New preclinical results support the anti-fibrotic potential of engineered macrophages in multiple fibrosis modelsEngineered TIM4-expressing macrophages correct defective efferocytosis in MASH, demonstrating potent anti-fibrotic activity PHILADELPHIA, Nov. 17, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today presented promising preclinical data on engin ...

Financial Performance - The company reported net losses of $42.8 million for the nine months ended September 30, 2024, compared to $65.9 million for the same period in 2023[103]. - As of September 30, 2024, the company had $26.9 million in cash and cash equivalents and an accumulated deficit of $287.9 million[103]. - Cash used in operating activities was $51.6 million for the nine months ended September 30, 2024, compared to $65.1 million in 2023[146]. - Interest income for the nine months ended September 30, 2024, was $1.9 million, down from $2.7 million in the same period of 2023, indicating sensitivity to interest rate changes[167]. - The company remains in a full valuation allowance position for deferred tax assets due to significant net losses since inception[120]. Research and Development - The lead product candidate, CT-0525, received FDA clearance for its investigational new drug application in November 2023 and treated its first patient in May 2024[89]. - CT-0525 has the potential to manufacture up to 10 billion cells from a single apheresis, utilizing a single-day manufacturing process[95]. - The company expects to report initial data from the CT-0525 Phase 1 clinical trial in the first quarter of 2025[89]. - The company achieved pre-clinical proof of concept in its liver fibrosis program in the second quarter of 2024, demonstrating anti-fibrotic potential[91]. - Research and development expenses for Q3 2024 were $11.3 million, down from $19.6 million in Q3 2023, a decrease of $8.3 million primarily due to the revised operating plan[127]. - The company expects research and development expenses to decrease for the remainder of 2024 due to the implementation of the revised operating plan, including a pause in the development of CT-1119[113]. - Research and development expenses were $44.1 million for the nine months ended September 30, 2024, a decrease of $10.6 million from $54.7 million in 2023, mainly due to halted development of CT-0508 and paused development of CT-1119[136]. Collaboration and Revenue - The collaboration with Moderna includes a $45 million upfront cash payment and a $35 million convertible promissory note, with potential milestone payments and royalties[100]. - The first Development Candidate under the Moderna collaboration targets Glypican-3 (GPC3) for treating hepatocellular carcinoma (HCC) and triggered a $2 million milestone payment from Moderna[100]. - Collaboration revenues for Q3 2024 were $3.4 million, compared to $3.8 million in Q3 2023, reflecting a decrease related to research and development activities under the Moderna License Agreement[124]. - Collaboration revenues increased to $16.0 million for the nine months ended September 30, 2024, compared to $10.6 million for the same period in 2023, primarily due to Moderna's Development Candidate nomination[133]. - The company has not yet commercialized any products or generated revenue from product sales, relying on financing from various sources[102]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying on collaboration revenues from the Moderna License Agreement[109]. Cost Management and Operational Changes - The revised operating plan approved in March 2024 aims to reduce monthly operating expenses and conserve cash, prioritizing CT-0525 as the lead product candidate[92]. - The company approved a revised operating plan in March 2024 to reduce monthly operating expenses and conserve cash, resulting in a 39 full-time employee reduction, approximately 37% of the total workforce[106]. - General and administrative expenses for Q3 2024 were $5.2 million, down from $6.6 million in Q3 2023, a decrease of $1.4 million attributed to the revised operating plan[129]. - General and administrative expenses decreased to $16.2 million for the nine months ended September 30, 2024, from $22.2 million in 2023, primarily due to reduced professional fees and personnel costs[138]. - Total operating expenses decreased to $60.3 million for the nine months ended September 30, 2024, down from $76.9 million in 2023, reflecting cost-saving measures implemented in the revised operating plan[136]. Future Funding and Financial Needs - The company expects to need substantial additional funding to support ongoing and planned activities, particularly for clinical trials and product development[152]. - The company anticipates receiving $73.9 million over the term of the Moderna License Agreement for expected research and development services[143]. - The company anticipates needing substantial additional financing to achieve business objectives, which may not be available on acceptable terms due to market conditions[156]. - The company expects to finance cash needs through a combination of public and private equity offerings, debt financings, and collaborations[158]. - The company may seek additional capital due to favorable market conditions or strategic considerations, even if current funds are deemed sufficient[157]. Market Risks and Economic Conditions - The company is exposed to market risks, primarily interest rate sensitivities, affecting its interest-earning assets[167]. - Inflation has not had a material effect on the company's business or financial condition during the three months ended September 30, 2024[168]. - The company may need to relinquish valuable rights to intellectual property or revenue streams if it raises funds through collaborations or licensing arrangements[159]. - The company faces uncertainties in generating necessary data for marketing approval of product candidates, which may delay commercial revenues[156].

Financial Performance - The net loss for Q3 2024 was $12.7 million, compared to a net loss of $21.4 million for the same period in 2023[12]. - Net loss for September 2024 was $(12,702,000), compared to $(21,403,000) in September 2023, indicating a reduction of approximately 40.5%[20]. - The operating loss improved from $(22,344,000) in September 2023 to $(13,144,000) in September 2024, reflecting a decrease in loss of about 41.2%[20]. - The net loss per share improved from $(0.53) in September 2023 to $(0.31) in September 2024, indicating a positive trend in per-share loss[20]. Cash and Assets - Carisma Therapeutics reported cash and cash equivalents of $26.9 million as of September 30, 2024, down from $40.4 million as of June 30, 2024[9]. - Cash and cash equivalents decreased significantly from $77,605,000 on December 31, 2023, to $26,881,000 on September 30, 2024, a drop of about 65.4%[19]. - Total current assets decreased from $80,471,000 on December 31, 2023, to $34,137,000 on September 30, 2024, a decline of approximately 57.6%[19]. - Total liabilities decreased from $63,022,000 on December 31, 2023, to $53,184,000 on September 30, 2024, a decline of approximately 15.6%[19]. - The accumulated deficit increased from $(245,102,000) on December 31, 2023, to $(287,944,000) on September 30, 2024, reflecting an increase of about 17.5%[19]. Research and Development - Research and development expenses for Q3 2024 were $11.3 million, a decrease of $8.3 million compared to $19.6 million in Q3 2023, primarily due to a revised operating plan[10]. - Initial results from the Phase 1 study of CT-0525 are expected in the first quarter of 2025[1]. - A development candidate for the liver fibrosis program is anticipated to be nominated in the first quarter of 2025[1]. - New preclinical efficacy data for anti-GPC3 in vivo CAR-M therapy will be presented on November 8, 2024, at the SITC Annual Meeting[1]. - The Phase 1 study of CT-0525 includes a protocol amendment allowing for repeat dosing of up to 2 billion CAR positive cells every three weeks[3]. Collaboration and Revenue - Carisma has expanded its collaboration with Moderna to include two research targets for autoimmune diseases[5]. - Collaboration revenues for September 2024 were $3,385,000, down from $3,827,000 in September 2023, representing a decrease of about 11.6%[20]. Operating Expenses - General and administrative expenses for Q3 2024 were $5.2 million, down from $6.6 million in Q3 2023, reflecting a $1.4 million decrease[11]. - Total operating expenses decreased from $26,171,000 in September 2023 to $16,529,000 in September 2024, a reduction of approximately 36.9%[20]. - The company expects to sustain its operations into the third quarter of 2025 with the current cash position[13].

Initial results from the Phase 1 study of CT-0525, lead product candidate, expected in the first quarter of 2025Nomination of a development candidate for liver fibrosis program expected in the first quarter of 2025New preclinical efficacy data from the anti-GPC3 in vivo CAR-M therapy to be presented on November 8 at SITC 2024 Annual MeetingNew preclinical efficacy data in liver fibrosis to be presented on November 17 at AASLD - The Liver Meeting ® 2024Cash and cash equivalents of $26.9 million expected to f ...

Core Viewpoint - Carisma Therapeutics Inc. (CARM) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Revisions - The Zacks rating system is based on the changing earnings picture of a company, specifically tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - For the fiscal year ending December 2024, Carisma is expected to earn -$1.43 per share, reflecting a 44.8% change from the previous year's reported number [8]. - Over the past three months, the Zacks Consensus Estimate for Carisma has increased by 8.3%, indicating a positive trend in earnings estimates [8]. Impact on Stock Price - The upgrade to Zacks Rank 2 suggests an improvement in Carisma's underlying business, which is likely to lead to an appreciation in stock price as investors respond to this trend [5][10]. - The correlation between earnings estimate revisions and near-term stock movements highlights the importance of tracking these revisions for investment decisions [6][4]. Zacks Rating System - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - Only the top 20% of Zacks-covered stocks receive a 'Strong Buy' or 'Buy' rating, indicating superior earnings estimate revision features [9][10].

Carisma Therapeutics Inc. (CARM) came out with a quarterly loss of $0.27 per share versus the Zacks Consensus Estimate of a loss of $0.36. This compares to loss of $0.49 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 25%. A quarter ago, it was expected that this company would post a loss of $0.37 per share when it actually produced a loss of $0.46, delivering a surprise of -24.32%. Over the last four quarters, the company ha ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________________________ FORM 10-Q ____________________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________to __________ ...

Exhibit 99.1 Carisma Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights Initial data for CT-0525, lead product candidate for anti-HER2 program, expected by year-end 2024 Nomination of a development candidate for liver fibrosis program expected in the first quarter of 2025 Nominated first in vivo CAR-M development candidate targeting Glypican-3 to treat hepatocellular carcinoma under the Moderna Collaboration in the second quarter of 2024 Cash and cash equivalents of $4 ...

Initial data for CT-0525, lead product candidate for anti-HER2 program, expected by year-end 2024 Nomination of a development candidate for liver fibrosis program expected in the first quarter of 2025 Nominated first in vivo CAR-M development candidate targeting Glypican-3 to treat hepatocellular carcinoma under the Moderna Collaboration in the second quarter of 2024 Cash and cash equivalents of $40.4 million and $2.0 million received in July under the Moderna Collaboration expected to fund the Company into ...

Core Insights - Carisma Therapeutics Inc. has appointed Dr. Scott Friedman and Dr. Ira Tabas to its Scientific Advisory Board, enhancing its expertise in liver fibrosis research [1][2] Group 1: Company Overview - Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies using a proprietary macrophage and monocyte cell engineering platform [8] - The company aims to create transformative treatments for cancer and other serious diseases, leveraging the role of engineered macrophages and monocytes in the immune response [8] Group 2: Key Appointments - Dr. Scott Friedman is recognized for his pioneering research in liver fibrosis and has authored over 300 peer-reviewed publications [3][4] - Dr. Ira Tabas has extensively studied pathways involved in metabolic dysfunction-associated steatohepatitis (MASH) fibrosis and has published approximately 300 original research articles [5][6] Group 3: Expertise and Contributions - Dr. Friedman has made significant contributions to understanding liver disease, including isolating the hepatic stellate cell, which is crucial for scar production in the liver [2][3] - Dr. Tabas's research has led to discoveries related to macrophage functions in liver health and disease, contributing to drug development efforts [5][6]