Cycle Pharmaceuticals Signs Exclusive U.S. Sales License for PHYRAGO™ (dasatinib) Tablets

CAMBRIDGE, UK and BOSTON, Massachusetts – July 21, 2025 – Cycle Pharmaceuticals (Cycle Pharma) has entered into an exclusive U.S. commercialization agreement with Handa Therapeutics, LLC (Handa), for PHYRAGO, an FDA approved drug for treating two types of leukemia, Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). PHYRAGO will be Cycle Pharma’s first oncology product (its ninth commercial product) and will see the company extend its expertise in caring for patients living with chronic conditions into oncology. PHYRAGO is a novel formulation of Sprycel ® (dasatinib) that allows concomitant use with proton pump inhibitors (PPIs) and H 2 receptor antagonists (H 2 RAs), 1 which can directly benefit patients on dasatinib therapy who are prescribed both medications. 2 With Sprycel ® , the drug exposure of dasatinib can be significantly reduced by more than 40% and 60% when administered with PPIs and H 2 RAs, respectively. 3 In contrast, with PHYRAGO, no clinically significant reduction in the bioavailability of dasatinib was observed following concomitant use with PPIs or H 2 RAs. 1 Handa will be working closely with Cycle Pharma to launch PHYRAGO in September 2025. PHYRAGO will be launched with best-in-class patient support from Cycle Vita™, providing individualized product, educational, and financial assistance* to adult patients with Ph+ CML and Ph+ ALL. “We are excited about our second partnership with Handa, and the expansion of our patient support offerings to oncology. With PHYRAGO, Cycle Vita’s expertise in providing individualized care to patients will soon be available to patients with leukemia,” says Chikai Lai – SVP & Chief Commercial Officer, Cycle Pharmaceuticals. Bill Liu, President and CEO of Handa Therapeutics, LLC, added “Handa is proud to continue its partnership with Cycle Pharmaceuticals in the commercialization of PHYRAGO, the first and only dasatinib product that can be taken concomitantly with PPIs and H 2 RAs. Handa is committed to bringing high quality oncology treatments such as PHYRAGO to patients.” Indications PHYRAGO™ is a kinase inhibitor indicated for the treatment of: Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) with resistance or intolerance to prior therapy. Important Safety Information Warnings and Precautions: Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia and anemia may occur. Use caution if used concomitantly with medication that inhibits platelet function or anticoagulants. Monitor complete blood counts regularly. Transfuse and interrupt PHYRAGO when indicated. Fluid Retention: Fluid retention, sometimes severe, including pleural effusions. Manage with supportive care measures and/or dose modification. Cardiovascular Toxicity: Monitor patients for signs or symptoms and treat appropriately. Pulmonary Arterial Hypertension (PAH): PHYRAGO may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment. Stop PHYRAGO if PAH is confirmed. QT Prolongation: Use PHYRAGO with caution in patients who have or may develop prolongation of the QT interval. Severe Dermatologic Reactions: Individual cases of severe mucocutaneous dermatologic reactions have been reported. Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain adequate hydration and correct uric acid levels prior to initiating therapy with PHYRAGO. Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential, of potential risk to fetus and to use effective contraception. Effects on Growth and Development in Pediatric Patients: Epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Monitor bone growth and development in pediatric patients. Hepatotoxicity: Assess liver function before initiation of treatment and monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy known to be associated with liver dysfunction. Adverse Reactions: Most common adverse reactions (≥15%) in patients receiving dasatinib as a single-agent therapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain. Postmarketing Experience: The following adverse reactions have been identified during post approval use of dasatinib: Hepatitis B virus reactivation, atrial fibrillation/atrial flutter, interstitial lung disease, chylothorax, Stevens-Johnson syndrome, nephrotic syndrome, thrombotic microangiopathy, hepatotoxicity. Drug Interactions: Strong CYP3A4 Inhibitors: Dose reduction may be necessary. Strong CYP3A4 Inducers: Dose increase may be necessary. Antacids: Avoid concomitant use. Use in Specific Populations: Pregnancy: Based on limited human data, PHYRAGO can cause fetal harm when administered to a pregnant woman and may result in fetal harm or neonatal death. Advise a pregnant woman of the potential risk to a fetus. Contraception: Advise females of reproductive potential and males with female partners with reproductive potential to use effective contraception during treatment and for 30 days after the last dose. Lactation: Breastfeeding is not recommended during treatment with PHYRAGO and for 2 weeks after the last dose. Pediatric Use: Monitor bone growth and development in pediatric patients. Pediatric use information is approved for Bristol-Myers Squibb Company’s SPRYCEL ® (dasatinib) tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Geriatric Use: Patients over 65 years of age and older are more likely to experience the commonly reported adverse reactions of fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, and appetite disturbance. Geriatric patients are more likely to experience the less frequently reported adverse reactions of abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary Cinzia, and weight decrease and should be monitored closely. For more detailed information, please refer to the full Prescribing Information at phyrago.com/pi/ . To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-844-784-1807, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch . US-DAS-2500002 | June 2025 References PHYRAGO™ (dasatinib). Prescribing Information. Handa Therapeutics, LLC. IQVIA. Longitudinal Prescription and Medical Claims Data, January 2013-March 2021. Available at: https://www.iqvia.com/solutions/real-world-evidence/real-world-data-and-insights . [Accessed: April 25 2025]. SPRYCEL ® (dasatinib). Prescribing Information. Bristol-Myers Squibb Company. -ENDS- ©2025 Cycle Pharmaceuticals Limited. All rights reserved. PHYRAGO™ is a trademark of Handa Therapeutics, LLC. Sprycel ® is a registered trademark of Bristol-Myers Squibb Company. Cycle Vita™ is a trademark of Cycle Pharmaceuticals Ltd. About Cycle Pharmaceuticals Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease community. Cycle Pharma focuses on rare genetic conditions in metabolic, immunology, urology, and oncology. In neurology, we focus on multiple sclerosis. Cycle Pharma is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit www.cyclepharma.com and follow us on X , LinkedIn and Facebook . About Handa Therapeutics, LLC. Handa is a specialty pharmaceutical company that focuses on developing high-quality medications that address significant unmet medical needs. Handa’s leadership has a proven track record of building effective teams, high quality product portfolios and successful pharmaceutical businesses. For more information, please visit www.handapharma.com . FOR FURTHER INFORMATION PLEASE CONTACT [email protected] Cycle Pharmaceuticals Limited Tel: +44 1223 354 118

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