learningcurve2020
3 days ago
FISCAL YEAR 2023 FINANCIAL HIGHLIGHTS
Cash Position and Guidance: At December 31, 2023, Marker had cash and cash equivalents of $15.1 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the fourth quarter of 2025, inclusive of available drawdowns from grant funds.
R&D Expenses: Research and development expenses were $10.4 million for the year ended December 31, 2023, compared to $12.0 million for the year ended December 31, 2022.
G&A Expenses: General and administrative expenses were $7.5 million for the year ended December 31, 2023, compared to $11.3 million for the year ended December 31, 2022.
Net Loss: Marker reported a net loss of $8.2 million for the year ended December 31, 2023, compared to a net loss of $29.9 million for the year ended December 31, 2022.
jobynimble
7 days ago
We are presenting at the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference on March 26, 2024!
Join our CEO Juan Vera and learn more about Marker’s #multiTAA T cell products.
📅 Date: March 26, 2024
⏰ Time: 10:00 AM, EDT
For more information: https://t.co/pS7hjNhblG pic.twitter.com/96sybCey1Y— Marker Therapeutics, Inc. (@MRKRTherapeutic) March 22, 2024
microcapbiotech
3 weeks ago
OK, let me get this straight.
It has been more than 20 years since TPIV came public,
about 6 years since the MRKR merger,
and what we have to show for it is basically nothing.
All TPIV legacy gone bye bye.
MRKR AML just about gone bye bye.
And here we are, back to almost square one, with a single early Phase 1 Lymphoma trial.
Just Peachy.
jobynimble
3 weeks ago
March 1st, the same day as the other news, I missed the 8-K alert so here it is…
https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1094038/000110465924029638/tm247674d1_8k.htm
ITEM 1.02. TERMINATION OF A MATERIAL DEFINITIVE AGREEMENT
On February 29, 2024, Marker Therapeutics, Inc. (the “Company”) delivered notice to Lincoln Park Capital Fund, LLC, an Illinois limited liability company (“LPC”), terminating the Purchase Agreement, dated December 12, 2022 (the “Purchase Agreement”), with LPC effective March 1, 2024 (the “Termination Date”). The Company projects a financial runway through the fourth quarter of 2025 and does not anticipate an immediate need for capital acquisition. The Purchase Agreement provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company had the right to sell to LPC up to $25 million of shares of the Company’s common stock, par value $0.001 per share (“Common Stock”), over the 24-month term of the Purchase Agreement. The Purchase Agreement provided the Company could terminate the Purchase Agreement for any reason or for no reason with one business day notice to LPC, however, certain provisions in the Purchase Agreement survive termination, as more fully described in the Purchase Agreement. In consideration for entering into the Purchase Agreement, the Company issued to LPC 1,804,098 shares of the Company’s Common Stock (the “Commitment Shares”). There are no early termination penalties attributable the Purchase Agreement. There were no material relationships between the Company, or any of the Company’s affiliates, and LPC other than with respect to the Purchase Agreement and Registration Rights Agreement, described below.
Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with LPC (the “Registration Rights Agreement”), pursuant to which the Company agreed to file a Form S-1 registration statement (the “Registration Statement”), as permissible and necessary under the Securities Act of 1933, as amended (the “Securities Act”), to register the sale of the shares of the Company’s Common Stock that may be sold to LPC under the Purchase Agreement, as well as the Commitment Shares. On January 3, 2023, the Company filed a Prospectus Supplement to the Registration Statement dated December 23, 2022 and declared effective on December 30, 2022 with the Securities and Exchange Commission registering the resale of all the shares of Common Stock that may be offered to LPC from time to time under the Purchase Agreement. From December 12, 2022 through the Termination Date, the Company sold 12,500 shares of Common Stock under the Purchase Agreement generating proceeds of approximately $33,000. The Company has no further obligations under the Purchase Agreement.
The descriptions of the Purchase Agreement and the Registration Rights Agreement contained in this Current Report on Form 8-K do not purport to be complete and are qualified in their entirety by reference to the copies of the Purchase Agreement and the Registration Rights Agreement filed as Exhibit 10.1 and Exhibit 10.2, respectively, to the Current Report on Form 8-K filed on December 13, 2022.
jobynimble
4 weeks ago
Marker Therapeutics Receives Approval from United States Adopted Name (USAN) Council and International Nonproprietary Names (INN) Expert Committee for “Neldaleucel” as Nonproprietary Name for MT-601
January 22, 2024 07:30 ET
| Source: Marker Therapeutics
HOUSTON, Jan. 22, 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, announced today that the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved “neldaleucel” as the nonproprietary (generic) name for MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product candidate for the treatment of patients with lymphoma.
The USAN Council in close collaboration with the WHO established INN expert committee select and assign a single unique name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical, ensuring clear identification, safe prescription and dispensing of medicines to patients. Nonproprietary names are intended for use in pharmacopoeias, labelling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g. for generics. Their use is normally required by national and international legislations. The adoption of the name neldaleucel is a step forward for continued advancements of multiTAA therapies Marker is developing. The Company recently provided a clinical update on the Phase 1 study investigating MT-601 in CAR relapse patients with lymphoma, demonstrating clinical safety and durability in the first study participant, suggesting the clinical benefit of neldaleucel (Press Release, Dec 11, 2023).
“The assignment of the nonproprietary name to MT-601 represents a significant milestone as we advance this potential treatment for patients with lymphoma,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “The INN and USAN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. The USAN and WHO INN approval of neldaleucel allows us to establish a universally recognized and conflict-free nonproprietary drug name for MT-601 and represents an important step in our path to ultimately market the drug.”
jobynimble
1 month ago
8-K filing: https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1094038/000110465924027293/tm247177d1_8k.htm
ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On February 22, 2024, Marker Therapeutics, Inc. (the “Company”) entered into a Master Services Agreement for Product Supply (the “Agreement”) with Cell Ready LLC (“Cell Ready”). Cell Ready, which is owned by one of the Company’s directors and shareholders, Mr. John Wilson, is a contract development and manufacturing organization (CDMO).
Pursuant to the Agreement, the Company may contract with Cell Ready for the provision of various products and services from time to time by entering into work orders with Cell Ready. If the services involve the supply of product, Cell Ready is required to supply such product in conformance with the product requirements set forth in the applicable work order(s). The Agreement contains customary representations, warranties and indemnification provision. The initial term of the Agreement is three years and may be extended upon the mutual written agreement of the parties. Either party may terminate the Agreement (a) for material breach by the other party if such breach has not been cured within 30 days following notice of termination or (b) if the other party is the subject of an insolvency event.
Also on February 22, 2024, the Company entered into Work Order #1 under the Agreement, pursuant to which Cell Ready will provide the Company with GMP drug product for Marker MT-401 and/or MT-601. The services include the delivery of final drug product and quality control testing. The Company also requested Cell Ready to provide general support services in connection therewith. The total projected sum (inclusive of taxes) for the services under Work Order #1 are not anticipated to exceed $750,000. The services will cover the anticipated manufacturing costs for the first quarter of 2024. Additional Work Orders are expected to be generated for the remainder of 2024.