MRKR on Nasdaq
Marker Therapeutics, Inc.
In its 2026 annual report the company says: “We are a clinical-stage immuno-oncology company specializing in the development of novel T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications.”4 It is headquartered in Houston, Texas.1 Its shares trade on Nasdaq under the symbol MRKR.1
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Last updated Oct 21, 2026.
Overview
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- TickerMRKR on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersHouston, Texas1
- Incorporated inDE2
- Business address2450 Holcombe Blvd, Tmc Partners Office 1.311, Houston, Tx 770212
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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We are a clinical-stage immuno-oncology company specializing in the development of novel T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Harnessing millions of years of immunologic evolution, Marker’s Multi Antigen Recognizing (“MAR”)-T cell technology is designed to recognize and kill highly heterogeneous tumors without the need for genetic modifications. This approach selectively expands natural tumor-specific T cells from a patient’s/donor’s blood that are capable of recognizing a broad range of tumor associated antigens, or TAAs. Unlike other T cell therapies, MAR-T cells are able to recognize hundreds of different epitopes within up to six tumor-specific antigens to produce broad spectrum anti-tumor activity. Targeting multiple antigens simultaneously exploits the natural capacity of T cells to recognize and kill tumor target…4 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
What sells
Revenue by product, business segment and region, as the company reports it to the SEC.
Products and services
Cancer Prevention And Research Institute Of Texas, Acute Myeloid Leukemia brought in 25% of the revenue Marker Therapeutics, Inc. broke down this way in fiscal 2025.
Products and services by year
| Products and services | 2024 | 2025 |
|---|---|---|
| Cancer Prevention And Research Institute Of Texas, Acute Myeloid Leukemia | $4.4M | $900.0K |
| National Institutes of Health Small Business Innovation Research For Lymphoma Grant | $665.0K | $665.0K |
| CPRIT Pancreatic Grant | $574.0K | |
| National Institutes of Health Small Business Innovation Research | $982.2K | $472.2K |
| National Institutes of Health Small Business Innovation Research For Pancreatic Cancer | $7.2K | $425.7K |
| National Institutes of Health National Cancer Institute Grant | $5.8K | $391.3K |
| FDA Grant | $519.8K | $118.5K |
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Research and development100¢$11.8M
- Income tax0¢$15.2K
Out of $3.5M in revenue.5 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Total revenues | $3.5M | $6.6M |
| Research and development | $11.8M | $13.5M |
| General and administrative | $4.2M | $4.2M |
| Loss on early termination of vendor agreement | $453.1K | |
| Total operating expenses | $16.4M | $17.7M |
| Loss from operations | -$12.9M | -$11.1M |
| Interest income | $594.2K | $437.0K |
| Other income | $117.4K | |
| Loss from operations before income taxes | -$12.2M | -$10.7M |
| Income tax (benefit) expense | -$15.2K | $50.0K |
| Net loss | -$12.2M | -$10.7M |
| Net loss per share, basic (in dollars per share) | -$0.79 | -$1.19 |
| Net loss per share, diluted (in dollars per share) | -$0.79 | -$1.19 |
| Basic (in shares) | 15.3M shares | 9.0M shares |
| Diluted (in shares) | 15.3M shares | 9.0M 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.5
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $16.1M | $19.2M | |
| Restricted cash | $974.8K | $0 | |
| Prepaid expenses and deposits | $658.8K | $483.7K | |
| Other receivables | $1.4M | $2.3M | |
| Total current assets | $19.1M | $22.0M | |
| Total assets | $19.1M | $22.0M | |
| Accounts payable and accrued liabilities | $1.3M | $1.8M | |
| Related party payable | $1.7M | ||
| Deferred revenue | $974.8K | ||
| Total current liabilities | $2.3M | $3.5M | |
| Total liabilities | $2.3M | $3.5M | |
| Common stock, $0.001 par value, 30 million shares authorized, 16.7 million and 10.7 million shares issued and outstanding as of December 31, 2025 and 2024, respectively (see Note 7) | $16.7K | $10.7K | |
| Additional paid-in capital | $476.0M | $465.6M | |
| Accumulated deficit | -$459.2M | -$447.0M | |
| Total stockholders' equity | $16.8M | $18.6M | $14.1M |
| Total liabilities and stockholders' equity | $19.1M | $22.0M | |
| Preferred stock par value (in dollars per share) | $0.00 | $0.00 | |
| Preferred stock authorized (in shares) | 5.0M shares | 5.0M shares | |
| Preferred stock issued (in shares) | 0 shares | 0 shares | |
| Preferred stock outstanding (in shares) | 0 shares | 0 shares | |
| Common stock par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock authorized (in shares) | 30.0M shares | 30.0M shares | |
| Common stock issued (in shares) | 16.7M shares | 10.7M shares | |
| Common stock outstanding (in shares) | 16.7M shares | 10.7M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $16.1M | $19.2M | |
| Restricted cash | $974.8K | $0 | |
| Prepaid expenses and deposits | $658.8K | $483.7K | |
| Other receivables | $1.4M | $2.3M | |
| Total current assets | $19.1M | $22.0M | |
| Total assets | $19.1M | $22.0M | |
| Accounts payable and accrued liabilities | $1.3M | $1.8M | |
| Related party payable | $1.7M | ||
| Deferred revenue | $974.8K | ||
| Total current liabilities | $2.3M | $3.5M | |
| Total liabilities | $2.3M | $3.5M | |
| Common stock, $0.001 par value, 30 million shares authorized, 16.7 million and 10.7 million shares issued and outstanding as of December 31, 2025 and 2024, respectively (see Note 7) | $16.7K | $10.7K | |
| Additional paid-in capital | $476.0M | $465.6M | |
| Accumulated deficit | -$459.2M | -$447.0M | |
| Total stockholders' equity | $16.8M | $18.6M | $14.1M |
| Total liabilities and stockholders' equity | $19.1M | $22.0M | |
| Preferred stock par value (in dollars per share) | $0.00 | $0.00 | |
| Preferred stock authorized (in shares) | 5.0M shares | 5.0M shares | |
| Preferred stock issued (in shares) | 0 shares | 0 shares | |
| Preferred stock outstanding (in shares) | 0 shares | 0 shares | |
| Common stock par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock authorized (in shares) | 30.0M shares | 30.0M shares | |
| Common stock issued (in shares) | 16.7M shares | 10.7M shares | |
| Common stock outstanding (in shares) | 16.7M shares | 10.7M 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.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$12.2M | -$10.7M |
| Stock-based compensation | $537.5K | $245.9K |
| Prepaid expenses and deposits | -$175.0K | $504.4K |
| Other receivables | $977.3K | -$1.3M |
| Related party payable | -$1.7M | $380.8K |
| Accounts payable and accrued expenses | -$454.6K | $8.8K |
| Deferred revenue | $974.8K | |
| Net cash used in operating activities | -$12.0M | -$10.9M |
| Proceeds from issuance of common stock, net | $9.9M | $14.9M |
| Proceeds from exercise of warrants and stock options | $605 | $62.2K |
| Net cash provided by financing activities | $9.9M | $15.0M |
| Net (decrease) increase in cash, cash equivalents, and restricted cash | -$2.1M | $4.1M |
No quarter-by-quarter statement was filed.
Corporate structure
Marker Therapeutics, Inc. sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Marker Therapeutics, Inc.
- New Enterprise Associates 16, L.P. Filed SCHEDULE 13D/A on Marker Therapeutics, Inc., latest Nov 17, 2025 (4 filings since May 17, 2024)
- Alyeska Investment Group, L.P. Filed SCHEDULE 13G/A on Marker Therapeutics, Inc., latest Nov 14, 2025 (2 filings since Feb 14, 2025)
- John Robert Wilson Filed SCHEDULE 13D/A on Marker Therapeutics, Inc., latest Aug 20, 2025 (2 filings since Aug 19, 2025)
- Blue Owl Capital Filed SCHEDULE 13G/A on Marker Therapeutics, Inc., latest May 15, 2025 (2 filings since Feb 14, 2025)
- Aisling Capital IV, LP Filed SC 13D/A on Marker Therapeutics, Inc., latest Mar 3, 2023
- Marker Therapeutics, Inc. Houston, Texas
- GeneMax Pharmaceuticals Subsidiary · Canada
Built from 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 Marker 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.
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $16.1M5 Dec 31, 2025 | $19.2M5 Dec 31, 2024 | −16.3% |
Properties, in its own words
We do not own any real estate or other properties. We utilize office space at 2450 Holcombe Blvd, TMC Partners Office 1.311, Houston, TX 77021, which is also our principal business office.
Item 2 of the 10-K filed Mar 18, 2026.4
Leadership
Who has led Marker Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief financial officer
Chief operating officer
- Chief executive officerJuan Vera May 11, 2023 to now14
- Chief executive officerPeter L. Hoang Sep 25, 2017 to Mar 28, 202215
- Chief executive officerGlynn Wilson Apr 5, 2011 to Mar 13, 201716
- Chief executive officerDenis Corin Jul 3, 2007 to Mar 18, 200917
- ChairGlynn Wilson Oct 26, 2009 to Apr 5, 201118
- PresidentJuan Vera May 11, 2023 to now14
- PresidentPeter L. Hoang Sep 25, 2017 to Mar 28, 202215
- PresidentJohn N. Bonfiglio Dec 14, 2016 to Mar 13, 201719
- PresidentDenis Corin Jul 3, 2007 to Apr 20, 201217
- Chief financial officerEliot M. Lurier Jul 5, 2023 to Jul 5, 202320
- Chief financial officerAnthony H. Kim Nov 29, 2018 to Mar 28, 202221
- Chief financial officerMichael Loiacono Aug 25, 2016 to Oct 23, 201822
- Chief financial officerDenis Corin Apr 5, 2011 to Apr 5, 201123
- Chief financial officerTracy A. Moore Sep 23, 2009 to Oct 16, 200924
- Chief financial officerPatrick A. McGowan Jul 3, 2007 to Jul 3, 200725
- Chief operating officerJuan Vera Feb 22, 2022 to Mar 1, 202326
- Chief operating officerJohn N. Bonfiglio Dec 14, 2016 to Mar 13, 201719
Board members and other officers (29)
- Vice President, QualityAnna Szymanska Mar 12, 2020 to Mar 1, 202327
- Vice President, Clinical Ops.Gerald Garrett Mar 12, 2020 to Feb 22, 202228
- Chief Development OfficerJuan Vera Mar 12, 2020 to Mar 18, 202129
- Chief Accounting OfficerMichael Loiacono Mar 12, 2020 to Mar 1, 202330
- Snr VP, Clinical DevelopmentMythili Koneru May 15, 2019 to Mar 1, 202331
- VP, Regulatory AffairsNadia Agopyan Aug 19, 2019 to Mar 1, 202332
- Chief Scientific OfficerAnn M. Leen Dec 28, 2018 to Feb 24, 202133
- VP, Research and DevelopmentTsvetelina P. Hoang Dec 28, 2018 to Mar 1, 202334
- OfficerJohn N. Bonfiglio Jul 19, 2016 to Jul 19, 201635
- Vice PresidentMark Reddish Apr 20, 2012 to Apr 20, 201236
- Board memberKathryn Penkus Corzo Nov 4, 2025 to now37
- Board memberKatharine Knobil Dec 9, 2021 to now38
- Board memberSteve Elms Aug 8, 2019 to now39
- Board memberAli Behbahani Oct 18, 2018 to Oct 18, 201840
- Board memberJuan Vera Oct 19, 2018 to now41
- Board memberN. David Eansor Oct 19, 2018 to now42
- Board memberPeter L. Hoang Sep 25, 2017 to Mar 28, 202215
- Board memberFrederick Gerald Wasserman Jan 28, 2016 to Jun 10, 202143
- Board memberJohn N. Bonfiglio Nov 9, 2015 to Mar 13, 201744
- Board memberDavid Laskow-Pooley Nov 13, 2015 to May 26, 202245
- Board memberMark Reddish Nov 13, 2015 to Oct 17, 201846
- Board memberSherry Grisewood Nov 13, 2015 to Oct 17, 201847
- Board memberLynn Depippo Sep 28, 2011 to Sep 28, 201148
- Board memberTracy A. Moore Sep 23, 2009 to Oct 16, 200924
- Board memberDenis Corin Oct 26, 2009 to Apr 20, 201249
- Board memberAlan P. Lindsay Jul 3, 2007 to Mar 20, 200950
- Board memberGlynn Wilson Jul 3, 2007 to Oct 10, 201851
- Board memberPatrick A. McGowan Jul 3, 2007 to Jul 3, 200725
- General counselKen Moseley Dec 28, 2018 to Dec 28, 201852
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorJohn Wilson named Dec 30, 202453
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- GeneMax Pharmaceuticals Canada, Inc.3
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
Timeline
- May 4, 20268-K Bylaws or fiscal year changed; Shareholder vote54
- Mar 19, 20268-K Results of operations55
- Feb 9, 20268-K Director nominations56
- Nov 14, 20258-K Results of operations57
- Nov 5, 20258-K Executive or director change; Other events58
- Oct 6, 20258-K Other events59
- Aug 26, 20258-K Regulation FD disclosure60
- Aug 12, 20258-K Change of auditor61
- Jun 17, 20258-K Entered a material agreement; Other events62
- Jun 9, 20258-K Shareholder vote63
- May 20, 20258-K Other events64
- Mar 31, 20258-K Results of operations65
- May 11, 2023New chief executive Juan Vera becomes CEO14
- Sep 25, 2017New chief executive Peter L. Hoang becomes CEO15
- Apr 5, 2011New chief executive Glynn Wilson becomes CEO16
- Jul 3, 2007New chief executive Denis Corin becomes CEO17
Calendar
Coming up
- Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.12) a share, on Nov 13, 2025.66
When it reported results
- Mar 19, 2026Reported quarterly or annual results55
- Nov 14, 2025Reported quarterly or annual results57
- Mar 31, 2025Reported quarterly or annual results65
- Nov 14, 2024Reported quarterly or annual results67
- Aug 14, 2024Reported quarterly or annual results68
- May 15, 2024Reported quarterly or annual results69
- Mar 26, 2024Reported quarterly or annual results70
- Nov 9, 2023Reported quarterly or annual results71
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
177 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 67 major events, 43 insider forms, 11 large holders, 1 private raises, 35 other. The latest 20:
- Aug 14, 202610-Q EDGAR
- May 15, 202610-Q EDGAR
- May 4, 20268-K EDGAR
- Mar 20, 2026DEFA14A EDGAR
- Mar 20, 2026ARS EDGAR
- Mar 20, 2026DEF 14A EDGAR
- Mar 19, 20268-K EDGAR
- Mar 18, 202610-K EDGAR
- Mar 10, 2026PRE 14A EDGAR
- Feb 9, 20268-K EDGAR
- Nov 19, 20254 PRIMARY DOCUMENT EDGAR
- Nov 19, 20254 PRIMARY DOCUMENT EDGAR
- Nov 19, 20254 OWNERSHIP DOCUMENT EDGAR
- Nov 17, 2025SCHEDULE 13D/A EDGAR
- Nov 14, 2025SCHEDULE 13G/A EDGAR
- Nov 14, 20258-K EDGAR
- Nov 13, 202510-Q EDGAR
- Nov 5, 20258-K EDGAR
- Nov 4, 20254 PRIMARY DOCUMENT EDGAR
- Nov 4, 20253 PRIMARY DOCUMENT EDGAR
The 177 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
2 open-market trades by officers, directors and large owners since October 2021: 2 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Dec 23, 2024 | ELMS STEVEDirector | Buy | 11,085 | $3.20 | $35.5K | Form 4 |
| Dec 23, 2024 | NEA Partners 16, L.P.10% owner | Buy | 554,250 | $3.20 | $1.8M | 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.
- New Enterprise Associates 16, L.P.SCHEDULE 13D/A, 4 filings May 17, 2024 to Nov 17, 202572
- Alyeska Investment Group, L.P.SCHEDULE 13G/A, 2 filings Feb 14, 2025 to Nov 14, 202573
- John Robert WilsonSCHEDULE 13D/A, 2 filings Aug 19, 2025 to Aug 20, 202574
- Blue Owl CapitalSCHEDULE 13G/A, 2 filings Feb 14, 2025 to May 15, 202575
- Aisling Capital IV, LPSC 13D/A, 1 filing Mar 3, 202376
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
Money raised
Private offerings the company reported to the SEC on Form D.
- Dec 23, 2024Raised $16.1 million in a private offering of equity Form D: 5 investors so far 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 35. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| NEA Management Company, LLC | 1,625,678 | $2.4M | 0.2% | No change |
| Blue Owl Capital Holdings LP | 554,250 | $814.7K | 0.1% | No change |
| Vanguard Capital Management LLC | 426,169 | $626.5K | 0.0% | +36,850 |
| Aisling Capital Management LP | 325,370 | $478.3K | 0.1% | No change |
| Renaissance Technologies LLC | 249,423 | $366.7K | 0.0% | +74,129 |
| Geode Capital Management, LLC | 139,816 | $205.6K | 0.0% | −21,094 |
| Osaic Holdings, Inc. | 112,649 | $165.6K | 0.0% | +19,528 |
| Vanguard Fiduciary Trust Co | 87,269 | $128.3K | 0.0% | No change |
| LPL Financial LLC | 83,147 | $122.2K | 0.0% | +100 |
| Concurrent Investment Advisors, LLC | 67,963 | $99.9K | 0.0% | New |
| Two Sigma Investments, LP | 60,201 | $88.5K | 0.0% | −800 |
| XTX Topco Ltd | 45,357 | $66.7K | 0.0% | −18,210 |
| Northern Trust Corp | 34,629 | $50.9K | 0.0% | +8,620 |
| Citadel Advisors LLC | 32,517 | $47.8K | 0.0% | New |
| State Street Corp | 20,948 | $30.8K | 0.0% | No change |
| Invst, LLC | 18,000 | $26.5K | 0.0% | −11,000 |
| Creative Planning | 17,312 | $25.4K | 0.0% | No change |
| Jane Street Group, LLC | 16,832 | $24.7K | 0.0% | −19,471 |
| Ashton Thomas Private Wealth, LLC | 16,400 | $24.1K | 0.0% | No change |
| Fifth Third Bancorp | 10,000 | $14.7K | 0.0% | No change |
| UBS Group AG | 8,150 | $12.0K | 0.0% | −24,219 |
| Vanguard Global Advisers, LLC | 2,512 | $3.7K | 0.0% | No change |
| International Assets Investment Management, LLC | 2,000 | $2.9K | 0.0% | No change |
| Tower Research Capital LLC (TRC) | 810 | $1.2K | 0.0% | −2,327 |
| Wells Fargo & Company/mn | 232 | $341 | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Marker 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 EDGARMarker Therapeutics, Inc.1
- CIK0001094038
- Employer ID (EIN)45-44979414
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address2450 Holcombe Blvd, Tmc Partners Office 1.311, Houston, TX 770211
- Phone(713) 400-64001
- Shares outstanding16,673,127 as of Aug 7, 202613
- Public float$17.3M as of Jun 30, 20254
- AuditorMarcum LLP, Houston, TX PCAOB ID 688; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceSep 3, 19991
- Filings903 in all: 8-K (205), 4 (154), 3 (57), 10-Q (56), CORRESP (32), NT 10-Q (29), UPLOAD (29), SC 13D (27)1
All 65 form types
10QSB (25), 5 (21), 10-K (18), SC 13D/A (17), 424B3 (15), NT 10-K (15), SC 13G/A (15), DEF 14A (13), EFFECT (13), SC 13G (11), 10-Q/A (9), D (9), 10KSB (8), 424B5 (8), DEFA14A (8), S-3 (8), REGDEX (7), S-8 (7), 8-K/A (6), PRE 14A (6), 10QSB/A (5), SCHEDULE 13D/A (5), 4/A (4), 424B7 (4), ARS (4), POS AM (4), 10KSB/A (3), CT ORDER (3), DEF 14C (3), PRE 14C (3), S-1 (3), S-3/A (3), 10-K/A (2), PRER14A (2), REGDEX/A (2), S-1/A (2), SCHEDULE 13G (2), SCHEDULE 13G/A (2), 10KSB40 (1), 10SB12G (1), 10SB12G/A (1), 3/A (1), 8-A12B (1), 8-A12B/A (1), CERTNAS (1), D/A (1), DEFM14A (1), DEFR14A (1), DEFS14A (1), DEL AM (1), NT 10-Q/A (1), NTN 10K (1), PREM14A (1), PRER14C (1), PRES14A (1), RW (1), S-8 POS (1)
- Latest filingsAnnual report (10-K) Mar 18, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Mar 20, 2026
Latest 8-K (8-K) May 4, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.001 per share | MRKR | Nasdaq |
From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Marker Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 18, 2026: 52 risks under these headings, as written.4
- Risks Associated with Our Business
- Risks Related to our Financial Position and Capital Needs
- We are a clinical stage company with a history of operating losses, and we expect losses to continue for the indefinite future. These factors raise substantial doubt regarding our ability to continue as a going concern.
- Risks Related to the Development of our Product Candidates
- All of our product candidates are in clinical development. If we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates, or successfully develop any other product candidates, or experience significant delays in doing so, our business will be harmed.
- The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.
- Preclinical studies and clinical trials are expensive, time-consuming, difficult to design and implement and involve an uncertain outcome. Further, we may encounter substantial delays in completing the development of our product candidates.
- The results of earlier preclinical and clinical trials may not be predictive of future clinical trial results.
- If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our products may be delayed.
- Our preclinical studies and clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent or delay regulatory approval and commercialization, increase our costs or necessitate the abandonment or limitation of the development of some of our product candidates.
- We may not obtain or maintain the benefits associated with orphan drug designation, including market exclusivity.
- Risks Related to Manufacturing
The other 44 risks
- We rely on third-party vendors and contract manufacturing organizations to maintain and support our manufacturing and cell processing operations.
- Our manufacturing process is reliant upon specialized equipment, and other specialty materials, which may not be available to us on acceptable terms or at all. We, our vendors, and contract manufacturing organizations rely or may rely on sole-source vendors or a limited number of vendors, which could impair the manufacture and supply of our product candidates.
- The manufacture of our product candidates is complex and we may encounter difficulties in production, particularly with respect to process development. If any of our third-party suppliers encounter such difficulties, the supply of our product candidates for clinical trials, or our product candidates for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
- No assurance can be given that we will be able to develop a new, FDA-compliant, more efficient, lower cost manufacturing process upon which our business plan to commercialize MAR-T cell-based product candidates is dependent.
- Risks Related to our Reliance on Third Parties
- We rely on third parties for the clinical and, if approved, commercial manufacture of our product candidates. The third-party manufacturing facilities on which we rely may have limited capacity or fail to meet the applicable stringent regulatory requirements.
- Our strategic relationship with BCM is dependent, in part, upon our ongoing relationship with key medical and scientific personnel and advisors.
- We may not be able to establish or maintain the third-party relationships, including strategic collaborations, that are necessary to develop, commercialize and/or market some or all of our product candidates.
- Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- Risks Related to the Commercialization of our Product Candidates
- Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, healthcare payors and the medical community.
- Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
- Our future success is highly dependent upon our key personnel, and our ability to attract, retain, and motivate additional qualified personnel. We will also be required to establish sales and marketing capabilities or enter into agreements with third parties to market and sell any approved products.
- The biotechnology and immunotherapy industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with more substantial enterprises.
- The market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small.
- New regulatory pathways for biosimilar competition could reduce the duration of market exclusivity for our products.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
- Risks Related to Our Intellectual Property
- If we are unable to protect our proprietary rights, we may not be able to compete effectively or operate profitably.
- The use of our technologies could potentially conflict with the rights of others.
- Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- If we fail to comply with any obligations under our existing license agreements or any future license agreements, or disputes arise with respect to those agreements, it could have a negative impact on our business and our intellectual property rights.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- Certain of our technologies are in-licensed from third parties, and the protection of those technologies is not entirely within our control.
- We rely upon patents and licensed technologies to protect our technology. We may be unable to protect our intellectual property rights, and we may be liable for infringing the intellectual property rights of others.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensor, which could be expensive, time-consuming and unsuccessful.
- We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.
- If we are unable to obtain licenses needed for the development of our product candidates, or if we breach any of the agreements under which we license rights to patents or other intellectual property from third parties, we could lose license rights that are important to our business.
- Risks Related to Government Regulation
- We are subject to extensive regulation, which can be costly, time consuming and can subject us to unanticipated delays. Even if we receive regulatory approval of our product candidates, we will be subject to ongoing quality and regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
- 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.
- Any relationships with healthcare professionals, principal investigators, consultants, customers (actual and potential) and third-party payors in connection with our current and future business activities are and will continue to be subject, directly or indirectly, to federal and state healthcare laws. If we are unable to comply, or have not fully complied, with such laws, we could face penalties, contractual damages, reputational harm, diminished profits and future earnings and curtailment or restructuring of our operations.
- Recently enacted and future legislation in the United States and other countries may affect the prices we may obtain for our product candidates and increase the difficulty and cost to commercialize our product candidates.
- We are subject to stringent and changing laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.
- Risks Related to our Securities
- The price of our stock may be volatile.
- Sales of additional equity securities may adversely affect the market price of our common stock and your rights may be reduced. Our stockholders may experience dilution in the future and it may adversely affect the market price of our securities.
- We do not intend to pay cash dividends.
- General Risk Factors
- From time to time, we may become involved in legal proceedings.
- If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, or are perceived to have been compromised, we could experience adverse consequences, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
- As a result of being a public company, we are obligated to develop and maintain proper and effective internal controls over financial reporting, and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common stock.
- Our ability to use net operating losses and certain other tax attributes to offset future taxable income may be subject to limitation.
- Catastrophic events may disrupt our business.
- Our business and operations could be adversely affected by the effects of health epidemics, including pandemics.
- Unfavorable global political or economic conditions could adversely affect our business, financial condition or results of operations.
- Changes in tax laws or regulations could materially adversely affect our company.
Legal proceedings
From time to time, we may become involved in legal proceedings, including those arising in the ordinary course of our business. We are not currently a party to any material legal proceedings that we believe could have an adverse effect on our business, operating results or financial condition.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 14SEC EDGARJuan Vera, Chief executive officer
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- 17SEC EDGARDenis Corin, Chief executive officer
- 18SEC EDGARGlynn Wilson, Chair
- 19SEC EDGARJohn N. Bonfiglio, President
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- 23SEC EDGARDenis Corin, Chief financial officer
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- 26SEC EDGARJuan Vera, Chief operating officer
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- 29SEC EDGARJuan Vera, Chief Development Officer
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- 35SEC EDGARJohn N. Bonfiglio, Officer
- 36SEC EDGARMark Reddish, Vice President
- 37SEC EDGARKathryn Penkus Corzo, Board member
- 38SEC EDGARKatharine Knobil, Board member
- 39SEC EDGARSteve Elms, Board member
- 40SEC EDGARAli Behbahani, Board member
- 41SEC EDGARJuan Vera, Board member
- 42SEC EDGARN. David Eansor, Board member
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- 44SEC EDGARJohn N. Bonfiglio, Board member
- 45SEC EDGARDavid Laskow-Pooley, Board member
- 46SEC EDGARMark Reddish, Board member
- 47SEC EDGARSherry Grisewood, Board member
- 48SEC EDGARLynn Depippo, Board member
- 49SEC EDGARDenis Corin, Board member
- 50SEC EDGARAlan P. Lindsay, Board member
- 51SEC EDGARGlynn Wilson, Board member
- 52SEC EDGARKen Moseley, General counsel
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- 55SEC EDGARResults of operations
- 56SEC EDGARDirector nominations
- 57SEC EDGARResults of operations
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- 59SEC EDGAROther events
- 60SEC EDGARRegulation FD disclosure
- 61SEC EDGARChange of auditor
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- 63SEC EDGARShareholder vote
- 64SEC EDGAROther events
- 65SEC EDGARResults of operations
- 66NasdaqNasdaq calendar
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