- Anzu-cel (anzutresgene autoleucel, IMA203) PRAME Cell Therapy: Global, randomized, controlled
Phase 3 trial, SUPRAME, in previously treated advanced melanoma ongoing; interim and final analyses will occur in 2026 - Anzu-cel (IMA203) PRAME Cell Therapy: One-time infusion continues to show strong clinical benefit and favorable tolerability in 16 patients with metastatic uveal melanoma in latest update on Phase 1b data presented at the ESMO 2025 Presidential Symposium: cORR of 67%, mDOR of 11.0 months, mPFS of 8.5 months and mOS not reached at 14.3 months mFU
- IMA203CD8 PRAME Cell Therapy (GEN2): Phase 1a clinical trial ongoing with next data update, including dose escalation data in ovarian cancer, melanoma and synovial sarcoma, planned to be presented at
ESMO Immuno-Oncology Congress 2025 - TCR Bispecifics: IMA402 and IMA401 TCR Bispecifics achieved clinical proof-of-concept, showed favorable tolerability at RP2D as well as deep and durable responses in heavily pre-treated, last-line patients with a range of solid tumors
- TCR Bispecifics data support development opportunities for IMA402 PRAME Bispecific in cutaneous melanoma, gynecologic cancers and in combination with IMA401 MAGEA4/8 Bispecific in sqNSCLC; Phase 1b dose expansion for IMA402 initiated
- Cash and cash equivalents as well as other financial assets of
$505.8 million 1 (€430.8 million) as ofSeptember 30, 2025 ; cash reach into 2H 2027
“In the last months, we have achieved significant clinical milestones and solidified Immatics’ position as the PRAME leader across two modalities, cell therapies and bispecifics,” said
Third Quarter 2025 and Subsequent Company Progress
PRAME Franchise –
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 will 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) cutaneous melanoma, as well as metastatic uveal melanoma, includes ~9,000 patients2.
- 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 checkpoint inhibitor. - SUPRAME is designed as a well-controlled clinical trial evaluating anzu-cel as a monotherapy in a late-stage cutaneous melanoma patient population and is intended to generate robust data to support regulatory approval of anzu-cel as
Immatics advances this PRAME cell therapy towards the market. - 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 about quality of life.
- 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). Data from the interim analysis is not intended to be published to protect the integrity of the ongoing clinical trial.
- The Company remains on track for planned BLA submission in 1H 2027 and launch of anzu-cel in 2H 2027. Given the event-driven nature of the clinical trial design and based on the clinical site activation timelines, the target number of clinical trial sites and the current strong enrollment rate,
Immatics estimates that the interim and final analyses will occur in 2026. - Patient recruitment is currently ongoing in the US and
Germany . The SUPRAME trial is planned to be conducted in more than 65 sites acrossNorth America andEurope , including the US,Germany ,France ,the Netherlands , theUK andCanada .
Phase 1b trial for anzu-cel (IMA203) PRAME cell therapy in patients with metastatic melanoma
- A one-time infusion of anzu-cel PRAME cell therapy in all melanoma patients demonstrated favorable tolerability and promising clinical activity (Wermke et al., ASCO 2025): cORR of 56%; mDOR of 12.1 months at mFU of 13.4 months; mPFS of 6.1 months; mOS of 15.9 months
- Cutaneous melanoma subgroup, all post-checkpoint inhibitor, showed cORR of 50%, mDOR not reached at mFU of 16.7 months; mPFS of 6.0 months
- Uveal melanoma subgroup, majority post-tebentafusp and checkpoint inhibitor, showed cORR of 67%, mDOR of 11.0 months at mFU of 13.4 months; mPFS of 8.5 months
- On
October 20, 2025 , updated data from the Phase 1b trial of anzu-cel in a subgroup of 16 patients with metastatic uveal melanoma were presented bySapna Patel , MD, at an oral presentation at the Presidential Symposium III at ESMO 2025. A one-time infusion of anzu-cel PRAME cell therapy in the 16 patients with uveal metastatic melanoma demonstrated favorable tolerability and continued strong anti-tumor activity and durability: cORR of 67%, mDOR of 11.0 months, mPFS of 8.5 months and mOS not reached at 14.3 months mFU. - Based on the promising clinical data in patients with metastatic uveal melanoma,
Immatics has initiated aPhase 2 cohort to treat approximately 30 uveal melanoma patients. The cohort is being conducted at select centers in theU.S. andGermany with deep expertise in uveal melanoma. - The consistent favorable tolerability, anti-tumor activity and pharmacokinetic profile of anzu-cel across both cutaneous and uveal melanoma provide a strong rationale for pursuing a parallel late-stage development strategy to serve both patient populations.
- Anzu-cel has recently received Orphan Drug Designation (ODD) from the
U.S. FDA for the treatment of uveal melanoma.
Data on anzu-cel in advanced melanoma further substantiates Immatics’ global leadership in precision targeting of PRAME and the potential of anzu-cel to be the Company’s first PRAME product to enter the market.
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.
- Phase 1a dose escalation in solid tumors is ongoing to evaluate higher doses of IMA203CD8 with and without IL-2.
- The next clinical trial update, which will report on the continued dose escalation in multiple PRAME cancers, including ovarian cancer, melanoma and synovial sarcoma treated at relevant doses, will be presented on
December 11, 2025 , byAntonia Busse , M.D., Charité-CBF, at theESMO Immuno-Oncology Congress 2025 during a mini oral presentation.
PRAME Franchise - TCR 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,
- On
November 12, 2025 ,Immatics announced updated data from the Phase 1a dose escalation clinical trial evaluating IMA402 in heavily pre-treated patients with solid tumors. - The data showed clinical proof-of-concept of IMA402 with favorable tolerability across all doses, as well as deep and durable responses and early, promising PFS/iPFS and
OS in patients treated within the RP2D range. - Across all indications at RP2D range a 30% (6/20) cORR was observed, including 29% cORR (4/14) in melanoma and 2/3 confirmed responses in ovarian carcinoma.
- Based on the promising Phase 1a dose escalation data,
Immatics is advancing its IMA402 PRAME Bispecific into Phase 1b dose expansion at two distinct doses to determine the final RP2D, both as a monotherapy and in combination with an immune checkpoint inhibitor with a focus on melanoma and gynecologic cancers in 2026. - Depending on the outcomes of these Phase 1b cohorts, the Company would seek to convert existing Phase 1b cohorts into
Phase 2 trials, which have the potential to become registration-directed. - As part of its strategy to maximize the IMA402 opportunity, the Company is also exploring the option 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.
- As an additional opportunity, the Company is exploring the potential combination of IMA402 with IMA401 MAGEA4/8 in squamous non-small cell lung cancer (sqNSCLC) and potentially other solid tumor indications.
IMA401 MAGEA4/8 Bispecific – Maximizing the Potential of Bispecifics Combinations
IMA401 is the Company’s off-the-shelf, next-generation, half-life extended TCR Bispecific targeting MAGEA4/8. Consistent with Immatics’ focus on advancing its PRAME Franchise, the Company is exploring IMA401 in combination with IMA402, starting with squamous non-small cell lung cancer (sqNSCLC). This opportunity with potentially synergistic clinical activity has the potential to address >90% of patients with sqNSCLC.
- On
November 12, 2025 ,Immatics announced updated dose escalation data from the Phase 1a clinical trial evaluating IMA401 with or without an immune checkpoint inhibitor (pembrolizumab) in heavily pre-treated patients with solid tumors. - The data showed clinical proof-of-concept with favorable tolerability at RP2D as well as promising clinical activity in patients in three focus indications treated with ≥1 mg: 25% cORR (2/8) in head and neck cancer, 29% cORR (2/7) in melanoma and promising clinical activity in sqNSCLC.
- Based on the clinical proof-of-concept of both bispecific candidates, including 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 and IMA401 targeting MAGEA4/8, with and without a checkpoint inhibitor. - As over 90% of patients with sqNSCLC are positive for PRAME and/or MAGEA4/8, a potential IMA402 and IMA401 combination treatment could provide broad treatment coverage for this patient population. Approximately 60% of patients with sqNSCLC are positive for both targets, which could boost anti-tumor activity and counteract potential tumor escape mechanisms. The current addressable patient population for metastatic sqNSCLC in
the United States and EU5 is an estimated 40,000 patients per year.
Corporate Development
- Chief Financial Officer Appointment: On
October 1, 2025 ,Immatics announced the appointment ofVenkat Ramanan , Ph.D., as Chief Financial Officer.Dr. Ramanan is a seasoned financial leader in the biopharmaceutical industry with over 25 years of experience at companies includingSeagen , Gilead Sciences and Amgen. He brings deep financial expertise in facilitating successful product launches, establishing scalable operations in global markets and enabling corporate transactions. - Chief People Officer Appointment: On
October 27, 2025 ,Immatics announced the appointment ofAmie Krause asChief People Officer .Ms. Krause brings more than 20 years of experience at companies includingRevance Therapeutics , Atara Biotherapeutics and Amgen in building high-performing teams, shaping culture, enhancing organizational excellence and efficiency and aligning talent with business strategy.
Third Quarter 2025 Financial Results
Cash Position: Cash and cash equivalents as well as other financial assets total
Revenue: Total revenue, consisting of revenue from collaboration agreements, was
Research and Development Expenses: R&D expenses were
General and Administrative Expenses: G&A expenses were
Net Profit and Loss: Net loss was
Full financial statements can be found in our Report on 6-K filed with the Securities and Exchange Commission (SEC) on
Upcoming Investor Conferences
Jefferies Global Healthcare Conference ,London, United Kingdom –November 17 - 20, 2025
To see the full list of events and presentations, visit: https://investors.immatics.com/events-presentations.
About PRAME
PRAME is a target expressed in more than 50 cancers.
About
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing of IND, CTA or BLA filings, estimated market opportunities of product candidates, the Company’s focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by
For more information, please contact:
Media
Phone: +49 151 74416179
immatics@trophic.eu
Head of Strategy
Phone: +1 346 319-3325
InvestorRelations@immatics.com
Condensed Consolidated Statement of Loss of
| Three months ended |
Nine months ended |
||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| (Euros in thousands, except per share data) | (Euros in thousands, except per share data) | ||||||||||||||||
| Revenue from collaboration agreements | 5,187 | 50,559 | 28,505 | 99,583 | |||||||||||||
| Research and development expenses | (47,176 | ) | (38,906 | ) | (134,190 | ) | (106,230 | ) | |||||||||
| General and administrative expenses | (12,673 | ) | (11,156 | ) | (37,520 | ) | (32,925 | ) | |||||||||
| Other income | 29 | 17 | 70 | 54 | |||||||||||||
| Operating result | (54,633 | ) | 514 | (143,135 | ) | (39,518 | ) | ||||||||||
| Change in fair value of liabilities for warrants | — | 3,833 | 1,730 | 4,228 | |||||||||||||
| Other financial income | 4,250 | 5,889 | 14,684 | 18,707 | |||||||||||||
| Other financial expenses | (289 | ) | (12,589 | ) | (36,151 | ) | (5,342 | ) | |||||||||
| Financial result | 3,961 | (2,867 | ) | (19,737 | ) | 17,593 | |||||||||||
| Loss before taxes | (50,672 | ) | (2,353 | ) | (162,872 | ) | (21,925 | ) | |||||||||
| Taxes on income | 127 | (2,952 | ) | 2,123 | (3,612 | ) | |||||||||||
| Net loss | (50,545 | ) | (5,305 | ) | (160,749 | ) | (25,537 | ) | |||||||||
| Net loss per share: | |||||||||||||||||
| Basic | (0.42 | ) | (0.05 | ) | (1.32 | ) | (0.25 | ) | |||||||||
| Diluted | (0.42 | ) | (0.08 |
) | (1.32 | ) | (0.27 | ) | |||||||||
Condensed Consolidated Statement of Comprehensive Loss of
| Three months ended |
Nine months ended |
||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| (Euros in thousands) | (Euros in thousands) | ||||||||||||||||
| Net loss | (50,545 | ) | (5,305 | ) | (160,749 | ) | (25,537 | ) | |||||||||
| Other comprehensive income/(loss) | |||||||||||||||||
| Items that may be reclassified subsequently to profit or loss | |||||||||||||||||
| Currency translation differences from foreign operations | (594 | ) | (1,377 | ) | (9,138 | ) | (579 | ) | |||||||||
| Total comprehensive loss for the period | (51,139 | ) | (6,682 | ) | (169,887 | ) | (26,116 | ) | |||||||||
Condensed Consolidated Statement of Financial Position of
| As of | ||||||||
2024 |
||||||||
| (Euros in thousands) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | 334,922 | 236,748 | ||||||
| Other financial assets | 95,915 | 367,704 | ||||||
| Accounts receivables | 3,199 | 5,857 | ||||||
| Other current assets | 23,987 | 19,246 | ||||||
| Total current assets | 458,023 | 629,555 | ||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 44,447 | 50,380 | ||||||
| Intangible assets | 1,561 | 1,629 | ||||||
| Right-of-use assets | 13,706 | 13,332 | ||||||
| Other non-current assets | 820 | 1,250 | ||||||
| Total non-current assets | 60,534 | 66,591 | ||||||
| Total assets | 518,557 | 696,146 | ||||||
| Liabilities and shareholders’ equity | ||||||||
| Current liabilities | ||||||||
| Provisions | 6,688 | — | ||||||
| Accounts payables | 22,532 | 20,693 | ||||||
| Deferred revenue | 25,562 | 35,908 | ||||||
| Liabilities for warrants | — | 1,730 | ||||||
| Lease liabilities | 2,879 | 2,851 | ||||||
| Other current liabilities | 4,597 | 6,805 | ||||||
| Total current liabilities | 62,258 | 67,987 | ||||||
| Non-current liabilities | ||||||||
| Deferred revenue | 22,442 | 34,161 | ||||||
| Lease liabilities | 13,500 | 13,352 | ||||||
| Deferred tax liability | 3,678 | 5,804 | ||||||
| Total non-current liabilities | 39,620 | 53,317 | ||||||
| Shareholders’ equity | ||||||||
| Share capital | 1,216 | 1,216 | ||||||
| Share premium | 1,173,861 | 1,162,136 | ||||||
| Accumulated deficit | (750,291) | (589,541) | ||||||
| Other reserves | (8,107) | 1,031 | ||||||
| Total shareholders’ equity | 416,679 | 574,842 | ||||||
| Total liabilities and shareholders’ equity | 518,557 | 696,146 | ||||||
Condensed Consolidated Statement of Cash Flows of Immatics N.V.
| Nine months ended |
||||||||
| 2025 | 2024 | |||||||
| (Euros in thousands) | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | (160,749 | ) | (25,537 | ) | ||||
| Taxes on income | (2,123 | ) | 3,612 | |||||
| Loss before tax | (162,872 | ) | (21,925 | ) | ||||
| Adjustments for: | ||||||||
| Interest income | (13,629 | ) | (18,185 | ) | ||||
| Depreciation and amortization | 9,231 | 9,149 | ||||||
| Interest expenses | 724 | 654 | ||||||
| Equity-settled share-based payment | 11,712 | 13,112 | ||||||
| Net foreign exchange differences and expected credit losses | 33,911 | 4,018 | ||||||
| Change in fair value of liabilities for warrants | (1,730 | ) | (4,228 | ) | ||||
| Loss from disposal of fixed assets | 157 | 1 | ||||||
| Changes in: | ||||||||
| Decrease in accounts receivables | 2,658 | 1,142 | ||||||
| (Increase)/decrease in other assets | (1,555 | ) | 83 | |||||
| Decrease in deferred revenue, accounts payables and other liabilities | (15,028 | ) | (91,113 | ) | ||||
| Interest received | 22,558 | 11,098 | ||||||
| Interest paid | (724 | ) | (654 | ) | ||||
| Income tax paid | (8,107 | ) | (2,706 | ) | ||||
| Income tax refunded | 4,733 | — | ||||||
| Net cash used in operating activities | (117,961 | ) | (99,554 | ) | ||||
| Cash flows from investing activities | ||||||||
| Payments for property, plant and equipment | (5,588 | ) | (14,598 | ) | ||||
| Payments for intangible assets | (190 | ) | (148 | ) | ||||
| Proceeds from disposal of property, plant and equipment | 47 | 1 | ||||||
| Payments for investments classified in Other financial assets | (280,651 | ) | (356,596 | ) | ||||
| Proceeds from maturity of investments classified in Other financial assets | 520,089 | 266,361 | ||||||
| Net cash provided by/(used in) investing activities | 233,707 | (104,980 | ) | |||||
| Cash flows from financing activities | ||||||||
| Net proceeds from issuance of shares to equity holders | 13 | 174,554 | ||||||
| Payments of lease liabilities | (2,211 | ) | (1,228 | ) | ||||
| Net cash provided by/(used in) financing activities | (2,198 | ) | 173,326 | |||||
| Net increase/(decrease) in cash and cash equivalents | 113,548 | (31,208 | ) | |||||
| Cash and cash equivalents at the beginning of the period | 236,748 | 218,472 | ||||||
| Effects of exchange rate changes and expected credit losses on cash and cash equivalents | (15,374 | ) | 1,935 | |||||
| Cash and cash equivalents at the end of the period | 334,922 | 189,199 | ||||||
Condensed Consolidated Statement of Changes in Shareholders’ Equity of
| (Euros in thousands) | Share capital |
Share premium |
Accumulated deficit |
Other reserves |
Total share- holders’ equity |
|||||||||||||||
| Balance as of |
847 | 823,166 | (604,759 | ) | (1,636 | ) | 217,618 | |||||||||||||
| Other comprehensive loss | — | — | — | (579 | ) | (579 | ) | |||||||||||||
| Net loss | — | — | (25,537 | ) | — | (25,537 | ) | |||||||||||||
| Comprehensive income/(loss) for the period | — | — | (25,537 | ) | (579 | ) | (26,116 | ) | ||||||||||||
| Equity-settled share-based compensation | — | 13,112 | — | — | 13,112 | |||||||||||||||
| Share options exercised | 1 | 1,113 | — | — | 1,114 | |||||||||||||||
| Issue of share capital – net of transaction costs | 183 | 173,257 | — | — | 173,440 | |||||||||||||||
| Balance as of |
1,031 | 1,010,648 | (630,296 | ) | (2,215 | ) | 379,168 | |||||||||||||
| Balance as of |
1,216 | 1,162,136 | (589,541 | ) | 1,031 | 574,842 | ||||||||||||||
| Other comprehensive loss | — | — | — | (9,138 | ) | (9,138 | ) | |||||||||||||
| Net loss | — | — | (160,750 | ) | — | (160,750 | ) | |||||||||||||
| Comprehensive loss for the period | — | — | (160,750 | ) | (9,138 | ) | (169,888 | ) | ||||||||||||
| Equity-settled share-based compensation | — | 11,712 | — | — | 11,712 | |||||||||||||||
| Share options exercised | — | 13 | — | — | 13 | |||||||||||||||
| Balance as of |
1,216 | 1,173,861 | (750,291 | ) | (8,107 | ) | 416,679 | |||||||||||||
1 All amounts translated using the exchange rate published by the
2 Refers to PRAME+/HLA-A*02:01+ patients per year in the US and EU5 in 2025; Source: Clarivate Disease Landscape and Forecast
Attachment
