- Randomized-controlled Phase 3 trial, SUPRAME, to evaluate ACTengine® IMA203 TCR-T (PRAME) in advanced melanoma patients; first patient randomized and enrollment continues as planned
- ACTengine® IMA203 TCR-T (PRAME): Phase 1b IMA203 data published in
October 2024 demonstrated a confirmed ORR of 54%, 12.1 months mDOR, 6 months mPFS and OS not reached at a mFU time of 8.6 months in advanced melanoma patients; next data update on Phase 1b trial with extended follow-up planned in 2025 - Second-generation ACTengine® IMA203CD8 TCR-T (PRAME): Phase 1a data published in
November 2024 showed enhanced pharmacology and potency, demonstrating potential to address solid tumor indications with both high- and medium-level PRAME copy numbers; dose escalation advancing as planned; next data update including ovarian cancer data planned in 2025 - TCER® IMA402 (PRAME): Phase 1a data published in
November 2024 demonstrated a favorable tolerability profile and initial clinical anti-tumor activity associated with dose and PRAME expression; dose escalation advancing as planned; next data update planned in 2025 - TCER® IMA401 (MAGEA4/8): Phase 1a data published in
September 2024 demonstrated clinical anti-tumor activity in multiple tumor types and manageable tolerability profile; monotherapy and checkpoint inhibitor combination dose refinement ongoing; next data update with a focus on head and neck cancer planned in 2025 - Cash and cash equivalents as well as other financial assets amount to
$628.0 million 1 (€604.5 million) as ofDecember 31, 2024 ; updated cash reach into 2H 2027
"2025 will be marked by milestones across our TCR-T and TCR Bispecifics clinical portfolio, including advancing two of our main objectives for this year: firstly, reporting data on solid cancer types beyond melanoma, such as ovarian cancer, head and neck cancer and others and secondly, demonstrating that our next-generation, half-life extended TCR Bispecifics can deliver meaningful response rates in advanced solid cancer patients," said
Full Year 2024 and Subsequent Company Progress
ACTengine® Cell Therapy Programs
ACTengine® IMA203 (PRAME)
IMA203 is Immatics’ lead TCR-T 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 TCR therapeutic targeting PRAME to enter the market. In parallel,
Clinical and commercial development plan for ACTengine® IMA203 TCR-T
Based on the positive Phase 1b clinical data presented in 2024 and supported by the FDA RMAT designation3,
SUPRAME is a prospective, multicenter, open-label, randomized-controlled Phase 3 clinical trial evaluating the efficacy, safety and tolerability of IMA203 TCR-T in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor. 360 HLA-A*02:01-positive patients will be randomized 1:1 to treatment with IMA203 or investigator’s choice of selected approved treatments in the 2L setting (nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US), chemotherapy). Based on the Company’s discussions with the FDA, the primary endpoint for seeking full approval will be blinded independent central review (“BICR”)-assessed (RECIST v1.1) progression-free survival (PFS). Given the expected median PFS of 2-3 months in this patient population4, as well as the median PFS of 6 months (> 1 year in patients with deep responses) observed in the data from the IMA203 Phase 1b trial, the Company has determined that utilizing PFS as the primary endpoint is the fastest pathway to seeking full approval and presents a more attractive commercial positioning as compared to objective response rate (ORR). Secondary endpoints for the trial include ORR, safety, DOR, OS and patient-reported outcomes.
The trial is planned to run internationally with approximately 50 sites in
Patient enrollment for SUPRAME is forecasted to be completed in 2026. A pre-specified interim data analysis will be triggered upon the occurrence of a defined number of events for PFS (progressive disease or death)5 anticipated to occur after approximately 200 patients are enrolled in 1Q 2026. The final analysis is planned for 4Q 2026.
In addition to cutaneous melanoma,
Manufacturing capabilities
Immatics’ proprietary manufacturing process, timeline, capabilities and facility support late-stage clinical and commercial cell therapy development and supply.
IMA203 products are manufactured from a patient's leukapheresis (with no surgery required) within 7 days, followed by 7-day QC release testing at >95% success rate6 to achieve the target dose (1-10x109 TCR-T cells). The Company’s state-of-the-art ~100,000 sq. ft. R&D and GMP manufacturing facility in the
Clinical data on ACTengine® IMA203 TCR-T as of
On
As of the data cut-off on
- Confirmed objective response rate of 54% and an objective response rate of 62%
- Disease control rate of 92% and tumor shrinkage in 88% of patients
- 12.1 months median duration of response, 6 months median progression-free survival and >1-year median progression-free survival in patients with deep responses
- Median overall survival has not yet been reached at a median follow-up time of 8.6 months
IMA203 monotherapy has maintained a favorable tolerability profile with no treatment-related Grade 5 events in the entire safety population (N=70 Phase 1a and Phase 1b patients across all dose levels and all tumor types).
ACTengine® IMA203CD8 TCR-T (GEN2) Monotherapy (PRAME)
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 PRAME-positive solid cancers beyond melanoma, starting with gynecologic cancers.
On
As of the data cut-off on
- Confirmed objective responses observed in 41% of patients (at low doses, dose escalation ongoing)
- Median duration of response of 9.2 months at a median follow-up of 13.1 months
- Tumor shrinkage of target lesions in 84% of patients and disease control rate at week 6 of 85%
- 10 out of 17 responses were ongoing, of which three confirmed responses were ongoing at 14+, 15+ and 24+ months
- Deep responses with ≥50% tumor size reduction were observed in 11 out of 17 responders. This group included two patients with complete response of target lesions, of which one patient showed a complete metabolic response according to a PET-CT scan
IMA203CD8 monotherapy has maintained a manageable tolerability profile in the 44 patients treated.
Based on the enhanced pharmacology of IMA203CD8 demonstrated in this trial, the evaluation of higher doses of IMA203CD8 in the ongoing dose escalation trial 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.
The next clinical data update including dose escalation and ovarian cancer is planned in 2025.
TCER® IMA402 (PRAME)
To expand the PRAME opportunity to additional solid cancer types and earlier lines of treatment, the Company is focusing on its half-life extended TCR Bispecific, IMA402. Upon delivering clinical proof-of-concept (“PoC”) in last-line melanoma,
On
As of the data cut-off on
Early pharmacokinetic data indicated a median half-life of approximately seven days, potentially enabling bi-weekly dosing. Initial signs of clinical anti-tumor activity have been observed and are associated with PRAME expression and IMA402 dose levels administered (up to 4 mg at DL8).
- In the PRAME-negative patient population across all doses and indications, only one patient out of seven (14%) showed tumor shrinkage of -2.9%
- 25% (3/12) of patients (PRAME+ or not tested) treated at low doses (DL1-6) showed tumor shrinkage, including one unconfirmed partial response in cutaneous melanoma
- 78% (7/9) of patients (PRAME+ or not tested) treated at relevant doses (8 patients at DL7 and 1 patient at DL8) experienced shrinkage of their target lesions, including one confirmed partial response in melanoma ongoing at 3 months and three patients with ongoing stable disease at 6+ weeks (cut. melanoma), 3 months (ovarian cancer), 8+ months (uveal melanoma)
Based on the initial signs of dose-dependent and PRAME target expression-dependent clinical activity observed during dose escalation, the Company will continue to evaluate IMA402 at higher dose levels to determine the optimal therapeutic dose.
As of
The next update on the Phase 1a trial with clinical data at relevant dose levels in second-line and later melanoma is planned in 2025.
TCER® IMA401 (MAGEA4/8)
On
As of data cut-off on
Proof-of-concept clinical data from the Phase 1a first-in-human dose escalation basket trial showed initial anti-tumor activity in multiple tumor types, durable objective responses, including confirmed responses ongoing at 13+ months, a manageable tolerability profile and a half-life of 14+ days.
Treatment with IMA401 monotherapy in patients with relevant IMA401 doses and MAGEA4/8high levels (N=17) demonstrated:
- Objective response rate of 29% with confirmed responses observed in 25% of patients
- Disease control rate of 53% and tumor shrinkage of 53%
As the clinical trial progresses, the Company aims to further leverage the potential of IMA401 by focusing on the enrollment of indications with high MAGEA4/8 target expression, such as lung and head and neck cancer patients, seeking to optimize the treatment schedule. By further combining IMA401 with a checkpoint inhibitor,
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.
Corporate Development
- IMA203 and mRNA Combination (Moderna collaboration): In
February 2025 , the FDA granted IND clearance for a Phase 1 trial evaluating Immatics’ IMA203 PRAME TCR-T in combination with Moderna’s PRAME adaptive immune modulating therapy. The objective of the combination is to further enhance IMA203 T cell responses with the potential to significantly reduce turn-around time and costs through the infusion of a much lower cell dose. 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 up to 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. - In
September 2024 ,Immatics regained full clinical development and commercialization rights to IMA401 due to ongoing portfolio prioritization efforts withinBristol Myers Squibb . The Phase 1 trial with IMA401 is ongoing and will continue to be conducted byImmatics .
Full Year 2024 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 profit was
Full financial statements can be found in our Annual Report on Form 20-F 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
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: +49 151 74416179 |
| immatics@trophic.eu |
| |
| |
| Head of Strategy |
| Phone: +1 346 319-3325 |
| InvestorRelations@immatics.com |
Consolidated Statement of Profit and Loss of
| Year ended |
|||||
| 2024 | 2023 | 2022 | |||
| (Euros in thousands, except per share data) | |||||
| Revenue from collaboration agreements | 155,835 | 53,997 | 172,831 | ||
| Research and development expenses | (148,079) | (118,663) | (106,779) | ||
| General and administrative expenses | (46,449) | (38,198) | (36,124) | ||
| Other income | 78 | 1,139 | 26 | ||
| Operating result | (38,615) | (101,725) | 29,954 | ||
| Change in fair value of liabilities for warrants | 17,264 | (2,079) | 10,945 | ||
| Other financial income | 44,018 | 13,850 | 9,416 | ||
| Other financial expenses | (1,321) | (7,040) | (8,279) | ||
| Financial result | 59,961 | 4,731 | 12,082 | ||
| Profit/(loss) before taxes | 21,346 | (96,994) | 42,036 | ||
| Taxes on income | (6,128) | |
2,345 | |
(14,333) |
| Net profit/(loss) | 15,218 | (94,649) | 27,703 | ||
| Net profit/(loss) per share: | |||||
| Basic | 0.14 | (1.18) | 0.41 | ||
| Diluted | 0.14 | (1.18) | 0.40 | ||
Consolidated Statement of Comprehensive Income/(Loss) of
| Year ended |
|
|||||
| 2024 | 2023 | 2022 | |
|||
| (Euros in thousands) | ||||||
| Net profit/(loss) | 15,218 | (94,649) | 27,703 | |
||
| Other comprehensive income/(loss) | |
|||||
| Items that may be reclassified subsequently to profit or loss | |
|||||
| Currency translation differences from foreign operations | 2,667 | (155) | 2,464 | |
||
| Total comprehensive income/(loss) for the year | 17,885 | (94,804) | 30,167 | |
||
Consolidated Statement of Financial Position of
| As of |
||||||
| 2024 | 2023 | |
||||
| (Euros in thousands) | ||||||
| Assets | |
|||||
| Current assets | |
|||||
| Cash and cash equivalents | 236,748 | 218,472 | |
|||
| Other financial assets | 367,704 | 207,423 | |
|||
| Accounts receivables | 5,857 | 4,093 | |
|||
| Other current assets | 19,246 | 19,382 | |
|||
| Total current assets | 629,555 | 449,370 | |
|||
| Non-current assets | |
|||||
| Property, plant and equipment | 50,380 | 43,747 | |
|||
| Intangible assets | 1,629 | 1,523 | |
|||
| Right-of-use assets | 13,332 | 13,308 | |
|||
| Other non-current assets | 1,250 | 2,017 | |
|||
| Total non-current assets | 66,591 | 60,595 | |
|||
| Total assets | 696,146 | 509,965 | |
|||
| Liabilities and shareholders’ equity | |
|||||
| Current liabilities | |
|||||
| Accounts payables | 20,693 | 25,206 | |
|||
| Deferred revenue | 35,908 | 100,401 | |
|||
| Liabilities for warrants | 1,730 | 18,993 | |
|||
| Lease liabilities | 2,851 | 2,604 | |
|||
| Other current liabilities | 6,805 | 9,348 | |
|||
| Total current liabilities | 67,987 | 156,552 | |
|||
| Non-current liabilities | |
|||||
| Deferred revenue | 34,161 | 115,527 | |
|||
| Lease liabilities | 13,352 | 12,798 | |
|||
| Other non-current liabilities | — | 4 | |
|||
| Deferred tax liability | 5,804 | 7,466 | |
|||
| Total non-current liabilities | 53,317 | 135,795 | |
|||
| Shareholders’ equity | |
|||||
| Share capital | 1,216 | 847 | |
|||
| Share premium | 1,162,136 | 823,166 | |
|||
| Accumulated deficit | (589,541) | (604,759) | |
|||
| Other reserves | 1,031 | (1,636) | |
|||
| Total shareholders’ equity | 574,842 | 217,618 | |
|||
| Total liabilities and shareholders’ equity | 696,146 | 509,965 | |
|||
Consolidated Statement of Cash Flows of
| Year ended |
|
|||||
| 2024 | 2023 | |
||||
| (Euros in thousands) | ||||||
| Cash flows from operating activities | |
|||||
| Net profit/(loss) | 15,218 | (94,649) | |
|||
| Taxes on income | 6,128 | (2,345) | |
|||
| Profit/(loss) before tax | 21,346 | (96,994) | |
|||
| Adjustments for: | |
|||||
| Interest income | (25,001) | (13,845) | |
|||
| Depreciation and amortization | 12,225 | 7,234 | |
|||
| Interest expenses | 886 | 831 | |
|||
| Equity-settled share-based payment | 17,642 | 20,705 | |
|||
| Net foreign exchange differences and expected credit losses | (18,706) | 6,861 | |
|||
| Change in fair value of liabilities for warrants | (17,264) | 2,079 | |
|||
| (Gains)/losses from disposal of fixed assets | 1 | (150) | |
|||
| Changes in: | |
|||||
| (Increase)/decrease in accounts receivables | (1,764) | (2,982) | |
|||
| (Increase)/decrease in other assets | (2,061) | (1,387) | |
|||
| Increase/(decrease) in deferred revenue, accounts payables and other liabilities | (160,053) | 85,999 | |
|||
| Interest received | 15,605 | 10,167 | |
|||
| Interest paid | (886) | (290) | |
|||
| Income tax paid | — | — | |
|||
| Net cash provided by/(used in) operating activities | (158,030) | 18,228 | |
|||
| Cash flows from investing activities | |
|||||
| Payments for property, plant and equipment | (16,272) | (30,799) | |
|||
| Payments for intangible assets | (208) | (158) | |
|||
| Proceeds from disposal of property, plant and equipment | 2 | 150 | |
|||
| Payments for investments classified in Other financial assets | (450,349) | (415,325) | |
|||
| Proceeds from maturity of investments classified in Other financial assets | 314,440 | 414,744 | |
|||
| Net cash (used in)/provided by investing activities | (152,387) | (31,388) | |
|||
| Cash flows from financing activities | |
|||||
| Proceeds from issuance of shares to equity holders | 343,010 | 90,404 | |
|||
| Transaction costs deducted from equity | (21,314) | (2,039) | |
|||
| Repayment of lease liabilities | (2,012) | (3,849) | |
|||
| Net cash provided by/(used in) financing activities | 319,684 | 84,516 | |
|||
| Net increase/(decrease) in cash and cash equivalents | 9,267 | 71,356 | |
|||
| Cash and cash equivalents at beginning of the year | 218,472 | 148,519 | |
|||
| Effects of exchange rate changes and expected credit losses on cash and cash equivalents | 9,009 | (1,403) | |
|||
| Cash and cash equivalents at end of the year | 236,748 | 218,472 | |
|||
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 |
629 | 565,192 | (537,813) | (3,945) | 24,063 | ||||
| Other comprehensive income | — | — | — | 2,464 | 2,464 | ||||
| Net profit | — | — | 27,703 | — | 27,703 | ||||
| Comprehensive income for the year | — | — | 27,703 | 2,464 | 30,167 | ||||
| Equity-settled share-based compensation | — | 22,570 | — | — | 22,570 | ||||
| Share options exercised | — | 311 | — | — | 311 | ||||
| Issue of share capital – net of transaction costs | 138 | 126,104 | — | — | 126,242 | ||||
| Balance as of |
767 | 714,177 | (510,110) | (1,481) | 203,353 | ||||
| Balance as of |
767 | 714,177 | (510,110) | (1,481) | 203,353 | ||||
| Other comprehensive loss | — | — | — | (155) | (155) | ||||
| Net loss | — | — | (94,649) | — | (94,649) | ||||
| Comprehensive loss for the year | — | — | (94,649) | (155) | (94,804) | ||||
| Equity-settled share-based compensation | — | 20,705 | — | — | 20,705 | ||||
| Share options exercised | — | 139 | — | — | 139 | ||||
| Issue of share capital – net of transaction costs | 80 | 88,145 | — | — | 88,225 | ||||
| Balance as of |
847 | 823,166 | (604,759) | (1,636) | 217,618 | ||||
| Balance as of |
847 | 823,166 | (604,759) | (1,636) | 217,618 | ||||
| Other comprehensive income | — | — | — | 2,667 | 2,667 | ||||
| Net profit | — | — | 15,218 | — | 15,218 | ||||
| Comprehensive income for the year | — | — | 15,218 | 2,667 | 17,885 | ||||
| Equity-settled share-based compensation | — | 17,642 | — | — | 17,642 | ||||
| Share options exercised | 1 | 1,114 | — | — | 1,115 | ||||
| Issue of share capital – net of transaction costs | 368 | 320,214 | — | — | 320,582 | ||||
| Balance as of |
1,216 | 1,162,136 | (589,541) | 1,031 | 574,842 |
1 All amounts translated using the exchange rate published by the
2
3 Includes all benefits of Breakthrough Therapy Designation.
4 Ascierto et al., 2023, Diab et al., 2024
5 Centrally assessed by BICR using RECIST v1.1.
6 As of
Attachment
