Edesa Biotech (NASDAQ: EDSA) extends EB05 ARDS funding and defers repayments

Rhea-AI Filing Summary

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.

Insights

Biotech funding and partnerships analyst

Edesa extends Canadian EB05 funding timeline and defers repayments, tied to future revenue.

Edesa Biotech and its subsidiary updated their contribution agreement with the Government of Canada providing up to CAD $23 million in partially repayable support for EB05 development in Acute Respiratory Distress Syndrome. The amendment broadens the clinical focus from Covid‑19–specific ARDS to general ARDS and links the program to a fully funded U.S. government platform study that will include EB05.

The changes push the project completion date to December 31, 2028 and extend the agreement’s expiration to the later of December 31, 2045 or the last repayment date. The repayment schedule is adjusted so the first annual repayment starts in 2032 and only if the company generates gross revenue, easing near- to medium-term cash obligations.

The amendment also introduces additional reporting on similar EB05 projects and replaces the Statement of Work with updated milestones and timelines. Future company filings describing progress on the Phase 3 study, regulatory submissions and any revenue that could trigger repayments will provide more clarity on how these revised terms affect funding and cash flows.

false 0001540159 0001540159 2025-09-30 2025-09-30 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): September 30, 2025

Edesa Biotech, Inc.

(Exact Name of Registrant as Specified in its Charter)

British Columbia, Canada		001-37619				N/A
(State or Other Jurisdiction of Incorporation)		(Commission File Number)				(IRS Employer Identification No.)
100 Spy Court, Markham, Ontario, Canada				L3R 5H6
(Address of Principal Executive Offices)				(Zip Code)

(289) 800-9600

Registrant’s telephone number, including area code

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of exchange on which registered
Common Shares		EDSA		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 1.01 Entry into a Material Definitive Agreement

As previously disclosed, on October 12, 2023, Edesa Biotech Research, Inc. (“Edesa Biotech Research”), a wholly owned subsidiary of Edesa Biotech, Inc. (the “Company”), and the Company, as guarantor, entered into a multi-year contribution agreement (the “Agreement”) with the Government of Canada, pursuant to which the Government of Canada committed up to CAD $23 million ($17 million USD) in partially repayable funding toward (i) conducting and completing the Company’s Phase 3 clinical study of its experimental drug EB05 (paridiprubart) in critical-care patients with Acute Respiratory Distress Syndrome (ARDS) caused by Covid-19 or other infectious agents, (ii) submitting EB05 for governmental approvals and manufacturing scale-up, following, and subject to, completing the Phase 3 study and (iii) conducting two non-clinical safety studies to assess the potential long-term impact of EB05 exposure (the “Project”).

On September 30, 2025, Edesa Biotech Research, the Company and the Government of Canada entered into Amendment Agreement No. 1 to the Agreement (the “Amendment”) to reflect a change in the Company’s clinical focus for EB05 to general ARDS from Covid-19 induced ARDS, and to benefit from a fully funded U.S. government platform study of host directed therapeutics, including EB05. The Amendment, among other things (i) extends the Project completion date to December 31, 2028 (from December 31, 2025), (ii) amends the expiration date of the Agreement to the later of December 31, 2045 (from December 31, 2042) or the date of the last repayment, unless earlier terminated, (iii) adds certain additional reporting requirements relating to other similar EB05 development projects, (iv) replaces the Statement of Work to reflect the updated scope, milestones and timelines for the Project and (v) amends the repayment schedule such that the first annual repayment would due in 2032 (from 2029), provided that repayment will only begin if the Company earns gross revenue. Except as amended by the Amendment, the terms of the Agreement remain in full force and effect.

The foregoing summary and description of the Agreement and the Amendment do not purport to be complete and are qualified in their entirety by reference to the Agreement, a copy of which is filed with the Company’s annual report on Form 10-K filed on December 15, 2023, and the Amendment, a copy of which will be filed with the Company’s annual report on Form 10-K for the fiscal year ending September 30, 2025.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant

The information set forth under Item 1.01 is incorporated into this Item 2.03 by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Edesa Biotech, Inc.
Date: September 30, 2025	By:	/s/ Peter J. Weiler
	Name:	Peter J. Weiler
	Title:	Chief Financial Officer

FAQ

What did Edesa Biotech (EDSA) change in its agreement with the Government of Canada?

Edesa Biotech and its subsidiary entered into an amendment to their multi-year contribution agreement with the Government of Canada that funds development of EB05. The amendment updates the clinical focus to general Acute Respiratory Distress Syndrome, revises the project scope and timelines, extends the agreement expiration, and adjusts the repayment schedule while keeping all other terms in effect.

How much funding is covered under Edesa Biotechs Canadian contribution agreement for EB05?

The contribution agreement with the Government of Canada provides up to CAD $23 million (stated as approximately $17 million USD) in partially repayable funding. This support is directed toward Edesas Phase 3 clinical study of EB05 in ARDS, related regulatory submissions and manufacturing scale-up, and two non-clinical safety studies.

How did the amendment affect the EB05 project timeline for Edesa Biotech (EDSA)?

The amendment extends the EB05 project completion date to December 31, 2028, compared with the prior completion date of December 31, 2025. It also extends the agreements expiration to the later of December 31, 2045 or the date of the last repayment, unless it is terminated earlier.

When will Edesa Biotech be required to start repaying the Canadian funding for EB05?

Under the amended terms, the first annual repayment under the contribution agreement would be due in 2032. Repayment will only begin if the company earns gross revenue, meaning no repayments are required before that year or in the absence of gross revenue.

How does the amendment change the clinical focus of EB05 for Edesa Biotech (EDSA)?

The amendment reflects a change in Edesa Biotechs clinical focus for EB05 from Covid‑19-induced Acute Respiratory Distress Syndrome to general ARDS. It also notes that the company will benefit from inclusion of EB05 in a fully funded U.S. government platform study of host-directed therapeutics.

What additional requirements did Edesa Biotech agree to under the amended EB05 funding arrangement?

The amendment adds certain additional reporting requirements for other similar EB05 development projects and replaces the Statement of Work to capture the updated project scope, milestones and timelines. All other original terms of the contribution agreement remain in full force and effect.