- SUPRAME Phase 3 interim and final analysis for PRAME cell therapy, anzu-cel, expected to be triggered in 2026, advancing toward the Company’s first commercial launch planned in 2027
- Multiple key clinical data sets expected in 2026 across the portfolio, including four clinical-stage cell therapy and bispecific candidates targeting cutaneous and uveal melanoma, gynecologic cancers (ovarian and uterine), head and neck cancer, and other solid tumor indications
- Phase 1 data readout with second-generation PRAME cell therapy, IMA203CD8, to be presented at the 2026 ASCO meeting, focusing on anti-tumor activity in gynecologic cancers
- Phase 1b clinical data from PRAME bispecific, IMA402, as monotherapy and initial data in combination with an immune checkpoint inhibitor at RP2D range expected in 2H 2026
- First Phase 1 trial evaluating the combination of Immatics’ TCR bispecifics, IMA402 targeting PRAME and IMA401 targeting MAGEA4/8 in sqNSCLC, expected to begin in mid-2026
- Cash and cash equivalents as well as other financial assets of
$521.5 million 1 (€453.6 million) as ofMarch 31, 2026 ; cash reach projected into 2028
“Immatics is entering a pivotal period as we continue to progress toward the pre-specified interim and final analyses from the Phase 3 SUPRAME trial of anzu-cel and actively prepare for commercialization in 2027,” said
First Quarter 2026 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 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 patients2.
- Anzu-cel received Orphan Drug Designation and RMAT designation3 from the
U.S. Food and Drug Administration (FDA) for the treatment of both cutaneous and uveal melanoma. - Secondary analyses of Phase 1b clinical data on anzu-cel in advanced cutaneous and uveal melanoma will be presented during the Oral Abstract Session - Melanoma/Skin Cancers at the 2026 ASCO Annual Meeting, with a focus on characterizing response dynamics.
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 data to support regulatory approval of anzu-cel.
- 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.
- Pre-specified interim and final data analyses are expected to be triggered in 2026 upon the occurrence of a defined number of events for PFS (progressive disease or death).
- 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 2 cohort for anzu-cel (IMA203) PRAME cell therapy in patients with metastatic uveal melanoma
- 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. andGermany 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 cutaneous melanoma.
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 (ovarian and uterine).
- Updated Phase 1a dose-escalation and Phase 1b dose-expansion data in gynecologic cancers at clinically relevant dose levels will be presented during the Rapid Oral Abstract Session – Gynecological Cancer at the 2026 ASCO Annual Meeting.
- The Company is on track to complete Phase 1a dose escalation and determine the recommended Phase 2 dose (RP2D) in 2026.
Further Updates on PRAME Cell Therapies
- PRAME cell therapy beyond melanoma and gynecologic cancers: updated Phase 1 data on PRAME cell therapies (anzu-cel or IMA203CD8 GEN2) in synovial sarcoma, further demonstrating the potential to address diverse tumor types beyond melanoma and gynecologic cancers, will be presented during the Rapid Oral Abstract Session - Sarcoma at the 2026 ASCO Annual Meeting.
- PRAME cell therapy using Immatics’ TCR in a pediatric patient with cancer: a late-breaking poster on a PRAME-directed TCR T-cell therapy using Immatics’ PRAME TCR administered under named-patient use in a heavily pretreated pediatric patient with extensive, multifocal nephroblastoma was presented at AACR Annual Meeting 2026. PRAME is expressed across multiple pediatric cancers, and these findings highlight the therapeutic potential of PRAME cell therapy in pediatric patients with solid tumors.
PRAME Franchise - Bispecifics
IMA402 PRAME Bispecific – Expansion to Earlier-Line PRAME Cancers
To expand our 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,
- 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.
Immatics expects to determine the final RP2D and present a clinical data update from a larger patient population, with an initial focus on melanoma and gynecologic cancers treated with IMA402 monotherapy or combination with an immune checkpoint inhibitor, in the second half of 2026. As part of its strategy to maximize the IMA402 opportunity, the Company is in the process of opening additional Phase 1b cohorts in mid-2026 across both earlier and later treatment lines.- Based on the initial promising activity of IMA401 in head and neck cancer and sqNSCLC,
Immatics believes it is uniquely 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. The Phase 1 trial evaluating the combination of IMA401/IMA402 in sqNSCLC is expected to commence mid-2026.
IMA401 MAGEA4/8 Bispecific – Maximizing the Potential of Bispecifics Combinations
- Updated results for IMA401 targeting MAGEA4/8 across multiple cancers will be presented during the Developmental Therapeutics – Immunotherapy Oral Abstract Session at the 2026 ASCO Annual Meeting.
- IMA401 clinical development will focus on a combination approach with the Company’s PRAME bispecific, IMA402, to exploit synergistic potential and expanded patient reach.
- The Phase 1 trial evaluating the combination of IMA401/IMA402 is expected to commence with sqNSCLC in mid-2026.
Corporate Development:
In collaboration, Moderna and
First Quarter 2026 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 Form 6-K filed with the Securities and Exchange Commission (SEC) on
Upcoming Investor Conferences
Bank of America Healthcare Conference ,Las Vegas (NV), USA –May 12 - 14, 2026 Jefferies Global Healthcare Conference ,New York (NY), USA –June 2 - 4, 2026 Cantor Global Healthcare Conference ,New York (NY), USA –September 9 - 11, 2026
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 and outcomes 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 | ||||||||||
| 2026 | 2025 | |||||||||
| (Euros in thousands, except per share data) | ||||||||||
| Revenue from collaboration agreements | 7,612 | 18,582 | ||||||||
| Research and development expenses | (59,186 | ) | (41,908 | ) | ||||||
| General and administrative expenses | (14,514 | ) | (12,067 | ) | ||||||
| Other income | 24 | 19 | ||||||||
| Operating result | (66,064 | ) | (35,374 | ) | ||||||
| Change in fair value of liabilities for warrants | — | 1,597 | ||||||||
| Other financial income | 8,748 | 6,264 | ||||||||
| Other financial expenses | (446 | ) | (13,336 | ) | ||||||
| Financial result | 8,302 | (5,475 | ) | |||||||
| Loss before taxes | (57,762 | ) | (40,849 | ) | ||||||
| Taxes on income | (52 | ) | 994 | |||||||
| Net loss | (57,814 | ) | (39,855 | ) | ||||||
| Net loss per share: | ||||||||||
| Basic | (0.43 | ) | (0.33 | ) | ||||||
| Diluted | (0.43 | ) | (0.33 | ) | ||||||
Condensed Consolidated Statement of Comprehensive Loss of
| Three months ended | ||||||||||
| 2026 | 2025 | |||||||||
| (Euros in thousands) | ||||||||||
| Net loss | (57,814 | ) | (39,855 | ) | ||||||
| Other comprehensive income/(loss) | ||||||||||
| Items that may be reclassified subsequently to profit or loss | ||||||||||
| Currency translation differences from foreign operations | 1,875 | (2,711 | ) | |||||||
| Total comprehensive loss for the period | (55,939 | ) | (42,566 | ) | ||||||
Condensed Consolidated Statement of Financial Position of
| As of | ||||||||||
| (Euros in thousands) | ||||||||||
| Assets | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 301,332 | 345,918 | ||||||||
| Other financial assets | 152,238 | 123,419 | ||||||||
| Accounts receivables | 4,153 | 6,099 | ||||||||
| Other current assets | 27,114 | 28,572 | ||||||||
| Total current assets | 484,837 | 504,008 | ||||||||
| Non-current assets | ||||||||||
| Property, plant and equipment | 41,225 | 42,111 | ||||||||
| Intangible assets | 1,580 | 1,582 | ||||||||
| Right-of-use assets | 12,214 | 12,786 | ||||||||
| Other non-current assets | 3,408 | 1,850 | ||||||||
| Total non-current assets | 58,427 | 58,329 | ||||||||
| Total assets | 543,264 | 562,337 | ||||||||
| Liabilities and shareholders’ equity | ||||||||||
| Current liabilities | ||||||||||
| Provisions | 2,683 | — | ||||||||
| Accounts payables | 31,580 | 18,832 | ||||||||
| Deferred revenue | 13,222 | 15,816 | ||||||||
| Lease liabilities | 2,607 | 2,757 | ||||||||
| Other current liabilities | 5,159 | 5,607 | ||||||||
| Total current liabilities | 55,251 | 43,012 | ||||||||
| Non-current liabilities | ||||||||||
| Deferred revenue | 15,879 | 18,541 | ||||||||
| Lease liabilities | 12,474 | 12,878 | ||||||||
| Deferred tax liabilities | 3,859 | 3,807 | ||||||||
| Total non-current liabilities | 32,212 | 35,226 | ||||||||
| Shareholders’ equity | ||||||||||
| Share capital | 1,367 | 1,341 | ||||||||
| Share premium | 1,304,953 | 1,277,338 | ||||||||
| Accumulated deficit | (843,802 | ) | (785,988 | ) | ||||||
| Other reserves | (6,717 | ) | (8,592 | ) | ||||||
| Total shareholders’ equity | 455,801 | 484,099 | ||||||||
| Total liabilities and shareholders’ equity | 543,264 | 562,337 | ||||||||
Condensed Consolidated Statement of Cash Flows of
| Three months ended | ||||||||
| 2026 | 2025 | |||||||
| (Euros in thousands) | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | (57,814 | ) | (39,855 | ) | ||||
| Taxes on income | 52 | (994 | ) | |||||
| Loss before tax | (57,762 | ) | (40,849 | ) | ||||
| Adjustments for: | ||||||||
| Interest income | (3,580 | ) | (5,463 | ) | ||||
| Depreciation and amortization | 2,775 | 3,140 | ||||||
| Interest expenses | 212 | 249 | ||||||
| Equity-settled share-based payment | 5,910 | 4,330 | ||||||
| Net foreign exchange differences and expected credit losses | (5,469 | ) | 12,248 | |||||
| Change in fair value of liabilities for warrants | — | (1,597 | ) | |||||
| Loss from disposal of fixed assets | 48 | 40 | ||||||
| Changes in: | ||||||||
| Decrease in accounts receivables | 1,946 | 257 | ||||||
| (Increase)/decrease in other assets | 1,157 | (90 | ) | |||||
| Increase/(decrease) in deferred revenue, accounts payables and other liabilities | 10,400 | (16,021 | ) | |||||
| Interest received | 3,370 | 14,673 | ||||||
| Interest paid | (212 | ) | (249 | ) | ||||
| Income tax paid | (838 | ) | (4,874 | ) | ||||
| Net cash used in operating activities | (42,043 | ) | (34,206 | ) | ||||
| Cash flows from investing activities | ||||||||
| Payments for property, plant and equipment | (763 | ) | (3,075 | ) | ||||
| Payments for intangible assets | — | (60 | ) | |||||
| Proceeds from disposal of property, plant and equipment | 24 | 47 | ||||||
| Payments for investments classified in other financial assets | (70,068 | ) | (258,644 | ) | ||||
| Proceeds from maturity of investments classified in other financial assets | 42,723 | 308,540 | ||||||
| Net cash provided by/(used in) investing activities | (28,084 | ) | 46,808 | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of shares to equity holders | 22,273 | — | ||||||
| Transaction costs deducted from equity | (542 | ) | — | |||||
| Payments of lease liabilities | (760 | ) | (737 | ) | ||||
| Net cash provided by/(used in) financing activities | 20,971 | (737 | ) | |||||
| Net increase/(decrease) in cash and cash equivalents | (49,156 | ) | 11,865 | |||||
| Cash and cash equivalents at the beginning of the period | 345,918 | 236,748 | ||||||
| Effects of exchange rate changes and expected credit losses on cash and cash equivalents | 4,570 | (5,769 | ) | |||||
| Cash and cash equivalents at the end of the period | 301,332 | 242,844 | ||||||
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 | 1,216 | 1,162,136 | (589,541 | ) | 1,031 | 574,842 | ||||||||||||||||
| Other comprehensive loss | — | — | — | (2,711 | ) | (2,711 | ) | |||||||||||||||
| Net loss | — | — | (39,855 | ) | — | (39,855 | ) | |||||||||||||||
| Comprehensive loss for the period | — | — | (39,855 | ) | (2,711 | ) | (42,566 | ) | ||||||||||||||
| Equity-settled share-based compensation | — | 4,330 | — | — | 4,330 | |||||||||||||||||
| Balance as of | 1,216 | 1,166,466 | (629,396 | ) | (1,680 | ) | 536,606 | |||||||||||||||
| Balance as of | 1,341 | 1,277,338 | (785,988 | ) | (8,592 | ) | 484,099 | |||||||||||||||
| Other comprehensive income | — | — | — | 1,875 | 1,875 | |||||||||||||||||
| Net loss | — | — | (57,814 | ) | — | (57,814 | ) | |||||||||||||||
| Comprehensive income/(loss) for the period | — | — | (57,814 | ) | 1,875 | (55,939 | ) | |||||||||||||||
| Equity-settled share-based compensation | — | 5,910 | — | — | 5,910 | |||||||||||||||||
| Share options exercised | 1 | 578 | — | — | 579 | |||||||||||||||||
| Issue of share capital – net of transaction costs | 25 | 21,127 | — | — | 21,152 | |||||||||||||||||
| Balance as of | 1,367 | 1,304,953 | (843,802 | ) | (6,717 | ) | 455,801 | |||||||||||||||
1 All amounts converted using the exchange rate published by the
2 Refers to PRAME+/HLA-A*02:01+ patients per year in the
3 Includes all benefits of Breakthrough Therapy Designation.
Attachment
Source: https://immatics.com/
