Edesa Biotech Reports Fiscal 2nd Quarter 2025 Results
- Secured $15 million equity financing from healthcare-focused institutional investors
- Reduced net loss per share to $0.30 from $0.58 year-over-year
- Decreased operating expenses by $0.6 million to $1.6 million
- Maintained strong cash position of $13.9 million
- Phase 2 study already approved in Canada
- Continued net losses of $1.6 million in Q2 2025
- Total other income decreased by $311,000 to $49,000
- Decrease in reimbursement funding from Canadian government's Strategic Innovation Fund
- Manufacturing timeline pushes IND application to second half of 2025
Insights
Edesa secured $15M funding for vitiligo drug development while reducing quarterly losses to $1.6M as focus shifts from respiratory to dermatology programs.
Edesa Biotech's Q2 FY2025 results reveal a strategic pivot from respiratory to dermatology, specifically their vitiligo program. The company completed a
The quarterly financial performance shows modest improvement, with net losses decreasing to
Their EB06 drug candidate, an anti-CXCL10 monoclonal antibody for nonsegmental vitiligo, represents a novel approach targeting the systemic autoimmune aspects of the disease rather than just symptomatic treatment. This positions Edesa in an underserved market with significant potential if successful, similar to how biologics transformed psoriasis treatment.
The operational timeline indicates manufacturing data submission to the FDA in H2 2025, with potential topline results 12-18 months after regulatory clearance. Importantly, the Phase 2 study has already received Canadian approval, reducing regulatory risk.
The cash runway appears sufficient for near-term milestones, with
The company also benefits from government support for its respiratory program (EB05), which has transitioned to a fully funded study for Acute Respiratory Distress Syndrome, allowing Edesa to focus resources on the vitiligo program while maintaining portfolio diversification.
TORONTO, May 14, 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 six months ended March 31, 2025 and provided an update on its business.
During the quarter, the company completed a
“The initial steps in the manufacturing of our biological drug are ongoing and we are excited about the potential of a novel immunotherapy like EB06. Vitiligo significantly impacts the lives of millions worldwide, yet there are no approved drugs that address the systemic nature of the disease. We believe we can ultimately change the treatment paradigm in much the same manner that immunotherapies have transformed other systemic autoimmune diseases like psoriasis,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech.
Edesa's Chief Financial Officer Peter Weiler reported that financial results for the quarter reflected a pivot in operational activity to the company’s vitiligo development program, from its respiratory program. Increased expenditures for the EB06 program were offset by decreased expenses for the EB05 drug candidate as the company benefits from a fully funded government study investigating Edesa’s respiratory drug as a treatment for Acute Respiratory Distress Syndrome (ARDS).
“We are deploying additional resources to manufacturing and preparatory regulatory activities to speed the launch of our upcoming vitiligo study, and we anticipate that related research expenditures will generally track activity in this program,” Mr. Weiler said.
Based on the current availability of manufacturing slots at third party service providers, Edesa reported that the company anticipates drug manufacturing data to be submitted to the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application in the second half of calendar 2025. Edesa anticipates topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA. The planned Phase 2 study is already approved in Canada.
Financial Results for the Three Months Ended March 31, 2025
Total operating expenses decreased by
- Research and development expenses decreased by
$0.7 million to$0.5 million for the three months ended March 31, 2025 compared to$1.2 million for the same period last year primarily due to decreased external research expenses related to manufacturing the company’s investigational drug, paridiprubart, which were partially offset by an increase in EB06-related expenses for the planned Phase 2 vitiligo study. - General and administrative expenses increased by
$0.2 million to$1.2 million for the three months ended March 31, 2025 compared to$1.0 million for the same period last year primarily due to an increase in salaries and related costs, which were partially offset by a decrease in noncash share-based compensation and professional service fees.
Total other income decreased by
For the quarter ended March 31, 2025, Edesa reported a net loss of
Financial Results for the Six Months Ended March 31, 2025
Total operating expenses decreased by
- Research and development expenses decreased by
$0.4 million to$1.5 million for the six months ended March 31, 2025 compared to$1.9 million for the same period last year primarily due to decreased external research expenses related to manufacturing the company’s investigational drug, paridiprubart, which were partially offset by an increase in EB06-related expenses for the planned Phase 2 vitiligo study. - General and administrative expenses decreased by
$0.2 million to$2.0 million for the six months ended March 31, 2025 compared to$2.2 million for the same period last year primarily due to a decrease in noncash share-based compensation and professional service fees, which were partially offset by an increase in salaries and related costs.
Total other income decreased by
For the six months ended March 31, 2025, Edesa reported a net loss of
Working Capital
At March 31, 2025, Edesa had cash and cash equivalents of
Calendar
Edesa plans to participate in the BIO International Convention being held June 16-19, 2025 in Boston, Mass. Attendees interested in meeting with company representatives 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 (
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 plans to seek and receive U.S. regulatory approval for a Phase 2 study of EB06 in moderate-to-severe nonsegmental vitiligo patients; the company’s belief in the transformational potential of a novel immunotherapy like EB06; the company’s belief that it can ultimately change the treatment paradigm for vitiligo in much the same manner that immunotherapies have transformed other systemic autoimmune diseases like psoriasis; the company’s ongoing plans to deploy additional resources to manufacturing, regulatory other preparations to speed the launch of its upcoming vitiligo study; the company’s anticipation that related research expenditures will generally track activity in this program; the company’s plans to submit drug manufacturing data to the FDA IND application in the second half of calendar 2025; Edesa’s anticipation that topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA; and; 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 | Six Months Ended | ||||||||||||||||
| March 31, 2025 | March 31, 2024 | March 31, 2025 | March 31, 2024 | ||||||||||||||
| Expenses: | |||||||||||||||||
| Research and development | 484,306 | 1,176,337 | $ | 1,504,124 | $ | 1,880,795 | |||||||||||
| General and administrative | 1,154,580 | 1,044,137 | 2,033,451 | 2,197,108 | |||||||||||||
| Loss from operations | (1,638,886 | ) | (2,220,474 | ) | (3,537,575 | ) | (4,077,903 | ) | |||||||||
| Other Income (Loss): | |||||||||||||||||
| Reimbursement grant income | 52,268 | 304,002 | 353,463 | 424,836 | |||||||||||||
| Other income (loss) | (3,030 | ) | 55,941 | (22,789 | ) | 114,085 | |||||||||||
| Income tax expense | 800 | 800 | 800 | 800 | |||||||||||||
| Net loss | (1,590,448 | ) | (1,861,331 | ) | (3,207,701 | ) | (3,539,782 | ) | |||||||||
| Exchange differences on translation | (63,731 | ) | (11,183 | ) | (45,075 | ) | (11,755 | ) | |||||||||
| Net comprehensive loss | $ | (1,654,179 | ) | $ | (1,872,514 | ) | $ | (3,252,776 | ) | $ | (3,551,537 | ) | |||||
| Weighted average number of common shares | 5,305,763 | 3,192,688 | 4,314,676 | 3,160,179 | |||||||||||||
| Loss per common share - basic and diluted | $ | (0.30 | ) | $ | (0.58 | ) | $ | (0.74 | ) | $ | (1.12 | ) | |||||
| Condensed Interim Consolidated Balance Sheets | |||||||
| (Unaudited) | |||||||
| March 31, 2025 | September 30, 2024 | ||||||
| Assets: | |||||||
| Cash and cash equivalents | $ | 13,896,650 | $ | 1,037,320 | |||
| Other current assets | 490,639 | 638,302 | |||||
| Non-current assets | 2,067,010 | 2,138,360 | |||||
| Total Assets | $ | 16,454,299 | $ | 3,813,982 | |||
| Liabilities and shareholders' equity: | |||||||
| Current liabilities | $ | 914,701 | $ | 1,832,827 | |||
| Non-current liabilities | - | - | |||||
| Shareholders' equity | 15,539,598 | 1,981,155 | |||||
| Total liabilities and shareholders' equity | $ | 16,454,299 | $ | 3,813,982 | |||
| Condensed Interim Consolidated Statements of Cash Flows | |||||||||
| (Unaudited) | |||||||||
| Six Months Ended | |||||||||
| March 31, 2025 | March 31, 2024 | ||||||||
| Cash flows from operating activities: | |||||||||
| Net loss | $ | (3,207,701 | ) | $ | (3,539,782 | ) | |||
| Adjustments for non-cash items | 215,454 | 409,715 | |||||||
| Change in working capital items | (908,254 | ) | 63,380 | ||||||
| Net cash used in operating activities | (3,900,501 | ) | (3,066,687 | ) | |||||
| Net cash provided by financing activities | 16,844,415 | 517,441 | |||||||
| Effect of exchange rate changes on cash and cash equivalents | (84,584 | ) | (12,520 | ) | |||||
| Net change in cash and cash equivalents | 12,859,330 | (2,561,766 | ) | ||||||
| Cash and cash equivalents, beginning of period | 1,037,320 | 5,361,397 | |||||||
| Cash and cash equivalents, end of period | $ | 13,896,650 | $ | 2,799,631 | |||||
FAQ
What were Edesa Biotech's (EDSA) Q2 2025 financial results?
How much funding did Edesa Biotech raise in Q2 2025?
When does Edesa expect to submit its IND application for EB06?
What is the timeline for Edesa's Phase 2 vitiligo study results?
What is the current cash position of Edesa Biotech (EDSA)?
