Edesa Biotech Reports Fiscal 3rd Quarter 2025 Results

Rhea-AI Summary

Edesa Biotech (Nasdaq:EDSA) reported its fiscal Q3 2025 results and provided updates on its drug development programs. The company is advancing manufacturing activities for EB06, an anti-CXCL10 monoclonal antibody for moderate-to-severe nonsegmental vitiligo, with FDA submission planned by end of 2025.

Financial highlights include: Q3 net loss of $1.7 million ($0.25 per share), unchanged from last year, with operating expenses stable at $1.9 million. The company maintains a strong financial position with $12.4 million in cash and $12.1 million in working capital. The company's EB05 program continues through a fully funded U.S. government "Just Breathe" study for ARDS patients.

Positive

• Strong cash position of $12.4 million and working capital of $12.1 million
• EB05 program costs fully funded by U.S. government through 'Just Breathe' study
• Operating expenses remained stable at $1.9 million quarter-over-quarter
• Reduced net loss per share from $0.52 in Q3 2024 to $0.25 in Q3 2025

Negative

• Total other income decreased by $110,000 to $154,000 compared to last year
• Decreased reimbursement funding from Canadian government's Strategic Innovation Fund
• Decline in interest income
• Manufacturing timeline extends FDA submission to end of 2025

Insights

Biotechnology Financial Analyst

Edesa reports stable quarterly loss while advancing vitiligo drug manufacturing for IND submission, maintaining $12.4M cash position.

Edesa's Q3 results reveal a stable financial position with a consistent quarterly net loss of $1.7 million year-over-year, though the per-share loss improved to $0.25 from $0.52 due to share dilution. The company maintained controlled R&D expenses at $0.9 million by strategically reallocating resources from its EB05 respiratory program to the more promising EB06 vitiligo candidate. This resource shift reflects a calculated pivot toward the vitiligo market opportunity.

The $12.4 million cash position provides approximately 7 quarters of runway at current burn rates, offering adequate funding through the anticipated IND submission for EB06 by year-end 2025. However, this timeline appears to be somewhat delayed due to manufacturing slot availability constraints with third-party providers, highlighting a common challenge for small biotechs without in-house manufacturing capabilities.

The company's nine-month operating expenses decreased by $0.6 million to $5.4 million, demonstrating disciplined cost management. Notably, the company benefits from government funding for its EB05 program through the "Just Breathe" study, effectively preserving capital while maintaining pipeline breadth. The 11% reduction in year-to-date expenses ($5.4M vs $6.0M) indicates prudent cash conservation without completely abandoning secondary programs.

The vitiligo program targeting patients with more extensive disease (>10% body surface area) represents a strategic positioning in an underserved segment of the market where current treatments have limitations. This focus on EB06, an anti-CXCL10 monoclonal antibody with a favorable safety profile, targets a specific niche where existing therapies pose safety concerns or lack efficacy.

Biotechnology Development Expert

Edesa's developmental strategy centers on their EB06 antibody for vitiligo, with manufacturing progress being the critical path item for their IND submission. The company has identified a clear regulatory milestone with the FDA submission expected by end of 2025, though the dependence on third-party manufacturing slots introduces timeline uncertainty.

The company's targeting of moderate-to-severe nonsegmental vitiligo patients with >10% body surface area involvement represents a strategic approach to an underserved patient population. Current vitiligo treatments like JAK inhibitors carry black box warnings and have varying efficacy profiles, creating an opportunity for novel approaches. EB06's mechanism as an anti-CXCL10 monoclonal antibody addresses a key inflammatory pathway in vitiligo pathogenesis, targeting both lesional and non-lesional skin.

Parallel advancement of their EB05 respiratory drug through the government-funded "Just Breathe" platform study for ARDS provides pipeline diversification without financial burden. The announcement that the first randomizations for this study have been completed indicates the program remains active despite reduced corporate focus.

The IND-enabling work for EB06 appears to be progressing methodically, with manufacturing being the primary focus. However, the disclosure around manufacturing slot availability suggests potential for timeline slippage. This cautious language around manufacturing timelines is noteworthy as it reveals a key dependency outside the company's direct control. The target for IND submission by year-end 2025 provides a clear near-term catalyst, though investors should monitor for potential delays in manufacturing data generation.

TORONTO, Aug. 08, 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 three and nine months ended June 30, 2025 and provided an update on its business.

During the quarter, the company advanced manufacturing-related activities to support U.S. regulatory approval of a Phase 2 study of Edesa’s drug candidate EB06 (an anti-CXCL10 monoclonal antibody) in patients with moderate-to-severe nonsegmental vitiligo. Edesa anticipates drug manufacturing data for EB06 to be submitted to the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application by the end of calendar 2025 based on the current availability of manufacturing slots at third party service providers.

“Our manufacturing plans are moving forward, and we’re energized by the opportunity to bring an innovative immunotherapy like EB06 into an area of high unmet need,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “We believe that the favorable safety profile of EB06, and its ability to target the immune system mechanisms impacting both lesional and non-lesional skin, has the potential to make it a preferable option for vitiligo patients – especially for those with lesions on more than 10% of their body surface area or those patients concerned about the safety risks of other treatments.”

Edesa's Chief Financial Officer Peter Weiler reported that financial results for the quarter and fiscal year-to-date were in line with management expectations and continued to reflect the refocusing of company resources to its vitiligo development program. He noted that increased expenditures for Edesa’s EB06 program were offset by decreased expenses for its EB05 drug candidate as the company benefits from the fully funded U.S. government “Just Breathe” study of EB05 and other host-directed therapeutics in a general ARDS patient population. During the quarter, the government announced that the first randomizations for the platform study were completed.

“We are channeling our operational efforts into regulatory preparation and drug manufacturing of our EB06 candidate with the goal of being in a position to move rapidly into clinical testing,” Mr. Weiler said.

Financial Results for the Three Months Ended June 30, 2025

Total operating expenses for each of the three months ended June 30, 2025 and June 30, 2024 were $1.9 million:

• Research and development expenses were $0.9 million for each of the three months ended June 30, 2025 and June 30, 2024, as an increase in EB06-related expenses for Edesa’s planned Phase 2 vitiligo study was offset by a decrease in external research expenses related to the company’s investigational respiratory drug, EB05 (paridiprubart).

• General and administrative expenses were $1.0 million for each of the three months ended June 30, 2025 and June 30, 2024, as a decrease in salaries and related costs was offset by an increase in noncash share-based compensation and professional service fees.
  
  

Total other income decreased by $110,000 to $154,000 for the three months ended June 30, 2025 compared to $264,000 for the same period last year. This decrease was primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Innovation Fund as well as a decrease in interest income.

For the quarter ended June 30, 2025, Edesa reported a net loss of $1.7 million, or $0.25 per common share, compared to a net loss of $1.7 million, or $0.52 per common share, for the quarter ended June 30, 2024.

Financial Results for the Nine Months Ended June 30, 2025

Total operating expenses decreased by $0.6 million to $5.4 million for the nine months ended June 30, 2025 compared to $6.0 million for the nine months ended June 30, 2024:

• Research and development expenses decreased by $0.4 million to $2.4 million for the nine months ended June 30, 2025 compared to $2.8 million for the same period last year primarily due to a decrease in external research expenses related to EB05 (paridiprubart), which was partially offset by an increase in EB06-related expenses associated with preparations for the planned Phase 2 vitiligo study.

• General and administrative expenses decreased by $0.2 million to $3.0 million for the nine months ended June 30, 2025 compared to $3.2 million for the same period last year primarily due to a decrease in professional service fees and noncash share-based compensation.
  
  

Total other income decreased by $0.3 million to $0.5 million for the nine months ended June 30, 2025 compared to $0.8 million for the same period last year, primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Innovation Fund as well as a decrease in interest income.

For the nine months ended June 30, 2025, Edesa reported a net loss of $5.0 million, or $0.95 per common share, compared to a net loss of $5.2 million, or $1.64 per common share, for the nine months ended June 30, 2024.

Working Capital

At June 30, 2025, Edesa had cash and cash equivalents of $12.4 million and working capital of $12.1 million.

Calendar

Edesa management is scheduled to participate in the Canaccord Genuity 45th Annual Growth Conference being held August 12-13, 2025 in Boston, Mass, and the H.C. Wainwright 27th Annual Global Investment Conference being held September 8-10, 2025 in New York, NY. Attendees interested in meeting with management can request meetings through the conference organizers or by contacting Edesa directly 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 EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. Edesa is also pursuing additional uses for paridiprubart in chronic diseases, such as pulmonary fibrosis. 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: the company’s belief that EB06 is an innovative immunotherapy and could provide benefits to an area of high unmet need; the company’s belief that EB06 has a favorable safety profile; the company’s belief that EB06 targets the immune mechanisms impacting both lesional and non-lesional skin, and this feature could make it a preferable option for vitiligo patients – especially for those with lesions on more than 10% of their body surface area or those concerned about the risks of other treatments; the company’s plans to channel its operational efforts into regulatory preparation and drug manufacturing of EB06 candidate with the goal of being in a position to move rapidly into clinical testing; the company’s plans to submit EB06 drug manufacturing data to the FDA IND application by the end of calendar 2025; 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

Condensed Interim Consolidated Statements of Operations
(Unaudited)
		Three Months Ended								Nine Months Ended
		June 30, 2025				June 30, 2024				June 30, 2025				June 30, 2024
Expenses:
Research and development			939,067				897,305			$	2,443,191			$	2,778,100
General and administrative			964,676				1,035,140				2,998,127				3,232,248
Loss from operations			(1,903,743	)			(1,932,445	)			(5,441,318	)			(6,010,348	)
Other Income (Loss):
Reimbursement grant income			183,281				236,226				536,744				661,062
Other income (loss)			(29,002	)			28,007				(51,791	)			142,092
Income tax expense			-				-				800				800
Net loss			(1,749,464	)			(1,668,212	)			(4,957,165	)			(5,207,994	)
Exchange differences on translation			164,611				1,612				119,536				(10,143	)
Net comprehensive loss		$	(1,584,853	)		$	(1,666,600	)		$	(4,837,629	)		$	(5,218,137	)
Weighted average number of common shares			7,022,678				3,221,806				5,217,343				3,180,647
Loss per common share - basic and diluted		$	(0.25	)		$	(0.52	)		$	(0.95	)		$	(1.64	)

Condensed Interim Consolidated Balance Sheets
(Unaudited)
		June 30, 2025				September 30, 2024
Assets:
Cash and cash equivalents		$	12,361,690			$	1,037,320
Other current assets			399,402				638,302
Non-current assets			2,043,708				2,138,360
Total Assets		$	14,804,800			$	3,813,982
Liabilities and shareholders' equity:
Current liabilities		$	672,674			$	1,832,827
Non-current liabilities			-				-
Shareholders' equity			14,132,126				1,981,155
Total liabilities and shareholders' equity		$	14,804,800			$	3,813,982

Condensed Interim Consolidated Statements of Cash Flows
(Unaudited)
		Nine Months Ended
		June 30, 2025				June 30, 2024
Cash flows from operating activities:
Net loss		$	(4,957,165	)		$	(5,207,994	)
Adjustments for non-cash items			418,622				570,636
Change in working capital items			(1,062,725	)			714,192
Net cash used in operating activities			(5,601,268	)			(3,923,166	)
Net cash provided by financing activities			16,844,415				623,466
Effect of exchange rate changes on cash and cash equivalents			81,223				(20,813	)
Net change in cash and cash equivalents			11,324,370				(3,320,513	)
Cash and cash equivalents, beginning of period			1,037,320				5,361,397
Cash and cash equivalents, end of period		$	12,361,690			$	2,040,884

FAQ

What were Edesa Biotech's (EDSA) key financial results for Q3 2025?

Edesa reported a net loss of $1.7 million ($0.25 per share) with operating expenses of $1.9 million. The company maintained $12.4 million in cash and $12.1 million in working capital.

What is the status of Edesa's EB06 drug development program?

Edesa is advancing manufacturing activities for EB06, an anti-CXCL10 monoclonal antibody for vitiligo treatment, with FDA submission planned for the end of 2025.

How much cash does Edesa Biotech (EDSA) have as of June 2025?

As of June 30, 2025, Edesa had $12.4 million in cash and cash equivalents with $12.1 million in working capital.

What is the progress of Edesa's EB05 program?

The EB05 program is continuing through a fully funded U.S. government 'Just Breathe' study for ARDS patients, with first randomizations completed.

How did Edesa's operating expenses change in Q3 2025?

Operating expenses remained stable at $1.9 million for both Q3 2025 and Q3 2024, with R&D expenses at $0.9 million and G&A expenses at $1.0 million.