EDSA

EX-99.1

2 exh_991.htm

PRESS RELEASE

EdgarFiling

EXHIBIT 99.1

Edesa Biotech Reports Fiscal 2nd Quarter 2026 Results

TORONTO, May 14, 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 six months ended March 31, 2026 and provided an update on its business.

During the second quarter, Edesa continued preparations for an upcoming Phase 2 clinical study of its drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), in moderate-to-severe nonsegmental vitiligo patients. The company reported that it has contracted a clinical research organization and initiated outreach to potential clinical sites and investigators. Based on this progress, Edesa reaffirmed its previous guidance that site activations and patient recruitment are expected to begin midyear 2026, subject to regulatory approval. For its respiratory program, the company also announced during the quarter additional positive data from its Phase 3 study of paridiprubart in subjects with Acute Respiratory Distress Syndrome. Most notably, treatment benefits were consistent across disease severity groups and in those patients with serious comorbidities, including acute kidney injury, pneumonia and sepsis.

“Our second quarter progress reflects the meaningful strides we are making across both our medical dermatology and respiratory programs,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “In dermatology, our vitiligo program is on track and we are executing against our clinical milestones. Alongside this, the new Phase 3 data for paridiprubart are particularly encouraging, and the consistent treatment benefits demonstrated across patient subgroups reinforce our confidence in this asset's potential to address critical care medicine's most challenging conditions.”

Edesa's Chief Financial Officer Peter Weiler reported that financial results for the second quarter reflected a continuation of trends from the prior period and were in line with management expectations. "We are pleased with the progress being made in our EB06 program as we advance the foundational work needed to bring this study to patients. As anticipated, operating expenses have edged higher in line with these preparations, and we expect that trend to continue as program activity builds,” he said.

Financial Results for the Three Months Ended March 31, 2026

Total operating expenses increased by $2.7 million to $4.3 million for the three months ended March 31, 2026 compared to $1.6 million for the same period in the last year:

Research and development expenses increased by $2.3 million to $2.8 million for the three months ended March 31, 2026 compared to $0.5 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; increased expenses related to regulatory and manufacturing readiness for paridiprubart; and increased unallocated research costs.

General and administrative expenses increased by $0.3 million to $1.5 million for the three months ended March 31, 2026 compared to $1.2 million for the same period year primarily due to an increase in salaries and related costs, and professional fees.

Total other income increased by $30,000 to $79,000 for the three months ended March 31, 2026 compared to $49,000 for the same period last year, primarily due to an increase in reimbursement funding from the Canadian government's Strategic Response Fund and a favorable impact from foreign currency exchange.

For the quarter ended March 31, 2026, Edesa reported a net loss of $4.2 million, or $0.49 per common share, compared to a net loss of $1.6 million, or $0.30 per common share, for the quarter ended March 31, 2025.

Financial Results for the Six Months Ended March 31, 2026

Total operating expenses increased by $3.1 million to $6.6 million for the six months ended March 31, 2026 compared to $3.5 million for the same period last year:

Research and development expenses increased by $2.4 million to $3.9 million for the six months ended March 31, 2026 compared to $1.5 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 expenses related to the completion of the Phase 3 study of paridiprubart.

General and administrative expenses increased by $0.7 million to $2.7 million for the six months ended March 31, 2026 compared to $2.0 million for the same period year primarily due to an increase in salaries and related costs, and professional fees.

Total other income decreased by $158,000 to $173,000 for the six months ended March 31, 2026 co

Form 8-KFalse000154015900015401592026-02-132026-02-13iso4217:USDxbrli:sharesiso4217:USDxbrli:shares

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported):  February 13, 2026

EDESA BIOTECH, INC.

(Exact name of registrant as specified in its charter)

British Columbia, Canada001-37619N/A (State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification No.) 100 Spy Court Markham, Ontario L3R 5H6 (Address of Principal Executive Offices) (Zip Code) (289) 800-9600 (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 classTrading Symbol(s)Name of each exchange on which registered Common SharesEDSAThe Nasdaq Stock Market LLC

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. ☐

Item 2.02. Results of Operations and Financial Condition.

On February 13, 2026, Edesa Biotech, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended December 31, 2025 (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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description

99.1 Press release issued by Edesa Biotech, Inc. dated February 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: February 13, 2026By: /s/ Peter J. Weiler Peter J. Weiler Chief Financial Officer

Form 8-KFalse000154015900015401592025-12-122025-12-12iso4217:USDxbrli:sharesiso4217:USDxbrli:shares

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported):  December 12, 2025

EDESA BIOTECH, INC.

(Exact name of registrant as specified in its charter)

British Columbia, Canada001-37619N/A (State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification No.) 100 Spy Court Markham, Ontario L3R 5H6 (Address of Principal Executive Offices) (Zip Code) (289) 800-9600 (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 classTrading Symbol(s)Name of each exchange on which registered Common SharesEDSAThe Nasdaq Stock Market LLC

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. ☐

Item 2.02. Results of Operations and Financial Condition.

On December 12, 2025, Edesa Biotech, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal year ended September 30, 2025 (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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description

99.1 Press release issued by Edesa Biotech, Inc. dated December 12, 2025. 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: December 12, 2025By: /s/ Peter J. Weiler Peter J. Weiler Chief Financial Officer