-- Enrollment in the SUPRAME Phase 3 trial of anzu-cel (anzutresgene
autoleucel, IMA203) remains on track to complete the required
randomizations by year-end to support final analysis for the primary PFS
endpoint; aggregate PFS events (progression or death) occurring more
slowly than originally modeled
-- Company plans to proceed directly to a streamlined final analysis for the
primary endpoint, PFS, while strengthening power for the secondary
endpoint, OS, to enhance the commercial product profile
-- SUPRAME topline data disclosure for the final PFS analysis expected in H1
2027, followed by BLA submission in 2027
-- Anzu-cel PRAME Cell Therapy: Updated Phase 1b data at ASCO 2026 continued
to show durable anti-tumor activity in metastatic melanoma, with 56% cORR,
14.6 months mDOR, 6.1 months mPFS, 16.2 months mOS and a 2-year OS rate
of 46%, as well as predictable and manageable tolerability
-- IMA203CD8 PRAME Cell Therapy: Updated Phase 1 data presented at ASCO 2026
demonstrated clinical activity in hard-to-treat gynecologic cancers with
a 63% ORR and 50% cORR; updated data across multiple PRAME-positive solid
tumors are planned for presentation at the ESMO Congress 2026
-- IMA402 PRAME Bispecific: Phase 1b data at recommended Phase 2 dose (RP2D)
range across multiple cancers planned for presentation at the ESMO
Congress 2026
-- IMA402 PRAME / IMA401 MAGEA4/8 Bispecific Combination: Combination cohort
in sqNSCLC enrolling patients with first data expected in 2027
-- Cash and cash equivalents as well as other financial assets of $448.2
million1 (EUR393.4 million) as of June 30, 2026; cash reach projected
into 2028
Houston, Texas and Tuebingen, Germany, August 18, 2026 -- Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, today provided a business update and reported financial results for the quarter ended June 30, 2026.
"The Phase 3 SUPRAME trial continues to enroll patients on schedule across sites in North America and Europe. In parallel, the data from the Phase 1b anzu-cel study continue to mature. We are now observing that aggregate progression and death events in the SUPRAME trial are occurring more slowly than originally modeled. Based on these results and FDA feedback, we plan to proceed directly to a streamlined final analysis, while maintaining robust statistical power for the primary PFS endpoint," said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics. "We believe this approach provides the most efficient path to generating definitive data for regulatory approval and look forward to reporting topline results in the first half of 2027. We continue to build the foundation for the commercial launch to bring anzu-cel to patients who urgently need new treatment options, while advancing the PRAME franchise across our pipeline."
Second Quarter 2026 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) .
Phase 3 trial, SUPRAME, for anzu-cel (IMA203) in previously treated, advanced 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
melanoma who have received prior treatment with a PD-1 immune checkpoint
inhibitor. Anzu-cel received FDA Orphan Drug Designation and FDA RMAT
designation, which includes all benefits of FDA Breakthrough Therapy
Designation.
-- SUPRAME is designed to be an adequate and well-controlled clinical trial
to generate the data supporting full regulatory approval of anzu-cel.
-- The primary endpoint for SUPRAME is blinded independent central review
("BICR")-assessed (RECIST v1.1) progression-free survival $(PFS)$. Key
secondary endpoints include overall survival (OS), objective response
rate $(ORR)$, safety and patient-reported outcomes measuring quality of
life.
-- Enrollment in SUPRAME, currently ongoing in North America and Europe,
remains on track to complete required randomizations by year-end to
support final analysis for the primary endpoint.
-- The aggregate number of PFS events (progressive disease or death) in the
SUPRAME trial is occurring more slowly than originally modeled.
-- As a result, Immatics intends to replace the previously planned interim
and final PFS analyses with a single streamlined final analysis, now
based on a lower prespecified number of PFS events while maintaining a
robust power of 90% for the primary endpoint.
-- At the same time, Immatics intends to increase the statistical power for
the secondary endpoint of OS by enrolling approximately 90 additional
patients, bringing the total trial size to approximately 450 patients.
This aims to further strengthen the commercial product profile of
anzu-cel. The increased number of events needed for the final OS analysis
has no impact on the timing of the final PFS analysis.
-- These planned protocol amendments are based on feedback from the FDA
following recent interaction with the agency, with whom Immatics
continues to engage.
-- The Company expects to disclose topline data from the final PFS analysis
in the first half of 2027, followed by a BLA submission in 2027.
-- The Company continues to build the commercial infrastructure for the
anticipated launch of anzu-cel after obtaining BLA approval.
Phase 1/2 trial for anzu-cel (IMA203) in previously treated, metastatic melanoma
-- Updated Phase 1b clinical data presented at the 2026 ASCO Annual Meeting
showed durable anti-tumor activity at longer follow-up in metastatic
melanoma, including 56% confirmed ORR, 14.6 months mDOR, 6.1 months mPFS
and 16.2 months mOS. The OS rate was 70% at 12 months and 46% at 24
months. Anzu-cel maintained a predictable and manageable tolerability
profile. Explorative analyses focusing on predictors of durable response
have been accepted for presentation at the ESMO Congress 2026.
Phase 2 cohort for anzu-cel (IMA203) PRAME cell therapy in patients with metastatic uveal melanoma
-- A Phase 2 cohort to treat approximately 30 additional patients with
metastatic uveal melanoma 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 trial as well as the Phase 2
cohort in metastatic uveal melanoma are intended to support a potential
label expansion for anzu-cel following expected initial approval in
unresectable or metastatic melanoma.
IMA203CD8 PRAME Cell Therapy -- Expansion to All Advanced PRAME Cancers
IMA203CD8 is the Company's PRAME cell therapy product candidate being developed with the goal of expanding into all advanced PRAME cancers. Given its enhanced pharmacology profile, the Company intends to pursue the clinical development of this product candidate with a tumor-agnostic approach, including gynecologic cancers (ovarian and uterine).
-- Updated Phase 1 data in hard-to-treat gynecologic cancers presented at
the 2026 ASCO Annual Meeting demonstrated anti-tumor activity at
clinically relevant doses, including 63% ORR and 50% confirmed ORR, four
complete responses and the longest ongoing response at 12 months.
Additional data in synovial sarcoma showed a 67% ORR and 64% confirmed
ORR, including one complete response and ongoing responses for up to
approximately three years. IMA203CD8 demonstrated a manageable and
consistent tolerability profile across patient populations.
-- The clinical activity observed to date across tumor types (ovarian
carcinoma, uterine cancer, melanoma, synovial sarcoma) with distinct
biology and differing levels of PRAME expression supports the broad
applicability of IMA203CD8 across solid tumors.
-- The Company completed Phase 1a dose escalation as planned in mid-2026.
-- Updated Phase 1 data from IMA203CD8 across multiple PRAME-positive solid
tumors will be presented at ESMO Congress 2026.
-- In addition to its broad expression across more than 50 adult cancer
types, PRAME is highly prevalent in multiple pediatric cancers. A case
report published in the New England Journal of Medicine3 highlights the
therapeutic potential of PRAME TCR T-cell therapy in pediatric patients
with solid tumors. Immatics intends to support further clinical
evaluation in this population by manufacturing and supplying IMA203CD8
PRAME TCR T-cell therapy for the planned investigator-initiated Phase 1/2
PRAMEtime trial at Hopp Children's Cancer Center Heidelberg (KiTZ),
Germany.
PRAME Franchise - Bispecifics
IMA402 PRAME Bispecific -- Expansion to Earlier-Line PRAME Cancers