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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): November 8, 2026
_______________________________
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) | (I.R.S. Employer Identification No.) |
333 Bay Street, Suite 2400,
Toronto, Ontario, Canada M5H 2T6
(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:
| ☐ | 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 each 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.
Collaboration and License Agreement
On November 8, 2026, Edesa Biotech, Inc., together with its wholly owned subsidiaries (the “Company”), entered into a Collaboration and License Agreement (the “License Agreement”) with Kyorin Pharmaceutical Co., Ltd. (“Kyorin”). Pursuant to the License Agreement, the Company granted Kyorin an exclusive, royalty-bearing license, with the right to grant sublicenses subject to the terms of the License Agreement, to develop and commercialize the Company’s anti-TLR4 monoclonal antibody, paridiprubart (EB05), for the treatment of acute respiratory distress syndrome (“ARDS”) in Japan (the “Licensed Territory”), subject to the terms of the License Agreement. The Company retains all rights to paridiprubart outside the Licensed Territory, including in the United States, Europe and Canada, as well as the right to manufacture paridiprubart.
Under the License Agreement, Kyorin will pay the Company a one-time, non-creditable and non-refundable upfront payment of $12 million. The Company is also eligible to receive development and regulatory milestone payments of up to $55 million in the aggregate and sales-based milestone payments of up to ¥12.0 billion in the aggregate, subject to the terms of the License Agreement.
In addition, Kyorin will pay the Company low double-digit tiered royalties on net sales of licensed products in the Licensed Territory, subject to specified reductions and adjustments.
Kyorin is generally responsible, at its own expense, for development, regulatory activities and commercialization of the licensed compounds and products in the Licensed Territory and is required to use commercially reasonable efforts to conduct these activities. The Company will continue to conduct specified development activities outside the Licensed Territory, with Kyorin funding specified activities conducted for the Licensed Territory and sharing specified costs of any multi-regional clinical studies. The Company will manufacture and supply licensed products to Kyorin pursuant to supply agreements to be entered into by the parties.
The License Agreement provides Kyorin with a right of first negotiation with respect to acute kidney injury and a non-exclusive right to negotiate with respect to certain other indications in the Licensed Territory.
Unless earlier terminated, the License Agreement will continue until the fifteenth anniversary of the first commercial sale of a licensed product in the Licensed Territory, subject to automatic renewal for successive two-year periods. Kyorin may terminate the License Agreement for convenience upon specified prior written notice. The parties also have specified termination rights, including for uncured material breach and specified bankruptcy or insolvency events. Upon termination, the applicable license rights granted to Kyorin will terminate, subject in specified circumstances to limited rights to sell existing inventory. The License Agreement also provides for specified transition and reversion rights in favor of the Company relating to regulatory filings, clinical trials and intellectual property.
The License Agreement contains customary representations, warranties, covenants and indemnification obligations of the parties.
Paridiprubart is licensed to the Company by NovImmune SA (“NovImmune”), which operates under the brand Light Chain Bioscience, pursuant to a License Agreement, dated April 17, 2020, between NovImmune and Edesa Biotech Research, Inc. (the “NovImmune License Agreement”).
The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, a copy of which will be filed with the Company’s annual report on Form 10-K for the fiscal year ended September 30, 2026.
Item 1.02. Termination of a Material Definitive Agreement.
On November 8, 2026, the Company provided notice to H.C. Wainwright & Co., LLC (“HCW”) of the termination of the At The Market Offering Agreement, dated October 4, 2024 (the “ATM Agreement”), between the Company and HCW, effective November 16, 2026. The ATM Agreement provided for the offer and sale of the Company’s common shares, without par value (“Common Shares”), from time to time through HCW as its sales agent and/or principal, subject to the maximum aggregate dollar amount registered pursuant to the applicable prospectus supplement. Sales of Common Shares through HCW were to be made (A) in negotiated transactions with the consent of the Company or (B) by any other method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including block transactions, sales made directly on the Nasdaq Capital Market or sales made into any other existing trading market for the Common Shares. The Company is not subject to any termination penalties related to the termination of the ATM Agreement.
The foregoing description of the ATM Agreement is not complete and is qualified in its entirety by reference to the full text of the ATM Agreement, a copy of which was filed as Exhibit 1.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 4, 2024.
Item 7.01. Regulation FD Disclosure.
On November 9, 2026, the Company issued a press release announcing the transaction contemplated by the License Agreement. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated in this Item 7.01 by reference.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | | Exhibit Description |
| 99.1 | | Press Release, dated November 9, 2026. |
| 104 | | The cover page of this Current Report on Form 8-K, formatted in Inline XBRL. |
SIGNATURE
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: November 9, 2026 | By: | /s/ Peter J. Weiler |
| | Name: | Peter J. Weiler |
| | Title: | Chief Financial Officer |
| | | |
EXHIBIT 99.1
Edesa Biotech Announces Agreement with KYORIN Pharmaceutical to Develop and Commercialize Paridiprubart in Japan
- Deal valued at more than $140 million in upfront and potential milestone payments, plus double-digit royalties.
- Kyorin obtains exclusive rights to develop and commercialize paridiprubart, an anti-TLR4 monoclonal antibody, in Japan for the treatment of ARDS.
TORONTO and TOKYO, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, and KYORIN Pharmaceutical Co., Ltd. (TSE: 4569), a leading Japanese pharmaceutical company, today announced that they have entered into an exclusive collaboration and license agreement for the development and commercialization of paridiprubart in Japan.
Under the terms of the agreement, Kyorin will obtain an exclusive license to further develop and commercialize Edesa’s drug candidate, paridiprubart, in Japan, in Acute Respiratory Distress Syndrome (ARDS). Edesa will receive an upfront payment of $12 million and is eligible to receive additional development, regulatory and sales-based milestones up to approximately $134 million, a portion of which is denominated in Japanese yen. Edesa is also eligible to receive tiered double-digit royalties on net sales of the product in Japan. Kyorin will fund development, regulatory and commercialization activities in Japan for the treatment of ARDS and has been granted a right of first negotiation for acute kidney injury (AKI) and a non-exclusive right to negotiate for other potential indications. Edesa will manufacture and supply product to Kyorin and the parties will coordinate development activities. Edesa retains all rights to paridiprubart outside of Japan. Japan is one of the world's largest pharmaceutical markets, accounting for approximately 4 to 5 percent of global pharmaceutical spending.
Paridiprubart is a monoclonal antibody candidate that targets toll-like receptor 4, a key regulator of the innate immune response. In a Phase 3 study in hospitalized patients with respiratory failure, paridiprubart plus standard of care demonstrated a statistically significant reduction in 28-day mortality compared to placebo (adjusted mortality risk of 39% versus 52%; p<0.001), a treatment benefit that was sustained at 60 days (p=0.003) and accompanied by a safety profile comparable to placebo. Positive exploratory analyses showed consistent survival benefits in less severe patients not on invasive mechanical ventilation and in subgroups with serious comorbidities, including acute kidney injury. These results were selected for oral presentations at the American Thoracic Society and the European Renal Association.
Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, stated, “We believe Kyorin’s experience with respiratory treatments and their extensive footprint in Japan make them a strong partner for the continued development and commercialization of paridiprubart, our potential first-in-class antibody. For Edesa shareholders, we believe this deal represents a validation of our business model and the ability to share in the future success of this drug candidate.”
Yutaka Ogihara, President and CEO of KYORIN Pharmaceutical Co., Ltd., stated, "We are pleased, as a company with a strong foundation in respiratory medicine, to secure the exclusive rights to develop and commercialize EB05 in Japan, an innovative therapeutic candidate for ARDS—an extremely severe condition that requires intensive care. Conquering ARDS represents one of the most formidable frontiers in drug discovery, but that is precisely why it is profoundly meaningful for KYORIN to proactively take on this challenge. Together with Edesa, by uniting our scientific passion, specialized expertise, and relentless driving force, we will dramatically accelerate global clinical development, including in Japan, to bring new hope to patients and healthcare professionals in critical care settings as expeditiously as possible."
About Paridiprubart
Paridiprubart is a first-in-class human monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. Paridiprubart represents a new class of host-directed therapeutics (HDTs) that are designed to modulate the body's own immune response when confronted with known or unknown public health threats such as pandemic influenza and other emerging infectious diseases, and chemical, biological, radiological, and nuclear incidents. Mechanistically, paridiprubart inhibits toll-like receptor 4 (TLR4), a key immune signaling receptor that has been shown to be activated by pathogens as well as in the pathogenesis of other diseases.
About Kyorin Pharmaceutical
Kyorin Pharmaceutical Co., Ltd. headquartered in Tokyo, Japan and founded in 1923, is a research-oriented pharmaceutical company operating under the corporate philosophy, "KYORIN continues to fulfil its mission of cherishing life and benefiting society by contributing to better health." Grounded in this principle, KYORIN aims to continuously provide high-value new medicines that meet medical needs, striving to be a company that contributes broadly to people's health. In drug discovery, KYORIN focuses its research efforts on the therapeutic areas of pain, autoimmune disorders, and neuromuscular diseases, working to create innovative new medicines that meet significant medical needs. In sales, KYORIN implements its Franchise Customer (FC) strategy, strategically concentrating resources on its core specialized areas: respiratory, otolaryngology, and urology.
About Edesa Biotech
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). The company’s most advanced Respiratory drug candidate is paridiprubart, which is being evaluated in a U.S. government-funded platform study as a treatment for ARDS, a life-threatening form of respiratory failure. The paridiprubart program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. Sign up for news alerts. Connect with us on X and LinkedIn.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the anticipated benefits of the collaboration and license agreement between Edesa and Kyorin; the parties' plans to develop, manufacture, obtain regulatory approval for and commercialize paridiprubart in Japan; the potential receipt and timing of upfront, milestone and royalty payments; and the therapeutic potential of paridiprubart. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the risk that the parties may be unable to realize the anticipated benefits of the collaboration; the risk that development, regulatory or sales milestones may not be achieved and that anticipated milestone and royalty payments may therefore not become payable; the ability of the parties to obtain regulatory approval for, and to successfully manufacture and commercialize, paridiprubart in Japan, including obtaining a satisfactory National Health Insurance price; the risk that paridiprubart may not be effective against the diseases tested in clinical trials; Edesa's dependence on Kyorin for the development and commercialization of the product in Japan; fluctuations in currency exchange rates between the U.S. dollar and Japanese yen; the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa; Edesa's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings; and the impacts of public health crises. Many of these factors that will determine actual results are beyond the parties' ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.
Note Regarding Kyorin. Statements in this press release attributable to Kyorin contain performance forecasts, goals, plans and other forward-looking statements relating to the Kyorin Group. These statements are based on Kyorin's assumptions and outlook using information available at the time of preparation and involve known and unknown risks and uncertainties. Actual performance and the progress, success or failure of development may therefore differ significantly. Information regarding medicines (including those under development) is not intended as advertising or medical advice.
CONTACTS:
Gary Koppenjan
Edesa Biotech, Inc.
investors@edesabiotech.com
Corporate Planning
Kyorin Pharmaceutical Co., Ltd
Phone: +81-3-6374-9702
