EDSA Edesa Biotech Inc.

7.22
-0.96  -12%
Previous Close 8.18
Open 8.01
52 Week Low 1.58
52 Week High 19.1
Market Cap $63,963,128
Shares 8,859,159
Float 3,935,968
Enterprise Value $67,161,230
Volume 545,823
Av. Daily Volume 2,319,413
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Drug Pipeline

Drug Stage Notes
EB05
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 trial to be initiated (Canada). IND also filed with U.S. July 30, 2020.
EB01
Hemorrhoids disease (HD)
Phase 1
Phase 1
Proof of concept trial to be initiated in 2020.
EB01
Allergic contact dermatitis (ACD)
Phase 2b
Phase 2b
Phase 2b trial ongoing.

Latest News

  1. 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…

    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.

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

    SOURCE: Edesa Biotech



    View source version on accesswire.com:
    https://www.accesswire.com/599552/Edesa-Biotech-Files-IND-Application-for-Phase-23-COVID-19-Study

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  2. 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…

    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.

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

    SOURCE: Edesa Biotech



    View source version on accesswire.com:
    https://www.accesswire.com/593854/Edesa-Biotech-Receives-Regulatory-Approval-to-Initiate-COVID-19-Study

    View Full Article Hide Full Article
  3. 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…

    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.

    Contacts

    Gary Koppenjan
    Edesa Biotech, Inc.
    (805) 488-2800 ext. 150

    Condensed Interim Consolidated Statements of Operations
    (Unaudited)

    Three Months Ended Six Months Ended
    March 31, 2020 March 31, 2019 March 31, 2020 March 31, 2019
    Total Revenues
    $ 110,516 $ - $ 218,316 $ -
    Expenses:
    Cost of sales and services
    10,037 - 13,815 -
    Research and development
    502,814 111,702 1,030,812 369,093
    General and administrative
    1,113,917 429,076 1,795,623 577,426
    1,626,768 540,778 2,840,250 946,519
    Loss from Operations
    (1,516,252) (540,778 ) (2,621,934) (946,519 )
    Other Income
    26,616 11,948 38,765 52,840
    Income tax expense
    - - 800 -
    Net Loss
    (1,489,636) (528,830 ) (2,583,969) (893,679 )
    Exchange differences on translation
    (39,908) 73,253 (21,794 ) 91,013
    Net Loss and Comprehensive Loss
    $ (1,529,544) $ (455,577 ) $ (2,605,763) $ (802,666 )
    Weighted average number of common shares outstanding
    8,740,065 3,239,902 8,118,891 3,239,902
    Loss per share - basic and diluted
    $ (0.17) $ (0.16 ) $ (0.32) $ (0.28 )

    Condensed Interim Consolidated Balance Sheets
    (Unaudited)

    March 31, September 30,
    2020 2019
    Assets:
    Cash and cash equivalents
    $ 6,989,930 $ 5,030,583
    Other current assets
    436,092 614,123
    Operating lease right-of-use assets
    181,492 -
    Property and equipment, net
    25,110 73,058
    Total Assets
    $ 7,632,624 $ 5,717,764
    Liabilities and Shareholders' Equity:
    Current liabilities
    $ 578,938 $ 461,634
    Noncurrent liabilities
    122,743 -
    Shareholders' equity
    6,930,943 5,256,130
    Total Liabilities and Shareholders' Equity
    $ 7,632,624 $ 5,717,764

    Condensed Interim Consolidated Statements of Cash Flows
    (Unaudited)

    Six Months Ended
    March 31, 2020 March 31, 2019
    Cash flows from operating activities:
    Net loss
    $ (2,583,969) $ (893,679 )
    Adjustments for non-cash items
    432,400 25,796
    Change in working capital items
    191,410 86,655
    Net cash used in operating activities
    (1,960,159) (781,228 )
    Net cash provided by (used in) investing activities
    42,359 (1,504 )
    Net cash provided by financing activities
    3,891,801 -
    Effect of exchange rate changes on cash and cash equivalents
    (14,654 ) 94,643
    Net change in cash and cash equivalents
    1,959,347 (688,089 )
    Cash and cash equivalents, beginning of period
    5,030,583 3,730,230
    Cash and cash equivalents, end of period
    $ 6,989,930 $ 3,042,141

    SOURCE: Edesa Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/589711/Edesa-Biotech-Reports-Fiscal-2nd-Quarter-2020-Results

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