On November 10, 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 September 30, 2026.
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"Our focus is clear: completing enrollment in the Phase 3 SUPRAME trial and preparing for the BLA filing for anzu-cel in melanoma. In addition, we continue to advance our Phase 1/2 bispecific and cell therapy programs across multiple cancer types," said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics. "Everything we do is guided by patients with cancer who urgently need new treatment options. This commitment drives our continued work across the PRAME franchise and our preparations for the anticipated launch of anzu-cel, positioning us well as we enter what we expect to be the defining year for Immatics."
Third Quarter 2026 and Subsequent Company Progress
PRAME Franchise – Cell Therap
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 estimated addressable patient population for anzu-cel in second-line or later (2L) advanced melanoma includes ~10,000 patients2.
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 the 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 Company expects to disclose topline data from the final PFS analysis in the first half of 2027, followed by a BLA submission in 2027.
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 objective response rate (cORR), 14.6 months median duration of response (mDOR), 6.1 months median PFS (mPFS) and 16.2 months median OS (mOS). The OS rate was 70% at 12 months and 46% at 24 months. Anzu-cel maintained an expected and manageable tolerability profile. Exploratory analyses, presented at ESMO (Free ESMO Whitepaper) Congress 2026, further characterized durable clinical benefit and hematologic recovery following one-time treatment with anzu-cel, strengthening its clinical profile.
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.
Commercial and Cell Product Manufacturing Update
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The Company continues to build the commercial infrastructure for the anticipated launch of anzu-cel, subject to FDA approval.
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Effective September 28, 2026, Jason Braun was appointed Chief Commercial Officer. Mr. Braun joined Immatics in January 2024 and has led the development of the Company’s commercial strategy and the build-out of its commercial team in preparation for the anticipated launch of anzu-cel. He previously led the marketing launch of Yescarta and held commercial leadership roles at Kite, Pharmacyclics, Dendreon and Amgen.
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Key leadership positions across the commercial and medical affairs teams have been filled with seasoned leaders from the U.S. biotech and pharmaceutical industry, bringing extensive expertise in commercial cell therapy.
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The Company operates a fully functional 100,000-square-foot R&D and cell therapy manufacturing facility in the Houston metropolitan area, with capacity to support ongoing clinical trials and commercial supply.
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 pharmacology profile, the Company intends to pursue the clinical development of this product candidate through targeted cohorts in selected tumor types to build the clinical evidence base for a broader, tumor-agnostic application.
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On October 23, 2026, updated Phase 1 data were presented at ESMO (Free ESMO Whitepaper) Congress 2026. IMA203CD8 PRAME cell therapy demonstrated deep and durable anti-tumor activity across multiple tumor types with a consistent and manageable safety profile, supporting its tumor-agnostic potential. Among patients with advanced, heavily pretreated gynecologic cancers treated at clinically relevant doses, the cORR was 55% and mDOR was 8.4 months.
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Phase 1a dose escalation is complete. Immatics is currently enrolling patients with uterine cancer at clinically relevant doses to further expand the clinical dataset in this indication.
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In addition, a Phase 1/2 investigator-initiated trial (IIT) in patients with PRAME-positive pediatric cancers is planned to start in H1 2027.
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The clinical activity of IMA203CD8 observed across tumor types with distinct biology and differing levels of PRAME expression, including ovarian cancer, uterine cancer, melanoma and synovial sarcoma, supports the broad applicability of IMA203CD8 across PRAME-positive cancers. The development approach for IMA203CD8 will leverage targeted cohorts of selected tumor types, such as ovarian cancer, uterine cancer, rare cancers and pediatric cancers to build the clinical evidence base for broader, tumor-agnostic application.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. 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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On October 24, 2026, updated Phase 1b data were presented at ESMO (Free ESMO Whitepaper) Congress 2026. IMA402 demonstrated favorable tolerability as monotherapy and in combination with an immune checkpoint inhibitor (ICI). In the efficacy population treated within the RP2D range, IMA402 demonstrated deep and durable responses, with a cORR of 25% across all tumor types and PRAME expression levels. Among patients with PRAME-high tumors a cORR of 32% was observed. In patients with PRAME-high advanced melanoma, cORR was 32%, mDOR was 12.5 months and 1-year OS was 91%.
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The promising clinical profile of IMA402 supports a development path across various solid tumors in earlier and later treatment lines. These include combination approaches with ICIs in melanoma and in gynecologic cancers, as well as IMA402 in combination with the Company’s MAGEA4/8-directed bispecific, IMA401, in lung cancer with first data expected in 2027.
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Furthermore, the use of Immatics’ proprietary rapid, sensitive and reliable liquid biopsy-based PRAME testing enables precise patient selection and could support potential fast-to-market strategies, subject to regulatory approval, in PRAME-high melanoma and beyond.
Third Quarter 2026 Financial Results
Cash Position: Cash and cash equivalents, as well as other financial assets, total $536.3 million1 (€472.3 million) as of September 30, 2026, compared to $532.9 million1 (€469.3 million) as of December 31, 2025. The change is primarily the result of gross proceeds of a public offering of $172.5 million and an at-the-market offering of $25 million, offset by ongoing research and development activities.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was $7.8 million1 (€6.9 million) for the three months ended September 30, 2026, compared to $5.9 million1 (€5.2 million) for the three months ended September 30, 2025. The increase is mainly due to a higher milestone as well as higher level of activity and proportion of costs incurred relative to the overall plan in our collaboration programs within the quarter.
Research and Development Expenses: R&D expenses were $79.8 million1 (€70.3 million) for the three months ended September 30, 2026, compared to $53.6 million1 (€47.2 million) for the three months ended September 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 $17.9 million1 (€15.8 million) for the three months ended September 30, 2026, compared to $14.4 million1 (€12.7 million) for the three months ended September 30, 2025. The increase mainly resulted from activities in preparation for commercialization of anzu-cel.
Net Loss: Net loss was $86.3 million1 (€76.0 million) for the three months ended September 30, 2026, compared to a net loss of $57.3 million1 (€50.5 million) for the three months ended September 30, 2025. The increase is mainly driven by higher costs associated with the SUPRAME trial in the three months ended September 30, 2026.
Full financial statements can be found in our Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on November 10, 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
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J.P. Morgan Healthcare Conference, San Francisco, US – January 11 – 14, 2027
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, NOV 10, 2026, View Source [SID1234674558])