Prolong Pharmaceuticals, LLC (the Company), a clinical-stage biopharmaceutical company, today announced that it will present key clinical data from HEMERA-1, its Phase 1/2 clinical trial in Acute Ischemic Stroke (AIS), at the World Stroke Conference (WSC) held on October 22^nd-24^th, 2025 in Barcelona, Spain.

The Company’s presentation will provide major updates on their lead asset, PP-007, a PEGylated carboxyhemoglobin bovine product, in anterior large vessel occlusion (A-LVO) AIS patients. According to the latest data, PP-007, when administered in adjunct to standard of care, demonstrated significantly improved functional outcomes and reduced mortality when compared to patients on mechanical thrombectomy alone. PP-007 has been granted Fast Track Designation by the FDA within this indication, and the Company is currently preparing for its global pivotal study.

WSC Presentation

“The HEMERA-1 data are very encouraging — despite the smaller, prospectively matched cohort, we observed signals suggesting improved functional outcomes compared to typical benchmarks in acute ischemic stroke,” said Dr. Raul Nogueira, Scientific Advisory Board Member of the PP-007 program, “These findings clearly warrant validation in a fully powered randomized clinical trial.”

“The HEMERA-1 study achieved its primary objective, demonstrating that PP-007, when added to standard-of-care therapy for acute ischemic stroke (AIS), was generally well tolerated and delivered a robust proof-of-concept signal,” said Dr. Kirsten Gruis, Chief Medical Officer of Prolong Pharmaceuticals, “In patients with anterior large vessel occlusion (A-LVO), PP-007 treatment resulted in a 20% absolute improvement in functional independence compared to expected 90-day outcomes, and 55% of patients achieved early responder status marked by rapid neurological recovery during hospitalization. These encouraging results support PP-007’s potential to meaningfully improve outcomes in AIS, and we look forward to advancing the program into the HEMERA-2 study, which has been aligned with the FDA following a successful Type C meeting earlier this year.”

More information about WSC 2025 can be found on the event website at the following link: https://worldstrokecongress.org/.

About PP-007

PP-007 (PEGylated carboxyhemoglobin bovine—SANGUINATE^®) is a novel biopharmaceutical product that is universally compatible, thermally stable, and in a ready-to-administer intravenous formulation. PP-007 has demonstrated improvement in blood flow, oxygen transfer, inflammation reduction, and supports perfusion and organ function as demonstrated across a number of pre-clinical and clinical studies. PP-007 received Fast Track Designation in AIS in 2024.

Numerous non-clinical studies have been published on ischemia/hypoxia and anemia. ~300 individuals in 12 completed clinical trials have received single and multi-dose PP-007 treatments including subarachnoid hemorrhage, life-threatening anemia, and other diseases/conditions with underlying ischemia/hypoxia, such as beta thalassemia and sickle cell disease. PP-007 is an investigational drug product and not approved for use in any country/indication.

About Prolong Pharmaceuticals, LLC

Prolong Pharmaceuticals is an advanced clinical stage pharmaceutical company that is vertically integrated with a proprietary state-of-the-art manufacturing facility headquartered in South Plainfield, New Jersey. Prolong Pharmaceuticals is developing PP-007 as a treatment for AIS to lessen the debilitating comorbidities associated with reduced quality of life, increased medical cost, and significant mortality.

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“HEMERA-1 achieved its primary objective, demonstrating that PP-007, when added to SOC therapy for AIS, was generally well tolerated and delivered a robust proof-of-concept signal,” said Dr. Kirsten Gruis, Chief Medical Officer of Prolong Pharmaceuticals.