Company: EDSA
Filing Date: 2025-09-09
Form Type: 424B5
Source: 0001171843-25-005799
Chunk: 9

Company: Edesa Biotech, Inc.
Filing Date: 2025-09-09
Form: 424B5
Chunk 9
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and we are in discussions with the U.S. Food and Drug Administration (FDA) for the same study. Preparation for the manufacturing campaign
began in our fiscal second quarter, and we have evaluated multiple development and manufacturing pathways to produce our drug. We anticipate
data to be submitted to the FDA by the end of calendar 2025 based on the current availability of manufacturing slots at third party service
providers. Our 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), a common occupational skin condition. This asset is at the partnering
stage.

Our most advanced Respiratory drug candidate is EB05
(paridiprubart). Paridiprubart represents a new class of emerging therapies called Host-Directed Therapeutics (HDTs) that are designed
to modulate the body’s own immune response when confronted with infectious diseases or even chemical agents. EB05 is currently being
evaluated in the U.S. government-funded “Just Breathe” study investigating three novel threat-agnostic HDTs in hospitalized
adult patients with Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. During the third fiscal
quarter, the U.S. government announced that the first randomizations of EB05 and other host directed therapeutics were completed. Certain
development expenses, including manufacturing scale-up, for our EB05 program are also eligible for reimbursement from the Government of
Canada under a 2023 grant and funding award. We are also pursuing additional uses for paridiprubart in chronic diseases, such as pulmonary
fibrosis (EB07 program). In light of our other development priorities, we are evaluating the timing for the next steps in our EB07 program.

#### Corporate Information
We are a British Columbia, Canada corporation
founded in 2007 and operate through our wholly owned subsidiaries, Edesa Biotech Research, Inc., an Ontario, Canada corporation, and Edesa
Biotech USA, Inc., a California, USA corporation. In June 2019, we acquired the Ontario corporation through a reverse acquisition and
changed our name to Edesa Biotech, Inc. Our common shares are traded on Nasdaq under the symbol “EDSA.” Our executive offices
are located at 100 Spy Court, Markham, Ontario L3R 5H6 Canada and our telephone number