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