Immatics: Immatics Announces Full Year 2024 Financial Results and Business Update

Randomized-controlled Phase 3 trial, SUPRAME, to evaluate ACTengine® IMA203 TCR-T (PRAME) in advanced melanoma patients; first patient randomized and enrollment continues as planned ACTengine® IMA203 TCR-T (PRAME): Phase 1b IMA203 data published in October 2024 demonstrated a confirmed ORR of 54%, 12.1 months mDOR, 6 months mPFS and OS not reached at a mFU time of 8.6 months in advanced melanoma patients; next data update on Phase 1b trial with extended follow-up planned in 2025 Second-generation ACTengine® IMA203CD8 TCR-T (PRAME): Phase 1a data published in November 2024 showed enhanced pharmacology and potency, demonstrating potential to address solid tumor indications with both high- and medium-level PRAME copy numbers; dose escalation advancing as planned; next data update including ovarian cancer data planned in 2025 TCER® IMA402 (PRAME): Phase 1a data published in November 2024 demonstrated a favorable tolerability profile and initial clinical anti-tumor activity associated with dose and PRAME expression; dose escalation advancing as planned; next data update planned in 2025 TCER® IMA401 (MAGEA4/8): Phase 1a data published in September 2024 demonstrated clinical anti-tumor activity in multiple tumor types and manageable tolerability profile; monotherapy and checkpoint inhibitor combination dose refinement ongoing; next data update with a focus on head and neck cancer planned in 2025 Cash and cash equivalents as well as other financial assets amount to $628.0 million 1 (€604.5 million) as of December 31, 2024; updated cash reach into 2H 2027 Houston, Texas and Tuebingen, Germany, March 27, 2025 - Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today provided a business update and reported financial results for the quarter and full year ended December 31, 2024. "2025 will be marked by milestones across our TCR-T and TCR Bispecifics clinical portfolio, including advancing two of our main objectives for this year: firstly, reporting data on solid cancer types beyond melanoma, such as ovarian cancer, head and neck cancer and others and secondly, demonstrating that our next-generation, half-life extended TCR Bispecifics can deliver meaningful response rates in advanced solid cancer patients," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "Additionally, the initiation of SUPRAME, the Phase 3 trial for our lead TCR-T cell therapy, IMA203, represents a transformative step in Immatics' journey towards becoming a commercial-stage enterprise. We believe IMA203 offers patients and their treating physicians a cell therapy with impressive response rates and favorable tolerability in advanced melanoma. Notably, it requires no surgery or biopsy, has a fast turnaround time and a high manufacturing success rate. We are committed to rapidly delivering the first TCR therapeutic targeting PRAME to the market and to cancer patients, serving their unmet medical needs." Full Year 2024 and Subsequent Company Progress ACTengine® Cell Therapy Programs ACTengine® IMA203 (PRAME) IMA203 is Immatics' lead TCR-T cell therapy, currently being evaluated in a Phase 3 trial (SUPRAME) in patients with previously treated advanced melanoma. IMA203 has the potential to become the first TCR therapeutic targeting PRAME to enter the market. In parallel, Immatics is priming its in-house, state-of-the-art TCR-T manufacturing facility to serve its planned commercial supply. In addition to maximizing the PRAME cell therapy opportunity, Immatics plans to expand IMA203 into uveal melanoma through the ongoing Phase 1b clinical trial. The current addressable patient population of PRAME/HLA-A*02:01-positive 2L unresectable or metastatic cutaneous melanoma in the US and EU5 2 is ~7,300 plus ~1,300 uveal melanoma patients in the US and EU5. Clinical and commercial development plan for ACTengine® IMA203 TCR-T Based on the positive Phase 1b clinical data presented in 2024 and supported by the FDA RMAT designation 3 , Immatics has advanced its lead TCR-T product candidate, IMA203 targeting PRAME, into a randomized-controlled Phase 3 trial, called "SUPRAME" ( NCT06743126 ). The trial commenced in December 2024. The first patient was randomized in the United States and enrollment continues as planned. SUPRAME is a prospective, multicenter, open-label, randomized-controlled Phase 3 clinical trial evaluating the efficacy, safety and tolerability of IMA203 TCR-T in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor. 360 HLA-A*02:01-positive patients will be randomized 1:1 to treatment with IMA203 or investigator's choice of selected approved treatments in the 2L setting (nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US), chemotherapy). Based on the Company's discussions with the FDA, the primary endpoint for seeking full approval will be blinded independent central review ("BICR")-assessed (RECIST v1.1) progression-free survival (PFS). Given the expected median PFS of 2-3 months in this patient population 4 , as well as the median PFS of 6 months (> 1 year in patients with deep responses) observed in the data from the IMA203 Phase 1b trial, the Company has determined that utilizing PFS as the primary endpoint is the fastest pathway to seeking full approval and presents a more attractive commercial positioning as compared to objective response rate (ORR). Secondary endpoints for the trial include ORR, safety, DOR, OS and patient-reported outcomes. The trial is planned to run internationally with approximately 50 sites in the United States and Europe. Patient enrollment for SUPRAME is forecasted to be completed in 2026. A pre-specified interim data analysis will be triggered upon the occurrence of a defined number of events for PFS (progressive disease or death) 5 anticipated to occur after approximately 200 patients are enrolled in 1Q 2026. The final analysis is planned for 4Q 2026. Immatics aims to submit a Biologics License Application (BLA) in 1Q 2027 for full approval and to launch IMA203 in 3Q 2027. In addition to cutaneous melanoma, Immatics intends to expand the IMA203 TCR-T opportunity to treat uveal melanoma patients and will continue to evaluate IMA203 in this patient population through the ongoing Phase 1b trial. Manufacturing capabilities Immatics' proprietary manufacturing process, timeline, capabilities and facility support late-stage clinical and commercial cell therapy development and supply. IMA203 products are manufactured from a patient's leukapheresis (with no surgery required) within 7 days, followed by 7-day QC release testing at >95% success rate 6 to achieve the target dose (1-10x10 9 TCR-T cells). The Company's state-of-the-art ~100,000 sq. ft. R&D and GMP manufacturing facility in the Houston Metropolitan Area was built with a modular design for efficient and cost-effective scalability (total of 8 manufacturing suites, plus further expansion space) to serve early-stage and registration-directed clinical trials as well as planned commercial supply. Through in-house manufacturing and QC testing, Immatics aims to better control the manufacturing process, shorten the turnaround time, ensure the manufacturing success rate and quality of the product and realize potential cost efficiencies, including manufacturing capacity optimization through scalability for a competitive and profitable commercial cell therapy product. Clinical data on ACTengine® IMA203 TCR-T as of October 2024 On October 10, 2024 , Immatics provided a data update on IMA203 monotherapy in 28 heavily pretreated metastatic melanoma patients from the ongoing Phase 1b dose expansion part of the clinical trial in which patients were treated at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR-T cells). As of the data cut-off on August 23, 2024, treatment with IMA203 monotherapy in this melanoma patient population has demonstrated: Confirmed objective response rate of 54% and an objective response rate of 62% Disease control rate of 92% and tumor shrinkage in 88% of patients 12.1 months median duration of response, 6 months median progression-free survival and >1-year median progression-free survival in patients with deep responses Median overall survival has not yet been reached at a median follow-up time of 8.6 months IMA203 monotherapy has maintained a favorable tolerability profile with no treatment-related Grade 5 events in the entire safety population (N=70 Phase 1a and Phase 1b patients across all dose levels and all tumor types). Immatics plans to present updated clinical data from the Phase 1b trial, including patients reported previously with longer follow-up and additional uveal melanoma patients, in 2025. ACTengine® IMA203CD8 TCR-T (GEN2) Monotherapy (PRAME) IMA203CD8 is the Company's second-generation cell therapy product candidate targeting PRAME. Given its pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product in PRAME-positive solid cancers beyond melanoma, starting with gynecologic cancers. On November 8, 2024 , Immatics announced updated Phase 1 dose escalation clinical data on its next-generation ACTengine® IMA203CD8 TCR-T cell therapy in 44 heavily pretreated HLA-A*02:01 and PRAME-positive patients with solid tumors, thereof 41 patients being evaluable for efficacy. Of note, these patients had been treated at substantially lower doses than IMA203 (GEN1), i.e. in a range of 0.2-0.48x10 9 TCR-T cells/m 2 BSA (dose level 3) to 0.801-1.2x10 9 TCR-T cells/m 2 BSA (dose level 4c) T cells infused. As of the data cut-off on September 30, 2024, treatment with IMA203CD8 monotherapy demonstrated: Confirmed objective responses observed in 41% of patients (at low doses, dose escalation ongoing) Median duration of response of 9.2 months at a median fol