Financial Performance - Edesa Biotech reported a net loss of $6.2 million, or $1.93 per common share, for the fiscal year ended September 30, 2024, compared to a net loss of $8.4 million, or $2.93 per common share, for the previous year[8]. - Total operating expenses decreased by $2.2 million to $7.0 million for the year ended September 30, 2024, down from $9.2 million in the prior year, reflecting a more than 20% reduction[6]. - Research and development expenses decreased by $1.9 million to $2.9 million for the year ended September 30, 2024, primarily due to reduced external research expenses and lower labor costs[6]. - Edesa's general and administrative expenses decreased by $0.3 million to $4.1 million for the year ended September 30, 2024, compared to $4.4 million in the prior year[7]. - Total other income remained unchanged at $0.8 million for the years ended September 30, 2024, and September 30, 2023[8]. Cash Position - Edesa's cash and cash equivalents stood at $1.0 million with negative working capital of $0.2 million as of September 30, 2024[9]. - The company received $1.5 million in gross proceeds under a securities purchase agreement after the fiscal year end[9]. Future Plans - The company anticipates topline results for its Phase 2 study could be available within 12 to 18 months following regulatory clearance in the U.S.[4]. - Edesa plans to manufacture EB06 and submit related data to the U.S. FDA as part of an investigational new drug application[4]. - Edesa has received two government funding awards to support the advancement of its anti-TLR4 technology, improving its position for future financing[5].

Core Viewpoint - Edesa Biotech, Inc. reported a strategic pivot in its drug development focus, particularly on its anti-TLR4 drug candidate, and demonstrated improved financial management with a significant reduction in operating expenses while advancing its clinical pipeline through government funding opportunities [2][3][4]. Financial Performance - Total operating expenses decreased by $2.2 million to $7.0 million for the fiscal year ended September 30, 2024, compared to $9.2 million for the prior year [4]. - Research and development expenses decreased by $1.9 million to $2.9 million, primarily due to reduced external research expenses and labor costs [4]. - General and administrative expenses decreased by $0.3 million to $4.1 million, mainly due to a reduction in noncash share-based compensation [4]. - Edesa reported a net loss of $6.2 million, or $1.93 per common share, compared to a net loss of $8.4 million, or $2.93 per common share, for the previous fiscal year [5][11]. Cash Flow and Working Capital - As of September 30, 2024, Edesa had cash and cash equivalents of $1.0 million and negative working capital of $0.2 million [6]. - The company received $1.5 million in gross proceeds from a securities purchase agreement and $0.6 million in net proceeds from common shares sold under an at-the-market offering program after the fiscal year end [6]. Business Development and Pipeline - Edesa is focusing on the development of EB05 (paridiprubart) for Acute Respiratory Distress Syndrome (ARDS) and plans to submit an investigational new drug (IND) application for EB06, an anti-CXCL10 monoclonal antibody candidate [2][8]. - The company aims to maximize synergies between U.S. and Canadian government-funded projects related to its drug candidates [2][3]. Future Outlook - Edesa anticipates topline results for its Phase 2 study could be available within 12 to 18 months following regulatory clearance in the U.S. [2]. - The company plans to participate in one-on-one meetings during JP Morgan week in January 2025, indicating ongoing engagement with investors and stakeholders [7].

TORONTO, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today announced that the company has entered into a purchase agreement with an entity affiliated with Par Nijhawan, MD, Edesa’s Chief Executive Officer and Founder, to invest up to $5.0 million in the company, including an immediate investment of approximately $1.5 million. The entity will purchase shares o ...

TORONTO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that Edesa management and business development staff plan to participate in the following upcoming conferences: BIO-Europe, Stockholm, Sweden, November 4-6, 2024Dermatology Drug Development Summit, Boston, Mass., November 12-14, 2024LSX Investival Showcase, London, UK, November 18, 2024 To s ...

MARKHAM, Ontario, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Dr. Pardeep Nijhawan ("Dr. Nijhawan") announces that as a result of grants of restricted share units ("RSUs") of Edesa Biotech, Inc. ("Edesa"), when combined with a series of transactions (the "Transactions") that have occurred since the date of the most recent early warning report filed by Dr. Nijhawan on November 18, 2022 (the "Previous Report"), Dr. Nijhawan has acquired "beneficial ownership" of common shares in the capital of Edesa ("Common Shares") ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37619 EDESA BIOTECH, INC. (Exact name of registrant as specified in its charter) British Columbia, Canada N/A (State or other jurisdiction ...

EXHIBIT 99.1 Edesa Biotech Reports Fiscal 3rd Quarter 2024 Results TORONTO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and nine months ended June 30, 2024 and provided an update on its business. During the quarter, the company's anti-TLR4 drug candidate, EB05 (paridiprubart), was selected by the U.S. Department ...

TORONTO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and nine months ended June 30, 2024 and provided an update on its business. During the quarter, the company's anti-TLR4 drug candidate, EB05 (paridiprubart), was selected by the U.S. Department of Health and Human Services for use in a U.S. government-funded pl ...

For the quarterly period ended March 31, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Registrant's telephone number, including area OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37619 EDESA BIOTECH, INC. (Exact name of registrant as specified in its charter) British Co ...

EX-99.1 2 edsa_ex991.htm PRESS RELEASE Edesa Biotech Reports Fiscal 2nd Quarter 2024 Results TORONTO, ON / ACCESSWIRE / May 10, 2024 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and six months ended March 31, 2024 and provided an update on its business. During the quarter, the company expanded site selection activities for a Phase 3 study of its ...