• CRYPTICS study met the primary efficacy endpoint measure, 24-hour chest tube drainage (Difference in LS Means was 142.0 mL; 95.576% confidence interval of volume difference lower than noninferiority margin)
• Sensitivity analyses of the primary endpoint were consistent and supportive
• Comprehensive review of the study efficacy data based on clinically relevant secondary endpoints further supports noninferiority of CLPH-511 to room temperature platelets
• Adverse events were well balanced between the two treatment groups.

Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic, platelet-derived, cellular therapeutics, announced that it has received the final topline results from its CRYPTICS clinical study and is pleased to report that it met the study’s primary efficacy endpoint.

To address a US public health crisis caused by platelet shortages, Cellphire is developing CLPH-511 (Frozen (Activated) Platelets) Injectable Suspension for the treatment of acute hemorrhage as an alternative to room-temperature platelets. Hemorrhage is a leading cause of preventable death in the United States- responsible for nearly 40% of early trauma-related mortality of civilians less than 65 years (Kauvar & Wade, 2005; Sauaia et al., 1995)and approximately 90% of potentially survivable deaths in combat (Eastridge et al., 2012). Each year, hemorrhage accounts for more than 60,000 deaths nationwide and remains the number one cause of preventable deaths in the US for individuals under 45 years of age. Behind these statistics are thousands of families and communities devastated by sudden, avoidable loss. Platelet shortages further exacerbate this crisis, leaving patients without timely, life-saving interventions.

The CRYPTICS study was a Phase 2/3 adaptive design study, titled “Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery” (CRYPTICS - NCT04709705) that investigated the use of CLPH-511 in acute hemorrhage.

The completion of this trial represents a significant milestone for Cellphire’s clinical program and advancement of our platelet therapeutics portfolio. The company is now preparing for its End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). “This is an important step in advancing our platelet-based platform,” said Damien Bates, Chief Medical Officer of Cellphire Therapeutics. “We look forward to discussing these important results with the FDA.”

"Topline data will be presented at the upcoming 2025 AABB Annual Meeting in San Diego by Dr. Glenn Whitman of Johns Hopkins Medical Institute during the Educational Session, Update on the Use of Cryopreserved Platelets in Acute Surgical Settings, scheduled for Sunday, October 26, 2025.”

Cellphire Therapeutics will continue to advance the clinical development of CLPH-511, leveraging the benefits of the product Fast Track and Medical Priority Product designations to bring this innovative therapy to patients as quickly and efficiently as possible.