Edesa Biotech Reports Fiscal Year 2025 Results

Rhea-AI Summary

Edesa Biotech (Nasdaq:EDSA) reported fiscal year 2025 results for the year ended September 30, 2025, highlighting clinical and financial updates. The company said a Phase 3 study of paridiprubart (EB05) met primary and secondary endpoints with statistical significance and that manufacturing activities began for a Phase 2 study of EB06 (anti-CXCL10) in vitiligo with recruitment anticipated by mid‑2026, subject to manufacturing and approvals. Financials showed total operating expenses $7.9M (up $0.9M), R&D $3.7M (up $0.8M), net loss $7.2M or $1.27 per share, cash and equivalents $10.8M, and working capital $10.4M. The company received $3.4M net proceeds from an at‑the‑market offering after year‑end and extended Canadian government funding to support programs.

Positive

• Phase 3 success: paridiprubart met primary and secondary endpoints
• R&D momentum: manufacturing initiated for EB06 Phase 2 (vitiligo)
• Year‑end cash: $10.8M cash and cash equivalents
• Post‑period financing: $3.4M net proceeds from ATM offering
• Government support: extended Canadian Strategic Innovation Fund reimbursement

Negative

• Total operating expenses increased to $7.9M (+$0.9M)
• Research and development expenses rose to $3.7M (+$0.8M)
• Net loss widened to $7.2M year ended Sept 30, 2025

Key Figures

Total operating expenses $7.9 million Fiscal year ended September 30, 2025 (vs $7.0 million prior year)

Research & development $3.7 million Fiscal 2025 R&D (vs $2.9 million prior year)

General & administrative $4.2 million Fiscal 2025 G&A (vs $4.1 million prior year)

Net loss $7.2 million Fiscal 2025 net loss (vs $6.2 million in 2024)

Net loss per share $1.27 per share Fiscal 2025 (vs $1.93 per share in 2024)

Cash & equivalents $10.8 million Cash position at September 30, 2025

Working capital $10.4 million Working capital at September 30, 2025

ATM net proceeds $3.4 million Net proceeds from shares sold under at-the-market program post year-end

Market Reality Check

$1.74 Last Close

Volume Volume 28,174 is close to the 20-day average of 29,465, suggesting typical trading interest ahead of this update. normal

Technical Shares at $1.74 are trading below the 200-day moving average of $2.20 and well under the $4.49 52-week high.

Peers on Argus

Peers in Biotechnology showed mixed moves, from +31.92% (NBY) to -9.23% (MTVA), while EDSA was up 0.57%, indicating a company-specific response to its earnings and clinical updates.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Oct 31	Conference participation	Neutral	-0.5%	Announced management attendance at two upcoming European industry conferences.
Oct 28	Phase 3 results	Positive	-17.9%	Reported statistically significant Phase 3 survival benefits for paridiprubart in ARDS.
Aug 08	Quarterly results	Neutral	-0.5%	Released Q3 2025 financials with stable loss and ongoing EB06 and EB05 development.

Pattern Detected

Recent news events, including strong Phase 3 data and prior earnings, were followed by modest to sharp share price declines, suggesting a pattern of negative or muted reactions even to positive catalysts.

Recent Company History

Over recent months, Edesa highlighted conference participation (Nov 3-5, 2025 and Nov 17, 2025), reported positive Phase 3 results for paridiprubart (EB05) in ARDS on Oct 28, 2025, and released fiscal Q3 2025 results on Aug 8, 2025. Despite positive clinical data and stable quarterly finances, 24-hour price reactions were negative (-17.87%, -0.53%, and -0.47%), showing a tendency for shares to trade lower following news.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-07-25

Edesa has an active S-3 shelf registration dated Jul 25, 2025 expiring Jul 25, 2028, with at least one usage via a 424B5 filed on Sep 9, 2025, indicating a framework for future capital-raising activities.

Market Pulse Summary

This announcement combines fiscal 2025 results with pipeline updates, including Phase 3 success for paridiprubart and preparation for a Phase 2 vitiligo study. Operating expenses rose to $7.9 million and net loss to $7.2 million, but cash of $10.8 million plus $3.4 million in post-year ATM proceeds support near-term plans. Investors may track execution of the vitiligo trial, partnering progress for paridiprubart, and use of the existing S-3 shelf.

Key Terms

phase 2 study medical

"initiated manufacturing activities for a Phase 2 study of Edesa’s dermatology drug"

A phase 2 study is a mid-stage clinical trial that tests whether an experimental drug or treatment actually works for the intended condition and continues to check safety in a larger group of patients than early trials. Think of it as a focused pilot test before a full market launch; positive or negative results strongly affect a drug’s chances of approval, the remaining development time and costs, and therefore an investment’s risk and potential value.

phase 3 study medical

"a Phase 3 study of its monoclonal antibody, paridiprubart (EB05), met primary"

A phase 3 study is the large-scale clinical trial that tests whether a new drug or medical treatment actually works and is safe in a broad group of patients, typically after earlier smaller tests. Investors watch these studies like a final dress rehearsal because their successful completion is often required for regulatory approval and market access; positive or negative results can sharply change a company’s future sales prospects and stock value.

monoclonal antibody medical

"EB06 (an anti-CXCL10 monoclonal antibody), in patients with moderate-to-severe"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

AI-generated analysis. Not financial advice.

TORONTO, Dec. 12, 2025 (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 fiscal year ended September 30, 2025 and provided an update on its business.

During the year, the company initiated manufacturing activities for a Phase 2 study of Edesa’s dermatology drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), in patients with moderate-to-severe nonsegmental vitiligo. Edesa anticipates that recruitment will begin by midyear 2026, subject to the completion of clinical-grade drug manufacturing and regulatory approvals. In its respiratory program, Edesa reported that a Phase 3 study of its monoclonal antibody, paridiprubart (EB05), met primary and secondary endpoints with statistical significance. Edesa is currently exploring development and commercialization partnerships for paridiprubart as well as expedited regulatory pathways that may be available in certain jurisdictions.

“Our strategy to advance a high-impact dermatology asset alongside a now-validated respiratory therapeutic is bearing fruit, and we believe Edesa is well positioned for our mission to deliver transformative therapies to patients with high unmet medical needs,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “With new momentum and data in hand, we are engaging with potential strategic and government partners to seek additional non-dilutive support and collaborative arrangements that advance our programs.”

Edesa's Chief Financial Officer Peter Weiler reported that financial results for the fiscal year reflected a ramp up in activities for the company’s vitiligo program as well as the completion and close-out of the Phase 3 clinical study of paridiprubart. “This year, we strengthened our balance sheet and extended our Canadian government funding agreement to support manufacturing and development for our respiratory program. Looking ahead, our priorities include executing the Phase 2 vitiligo study, advancing respiratory assets toward partnering and commercialization, expanding manufacturing capacity, and maintaining financial discipline,” he said.

Financial Results for the Fiscal Year Ended September 30, 2025

Total operating expenses increased by $0.9 million to $7.9 million for the year ended September 30, 2025 compared to $7.0 million for the prior year:

• Research and development expenses increased by $0.8 million to $3.7 million for the year ended September 30, 2025 compared to $2.9 million for the prior year primarily due to increased expenses for manufacturing-related activities and other preparations for a planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased external research expenses related to the completion of a Phase 3 study of paridiprubart (EB05) and drug supply costs for an ongoing U.S. government study of paridiprubart, partially offset by lower spend on other development programs.
  
  
• General and administrative expenses increased by $0.1 million to $4.2 million for the year ended September 30, 2025 compared to $4.1 million for the prior year primarily due to an increase in noncash share-based compensation, which was partially offset by a decrease in professional fees.
  
  

Total other income decreased by $0.1 million to $0.7 million for the year ended September 30, 2025 compared to $0.8 million for the prior year, primarily due to a decrease in interest income, which was partially offset by an increase in reimbursement funding from the Canadian government's Strategic Innovation Fund.

For the year ended September 30, 2025, Edesa reported a net loss of $7.2 million, or $1.27 per common share, compared to a net loss of $6.2 million, or $1.93 per common share, for the year ended September 30, 2024.

Working Capital

At September 30, 2025, Edesa had cash and cash equivalents of $10.8 million and working capital of $10.4 million. Subsequent to the fiscal year end, the company received $3.4 million in net proceeds, after deducting sales agent commissions, from common shares sold under an at-the-market offering program.

Calendar

Edesa management plans to participate in one-on-one meetings during JP Morgan week, which begins on January 12, 2026, in San Francisco, California. Attendees interested in meeting with management can request meetings by contacting Edesa at investors@edesabiotech.com.

About Edesa Biotech, Inc.

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), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is paridiprubart, which is being developed as a potential treatment for Acute Respiratory Distress Syndrome, 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, and is currently being evaluated in a U.S. government-funded platform study. Edesa is also pursuing additional uses for paridiprubart in chronic respiratory diseases. Sign up for news alerts. Connect with us on X and LinkedIn.

Edesa Forward-Looking Statements

This press release may contain 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: anticipated initiation of patient recruitment for a Phase 2 vitiligo study by midyear 2026, subject to manufacturing and regulatory approvals; efforts to pursue development and commercialization partnerships for paridiprubart; potential expedited regulatory pathways; strategic initiatives to secure non-dilutive funding and collaborative arrangements; ongoing priorities such as executing clinical studies, advancing respiratory assets toward partnering and commercialization, expanding manufacturing capacity, and maintaining financial discipline; and the company's timing and plans regarding its clinical studies in general. 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 ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, 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, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, 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 company's 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.

Contact:
Gary Koppenjan
Edesa Biotech, Inc.
investors@edesabiotech.com

Consolidated Statements of Operations
			Years Ended
			September 30, 2025				September 30, 2024
Expenses:
Research and development			$	3,668,738			$	2,881,967
General and administrative				4,242,828				4,132,777
Loss from operations				(7,911,566	)			(7,014,744	)
Other Income (Loss):
Reimbursement grant income				783,894				698,277
Other income (loss)				(57,051	)			147,222
Income tax expense				800				800
Net loss				(7,185,523	)			(6,170,045	)
Exchange differences on translation				76,842				(27,965	)
Net comprehensive loss			$	(7,108,681	)		$	(6,198,010	)
Weighted average number of common shares				5,676,708				3,197,423
Loss per common share - basic and diluted			$	(1.27	)		$	(1.93	)

Consolidated Balance Sheets
		September 30, 2025			September 30, 2024
Assets:
	Cash and cash equivalents	$	10,792,172		$	1,037,320
	Other current assets		720,704			638,302
	Non-current assets		2,017,642			2,138,360
	Total Assets	$	13,530,518		$	3,813,982
Liabilities and shareholders' equity:
	Current liabilities	$	1,078,536		$	1,832,827
	Shareholders' equity		12,451,982			1,981,155
	Total liabilities and shareholders' equity	$	13,530,518		$	3,813,982

Consolidated Statements of Cash Flows
	Years Ended
	September 30, 2025				September 30, 2024
Cash flows from operating activities:
Net loss	$	(7,185,523	)		$	(6,170,045	)
Adjustments for non-cash items		848,915				708,775
Change in working capital items		(985,654	)			571,065
Net cash used in operating activities		(7,322,262	)			(4,890,205	)
Net cash provided by financing activities		17,030,898				592,031
Effect of exchange rate changes on cash and cash equivalents		46,216				(25,903	)
Net change in cash and cash equivalents		9,754,852				(4,324,077	)
Cash and cash equivalents, beginning of period		1,037,320				5,361,397
Cash and cash equivalents, end of period	$	10,792,172			$	1,037,320

FAQ

What did Edesa Biotech (EDSA) report for fiscal year ended Sept 30, 2025?

Edesa reported a $7.2M net loss ($1.27 per share), $10.8M cash, and said paridiprubart Phase 3 met primary and secondary endpoints.

What clinical progress did Edesa (EDSA) announce on Dec 12, 2025 for paridiprubart (EB05)?

Edesa announced the Phase 3 study of paridiprubart met primary and secondary endpoints with statistical significance.

When will Edesa (EDSA) begin recruitment for the EB06 vitiligo Phase 2 study?

Edesa expects recruitment to begin by mid‑2026, subject to completion of clinical‑grade manufacturing and regulatory approvals.

How much cash and working capital did Edesa (EDSA) report on Sept 30, 2025?

Edesa reported $10.8M cash and cash equivalents and $10.4M working capital as of Sept 30, 2025.

Did Edesa (EDSA) raise additional capital after its fiscal year end?

Yes—Edesa received $3.4M in net proceeds from common shares sold under an at‑the‑market offering program.

How did Edesa's (EDSA) operating and R&D expenses change in fiscal 2025?

Total operating expenses rose to $7.9M (+$0.9M) and R&D expenses increased to $3.7M (+$0.8M) year‑over‑year.