Edesa Biotech announced Q1 2025 results, advancing its EB06 vitiligo treatment and reporting a net loss of $1.6 million.
Quiver AI Summary
Edesa Biotech, Inc. reported its financial results for the quarter ending December 31, 2024, highlighting progress on its leading asset, EB06, an anti-CXCL10 monoclonal antibody for vitiligo. The company is preparing for a manufacturing campaign and plans to submit regulatory data to the FDA by mid-2025 while seeking an IND application for a Phase 2 study in nonsegmental vitiligo patients. The study has already received approval from Health Canada. Edesa’s financial position improved with a $15 million raise from an equity offering, supporting its ongoing projects, which include the government-funded EB05 study. The company reported a net loss of $1.6 million for the quarter, consistent with prior expectations, and aims to rapidly advance its vitiligo clinical trials as part of its development strategy for effective treatments.
Potential Positives
- The company advanced its main asset, EB06, which is being developed for the treatment of vitiligo, with key preparations underway for a manufacturing campaign.
- Edesa anticipates submitting data to the FDA in mid-2025, positioning itself for a potential market entry in the following years.
- Financial results indicate a net loss reduction compared to the previous year, demonstrating improved financial performance despite ongoing investments in R&D.
- The company successfully raised $15.0 million in gross proceeds through an equity financing, strengthening its balance sheet and positioning it well for future developments.
Potential Negatives
- Company reported a net loss of $1.6 million, indicating ongoing financial challenges despite a slight improvement from the previous year's loss.
- Cash and cash equivalents were reported at only $1.6 million, raising concerns about the company's liquidity and ability to fund ongoing operations.
- The overall lack of new initiatives or partnerships disclosed in the release may suggest stagnation in business growth and development opportunities.
FAQ
What is Edesa Biotech's main focus in drug development?
Edesa Biotech focuses on developing host-directed therapeutics for immuno-inflammatory diseases, particularly for medical dermatology and respiratory conditions.
What is the status of Edesa's EB06 vitiligo therapy?
Edesa's EB06 is advancing towards a Phase 2 clinical trial for vitiligo, with regulatory submissions anticipated in mid-2025.
How were Edesa's financial results for Q1 2025?
Edesa reported a net loss of $1.6 million for Q1 2025, consistent with management's expectations and following a successful equity financing.
What conferences will Edesa participate in 2025?
Edesa will attend the American Academy of Dermatology Annual Meeting, BIO Europe Spring, and the H.C. Wainwright Autoimmune Conference in March 2025.
How is Edesa funded for its drug development programs?
Edesa's drug development, including EB05 for respiratory issues, is funded by the U.S. government, allowing them to prioritize EB06 for vitiligo.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$EDSA Hedge Fund Activity
We have seen 3 institutional investors add shares of $EDSA stock to their portfolio, and 5 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- DIMENSIONAL FUND ADVISORS LP removed 11,333 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $19,039
- CIBC WORLD MARKET INC. removed 10,770 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $47,926
- TOWER RESEARCH CAPITAL LLC (TRC) added 2,422 shares (+238.4%) to their portfolio in Q4 2024, for an estimated $4,068
- GEODE CAPITAL MANAGEMENT, LLC removed 1,005 shares (-4.8%) from their portfolio in Q4 2024, for an estimated $1,688
- AVION WEALTH removed 242 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $406
- ROYAL BANK OF CANADA added 79 shares (+4.5%) to their portfolio in Q4 2024, for an estimated $132
- NATIONAL BANK OF CANADA /FI/ removed 8 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $13
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
TORONTO, Feb. 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 months ended December 31, 2024 and provided an update on its business.
During the quarter, the company advanced its main asset, EB06, an anti-CXCL10 monoclonal antibody candidate being developed for the effective and durable treatment of vitiligo. Preparation for the manufacturing campaign is underway, with data anticipated to be submitted to regulators at the U.S. Food and Drug Administration (FDA) during the middle of 2025. The company intends to pursue an investigational new drug (IND) application for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients. Edesa anticipates topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA. Health Canada has previously granted approval to initiate this Phase 2 clinical study. The company also reported recently that the development of its anti-TLR4 drug candidate, EB05 (paridiprubart), is fully funded by the U.S. government in a Phase 2 study investigating novel threat-agnostic host-directed therapeutics. As a result of this trial being sponsored and run by the U.S. government, Edesa can prioritize the development of EB06 as a vitiligo therapy.
“Our goal is to be in a position to rapidly launch our vitiligo clinical trial following regulatory clearance,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “Vitiligo significantly impacts the lives of millions worldwide, yet there are no approved drugs that address the systemic nature of the disease. We believe that a targeted immunotherapy, like EB06, that interrupts the disease process on a key point in vitiligo pathogenesis (further downstream from JAK inhibitors) could offer a safe and efficacious treatment.”
Edesa's Chief Financial Officer Stephen Lemieux reported that financial results for the first quarter of fiscal year 2025 were in line with management’s expectations and benefited from a subsequent equity financing. "With a stronger balance sheet, which includes $15.0 million in gross proceeds raised in our institutional investor-led offering, we believe we are well positioned to advance our vitiligo program toward topline data and fund Edesa’s current operating plan.”
Financial
Results
for
the
Three
Months Ended
December
31,
2024
Total operating expenses were unchanged at $1.9 million for the three months ended December 31, 2024 and December 31, 2023:
Research and development expenses increased by $0.3 million to $1.0 million for the three months ended December 31, 2024 compared to $0.7 million for the same period last year primarily due to increased external research expenses related to manufacturing the company’s investigational drug, paridiprubart.
General and administrative expenses decreased by $0.3 million to $0.9 million for the three months ended December 31, 2024 compared to $1.2 million for the same period last year primarily due to a decrease in salaries and related costs, noncash share-based compensation and professional service fees.
Total other income increased by $102,000 to $281,000 for the three months ended December 31, 2024 compared to $179,000 for the same period last year. This increase was primarily due to an increase in reimbursement funding from the Canadian government's Strategic Innovation Fund, which was partially offset by a decrease in interest income.
For the quarter ended December 31, 2024, Edesa reported a net loss of $1.6 million, or $0.48 per common share, compared to a net loss of $1.7 million, or $0.54 per common share, for the quarter ended December 31, 2023.
Working
Capital
At December 31, 2024, Edesa had cash and cash equivalents of $1.6 million and working capital of $0.2 million. Subsequent to the quarter end, the company received $15.0 million in gross proceeds from a private placement of preferred and common shares.
Calendar
Edesa plans to participate in the American Academy of Dermatology Annual Meeting from March 7- 11, 2025, BIO Europe Spring 2025 from March 17-19, 2025, and the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025. 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 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. In addition to EB05, Edesa is preparing an investigational new drug application (IND) in the United States for EB07 (paridiprubart) to conduct a future Phase 2 study in patients with pulmonary fibrosis. Sign up for
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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 preparations for a manufacturing campaign of its anti- CXCL10 monoclonal antibody candidate with data anticipated to be submitted to regulators at the FDA during the middle of 2025; the company’s plans to submit data from the planned manufacturing campaign will U.S. regulators as part of an IND application for a Phase 2 study in vitiligo patients; the company’s anticipation that topline results could be available within as few as 12 to 18 months following regulatory clearance in the U.S; the company’s plans for future funding to support the vitiligo development program; the company’s plans to redeploy more resources to its vitiligo drug development program; the company’s goal to be in a position to rapidly launch its vitiligo clinical trial following regulatory clearance; the company’s belief that a targeted immunotherapy, like EB06, that interrupts the disease process on a key point in vitiligo pathogenesis (further downstream from JAK inhibitors) could offer a safe and efficacious treatment; the company’s belief that first quarter results were in line with management’s expectations, and benefited from a subsequent equity financing; the company’s belief that with a stronger balance sheet, which includes $15.0 million in gross proceeds raised in February 2025, the company is well positioned to advance its vitiligo program toward topline data and fund Edesa’s current operating plan; 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.
(289) 800-9600
investors@edesabiotech.com
Condensed Interim Consolidated Statements of Operations | |||||||||
(Unaudited) | |||||||||
Three Months Ended | |||||||||
December 31, 2024 | December 31,2023 | ||||||||
Expenses: | |||||||||
Research and development | 1,019,818 | 704,458 | |||||||
General and administrative | 878,871 | 1,152,971 | |||||||
Loss from operations | (1,898,689 | ) | (1,857,429 | ) | |||||
Other Income (Loss): | |||||||||
Reimbursement grant income | 301,195 | 120,834 | |||||||
Other income (loss) | (19,759 | ) | 58,144 | ||||||
Net loss | (1,617,253 | ) | (1,678,451 | ) | |||||
Exchange differences on translation | 18,656 | (572 | ) | ||||||
Net comprehensive loss | $ | (1,598,597 | ) | $ | (1,679,023 | ) | |||
Weighted average number of common shares | 3,345,135 | 3,128,024 | |||||||
Loss per common share - basic and diluted | $ | (0.48 | ) | $ | (0.54 | ) | |||
Condensed Interim Consolidated Balance Sheets | |||||||
(Unaudited) | |||||||
December 31, 2024 | September 30, 2024 | ||||||
Assets: | |||||||
Cash and cash equivalents | $ | 1,563,502 | $ | 1,037,320 | |||
Other current assets | 508,426 | 638,302 | |||||
Non-current assets | 2,092,253 | 2,138,360 | |||||
Total Assets | $ | 4,164,181 | $ | 3,813,982 | |||
Liabilities and shareholders' equity: | |||||||
Current liabilities | $ | 1,900,219 | $ | 1,832,827 | |||
Shareholders' equity | 2,263,962 | 1,981,155 | |||||
Total liabilities and shareholders' equity | $ | 4,164,181 | $ | 3,813,982 | |||
Condensed Interim Consolidated Statements of Cash Flows | |||||||||
(Unaudited) | |||||||||
Three Months Ended | |||||||||
December 31, 2024 | December 31,2023 | ||||||||
Cash flows from operating activities: | |||||||||
Net loss | $ | (1,617,253 | ) | $ | (1,678,451 | ) | |||
Adjustments for non-cash items | 124,292 | 229,388 | |||||||
Change in working capital items | (24,242 | ) | 42,535 | ||||||
Net cash used in operating activities | (1,517,203 | ) | (1,406,528 | ) | |||||
Net cash provided by financing activities | 2,071,545 | 305,742 | |||||||
Effect of exchange rate changes on cash and cash equivalents | (28,160 | ) | 7,176 | ||||||
Net change in cash and cash equivalents | 526,182 | (1,093,610 | ) | ||||||
Cash and cash equivalents, beginning of period | 1,037,320 | 5,361,397 | |||||||
Cash and cash equivalents, end of period | $ | 1,563,502 | $ | 4,267,787 | |||||
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