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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Carisma Therapeutics Inc | NASDAQ:CARM | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.011 | 2.84% | 0.399 | 0.3989 | 0.399 | 0.4075 | 0.38 | 0.38 | 439,958 | 22:00:00 |
Initial results from the Phase 1 study of CT-0525, lead product candidate, expected in the first quarter of 2025
Nomination of a development candidate for liver fibrosis program expected in the first quarter of 2025
New preclinical efficacy data from the anti-GPC3 in vivo CAR-M therapy to be presented on November 8 at SITC 2024 Annual Meeting
New preclinical efficacy data in liver fibrosis to be presented on November 17 at AASLD - The Liver Meeting ® 2024
Cash and cash equivalents of $26.9 million expected to fund the Company into the third quarter of 2025
PHILADELPHIA, Nov. 7, 2024 /PRNewswire/ -- 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 quarter ended September 30, 2024, and highlighted recent business updates.
"Our recent progress across clinical and preclinical programs demonstrates our commitment to pioneering therapies that address significant unmet medical needs," said Steven Kelly, President and CEO of Carisma Therapeutics. "We are advancing on multiple fronts. We expect to report initial data from the Phase 1 study of CT-0525 in the first quarter of 2025. We also recently nominated our first development candidate in hepatocellular carcinoma with Moderna and are excited to bring additional in vivo CAR-M therapies forward, including autoimmune targets. Our liver fibrosis program is progressing as well, with the nomination of a development candidate anticipated in the first quarter of 2025. These key milestones move us closer to delivering transformative treatments for patients in need."
Third Quarter 2024 Highlights and Upcoming Milestones
Ex Vivo Oncology
In Vivo Program (Moderna Collaboration)
Fibrosis
Corporate Update
Third Quarter 2024 Financial Results
Outlook
Carisma anticipates that its cash and cash equivalents of $26.9 million as of September 30, 2024 are sufficient to sustain its planned operations into the third quarter of 2025. The Company's cash forecast contains estimates and assumptions, and management cannot predict the timing of all cash receipts and expenditures with certainty. Variances from management's estimates and assumptions could impact the Company's liquidity prior to the third quarter of 2025.
About CT-0525
CT-0525 is a first-in-class, ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). It is being studied in a multi-center, open label, Phase 1 clinical trial for patients with advanced/metastatic HER2-overexpressing solid tumors that have progressed on available therapies. The CAR-Monocyte approach has the potential to address some of the challenges of treating solid tumors with cell therapies, including tumor infiltration, immunosuppression within the tumor microenvironment, and antigen heterogeneity. CT-0525 has the potential to enable significant dose escalation, enhance tumor infiltration, increase persistence, and reduce manufacturing time compared to macrophage therapy.
About Carisma Therapeutics
Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.
Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma's business, strategy, future operations, cash runway, the advancement of Carisma's product candidates and product pipeline, and clinical development of Carisma's product candidates, including expectations regarding timing of initiation and results of clinical trials. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "goals," "intend," "may," "might," "outlook," "plan," "project," "potential," "predict," "target," "possible," "will," "would," "could," "should," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) Carisma's ability to realize the anticipated benefits of its pipeline reprioritization and corporate restructuring, (ii) Carisma's ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (iii) Carisma's ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials and with its current financial and human resources; (iv) Carisma's ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (v) Carisma's ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (vi) regulatory requirements or developments and Carisma's ability to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities related to its product candidates; (vii) changes to clinical trial designs and regulatory pathways; (viii) risks associated with Carisma's ability to manage expenses; (ix) changes in capital resource requirements; (x) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (xi) legislative, regulatory, political and economic developments.
For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as discussions of potential risks, uncertainties, and other important factors in Carisma's other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
Investors:
Shveta Dighe
Head of Investor Relations
investors@carismatx.com
Media Contact:
Julia Stern
(763) 350-5223
jstern@realchemistry.com
CARISMA THERAPEUTICS INC. Unaudited Consolidated Balance Sheets (in thousands, except share and par value) | |||
September 30, | December 31, | ||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 26,881 | $ 77,605 | |
Prepaid expenses and other assets | 7,256 | 2,866 | |
Total current assets | 34,137 | 80,471 | |
Property and equipment, net | 5,391 | 6,764 | |
Right of use assets – operating leases | 2,322 | 2,173 | |
Deferred financing costs | 208 | 146 | |
Total assets | $ 42,058 | $ 89,554 | |
Liabilities and Stockholders' (Deficit) Equity | |||
Current liabilities: | |||
Accounts payable | $ 1,728 | $ 3,933 | |
Accrued expenses | 4,542 | 7,662 | |
Deferred revenue | 682 | 1,413 | |
Operating lease liabilities | 1,386 | 1,391 | |
Finance lease liabilities | 1,074 | 544 | |
Other current liabilities | 1,146 | 965 | |
Total current liabilities | 10,558 | 15,908 | |
Deferred revenue | 41,250 | 45,000 | |
Operating lease liabilities | 761 | 860 | |
Finance lease liabilities | 96 | 328 | |
Other long-term liabilities | 519 | 926 | |
Total liabilities | 53,184 | 63,022 | |
Stockholders' (deficit) equity: | |||
Preferred stock $0.001 par value, 5,000,000 shares authorized, none issued or | — | — | |
Common stock $0.001 par value, 350,000,000 shares authorized, 41,750,109 and | 41 | 40 | |
Additional paid-in capital | 276,777 | 271,594 | |
Accumulated deficit | (287,944) | (245,102) | |
Total stockholders' (deficit) equity | (11,126) | 26,532 | |
Total liabilities and stockholders' (deficit) equity | $ 42,058 | $ 89,554 |
CARISMA THERAPEUTICS INC. Unaudited Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) | |||
Three Months Ended | |||
2024 | 2023 | ||
Collaboration revenues | $ 3,385 | $ 3,827 | |
Operating expenses: | |||
Research and development | 11,326 | 19,551 | |
General and administrative | 5,203 | 6,620 | |
Total operating expenses | 16,529 | 26,171 | |
Operating loss | (13,144) | (22,344) | |
Change in fair value of derivative liability | — | — | |
Interest income, net | 442 | 941 | |
Pre-tax loss | (12,702) | (21,403) | |
Income tax expense | — | — | |
Net loss | $ (12,702) | $ (21,403) | |
Share information: | |||
Net loss per share of common stock, basic and diluted | $ (0.31) | $ (0.53) | |
Weighted-average shares of common stock outstanding, basic and diluted | 41,588,035 | 40,285,858 | |
Comprehensive loss | |||
Net loss | $ (12,702) | $ (21,403) | |
Unrealized gain on marketable securities | — | 108 | |
Comprehensive loss | $ (12,702) | $ (21,295) |
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SOURCE Carisma Therapeutics Inc.
Copyright 2024 PR Newswire
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