Edesa News Archive

TORONTO, ON / ACCESSWIRE / December 28, 2021 / 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, 2021 and provided an update on its business.

During the fiscal year, Edesa reported favorable interim results for both of the company’s leading drug candidates, EB05 and EB01. EB05 is being developed as a potential treatment for ARDS, a life-threatening form of respiratory failure that accounts for approximately 10% of all ICU admissions (pre-pandemic) and is the leading cause of death among COVID-19 patients. In September 2021, the Phase 2 part of an international Phase 2/3 study of EB05 was preemptively unblinded due to an important efficacy signal, and an independent monitoring board determined the study had met its objective. Earlier this year, the company also achieved a key interim milestone in a Phase 2b study evaluating another Edesa anti-inflammatory drug, designated EB01, for chronic allergic contact dermatitis, a common, potentially debilitating disease. In December 2021, the company reported that more than 75% of the subjects in the primary cohort of the Phase 2b study of EB01 have been randomized.

“The past twelve months have been transformational for Edesa as we validated our technologies in the clinic, received high-level recognition from the federal government, established an international acute-care trialing network, and broadened our strategic outreach,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “In the coming quarters we look forward to building on our momentum and presenting topline results for our EB05 and EB01 product candidates. Success in either of these two later-stage programs – each of which represents a separate anti-inflammatory technology – could provide a game-changing opportunity for the company.”

Edesa’s Chief Financial Officer Kathi Niffenegger said that the company’s year-end results reflect the company’s increased clinical activities, which included the launch and completion of the Phase 2 part of the company’s EB05 study. She noted that these research activities were funded in part by a federal innovation grant from the Canadian government. For the year ended September 30, 2021, Edesa recorded $10.34 million in grant income.

“Our fiscal year results demonstrate the positive impact of the government grant funding and the targeted approach we are taking to efficiently reach clinical milestones,” Ms. Niffenegger said.

Financial Results for the Fiscal Year Ended September 30, 2021

There were no revenues for the year ended September 30, 2021 compared to $0.33 million for the prior year, reflecting the winddown and discontinuation of sales of product inventory from legacy operations.

Total operating expenses increased by $16.95 million to $23.68 million for the year ended September 30, 2021 compared to $6.73 million for the prior year:

• Research and development expenses increased by $14.62 million to $17.95 million for the year ended September 30, 2021 compared to $3.33 million for the prior year primarily due to milestone payments related to advancement of the company’s EB05 clinical program, increased external research expenses related to accelerated activity in ongoing clinical studies, increased investigational drug product expenses and an increase in noncash share-based compensation. Higher salary and related personnel expenses and patent fees also contributed to the increase.
• General and administrative expenses increased by $2.35 million to $5.73 million for the year ended September 30, 2021 compared to $3.38 million for the prior year primarily as a result of higher salary and related personnel expenses, noncash share-based compensation and increased headcount. Higher legal and other professional services also contributed to the increase.

Total other income increased by $10.30 million to $10.34 million for the year ended September 30, 2021 compared to $0.04 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 fiscal year ended September 30, 2021, Edesa reported a net loss of $13.34 million, or $1.10 per common share, compared to a net loss of $6.36 million, or $0.74 per common share, for the year ended September 30, 2020.

Working Capital

At September 30, 2021, Edesa had working capital of $10.63 million. Cash and cash equivalents totaled $7.84 million. Subsequent to the end of the fiscal year, the company received gross proceeds of approximately $1.29 million from the issuance of common shares under an equity distribution agreement with RBC Capital Markets.

Calendar

Edesa management plans to participate in the11th Annual LifeSci Partners Corporate Access Event scheduled for January 5-7, 2022, as well as the H.C. Wainwright BioConnect Conference scheduled for January 10-13, 2022. Investors interested in meetings with management can schedule one-on-one meetings by contacting the conference organizers or 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 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 plans to build on its past performance momentum and present topline results from our EB05 and EB01 product candidates in the coming quarters; the company’s belief that success in either of its two later-stage clinical development programs could provide a game-changing opportunity for the company; the potential efficacy of its drug candidates; 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/678704/Edesa-Biotech-Reports-Fiscal-Year-2021-Results

TORONTO, ON / ACCESSWIRE / December 1, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has completed enrollment of more than 75% of the patients planned for the primary cohort of a Phase 2b clinical study evaluating the company’s drug candidate, designated EB01, as a monotherapy for chronic allergic contact dermatitis.

The double-blind, placebo-controlled 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 is preparing to initiate the exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01 in an additional 40 subjects. The company noted that telehealth options and expanded recruitment efforts have helped investigators reach new patient populations and bolster enrollment, despite pandemic-related disruptions.

Due to physician and patient interest, the company has also added a voluntary open-label extension for study patients once they complete their treatment in the main study. This guarantees that participants in the placebo arm have access to treatment with the active ingredient. The open label extension is also designed to provide longer term usage data, since allergic contact dermatitis (ACD) often reoccurs, or is chronic.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the pace of enrollment has increased since the company reported positive interim results this summer. “Enrollment trends have been very encouraging, and we are turning our focus to rapidly completing the study and preparing for the next steps in the development of this potentially first-in-class drug technology.”

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.

“Developing a safe and effective alternative to steroids is especially important for ACD patients with chronic lesions and other debilitating symptoms, and we are pleased to be one step closer to a solution,” said Dr. Nijhawan.

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. The Canadian Center for Occupational Health and Safety reports that 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, according to the agency. 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 one 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 intention to focus on rapidly completing the Phase 2b study of EB01 and preparing for the next steps in the development; the company’s belief that EB01 could be potential first-in-class drug technology; 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/675369/Edesa-Biotech-Marks-Enrollment-Milestone-in-Dermatitis-Study

• Expansion to European Union country follows favorable Phase 2 results
• Company focusing on critically ill hospitalized patients

TORONTO, ON / ACCESSWIRE / November 4, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that Polish regulators have approved a clinical trial application for the investigational use of the company’s monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized COVID-19 patients. Enrollment in the Phase 2/3 drug trial is ongoing in the U.S., Canada and Colombia.

Edesa believes that EB05 could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. The company recently reported that critically ill hospitalized 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.

Due to the lack of treatments available to patients with severe respiratory distress, the company has reported that it will focus enrollment for the Phase 3 portion of its international study on patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV) plus organ support.

“We urgently need effective therapies for patients once they become hospitalized, especially for ARDS patients who have failed all other drugs and treatment modalities. Given the profound effect that EB05 has demonstrated in reducing death in the most critically ill patient population, we are looking forward to expanding the study to Poland where daily COVID-19 case counts are high and on the rise,” said Par Nijhawan, MD, Chief Executive Officer of Edesa.

Dr. Nijhawan reported that Edesa has enlisted the support of a local research organization and will begin activating hospital sites in major metropolitan areas.

Edesa’s international Phase 2/3 study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. The company is currently filing amendments with regulators in the United States, Canada and Colombia to update the Phase 3 protocol based on Phase 2 results, and set targeted enrollment. Edesa is also evaluating opportunities to apply for expedited regulatory review and conditional approval programs in the U.S., Canada and other jurisdictions.

About EB05
EB05 is a monoclonal antibody developed 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, Edesa announced positive results from the Phase 2 portion of its international Phase 2/3 study of EB05. The company reported that independent monitoring board concluded that “a clinically important efficacy signal” was detected and that the study “met its objective.” The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial.

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 results in edema that 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 the company 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 EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; the company’s belief in the broad potential utility and potential life-saving impact of its EB05 monoclonal antibody candidate; the company’s plans to activate hospitals in Poland; the company’s plans to file amendments with regulators to update the Phase 3 protocol and set targeted enrollment; 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/670901/Edesa-Biotech-Extends-COVID-19-Clinical-Study-to-Poland

• Mortality reductions demonstrated across multiple patient groups
• Additional efficacy signals recorded in a broad range of mild to severe ARDS patients
• Company to focus on critically ill population for Phase 3

TORONTO, ON / ACCESSWIRE / October 19, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced additional results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company’s monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized COVID-19 patients.

The Phase 2 data were preemptively unblinded last month by the study’s Data and Safety Monitoring Board (DSMB) due to a clinically important efficacy signal detected among the most critically ill patients. Since then, the analysis of the results has continued in other patient groups. Edesa believes EB05 regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients.

Edesa reported today that EB05 demonstrated mortality reductions in multiple patient groups beyond the initial findings, which showed that critically ill hospitalized patients treated with EB05 + Standard of Care treatment (SOC) had a 68.5% reduction in the risk of dying when compared to placebo + SOC at 28 days. Additional efficacy signals have also been identified.

Among the findings, the DSMB noted another mortality benefit in 136 hospitalized COVID-19 patients receiving supplemental oxygen (28-day mortality rate of 8.2% (5/61) in the EB05 + SOC arm versus 12.0% (9/75) in the placebo + SOC arm, Hazard Ratio (HR): 1.52 placebo vs. EB05, n=136). Within this group, a strong signal for patients with severe ARDS at baseline (based on the Berlin score) was investigated by the DSMB and was part of their decision to unblind the study. Consistent with the signal previously reported in critically ill patients, the DSMB concluded that the severe ARDS patients receiving supplemental oxygen at baseline had “a clinically important efficacy signal” with a 28-day mortality rate of 16.7% (2/12) in the EB05 + SOC arm versus 42.9% (6/14) in the placebo + SOC arm. Survival Analysis using Cox’s Proportional Hazard Model in this group showed that the subjects treated with EB05 + SOC had a 66.0% reduction in the risk of dying when compared to placebo + SOC at 28 days (HR: 2.94 placebo vs. EB05; 95% CI: 0.59-14.60; p=0.19).

There were confirmatory efficacy signals detected in other groups including the 190 patients with mild to moderate ARDS at baseline (28-day mortality rate of 7.8% (7/90) in the EB05 + SOC arm versus 11.0% (11/100) in the placebo + SOC arm, HR: 1.46 placebo vs. EB05, n=190). Within this group, patients with mild to moderate ARDS receiving oxygen support beyond supplemental oxygen demonstrated a 50.7% reduction in the risk of dying in the EB05 + SOC arm compared to placebo + SOC at 28 days (HR: 2.03 placebo vs. EB05; 95% CI: 0.61-6.74; p=0.25). The 28-day mortality rate was 10.8% (4/37) in the EB05 + SOC arm versus 20.5% (8/39) in the placebo + SOC arm. In this group, patients treated with EB05 + SOC also had an increase of approximately 6.1 days alive and free of invasive mechanical ventilation (IMV) at 28 days versus those treated with placebo + SOC (p<0.05).

“We are excited about the potential utility of our monoclonal antibody given the profound effect that it demonstrated in reducing death in the most critically ill patient population. These results further strengthen our hypothesis and our belief in the potential life-saving impact of this drug,” said Par Nijhawan, MD, Chief Executive Officer of Edesa.

Due to the lack of treatments available to critically ill patients and the clinically meaningful impact observed with respect to 28-day mortality, the company has decided to focus on this patient segment for the Phase 3 portion of the study. Edesa may also advance other subgroups of patients into Phase 3 at a later time.

Michael Brooks, PhD, President of Edesa, said that this approach could substantially reduce the number of additional patients needed for the Phase 3 study and put the company in the position to potentially file for its first marketing authorization application sooner than anticipated.

“The Phase 2 part of the study met its primary objective of identifying efficacy signals among the various patient stratifications. We are excited to see supportive efficacy signals across multiple patient segments. We plan to continue forward into the Phase 3 study prioritizing critically ill patients and are evaluating the most efficient way to utilize the existing dataset to support future regulatory filings, trials and applications,” said Dr. Brooks.

Edesa plans to file amendments with regulators in the United States, Canada and Colombia to update the Phase 3 protocol and set targeted enrollment. Edesa is also evaluating opportunities to apply for expedited regulatory review programs in the U.S., Canada and other jurisdictions. The company plans to provide additional updates regarding its clinical activities and regulatory filings as they become available.

Summary of Efficacy Signals
The following table is a summary of the key signals detected in the Phase 2 patient population:

Berlin ARDS Criteria: Mild = PaO2/FiO2 between 200 and 300 mm Hg; Moderate = PaO2/FiO2 between 100 and 200 mm Hg; Severe = PaO2/FiO2 under 100 mm Hg.

About EB05
EB05 is an experimental monoclonal antibody that Edesa believes regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. Specifically, the drug 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. Edesa’s study of EB05 in hospitalized COVID-19 patients is being funded in part by a C$14 million grant from the Canadian Government.

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 results in edema that prevents the lungs from oxygenating blood. 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 .

JSS Medical Research (www.jssresearch.com) was the company’s contract research organization for the study and conducted the data analyses.

Cautionary Note Regarding Clinical Studies
The company plans to analyze the topline data along with additional information gathered during this study, including safety and other outcome measures. Such analysis may result in additional, different or inconsistent findings to those included in this release. As such, investors should not rely on topline or Phase 2 (interim) results reported in this release as the final, definitive results of the Phase 2/3 study.

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 use of EB05 to treat hospitalized COVID-19 patients; the company’s belief in the broad potential utility and potential life-saving impact of its EB05 monoclonal antibody candidate; the potential to advance additional subgroups of patients into Phase 3 at a later time; the company’s belief that its clinical strategy could substantially reduce the number of additional patients needed for the Phase 3 study and put the company in the position to potentially file for its first marketing authorization application sooner than anticipated; the company’s plans to file amendments with regulators to update the Phase 3 protocol and set targeted enrollment; 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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https://www.accesswire.com/668278/Edesa-Biotech-Reports-Favorable-Mortality-Reductions-in-COVID-19-Study

• Study unblinded due to strong efficacy signal for 28-day mortality endpoint
• Critically ill patients demonstrated a 68.5% reduction in the risk of dying when treated with EB05 over Standard of Care
• Data monitoring board recommends continuation to confirmatory Phase 3 study

TORONTO, ON / ACCESSWIRE / September 20, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced positive results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company’s monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized COVID-19 patients.

An independent Data and Safety Monitoring Board (DSMB), composed of subject matter experts, informed the company that during its initial analysis of the Phase 2 portion of the study they identified an important signal between the treatment arms for 28-day mortality, and requested that the study be preemptively unblinded. While the Phase 2 portion was primarily designed to refine patient stratification and statistical powering for the Phase 3 study, the DSMB concluded that “a clinically important efficacy signal” was detected and that the study has “met its objective.” The DSMB further recommended continuation of the study into a Phase 3 confirmatory trial.

Among the findings, the DSMB reported a 28-day death rate of 14.3% (2/14) in the EB05 arm versus 36.8% (7/19) in the placebo arm in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation). Survival Analysis using Cox’s Proportional Hazard Model showed that the patients treated with EB05 plus standard of care had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days (HR: 3.17 placebo vs. EB05; 95% CI: 0.66-15.35; p=0.15). The currently available data indicates that greater than 90% of patients received dexamethasone (or other steroids), more than 45% received both tocilizumab and a steroid.

The results from the Phase 2 analysis also suggest that EB05 has been generally well-tolerated and consistent with the observed safety profile to date. In addition, the DSMB identified another patient group with robust signals for mortality reduction at 28 days and the company plans to review this data as well as the full dataset.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, said that the unblinded Phase 2 data offer compelling preliminary evidence that EB05 can mediate the overactive immune response associated with Acute Respiratory Distress Syndrome, the leading cause of death among COVID-19 patients.

“The strong effect in reducing death in the most critically ill hospitalized patients who have been treated with systemic corticosteroids, including dexamethasone, and IL-6 inhibitors, shows the potential life-saving impact of this drug, irrespective of SARS-CoV-2 variant,” he said. “On behalf of Edesa, I’d like to express our continuing gratitude to the patients, their families and healthcare workers participating in the study as well as our partners for helping facilitate the rapid completion of this first leg of the study.”

The analysis reviewed data from approximately 360 patients, 24 to 93 years of age, from investigational sites in the United States, Canada and Colombia. Participants were treated with a single intravenous infusion of either EB05 plus standard of care treatment, or placebo plus standard of care (randomized 1:1). The DSMB’s initial analysis was limited to the mortality endpoint, and a review of other endpoints is ongoing.

Next Steps

Based on the Phase 2 results and guidance from the DSMB, Edesa plans to focus on patient segments that have demonstrated the strongest efficacy signals and have the greatest potential of rapidly completing enrollment, beginning with critically severe patients. The company intends to file amendments with regulators in the United States, Canada and Colombia to update the Phase 3 protocol and set targeted enrollment. Edesa is also evaluating opportunities to apply for expedited regulatory review programs in the U.S. and Canada.

“With few meaningful treatment options available for hospitalized patients, and clear evidence that the COVID-19 virus is becoming endemic, we are evaluating ways to expedite the next steps in our development and commercialization plans,” said Blair Gordon, PhD, Vice President of Research and Development.

About EB05

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. Specifically, the drug 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. Edesa’s study of EB05 in hospitalized COVID-19 patients is being funded in part by a C$14 million grant from the Canadian Government.

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 results in edema that 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.

Cautionary Note Regarding Clinical Studies

The company plans to analyze the topline data along with additional information gathered during this study, including safety and other outcome measures. Such analysis may result in additional, different or inconsistent findings to those included in this release. As such, investors should not rely on topline or interim results reported in this release as the final, definitive results of the study.

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 immune response associated with ARDS, the company’s belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, and the company’s timing and plans regarding its Phase 2/3 study, including the company’s efforts to expedite the next development and regulatory steps. 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/664687/Edesa-Biotech-Announces-Positive-Phase-2-Data-of-Its-Monoclonal-Antibody-in-Hospitalized-COVID-19-Patients

TORONTO, ON / ACCESSWIRE / September 9, 2021 / 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 present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually from September 13 to 15, 2021. Dr. Nijhawan is expected to provide an overview of Edesa’s business and corporate strategy.

An on-demand corporate presentation will be accessible to conference attendees starting on Monday, September 13, 2021 at 7:00 am ET. Dr. Nijhawan and Edesa senior management will also be available for one-on-one meetings. 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.

More information about the 23rd Annual Global Investment Conference is available at the H.C. Wainwright conference 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 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. 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/663053/Edesa-Biotech-to-Present-at-the-HC-Wainwright-Global-Investment-Conference

• Delta variant contributes to rapid enrollment amid growing scientific rationale for targeting Toll-like Receptor 4 (TLR4)
• Blinded interim analysis from Phase 2/3 study expected in current quarter

TORONTO, ON / ACCESSWIRE / August 26, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today provided an update on a Phase 2/3 clinical study evaluating the company’s monoclonal antibody candidate as a single-dose therapy for hospitalized COVID-19 patients.

As of August 25, 2021, Edesa reported that more than 525 subjects have been randomized into the study to be treated with either Edesa’s monoclonal antibody (designated EB05) plus standard of care treatment, or placebo plus standard of care. Approximately 35 of these patients have been assigned to an investigation sub-study evaluating EB05 as a rescue therapy for patients with critically severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy.

Additionally, the company reported that all patients planned for a key interim analysis have been randomized and completed the treatment protocol. Edesa expects the analysis from third-party statisticians to be completed in the coming weeks.

The company said that the interim analysis will include data from approximately 316 subjects. The blinded comparative interim analysis of treatment data and events is expected to inform patient segmentation and associated endpoints for the final part of study. As a Phase 2/3 study, enrollment has continued during the analysis.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, attributed the rapid pace of enrollment to the growing scientific rationale for targeting Toll-like Receptor 4 (TLR4), the attractiveness of the single-dose treatment, the broad potential utility for the drug candidate as well as increased disease incidence in regions where Edesa’s clinical sites are located.

“We have continued to see rapid enrollment in our trial this summer, especially in the southern hemisphere. With the Delta variant causing another wave of infections in North America, we are now experiencing some of the highest weekly rates of enrollment since we initiated our study,” said Dr. Nijhawan. “The prevalence of the Delta variant, as well as any future variants, underscores the urgent need for therapeutics that can address the mechanisms underlying the progression to severe disease and respiratory failure.”

“We anticipate being in a position to provide the interim results for our Phase 2/3 study this quarter,” said Dr. Nijhawan. “On behalf of Edesa, I’d like to express our continuing gratitude to the patients, their families and healthcare workers along with the clinical site teams for enabling us to reach these key milestones.”

Dr. Blair Gordon, Edesa’s Vice President of Research and Development, reported that with support from the federal government, the company has now established a network of 46 clinical sites at hospitals in Canada, Colombia and the United States.

“With all the planned clinical sites trained and up-and-running, and drug product on hand, our research and development team and study partners are preparing for an efficient transition into the anticipated Phase 3 study portion of the study,” he said.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. Specifically, the drug 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. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

Edesa’s study of EB05 in hospitalized COVID-19 patients is being funded in part by a C$14 million grant from the Canadian Government. To date, the company has reached all clinical enrollment and project targets specified under the grant ahead of schedule.

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 results in edema that 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.

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 immune response associated with ARDS, the company’s belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, and the company’s timing and plans regarding its Phase 2/3 study, including the company’s belief that it will be in a position to provide interim results for its Phase 2/3 study within the next three to four weeks. 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/661420/Edesa-Biotech-Enrolls-More-Than-525-COVID-19-Patients-Ahead-of-Schedule

TORONTO, ON / ACCESSWIRE / August 13, 2021 / 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, 2021 and provided an update on its business.

During the quarter, the company achieved key interim milestones for both of its lead product candidates, EB05 and EB01. Independent monitoring boards assessed blinded interim treatment data and based on their positive findings recommended that the two development programs advance to the final stages of enrollment. Edesa expects the end of Phase 2 (interim) analysis of a Phase 2/3 study of EB05 as a single-dose treatment for hospitalized COVID-19 patients will be completed as early as the current quarter. The company plans to provide more detailed clinical updates as they become available. In parallel, the company has begun patient randomizations for the final part of a Phase 2b clinical study evaluating EB01 as a monotherapy for chronic Allergic Contact Dermatitis. Edesa recently added new investigational sites and expanded recruitment beyond the U.S. to Canada.

“We are pleased to have these two key programs advancing side by side toward data readouts and value inflection opportunities. EB05 and EB01 each represent novel anti-inflammatory technologies with the potential to provide transformational therapies for a broad range of inflammatory and autoimmune conditions,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “We look forward to maintaining the momentum we achieved year to date, and announcing our end of Phase 2 results of our EB05 program as soon as available.”

Edesa’s Chief Financial Officer Kathi Niffenegger reported that expenditures for the fiscal third quarter were in line with management’s expectations and driven primarily by incremental clinical study expenses related to patient enrollment, expanded operations and drug product-related costs. “Our R&D expenditures for the three-month and nine-month periods have largely tracked the accelerated progress of our clinical studies as well as preparations related to commercial-scale manufacturing of our product candidates,” she said.

For the nine-month period ended June 30, 2021, Ms. Niffenegger reported that the company recorded reimbursements of approximately $8.5 million under a C$14 million reimbursement grant from the Canadian Government, including $1.3 million for the fiscal third quarter. At June 30, 2021, Edesa had working capital of $13.35 million, including cash and cash equivalents of $8.05 million.

Financial Results for the three months Ended June 30, 2021

There were no revenues for the three months ended June 30, 2021 compared to $0.11 million for the three months ended June 30, 2020, reflecting the winddown and discontinuation of sales of product inventory from legacy operations.

Total operating expenses increased by $4.19 million to $6.07 million for the three months ended June 30, 2021 compared to $1.88 million for the same period last year:

• Research and development expenses increased by $3.32 million to $4.46 million for the three months ended June 30, 2021 compared to $1.14 million for the same period last year primarily due to increased external research expenses related to recruitment and enrollment in the company’s ongoing clinical studies, increased investigational drug product expenses and an increase in noncash share-based compensation. Higher salary and related personnel expenses and patent fees also contributed to the increase.
• General and administrative expenses increased by $0.88 million to $1.61 million for the three months ended June 30, 2021 compared to $0.73 million for the same period last year primarily as a result of higher salary and related personnel expenses, noncash share-based compensation and increased headcount. Higher legal and other professional services also contributed to the increase.

Total other income increased by $1.31 million to $1.31 million for the three months ended June 30, 2021 compared to less than $0.01 million for the same period last year primarily due to increased grant income under the company’s federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.

For the three months ended June 30, 2021, Edesa reported a net loss of $4.76 million, or $0.36 per common share, compared to a net loss of $1.77 million, or $0.20 per common share, for the three months ended June 30, 2020.

Financial Results for the Nine Months Ended June 30, 2021

There were no revenues for the nine months ended June 30, 2021 compared to $0.33 million for the nine months ended June 30, 2020, reflecting the winddown and discontinuation of sales of product inventory from legacy operations.

Total operating expenses increased by $13.48 million to $18.20 million for the nine months ended June 30, 2021compared to $4.72 million for the same period last year:

• Research and development expenses increased by $11.65 million to $13.82 million for the nine months ended June 30, 2021 compared to $2.17 million for the same period last year primarily due to milestone payments related to advancement of the company’s EB05 clinical program, increased external research expenses related to accelerated activity in the company’s ongoing clinical studies, increased investigational drug product expenses and an increase in noncash share-based compensation. Higher salary and related personnel expenses and patent fees also contributed to the increase.
• General and administrative expenses increased by $1.85 million to $4.38 million for the nine months ended June 30, 2021 compared to $2.53 million for the same period last year primarily as a result of higher salary and related personnel expenses, noncash share-based compensation and increased headcount. Higher legal and other professional services also contributed to the increase.

Total other income increased by $8.50 million to $8.54 million for the nine months ended June 30, 2021 compared to $0.04 million for the same period last year primarily due to increased grant income under the company’s federal reimbursement grant with the Canadian government’s Strategic Innovation Fund.

For the nine months ended June 30, 2021, Edesa reported a net loss of $9.66 million, or $0.83 per common share, compared to a net loss of $4.35 million, or $0.52 per common share, for the nine months ended June 30, 2020.

Event Calendar

Edesa management is scheduled to present at the H.C. Wainwright Global Investment Conference being held September 13-15, 2021 in New York City. Attendees interested in meeting with management can schedule one-on-one meetings through the conference or by contacting Edesa at investors@edesabiotech.com.

View source version on accesswire.com:
https://www.accesswire.com/658971/Edesa-Biotech-Reports-Fiscal-3rd-Quarter-2021-Financial-Results

TORONTO, ON / ACCESSWIRE / July 13, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that the company has expanded patient enrollment to Canada for the final part of a Phase 2b study evaluating its EB01 drug candidate as a monotherapy for chronic Allergic Contact Dermatitis (Eczema), or ACD. The first part of the ACD study was conducted in the United States, where enrollment is ongoing.

ACD is one of the most common skin diseases. The Canadian Center for Occupational Health and Safety reports that 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, according to the agency.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that occupational dermatitis adversely impacts both employees and employers. “In addition to the debilitating symptoms for patients, it can be very difficult to identify or mitigate exposure when the allergen occurs in the workplace. Changes in work responsibilities or the substitution of materials is not always possible and many chronic ACD patients can end up on disability, resulting in lost income and disability claims,” Dr. Nijhawan said. “Our hope with EB01 is to provide patients with meaningful symptom relief and get them back to work.”

Edesa recently reported that EB01, a non-steroidal anti-inflammatory compound, met a key interim study parameter and an independent data monitoring board recommended that the company continue to enroll subjects in the study. The company plans to enroll up to at least 120 additional evaluable subjects, who will be provided with either Edesa’s EB01 topical treatment (at a 2.0%, 1.0% or 0.2% concentration) or a placebo cream.

The study’s primary outcome will be the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. A key secondary outcome will be the proportion of patients achieving success on the ISGA (Investigator’s Static Global Assessment) scale. Due to physician and patient interest, the company is also adding an open-label extension for study patients.

Blair Gordon, PhD, Edesa’s Vice President of Research and Development, said that making EB01 available at Canadian investigational sites is expected to accelerate the completion of enrollment. “I’m pleased to report that we have already randomized the first Canadian patients for the 28-day treatment.”

Dr. Gordon noted that here are limited options for chronic ACD patients. “We believe that addressing the inflammation cascade at its inception represents a potentially innovative approach to treating ACD and other inflammatory diseases,” he said. In two previous clinical studies, Edesa’s EB01 drug candidate has demonstrated statistically significant improvement of multiple symptoms, including itching, scaling, rash and fissures.

Canadian and U.S physicians interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT03680131).

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 plans regarding its Phase 2b clinical study, including its expectation that making EB01 available at Canadian investigational sites can accelerate the completion of enrollment; and the company’s belief that EB01 could potentially exert a powerful anti-inflammatory effect. 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/655226/Edesa-Biotech-Extends-Dermatitis-Study-to-Canada

TORONTO, ON / ACCESSWIRE / June 23, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced the appointment of a key member to its management team to support the company’s expanding manufacturing activities.

Rajan Puri has been appointed to the newly established position of Senior Vice President of Manufacturing. Mr. Puri is an expert in Chemistry, Manufacturing and Controls (CMC) in the biopharmaceutical field and will lead the company’s strategic planning and operations related to scale-up, manufacturing and quality control.

“We are pleased to welcome Raj to our management team in anticipation of multiple potential growth opportunities this year. He brings a wealth of strategic and operational expertise with process development, scale-up and GMP production that will be critical to the advancement of our clinical and commercialization plans,” said Michael Brooks, President of Edesa Biotech.

Mr. Puri is a biopharma executive with more than 20 years of experience leading cross-functional initiatives and teams in biologics manufacturing, business development, regulatory affairs and product marketing. Prior to joining Edesa, Mr. Puri served as Vice President of Business Development for CMAB Biopharma, a start-up contract development and manufacturing organization (CDMO) sold to Wuxi Biologics. He was an original member of the Therapure Biopharma executive team, another biologic CDMO, and helped successfully grow the business from 20 employees to over 250 during a ten year tenure. Prior to his experience with CDMO’s, Mr. Puri worked in both biotech and large pharma companies including regulatory affairs at Eli Lilly. In addition to his career positions, Mr. Puri was a board member for the Pharma & Biopharma Outsourcing Association (PBOA), a non-profit trade association representing pharmaceutical contract manufacturing organizations. He holds an MBA in Science and Technology, and a Master of Science degree in Pharmacology and Toxicology from Queen’s University, Kingston, Canada.

Mr. Puri said that Edesa provides an exciting opportunity to work in a pivotal area of inflammatory and autoimmune diseases. “I’m excited to join Edesa at such a transformational time for the company. I look forward to working with the Edesa team and contributing to the advancement of Edesa’s pipeline and helping expand the company’s ability to deliver important new drug products for patients worldwide,” he said.

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.

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 timing and plans regarding its clinical studies, and the company’s plans to increase manufacturing activities and capabilities. 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/652709/Edesa-Biotech-Team-Expands-Leadership-Team-with-Key-Manufacturing-Appointment

TORONTO, ON / ACCESSWIRE / June 18, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that an independent Data and Safety Monitoring Board (DSMB) has completed an interim review of the company’s COVID-19 drug candidate, and based on blinded comparative data, has recommended that the company’s international study continue as planned.

The safety monitoring board, composed of independent subject matter experts, conducted a pre-planned interim review of the first patient cohort participating in Edesa’s Phase 2/3 clinical study evaluating the company’s EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients. The DSMB assessed treatment data for safety and futility. After completing their analysis, the DSMB recommended that enrollment in the trial continue.

“The DSMB’s recommendation that the trial continue is consistent with our expectation and the previous safety and tolerability profile of EB05,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “While it is not possible yet to draw conclusions, we are encouraged by the monitoring board’s findings as well as the robust enrollment we have achieved to date.”

Dr. Nijhawan said that Edesa is evaluating opportunities to expedite the timeline for completing the remaining part of the study and building a single robust dataset. As of June 16, 2021, more than 370 subjects in the U.S., Canada and Colombia have been enrolled in the Phase 2/3 study. The company plans to perform the next interim analysis on 316 evaluable subjects once treatment is completed and subject data is validated and aggregated.

The company recently filed a trial amendment with the Food and Drug Administration to streamline the U.S. protocol and align it with other jurisdictions. Following the exploratory analysis, the company also plans to adjust its current patient segmentation and associated endpoints, and maintain blinded data through the end of Phase 3.

“These planned changes could significantly reduce the number of additional patients enrolled in the study and could put us in the position to demonstrate results sooner,” said Blair Gordon, PhD, Edesa Vice President of Research and Development.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. Specifically, the drug 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. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives.

JSS Medical Research is acting as Edesa’s contract research organization for the international Phase 2/3 study. Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475).

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 results in edema that 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.

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 immune response associated with ARDS; the company’s belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients; the company’s timing and plans regarding its Phase 2/3 study; the company’s plans to adjust its current patient segmentation and associated endpoints, and maintain blinded data through the end of Phase 3; and the company’s believe that such planned changes could significantly reduce the number of additional patients enrolled in the study and demonstrate results sooner. 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/652244/Edesa-Biotech-Reports-Favorable-Review-of-COVID-19-Study

TORONTO, ON / ACCESSWIRE / June 8, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that the company’s senior management are scheduled to attend the 2021 BIO Digital Conference being held June 14-18, 2021.

Members of the biopharma or investment community who are interested in meeting with Edesa during the conference may contact the company on the BIO One-on-One Partnering system, or at investors@edesabiotech.com.

For additional information on the 2021 BIO Digital Conference, visit: https://www.bio.org/events/bio-digital/registration.

About BIO

BIO is the world’s largest advocacy organization representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

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.

For more information, visit www.edesabiotech.com or follow 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 company’s clinical development pipeline, including enrollment milestones and data 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: 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 / June 3, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that the company’s drug candidate EB01 has met a key interim study parameter. The company has now passed the initial inflection point of its Phase2b study and will continue enrolling the final cohort of patients.

Edesa reported that interim study data from the first cohort met statistical thresholds previously approved by the U.S. Food and Drug Administration as part of an adaptive Phase 2b trial evaluating EB01 as a monotherapy for moderate to severe chronic Allergic Contact Dermatitis (ACD). Though blinded to treatment assignment, the study’s Data and Safety Monitoring Board (DSMB) 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.

Likewise, the DSMB 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. Success on the ISGA is defined as a two-point reduction from baseline and a final ISGA score of ‘0’ or ‘1’ indicating clear or almost clear skin, respectively. 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.

Based on these findings, the DSMB has recommended progression to the second cohort of patients. Interim study data is preliminary and full study results are subject to change; and since the analysis remains blinded, it is not possible to definitively conclude if EB01 may be outperforming placebo or vice versa. The initial cohort analyzed consisted of a population of 46 subjects, of whom 36 completed the study follow-up and were used in the interim analysis. As of June 2, 2021, 66 total patients (including the first cohort) have been randomized in the Phase 2b study.

“This milestone represents a significant step in our plans to develop an effective and safe treatment option for chronic ACD patients. Although blinded, these results are highly encouraging and we are excited to move into the final phase of the study,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “I would like to thank the patients, physicians and research staff for enabling us to reach this important milestone and we are encouraged by the ongoing interest in the novel mechanism of action employed by EB01.”

Blair Gordon, PhD, Vice President of Research and Development, said that based on the interim findings and the safety monitoring board’s recommendations, Edesa will continue with an additional cohort of at least 120 evaluable subjects, who will be provided with either Edesa’s EB01 topical treatment (at a 2.0%, 1.0% and 0.2% concentration) or a placebo cream. The company is also evaluating a potential open-label extension for study patients.

“We are excited to see meaningful early signals between the treatment arms for both the CDSI and ISGA interim endpoints. Now that we are beyond the futility cut-off hurdle, we are fine-tuning the final subject population to be in the best position to demonstrate unequivocal results for both these endpoints, which will be important for Phase 3 trial design,” said Dr. Gordon.

EB01 cream contains a non-steroidal anti-inflammatory compound known as an sPLA2 (secretory phospholipase-2) inhibitor. Since EB01 is designed to inhibit the inflammatory process at its inception rather than after inflammation has occurred, the company believes that the drug could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients.

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. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. To the company’s knowledge there are currently no treatment options specifically labelled for ACD.

JSS Medical Research is acting as Edesa’s contract research organization for the Phase 2b study. Physicians interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT03680131).

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.

Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans regarding its Phase 2b clinical study, the company’s belief that data from the full study population will demonstrate statistical significance, plans to adjust subject population to be in the best position to demonstrate unequivocal results for both for the CDSI and ISGA endpoints, and the company’s belief that EB01 could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. 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/649973/Edesa-Biotech-Reports-Positive-Interim-Results-in-Dermatitis-Trial

TORONTO, ON / ACCESSWIRE / May 28, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, announced today that Dr. Par Nijhawan, Chief Executive Officer, is scheduled to participate in a virtual event organized by the Ontario Bioscience Innovation Organization. As part of a panel of health science and investment professionals, Dr. Nijhawan is expected to discuss publicly available information regarding Edesa and its corporate strategy.

The panel discussion, which is titled “Health Science IPOs: Will We Continue To Break Records?” is scheduled to take place on Tuesday, June 1, 2021 at 12:00 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.

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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https://www.accesswire.com/649442/Edesa-Biotech-to-Join-Panel-Discussion-at-Industry-Event

TORONTO, ON / ACCESSWIRE / May 14, 2021 / 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, 2021 and provided an update on its business.

The company reported that it has enrolled more than 285 patients in an ongoing Phase 2/3 clinical study of its investigational drug, EB05, as a single-dose treatment for hospitalized COVID-19 patients with or at risk of developing Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. The study is being funded in part by a C$14 million reimbursement grant from the Canadian Government. In addition, Edesa completed enrollment of the first cohort of a Phase 2b clinical study evaluating another drug candidate, EB01, as a monotherapy for chronic Allergic Contact Dermatitis. The company is currently performing a blinded interim analysis on EB01. Edesa recently expanded its global rights to the technology that forms the basis of EB01 for all fields of use in humans and animals. During the second fiscal quarter, Edesa raised net cash proceeds of approximately $12.1 million from equity financings and warrant/option exercises.

“We achieved another quarter of positive momentum, highlighted by key enrollment milestones in two separate clinical programs, the award of a C$14 million competitive grant announced by the Prime Minister of Canada, and the completion of an over-subscribed equity offering. While the results of our clinical studies will be data-driven, and are subject to regulatory review, we are already preparing to be in position to rapidly advance these studies should the interim results be positive and get these promising treatments in the hands of physicians. With these projects and initiatives in mind, we believe 2021 could be a transformative year for the company,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa Biotech.

Edesa’s Chief Financial Officer Kathi Niffenegger reported that working capital was significantly bolstered by the federal reimbursement grant and equity financings. At March 31, 2021, Edesa had working capital of $16.80 million. Cash and cash equivalents totaled $10.97 million. Research and development expenditures have largely tracked the company’s accelerated clinical progress.

“We have recorded cash reimbursements of approximately $7.2 million under our federal grant. This has allowed us to advance our ARDS project more quickly and significantly offset development costs,” said Ms. Niffenegger.

She added, “In the second fiscal quarter, research and development expenditures have been driven by the achievement of development milestones and drug product costs, and have generally shifted earlier than originally estimated due to the rapid pace of enrollment and related activities in our two ongoing clinical trials. Overall project expenditures have been in line with management’s expectations.”

Financial Results for the Three Months Ended March 31, 2021

There were no revenues for the three months ended March 31, 2021 compared to $0.11 million for the three months ended March 31, 2020, reflecting the winddown and discontinuation of sales of product inventory from legacy operations.

Total operating expenses increased by $7.88 million to $9.51 million for the three months ended March 31, 2021 compared to $1.63 million for the same period last year:

• Research and development expenses increased by $7.48 million to $7.98 million for the three months ended March 31, 2021 compared to $0.50 million for the same period last year primarily due to milestone payments related to advancement of the company’s EB05 clinical program, increased external research expenses related to accelerated activity in ongoing clinical studies, increased investigational drug product expenses and an increase in non-cash share-based compensation. Higher salary and related personnel expenses, increased employee headcount and patent fees also contributed to the increase.
• General and administrative expenses increased by $0.43 million to $1.54 million for the three months ended March 31, 2021 compared to $1.11 million for the same period last year primarily as a result of higher salary and related personnel expenses. Higher legal and other professional services also contributed to the increase.

Total other income increased by $7.22 million to $7.25 million for the three months ended March 31, 2021 compared to $0.03 million for the same period last year primarily due to increased grant income related to the initiation of reimbursements under the company’s federal grant with the Canadian government’s Strategic Innovation Fund.

For the three months ended March 31, 2021, Edesa reported a net loss of $2.26 million, or $0.19 per common share, compared to a net loss of $1.49 million, or $0.17 per common share, for the three months ended March 31, 2020.

Financial Results for the Six Months Ended March 31, 2021

There were no revenues for the six months ended March 31, 2021 compared to $0.22 million for the six months ended March 31,2020, reflecting the winddown and discontinuation of sales of product inventory from legacy operations.

Total operating expenses increased by $9.28 million to $12.12 million for the six months ended March 31, 2021 compared to $2.84 million for the same period last year:

• Research and development expenses increased by $8.32 million to $9.35 million for the six months ended March 31, 2021 compared to $1.03 million for the same period last year primarily due to milestone payments related to advancement of the company’s EB05 clinical program, increased external research expenses related to accelerated activity in ongoing clinical studies, increased investigational drug product expenses and an increase in non-cash share-based compensation. Higher salary and related personnel expenses, increased employee headcount and patent fees also contributed to the increase.
• General and administrative expenses increased by $0.97 million to $2.77 million for the six months ended March 31, 2021 compared to $1.80 million for the same period last year primarily as a result of higher salary and related personnel expenses, and non-cash share-based compensation. Higher legal and other professional services also contributed to the increase.

Total other income increased by $7.19 million to $7.23 million for the six months ended March 31, 2021 compared to $0.04 million for the same period last year primarily due to increased grant income related to the initiation of reimbursements under the company’s federal grant with the Canadian government’s Strategic Innovation Fund.

For the six months ended March 31, 2021, Edesa reported a net loss of $4.90 million, or $0.45 per common share, compared to a net loss of $2.58 million, or $0.32 per common share, for the six months ended March 31, 2020.

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 the company 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. 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.

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: upcoming milestones in the company’s clinical studies, including enrollment milestones and interim readouts for its COVID-19 and dermatitis studies, the company’s preparations to be in position to rapidly advance its clinical studies and the company’s belief that 2021 could be a transformative year. 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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Virtual event scheduled for Thursday, April 29 at 1 pm Eastern Time

TORONTO, ON / ACCESSWIRE / April 22, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that it will host a key opinion leader (KOL) webinar on EB05, the company’s lead asset for the treatment of Acute Respiratory Distress Syndrome (ARDS), on Thursday, April 29, 2021 at 1:00 pm Eastern Time.

The webinar will feature a presentation by KOL Ted Steiner, MD, University of British Columbia, who will discuss the current treatment landscape and unmet medical need in treating patients with COVID-19 induced ARDS. Dr. Steiner will be available to answer questions following the formal presentations.

Edesa’s management team will also provide an enrollment update on their pipeline candidate, EB05, which is an experimental monoclonal antibody developed to regulate the overactive immune response associated with ARDS – the leading cause of death in COVID-19 patients.

Edesa’s ongoing Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Up to 316 patients will be enrolled in the first phase of the trial. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.

To register for the webinar, please click here.

Dr. Ted Steiner is Professor of Medicine at the University of British Columbia and Head of the Division of Infectious Diseases. His research interests are in intestinal infections and host immune responses. He leads a number of clinical and basic science investigations on subjects including C. difficile infection, inflammatory bowel disease, COVID-19, and other topics.

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.

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 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: 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 and the timing and success of submission, acceptance and approval of regulatory filings. 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 / March 22, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that it has entered into a definitive license agreement under which the company, through a subsidiary, has acquired additional global rights to a non-steroidal anti-inflammatory technology that forms the basis of the company’s EB01 and EB02 drug candidates.

The license agreement, with the technology’s inventor, provides Edesa with development and commercialization rights to multiple patent families as well as know-how related to the underlying technology. Edesa previously licensed this drug technology from Hebrew University of Jerusalem for topical dermatology and certain gastrointestinal indications, and through this additional license agreement now holds exclusive global rights for all fields of use in humans and animals.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the move bolsters the company’s strategic position on a key inflammatory pathway ahead of an upcoming clinical milestone. “This agreement significantly strengthens the breadth of our intellectual property position for a proprietary technology that we believe could have broad utility across multiple indications.” He noted that the agreement was structured to minimize immediate cash outlays.

Edesa recently announced that it has completed enrollment of the first cohort of a Phase 2b clinical study evaluating EB01 as a monotherapy for chronic Allergic Contact Dermatitis (ACD), a potentially debilitating condition and occupational illness. The company plans to initiate a blinded interim analysis once all subjects in the first cohort complete the 28-day treatment. In two previous clinical studies, EB01 has demonstrated significant improvement of multiple symptoms in ACD patients.

EB01 contains a non-steroidal anti-inflammatory compound known as an sPLA2 (secretory phospholipase-2) 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 and other anti-inflammatory drugs such as ibuprofen. 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.

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. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. To the company’s knowledge there are currently no treatment options specifically labelled for ACD. Additional details about the Phase 2b trial of EB01 (NCT03680131) can be found at www.clinicaltrials.gov.

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.

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 potential value, success and timing of clinical milestones; the company’s belief that this license agreement could significantly strengthen its intellectual property position; the company’s belief that the licensed technology could have broad utility across multiple indications; and the company’s belief that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. 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 and the timing and success of submission, acceptance and approval of regulatory filings. 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 15, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has completed enrollment of more than 50% of the patients planned for the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study evaluating the company’s EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients with or at risk of developing Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients.

The company reported that more than 160 of the expected 316 subjects in the Phase 2 portion of the study have been randomized and dosed with either EB05 or placebo. The patients were treated at hospital sites across Canada, the United States and Colombia. In preparation for the potential Phase 3 portion of the study, the company plans to activate approximately 20 additional hospital sites in the next two months.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the pace of enrollment has exceeded the company’s expectations. “We have passed the halfway mark for the Phase 2 portion of the study and are now one step closer to providing a new, potentially more effective treatment option for patients facing some of the worst effects of the SARS-CoV2 infection. We are grateful to the patients, physicians and caregivers for enabling us to reach this important milestone.”

Dr. Nijhawan reported that the company plans to continue adding hospital sites to speed enrollment and to provide broad access to a promising experimental therapy. “ARDS represents a serious unmet medical need; even prior to COVID-19, ARDS accounted for 10% of ICU admissions. If the pandemic becomes endemic, as many believe, the need for an effective treatment will be even more pressing,” he said.

As designed, the international study is an adaptive, double-blind study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Should the experimental antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with ARDS. Specifically, the drug 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. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives.

Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475).

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 results in edema that 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) in COVID-19 patients. 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.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans to add hospital sites to speed enrollment, the company’s belief that EB05 could regulate the overactive immune response associated with ARDS, the company’s belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, and the company’s timing and plans regarding its Phase 2/3 study. 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

SOURCE: Edesa Biotech

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TORONTO, ON / ACCESSWIRE / March 9, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has completed enrollment of the first cohort of a Phase 2b clinical study evaluating the company’s drug candidate EB01 as a monotherapy for chronic Allergic Contact Dermatitis (ACD), a potentially debilitating condition and occupational illness.

Edesa reported that all 46 subjects in the first cohort have been randomized and dosed with either Edesa’s EB01 topical treatment or a placebo cream. EB01 contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. Since EB01 is designed to inhibit the inflammatory process at its inception rather than after inflammation has occurred, the company believes that the drug could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids.

Once all the subjects in the first cohort complete the 28-day treatment, Edesa plans to initiate a blinded interim analysis. The interim results will determine the number of patients for the final part of the Phase 2b study based on probability thresholds previously approved by the Food and Drug Administration. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the company is grateful to the patients, physicians and research staff for their participation and diligent work despite the challenges presented by the pandemic.

“We are encouraged by the strong interest in the program. Should the blinded analysis confirm that the probability of success meets or exceeds the predetermined thresholds, we plan to move rapidly into the final part of the study,” said Dr. Nijhawan. He noted that enrollment activities for the second half of the Phase 2b study would continue during the interim analysis period.

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. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic 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.

Physicians interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT03680131).

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.

Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans regarding its Phase 2b clinical study, including its plans to initiate a blinded interim analysis, and the company’s belief that EB01 could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. 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 / March 2, 2021 / 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 underwritten public offering of 1,562,500 common shares of Edesa, at a price to the public of $6.40 per share, less underwriting discounts and commissions. The gross proceeds were $10.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Edesa.

H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

Edesa also has granted to the underwriter a 30-day option to purchase up to 234,375 additional common shares at the public offering price, less underwriting discounts and commissions.

Edesa intends to use the net proceeds from the offering for general corporate purposes, which may include working capital, capital expenditures and research and development expenses.

A shelf registration statement on Form S-3 (Registration No. 333-233567) was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on September 12, 2019. The offering was made only by means of a prospectus supplement and accompanying base prospectus. A final prospectus supplement and accompanying base prospectus relating to the offering was filed with the SEC and are available for free on the SEC’s website located at http://www.sec.gov. Electronic copies of the final prospectus supplement and accompanying base prospectus relating to the offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or by email to placements@hcwco.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying base prospectus forming a part of the effective registration statement.

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.

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: 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 / February 25, 2021 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 1,562,500 common shares of Edesa, at a price to the public of $6.40 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about March 2, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

Edesa also has granted to the underwriter a 30-day option to purchase up to 234,375 additional common shares at the public offering price, less underwriting discounts and commissions.

The gross proceeds are expected to be $10.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Edesa. Edesa intends to use the net proceeds from the offering for general corporate purposes, which may include working capital, capital expenditures and research and development expenses.

A shelf registration statement on Form S-3 (Registration No. 333-233567) was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on September 12, 2019. The offering is being made only by means of a prospectus supplement and accompanying base prospectus. A preliminary prospectus supplement and accompanying base prospectus relating to the offering was filed with the SEC and are available for free on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering, and the final prospectus supplement and the accompanying prospectus relating to this offering when filed, may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or by email to placements@hcwco.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying base prospectus forming a part of the effective registration statement.

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.

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: 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 / February 16, 2021 / 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, 2020 and provided an update on its business.

Earlier this month, the company announced that it has been awarded a C$14 million reimbursement grant from the Canadian government. The funds will support the Phase 2 portion of an ongoing Phase 2/Phase 3 clinical study of Edesa’s investigational drug, EB05, 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. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study and enter negotiations for additional government funding. Last month, the company announced that it received approval from the U.S. Food and Drug Administration and Health Canada to add a sub-study to the ARDS trial. The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases.

“We initiated our ARDS study in the midst of an unprecedented resurgence of SARS-CoV-2 infections and are working closely with our hospital partners to help meet the urgent medical needs of COVID-19 patients. The federal funding will allow us to move ahead much more quickly than we could do otherwise,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “Based on current enrollment trends, we are looking forward to the first interim analysis in the near term and moving another step closer to providing a new, effective treatment option for COVID-19 patients.”

In addition to its ARDS clinical program, during the first fiscal quarter, the company also reported ongoing progress in a Phase 2b study of its non-steroidal anti-inflammatory drug candidate in chronic allergic contact dermatitis. More than 50% of the patients planned for the first cohort had been randomized and dosed.

Edesa’s Chief Financial Officer Kathi Niffenegger reported that the company’s expenditures during the first fiscal quarter were in line with management’s expectations and reflected the company’s plans to advance both its ARDS and dermatitis studies concurrently. “The change in our research and development expenses over the comparable period reflect the priority we have placed in rapidly getting our monoclonal antibody candidate in the hands of frontline physicians, and expanding our international Phase 2/3 study to multiple jurisdictions,” said Ms. Niffenegger.

Financial Results for the Three Months Ended December 31, 2020

There were no revenues for the three months ended December 31, 2020 compared to $0.11 million for the three months ended December 31, 2019, reflecting the winddown and discontinuation of sales of product inventory obtained in the reverse acquisition.

Total operating expenses increased by $1.40 million to $2.61 million for the three months ended December 31, 2020 compared to $1.21 million for the same period last year:

• There were no cost of sales for the three months ended December 31, 2020 as a result of the winddown and discontinuation of sales of product inventory obtained in the reverse acquisition. For the same period last year, cost of sales was less than $0.01 million.
• Research and development expenses increased by $0.85 million to $1.38 million for the three months ended December 31, 2020 compared to $0.53 million for the same period last year primarily due to increased external research expenses related to the company’s ongoing clinical studies and an increase in non-cash share-based compensation. Higher salary and related personnel expenses and patent fees also contributed to the increase.
• General and administrative expenses increased by $0.55 million to $1.23 million for the three months ended December 31, 2020 compared to $0.68 million for the same period last year primarily as a result of an increase in non-cash share-based compensation. Higher salary and related personnel expenses, and legal and other professional services also contributed to the increase.

For the three months ended December 31, 2020, Edesa reported a net loss of $2.64 million, or $0.26 per common share, compared to a net loss of $1.09 million, or $0.15 per common share, for the three months ended December 31, 2019.

Working Capital

At December 31, 2020, Edesa had working capital of $6.76 million. Cash and cash equivalents totaled $6.31 million. From January 1 to February 12, 2021, the company received combined net proceeds of $3.13 million from the issuance of common shares under an equity distribution agreement with RBC Capital Markets and exercises of common share purchase warrants and share options.

Calendar

Edesa management plans to participate in the H.C. Wainwright Annual Global Life Sciences Conference scheduled for March 9-10, 2021. Investors interested in meetings with management can schedule one-on-one teleconference and video meetings 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 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.

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: 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: 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 / February 2, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has secured a commitment of up to C$14 million (US$ 11 million) from the Government of Canada to complete the Phase 2 portion of a Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. The funding will also help fund certain pre-clinical research intended to broaden the utility of the company’s experimental therapy, including treatments for other respiratory pathogens. The funds were awarded under the federal government’s Strategic Innovation Fund following a multi-disciplinary review of Edesa’s drug technology and plans.

“The award of this competitive funding is an important validation of the therapeutic potential of EB05 and the scientific rationale behind our efforts. The funds will be targeted toward rapidly getting EB05 into the hands of physicians on the front line of this health crisis,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “By targeting the body’s underlying response, our experimental drug offers a potential solution that could be effective despite variations in the virus.”

The Honorable François-Philippe Champagne, Minister of Innovation, Science and Industry, said that Strategic Innovation Fund (SIF) funding announced today is part of the government’s plan to support the development of novel medical countermeasures for COVID-19 patients. “As countries around the world begin to distribute and administer COVID-19 vaccines to their populations, we cannot lose sight of the importance of developing treatments to limit the long-term impacts of the virus on Canadians. Today’s contribution will support Edesa as they take their promising treatment through clinical trials and subsequent approvals. Once approved, this therapy has the potential to be an important tool in treating and preventing lung injuries caused by COVID-19. As the government continues to protect and support Canadians through this pandemic, it must also lay the foundation for a better-prepared, healthier and more prosperous future,” he said.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. Specifically, the drug 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. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of ICU patients and intubation/ventilation procedures, and ultimately saving lives.

The company intends to use the SIF funding for Phase 2 study expenses. Edesa’s ongoing Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Up to 316 patients will be enrolled in the first phase of the trial. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.

“We greatly appreciate the support of the Government of Canada and the effort of the staff of the Innovation, Science and Economic Development (ISED) department in leading the technical review of our application,” said Michael Brooks, PhD, President of Edesa Biotech. “We look forward to working with the government on the next steps in the program and continuing to build on Canada’s emergency preparedness capabilities.”

In addition to the ongoing clinical study, the SIF funding will also be used to support a research project at a Canadian university. Among other objectives, the in vitro pre-clinical study will examine the potential therapeutic utility of EB05 against a panel of pathogens, including coronavirus variants and influenza strains.

Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475)

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 results in edema that 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 approximately 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. Edesa’s lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. The company is developing late-stage monoclonal antibodies that block certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including the inflammation associated infectious diseases. Due to the global health emergency, Edesa has prioritized the development of EB05 as a potential treatment for hospitalized COVID-19 patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.

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 immune response associated with ARDS, the company’s belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, the company’s belief that EB05 could provide effective treatment for current and future variations of the SARS-CoV2 virus, and the company’s plans regarding its Phase 2/3 study and the use of SIF funding. 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 / January 26, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received regulatory approval from the U.S. Food and Drug Administration (FDA) and Health Canada to add a sub-study to its ongoing Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that physicians involved in the company’s ARDS study identified a number of COVID-19 patients who they believed could benefit from the experimental treatment, but were too ill to be considered for the main study. “This sub-study will allow us to potentially expand the use of EB05 to critically ill patients suffering from profound, medically refractory COVID-19 respiratory failure,” Dr. Nijhawan said.

Edesa’s sub-study is expected to enroll up to 100 ICU patients with severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy. The sub-study does not impact the design or results of Edesa’s ongoing international Phase 2/3 study.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with ARDS. Specifically, the drug 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. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives.

Edesa’s Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Up to 316 patients will be enrolled in the Phase 2 part of the trial in Canada, the United States and Colombia. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.

Edesa’s Vice President of Research and Development, Blair Gordon, PhD. said that data from the international sites will be aggregated and analyzed together. The sub-study, which is identical to the main study except for the patient enrollment criteria, will be analyzed separately. “The consistency of the study design across geographic regions and patient groups will allow us to efficiently evaluate the utility of the EB05 across a broad spectrum of hospitalized patients.”

Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475).

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 results in edema that 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) in COVID-19 patients. 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.

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 immune response associated with ARDS, the company’s belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, the company’s believe that the sub-study could expand the use of EB05 to critically ill patients suffering from profound, medically refractory COVID-19 respiratory failure, and the company’s plans regarding its Phase 2/3 study. 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 / January 20, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, announced today that Dr. Par Nijhawan, Chief Executive Officer, is scheduled to participate in a virtual event organized by Clinical Trials Ontario in collaboration with the Bureau du Québec à Toronto and the Canadian and International Innovation Partnerships Directorate. As part of a government and industry panel, Dr. Nijhawan is expected to discuss the importance of developing multiple countermeasures to the COVID-19 pandemic, including therapies, like Edesa’s EB05 drug candidate, that target the overactive host immune response in COVID-19 patients.

The panel discussion, which is titled “Canadian Innovative COVID Solutions,” is scheduled to take place on Thursday, January 26, 2021 at 2:20 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) in COVID-19 patients. 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.

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TORONTO, ON / ACCESSWIRE / January 11, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from the Ministry of Health (INVIMA) in Colombia to expand the clinical trial of its investigational drug EB05 in hospitalized COVID-19 patients. The study was previously approved in the U.S. and Canada, where enrollment is ongoing. The company reported that it has enlisted the support of a local research organization and will begin activating hospital sites in Bogota, Medellín, Bucaramanga, and other major metropolitan centers.

EB05 is a clinical-stage monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. The drug is delivered intravenously in a single infusion to hospitalized COVID-19 patients.

EB05 is intended to fill a critical gap in combatting the pandemic – alongside anti-viral treatments and vaccines under development by others. Based on previous clinical data and the mechanism of action, the company believes that modulating the TLR4 signaling pathway could reduce the number of ICU patients and decrease the need for mechanical ventilation, ultimately saving lives.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said the investigative sites in Colombia are among the best in Latin America, with well-established programs adhering to Good Clinical Practices and other internationally accepted standards, and the company looks forward to joining other pharmaceutical companies in extending innovative treatments to nations in Latin America.

“We greatly appreciate the actions being taken by the Colombian government to review and approve our clinical study. Collaborating with physicians and hospitals in Colombia allows us to complete this important study more quickly and reaffirms our commitment to provide broad access to a promising experimental treatment to people around the world,” said Dr. Nijhawan.

Edesa’s drug works by directly inhibiting a pattern recognition receptor called toll-like receptor 4 (TLR4), which has been shown to mediate inflammation as a result of infection by SARS-CoV2 and other respiratory infections, such as influenza. Recent third-party studies have demonstrated that severe COVID-19 patients frequently display elevated levels of certain damage-associated molecule patterns (DAMPs) that activate TLR4. Edesa believes targeting this key innate signaling pathway with EB05 could potentially disrupt the overactive and self-amplifying network of downstream proinflammatory cytokines, and thereby, reduce morbidity and mortality in hospitalized COVID-19 patients. The antibody therapy has previously demonstrated an ability to resolve fever as well as stabilize heart rates and breathing rates in test subjects who were injected with a potent inducer of acute systemic inflammation.

Edesa’s international Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Edesa plans to enroll approximately 316 patients in the Phase 2 portion of the study. Data from the Colombian, Canadian and U.S. sites will be aggregated and analyzed together. Should the drug treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a Phase 3 study.

Hospitals interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475).

About ARDS

Acute Respiratory Distress Syndrome is the leading cause of death in COVID-19 patients. The U.S. Centers for Disease Control 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 the patient population, according to the CDS. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that results in edema that 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 the company is developing as a treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients. 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.

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 modulate the TLR4 signaling pathway for the benefit of patients, and that by expanding the study to Colombia, the company can complete the Phase 2/3 study more quickly. 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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