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Marker Therapeutics signs $16.1 million private placement

Tickers MRKR

Investors agreed to buy 1,783,805 shares plus warrants. The warrants need stockholder approval before they can be exercised.

Key facts

Company
Marker Therapeutics, Inc. (NASDAQ: MRKR)
News type
Financings
Primary source
Marker Therapeutics, Inc. 8-K (2024-12-19)
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Marker Therapeutics, Inc. of Houston, Texas, signed a securities purchase agreement on December 19, 2024 with various investors for a private placement. The investors would buy 1,783,805 shares of common stock, Series A warrants for 5,031,250 shares and pre-funded warrants for 3,248,445 shares. Gross proceeds are approximately $16.1 million before placement agent fees and offering expenses. The company intends to use the net proceeds for general corporate purposes and working capital. The filings give no cash balance and no runway figure.

The warrants and the stockholder vote

The pre-funded warrants have a $0.001 exercise price. The Series A warrants have a $4.00 exercise price. Neither can be exercised for the underlying shares until stockholders approve the issuance. Marker must call a stockholder meeting within 90 days of closing to seek that approval. If approval is not obtained there, it must hold another meeting by the 180th day after closing, and then semi-annual meetings until approval is granted. Stockholders who together own about 27% of the shares outstanding before the closing have signed voting agreements to vote in favor. Once approved, the warrants run for five years.

Placement agents and fees

Canaccord Genuity LLC is lead placement agent. Brookline Capital Markets, a division of Arcadia Securities, LLC, is co-placement agent. Both work under an engagement letter with Canaccord dated June 14, 2024. The fee is 6% of gross proceeds from investors other than certain identified investors, which the filing calls Reduced Fee Investors. For Reduced Fee Investors, the fee is 3% on the first $5 million and 6% above that. The company also agreed to pay expenses of a party the filing refers to only as Wainwright. The filing names no company counsel or agent counsel.

Under a registration rights agreement dated December 19, 2024, the company agreed to file a resale registration statement by January 14, 2025.

The APOLLO update

The same day, Marker released early clinical data from its Phase 1 APOLLO study of MT-601, a multi-antigen recognizing T cell product, in patients with lymphoma who relapsed after anti-CD19 CAR-T therapy or for whom CAR-T is not an option. The data cutoff was September 10, 2024. Ten patients have been treated at five clinical sites in the United States, and data are available for nine.

In the first dose cohort, seven of nine patients had an objective response at the first assessment, a rate of 78%, and four had a complete response, or 44.4%. The company says these patients were heavily pre-treated, with three to 12 prior lines of therapy. Follow-up is 6 to 12 months for three patients. One patient has been followed for at least 12 months, two have a complete response lasting at least six months, and four have a complete or partial response lasting one to four months.

Marker reports no immune-effector cell associated neurotoxicity syndrome, or ICANS, and one reported Grade 1 cytokine release syndrome. No dose-limiting toxicities have been reported.

What the data do not show

The study is an open-label, exploratory Phase 1 trial sponsored by the company, with up to about 30 participants planned for dose escalation, and the efficacy figures come from nine patients at their first assessment. The release gives no confidence intervals and no statistical test. A response at first assessment is not a measure of durability, and the company says ongoing follow-up is meant to assess that.

The release cites a 40% to 60% relapse rate within the first year of CD19 CAR-T therapy and says there is no approved standard of care for patients who relapse after it. The release says MAR-T cells have shown no evidence of ICANS in trials to date, a company comparison that does not use a control group.

The company and its lead product

Marker describes itself as a clinical-stage immuno-oncology company. Its lead product, MT-601, is a non-genetically modified T cell product that targets six tumor antigens upregulated in lymphoma cells: Survivin, PRAME, WT-1, NY-ESO-1, SSX-2 and MAGEA-4. Monic Stuart, M.D., is chief medical officer.

What the filings leave open

The filings give no price per share for the placement and no timetable for the next APOLLO readout. They name no counsel, and the release does not say what the company would do if the stockholder vote fails at every meeting.

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