EDSA Edesa Biotech Inc.

6.09
+0.08  (+1%)
Previous Close 6.01
Open 5.89
52 Week Low 2.7
52 Week High 19.1
Market Cap $80,256,712
Shares 13,178,442
Float 7,802,244
Enterprise Value $73,051,943
Volume 71,629
Av. Daily Volume 227,398
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Drug Pipeline

Drug Stage Notes
EB01
Allergic contact dermatitis (ACD)
Phase 2b
Phase 2b
Phase 2b enrollment of the first cohort has completed - March 9, 2021.
EB05
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 commencement of enrollment announced November 30, 2020.
EB01
Hemorrhoids disease (HD)
Phase 1
Phase 1
Proof of concept trial planned.

Latest News

  1. TORONTO, ON / ACCESSWIRE / May 14, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the three and six months ended March 31, 2021 and provided an update on its business.

    The company reported that it has enrolled more than 285 patients in an ongoing Phase 2/3 clinical study of its investigational drug, EB05, as a single-dose treatment for hospitalized COVID-19 patients with or at risk of developing Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. The study is being funded in part by a C$14 million reimbursement grant from the Canadian Government. In addition, Edesa completed…

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

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

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

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

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

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

    Financial Results for the Three Months Ended March 31, 2021

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

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

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

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

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

    Financial Results for the Six Months Ended March 31, 2021

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

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

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

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

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

    About Edesa Biotech, Inc.

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

    Edesa Forward-Looking Statements

    This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: upcoming milestones in the company's clinical studies, including enrollment milestones and interim readouts for its COVID-19 and dermatitis studies, the company's preparations to be in position to rapidly advance its clinical studies and the company's belief that 2021 could be a transformative year. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

    Condensed Interim Consolidated Statements of Operations
    (Unaudited)
    Three Months Ended Six Months Ended
    March 31, 2021 March 31, 2020 March 31, 2021 March 31, 2020
    Total Revenues
    $ - $ 110,516 $ - $ 218,316
    Expenses:
    Cost of sales
    - 10,037 - 13,815
    Research and development
    7,975,304 502,814 9,354,958 1,030,812
    General and administrative
    1,535,127 1,113,917 2,769,275 1,795,623
    9,510,431 1,626,768 12,124,233 2,840,250
    Loss from operations
    (9,510,431) (1,516,252) (12,124,233) (2,621,934)
    Other Income (Loss):
    Reimbursement grant income
    7,170,465 - 7,170,465 -
    Other income (loss)
    80,779 26,616 56,969 38,765
    Loss before income taxes
    (2,259,187) (1,489,636) (4,896,799) (2,583,169)
    Income tax expense
    800 - 800 800
    Net loss
    (2,259,987) (1,489,636) (4,897,599) (2,583,969)
    Exchange differences on translation
    (10,480) (39,908) 92,947 (21,794)
    Net comprehensive loss
    $ (2,270,467) $ (1,529,544) $ (4,804,652) $ (2,605,763)
    Weighted average number of common shares
    11,641,201 8,740,065 10,894,441 8,118,891
    Loss per common share - basic and diluted
    $ (0.19) $ (0.17) $ (0.45) $ (0.32)
    Condensed Interim Consolidated Balance Sheets
    (Unaudited)
    March 31, 2021
    September 30, 2020
    Assets:
    Cash and cash equivalents
    $10,966,194 $7,213,695
    Other current assets
    10,452,165 890,323
    Non-current assets
    2,583,331 2,658,357
    Total Assets
    $24,001,690 $10,762,375
    Liabilities, shareholders' equity and temporary equity:
    Current liabilities
    $4,620,135 $1,529,857
    Noncurrent liabilities
    108,771 124,388
    Temporary equity
    - 2,476,955
    Shareholders' equity
    19,272,784 6,631,175
    Total liabilities, shareholders' equity and temporary equity
    $24,001,690 $10,762,375
    Condensed Interim Consolidated Statements of Cash Flows
    (Unaudited)
    Six Months Ended
    March 31, 2021 March 31, 2020
    Cash flows from operating activities:
    Net loss
    $(4,897,599) $(2,583,969)
    Adjustments for non-cash items
    1,248,994 393,829
    Change in working capital items
    (6,541,452) 229,981
    Net cash used in operating activities
    (10,190,057) (1,960,159)
    Net cash provided by (used in) investing activities
    (4,098) 42,359
    Net cash provided by financing activities
    13,937,798 3,891,801
    Effect of exchange rate changes on cash and cash equivalents
    8,856 (14,654)
    Increase in cash and cash equivalents during the period
    3,752,499 1,959,347
    Cash and cash equivalents, beginning of period
    7,213,695 5,030,583
    Cash and cash equivalents, end of period
    $10,966,194 $6,989,930

    Contact:

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

    SOURCE: Edesa Biotech, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/646981/Edesa-Biotech-Reports-Fiscal-2nd-Quarter-2021-Results

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  2. Virtual event scheduled for Thursday, April 29 at 1 pm Eastern Time

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

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

    Virtual event scheduled for Thursday, April 29 at 1 pm Eastern Time

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

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

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

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

    To register for the webinar, please click here.

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

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

    Edesa Forward-Looking Statements
    This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to upcoming milestones in the company's clinical studies, including enrollment milestones and interim readouts for its COVID-19 and dermatitis studies. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property and the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

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

    SOURCE: Edesa Biotech



    View source version on accesswire.com:
    https://www.accesswire.com/641465/Edesa-Biotech-to-Host-Key-Opinion-Leader-Webinar-on-EB05-for-the-Treatment-of-Acute-Respiratory-Distress-Syndrome

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

    The license agreement, with the technology's inventor, provides Edesa with development and commercialization rights to multiple patent families as well as know-how related to the underlying technology. Edesa previously licensed this drug technology from Hebrew University of Jerusalem for topical dermatology…

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

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

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

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

    EB01 contains a non-steroidal anti-inflammatory compound known as an sPLA2 (secretory phospholipase-2) inhibitor. When activated, sPLA2 enzymes have been shown to initiate a cascade of inflammatory lipid mediators along a well-known pathway that is currently the target of steroids and other anti-inflammatory drugs such as ibuprofen. By targeting sPLA2 with enzyme inhibitors - at the inception of inflammation rather than after inflammation has occurred - Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions.

    About Allergic Contact Dermatitis

    Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. To the company's knowledge there are currently no treatment options specifically labelled for ACD. Additional details about the Phase 2b trial of EB01 (NCT03680131) can be found at www.clinicaltrials.gov.

    About Edesa Biotech, Inc.

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

    Edesa Forward-Looking Statements

    This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to the potential value, success and timing of clinical milestones; the company's belief that this license agreement could significantly strengthen its intellectual property position; the company's belief that the licensed technology could have broad utility across multiple indications; and the company's belief that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property and the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

    Contact:

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

    SOURCE: Edesa Biotech



    View source version on accesswire.com:
    https://www.accesswire.com/636499/Edesa-Biotech-Expands-Rights-to-Anti-Inflammatory-Technology

    View Full Article Hide Full Article
  4. TORONTO, ON / ACCESSWIRE / March 15, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has completed enrollment of more than 50% of the patients planned for the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study evaluating the company's EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients with or at risk of developing Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients.

    The company reported that more than 160 of the expected 316 subjects in the Phase 2 portion of the study have been randomized and dosed with either EB05 or placebo. The patients were treated…

    TORONTO, ON / ACCESSWIRE / March 15, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has completed enrollment of more than 50% of the patients planned for the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study evaluating the company's EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients with or at risk of developing Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients.

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

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

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

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

    EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with ARDS. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives.

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

    About ARDS

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

    About Edesa Biotech, Inc.

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

    Edesa Forward-Looking Statements

    This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company's plans to add hospital sites to speed enrollment, the company's belief that EB05 could regulate the overactive immune response associated with ARDS, the company's belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, and the company's timing and plans regarding its Phase 2/3 study. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

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

    SOURCE: Edesa Biotech



    View source version on accesswire.com:
    https://www.accesswire.com/635187/Edesa-Biotech-Reaches-Enrollment-Milestone-in-COVID-Study

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

    Edesa reported that all 46 subjects in the first cohort have been randomized and dosed with either Edesa's EB01 topical treatment or a placebo cream. EB01 contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. Since EB01 is designed to inhibit the inflammatory process at its inception…

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

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

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

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

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

    Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than 1 million patients are estimated to have chronic ACD. To the company's knowledge, there are currently no treatment options specifically labelled for ACD.

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

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

    Edesa Forward-Looking Statements
    This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company's plans regarding its Phase 2b clinical study, including its plans to initiate a blinded interim analysis, and the company's belief that EB01 could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

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

    SOURCE: Edesa Biotech



    View source version on accesswire.com:
    https://www.accesswire.com/634177/Edesa-Biotech-Completes-Enrollment-for-Interim-Clinical-Study-Milestone

    View Full Article Hide Full Article
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