss | -$14.0M | -$12.1M |
| Other income | $20.0K | |
| Unrealized gain on digital assets at fair value | $295.2K | |
| Interest and dividend income, net | $109.5K | $201.1K |
| Net Operating Loss Before Income Tax Benefit | -$13.6M | -$11.9M |
| Net Loss | -$13.6M | -$11.9M |
| Net Loss Per Common Share - Basic | -$10.36 | -$96.78 |
| Net Loss Per Common Share - Diluted | -$10.36 | -$96.78 |
| Weighted Average Common Shares Used to Compute Net Loss Per Common Shares - Basic | 1.3M shares | 122.4K shares |
| Weighted Average Common Shares Used to Compute Net Loss Per Common Shares - Diluted | 1.3M shares | 122.4K 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.13
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $5.5M | $1.2M | |
| Prepaid expenses and other | $133.9K | $687.8K | |
| Total Current Assets | $5.7M | $1.9M | |
| Digital assets at fair value | $1.1M | ||
| Prepaid expenses | $993.7K | $1.3M | |
| Equipment, net | $3.8K | $5.0K | |
| Operating lease right-of-use assets, net | $70.7K | ||
| Total Assets | $7.8M | $3.2M | |
| Current maturities of lease liability | $73.0K | ||
| Accounts payable | $1.1M | $880.9K | |
| Accrued expenses | $1.2M | $578.7K | |
| Total Current Liabilities | $2.2M | $1.5M | |
| Non-current lease liability | $487 | ||
| Total Liabilities | $2.2M | $1.5M | |
| Common stock, par value $0.0001, 1,000,000,000 shares authorized; 2,572,114 issued and 2,571,914 outstanding at December 31, 2025 and 148,308 issued and 148,108 outstanding at December 31, 2024 | $257 | $15 | |
| Additional paid-in capital | $106.7M | $89.2M | |
| Treasury stock, 200 shares at cost | -$300.0K | -$300.0K | |
| Accumulated deficit | -$100.8M | -$87.2M | |
| Total Stockholders Equity | $5.6M | $1.7M | $5.0M |
| Total Liabilities and Stockholders Equity | $7.8M | $3.2M | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 1.0M shares | 1.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 1.0B shares | 100.0M shares | |
| Common stock, shares issued | 2.6M shares | 148.3K shares | |
| Common stock, shares outstanding | 2.6M shares | 148.1K shares | |
| Treasury stock, shares | 200 shares | 200 shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $5.5M | $1.2M | |
| Prepaid expenses and other | $133.9K | $687.8K | |
| Total Current Assets | $5.7M | $1.9M | |
| Digital assets at fair value | $1.1M | ||
| Prepaid expenses | $993.7K | $1.3M | |
| Equipment, net | $3.8K | $5.0K | |
| Operating lease right-of-use assets, net | $70.7K | ||
| Total Assets | $7.8M | $3.2M | |
| Current maturities of lease liability | $73.0K | ||
| Accounts payable | $1.1M | $880.9K | |
| Accrued expenses | $1.2M | $578.7K | |
| Total Current Liabilities | $2.2M | $1.5M | |
| Non-current lease liability | $487 | ||
| Total Liabilities | $2.2M | $1.5M | |
| Common stock, par value $0.0001, 1,000,000,000 shares authorized; 2,572,114 issued and 2,571,914 outstanding at December 31, 2025 and 148,308 issued and 148,108 outstanding at December 31, 2024 | $257 | $15 | |
| Additional paid-in capital | $106.7M | $89.2M | |
| Treasury stock, 200 shares at cost | -$300.0K | -$300.0K | |
| Accumulated deficit | -$100.8M | -$87.2M | |
| Total Stockholders Equity | $5.6M | $1.7M | $5.0M |
| Total Liabilities and Stockholders Equity | $7.8M | $3.2M | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 1.0M shares | 1.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 1.0B shares | 100.0M shares | |
| Common stock, shares issued | 2.6M shares | 148.3K shares | |
| Common stock, shares outstanding | 2.6M shares | 148.1K shares | |
| Treasury stock, shares | 200 shares | 200 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.13
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net Loss | -$13.6M | -$11.9M |
| Depreciation | $1.2K | $782 |
| Non-cash lease expense for right-of-use assets | $70.7K | $87.2K |
| Unrealized gain on digital assets at fair value | -$295.2K | |
| Stock-based compensation | $857.5K | $629.5K |
| Prepaid expenses and other | $834.7K | -$1.0M |
| Operating lease liability | -$66.9K | -$83.6K |
| Accounts payable | $175.9K | $569.3K |
| Due from related parties | -$39 | |
| Accrued expenses | $600.7K | $432.5K |
| Net cash used in operating activities | -$11.4M | -$11.2M |
| Purchase of digital asset | -$850.0K | |
| Purchase of equipment | -$3.2K | |
| Net cash used in investing activities | -$850.0K | -$3.2K |
| Net proceeds from issuance of common stock | $16.6M | $7.8M |
| Shares withheld to pay taxes on stock-based compensation | -$10.4K | -$15.9K |
| Settlement of stock award | -$8.6K | |
| Payment of finance lease obligation | -$6.6K | -$5.2K |
| Net cash provided by financing activities | $16.6M | $7.7M |
| Net Increase (Decrease) in Cash and Cash Equivalents | $4.3M | -$3.5M |
| Cash paid for interest | $5.6K | $1.2K |
| Issuance of 200 shares of common stock in connection with a licensing agreement which had previously been recorded as a due to licensor | $189.0K | |
| Right-of-use asset obtained in exchange for financing lease liability | $11.8K | |
| Financing lease liability | -$11.8K |
No quarter-by-quarter statement was filed.
Corporate structure
Processa Pharmaceuticals, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Processa Pharmaceuticals, Inc.
- Soleus Capital Master Fund, L.P. Filed SCHEDULE 13G on Processa Pharmaceuticals, Inc., latest Aug 18, 2026
- CVI Investments, Inc. Filed SCHEDULE 13G/A on Processa Pharmaceuticals, Inc., latest May 15, 2026 (4 filings since Jun 24, 2025)
- Chiliz Group Ltd. Filed SCHEDULE 13D/A on Processa Pharmaceuticals, Inc., latest Feb 23, 2026 (3 filings since Aug 13, 2025)
- INTRACOASTAL CAPITAL, LLC Filed SCHEDULE 13G/A on Processa Pharmaceuticals, Inc., latest Feb 13, 2026 (3 filings since Jun 23, 2025)
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Processa Pharmaceuticals, Inc., latest Aug 14, 2025 (2 filings since May 15, 2025)
- 3i, LP Filed SCHEDULE 13G on Processa Pharmaceuticals, Inc., latest Jun 23, 2025
- Processa Pharmaceuticals, Inc. Vero Beach, Florida, United States
- Processa Therapeutics LLC Subsidiary · Delaware, United States
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 Processa Pharmaceuticals, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, net | $3.8K13 Dec 31, 2025 | $5.0K13 Dec 31, 2024 | −24.0% |
| Operating-lease assets (leased space) | $70.7K13 Dec 31, 2024 | $146.1K6 Dec 31, 2023 | −51.6% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $5.5M13 Dec 31, 2025 | $1.2M13 Dec 31, 2024 | +364.8% |
Properties, in its own words
We maintain our principal executive office at 601 21st Street, Suite 300 Vero Beach, FL 32960 pursuant to a virtual office agreement.
Item 2 of the 10-K filed Mar 18, 2026.5
Leadership
Who has led Processa Pharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerGeorge K. Ng Aug 9, 2023 to now14
- Chief financial officerRussell Skibsted Jul 18, 2024 to now15
- Chief financial officerJames H. Stanker Oct 2, 2020 to Aug 2, 202416
- Chief operating officerRobert Michael Floyd Oct 16, 2020 to Feb 10, 202317
Board members and other officers (10)
- Chief Business - Strategy OffPatrick Lin Oct 2, 2020 to now18
- Chief Development OfficerSian Bigora Oct 2, 2020 to now19
- Chief Administrative OfficerWendy Guy Oct 2, 2020 to now20
- Board memberSheila Gujrathi Jul 30, 2026 to now21
- Board memberGeorge K. Ng Oct 10, 2023 to now22
- Board memberKhoso Baluch Jul 11, 2022 to now23
- Board memberJames R. Neal Jul 21, 2022 to now24
- Board memberGeraldine Pannu Oct 2, 2020 to now25
- Board memberJustin W. Yorke Oct 2, 2020 to now26
- Board memberKhalid Islam Nov 13, 2020 to Apr 19, 202227
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- Processa Therapeutics LLC Delaware4
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
- Heatwurx, Inc.Oct 28, 2011 to Oct 20, 20173
Timeline
- Oct 5, 20268-K Other events28
- Aug 4, 20268-K Executive or director change; Shareholder vote29
- Jul 29, 20268-K Entered a material agreement; Ended a material agreement; Completed an acquisition or sale30
- Apr 30, 20268-K Executive or director change31
- Feb 19, 20268-K Ended a material agreement32
- Jan 7, 20268-K Other events33
- Dec 15, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed34
- Sep 16, 20258-K Bylaws or fiscal year changed; Shareholder vote35
- Sep 12, 20258-K Shareholder vote36
- Sep 10, 20258-K Shareholder vote37
- Sep 2, 20258-K Shareholder vote38
- Aug 25, 20258-K Other events39
- Aug 9, 2023New chief executive George K. Ng becomes CEO14
- Mar 29, 2011Founded Processa Pharmaceuticals, Inc. is founded2
Calendar
Coming up
- Nov 5, 2026Reports results for the quarter ending Sep/202640
When it reported results
- Mar 31, 2023Reported quarterly or annual results41
- Nov 8, 2022Reported quarterly or annual results42
- Aug 12, 2022Reported quarterly or annual results43
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
423 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 77 major events, 246 insider forms, 14 large holders, 64 other. The latest 20:
- Oct 9, 2026PRE 14A EDGAR
- Oct 9, 2026PRE 14A EDGAR
- Oct 9, 2026S-3 EDGAR
- Oct 5, 20268-K/A EDGAR
- Aug 18, 2026SCHEDULE 13G EDGAR
- Aug 14, 202610-Q EDGAR
- Aug 11, 20264 EDGAR
- Aug 4, 20268-K EDGAR
- Jul 30, 20264 EDGAR
- Jul 30, 20263 EDGAR
- Jul 29, 20268-K EDGAR
- Jul 28, 20264 EDGAR
- Jul 28, 20264 EDGAR
- Jul 28, 20264 EDGAR
- Jul 28, 20264 EDGAR
- Jul 28, 20264 EDGAR
- Jul 28, 20264 EDGAR
- Jul 28, 20264 EDGAR
- Jul 28, 20264 EDGAR
- Jul 1, 20264 EDGAR
The 423 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
69 open-market trades by officers, directors and large owners since October 2021: 66 buys and 3 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jul 1, 2026 | Ng George KChief Executive Officer | Buy | 3,057 | $1.93 | $5.9K | Form 4 |
| Jun 30, 2026 | Guy WendyChief Administrative Officer | Buy | 2,436 | $1.93 | $4.7K | Form 4 |
| Jun 30, 2026 | Lin PatrickChief Business - Strategy Off | Buy | 2,106 | $1.93 | $4.1K | Form 4 |
| Jun 30, 2026 | SKIBSTED RUSSELLChief Financial Officer | Buy | 3,277 | $1.93 | $6.3K | Form 4 |
| Jun 30, 2026 | Young DavidPres. Research & Development | Buy | 2,531 | $1.93 | $4.9K | Form 4 |
| Jun 15, 2026 | Young DavidPres. Research & Development | Buy | 2,067 | $2.22 | $4.6K | Form 4 |
| Jun 15, 2026 | SKIBSTED RUSSELLChief Financial Officer | Buy | 2,654 | $2.22 | $5.9K | Form 4 |
| Jun 15, 2026 | Ng George KChief Executive Officer | Buy | 2,465 | $2.22 | $5.5K | Form 4 |
| Jun 15, 2026 | Lin PatrickChief Business - Strategy Off | Buy | 1,831 | $2.22 | $4.1K | Form 4 |
| Jun 15, 2026 | Guy WendyChief Administrative Officer | Buy | 2,118 | $2.22 | $4.7K | Form 4 |
| May 29, 2026 | Young DavidPres. Research & Development | Buy | 1,786 | $2.57 | $4.6K | Form 4 |
| May 29, 2026 | SKIBSTED RUSSELLChief Financial Officer | Buy | 2,292 | $2.57 | $5.9K | Form 4 |
| May 29, 2026 | Ng George KChief Executive Officer | Buy | 2,129 | $2.57 | $5.5K | Form 4 |
| May 29, 2026 | Lin PatrickChief Business - Strategy Off | Buy | 1,582 | $2.57 | $4.1K | Form 4 |
| May 29, 2026 | Guy WendyChief Administrative Officer | Buy | 1,829 | $2.57 | $4.7K | Form 4 |
| May 15, 2026 | Ng George KChief Executive Officer | Buy | 1,843 | $2.97 | $5.5K | Form 4 |
| May 15, 2026 | Young DavidPres. Research & Development | Buy | 1,545 | $2.97 | $4.6K | Form 4 |
| May 15, 2026 | Lin PatrickChief Business - Strategy Off | Buy | 1,369 | $2.97 | $4.1K | Form 4 |
| May 15, 2026 | Guy WendyChief Administrative Officer | Buy | 1,583 | $2.97 | $4.7K | Form 4 |
| May 15, 2026 | SKIBSTED RUSSELLChief Financial Officer | Buy | 1,984 | $2.97 | $5.9K | Form 4 |
All 69 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.
- Soleus Capital Master Fund, L.P.SCHEDULE 13G, 1 filing Aug 18, 202644
- CVI Investments, Inc.SCHEDULE 13G/A, 4 filings Jun 24, 2025 to May 15, 202645
- Chiliz Group Ltd.SCHEDULE 13D/A, 3 filings Aug 13, 2025 to Feb 23, 202646
- INTRACOASTAL CAPITAL, LLCSCHEDULE 13G/A, 3 filings Jun 23, 2025 to Feb 13, 202647
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 2 filings May 15, 2025 to Aug 14, 202548
- 3i, LPSCHEDULE 13G, 1 filing Jun 23, 202549
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 | George Ng | 52 | $400.0K | $673.3K50 |
| 2025 | Russell Skibsted | 67 | $400.0K | $566.8K50 |
| 2025 | Sian Bigora | $367.8K | $495.1K50 | |
| 2024 | Chief Executive Officer | $400.0K | $521.0K50 | |
| 2024 | Former Chief Development and Regulatory Officer | $290.9K | $328.3K50 | |
| 2024 | Chief Financial Officer | $183.3K | $244.2K50 |
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 |
|---|---|---|---|---|
| Connective Capital Management, LLC | 85,274 | $163.7K | 0.1% | +14,538 |
| Stonepine Capital Management, LLC | 55,000 | $105.6K | 0.1% | No change |
| Geode Capital Management, LLC | 22,090 | $42.4K | 0.0% | −2,818 |
| Citadel Advisors LLC | 21,306 | $40.9K | 0.0% | New |
| StoneX Group Inc. | 11,437 | $29.6K | 0.0% | New |
| XTX Topco Ltd | 13,292 | $25.5K | 0.0% | New |
| Jane Street Group, LLC | 13,264 | $25.5K | 0.0% | New |
| Vanguard Capital Management LLC | 12,729 | $24.4K | 0.0% | No change |
| Vanguard Fiduciary Trust Co | 10,857 | $20.8K | 0.0% | No change |
| UBS Group AG | 7,794 | $15.0K | 0.0% | +5,263 |
| Tower Research Capital LLC (TRC) | 2,499 | $4.8K | 0.0% | +1,581 |
| Jones Financial Companies Lllp | 7 | $13 | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Processa 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 EDGARProcessa Pharmaceuticals, Inc.1
- CIK0001533743
- Employer ID (EIN)45-15397855
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company5
- Incorporated inDelaware5
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address601 21St Street, Suite 300, Vero Beach, FL 329601
- Phone443-776-31331
- Shares outstanding2,793,386 as of Aug 7, 202612
- Public float$8.1M 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 28, 20111
- Filings698 in all: 4 (238), 8-K (156), 10-Q (40), 4/A (38), CORRESP (25), UPLOAD (19), 3 (16), D (14)1
All 46 form types
S-1/A (14), 10-K (13), DEF 14A (10), EFFECT (9), DEFA14A (8), PRE 14A (7), 8-K/A (6), S-1 (6), S-8 (6), SCHEDULE 13G/A (6), 10-K/A (5), 424B5 (5), NT 10-Q (5), SCHEDULE 13G (5), 3/A (4), 424B3 (4), 424B4 (4), S-3 (4), DEF 14C (3), NT 10-K (3), PRE 14C (3), SC 13G (3), D/A (2), SC 13G/A (2), SCHEDULE 13D/A (2), 10-Q/A (1), 8-A12B (1), ARS (1), CERT (1), DEFR14A (1), DRS (1), DRSLTR (1), PRER14A (1), RW (1), RW WD (1), S-1MEF (1), SC 13D (1), SCHEDULE 13D (1)
- Latest filingsAnnual report (10-K) Mar 18, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Jun 18, 2026
Latest 8-K (8-K) Aug 4, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 par value per share | PCSA | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks Processa Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Mar 18, 2026: 53 risks under these headings, as written.5
- We are providing the following summary of the risk factors contained in our Form 10-K to enhance the readability and accessibility of our risk factor disclosures. We encourage our stockholders to carefully review the full risk factors contained in this Form 10-K in their entirety for additional information regarding the risks and uncertainties that could cause our actual results to vary materially from our recent results or from our anticipated future results.
- Risks Related to Our Financial Position and Need for Additional Capital
- Risks Relating to Clinical Development and Commercialization of Our Product Candidates
- Risks Related to our Digital Asset Treasury Strategy
- Risks Relating to Our Intellectual Property Rights
- General Company-Related Risks
- Risks Related to Ownership of Our Common Stock
- We need to raise additional capital to fund our operations.
- We have incurred a history of operating losses and expect to continue to incur substantial costs for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability. Our financial situation creates doubt whether we will continue as a going concern.
- We have limited cash resources and will require additional financing.
- We will need to raise additional capital to complete the development efforts for NGC-Cap and/or NGC-Iri. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
- Our financial statements contain a statement regarding a substantial doubt about our ability to continue as a going concern.
The other 47 risks
- Our ability to use our net operating loss carryforwards and other tax attributes may be limited.
- Our licenses are subject to termination by the licensor in certain circumstances and any termination of a license agreement would result in a loss of important rights and have a material adverse impact on our business and prospects.
- We currently do not have, and may never develop, any FDA-approved, licensed or commercialized products.
- We depend entirely on the successful development of our product candidates, which have not yet demonstrated efficacy for their target indications in clinical trials. We may never be able to demonstrate efficacy for our product candidates, thus preventing us from licensing, obtaining marketing approval by any regulatory agency, and/or commercializing our product(s).
- We must successfully complete clinical trials for our product candidates before we can apply for marketing approval.
- We have little corporate history of conducting clinical trials. Our planned clinical trials or those of our collaborators may reveal significant adverse events, toxicities or other side effects not seen in our preclinical studies and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates.
- Disruptions at the FDA and other government agencies could hinder new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
- Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully license or commercialize the product and the revenue that we generate from its sales, if any, may be limited.
- We are completely dependent on third parties to manufacture our product candidates, and our commercialization of our product candidates could be halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable foreign regulatory authorities, fail to provide us with sufficient quantities of our product candidates or fail to do so at acceptable quality levels or prices.
- Even if we obtain marketing approval for any of our product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expenses.
- Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
- Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
- We could face competition from other biotechnology and pharmaceutical companies, and our operating results would suffer if we fail to innovate and compete effectively.
- We rely on third parties to conduct clinical trials for our product candidates. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize any of our product candidates and our business would be substantially harmed.
- Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
- Even though we may apply for orphan drug designation for a product candidate, we may not be able to obtain orphan drug marketing exclusivity.
- Although we may pursue expedited regulatory approval pathways for a product candidate, it may not qualify for expedited development or, if it does qualify for expedited development, it may not actually lead to a faster development, regulatory review or approval process.
- Third-party coverage and reimbursement, health care cost containment initiatives and treatment guidelines may constrain our future revenues.
- Legal, regulatory and legislative changes with respect to reimbursement, pricing and contracting may adversely affect our business and future prospects.
- 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.
- If any of our product candidates are approved for marketing and we are found to have improperly promoted off-label uses, or if physicians misuse our products or use our products off-label, we may become subject to prohibitions on the sale or marketing of our products, product liability claims and significant fines, penalties and sanctions, and our brand and reputation could be harmed.
- 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.
- Changes in U.S. and international trade policies, particularly with respect to China, Europe and India may adversely impact our business and operating results.
- Investments in Digital Assets are substantially speculative and have a significant risk of resulting in a loss compared to other forms of investment.
- Digital Assets have historically experienced, and are expected to continue to experience, high price volatility which may influence our financial results and the market price of our common stock.
- We may be unable to successfully implement our Digital Asset Strategy.
- Our Digital Asset holdings will be less liquid than existing cash and cash equivalents and may not be able to serve as a source of liquidity to the same extent as cash and cash equivalents.
- If we or our third-party service providers experience a security breach or cyberattack and unauthorized parties obtain access to our Digital Assets, we may lose some or all of our Digital Assets and our financial condition and results of operations could be materially adversely affected.
- We face risks relating to the custody of our Digital Assets, including the loss or destruction of private keys required to access our Digital Assets, and cyberattacks or other data loss relating to our Digital Assets.
- Our custodially-held Digital Assets may become part of the custodian’s insolvency estate if one or more of our custodians enters bankruptcy, receivership or similar insolvency proceedings.
- Digital Assets held by us are not subject to FDIC or SIPC protections.
- Digital Assets are novel assets, and are subject to significant legal, commercial, regulatory, and technical uncertainty.
- We could be subject to legal or regulatory action, including fines, in the event the SEC, a foreign regulatory authority, or a court were to determine that a digital asset held by us is a “security” under applicable laws.
- We cannot ensure protection of our licensed intellectual property rights.
- Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Litigation or legal proceedings could expose us to significant liabilities and have a negative impact on our business.
- If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to identify and develop new or next generation product candidates will be impaired, could result in loss of markets or market share and could make us less competitive.
- If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions, interruptions or disruptions to operations or clinical trials, reputational harm, litigation, fines and penalties.
- We are exposed to cyber-attacks and data breaches, including the risks and costs associated with protecting our systems and maintaining integrity and security of our business information, as well as personal data of our guests, employees and business partners.
- Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our Common Stock.
- Future equity offerings, license transactions or acquisitions may dilute our existing stockholders’ ownership and/or have other adverse effects on our operations.
- Our common stock price is volatile.
- We are a “smaller reporting company,” and the reduced disclosure requirements applicable to us as such may make our common stock less attractive to our stockholders and investors.
- We do not currently intend to pay dividends to our stockholders in the foreseeable future, and consequently, your ability to achieve a return on your investment will depend on appreciation in our value.
- Provisions in our corporate documents and Delaware law could have the effect of delaying, deferring, or preventing a change in control of us, even if that change may be considered beneficial by some of our stockholders.
- Provisions in our bylaws provide for indemnification of officers and directors, which could require us to direct funds away from our business and the development of our product candidates.
Legal proceedings
From time to time, we may become involved in litigation or other legal proceedings. Except as described below, we are not currently a party to any material litigation or legal proceedings. Regardless of outcome, any litigation that we may become involved in can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
On May 7, 2024, the Company received notification from Elion purporting to terminate the license agreement by and between the Company and Elion as a result of the Company’s alleged breach thereof. The Company believes that Elion’s claims are without merit and disputes that the license agreement has been validly terminated. On July 5, 2024, the Company filed a complaint in the Commercial Division of the Supreme Court of the State of New York, New York County seeking monetary damages, declaratory judgement and injunctive relief. On August 14, 2024, the Company received Elion’s answer and counterclaims. On October 10, 2024, the Company filed its response to Elion’s counterclaims. The Company intends to enforce its rights under the license agreement and will pursue such other remedies as it determines are appropriate. The discovery phase of the matter commenced several months ago and is ongoing.
The opening of Item 3, Legal Proceedings.5
Sources
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- 21SEC EDGARSheila Gujrathi, Board member
- 22SEC EDGARGeorge K. Ng, Board member
- 23SEC EDGARKhoso Baluch, Board member
- 24SEC EDGARJames R. Neal, Board member
- 25SEC EDGARGeraldine Pannu, Board member
- 26SEC EDGARJustin W. Yorke, Board member
- 27SEC EDGARKhalid Islam, Board member
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- 31SEC EDGARExecutive or director change
- 32SEC EDGAREnded a material agreement
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- 36SEC EDGARShareholder vote
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