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Carisma Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights

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Carisma Therapeutics reported Q3 2024 financial results with cash and cash equivalents of $26.9 million, expected to fund operations into Q3 2025. Research and development expenses decreased to $11.3 million from $19.6 million year-over-year. The company anticipates initial results from the Phase 1 study of CT-0525 in Q1 2025 and plans to nominate a development candidate for its liver fibrosis program in the same quarter. New preclinical data for anti-GPC3 CAR-M therapy and liver fibrosis will be presented at upcoming scientific meetings. The company recently expanded its collaboration with Moderna to include autoimmune disease targets.

Carisma Therapeutics ha riportato i risultati finanziari del terzo trimestre 2024, con liquidità e equivalenti di cassa pari a $26,9 milioni, previsti per finanziare le operazioni fino al terzo trimestre del 2025. Le spese per ricerca e sviluppo sono diminuite a $11,3 milioni rispetto ai $19,6 milioni dell'anno precedente. L'azienda si aspetta risultati iniziali dallo studio di Fase 1 di CT-0525 nel primo trimestre del 2025 e prevede di nominare un candidato allo sviluppo per il suo programma sulla fibrosi epatica nello stesso trimestre. Nuovi dati preclinici per la terapia anti-GPC3 CAR-M e la fibrosi epatica saranno presentati alle prossime riunioni scientifiche. Recentemente, l'azienda ha ampliato la sua collaborazione con Moderna per includere obiettivi di malattie autoimmuni.

Carisma Therapeutics reportó los resultados financieros del tercer trimestre de 2024, con efectivo y equivalentes de $26,9 millones, que se espera financien las operaciones hasta el tercer trimestre de 2025. Los gastos de investigación y desarrollo disminuyeron a $11,3 millones desde $19,6 millones en comparación con el año anterior. La compañía anticipa resultados iniciales del estudio de Fase 1 de CT-0525 en el primer trimestre de 2025 y planea nominar a un candidato para el desarrollo de su programa de fibrosis hepática en el mismo trimestre. Nuevos datos preclínicos sobre la terapia CAR-M anti-GPC3 y la fibrosis hepática serán presentados en próximas reuniones científicas. Recientemente, la compañía amplió su colaboración con Moderna para incluir objetivos de enfermedades autoinmunes.

Carisma Therapeutics는 2024년 3분기 재무 결과를 보고하였으며, 현금 및 현금 등가물은 $26.9 백만으로, 2025년 3분기까지 운영 자금을 지원할 것으로 예상됩니다. 연구 개발 비용은 1년 전의 $19.6 백만에서 $11.3 백만으로 감소했습니다. 회사는 2025년 1분기에 CT-0525의 1상 연구 초기 결과를 기대하고 있으며, 같은 분기에 간 섬유증 프로그램의 개발 후보를 지명할 계획입니다. GPC3 CAR-M 요법 및 간 섬유증에 대한 새로운 전임상 데이터가 다가오는 과학 회의에서 발표될 예정입니다. 최근 회사는 Moderna와 자가면역 질환 목표를 포함하는 협력을 확대했습니다.

Carisma Therapeutics a reporté les résultats financiers du troisième trimestre 2024, avec des liquidités et équivalents de $26,9 millions, prévus pour financer les opérations jusqu'au troisième trimestre 2025. Les dépenses en recherche et développement ont diminué à $11,3 millions contre $19,6 millions l'année précédente. La société anticipe des résultats initiaux de l'étude de Phase 1 de CT-0525 au premier trimestre 2025 et prévoit de nommer un candidat au développement pour son programme de fibrose hépatique au même trimestre. De nouvelles données précliniques sur la thérapie CAR-M anti-GPC3 et la fibrose hépatique seront présentées lors des prochaines réunions scientifiques. Récemment, la société a élargi sa collaboration avec Moderna pour inclure des cibles de maladies auto-immunes.

Carisma Therapeutics berichtete über die finanziellen Ergebnisse des 3. Quartals 2024 mit Cash und Zahlungsmitteläquivalenten von $26,9 Millionen, die voraussichtlich die Betriebe bis ins 3. Quartal 2025 finanzieren werden. Die Forschungs- und Entwicklungskosten sanken auf $11,3 Millionen im Vergleich zu $19,6 Millionen im Vorjahr. Das Unternehmen erwartet erste Ergebnisse aus der Phase-1-Studie zu CT-0525 im 1. Quartal 2025 und plant, im selben Quartal einen Entwicklungskandidaten für sein Programm zur Leberfibrose zu nominieren. Neue präklinische Daten zur anti-GPC3 CAR-M-Therapie und zur Leberfibrose werden bei bevorstehenden wissenschaftlichen Tagungen präsentiert. Das Unternehmen hat kürzlich die Zusammenarbeit mit Moderna ausgeweitet, um Ziele für Autoimmunerkrankungen zu integrieren.

Positive
  • Cash position of $26.9M expected to fund operations into Q3 2025
  • R&D expenses decreased by $8.3M year-over-year
  • G&A expenses reduced by $1.4M compared to previous year
  • Net loss decreased to $12.7M from $21.4M in Q3 2023
  • Expanded collaboration with Moderna for autoimmune disease targets
Negative
  • Cash decreased from $40.4M in Q2 2024 to $26.9M in Q3 2024
  • Halted development of CT-0508 and paused CT-1119 development
  • Implemented workforce reduction as part of revised operating plan

Insights

A critical analysis of Carisma's Q3 financials reveals concerning trends despite operational streamlining. The $26.9M cash position represents a significant $13.5M burn from $40.4M in Q2, though R&D expenses decreased by 42.3% to $11.3M. The runway extension into Q3 2025 appears tight given the current burn rate and multiple clinical programs.

Key positives include reduced operating expenses through strategic program cuts and the expanded Moderna collaboration. However, investors should note that the company will likely need additional funding before reaching significant clinical milestones in 2025. The operational restructuring has helped, with G&A expenses down 21.2%, but sustainable financing remains a critical challenge.

The clinical development strategy shows promising focus with CT-0525's protocol amendment introducing multiple dosing regimens. The expansion to include combination therapy with pembrolizumab and various dosing schedules demonstrates clinical sophistication. However, the timeline for initial data from Cohorts 1 and 2 in Q1 2025 coincides with dwindling cash reserves.

The GPC3+ solid tumor program and liver fibrosis candidate nominations represent potential value drivers, but their early stage nature means significant development costs lie ahead. The autoimmune disease collaboration with Moderna provides strategic validation but may not translate to near-term financial relief.

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

  • CT-0525 (Anti-HER2 chimeric antigen receptor monocyte (CAR-Monocyte))
    • On November 5, 2024, Carisma announced the upcoming presentation of a trial in progress (TIP) poster for its Phase 1 clinical trial evaluating CT-0525, an autologous CAR-Monocyte therapy for the treatment of HER2+ solid tumors. The poster will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, Texas, on November 8, 2024.
    • In September 2024, Carisma submitted a protocol amendment for its Phase 1 study of CT-0525 to allow for the expansion of the study to include repeat dosing (up to two billion CAR positive cells administered every three weeks for up to five cycles) in combination with pembrolizumab, bolus dosing (up to10 billion CAR positive cells in a single dose) in combination with pembrolizumab, or either of these two dosing schedules as monotherapy (without checkpoint inhibitor). Repeat dosing in combination with pembrolizumab will be prioritized and the other three study arms may be activated as data indicates.
    • Carisma expects to report initial data for Cohorts 1 and 2 of its Phase 1 study of CT-0525 in the first quarter of 2025.

In Vivo Program (Moderna Collaboration)

  • Autoimmune disease (CAR-M + mRNA/LNP)
    • On September 10, 2024, Carisma announced the expansion of its in vivo chimeric antigen receptor macrophage and monocyte ("CAR-M") collaboration with Moderna, Inc. ("Moderna") to include the nomination of two research targets for the treatment of autoimmune diseases. Carisma retains all rights in autoimmune disease beyond the two nominated targets, which will be exclusively partnered with Moderna.
  • GPC3+ solid tumors (CAR-M + mRNA/LNP)
    • On November 5, 2024, Carisma announced the upcoming presentation of new pre-clinical data for its anti-GPC3 in vivo CAR-M therapy for the treatment of hepatocellular carcinoma (HCC), developed in collaboration with Moderna. These data will be presented in a poster session at the SITC Annual Meeting in Houston, Texas, on November 8, 2024. These preclinical data demonstrate robust anti-tumor activity and introduce a novel, off-the-shelf approach for GPC3+ solid tumors.

Fibrosis

    • On August 6, 2024, Carisma announced that new preclinical data for liver fibrosis will be highlighted in a poster presentation at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2024, to be held November 15 through 19, 2024, in San Diego, California.
    • Carisma expects to nominate a development candidate for its liver fibrosis program in the first quarter of 2025.

Corporate Update

  • On October 30, 2024, Carisma announced the appointment of Sohanya Cheng to the Board of Directors of the Company, effective October 31, 2024. Ms. Cheng brings over 20 years of experience in biopharmaceutical commercialization and research, with a strong focus on oncology. The Company concurrently announced the resignation of Michael Torok from Carisma's Board of Directors, also effective October 31, 2024.

Third Quarter 2024 Financial Results

  • Cash and cash equivalents as of September 30, 2024, were $26.9 million, compared to $40.4 million as of June 30, 2024.
  • Research and development expenses for the three months ended September 30, 2024 were $11.3 million, compared to $19.6 million for the three months ended September 30, 2023. The decrease of $8.3 million was primarily due to implementation of our revised operating plan in the second quarter of 2024 in which we halted further development of CT-0508, paused development of CT-1119 and implemented a workforce reduction. As result of the revised operating plan, we experienced a decrease of $2.4 million related to halting development of CT-0508 and a $0.1 million decrease from pausing the development of CT-1119. In addition, the implementation of the revised operating plan resulted in a decrease in facilities and other expenses of $3.1 million due to less laboratory supplies and laboratory space needs and a $0.9 million decrease in direct personnel costs due to a reduction in headcount. Further, we experienced a $0.9 million decrease in direct costs associated with pre-clinical development of CT-0525 due to the timing of the development program and a decrease of $0.9 million in other clinical and pre-clinical development expenses resulting from the timing of certain studies in our in vivo collaboration with Moderna.
  • General and administrative expenses for the three months ended September 30, 2024 were $5.2 million, compared to $6.6 million for the three months ended September 30, 2023. The decrease of $1.4 million was primarily due to our revised operating plan in which we recognized a $1.3 million decrease in professional fees as a result of our patent portfolio and expanding infrastructure in 2023, a $0.3 million decrease in facilities and supplies due to a decrease in office expenditures, a $0.2 million decrease in insurance costs, and a $0.1 million decrease in other expenses related to a decline in travel costs, partially offset by a $0.5 million increase in personnel costs driven by an increase in stock-based compensation.
  • Net loss was $12.7 million for the third quarter of 2024, compared to a $21.4 million net loss for the same period in 2023.

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,
2024


December 31,
2023

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
outstanding


Common stock $0.001 par value, 350,000,000 shares authorized, 41,750,109 and
40,609,915 shares issued and outstanding at September 30, 2024 and December 31,
2023, respectively

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
September 30,


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.

FAQ

When will Carisma Therapeutics (CARM) report initial Phase 1 results for CT-0525?

Carisma Therapeutics expects to report initial data from Cohorts 1 and 2 of the Phase 1 study of CT-0525 in the first quarter of 2025.

What was Carisma Therapeutics' (CARM) cash position in Q3 2024?

Carisma Therapeutics reported cash and cash equivalents of $26.9 million as of September 30, 2024.

How long will Carisma Therapeutics' (CARM) current cash runway last?

The company's current cash position is expected to fund operations into the third quarter of 2025.

What was Carisma Therapeutics' (CARM) net loss in Q3 2024?

Carisma Therapeutics reported a net loss of $12.7 million for the third quarter of 2024.

Carisma Therapeutics, Inc.

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