Latest news with #SUPRAME
Business Insider
3 days ago
- Business
- Business Insider
Immatics announces presentation of data from ongoing Phase 1b trial on IMA203
Immatics (IMTX) announced the presentation of expanded data from the ongoing Phase 1b clinical trial evaluating IMA203 PRAME cell therapy in heavily pretreated patients with metastatic melanoma. The longer follow-up of patients demonstrates a consistent and favorable tolerability profile as well as durable responses with a confirmed ORR of 56%. In addition, the Company provided details from a Trial in Progress poster on SUPRAME, the ongoing Phase 3 clinical trial evaluating IMA203 in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor. The most frequent treatment-emergent adverse events were anticipated cytopenias associated with lymphodepletion. Expected and manageable cytokine release syndrome was mostly Grades 1 and 2, which is consistent with the mechanism of action. The expected median PFS in this post-checkpoint inhibitor patient population6 is 2-3 months, and the IMA203 Phase 1b data presented today at ASCO indicate a continued median PFS of greater than or equal to 6 months. Confident Investing Starts Here:
Yahoo
13-05-2025
- Business
- Yahoo
Immatics Announces First Quarter 2025 Financial Results and Business Update
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 million1 (€543.8 million) as of March 31, 2025; cash reach into 2H 2027 Houston, Texas and Tuebingen, Germany, May 13, 2025 – Immatics N.V. (NASDAQ: IMTX, 'Immatics' or the 'Company'), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today provided a business update and reported financial results for the quarter ended March 31, 2025. '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 Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. 'At the upcoming ASCO Annual Meeting, we will present another Phase 1b clinical update on our PRAME cell therapy, IMA203, in melanoma with substantially longer follow-up. We also look forward to providing clinical trial updates for our cell therapy and bispecific programs later this year, highlighting the potential of our therapies in and beyond melanoma. We maintain a strong cash position, enabling us to rapidly advance the development of all our clinical programs, with a specific focus on progressing IMA203 toward commercialization and delivering this highly differentiated PRAME therapy to cutaneous and uveal melanoma patients with unmet medical needs as quickly as possible.' First Quarter 2025 and Subsequent Company Progress PRAME Programs IMA203 PRAME Cell TherapyIMA203 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, Immatics is preparing its in-house, state-of-the-art cell therapy manufacturing facility to serve its planned commercial supply. As part of maximizing the PRAME cell therapy opportunity, Immatics plans to expand IMA203 into uveal melanoma through the ongoing Phase 1b clinical trial. The current addressable patient population of PRAME/HLA-A*02:01-positive 2L unresectable or metastatic cutaneous melanoma in the US and EU52 is ~7,300 plus ~1,300 uveal melanoma patients in the US and EU5. 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 in Germany. 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 on June 2, 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 by Martin Wermke, MD, in an oral presentation at the 2025 ASCO Annual Meeting on May 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 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, Immatics plans to explore its potential in gynecologic cancers, NSCLC, breast cancer, and other solid tumor indications as well as earlier treatment lines of solid cancers, such as first-line (1L) cutaneous 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. In November 2024, Immatics presented preclinical proof-of-concept data at SITC supporting this combination. Other Programs IMA401 MAGEA4/8 Bispecific Immatics is further harnessing the potential of its proprietary bispecific platform to develop innovative therapeutics and unlock more cancer types. The Company's half-life extended TCR Bispecific, IMA401 targeting MAGEA4/8, is progressing through a Phase 1 trial in patients with late-stage NSCLC, head & neck cancer, bladder cancer and other solid tumor indications, with the primary goal of developing this product candidate in earlier treatment lines. 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 CollaborationImmatics 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 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. First Quarter 2025 Financial Results Cash Position: Cash and cash equivalents as well as other financial assets total $588.1 million1 (€543.8 million) as of March 31, 2025, compared to $653.8 million1 (€604.5 million) as of December 31, 2024. The decrease is mainly due to ongoing research and development activities and includes unrealized foreign exchange translational losses of $14.2 million1 (€13.1 million). Revenue: Total revenue, consisting of revenue from collaboration agreements, was $20.1 million1 (€18.6 million) for the three months ended March 31, 2025, compared to $32.8 million1 (€30.3 million) for the three months ended March 31, 2024. The decrease is mainly the result of the one-time revenue associated with the termination of the Genmab collaboration during the three months ended March 31, 2024. Research and Development Expenses: R&D expenses were $45.3 million1 (€41.9 million) for the three months ended March 31, 2025, compared to $34.7 million1 (€32.1 million) for the three months ended March 31, 2024. The increase mainly resulted from costs associated with the advancement of the product candidates in clinical trials. General and Administrative Expenses: G&A expenses were $13.1 million1 (€12.1 million) for the three months ended March 31, 2025, compared to $12.5 million1 (€11.6 million) for the three months ended March 31, 2024. Net Profit and Loss: Net loss was $43.2 million1 (€39.9 million) for the three months ended March 31, 2025, compared to a net loss of $2.4 million1 (€2.2 million) for the three months ended March 31, 2024. The increase mainly resulted from lower revenue recognized and unrealized non-cash foreign exchange rate losses. Full financial statements can be found in our Report on 6-K filed with the Securities and Exchange Commission (SEC) on May 13, 2025, and published on the SEC website under 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 - END - About ImmaticsImmatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Immatics intends to use its website as a means of disclosing material non-public information. For regular updates you can also follow us on LinkedIn and Instagram. Forward-Looking StatementsCertain 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 Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in the Company's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification. For more information, please contact: MediaTrophic Communications Phone: +49 171 1855682 immatics@ Immatics N.V. Jordan Silverstein Head of Strategy Phone: +1 346 319-3325 InvestorRelations@ Immatics N.V. and subsidiariesCondensed Consolidated Statement of Loss of Immatics months ended March 31,20252024(Euros in thousands) Revenue from collaboration agreements 18,58230,269 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 1,5971,043 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)Immatics N.V. and subsidiaries Condensed Consolidated Statement of Comprehensive Loss of Immatics months ended March 31, 20252024(Euros in thousands) Net loss (39,855) (2,240) Other comprehensive income/(loss)Items that may be reclassified subsequently to profit or lossCurrency translation differences from foreign operations (2,711) 336 Total comprehensive loss for the period (42,566) (1,904)Immatics N.V. and subsidiariesCondensed Consolidated Statement of Financial Position of Immatics of March 31, 2025December 31, 2024 (Euros in thousands) Assets Current assets Cash and cash equivalents 242,844236,748Other financial assets 300,914 367,704Accounts receivables 5,600 5,857Other current assets 24,20519,246Total current assets 573,563 629,555 Non-current assets Property, plant and equipment 49,820 50,380Intangible assets 1,6001,629Right-of-use assets 15,57713,332Other non-current assets 1,132 1,250Total 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 20,693Deferred revenue 25,29535,908Liabilities for warrants 133 1,730Lease liabilities 3,0462,851Other current liabilities 6,644 6,805Total current liabilities 55,770 67,987 Non-current liabilities Deferred revenue 29,16534,161Lease liabilities 15,341 13,352Deferred tax liability 4,810 5,804Total non-current liabilities 49,316 53,317 Shareholders' equity Share capital 1,216 1,216Share premium 1,166,4661,162,136Accumulated deficit (629,396)(589,541)Other reserves (1,680)1,031Total shareholders' equity 536,606 574,842 Total liabilities and shareholders' equity 641,692 696,146 Immatics N.V. and subsidiaries Condensed Consolidated Statement of Cash Flows of Immatics N.V. Three months ended March 31, 2025 2024 (Euros in thousands) Cash flows from operating activitiesNet loss (39,855) (2,240)Taxes on income (994) 518Loss before tax (40,849) (1,722)Adjustments for:Interest income (5,463) (6,294)Depreciation and amortization 3,140 3,014Interest expenses 249 194Equity-settled share-based payment 4,330 4,297Net 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) 1,134Decrease in deferred revenue, accounts payables and other liabilities (16,021) (31,674)Interest received 14,673 2,484Interest 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 activitiesPayments 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 57,957Net cash (used in)/provided by investing activities 46,808 (241,818)Cash flows from financing activitiesProceeds from issuance of shares to equity holders — 185,669Transaction costs deducted from equity — (11,548)Repayment/(payment) of lease liabilities (737) 524Net 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 236,748 218,472Effects of exchange rate changes and expected credit losses on cash and cash equivalents (5,769) 3,399Cash and cash equivalents at end of the period 242,844 122,093 Immatics N.V. and subsidiaries Condensed Consolidated Statement of Changes in Shareholders' Equity of Immatics N.V. (Euros in thousands) SharecapitalSharepremiumAccumulateddeficitOtherreservesTotalshare-holders'equity Balance as of January 1, 2024 847 823,166 (604,759) (1,636) 217,618 Other comprehensive income ———336336 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 March 31, 2024 1,031 1,001,402 (607,000) (1,300) 394,133 Balance as of January 1, 2025 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 March 31, 2025 1,216 1,166,466 (629,396) (1,680)536,606 1 All amounts translated using the exchange rate published by the European Central Bank in effect as of March 31, 2025 (1 EUR = 1.0815 USD).2 France, Germany, Italy, Spain, United Kingdom. 3 Centrally assessed by BICR using RECIST v1.1.4 As of August 23, 2024. Attachment PDF VersionError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
27-03-2025
- Business
- Yahoo
Immatics Announces Full Year 2024 Financial Results and Business Update
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 million1 (€604.5 million) as of December 31, 2024; updated cash reach into 2H 2027 Houston, Texas and Tuebingen, Germany, March 27, 2025 – Immatics N.V. (NASDAQ: IMTX, 'Immatics' or the 'Company'), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today provided a business update and reported financial results for the quarter and full year ended December 31, 2024. "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 Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "Additionally, the initiation of SUPRAME, the Phase 3 trial for our lead TCR-T cell therapy, IMA203, represents a transformative step in Immatics' journey towards becoming a commercial-stage enterprise. We believe IMA203 offers patients and their treating physicians a cell therapy with impressive response rates and favorable tolerability in advanced melanoma. Notably, it requires no surgery or biopsy, has a fast turnaround time and a high manufacturing success rate. We are committed to rapidly delivering the first TCR therapeutic targeting PRAME to the market and to cancer patients, serving their unmet medical needs.' 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, Immatics is priming its in-house, state-of-the-art TCR-T manufacturing facility to serve its planned commercial supply. In addition to maximizing the PRAME cell therapy opportunity, Immatics plans to expand IMA203 into uveal melanoma through the ongoing Phase 1b clinical trial. The current addressable patient population of PRAME/HLA-A*02:01-positive 2L unresectable or metastatic cutaneous melanoma in the US and EU52 is ~7,300 plus ~1,300 uveal melanoma patients in the US and EU5. Based on the positive Phase 1b clinical data presented in 2024 and supported by the FDA RMAT designation3, Immatics has advanced its lead TCR-T product candidate, IMA203 targeting PRAME, into a randomized-controlled Phase 3 trial, called 'SUPRAME' (NCT06743126). The trial commenced in December 2024. The first patient was randomized in the United States and enrollment continues as planned. 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 the United States and Europe. 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. Immatics aims to submit a Biologics License Application (BLA) in 1Q 2027 for full approval and to launch IMA203 in 3Q 2027. In addition to cutaneous melanoma, Immatics intends to expand the IMA203 TCR-T opportunity to treat uveal melanoma patients and will continue to evaluate IMA203 in this patient population through the ongoing Phase 1b trial. 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 Houston Metropolitan Area was built with a modular design for efficient and cost-effective scalability (total of 8 manufacturing suites, plus further expansion space) to serve early-stage and registration-directed clinical trials as well as planned commercial supply. Through in-house manufacturing and QC testing, Immatics aims to better control the manufacturing process, shorten the turnaround time, ensure the manufacturing success rate and quality of the product and realize potential cost efficiencies, including manufacturing capacity optimization through scalability for a competitive and profitable commercial cell therapy product. On October 10, 2024, Immatics provided a data update on IMA203 monotherapy in 28 heavily pretreated metastatic melanoma patients from the ongoing Phase 1b dose expansion part of the clinical trial in which patients were treated at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR-T cells). As of the data cut-off on August 23, 2024, treatment with IMA203 monotherapy in this melanoma patient population has demonstrated: 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). Immatics plans to present updated clinical data from the Phase 1b trial, including patients reported previously with longer follow-up and additional uveal melanoma patients, in 2025. 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 November 8, 2024, Immatics announced updated Phase 1 dose escalation clinical data on its next-generation ACTengine® IMA203CD8 TCR-T cell therapy in 44 heavily pretreated HLA-A*02:01 and PRAME-positive patients with solid tumors, thereof 41 patients being evaluable for efficacy. Of note, these patients had been treated at substantially lower doses than IMA203 (GEN1), i.e. in a range of 0.2-0.48x109 TCR-T cells/m2 BSA (dose level 3) to 0.801-1.2x109 TCR-T cells/m2 BSA (dose level 4c) T cells infused. As of the data cut-off on September 30, 2024, treatment with IMA203CD8 monotherapy demonstrated: 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. TCR Bispecifics Programs 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, Immatics plans to explore its potential in gynecologic cancers, sqNSCLC, breast cancer and other solid tumor indications as well as earlier lines of solid cancers, such as first-line (1L) cutaneous melanoma. On November 18, 2024, Immatics announced the first clinical data update from the ongoing Phase 1 dose escalation trial evaluating its next-generation, half-life extended TCR Bispecific molecule, TCER® IMA402 targeting PRAME, in 33 heavily pretreated (3 median lines of prior therapies) HLA-A*02:01-positive patients with recurrent and/or refractory solid tumors. As of the data cut-off on November 6, 2024, treatment with IMA402 demonstrated a favorable tolerability profile in the 33 patients treated. 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 March 27, 2025, dose escalation remains ongoing at DL10 (8 mg) with MTD not reached. 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) Immatics is further harnessing the potential of its proprietary bispecific platform to develop innovative therapeutics and unlock more cancer types. The Company's half-life extended TCR Bispecific, IMA401 targeting MAGEA4/8, is progressing through a Phase 1 trial in patients with sqNSCLC, HNSCC, bladder cancer and other solid tumor indications, with the primary goal of developing this product candidate in earlier treatment lines. On September 16, 2024, Immatics announced the proof-of-concept clinical data for the first candidate of its next-generation, half-life extended TCR Bispecifics platform, TCER® IMA401 (MAGEA4/8), during an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024. As of data cut-off on July 23, 2024, 35 heavily pretreated patients with recurrent and/or refractory solid tumors were treated with IMA401 monotherapy across nine escalating dose levels. The treated patient population was composed of patients with 16 different solid tumor indications who were both HLA-A*02:01 and MAGEA4/8-positive, had received a median of four and up to eight lines of prior systemic treatments and the majority had an ECOG performance status of ≥ 1. 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, 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. 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. In November 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 within Bristol Myers Squibb. The Phase 1 trial with IMA401 is ongoing and will continue to be conducted by Immatics. Full Year 2024 Financial Results Cash Position: Cash and cash equivalents as well as other financial assets total $628.0 million1 (€604.5 million) as of December 31, 2024, compared to $442.5 million1 (€425.9 million) as of December 31, 2023. The increase is mainly due to the public offering in January and October 2024, partly offset by ongoing research and development activities. Revenue: Total revenue, consisting of revenue from collaboration agreements, was $161.9 million1 (€155.8 million) for the year ended December 31, 2024, compared to $56.1 million1 (€54.0 million) for the year ended December 31, 2023. The increase is mainly the result of the one-time revenue associated with the termination of the IMA401 and ACTallo® collaborations by Bristol Myers Squibb during the year ended December 31, 2024. Research and Development Expenses: R&D expenses were $153.9 million1 (€148.1 million) for the year ended December 31, 2024, compared to $123.3 million1 (€118.7 million) for the year ended December 31, 2023. The increase mainly resulted from costs associated with the advancement of the product candidates in clinical and Administrative Expenses: G&A expenses were $48.2 million1 (€46.4 million) for the year ended December 31, 2024, compared to $39.7 million1 (€38.2 million) for the year ended December 31, 2023. Net Profit and Loss: Net profit was $15.8 million1 (€15.2 million) for the year ended December 31, 2024, compared to a net loss of $98.3 million1 (€94.6 million) for the year ended December 31, 2023. The net profit largely resulted from the one-time revenue from collaborations, offset by ongoing expenses. Full financial statements can be found in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) on March 27, 2025, and published on the SEC website under 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 - END - About ImmaticsImmatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Immatics intends to use its website as a means of disclosing material non-public information. For regular updates you can also follow us on LinkedIn and Instagram. Forward-Looking StatementsCertain 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 Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in the Company's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification. For more information, please contact: Media Trophic Communications Phone: +49 151 74416179 immatics@ N.V. Jordan Silverstein Head of Strategy Phone: +1 346 319-3325 InvestorRelations@ Immatics N.V. and subsidiariesConsolidated Statement of Profit and Loss of Immatics N.V. Year ended December 31, 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 Immatics N.V. and subsidiaries Consolidated Statement of Comprehensive Income/(Loss) of Immatics N.V. Year ended December 31, 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) 2,464Total comprehensive income/(loss) for the year 17,885 (94,804) 30,167 Immatics N.V. and subsidiariesConsolidated Statement of Financial Position of Immatics N.V. As of December 31, 2024 2023 (Euros in thousands) Assets Current assets Cash and cash equivalents 236,748 218,472Other financial assets 367,704 207,423Accounts receivables 5,857 4,093Other current assets 19,246 19,382Total current assets 629,555 449,370 Non-current assets Property, plant and equipment 50,380 43,747Intangible assets 1,629 1,523Right-of-use assets 13,332 13,308Other non-current assets 1,250 2,017Total non-current assets 66,591 60,595 Total assets 696,146 509,965 Liabilities and shareholders' equity Current liabilities Accounts payables 20,693 25,206Deferred revenue 35,908 100,401Liabilities for warrants 1,730 18,993Lease liabilities 2,851 2,604Other current liabilities 6,805 9,348Total current liabilities 67,987 156,552 Non-current liabilities Deferred revenue 34,161 115,527Lease liabilities 13,352 12,798Other non-current liabilities — 4Deferred tax liability 5,804 7,466Total non-current liabilities 53,317 135,795 Shareholders' equity Share capital 1,216 847Share premium 1,162,136 823,166Accumulated 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 Immatics N.V. and subsidiariesConsolidated Statement of Cash Flows of Immatics N.V. Year ended December 31, 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 7,234Interest expenses 886 831Equity-settled share-based payment 17,642 20,705Net foreign exchange differences and expected credit losses (18,706) 6,861Change 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) 85,999Interest received 15,605 10,167Interest 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 150Payments for investments classified in Other financial assets (450,349) (415,325)Proceeds from maturity of investments classified in Other financial assets 314,440 414,744Net 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 90,404Transaction 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 Immatics N.V. and subsidiaries Consolidated Statement of Changes in Shareholders' Equity of Immatics N.V. (Euros in thousands) Sharecapital Sharepremium Accumulateddeficit Otherreserves Totalshare-holders'equity Balance as of January 1, 2022 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 December 31, 2022 767 714,177 (510,110) (1,481) 203,353 Balance as of January 1, 2023 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 December 31, 2023 847 823,166 (604,759) (1,636) 217,618 Balance as of January 1, 2024 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 December 31, 2024 1,216 1,162,136 (589,541) 1,031 574,842 1 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2024 (1 EUR = 1.0389 USD).2 France, Germany, Italy, Spain, United Kingdom. 3 Includes all benefits of Breakthrough Therapy Designation.4 Ascierto et al., 2023, Diab et al., 20245 Centrally assessed by BICR using RECIST v1.1.6 As of August 23, 2024. Attachment PDF Version
