View Future GrowthImmatics 過去の業績過去 基準チェック /06Immaticsの収益は年間平均-3.4%の割合で減少していますが、 Biotechs業界の収益は年間 増加しています。収益は年間17% 5.8%割合で 増加しています。主要情報-3.44%収益成長率16.87%EPS成長率Biotechs 業界の成長-14.59%収益成長率5.82%株主資本利益率-47.04%ネット・マージン-574.88%前回の決算情報31 Mar 2026最近の業績更新Reported Earnings • Aug 14Second quarter 2024 earnings released: €0.17 loss per share (vs €0.32 loss in 2Q 2023)Second quarter 2024 results: €0.17 loss per share (improved from €0.32 loss in 2Q 2023). Revenue: €18.8m (down 16% from 2Q 2023). Net loss: €18.0m (loss narrowed 27% from 2Q 2023). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe.Reported Earnings • May 17First quarter 2024 earnings released: €0.03 loss per share (vs €0.26 loss in 1Q 2023)First quarter 2024 results: €0.03 loss per share (improved from €0.26 loss in 1Q 2023). Revenue: €30.3m (up 209% from 1Q 2023). Net loss: €3.05m (loss narrowed 85% from 1Q 2023). Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe.Reported Earnings • Mar 21Full year 2023 earnings released: €1.20 loss per share (vs €0.56 profit in FY 2022)Full year 2023 results: €1.20 loss per share (down from €0.56 profit in FY 2022). Revenue: €54.0m (down 69% from FY 2022). Net loss: €97.0m (down 359% from profit in FY 2022). Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany.Reported Earnings • May 17First quarter 2023 earnings released: €0.26 loss per share (vs €1.36 profit in 1Q 2022)First quarter 2023 results: €0.26 loss per share (down from €1.36 profit in 1Q 2022). Revenue: €9.80m (down 91% from 1Q 2022). Net loss: €19.7m (down 123% from profit in 1Q 2022). Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany.Reported Earnings • Mar 22Full year 2022 earnings released: EPS: €0.56 (vs €1.48 loss in FY 2021)Full year 2022 results: EPS: €0.56 (up from €1.48 loss in FY 2021). Revenue: €172.8m (up 397% from FY 2021). Net income: €37.5m (up €130.8m from FY 2021). Profit margin: 22% (up from net loss in FY 2021). The move to profitability was driven by higher revenue. Revenue is expected to decline by 95% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Europe are expected to grow by 20%.Reported Earnings • Nov 19Third quarter 2022 earnings released: €0.32 loss per share (vs €0.43 loss in 3Q 2021)Third quarter 2022 results: €0.32 loss per share (improved from €0.43 loss in 3Q 2021). Revenue: €15.1m (up 134% from 3Q 2021). Net loss: €20.9m (loss narrowed 23% from 3Q 2021). Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 25% growth forecast for the Biotechs industry in Germany.すべての更新を表示Recent updatesBoard Change • May 21Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Non-Executive Director Mike Atieh was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.お知らせ • Apr 18Immatics N.V. Highlights Prame-Directed Tcr T-Cell Therapy Inducing Remission In Pediatric Nephroblastoma PatientImmatics N.V. announced that an abstract highlighting a pediatric patient treated with a PRAME-directed cell therapy using Immatics’ PRAME T-cell receptor (TCR) has been accepted for a late-breaking poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego, California, USA. The abstract highlights the case of a 17-year-old adolescent with PRAME-positive advanced nephroblastoma, a malignant kidney cancer that predominantly occurs in children. The patient had rapidly progressing disease with metastases to the lung, liver and brain with an abdominal lesion measuring 16 cm in longest diameter. After exhausting all available treatment options and being ineligible for any ongoing clinical trial, the treating physician requested Immatics’ PRAME-directed TCR (encoded by the IMA203CD8 lentiviral vector) for an individual experimental treatment attempt (named-patient use; “Individueller Heilversuch” in Germany) at KiTZ, where a TCR T-cell therapy was manufactured. Following treatment, the patient experienced a deep anti-tumor response, with remission observed three months post-infusion and ongoing at six months of follow-up. PET scan and MRI imaging demonstrated marked tumor regression across all lesion sites. Additionally, liquid biopsy monitoring showed no more tumor-derived DNA, indicating molecular remission. Safety events reported in the abstract by the treating physician included cytokine release syndrome, which was manageable and resolved under multi-modal anti-cytokine therapy and corticosteroids. At six months of follow-up, the patient is in excellent physical condition. PRAME is a tumor target present on the cell surface of more than 50 cancers and can be targeted by TCR T-cell therapies. Based on the high PRAME expression across multiple different pediatric tumors in combination with the potential benefit of particularly strong immune responses in young patients, PRAME TCR T-cell therapies may offer a promising new treatment option for these patients. Immatics is planning to evaluate the potential of its PRAME TCR T-cell therapy candidates in pediatric patients with cancer and is assessing multiple options for clinical development including a potential first-in-pediatrics Phase 1/2 basket study in pediatric patients with HLA-A02:01-positive, PRAME-expressing relapsed or refractory solid tumors at KiTZ in Heidelberg. Immatics is developing PRAME-directed TCR T-cell therapies engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A02:01 on the surface of tumor cells and to initiate a potent and specific anti-tumor response. Immatics’ PRAME-directed cell therapies are being evaluated in clinical trials across multiple PRAME-positive solid tumors in adult patients. Its lead PRAME cell therapy candidate, anzu-cel (anzutresgene autoleucel, IMA203) is currently being evaluated in a registration-enabling Phase 3 trial “SUPRAME” in previously treated advanced cutaneous melanoma and a Phase 2 trial in metastatic uveal melanoma. In addition, Immatics is evaluating its second-generation PRAME cell therapy, IMA203CD8, in a Phase 1a dose escalation trial in patients with PRAME-positive solid tumors, with a focus on gynecologic cancers. PRAME is a target expressed in more than 50 cancers. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and two combination therapies that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific as monotherapy and in combination with an immune checkpoint inhibitor as well as anzu-cel in combination with Moderna’s PRAME mRNA designed to enhance cell therapy.お知らせ • Dec 05Immatics N.V. has filed a Follow-on Equity Offering.Immatics N.V. has filed a Follow-on Equity Offering. Security Name: Ordinary Shares Security Type: Common Stockお知らせ • Oct 27Immatics N.V. Appoints Amie Krause as Chief People Officer, Effective October 27, 2025Immatics N.V. announced the appointment of Amie Krause as Chief People Officer ("CPO") effective October 27, 2025. Ms. Krause brings more than 20 years of experience in shaping culture, leading organizational growth and aligning talent with business strategy, including across global biopharmaceutical companies. In this newly established role, she will lead Immatics' human resources, focusing on organizational development and operations as the company transitions to commercial stage. Amie Krause joins Immatics from Dompé, where she served as Chief Human Resources Officer. Prior to that, she was Chief People Officer at Revance Therapeutics. She previously served as Chief People Officer at Atara Biotherapeutics, a cell therapy company. Before Atara, Amie Krause spent over 10 years at Amgen, where she held multiple senior HR roles, including leading initiatives for global commercial operations for the Americas, Europe, Asia, Africa and the Middle East. In addition to her industry experience, Amie Krause serves as an Adjunct Professor at California Lutheran University's School of Management and a guest lecturer at the University of Southern California and the University of Alabama. Amie holds both a B.S. in business management and an MBA from California Lutheran University.お知らせ • Oct 02Immatics Announces CFO ChangesImmatics N.V. announced the appointment of Venkat Ramanan, Ph.D., as Chief Financial Officer (“CFO”), effective immediately. Dr. Ramanan is a seasoned financial leader in the biopharmaceutical industry with over 25 years of experience at companies including Seagen, Gilead Sciences and Amgen. He brings deep financial expertise in facilitating successful product launches, establishing scalable operations in global markets and enabling corporate transactions. He joins Immatics from Anthos Therapeutics, a Novartis company, where he served as CFO. He will succeed Immatics’ current CFO, Arnd Christ. Dr. Ramanan brings more than 25 years of experience and leadership in finance, strategy and operations across large and small biopharmaceutical companies, with a proven track record of leading companies through periods of successful transformation and growth. He joins Immatics from Anthos Therapeutics, a clinical-stage biotechnology company acquired by Novartis in April 2025, where he served as CFO. Previously, he was CFO at Turnstone Biologics, where he led the company’s transition from a private to public company through its IPO. Earlier, as Senior Vice President Finance at Seagen, he oversaw the finance department enabling multiple product launches, global expansion and strategic transactions. He also held senior finance and business leadership roles at Gilead Sciences and Amgen. He began his career in the biopharmaceutical industry as a consultant with ZS Associates. Dr. Ramanan holds a Ph.D. in Engineering Mechanics from The Ohio State University.Board Change • Aug 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Non-Executive Director Mike Atieh was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.お知らせ • Jun 03Immatics N.V., Annual General Meeting, Jun 18, 2025Immatics N.V., Annual General Meeting, Jun 18, 2025. Location: offices of nautadutilh n.v., beethovenstraat 400, 1082 pr amsterdam, Netherlandsお知らせ • Jun 01Immatics IMA203 PRame Cell Therapy Data Presented at 2025 ASCO Annual Meeting Continues to Show Strong Anti-Tumor Activity and Durability in Patients with Metastatic MelanomaImmatics N.V. 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 data from the ongoing Phase 1ss trial will be presented on Saturday, May 31, 2025, during an oral presentation by Martin Wermke, M.D. These individuals are in urgent need of new treatments that deliver deeper and more durable responses.お知らせ • Apr 23Immatics N.V. Announces Upcoming Oral and Poster Presentation on IMA203 TCR T-Cell Therapy At 2025 Asco Annual MeetingImmatics N.V. announced upcoming presentations on its lead cell therapy product candidate, IMA203 TCR T-cell therapy targeting PRAME, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting to be held from May 30 - June 3, 2025, in Chicago, Illinois. Updated data from the Phase 1b trial of IMA203 in patients with 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 in an oral presentation. In addition, 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, will be presented at the conference. IMA203 is an autologous, engineered T-cell receptor T-cell therapy (TCR T) that targets PRAME, an intracellular protein displayed as a peptide antigen on the surface of multiple solid tumors via HLA-A*02:01, with minimal expression on healthy tissues. With precise targeting and a turnaround time of approximately 14 days, IMA203 has demonstrated a favorable clinical profile in patients with unmet medical needs. IMA203 TCR T-cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, “SUPRAME,” in patients with unresectable or metastatic cutaneous melanoma who have disease progression on or after at least one PD-1 inhibitor. In parallel, the Phase 1b clinical trial in patients with solid tumors expressing PRAME is ongoing with a focus on uveal melanoma.Board Change • Dec 30Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Non-Executive Director Mike Atieh was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.お知らせ • Oct 12Immatics N.V. has completed a Follow-on Equity Offering in the amount of $150.3125 million.Immatics N.V. has completed a Follow-on Equity Offering in the amount of $150.3125 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 16,250,000 Price\Range: $9.25 Discount Per Security: $0.555お知らせ • Oct 10+ 2 more updatesImmatics N.V. has filed a Follow-on Equity Offering.Immatics N.V. has filed a Follow-on Equity Offering. Security Name: Ordinary Shares Security Type: Common Stock Transaction Features: At the Market OfferingReported Earnings • Aug 14Second quarter 2024 earnings released: €0.17 loss per share (vs €0.32 loss in 2Q 2023)Second quarter 2024 results: €0.17 loss per share (improved from €0.32 loss in 2Q 2023). Revenue: €18.8m (down 16% from 2Q 2023). Net loss: €18.0m (loss narrowed 27% from 2Q 2023). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe.お知らせ • Jul 31Immatics N.V. Appoints Alise Reicin to Board of DirectorsImmatics N.V. announced the appointment of Alise Reicin, M.D., to its Board of Directors. Alise Reicin is an experienced and expert pharmaceutical industry executive and leader who has led the development of multiple important new therapies, including Keytruda®. Dr. Reicin currently serves as the President and CEO of Tectonic Therapeutic and is also a member of the Board of Directors of Sana Biotechnology. She joins Immatics’ Board of Directors as the Company advances its pipeline of novel TCR-based cell therapy and bispecific product candidates into the next phase of development. Dr. Reicin brings extensive experience in early- and late-stage clinical development and a legacy of approved drugs in diverse therapeutic areas. Most recently, Dr. Reicin joined Tectonic Therapeutic, a company transforming the discovery of novel GPCR-targeted therapies, and, under her leadership, the company completed an $80 million Series A financing, moved its first asset into the clinic and entered the Nasdaq Global Market under the ticker symbol “TECX.” Before joining Tectonic Therapeutic, Dr. Reicin held leadership positions at several international pharmaceutical companies, including Celgene as President, Global Clinical Development, and EMD Serono as Senior Vice President, Global Head of Clinical Development. Dr. Reicin also held the position of Vice President, Project and Pipeline Leadership, Oncology Franchise, Merck Research Laboratories at Merck & Co. During her tenure, she led the initial development and filing activities that resulted in the first approvals of Keytruda® in the United States and European Union. Prior to Merck & Co., she was a full-time faculty member at Columbia Medical School as well as a physician and researcher at Columbia Presbyterian Hospital. Dr. Reicin received her M.D. from Harvard Medical School and her B.A. in Biochemistry from Barnard College of Columbia University. Dr. Reicin’s appointment to the Board of Directors continues through the Company’s Annual General Meeting in 2025.New Risk • Jun 13New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 10% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€157m net loss in 3 years). Shareholders have been diluted in the past year (34% increase in shares outstanding).Reported Earnings • May 17First quarter 2024 earnings released: €0.03 loss per share (vs €0.26 loss in 1Q 2023)First quarter 2024 results: €0.03 loss per share (improved from €0.26 loss in 1Q 2023). Revenue: €30.3m (up 209% from 1Q 2023). Net loss: €3.05m (loss narrowed 85% from 1Q 2023). Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe.New Risk • May 17New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€26m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€26m free cash flow). Earnings are forecast to decline by an average of 8.4% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€157m net loss in 3 years). Share price has been volatile over the past 3 months (8.1% average weekly change). Shareholders have been diluted in the past year (34% increase in shares outstanding).New Risk • Mar 22New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 5.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 5.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€171m net loss in 3 years). Share price has been volatile over the past 3 months (9.7% average weekly change). Shareholders have been diluted in the past year (34% increase in shares outstanding).Reported Earnings • Mar 21Full year 2023 earnings released: €1.20 loss per share (vs €0.56 profit in FY 2022)Full year 2023 results: €1.20 loss per share (down from €0.56 profit in FY 2022). Revenue: €54.0m (down 69% from FY 2022). Net loss: €97.0m (down 359% from profit in FY 2022). Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany.お知らせ • Jan 30Immatics N.V., Annual General Meeting, Jun 19, 2024Immatics N.V., Annual General Meeting, Jun 19, 2024.お知らせ • Jan 19Immatics N.V. has completed a Follow-on Equity Offering in the amount of $175.175 million.Immatics N.V. has completed a Follow-on Equity Offering in the amount of $175.175 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 15,925,000 Price\Range: $11 Discount Per Security: $0.66お知らせ • Jan 18Immatics N.V. has filed a Follow-on Equity Offering.Immatics N.V. has filed a Follow-on Equity Offering. Security Name: Ordinary Shares Security Type: Common StockNew Risk • Nov 17New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 7.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€117m free cash flow). Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings are forecast to decline by an average of 7.5% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€141m net loss in 3 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).New Risk • Nov 15New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€117m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€117m free cash flow). Share price has been highly volatile over the past 3 months (10.0% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€98m net loss in 3 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).お知らせ • Nov 09Immatics N.V. Reports Interim Clinical Data from ACTengine IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRame in an Ongoing Phase 1 TrialImmatics N.V. announced interim data from the ongoing Phase 1 trial with ACTengine®? IMA203 in patients with recurrent and/or refractory solid cancers. The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2. Treatment with IMA203 GEN1 monotherapy in Phase 1a and Phase 1b Cohort A at RP2D demonstrated durable objective responses in melanoma patients with one patient exceeding 12 months and two patients exceeding 15 months post infusion and a 50% (6/12) confirmed objective response rate (cORR). In line with previous results, IMA203 GEN1 monotherapy was well tolerated at total doses up to 10x109 TCR-T cells infused. In addition, the first data on the company’s second-generation product candidate IMA203CD8 demonstrated 56% (5/9) cORR with enhanced pharmacology and a differentiated response pattern compared to IMA203 GEN1. The company plans to develop IMA203 GEN1 in melanoma and to pursue development of IMA203 in ovarian cancer, uterine cancer, NSCLC, triple-negative breast cancer and other tumor types preferentially with IMA203CD8 GEN2. The melanoma-focused data on IMA203 GEN1 will be presented by Martin Wermke, MD, Professor at the University Hospital Dresden and Coordinating Investigator of the ACTengine® IMA203 TCR-T trial, at the 20th International Congress of the Society for Melanoma Research in Philadelphia, PA, taking place November 6th-9th, 2023. IMA203 GEN1 in melanoma patients treated at RP2D: IMA203 GEN1 demonstrates a high rate of objective responses with ongoing durability of more than 15 months after treatment: At data cut-off on September 30, 2023, a total of 16 PRAME-positive patients with cutaneous, uveal or melanoma of unknown primary origin were infused with IMA203 GEN1 at the recommended Phase 2 dose (RP2D, 1-10x109 total TCR-T cells) across Phase 1a or Phase 1b Cohort A. IMA203 GEN1 monotherapy continues to be well tolerated. All 16 patients experienced cytopenia (Grade 1-4) associated with lymphodepletion as expected. Patients had mostly mild-moderate cytokine release syndrome (CRS), of which 10 patients (63%) had Grade 1, and 5 patients (31%) Grade 2 and 1 patient (6%) Grade 3 CRS. One non-serious, mild (Grade 1) immune effector cell associated neurotoxicity syndrome (ICANS) was observed. No dose-dependent increase of CRS, no dose-limiting toxicities (DLTs) and no IMA203-related death was observed. The safety profile for non-melanoma patients treated with IMA203 GEN1 was generally consistent with safety in the melanoma subset and is provided in the appendix of the presentation. 13 out of 16 infused patients were evaluable for efficacy analysis based on at least one tumor response assessment being available post treatment. These patients received a median total infused dose of 1.73x109 IMA203 TCR-T cells (range 1.07-5.12x109 TCR-T cells). Most patients were heavily pre-treated with a median of 4 lines of systemic therapies, thereof a median of 2 lines of checkpoint inhibitors; all 8 cutaneous melanoma patients were checkpoint inhibitor-refractory and 5 of 8 were BRAF inhibitor-pretreated. 50% (6/12) confirmed objective response rate (cORR) and 62% (8/13) initial ORR (RECIST 1.1). Durability of responses ongoing beyond 12 months in one patient and 15 months in two patients after treatment. Median duration of response (mDOR) was not reached (min 2.2+ months, max 14.7+ months) at a median follow-up (mFU) of 14.4 months. RP2D has been defined at 1-10x109 total TCR-T cells. Cell product manufacturing: 7-day manufacturing process plus 7-day release testing. Manufacturing success rate: >95% to reach RP2D. Immatics has recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for IMA203 GEN1 in multiple PRAME-expressing cancers, including cutaneous and uveal melanoma, and is now targeting a registration-enabling Phase 2 trial in cutaneous melanoma potentially bundled with uveal melanoma in 2024. Discussions with FDA to align on patient populations, trial design and CMC aspects concerning the planned Phase 2 trial are ongoing. IMA203CD8 GEN2 in Cohort C: First clinical data set on IMA203CD8 shows an enhanced pharmacology profile with a differentiated response pattern compared to IMA203 GEN1 At data cut-off on September 30, 2023, a total of 12 PRAME-positive patients were infused with IMA203CD8 GEN2 across DL3 (0.2-0.48x109 TCR-T cells/m2 BSA), DL4a (0.481-0.8x109 TCR-T cells/m2 BSA) and DL4b (0.801-1.2x109 TCR-T cells/m2) in Cohort C with a median total infused dose of 1.17x109 IMA203CD8 TCR-T cells (range 0.64-2.05x109 TCR-T cells). All patients were heavily pre-treated with a median of 3 lines of systemic therapies. All patients experienced cytopenia (Grade 1-4) associated with lymphodepletion as expected. 11 out of 12 patients (92%) experienced a cytokine release syndrome (CRS), of which 8 patients (67%) had Grade 1 or 2 CRS, 2 patients (17%) had Grade 3 CRS and 1 patient (8%) had a Grade 4 CRS. The latter patient also had a reported Grade 4 neurotoxicity. No ICANS or neurotoxicity was reported for the other patients. No IMA203CD8-related deaths were observed. Dose-limiting toxicities (DLTs) were reported for 2 of 4 patients treated at DL4b. No DLT was reported for all 4 patients treated at DL3, or all 4 patients treated at DL4a. DL4a dose cohort is ongoing. Initial clinical activity was observed with a cORR of 56% (5/9) and initial ORR of 58% (7/12) (RECIST 1.1). 6 of 7 responses (including two unconfirmed responses with no subsequent scan available at data cut-off) were ongoing at data cut-off with longest response at >12 months after infusion. mDOR was not reached (min 2.0+ months, max 11.5+ months) at a mFU of 4.8 months. Reduction of tumor size was observed in 11 out of 12 patients, with a deepening of response from initially stable disease (SD) to partial response (PR) observed in two patients. Translational data showed enhanced pharmacology of IMA203CD8 GEN2: trend towards responses at lower T cell dose and higher tumor burden compared to IMA203 GEN1; IMA203CD8 GEN2 achieved higher peak expansion (Cmax) when normalized to infused dose and T cells showed higher initial activation levels without exhaustion over time.New Risk • Nov 07New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 13% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.9% average weekly change). Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€111m net loss in 2 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).New Risk • Nov 03New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 1.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (8.9% average weekly change). Earnings are forecast to decline by an average of 1.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€135m net loss in 3 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).お知らせ • Oct 25Immatics N.V. Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine(R) IMA203 TCR-T MonotherapyImmatics N.V. announced that its IMA203 TCR-T program has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA Center for Biologics Evaluation and Research (CBER) in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors. Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation programs. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints for accelerated approval and potential ways to satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review. Based on publicly available information1, it is the Company’s understanding that this is the first time that FDA has granted a RMAT designation for an oncology drug candidate for more than two solid tumor indications. As of Sep 30, 2023, the U.S. FDA has received at least 238 requests for RMAT designations and granted 92.New Risk • Oct 19New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 8.4% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (8.4% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€113m net loss in 3 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).お知らせ • Aug 11Immatics N.V. Initiates Phase 1/2 Clinical Trial to Evaluate Promame TCR Bispecific IMA402 in Patients with Advanced Solid TumorsImmatics N.V. announced the initiation of a Phase 1/2 clinical trial with its proprietary Bispecific T cell engaging receptor (TCER®) IMA402. IMA402 is the second product candidate in Immatics’ TCER® pipeline of next-generation, half-life extended bispecific molecules to enter clinical development. It targets an HLA-A02:01-presented peptide derived from PRAME, a clinically established cancer target frequently expressed in a large variety of solid tumors. The Phase 1/2 clinical trial (NCT05958121) investigates TCER® IMA402 in HLA-A02:01-positive patients with PRAME-expressing recurrent and/or refractory solid tumors. The dose escalation part of the study is designed as a basket trial in focus indications to accelerate signal finding. Initial focus indications are cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others. Primary objectives of the IMA402 Phase 1/2 trial are to determine the maximum tolerated dose (MTD) and/or the recommended doses for trial extensions, as well as to characterize safety and tolerability of IMA402. Secondary objectives are to evaluate anti-tumor activity and assess pharmacokinetics of IMA402. The Phase 1a dose escalation will be followed by a Phase 1b dose expansion, with the plan then to initiate a Phase 2 with indication-specific cohorts and/or combination therapies. Immatics has implemented an adaptive design for the dose escalation with the goal to accelerate the clinical development timeline of IMA402. Pharmacokinetics data will be assessed throughout the trial and might provide an early opportunity for adjustment of the treatment interval based on the half-life extended TCER® format. The trial is initially planned to be conducted at approximately 15 sites in Europe, with extension into the US at dose expansion stage. The Phase 1a is designed to enroll approximately 45 patients. The trial initiation is based on the comprehensive preclinical studies with IMA402 presented at the European Society for Medical Oncology (ESMO) Congress 2022. TCER® IMA402 is the second Immatics clinical program targeting PRAME, with the first being ACTengine® IMA203, a TCR-T cell therapy that is currently in Phase 1b dose expansion – see recent data release. Both approaches, ACTengine® and TCER®, are distinct therapeutic modalities that the company believe have the potential to provide innovative treatment options for a variety of cancer patient populations with different medical needs.お知らせ • May 27Immatics N.V., Annual General Meeting, Jun 20, 2023Immatics N.V., Annual General Meeting, Jun 20, 2023, at 14:00 Central European Standard Time. Location: At the offices of NautaDutilh N.V., Beethovenstraat 400, 1082 PR Amsterdam Amsterdam Netherlands Agenda: To consider discussion of the statutory board report regarding the financial year ended 31 December 2022; to consider discussion of the Company’s dividend and reservation policy; to consider adoption of the statutory annual accounts for the financial year ended 31 December 2022; to consider discharge from liability for the members of the Company’s board of directors (the 'Board') with respect to the performance of their duties during the financial year ended 31 December 2022; to consider reappointment of Dr. H. Singh Jasuja as executive director class III; to consider appointment of Dr. M.P. Hothum as non-executive director class III; to consider extension of the authorisation of the Board to acquire ordinary shares or depositary receipts thereof; and to consider other matters.Reported Earnings • May 17First quarter 2023 earnings released: €0.26 loss per share (vs €1.36 profit in 1Q 2022)First quarter 2023 results: €0.26 loss per share (down from €1.36 profit in 1Q 2022). Revenue: €9.80m (down 91% from 1Q 2022). Net loss: €19.7m (down 123% from profit in 1Q 2022). Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany.Valuation Update With 7 Day Price Move • May 04Investor sentiment improves as stock rises 49%After last week's 49% share price gain to €8.82, the stock trades at a trailing P/E ratio of 17.8x. Average forward P/E is 33x in the Biotechs industry in Europe. Total returns to shareholders of 19% over the past year.Valuation Update With 7 Day Price Move • Apr 19Investor sentiment improves as stock rises 16%After last week's 16% share price gain to €6.22, the stock trades at a trailing P/E ratio of 13.4x. Average forward P/E is 29x in the Biotechs industry in Europe. Total loss to shareholders of 18% over the past year.Reported Earnings • Mar 22Full year 2022 earnings released: EPS: €0.56 (vs €1.48 loss in FY 2021)Full year 2022 results: EPS: €0.56 (up from €1.48 loss in FY 2021). Revenue: €172.8m (up 397% from FY 2021). Net income: €37.5m (up €130.8m from FY 2021). Profit margin: 22% (up from net loss in FY 2021). The move to profitability was driven by higher revenue. Revenue is expected to decline by 95% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Europe are expected to grow by 20%.Valuation Update With 7 Day Price Move • Dec 15Investor sentiment deteriorated over the past weekAfter last week's 15% share price decline to €8.80, the stock trades at a trailing P/E ratio of 20.3x. Average forward P/E is 27x in the Biotechs industry in Europe. Total loss to shareholders of 20% over the past year.Reported Earnings • Nov 19Third quarter 2022 earnings released: €0.32 loss per share (vs €0.43 loss in 3Q 2021)Third quarter 2022 results: €0.32 loss per share (improved from €0.43 loss in 3Q 2021). Revenue: €15.1m (up 134% from 3Q 2021). Net loss: €20.9m (loss narrowed 23% from 3Q 2021). Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 25% growth forecast for the Biotechs industry in Germany.お知らせ • Oct 11Immatics Reports Interim Clinical Data Update on Actengine(R) Ima203 Tcr-T Monotherapy Targeting PrameImmats N.V. announced a clinical data update for the IMA203 monotherapy covering the completed Phase 1a dose escalation part of the trial and initial data from the first 5 patients in the ongoing Phase 1b dose expansion cohort A (monotherapy). In the Phase 1 trial with ACTengine(R) IMA203, Immatics is treating recurrent and/or refractory solid cancer patients utilizing TCR-T cells directed against an HLA-A02-presented peptide derived from PRAME, which is frequently expressed across several solid cancer indications. Overall, IMA203 continues to be well tolerated and achieved confirmed objective responses across multiple solid cancers such as cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma. Encouraging early signs of improved durability were seen with a 50% (6/12) confirmed objective response rate, when patients were infused at the target dose or above with more than 1 billion TCR-T cells. Key clinical findings from IMA203 TCR-T monotherapy The data obtained during the Phase 1a and Phase 1b cohort A trial provide clinical validation of PRAME as a highly promising T cell target for solid cancers. Confirmed clinical responses were observed at high and low PRAME-expression levels above threshold, indicating IMA203's potential to provide clinical benefit for all PRAME biomarker-positive cancer patients. The predicted high PRAME prevalence across key indications has so far been supported by prevalence rates obtained during the clinical screening of patients.Valuation Update With 7 Day Price Move • Sep 13Investor sentiment deteriorated over the past weekAfter last week's 15% share price decline to €11.00, the stock trades at a trailing P/E ratio of 25.9x. Average forward P/E is 20x in the Biotechs industry in Europe.お知らせ • Sep 13Immatics N.V. Presents Comprehensive Preclinical Data Set for Tcr Bispecific Candidate Ima402 Targeting Prame At European Society for Medical Oncology (Esmo) Congress 2022Immatics N.V. announced a comprehensive preclinical data set for its T cell engaging receptor (TCER®) product candidate IMA402 at the European Society for Medical Oncology (ESMO) Congress 2022 held in Paris, France, from September 9 to 13, 2022. IMA402 is the company’s second program in its TCR Bispecifics pipeline and is directed against an HLA-A02:01-presented peptide derived from PRAME, a cancer target broadly expressed in many solid tumors. The data are available as an ePoster on the ESMO platform at 9 AM on September 10, and will be presented during the poster session from noon to 1 PM CEST on September 12. Immatics TCER® molecules are “off-the-shelf§ TCR Bispecifics engineered with two binding regions: a TCR domain and a T cell recruiter domain. 1) Clinical Trial Application (CTA) is the equivalent of an Investigational New Drug (IND) application in Europe. Data Highlights: TCER® format is optimized for efficacy and safety: The IMA402 TCER® utilizes a high-affinity TCR designed to specifically bind to an HLA-A02:01-presented peptide derived from PRAME on tumor cells, The T cell recruiter domain is a proprietary low-affinity T cell recruiter against the TCR/CD3 complex that demonstrates superior in vivo tumor control compared to analogous TCER® molecules designed with higher-affinity variants of a widely used antibody recruiter, The IMA402 TCER® is optimized to reduce T cell engager-associated toxicities in patients, which is demonstrated by reduced recruiter-mediated cytokine release in vitro; Compelling preclinical data: IMA402 showed potent and selective activity against PRAME-positive tumor cell lines in vitro, In vivo studies in mice demonstrated dose-dependent anti-tumor activity of IMA402. Sufficiently high drug doses were key to achieving the desired anti-tumor effects over a prolonged period, In vitro safety assessment including toxicity screening against 20 normal tissue types, whole blood cytokine release assessment and alloreactivity evaluation confirmed favorable safety profile for IMA402, The half-life extended format of IMA402 confers a serum half-life of >1 week in mice suggesting a favorable dosing regimen and prolonged drug exposure at therapeutic levels when compared to TCR Bispecifics lacking half-life extension strategies; Clinical trial evaluating IMA402 in patients with solid tumors to start in 2023: IMA402 is designed to allow high dosing not limited by toxicities with the goal of reaching relevant therapeutic doses in tumor tissue and achieve a meaningful clinical benefit in patients. To enable the start of the Phase 1/2 trial in 2023, Immatics has completed the manufacturing process development for IMA402 and manufacturing of the clinical batch is on track for 2H 2022. The Phase 1 part of the trial will start with a minimal anticipated biological effect level (MABEL) dose of IMA402 and will have an adaptive design aimed at accelerating dose escalation to determine the recommended Phase 2 dose (RP2D). HLA-A*02:01-positive patients with different solid tumors expressing PRAME will initially receive weekly infusions of IMA402. Pharmacokinetics data will be assessed throughout the trial and might provide an opportunity to adapt the treatment interval. The Phase 2a dose expansion part of the trial will be designed to comprise several cohorts to further evaluate IMA402 in specific indications and combination therapies. Submission of the IND1 application is planned for Second Quarter 2023.お知らせ • Aug 24Immatics N.V. Announces First Cancer Patient Treated with Second-Generation Actengine(R) Tcr-T Candidate Ima203cd8 Targeting PrameImmaticsN.V. announced the treatment of the first patient in its Phase 1b expansion cohort C (NCT03686124) evaluating IMA203CD8, the company’s 2nd generation TCR-T monotherapy approach where a proprietary CD8aß co-receptor is added to PRAME-specific IMA203 T cells. The CD8 co-receptor plays an important role during T cell antigen recognition and T cell activation, enabling the effective engagement of CD8 and CD4 T cells in the anti-tumor response. The 2nd generation TCR-T IMA203CD8 aims to further enhance depth and durability of anti-tumor responses and clinical outcomes of TCR-T targeting PRAME in patients with solid cancers. PRAME is highly prevalent across several indications thereby supporting the program’s potential to reach a broad patient population. The importance of CD4 T cells for the duration of responses has been demonstrated by Immatics in preclinical assays where IMA203CD8 showed enhanced potency and prolonged anti-tumor activity compared to IMA203 alone. These findings are in line with a growing body of literature from CD19 CAR-T cells in hematological cancers that suggest a relevant role of engineered CD4 T cells in maintaining durable anti-tumor responses over a long period. Immatics’ proprietary lentiviral vector enables CD4 and CD8 T cells to be engineered with the PRAME-specific IMA203 TCR and a CD8aß construct. In the preclinical studies, this approach showed functional superiority over multiple other CD8 constructs in conjunction with the PRAME-specific IMA203 TCR. Immatics has successfully developed a proprietary 4-in-1 vector that includes both IMA203 TCRa and TCRß as well as CD8a and CD8ß chains while maintaining a high transduction rate, circumventing the challenges associated with increasing the lentiviral vector payload. The IMA203CD8 Phase 1b dose expansion cohort is expected to enroll up to 24 patients with different types of solid tumors across several clinical trial sites in the U.S. and in Germany. Following personalized manufacturing and lymphodepletion, patients will receive a single dose of IMA203CD8. Initially, 3 patients will be treated at a dose level 3 (DL3, up to 0.48 billion total transduced T cells per m² body surface area) before patient treatment at the provisional recommended Phase 2 dose, DL4 (up to 1.2 billion total transduced cells per m² body surface area). The primary objective of this Phase 1b cohort is to evaluate the safety profile of IMA203CD8. Secondary objectives include evaluating initial anti-tumor and biological activity. The 2nd generation TCR-T IMA203CD8 is part of Immatics’ strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME. This strategy includes three Phase 1b expansion cohorts, which have all been initiated during the first half of 2022 and build on the promising early clinical results during the company’s Phase 1a trial. Interim data showed a 50% objective response rate (8/16 patients) across several solid tumor indications including melanoma, head and neck cancer, uveal melanoma and synovial sarcoma. Cohort A – IMA203 as monotherapy at the provisional, recommended Phase 2 dose (RP2D) plus exploration of a higher dose level DL5 (up to 4.7 billion transduced CD8 T cells per m² body surface area), Cohort B – IMA203 in combination with an immune checkpoint inhibitor, Opdivo® (nivolumab), Cohort C – IMA203CD8, a 2nd generation monotherapy in which IMA203 is co-transduced with a CD8 co-receptor. Each Phase 1b expansion cohort is designed to evaluate the observed objective response rate, demonstrate durability of response and provide the basis for entering registration trials. The next data readout for the IMA203 monotherapy cohort at RP2D is expected during 2H 2022 and an initial data readout for Cohort B and Cohort C is planned for YE2022.Reported Earnings • Aug 10Second quarter 2022 earnings released: €0.21 loss per share (vs €0.42 loss in 2Q 2021)Second quarter 2022 results: €0.21 loss per share (up from €0.42 loss in 2Q 2021). Revenue: €17.2m (up 232% from 2Q 2021). Net loss: €14.0m (loss narrowed 47% from 2Q 2021). Over the next year, revenue is expected to shrink by 33% compared to a 15% growth forecast for the industry in Germany.Valuation Update With 7 Day Price Move • Aug 06Investor sentiment improved over the past weekAfter last week's 16% share price gain to €12.58, the stock trades at a trailing P/E ratio of 51x. Average forward P/E is 24x in the Biotechs industry in Europe.Valuation Update With 7 Day Price Move • Jul 23Investor sentiment improved over the past weekAfter last week's 20% share price gain to €10.01, the stock trades at a trailing P/E ratio of 41.7x. Average forward P/E is 31x in the Biotechs industry in Europe.Reported Earnings • Jun 03First quarter 2022 earnings released: EPS: €1.36 (vs €0.36 loss in 1Q 2021)First quarter 2022 results: EPS: €1.36 (up from €0.36 loss in 1Q 2021). Revenue: €102.9m (up €95.5m from 1Q 2021). Net income: €85.7m (up €108.5m from 1Q 2021). Profit margin: 83% (up from net loss in 1Q 2021). The move to profitability was primarily driven by higher revenue. Over the next year, revenue is forecast to grow 1.6%, compared to a 29% growth forecast for the industry in Germany.お知らせ • May 28Immatics N.V., Annual General Meeting, Jun 13, 2022Immatics N.V., Annual General Meeting, Jun 13, 2022, at 14:00 Central European Standard Time. Location: the offices of NautaDutilh N.V., Beethovenstraat 400 Amsterdam Netherlands Agenda: To consider Discussion of the statutory board report regarding the financial year ended 31 December 2021; to consider Discussion of the Company's dividend and reservation policy; to consider Adoption of the statutory annual accounts for the financial year ended 31 December 2021; to consider appointment and Reappointment of Mr. P.A. Chambré as non-executive director class II; to consider Approval of the Company's 2022 stock option and incentive plan; to consider Extension of the authorisation of the Board to acquire ordinary shares or depositary receipts thereof; to consider Instruction to PricewaterhouseCoopers Accountants N.V. as auditor for the financial year ending 31 December 2022; and to consider other related matters.お知らせ • May 19Immatics N.V. Announces First Patient Treated with Actengine® Ima203 Tcr-T in Combination with Checkpoint Inhibitor Opdivo® (Nivolumab) in Patients with Advanced Solid TumorsImmatics N.V. announced that the first patient has been dosed in the IMA203 and nivolumab combination Phase 1b dose expansion cohort. This cohort will evaluate Immatics’ TCR-engineered cell therapy (TCR-T) approach ACTengine® IMA203 targeting an HLA-A02-presented peptide derived from PRAME, in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor nivolumab, in patients with advanced solid tumors. The objectives of the study will be to evaluate the safety, biological activity, and initial anti-tumor activity of the IMA203 and nivolumab combination. The IMA203 and nivolumab combination Phase 1b dose expansion cohort is expected to enroll up to 18 patients with different types of solid tumors across 10 clinical trial sites in Germany and the U.S. Bristol Myers Squibb will provide Immatics, the study sponsor of the combination trial, with nivolumab as part of a clinical supply agreement. Nivolumab has become the standard of care treatment for many solid cancer indications and believe it fits well into the IMA203 treatment and observation schedule. According to the clinical trial protocol for ACTengine® IMA203, nivolumab will be administered at regular intervals following IMA203 treatment. The primary endpoint of this cohort is to assess the safety of the combination. Anti-tumor activity resulting from the drug combination is a secondary endpoint, which will be assessed through imaging and measured according to the standard Response Evaluation Criteria In Solid Tumors (RECIST). The combination treatment of IMA203 and nivolumab is part of Immatics' strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME. Based on this strategy, the company has expanded the IMA203 trial to a total of three Phase 1b dose expansion cohorts – each designed to assess observed objective response rates, demonstrate durability of response, and form the basis for enrollment in pivotal studies. In addition to the IMA203 and nivolumab combination (first patient treated, initial data read-out planned for YE 2022), Immatics will also investigate IMA203 as monotherapy (patient enrollment ongoing, next data read-out planned in 2H 2022) and IMA203CD8, a next-generation cell therapy where IMA203-engineered T cells are co-transduced with a CD8aß co-receptor (initiation planned for Second Quarter 2022, initial data read-out planned for YE 2022). ACTengine® IMA203 T cells are directed against an HLA-A02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers thereby supporting the programs’ potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine® IMA203.お知らせ • May 12Immatics Initiates Phase 1 Clinical Trial to Evaluate Lead TCR Bispecific IMA401 in Patients with Advanced Solid TumorsImmatics N.V. announced the initiation of a Phase 1 clinical trial with its T cell engaging receptor (TCER®) IMA401 for patients with recurrent and/or refractory solid tumors. IMA401 is the most advanced product candidate from Immatics’ TCR Bispecific pipeline targeting an HLA-A02-presented peptide derived from both MAGEA4 and MAGEA8. TCER® IMA401 will be developed in collaboration with Bristol Myers Squibb. Immatics is responsible for conducting the Phase 1 clinical trial. The primary objectives of the clinical trial (NCT#05359445) are to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for IMA401 in biomarker-positive (HLA-A02:01 and MAGEA4/8) patients with recurrent and/or refractory solid tumors. Secondary objectives are to characterize safety and tolerability, evaluate initial anti-tumor activity and assess pharmacokinetics of IMA401. The Phase 1 trial consists of a dose-escalation (Phase 1a) portion that will be followed by a dose-expansion (Phase 1b) portion to treat patients at the recommended dose level. The trial is planned to be conducted at up to 15 centers in Germany, with the first site already being initiated. The Phase 1 trial is designed to enroll approximately 50 patients. Immatics’ TCR Bispecific pipeline includes a second TCER® product candidate, IMA402, which targets PRAME. Manufacturing of the clinical IMA402 batch is planned for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023. Immatics’ TCER® pipeline is further strengthened by additional innovative TCER® program(s), IMA40X, in preclinical development. IMA401 is Immatics’ most advanced TCER® molecule that targets an HLA-A*02-presented (human leukocyte antigen) peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 (“MAGEA4/8”). The MAGEA4/8 peptide has been identified and validated by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT® and is presented at a 5-fold higher copy number per tumor cell than a MAGEA4 peptide targeted in other clinical trials. Following preclinical proof-of-concept data, including complete remissions of transplanted human-derived tumors in xenograft mouse models, the Phase 1 trial investigates IMA401 in patients with tumors of high MAGEA4/8 prevalence, such as squamous non-small cell lung carcinoma (sqNSCLC), small cell lung cancer (SCLC), head and neck squamous cell carcinoma (HNSCC), bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.Breakeven Date Change • Apr 27Forecast to breakeven in 2022The 5 analysts covering Immatics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €36.7m in 2022. Earnings growth of 16% is required to achieve expected profit on schedule.Breakeven Date Change • Apr 02Forecast to breakeven in 2022The 5 analysts covering Immatics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €36.7m in 2022. Earnings growth of 16% is required to achieve expected profit on schedule.Breakeven Date Change • Mar 28Forecast to breakeven in 2022The 4 analysts covering Immatics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €36.7m in 2022. Earnings growth of 16% is required to achieve expected profit on schedule.Reported Earnings • Nov 18Third quarter 2021 earnings released: €0.43 loss per share (vs €2.61 loss in 3Q 2020)The company reported a decent third quarter result with reduced losses and improved control over expenses, although revenues were weaker. Third quarter 2021 results: Revenue: €6.44m (down 18% from 3Q 2020). Net loss: €27.2m (loss narrowed 83% from 3Q 2020).収支内訳Immatics の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史DB:4A3 収益、費用、利益 ( )EUR Millions日付収益収益G+A経費研究開発費31 Mar 2637-214541731 Dec 2548-19651030 Sep 2585-12051030 Jun 25130-7550031 Mar 25144-2247031 Dec 241561546030 Sep 24116-4943030 Jun 2471-7441-231 Mar 2474-7740031 Dec 2354-9538030 Sep 2376-8438030 Jun 2385-7937731 Mar 2380-6836031 Dec 221732836030 Sep 221513435030 Jun 221422835031 Mar 221301535031 Dec 2135-9334030 Sep 2128-9534030 Jun 2130-23135031 Mar 2132-22636031 Dec 2031-21134030 Sep 2026-20830030 Jun 2023-4924031 Mar 2022-3416031 Dec 1918-3212031 Dec 184-3180質の高い収益: 4A3は現在利益が出ていません。利益率の向上: 4A3は現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: 4A3は利益が出ておらず、過去 5 年間で損失は年間3.4%の割合で増加しています。成長の加速: 4A3の過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: 4A3は利益が出ていないため、過去 1 年間の収益成長をBiotechs業界 ( 45% ) と比較することは困難です。株主資本利益率高いROE: 4A3は現在利益が出ていないため、自己資本利益率 ( -47.04% ) はマイナスです。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/22 23:12終値2026/05/22 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Immatics N.V. 10 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。14 アナリスト機関Alec StranahanBofA Global ResearchEric SchmidtCantor Fitzgerald & Co.Yevgeniya LivshitsChardan Capital Markets, LLC11 その他のアナリストを表示
Reported Earnings • Aug 14Second quarter 2024 earnings released: €0.17 loss per share (vs €0.32 loss in 2Q 2023)Second quarter 2024 results: €0.17 loss per share (improved from €0.32 loss in 2Q 2023). Revenue: €18.8m (down 16% from 2Q 2023). Net loss: €18.0m (loss narrowed 27% from 2Q 2023). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe.
Reported Earnings • May 17First quarter 2024 earnings released: €0.03 loss per share (vs €0.26 loss in 1Q 2023)First quarter 2024 results: €0.03 loss per share (improved from €0.26 loss in 1Q 2023). Revenue: €30.3m (up 209% from 1Q 2023). Net loss: €3.05m (loss narrowed 85% from 1Q 2023). Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe.
Reported Earnings • Mar 21Full year 2023 earnings released: €1.20 loss per share (vs €0.56 profit in FY 2022)Full year 2023 results: €1.20 loss per share (down from €0.56 profit in FY 2022). Revenue: €54.0m (down 69% from FY 2022). Net loss: €97.0m (down 359% from profit in FY 2022). Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany.
Reported Earnings • May 17First quarter 2023 earnings released: €0.26 loss per share (vs €1.36 profit in 1Q 2022)First quarter 2023 results: €0.26 loss per share (down from €1.36 profit in 1Q 2022). Revenue: €9.80m (down 91% from 1Q 2022). Net loss: €19.7m (down 123% from profit in 1Q 2022). Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany.
Reported Earnings • Mar 22Full year 2022 earnings released: EPS: €0.56 (vs €1.48 loss in FY 2021)Full year 2022 results: EPS: €0.56 (up from €1.48 loss in FY 2021). Revenue: €172.8m (up 397% from FY 2021). Net income: €37.5m (up €130.8m from FY 2021). Profit margin: 22% (up from net loss in FY 2021). The move to profitability was driven by higher revenue. Revenue is expected to decline by 95% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Europe are expected to grow by 20%.
Reported Earnings • Nov 19Third quarter 2022 earnings released: €0.32 loss per share (vs €0.43 loss in 3Q 2021)Third quarter 2022 results: €0.32 loss per share (improved from €0.43 loss in 3Q 2021). Revenue: €15.1m (up 134% from 3Q 2021). Net loss: €20.9m (loss narrowed 23% from 3Q 2021). Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 25% growth forecast for the Biotechs industry in Germany.
Board Change • May 21Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Non-Executive Director Mike Atieh was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
お知らせ • Apr 18Immatics N.V. Highlights Prame-Directed Tcr T-Cell Therapy Inducing Remission In Pediatric Nephroblastoma PatientImmatics N.V. announced that an abstract highlighting a pediatric patient treated with a PRAME-directed cell therapy using Immatics’ PRAME T-cell receptor (TCR) has been accepted for a late-breaking poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego, California, USA. The abstract highlights the case of a 17-year-old adolescent with PRAME-positive advanced nephroblastoma, a malignant kidney cancer that predominantly occurs in children. The patient had rapidly progressing disease with metastases to the lung, liver and brain with an abdominal lesion measuring 16 cm in longest diameter. After exhausting all available treatment options and being ineligible for any ongoing clinical trial, the treating physician requested Immatics’ PRAME-directed TCR (encoded by the IMA203CD8 lentiviral vector) for an individual experimental treatment attempt (named-patient use; “Individueller Heilversuch” in Germany) at KiTZ, where a TCR T-cell therapy was manufactured. Following treatment, the patient experienced a deep anti-tumor response, with remission observed three months post-infusion and ongoing at six months of follow-up. PET scan and MRI imaging demonstrated marked tumor regression across all lesion sites. Additionally, liquid biopsy monitoring showed no more tumor-derived DNA, indicating molecular remission. Safety events reported in the abstract by the treating physician included cytokine release syndrome, which was manageable and resolved under multi-modal anti-cytokine therapy and corticosteroids. At six months of follow-up, the patient is in excellent physical condition. PRAME is a tumor target present on the cell surface of more than 50 cancers and can be targeted by TCR T-cell therapies. Based on the high PRAME expression across multiple different pediatric tumors in combination with the potential benefit of particularly strong immune responses in young patients, PRAME TCR T-cell therapies may offer a promising new treatment option for these patients. Immatics is planning to evaluate the potential of its PRAME TCR T-cell therapy candidates in pediatric patients with cancer and is assessing multiple options for clinical development including a potential first-in-pediatrics Phase 1/2 basket study in pediatric patients with HLA-A02:01-positive, PRAME-expressing relapsed or refractory solid tumors at KiTZ in Heidelberg. Immatics is developing PRAME-directed TCR T-cell therapies engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A02:01 on the surface of tumor cells and to initiate a potent and specific anti-tumor response. Immatics’ PRAME-directed cell therapies are being evaluated in clinical trials across multiple PRAME-positive solid tumors in adult patients. Its lead PRAME cell therapy candidate, anzu-cel (anzutresgene autoleucel, IMA203) is currently being evaluated in a registration-enabling Phase 3 trial “SUPRAME” in previously treated advanced cutaneous melanoma and a Phase 2 trial in metastatic uveal melanoma. In addition, Immatics is evaluating its second-generation PRAME cell therapy, IMA203CD8, in a Phase 1a dose escalation trial in patients with PRAME-positive solid tumors, with a focus on gynecologic cancers. PRAME is a target expressed in more than 50 cancers. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and two combination therapies that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific as monotherapy and in combination with an immune checkpoint inhibitor as well as anzu-cel in combination with Moderna’s PRAME mRNA designed to enhance cell therapy.
お知らせ • Dec 05Immatics N.V. has filed a Follow-on Equity Offering.Immatics N.V. has filed a Follow-on Equity Offering. Security Name: Ordinary Shares Security Type: Common Stock
お知らせ • Oct 27Immatics N.V. Appoints Amie Krause as Chief People Officer, Effective October 27, 2025Immatics N.V. announced the appointment of Amie Krause as Chief People Officer ("CPO") effective October 27, 2025. Ms. Krause brings more than 20 years of experience in shaping culture, leading organizational growth and aligning talent with business strategy, including across global biopharmaceutical companies. In this newly established role, she will lead Immatics' human resources, focusing on organizational development and operations as the company transitions to commercial stage. Amie Krause joins Immatics from Dompé, where she served as Chief Human Resources Officer. Prior to that, she was Chief People Officer at Revance Therapeutics. She previously served as Chief People Officer at Atara Biotherapeutics, a cell therapy company. Before Atara, Amie Krause spent over 10 years at Amgen, where she held multiple senior HR roles, including leading initiatives for global commercial operations for the Americas, Europe, Asia, Africa and the Middle East. In addition to her industry experience, Amie Krause serves as an Adjunct Professor at California Lutheran University's School of Management and a guest lecturer at the University of Southern California and the University of Alabama. Amie holds both a B.S. in business management and an MBA from California Lutheran University.
お知らせ • Oct 02Immatics Announces CFO ChangesImmatics N.V. announced the appointment of Venkat Ramanan, Ph.D., as Chief Financial Officer (“CFO”), effective immediately. Dr. Ramanan is a seasoned financial leader in the biopharmaceutical industry with over 25 years of experience at companies including Seagen, Gilead Sciences and Amgen. He brings deep financial expertise in facilitating successful product launches, establishing scalable operations in global markets and enabling corporate transactions. He joins Immatics from Anthos Therapeutics, a Novartis company, where he served as CFO. He will succeed Immatics’ current CFO, Arnd Christ. Dr. Ramanan brings more than 25 years of experience and leadership in finance, strategy and operations across large and small biopharmaceutical companies, with a proven track record of leading companies through periods of successful transformation and growth. He joins Immatics from Anthos Therapeutics, a clinical-stage biotechnology company acquired by Novartis in April 2025, where he served as CFO. Previously, he was CFO at Turnstone Biologics, where he led the company’s transition from a private to public company through its IPO. Earlier, as Senior Vice President Finance at Seagen, he oversaw the finance department enabling multiple product launches, global expansion and strategic transactions. He also held senior finance and business leadership roles at Gilead Sciences and Amgen. He began his career in the biopharmaceutical industry as a consultant with ZS Associates. Dr. Ramanan holds a Ph.D. in Engineering Mechanics from The Ohio State University.
Board Change • Aug 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Non-Executive Director Mike Atieh was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
お知らせ • Jun 03Immatics N.V., Annual General Meeting, Jun 18, 2025Immatics N.V., Annual General Meeting, Jun 18, 2025. Location: offices of nautadutilh n.v., beethovenstraat 400, 1082 pr amsterdam, Netherlands
お知らせ • Jun 01Immatics IMA203 PRame Cell Therapy Data Presented at 2025 ASCO Annual Meeting Continues to Show Strong Anti-Tumor Activity and Durability in Patients with Metastatic MelanomaImmatics N.V. 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 data from the ongoing Phase 1ss trial will be presented on Saturday, May 31, 2025, during an oral presentation by Martin Wermke, M.D. These individuals are in urgent need of new treatments that deliver deeper and more durable responses.
お知らせ • Apr 23Immatics N.V. Announces Upcoming Oral and Poster Presentation on IMA203 TCR T-Cell Therapy At 2025 Asco Annual MeetingImmatics N.V. announced upcoming presentations on its lead cell therapy product candidate, IMA203 TCR T-cell therapy targeting PRAME, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting to be held from May 30 - June 3, 2025, in Chicago, Illinois. Updated data from the Phase 1b trial of IMA203 in patients with 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 in an oral presentation. In addition, 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, will be presented at the conference. IMA203 is an autologous, engineered T-cell receptor T-cell therapy (TCR T) that targets PRAME, an intracellular protein displayed as a peptide antigen on the surface of multiple solid tumors via HLA-A*02:01, with minimal expression on healthy tissues. With precise targeting and a turnaround time of approximately 14 days, IMA203 has demonstrated a favorable clinical profile in patients with unmet medical needs. IMA203 TCR T-cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, “SUPRAME,” in patients with unresectable or metastatic cutaneous melanoma who have disease progression on or after at least one PD-1 inhibitor. In parallel, the Phase 1b clinical trial in patients with solid tumors expressing PRAME is ongoing with a focus on uveal melanoma.
Board Change • Dec 30Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Non-Executive Director Mike Atieh was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
お知らせ • Oct 12Immatics N.V. has completed a Follow-on Equity Offering in the amount of $150.3125 million.Immatics N.V. has completed a Follow-on Equity Offering in the amount of $150.3125 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 16,250,000 Price\Range: $9.25 Discount Per Security: $0.555
お知らせ • Oct 10+ 2 more updatesImmatics N.V. has filed a Follow-on Equity Offering.Immatics N.V. has filed a Follow-on Equity Offering. Security Name: Ordinary Shares Security Type: Common Stock Transaction Features: At the Market Offering
Reported Earnings • Aug 14Second quarter 2024 earnings released: €0.17 loss per share (vs €0.32 loss in 2Q 2023)Second quarter 2024 results: €0.17 loss per share (improved from €0.32 loss in 2Q 2023). Revenue: €18.8m (down 16% from 2Q 2023). Net loss: €18.0m (loss narrowed 27% from 2Q 2023). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe.
お知らせ • Jul 31Immatics N.V. Appoints Alise Reicin to Board of DirectorsImmatics N.V. announced the appointment of Alise Reicin, M.D., to its Board of Directors. Alise Reicin is an experienced and expert pharmaceutical industry executive and leader who has led the development of multiple important new therapies, including Keytruda®. Dr. Reicin currently serves as the President and CEO of Tectonic Therapeutic and is also a member of the Board of Directors of Sana Biotechnology. She joins Immatics’ Board of Directors as the Company advances its pipeline of novel TCR-based cell therapy and bispecific product candidates into the next phase of development. Dr. Reicin brings extensive experience in early- and late-stage clinical development and a legacy of approved drugs in diverse therapeutic areas. Most recently, Dr. Reicin joined Tectonic Therapeutic, a company transforming the discovery of novel GPCR-targeted therapies, and, under her leadership, the company completed an $80 million Series A financing, moved its first asset into the clinic and entered the Nasdaq Global Market under the ticker symbol “TECX.” Before joining Tectonic Therapeutic, Dr. Reicin held leadership positions at several international pharmaceutical companies, including Celgene as President, Global Clinical Development, and EMD Serono as Senior Vice President, Global Head of Clinical Development. Dr. Reicin also held the position of Vice President, Project and Pipeline Leadership, Oncology Franchise, Merck Research Laboratories at Merck & Co. During her tenure, she led the initial development and filing activities that resulted in the first approvals of Keytruda® in the United States and European Union. Prior to Merck & Co., she was a full-time faculty member at Columbia Medical School as well as a physician and researcher at Columbia Presbyterian Hospital. Dr. Reicin received her M.D. from Harvard Medical School and her B.A. in Biochemistry from Barnard College of Columbia University. Dr. Reicin’s appointment to the Board of Directors continues through the Company’s Annual General Meeting in 2025.
New Risk • Jun 13New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 10% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€157m net loss in 3 years). Shareholders have been diluted in the past year (34% increase in shares outstanding).
Reported Earnings • May 17First quarter 2024 earnings released: €0.03 loss per share (vs €0.26 loss in 1Q 2023)First quarter 2024 results: €0.03 loss per share (improved from €0.26 loss in 1Q 2023). Revenue: €30.3m (up 209% from 1Q 2023). Net loss: €3.05m (loss narrowed 85% from 1Q 2023). Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe.
New Risk • May 17New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€26m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€26m free cash flow). Earnings are forecast to decline by an average of 8.4% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€157m net loss in 3 years). Share price has been volatile over the past 3 months (8.1% average weekly change). Shareholders have been diluted in the past year (34% increase in shares outstanding).
New Risk • Mar 22New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 5.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 5.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€171m net loss in 3 years). Share price has been volatile over the past 3 months (9.7% average weekly change). Shareholders have been diluted in the past year (34% increase in shares outstanding).
Reported Earnings • Mar 21Full year 2023 earnings released: €1.20 loss per share (vs €0.56 profit in FY 2022)Full year 2023 results: €1.20 loss per share (down from €0.56 profit in FY 2022). Revenue: €54.0m (down 69% from FY 2022). Net loss: €97.0m (down 359% from profit in FY 2022). Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany.
お知らせ • Jan 30Immatics N.V., Annual General Meeting, Jun 19, 2024Immatics N.V., Annual General Meeting, Jun 19, 2024.
お知らせ • Jan 19Immatics N.V. has completed a Follow-on Equity Offering in the amount of $175.175 million.Immatics N.V. has completed a Follow-on Equity Offering in the amount of $175.175 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 15,925,000 Price\Range: $11 Discount Per Security: $0.66
お知らせ • Jan 18Immatics N.V. has filed a Follow-on Equity Offering.Immatics N.V. has filed a Follow-on Equity Offering. Security Name: Ordinary Shares Security Type: Common Stock
New Risk • Nov 17New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 7.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€117m free cash flow). Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings are forecast to decline by an average of 7.5% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€141m net loss in 3 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).
New Risk • Nov 15New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€117m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€117m free cash flow). Share price has been highly volatile over the past 3 months (10.0% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€98m net loss in 3 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).
お知らせ • Nov 09Immatics N.V. Reports Interim Clinical Data from ACTengine IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRame in an Ongoing Phase 1 TrialImmatics N.V. announced interim data from the ongoing Phase 1 trial with ACTengine®? IMA203 in patients with recurrent and/or refractory solid cancers. The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2. Treatment with IMA203 GEN1 monotherapy in Phase 1a and Phase 1b Cohort A at RP2D demonstrated durable objective responses in melanoma patients with one patient exceeding 12 months and two patients exceeding 15 months post infusion and a 50% (6/12) confirmed objective response rate (cORR). In line with previous results, IMA203 GEN1 monotherapy was well tolerated at total doses up to 10x109 TCR-T cells infused. In addition, the first data on the company’s second-generation product candidate IMA203CD8 demonstrated 56% (5/9) cORR with enhanced pharmacology and a differentiated response pattern compared to IMA203 GEN1. The company plans to develop IMA203 GEN1 in melanoma and to pursue development of IMA203 in ovarian cancer, uterine cancer, NSCLC, triple-negative breast cancer and other tumor types preferentially with IMA203CD8 GEN2. The melanoma-focused data on IMA203 GEN1 will be presented by Martin Wermke, MD, Professor at the University Hospital Dresden and Coordinating Investigator of the ACTengine® IMA203 TCR-T trial, at the 20th International Congress of the Society for Melanoma Research in Philadelphia, PA, taking place November 6th-9th, 2023. IMA203 GEN1 in melanoma patients treated at RP2D: IMA203 GEN1 demonstrates a high rate of objective responses with ongoing durability of more than 15 months after treatment: At data cut-off on September 30, 2023, a total of 16 PRAME-positive patients with cutaneous, uveal or melanoma of unknown primary origin were infused with IMA203 GEN1 at the recommended Phase 2 dose (RP2D, 1-10x109 total TCR-T cells) across Phase 1a or Phase 1b Cohort A. IMA203 GEN1 monotherapy continues to be well tolerated. All 16 patients experienced cytopenia (Grade 1-4) associated with lymphodepletion as expected. Patients had mostly mild-moderate cytokine release syndrome (CRS), of which 10 patients (63%) had Grade 1, and 5 patients (31%) Grade 2 and 1 patient (6%) Grade 3 CRS. One non-serious, mild (Grade 1) immune effector cell associated neurotoxicity syndrome (ICANS) was observed. No dose-dependent increase of CRS, no dose-limiting toxicities (DLTs) and no IMA203-related death was observed. The safety profile for non-melanoma patients treated with IMA203 GEN1 was generally consistent with safety in the melanoma subset and is provided in the appendix of the presentation. 13 out of 16 infused patients were evaluable for efficacy analysis based on at least one tumor response assessment being available post treatment. These patients received a median total infused dose of 1.73x109 IMA203 TCR-T cells (range 1.07-5.12x109 TCR-T cells). Most patients were heavily pre-treated with a median of 4 lines of systemic therapies, thereof a median of 2 lines of checkpoint inhibitors; all 8 cutaneous melanoma patients were checkpoint inhibitor-refractory and 5 of 8 were BRAF inhibitor-pretreated. 50% (6/12) confirmed objective response rate (cORR) and 62% (8/13) initial ORR (RECIST 1.1). Durability of responses ongoing beyond 12 months in one patient and 15 months in two patients after treatment. Median duration of response (mDOR) was not reached (min 2.2+ months, max 14.7+ months) at a median follow-up (mFU) of 14.4 months. RP2D has been defined at 1-10x109 total TCR-T cells. Cell product manufacturing: 7-day manufacturing process plus 7-day release testing. Manufacturing success rate: >95% to reach RP2D. Immatics has recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for IMA203 GEN1 in multiple PRAME-expressing cancers, including cutaneous and uveal melanoma, and is now targeting a registration-enabling Phase 2 trial in cutaneous melanoma potentially bundled with uveal melanoma in 2024. Discussions with FDA to align on patient populations, trial design and CMC aspects concerning the planned Phase 2 trial are ongoing. IMA203CD8 GEN2 in Cohort C: First clinical data set on IMA203CD8 shows an enhanced pharmacology profile with a differentiated response pattern compared to IMA203 GEN1 At data cut-off on September 30, 2023, a total of 12 PRAME-positive patients were infused with IMA203CD8 GEN2 across DL3 (0.2-0.48x109 TCR-T cells/m2 BSA), DL4a (0.481-0.8x109 TCR-T cells/m2 BSA) and DL4b (0.801-1.2x109 TCR-T cells/m2) in Cohort C with a median total infused dose of 1.17x109 IMA203CD8 TCR-T cells (range 0.64-2.05x109 TCR-T cells). All patients were heavily pre-treated with a median of 3 lines of systemic therapies. All patients experienced cytopenia (Grade 1-4) associated with lymphodepletion as expected. 11 out of 12 patients (92%) experienced a cytokine release syndrome (CRS), of which 8 patients (67%) had Grade 1 or 2 CRS, 2 patients (17%) had Grade 3 CRS and 1 patient (8%) had a Grade 4 CRS. The latter patient also had a reported Grade 4 neurotoxicity. No ICANS or neurotoxicity was reported for the other patients. No IMA203CD8-related deaths were observed. Dose-limiting toxicities (DLTs) were reported for 2 of 4 patients treated at DL4b. No DLT was reported for all 4 patients treated at DL3, or all 4 patients treated at DL4a. DL4a dose cohort is ongoing. Initial clinical activity was observed with a cORR of 56% (5/9) and initial ORR of 58% (7/12) (RECIST 1.1). 6 of 7 responses (including two unconfirmed responses with no subsequent scan available at data cut-off) were ongoing at data cut-off with longest response at >12 months after infusion. mDOR was not reached (min 2.0+ months, max 11.5+ months) at a mFU of 4.8 months. Reduction of tumor size was observed in 11 out of 12 patients, with a deepening of response from initially stable disease (SD) to partial response (PR) observed in two patients. Translational data showed enhanced pharmacology of IMA203CD8 GEN2: trend towards responses at lower T cell dose and higher tumor burden compared to IMA203 GEN1; IMA203CD8 GEN2 achieved higher peak expansion (Cmax) when normalized to infused dose and T cells showed higher initial activation levels without exhaustion over time.
New Risk • Nov 07New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 13% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.9% average weekly change). Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€111m net loss in 2 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).
New Risk • Nov 03New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 1.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (8.9% average weekly change). Earnings are forecast to decline by an average of 1.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€135m net loss in 3 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).
お知らせ • Oct 25Immatics N.V. Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine(R) IMA203 TCR-T MonotherapyImmatics N.V. announced that its IMA203 TCR-T program has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA Center for Biologics Evaluation and Research (CBER) in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors. Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation programs. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints for accelerated approval and potential ways to satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review. Based on publicly available information1, it is the Company’s understanding that this is the first time that FDA has granted a RMAT designation for an oncology drug candidate for more than two solid tumor indications. As of Sep 30, 2023, the U.S. FDA has received at least 238 requests for RMAT designations and granted 92.
New Risk • Oct 19New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 8.4% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (8.4% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€113m net loss in 3 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding).
お知らせ • Aug 11Immatics N.V. Initiates Phase 1/2 Clinical Trial to Evaluate Promame TCR Bispecific IMA402 in Patients with Advanced Solid TumorsImmatics N.V. announced the initiation of a Phase 1/2 clinical trial with its proprietary Bispecific T cell engaging receptor (TCER®) IMA402. IMA402 is the second product candidate in Immatics’ TCER® pipeline of next-generation, half-life extended bispecific molecules to enter clinical development. It targets an HLA-A02:01-presented peptide derived from PRAME, a clinically established cancer target frequently expressed in a large variety of solid tumors. The Phase 1/2 clinical trial (NCT05958121) investigates TCER® IMA402 in HLA-A02:01-positive patients with PRAME-expressing recurrent and/or refractory solid tumors. The dose escalation part of the study is designed as a basket trial in focus indications to accelerate signal finding. Initial focus indications are cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others. Primary objectives of the IMA402 Phase 1/2 trial are to determine the maximum tolerated dose (MTD) and/or the recommended doses for trial extensions, as well as to characterize safety and tolerability of IMA402. Secondary objectives are to evaluate anti-tumor activity and assess pharmacokinetics of IMA402. The Phase 1a dose escalation will be followed by a Phase 1b dose expansion, with the plan then to initiate a Phase 2 with indication-specific cohorts and/or combination therapies. Immatics has implemented an adaptive design for the dose escalation with the goal to accelerate the clinical development timeline of IMA402. Pharmacokinetics data will be assessed throughout the trial and might provide an early opportunity for adjustment of the treatment interval based on the half-life extended TCER® format. The trial is initially planned to be conducted at approximately 15 sites in Europe, with extension into the US at dose expansion stage. The Phase 1a is designed to enroll approximately 45 patients. The trial initiation is based on the comprehensive preclinical studies with IMA402 presented at the European Society for Medical Oncology (ESMO) Congress 2022. TCER® IMA402 is the second Immatics clinical program targeting PRAME, with the first being ACTengine® IMA203, a TCR-T cell therapy that is currently in Phase 1b dose expansion – see recent data release. Both approaches, ACTengine® and TCER®, are distinct therapeutic modalities that the company believe have the potential to provide innovative treatment options for a variety of cancer patient populations with different medical needs.
お知らせ • May 27Immatics N.V., Annual General Meeting, Jun 20, 2023Immatics N.V., Annual General Meeting, Jun 20, 2023, at 14:00 Central European Standard Time. Location: At the offices of NautaDutilh N.V., Beethovenstraat 400, 1082 PR Amsterdam Amsterdam Netherlands Agenda: To consider discussion of the statutory board report regarding the financial year ended 31 December 2022; to consider discussion of the Company’s dividend and reservation policy; to consider adoption of the statutory annual accounts for the financial year ended 31 December 2022; to consider discharge from liability for the members of the Company’s board of directors (the 'Board') with respect to the performance of their duties during the financial year ended 31 December 2022; to consider reappointment of Dr. H. Singh Jasuja as executive director class III; to consider appointment of Dr. M.P. Hothum as non-executive director class III; to consider extension of the authorisation of the Board to acquire ordinary shares or depositary receipts thereof; and to consider other matters.
Reported Earnings • May 17First quarter 2023 earnings released: €0.26 loss per share (vs €1.36 profit in 1Q 2022)First quarter 2023 results: €0.26 loss per share (down from €1.36 profit in 1Q 2022). Revenue: €9.80m (down 91% from 1Q 2022). Net loss: €19.7m (down 123% from profit in 1Q 2022). Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany.
Valuation Update With 7 Day Price Move • May 04Investor sentiment improves as stock rises 49%After last week's 49% share price gain to €8.82, the stock trades at a trailing P/E ratio of 17.8x. Average forward P/E is 33x in the Biotechs industry in Europe. Total returns to shareholders of 19% over the past year.
Valuation Update With 7 Day Price Move • Apr 19Investor sentiment improves as stock rises 16%After last week's 16% share price gain to €6.22, the stock trades at a trailing P/E ratio of 13.4x. Average forward P/E is 29x in the Biotechs industry in Europe. Total loss to shareholders of 18% over the past year.
Reported Earnings • Mar 22Full year 2022 earnings released: EPS: €0.56 (vs €1.48 loss in FY 2021)Full year 2022 results: EPS: €0.56 (up from €1.48 loss in FY 2021). Revenue: €172.8m (up 397% from FY 2021). Net income: €37.5m (up €130.8m from FY 2021). Profit margin: 22% (up from net loss in FY 2021). The move to profitability was driven by higher revenue. Revenue is expected to decline by 95% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Europe are expected to grow by 20%.
Valuation Update With 7 Day Price Move • Dec 15Investor sentiment deteriorated over the past weekAfter last week's 15% share price decline to €8.80, the stock trades at a trailing P/E ratio of 20.3x. Average forward P/E is 27x in the Biotechs industry in Europe. Total loss to shareholders of 20% over the past year.
Reported Earnings • Nov 19Third quarter 2022 earnings released: €0.32 loss per share (vs €0.43 loss in 3Q 2021)Third quarter 2022 results: €0.32 loss per share (improved from €0.43 loss in 3Q 2021). Revenue: €15.1m (up 134% from 3Q 2021). Net loss: €20.9m (loss narrowed 23% from 3Q 2021). Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 25% growth forecast for the Biotechs industry in Germany.
お知らせ • Oct 11Immatics Reports Interim Clinical Data Update on Actengine(R) Ima203 Tcr-T Monotherapy Targeting PrameImmats N.V. announced a clinical data update for the IMA203 monotherapy covering the completed Phase 1a dose escalation part of the trial and initial data from the first 5 patients in the ongoing Phase 1b dose expansion cohort A (monotherapy). In the Phase 1 trial with ACTengine(R) IMA203, Immatics is treating recurrent and/or refractory solid cancer patients utilizing TCR-T cells directed against an HLA-A02-presented peptide derived from PRAME, which is frequently expressed across several solid cancer indications. Overall, IMA203 continues to be well tolerated and achieved confirmed objective responses across multiple solid cancers such as cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma. Encouraging early signs of improved durability were seen with a 50% (6/12) confirmed objective response rate, when patients were infused at the target dose or above with more than 1 billion TCR-T cells. Key clinical findings from IMA203 TCR-T monotherapy The data obtained during the Phase 1a and Phase 1b cohort A trial provide clinical validation of PRAME as a highly promising T cell target for solid cancers. Confirmed clinical responses were observed at high and low PRAME-expression levels above threshold, indicating IMA203's potential to provide clinical benefit for all PRAME biomarker-positive cancer patients. The predicted high PRAME prevalence across key indications has so far been supported by prevalence rates obtained during the clinical screening of patients.
Valuation Update With 7 Day Price Move • Sep 13Investor sentiment deteriorated over the past weekAfter last week's 15% share price decline to €11.00, the stock trades at a trailing P/E ratio of 25.9x. Average forward P/E is 20x in the Biotechs industry in Europe.
お知らせ • Sep 13Immatics N.V. Presents Comprehensive Preclinical Data Set for Tcr Bispecific Candidate Ima402 Targeting Prame At European Society for Medical Oncology (Esmo) Congress 2022Immatics N.V. announced a comprehensive preclinical data set for its T cell engaging receptor (TCER®) product candidate IMA402 at the European Society for Medical Oncology (ESMO) Congress 2022 held in Paris, France, from September 9 to 13, 2022. IMA402 is the company’s second program in its TCR Bispecifics pipeline and is directed against an HLA-A02:01-presented peptide derived from PRAME, a cancer target broadly expressed in many solid tumors. The data are available as an ePoster on the ESMO platform at 9 AM on September 10, and will be presented during the poster session from noon to 1 PM CEST on September 12. Immatics TCER® molecules are “off-the-shelf§ TCR Bispecifics engineered with two binding regions: a TCR domain and a T cell recruiter domain. 1) Clinical Trial Application (CTA) is the equivalent of an Investigational New Drug (IND) application in Europe. Data Highlights: TCER® format is optimized for efficacy and safety: The IMA402 TCER® utilizes a high-affinity TCR designed to specifically bind to an HLA-A02:01-presented peptide derived from PRAME on tumor cells, The T cell recruiter domain is a proprietary low-affinity T cell recruiter against the TCR/CD3 complex that demonstrates superior in vivo tumor control compared to analogous TCER® molecules designed with higher-affinity variants of a widely used antibody recruiter, The IMA402 TCER® is optimized to reduce T cell engager-associated toxicities in patients, which is demonstrated by reduced recruiter-mediated cytokine release in vitro; Compelling preclinical data: IMA402 showed potent and selective activity against PRAME-positive tumor cell lines in vitro, In vivo studies in mice demonstrated dose-dependent anti-tumor activity of IMA402. Sufficiently high drug doses were key to achieving the desired anti-tumor effects over a prolonged period, In vitro safety assessment including toxicity screening against 20 normal tissue types, whole blood cytokine release assessment and alloreactivity evaluation confirmed favorable safety profile for IMA402, The half-life extended format of IMA402 confers a serum half-life of >1 week in mice suggesting a favorable dosing regimen and prolonged drug exposure at therapeutic levels when compared to TCR Bispecifics lacking half-life extension strategies; Clinical trial evaluating IMA402 in patients with solid tumors to start in 2023: IMA402 is designed to allow high dosing not limited by toxicities with the goal of reaching relevant therapeutic doses in tumor tissue and achieve a meaningful clinical benefit in patients. To enable the start of the Phase 1/2 trial in 2023, Immatics has completed the manufacturing process development for IMA402 and manufacturing of the clinical batch is on track for 2H 2022. The Phase 1 part of the trial will start with a minimal anticipated biological effect level (MABEL) dose of IMA402 and will have an adaptive design aimed at accelerating dose escalation to determine the recommended Phase 2 dose (RP2D). HLA-A*02:01-positive patients with different solid tumors expressing PRAME will initially receive weekly infusions of IMA402. Pharmacokinetics data will be assessed throughout the trial and might provide an opportunity to adapt the treatment interval. The Phase 2a dose expansion part of the trial will be designed to comprise several cohorts to further evaluate IMA402 in specific indications and combination therapies. Submission of the IND1 application is planned for Second Quarter 2023.
お知らせ • Aug 24Immatics N.V. Announces First Cancer Patient Treated with Second-Generation Actengine(R) Tcr-T Candidate Ima203cd8 Targeting PrameImmaticsN.V. announced the treatment of the first patient in its Phase 1b expansion cohort C (NCT03686124) evaluating IMA203CD8, the company’s 2nd generation TCR-T monotherapy approach where a proprietary CD8aß co-receptor is added to PRAME-specific IMA203 T cells. The CD8 co-receptor plays an important role during T cell antigen recognition and T cell activation, enabling the effective engagement of CD8 and CD4 T cells in the anti-tumor response. The 2nd generation TCR-T IMA203CD8 aims to further enhance depth and durability of anti-tumor responses and clinical outcomes of TCR-T targeting PRAME in patients with solid cancers. PRAME is highly prevalent across several indications thereby supporting the program’s potential to reach a broad patient population. The importance of CD4 T cells for the duration of responses has been demonstrated by Immatics in preclinical assays where IMA203CD8 showed enhanced potency and prolonged anti-tumor activity compared to IMA203 alone. These findings are in line with a growing body of literature from CD19 CAR-T cells in hematological cancers that suggest a relevant role of engineered CD4 T cells in maintaining durable anti-tumor responses over a long period. Immatics’ proprietary lentiviral vector enables CD4 and CD8 T cells to be engineered with the PRAME-specific IMA203 TCR and a CD8aß construct. In the preclinical studies, this approach showed functional superiority over multiple other CD8 constructs in conjunction with the PRAME-specific IMA203 TCR. Immatics has successfully developed a proprietary 4-in-1 vector that includes both IMA203 TCRa and TCRß as well as CD8a and CD8ß chains while maintaining a high transduction rate, circumventing the challenges associated with increasing the lentiviral vector payload. The IMA203CD8 Phase 1b dose expansion cohort is expected to enroll up to 24 patients with different types of solid tumors across several clinical trial sites in the U.S. and in Germany. Following personalized manufacturing and lymphodepletion, patients will receive a single dose of IMA203CD8. Initially, 3 patients will be treated at a dose level 3 (DL3, up to 0.48 billion total transduced T cells per m² body surface area) before patient treatment at the provisional recommended Phase 2 dose, DL4 (up to 1.2 billion total transduced cells per m² body surface area). The primary objective of this Phase 1b cohort is to evaluate the safety profile of IMA203CD8. Secondary objectives include evaluating initial anti-tumor and biological activity. The 2nd generation TCR-T IMA203CD8 is part of Immatics’ strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME. This strategy includes three Phase 1b expansion cohorts, which have all been initiated during the first half of 2022 and build on the promising early clinical results during the company’s Phase 1a trial. Interim data showed a 50% objective response rate (8/16 patients) across several solid tumor indications including melanoma, head and neck cancer, uveal melanoma and synovial sarcoma. Cohort A – IMA203 as monotherapy at the provisional, recommended Phase 2 dose (RP2D) plus exploration of a higher dose level DL5 (up to 4.7 billion transduced CD8 T cells per m² body surface area), Cohort B – IMA203 in combination with an immune checkpoint inhibitor, Opdivo® (nivolumab), Cohort C – IMA203CD8, a 2nd generation monotherapy in which IMA203 is co-transduced with a CD8 co-receptor. Each Phase 1b expansion cohort is designed to evaluate the observed objective response rate, demonstrate durability of response and provide the basis for entering registration trials. The next data readout for the IMA203 monotherapy cohort at RP2D is expected during 2H 2022 and an initial data readout for Cohort B and Cohort C is planned for YE2022.
Reported Earnings • Aug 10Second quarter 2022 earnings released: €0.21 loss per share (vs €0.42 loss in 2Q 2021)Second quarter 2022 results: €0.21 loss per share (up from €0.42 loss in 2Q 2021). Revenue: €17.2m (up 232% from 2Q 2021). Net loss: €14.0m (loss narrowed 47% from 2Q 2021). Over the next year, revenue is expected to shrink by 33% compared to a 15% growth forecast for the industry in Germany.
Valuation Update With 7 Day Price Move • Aug 06Investor sentiment improved over the past weekAfter last week's 16% share price gain to €12.58, the stock trades at a trailing P/E ratio of 51x. Average forward P/E is 24x in the Biotechs industry in Europe.
Valuation Update With 7 Day Price Move • Jul 23Investor sentiment improved over the past weekAfter last week's 20% share price gain to €10.01, the stock trades at a trailing P/E ratio of 41.7x. Average forward P/E is 31x in the Biotechs industry in Europe.
Reported Earnings • Jun 03First quarter 2022 earnings released: EPS: €1.36 (vs €0.36 loss in 1Q 2021)First quarter 2022 results: EPS: €1.36 (up from €0.36 loss in 1Q 2021). Revenue: €102.9m (up €95.5m from 1Q 2021). Net income: €85.7m (up €108.5m from 1Q 2021). Profit margin: 83% (up from net loss in 1Q 2021). The move to profitability was primarily driven by higher revenue. Over the next year, revenue is forecast to grow 1.6%, compared to a 29% growth forecast for the industry in Germany.
お知らせ • May 28Immatics N.V., Annual General Meeting, Jun 13, 2022Immatics N.V., Annual General Meeting, Jun 13, 2022, at 14:00 Central European Standard Time. Location: the offices of NautaDutilh N.V., Beethovenstraat 400 Amsterdam Netherlands Agenda: To consider Discussion of the statutory board report regarding the financial year ended 31 December 2021; to consider Discussion of the Company's dividend and reservation policy; to consider Adoption of the statutory annual accounts for the financial year ended 31 December 2021; to consider appointment and Reappointment of Mr. P.A. Chambré as non-executive director class II; to consider Approval of the Company's 2022 stock option and incentive plan; to consider Extension of the authorisation of the Board to acquire ordinary shares or depositary receipts thereof; to consider Instruction to PricewaterhouseCoopers Accountants N.V. as auditor for the financial year ending 31 December 2022; and to consider other related matters.
お知らせ • May 19Immatics N.V. Announces First Patient Treated with Actengine® Ima203 Tcr-T in Combination with Checkpoint Inhibitor Opdivo® (Nivolumab) in Patients with Advanced Solid TumorsImmatics N.V. announced that the first patient has been dosed in the IMA203 and nivolumab combination Phase 1b dose expansion cohort. This cohort will evaluate Immatics’ TCR-engineered cell therapy (TCR-T) approach ACTengine® IMA203 targeting an HLA-A02-presented peptide derived from PRAME, in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor nivolumab, in patients with advanced solid tumors. The objectives of the study will be to evaluate the safety, biological activity, and initial anti-tumor activity of the IMA203 and nivolumab combination. The IMA203 and nivolumab combination Phase 1b dose expansion cohort is expected to enroll up to 18 patients with different types of solid tumors across 10 clinical trial sites in Germany and the U.S. Bristol Myers Squibb will provide Immatics, the study sponsor of the combination trial, with nivolumab as part of a clinical supply agreement. Nivolumab has become the standard of care treatment for many solid cancer indications and believe it fits well into the IMA203 treatment and observation schedule. According to the clinical trial protocol for ACTengine® IMA203, nivolumab will be administered at regular intervals following IMA203 treatment. The primary endpoint of this cohort is to assess the safety of the combination. Anti-tumor activity resulting from the drug combination is a secondary endpoint, which will be assessed through imaging and measured according to the standard Response Evaluation Criteria In Solid Tumors (RECIST). The combination treatment of IMA203 and nivolumab is part of Immatics' strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME. Based on this strategy, the company has expanded the IMA203 trial to a total of three Phase 1b dose expansion cohorts – each designed to assess observed objective response rates, demonstrate durability of response, and form the basis for enrollment in pivotal studies. In addition to the IMA203 and nivolumab combination (first patient treated, initial data read-out planned for YE 2022), Immatics will also investigate IMA203 as monotherapy (patient enrollment ongoing, next data read-out planned in 2H 2022) and IMA203CD8, a next-generation cell therapy where IMA203-engineered T cells are co-transduced with a CD8aß co-receptor (initiation planned for Second Quarter 2022, initial data read-out planned for YE 2022). ACTengine® IMA203 T cells are directed against an HLA-A02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers thereby supporting the programs’ potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine® IMA203.
お知らせ • May 12Immatics Initiates Phase 1 Clinical Trial to Evaluate Lead TCR Bispecific IMA401 in Patients with Advanced Solid TumorsImmatics N.V. announced the initiation of a Phase 1 clinical trial with its T cell engaging receptor (TCER®) IMA401 for patients with recurrent and/or refractory solid tumors. IMA401 is the most advanced product candidate from Immatics’ TCR Bispecific pipeline targeting an HLA-A02-presented peptide derived from both MAGEA4 and MAGEA8. TCER® IMA401 will be developed in collaboration with Bristol Myers Squibb. Immatics is responsible for conducting the Phase 1 clinical trial. The primary objectives of the clinical trial (NCT#05359445) are to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for IMA401 in biomarker-positive (HLA-A02:01 and MAGEA4/8) patients with recurrent and/or refractory solid tumors. Secondary objectives are to characterize safety and tolerability, evaluate initial anti-tumor activity and assess pharmacokinetics of IMA401. The Phase 1 trial consists of a dose-escalation (Phase 1a) portion that will be followed by a dose-expansion (Phase 1b) portion to treat patients at the recommended dose level. The trial is planned to be conducted at up to 15 centers in Germany, with the first site already being initiated. The Phase 1 trial is designed to enroll approximately 50 patients. Immatics’ TCR Bispecific pipeline includes a second TCER® product candidate, IMA402, which targets PRAME. Manufacturing of the clinical IMA402 batch is planned for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023. Immatics’ TCER® pipeline is further strengthened by additional innovative TCER® program(s), IMA40X, in preclinical development. IMA401 is Immatics’ most advanced TCER® molecule that targets an HLA-A*02-presented (human leukocyte antigen) peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 (“MAGEA4/8”). The MAGEA4/8 peptide has been identified and validated by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT® and is presented at a 5-fold higher copy number per tumor cell than a MAGEA4 peptide targeted in other clinical trials. Following preclinical proof-of-concept data, including complete remissions of transplanted human-derived tumors in xenograft mouse models, the Phase 1 trial investigates IMA401 in patients with tumors of high MAGEA4/8 prevalence, such as squamous non-small cell lung carcinoma (sqNSCLC), small cell lung cancer (SCLC), head and neck squamous cell carcinoma (HNSCC), bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.
Breakeven Date Change • Apr 27Forecast to breakeven in 2022The 5 analysts covering Immatics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €36.7m in 2022. Earnings growth of 16% is required to achieve expected profit on schedule.
Breakeven Date Change • Apr 02Forecast to breakeven in 2022The 5 analysts covering Immatics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €36.7m in 2022. Earnings growth of 16% is required to achieve expected profit on schedule.
Breakeven Date Change • Mar 28Forecast to breakeven in 2022The 4 analysts covering Immatics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €36.7m in 2022. Earnings growth of 16% is required to achieve expected profit on schedule.
Reported Earnings • Nov 18Third quarter 2021 earnings released: €0.43 loss per share (vs €2.61 loss in 3Q 2020)The company reported a decent third quarter result with reduced losses and improved control over expenses, although revenues were weaker. Third quarter 2021 results: Revenue: €6.44m (down 18% from 3Q 2020). Net loss: €27.2m (loss narrowed 83% from 3Q 2020).