ALGERNON PHRMCTCLS A INC - AGNPF STOCK NEWS

Algernon Pharmaceuticals has filed patent applications for novel salt forms of N,N-Dimethyltryptamine (DMT), enhancing its intellectual property portfolio. These novel salts aim to improve the drug's efficacy, safety, and stability. The company is also progressing in its planned Phase 1 DMT clinical human stroke study, having filed for regulatory approval in the UK. Previous studies suggest DMT may promote brain recovery following injury. Algernon focuses on repurposing safe, approved drugs to create new therapeutic applications.

Algernon Pharmaceuticals Inc. has submitted a combined Clinical Trials and Ethics Approval application to the UK Medicines and Healthcare Products Regulatory Agency for a Phase 1 study of AP-188 (DMT). This study aims to assess the safety, tolerability, and pharmacokinetics of DMT through prolonged intravenous infusion, involving 96 healthy volunteers. Positive feedback was previously received from the UK MHRA regarding the proposed DMT Stroke study. This research will inform future Phase 2 studies targeting acute stroke and rehabilitation patients.

Algernon Pharmaceuticals (CSE: AGN, OTCQB: AGNPF) announced positive feedback from the U.S. FDA regarding its pre-Investigational New Drug (pre-IND) meeting for NP-120 (Ifenprodil) targeting chronic cough treatment. The FDA provided guidance on the Phase 2b study protocol and requested genotoxicity testing, estimated to take 90 days. Interim data from a previous study indicated a trend toward reduced cough counts in patients. Ifenprodil demonstrated significant efficacy in preclinical studies, outperforming Merck's gefapixant in cough reduction.

Algernon Pharmaceuticals has expanded its clinical trial for NP-120 (Ifenprodil) in idiopathic pulmonary fibrosis (IPF) and chronic cough by adding a site in Perth, Australia. With seven sites now participating, the company aims for full enrollment by December 2021 and anticipates a data readout in Q2 2022. Positive interim data from the trial shows a trend of reduced cough counts after Ifenprodil treatment. The trial's objective is to evaluate Ifenprodil's efficacy in preserving lung function in IPF patients and assessing its anti-inflammatory effects.

Algernon Pharmaceuticals has appointed James Kinley as the new Chief Financial Officer (CFO), effective December 1, 2021. Kinley, a Certified Professional Accountant with over 15 years of experience, previously served as CFO for Medicure Inc. for nearly a decade. The CEO, Christopher J. Moreau, expressed confidence in Kinley’s expertise to help execute the company's ambitious business plan amid a growing pipeline of research programs. The company also acknowledged departing CFO Mike Sadhra for his contributions.

Algernon Pharmaceuticals has received favorable feedback from the U.S. FDA during its pre-IND meeting for NP-120 (Ifenprodil) aimed at treating small cell lung cancer (SCLC). The company plans to bypass additional pre-clinical research and will proceed with filing an IND application to initiate a Phase 1 clinical study. The FDA's guidance aids in protocol design for the study. Algernon intends to apply for orphan drug designation for Ifenprodil in SCLC treatment, aiming to expedite investigations into this potentially non-toxic cancer therapy.

Algernon Pharmaceuticals Inc. will consolidate its Class A common shares on a 100:1 basis, effective November 24, 2021. Following this consolidation, approximately 1,678,809 common shares will be outstanding. The company aims to meet Nasdaq Capital Market listing requirements, and the listing remains subject to regulatory approval. The name and trading symbol will not change, but new CUSIP and ISIN numbers will be assigned. Shareholder instructions for certificate submissions during the transition will be provided.

Algernon Pharmaceuticals has received positive feedback from the UK MHRA regarding its Phase 1/2a stroke study utilizing AP-188 (DMT). The Company plans to file a Clinical Trial Authorization and is considering DMT for acute stroke treatment. The study aims to investigate DMT's efficacy as both a primary treatment and an adjunct for rehabilitation. Conducted at Hammersmith Medicines Research in London, the trial is scheduled to commence in January 2022.

Algernon Pharmaceuticals announced plans to consolidate its Class A common shares on a 100-to-1 basis, aiming to have approximately 1,678,809 shares outstanding post-consolidation. This move is intended to assist in meeting the listing requirements for the Nasdaq Capital Market, pending approval. The consolidation is subject to acceptance from the Canadian Securities Exchange. A formal letter will be sent to registered shareholders outlining the exchange process for new share certificates. The effective date of the consolidation will be released after CSE approval.