Uveal Melanoma

FRIENDSWOOD, Texas, April 28, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its achievement of surpassing a significant milestone of 200,000 DecisionDx-Melanoma clinical test orders. DecisionDx-Melanoma is a 31-gene expression profile test that provides comprehensive, personalized results designed to improve risk-aligned management decisions for patients with stage I-III cutaneous melanoma. “We are excited by this milestone, which we believe is a testament to our shared desire with the melanoma healthcare community to improve the lives of patients,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “With every DecisionDx-Melanoma test, we aim to enable clinicians to make more informed, more precise treatment decisions that can improve patient outcomes.” Hear more from Maetzold and patients whose lives have been impacted by the DecisionDx-Melanoma test in this video. By harnessing the genetic information within a patient’s tumor biology and incorporating traditional clinicopathologic features, DecisionDx-Melanoma is designed to stratify patient risk and provide personalized results regarding a patient's individual predicted risk of recurrence and/or metastasis and likelihood of sentinel lymph node positivity. DecisionDx-Melanoma’s clinical value is supported by more than 50 peer-reviewed publications, has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. For more information about DecisionDx-Melanoma, visit www.CastleBiosciences.com. About DecisionDx-MelanomaDecisionDx-Melanoma is a 31-gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient's personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through March 31, 2025, DecisionDx-Melanoma has been ordered more than 200,000 times for patients diagnosed with cutaneous melanoma. About Castle BiosciencesCastle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in these and other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis seeking biologic treatment. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram. DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: DecisionDx-Melanoma’s ability to (i) provide comprehensive, personalized results to guide risk-aligned management decisions for patients with stage I-III cutaneous melanoma and (ii) help clinicians make more informed, more precise treatment decisions; and Castle’s ability to improve the lives of melanoma patients. The words “believe,” “can,” “could,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. Investor Contact:Camilla Zuckeroczuckero@castlebiosciences.com Media Contact:Allison Marshallamarshall@castlebiosciences.com Source: Castle Biosciences Inc. A video accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/922474ef-72a9-41fc-8ca8-b89137e201f9

Houston, Texas and Tuebingen, Germany, April 23, 2025 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today 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. Full abstracts will be available on the ASCO website on May 22, 2025, at 5:00 pm ET. Oral Presentation Title: Phase 1 clinical update of IMA203, an autologous TCR-T targeting PRAME in patients with PD1 refractory metastatic melanomaPresenting author: Martin Wermke, MDSession: Developmental Therapeutics – ImmunotherapyDate / Time: May 31, 2025 / 3:00 – 6:00 pm CDTAbstract ID: 2508 Poster Presentation Title: SUPRAME: A phase 3 trial comparing IMA203, an engineered T-cell receptor expressing T cell therapy (TCR T) vs investigator’s choice in patients with previously treated advanced cutaneous melanomaPresenting author: Jason Luke, MD, FACP, FASCOSession: Developmental Therapeutics - ImmunotherapyDate / Time: June 2, 2025 / 1:30 - 4:30 pm CDTAbstract ID: TPS2673 About IMA203 TCR T-cell Therapy and Target PRAMEIMA203 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. About ImmaticsImmatics combines the discovery of true targets for cancer immunotherapies with the development of the right T-cell receptors with the goal of enabling a robust and specific T-cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on Instagram and LinkedIn. For more information, please contact: Media Trophic CommunicationsPhone: +49 151 74416179immatics@trophic.eu Immatics N.V.Jordan SilversteinHead of StrategyPhone: +1 346 319-3325InvestorRelations@immatics.com Attachment PDF Version

Many parts of the pharma supply chain could be at risk as the Commerce Department investigates the sector for potential tariffs. But even before details are ironed out, some biotechs and CDMOs are already assessing their vulnerabilities and making moves. Primarily, companies have been reassuring investors by touting their existing — and future — US production as a way to potentially sidestep incoming levies. Some have started to disclose which of their products are likely to be affected by tariffs and have even spelled out plans for stockpiling. Immunocore CEO Bahija Jallal noted that the drug substance and finished product of its uveal melanoma immunotherapy Kimmtrak is done in Europe. This means that Kimmtrak could be sensitive to a potential price increase once tariffs are in place, she told delegates at the Needham Healthcare Conference earlier this month, according to an AlphaSense transcript. In 2024, Kimmtrak collected $227 million in US sales out of $310 million globally. When it comes to evading tariff headwinds, drugs might increase somewhat in price, but it will be “politically untenable” for pharma to raise drug prices to fully offset the levies, TD Cowen analysts said in a Wednesday note. Pharma tariffs are expected in the next month or so, with the Section 232 investigation initiated on April 1. Johnson & Johnson, the first large pharma to report its first-quarter earnings, said it expects to incur around $400 million in tariff-related costs from global levies already announced, mainly to do with med tech shipments to China. J&J said it is focused on boosting its US production capacity as it awaits the outcome of the 232 investigation. Some biotechs have started stockpiling finished products in the US. Acadia Pharmaceuticals CFO Mark Schneyer said at the Needham Healthcare confab that it has accumulated a two-year supply for two of its lead products in the US: the Parkinson’s disease drug Nuplazid and its Rett syndrome treatment Daybue. But the API for Nuplazid is sourced from Switzerland, and ones for Daybue are shipped from Italy. Schneyer noted tariffs will likely expose these APIs to increased costs, but changes to its strategy are not a part of its immediate game plan. Nuplazid and Daybue together pulled in $958 million last year. In the face of tariffs, biopharma companies have commonly emphasized their manufacturing presence in the US. Esperion Therapeutics CEO Sheldon Koenig noted at the same conference that 50% of its production is in the US. While it sources some API from France and India, it also has a US-based supplier, the company said. Esperion has two marketed products in the US and Europe that it developed with Daiichi-Sankyo, Nexletol and Nexlizet, both of which are used to lower blood cholesterol. Eyepoint Pharmaceuticals similarly highlighted that it sources certain API in the US and has a future commercial factory in Northbridge, MA. Once that factory is running, it should have enough capacity to supply the US, as well as the global market, CEO Jay Duker said during the RBC Capital Markets Ophthalmology Conference earlier this month, according to an AlphaSense transcript. Eyepoint markets Yutiq for chronic non-infectious uveitis and Dexycu to reduce eye inflammation after surgery. CDMOs are also taking stock of their US resources. Oxford Biomedica noted that, because it has a manufacturing site in Bedford, MA, it should be in a “good position” once the tariffs go live, CEO Frank Mathias said during its earnings call Thursday. While the cell and gene CDMO has some raw materials sourced outside of the US, this is “relatively modest,” CFO Lucy Crabtree added. While the biopharma industry has evaded tariffs so far, packaging and life science tool manufacturers are already grappling with them as their products are not exempt from the initial levy rollout. To reassure investors, German packaging company Gerresheimer noted that its manufacturing footprint is “well positioned” to withstand any tariff impact, CEO Dietmar Siemssen said during its earnings call Friday. It has six production facilities in the US and two sales offices, according to its website.