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Edesa Biotech (NASDAQ: EDSA) posts larger Q3 2026 loss as R&D spending climbs

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Edesa Biotech, Inc. reported fiscal third-quarter 2026 results and business updates. The company completed preparations for a Phase 2 clinical study of EB06 for moderate-to-severe vitiligo and began activating investigational sites after quarter-end, with initial recruitment expected in Canada, followed by additional jurisdictions subject to regulatory approvals.

In its respiratory program, exploratory analyses in ARDS patients with concurrent acute kidney injury associated paridiprubart plus standard of care with mortality reductions and improvements in the kidney-specific MAKE30 composite endpoint, and Edesa is evaluating regulatory pathways and strategic options. Financially, total operating expenses for the quarter rose to $5.5 million from $1.9 million a year earlier, driven mainly by higher R&D spending on EB06 and increased general and administrative costs. Net loss for the quarter widened to $5.4 million, or $0.60 per share, from $1.7 million, or $0.25 per share. For the nine months ended June 30, 2026, net loss was $11.9 million versus $5.0 million in the prior-year period. At June 30, 2026, Edesa held $10.3 million in cash and cash equivalents and reported working capital of $6.9 million.

Positive

  • None.

Negative

  • Net losses significantly widened, reaching $5.4 million for Q3 2026 and $11.9 million for the nine months, compared with $1.7 million and $5.0 million in the prior-year periods.
  • Total operating expenses more than doubled to $5.5 million for Q3 2026 and $12.2 million for the nine months, primarily from higher R&D related to the EB06 Phase 2 study and increased G&A costs.

Filing Explained

This Form 8-K furnishes Edesa’s results and business update for the period ended 2026-06-30 under Item 2.02; its Exhibit 99.1 is not deemed filed under Section 18 or incorporated by reference unless another filing expressly references it.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Q3 2026 Total Operating Expenses $5,519,549 Three months ended June 30, 2026
Q3 2025 Total Operating Expenses $1,903,743 Three months ended June 30, 2025
Q3 2026 Net Loss $5,407,611 Three months ended June 30, 2026
Nine Months 2026 Net Loss $11,873,612 Nine months ended June 30, 2026
Cash and Cash Equivalents $10,332,520 As of June 30, 2026
Working Capital $6,900,000 Approximate working capital at June 30, 2026
Net Cash Used in Operating Activities $7,186,629 Nine months ended June 30, 2026
Net Cash Provided by Financing Activities $6,793,376 Nine months ended June 30, 2026
Phase 2 clinical study medical
"completed preparations for its Phase 2 clinical study of EB06"
A phase 2 clinical study is a mid-stage human test that checks whether a new drug or medical treatment works for the intended condition and further evaluates safety and dosing in a larger but still limited group of patients. For investors, phase 2 results are a key signal: positive findings make it more likely the treatment will progress toward larger, definitive trials and regulatory approval, while negative results can sharply reduce a drug’s commercial prospects, much like a prototype failing vital real-world tests.
nonsegmental vitiligo medical
"in patients with moderate-to-severe nonsegmental vitiligo"
Nonsegmental vitiligo is a chronic autoimmune condition in which the immune system attacks pigment-producing cells, causing irregular, often symmetrical white patches of skin. Investors watch it because treatments and approvals can create long-term markets—similar to replacing a worn paint job on many houses, effective therapies can require ongoing care, drive substantial drug sales, and influence company value and regulatory risk.
Acute Respiratory Distress Syndrome (ARDS) medical
"developed as a potential treatment for Acute Respiratory Distress Syndrome (ARDS)"
Acute respiratory distress syndrome (ARDS) is a sudden, severe lung condition where fluid fills the tiny air sacs and the lungs become stiff, making it hard for oxygen to get into the blood—think of lungs like sponges that have become waterlogged and rigid. It matters to investors because ARDS drives urgent hospital care, use of ventilators and monitoring equipment, and demand for drugs and therapies, so changes in its incidence or treatment can affect healthcare costs, hospital capacity and the outlook for medical companies.
acute kidney injury (AKI) medical
"ARDS patients with concurrent acute kidney injury (AKI)"
A sudden decline in kidney function that happens over hours to days, reducing the organ’s ability to filter waste and balance fluids and salts. It matters to investors because it can drive demand for therapies, devices, diagnostics, and hospital care, alter clinical trial results, trigger regulatory scrutiny, and create unexpected costs or liability—much like a sudden engine failure forces an expensive and urgent repair that affects the value of related businesses.
MAKE30 composite endpoint medical
"improvements in the kidney-specific MAKE30 composite endpoint"
A MAKE30 composite endpoint is a commonly used clinical trial measure that combines several serious kidney-related outcomes observed within 30 days, typically death, the need for new dialysis (renal replacement therapy), and persistent decline in kidney function. It matters to investors because it summarizes short-term safety and effectiveness in a single metric that regulators, clinicians, and payers use to judge a therapy’s impact—similar to a car’s safety rating that bundles multiple crash outcomes into one score.
Strategic Response Fund financial
"funding from the Canadian government's Strategic Response Fund"
Q3 2026 Net Loss $5,407,611 Higher than Q3 2025 net loss of $1,749,464
Nine Months 2026 Net Loss $11,873,612 Higher than nine months 2025 net loss of $4,957,165
Q3 2026 Total Operating Expenses $5,519,549 Higher than Q3 2025 total operating expenses of $1,903,743
Cash and Cash Equivalents $10,332,520 Slightly lower than September 30, 2025 balance of $10,792,172

FAQ

How did Edesa Biotech (EDSA) perform financially in Q3 2026?
Edesa Biotech reported a Q3 2026 net loss of $5.4 million, or $0.60 per share, compared with a net loss of $1.7 million, or $0.25 per share, in the same quarter of 2025, reflecting higher operating expenses.

What were Edesa Biotech's (EDSA) operating expenses for Q3 and the first nine months of 2026?
Total operating expenses were $5.5 million for Q3 2026 and $12.2 million for the nine months ended June 30, 2026. These increases were mainly driven by higher R&D spending on EB06 and increased general and administrative costs.

What is Edesa Biotech's (EDSA) cash position and working capital as of June 30, 2026?
As of June 30, 2026, Edesa Biotech had $10.3 million in cash and cash equivalents and $6.9 million in working capital. This reflects year-to-date net cash used in operating activities of $7.2 million, partially offset by $6.8 million from financing activities.

What clinical progress did Edesa Biotech (EDSA) report for EB06 in vitiligo?
Edesa completed preparations for its Phase 2 clinical study of EB06 in moderate-to-severe nonsegmental vitiligo and, after quarter-end, began activating investigational sites. The company expects patient recruitment to begin in the coming weeks in Canada, with additional jurisdictions to follow.

What did Edesa Biotech (EDSA) report about paridiprubart in ARDS with acute kidney injury?
In ARDS patients with concurrent acute kidney injury, paridiprubart plus standard of care was associated with mortality reductions and improvements in the MAKE30 composite endpoint. Edesa is assessing regulatory pathways in major markets and pursuing strategic discussions for this program.

How did Edesa Biotech's (EDSA) research and development and G&A expenses change in Q3 2026?
For Q3 2026, R&D expenses rose to $4.0 million from $0.9 million, mainly due to EB06 Phase 2 preparations. General and administrative expenses increased to $1.6 million from $1.0 million, primarily reflecting higher share-based compensation and professional fees.

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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):  August 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 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.

 

Item 9.01. Financial Statements and Exhibits.

 

(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, 2026By: /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 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 (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.
investors@edesabiotech.com

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 

Source: View Original Filing on SEC EDGAR

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