Edesa Biotech, Inc. SEC Filings

The company whose common shares trade on Nasdaq under the symbol EDSA is updating its at-the-market offering so it may sell up to $2,262,508 of common shares from time to time through H.C. Wainwright & Co. as sales agent. This amount reflects the limits of General Instruction I.B.6 of Form S-3, which caps annual sales at one-third of public float for issuers with less than $75,000,000 held by non-affiliates. As of October 24, 2025, the public float was $19,273,618, based on 7,034,167 common shares held by non-affiliates at $2.74 per share. During the 12 months prior to this supplement, the company sold $4,162,030.62 of its securities under this rule, including $3,718,324.61 under the prior prospectus and $837,134 under an earlier prospectus supplement.

Edesa Biotech, Inc. files its annual report describing a biopharmaceutical company focused on inflammatory and immune-related diseases. Its lead respiratory candidate EB05 (paridiprubart) showed positive Phase 3 results in acute respiratory distress syndrome, with 28-day mortality of 39% on EB05 plus standard of care versus 52% on placebo, an absolute survival improvement of 13%, and a similar 13% benefit at 60 days, alongside a generally well-tolerated safety profile. EB05 is also being studied in a U.S. government-funded Phase 2 platform trial and backed by a Canadian Strategic Innovation Fund commitment of up to C$23 million, including up to C$5.75 million that is not repayable.

In medical dermatology, Edesa is advancing EB06, an anti-CXCL10 antibody for vitiligo, toward a Phase 2 trial in approximately 150 patients and is seeking partners for EB01, a Phase 3-ready topical therapy for allergic contact dermatitis. As of March 31, 2025, nonaffiliates held 5,728,786 of 7,022,678 common shares, with an aggregate market value of $13,978,238, and 8,333,823 common shares were outstanding as of December 12, 2025.

Edesa Biotech, Inc. filed a current report to disclose that on December 12, 2025 it issued a press release announcing its financial results for the fiscal year ended September 30, 2025. The press release is included as Exhibit 99.1 and is furnished, rather than filed, so it is not automatically subject to certain Exchange Act liabilities or incorporated into other SEC reports unless specifically referenced.

Edesa Biotech (EDSA) reported an insider transaction by CEO, Director and 10% Owner Pardeep Nijhawan. On 11/03/2025, he acquired 6,968 common shares via a grant of restricted share units that vested in full upon grant under the company’s 2019 Equity Incentive Compensation Plan at a reported price of $0.

Following the transaction, the reporting person beneficially owned 482,612 shares directly. He also reported indirect holdings of 341,702 shares held by Pardeep Nijhawan Medicine Professional Corporation, 32,609 shares held by The New Nijhawan Family Trust 2015, 32,013 shares held by The Digestive Health Clinic Inc., and 53,104 shares held by 1968160 Ontario Inc.

Edesa Biotech (EDSA) reported positive Phase 3 results for paridiprubart (EB05) in ARDS, stating the study met primary and secondary endpoints with statistical significance. In the intention-to-treat population (n=104), 28-day mortality was 39% with paridiprubart plus standard of care versus 52% with placebo, an absolute survival improvement of 13% and a 25% relative risk reduction (p<0.001). A survival benefit persisted at 60 days: 46% vs 59%, a 13% absolute improvement and 22% relative risk reduction (p=0.003).

The company also reported fewer patients required invasive mechanical ventilation, with a 41% higher relative rate of clinical improvement at Day 28. In a safety population of more than 275 subjects across Phase 2/3, EB05 was generally well-tolerated. Patients were enrolled at 38 hospitals in the U.S., Canada and Colombia. The program is supported by the U.S. government’s “Just Breathe” study and Canada’s Strategic Innovation Fund. Enrollment was discontinued early for business reasons, and efficacy analyses used multivariate logistic regression with prespecified adjustments.

Pardeep Nijhawan, Chief Executive Officer, Director and reported >10% owner of Edesa Biotech, Inc. (EDSA), received a grant of 5,908 restricted share units that vested in full upon grant on 10/02/2025 under the company's 2019 Equity Incentive Compensation Plan. The filing shows 475,644 common shares beneficially owned following the transaction, with 341,702 shares held indirectly by Pardeep Nijhawan Medicine Professional Corporation and additional indirect holdings through related entities and a family trust totaling 118,726 shares. The filing includes standard disclaimers that the reporting person disclaims beneficial ownership of certain indirect holdings except to the extent of pecuniary interest. The form was signed by an attorney-in-fact on 10/03/2025.

Edesa Biotech, Inc. has amended its multi-year contribution agreement with the Government of Canada covering up to CAD $23 million in partially repayable funding for its experimental ARDS drug EB05 (paridiprubart). The amendment shifts the clinical focus from Covid-19–induced Acute Respiratory Distress Syndrome to general ARDS and aligns with participation in a fully funded U.S. government platform study of host-directed therapeutics that includes EB05. The project completion date is extended to December 31, 2028, and the agreement’s expiration moves to the later of December 31, 2045 or the date of last repayment, unless terminated earlier. The repayment schedule is also revised so that the first annual repayment would be due in 2032, and only if the company earns gross revenue, while other terms of the agreement remain in effect.

Edesa Biotech, Inc. filed an 8-K to report that it has filed a new prospectus supplement supporting its at-the-market offering program for the offer and sale of up to $4,006,544 of common shares through H.C. Wainwright & Co. as sales agent. This program operates under an existing At the Market Offering Agreement originally dated October 4, 2024.

The company has previously sold an aggregate of $837,134 of common shares under that agreement and an earlier prospectus supplement tied to a prior Form S-3 registration. The new prospectus supplement and base prospectus form part of a shelf registration statement on Form S-3 that was declared effective by the SEC on September 9, 2025, and a related legal opinion on the validity of the common shares is filed as an exhibit.

Edesa Biotech, Inc. prospectus supplement for debt securities highlights numerous standard biotech risks and detailed outstanding and potential share issuances that could affect shareholders. The filing lists categories of risks including funding availability, clinical trial timing and results, regulatory approvals, competition, intellectual property protection, Nasdaq listing compliance and reliance on key personnel. It discloses a cash-related figure of $4,006,544 and specific share counts: 378,235 options (weighted average exercise $24.71), 137,936 fully vested RSUs, 1,124,171 unvested RSUs, 680,846 shares available under the equity plan, 435,414 Series A-1 convertible preferred, 4,343,750 Series B-1 convertible preferred and 934,590 warrants (weighted average exercise $15.35). The supplement references prior SEC filings including the Annual Report for the year ended September 30, 2024 and several 10-Qs and 8-Ks. Contact for investor relations is provided in Markham, Ontario.