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Edesa Biotech (NASDAQ: EDSA) ramps R&D as Q2 2026 loss reaches $4.2M

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Rhea-AI Filing Summary

Edesa Biotech reported fiscal second quarter 2026 results with a net loss of $4.2 million, or $0.49 per share, for the three months ended March 31, 2026, compared with a net loss of $1.6 million, or $0.30 per share, a year earlier.

Total operating expenses rose to $4.3 million from $1.6 million, driven mainly by higher research and development spending for EB06 vitiligo trial preparations and regulatory and manufacturing work for paridiprubart, along with increased salaries and professional fees.

For the six-month period, the company recorded a net loss of $6.5 million, or $0.78 per share, versus $3.2 million, or $0.74 per share, in the prior-year period. Edesa ended March 31, 2026 with cash and cash equivalents of $10.0 million and working capital of $8.2 million, while advancing preparations for a Phase 2 EB06 vitiligo study and reporting additional positive Phase 3 data for paridiprubart in Acute Respiratory Distress Syndrome.

Positive

  • None.

Negative

  • None.
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.
Q2 2026 net loss $4,218,332 Three months ended March 31, 2026
Q2 2025 net loss $1,590,448 Three months ended March 31, 2025
Q2 2026 operating expenses $4,297,000 Total operating expenses, quarter ended March 31, 2026
Q2 2026 R&D expense $2,767,088 Research and development, quarter ended March 31, 2026
Six-month net loss 2026 $6,466,001 Six months ended March 31, 2026
Cash and equivalents $10,003,683 As of March 31, 2026
Working capital $8,200,000 As of March 31, 2026
Shares outstanding (basic EPS) 8,541,146 shares Weighted average common shares, Q2 2026
Phase 2 clinical study medical
"continued preparations for an upcoming Phase 2 clinical study of its drug candidate, 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.
Acute Respiratory Distress Syndrome medical
"Phase 3 study of paridiprubart in subjects with Acute Respiratory Distress Syndrome"
Acute respiratory distress syndrome (ARDS) is a sudden, severe lung condition in which the air sacs fill with fluid or collapse, making it hard for oxygen to pass into the bloodstream — imagine a sponge that can’t hold air. It matters to investors because ARDS drives demand for critical care treatments, ventilators, drugs and longer hospital stays, influences clinical trial design and approval chances for therapies, and can materially affect healthcare costs and company revenues tied to respiratory care.
monoclonal antibody medical
"EB06 (an anti-CXCL10 monoclonal antibody), in moderate-to-severe nonsegmental vitiligo patients"
A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.
working capital financial
"At March 31, 2026, Edesa had cash and cash equivalents of $10.0 million and working capital of $8.2 million"
Working capital is the money a business has available to cover its daily expenses, like paying bills and buying supplies. It’s like the cash in your wallet that helps you handle everyday costs; having enough ensures the business can operate smoothly without running into money shortages.
forward-looking statements regulatory
"This press release may contain forward-looking statements within the meaning of Section 27A"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Net loss $4,218,332
Operating expenses $4,296,994
R&D expense $2,767,088
G&A expense $1,529,906
Understanding 8-K Material Events →
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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):  May 14, 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 May 14, 2026, Edesa Biotech, Inc. (the “Company”) issued a press release announcing its financial results for the three and six months ended March 31, 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 May 14, 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: May 14, 2026By: /s/ Peter J. Weiler        
  Peter J. Weiler
  Chief Financial Officer
  

 

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 compared to $331,000 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 six months ended March 31, 2026, Edesa reported a net loss of $6.5 million, or $0.78 per common share, compared to a net loss of $3.2 million, or $0.74 per common share, for the six months ended March 31, 2025.

Working Capital

At March 31, 2026, Edesa had cash and cash equivalents of $10.0 million and working capital of $8.2 million.

Calendar

Edesa plans to participate in the Respiratory Innovation Summit from May 15-16, 2026; the American Thoracic Society (ATS) 2026 International Conference from May 15-20. 2026; the Dermatology Drug Development Summit from May 19-21, 2026; and the BIO International Convention being held June 22-25, 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 (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, 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 for an upcoming Phase 2 study in moderate-to-severe nonsegmental vitiligo; the company’s belief that site activations and patient recruitment for its vitiligo study will begin midyear 2026; the company’s belief that second quarter progress reflects the meaningful strides across both its medical dermatology and respiratory programs; the company’s belief that its vitiligo program is on track and staff are executing against the company’s clinical milestones; the company’s belief that paridiprubart has the potential to address critical care medicine's most challenging conditions; the company’s belief that trends for increased operating expenses will continue as program activity builds; 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 Six Months Ended 
  March 31, 2026 March 31, 2025 March 31, 2026 March 31, 2025 
          
Expenses:         
Research and development  2,767,088   484,306  $3,891,815  $1,504,124  
General and administrative  1,529,906   1,154,580   2,746,562   2,033,451  
          
Loss from operations  (4,296,994)  (1,638,886)  (6,638,377)  (3,537,575) 
          
Other Income (Loss):         
Reimbursement grant income  66,228   52,268   168,653   353,463  
Other income (loss)  79,462   49,238   173,176   330,674  
          
Loss before income taxes  (4,217,532)  (1,589,648)  (6,465,201)  (3,206,901) 
          
Income tax expense  800   800   800   800  
          
Net loss  (4,218,332)  (1,590,448)  (6,466,001)  (3,207,701) 
          
Exchange differences on translation  (15,003)  (63,731)  (20,318)  (45,075) 
          
Net comprehensive loss $(4,233,335) $(1,654,179) $(6,486,319) $(3,252,776) 
          
Weighted average number of common shares  8,541,146   5,305,763   8,253,715   4,314,676  
          
Loss per common share - basic and diluted $(0.49) $(0.30) $(0.78) $(0.74) 
          
          
          



      
Condensed Interim Consolidated Balance Sheets 
(Unaudited) 
      
  March 31, 2026 September 30, 2025 
      
Assets:    
 Cash and cash equivalents$10,003,683 $10,792,172 
 Other current assets 414,044  720,704 
 Non-current assets 1,967,011  2,017,642 
      
 Total Assets$12,384,738 $13,530,518 
      
Liabilities and shareholders' equity:    
 Current liabilities$2,187,921 $1,078,536 
 Shareholders' equity 10,196,817  12,451,982 
      
 Total liabilities and shareholders' equity$12,384,738 $13,530,518 
      
      
      



Condensed Interim Consolidated Statements of Cash Flows
(Unaudited)
     
 Six Months Ended 
 March 31, 2026 March 31, 2025 
     
Cash flows from operating activities:    
Net loss$(6,466,001) $(3,207,701) 
Adjustments for non-cash items 936,047   215,454  
Change in working capital items 1,425,998   (908,254) 
     
Net cash used in operating activities (4,103,956)  (3,900,501) 
     
Net cash provided by financing activities 3,346,439   16,844,415  
     
Effect of exchange rate changes on cash and cash equivalents (30,972)  (84,584) 
     
Net change in cash and cash equivalents (788,489)  12,859,330  
Cash and cash equivalents, beginning of period 10,792,172   1,037,320  
     
Cash and cash equivalents, end of period$10,003,683  $13,896,650  
     


Source: View Original Filing on SEC EDGAR

FAQ

How did Edesa Biotech (EDSA) perform in fiscal Q2 2026?

Edesa Biotech reported a net loss of $4.2 million, or $0.49 per share, for the quarter ended March 31, 2026. This compares with a net loss of $1.6 million, or $0.30 per share, in the same quarter of 2025.

What drove higher operating expenses for Edesa Biotech (EDSA) in Q2 2026?

Total operating expenses increased to $4.3 million from $1.6 million, mainly due to higher research and development spending. Key drivers were manufacturing and preparation costs for the planned Phase 2 EB06 vitiligo trial and regulatory and manufacturing readiness activities for paridiprubart.

What were Edesa Biotech’s (EDSA) results for the six months ended March 31, 2026?

For the six-month period, Edesa Biotech reported a net loss of $6.5 million, or $0.78 per share. This compares with a net loss of $3.2 million, or $0.74 per share, in the same six-month period of 2025.

How much cash and working capital does Edesa Biotech (EDSA) have?

As of March 31, 2026, Edesa Biotech held $10.0 million in cash and cash equivalents and reported $8.2 million of working capital. These figures reflect funding for ongoing research and clinical development programs.

What clinical programs is Edesa Biotech (EDSA) advancing based on this update?

Edesa is preparing a Phase 2 clinical study of EB06 for moderate-to-severe nonsegmental vitiligo and reported additional positive Phase 3 data for paridiprubart in Acute Respiratory Distress Syndrome, highlighting consistent treatment benefits across disease severity and key comorbidity subgroups.

How did Edesa Biotech’s (EDSA) research and development spending change?

For the quarter ended March 31, 2026, research and development expenses rose to $2.8 million from $0.5 million a year earlier. The increase reflects manufacturing-related work and other preparations for the planned EB06 vitiligo Phase 2 study and higher unallocated research costs.

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