Edesa Biotech Files 8-K

TL;DR

Edesa Biotech filed an 8-K on 6/24/24 covering Reg FD, other events, and financials.

AI Summary

Edesa Biotech, Inc. filed an 8-K on June 24, 2024, reporting on several items including Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits. The company, formerly known as Stellar Biotechnologies, Inc., is incorporated in British Columbia, Canada, and has its principal executive offices in Markham, Ontario. The filing does not disclose specific financial figures or material events beyond the reporting of these categories.

Why It Matters

This 8-K filing indicates Edesa Biotech is providing updates to the SEC, which could include material information relevant to investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K reporting form without specific details of negative events or significant financial changes.

Key Players & Entities

• Edesa Biotech, Inc. (company) — Registrant
• Stellar Biotechnologies, Inc. (company) — Former company name
• June 24, 2024 (date) — Date of earliest event reported

FAQ

Filing Documents

• edsa_8k.htm (8-K) — 30KB
• edsa_ex991.htm (EX-99.1) — 15KB
• edsa_ex991img2.jpg (GRAPHIC) — 3KB
• 0001654954-24-008062.txt ( ) — 174KB
• edsa-20240624.xsd (EX-101.SCH) — 6KB
• edsa-20240624_lab.xml (EX-101.LAB) — 14KB
• edsa-20240624_cal.xml (EX-101.CAL) — 1KB
• edsa-20240624_pre.xml (EX-101.PRE) — 9KB
• edsa-20240624_def.xml (EX-101.DEF) — 2KB
• edsa_8k_htm.xml (XML) — 4KB

01 Regulation FD

Item 7.01 Regulation FD. On June 24, 2024, Edesa Biotech, Inc. (the "Company" or "Edesa") issued a press release announcing that its drug candidate, paridiprubart ("EB05"), has been selected by the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for evaluation in a U.S. government-funded clinical study. A copy of the press release is attached hereto as Exhibit 99.1. The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission (the "SEC"), and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

01 Other Events

Item 8.01 Other Events. On June 24, 2024, the Company announced that its drug candidate, paridiprubart ("EB05"), has been selected by the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for evaluation in a U.S. government-funded clinical study. Paridiprubart represents a new class of host-directed therapeutics ("HDTs") that are designed to modulate the body's own immune response when confronted with known or unknown public health threats such as pandemic influenza, COVID-19, other emerging infectious diseases, and chemical, biological, radiological, and nuclear incidents. Importantly, HDTs are agnostic to the causal agent and can be stockpiled preemptively to respond to public health emergencies and biodefense. The BARDA-funded Phase 2 platform trial will be a randomized, double-blinded, placebo-controlled, multi-center U.S. clinical trial to investigate three novel threat-agnostic host-directed therapeutics, including EB05, in hospitalized adult patients with Acute Respiratory Distress Syndrome ("ARDS") due to a variety of causes. The BARDA study of EB05 is expected to build on the success of a Phase 2 clinical study that the Company completed during the COVID-19 pandemic which demonstrated that paridiprubart reduced mortality by 84% among critically ill ARDS patients. A parallel study using an in vitro model also demonstrated that EB05 inhibits a key mediator of inflammatory responses from influenza and other pathogens. A separate Edesa-sponsored Phase 3 study of EB05 in patients with ARDS due to SARS-CoV-2 infection is currently ongoing in Canada and the U.S. The BARDA-funded study will be managed under a BARDA contract with PPD Development, LP, a clinical research business of Thermo Fisher Scientific, Inc. For the EB05 cohort of the study, patients will be randomized one-to-one to either EB05plus Standard of Care ("S

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated June 24, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). 2

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Edesa Biotech, Inc. Date: June 24, 2024 By: /s/ Stephen Lemieux Name: Stephen Lemieux Title: Chief Financial Officer 3

View Full Filing

View this 8-K filing on SEC EDGAR