Carisma Therapeutics Announces Strategic Restructuring to Re-prioritize Pipeline
Carisma Therapeutics (NASDAQ: CARM) announced a strategic restructuring, including discontinuation of CT-0525 development and a 34% workforce reduction. The company will redirect focus to its in vivo macrophage engineering platform for fibrosis, oncology, and autoimmune disease therapies.
Key developments include: plans to nominate a liver fibrosis development candidate in Q1 2025; ongoing collaboration with Moderna on multiple oncology and autoimmune programs; and expected restructuring costs of approximately $2.7 million. Three senior executives, including the CFO, General Counsel, and SVP of Human Resources, will depart by December 31, 2024.
The decision to discontinue the anti-HER2 program was based on competitive landscape assessment and recent developments in anti-HER2 therapies affecting antigen loss/downregulation.
Carisma Therapeutics (NASDAQ: CARM) ha annunciato una ristrutturazione strategica, che include la sospensione dello sviluppo di CT-0525 e una riduzione del personale del 34%. L'azienda si concentrerà sulla sua piattaforma di ingegneria dei macrofagi in vivo per terapie contro la fibrosi, l'oncologia e le malattie autoimmuni.
Sviluppi chiave includono: piani per nominare un candidato allo sviluppo per la fibrosi epatica nel primo trimestre del 2025; collaborazione in corso con Moderna su diversi programmi oncologici e autoimmuni; e costi di ristrutturazione previsti di circa 2,7 milioni di dollari. Tre dirigenti senior, tra cui il CFO, il Consigliere Generale e il SVP delle Risorse Umane, lasceranno l'azienda entro il 31 dicembre 2024.
La decisione di interrompere il programma anti-HER2 è stata presa in base a una valutazione del panorama competitivo e degli sviluppi recenti nelle terapie anti-HER2 che influenzano la perdita/regolazione a ribasso dell'antigene.
Carisma Therapeutics (NASDAQ: CARM) anunció una reestructuración estratégica, que incluye la interrupción del desarrollo de CT-0525 y una reducción del 34% de la plantilla. La empresa redirigirá su enfoque hacia su plataforma de ingeniería de macrófagos in vivo para terapias contra la fibrosis, la oncología y enfermedades autoinmunitarias.
Los desarrollos clave incluyen: planes para nominar un candidato para el desarrollo de fibrosis hepática en el primer trimestre de 2025; colaboración continua con Moderna en múltiples programas de oncología y autoinmunidad; y costos de reestructuración esperados de aproximadamente 2,7 millones de dólares. Tres altos ejecutivos, incluidos el CFO, el Asesor General y el SVP de Recursos Humanos, se irán antes del 31 de diciembre de 2024.
La decisión de discontinuar el programa anti-HER2 se basó en la evaluación del panorama competitivo y en los desarrollos recientes en las terapias anti-HER2 que afectan la pérdida/regulación a la baja del antígeno.
Carisma Therapeutics (NASDAQ: CARM)는 전략적 구조조정을 발표하며 CT-0525 개발 중단과 34% 인력 감축을 포함한다고 밝혔습니다. 이 회사는 섬유증, 종양학 및 자가면역 질환 치료를 위한 생체 내 대식세포 공학 플랫폼에 집중할 것입니다.
주요 개발 사항으로는 2025년 1분기에 간 섬유증 개발 후보를 지명할 계획, 다수의 종양학 및 자가면역 프로그램에 대한 Moderna와의 지속적인 협업, 약 270만 달러의 구조조정 비용이 예상됩니다. CFO, 일반 고문, 인사 부사장을 포함한 3명의 고위 임원이 2024년 12월 31일까지 퇴사할 것입니다.
항-HER2 프로그램 중단 결정은 경쟁 환경 평가와 항-HER2 치료의 최근 발전에 기반하여 항원이 손실되거나 하향 조절되는 영향을 미쳤습니다.
Carisma Therapeutics (NASDAQ: CARM) a annoncé une restructuration stratégique, y compris l'arrêt du développement de CT-0525 et une réduction de 34 % de la main-d'œuvre. L'entreprise concentrera son activité sur sa plateforme d'ingénierie des macrophages in vivo pour les thérapies contre la fibrose, l'oncologie et les maladies auto-immunes.
Les développements clés incluent : des plans pour nommer un candidat au développement de la fibrose hépatique au premier trimestre 2025 ; une collaboration continue avec Moderna sur plusieurs programmes en oncologie et en auto-immunité ; et des coûts de restructuration estimés à environ 2,7 millions de dollars. Trois cadres supérieurs, dont le CFO, le conseiller général et le SVP des ressources humaines, quitteront leurs postes d'ici le 31 décembre 2024.
La décision d'arrêter le programme anti-HER2 a été basée sur une évaluation du paysage concurrentiel et des développements récents dans les thérapies anti-HER2 affectant la perte/régulation à la baisse de l'antigène.
Carisma Therapeutics (NASDAQ: CARM) hat eine strategische Umstrukturierung angekündigt, einschließlich der Einstellung der Entwicklung von CT-0525 und einer Reduzierung der Belegschaft um 34%. Das Unternehmen wird den Fokus auf seine in vivo Makrophagen-Engineering-Plattform für Therapien gegen Fibrose, Onkologie und Autoimmunerkrankungen richten.
Zu den wichtigsten Entwicklungen gehören: Pläne zur Nominierung eines Entwicklungskandidaten für Leberfibrose im ersten Quartal 2025; fortlaufende Zusammenarbeit mit Moderna an mehreren onkologischen und autoimmunen Programmen; und voraussichtliche Umstrukturierungskosten von etwa 2,7 Millionen Dollar. Drei leitende Angestellte, darunter der CFO, der General Counsel und der SVP für Personalwesen, werden bis zum 31. Dezember 2024 ausscheiden.
Die Entscheidung, das Anti-HER2-Programm einzustellen, basierte auf der Bewertung der Wettbewerbslandschaft und den jüngsten Entwicklungen in den Anti-HER2-Therapien, die den Antigenverlust/die Abwärtsregulierung betreffen.
- Strategic focus on potentially more profitable in vivo macrophage engineering platform
- Ongoing collaboration with Moderna includes multiple oncology programs with up to 10 development targets
- Preclinical data shows promise in liver fibrosis treatment
- Cost reduction through workforce restructuring
- Discontinuation of CT-0525 development program
- 34% workforce reduction including departure of three senior executives
- $2.7 million in restructuring costs
- Competitive challenges in anti-HER2 market leading to program termination
Insights
This strategic restructuring marks a significant shift for Carisma Therapeutics, with both immediate financial and long-term strategic implications. The 34% workforce reduction and discontinuation of CT-0525 should generate substantial cost savings, with restructuring costs of
The pivot to focus on the in vivo macrophage engineering platform, particularly through the Moderna collaboration, represents a more capital-efficient approach. The partnership with Moderna provides valuable validation and potential milestone payments, which could help extend the company's runway. The departure of key executives, including the CFO, signals a deeper organizational transformation that could impact near-term operations.
The strategic shift away from the anti-HER2 program CT-0525 reflects the challenging competitive landscape in HER2-targeted therapies. However, the focus on in vivo macrophage engineering, particularly in liver fibrosis and autoimmune diseases, targets significant unmet medical needs with potentially higher commercial potential. The preclinical liver fibrosis data showing reduced inflammation and fibrosis resolution is promising, with a development candidate expected in Q1 2025.
The Moderna collaboration spanning multiple oncology targets and two autoimmune programs provides scientific validation of the platform. The GPC3-targeted CAR-M approach for solid tumors could offer advantages over traditional cell therapies, potentially enabling better manufacturing scalability and patient accessibility.
Resources realigned to focus primarily on in vivo macrophage engineering platform for fibrosis, oncology and autoimmune disease therapies
Development of CT-0525 to be discontinued; workforce reduced by
"Following a comprehensive review of our portfolio, we have made the strategic decision to prioritize advancing our in vivo macrophage engineering platform," said Steven Kelly, President and Chief Executive Officer of Carisma. "The compelling data generated by both the Moderna-partnered in vivo CAR-M oncology programs as well as our internal liver fibrosis program underscore the potential to revolutionize treatment paradigms with an innovative and patient-centric approach."
"These strategic initiatives, re-directing our investments to the in vivo macrophage engineering platform, discontinuing development of our anti-HER2 program and reducing our workforce, aim to streamline our operations and reduce operating expenses over time," Kelly continued. "While these decisions are very challenging, they are made in the best interest of our shareholders. We remain deeply grateful for the significant contributions of the employees departing Carisma."
Reprioritization Plan, Pipeline Updates, and Upcoming Milestones:
As part of this reprioritization of our pipeline, Carisma will discontinue development of the anti-human epidermal growth factor receptor 2 ("anti-HER2") program, and redirect the Company's focus to developing off-the-shelf products using its in vivo macrophage engineering platform:
Fibrosis
- Carisma's initial fibrosis program is focused on addressing liver fibrosis, a significant global health challenge. Preclinical data presented at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting® 2024 demonstrated the potential of Carisma's engineered macrophages to reduce inflammation, resolve fibrosis, and promote liver regeneration.
- The Company plans to nominate a development candidate for its liver fibrosis program in the first quarter of 2025, reflecting its expertise in macrophage biology and fibrotic diseases.
Oncology
- In collaboration with Moderna, Inc. (Nasdaq: MRNA), Carisma is advancing multiple programs utilizing an in vivo chimeric antigen receptor macrophage and monocyte ("CAR-M") plus mRNA/LNP approach. The lead program is an anti-glypican 3 (GPC3) in vivo CAR-M therapy that has demonstrated the potential for this scalable, patient-friendly approach to transform solid tumor therapy. In addition to this program, Moderna has nominated four undisclosed oncology research targets under the collaboration and has the right to designate up to ten oncology targets as development targets.
Autoimmune
- In collaboration with Moderna, Carisma has two in vivo CAR-M research programs for the treatment of autoimmune diseases associated with two distinct targets where there is significant unmet medical need.
- Carisma retains all rights in autoimmune disease beyond these two nominated targets.
Discontinuation of anti-HER2 Development
- The Company's decision was based on an assessment of the competitive landscape in anti-HER2 treatments, including the impact of recently approved anti-HER2 therapies on HER2 antigen loss/downregulation, and the effects on the future development strategy of any anti-HER2 treatment.
- The Company has completed patient enrollment of the Phase 1 clinical trial of CT-0525 and will not enroll patients in the previously planned Cohort 3 of the study.
- Based on the data available to date from the anti-HER2 program, CAR-M cell therapy has been shown to be safe, well-tolerated, and feasible to manufacture, and it holds the potential to become a meaningful treatment option for patients.
Corporate Updates
- As part of the strategic restructuring, Carisma will reduce its workforce by
34% . The Company expects the reduction in workforce to be substantially complete and to pay the majority of related reduction in workforce amounts by the end of the first quarter of 2025. The Company is committed to supporting affected employees through this transition. - As part of the workforce reductions, our Chief Financial Officer, Richard Morris, our General Counsel, Eric Siegel, and our Senior Vice President, Human Resources, Terry Shields, will leave the Company effective December 31, 2024. Carisma expresses gratitude for their contributions.
- The Company expects to incur approximately
$2.7 million
About Carisma
Carisma Therapeutics is a biopharmaceutical Company pioneering macrophage engineering to develop groundbreaking therapies for fibrosis, cancer, and other diseases. With a strong commitment to patient-centric innovation, Carisma aims to deliver scalable, next-generation solutions that transform treatment paradigms. Carisma is headquartered in
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 the Company's intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the expected timing for the completion of the reduction in workforce; the expected charges to be incurred and the related cash payments and the timing thereof; future employment relationships; the future development focus of the Company and related timelines; and other statements that are not historical fact. The words "continue," "estimate," "expect," "may," "plan," "will," 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, changes to the assumptions on which the estimated charges associated with the reduction in workforce are based; the "at-will" nature of employment relationships; changes in the macroeconomic environment or competitive landscape that impact the Company's business; and risks related to the Company's business and the Company's ongoing evaluation of strategic alternatives. For a discussion of these risks and uncertainties, and other important factors, any of which could cause the Company'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 the Company'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. The Company 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:
Julia Stern
(763) 350-5223
jstern@realchemistry.com
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SOURCE Carisma Therapeutics Inc.
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