Edesa News Archive

TORONTO, ON / ACCESSWIRE / December 7, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the fiscal year ended September 30, 2020 and provided an update on its business.

During the fiscal year, Edesa added two Phase 2-ready biologics to its development pipeline, with a focus on COVID-19 and other strategic indications. Last month, the company initiated a Phase 2/Phase 3 study of the most advanced one of these acquired monoclonal antibodies in hospitalized COVID-19 patients, and is currently enrolling subjects in the U.S. and Canada. In response to the pandemic, Edesa also took actions to facilitate enrollment for an ongoing Phase 2b clinical study of its EB01 drug candidate in chronic allergic contact dermatitis patients, and recently announced that that the project had reached an enrollment milestone.

“While 2020 brought unexpected challenges, it also brought opportunities for Edesa to demonstrate the flexibility and breadth of our clinical development strategy. In a matter of months, we achieved new regulatory approvals in two jurisdictions and launched a Phase 2/3 study of a potential best-in-class anti-TLR4 antibody treatment for Acute Respiratory Distress Syndrome – the leading cause of death in COVID-19 patients,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “Our team continues to operate at a high level and we are looking forward to building on our momentum, achieving our near-term milestones and, ultimately, building value for shareholders.”

Chief Financial Officer Kathi Niffenegger reported that Edesa’s year-end results reflect the company’s increased clinical activities and growth-related expenditures, which included COVID-19 study preparations, fill-finish expenses for its EB05 drug product, increased staffing and enrollment-based expenses for the company’s ongoing dermatitis study. “Our fiscal year results demonstrate the efficiency of our business model and the disciplined approach we are taking to deploying our working capital to studies with near-term inflection points,” she said.

Ms. Niffenegger reported that cash and cash equivalents totaled approximately $7.2 million at September 30, 2020. In addition, she noted that subsequent to end of the fiscal year, Edesa received cash proceeds of approximately $2.0 million as a result of warrant exercises and issuances of common shares under the company’s at-the-market equity distribution program.

Financial Results for the Fiscal Year Ended September 30, 2020*

Total revenues for fiscal year 2020 were $0.33 million compared to $0.41 million for the nine-month period ended September 30, 2019, reflecting a reduction in sales of product inventory obtained in the June 2019 reverse acquisition. The company expects such product sales to continue to decline as a result of the discontinuation of legacy operations.

Total operating expenses increased by $3.49 million to $6.73 million for fiscal year 2020 compared to $3.24 million for the nine-month period ended September 30, 2019:

• Cost of sales was $0.02 million for fiscal year 2020 compared to $0.10 million for the nine-month period ended September 30, 2019, reflecting a reduction in sales of product inventory obtained in the reverse acquisition.

• Research and development expenses were $3.33 million for the year ended September 30, 2020, reflecting increased external research expenses related to the clinical study of the company’s EB01 drug candidate and increased activities and preparations related to the company’s Phase 2/3 clinical study of EB05 as a potential treatment for hospitalized COVID-19 patients, as well as increased salary and related personnel expenses. Research and development expenses were $1.10 million for the nine-month period ended September 30, 2019.

• General and administrative expenses were $3.38 million for the year ended September 30, 2020, reflecting increased salary and related personnel expenses, and increased public company expenses. General and administrative expenses were $2.05 million for the nine-month period ended September 30, 2019.

For the fiscal year ended September 30, 2020, Edesa reported a net loss of $6.36 million, or $0.74 per common share, compared to a net loss of $2.78 million, or $0.55 per common share, for the nine-month period ended September 30, 2019.

* As a result of the acquisition accounting for the business combination completed on June 7, 2019, and the subsequent change in year-end of the company’s subsidiary Edesa Biotech Research, Inc., the comparative year-end data represent the twelve-month period ended September 30, 2020 and the nine-months ended September 30, 2019, which should be taken into account when reviewing comparative results. Financial results for any periods ended prior to June 7, 2019 reflect the financials of the company’s subsidiary Edesa Biotech Research, Inc. on a standalone basis.

Working Capital
At September 30, 2020, Edesa had working capital of $6.57 million. Cash and cash equivalents totaled $7.21 million. From October 1 to December 2, 2020, the exercise of common share purchase warrants resulted in cash proceeds to the company of approximately $1.0 million. During this same period, the company also received cash proceeds of approximately $1.0 million from the issuance of common shares under an equity distribution agreement with RBC Capital Markets, LLC.

Calendar
From January 11-14, 2021, Edesa is scheduled to participate in the H.C. Wainwright Bioconnect Conference. Investors and biopharma executives 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) 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: upcoming milestones in the company’s clinical studies and the expectation that legacy product sales will continue to decline. 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.

Contacts
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

Consolidated Statements of Operations

Consolidated Balance Sheets

Consolidated Statements of Cash Flows

SOURCE: Edesa Biotech

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TORONTO, ON / ACCESSWIRE / November 30, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced that the first patient has been enrolled in a Phase 2/Phase3 clinical trial evaluating the company’s investigational drug, EB05, as a therapy for hospitalized COVID-19 patients.

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.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that 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, Dr. Nijhawan believes that modulating the TLR4 signaling pathway could reduce the number of ICU patients and decrease the need for mechanical ventilation, ultimately saving lives.

“Initiating this study brings us one step closer to providing effective treatment options for patients facing some of the worst effects of the SARS-CoV2 infection. By preventing or treating ARDS, our drug candidate could help lessen concerns about COVID-19 by providing a treatment option even for the most serious patients,” 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. The safety and tolerability of EB05 has been demonstrated in more than 120 subjects.

Blair Gordon, PhD, Vice President of Research and Development of Edesa, said that Edesa plans to enroll approximately 316 patients in the Phase 2 portion of the multicenter, double-blind, placebo-controlled study. The company expects to enroll up to approximately 40 hospitals in the study.

“We are excited to announce the first patient was dosed in Toronto, Ontario and we look forward to providing access to this promising therapy to patients across both Canada and the U.S.,” said Dr. Gordon. “Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal 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 (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. ARDS has historically affected approximately 200,000 patients each year in the United States, resulting in nearly 75,000 deaths annually.

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, 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 / November 6, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, announced today that Dr. Par Nijhawan, Chief Executive Officer, is scheduled to present at the H.C. Wainwright 6th Annual Israel Conference on November 12, 2020 at 12:30 pm ET.

Edesa senior management will be available during the conference for one-on-one meetings. Members of the investment community who are interested in meeting with the company should contact conference coordinators to arrange an appointment or contact Edesa directly via email at investors@edesabiotech.com.

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later-stage clinical studies. EB05 is a monoclonal antibody therapy that 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.

CONTACT:
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech

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TORONTO, ON / ACCESSWIRE / November 3, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced that it has completed enrollment of more than 50% of the patients planned for the first cohort of a Phase 2b clinical study evaluating the company’s drug candidate as a monotherapy for chronic allergic contact dermatitis.

The adaptive, double-blind study is evaluating the safety and efficacy of EB01 cream in approximately 46 subjects in the first cohort. EB01 is an investigational medicine that contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the company plans to perform a blinded interim analysis following the completion of the first cohort. This adaptive protocol design is intended to make the study more flexible and efficient, and will determine the total number of patients for the second part of the study.

“The patient recruitment rate for our EB01 Phase 2b study in the context of the pandemic is very encouraging. We have now passed the halfway mark for the first cohort and look forward to the trial continuing to progress toward the interim analysis,” said Dr. Nijhawan. “We are grateful to the physicians, research staff and participating patients for enabling us to reach this important milestone and encouraged by the interest expressed by the dermatology community for the non-steroidal novel mechanism employed by EB01.”

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. 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 plans regarding its Phase 2b clinical 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 / October 19, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received clearance from the U.S. Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. The Phase 2/3 study protocol has previously been approved by Health Canada. The company has begun the site initiation process at U.S. hospitals.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the company is committed to rapidly getting EB05 into the hands of physicians on the front line of the pandemic. “Our EB05 study has been deemed safe to proceed by the FDA, marking another milestone in our plans to begin patient enrollment. We believe our drug candidate has the potential to inhibit a key proinflammatory pathway linked to some of the worst effects of the disease.”

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-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.

As planned, Edesa’s Phase 2/3 study will be an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized patients who have or are at risk of developing ARDS. 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.

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 (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. ARDS has historically affected approximately 200,000 patients each year in the United States, resulting in nearly 75,000 deaths annually.

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 moderate to severe 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, 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 / August 12, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the three and nine months ended June 30, 2020 and provided an update on its business.

During the quarter, Edesa received Canadian regulatory approval to begin a Phase 2/Phase 3 clinical study of its biologic drug candidate, EB05, as a potential treatment for hospitalized COVID-19 patients. Based on previous clinical data and the drug’s mechanism of action, the company believes that EB05 could regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. In July, Edesa filed an investigational new drug (IND) application with the Food and Drug Administration to expand the company’s planned clinical study to U.S. hospitals. Edesa also reported that protocol amendments to facilitate enrollment for its ongoing Phase 2b clinical study in allergic contact dermatitis have been implemented at the majority of the company’s investigational centers.

“During the quarter, we continued the dosing of subjects in our dermatitis study, while simultaneously preparing for the launch of a Phase 2/3 study of our first biologic candidate – a novel monoclonal antibody targeting TLR4,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “The lack of effective therapies for ARDS has been made even more devastating by the COVID-19 pandemic, which can cause severe acute respiratory failure in up to 40% of hospitalized COVID-19 patients and up to 85% of patients admitted to the ICU.” Dr. Nijhawan said that, subject to funding and IND approval, the company is presently on track to be ready to initiate patient enrollment ahead of the anticipated resurgence of SARS-CoV-2 infections this fall/winter.

Edesa’s Chief Financial Officer Kathi Niffenegger reported that expenditures during the quarter reflected increased activities and preparations related to the planned COVID-19 study as well as trial expenses for the company’s ongoing dermatitis study. She also noted that subsequent to the quarter end the company has received cash proceeds of approximately $2.42 million as a result of exercises of common share purchase warrants.

“We have built flexibility into our business planning processes, and have prioritized working capital for our clinical projects based on their feasibility amid the pandemic, the nearness of their inflection points and their ability to address significant unmet medical needs,” said Ms. Niffenegger.

Financial Results for the Three Months Ended June 30, 2020*

Total revenues for the three months ended June 30, 2020 were $0.11 million, reflecting sale of product inventory obtained in the reverse acquisition completed in June 2019. There were no significant revenues for the three months ended June 30, 2019.

Total operating expenses increased by $0.56 million to $1.88 million for the three months ended June 30, 2020 compared to $1.32 million for the same period last year:

• Cost of sales and services was less than $0.01 million for the three months ended June 30, 2020, reflecting the sales of product inventory obtained in the reverse acquisition. There were no product sales in the same period last year.

• Research and development expenses increased by $0.64 million to $1.14 million for the three months ended June 30, 2020 compared to $0.50 million for the same period last year. The increase was primarily due to increased external research expenses related to the clinical study of the company’s EB01 drug candidate, and increased activities and preparations related to the planned Phase 2/Phase 3 clinical study of EB05 as a potential treatment for hospitalized COVID-19 patients.

• General and administrative expenses decreased by $0.09 million to $0.73 million for the three months ended June 30, 2020 compared to $0.82 million for the same period last year primarily due to a decrease in legal fees, which was partially offset by increased salary and related personnel expenses and higher public company expenses.

For the three months ended June 30, 2020, Edesa reported a net loss of $1.77 million, or $0.20 per basic share, compared to a net loss of $1.29 million, or $0.30 per basic share, for the three months ended June 30, 2019.

Financial Results for the Nine Months Ended June 30, 2020*

Total revenues for the nine months ended June 30, 2020 were $0.33 million, reflecting sale of product inventory obtained in the reverse acquisition completed in June 2019. There were no significant revenues for the nine months ended June 30, 2019.

Total operating expenses increased by $2.45 million to $4.72 million for the nine months ended June 30, 2020 compared to $2.27 million for the same period last year:

• Cost of sales and services was $0.02 million for the nine months ended June 30, 2020, reflecting the sales of product inventory obtained in the reverse acquisition. There were no product sales in the same period last year.

• Research and development expenses increased by $1.30 million to $2.17 million for the nine months ended June 30, 2020 compared to $0.87 million for the same period last year. The increase was primarily due to increased external research expenses related to the clinical study of the company’s EB01 drug candidate, and increased activities and preparations related to the planned Phase 2/Phase 3 clinical study of EB05 as a potential treatment for hospitalized COVID-19 patients, as well as increased salary and related personnel expenses.

• General and administrative expenses increased by $1.13 million to $2.53 million for the nine months ended June 30, 2020 compared to $1.40 million for the same period last year. The increase was primarily due to increased salary and related personnel expenses, increased legal and professional fees, and higher public company expenses.

For the nine months ended June 30, 2020, Edesa reported a net loss of $4.35 million, or $0.52 per basic share, compared to a net loss of $2.19 million, or $0.61 per basic share, for the nine months ended June 30, 2019.

* Financial results for any periods ended prior to June 7, 2019 reflect the financials of the company’s subsidiary Edesa Biotech Research, Inc. on a standalone basis.

Working Capital

At June 30, 2020, Edesa had working capital of $5.24 million. Cash and cash equivalents totaled $5.64 million. From July 8 to August 10, 2020, the exercise of common share purchase warrants resulted in net cash proceeds to the company of approximately $2.42 million.

Calendar

Edesa management will be remotely joining the H.C. Wainwright Global Investment Conference on September 14-16, 2020 and the LD Micro 500 conference being held September 1-4, 2020. Attendees interested in meetings with management can schedule video one-on-one meetings through the conferences 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. 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 and the company’s plans regarding its Phase 2/3 study, including its belief that, subject to funding and IND approval, the company could be ready to initiate patient enrollment ahead of the anticipated resurgence of SARS-CoV-2 infections this fall/winter. 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 / July 30, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. The company recently received expedited approval to begin the Phase 2/3 study in Canada and is seeking government grants to accelerate site selection and initiate patient enrollment.

EB05 is an experimental monoclonal antibody that the company 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-CoV1 and Influenza viruses.

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. The safety and tolerability of EB05 has been demonstrated in more than 120 subjects. The antibody therapy has 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.

“The submission of the IND for EB05 in COVID-19 patients marks a key step in our plans to extend our planned Phase 2/3 study,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “We have received positive interest from key opinion leaders regarding our proposed clinical trial and are communicating with hospitals across the country regarding our protocol.”

As planned, Edesa’s Phase 2/3 study will be an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized patients who have or are at risk of developing ARDS. The company plans to enroll up to 450 patients in the first phase of the trial. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the drug treatment demonstrate promising results at the Phase 2 readout, the protocol allows for enrollment to continue as a pivotal Phase 3 study. The newly filed IND application for the COVID-19 study supplements and references an existing approved IND for EB05.

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. ARDS has historically affected approximately 200,000 patients each year in the United States, resulting in nearly 75,000 deaths annually.

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 moderate to severe 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, 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 / June 15, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received expedited approval from Health Canada to begin a Phase 2/3 clinical study of its investigational drug, EB05, which the company is developing as a potential treatment for moderate to severe COVID-19 patients. The company reported that it has EB05 drug product available now and is seeking government grants to accelerate the initiation and rollout of the study, beginning at up to 30 sites.

EB05 is a monoclonal antibody that has demonstrated the ability to suppress the release of proinflammatory cytokines that are often observed in severe COVID-19 patients. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling – a key component of the innate immune system and an important mediator of inflammation responsible for acute lung injury that has been shown to be activated during SARS and Influenza infection. Based on previous clinical data and the mechanism of action, the company believes that modulating this well understood signaling pathway could reduce the number of ICU patients and intubation/ventilation procedures, ultimately saving lives. The safety and tolerability of EB05 have been demonstrated previously in over 120 subjects.

As planned, Edesa’s Phase 2/3 study will be an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized patients with moderate to severe COVID-19. The company plans to enroll up to 355 patients in the first phase of the trial. Patients will be infused intravenously with EB05 or placebo. Should the drug treatment demonstrate promising results at the Phase 2 readout, the protocol allows for enrollment to continue as a pivotal Phase 3 study.

“Health Canada’s expedited review process and subsequent approval of our Clinical Trial Application represents a significant step in developing new drugs that can treat the underlying conditions induced by the SARS-CoV-2 infection,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “We greatly appreciate the actions being taken by the government to expedite COVID-19 applications and provide support for clinical studies.”

Dr. Nijhawan explained that COVID-19 patients often have inflammation and injury to the lungs as a result of an overactive immune response, sometimes described as a “cytokine storm.” Moderate to severe patients often progress to ARDS (acute respiratory distress syndrome), a life-threatening form of respiratory failure, and the leading cause of death in COVID-19 patients. Countering this cytokine storm in hospitalized COVID-19 patients has been a key area of interest among researchers. There are currently few meaningful treatments for ARDS, other than supplemental oxygen and mechanical ventilation.

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 infectious diseases. Due to the global health emergency, Edesa has prioritized the development these antibodies as potential treatments for moderate to severe COVID19 patients. The company is based in Markham, Ontario, Canada, with U.S. offices 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 seek grant funding and initiate new clinical studies in COVID-19 patients. 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 / May 15, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the three and six months ended March 31, 2020 and provided an update on its business.

Edesa reported that two new biologic drug candidates acquired last month are rapidly being integrated into the company’s development pipeline. Known as EB05 and EB06, these TLR4 and CXCL10 antagonists are believed to have application in a broad range of therapeutic areas, including potential treatments for COVID-19 pneumonia and acute respiratory distress syndrome (ARDS). Since the lead drug has already been manufactured, the company believes that with government support it could quickly begin clinical studies in COVID-19 patients.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the company is applying its expertise in immune modulation and inflammation therapies toward finding solutions for hospitalized COVID-19 patients. “We believe there is compelling data to prioritize this project, and we are optimistic that modulating these well understood TLR4 and CXCL10 signaling pathways could reduce the number of ICU patients and intubation/ventilation procedures, and save lives,” he said.

Dr. Nijhawan noted that ARDS, a respiratory condition which stops oxygen from reaching the bloodstream, remains a serious unmet medical need. “Even excluding COVID-19 patients, there are approximately 3 million cases of ARDS each year globally despite the widespread use of prophylactic vaccines and herd immunity,” he said.

During the quarter, Edesa also reported that the company took steps to simplify enrollment and patient care for its ongoing Phase 2b clinical study of EB01 for the treatment of allergic contact dermatitis. To support current social distancing requirements, the trial protocol now allows for fewer in-person office visits and provides guidelines for remote telehealth appointments, among other procedural updates. The company is closely monitoring the impacts of governmental directives related to COVID-19 on its investigation centers and patient enrollment.

Edesa’s Chief Financial Officer, Kathi Niffenegger, reported that there have been no significant changes to the company’s internal operations related to the pandemic, and that Edesa staff have been working remotely since early March. “Expenditures have continued to track in line with management’s plans and our clinical activities. We strengthened our balance sheet in January and plan to continue to evaluate our options for non-dilutive grant funding to accelerate the advancement of our newly acquired drug candidates.”

Financial Results for the Three Months Ended March 31, 2020*

Total revenues for the three months ended March 31, 2020 were $0.11 million, reflecting sale of product inventory obtained in the reverse acquisition completed in June 2019. There were no revenues for the three months ended March 31, 2019.

Total operating expenses increased by $1.09 million to $1.63 million for the three months ended March 31, 2020 compared to $0.54 million for the same period last year:

• Cost of sales and services was $0.01 million for the three months ended March 31, 2020, reflecting the sales of product inventory obtained in the reverse acquisition. There were no product sales in the same period last year.
• Research and development expenses increased by $0.39 million to $0.50 million for the three months ended March 31, 2020 compared to $0.11 million for the same period last year. The increase was primarily due to increased external research expenses related to the initiation of clinical studies for the company’s EB01 drug product candidate as well as increased salary and related personnel expenses.
• General and administrative expenses increased by $0.68 million to $1.11 million for the three months ended March 31, 2020 compared to $0.43 million for the same period last year. The increase was primarily due to increased salary and related personnel expenses, increased legal and professional fees, and public company expenses.

For the three months ended March 31, 2020, Edesa reported a net loss of $1.49 million, or $0.17 per basic share, compared to a net loss of $0.53 million, or $0.16 per basic share, for the three months ended March 31, 2019.

Financial Results for the Six Months Ended March 31, 2020*

Total revenues for the six months ended March 31, 2020 were $0.22 million, reflecting sale of product inventory obtained in the reverse acquisition completed in June 2019. There were no revenues for the six months ended March 31, 2019.

Total operating expenses increased by $1.89 million to $2.84 million for the six months ended March 31, 2020 compared to $0.95 million for the same period last year:

• Cost of sales and services was $0.01 million for the six months ended March 31, 2020, reflecting the sales of product inventory obtained in the reverse acquisition. There were no product sales in the same period last year.
• Research and development expenses increased by $0.66 million to $1.03 million for the six months ended March 31, 2020 compared to $0.37 million for the same period last year. The increase was primarily due to increased external research expenses related to the initiation of clinical studies for the company’s EB01 drug product candidate as well as increased salary and related personnel expenses.
• General and administrative expenses increased by $1.22 million to $1.80 million for the six months ended March 31, 2020 compared to $0.58 million for the same period last year. The increase was primarily due to increased salary and related personnel expenses, increased legal and professional fees, and public company expenses.

For the six months ended March 31, 2020, Edesa reported a net loss of $2.58 million, or $0.32 per basic share, compared to a net loss of $0.89 million, or $0.28 per basic share, for the six months ended March 31, 2019.

* Financial results for any periods ended prior to June 7, 2019 reflect the financials of the company’s subsidiary Edesa Biotech Research, Inc. on a standalone basis.

Working Capital

At March 31, 2020, the company had working capital of $6.85 million. Cash and cash equivalents totaled $6.99 million.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. A Phase 2b clinical study of EB01 was initiated in October 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices 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 seek non-dilutive grant funding and initiate new clinical studies for ARDS in COVID-19 patients. 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 / April 20, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced a strategic agreement with Light Chain Bioscience (a brand of NovImmune SA), a leading Swiss pharmaceutical development company, for an exclusive worldwide license to develop and commercialize two Phase 2-ready biologic drug candidates for all therapeutic, prophylactic and diagnostic applications.

The monoclonal antibodies licensed from Light Chain Bioscience block certain signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including infectious diseases. Edesa plans to pursue the development of these signaling molecules as potential treatments for acute respiratory distress syndrome and lung injury resulting from viral respiratory infections, such as the coronavirus that causes COVID-19, and other disorders.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the company’s work has been made more urgent by the COVID-19 crisis. “While we originally sought these assets primarily for use in indications in line with our strategic focus areas, there is compelling data that these drug candidates could help regulate the exaggerated immune response that causes acute injury to the respiratory tract in patients with coronavirus pneumonia and other respiratory infections.”

Dr. Nijhawan noted that the administration of TLR4 and CXCL10 antagonists have been demonstrated to rescue mice from lethal influenza infection and ameliorate virus-induced acute lung injury. “With human safety data available and the lead drug already manufactured, we are preparing regulatory applications for clinical studies and plan to seek expedited government approval and support, including potential non-dilutive funding,” he said.

In consideration for the late-stage clinical assets, Edesa will issue to Light Chain Bioscience Series A-1 Convertible Preferred Shares at an agreed value of $2.5 million with a fixed conversion price and, subject to meeting certain business and clinical milestones, provide near-term consideration of up to $6.0 million for drug product inventory and other milestone fees. Edesa will be responsible for development, product registration and commercialization. Light Chain Bioscience will be eligible to receive up to $363.5 million in aggregate development, approval and commercial sales milestone payments and other consideration. Light Chain Bioscience is also eligible to receive royalties based on sales. During the term of the agreement, Edesa has the option to purchase the assets.

“Light Chain Bioscience has been at the forefront of antibody development technology for the last two decades and is a world leader in antibody engineering, and we are pleased to have been able to identify and in-license two potential best-in-class biologics for use in a broad range of therapeutic areas. As we learned more about these assets we were excited to recognize their potential application for acute respiratory distress syndrome and lung injury,” said Dr. Nijhawan. “Our strategic agreement with Light Chain Bioscience is structured to allow us to rapidly advance these experimental therapies into the clinic while minimizing immediate cash outlays.”

Light Chain Bioscience’s Chief Executive Officer Nicolas Fischer commented, “This global agreement with Edesa provides further validation of our unique expertise in the discovery and development of antibody-based therapeutics. We believe that the scientific rationale behind Edesa’s therapeutic targets are sound and the company is well positioned to advance these assets and unlock their therapeutic potential.”

About COVID-19 Acute Respiratory Distress Syndrome (ARDS)

Nearly all serious cases of COVID-19 feature rapidly progressive pneumonia, diffuse alveolar damage, severe acute respiratory distress syndrome, respiratory failure and fibrosis. As in other viral pneumonia, the infection causes inflammation and injury to the respiratory tract as a result of direct viral injury and, often to a greater extent, from an exaggerated innate immune response. According to evolving data the current global pandemic, the most common cause of death in COVID-19 patients is ARDS.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. A Phase 2b clinical study of EB01 was initiated in October 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

About Light Chain Bioscience

Light Chain Bioscience is a brand of NovImmune SA, a privately held Swiss pharmaceutical development company focused on the discovery and development of therapies based on bispecific and multi-specific antibody formats. Since 1998 the company has brought seven monoclonal antibodies to clinical development stage, one of which, Emapalumab, a monoclonal antibody that binds and neutralizes interferon gamma, was approved by the FDA in 2018. In 2019, Swedish Orphan Biovitrum AB, acquired NovImmune’s Emapalumab business for US$519 million. Since the successful divestment of Emapalumab, the company has focused on its bispecific technology to build a pipeline of multispecific antibodies under its Light Chain Bioscience business. For more information, visit www.lightchainbio.com

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 project milestones as well as disease treatments of interest. 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 12, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced a collaborative research project with the National Research Council of Canada (NRC) to develop novel immunotherapies for vitiligo as well as other indications.

Vitiligo is a life-altering autoimmune disease that results in the depigmenting of the skin. People who have vitiligo develop white patches of skin due to the destruction of special cells called melanocytes which produce the skin pigment melanin. The cause of vitiligo is not known but evidence strongly suggests that vitiligo is an autoimmune disorder in which the body’s immune system mistakenly targets and injures these cells. Vitiligo can affect any area of skin, but it commonly occurs on the face, neck and hands. According to the World Health Organization, vitiligo affects approximately 1% of the world’s population. It is a lifelong condition.

“Despite high prevalence, vitiligo remains one of the most untouched areas in modern medical treatments and there has been little research compared to other immune disorders. Currently there are few treatment options available for patients with limited efficacy,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “To address this unmet medical need, we are focusing our development on novel immune targets implicated in vitiligo pathogenesis and with the support of the NRC plan to advance these treatments toward clinical validation in a rapid, cost effective manner.”

“Working with innovative Canadian companies like Edesa is core to our aim here at the NRC of advancing and accelerating the development of therapeutic technologies,” said Anne Marcil, NRC Team Lead for the project. “Immunotherapies are changing the standard of care for many diseases and we’re excited to support Edesa’s efforts in developing new therapies for patients with vitiligo and other autoimmune diseases.”

Under the agreement, NRC scientists will produce multiple monoclonal antibodies for Edesa to identify a lead candidate to take into IND-enabling studies. The NRC will grant Edesa an exclusive worldwide license for the antibodies arising from the project. Edesa expects to complete the initial phase of the project by the end of the year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. A Phase 2b clinical study of EB01 was initiated in October 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

National Research Council Canada

Founded in 1916, the National Research Council of Canada (NRC) is Canada’s largest federal research and development organization. The NRC partners with Canadian industry to take research impacts from the lab to the marketplace. This market-driven focus is designed to shorten the time between early-stage research and development and commercialization, enhance people’s lives and address some of the world’s most pressing problems. The Ministry of Innovation, Science and Economic Development oversees the NRC.

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 timing of project milestones. 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 / February 13, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the three months ended December 31, 2019 and provided an update on its business.

During the quarter, Edesa expanded an ongoing Phase 2b study of its lead product candidate, EB01, following positive safety data in healthy volunteers. The company is developing EB01 as a monotherapy for patients with chronic allergic contact dermatitis (ACD), a debilitating disease that is frequently caused by allergens present in the workplace. Edesa plans to expand the utility of its anti-inflammatory technology, which forms the basis of EB01, into additional indications, including hemorrhoids disease (HD). The company expects to initiate a proof of concept study in HD later this year. Following the quarter end, in January, the company completed a $4.36 million equity financing, which included significant participation from Edesa’s current institutional investors and insiders.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the company intends to move rapidly to initiate the proof of concept study in HD. “This indication represents a significant expansion and market opportunity for our anti-inflammatory technology platform. We also plan to identify new clinical assets and technologies that fit our strategy of developing new treatments that address unmet medical needs, have large addressable markets and are complementary to the portfolios of larger biopharmaceutical companies.”

Edesa’s Chief Financial Officer, Kathi Niffenegger, reported that expenditures during the quarter reflected increased activity levels in the company’s clinical programs as well public company expenses that Edesa did not incur as a privately held company. “The change in our operational expenses over the comparable period reflect the ongoing transformation of the company and the priority we have placed on advancing our EB01 program, building on our technology platform and delivering on clinical and corporate milestones.”

Financial Results for the Three Months Ended December 31, 2019*

Total revenues for the three months ended December 31, 2019 were $0.11 million, reflecting sale of product inventory obtained in the reverse acquisition completed in June 2019. There were no revenues for the three months ended December 31, 2018.

Total operating expenses increased by $0.80 million to $1.21 million for the three months ended December 31, 2019 compared to $0.41 million for the same period last year:

• Cost of sales and services was less than $0.01 million for the three months ended December 31, 2019, reflecting the sales of product inventory obtained in the reverse acquisition. There were no product sales in the same period last year.
• Research and development expenses increased by $0.27 million to $0.53 million for the three months ended December 31, 2019 compared to $0.26 million for the same period last year. The increase was primarily due to increased external research expenses related to the initiation of clinical studies for the company’s EB01 drug product candidate as well as higher personnel expenses.
• General and administrative expenses increased by $0.53 million to $0.68 million for the three months ended December 31, 2019 compared to $0.15 million for the same period last year. The increase was primarily due to increased salaries and related personnel expenses, increased legal and professional fees, and public company expenses.

For the three months ended December 31, 2019, Edesa reported a net loss of $1.09 million, or $0.15 per basic share, compared to a net loss of $0.36 million, or $0.11 per basic share, for the three months ended December 31, 2018.

* Financial results for any periods ended prior to June 7, 2019 reflect the financials of the company’s subsidiary Edesa Biotech Research, Inc. on a standalone basis.

Working Capital

At December 31, 2019, the company had working capital of $4.12 million. Cash and cash equivalents totaled $4.33 million.

On January 8, 2020, the company closed a registered direct offering of common shares and concurrent private placement of purchase warrants. The company received aggregate gross proceeds in the offering of $4.36 million, before deducting fees to the placement agent and other estimated offering expenses payable by the company. The company intends to use the net proceeds from the financing for general corporate purposes, which may include working capital, capital expenditures, and research and development expenses.

Calendar

Edesa management will be attending the American Contact Dermatitis Society Annual Meeting and Dermatology Innovation Forum, both on March 19, 2020 in Denver, Colorado; and the Bio-Europe Spring 2020 Conference being held March 23-25, 2020 in Paris. Members of the investment or biopharma communities interested in meetings with management can schedule one-on-ones through the conference online systems 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 efficiently developing innovative treatments that address significant 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. A Phase 2b clinical study of EB01 was initiated in October 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

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 initiate a proof of concept study in HD later this year and its plans to expand its pipeline with new clinical assets and technologies. 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.

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 / January 6, 2020 / Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, today announced that it has entered into definitive securities purchase agreements with certain institutional and accredited investors as well as company insiders in a registered direct offering of an aggregate of 1,355,380 common shares. The price per share for investors other than investors that are officers, directors, employees or consultants of the company is $3.20 and, for each investor that is an officer, director, employee or consultant of the company, $4.11.

In a concurrent private placement, the company agreed to sell to such investors Class A Purchase Warrants to purchase an aggregate of up to 1,016,553 of the company’s common shares, or 0.75 of a common share for each share purchased in the offering, and Class B Purchase Warrants to purchase an aggregate of up to 677,703 of the company’s common shares, or 0.50 of a common share for each share purchased in the offering. The Class A Purchase Warrants will be exercisable at any time on or after the six month anniversary of their date of issuance, at an exercise price of $4.80 per share and will expire on the third anniversary of the date they initially become exercisable. The Class B Purchase Warrants will be exercisable at any time on or after the six month anniversary of their date of issuance, at an exercise price of $4.00 per share and will expire on the four month anniversary of the date they initially become exercisable.

Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as Edesa’s U.S. financial adviser and placement agent for the offering in the United States. Non-U.S. investors participated in the offering via a concurrent non-brokered placement. The closing of the offering and concurrent private placement is expected to occur on or about January 8, 2020, subject to the satisfaction of customary closing conditions.

The gross proceeds to Edesa are expected to be approximately $4.36 million. Edesa intends to use the net proceeds from the offering primarily for working capital and for general corporate purposes, including research and development.

The common shares are being offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233567), that was previously filed with the Securities and Exchange Commission (SEC) and declared effective on September 12, 2019. The warrants to be issued in the concurrent private placement and shares issuable upon exercise of such warrants have not been registered under the Securities Act of 1933, as amended (the Securities Act) or applicable state securities law and are being offered pursuant to Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder.

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

A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Edesa Biotech, Inc. via email at investors@edesabiotech.com or telephone at (805) 488-2800. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the securities in connection with the offering.

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. A Phase 2b clinical study of EB01 was initiated in October 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

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. Forward looking statements in this press release include the anticipated closing date of the offering and anticipated proceeds from the offering. 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 / December 12, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the nine-month period ended September 30, 2019 and provided an update on its business.

Edesa recently enrolled the first patient in a Phase 2b clinical study of its lead product candidate, EB01. The company is developing EB01 as a monotherapy for patients with chronic allergic contact dermatitis (ACD), a debilitating disease that is frequently caused by allergens present in the workplace. In December, the company reported that based on positive safety data in healthy volunteers, the company would expand the study to include ACD patients with symptoms on the face, a commonly effected area. The experimental drug previously demonstrated positive results in two previous studies in ACD patients.

In 2019, Edesa also advanced plans to expand the utility of its anti-inflammatory technology, which forms the basis of EB01, into additional indications. This included an approval by Health Canada to conduct a proof-of-concept study of the company’s product candidate, EB02, as a treatment for hemorrhoids disease (HD).

“We have maintained a rapid pace this year and I’m pleased to report that our team has delivered on our key clinical and corporate milestones. In addition to the transition we made to the public equity markets, we laid the foundation for a number of value creation opportunities in the coming year,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “We are looking forward to the interim data readout for our Phase 2b study in ACD as well as initiating a clinical study of our anti-inflammatory technology in HD.”

Edesa’s Chief Financial Officer, Kathi Niffenegger, CPA reported that operating expenses, including expenditures related to increased activities for the EB01 clinical program, were largely in line with management’s expectations for the fiscal year. “We remain committed to the capital efficient product development model that Edesa adopted as a private company and plan to continue to focus our working capital on the advancement of our clinical pipeline.”

Financial Results for the Nine-Month Period Ended September 30, 2019*

The company’s year-end financial results reflect a nine-month period as a result of a change in fiscal year following the company’s reverse acquisition completed in June 2019.

Total revenues for the nine-month period ended September 30, 2019 were $0.41 million, reflecting the initiation of sales of product inventory obtained in the reverse acquisition completed in June 2019. There were no revenues for the year ended December 31, 2018.

Total operating expenses increased by $1.62 million to $3.24 million for the nine-month period ended September 30, 2019 compared to $1.62 million for the prior year ended December 31, 2018:

• Cost of sales and services was $0.10 million for the nine-month period ended September 30, 2019, reflecting the initiation of sales of product inventory obtained in the reverse acquisition. There were no revenues in the prior year ended December 31, 2018.

• Research and development expenses were $1.10 million for the nine-month period ended September 30, 2019, reflecting greater clinical research activities related to the initiation of the company’s Phase 2B clinical study of its EB01 product candidate as well as higher personnel expenses. Research and development expenses were $1.08 million for the prior year.

• General and administrative expenses were $2.05 million for the nine-month period ended September 30, 2019, reflecting increased legal and professional fees related to the company’s reverse acquisition, increased personnel expenses and public company expenses, which Edesa did not incur as a privately held company. General and administrative expenses were $0.54 million for the prior year.

For the nine-month period ended September 30, 2019, Edesa reported a net loss of $2.78 million, or $0.55 per basic share, compared to a net loss of $1.54 million, or $0.47 per basic share, for the prior year ended December 31, 2018.

Working Capital

At September 30, 2019, the company had working capital of $5.18 million. Cash and cash equivalents totaled $5.03 million.

Calendar

Management will be attending the Dermatology Summit on January 12, 2020 and the Biotech Showcase from January 13-15, 2020. Both events are being held in San Francisco, California. Members of the investment or biopharma communities interested in meetings with management can schedule one-on-ones through the conference online systems or by contacting Edesa at investors@edesabiotech.com.

*As a result of the acquisition accounting for the business combination completed on June 7, 2019, and the subsequent change in year end of the company’s subsidiary Edesa Biotech Research, Inc., the comparative year-end data represent the nine months period ended September 30, 2019 and the twelve months ended December 31, 2018, which should be taken into account when reviewing comparative results. Financial results for any periods ended prior to June 7, 2019 reflect the financials of Edesa Biotech Research, Inc. on a standalone basis.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. A Phase 2b clinical study of EB01 was initiated in October 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

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 expand the utility of its sPLA2 anti-inflammatory technology into additional indications, including HD. 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.

Edesa Biotech, Inc.
Consolidated Statements of Operations

Edesa Biotech, Inc.
Consolidated Balance Sheets

Edesa Biotech, Inc.
Consolidated Statements of Cash Flows

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TORONTO, ON / ACCESSWIRE / December 3, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported that the company’s lead product candidate, EB01, has demonstrated positive safety data in healthy volunteers participating in its ongoing Phase 2b clinical study in chronic allergic contact dermatitis (ACD), a debilitating disease that is frequently caused by allergens present in the workplace.

The healthy volunteer cohort at the outset of Edesa’s study is designed to clear the way for using the experimental topical treatment on the face of ACD patients. Due to the high prevalence of symptoms on the face of ACD patients, the expansion of the study to facial symptoms is expected to address a key aspect of the disease, while broadening the potential patient population.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the face and hands are the most common body parts presenting with ACD because they are typically more open to contact with allergens. “Symptoms on the face have a powerful impact on patients’ quality of life and can be especially problematic for chronic ACD patients. The lesions are highly visible and difficult to treat with steroids due to concerns about skin thinning, dyspigmentation, abnormal hair growth and other common side effects of continuous steroid use.”

The data from the healthy volunteers were consistent with safety data from five previous clinical studies that demonstrated no serious adverse events or discontinuations due to adverse events. Since previous studies were focused solely on symptoms on the hands and arms, the company included the healthy volunteer cohort as a precautionary measure.

Edesa Vice President of Research and Development, Blair Gordon, PhD reported that the healthy volunteers were treated with EB01 cream on one side of the face, while the placebo cream was applied to the other side of the face twice daily for one week. “We are very pleased to see that none of the patients reported burning, stinging or itch associated with either the drug product or the placebo cream. No adverse events attributable to either treatment were observed. These results reaffirm the safety profile of our sPLA2 inhibitor technology and EB01,” said Dr. Gordon.

ACD patients participating in the study are being treated for 28 days with EB01 cream, which contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. In addition to the safety and efficacy of EB01 in ACD patients, investigators will also evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream as secondary and exploratory measures. Edesa plans to perform a blinded interim analysis after the first 46 subjects are treated to determine the total number of patients for the second part of the study.

Investigational centers for the EB01 study are located in Baton Rouge, LA; Bexley, OH; Chapel Hill, NC; Fridley, MN; Long Beach, CA; Louisville, KY; New York, NY; Plainfield, IN; and Washington, DC.

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 efficiently developing innovative treatments that address significant 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. Edesa’s investigational new drug (IND) application for EB01 was accepted by the FDA in November 2018. Edesa also intends to expand the utility of its sPLA2 inhibitor technology across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

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 perform a blinded interim analysis following the completion of the first cohort. 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 / November 5, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, announced today that its management will present at the H.C. Wainwright 5th Annual Israel Conference in Tel Aviv, Israel.

The company is scheduled to participate in a panel discussion related to initial public offerings and reverse acquisitions on November 10, 2019 at 1:00 pm (IST) at the Hilton Tel Aviv hotel. Edesa completed a reverse acquisition with a Nasdaq listed company in June of this year and has since initiated a Phase 2b clinical study of its lead product candidate in allergic contact dermatitis.

Management will also be participating in the following conferences:

BIO Europe
November 11-13, 2019
Hamburg, Germany

Jefferies 2019 London Healthcare Conference
November 20-21, 2019
London, UK

Piper Jaffrey 31st Annual Healthcare Conference
December 3-5, 2019
New York City

Dermatology Summit
January 12, 2020
San Francisco, Calif.

Biotech Showcase
January 13-15, 2020
San Francisco, Calif.

Members of the investment or biopharma communities interested in meetings with management can schedule meetings through the conference scheduling systems, or by contacting Edesa directly at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. A Phase 2b clinical study of EB01 was initiated in October 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

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 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 / October 21, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced that the first patient has been enrolled in a Phase 2b clinical trial evaluating the company’s lead product candidate, EB01, as a monotherapy for patients with moderate to severe chronic allergic contact dermatitis (ACD). The U.S. Food and Drug Administration recently approved Edesa’s clinical protocol and provided a “safe to proceed” letter, which formally authorized the company to begin its clinical investigation.

In the first cohort, ACD patients will be treated for 28 days with EB01 cream, an investigational medicine that contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. The adaptive-designed study will primarily evaluate the safety and efficacy of EB01 in ACD patients. Investigators will also evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream as secondary and exploratory measures. Edesa plans to perform a blinded interim analysis following the completion of the first cohort to determine the total number of patients for the second part of the study.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the initiation of the study has been a key company priority. “Initiating this study brings us one step closer to providing new options for patients with ACD, especially for those patients coping with side effects and limitations of current treatments,” he said. “We believe that addressing the inflammation cascade at its inception represents a potentially innovative approach to treating ACD and other inflammatory diseases and we look forward to sharing our progress.”

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. There are currently no treatment options specifically indicated for ACD.

Investigational centers for the EB01 study are located in Baton Rouge, LA; Bexley, OH; Chapel Hill, NC; Fridley, MN; Long Beach, CA; Louisville, KY; New York, NY; Plainfield, IN; and Washington, DC.

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 efficiently developing innovative treatments that address significant 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. Edesa’s investigational new drug (IND) application for EB01 was accepted by the FDA in November 2018. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

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 perform a blinded interim analysis following the completion of the first cohort and its belief that the study brings it closer to providing new options for patients with ACD. 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 / September 5, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from Health Canada to begin a clinical study of its investigational drug, EB02, which the company is developing as a potential treatment for patients with grade I-III internal hemorrhoids.

Health Canada reviewed Edesa’s clinical trial application and approved it by issuing a “no objection letter,” a standard guidance document that allows the company to proceed with its planned study. The exploratory study is designed to assess the safety and efficacy of EB02 among hemorrhoid patients at leading clinical research sites in Canada. The company plans to enroll up to 48 patients in the first stage of the trial. Should the initial results be encouraging, the company plans to transition from a proof of concept study to a Phase 2 study.

“Health Canada’s approval to begin clinical trials represents a significant milestone in our goal of demonstrating the broad potential of our novel non-steroidal anti-inflammatory technology,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “Based on our analysis of clinical data in dermatitis, there’s good reason to believe that EB02 may be effective in treating the erythema, swelling and exudation associated with hemorrhoids.”

Formulated as a topical cream, EB02 employs a novel mechanism of action against a common inflammation pathway. Unlike steroids and other anti-inflammatory drugs, the treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. The molecule has demonstrated highly selective, antagonistic activity against the secretory enzyme family involved in inflammation, pruritus and fibrosis.

“Despite the high prevalence of this condition, patients have limited treatment options available to them. This product candidate represents a potential novel treatment for an indication where there has been little to no innovation,” said Michael Brooks, President of Edesa.

Based on National Institutes of Health reports, hemorrhoids affect approximately 12.5 million adults in the U.S., or approximately 5% of the U.S. adult population; almost half of individuals 50 years and older experience symptomatic hemorrhoids. While there are commonly used products, the company noted that, to its knowledge, none have been subjected to formal review and/or approved by the FDA because they entered the market prior to 1962.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

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 plan to enroll up to 48 patients in the first stage of the trial and the company’s plans to transition from a proof of concept study to a Phase 2 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 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 / August 29, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, announced today that Dr. Par Nijhawan, Chief Executive Officer, will present at the H. C. Wainwright 21st Annual Global Investment Conference to be held September 8-10, 2019 in New York City.

Edesa Presentation Details

Date: Monday, September 9, 2019
Time: 2:35 pm Eastern Time
Location: Lotte New York Palace Hotel

Edesa senior management will be available during the conference for one-on-one meetings. Members of the investment community who are interested in meeting with the company should contact conference coordinators to arrange an appointment or contact Edesa directly via email at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. Edesa’s investigational new drug (IND) application for EB01 was accepted by the FDA in November 2018. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

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 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 / August 14, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the three and six months ended June 30, 2019 and provided an update on its business.

During the quarter, Edesa completed its reverse acquisition and Nasdaq listing, and announced plans to proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which the company is developing as a potential treatment for chronic allergic contact dermatitis (ACD). Edesa is currently performing site initiation visits at investigational centers in the U.S. and expects to proceed with enrolling the first patient into its Phase 2b clinical trial in the current quarter.

“Our first quarter as a public company has been very productive and I am pleased to report that our team has maintained a rapid pace toward the initiation of our Phase 2b clinical study of EB01,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “The next few quarters will be an exciting time for Edesa as we expect to enroll our first EB01 patient, expand the utility of our sPLA2 anti-inflammatory technology into additional indications and evaluate additional assets that can provide new value creation opportunities.”

Edesa’s Chief Financial Officer, Kathi Niffenegger, reported that the combined company’s working capital at the end of the fiscal quarter was higher than projected. “Our working capital benefited from lower than expected acquisition-related costs as well as steps taken by management to conserve cash during the transaction. As a result, we are well positioned to support our current clinical plans and activities,” she said.

Financial Results

Three months ended June 30, 2019

Total revenues were not material for the three months ended June 30, 2019 and June 30, 2018 as the company continued to focus on developing and obtaining regulatory approval for its product candidates.

Total operating expenses increased by $0.90 million to $1.32 million for the three months ended June 30, 2019 compared to $0.42 million for the same period last year:

• Research and development expenses increased by $0.20 million to $0.50 million for the three months ended June 30, 2019 compared to $0.30 million for the same period last year primarily due to an increase in clinical research expenses associated with the Phase 2B clinical study of Edesa’s EB01 product candidate as well as higher personnel expenses.
• General and administrative expenses increased by $0.70 million to $0.82 million for the three months ended June 30, 2019 compared to $0.12 million for the same period last year primarily due to increased legal and professional fees related to the company’s reverse acquisition, increased personnel expenses and the initiation of public company expenses, which Edesa did not incur as a privately held company.

Net loss for the three months ended June 30, 2019 was $1.29 million, or $0.30 per basic share, compared to a net loss of $0.41 million, or $0.13 per basic share, for the three months ended June 30, 2018.

Six months ended June 30, 2019

Total revenues were not material for the six months ended June 30, 2019 and June 30, 2018.

Total operating expenses increased by $1.01 million to $1.86 million for the six months ended June 30, 2019 compared to $0.85 million for the same period last year:

• Research and development expenses increased by $0.03 million to $0.61 million for the six months ended June 30, 2019 compared to $0.58 million for the same period last year primarily due to an increase in clinical research expenses associated with the Phase 2B clinical study of Edesa’s EB01 product candidate as well as higher patent fees and personnel expenses.
• General and administrative expenses increased by $0.97 million to $1.25 million for the six months ended June 30, 2019 compared to $0.28 million for the same period last year primarily due to increased legal and professional fees related to the company’s reverse acquisition, increased personnel expenses and the initiation of public company expenses, which Edesa did not incur as a privately held company.

Net loss for the six months ended June 30, 2019 was $1.82 million, or $0.48 per basic share, compared to a net loss of $0.83 million, or $0.26 per basic share, for the six months ended June 30, 2018.

Edesa changed its year end from December 31 to September 30 resulting in six months activity during this transitional period through June 30, 2019.

Working Capital

At June 30, 2019, the company had working capital of $6.11 million. Cash and cash equivalents totaled $6.36 million.

Investor Calendar

The company is scheduled to present at the H.C. Wainwright & Co. 21st Annual Global Investment Conference, September 8-10, 2019 in New York, NY. Management will also be attending the BIO Investor Forum in San Francisco, October 22-23, 2019. Investors interested in meetings with management can schedule through the conference meeting systems, or by contacting Edesa investors relations at investors@edesabiotech.com

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

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 commitment to rapidly advance its clinical plans and in the next few quarters enroll its first EB01 patient, expand the utility of its sPLA2 anti-inflammatory technology into additional indications and evaluate additional assets that can provide new value creation opportunities. 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.

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 / July 25, 2019 / Edesa Biotech, Inc. (NASDAQ: EDSA), a clinical-stage biopharmaceutical company, reported today that the company has completed the manufacturing of its lead drug candidate EB01, a novel sPLA2 inhibitor that Edesa is developing as a potential treatment for chronic allergic contact dermatitis (ACD). Edesa is currently evaluating investigational centers in the U.S. and expects to proceed with enrolling the first patient into its Phase 2b clinical trial in the current quarter.

“We have completed the manufacturing of our active pharmaceutical ingredient and have the drug product for the first cohort ready to distribute to our investigational centers in the U.S.,” said Michael Brooks , President of Edesa. “During our site evaluation visits, we have been encouraged by the high level of interest from physicians familiar with the limited treatment options for chronic suffers of ACD.”

The company’s Phase 2b adaptive designed study of EB01 in chronic ACD will primarily evaluate safety and efficacy. Secondary and exploratory measures will evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, noted that the expedited clinical development of EB01 remains a strategic priority for the company. “Based on encouraging results from two previous clinical studies, we believe our novel therapy has the potential to be an effective and safe treatment for patients with ACD. Our upcoming Phase 2b study of EB01 supports our goal to develop therapies for patients with serious unmet medical needs, particularly in inflammatory conditions where current treatments have serious limitations or side effects.”

The company recently announced the receipt of an FDA “safe to proceed” letter, which formally approved the company’s Phase 2b clinical protocol and authorized Edesa to begin its clinical investigation.

About Allergic Contact Dermatitis (ACD)

Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States, and has been estimated to cost $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa Biotech estimates that there are more than 13.2 million people in the U.S. with contact dermatitis, with between 20% and 60% of all cases diagnosed as ACD. Approximately 1.2 million patients have chronic ACD. There are no treatment options specifically indicated for ACD and physicians must utilize agents approved for other dermatology conditions, such as topical corticosteroids, which are able to manage disease symptoms in less than half of patients and have well-known side-effects.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. Edesa’s investigational new drug (IND) application for EB01 was accepted by the FDA in November 2018. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Toronto, Canada, with U.S. offices in Southern California.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s expectation that it will enroll the first patient into its Phase 2b clinical trial in the current quarter and the company’s goal to rapidly develop therapies for patients with serious unmet medical needs, particularly in inflammatory conditions where current treatments have serious limitations or side effects. 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, June 20, 2019 /CNW/ — Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, reported today that the U.S. Food and Drug Administration has notified the company that it may proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which Edesa is developing as a potential treatment for chronic allergic contact dermatitis.

The FDA “safe to proceed” letter formally approves the company’s Phase 2b clinical protocol and authorizes the company to begin its clinical investigation. Edesa expects the first patient to be enrolled in the coming quarter following the manufacturing of its drug candidate.

EB01 employs a novel mechanism of action against a common inflammation pathway. Unlike steroids and other anti-inflammatory drugs, like ibuprofen, the topical treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. In two previous clinical studies, EB01 has demonstrated significant improvement of multiple symptoms in contact dermatitis patients.   

“There are limited options for ACD patients and we have been pleased with the level of interest from physicians in the U.S.,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “The company is committed to rapidly advancing our clinical plans and remains on track to initiate our clinical study for EB01.”

In addition to its lead product candidate, Dr. Nijhawan noted that the company plans to selectively target additional indications within the areas of dermatology and gastroenterology. The company also plans to expand its portfolio with assets that can drive long-term growth opportunities.

“This is an active and exciting time for Edesa and we look forward to providing clinical and business updates over the coming quarter,” said Dr. Nijhawan. 

Clinical Protocol for Phase 2b Trial of EB01
The protocol evaluates EB01 in a randomized, double-blind, vehicle-controlled, sample size adaptive design. ACD patients in this study will be treated for 28 days with various strengths of EB01 cream. Primary outcome measures will evaluate safety and efficacy. Secondary and exploratory measures will evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream. The company plans to complete an interim analysis following the enrollment of the first cohort to determine the total sample size in the second part of the study; up to 166 total patients may be enrolled. Additional details on the protocol are available on www.clinicaltrials.gov.

About Allergic Contact Dermatitis (ACD)
Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States, and has been estimated to cost $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa Biotech estimates that there are more than 13.2 million people in the U.S. with contact dermatitis, with between 20% and 60% of all cases diagnosed as ACD. Approximately 1.2 million patients have chronic ACD. There are no treatment options specifically indicated for ACD and physicians must utilize agents approved for other dermatology conditions, such as topical corticosteroids, which are able to manage disease symptoms in less than half of patients and have well-known side-effects.

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. Edesa’s investigational new drug (IND) application for EB01 was accepted by the FDA in November 2018. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Toronto, Canada, with U.S. offices in Southern California.

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 commitment to rapidly advance its clinical plans and the company’s plans to selectively target additional indications within the areas of dermatology and gastroenterology and expand its portfolio with assets that can drive long term growth opportunities. 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, June 7, 2019 /CNW/ — Edesa Biotech, Inc., a clinical-stage biopharmaceutical company, today reported that the previously announced business combination with Stellar Biotechnologies, Inc. (Nasdaq: SBOT) (“Stellar”), which was completed pursuant to a share exchange agreement, has closed. The combined company will focus on the development and advancement of innovative treatments for dermatological and gastrointestinal indications. The combined company will be called Edesa Biotech, Inc. and will commence trading on the Nasdaq Capital Market on June 10, 2019 under the symbol “EDSA.”

“With the transaction now completed, we are working diligently to deliver on our mission to develop and commercialize innovative drug products that address unmet medical needs for large, underserved patient populations,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “We have a number of upcoming clinical milestones and look forward to completing the studies needed to advance our lead asset and developing additional innovative products”

Edesa’s lead product candidate, EB01, is a non-steroidal, anti-inflammatory treatment for chronic allergic contact dermatitis. The topical therapy employs a novel mechanism of action, and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in contact dermatitis patients. Edesa is in the early stages of conducting a 160-patient Phase 2B clinical study evaluating EB01, and expects the first patient to be enrolled by the third quarter of 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and seek additional novel products or technologies.

After giving effect to the new Stellar shares issued in the share exchange, the former shareholders and option holders of Edesa own approximately 88% and the shareholders and option holders of Stellar prior to the share exchange own approximately 12% of the combined company on a fully-diluted basis, calculated in accordance with the share exchange agreement.

In connection with the closing of the transaction, the combined company plans to effect a one-for-six reverse share split at 4:00 p.m. Eastern Time on June 7, 2019. At the effective time of the reverse share split, every six shares of the combined company’s common shares will be consolidated into one common share. No fractional shares will be issued in the reverse share split. Pursuant to the laws of the province of British Columbia, each fractional share resulting from the reverse share split that is less than ½ a share will be cancelled and each fractional share that is at least ½ a share will change to one whole share. This action is being taken to meet the minimum bid price requirement of new listings on the Nasdaq Capital Market.  Following the closing of the exchange transaction and after giving effect to the reverse share split, the combined company expects to have approximately 7,138,233, shares issued and outstanding.

The combined company will operate under the leadership of Dr. Par Nijhawan, Edesa’s Chief Executive Officer, Michael Brooks, Edesa’s Vice President Corporate Development and Strategy and Kathi Niffenegger, Stellar’s Chief Financial Officer.

The securities issued in the share exchange have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements.

Fasken Martineau DuMoulin LLP (Canada) and Stubbs Alderton & Markiles, LLP (USA) acted as legal advisors to Edesa in the transaction.  H.C. Wainwright & Co. acted as transaction advisor and Greenburg Traurig LLP (USA) and McMillan LLP (Canada) acted as legal advisors to Stellar.

Information for Shareholders
Shareholders owning Edesa (formerly Stellar) shares via a broker, bank or other nominee will have their positions updated to reflect the reverse share split as well as the change in company name and trading symbol, subject to such broker’s particular processes, and will not be required to take any action in connection with the share split or business combination. Similarly, registered shareholders holding shares electronically in book-entry form do not need to take any action. Edesa’s transfer agent, Computershare Investor Services Inc., will instruct any shareholders with paper certificates on the exchange process. The new CUSIP number for the combined company’s common shares will be 27966L108.

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications. The company is based in Toronto, Canada, with U.S. offices in Southern California.

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 expectations related to the reverse share split, the number of shares outstanding following the exchange and reverse share split and strategic plans relating to the combined company’s business. 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 inability to successfully integrate the businesses or the risk that such integration may be more difficult, time-consuming or costly than expected, the risk that the expected benefits of the proposed combination are not realized, 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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