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Business Upturn
22-07-2025
- Business
- Business Upturn
Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity
New York, USA, July 22, 2025 (GLOBE NEWSWIRE) — Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity | DelveInsight The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes. DelveInsight's Melanoma Market Insights report includes a comprehensive understanding of current treatment practices, emerging melanoma drugs, market share of individual therapies, and current and forecasted Melanoma market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Melanoma Market Report According to DelveInsight's analysis, the total melanoma market size is expected to grow positively by 2034. The United States accounts for the largest market size of melanoma, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan. In 2024, the total number of incident cases of melanoma was approximately 105K in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around 20% of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease. in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease. Prominent companies, including Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others, are actively working on innovative melanoma drugs. and others, are actively working on innovative melanoma drugs. Some of the key melanoma therapies in the pipeline include Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab , and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market. , and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market. In May 2025, Immatics announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma In April 2025, IDEAYA Biosciences announced a successful FDA Type D meeting on the Phase III registrational trial design that would assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma. Discover which melanoma medications are expected to grab the market share @ Melanoma Market Report Melanoma Overview Melanoma is a type of skin cancer that originates in melanocytes, the pigment-producing cells responsible for giving skin its color. While it is less common than other skin cancers, melanoma is significantly more aggressive and has a higher risk of spreading to other parts of the body if not detected early. It can occur anywhere on the body but is most frequently found on areas exposed to the sun, such as the back, legs, arms, and face. The primary cause of melanoma is ultraviolet radiation from sunlight or artificial sources like tanning beds, which can damage the DNA in skin cells. Individuals with fair skin, a history of sunburns, a large number of moles, or a family history of melanoma are at higher risk. Genetic mutations, such as in the BRAF gene, also play a significant role in the development of melanoma in certain cases. Symptoms of melanoma often begin with changes in the appearance of a mole or pigmented area. Warning signs include asymmetry, irregular borders, color variation, a diameter larger than 6 mm, and evolving shape or size, summarized by the ABCDE rule. Itching, bleeding, or the appearance of a new mole can also be concerning signs. Diagnosis typically involves a thorough skin examination followed by a biopsy of any suspicious lesion. If melanoma is confirmed, further tests such as sentinel lymph node biopsy, imaging scans (CT, MRI, or PET), and blood work may be conducted to determine the stage and whether the cancer has spread. Early diagnosis is critical, as it significantly improves the prognosis and expands treatment options. Melanoma Epidemiology Segmentation The melanoma epidemiology section provides insights into the historical and current melanoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The melanoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Melanoma Stage-specific Incident Cases of Melanoma Mutation-specific Incident Cases of Melanoma Line-wise Treated Cases of Melanoma Download the report to understand which factors are driving melanoma epidemiology trends @ Melanoma Treatment Algorithm Melanoma Treatment Market There remains a substantial unmet need for effective treatment options in melanoma patients who are resistant to, unsuitable for, or unresponsive to standard therapies like checkpoint inhibitors or BRAF/MEK-targeted treatments. The FDA has approved several therapies for melanoma, including AMTAGVI (lifileucel, Iovance Biotherapeutics), OPDUALAG (nivolumab + relatlimab, Bristol Myers Squibb), KEYTRUDA (pembrolizumab, Merck), OPDIVO (nivolumab, BMS), KIMMTRAK (tebentafusp-tebn, Immunocore), YERVOY (ipilimumab, BMS), TECENTRIQ (atezolizumab, Roche), among others. AMTAGVI, from Iovance Biotherapeutics, became the first FDA-approved, personalized, one-time T cell therapy in February 2024. It is intended for adults with unresectable or metastatic melanoma who have previously been treated with PD-1 inhibitors, and for those with BRAF V600 mutations, after BRAF inhibitor ± MEK inhibitor therapy. That same year, Iovance submitted a Marketing Authorization Application (MAA) for lifileucel to the EMA in June (validated in August) and to the UK's MHRA in October. In June 2025, Iovance announced that the final results from the Phase II C-144-01 trial of AMTAGVI in advanced melanoma patients were published in the Journal of Clinical Oncology and presented at the 2025 ASCO Annual Meeting. Bristol Myers Squibb's OPDUALAG combines nivolumab, a PD-1 inhibitor, with relatlimab, a LAG-3 inhibitor, and is indicated for the treatment of unresectable or metastatic melanoma. The FDA approved it in March 2022 for adults and children aged 12 and above. However, in February 2025, BMS reported that the Phase III RELATIVITY-098 trial did not achieve its primary endpoint of recurrence-free survival (RFS) in the adjuvant setting for completely resected stage III–IV melanoma, although the safety profile remained consistent with existing data on the combination. KEYTRUDA and OPDIVO both demonstrate strong efficacy in treating melanoma, though OPDIVO has gained greater commercial traction through effective combination regimens and broader clinical use. Despite metastatic melanoma often being incurable, the emergence of advanced treatments such as immune checkpoint inhibitors and targeted therapies has markedly improved survival and quality of life, signaling a significant evolution in the standard of care. Learn more about the melanoma treatment options @ Melanoma Treatment Guidelines Melanoma Emerging Drugs and Companies Some of the products in the pipeline include Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), RP1 (vusolimogene oderparepvec) plus nivolumab (Replimune and BMS), APG-115 (Ascentage Pharma), Naporafenib (ERAS-254) (Erasca), KB707 (Krystal Biotech), Darovasertib (IDE196) (IDEAYA Biosciences and Novartis), HBI-8000 (HUYA Bioscience and BMS), Fianlimab (Regeneron Pharmaceuticals), and others. IMA203 is a TCR T-cell therapy that targets the Preferentially Expressed Antigen in Melanoma (PRAME). It's designed to identify an intracellular PRAME-derived peptide displayed on the surface of cells by HLA-A*02:01, triggering a strong and specific anti-tumor immune response. Encouraging Phase Ib results, along with PRAME's high expression rate in melanoma (~90–95%), support IMA203's therapeutic promise. The therapy is currently under investigation in the SUPRAME Phase III trial (NCT06743126) for previously treated advanced or metastatic cutaneous melanoma, and its Phase Ib expansion now includes uveal melanoma. According to the company's 2024 Annual Report, interim analysis for IMA203 is expected in Q1 2026, with final Phase III results in Q4 2026. A Biologics License Application (BLA) submission is planned for Q1 2027, aiming for a market launch in Q3 2027. RP1 is a herpes simplex virus-based therapy modified with a fusogenic protein (GALV-GP R) and GM-CSF to enhance tumor cell destruction, increase immunogenic cell death, and promote a systemic anti-tumor immune response. The FDA has awarded Breakthrough Therapy Designation (BTD) for RP1 in combination with nivolumab for adults with advanced melanoma that has progressed after anti-PD1 treatment. In June 2025, Replimune shared updated results from the IGNYTE study (RP1 + nivolumab in anti-PD1-refractory melanoma) at the 2025 ASCO Annual Meeting. Darovasertib (IDE196) is a potent, selective PKC inhibitor in clinical development. PKC lies downstream of the GNAQ and GNA11 pathways. Darovasertib is currently in a Phase III trial for primary non-metastatic uveal melanoma, a Phase II/III (DAR-UM-2) study for HLA-A2-negative metastatic uveal melanoma (MUM), and other Phase II trials in ocular melanoma. The company expects results from the pivotal DAR-UM-2 trial in first-line HLA-A2-negative MUM by late 2025. In March 2025, the FDA granted BTD to darovasertib for neoadjuvant treatment of primary uveal melanoma patients recommended for enucleation. The anticipated launch of these emerging melanoma therapies are poised to transform the Melanoma market landscape in the coming years. As these cutting-edge melanoma therapies continue to mature and gain regulatory approval, they are expected to reshape the melanoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about new treatment for melanoma, visit @ Melanoma Management Melanoma Market Dynamics The melanoma market dynamics are anticipated to change in the coming years. Drugs like OPDIVO and KEYTRUDA, particularly in combination with ipilimumab, have significantly improved overall survival and achieved durable response rates (~30–40%) in metastatic melanoma; however, the limited long-term efficacy in many patients highlights the urgent need for effective second-line therapies and continued innovation. With nearly 50% of melanoma patients harboring BRAF mutations, targeted therapy has become a viable option, while molecular profiling enables patient stratification even in refractory settings for clinical trials and off-label interventions. Moreover, targeting underrepresented melanoma subtypes such as uveal, mucosal, and acral presents opportunities for market expansion and accelerated regulatory pathways, given the high unmet need and paucity of existing therapies. Furthermore, many potential therapies are being investigated for the treatment of melanoma, and it is safe to predict that the treatment space will significantly impact the melanoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the melanoma market in the 7MM. However, several factors may impede the growth of the melanoma market. Moreover, melanoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the melanoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the melanoma market growth. Melanoma Report Metrics Details Study Period 2020–2034 Melanoma Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Melanoma Companies Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others Key Melanoma Therapies Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others Scope of the Melanoma Market Report Melanoma Therapeutic Assessment: Melanoma current marketed and emerging therapies Melanoma current marketed and emerging therapies Melanoma Market Dynamics: Conjoint Analysis of Emerging Melanoma Drugs Conjoint Analysis of Emerging Melanoma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Melanoma Market Access and Reimbursement Discover more about melanoma drugs in development @ Melanoma Clinical Trials Table of Contents 1. Melanoma Market Key Insights 2. Melanoma Market Report Introduction 3. Melanoma Market Overview at a Glance 4. Melanoma Market Executive Summary 5. Disease Background and Overview 6. Melanoma Treatment and Management 7. Melanoma Epidemiology and Patient Population 8. Patient Journey 9. Melanoma Marketed Drugs 10. Melanoma Emerging Drugs 11. Seven Major Melanoma Market Analysis 12. Melanoma Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Melanoma Pipeline Melanoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key melanoma companies, including IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, BioNTech SE, TILT Biotherapeutics LLC, Nykode Therapeutics, Achilles Therapeutics UK Limited, Evaxion Biotech, InxMed, AiVita Biomedical, Cytovation AS, Ono Pharmaceuticals, Neon Therapeutics, Iovance Biotherapeutics, among others. Ocular Melanoma Market Ocular Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ocular melanoma companies, including Bristol Myers Squibb, Merck & Co., Inc., Novartis AG, Roche Holding AG, Pfizer Inc., AstraZeneca PLC, Eli Lilly and Company, Bayer AG, GlaxoSmithKline PLC, Amgen Inc., among others. Uveal Melanoma Market Uveal Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key uveal melanoma companies, including Novartis Pharmaceuticals, Foghorn Therapeutics, TriSalus Life Sciences, Inc., Bristol Myers Squibb, Array BioPharma, Ono Pharmaceutical, AstraZeneca, Roche, IDEAYA Biosciences, Merck & Co, GlaxoSmithKline, Janssen, among others. Metastatic Melanoma Market Metastatic Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic melanoma companies, including Cancer Insight LLC, Elios Therapeutics LLC, Evaxion Biotech A/S, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, InxMed (Shanghai) Co. Ltd., Aivita Biomedical Inc., Hoffmann-La Roche, Idera Pharmaceuticals, Iovance Biotherapeutics Inc., Eisai Inc., Biocad, Myrexis Inc., Pain Therapeutics, Altor BioScience, among others. Refractory Metastatic Melanoma Market Refractory Metastatic Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key refractory metastatic melanoma companies, including BioNTech SE, Y-mAbs Therapeutics, Seagen Inc., among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Connect with us on LinkedIn|Facebook|Twitter Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
09-07-2025
- Business
- Yahoo
Here Is What You Need To Know Before Investing In Immatics N.V. (IMTX)
Immatics N.V. (NASDAQ:IMTX) is among the 13 Best German Stocks to Invest in Now. On May 31, the company shared results from the ongoing Phase 1b clinical trial evaluating the efficacy of IMA203 PRAME cell therapy in heavily pretreated patients with metastatic melanoma. A close-up of test tubes and laboratory equipment, showing the complexity of biopharmaceutical research. The updated data showed that the treatment is well-tolerated and demonstrated durable responses with a confirmed ORR of 56%. Cedrik Britten, M.D., Chief Medical Officer at Immatics N.V. (NASDAQ:IMTX), stated the following on the development: 'Patients with advanced melanoma post-failure of checkpoint inhibition are left to face frequent and often rapid disease progression and limited long-term survival. These individuals are in urgent need of new treatments that deliver deeper and more durable responses. We believe the data presented today emphasize the strength, durability and tangible therapeutic potential of our one-time infusion PRAME cell therapy, IMA203, in this patient population. These positive results reinforce our commitment to actively advance IMA203 through the ongoing Phase 3 SUPRAME trial to bring this PRAME therapy to the market as soon as possible.' Immatics N.V. (NASDAQ:IMTX) focuses on the research and development of potential T cell redirecting immunotherapies for cancer treatment. While the stock is down nearly 20% year-to-date, Wall Street analysts have a one-year average price target of $14.33 per share, reflecting a 151% upside potential from its current trading level. On May 28, Deutsche Bank initiated coverage of Immatics N.V. (NASDAQ:IMTX) with a Buy rating and announced a price target of $10, with the firm's analysis suggesting a promising outlook for the company considering its approach to treating 2L+ Cutaneous Melanoma, especially with the IMA203. While we acknowledge the potential of IMTX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: Goldman Sachs Stock Portfolio: 10 Large-Cap Stocks To Buy and 13 Best Big Name Stocks to Buy Now. Disclosure: None.
Business Insider
02-06-2025
- 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. 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