EDSA 8-K
Edesa Biotech, Inc. (EDSA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
_______________________________
(Exact name of registrant as specified in its charter)
_______________________________
| N/A | ||
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
(Address of Principal Executive Offices) (Zip Code)
(
(Registrant's telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
_______________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On August 13, 2026, Edesa Biotech, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended June 30, 2026 (the “Earnings Release”). The full text of the Earnings Release is attached hereto as Exhibit 99.1. The information furnished herein and therein shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release issued by Edesa Biotech, Inc. dated August 13, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EDESA BIOTECH, INC. | ||
| Date: August 13, 2026 | By: | /s/ Peter J. Weiler |
| Peter J. Weiler | ||
| Chief Financial Officer | ||
EXHIBIT 99.1
Edesa Biotech Reports Fiscal 3rd Quarter 2026 Results
TORONTO, Aug. 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 and nine months ended June 30, 2026 and provided an update on its business.
During the third quarter, Edesa completed preparations for its Phase 2 clinical study of EB06 (an anti-CXCL10 monoclonal antibody) in patients with moderate-to-severe nonsegmental vitiligo. Subsequent to quarter-end, the company began activating its first investigational sites and expects recruitment to begin in the coming weeks in Canada, with additional jurisdictions to follow, subject to regulatory approval and administrative filings. In its respiratory program, the company conducted additional exploratory analyses to evaluate paridiprubart’s effect in ARDS patients with concurrent acute kidney injury (AKI). In this population, paridiprubart plus standard of care treatment was associated with significant mortality reductions supported by concordant improvements in the kidney-specific MAKE30 composite endpoint. Edesa continues to evaluate potential regulatory pathways in major markets while advancing strategic discussions for the program.
"Our third quarter marked an important operational inflection point for Edesa, with the completion of preparations for our Phase 2 vitiligo study keeping us on track for initial enrollment in the coming weeks," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "In addition, the positive exploratory data in patients with acute kidney injury further reinforce the versatility of paridiprubart and support our engagement with potential partners as we advance late-stage development and evaluate future commercialization pathways."
Edesa’s Chief Financial Officer Peter Weiler said third quarter results tracked to the company’s operating plan, with spending beginning to shift from preparatory activities toward clinical trial execution. “We are prioritizing execution of the EB06 Phase 2 study while continuing to support regulatory, manufacturing and business development activities for paridiprubart,” he said.
Financial Results for the Three Months Ended June 30, 2026
Total operating expenses increased by $3.6 million to $5.5 million for the three months ended June 30, 2026 compared to $1.9 million for the same period last year:
- Research and development expenses increased by $3.1 million to $4.0 million for the three months ended June 30, 2026 compared to $0.9 million for the same period last year primarily due to increased expenses for manufacturing-related activities and other preparations for the planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased unallocated research costs, which were partially offset by decreased expenditures for the company’s paridiprubart program.
- General and administrative expenses increased by $0.6 million to $1.6 million for the three months ended June 30, 2026 compared to $1.0 million for the same period last year primarily due to increases in noncash share-based compensation and professional fees.
Total other income decreased by approximately $42,000 to $112,000 for the three months ended June 30, 2026 compared to $154,000 for the same period last year, primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Response Fund, which was partially offset by a favorable impact from foreign currency exchange.
For the quarter ended June 30, 2026, Edesa reported a net loss of $5.4 million, or $0.60 per common share, compared to a net loss of $1.7 million, or $0.25 per common share, for the quarter ended June 30, 2025.
Financial Results for the Nine Months Ended June 30, 2026
Total operating expenses increased by $6.8 million to $12.2 million for the nine months ended June 30, 2026 compared to $5.4 million for the same period last year:
- Research and development expenses increased by $5.4 million to $7.8 million for the nine months ended June 30, 2026 compared to $2.4 million for the same period last year primarily due to increased expenses for manufacturing-related activities and other preparations for the planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased unallocated research costs, which were partially offset by decreased expenditures for the company’s paridiprubart program.
- General and administrative expenses increased by $1.3 million to $4.3 million for the nine months ended June 30, 2026 compared to $3.0 million for the same period last year primarily due to increases in noncash share-based compensation and professional fees.
Total other income decreased by $200,000 to $285,000 for the nine months ended June 30, 2026 compared to $485,000 for the same period last year, primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Response Fund, which was partially offset by a favorable impact from foreign currency exchange.
For the nine months ended June 30, 2026, Edesa reported a net loss of $11.9 million, or $1.40 per common share, compared to a net loss of $5.0 million, or $0.95 per common share, for the nine months ended June 30, 2025.
Working Capital
At June 30, 2026, Edesa had cash and cash equivalents of $10.3 million and working capital of $6.9 million.
Calendar
Edesa management is scheduled to participate in the H.C. Wainwright 28th Annual Global Investment Conference to be held September 12-13, 2026 in New York, NY. Attendees interested in meeting with company representatives can request meetings through the conference organizers or by contacting Edesa directly at [email protected].
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 (ARDS), 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. 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 plans and expectations regarding the conduct of its Phase 2 clinical study of EB06 in vitiligo patients; the company's expectation that patient recruitment and enrollment will commence in the coming weeks in Canada, with additional jurisdictions to follow, subject to regulatory approvals and any required administrative filings; the company's belief that findings from its exploratory analyses in ARDS patients with acute kidney injury at baseline further support the therapeutic potential of paridiprubart; the company's plans to evaluate potential regulatory pathways for paridiprubart in major markets; the company's plans to engage in strategic and business development discussions regarding paridiprubart, including with potential partners, and the potential outcomes of such discussions; the company's plans to advance paridiprubart through late-stage development and evaluate future commercialization opportunities; the company's belief that the third quarter represented an important operational milestone for the company; the company's expectations regarding the shift in spending from preparatory activities toward clinical trial execution and the composition of its operating expenses; the company's plans regarding capital allocation, including prioritizing execution of the Phase 2 EB06 study while continuing to support regulatory and business development activities for paridiprubart; and the company's timing and plans regarding its clinical programs 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.
[email protected]
| Condensed Interim Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| June 30, 2026 | June 30, 2025 | June 30, 2026 | June 30, 2025 | |||||||||||||
| Expenses: | ||||||||||||||||
| Research and development | 3,957,875 | 939,067 | $ | 7,849,690 | $ | 2,443,191 | ||||||||||
| General and administrative | 1,561,674 | 964,676 | 4,308,236 | 2,998,127 | ||||||||||||
| Loss from operations | (5,519,549 | ) | (1,903,743 | ) | (12,157,926 | ) | (5,441,318 | ) | ||||||||
| Other Income (Loss): | ||||||||||||||||
| Reimbursement grant income | 107,368 | 183,281 | 276,021 | 536,744 | ||||||||||||
| Other income (loss) | 111,938 | 154,279 | 285,114 | 484,953 | ||||||||||||
| Loss before income taxes | (5,407,611 | ) | (1,749,464 | ) | (11,872,812 | ) | (4,956,365 | ) | ||||||||
| Income tax expense | - | - | 800 | 800 | ||||||||||||
| Net loss | (5,407,611 | ) | (1,749,464 | ) | (11,873,612 | ) | (4,957,165 | ) | ||||||||
| Exchange differences on translation | 27,548 | 164,611 | 7,230 | 119,536 | ||||||||||||
| Net comprehensive loss | $ | (5,380,063 | ) | $ | (1,584,853 | ) | $ | (11,866,382 | ) | $ | (4,837,629 | ) | ||||
| Weighted average number of common shares | 9,007,474 | 7,022,678 | 8,504,968 | 5,217,343 | ||||||||||||
| Loss per common share - basic and diluted | $ | (0.60 | ) | $ | (0.25 | ) | $ | (1.40 | ) | $ | (0.95 | ) | ||||
| Condensed Interim Consolidated Balance Sheets | ||||||||
| (Unaudited) | ||||||||
| June 30, 2026 | September 30, 2025 | |||||||
| Assets: | ||||||||
| Cash and cash equivalents | $ | 10,332,520 | $ | 10,792,172 | ||||
| Other current assets | 447,758 | 720,704 | ||||||
| Non-current assets | 1,940,917 | 2,017,642 | ||||||
| Total Assets | $ | 12,721,195 | $ | 13,530,518 | ||||
| Liabilities and shareholders' equity: | ||||||||
| Current liabilities | $ | 3,910,041 | $ | 1,078,536 | ||||
| Shareholders' equity | 8,811,154 | 12,451,982 | ||||||
| Total liabilities and shareholders' equity | $ | 12,721,195 | $ | 13,530,518 | ||||
| Condensed Interim Consolidated Statements of Cash Flows | ||||||||
| (Unaudited) | ||||||||
| Nine Months Ended | ||||||||
| June 30, 2026 | June 30, 2025 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (11,873,612 | ) | $ | (4,957,165 | ) | ||
| Adjustments for non-cash items | 1,509,154 | 418,622 | ||||||
| Change in working capital items | 3,177,829 | (1,062,725 | ) | |||||
| Net cash used in operating activities | (7,186,629 | ) | (5,601,268 | ) | ||||
| Net cash provided by financing activities | 6,793,376 | 16,844,415 | ||||||
| Effect of exchange rate changes on cash and cash equivalents | (66,399 | ) | 81,223 | |||||
| Net change in cash and cash equivalents | (459,652 | ) | 11,324,370 | |||||
| Cash and cash equivalents, beginning of period | 10,792,172 | 1,037,320 | ||||||
| Cash and cash equivalents, end of period | $ | 10,332,520 | $ | 12,361,690 | ||||