Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA) is a Canadian clinical-stage drug development and repurposing company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals has active research programs for IPF with chronic cough, and chronic kidney disease, and is the parent company of a newly created private subsidiary called Algernon NeuroScience, which is advancing a psychedelic program investigating a proprietary form of DMT for stroke and traumatic brain injury.
Drug repurposing is the process of discovering new therapeutic uses for existing drugs.
New Advisory Board Member From the NFL
On March 2, Algernon announced that its subsidiary Algernon NeuroScience (AGN Neuro) had appointed Dr. David L. Brody as a consultant for its clinical research program for the treatment of traumatic brain injury (TBI) with N,N-Dimethyltryptamine (DMT).
According to a report from the DEA, DMT “is the prototypical indolethylamine hallucinogen. The history of human experience with DMT probably goes back several hundred years since DMT usage is associated with a number of religious practices and rituals. As a naturally occurring substance in many species of plants, DMT is present in a number of South American snuffs and brewed concoctions, like Ayahuasca.”
DMT can be produced synthetically, and the original synthesis was conducted by German-Canadian chemist Richard Manske in 1931. It “gained popularity as a drug of abuse in the 1960s,” the report continues, “and was placed under federal control in schedule I when the Controlled Substances Act was passed in 1971. Today, it is still encountered on the illicit market along with a number of other tryptamine hallucinogens.”
According to a report from Global Market Estimates, “the global traumatic brain injury market is projected to grow from US$3.1 billion in 2021 to US$4.5 billion by 2026 at a CAGR of 8.0%.”
Dr. Brody, MD, Ph.D., is a board-certified neurologist with a research and clinical specialization in TBI and neurodegenerative diseases.
He was the Norman J. Stupp Professor of Neurology at the Washington University School of Medicine and the Washington University site director for the NFL Neurological Player Care Program.
He is the recipient of several awards, including a Career Development Award from the National Institute of Neurological Disorders and Stroke (NINDS) and a Burroughs Wellcome Career Award in the Biomedical Sciences. In addition, his clinical monograph ‘Concussion Care Manual: A Practical Guide’ was published by Oxford University Press, and he is the editor-in-chief of the Journal of Neurotrauma and a member of the editorial board of Acta Neuropathologica.
“Algernon has identified a novel approach to potentially treat TBI patients focused on neuroplasticity, which would be welcome in a clinical environment without any approved pharmacological options,” he said regarding his new position. “I am excited to help further the science and work with them on advancing the DMT research TBI program through clinical trials.”
Algernon Pharmaceuticals CEO Christopher J. Moreau said the company looks forward to “benefitting from [Brody’s] unique clinical and research experience, especially his involvement in the NFL player care program as we design our clinical studies of DMT for TBI patients.”
Algernon NeuroScience is a private equity subsidiary of Algernon Pharmaceuticals created to advance the company’s DMT stroke and TBI research program. AGN Neuro has filed a Form 1-A offering statement with the U.S. Securities and Exchange Commission, seeking qualification to raise up to US$10 million for AGN Neuro by offering up to 37.5% of its common shares (including the maximum amount of bonus shares) with majority ownership residing with AGN Pharma, under a Tier II Regulation A+ offering.
Algernon Launches Rights Offering
This morning, March 21, 2023, Algernon Pharmaceuticals released it will be launching a rights offering to raise gross proceeds of approximately CA$2,416,747. Algernon will be offering 9,666,988 rights to shareholders of its Class A common shares at the close of business on March 29, 2023.
Each right will entitle the holder to subscribe for one unit at the subscription price of CA$0.25 per unit. Each unit consists of one share and one share purchase warrant, with each warrant being exercisable for one Share at the exercise price of CA$0.52 for a period of 18 months.
Algernon also entered into an agreement with Research Capital Corp. giving Research Capital the ability to purchase up to CA$500,000 of units.
AlphaNorth Asset Management an insider and holder of greater than 10% of the issued and outstanding shares has stated that it intends to exercise, subject to relevant restrictions, its basic subscription privilege to acquire 1,268,040 units for total gross proceeds to the company of CA$317,010.
The company expects to use the income from this offering for working capital and general corporate purposes, and administrative expenses.
Why This sector?
Publicly traded drug development small-cap and micro-cap companies can see significant increases in liquidity and value as drugs are advanced through the clinical trial process successfully.
According to a report from Global Market Estimates, “the global traumatic brain injury market is projected to grow from US$3.1 billion in 2021 to US$4.5 billion by 2026 at a CAGR of 8.0%.”
Last December, technical analyst Clive Maund rated the company a strong speculative Buy, saying it had a favorable risk/reward ratio.
“The increasing prevalence of traumatic brain injuries (TBIs), rising preference for minimally invasive procedures, and increasing awareness regarding early diagnosis of brain injuries are the major factors expected to fuel the market growth. In addition, the adoption of advanced medical devices and products and increasing implementation of government policies for healthcare services are a few more factors contributing to the market growth.”
Additionally, according to Data Bridge Market Research analysis, the global chronic cough market was valued at US$6.15 billion in 2021 and will grow to US$11.38 billion by 2029. Algernon’s keystone drug, Ifenprodil, has successfully completed a phase 2a trial for both IPF and chronic cough indications.
Why This company?
In addition to seeing positive results from its Ifenprodil clinical trial, AGN Neuro is the first company in the world to investigate using the psychedelic drug DMT for stroke and TBI. Thanks to its efficient business model based on drug repurposing, it can dip its toes in multiple markets.
"I am very pleased Algernon has decided to conduct a stand-alone, Phase 2b study for cough," said Dr. Jacky Smith, Professor of Respiratory Medicine.
AGN Neuro is currently engaged in a Phase 1 study of DMT. The trial is being conducted at the Centre for Human Drug Research (“CHDR”) in Leiden, Netherlands. The purpose of the study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by prolonged infusion for six hours, recently completed testing the first cohort of subjects in the study. It reported on February 16, 2023, that the safety review committee has approved moving the study forward with the next cohort at an escalated dose after observing no safety or tolerability issues.
AGN Neuro was established as a subsidiary of Algernon Pharmaceuticals specifically for the DMT research program and is seeking U.S. SEC qualification to raise up to US$10 million through a Tier 2 Regulation A financing.
The capital raised will be used for research, development, and program management costs related to the completion of the Phase 1 segment of the DMT study, as well as funding a Phase 2a stroke and TBI study.
Last December, technical analyst Clive Maund rated the company a strong speculative Buy, saying it had a favorable risk/reward ratio. Other experts following the stock include Dr. André Uddin of Research Capital Corp.,
Catalyst: Upcoming Phase 2b Study
Algernon has been on the move this year, with a plethora of catalysts every quarter.
On January 9, the company announced plans for a 180-patient phase 2b study using Ifenprodil to treat chronic cough. The 90-day treatment study is planned to begin in Q4 2023.
Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B), which prevents glutamate signaling. It represents a novel first-in-class potential treatment for chronic cough and is thought to interfere with central signaling in the brain, suppressing the urge to cough.
"I am very pleased Algernon has decided to conduct a stand-alone, Phase 2b study for cough," said Dr. Jacky Smith, Professor of Respiratory Medicine at the University of Manchester and an Honorary Consultant at Manchester University NHS Foundation Trust.
"I recommended, based on Algernon's encouraging Phase 2a clinical data, that the company further explore Ifenprodil in chronic cough in a well-designed, sufficiently powered study that will give clear answers on the potential efficacy of the drug in this population."
In addition to being Algernon's lead chronic cough advisor, Dr. Smith is also a consultant to Merck & Co. and Bellus Health. Both companies are pursuing a drug for the prevention of chronic cough.
The decision to advance the study is based on positive data previously reported on July 28, 2022, from the company's Phase 2a study of IPF and chronic cough, where Ifenprodil showed a significant improvement in mean objective 24-hour and waking cough counts in patients after four and 12 weeks. Patients with IPF are usually excluded from trials in chronic refractory cough, and cough in this population is regarded as extremely difficult to treat.
Streetwise Ownership Overview*
Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA)
Ownership and Share Structure
Management and directors own approximately 5% of the company.
Reuters notes that 14.39% of the stock is with institutions.
The largest shareholder is Canada’s Alpha North Asset Management, with a 13.15% stake or 1.27 million shares. 3.87% is with strategic investors, and the rest is in retail.
Scientific and medical advisory board members include Dr. Jacky Smith, MB, ChB, FRCP, Ph.D., Peter Dicpinigaitis MD, Dr. Rick Strassman MD, Dr. David Nutt DM, FRCP, FRCPSYCH, FSB, FMEDSCI, Dr. Anthony Rudd, MB, BChir, FRCP, CBE, Dr. Robert Simister MA MB BS Ph.D. FRCP, Dr. Steven Wolf, PT, Ph.D., FAPTA, Dr. Andrew Maas, MD, Ph.D., and Dr. Martin Kolb, MD, Ph.D. Following this announcement, they have added Dr. Brody, MD, Ph.D., to the list.
Algernon has roughly CA$500,000 in the bank, with no debts but a G&A monthly burn rate of approximately CA$80,000, which does not include the costs for its clinical research programs. With 9,653,656 shares of common stock issues, along with 2,769,768 warrants, 931,000 options, and 780,004 RSUs, the total fully-diluted equities base is 14,134,428.
According to Market Watch, the company has 9.67 million shares outstanding and trades in the 52-week range between CA$0.2825 and CA$1.3250.
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