Ceritinib

Garching / Munich, Germany, April 09, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the election of Barbara Weber, M.D., to its Supervisory Board, effective May 01, 2025. The election occurred at ITM’s Extraordinary General Meeting. Dr. Weber is the President, Chief Executive Officer and Founder of Tango Therapeutics (Nasdaq: TNGX). She has over 25 years of executive and research and development leadership experience in biotech, venture capital and at major pharmaceutical companies, including Novartis (NYSE: NVS) and GlaxoSmithKline (NYSE: GSK). ITM’s Supervisory Board and the company overall will benefit from Dr. Weber’s deep expertise as it advances its lead Phase 3 candidate, n.c.a. 177Lu-edotreotide (ITM-11), and continues advancing its radiopharmaceutical pipeline and medical radioisotope manufacturing business. “Dr. Weber’s impressive track record in building transformative oncology biotech companies speaks volumes for her business acumen and her dedication to improving the lives of people living with cancer. Her profound industry and scientific knowledge, including her demonstrated ability to bring novel compounds through the clinic to FDA approval, will be an invaluable asset to ITM,” said Udo J. Vetter, Chairman of the Supervisory Board of ITM. “The expansion of our Supervisory Board and its insights ensures that ITM is optimally positioned to continue accelerating the growth of its radiopharmaceutical pipeline and medical radioisotope business.” Dr. Weber is a physician-scientist with a distinguished clinical and academic career and extensive leadership expertise in global pharmaceutical development. As the President, Chief Executive Officer and Founder of Tango Therapeutics, she led the company’s transition to being publicly listed and the development of its precision oncology product candidates based on the genetic principle of synthetic lethality. As a Venture Partner at Third Rock Ventures, she led teams in creating new oncology drug discovery companies, including Tango Therapeutics, Neon Therapeutics (acquired by BioNTech (Nasdaq: BNTX)) and Relay Therapeutics (Nasdaq: RLAY). “As a physician and business executive devoted to fighting cancer, I recognize the significant potential of targeted radiopharmaceutical therapy to improve the precision oncology treatment paradigm and outcomes for patients. I look forward to working with ITM’s Supervisory Board and Leadership Team as the company plans an NDA submission for ITM-11 and expands its pipeline with various promising alpha- and beta-emitting radioisotopes coupled with novel targeting agents,” said Dr. Weber. Prior to her tenure at Third Rock Ventures, Dr. Weber was Senior Vice President, Oncology Translational Medicine at Novartis and Vice President, Oncology Discovery and Translational Medicine at GlaxoSmithKline, where she was instrumental in leading clinical studies and obtaining FDA approvals for numerous drugs including Zykadia®, Kisqali®, Vijoice® and Promacta®. Dr. Weber received her Doctor of Medicine from the University of Washington and has been affiliated with the University of Pennsylvania, Yale University and the Dana-Farber Cancer Institute. She is a member of the Board of Directors at Tango Therapeutics, Revolution Medicines Inc. (Nasdaq: RVMD), Parabilis Medicines and Sesame Therapeutics. About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com ITM ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.com Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com Attachments 20250409_Barbara Weber, M.D., Elected to ITM Supervisory Board Barbara Weber, M.D., Elected to ITM Supervisory Board

Before the FDA go-ahead, ensartinib was first approved in China in 2020. Following in the footsteps of several Big Pharma companies, another ALK inhibitor has made its entry into the U.S. The new entrant is ensartinib from Xcovery Holdings, a subsidiary of China’s Betta Pharmaceuticals. The FDA on Wednesday approved the drug under the brand name Ensacove as a first-line treatment for ALK-positive non-small cell lung cancer among patients who’ve not previously received an ALK inhibitor.Before the FDA go-ahead, ensartinib was first approved in China in 2020 under the trade name Beimeina. There, the drug moved into the first-line setting in 2022.Betta noted that Ensacove marks the first innovative targeted lung cancer drug developed by a Chinese company to make it to the global market. Still, the drug is entering a niche market dominated by Big Pharma companies.As a second-generation ALK inhibitor, Ensacove is clearly better than Pfizer’s first-generation Xalkori. But Roche’s Alecensa, Takeda’s Alunbrig and Pfizer’s third-generation med Lorbrena have all outperformed Xalkori to secure their respective first-line approvals from the FDA. Novartis also has an ALK inhibitor, Zykadia, which was cleared for first-line treatment in 2017 based on a comparison with chemotherapy.The FDA’s nod for Ensacove came more than three years after results from the drug’s first-line eXalt3 study were published in JAMA Oncology. Compared with Xalkori, Ensacove reduced the risk of progression or death by 44% in first-line ALK-positive NSCLC, according to the FDA. No statistically significant difference in overall survival was observed, as Ensacove was linked to a non-statistically significant 12% lower risk of death.The data cited by the FDA, which will be featured on Ensacove’s U.S. label, appear to come from a longer follow-up of eXalt3. Ensacove’s efficacy data were not very differentiated compared with those Big Pharma offerings that have been available on the U.S. market for years.The current ALK leader, Roche’s Alecensa, broke into the first-line ALK setting seven years ago after the phase 3 ALEX trial showed it slashed the risk of disease worsening or death by 47% versus Xalkori. The number later expanded to 57% at the trial’s final progression-free survival analysis. By that time, overall survival data were also immature but showed a 33% improvement trend in favor of the Roche med.What’s more, Alecensa in April jumped into early-stage disease with a first-in-class FDA nod to treat ALK-positive NSCLC as an adjuvant treatment following tumor resection.Ensacove has its own ongoing phase 3 in the adjuvant setting, albeit only among Chinese patients. It’s estimated that about 5% of NSCLC cases are ALK-positive, and treatment can last for a long time for many patients. In the first nine months of 2024, Alecensa brought in 1.15 billion Swiss francs ($1.28 billion) in sales, while Pfizer’s Lorbrena commanded $538 million and Takeda’s Alunbrig generated 25.6 billion Japanese yen ($163 million). Still, those are large numbers compared with Betta’s 2.34 billion Chinese yuan ($321 million) of total revenue earned during the same period from five products, including ensartinib in China.Betta Pharma is revered as a pioneer in China’s biotech industry. The company’s EGFR tyrosine kinase inhibitor icotinib, a competitor to AstraZeneca’s Tagrisso, was the first targeted cancer drug invented and fully owned by a Chinese company. Its approval by Chinese authorities in 2011 was hailed as a landmark event.But the company has fallen behind many of its peers because of its heavy reliance on traditional small-molecule drugs rather than newer technologies.