**SystImmune and BMS Announce US FDA Breakthrough Therapy Designation for Izalontamab Brengitecan in Previously Treated EGFR-Mutated Non-Small Cell Lung Cancer**

SEATTLE, WA – August 19, 2025 – SystImmune Inc., a clinical-stage biotechnology company, and Bristol Myers Squibb (BMS), a global pharmaceutical leader, jointly announced today a significant regulatory milestone in the fight against a common and deadly form of lung cancer. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to izalontamab brengitecan, an investigational therapy being developed by the two companies, for the treatment of patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have previously received treatment.

This designation is a major step forward in addressing the unmet needs of patients battling this specific type of lung cancer. EGFR mutations are a common driver of NSCLC, and while initial treatments targeting these mutations can be effective, resistance often develops, leaving patients with limited options. Izalontamab brengitecan represents a novel approach and offers hope for improved outcomes in these previously treated individuals.

The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of drugs intended to treat serious or life-threatening conditions. It is granted when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints, such as overall survival or disease progression. This designation provides SystImmune and BMS with increased access to the FDA during the development process, including more frequent meetings and guidance, ensuring a more efficient review process.

This collaboration between SystImmune and BMS highlights the commitment of both companies to developing innovative cancer treatments. The designation underscores the potential of izalontamab brengitecan to address a critical need in the treatment of EGFR-mutated NSCLC and offers a beacon of hope for patients facing this challenging disease. Further details about the clinical data supporting this designation are expected to be presented at upcoming medical conferences. The companies are working diligently to advance the development of izalontamab brengitecan and bring this potentially life-saving treatment to patients as quickly as possible.