Edesa Biotech Reports Fiscal 1st Quarter 2026 Results
Rhea-AI Summary
Edesa Biotech (Nasdaq:EDSA) reported Q1 FY2026 results for the three months ended December 31, 2025, and program updates.
The company advanced manufacturing of EB06 and placebo for a planned Phase 2 vitiligo study with recruitment anticipated mid‑2026, reported positive Phase 3 results for paridiprubart in ARDS and is evaluating subgroup efficacy signals.
Financials: Operating expenses $2.3M, net loss $2.2M ($0.28/sh), cash and equivalents $12.1M, working capital $12.0M.
Positive
- Phase 3 positive results for paridiprubart in ARDS
- Manufacturing advanced for EB06 and placebo for Phase 2 vitiligo
- Cash and cash equivalents of $12.1M at Dec 31, 2025
Negative
- Net loss of $2.2M (Q1 FY2026)
- Total operating expenses increased by $0.4M to $2.3M
- Total other income decreased by $0.2M to $0.1M
Key Figures
Market Reality Check
Peers on Argus
EDSA fell 7.01% while key peers showed mixed moves: in sector context NBY -13.39%, BLRX -3.3%, THAR -2.95%, LGVN -1.07%, MTVA -1.19%. Momentum peers were split with PULM -2.03% and MTVA, NBY in the up direction. This points to largely stock-specific pressure on EDSA.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 12 | Annual results & update | Positive | -16.1% | Fiscal 2025 results with positive Phase 3 ARDS data and EB06 progress. |
| Oct 31 | Conference participation | Neutral | -0.5% | Announcement of management participation at BIO-Europe and LSX Investival. |
| Oct 28 | Phase 3 clinical data | Positive | -17.9% | Positive Phase 3 ARDS results for paridiprubart with mortality reduction. |
Recent history shows sharp negative reactions to positive clinical and earnings-related updates, suggesting a pattern of selloffs on ostensibly favorable news.
Over the past few months, Edesa reported multiple catalysts. On Oct 28, 2025, it announced positive Phase 3 ARDS results for paridiprubart yet the stock fell 17.87%. On Dec 12, 2025, fiscal 2025 results highlighted statistically significant Phase 3 data and progress on EB06, but shares declined 16.09%. A conference-participation update on Oct 31, 2025 had little effect (-0.53%). Today’s quarter shows higher operating expenses and net loss while advancing the same core programs, fitting this pattern of pressure despite pipeline progress.
Regulatory & Risk Context
The company has an active shelf registration on Form S-3 filed on 2025-07-25, currently indicated as not effective, with an expiration date of 2028-07-25. It has been used in 2 prospectus supplements (forms 424B5 dated 2025-09-09 and 2025-12-12).
Market Pulse Summary
This announcement details higher operating expenses of $2.3 million and a wider net loss of $2.2 million as Edesa advances EB06 toward a Phase 2 vitiligo trial and analyzes positive Phase 3 ARDS data for paridiprubart. Recent history shows significant moves around clinical and earnings disclosures, including reactions of -16.09% and -17.87%. Investors may want to track upcoming conference presentations, progress toward mid‑2026 recruitment, cash usage versus the $12.1 million balance, and any further use of the company’s active S‑3 shelf.
Key Terms
monoclonal antibody medical
phase 2 medical
phase 3 medical
AI-generated analysis. Not financial advice.
TORONTO, Feb. 13, 2026 (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, 2025 and provided an update on its business.
During the first quarter, Edesa progressed manufacturing of its dermatology drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), and placebo for an upcoming Phase 2 study in moderate-to-severe nonsegmental vitiligo. The company anticipates recruitment will begin midyear 2026, subject to regulatory approvals. In its respiratory program, Edesa reported that it is evaluating subgroup data for additional efficacy signals among subjects with certain comorbidities following positive results from a Phase 3 study of its monoclonal antibody, paridiprubart, in patients with Acute Respiratory Distress Syndrome. The company plans to present its Phase 3 respiratory and subgroup data at upcoming scientific and medical conferences.
“Manufacturing plans for our upcoming vitiligo study are on schedule, and we are advancing the EB06 program toward regulatory readiness and launch,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “In parallel, we are utilizing positive Phase 3 data to explore accelerated commercialization pathways as well as potential broader strategic opportunities for paridiprubart.”
Edesa's Chief Financial Officer Peter Weiler reported that financial results for the first quarter reflected the continuation of trends from the preceding period, including the ramp up in activities for the company’s vitiligo drug development program as well as the completion of the Phase 3 clinical study of paridiprubart. “Management remains disciplined in deploying resources and executing in line with our plans. Going forward, we anticipate that research expenditures will generally track activity in our EB06 program, including the manufacturing of clinical drug supplies. We continue to evaluate opportunities to achieve our clinical objectives more efficiently, such as establishing investigational sites across multiple jurisdictions to provide greater cost and operational flexibility.”
Financial Results for the Three Months Ended December 31, 2025
Total operating expenses increased by
- Research and development expenses increased by
$0.1 million to$1.1 million for the three months ended December 31, 2025 compared to$1.0 million for the same period last 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 unallocated research costs, which were offset by decreased expenses related to the completion of the Phase 3 study of paridiprubart. - General and administrative expenses increased by 0.3 million to
$1.2 million for the three months ended December 31, 2025 compared to$0.9 million for the same period year primarily due to an increase in noncash share-based compensation.
Total other income decreased by
For the quarter ended December 31, 2025, Edesa reported a net loss of
Working Capital
At December 31, 2025, Edesa had cash and cash equivalents of
Calendar
Edesa plans to participate in the Global Vitiligo Foundation Annual Scientific Symposium on March 26, 2026; BIO Europe Spring 2026 from March 23-25, 2026; the Respiratory Innovation Summit from May 15-16, 2026; the American Thoracic Society (ATS) 2026 International Conference from May 15-20. 2026; and the Dermatology Drug Development Summit from May 19-21, 2026. 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 for an upcoming Phase 2 study in moderate-to-severe nonsegmental vitiligo; the company’s belief that recruitment for its vitiligo study will begin midyear 2026, subject to regulatory approvals; the company’s plans to present its Phase 3 respiratory and subgroup data at upcoming scientific and medical conferences; the company’s belief that its manufacturing plans for the vitiligo study are on schedule and advancing toward regulatory readiness and launch; the company’s belief that positive Phase 3 data for paridiprubart creates opportunities for accelerated commercialization pathways as well as potential broader strategic opportunities for the drug candidate; management’s intentions to remain disciplined in deploying resources and executing in line with its plans; the company’s anticipation that research expenditures will generally track activity in its EB06 program, including the manufacturing of clinical drug supplies; the company’s intention to evaluate opportunities to achieve its clinical objectives more efficiently, such as establishing investigational sites across multiple jurisdictions to provide greater cost and operational flexibility; 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 | ||||||||||
| December 31, 2025 | December 31, 2024 | |||||||||
| Expenses: | ||||||||||
| Research and development | $ | 1,124,727 | $ | 1,019,818 | ||||||
| General and administrative | 1,216,656 | 878,871 | ||||||||
| Loss from operations | (2,341,383 | ) | (1,898,689 | ) | ||||||
| Other Income (Loss): | ||||||||||
| Reimbursement grant income | 102,425 | 301,195 | ||||||||
| Other income (loss) | (8,711 | ) | (19,759 | ) | ||||||
| Net loss | (2,247,669 | ) | (1,617,253 | ) | ||||||
| Exchange differences on translation | (5,315 | ) | 18,656 | |||||||
| Net comprehensive loss | $ | (2,252,984 | ) | $ | (1,598,597 | ) | ||||
| Weighted average number of common shares | 7,972,532 | 3,345,135 | ||||||||
| Loss per common share - basic and diluted | $ | (0.28 | ) | $ | (0.48 | ) | ||||
| Condensed Interim Consolidated Balance Sheets | |||||||
| (Unaudited) | |||||||
| December 31, 2025 | September 30, 2025 Audited | ||||||
| Assets: | |||||||
| Cash and cash equivalents | $ | 12,051,748 | $ | 10,792,172 | |||
| Other current assets | 665,739 | 720,704 | |||||
| Non-current assets | 1,992,955 | 2,017,642 | |||||
| Total Assets | $ | 14,710,442 | $ | 13,530,518 | |||
| Liabilities and shareholders' equity: | |||||||
| Current liabilities | $ | 756,163 | $ | 1,078,536 | |||
| Shareholders' equity | 13,954,279 | 12,451,982 | |||||
| Total liabilities and shareholders' equity | $ | 14,710,442 | $ | 13,530,518 | |||
| Condensed Interim Consolidated Statements of Cash Flows | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended | ||||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (2,247,669 | ) | $ | (1,617,253 | ) | ||
| Adjustments for non-cash items | 425,322 | 124,292 | ||||||
| Change in working capital items | (264,987 | ) | (24,242 | ) | ||||
| Net cash used in operating activities | (2,087,334 | ) | (1,517,203 | ) | ||||
| Net cash provided by financing activities | 3,355,419 | 2,071,545 | ||||||
| Effect of exchange rate changes on cash and cash equivalents | (8,509 | ) | (28,160 | ) | ||||
| Net change in cash and cash equivalents | 1,259,576 | 526,182 | ||||||
| Cash and cash equivalents, beginning of period | 10,792,172 | 1,037,320 | ||||||
| Cash and cash equivalents, end of period | $ | 12,051,748 | $ | 1,563,502 | ||||
FAQ
When will Edesa (EDSA) begin recruiting patients for the Phase 2 EB06 vitiligo study?
What did Edesa (EDSA) report about paridiprubart Phase 3 results and next steps?
What were Edesa's (EDSA) key financials for the quarter ended December 31, 2025?
Why did Edesa's (EDSA) operating expenses increase in Q1 FY2026?
Will Edesa (EDSA) present clinical data at upcoming conferences in 2026?
