On December 12, 2025, Edesa Biotech, Inc. (EDSA) filed an 8-K form with the U.S. Securities and Exchange Commission. The filing disclosed that the company's Phase 3 study of paridiprubart (EB05) for Acute Respiratory Distress Syndrome (ARDS) met its primary and secondary endpoints with statistical significance.

According to the filing, Edesa Biotech reported a net loss of $7.2 million, or $1.27 per common share, for the fiscal year ended September 30, 2025. This compares to a net loss of $6.2 million, or $1.93 per common share, for the prior fiscal year. The company held cash and cash equivalents of $10.8 million as of September 30, 2025.

Chief Executive Officer Par Nijhawan commented on the company's strategic progress in the filing.

"Our strategy to advance a high-impact dermatology asset alongside a now-validated respiratory therapeutic is bearing fruit, and we believe Edesa is well positioned for our mission to deliver transformative therapies to patients with high unmet medical needs." — Par Nijhawan, Chief Executive Officer, Edesa Biotech, Inc.

The company also initiated manufacturing activities for a Phase 2 study of EB06 in patients with moderate-to-severe nonsegmental vitiligo. Recruitment for this study is anticipated by midyear 2026, subject to manufacturing and regulatory approvals, according to the filing.

Edesa Biotech stated it is exploring development and commercialization partnerships for paridiprubart. The drug is also being evaluated in a U.S. government-funded platform study. Chief Financial Officer Peter Weiler noted the company's financial priorities, stating in the filing,

"With new momentum and data in hand, we are engaging with potential strategic and government partners to seek additional non-dilutive support and collaborative arrangements that advance our programs." — Peter Weiler, Chief Financial Officer, Edesa Biotech, Inc.

The company received $3.4 million in net proceeds from common shares sold under an at-the-market offering program. Management plans to participate in one-on-one meetings during JP Morgan week, beginning on January 12, 2026.