On 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, reported a business update and announced financial results for the quarter ended June 30, 2026.
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"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.
Phase 3 trial, SUPRAME, for anzu-cel (IMA203) in previously treated, advanced melanoma
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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.
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SUPRAME is designed to be an adequate and well-controlled clinical trial to generate the data supporting full regulatory approval of anzu-cel.
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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.
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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.
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The aggregate number of PFS events (progressive disease or death) in the SUPRAME trial is occurring more slowly than originally modeled.
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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.
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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.
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These planned protocol amendments are based on feedback from the FDA following recent interaction with the agency, with whom Immatics continues to engage.
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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.
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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
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Updated Phase 1b clinical data presented at the 2026 ASCO (Free ASCO Whitepaper) 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 (Free ESMO Whitepaper) Congress 2026.
Phase 2 cohort for anzu-cel (IMA203) PRAME cell therapy in patients with metastatic uveal melanoma
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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.
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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).
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Updated Phase 1 data in hard-to-treat gynecologic cancers presented at the 2026 ASCO (Free ASCO Whitepaper) 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.
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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.
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The Company completed Phase 1a dose escalation as planned in mid-2026.
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Updated Phase 1 data from IMA203CD8 across multiple PRAME-positive solid tumors will be presented at ESMO (Free ESMO Whitepaper) Congress 2026.
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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
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 combination of IMA402 PRAME bispecific with IMA401 MAGEA4/8 bispecific in squamous non-small cell lung cancer (sqNSCLC) and potentially other solid tumor indications.
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IMA402 PRAME bispecific showed clinical proof-of-concept during the Phase 1a dose escalation trial in heavily pre-treated patients with solid tumors, including melanoma and ovarian cancer.
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As part of its strategy to maximize IMA402 opportunity, the Company opened additional Phase 1b cohorts in mid-2026 across both earlier and later treatment lines and is currently evaluating IMA402 as monotherapy and in combination with immune checkpoint inhibitors.
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Phase 1b data from IMA402 at the RP2D range across multiple cancers will be presented at ESMO (Free ESMO Whitepaper) Congress 2026.
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Based on the initial promising activity of IMA401 in head and neck cancer and sqNSCLC presented at ASCO (Free ASCO Whitepaper) 2026 and published simultaneously in Nature Medicine, Immatics has initiated a Phase 1b cohort evaluating IMA402 targeting PRAME in combination with IMA401 targeting MAGEA4/8 in sqNSCLC at multiple clinical trial sites. First data from the IMA402/IMA401 combination cohort are expected in 2027.Corporate Development:
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In collaboration, Moderna and Immatics discovered a cancer antigen therapeutic candidate (mRNA-4200) under the Database Program, incorporating targets identified using Immatics’ XPRESIDENT target discovery and validation platform and its bioinformatics and AI platform XCUBE. The first patient in the clinical trial sponsored by Moderna was dosed in July, 2026, marking a key clinical milestone and triggering a milestone payment to Immatics.
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Immatics’ General Counsel and Corporate Secretary, Edward Sturchio, has decided to transition out of the Company to pursue other opportunities after more than six years with Immatics. He played a key role in supporting the Company through its transition to a public company and pre-commercial growth stage.
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Effective July 20, 2026, Jim Pepin has been appointed as General Counsel and Corporate Secretary and joined Immatics’ Executive Team. Mr. Pepin brings more than 20 years of legal leadership experience across life sciences and consumer health industries, with expertise spanning public-company governance, compliance, transactions and intellectual property strategy. Most recently, he served as General Counsel of Legend Biotech, a global commercial-stage cell therapy company, and previously served as General Counsel and Corporate Secretary at Aimmune Therapeutics and Nestlé Health Science USA.
Second Quarter 2026 Financial Results
Cash Position: Cash and cash equivalents, as well as other financial assets, total $448.2 million1 (€393.4 million) as of June 30, 2026, compared to $534.7 million1 (€469.3 million) as of December 31, 2025. The decrease is the result of ongoing research and development activities, partially offset by the net proceeds of an at-the-market offering of $24.2 million1 (€21.2 million) as well as changes in net working capital and foreign exchange rate differences.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was $10.4 million1 (€9.1 million) for the three months ended June 30, 2026, compared to $5.4 million1 (€4.7 million) for the three months ended June 30, 2025. The increase is mainly due to a higher level of activity and proportion of costs incurred relative to the overall plan of collaboration activities within the quarter.
Research and Development Expenses: R&D expenses were $71.1 million1 (€62.4 million) for the three months ended June 30, 2026, compared to $51.4 million1 (€45.1 million) for the three months ended June 30, 2025. The increase mainly resulted from costs associated with advancing the product candidates in clinical trials, particularly the SUPRAME trial.
General and Administrative Expenses: G&A expenses were $15.8 million1 (€13.9 million) for the three months ended June 30, 2026, compared to $14.6 million1 (€12.8 million) for the three months ended June 30, 2025. The increase mainly results from activities in preparation for commercialization.
Net Profit and Loss: Net loss was $71.2 million1 (€62.5 million) for the three months ended June 30, 2026, compared to a net loss of $80.1 million1 (€70.3 million) for the three months ended June 30, 2025. The decrease is mainly driven by unrealized non-cash foreign exchange rate losses during the three months ended June 30, 2025, and to a lesser extent by higher collaboration revenue, partially offset by higher costs associated with the SUPRAME trial in the three months ended June 30, 2026.
Full financial statements can be found in our Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on August 18, 2026, and published on the SEC website under www.sec.gov.
Upcoming Investor Conferences
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Jefferies Global Healthcare Conference, London, United Kingdom – November 16 – 19, 2026
To see the full list of events and presentations, visit: View Source
About PRAME
PRAME is a tumor-associated target expressed in more than 50 cancers. Immatics’ PRAME franchise includes multiple product candidates, therapeutic modalities, indications and combination approaches: anzu-cel (anzutresgene autoleucel; IMA203) and IMA203CD8, both PRAME-directed cell therapies, and IMA402, a PRAME-directed bispecific. Combination approaches include IMA402 with immune checkpoint inhibitors, IMA402 with the MAGEA4/8-directed bispecific IMA401, and anzu-cel in combination with Moderna’s PRAME mRNA therapy designed to enhance the cell therapy response.
(Press release, Immatics, AUG 18, 2026, View Source [SID1234670206])