- IMA203 PRAME Cell Therapy: Randomized-controlled Phase 3 trial, SUPRAME, in previously treated advanced melanoma ongoing and expected to complete enrollment in 2026
- IMA203 PRAME Cell Therapy: Phase 1b clinical trial ongoing with updated data in metastatic melanoma with substantially longer follow-up and additional uveal melanoma patients to be presented in an oral presentation at the 2025 ASCO Annual Meeting
- IMA203CD8 PRAME Cell Therapy (GEN2): Phase 1a clinical trial in solid tumors ongoing with next data update, including dose escalation and ovarian cancer data, planned in 2025
- IMA402 PRAME Bispecific: Phase 1a clinical trial in solid tumors ongoing with next data update at relevant dose levels planned in 2025
- Combination of IMA203 PRAME cell therapy and Moderna’s PRAME adaptive immune modulating therapy: FDA granted IND clearance for a Phase 1 trial
- 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 2025
- Cash and cash equivalents as well as other financial assets of
$588.1 million 1 (€543.8 million) as ofMarch 31, 2025 ; cash reach into 2H 2027
“Our focus in the first quarter of 2025 was led by the execution of our SUPRAME Phase 3 clinical trial in melanoma as well as our other clinical-stage PRAME product candidates,” said
First Quarter 2025 and Subsequent Company Progress
PRAME Programs
IMA203 PRAME Cell Therapy
IMA203 is Immatics’ lead PRAME cell therapy, currently being evaluated in a Phase 3 trial (SUPRAME) in patients with previously treated advanced melanoma. IMA203 has the potential to become the first PRAME therapy to enter the market. In parallel,
Phase 3 trial, SUPRAME, for IMA203 in previously treated, advanced cutaneous melanoma
- Based on the positive Phase 1b clinical data,
Immatics has advanced its PRAME cell therapy, IMA203, into a randomized-controlled Phase 3 clinical trial, SUPRAME, evaluating the efficacy, safety and tolerability of IMA203 TCR T-cell therapy vs. investigator's choice of treatment in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor. - Primary endpoint for seeking full approval will be blinded independent central review (“BICR”)-assessed (RECIST v1.1) progression-free survival (PFS). Secondary endpoints for the trial include objective response rate (ORR), safety, duration of response (DOR), overall survival (OS) and patient-reported outcomes.
- The trial will be conducted internationally with approximately 50 sites in the US and
Europe . - Patient enrollment and randomization for the trial was initiated in early 2025 and is expected to be completed in 2026. In
April 2025 ,Immatics received regulatory approval from the German regulatory authority, Paul-Ehrlich-Institute (PEI), to commence the IMA203 SUPRAME Phase 3 trial inGermany . - A pre-specified interim data analysis will be triggered upon the occurrence of a defined number of events for PFS (progressive disease or death)3, anticipated to occur after approximately 200 patients.
Immatics aims to submit a Biologics License Application (BLA) in 1Q 2027 for full approval. - IMA203 PRAME cell therapy development is supported by the FDA RMAT designation. Advantages of the RMAT designation (which includes all benefits of Breakthrough Therapy designation) include potential priority review of the BLA and frequent interactions with the
US FDA as an opportunity to expedite development and review. - A trial-in-progress poster on SUPRAME will be presented in a poster presentation by the SUPRAME lead principal investigator,
Jason Luke , MD, FACP, FASCO, at the 2025 ASCO Annual Meeting onJune 2, 2025 .
Phase 1b trial for IMA203 PRAME cell therapy in solid tumors with a focus on uveal melanoma
- In addition to cutaneous melanoma,
Immatics intends to expand the IMA203 opportunity to treat uveal melanoma patients and will continue to evaluate IMA203 in this patient population through the ongoing trial. - Updated data from the Phase 1b trial of IMA203 in metastatic melanoma with substantially longer follow-up compared to the last presentation in
October 2024 , and including data from additional uveal melanoma patients enrolled since then, will be highlighted byMartin Wermke , MD, in an oral presentation at the 2025 ASCO Annual Meeting onMay 31, 2025 . - In
April 2025 , Nature Medicine published a manuscript covering prior clinical results on IMA203. The publication includes data from 40 heavily pretreated patients with PRAME cancers, mostly treated during the Phase 1a dose escalation part of the trial.
Cell therapy manufacturing capabilities
- The IMA203 PRAME cell therapy products are manufactured from a patient's leukapheresis (with no surgery required) within 7-8 days, followed by 7-day QC release testing at >95% success rate4 to achieve the target dose (1-10x109 TCR T cells).
- Immatics’ proprietary manufacturing process, timeline, capabilities and facility support late-stage clinical development and commercial cell therapy supply.
IMA203CD8 PRAME Cell Therapy (GEN2)
IMA203CD8 is the Company’s second-generation cell therapy product candidate targeting PRAME. Given its pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product in multiple PRAME cancers, starting with gynecologic cancers.
- Clinical data demonstrated enhanced pharmacology of IMA203CD8, which opens the possibility of addressing hard-to-treat solid tumor indications with both high- and medium-level PRAME copy numbers, such as ovarian cancer, uterine cancer, squamous non-small cell lung carcinoma, triple negative breast cancer and others.
- Phase 1a dose escalation in solid tumors is ongoing to evaluate higher doses of IMA203CD8 with and without IL-2. As of today, patients are being treated with up to ~8 billion total GEN2 TCR T cells.
- The next clinical trial update, which will report on the continued dose escalation in multiple PRAME cancers, including ovarian cancer patients treated at relevant doses, is planned in 2025.
IMA402 PRAME Bispecific
To expand the PRAME opportunity to additional solid cancer types and earlier lines of treatment, the Company is developing its half-life extended TCR Bispecific, IMA402. Upon delivering clinical proof-of-concept (“PoC”) in last-line melanoma,
- First clinical data from the early Phase 1a dose escalation trial demonstrated initial signs of dose-dependent and PRAME target expression-dependent clinical activity.
- Phase 1a dose escalation at higher dose levels to determine the optimal therapeutic dose is advancing and currently ongoing at dose level 11 (12 mg).
- The next Phase 1a clinical trial update with clinical data at relevant dose levels in second-line or later (2L) melanoma is planned in 2025.
Combination of IMA203 PRAME Cell Therapy and PRAME Adaptive Immune Modulating Therapy
- In
February 2025 , the FDA granted IND clearance for a Phase 1 trial evaluating Immatics’ IMA203 PRAME cell therapy in combination with Moderna’s PRAME adaptive immune modulating therapy. The first-in-human, Phase 1a/1b trial is a multicenter, open-label, dose escalation/de-escalation (adaptive design) trial evaluating the safety, tolerability and efficacy of the combination therapy in an estimated 15 patients with advanced or recurrent cutaneous melanoma and synovial sarcoma.Immatics is responsible for conducting the Phase 1 trial. Each party retains full ownership of its investigational PRAME compound, and the parties will fund the clinical study on a cost sharing basis. InNovember 2024 ,Immatics presented preclinical proof-of-concept data at SITC supporting this combination.
Other Programs
IMA401 MAGEA4/8 Bispecific
- Clinical proof-of-concept data from the Phase 1a dose escalation trial showed initial anti-tumor activity in multiple tumor types, including durable confirmed objective responses, a manageable tolerability profile and a half-life of 14+ days, which supported the switch to q2w dosing (once every two weeks).
- The Phase 1a trial is ongoing and the Company continues to focus enrollment on indications with high MAGEA4/8 target expression, such as lung and head and neck cancer.
- Dose refinement for IMA401 as monotherapy and in combination with a checkpoint inhibitor is ongoing. Through the combination,
Immatics aims to generate relevant clinical data to position IMA401 as a combination therapy in earlier treatment lines. - The next update on IMA401 Phase 1a data, with a focus on head and neck cancer, is expected in 2025, and the Company plans to share data with a focus on non-small cell lung carcinoma in 2026.
Moderna Collaboration
First 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
Bank of America Healthcare Conference ,Las Vegas (NV) –May 13 - 15, 2025 Jefferies Global Healthcare Conference ,New York (NY) –June 3 - 5, 2025 Cantor Global Healthcare Conference ,New York (NY) –September 3 - 5, 2025
To see the full list of events and presentations, visit https://investors.immatics.com/events-presentations.
- END -
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 or CTA filing for pre-clinical stage product candidates, 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: +49 171 1855682
immatics@trophic.eu
Jordan Silverstein
Head of Strategy
Phone: +1 346 319-3325
InvestorRelations@immatics.com
Condensed Consolidated Statement of Loss of
| |
Three months ended |
|||
| |
2025 | |
2024 | |
| |
(Euros in thousands) | |||
| Revenue from collaboration agreements | 18,582 | |
30,269 | |
| Research and development expenses | (41,908) | |
(32,108) | |
| General and administrative expenses | (12,067) | |
(11,642) | |
| Other income | 19 | |
12 | |
| Operating result | (35,374) | |
(13,469) | |
| Change in fair value of liabilities for warrants | 1,597 | |
1,043 | |
| Other financial income | 6,264 | |
11,381 | |
| Other financial expenses | (13,336) | |
(677) | |
| Financial result | (5,475) | |
11,747 | |
| Loss before taxes | (40,849) | |
(1,722) | |
| Taxes on income | 994 | (518) | ||
| Net loss | (39,855) | |
(2,240) | |
| Net loss per share: | |
|
|
|
| Basic | (0.33) | |
(0.02) | |
| Diluted | (0.33) | |
(0.03) | |
Condensed Consolidated Statement of Comprehensive Loss of
| |
Three months ended |
||
| 2025 | |
2024 | |
| |
(Euros in thousands) | ||
| Net loss | (39,855) | |
(2,240) |
| Other comprehensive income/(loss) | |
|
|
| Items that may be reclassified subsequently to profit or loss | |
|
|
| Currency translation differences from foreign operations | (2,711) | |
336 |
| Total comprehensive loss for the period | (42,566) | |
(1,904) |
Condensed Consolidated Statement of Financial Position of
| |
As of | |
|
|||
| |
|
|
|
|
||
| (Euros in thousands) | ||||||
| Assets | |
|
|
|
||
| Current assets | |
|
|
|
||
| Cash and cash equivalents | 242,844 | |
236,748 | |
||
| Other financial assets | 300,914 | |
367,704 | |
||
| Accounts receivables | 5,600 | |
5,857 | |
||
| Other current assets | 24,205 | |
19,246 | |
||
| Total current assets | 573,563 | |
629,555 | |
||
| Non-current assets | |
|
|
|
||
| Property, plant and equipment | 49,820 | |
50,380 | |
||
| Intangible assets | 1,600 | |
1,629 | |
||
| Right-of-use assets | 15,577 | |
13,332 | |
||
| Other non-current assets | 1,132 | |
1,250 | |
||
| Total non-current assets | 68,129 | |
66,591 | |
||
| Total assets | 641,692 | |
696,146 | |
||
| Liabilities and shareholders’ equity | |
|
|
|
||
| Current liabilities | |
|
|
|
||
| Provisions | 2,257 | |
— | |||
| Accounts payables | 18,395 | |
20,693 | |
||
| Deferred revenue | 25,295 | |
35,908 | |
||
| Liabilities for warrants | 133 | |
1,730 | |
||
| Lease liabilities | 3,046 | |
2,851 | |
||
| Other current liabilities | 6,644 | |
6,805 | |
||
| Total current liabilities | 55,770 | 67,987 | |
|||
| Non-current liabilities | |
|
|
|
||
| Deferred revenue | 29,165 | |
34,161 | |
||
| Lease liabilities | 15,341 | |
13,352 | |
||
| Deferred tax liability | 4,810 | |
5,804 | |
||
| Total non-current liabilities | 49,316 | |
53,317 | |
||
| Shareholders’ equity | |
|
|
|
||
| Share capital | 1,216 | |
1,216 | |
||
| Share premium | 1,166,466 | |
1,162,136 | |
||
| Accumulated deficit | (629,396) | |
(589,541) | |
||
| Other reserves | (1,680) | |
1,031 | |
||
| Total shareholders’ equity | 536,606 | |
574,842 | |
||
| Total liabilities and shareholders’ equity | 641,692 | |
696,146 | |
||
Condensed Consolidated Statement of Cash Flows of
| |
Three months ended |
|
|||
| 2025 | 2024 | |
|||
| (Euros in thousands) | |||||
| Cash flows from operating activities | |
|
|
||
| Net loss | (39,855) | (2,240) | |
||
| Taxes on income | (994) | 518 | |
||
| Loss before tax | (40,849) | (1,722) | |
||
| Adjustments for: | |
|
|
||
| Interest income | (5,463) | (6,294) | |
||
| Depreciation and amortization | 3,140 | 3,014 | |
||
| Interest expenses | 249 | 194 | |
||
| Equity-settled share-based payment | 4,330 | 4,297 | |
||
| Net foreign exchange differences and expected credit losses | 12,248 | (4,553) | |
||
| Change in fair value of liabilities for warrants | (1,597) | (1,043) | |
||
| Losses from disposal of fixed assets | 40 | — | |
||
| Changes in: | |
|
|
||
| Decrease in accounts receivables | 257 | 2,312 | |
||
| (Increase)/decrease in other assets | (90) | 1,134 | |
||
| Decrease in deferred revenue, accounts payables and other liabilities | (16,021) | (31,674) | |
||
| Interest received | 14,673 | 2,484 | |
||
| Interest paid | (249) | (194) | |
||
| Income tax paid | (4,874) | (560) | |
||
| Net cash provided by/(used in) operating activities | (34,206) | (32,605) | |
||
| Cash flows from investing activities | |
|
|
||
| Payments for property, plant and equipment | (3,075) | (9,174) | |
||
| Payments for intangible assets | (60) | (2) | |
||
| Proceeds from disposal of property, plant and equipment | 47 | — | |
||
| Payments for investments classified in Other financial assets | (258,644) | (290,599) | |
||
| Proceeds from maturity of investments classified in Other financial assets | 308,540 | 57,957 | |
||
| Net cash (used in)/provided by investing activities | 46,808 | (241,818) | |
||
| Cash flows from financing activities | |
|
|
||
| Proceeds from issuance of shares to equity holders | — | 185,669 | |
||
| Transaction costs deducted from equity | — | (11,548) | |
||
| Repayment/(payment) of lease liabilities | (737) | 524 | |
||
| Net cash provided by/(used in) financing activities | (737) | 174,645 | |
||
| Net increase/(decrease) in cash and cash equivalents | 11,865 | (99,778) | |
||
| Cash and cash equivalents at beginning of the year | 236,748 | 218,472 | |
||
| Effects of exchange rate changes and expected credit losses on cash and cash equivalents | (5,769) | 3,399 | |
||
| Cash and cash equivalents at end of the period | 242,844 | 122,093 | |
||
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 | — | |
— | |
— | |
336 | |
336 |
| Net loss | — | |
— | |
(2,240) | |
— | |
(2,240) |
| Comprehensive loss for the period | — | |
— | |
(2,240) | |
336 | |
(1,904) |
| Equity-settled share-based compensation | — | |
4,297 | |
— | |
— | |
4,297 |
| Share options exercised | 1 | |
682 | |
— | |
— | |
683 |
| Issue of share capital – net of transaction costs | 183 | |
173,257 | |
— | |
— | |
173,440 |
| Balance as of |
1,031 | |
1,001,402 | |
(607,000) | |
(1,300) | |
394,133 |
| 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 |
| Share options exercised | — | |
— | |
— | |
— | |
— |
| Issue of share capital – net of transaction costs | — | |
— | |
— | |
— | |
— |
| Balance as of |
1,216 | |
1,166,466 | |
(629,396) | |
(1,680) | |
536,606 |
1 All amounts translated using the exchange rate published by the
2
3 Centrally assessed by BICR using RECIST v1.1.
4 As of
Attachment
