Novel anti-fibrotic engineered macrophage therapy reduced liver fibrosis in preclinical models Development candidate nomination expected in the first quarter of 2025 PHILADELPHIA, May 8, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced new data demonstrating preclinical proof of concept using engineered anti-fibrotic macrophages for the treat ...

Industry veteran with expertise in oncology and immuno-oncology and a strong track record of advancing programs through clinical development PHILADELPHIA, May 2, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the appointment of Eugene P. Kennedy, M.D., F.A.C.S. as the Company's Chief Medical Officer. Dr. Kennedy brings over 15 years of cli ...

PHILADELPHIA, April 24, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced its upcoming presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting taking place from May 31- June 4, 2024, in Chicago, IL. Details on the poster presentation at ASCO 2024 are below: Poster Title: A phase 1, first-in-human study of autologou ...

Shares of Carisma Therapeutics Inc. (CARM) have been struggling lately and have lost 12.1% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about th ...

Product Development - The company is focused on developing CAR-M cell therapy to treat solid tumors, with its first product candidate, CT-0508, currently in a Phase 1 clinical trial in the U.S.[409] - CT-0525, a novel CAR-M therapy, received FDA clearance in November 2023, with the first patient expected to be treated in Q2 2024 and preliminary data anticipated by the end of 2024[410] - The company is developing a pipeline of product candidates targeting not only oncology but also diseases like fibrosis and other immunologic conditions[413] - The follow-on product candidate CT-0525, a CAR-Monocyte, can manufacture up to ten billion cells from a single apheresis, enabling a larger dose than CAR-Macrophages[187] - CT-0525 is currently in a Phase 1 clinical trial with two cohorts: Cohort 1 receiving 3 billion CAR-positive cells and Cohort 2 receiving up to 10 billion CAR-positive cells[221] - The company plans to focus clinical development primarily on CT-0525 due to its favorable attributes compared to CT-0508[221] - The company is studying the safety and tolerability of CT-0525 in patients with locally advanced or metastatic solid tumors over-expressing HER2[221] - The anti-HER2 CAR in CT-0508 is derived from trastuzumab, specifically targeting HER2 over-expressing tumor cells[225] - The company is developing strategies to enhance the anti-tumor effects of CAR-Monocyte therapies compared to CAR-Macrophage approaches[221] - Pre-clinical proof of concept for new product candidates targeting liver fibrosis and other immunologic diseases is expected in Q2 2024[228] Financial Overview - The company has incurred significant losses since inception and expects to continue incurring substantial expenses and operating losses for the foreseeable future[416] - The company has sufficient cash and cash equivalents to sustain operations into Q3 2025, but may require additional funding to avoid delays in product development[419] - The company plans to pursue additional financing and collaboration opportunities to support product development and reassess expense allocation[412] - The revised operating plan aims to balance value creation and expense management, focusing on high potential value programs and eliminating non-essential expenses[253] Collaborations and Partnerships - The collaboration with Moderna aims to develop in vivo engineered CAR-M therapeutics for up to 12 oncology programs, with the first five research targets currently in the discovery phase[422] - Under the Moderna License Agreement, the company received a $45 million upfront cash payment and is eligible for up to $253 million per product in milestone payments[207] - The collaboration with Moderna allows the development of an mRNA-based in vivo CAR-M platform, potentially expanding the pipeline to 12 additional oncology candidates[227] - The strategic partnership with Moderna enables the application of learnings from autologous CAR-M development to new oncology candidates[227] Regulatory Environment - The regulatory approval process for product candidates is lengthy and unpredictable, posing risks to the company's business[415] - The FDA may require sponsors of products receiving accelerated approval to perform adequate and well-controlled post-marketing clinical trials[270] - The FDA aims to complete its review of priority review applications within six months, compared to ten months for standard reviews[270] - The FDA's new draft guidance in March 2023 outlines considerations for designing trials to support accelerated approvals of oncology therapeutics[270] - The FDA's Breakthrough Therapy designation provides intensive guidance and review for products showing substantial improvement over existing therapies[270] - Sponsors receiving a Complete Response Letter (CRL) have one year to address deficiencies identified by the FDA[268] - The application user fee for a BLA requiring clinical data for federal fiscal year 2024 is $4,048,695, with an annual program fee of $416,734[265] - The annual program fee for a licensed BLA in federal fiscal year 2024 is $416,734[265] - The FDA may refer applications for novel biologic products to an advisory committee for review and recommendations[267] Intellectual Property - The company currently controls over 26 granted patents, expected to expire between 2033 and 2042, and has over 104 pending patent applications[199] - The company is actively developing intellectual property to maximize returns on investments, focusing on patents related to CAR-M technology[199] - The company is obligated to pursue the development and commercialization of at least one CAR-M product in oncology and non-oncology fields under the Penn License Agreement[208] Manufacturing and Supply Chain - The company relies on third-party contract manufacturing organizations (CMOs) for clinical materials and manufacturing capabilities[195] - The company has established arrangements with contract manufacturers for clinical trials but does not have long-term supply agreements in place[196] Cybersecurity - The company emphasizes the importance of cybersecurity risk management to protect its operations and patient information[429] Competition - The company faces competition from various established companies in the myeloid cell therapy and CAR-T therapy sectors[211]

Carisma Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results Other prioritized pipeline programs include the Company's in vivo CAR-M collaboration with Moderna, and research programs including fibrosis PHILADELPHIA – April 1, 2024 – Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today reported financial results for the fourth qu ...

Company to prioritize CT-0525 as its anti-HER2 CAR-M product candidate and will cease further development of CT-0508 Other prioritized pipeline programs include the Company's in vivo CAR-M collaboration with Moderna, and research programs including fibrosis Cash and cash equivalents of $77.6 million as of December 31, 2023, combined with a restructuring of operations, including pausing development of CT-1119, expected to fund the Company into the third quarter of 2025 PHILADELPHIA, April 1, 2024 /PRNewswire ...

Appointment of John Hohneker, M.D. Resignation of Chidozie Ugwumba PHILADELPHIA, April 1, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the appointment of John Hohneker, M.D. to the Board of Directors of the Company, effective April 1, 2024. Additionally, the Company announced that Chidozie Ugwumba, who has served on Carisma's Board of Dir ...

PHILADELPHIA, March 21, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced its upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 5-10, 2024, in San Diego, California. The poster presentation will showcase preclinical data illustrating the advancements made with Carisma's proprie ...

PHILADELPHIA, Feb. 28, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that Steven Kelly, President and Chief Executive Officer, will participate in the TD Cowen 44th Annual Health Care Conference on Wednesday, March 6th at 2:50 pm ET. An audio webcast of the event will be available on the Company's Investor Events section of the Investor Re ...