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EDESA BIOTECH, INC.

(EDSA)
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Edesa Biotech Sees Positive Results From Study for Covid-19 Treatment

09/20/2021 | 08:46am EDT

By Chris Wack

Edesa Biotech Inc. said it saw positive results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized Covid-19 patients.

The biopharmaceutical company said an independent Data and Safety Monitoring Board informed the company that during its initial analysis of the Phase 2 portion of the study, they identified an important signal between the treatment arms for 28-day mortality, and requested that the study be preemptively unblinded.

While the Phase 2 portion was primarily designed to refine patient stratification and statistical powering for the Phase 3 study, the DSMB concluded that a "clinically important efficacy signal" was detected and that the study has met its objective, the company said. The DSMB further recommended continuation of the study into a Phase 3 confirmatory trial.

Among the findings, the DSMB reported a 28-day death rate of 14.3% in the EB05 arm versus 36.8% in the placebo arm in critically severe patients on extracorporeal membrane oxygenation therapy.

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

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

Edesa shares were up 52% to $8.95 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

09-20-21 0845ET

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Financials (USD)
Sales 2021 - - -
Net income 2021 -15,7 M - -
Net Debt 2021 - - -
P/E ratio 2021 -6,93x
Yield 2021 -
Capitalization 108 M 108 M -
Capi. / Sales 2021 -
Capi. / Sales 2022 4,41x
Nbr of Employees 12
Free-Float 71,2%
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Mean consensus BUY
Number of Analysts 1
Last Close Price 8,14 $
Average target price 19,00 $
Spread / Average Target 133%
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Managers and Directors
Pardeep Nijhawan Chief Executive Officer, Secretary & Director
Michael Brooks President
Kathi Niffenegger Chief Financial Officer
Sean A. MacDonald Chairman
Blair Gordon Vice President-Research & Development
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