Company: EDSA
Filing Date: 2025-10-28
Form Type: 8-K
Source: 0001171843-25-006690
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Company: Edesa Biotech, Inc.
Filing Date: 2025-10-28
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Events.

On October 8, 2025, Edesa Biotech, Inc. (the “ Company”) announced positive results from a Phase 3 study evaluating the Company’s drug candidate paridiprubart (EB05) as a treatment for Acute Respiratory Distress Syndrome (“ ARDS”), a life-threatening form of respiratory failure.

The data from the Phase 3 study demonstrated that paridiprubart met primary and secondary endpoints with statistical significance. Paridiprubart led to a clinically significant reduction in mortality through 60 days, as well as a significant reduction in the proportion of patients requiring invasive mechanical ventilation (“ IMV”).

Paridiprubart in the most conservative intention-to-treat (“ ITT”) population met the primary endpoint, demonstrating a statistically significant and clinically meaningful benefit for reduced mortality at 28 days. Patients treated with paridiprubart plus standard of care treatments (“ SOC”) had a lower risk of death (39%) compared to those receiving placebo (52%), representing an absolute improvement in survival of 13% at 28 days with paridiprubart demonstrating a relative reduction in the risk of death of 25% compared to placebo (n=104; p<0.001). A durable survival benefit was also demonstrated at 60 days, with patients treated with paridiprubart plus SOC demonstrating a lower risk of death (46%) compared to those receiving placebo (59%), representing an absolute improvement in survival of 13% with a relative risk reduction of 22% for paridiprubart compared to placebo (n=104; p=0.003). In addition, subjects
receiving paridiprubart + SOC demonstrated a 41% higher relative rate of clinical improvement, meaning patients no longer required IMV and/or organ support at Day 28.

The results from a safety population of more than 275 subjects, which included patients enrolled during the interim between the Phase 2 and Phase 3 study, demonstrated that EB05 was generally well-tolerated and consistent with the observed safety profile to date.

Paridiprubart is currently being evaluated in the U. S. government’s “ Just Breathe” study investigating three novel threat-agnostic therapeutics in hospitalized adult patients with ARDS. The Company’s paridiprubart development program, including this Phase 3 study and manufacturing scale-up, also receives funding from the Government of Canada’s Strategic Innovation Fund.

Detailed Results

Patients were enrolled from