What changed in this filing

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Item 1. Business

2025-12-12 compared with 2024-12-13 · 78 added, 83 removed, 456 unchanged (26% of the section changed)

9 unchanged sentences

Food and Drug Administration (“FDA”) for the same study.

Subject to regulatory approval, we anticipate initiating enrollment by midyear 2026.

Our 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.

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Paridiprubart represents a new class of emerging therapies called Host-Directed Therapeutics (“HDTs”) that are designed to modulate the body’s own immune response when confronted with infectious diseases or even chemical agents.

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 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.

Certain development expenses, including manufacturing scale-up, for our EB05 program are also eligible for reimbursement from the Government of Canada under a 2023 grant and funding award.

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.

We are also pursuing additional uses for paridiprubart in chronic diseases.

Competitive Strengths

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We do not currently intend to invest significant capital in basic research, which can be expensive and time-consuming.

Acute Respiratory Distress Syndrome

ARDS is a life-threatening form of respiratory failure characterized by an exaggerated and dysfunctional immune response, rapid onset of widespread inflammation in the lungs, and hypoxia (an absence of enough oxygen in the tissues to sustain bodily functions).

ARDS can be precipitated by a number of conditions including viral and bacterial pneumonia, sepsis, chest injury and even mechanical ventilation, among other causes.

ARDS has historically accounted for 10% of ICU admissions, representing more than 3 million patients globally each year.

Based on the prevalence data of ARDS, we estimate that there are as many as 600,000 ARDS-related admissions to ICUs each year in the seven major markets (U.S, UK, Germany, France, Spain, Italy, Japan) and Canada.

According to medical literature, ICU stays for ARDS patients in the U.S.

range from 7 to 21 days on average, at an average cost of more than $100,000 per patient.

For moderate to severe cases of ARDS, treatments remain limited and patients suffer high mortality rates.

Countering the exaggerated innate immune response in ARDS patients has been a key area of interest among researchers.

One of the most studied targets has been Toll-like receptor 4 (TLR4) - a key component of the innate immune system and an important mediator of inflammation.

Since TLR4 detects molecules found in pathogens and also binds to endogenous molecules produced as a result of injury, it is a key receptor on which both infectious and noninfectious stimuli converge to induce a proinflammatory response.

EB05 (paridiprubart)

EB05 is an intravenous formulation of paridiprubart, a first-in-class monoclonal antibody (mAb) that has been engineered to alter inflammatory signaling by binding to and blocking the activation of TLR4.

Specifically, paridiprubart dampens TLR4 signaling by blocking receptor dimerization (and subsequent intracellular signaling cascades).

The drug has demonstrated the ability to block signaling irrespective of the presence or concentration of the various molecules that frequently bind with TLR4, known as ligands.

Based on this broad mechanism of action and clinical results to date, we believe that paridiprubart could ameliorate TLR4-mediated inflammation cascades in ARDS patients, thereby reducing lung injury, ventilation rates and mortality.

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.

Government Funded Study

In June 2024, EB05 was selected through a competitive process by BARDA, part of the Administration for Strategic Preparedness and Response within the U.S.

Department of Health and Human Services, as one of three drug candidates for evaluation in a U.S.

government-funded Phase 2 platform study.

The randomized, double-blinded, placebo-controlled, multi-center clinical trial is investigating novel threat-agnostic host-directed therapeutics, including EB05, in hospitalized adult patients with ARDS due to a variety of causes.

The BARDA-funded study is being managed under a BARDA contract with PPD Development, LP, a clinical research business of Thermo Fisher Scientific, Inc.

For the EB05 cohort of the study, patients are being randomized one-to-one to either EB05 + SOC or to a placebo + SOC control arm.

We are providing drug products to the study as well as technical support at our own expense.

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.

Of the C$23 million committed by SIF, up to C$5.75 million is not repayable.

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.

In the event that we or Edesa Biotech Research breach our obligations under the 2023 SIF Agreement, subject to applicable cure, the SIF may exercise a number of remedies, including suspending or terminating funding under the 2023 SIF Agreement, demanding repayment of funding previously received and/or terminating the 2023 SIF Agreement.

The performance obligations of Edesa Biotech Research under the 2023 SIF Agreement are guaranteed by us.

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.

Our previously completed Phase 2 study of EB05 was also funded, in part, by SIF.

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.

In the event that we or Edesa Biotech Research breach our obligations under the 2021 SIF Agreement, subject to applicable cure, the SIF may exercise a number of remedies, including demanding repayment of funding previously received and/or terminating the agreement.

The performance obligations of Edesa Biotech Research under the contribution agreement are guaranteed by us.

All potential funding available under the 2021 SIF Agreement has been received.

As of the date of this filing, we have met all of our performance and reporting requirements under our SIF Agreements.

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.

Initiating recruitment in the EB07 study is subject to, among other limitations, funding, regulatory approvals, drug manufacturing and activation of clinical investigational sites.

Medical Dermatology

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F-VASI is a composite measurement of the overall area of facial vitiligo patches and degree of depigmentation within patches.

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 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.

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.

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Our ACD development program is at the partnering stage following completion of a Phase 2b clinical study.

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.

Acute Respiratory Distress Syndrome

ARDS can be precipitated by a number of conditions including viral and bacterial pneumonia, sepsis, chest injury and even mechanical ventilation, among other causes.

ARDS has historically accounted for 10% of ICU admissions, representing more than 3 million patients globally each year.

According to medical literature, ICU stays for ARDS patients in the U.S.

range from 7 to 21 days on average, at an average cost of more than $100,000 per patient.

For moderate to severe cases of ARDS, treatments remain limited and patients suffer high mortality rates.

Countering the exaggerated innate immune response in ARDS patients has been a key area of interest among researchers.

One of the most studied targets has been Toll-like receptor 4 (“TLR4”) - a key component of the innate immune system and an important mediator of inflammation.

EB05 (paridiprubart)

Specifically, paridiprubart dampens TLR4 signaling by blocking receptor dimerization (and subsequent intracellular signaling cascades).

The drug has demonstrated the ability to block signaling irrespective of the presence or concentration of the various molecules that frequently bind with TLR4, known as ligands.

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;

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;

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.

Government Funded Study

In June 2024, EB05 was selected through a competitive process by BARDA, part of the Administration for Strategic Preparedness and Response within the U.S.

Department of Health and Human Services, as one of three drug candidates for evaluation in a U.S.

government-funded Phase 2 platform study.

The randomized, double-blinded, placebo-controlled, multi- center clinical trial is investigating novel threat-agnostic host-directed therapeutics, including EB05, in hospitalized adult patients with ARDS due to a variety of causes.

The BARDA-funded study is being managed under a BARDA contract with PPD Development, LP, a clinical research business of Thermo Fisher Scientific, Inc.

For the EB05 cohort of the study, patients are being randomized one-to-one to either EB05 + SOC or to a placebo + SOC control arm.

We are providing drug products to the study as well as technical support at our own expense.

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.

Of the C$23 million committed by SIF, up to C$5.75 million is not repayable.

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.

The performance obligations of Edesa Biotech Research under the 2023 SIF Agreement are guaranteed by us.

Our previously completed Phase 2 study of EB05 was also funded, in part, by SIF.

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.

The performance obligations of Edesa Biotech Research under the contribution agreement are guaranteed by us.

All potential funding available under the 2021 SIF Agreement has been received.

As of the date of this filing, we have met all of our performance and reporting requirements under our SIF Agreements.

Other Future Product Candidates

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In addition, we plan to continue to identify, evaluate and potentially obtain rights to and develop additional clinical assets across various stages of development, focusing primarily on inflammatory and immune-related diseases.

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.

Initiating recruitment in the EB07 study is subject to, among other limitations, funding, regulatory approvals, drug manufacturing and activation of clinical investigational sites.

Intellectual Property and Key Licenses

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(“Yissum”), for patents and patent applications that cover EB01 in the U.S., Canada, Australia and various countries in Europe.

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 that will expire in 2024.

We expect to seek patent term extension in the U.S.

related to time under IND, which could add up to three to five years of additional protection.

We did not seek patent term extension in the U.S.

for these patents, and they no longer provide patent protection for EB01.

Additional patents subject to the license agreement have been filed by Yissum which we believe, if issued, could potentially prevent generic substitution until after 2033.

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We also have a commitment to pay NovImmune a royalty based on net sales of Licensed Products in countries where we directly commercialize Licensed Products and a percentage of sublicensing revenue received by us in the countries where we do not directly commercialize Licensed Products.

As of the date of this 10-K, the commercialization milestones have not been achieved.

The NovImmune License Agreement provides that NovImmune will remain the exclusive owner of existing intellectual property in the Constructs and that we will be the exclusive owner of all intellectual property resulting from the exploitation of the Constructs pursuant to the license.

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We also have a commitment to pay Yissum a royalty based on net sales of the product in countries where we, or an affiliate of ours, directly commercializes the product and a percentage of sublicensing revenue received by us and our affiliates in the countries where we do not directly commercialize the product.

As of the date of this 10-K, the commercialization milestones have not been achieved.

The Yissum License Agreement provides that Yissum shall remain the exclusive owner of the licensed technology and that we are responsible for preparing, filing, prosecuting and maintaining the patents on the licensed technology in Yissum’s name.

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While we have not experienced significant shortages of raw materials to date, as a result of increased industry demand, CMOs have generally reported that supplies of raw materials and critical components necessary for manufacturing processes have been more challenging and expensive to obtain, and longer lead times may be required for scheduling future production runs.

We believe that we have sufficient supplies on hand to complete the Phase 3 clinical study for EB05.

To supply future clinical studies and potential commercialization of our product candidates, we are engaged in discussions with various CMOs regarding long-term supply agreements.

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As of the date of this filing, we have 17 full-time employees:

nine employees are primarily engaged in research and development, and seven employees are engaged in management, administration, business development and finance.

ten employees are primarily engaged in research and development, and seven employees are engaged in management, administration, business development and finance.

All employees are located in Canada or the U.S.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business