Marker Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Updates

MRKR 11.14.2024

SERA-AI Powered Highlights
Drug:MT-601-UNKNOWN MT-601
Drug:MT-601-UNKNOWN MT-601
Diseases:lymphoma
Diseases:pancreatic cancer
Full Press ReleaseSEC FilingsOur MRKR Tweets

About Gravity Analytica

Recent News

  • 12.19.2024 - Marker Therapeutics Announces $16.1 Million Private Placement
  • 12.19.2024 - Marker Therapeutics Provides a Clinical Update on MT-601 in Patients with Lymphoma
  • 12.17.2024 - Marker Therapeutics Awarded $9.5 Million Grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to Support the Investigation of MT-601 in Patients with Pancreatic Cancer

Recent Filings

  • 01.17.2025 - EFFECT Notice of Effectiveness
  • 01.17.2025 - 424B3 Prospectus [Rule 424(b)(3)]
  • 01.13.2025 - PRE 14A Other preliminary proxy statements
Marker Therapeutics to receive two grants from NIH Small Business Innovation Research (SBIR) program to support clinical investigation of MT-601 in patients with lymphoma and metastatic pancreatic cancer

HOUSTON,Nov. 14, 2024(GLOBE NEWSWIRE) --Marker Therapeutics, Inc.(Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors, today reported corporate updates and financial results for the third quarter endedSeptember 30, 2024.

“As we approach the end of 2024, we continue to build momentum across our clinical and corporate programs,” saidJuan Vera, M.D., President and Chief Executive Officer ofMarker Therapeutics. “During the third quarter, we made significant progress in our ongoing Phase 1 APOLLO study investigating MT‐601 in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cell therapy or where CAR-T cells are not an option. Enrollment is ongoing and we expect to be able to report preliminary safety and efficacy data by the end of this year. We, along with our study investigators, have been encouraged by the promising activity shown in this platform and look forward to continuing assessments from the trial.”

“We also recently strengthened our financial position with the receipt of two,$2 millionSmall Business Innovation Research(SBIR) grants from theNational Institutes of Health(NIH). The non-dilutive funding will be used to support further development of MT-601 in patients with non-Hodgkin’s lymphoma who have relapsed following anti-CD19 CAR-T cell therapy, as well as assist in funding the clinical investigation of MT‐601 in pancreatic cancer. We continue to make meaningful progress and remain focused on execution as we move our programs through the clinical trials,” addedDr. Vera.

PROGRAM UPDATES & EXPECTED MILESTONES

MT-601 (Lymphoma)

  • Marker’s lead program is investigating MT-601 in the nationwide multicenter Phase 1 APOLLO study (clinicaltrials.govidentifier: NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or where CAR-T cells are not an option.
  • The Company previously reported that one of the Principal Investigators presented preliminary safety and efficacy with sustained objective responses observed in three study participants treated atCity of Hope National Medical Center(Press Release,April 8, 2024). Treatment was well tolerated among all study participants with no observation of severe adverse effects such as immune effector cell associated neurotoxicity syndrome (ICANS).
  • All study participants continue to be observed for long-term treatment effects and durability of response.
  • The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expects to provide an update on safety and durability during the fourth quarter of 2024.
  • Marker Therapeuticswas awarded a$2 milliongrant from NIH Small Business Innovation Research Program (SBIR) to support the clinical investigation of MT-601 in patients with lymphoma who have relapsed following anti-CD19 CAR-T cell therapy (Press Release,August 12, 2024).

MT-601 (Pancreatic)

  • The Company was awarded a$2 milliongrant fromNIH Small Business Innovation Research(SBIR) Program to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.
  • The Company expects to start the clinical program of MT-601 in patients with metastatic pancreatic cancer in 2025.

MT-401-OTS(Acute Myeloid Leukemia or Myelodysplastic Syndrome)

  • The Company previously secured non-dilutive funding to support the clinical investigation of MT‐401‐OTS in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and anticipates clinical program initiation during the first half of 2025.

THIRD QUARTER 2024 FINANCIAL HIGHLIGHTS

Cash Position and Guidance: AtSeptember 30, 2024, Marker had cash and cash equivalents of$9 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses intoOctober 2025. This estimate is subject to the Company’s ability to effectively manage its costs and utilize drawdowns of available grant funds.

R&D Expenses: Research and development expenses were$3.5 millionfor the quarter endedSeptember 30, 2024, compared to$2.0 millionfor the quarter endedSeptember 30, 2023as a result of our increased clinical trial activity in the quarter.

G&A Expenses: General and administrative expenses were$0.9 millionfor the quarter endedSeptember 30, 2024, compared to$1.4 millionfor the quarter endedSeptember 30, 2023reflecting the savings from the reorganization that was completed in late 2023.

Net Loss: Marker reported a net loss from continuing operations of$2.3 millionfor the quarter endedSeptember 30, 2024, compared to$3.0 millionfor the quarter endedSeptember 30, 2023.

About multiTAA-specific T cells

The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, multiTAA-specific T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile, compared to current engineered T cell approaches, and may provide patients with meaningful clinical benefits.

AboutMarker Therapeutics, Inc.

Marker Therapeutics, Inc.is aHouston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. Clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding fromU.S.state and federal agencies supporting cancer research.

To receive future press releases via email, please visit:https://www.markertherapeutics.com/email-alerts.

Forward-Looking Statements

This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct and success of our clinical trials of our product candidates, including MT-601 for the treatment of patients with lymphoma. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and otherSECfilings which are available through EDGAR atWWW.SEC.GOV. The Company assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release except as may be required by law.

Marker Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
September 30,December 31,
20242023
ASSETS
Current assets:
Cash and cash equivalents$8,999,664$15,111,450
Prepaid expenses and deposits1,166,274988,126
Other receivables744,4101,027,815
Total current assets10,910,34817,127,391
Total assets$10,910,348$17,127,391
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities$2,557,335$1,745,193
Related party payable903,4381,329,655
Total current liabilities3,460,7733,074,848
Total liabilities3,460,7733,074,848
Stockholders’ equity:
Preferred stock,$0.001par value, 5 million shares authorized, 0 shares issued and outstanding atSeptember 30, 2024andDecember 31, 2023, respectively——
Common stock,$0.001par value, 30 million shares authorized, 8.9 million shares issued and outstanding as ofSeptember 30, 2024andDecember 31, 2023(see Note 9)8,9238,891
Additional paid-in capital450,620,206450,329,515
Accumulated deficit(443,179,554)(436,285,863)
Total stockholders’ equity7,449,57514,052,543
Total liabilities and stockholders’ equity$10,910,348$17,127,391

Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
For the Three Months EndedFor the Nine Months Ended
September 30,September 30,
2024202320242023
Revenues
Grant income$1,926,020$257,606$4,339,317$2,254,601
Total revenues1,926,020257,6064,339,3172,254,601
Operating expenses:
Research and development3,471,2162,044,9808,381,6617,799,472
General and administrative854,6771,412,6723,214,6116,098,716
Total operating expenses4,325,8933,457,65211,596,27213,898,188
Loss from operations(2,399,873)(3,200,046)(7,256,955)(11,643,587)
Other income (expenses):
Interest income91,681218,085363,264337,819
Loss from continuing operations(2,308,192)(2,981,961)(6,893,691)(11,305,768)
Discontinued operations:
Loss from discontinued operations, net of tax———(2,922,406)
Gain on disposal of discontinued operations before income taxes———8,794,426
Income from discontinued operations———5,872,020
Net (loss) income$(2,308,192)$(2,981,961)$(6,893,691)$(5,433,748)
Net (loss) earnings per share:
Loss from continuing operations, basic and diluted$(0.26)$(0.34)$(0.77)$(1.29)
Income from discontinued operations, basic$—$—$—$0.67
Income from discontinued operations, diluted$—$—$—$0.66
Net loss per share$(0.26)$(0.34)$(0.77)$(0.62)
Weighted average number of common shares outstanding:
Basic8,923,1708,825,8818,914,4878,782,340
Diluted8,923,1708,825,8818,914,4878,834,512

Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
For the Nine Months Ended
September 30,
20242023
Cash Flows from Operating Activities:
Net loss$(6,893,691)$(5,433,748)
Less: gain from discontinued operations, net of tax—5,872,020
Net loss from continuing operations(6,893,691)(11,305,768)
Reconciliation of net loss to net cash used in operating activities:
Stock-based compensation195,320714,899
Changes in operating assets and liabilities:
Prepaid expenses and deposits(178,148)(80,116)
Other receivables283,4052,318,691
Related party payable(426,217)367,915
Accounts payable and accrued expenses812,142(159,567)
Deferred revenue—107,530
Net cash used in operating activities - continuing operations(6,207,189)(8,036,416)
Net cash used in operating activities - discontinued operations—(6,035,961)
Net cash used in operating activities(6,207,189)(14,072,377)
Cash Flows from Investing Activities:
Net cash provided by investing activities - discontinued operations—18,664,122
Net cash provided by investing activities—18,664,122
Cash Flows from Financing Activities:
Proceeds from issuance of common stock, net36,9021,014,640
Proceeds from stock options exercise58,50185,342
Net cash provided by financing activities95,4031,099,982
Net (decrease) increase in cash and cash equivalents(6,111,786)5,691,727
Cash and cash equivalents at beginning of the period15,111,45011,782,172
Cash and cash equivalents at end of the period$8,999,664$17,473,899

ContactsInvestorsTIBEREND STRATEGIC ADVISORS, INC.Jonathan Nugent205-566-3026jnugent@tiberend.com

Primary Logo

Source: Marker Therapeutics

Please be aware that the following content has been generated by an AI system and may contain errors, inconsistencies, or outdated information. It is provided as-is without any warranties or guarantees of accuracy. We strongly recommend using this content as a starting point for further research and consultation with relevant experts or authorities. We disclaim any liability for damages or losses resulting from the use or reliance on this content.Please note that this is a beta version of the Gravity Analytica LLC’s AI Service which isstill undergoing final testing before its official release. Theplatform, its software and all content found on it are provided on an“as is” and “as available” basis. Gravity Analytica LLC does not give any warranties,whether express or implied, as to the suitability or usability of thisservice, webpage, or its software or any of its content.Should you encounter any bugs, glitches, lack of functionality orother problems on the website, please let us know immediately so wecan rectify these accordingly. Your help in this regard is greatlyappreciated! You can write to us at this addressteam@gravityanalytica.com