Edesa Biotech Issues Letter to Shareholders

Rhea-AI Summary

Edesa Biotech, Inc. (NASDAQ:EDSA) reflected on a challenging yet productive 2020 in a letter to shareholders from CEO Par Nijhawan. Despite the global pandemic, the company made strides in expanding its development pipeline, acquiring global rights to key monoclonal antibody candidates. Regulatory approvals were obtained for clinical studies targeting COVID-19, and the Phase 2/3 study for EB05 was launched. Edesa also reported encouraging patient recruitment for its Allergic Contact Dermatitis study. The company is focused on efficiently utilizing its capital and prioritizing projects that meet significant medical needs.

Positive

• Acquired global rights to best-in-class monoclonal antibody candidates to expand the development pipeline.
• Achieved regulatory approvals for clinical studies, including for a COVID-19 study.
• Launched Phase 2/3 study for EB05 targeting Acute Respiratory Distress Syndrome.
• Reported significant patient recruitment progress for Allergic Contact Dermatitis study.

Negative

• None.

TORONTO, ON / ACCESSWIRE / December 30, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, issued a letter to shareholders from its Chief Executive Officer, Par Nijhawan, providing a review of 2020.

Dear Fellow Shareholders,

It would be difficult to begin any year-end review without acknowledging the impact that the global health crisis has had on our communities and families, our economy, and on our operations. 2020 has been anything but an ordinary year.

While Edesa's first full year as a public company brought unexpected challenges, it also brought opportunities to demonstrate the flexibility and breadth of our clinical development strategy. During the past twelve months, despite lock-downs and other pandemic related disruptions, we continued to deliver on corporate and clinical milestones, expanded our pipeline, and set our sights on new, ambitious goals. While much work remains, I am pleased to report the following progress:

• Best-in-Class Biologics. One of our key corporate goals for 2020 was to expand our development pipeline. This spring we acquired global rights to what we believe are two best-in-class monoclonal antibody candidates. Our strategic arrangement for these later-stage assets has been structured to allow us to rapidly advance these experimental therapies into the clinic while minimizing immediate cash outlays.

• Clinical Study Approvals. We achieved regulatory approvals in multiple jurisdictions for the initiation of our clinical studies, including, for our COVID-19 study, a Clinical Trial Application in Canada and an Investigational New Drug Application in the United States.

• Phase 2/3 Study Launch. In the midst of the resurgence of COVID-19 this fall, we launched a clinical 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. EB05 is intended to fill a critical gap in combatting the pandemic.

• Enrollment Milestone. When the full impact of the pandemic was becoming clear this spring, our team rapidly implemented protocol amendments to facilitate enrollment for our ongoing Phase 2b clinical study in chronic Allergic Contact Dermatitis. As a result, patient recruitment has been encouraging, and we were pleased to report that we passed the halfway mark for the first cohort this November. The blinded interim results from the first cohort will determine the total number of patients for the second part of the study.

• Pipeline expansion. In 2020, we started building out the early stages of our development pipeline with a pre-clinical research project with the National Research Council of Canada (NRC). The collaborative project is designed to develop novel immunotherapies for vitiligo as well as other indications. We are focusing on novel immune targets implicated in vitiligo pathogenesis and with the NRC look forward to advancing these leads toward clinical validation.

• Capital efficient model. Our financial results demonstrate the efficiency of our business model and the disciplined approach we are taking to deploying our working capital. We have also 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.

We are grateful to the patients, physicians and research staff participating in our clinical studies who are helping us in our mission to address serious unmet medical needs, which are being made even more urgent by the pandemic. Our team continues to operate at a high level and we are looking forward to maintaining our momentum, achieving our near-term milestones and, ultimately, building value for shareholders.

On behalf of the board of directors, management and employees of Edesa Biotech - many of whom are investing alongside you - thank you for your investment and continued support. We look forward to sharing our progress with you.

Stay healthy and safe,

Par Nijhawan, MD, FRCPC, AGAF
Chief Executive Officer
December 30, 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 we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients. ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common, potentially debilitating condition and occupational illness. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.

Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company's belief that EB05 could successfully treat COVID-19 induced ARDS, the company's plans regarding its Phase 2/3 study, the company's belief that it can advance its vitiligo research toward clinical validation, and the company's belief that it can achieve its near-term milestones in a timely manner and build value for shareholders. 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

SOURCE: Edesa Biotech

View source version on accesswire.com:
https://www.accesswire.com/622555/Edesa-Biotech-Issues-Letter-to-Shareholders

FAQ

What progress did Edesa Biotech make in 2020?

Edesa Biotech expanded its pipeline, launched COVID-19 studies, and achieved patient recruitment milestones.

What is Edesa Biotech's strategy for clinical studies?

Edesa focuses on acquiring best-in-class treatments and efficiently utilizing capital for clinical development.

What are the lead product candidates for Edesa Biotech?

Edesa's lead candidates are EB05 for Acute Respiratory Distress Syndrome and EB01 for Allergic Contact Dermatitis.

How did the pandemic affect Edesa Biotech's operations?

Despite disruptions, Edesa continued its clinical studies and achieved significant regulatory milestones.

What is Edesa Biotech's focus for future developments?

Edesa aims to address unmet medical needs through innovative treatments for immune-related diseases.