COYA on Nasdaq
Coya Therapeutics, Inc.
American pharmaceutical preparations company based in Houston1
In its 2026 annual report the company says: “We are a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of regulatory T cells.”3 Its shares trade on Nasdaq under the symbol COYA.1
Price unavailable
Last updated Oct 21, 2026.
Overview
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- TickerCOYA on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersHouston, Texas1
- Incorporated inDE2
- Business address12645 Memorial Dr., Suite F1 #305, Houston, Tx 770242
- Filer category, Emerging growth company2
- Legal formCorporation
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All references in this report to "Coya," the "Company," "we," "us," or "our" mean Coya Therapeutics, Inc. unless stated otherwise or the context otherwise indicates.3 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 2025
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Other costs100¢$7.9M
- Income tax0¢$3.1K
Out of $7.9M in revenue.4 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Collaboration revenue | $7.9M | $3.6M |
| Research and development | $16.7M | $11.9M |
| In-process research and development | $2.3M | $25.0K |
| General and administrative | $11.4M | $8.9M |
| Depreciation | $27.4K | $27.4K |
| Total operating expenses | $30.5M | $20.8M |
| Loss from operations | -$22.6M | -$17.2M |
| Other income | $1.3M | $1.6M |
| Pre-tax loss | -$21.2M | -$15.6M |
| Income tax (expense) benefit | -$3.1K | $720.3K |
| Net loss | -$21.2M | -$14.9M |
| Net loss per share of common stock, basic | -$1.27 | -$0.98 |
| Net loss per share of common stock, diluted | -$1.27 | -$0.98 |
| Weighted-average shares of common stock outstanding, basic | 16.7M shares | 15.2M shares |
| Weighted-average shares of common stock outstanding, diluted | 16.7M shares | 15.2M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.4
| Period ending | 2025-12-31 | 2025-10-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $46.8M | $38.3M | ||
| Prepaids and other current assets | $3.1M | $6.0M | ||
| Total current assets | $49.9M | $44.3M | ||
| Fixed assets, net | $11.2K | $38.6K | ||
| Total assets | $50.0M | $44.3M | ||
| Accounts payable | $1.1M | $1.6M | ||
| Accrued expenses | $3.6M | $1.4M | ||
| Deferred collaboration revenue | $1.2M | $848.3K | ||
| Total current liabilities | $5.9M | $3.8M | ||
| Deferred collaboration revenue | $1.1M | $945.4K | ||
| Total liabilities | $6.9M | $4.8M | ||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 20,934,456 and 16,707,441 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $2.1K | $1.7K | ||
| Additional paid-in capital | $105.0M | $80.3M | ||
| Accumulated deficit | -$62.0M | -$40.7M | ||
| Total stockholders' equity | $43.0M | $39.6M | $35.6M | |
| Total liabilities and stockholders' equity | $50.0M | $44.3M | ||
| Series A convertible preferred stock, par value | $0.00 | $0.00 | ||
| Series A convertible preferred stock, shares authorized | 10.0M shares | 10.0M shares | ||
| Series A convertible preferred stock, shares issued | 0 shares | 0 shares | ||
| Series A convertible preferred stock, shares outstanding | 0 shares | 0 shares | ||
| Common stock, par value | $0.00 | $0.00 | $0.00 | |
| Common stock, shares authorized | 200.0M shares | 200.0M shares | ||
| Common stock, shares issued | 20.9M shares | 16.7M shares | ||
| Common stock, shares outstanding | 20.9M shares | 16.7M shares |
| Period ending | 2025-12-31 | 2025-10-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $46.8M | $38.3M | ||
| Prepaids and other current assets | $3.1M | $6.0M | ||
| Total current assets | $49.9M | $44.3M | ||
| Fixed assets, net | $11.2K | $38.6K | ||
| Total assets | $50.0M | $44.3M | ||
| Accounts payable | $1.1M | $1.6M | ||
| Accrued expenses | $3.6M | $1.4M | ||
| Deferred collaboration revenue | $1.2M | $848.3K | ||
| Total current liabilities | $5.9M | $3.8M | ||
| Deferred collaboration revenue | $1.1M | $945.4K | ||
| Total liabilities | $6.9M | $4.8M | ||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 20,934,456 and 16,707,441 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $2.1K | $1.7K | ||
| Additional paid-in capital | $105.0M | $80.3M | ||
| Accumulated deficit | -$62.0M | -$40.7M | ||
| Total stockholders' equity | $43.0M | $39.6M | $35.6M | |
| Total liabilities and stockholders' equity | $50.0M | $44.3M | ||
| Series A convertible preferred stock, par value | $0.00 | $0.00 | ||
| Series A convertible preferred stock, shares authorized | 10.0M shares | 10.0M shares | ||
| Series A convertible preferred stock, shares issued | 0 shares | 0 shares | ||
| Series A convertible preferred stock, shares outstanding | 0 shares | 0 shares | ||
| Common stock, par value | $0.00 | $0.00 | $0.00 | |
| Common stock, shares authorized | 200.0M shares | 200.0M shares | ||
| Common stock, shares issued | 20.9M shares | 16.7M shares | ||
| Common stock, shares outstanding | 20.9M shares | 16.7M 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.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$21.2M | -$14.9M |
| Depreciation | $27.4K | $27.4K |
| Stock-based compensation, including the issuance of restricted stock | $4.3M | $2.7M |
| Acquired in-process research and development | $2.3M | $25.0K |
| Collaboration receivable | $7.5M | |
| Prepaids and other current assets | $2.9M | -$4.9M |
| Accounts payable | -$527.0K | $477.4K |
| Accrued expenses | $1.1M | -$1.5M |
| Deferred collaboration revenue | $454.2K | $295.9K |
| Net cash used in operating activities | -$10.7M | -$10.3M |
| Purchase of in-process research and development assets | -$1.2M | -$25.0K |
| Net cash used in investing activities | -$1.2M | -$25.0K |
| Proceeds from sale of common stock, net of offering costs | $20.3M | $14.0M |
| Payment of financing costs related to the 2023 Private Placement | -$131.9K | |
| Proceeds from subscription receivable | $11.2K | |
| Proceeds from the exercise of stock options | $38.3K | $2.0K |
| Proceeds from the exercise of warrants | $2.1M | |
| Net cash provided by financing activities | $20.4M | $16.0M |
| Net increase in cash and cash equivalents | $8.5M | $5.7M |
| In process research and development costs in accrued expenses | $1.1M |
No quarter-by-quarter statement was filed.
Corporate structure
Coya 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 Coya Therapeutics, Inc.
- Orin Hirschman Filed SCHEDULE 13G/A on Coya Therapeutics, Inc., latest Jul 27, 2026 (5 filings since Jan 5, 2023)
- Dr. Reddy's Laboratories Filed SCHEDULE 13G on Coya Therapeutics, Inc., latest Mar 12, 2026
- VANGUARD GROUP INC Filed SCHEDULE 13G/A on Coya Therapeutics, Inc., latest Jan 30, 2026 (4 filings since Nov 4, 2024)
- DME Capital Management, LP Filed SCHEDULE 13G/A on Coya Therapeutics, Inc., latest Feb 14, 2025
- GREENLIGHT CAPITAL INC Filed SC 13G/A on Coya Therapeutics, Inc., latest Feb 14, 2024 (2 filings since Dec 12, 2023)
- Howard Berman Filed SC 13G/A on Coya Therapeutics, Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2023)
- Coya Therapeutics, Inc. Houston, Texas
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Coya 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, before depreciation | $136.8K6 Dec 31, 2024 | $136.8K6 Dec 31, 2023 | 0% |
| Accumulated depreciation | $98.2K6 Dec 31, 2024 | $70.9K6 Dec 31, 2023 | +38.6% |
| Property and equipment, net | $11.2K4 Dec 31, 2025 | $38.6K4 Dec 31, 2024 | −70.9% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $46.8M4 Dec 31, 2025 | $38.3M4 Dec 31, 2024 | +22.1% |
Properties, in its own words
We currently conduct business operations from our virtual headquarters in Houston, Texas. We have intentions to move into a physical corporate headquarters sometime in the near future.
Item 2 of the 10-K filed Mar 16, 2026.3
Leadership
Who has led Coya Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
- Chief executive officerArun Swaminathan Nov 12, 2024 to now10
- Chief executive officerHoward Berman Dec 28, 2022 to Jun 5, 202411
- ChairHoward Berman Jan 26, 2026 to now12
- Chief financial officerDavid S. Snyder Dec 28, 2022 to now13
Board members and other officers (9)
- Chief Medical OfficerFred Grossman Jul 19, 2023 to now14
- Chief Medical OfficerAdrian Hepner Dec 28, 2022 to Mar 1, 202315
- Board memberMark H. Pavao Apr 9, 2026 to now16
- Board memberArun Swaminathan Aug 20, 2024 to now17
- Board memberDieter Weinand Aug 21, 2023 to now18
- Board memberAnabella Villalobos Dec 28, 2022 to now19
- Board memberDov A. Goldstein Md. Dec 28, 2022 to now20
- Board memberHideki Garren Dec 28, 2022 to Jan 19, 202421
- Board memberHoward Berman Dec 28, 2022 to now11
Named in SEC Form D filings
People the company listed in its private-offering notices.
Timeline
- Oct 14, 20268-K Other events24
- Oct 5, 20268-K Other events25
- Sep 15, 20268-K Other events26
- Aug 11, 20268-K Results of operations27
- Aug 7, 20268-K Executive or director change28
- Jun 25, 20268-K Shareholder vote29
- May 12, 20268-K Results of operations; Other events30
- May 12, 20268-K Entered a material agreement31
- Apr 2, 20268-K Executive or director change32
- Mar 16, 20268-K Results of operations33
- Jan 30, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure34
- Jan 20, 20268-K Other events35
- Nov 12, 2024New chief executive Arun Swaminathan becomes CEO10
- Dec 28, 2022New chief executive Howard Berman becomes CEO11
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.10) a share, on Nov 12, 2025.36
When it reported results
- Aug 11, 2026Reported quarterly or annual results27
- May 12, 2026Reported quarterly or annual results30
- Mar 16, 2026Reported quarterly or annual results33
- Nov 12, 2025Reported quarterly or annual results37
- Aug 12, 2025Reported quarterly or annual results38
- May 13, 2025Reported quarterly or annual results39
- Mar 18, 2025Reported quarterly or annual results40
- Nov 6, 2024Reported quarterly or annual results41
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
229 filings to the SEC since October 2021: 6 annual reports, 11 quarterly reports, 55 major events, 68 insider forms, 15 large holders, 3 private raises, 71 other. The latest 20:
- Oct 14, 20268-K EDGAR
- Oct 5, 20268-K EDGAR
- Sep 15, 20268-K EDGAR
- Aug 11, 202610-Q EDGAR
- Aug 11, 20268-K EDGAR
- Aug 7, 20268-K/A EDGAR
- Jul 27, 2026SCHEDULE 13G/A EDGAR
- Jun 25, 20268-K EDGAR
- May 13, 2026ARS EDGAR
- May 13, 2026DEFA14A EDGAR
- May 13, 2026DEF 14A EDGAR
- May 12, 20268-K EDGAR
- May 12, 2026424B5 EDGAR
- May 12, 202610-Q EDGAR
- May 12, 20268-K EDGAR
- Apr 9, 20264 EDGAR
- Apr 9, 20263 EDGAR
- Apr 2, 20268-K EDGAR
- Mar 20, 2026EFFECT EDGAR
- Mar 20, 2026424B3 EDGAR
The 229 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
12 open-market trades by officers, directors and large owners since October 2021: 12 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Nov 14, 2024 | SNYDER DAVID SChief Financial Officer | Buy | 1,800 | $7.19 | $12.9K | Form 4 |
| Nov 13, 2024 | Swaminathan ArunChief Executive Officer | Buy | 5,000 | $7.36 | $36.8K | Form 4 |
| Nov 11, 2024 | Grossman FredChief Medical Officer | Buy | 2,710 | $7.37 | $20.0K | Form 4 |
| Nov 11, 2024 | Swaminathan ArunChief Executive Officer | Buy | 5,000 | $7.34 | $36.7K | Form 4 |
| Aug 22, 2023 | Lee AnnDirector | Buy | 1,000 | $3.62 | $3.6K | Form 4 |
| Jan 3, 2023 | Berman HowardExecutive Chairman | Buy | 10,000 | Form 4 | ||
| Jan 3, 2023 | Lee AnnDirector | Buy | 10,000 | Form 4 | ||
| Jan 3, 2023 | Hepner AdrianChief Medical Officer | Buy | 10,000 | Form 4 | ||
| Jan 3, 2023 | SNYDER DAVID SChief Financial Officer | Buy | 7,000 | Form 4 | ||
| Jan 3, 2023 | Garren HidekiDirector | Buy | 2,000 | Form 4 | ||
| Jan 3, 2023 | Villalobos AnabellaDirector | Buy | 10,000 | Form 4 | ||
| Jan 3, 2023 | GOLDSTEIN DOV A MDDirector | Buy | 10,000 | 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.
- Orin HirschmanSCHEDULE 13G/A, 5 filings Jan 5, 2023 to Jul 27, 202642
- Dr. Reddy's LaboratoriesSCHEDULE 13G, 1 filing Mar 12, 202643
- VANGUARD GROUP INCSCHEDULE 13G/A, 4 filings Nov 4, 2024 to Jan 30, 202644
- DME Capital Management, LPSCHEDULE 13G/A, 1 filing Feb 14, 202545
- GREENLIGHT CAPITAL INCSC 13G/A, 2 filings Dec 12, 2023 to Feb 14, 202446
- Howard BermanSC 13G/A, 2 filings Feb 14, 202347
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 | Arun Swaminathan | 57 | $546.0K | $2.1M48 |
| 2025 | Howard Berman | $436.8K | $1.5M48 | |
| 2025 | Fred Grossman | $498.2K | $1.5M48 | |
| 2025 | David Snyder | 65 | $442.0K | $1.4M48 |
| 2024 | Former Chief Executive OfficerFormer Executive Chairman of the Board | $553.3K | $2.7M48 | |
| 2024 | PresidentChief Medical Officer | $479.0K | $1.9M48 | |
| 2024 | Chief Executive OfficerDirector | $441.7K | $1.5M48 | |
| 2024 | Chief Financial Officer and Chief Operating Officer | $425.0K | $1.5M48 |
Money raised
Private offerings the company reported to the SEC on Form D.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 54. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| DME Capital Management, LP | 2,335,540 | $13.7M | 0.3% | No change |
| Vanguard Capital Management LLC | 842,220 | $4.9M | 0.0% | −2,693 |
| Alyeska Investment Group, L.P. | 800,000 | $4.7M | 0.0% | No change |
| AIGH Capital Management LLC | 631,912 | $3.7M | 0.3% | −343,492 |
| CM Management, LLC | 400,000 | $2.3M | 1.5% | +25,000 |
| Private Management Group Inc | 384,217 | $2.2M | 0.1% | +15,121 |
| Marshall Wace, Llp | 249,793 | $1.5M | 0.0% | +24,001 |
| Geode Capital Management, LLC | 228,243 | $1.3M | 0.0% | −5,159 |
| Renaissance Technologies LLC | 192,986 | $1.1M | 0.0% | +89,022 |
| Prosight Management, LP | 170,000 | $994.5K | 0.2% | −250,360 |
| Dimensional Fund Advisors LP | 155,917 | $913.0K | 0.0% | +59,998 |
| Vanguard Fiduciary Trust Co | 129,551 | $757.9K | 0.0% | −10,335 |
| Jones Financial Companies Lllp | 110,910 | $610.0K | 0.0% | +65,950 |
| BlackRock, Inc. | 102,408 | $599.1K | 0.0% | +19,639 |
| Prelude Capital Management, LLC | 101,330 | $592.8K | 0.0% | No change |
| JBF Capital, Inc. | 100,006 | $585.0K | 0.1% | No change |
| Royal Bank Of Canada | 93,414 | $546.0K | 0.0% | +80,022 |
| Morgan Stanley | 82,106 | $480.3K | 0.0% | −3,594 |
| State Street Corp | 79,813 | $466.9K | 0.0% | No change |
| Susquehanna International Group, Llp | 61,006 | $356.9K | 0.0% | +21,690 |
| Northern Trust Corp | 45,072 | $263.7K | 0.0% | +4,654 |
| XTX Topco Ltd | 41,401 | $242.2K | 0.0% | −5,937 |
| ADAR1 Capital Management, LLC | 40,900 | $239.3K | 0.0% | No change |
| Long Corridor Asset Management Ltd | 38,766 | $226.8K | 0.1% | No change |
| Cetera Investment Advisers | 34,000 | $198.9K | 0.0% | +4,000 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Coya 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 EDGARCoya Therapeutics, Inc.1
- CIK0001835022
- Employer ID (EIN)85-40177813
- 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 address12645 Memorial Dr., Suite F1 #305, Houston, TX 770241
- Phone650.739.39391
- Shares outstanding23,457,849 as of Aug 7, 20269
- Public float$89.4M as of Jun 30, 20253
- AuditorWeaver and Tidwell, L.L.P., New York, NY PCAOB ID 410; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceJan 5, 20211
- Filings230 in all: 4 (54), 8-K (54), 3 (13), 10-Q (11), CORRESP (10), UPLOAD (10), EFFECT (7), SC 13G/A (6)1
All 35 form types
DEFA14A (5), S-3 (5), SCHEDULE 13G/A (5), 10-K (4), 424B3 (4), ARS (4), D (4), DEF 14A (4), 424B5 (3), SC 13G (3), 10-K/A (2), 424B4 (2), DRS/A (2), DRSLTR (2), S-1/A (2), S-8 (2), SEC STAFF LETTER (2), 4/A (1), 424B7 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), FWP (1), POS AM (1), S-1 (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Mar 16, 2026
Quarterly report (10-Q) Aug 11, 2026
Proxy statement (DEF 14A) May 13, 2026
Latest 8-K (8-K) Oct 14, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | COYA | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Coya Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 16, 2026: 73 risks under these headings, as written.3
- Risks Related to Our Business, Financial Condition and Capital Requirements
- We are a clinical-stage biotechnology company with limited resources, have a limited operating history and have no products approved for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.
- We have incurred significant losses since our inception and we expect to incur significant losses for the foreseeable future, and we will require sufficient additional funding to finance our operations, which may not be available.
- We have never generated revenue from product sales and may never achieve or maintain profitability.
- We will need to raise additional capital and if we are unable to successfully raise additional capital, our future clinical trials and product development could be limited and our long-term viability may be threatened.
- As a public company, we are obligated to develop and maintain proper and effective controls over financial reporting. If we fail to maintain proper and effective internal controls over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our securities.
- Any acquisitions or strategic collaborations may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities or subject us to other risks.
- Drug development is a highly uncertain undertaking and involves a substantial degree of risk. We have never generated any revenue from product sales, we may never generate any revenue from product sales, and we may fail to generate further revenue from grants or contracts or to be profitable.
- Due to the significant resources required for the development of our programs, and depending on our ability to access capital, we may prioritize development of certain product candidates over others. We may expend our limited resources on programs that do not yield a successful product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- We face risks related to public health epidemics and pandemics, which could significantly disrupt our preclinical studies and clinical trials.
- Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations.
- Unfavorable global economic conditions and adverse developments with respect to financial institutions and associated liquidity risk could adversely affect our business, financial condition and stock price.
The other 62 risks
- Adverse global conditions, including economic uncertainty, may negatively impact our financial results.
- Our ability to use our net operating loss carryovers and certain other tax attributes may be limited.
- Risks Related to Development and Regulatory Approval
- Our business depends upon the success of our potential therapeutic modalities and product candidates.
- Utilizing Treg cells represents a novel approach to the treatment of neurodegenerative and auto immune diseases, and we must overcome significant challenges in order to develop, commercialize and manufacture our product candidates.
- Clinical development involves a lengthy and expensive process with an uncertain outcome, and we may encounter substantial delays due to a variety of reasons outside our control.
- Changes in the U.S. political and regulatory environment could affect availability of government funding that we or our third party collaborators may rely on, which could negatively impact the development of our product candidates.
- There is no assurance that we will develop our product candidates successfully or be able to obtain regulatory approval for them.
- We currently collaborate with various research institutions to perform the research and development activities needed to develop our product candidates, and if we ever choose to or need to find alternative research institutions, we may not be able to do so at all or, if we are able to do so, it may be costly and may cause significant delays in the development and commercialization of our product candidates.
- Positive results from early studies of our product candidates are not necessarily predictive of the results of later studies and any future clinical trials of our product candidates. If we cannot show positive results or replicate any positive results from our earlier studies of our product candidates in our later studies and future clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our product candidates.
- We may encounter substantial delays in our planned clinical trials, or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.
- Disruptions at the FDA and other government agencies caused by shutdowns or funding shortages could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
- We may be unable to obtain regulatory approval for our product candidates under applicable regulatory requirements. If we are unable to design, conduct and complete our planned clinical trials successfully, our product candidates will not be able to receive regulatory approval.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.
- Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all.
- If any of our product candidates, or any competing product candidates, demonstrate serious adverse events, including the development of severe or fatal cytokine release syndrome, neurotoxicity or graft-versus-host disease, we may be required to halt or delay further clinical development.
- Approval may be delayed or denied because we cannot satisfy FDA’s Chemistry, Manufacturing and Control Requirements.
- We may seek special designations by the regulatory authorities to expedite regulatory approvals, but may not be successful in receiving such designations, and even if received, they may not benefit the development and regulatory approval process.
- We may seek Orphan Drug Designation for our product candidates, and we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity.
- We may not identify or discover other product candidates and may fail to capitalize on programs or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success.
- If third parties that we rely on to conduct clinical trials do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our product candidates.
- We have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates.
- Risks Related to Commercialization
- If any of our product candidates are approved for marketing and commercialization and we have not developed or secured third- party marketing, sales and distribution capabilities, we will be unable to successfully commercialize such products and may not be able to generate product revenue.
- If we fail to compete effectively with academic institutions and other biotechnology companies that are developing similar or alternatives to cellular immunotherapy product candidates, our business will be materially adversely affected.
- If we are not able to establish pharmaceutical or biotechnology collaborations on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans.
- If we enter into collaborations with third parties to develop or commercialize our product candidates, our prospects with respect to those product candidates will depend in significant part on the success of those collaborations.
- Our product candidates could be subject to regulatory limitations following approval, if and when such approval is granted.
- The commercial success of any of our product candidates will depend upon such product candidate’s degree of market acceptance by physicians, patients, third-party payors and others in the medical community.
- The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market such products and to generate product revenue.
- Healthcare reform initiatives and other administrative and legislative proposals may harm our business.
- Obtaining and maintaining marketing approval or commercialization of our product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions.
- Our business operations and relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable fraud and abuse and other healthcare laws and regulations, which could expose us to penalties.
- Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set.
- Risks Related to Our Employees, Managing Our Growth and Our Operations
- We will need to increase the size of our organization, and we may experience difficulties in managing growth.
- If we fail to attract and retain senior management and clinical and key scientific personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
- Our insurance policies may be inadequate, may not cover all of our potential liabilities and may potentially expose us to unrecoverable risks.
- Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
- Computer system interruptions, cyber-attacks or security breaches could significantly disrupt our product development programs and our ability to operate our business.
- Risks Related to Manufacturing
- Our manufacturing process is complex and we may encounter difficulties in production, which would delay or prevent our ability to provide a sufficient supply of our product candidates for clinical trials or our products for patients, if approved.
- We rely on third parties to manufacture our product candidates, which increases the risk that we will not have sufficient quantities of such product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- We are dependent on third parties to store our Treg cells and other products and any damage or loss would cause delays in replacement, and our business could suffer.
- We have not yet developed a validated methodology for freezing and thawing large quantities of Treg cells, which we believe will be required for the storage and distribution of our Treg product candidates.
- Risks Related to Our Intellectual Property
- If our license agreement with The Methodist Hospital is terminated, we could lose our rights to key components enabling our Treg Modalities.
- Our development and commercialization rights to our current and future product candidates and technology are subject, in part, to the terms and conditions of licenses granted to us by others.
- Duration of patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time, and the expiration of our patents may subject us to increased competition.
- If any patent protection we obtain is not sufficiently robust, our competitors could develop and commercialize products and technology similar or identical to ours.
- Even after issuance, our owned and in-licensed patents may be subject to challenge, which if successful could require us to obtain licenses from third parties, which may not be available on commercially reasonable terms or at all, or to cease the use of the underlying technology, which could materially adversely affect our business.
- We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which could materially adversely affect our ability to develop, manufacture and market our product candidates.
- Claims brought against us for infringing, misappropriating or otherwise violating intellectual property rights of third parties or engaging in unfair competition, would be costly and time-consuming and could prevent or delay us from successfully developing or commercializing our product candidates.
- We may not be able to effectively monitor unauthorized use of our intellectual property and enforce our intellectual property rights against infringement, and may incur substantial costs as a result of bringing litigation or other proceedings relating to our intellectual property rights.
- We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
- Changes in U.S. patent law or the patent law of other jurisdictions could decrease the certainty of our ability to obtain patents and diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates.
- We may fail to obtain or enforce assignments of intellectual property rights from our employees and contractors.
- If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be materially diminished.
- Risks Related to Our Securities
- If we sell securities in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.
- Our directors, executive officers and principal stockholders have substantial control over us and could delay or prevent a change of corporate control.
- The market price for our common stock may be volatile, and your investment in our securities could decline in value.
- Certain companies with public floats comparable to our public float have experienced extreme volatility that was seemingly unrelated to the underlying performance of the respective company. We may experience similar volatility, which may make it difficult for prospective investors to assess the value of our common stock.
- We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
- We are an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make our securities less attractive to investors.
- We do not anticipate paying dividends on our common stock and, accordingly, stockholders must rely on stock appreciation for any return on their investment.
- The administrator of our amended and restated 2021 Equity Incentive Plan (the “Amended and Restated Equity Plan”) is authorized to exercise its discretion to effect the repricing of stock options and stock appreciation rights and there may be adverse consequences to our business if the administrator of the Amended and Restated Equity Plan exercises such discretion.
Legal proceedings
From time to time, we may be involved in claims that arise during the ordinary course of business. Although the results of litigation and claims cannot be predicted with certainty, we do not currently have any pending litigation to which we are a party or to which our property is subject that we believe to be material. Regardless of the outcome, litigation can be costly and time consuming, and it can divert management’s attention from important business matters and initiatives, negatively impacting our overall 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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- 12SEC EDGARHoward Berman, Chair
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- 14SEC EDGARFred Grossman, Chief Medical Officer
- 15SEC EDGARAdrian Hepner, Chief Medical Officer
- 16SEC EDGARMark H. Pavao, Board member
- 17SEC EDGARArun Swaminathan, Board member
- 18SEC EDGARDieter Weinand, Board member
- 19SEC EDGARAnabella Villalobos, Board member
- 20SEC EDGARDov A. Goldstein Md., Board member
- 21SEC EDGARHideki Garren, Board member
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- 24SEC EDGAROther events
- 25SEC EDGAROther events
- 26SEC EDGAROther events
- 27SEC EDGARResults of operations
- 28SEC EDGARExecutive or director change
- 29SEC EDGARShareholder vote
- 30SEC EDGARResults of operations; Other events
- 31SEC EDGAREntered a material agreement
- 32SEC EDGARExecutive or director change
- 33SEC EDGARResults of operations
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- 35SEC EDGAROther events
- 36NasdaqNasdaq calendar
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