EDSA

Subject to regulatory approval, we anticipate initiating enrollment by midyear 2026.
In October 2025, we reported that paridiprubart met primary and secondary endpoints with statistical significance, providing clinically meaningful improvement in survival and recovery, in a truncated Phase 3 clinical study of hospitalized patients with Acute Respiratory Distress Syndrome (“ARDS”), a life-threatening form of respiratory failure.
Paridiprubart is also being evaluated in an ongoing U.S. government-funded platform study investigating three novel threat-agnostic HDTs in hospitalized patients with ARDS.
We are also pursuing additional uses for paridiprubart in chronic diseases.
Before proceeding with enrollment in Canada, we may modify our current Canadian study design with Health Canada to conform the protocol with other jurisdictions.
To conduct the planned study at U.S. investigational centers, we must first complete the manufacturing of the drug and submit related data to the FDA as part of an investigational new drug application (“IND”).
To date, we have completed a process confirmation batch of EB06 and intend to initiate engineering and clinical-grade (“GMP”) manufacturing runs in the coming weeks.
We anticipate data from these activities to be submitted to the FDA once the work is completed.
Subject to regulatory approval, we anticipate initiating recruitment by midyear 2026.
We anticipate topline results for this Phase 2 study could be available within as few as 9 to 12 months following regulatory clearance in the U.S.
We are currently exploring development and commercialization partnerships for paridiprubart as well as expedited regulatory pathways that may be available in certain jurisdictions.
Positive Phase 3 Results In a Phase 3 clinical study, we evaluated paridiprubart (EB05) as a treatment for ARDS.
Participants were 18 years or older, receiving Invasive Mechanical Ventilation (“IMV”) with or without additional organ support at the time of hospitalization.
They were randomly assigned (1:1) to standard of care treatment (“SOC”) with paridiprubart (n=56), or SOC with placebo (n=48).
Efficacy outcomes were 28-day and 60-day mortality and proportion of patients with a decrease of ≥ 2 points in the WHO Covid-19 Severity Scale (“WCSS”) at 28-days.
We opted to discontinue enrollment early for business reasons.
The data from the Phase 3 study demonstrated that paridiprubart met primary and secondary endpoints with statistical significance.
Paridiprubart led to a clinically significant reduction in mortality through 60 days, as well as a significant reduction in the proportion of patients requiring IMV.
Paridiprubart in the most conservative intention-to-treat (“ITT”) population met the primary endpoint, demonstrating a statistically significant and clinically meaningful benefit for reduced mortality at 28 days.
Patients treated with paridiprubart + SOC had a lower risk of death (39%) compared to those receiving placebo (52%), representing an absolute improvement in survival of 13% at 28 days with paridiprubart demonstrating a relative reduction in the risk of death of 25% compared to placebo (n=104; p<0.001).
A durable survival benefit was also demonstrated at 60 days, with patients treated with paridiprubart plus SOC demonstrating a lower risk of death (46%) compared to those receiving placebo (59%), representing an absolute improvement in survival of 13% with a relative risk reduction of 22% for paridiprubart compared to placebo (n=104; p=0.003).
In addition, subjects receiving paridiprubart + SOC demonstrated a 41% higher relative rate of clinical improvement, meaning patients no longer required IMV and/or organ support at Day 28.
The results from a safety population of more than 275 subjects, which included patients enrolled during the interim between the Phase 2 and Phase 3 study, demonstrated that EB05 was generally well-tolerated and consistent with the observed safety profile to date.
Previous Phase 2 Clinical Study In a signal-finding Phase 2 clinical study evaluating paridiprubart in hospitalized Covid-19 patients at various disease severity levels, paridiprubart demonstrated a statistically significant and clinically meaningful trend for 28-day mortality for all randomized subjects in the critically ill cohort (the intent to treat, or ITT, population).
The 28-day death rate in the EB05 plus SOC arm was 7.7% versus 40% in the placebo + SOC arm in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation) IMV plus organ support with ARDS at baseline (p=0.04).
The Survival Analysis using Cox’s Proportional Hazard Model also demonstrated that patients treated with paridiprubart + SOC had an 84% reduction in the risk of dying when compared to placebo + SOC at 28 days.
The Phase 2 study demonstrated that paridiprubart appears to be well-tolerated and consistent with the observed safety profile.
Federal Funding from the Government of Canada Our wholly owned subsidiary Edesa Biotech Research, Inc.
(“Edesa Biotech Research”) is party to a multi- year contribution agreement with the Canadian government’s Strategic Innovation Fund, or SIF, dated October 12, 2023, and an Amendment Agreement No. 1 to the agreement, dated September 30, 2025 (together, the “2023 SIF Agreement”).
Under the 2023 SIF Agreement, the Government of Canada committed up to C$23 million in partially repayable funding toward (i) conducting and completing a Phase 3 clinical study of our investigational therapy EB05 in critical-care patients with ARDS, and (ii) submitting EB05 for governmental approvals and manufacturing scale-up, following, and subject to, completing the Phase 3 study and (iii) conducting two non-clinical safety studies to assess the potential long-term impact of EB05 exposure.
The remaining C$17.25 million is conditionally repayable starting in 2032 only if and when we earn gross revenue.
Edesa Biotech Research has agreed to complete the project by December 31, 2028.
Under a February 2021 agreement (the “2021 SIF Agreement” and together with the 2023 SIF Agreement, the “SIF Agreements”), the Government of Canada committed C$14.1 million in nonrepayable funding for an international Phase 2 study and certain pre-clinical experiments.
For instance, there is significant evidence that targeting TLR4 in chronic respiratory conditions, such as pulmonary fibrosis, could result in therapeutic benefit for patients.
In light of our other development priorities, we are evaluating the timing for the next steps in our EB07 program for the treatment of pulmonary fibrosis.
Method of use patents, for which we hold an inbound license from Yissum and an affiliate of Yissum, have been issued for use in dermatologic and gastrointestinal conditions and infections and expired in 2024.
We did not seek patent term extension in the U.S. for these patents, and they no longer provide patent protection for EB01.
As of the date of this 10-K, the commercialization milestones have not been achieved.
Review and Approval Processes After the completion of clinical trials of an investigational drug or biologic product, an NDA or BLA is prepared and submitted to the FDA.
The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will file the NDA or BLA and, even if filed, that any approval will be granted on a timely basis, if at all.

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Gone since FY2024

EB05 is currently being evaluated in a U.S. government-funded platform study investigating three novel threat-agnostic HDTs in hospitalized adult patients with Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure.
In addition to EB05, we are also preparing an investigational new drug application (IND) in the United States to conduct a future Phase 2 study for EB07 (paridiprubart) in patients with pulmonary fibrosis.
In the signal-finding Phase 2 part of a Phase 2/3 clinical study evaluating EB05 in hospitalized Covid-19 patients at various disease severity levels, EB05 demonstrated a statistically significant and clinically meaningful trend for 28-day mortality for all randomized subjects in the critically ill cohort (the intent to treat, or ITT, population).
The 28-day death rate in the EB05 plus standard of care (SOC) arm was 7.7% versus 40% in the placebo + SOC arm in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation) or Invasive Mechanical Ventilation (IMV) plus organ support with ARDS at baseline (p=0.04).
The Survival Analysis using Cox’s Proportional Hazard Model also demonstrated that patients treated with EB05 + SOC had an 84% reduction in the risk of dying when compared to placebo + SOC at 28 days.
The Phase 2 study demonstrated that EB05 appears to be well-tolerated and consistent with the observed safety profile to date.
The FDA has granted EB05 a fast-track designation for the treatment of hospitalized Covid-19 patients.
Phase 3 Study Given the BARDA-sponsored study opportunity, we have shifted our clinical focus for EB05 to general ARDS from Covid-19 induced ARDS.
Our plan is to await the results of the BARDA-funded study before continuing with our Canadian government-supported Phase 3 study, which had exclusively recruited ARDS patients hospitalized with Covid-19.
As a result, we have discontinued enrollment in a Covid-19 focused Phase 3 study and plan to file a new study design with FDA and Health Canada based on the results of the BARDA-funded ARDS study.
We believe this strategy provides a more efficient and cost-effective path toward a commercially approved therapy for general ARDS, increases the potential commercial opportunity for EB05 and better aligns our development programs with government goals for HDTs as well as interest from potential strategic commercialization and licensing partners.
Any changes we have made and make in the future to our clinical plans and enrollment criteria may limit how data from previously enrolled subjects are utilized by the company for regulatory purposes.
Federal Funding from the Government of Canada In October 2023, our wholly owned subsidiary Edesa Biotech Research, Inc.
(Edesa Biotech Research) entered into a multi-year contribution agreement (the 2023 SIF Agreement) with the Canadian government’s Strategic Innovation Fund, or SIF.
Under the 2023 SIF Agreement, the Government of Canada committed up to C$23 million in partially repayable funding toward (i) conducting and completing a Phase 3 clinical study of our investigational therapy EB05 in critical-care patients with ARDS caused by Covid-19 or other infectious agents, and (ii) submitting EB05 for governmental approvals and manufacturing scale-up, following, and subject to, completing the Phase 3 study and (iii) conducting two non-clinical safety studies to assess the potential long-term impact of EB05 exposure.
The remaining C$17.25 million is conditionally repayable starting in 2029 only if and when we earn gross revenue.
Edesa Biotech Research has agreed to complete the project by December 31, 2025.
As a result of the opportunity created by U.S. government-funded study, we are in discussions with the Government of Canada to amend our 2023 SIF Agreement, including extending the project timeline and completion date.
There can be no assurance that the government will accept our proposals or, if rejected, seek the applicable remedies described above.
Under a February 2021 agreement (the 2021 SIF Agreement), the Government of Canada committed C$14.1 million in nonrepayable funding for an international Phase 2 study and certain pre-clinical experiments.
Pulmonary Fibrosis and EB07 (Paridiprubart) There is significant evidence that targeting TLR4 in fibrotic conditions could result in therapeutic benefit for patients.
Third party preclinical research has demonstrated that blocking TLR4 in animal models has been shown to reduce and in some cases reverse fibrosis.
Similarly, TLR4 knockout mice display attenuated fibrosis.
In addition, concentrations of agonists that bind to and activate TLR4 are often good predictors of disease severity and progression.
We are preparing an IND in the U.S. for our EB07 (paridiprubart) product candidate to conduct a future Phase 2 proof of concept study in subjects with pulmonary fibrosis.
This project represents a potential additional use for our anti-TLR4 monoclonal antibody candidate in a chronic disease with limited treatment options and high mortality and morbidity.
To conduct the planned study at U.S. investigational centers, we must first manufacture the drug and submit related data to the FDA as part of an IND application.
Based on feedback from the FDA and key opinion leaders, we may modify our Canadian study design and submit conforming amendments to our clinical trial application (CTA) in Canada, before proceeding with enrollment.
The manufacturing of clinical-grade drug batches and initiation of the patient enrollment is subject to funding.
We anticipate topline results for this Phase 2 study could be available within as few as 12 to 18 months following regulatory clearance in the U.S.
In a Phase 2b clinical study of EB01 we evaluated multiple concentrations of our drug candidate, EB01, as a monotherapy for chronic moderate-to-severe ACD.
The double-blind, placebo-controlled trial evaluated the safety and efficacy of EB01 in approximately 200 subjects, who were treated for 28 days with either EB01 cream (2.0%, 1.0% or 0.2%) or a placebo/vehicle cream.
The primary efficacy outcome measurement was the mean percent improvement in symptoms from baseline at day 29 on the Contact Dermatitis Severity Index (CDSI).
A key secondary efficacy measurement was the success rate of subjects achieving a score of "clear" or "almost clear" with at least a 2-point improvement from baseline after treatment at day 29 on the Investigator's Static Global Assessment (ISGA) scale.
The 1.0% EB01 cream demonstrated statistically significant improvement over placebo.
For the primary endpoint, patients with 1.0% EB01-treated lesions demonstrated a 60% average improvement in symptoms from baseline at day 29 on the CDSI versus 40% for placebo/vehicle (p=0.027).
For the ISGA secondary efficacy endpoint, 53% of patients with 1.0% EB01-treated lesions achieved a score of "clear" or "almost clear" with at least a 2-point improvement from baseline after treatment at day 29 (p=0.048).
Only 29% of patients in the placebo group reached the same endpoint.
No serious treatment-related adverse events were reported across all concentrations.
The 2.0% and 0.2% formulations did not show significant differences compared to placebo.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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