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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) |
| |
|
|
|
|
|
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(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 |
