- Anzu-cel (anzutresgene autoleucel, IMA203) PRAME Cell Therapy: One-time infusion continues to show favorable tolerability as well as strong anti-tumor activity and durability in 33 heavily pretreated patients with metastatic melanoma in data from a Phase 1b trial presented at the 2025 ASCO Annual Meeting: 56% cORR, 12.1 months mDOR at 13.4 months mFU, 6.1 months mPFS and 15.9 months mOS
- Anzu-cel (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
- 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 in 4Q 2025
- IMA402 PRAME Bispecific: Phase 1a clinical trial in solid tumors ongoing with next data update with a focus on melanoma at relevant dose levels planned in 4Q 2025
- IMA401 MAGEA4/8 Bispecific: Phase 1a clinical trial, including a checkpoint inhibitor combination, ongoing with next data update with a focus on head and neck cancer planned in 4Q 2025
- Cash and cash equivalents as well as other financial assets of
$560.5 million 1 (€478.2 million) as ofJune 30, 2025 ; cash reach into 2H 2027
“The presentation of positive and extended follow-up Phase 1b data at ASCO has further strengthened our conviction in the transformative therapeutic potential of our PRAME cell therapy, anzu-cel, in patients with advanced cutaneous and uveal melanoma,” said
Second Quarter 2025 and Subsequent Company Progress
PRAME Franchise
Anzu-cel (IMA203) PRAME Cell Therapy – 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.
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 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 will be 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
- On
May 31, 2025 , extended follow-up data from the Phase 1b trial of anzu-cel in metastatic melanoma were presented byMartin Wermke , MD, in an oral presentation at the 2025 ASCO Annual Meeting. The data further substantiate 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. A one-time infusion of anzu-cel PRAME cell therapy in all melanoma patients demonstrated favorable tolerability and promising clinical activity: 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
Anzu-cel (IMA203) PRAME cell therapy in patients with uveal melanoma
Immatics will continue to evaluate anzu-cel in patients with uveal melanoma through the ongoing Phase 1b clinical trial. In addition, a Phase 2 cohort for ~30 patients with uveal melanoma is planned to commence in 4Q 2025.- Uveal melanoma data from the Phase 1b trial that support the Phase 2 cohort will be presented by
Sapna Patel , MD, in a proffered paper presentation at theEuropean Society for Medical Oncology (ESMO) Congress 2025 onOctober 20, 2025 .
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 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, is planned for 4Q 2025.
IMA402 PRAME Bispecific – Expansion to Early-Stage PRAME Cancers
To expand the PRAME opportunity to early-stage PRAME cancers, the Company is developing its off-the-shelf, next-generation, half-life extended TCR Bispecific, IMA402. Upon delivering clinical proof-of-concept (“PoC”) in last-line melanoma,
- Phase 1a dose escalation is ongoing, and the next update with clinical data at relevant dose levels with a focus on second-line or later (2L) melanoma is planned for 4Q 2025.
Beyond the PRAME Franchise
IMA401 MAGEA4/8 Bispecific – Driving Innovation Beyond PRAME
- Dose refinement in the Phase 1a trial evaluating IMA401 as a monotherapy and in combination with a checkpoint inhibitor is ongoing with a focus on indications with high MAGEA4/8 target expression, such as lung and head and neck cancer.
- The Company expects to report updated data with a focus on head and neck cancer in 4Q 2025. Data with a focus on NSCLC are expected in 2026.
Corporate Development
- The Company’s Chief Financial Officer,
Arnd Christ , has informed the Company that he intends to transition out of the Company to pursue other opportunities.Arnd Christ has served as Chief Financial Officer ofImmatics since 2020 and has been instrumental in driving the Company’s maturation as a publicly listed entity. He will be stepping down asImmatics enters its next phase of development and transitions to become a commercial-stage organization. The Company is commencing a search for his replacement.Arnd Christ will remain as the Company’s CFO to ensure a smooth transition until the earlier of the appointment of his successor or the end of 1Q 2026. - Moderna Collaboration:
Immatics generated regulatory support data for one of Moderna’s mRNA product candidates that leveraged Immatics’ XPRESIDENT® and its bioinformatics and AI platform XCUBE™. Pursuant to the 2023 Collaboration Agreement under the Database/Vaccine Program,Immatics received a milestone payment triggered by the initiation of the first Phase 1 clinical trial for the Moderna product candidate. - International Nonproprietary Name:
The International Nonproprietary Names (INN) Expert Committee of the World Health Organization selected anzutresgene autoleucel (anzu-cel) as the INN for Immatics’ PRAME cell therapy, previously known as IMA203. Each INN, often called a generic name, is a distinct and globally recognized designation used to identify pharmaceutical substances or active ingredients.
Second 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
Upcoming Investor Conferences
Cantor Global Healthcare Conference ,New York (NY) –September 3 - 5, 2025 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 |
|
|
|
Six months ended |
|
||||||||||
| |
|
2025 | |
|
2024 | |
|
|
2025 | |
|
2024 | |
||||
| |
|
(Euros in thousands, except per share data) | |
|
|
(Euros in thousands, except per share data) | |
||||||||||
| Revenue from collaboration agreements |
|
|
4,737 | |
|
|
18,755 | |
|
|
|
23,318 | |
|
|
49,024 | |
| Research and development expenses |
|
|
(45,106 | ) | |
|
(35,216 | ) | |
|
|
(87,014 | ) | |
|
(67,324 | ) |
| General and administrative expenses |
|
|
(12,780 | ) | |
|
(10,128 | ) | |
|
|
(24,847 | ) | |
|
(21,770 | ) |
| Other income |
|
|
22 | |
|
|
25 | |
|
|
|
41 | |
|
|
37 | |
| Operating result |
|
|
(53,127 | ) | |
|
(26,564 | ) | |
|
|
(88,502 | ) | |
|
(40,033 | ) |
| Change in fair value of liabilities for warrants |
|
|
133 | |
|
|
(648 | ) | |
|
|
1,730 | |
|
|
395 | |
| Other financial income |
|
|
4,421 | |
|
|
9,665 | |
|
|
|
10,685 | |
|
|
20,580 | |
| Other financial expenses |
|
|
(22,776 | ) | |
|
(305 | ) | |
|
|
(36,113 | ) | |
|
(515 | ) |
| Financial result |
|
|
(18,222 | ) | |
|
8,712 | |
|
|
|
(23,698 | ) | |
|
20,460 | |
| Loss before taxes |
|
|
(71,349 | ) | |
|
(17,852 | ) | |
|
|
(112,200 | ) | |
|
(19,573 | ) |
| Taxes on income |
|
|
1,001 | |
|
|
(140 | ) | |
|
|
1,996 | |
|
|
(660 | ) |
| Net loss |
|
|
(70,348 | ) | |
|
(17,992 | ) | |
|
|
(110,204 | ) | |
|
(20,233 | ) |
| Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
| Basic |
|
|
(0.58 | ) | |
|
(0.17 | ) | |
|
|
(0.91 | ) | |
|
(0.20 | ) |
| Diluted |
|
|
(0.58 | ) | |
|
(0.17 | ) | |
|
|
(0.91 | ) | |
|
(0.20 | ) |
Condensed Consolidated Statement of Comprehensive Loss of
| |
|
Three months ended |
|
|
|
Six months ended |
|
||||||||||
| |
2025 | |
|
2024 | |
|
|
2025 | |
|
2024 | |
|||||
| |
(Euros in thousands) | |
|
|
(Euros in thousands) | |
|||||||||||
| Net loss |
|
|
(70,348 | ) | |
|
(17,992 | ) | |
|
|
(110,204 | ) | |
|
(20,233 | ) |
| Other comprehensive income/(loss) | |
|
|
|
|
|
|
|
|
|
|
|
|
||||
| Items that may be reclassified subsequently to profit or loss | |
|
|
|
|
|
|
|
|
|
|
|
|
||||
| Currency translation differences from foreign operations |
|
|
(5,833 | ) | |
|
462 | |
|
|
|
(8,544 | ) | |
|
798 | |
| Total comprehensive loss for the period |
|
|
(76,181 | ) | |
|
(17,530 | ) | |
|
|
(118,748 | ) | |
|
(19,435 | ) |
Condensed Consolidated Statement of Financial Position of
| |
|
As of | |
|||||
| |
|
|
|
2024 |
|
|||
| |
(Euros in thousands) | |
||||||
| Assets | |
|
|
|
|
|
||
| Current assets | |
|
|
|
|
|
||
| Cash and cash equivalents | |
|
256,635 | |
|
|
236,748 | |
| Other financial assets | |
|
221,551 | |
|
|
367,704 | |
| Accounts receivables | |
|
1,962 | |
|
|
5,857 | |
| Other current assets | |
|
23,788 | |
|
|
19,246 | |
| Total current assets | |
|
503,936 | |
|
|
629,555 | |
| Non-current assets | |
|
|
|
|
|
||
| Property, plant and equipment | |
|
46,306 | |
|
|
50,380 | |
| Intangible assets | |
|
1,598 | |
|
|
1,629 | |
| Right-of-use assets | |
|
14,462 | |
|
|
13,332 | |
| Other non-current assets | |
|
1,000 | |
|
|
1,250 | |
| Total non-current assets | |
|
63,366 | |
|
|
66,591 | |
| Total assets | |
|
567,302 | |
|
|
696,146 | |
| Liabilities and shareholders’ equity | |
|
|
|
|
|
||
| Current liabilities | |
|
|
|
|
|
||
| Provisions | |
|
4,391 | |
|
|
— | |
| Accounts payables | |
|
18,701 | |
|
|
20,693 | |
| Deferred revenue | |
|
24,389 | |
|
|
35,908 | |
| Liabilities for warrants | |
|
— | |
|
|
1,730 | |
| Lease liabilities | |
|
3,004 | |
|
|
2,851 | |
| Other current liabilities | |
|
6,762 | |
|
|
6,805 | |
| Total current liabilities | |
|
57,247 | |
|
|
67,987 | |
| Non-current liabilities | |
|
|
|
|
|
||
| Deferred revenue | |
|
27,561 | |
|
|
34,161 | |
| Lease liabilities | |
|
14,112 | |
|
|
13,352 | |
| Deferred tax liability | |
|
3,808 | |
|
|
5,804 | |
| Total non-current liabilities | |
|
45,481 | |
|
|
53,317 | |
| Shareholders’ equity | |
|
|
|
|
|
||
| Share capital | |
|
1,216 | |
|
|
1,216 | |
| Share premium | |
|
1,170,616 | |
|
|
1,162,136 | |
| Accumulated deficit | |
|
(699,745 | ) | |
|
(589,541) | |
| Other reserves | |
|
(7,513 | ) | |
|
1,031 | |
| Total shareholders’ equity | |
|
464,574 | |
|
|
574,842 | |
| Total liabilities and shareholders’ equity | |
|
567,302 | |
|
|
696,146 | |
Condensed Consolidated Statement of Cash Flows of
| |
|
Six months ended |
|
|||||
| |
2025 | |
|
2024 | |
|||
| |
(Euros in thousands) | |
||||||
| Cash flows from operating activities | |
|
|
|
|
|
||
| Net loss |
|
|
(110,204 | ) | |
|
(20,233 | ) |
| Taxes on income |
|
|
(1,996 | ) | |
|
660 | |
| Loss before tax |
|
|
(112,200 | ) | |
|
(19,573 | ) |
| Adjustments for: | |
|
|
|
|
|
||
| Interest income |
|
|
(9,719 | ) | |
|
(12,660 | ) |
| Depreciation and amortization |
|
|
6,166 | |
|
|
6,116 | |
| Interest expenses |
|
|
493 | |
|
|
420 | |
| Equity-settled share-based payment |
|
|
8,471 | |
|
|
8,605 | |
| Net foreign exchange differences and expected credit losses |
|
|
34,241 | |
|
|
(7,723 | ) |
| Change in fair value of liabilities for warrants |
|
|
(1,730 | ) | |
|
(395 | ) |
| Gains from disposal of fixed assets |
|
|
40 | |
|
|
1 | |
| Changes in: |
|
|
|
|
|
|
||
| Decrease in accounts receivables |
|
|
3,894 | |
|
|
1,283 | |
| (Increase)/decrease in other assets |
|
|
(277 | ) | |
|
766 | |
| Decrease in deferred revenue, accounts payables and other liabilities |
|
|
(15,534 | ) | |
|
(48,493 | ) |
| Interest received |
|
|
18,012 | |
|
|
8,260 | |
| Interest paid |
|
|
(493 | ) | |
|
(420 | ) |
| Income tax paid |
|
|
(5,445 | ) | |
|
(2,012 | ) |
| Income tax refunded |
|
|
820 | |
|
|
— | |
| Net cash used in operating activities |
|
|
(73,261 | ) | |
|
(65,825 | ) |
| Cash flows from investing activities |
|
|
|
|
|
|
||
| Payments for property, plant and equipment |
|
|
(4,503 | ) | |
|
(11,797 | ) |
| Payments for intangible assets |
|
|
(190 | ) | |
|
(148 | ) |
| Proceeds from disposal of property, plant and equipment |
|
|
47 | |
|
|
— | |
| Payments for investments classified in Other financial assets |
|
|
(280,651 | ) | |
|
(356,596 | ) |
| Proceeds from maturity of investments classified in Other financial assets |
|
|
396,353 | |
|
|
196,548 | |
| Net cash provided by/(used in) investing activities |
|
|
111,056 | |
|
|
(171,993 | ) |
| Cash flows from financing activities |
|
|
|
|
|
|
||
| Net proceeds from issuance of shares to equity holders |
|
|
9 | |
|
|
174,476 | |
| Payments of lease liabilities |
|
|
(1,473 | ) | |
|
(397 | ) |
| Net cash provided by/(used in) financing activities |
|
|
(1,464 | ) | |
|
174,079 | |
| Net increase/(decrease) in cash and cash equivalents |
|
|
36,331 | |
|
|
(63,739 | ) |
| 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 |
|
|
(16,444 | ) | |
|
3,410 | |
| Cash and cash equivalents at the end of the period |
|
|
256,635 | |
|
|
158,143 | |
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 income |
|
|
— | |
|
|
— | |
|
— | |
|
|
798 | |
|
|
798 | |
|
| Net loss |
|
|
— | |
|
|
— | |
|
|
(20,233 | ) | |
|
— | |
|
|
(20,233 | ) |
| Comprehensive income/(loss) for the period |
|
|
— | |
|
|
— | |
|
|
(20,233 | ) | |
|
798 | |
|
|
(19,435 | ) |
| Equity-settled share-based compensation |
|
|
— | |
|
|
8,605 | |
|
|
— | |
|
|
— | |
|
|
8,605 | |
| Share options exercised |
|
|
1 | |
|
|
1,036 | |
|
|
— | |
|
|
— | |
|
|
1,037 | |
| Issue of share capital – net of transaction costs |
|
|
183 | |
|
|
173,257 | |
|
|
— | |
|
|
— | |
|
|
173,440 | |
| Balance as of |
|
|
1,031 | |
|
|
1,006,064 | |
|
|
(624,992 | ) | |
|
(838 | ) | |
|
381,265 | |
| Balance as of |
|
|
1,216 | |
|
|
1,162,136 | |
|
|
(589,541 | ) | |
|
1,031 | |
|
|
574,842 | |
| Other comprehensive loss |
|
|
— | |
|
|
— | |
|
|
— | |
|
|
(8,544 | ) | |
|
(8,544 | ) |
| Net loss |
|
|
— | |
|
|
— | |
|
|
(110,204 | ) | |
|
— | |
|
|
(110,204 | ) |
| Comprehensive loss for the period |
|
|
— | |
|
|
— | |
|
|
(110,204 | ) | |
|
(8,544 | ) | |
|
(118,748 | ) |
| Equity-settled share-based compensation |
|
|
— | |
|
|
8,471 | |
|
|
— | |
|
|
— | |
|
|
8,471 | |
| Share options exercised |
|
|
— | |
|
|
9 | |
|
|
— | |
|
|
— | |
|
|
9 | |
| Balance as of |
|
|
1,216 | |
|
|
1,170,616 | |
|
|
(699,745 | ) | |
|
(7,513 | ) | |
|
464,574 | |
1 All amounts translated using the exchange rate published by the
2 Refers to PRAME+/HLA-A*02:01+ patients in the US and EU5 in 2025; Source: Clarivate Disease Landscape and Forecast
Attachment
