On August 10, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported financial results for the quarter ended June 30, 2023, and highlighted recent business updates (Press release, Carisma Therapeutics, AUG 10, 2023, View Source [SID1234634214]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In the second quarter, the Carisma team successfully achieved the important clinical milestone of dosing the first patient in the Phase 1 clinical trial of CT-0508 in combination with KEYTRUDA, which represents the next step in our progression of engineering macrophages for the treatment of solid tumors," said Steven Kelly, President and Chief Executive Officer of Carisma. "We continue to execute on our overall strategic plan and we are excited to use this momentum to reach our upcoming potential value inflection points within our HER2 franchise and across our pipeline. We believe we are well-positioned to drive innovation as the leader in engineered macrophages and deliver value to our stakeholders."
Pipeline Updates
· CT-0508
o Announced the first patient has been dosed in the Company’s Phase I clinical trial that will test the safety and tolerability of the Company’s lead candidate, CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M) in combination with Merck’s anti-PD1 therapy KEYTRUDA (pembrolizumab) for the treatment of HER2 overexpressing solid tumors.
· In Vivo Oncology Program (Moderna Collaboration)
o Nominated and initiated research on an additional oncology target under the Moderna research collaboration to develop in-vivo targeted CAR-M therapies. The goal of the program, which now has five nominated targets, is to create novel in vivo CAR-M therapies with an approach that uses Moderna’s mRNA/LNP technology together with Carisma’s CAR-M platform technology.
Recent Business Highlights
· Expanded Leadership Team to support legal and human resources functions. The Company appointed Eric Siegel as General Counsel and Corporate Secretary and Terry Shields as Senior Vice President of Human Resources. Mr. Siegel and Ms. Shields each bring to Carisma more than 25 years of experience in their respective fields.
· Added to the Russell 2000, Russell 3000, and Russell Microcap Indexes. Following the conclusion of the 2023 Russell indexes annual reconstitution, the Company joined three Russell indexes that capture the 4,000 largest U.S. stocks as of April 28, 2023, ranked by total market capitalization.
Anticipated Upcoming Milestones
· Data from Group 2 of Phase 1 clinical trial of CT-0508 expected in the second half of 2023
· Initial data from Phase 1 clinical trial of CT-0508 in combination with KEYTRUDA (pembrolizumab) expected in the second half of 2023
· Submission of Investigational New Drug (IND) application to the U.S. Food and Drug Administration for CT-0525, Carisma’s first anti-HER2 CAR-Monocyte product candidate, expected in the second half of 2023
· Selection of next-generation candidate for CT-1119 expected in the first half of 2024
· Proof-of-concept data for the Company’s initial non-oncology program expected in the first half of 2024
Second Quarter 2023 Financial Results
· Cash, cash equivalents and marketable securities as of June 30, 2023 were $117.1 million, compared to $139.0 million as of March 31, 2023.
· Research & development expenses were $18.5 million for the second quarter of 2023, compared to $14.2 million for the same period in 2022. The increase of $4.3 million was primarily due to a $1.5 million increase in direct costs associated with the preclinical development of CT-0525, a $1.3 million increase in direct costs associated with CT-0508, a $1.0 million increase in personnel costs due to growth in research and development employee headcount, a $0.5 million increase in direct costs related to CT-1119, and a $0.2 million increase in facilities and other expenses due to an increase in rent expense, partially offset by a $0.2 million decrease of other clinical and pre-clinical development expenses associated with tracking CT-0525 and CT-1119 separately.
· General & administrative expenses were $6.0 million for the second quarter of 2023, compared to $2.4 million for the same period in 2022. The increase of $3.6 million was attributable to $1.9 million increase in legal and professional fees in support of our expanding infrastructure and patent portfolio, a $1.5 million increase of higher personnel costs as a result of an increase in headcount, as well as a $0.3 million increase in other expenses due to an increase in travel and other administrative costs, partially offset by a $0.1 million decrease in facilities and supplies due to a decline in office expenditures.
· Net loss was $19.9 million for the second quarter of 2023, compared to net loss of $14.8 for the same period in 2022, primarily due to increased research and development expenses to support CT-0508 and CT-0525 as well as increase in expanding headcount and infrastructure, which was partially offset by Moderna collaboration revenue.
Outlook
Carisma believes that its cash, cash equivalents and marketable securities of $117.1 million as of June 30, 2023, are sufficient to sustain Carisma’s planned operations through the end of 2024.
About CT-0508
CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. Carisma is selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for its CAR-M. The Phase 1 clinical trial is first-of-its-kind, marking the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) the University of Pennsylvania Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center.