Edesa News Archive

• Fast Track improves the speed and frequency of communication with FDA, potentially leading to earlier drug approval and access by patients.

TORONTO, ON / ACCESSWIRE / December 20, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, has received Fast Track designation from the U.S. Food and Drug Administration for its monoclonal antibody candidate, EB05. Approval of the company’s application follows favorable Phase 2 results from an international Phase 2/3 study of EB05 in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs.

The Fast Track program provides Edesa with the opportunity for more frequent communication with the agency to discuss the development path for EB05 as a treatment for ARDS in critically ill Covid-19 patients. Investigational drugs that receive Fast Track designation are also eligible for rolling review of their marketing application as well as potential pathways for accelerated regulatory approval. To receive this designation, drug candidates must both treat a serious disease and have non-clinical or clinical data that demonstrate the potential to address an unmet medical need.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that FDA’s decision is a significant development milestone for the company. “Fast Track designation provides additional validation of EB05’s potential to address a significant unmet need in hospitalized patients with ARDS,” said Dr. Nijhawan. “The Fast Track designation will facilitate our interactions with the FDA and will also allow for faster review and approval upon successful completion of a Phase 3 development program.”

Edesa recently reported that Phase 2 results offered statistically significant evidence of EB05’s ability to reduce death in the most critically ill hospitalized Covid-19 patients. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

About EB05

EB05 is a monoclonal antibody designed to inhibit toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses.

About Acute Respiratory Distress Syndrome (ARDS)

ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contact dermatitis (ACD) – Phase 2b: Fully Enrolled.

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials.

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 belief that EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; the company’s belief in the broad potential life-saving impact of its EB05 monoclonal antibody candidate; the FDA’s Fast Track program’s ability to get new drugs to market earlier; the company’s ability or intention to have more frequent communication with FDA regarding the development path of EB05; the eligibility for EB05 to receive rolling review of a future potential marketing application or accelerated regulatory approval; the company’s belief that EB05 has the potential to address a significant unmet need in hospitalized patients with severe disease, and that Fast Track designation for EB05 will facilitate its interactions with the FDA and will also allow for faster review and approval upon successful completion of a Phase 3 development program; 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, such as COVID-19. 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.

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TORONTO, ON / ACCESSWIRE / December 16, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the fiscal year ended September 30, 2022 and provided an update on its business.

During the fiscal year, Edesa reported positive final results from the Phase 2 part of a Phase 2/3 study of its monoclonal antibody in Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS). Among the results, critically ill patients given EB05 plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days. The company has submitted a Phase 2 Clinical Study Report to the U.S. Food and Drug Administration as part of the review of Edesa’s Phase 3 clinical protocol design and statistical plan. In the fourth quarter, the company also completed enrollment in its Phase 2b dermatology study, and expects to report topline data in the next four weeks.

“We believe the significant strides we made in 2022 have positioned us for continued and accelerated progress,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “With two late-stage studies, a growing development pipeline, large addressable markets and interest from potential partners, we are excited about the opportunities we are bringing into the new year.”

Edesa’s Chief Financial Officer Kathi Niffenegger reported that operational expenses for fiscal 2022 decreased by more than 20% over the previous year, benefitting from the completion of clinical activities related to the company’s Phase 2b dermatitis study and the flexibility of Edesa’s business model to manage working capital. “Our full fiscal year results reflect the trend demonstrated in the past three quarters of reduced operating expenses and prudent management of working capital,” she said.

Edesa reported that near-term operational objectives include, among others, completing the FDA review of the company’s Phase 3 protocol design for EB05; fully enrolling the Phase 3 study of EB05; reporting Phase 2b results for EB01; completing a Phase 2 investigational new drug application in the U.S. for systemic sclerosis; and submitting a clinical trial application for vitiligo in Canada.

Financial Results for the Fiscal Year Ended September 30, 2022

Total operating expenses decreased by $5.31 million to $18.37 million for the year ended September 30, 2022 compared to $23.68 million for the prior year:

• Research and development expenses decreased by $4.61 million to $13.34 million for the year ended September 30, 2022 compared to $17.95 million for the prior year primarily due to decreased milestone payments, external research expenses related to the company’s clinical studies and investigational drug product manufacturing expenses, which were partially offset by increased personnel expenses.
• General and administrative expenses decreased by $0.69 million to $5.04 million for the year ended September 30, 2022 compared to $5.73 million for the prior year primarily due to a decrease in noncash share-based compensation.

Total other income decreased by $9.52 million to $0.82 million for year ended September 30, 2022 compared to $10.34 million for the prior year primarily due to a decrease in grant income associated with the completion of clinical study activities under Edesa’s federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.

For the fiscal year ended September 30, 2022, Edesa reported a net loss of $17.55 million, or $1.05 per common share, compared to a net loss of $13.34 million, or $1.10 per common share, for the fiscal year ended September 30, 2021.

Working Capital

At September 30, 2022, Edesa had cash and cash equivalents of $7.09 million and working capital of $6.95 million. Subsequent to the end of the fiscal year, the company received gross proceeds of approximately $3.0 million from a private placement of common shares and warrants.

Calendar

Edesa management plans to participate in the 2023 Dermatology Summit on January 8, 2023 and in one-on-one meetings during JP Morgan week on January 9-12, 2023, in San Francisco, California. Attendees interested in meeting with management 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 focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in late-stage clinical studies. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury. EB05 has extensive preclinical and clinical experience, including evaluations in more than 600 hospitalized Covid-19 subjects. In an international Phase 2 study, a single dose of EB05 demonstrated compelling preliminary evidence of the drug’s ability to reduce mortality in target patient populations.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contact dermatitis (ACD) – Phase 2b: Fully Enrolled.

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials.

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 expectation to report preliminary topline data from its Phase 2b study of EB01 by mid-January 2023; the company’s belief that the significant accomplishments it made in 2022 have positioned it for continued and accelerated progress; the company’s belief that its product candidates have large addressable markets, and will draw continued interest from potential partners; the company’s plans to complete the FDA review process of the its Phase 3 protocol design for EB05; the company’s plans to fully enroll the Phase 3 study of EB05; the company’s plans to complete a Phase 2 investigational new drug application in the U.S. for systemic sclerosis; the company’s plans to submit a clinical trial application for vitiligo in Canada; 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, such as Covid-19. 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.
(805) 488-2800 ext. 150
investors@edesabiotech.com

Condensed Consolidated Statements of Operations

Condensed Consolidated Balance Sheets

Condensed Consolidated Statements of Cash Flows

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TORONTO, ON / ACCESSWIRE / December 2, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that Dr. Par Nijhawan, Chief Executive Officer, will participate in a panel discussion and host one-on-one meetings at the Cantor Fitzgerald Medical Dermatology, Opthalmology & Medtech Conference.

The panel discussion is scheduled to take place on Thursday, December 8, 2022 at 10:00 am ET, and is open to those who are registered to attend the event. To schedule a meeting with Edesa during the conference, please contact your Cantor representative or the company directly at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in late stage clinical studies. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contact dermatitis (ACD) – Phase 2b: Fully Enrolled.

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

EB05 has extensive preclinical and clinical experience, including evaluations in more than 600 hospitalized Covid-19 subjects. In an international Phase 2 study, a single dose of EB05 demonstrated compelling preliminary evidence of the drug’s ability to reduce mortality in target patient populations. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

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 scheduled events and the company’s timing and plans regarding its drug development studies. 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, such as COVID-19. 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.

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TORONTO, ON / ACCESSWIRE / November 3, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA) (the “Company” or “Edesa”), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced the closing a private placement directly with investors priced at-the-market under the rules of the Nasdaq Stock Market of 2,691,337 common shares, 12-month warrants to purchase up to an aggregate of 1,345,665 common shares and 3-year warrants to purchase up to an aggregate of 1,345,665 common shares. Officers and directors of the Company purchased approximately $0.5 million of the securities sold in the offering.

Each common share was sold together with one-half of a whole 12-month warrant to purchase one common share and one-half of a whole 3-year warrant to purchase one common share. The common shares and accompanying warrants were sold at a combined offering price of $1.125. The warrants will be exercisable on the earlier to occur of (i) the date that is 60 days from the closing date and (ii) the date a registration statement for the common shares issuable upon exercise of the warrants is declared effective. The exercise price of the 12-month warrants is $1.00, and the exercise price of the 3-year warrants is $1.50.

The gross proceeds to the Company from this offering are approximately $3.0 million, before offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for the advancement of its clinical programs, including the completion of its Phase 2b study in allergic contact dermatitis, working capital and general corporate purposes.

The common shares and warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the common shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the common shares, warrants and underlying common shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The common shares, warrants and the common shares underlying the warrants were offered to “accredited investors” within the meaning of the Canadian National Instrument 45-106 – Prospectus Exemptions. The securities issued will be subject to applicable Canadian hold periods imposed under applicable securities legislation.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that Edesa is developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. Sign up for news alerts. Connect with Edesa Biotech on Twitter 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 offering, including the use of proceeds. 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: market and other conditions, those relating to the anticipated use of proceeds, 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, such as COVID-19. 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.

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• Mortality reduction in critically ill subjects at 28 days revised favorably, statistically significant
• EB05 demonstrated an 84% reduction in the risk of dying when compared to placebo
• Clinical Study Report submitted to FDA

TORONTO, ON / ACCESSWIRE / September 30, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced final results from the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study. The study is evaluating the company’s monoclonal antibody candidate, EB05, as a single-dose treatment for hospitalized patients with or at risk of developing Covid-19 induced Acute Respiratory Distress Syndrome (ARDS). The company previously reported initial topline data provided by the study’s data safety monitoring board, which preemptively unblinded certain study data for efficacy signals. Edesa has now completed a formal Clinical Study Report (CSR) for U.S. regulators on the full, validated Phase 2 dataset.

In the final Phase 2 clinical trial results, Edesa reported that EB05 demonstrated a statistically significant and clinically meaningful trend for mortality and survival time for all randomized subjects in the critically ill cohort (the intent to treat, or ITT, population). Today, the company reported a revised 28-day death rate of 7.7% in the EB05 plus standard of care (SOC) arm 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 revised Survival Analysis using Cox’s Proportional Hazard Model demonstrated that patients treated with EB05 plus SOC had an 84.0% reduction in the risk of dying when compared to placebo + SOC at 28 days.

“Achieving statistical significance within one of the most difficult to treat subgroups of patients with Covid-induced ARDS has increased our excitement and belief that EB05 could become a standard-of-care treatment option,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “These validated data along with additional efficacy signals observed strengthen the previously released results and suggests that the utility of EB05 may be more significant and wide-ranging than the initial topline data indicated.”

Dr. Nijhawan noted that since EB05 is designed to target the patient’s own immune response rather than the virus itself, the investigation therapy could potentially have broad application across multiple disease indications, including ARDS caused by influenza and other potentially deadly pathogens. “There is a significant unmet medical need for critically ill ARDS patients caused by seasonal influenza and pneumonia that’s made considerably worse by the endemic nature of Covid-19, and we believe that EB05 can help address this problem,” he said.

The company submitted the Phase 2 CSR this week to the U.S. Food and Drug Administration as part of the review of Edesa’s Phase 3 clinical protocol design and statistical plan. The Phase 3 study design has already been approved in Canada, Colombia and Poland, where recruitment is ongoing.

Edesa’s Phase 2 study of EB05 was funded in part by a C$14 million grant from the Canadian Government’s Strategic Innovation Fund.

Additional Phase 2 Results

Study Design

The Phase 2 part of the Phase 2/3 study was primarily exploratory and designed to refine patient stratification and statistical powering for the Phase 3 study. All levels of hospitalized Covid-19 patients were enrolled, ranging from Level 3 (hospitalized, not requiring supplemental oxygen) on the nine-point WHO Covid-19 Severity Scale (WCSS) to WCSS Level 7 (hospitalized, requiring intubation plus additional organ support such as ECMO). Enrollment in the study as well as the analysis was stratified according to baseline WCSS level into patients with mild Covid-19, defined as WCSS level ≤4, or severe Covid-19, defined as WCSS level ≥5.

Additional Results

In addition to the critically ill population, the analysis of the full Phase 2 dataset revealed other efficacy signals.

For severe Covid-19 patients at WCSS Level ≥5 (99% of patients had ARDS at baseline), there were clinically meaningful differences with respect to the proportion of patients who were alive without any need for oxygen support at Day 28 (the Phase 2 study’s primary endpoint). From the ITT analysis of this population, 45.8% in the EB05 + SOC arm versus 36.1% in the placebo + SOC arm achieved the primary endpoint (p = 0.16).

Similarly positive efficacy signals were also demonstrated in this same population for the proportion of patients who achieved at least a 2-point improvement in on the WCSS. From the ITT analysis of this population, 46.7% in the EB05 + SOC arm versus 36.1% in the placebo + SOC arm achieved at least a 2-point improvement in on the WCSS (p = 0.12).

For mild Covid-19 patients at WCSS Level ≤4, the study did not detect meaningful clinical differences between the arms for these endpoints, which is likely the result of the baseline severity score being too close to the endpoint (WCSS of 3 or less) on these scoring scales.

The Phase 2 results demonstrated that EB05 was generally well-tolerated and consistent with the observed safety profile to date. Serious adverse events from 352 subjects showed comparable results between treatment groups. Incidence of Treatment Emergent Adverse Events (TEAEs) and serious TEAEs were similar across the treatment groups.

Summary of Key Clinical Results

The following tables summarize the key signals detected in the Phase 2 study.

Mortality Rates – Critically Ill Patients (WCSS Level 7)

Mortality – Hazard and Odds Ratios¹ – Critical Patients (WCSS Level 7)

Note 1: placebo vs. EB05

Severe Patients – WCSS Levels ≥5

Note 1: mLOCF imputed for Day 28.

About Acute Respiratory Distress Syndrome (ARDS)

ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contact dermatitis (ACD) – Phase 2b: Fully Enrolled.

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models.

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 belief that the final data, including reaching statistical significance for multiple endpoints, could increase the likelihood that EB05 could become a standard-of-care treatment option; the company’s belief that EB05 could potentially have broad application and effectiveness across multiple disease indications, including ARDS caused by influenza and other potentially deadly pathogens; 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, such as Covid-19. 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.

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TORONTO, ON / ACCESSWIRE / September 8, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that Par Nijhawan, MD, Chief Executive Officer, will present at the H.C. Wainwright Global Investment Conference being held in New York, NY on September 12-14, 2022.

Edesa Presentation Details

Date: September 12, 2022
Time: 10:00 am Eastern Time
Presentation Slides: Available in the events section of the Edesa website.

Attendees who are interested in meeting with the company should contact their H.C. Wainwright representative or Edesa directly via email at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that Edesa is developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. Sign up for news alerts. Connect with Edesa Biotech on Twitter and LinkedIn.

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• Primary Endpoint To Be Reached Within 30 Days, With Topline Data Available by End of Year
• Company Evaluating Partnership and Out-Licensing Opportunities Outside North America for Its First-in-Class, Anti-Inflammatory Drug Candidate

TORONTO, ON / ACCESSWIRE / September 7, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that patient recruitment has been completed for a Phase 2b clinical study evaluating the company’s drug candidate, designated EB01, as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). EB01 represents a potentially new class of non-steroidal, anti-inflammatory treatment for this often-debilitating occupational disease.

All the remaining subjects are expected to complete the primary treatment period within the next 30 days, and Edesa anticipates that topline data will be available by the end of the year.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that encouraging interim data as well as the robust pace of enrollment are driving the company’s excitement regarding the upcoming readout.

“We are pleased to have completed enrollment ahead of schedule, and we are especially grateful to the patients, physicians and research staff for enabling us to reach this important milestone. EB01 represents a potentially powerful new way to manage inflammation, even in severe cases, without the safety concerns and side effects of topical corticosteroids. This is especially important for patients with chronic lesions and inflammation,” said Dr. Nijhawan.

Edesa reported that while topline and final study results are pending and subject to regulatory review, the company is advancing its commercialization strategy for its EB01 drug candidate. This includes preparing trial design and regulatory filings, prioritizing potential add-on or adjacent disease indications for future studies, and exploring potential commercialization partners.

“Outside our primary target markets in North America, we plan to evaluate strategic licensing or partnering arrangements with pharmaceutical companies for the further development or commercialization of EB01, such as in areas where a partner may contribute additional resources, infrastructure and expertise,” Dr. Nijhawan said.

EB01 is a topical vanishing cream that contains a novel, non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. When activated, sPLA2 enzymes have been shown to initiate a cascade of inflammatory lipid mediators along a well-known pathway that is currently the target of steroids. By targeting sPLA2 – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory and allergic conditions.

The double-blind, placebo-controlled confirmatory study is evaluating the safety and efficacy of 2.0% EB01 cream in approximately 170 evaluable subjects in total. In addition to the primary cohort, the company has included an exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01 in an additional 40 subjects. Due to physician and patient interest, the company also added a voluntary 90-day open-label extension with the 2% cream for study patients once they complete their treatment in the main study. The complete data package will be analyzed following the completion of the main study’s primary and secondary endpoints as well as the open label extension.

The company previously reported that EB01 met key interim parameters in the ongoing Phase 2b study. Though blinded to treatment assignment, the study’s Data and Safety Monitoring Board reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. The monitoring board also reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator’s Static Global Assessment), a key secondary efficacy endpoint. A decrease in score relates to an improvement in signs and symptoms. No serious treatment-related adverse events were reported for either treatment group.

About Allergic Contact Dermatitis

Contact dermatitis, which can be either irritant contact dermatitis or ACD (sometimes called allergic contact eczema), is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. The condition is caused by an allergen interacting with skin, usually on the hands and face. Inflammation can vary from irritation and redness to open sores, and in many chronic cases, the causative allergen is unknown or difficult to avoid. Approximately 3,000 substances are recognized as contact allergens. Edesa estimates that there are more than 30 million people globally with allergic contact dermatitis, with approximately 5 million patients estimated to have chronic or reoccurring exposure to the causal allergen. To the company’s knowledge, there are currently no treatment options specifically labelled for ACD.

About Edesa Biotech

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contact dermatitis (ACD) – Phase 2b: Ongoing; Fully Enrolled.

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models.

Edesa has completed enrollment for the final cohorts of patients in a double-blind, placebo-controlled confirmatory Phase 2b study evaluating the safety and efficacy of 2.0% EB01 topical cream. In addition to the primary cohort, the company has included an exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01. At the interim analysis for the Phase 2b study, an independent data monitoring board reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. The monitoring board also reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator’s Static Global Assessment), a key secondary efficacy endpoint. A decrease in the ISGA score relates to an improvement in signs and symptoms.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

EB05 has extensive preclinical and clinical experience, including evaluations in more than 600 hospitalized Covid-19 subjects. In an international Phase 2 study, a single dose of EB05 demonstrated compelling preliminary evidence of the drug’s ability to reduce mortality in target patient populations. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Edesa is evaluating two study cohorts based on the World Health Organization Covid-19 Severity Index for the Phase 3 part of a Phase 2/3 clinical trial. The first cohort will assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus additional organ support (WHO Level 7). The primary endpoint for the Level 7 patients will be 28-day mortality. The second cohort is enrolling hospitalized patients on invasive mechanical ventilation alone (WHO Level 6 patients). The primary endpoint for the Level 6 patients will be the number of ventilator free days at 28 days.

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 forecast that all the remaining subjects should complete the primary treatment period within the next 30 days, with topline data available by the end of the year; the company’s belief that EB01 represents a potentially powerful new way to manage inflammation, even in severe cases, without the safety concerns and side effects of topical corticosteroids; the company’s plans to further develop its commercialization strategy, including plans for registration trial design, and related regulatory filings; the company’s plans to evaluate strategic licensing or partnering arrangements with pharmaceutical companies for the further development or commercialization of EB01, such as in areas where a partner may contribute additional resources, infrastructure and expertise; the company’s evaluation of EB01 potential utility for other inflammatory conditions; and the company’s timing and plans regarding its clinical studies. 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, such as Covid-19. 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.

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• Phase 3 ARDS drug study in hospitalized Covid-19 patients expanded
• Company reaffirms guidance on completion of Phase 2b dermatology drug study

TORONTO, ON / ACCESSWIRE / August 12, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the three and nine months ended June 30, 2022 and provided an update on its business.

During the quarter, the company expanded an international Phase 3 study of its critical care drug candidate in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS). The company is now recruiting a second cohort of subjects in parallel to its critically severe cohort. For its dermatology drug candidate, Edesa reported that recruitment in its Phase 2b clinical study in chronic Allergic Contact Dermatitis (ACD) has continued at a robust pace, and the company expects to randomize all planned 210 subjects by the fourth calendar quarter of 2022, as previously guided, with initial topline data available as early as the first calendar quarter of 2023.

“We continue to be excited about the momentum we demonstrated in the first nine months of the fiscal year. Our focus is squarely on accelerating our two active clinical programs toward full enrollment and topline data, increasing our business development activities, applying for non-dilutive grant funding, where applicable, and, as we approach our initial clinical targets, setting our sights on adjacent and secondary disease indications for our current clinical assets,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech.

Edesa’s Chief Financial Officer Kathi Niffenegger reported that financial results for the quarter and nine months ended June 30, 2022 reflected reduced operational expenditures compared to prior year periods and a continued the trend of prudent management of working capital.

“Operational expenditures for the quarter and the first nine months of fiscal 2022 were in line with management’s expectations and benefitted from our continued focus on core development and commercialization activities,” she said.

Financial Results for the Three Months Ended June 30, 2022

Total operating expenses decreased by $0.27 million to $5.80 million for the three months ended June 30, 2022 compared to $6.07 million for the same period last year:

• Research and development expenses increased by $0.08 million to $4.55 million for the three months ended June 30, 2022 compared to $4.46 million for the same period last year primarily due to a contractual payment for bulk drug product of EB05, which was substantially offset by decreased external research expenses related to the company’s ongoing clinical studies and drug manufacturing.
• General and administrative expenses decreased by $0.36 million to $1.25 million for the three months ended June 30, 2022 compared to $1.61 million for the same period last year primarily due to a decrease in noncash share-based compensation.

Total other income decreased by $1.30 million to $0.01 million for the three months ended June 30, 2022 compared to $1.31 million for the same period last year primarily due to a decrease in grant income associated with the completion of clinical study activities under Edesa’s federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.

For the quarter ended June 30, 2022, Edesa reported a net loss of $5.79 million, or $0.37 per common share, compared to a net loss of $4.76 million, or $0.36 per common share, for the three months ended June 30, 2021.

Financial Results for the Nine Months Ended June 30, 2022

Total operating expenses decreased by $2.67 million to $15.53 million for the nine months ended June 30, 2022 compared to $18.20 million for the same period last year:

• Research and development expenses decreased by $2.28 million to $11.54 million for the nine months ended June 30, 2022 compared to $13.82 million for the same period last year primarily due to decreased milestone payments, which were partially offset by higher external research expenses related to the company’s ongoing clinical studies and increased personnel expenses.
• General and administrative expenses decreased by $0.39 million to $3.99 million for the nine months ended June 30, 2022 compared to $4.38 million for the same period last year primarily due to a decrease in noncash share-based compensation.

Total other income decreased by $7.74 million to $0.80 million for the nine months ended June 30, 2022 compared to $8.54 million for the same period last year primarily due to a decrease in grant income associated with the completion of clinical study activities under Edesa’s federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.

For the nine months ended June 30, 2022, Edesa reported a net loss of $14.74 million, or $1.04 per common share, compared to a net loss of $9.66 million, or $0.83 per common share, for the nine months ended June 30, 2021.

Working Capital

At June 30, 2022, Edesa had cash and cash equivalents of $12.81 million and working capital of $9.52 million.

Calendar

Edesa management plans to participate in the H.C. Wainwright Global Investment Conference scheduled for September 12-14, 2022 in New York City. Attendees interested in meeting with management can schedule one-on-one meetings through the conference website or by contacting Edesa directly at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

EB05 has extensive preclinical and clinical experience, including evaluations in more than 600 hospitalized Covid-19 subjects. In an international Phase 2 study, a single dose of EB05 demonstrated compelling preliminary evidence of the drug’s ability to reduce mortality in target patient populations. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Edesa is evaluating two study cohorts based on the World Health Organization Covid-19 Severity Index for the Phase 3 part of a Phase 2/3 clinical trial. The first cohort will assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus additional organ support (WHO Level 7). The primary endpoint for the Level 7 patients will be 28-day mortality. The second cohort is enrolling hospitalized patients on invasive mechanical ventilation alone (WHO Level 6 patients). The primary endpoint for the Level 6 patients will be the number of ventilator free days at 28 days.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contract dermatitis (ACD) – Phase 2b: Enrolling

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models.

Edesa is enrolling the final cohorts of patients in a double-blind, placebo-controlled confirmatory Phase 2b study evaluating the safety and efficacy of 2.0% EB01 topical cream. In addition to the primary cohort, the company has included an exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01. At the interim analysis for the Phase 2b study, an independent data monitoring board reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. The monitoring board also reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator’s Static Global Assessment), a key secondary efficacy endpoint. A decrease in the ISGA score relates to an improvement in signs and symptoms.

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 expectation that enrollment in the Phase 2b study of EB01 will be completed by the fourth calendar quarter of 2022, with initial topline data available as early as the first calendar quarter of 2023; the company’s belief that recruitment for its Phase 3 study will continue to follow Covid-19-related ICU admissions and seasonality; the company’s belief that it will be successful in positioning additional investigational centers to be available for current and future waves of hospitalizations; the company’s plans to explore strategic business development opportunities; the company’s interest in expanding its drug development activities for adjacent and secondary disease indications for its current clinical assets; the company’s plans to accelerate its clinical programs toward full enrollment; the company’s plans to manage its working capital; 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, such as Covid-19. 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.

Condensed Interim Consolidated Statements of Operations
(Unaudited)

Condensed Interim Consolidated Balance Sheets
(Unaudited)

Condensed Interim Consolidated Statements of Cash Flows
(Unaudited)

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TORONTO, ON / ACCESSWIRE / August 3, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that its executive management will participate in the upcoming BTIG Biotechnology Conference being held in New York, NY on August 8-9, 2022. The hybrid event will be held both virtually and in-person.

Attendees who are interested in meeting with the company should contact their BTIG representative or Edesa directly via email at investors@edesabiotech.com.

About Edesa Biotech

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that Edesa is developing as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure and the leading cause of death among Covid-19 patients. EB01 is an sPLA2 inhibitor being developed as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. Sign up for news alerts. Connect with us on Twitter 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. 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, such as Covid-19. 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.

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TORONTO, ON / ACCESSWIRE / July 11, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that Par Nijhawan, MD, Chief Executive Officer, will present at the 2nd Annual ARDS Drug Development Summit being held July 13-15, 2022 in Boston, Mass.

Dr. Nijhawan’s presentation is scheduled for 8:25 am ET on July 14, 2022. Among his remarks, he is expected to provide an overview of Edesa’s EB05 drug candidate as a potential treatment for Acute Respiratory Distress Syndrome (ARDS) and how the evolving nature of Covid-19-mediated ARDS and standards of care informed the company’s Phase 2/3 clinical trial design.

Dr. Nijhawan will also join a panel discussion of biopharmaceutical professionals, titled “Considering Early Endpoints in Clinical Trials to Benchmark ARDS Therapeutic Progress & Confidently Prove Proof of Concept,” which is scheduled for 9:15 am ET the same day. More information is available at the event website.

About Edesa Biotech

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. The company is based in Ontario, Canada, with a U.S. subsidiary located in California. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

EB05 has extensive preclinical and clinical experience, including evaluations in more than 600 hospitalized Covid-19 subjects. In an international Phase 2 study, a single dose of EB05 demonstrated compelling preliminary evidence of the drug’s ability to reduce mortality in target patient populations. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Edesa is evaluating two study cohorts based on the World Health Organization Covid-19 Severity Index for the Phase 3 part of a Phase 2/3 clinical trial. The first cohort will assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus additional organ support (WHO Level 7). The primary endpoint for the Level 7 patients will be 28-day mortality. The second cohort is enrolling hospitalized patients on invasive mechanical ventilation alone (WHO Level 6 patients). The primary endpoint for the Level 6 patients will be the number of ventilator free days at 28 days.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contract dermatitis (ACD) – Phase 2b: Enrolling

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models.

Edesa is enrolling the final cohorts of patients in a double-blind, placebo-controlled confirmatory Phase 2b study evaluating the safety and efficacy of 2.0% EB01 topical cream. In addition to the primary cohort, the company has included an exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01. At the interim analysis for the Phase 2b study, an independent data monitoring board reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. The monitoring board also reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator’s Static Global Assessment), a key secondary efficacy endpoint. A decrease in the ISGA score relates to an improvement in signs and symptoms.

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 belief in the potential utility of its investigational drugs and market opportunity, and the company’s timing and plans regarding its clinical studies. 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, such as Covid-19. 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.

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https://www.accesswire.com/708035/Edesa-Biotech-to-Present-at-ARDS-Drug-Development-Summit

TORONTO, ON / ACCESSWIRE / May 24, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that the company has initiated enrollment for a second cohort of patients for the Phase 3 part of a Phase 2/3 study of the company’s critical care drug candidate, designated EB05.

Edesa is currently evaluating EB05, a monoclonal antibody, in critically ill patients with Covid-19-induced Acute Respiratory Distress Syndrome (ARDS), a severe respiratory illness that can result in long ICU stays and high mortality rates. The company’s first study cohort is recruiting the most critically severe patients receiving mechanical ventilation plus additional organ support, including extracorporeal membrane oxygenation (ECMO) therapy, also known as Level 7 patients under the World Health Organization’s Covid-19 Severity Scale. This new, second cohort is open to hospitalized patients on invasive mechanical ventilation alone (WHO Level 6 patients). Edesa’s decision to include the second cohort followed a company review of drug product inventories of EB05.

“We are pleased to be in a position to expand the eligible patient population to include a broader spectrum of critically ill patients,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “This will allow ICU physicians in the critical care setting to utilize EB05 earlier in the treatment paradigm – before it may be needed as a potential rescue therapy – with the hope of further reducing the number of days in the ICU and preventing more deaths.”

The primary endpoint for the Level 6 patients will be the number of ventilator free days at Day 28 following administration of a single intravenous infusion of EB05. Secondary endpoints will include ventilator free days at Day 60 as well as the mortality rate at Day 28 and Day 60. The protocol for the Level 6 cohort calls for approximately 500 evaluable subjects. As previously reported, the primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The protocol for the Level 7 patients calls for approximately 315 evaluable subjects.

The evaluation of EB05 in both the Level 6 and Level 7 patient populations was previously approved by regulators in Canada, Colombia and Poland. Edesa, however, prioritized the initiation of the most severe cohort first given the urgent medical need. Enrollment for both cohorts is now running in parallel, and results will be evaluated independently. The company is currently in discussions with regulators in the U.S. regarding the approval of the final Phase 3 design.

ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Connect with us on Twitter and LinkedIn. Sign up for news alerts.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

EB05 has extensive preclinical and clinical experience, including evaluations in more than 600 hospitalized Covid-19 subjects. In an international Phase 2 study, a single dose of EB05 demonstrated compelling preliminary evidence of the drug’s ability to reduce mortality in target patient populations. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Edesa is evaluating two study cohorts based on the World Health Organization Covid-19 Severity Index for the Phase 3 part of a Phase 2/3 clinical trial. The first cohort will assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus additional organ support (WHO Level 7). The primary endpoint for the Level 7 patients will be 28-day mortality. The second cohort is enrolling hospitalized patients on invasive mechanical ventilation alone (WHO Level 6 patients). The primary endpoint for the Level 6 patients will be the number of ventilator free days at 28 days.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contract dermatitis (ACD) – Phase 2b: Enrolling

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models.

Edesa is enrolling the final cohorts of patients in a double-blind, placebo-controlled confirmatory Phase 2b study evaluating the safety and efficacy of 2.0% EB01 topical cream. In addition to the primary cohort, the company has included an exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01. At the interim analysis for the Phase 2b study, an independent data monitoring board reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. The monitoring board also reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator’s Static Global Assessment), a key secondary efficacy endpoint. A decrease in the ISGA score relates to an improvement in signs and symptoms.

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 belief that EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; the company’s plans to expand the eligible patient population for the EB05 study to include the full spectrum of critically ill patients; the company’s belief that its plans will allow ICU physicians in the critical care setting to utilize EB05 earlier in the treatment paradigm, with the hope of potentially further reducing the number of days in the ICU and preventing more deaths; the company’s belief that EB05 could increase the number of ventilator free days and reduce mortalities in Level 6 and Level 7 patients; the ability of the company to enroll the required number of evaluable subjects in the study; the company’s ability to receive approval for the Phase 3 study design in the U.S.; 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, such as Covid-19. 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.

View source version on accesswire.com:
https://www.accesswire.com/702163/Edesa-Biotech-Adds-Mechanically-Ventilated-Patients-to-Phase-3-ARDS-Study

TORONTO, ON / ACCESSWIRE / May 13, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the three and six months ended March 31, 2022 and provided an update on its business.

For its critical care drug candidate, Edesa reported during the quarter that more than 25% of the subjects have been randomized for the Phase 3 part of the company’s clinical study in critically ill Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS). The final Phase 3 study protocol has been approved in Canada, Poland and Colombia. Discussions with U.S. regulators on the final Phase 3 design are ongoing. Recruitment for the Phase 3 study has followed Covid-19-related ICU admissions and seasonality, and the company is positioning additional investigational centers to be available for current and future waves of hospitalizations.

For its dermatology drug candidate, the company recently announced that its Phase 2b clinical study in chronic Allergic Contact Dermatitis (ACD) reached an enrollment milestone of 75% subjects randomized, and that recruitment was proceeding at a more accelerated pace than planned. Edesa anticipates that enrollment will be completed by the fourth calendar quarter of 2022, with initial topline data available as early as the first calendar quarter of 2023.

“This is an exciting time for Edesa as we prepare for the most meaningful milestones since our inception,” said Edesa Chief Executive Officer Par Nijhawan, MD. “Edesa management remains focused on fundamental value creation through the advancement of these later stage clinical assets. Successful results for one of these programs could significantly change the growth trajectory of the company and validate the broad potential utility of our underlying technologies.” He added that the company continues to explore strategic business development opportunities to further bolster the growth opportunities of Edesa’s clinical assets.

Edesa’s Chief Financial Officer Kathi Niffenegger reported that during first half of fiscal 2022 Edesa raised net cash proceeds of approximately $11.6 million from equity sales under an at-the-market offering program and a direct investment with a healthcare-focused institutional fund.

“With a stronger balance sheet, we are well positioned to maintain our operational momentum and advance our two later-stage clinical programs toward completion,” said Ms. Niffenegger. She added that for the three and six-month periods, operational expenditures were in line with management’s expectations and benefitted from the flexibility of the company’s business model to manage working capital and prioritize core development and commercialization activities.

Financial Results for the Three Months Ended March 31, 2022

Total operating expenses decreased by $4.93 million to $4.58 million for the three months ended March 31, 2022 compared to $9.51 million for the same period last year:

• Research and development expenses decreased by $4.94 million to $3.04 million for the three months ended March 31, 2022 compared to $7.98 million for the same period last year primarily due to decreased milestone and bulk drug substance payments, lower license fees and decreased external research expenses, which were partially offset by higher manufacturing expenses, and increased salary and related personnel expenses.
• General and administrative expenses remained relatively unchanged at $1.53 million for the three months ended March 31, 2022 compared to $1.54 million for the same period last year.

Total other income (loss) decreased by $7.24 million to an overall gain of $0.01 million for the three months ended March 31, 2022 compared to an overall gain of $7.25 million for the same period last year primarily due to a decrease in grant income associated with the completion of clinical study activities under the company’s federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.

For the quarter ended March 31, 2022, Edesa reported a net loss of $4.57 million, or $0.33 per common share, compared to a net loss of $2.26 million, or $0.19 per common share, for the three months ended March 31, 2021.

Financial Results for the Six Months Ended March 31, 2022

Total operating expenses decreased by $2.38 million to $9.74 million for the six months ended March 31, 2022 compared to $12.12 million for the same period last year:

• Research and development expenses decreased by $2.36 million to $6.99 million for the six months ended March 31, 2022 compared to $9.35 million for the same period last year primarily due to decreased milestone and bulk drug substance payments and lower license fees, which were partially offset by higher external research expenses, higher manufacturing expenses and increased salary and related personnel expenses.
• General and administrative expenses decreased by $0.03 million to $2.74 million for the six months ended March 31, 2022 compared to $2.77 million for the same period last year primarily due to lower salary and related personnel expenses, which were partially offset by increased legal and other professional service fees.

Total other income (loss) decreased by $6.44 million to an overall gain of $0.79 million for the six months ended March 31, 2022 compared to an overall gain of $7.23 million for the same period last year primarily due to a decrease in grant income associated with the completion of clinical study activities under Edesa’s federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.

For the six months ended March 31, 2022, Edesa reported a net loss of $8.95 million, or $0.66 per common share, compared to a net loss of $4.90 million, or $0.45 per common share, for the six months ended March 31, 2021

Working Capital

At March 31, 2022, Edesa had working capital of $14.66 million. Cash and cash equivalents totaled $15.89 million.

Calendar

Edesa management plans to participate in the H.C. Wainwright Global Investment Conference scheduled for May 23-25, 2022 and the BIO International Conference scheduled for June 13-16, 2022. Edesa will also join panel discussions at the 2nd ARDS Drug Development Summit scheduled for July 13-15, 2022. Members of the investment or biopharma community who are interested in meeting with management can schedule one-on-one calls or meetings through the conference websites or by contacting Edesa directly at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that Edesa is developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among Covid-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter 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 belief that enrollment in the Phase 2b study of EB01 can be completed by the fourth calendar quarter of 2022, with initial topline data available as early as the first calendar quarter of 2023; the company’s belief that recruitment for its Phase 3 study will continue to follow Covid-19-related ICU admissions and seasonality, and the company will be successful in positioning additional investigational centers to be available for current and future waves of hospitalizations; the company’s belief that it is nearing the most meaningful milestones since its inception; management’s efforts to remain focused on fundamental value creation; the company’s belief that successful results for even one of its clinical programs could significantly change the growth trajectory of the company and validate the broad potential utility of its underlying technologies; the company plans to explore strategic business development opportunities to further bolster the growth opportunities; the company’s belief that it is well positioned financially to maintain its operational momentum and advance its two later-stage clinical programs toward completion; 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, such as Covid-19. 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.

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• Completion of enrollment is anticipated by calendar fourth quarter for the Phase 2b study of Edesa’s potentially first-in-class, anti-inflammatory drug

TORONTO, ON / ACCESSWIRE / April 28, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that patient recruitment for a Phase 2b clinical study evaluating the company’s drug candidate, designated EB01, as a monotherapy for chronic allergic contact dermatitis (ACD) has been enrolling ahead of schedule.

Based on the current pace of recruitment, which had previously been impacted by pandemic-related shutdowns, the company anticipates completing enrollment of all 210 planned subjects by the fourth calendar quarter of 2022, with initial topline data available as early as the first calendar quarter of 2023. The company noted that interest in the novel mechanism of action and positive interim data have helped bolster enrollment.

“As patients return to work and re-enter social circles, there’s both an increase in potential exposure to the causal allergens and a greater desire to treat the inflammation,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “EB01 is being developed as a safe and effective alternative to steroids. This is especially important for ACD patients with chronic lesions, which are often on the hands and face and problematic to treat long-term with steroids.”

Dr. Nijhawan noted that while study results will be data-driven, and are subject to regulatory review, the company is preparing to be in position to rapidly move forward. “We are preparing for the next steps in the advancement of this novel drug candidate toward commercialization, including registration trial design, regulatory filings, price modeling and potential regional partnering.”

EB01 is an investigational medicine that contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. When activated, sPLA2 enzymes have been shown to initiate a cascade of inflammatory lipid mediators along a well-known pathway that is currently the target of steroids. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory and allergic conditions.

The double-blind, placebo-controlled confirmatory study is evaluating the safety and efficacy of 2.0% EB01 cream in approximately 170 evaluable subjects in total. In addition to the primary cohort, the company has included an exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01 in an additional 40 subjects.

The company previously reported that EB01 met key interim parameters in the ongoing Phase 2b study. Though blinded to treatment assignment, the study’s Data and Safety Monitoring Board reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. The monitoring board also reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator’s Static Global Assessment), a key secondary efficacy endpoint. A decrease in score relates to an improvement in signs and symptoms. For both the CDSI and ISGA endpoints, double-digit absolute differences were observed among the two treatment arms. No serious treatment-related adverse events were reported for either treatment group.

About EB01

EB01 is a topical vanishing cream containing a novel, non-steroidal anti-inflammatory compound. EB01 exerts its anti-inflammatory activity through the inhibition of certain pro-inflammatory enzymes known as secretory phospholipase 2, or sPLA2. These enzymes are secreted by immune cells upon their activation and produce arachidonic acid via phospholipid hydrolysis, which, in turn, initiates a broad inflammatory cascade. The sPLA2 enzyme family plays a key role in initiating inflammation associated with many diseases, and the company believes that targeting the sPLA2 enzyme family with enzyme inhibitors will have a superior anti-inflammatory therapeutic effect because the inflammatory process will be inhibited at its inception rather than after inflammation has occurred.

About Allergic Contact Dermatitis

Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. ACD accounts for about 20% of all cases of occupational dermatitis.

The condition is caused by an allergen interacting with skin, usually on the hands and face. Inflammation can vary from irritation and redness to open sores, and in many chronic cases, the causative allergen is unknown or difficult to avoid. Approximately 3,000 substances are recognized as contact allergens. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with scientific literature pointing to a potentially larger undiagnosed population. More than 1 million patients are estimated to have chronic ACD. To the company’s knowledge there are currently no treatment options specifically labelled for ACD.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter 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 belief that targeting the sPLA2 enzyme family with enzyme inhibitors will have a superior anti-inflammatory therapeutic effect; the company’s belief that enrollment Phase 2b study of EB01 can be completed by the fourth calendar quarter of 2022, with initial topline data available as early as the first calendar quarter of 2023; the company’s belief that EB01 is potentially a first-in-class drug technology; the company’s preparations to be in position to rapidly move forward, including regulatory filings, registration trial design, price modeling and potential regional partnering; 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, such as COVID-19. 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.

View source version on accesswire.com:
https://www.accesswire.com/699196/Edesa-Biotech-Reports-Dermatitis-Study-Enrolling-Faster-than-Expected

TORONTO, ON / ACCESSWIRE / March 29, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced the appointment of Jennifer M. Chao to the company’s Board of Directors.

“Ms. Chao’s appointment to our Board comes at an exciting time as we prepare for the most meaningful milestones yet in our clinical programs. Her extensive experience in the life science sector and capital markets will be a valuable resource to Edesa and its shareholders,” said Par Nijhawan, MD, Chief Executive Officer of Edesa.

Ms. Chao has more than 25 years of experience in the biotech and life sciences industries focused primarily on finance and corporate strategy. She is the founder of CoreStrategies Management, LLC, which provides corporate and financial consulting to biotech and life sciences companies. Ms. Chao currently serves as a Board Director of Endo International plc. and is a member of its Audit Committee and Compliance Committee. Prior to joining Endo, Ms. Chao served as a Director (since 2015) and as Board Chair (since October 2019) of BioSpecifics Technologies Corp. until its acquisition by Endo. In addition, since March 2022, she has been a board member of Cardiol Therapeutics Inc. and serves as Chair of Cardiol’s Corporate Governance and Compensation Committee.

Previously, Ms. Chao was Managing Director and Senior Lead Biotechnology Securities Analyst at Deutsche Bank. She was also a Managing Director and Senior Lead Biotechnology Analyst at RBC Capital Markets and a Senior Analyst in Biotechnology at Leerink Swann & Co. Ms. Chao was a research fellow at Massachusetts General Hospital/Harvard Medical School as a recipient of the BioMedical Research Career Award. She received her BA in Politics and Greek Classics from New York University.

“I am looking forward to working with the Board of Directors and the Edesa team in supporting Edesa’s strategic outlook for advancing important new treatments in the fields of immunotherapy and inflammatory disease, as the company continues to further its corporate, regulatory and commercial strategy,” said Ms. Chao.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among Covid-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter 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 current and future market opportunities; the company’s belief that it is approaching the most meaningful milestones to date in its clinical programs; the company’s belief that Ms. Chao’s expertise will be a valuable resource to the company and its shareholders; and the timing and plans regarding the company’s clinical studies and commercialization activities. 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, such as Covid-19. 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.

View source version on accesswire.com:
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TORONTO, ON / ACCESSWIRE / March 24, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules with a single healthcare-focused institutional investor of 2,739,727 of the Company’s common shares (or common share equivalents) at a purchase price of $3.65 per common share (or common share equivalent).

In addition, in a concurrent private placement, the Company issued to the investor warrants to purchase up to 2,739,727 common shares. The warrants have an exercise price of $3.52 per common share, were immediately exercisable and have a term of five and one-half years.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are approximately $10.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The common shares (or common share equivalents) described above (but not the warrants issued in the concurrent private placement or the common shares underlying such warrants) were offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-233567) previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on September 12, 2019. The offering of the common shares (or common share equivalent) was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at placements@hcwco.com.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the common shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying common shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter 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 anticipated use of proceeds, upcoming milestones in the company’s clinical studies, including enrollment milestones and interim readouts for its COVID-19 and dermatitis studies. 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: market and other conditions, those relating to the anticipated use of proceeds, 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, such as COVID-19. 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.

View source version on accesswire.com:
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TORONTO, ON / ACCESSWIRE / March 22, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the purchase and sale of 2,739,727 of the Company’s common shares (or common share equivalents) at a purchase price of $3.65 per common share (or common share equivalent) in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about March 24, 2022, subject to the satisfaction of customary closing conditions.

In addition, in a concurrent private placement, the Company will issue to the investor warrants to purchase up to 2,739,727 common shares. The warrants have an exercise price of $3.52 per common share, will be immediately exercisable and will have a term of five and one-half years.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $10.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The common shares (or common share equivalents) described above (but not the warrants issued in the concurrent private placement or the common shares underlying such warrants) are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-233567) previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on September 12, 2019. The offering of the common shares (or common share equivalent) is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at placements@hcwco.com.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the common shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying common shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter 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 completion of the offering and the anticipated use of proceeds, upcoming milestones in the company’s clinical studies, including enrollment milestones and interim readouts for its COVID-19 and dermatitis studies. 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: market and other conditions, those relating to the completion of the offering and the anticipated use of proceeds, 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, such as COVID-19. 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.

View source version on accesswire.com:
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TORONTO, ON / ACCESSWIRE / February 17, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today provided an update on the Phase 3 part of a Phase 2/3 clinical study evaluating the company’s monoclonal antibody candidate, designated EB05, as a single-dose therapy for hospitalized Covid-19 patients.

Edesa reported that more than 25% of the subjects have been randomized to date under the Phase 3 protocol design approved by Health Canada. The enrollment milestone follows favorable Phase 2 results, which demonstrated compelling preliminary evidence of EB05’s ability to reduce mortality in the sickest patients. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, said that as SARS-CoV2 continues to evolve and becomes endemic there’s an urgent need for therapeutics, like EB05, that are agnostic to variants. “Since EB05 is designed to target the patient’s own immune response rather than the virus itself, we believe it has broad potential application for Covid and beyond,” he said.

“We greatly appreciate the extraordinary efforts of the clinical teams and research staff who have been supporting the EB05 study,” said Dr. Nijhawan. “Based on the significant effect demonstrated in reducing mortality in the Phase 2 study, we believe that Edesa’s monoclonal antibody EB05 could significantly reduce mortalities and alleviate the stress on the healthcare system, especially in the ICU where beds are limited, care is very expensive and patient outcomes have been tragically poor.”

EB05 was developed to regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure that accounts for ~10% of all ICU admissions (pre-pandemic) and is the leading cause of death among Covid-19 patients. Specifically, EB05 inhibits toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. In September 2021, the company reported that an independent monitoring board for the Phase 2/3 study concluded that “a clinically important efficacy signal” was detected. The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial. Edesa’s Phase 2 study of EB05 in hospitalized Covid-19 patients was funded in part by a C$14 million grant from the Canadian Government’s Strategic Innovation Fund.

The Phase 3 double-blind study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus organ support (IMV+), defined as Level 7 on the World Health Organization’s COVID-19 Severity Scale. The primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The amended trial protocol design calls for approximately 315 evaluable subjects. Edesa has filed similar protocol amendments with the U.S. Food and Drug Administration (FDA) as well as other jurisdictions. In the U.S., the company is currently in discussions with the FDA on the design of the final Phase 3 protocol.

About ARDS
Acute Respiratory Distress Syndrome is the leading cause of death in Covid-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized Covid-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among Covid-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter 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 belief that EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; the company’s belief in the broad potential life-saving impact of its EB05 monoclonal antibody candidate; the company’s belief that there’s an urgent need for therapeutics that are agnostic to SARS-CoV2 variants; the company’s belief that EB05 could significantly reduce mortalities and alleviate the stress on the healthcare system; 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, such as Covid-19. 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.

View source version on accesswire.com:
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TORONTO, ON / ACCESSWIRE / February 14, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the three months ended December 31, 2021 and provided an update on its business.

During the quarter, Health Canada approved the Phase 3 design of a Phase 2/3 clinical study evaluating the company’s monoclonal antibody, designated EB05, as a rescue therapy for critically ill patients with a life-threatening form of respiratory failure known as ARDS. The authorization follows Phase 2 results that demonstrated a significant reduction in mortality among critically ill Covid-19 patients treated with EB05.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the promising EB05 results provide an opportunity for the company to play a significant role in building a lasting solution to the pandemic, as Covid becomes endemic and governments focus more on treatments for those who become hospitalized.

“Our expectation is that Covid-19 cases are going to continue to drive ARDS-related ICU admissions well beyond historical levels for the foreseeable future. There’s a significant and urgent unmet medical need for critical care treatments and we believe that EB05 could become an important part of reducing mortality and improving ICU capacity. If these two challenges can be managed, it helps provide the world with a way forward to live with Covid,” he said.

The company also reported that its Phase 2b clinical study in chronic Allergic Contact Dermatitis (ACD) reached an enrollment milestone during the quarter, and that enrollment in the study has returned to a pre-pandemic pace in recent months. Recruitment also continues for the EB05 study. The company plans to provide more detailed clinical updates for these development programs as they become available. “In the coming quarters we look forward to completing recruitment and presenting topline results for these lead product candidates,” said Dr. Nijhawan.

Edesa’s Chief Financial Officer Kathi Niffenegger said that the fiscal first quarter reflected increased development and regulatory activities for the company’s ongoing clinical programs. Results continued to benefit from reimbursements under the company’s government grant.

“Our fiscal first quarter results demonstrated the disciplined approach we are taking to deploying our working capital and the flexibility management has to align the timing of scale-up expenditures with clinical advancements and other important value inflection points,” said Ms. Niffenegger.

Financial Results for the Three Months Ended December 31, 2021

Total operating expenses increased by $2.55 million to $5.16 million for the three months ended December 31, 2021 compared to $2.61 million for the same period last year:

• Research and development expenses increased by $2.57 million to $3.95 million for the three months ended December 31, 2021 compared to $1.38 million for the same period last year primarily due to increased external research expenses related to the company’s ongoing clinical studies, increased investigational drug product expenses, higher salary and related personnel expenses due to increased headcount and higher patent fees, which were partially offset by a decrease in noncash share-based compensation.
• General and administrative expenses decreased by $0.02 million to $1.21 million for the three months ended December 31, 2021 compared to $1.23 million for the same period last year primarily as a result of decreased noncash share-based compensation, which was partially offset by higher insurance, and legal and other professional service fees.

Total other income (loss) increased by $0.80 million to an overall gain of $0.78 million for the three months ended December 31, 2021 compared to an overall loss of $0.02 million for the prior year primarily due to increased grant income under the company’s federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.

For the quarter ended December 31, 2021, Edesa reported a net loss of $4.38 million, or $0.33 per common share, compared to a net loss of $2.64 million, or $0.26 per common share, for the quarter ended December 31, 2020.

Working Capital

At December 31, 2021, Edesa had working capital of $8.14 million. Cash and cash equivalents totaled $5.88 million. Subsequent to the end of the fiscal first quarter, the company received gross proceeds of approximately $1.19 million from the issuance of common shares under an equity distribution agreement with RBC Capital Markets.

Calendar

Edesa management plans to participate in the BIO Europe Spring 2022 virtual conference scheduled for March 28-31, 2022. Members of the investment or biopharma community who are interested in meeting with management can schedule one-on-one calls through the conference website or by contacting Edesa at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that Edesa is developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among Covid-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter 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 belief that promising EB05 results provide an opportunity for it to play a significant role in building a lasting solution to the pandemic; the company’s expectation that Covid-19 cases are going to continue to drive ARDS-related ICU admissions well beyond historical levels for the foreseeable future; the company’s belief that there’s a significant and urgent unmet medical need for critical care treatments and that EB05 could become an important part of reducing mortality and improving ICU capacity; the company’s plans to provide more detailed clinical updates for these development programs as they become available; 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, such as Covid-19. 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.

View source version on accesswire.com:
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TORONTO, ON / ACCESSWIRE / January 26, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that Dr. Par Nijhawan, Chief Executive Officer, is scheduled to participate in a virtual event at the 2022 OBIO Investment Summit hosted by the Ontario Bioscience Innovation Organization.

As part of an industry panel, Dr. Nijhawan is expected to discuss, among other topics, how Edesa adapted its drug development programs and aligned its business with government and industry priorities to respond to the COVID-19 health crisis.

The panel discussion, which is titled “Pivoting and Adapting to the Changing Environment,” is scheduled to take place on Thursday, February 10, 2022 at 1:00 pm Eastern Time. More information is available at the event website.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter 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 scheduled events and the company’s timing and plans regarding its drug development 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, such as COVID-19. 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.

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• Phase 3 study will focus on critically ill patients, many of whom have run out of effective drug treatment options

TORONTO, ON / ACCESSWIRE / January 13, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that the company has received approval from Health Canada to test its monoclonal antibody candidate, designated EB05, as a rescue therapy for critically ill patients in the Phase 3 part of a Phase 2/3 clinical study.

Edesa believes that EB05 regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure that accounts for ~10% of all ICU admissions (pre-pandemic) and is the leading cause of death among COVID-19 patients. Approval of the company’s Phase 3 study design follows favorable Phase 2 results, which demonstrated compelling preliminary evidence of EB05’s ability to reduce mortality in the sickest patients. Among the results, critically ill hospitalized COVID-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

“Health Canada’s approval represents a significant milestone in our goal of demonstrating the broad potential utility of EB05 in a critical care setting,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. He noted that there’s an urgent need for therapeutics that are agnostic to SARS-CoV2 variants.

“The growing number of COVID variants – and the inherent limits of vaccines and anti-viral drugs – have highlighted the importance of agnostic therapies, like EB05, that target the patient’s immune response rather than the virus. While the Phase 3 study is designed to confirm the Phase 2 results, the preliminary data shows that EB05 has already saved lives. Perhaps just as important, this innovative technology is providing greater confidence that COVID can be well managed one day, like other endemic diseases,” said Dr. Nijhawan.

Edesa reported that the Phase 3 double-blind study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus organ support (IMV+), defined as Level 7 on the World Health Organization’s COVID-19 Severity Scale. The primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The amended trial protocol design calls for approximately 315 evaluable subjects. The company has opened patient enrollment under the amended protocol.

Health Canada reviewed Edesa’s study design amendment and approved it by issuing a “Notice of Authorization,” which allows the company to proceed with its planned study design. Under the amended protocol, Edesa also has the option to complete a separate study group of less severe patients receiving only invasive mechanical ventilation (WHO COVID-19 Severity Scale Level 6), which would be evaluated independently.

Edesa has filed similar protocol amendments with the U.S. Food and Drug Administration (FDA) as well as other jurisdictions. In the U.S., the company is currently in discussions with the FDA on the design of the final Phase 3 protocol.

About EB05
EB05 is a monoclonal antibody designed to inhibit toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. In September 2021, the company reported that an independent monitoring board for the Phase 2/3 study concluded that “a clinically important efficacy signal” was detected and that the Phase 2 study “met its objective.” The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial. Edesa’s Phase 2 study of EB05 in hospitalized COVID-19 patients was funded in part by a C$14 million grant from the Canadian Government’s Strategic Innovation Fund.

About ARDS
Acute Respiratory Distress Syndrome is the leading cause of death in COVID-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized COVID-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter 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 belief that EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; the company’s belief in the broad potential life-saving impact of its EB05 monoclonal antibody candidate; the company’s belief that there’s a critical need for therapeutics that are agnostic to SARS-CoV2 variants; 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, such as COVID-19. 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.

View source version on accesswire.com:
https://www.accesswire.com/683286/Edesa-Biotech-Receives-Canadian-Approval-to-Test-COVID-19-Drug-as-Rescue-Therapy