Press Release: Immatics Announces Full Year 2025 Financial Results and Business Update

Dow Jones
Mar 05
   -- Anzu-cel (anzutresgene autoleucel, IMA203) PRAME Cell Therapy: Global, 
      randomized, controlled Phase 3 trial, SUPRAME, in previously treated 
      advanced melanoma ongoing; anzu-cel received Orphan Drug Designation from 
      the FDA for the treatment of both cutaneous and uveal melanoma 
 
   -- SUPRAME timelines remain unchanged; interim and final analyses remain 
      expected to be triggered in 2026, BLA submission in 1H 2027 and 
      commercial launch in 2H 2027 as planned 
 
   -- IMA203CD8 PRAME Cell Therapy (GEN2): Data update from ongoing Phase 1a 
      trial, with a focus on ovarian cancer at relevant doses, planned for 
      presentation at a major medical conference in 1H 2026 
 
   -- IMA402 PRAME Bispecific: RP2D determination and Phase 1 clinical data 
      update with focus on melanoma and gynecologic cancers treated with IMA402 
      monotherapy and combination with immune checkpoint inhibitor planned for 
      2H 2026 
 
   -- IMA402 PRAME / IMA401 MAGEA4/8 Bispecific Combination: Phase 1 trial in 
      sqNSCLC expected to commence in 2026 
 
   -- Moderna Collaboration: First patient dosed in Phase 1 anzu-cel and 
      mRNA-4203 combination trial in 3Q 2025; TCER$(R)$ collaboration expanded 
      and milestone payment received in January 2026, with the first mRNA-based 
      TCER(R) product candidate planned to advance into clinical development 
 
   -- $125 million public offering completed on December 8, 2025 
 
   -- Cash and cash equivalents as well as other financial assets of $551.4 
      million1 (EUR469.3 million) as of December 31, 2025; extended cash reach 
      into 2028 

Houston, Texas and Tuebingen, Germany, March 5, 2026 -- Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, today provided a business update and reported financial results for the quarter and full year ended December 31, 2025.

"Following a year of strong execution and data updates across our entire PRAME franchise, Immatics is entering 2026 with multiple high-impact milestones ahead, including advancing our PRAME cell therapy, anzu-cel, towards approval," said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics. "In parallel, we strive to expand our reach to more patients with our second-generation PRAME cell therapy, IMA203CD8, with meaningful data in gynecologic cancers expected this year, and with our PRAME bispecific IMA402, where we plan to report expanded clinical data supporting initiation of indication-specific expansion cohorts. In addition, we look forward to opening a new therapeutic avenue by initiating a combination study with IMA402 and IMA401, our MAGEA4/8 bispecific, in lung cancer. Above all, we remain focused on translating this positive momentum into transformative outcomes for patients with cancer."

Full Year 2025 and Subsequent Company Progress

PRAME Franchise -- Cell Therapy

Anzu-cel (IMA203) PRAME Cell Therapy -- First Market Entry in Advanced Melanoma

Anzu-cel (anzutresgene autoleucel), previously called IMA203, is Immatics' lead PRAME cell therapy and is expected to be the Company's first PRAME therapy to enter the market in advanced melanoma. The current addressable patient population for anzu-cel's first target indications, second-line or later (2L) advanced cutaneous melanoma as well as metastatic uveal melanoma includes 9,000 patients(2) .

   -- Anzu-cel received Orphan Drug Designation as well as RMAT designation3 
      from the U.S. Food and Drug Administration (FDA) for the treatment of 
      both cutaneous and uveal melanoma. 

Phase 3 trial, SUPRAME, for anzu-cel (IMA203) in previously treated, advanced cutaneous melanoma

   -- Immatics' global, randomized, controlled, multi-center Phase 3 clinical 
      trial, SUPRAME, is currently ongoing to evaluate the efficacy, safety and 
      tolerability of anzu-cel PRAME cell therapy as monotherapy vs. 
      investigator's choice in patients with unresectable or metastatic 
      cutaneous melanoma who have received prior treatment with a PD-1 immune 
      checkpoint inhibitor. 
 
   -- SUPRAME is designed to be an adequate and well-controlled clinical trial 
      intended to generate robust data to support regulatory approval of 
      anzu-cel as Immatics advances this PRAME cell therapy. 
 
   -- Primary endpoint for seeking full approval is blinded independent central 
      review ("BICR")-assessed (RECIST v1.1) progression-free survival $(PFS)$. 
      Secondary endpoints include overall survival (OS), objective response 
      rate $(ORR)$, safety and patient-reported outcomes measuring quality of 
      life. 
 
   -- SUPRAME timelines remain unchanged. Pre-specified interim and final data 
      analyses will be triggered upon the occurrence of a defined number of 
      events for PFS (progressive disease or death). Interim and final analyses 
      remain expected to be triggered in 2026 as planned, given current strong 
      enrollment rate. As communicated previously and in line with general FDA 
      guidance, data from the interim analysis is not intended to be published 
      to protect the integrity of the clinical trial as long as enrollment 
      remains ongoing. 
 
   -- The Company continues to expect BLA submission in the first half of 2027 
      and commercial launch of anzu-cel in the second half of 2027. 
 
   -- Patient recruitment is currently ongoing in North America and Europe. 

Phase 1/2 trial for anzu-cel (IMA203) PRAME cell therapy in patients with advanced melanoma

   -- Phase 1b data in patients with advanced melanoma were published at ASCO 
      2025 and a subset analysis in uveal melanoma was published at ESMO 2025, 
      both showing favorable tolerability and strong clinical benefit of 
      anzu-cel one-time infusion. 
 
   -- A Phase 2 cohort to treat approximately 30 additional metastatic uveal 
      melanoma patients is ongoing and being conducted at select centers in the 
      U.S. and Germany with expertise in uveal melanoma. 
 
   -- Data from the ongoing single-arm Phase 1b as well as Phase 2 trial in 
      metastatic uveal melanoma are intended to support a potential label 
      expansion for anzu-cel. 
 
   -- The next data update from the Phase 1/2 trial with ongoing follow-up of 
      patients with cutaneous and uveal melanoma is planned for 2026. 

Phase 1 combination trial for anzu-cel (IMA203) PRAME cell therapy and Moderna's PRAME cell therapy enhancer, mRNA-4203, in patients with solid tumors

   -- First patient dosed in Phase 1 dose escalation trial in 3Q 2025; the 
      combination treatment has the potential to further enhance anti-tumor 
      activity of anzu-cel, strengthen clinical outcomes and broaden the 
      addressable patient population. 
 
   -- Each party retains full ownership of its investigational PRAME compound, 
      and the parties fund the clinical study on a cost-sharing basis. 

IMA203CD8 PRAME Cell Therapy (GEN2) -- Expansion to all Advanced PRAME Cancers

IMA203CD8 is the Company's second-generation PRAME cell therapy product candidate being developed with the goal of expanding into all advanced PRAME cancers. Given its enhanced pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product candidate with a tumor-agnostic approach, starting with gynecologic cancers.

   -- Updated Phase 1a dose escalation data presented at ESMO-IO 2025 Congress 
      showed manageable tolerability as well as promising initial anti-tumor 
      activity in PRAME-positive tumors at low median dose, including 
      proof-of-concept data in ovarian carcinoma. 
 
   -- Results could support the positioning of IMA203CD8 to treat patients with 
      PRAME cancers without post-infusion IL-2. 
 
   -- Immatics plans to present Phase 1a data with a focus on ovarian cancer at 
      relevant doses at a major medical conference in the first half of 2026. 
 
   -- The Company is on track to complete Phase 1a dose escalation and 
      determine recommended Phase 2 dose (RP2D) in 2026. 

PRAME Franchise - Bispecifics

IMA402 PRAME Bispecific -- Expansion to Earlier-Line PRAME Cancers

To expand the PRAME opportunity to earlier-line PRAME cancers, the Company is developing its off-the-shelf, next-generation, half-life extended TCR bispecific, IMA402, as a monotherapy or in combination with standard of care, with a focus on melanoma and gynecologic cancers. In addition, Immatics is exploring the potential combination of IMA402 with IMA401 MAGEA4/8 bispecific in squamous non-small cell lung cancer (sqNSCLC) and potentially other solid tumor indications.

   -- In November 2025, Immatics announced clinical proof-of-concept for its 
      IMA402 PRAME bispecific with updated data from the Phase 1a dose 
      escalation trial in heavily pre-treated patients with solid tumors, 
      including melanoma and ovarian cancer. 
 
   -- Immatics expects to determine the final RP2D and present a clinical data 
      update from a larger patient population with a focus on melanoma and 
      gynecologic cancers treated with IMA402 monotherapy or combination with 
      an immune checkpoint inhibitor in the second half of 2026. Based thereon, 
      the Company may seek to convert existing Phase 1b cohorts into Phase 2 
      trials, which may have the potential to become registration-enabling. As 
      part of its strategy to maximize the IMA402 opportunity, the Company also 
      plans to initiate additional Phase 1b cohorts in 2026 to determine the 
      monotherapy and combination potential of IMA402 with immune checkpoint 
      inhibitors and standard of care in late as well as earlier treatment 
      lines. 
 
   -- Based on the initial promising activity of IMA401 in head and neck cancer 
      and sqNSCLC, Immatics is well-positioned to assess the synergistic 
      potential of combining two different bispecifics, IMA402 targeting PRAME 

(MORE TO FOLLOW) Dow Jones Newswires

March 05, 2026 07:00 ET (12:00 GMT)

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