Biotech Co. Set To Reach New Highs

Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA) has dosed the second cohort in its Phase 1 clinical trial for the investigation of DMT for brain injuries. Algernon's subsidiary, Algernon NeuroScience,  has qualified its Form 1-A offering statement filed with the U.S. Securities and Exchange Commission (the “SEC”) to raise up to US$10M under a Tier II Regulation A+ offering (Reg A+).

Algernon Pharmaceuticals Inc. is a Canadian-based drug company that focuses on investigating re-purposed drug compounds for unmet medical needs. The CEO is Christopher J. Moreau, who has over 15 years of C-Suite experience, and Dr. Christopher Bryan, Ph.D., is the Vice President of Research and Operations. Dr. Ahmad Khalil, MD, Ph.D., is the Medical Director.

New Step in Clinical Trials and Shares on Offer

Algernon NeuroScience (AGN Neuro), a subsidiary of Algernon Pharmaceuticals, has reached "another important step in our DMT clinical research program," according to Christopher J. Moreau, "the sooner we can finalize the correct dose and the optimum exposure period, the faster we can move into Phase 2 studies where we can test DMT on patients that have suffered a serious brain injury."

Algernon has completed dosing the second cohort in the escalating-dose Phase 1 clinical study of an intravenous formulation of AP-188.

Psychedelic substances have seen recent acceptance from state legislative bodies.

N, N-Dimethyltryptamine, also known as DMT, is a hallucinogenic tryptamine drug that occurs naturally in some plants and animals, and it can also be synthesized in a laboratory. It is used in the religious practices of indigenous people in the Amazon basin.

Algernon has filed patents for two new salt forms of DMT (pamoate and nicotinate) for use with patients who have suffered a brain injury. The company also filed patents for other combinations of DMT and conventional post-stroke treatments.

Christopher J. Moreau, CEO of Algernon, stated, "We believe DMT holds tremendous promise as a drug that could have a significant positive impact on the healing and recovery of brain injury victims on a global scale."

The first part of the study is focused on investigating several concentrations of DMT administered initially with a bolus injection followed by a slow intravenous infusion over six hours. The second part will use the optimum concentration for a 6-hour duration every two days over a 2-week period. According to Algernon, a DMT study based on these doses and durations have never been conducted before. 

Algernon has qualified its Form 1-A offering statement filed with the U.S. Securities and Exchange Commission (the “SEC”) to raise up to US$10M under a Tier II Regulation A+ offering (Reg A+).

Algernon Neuro will be offering up to 37.5% of its common shares. The majority of the company's shares will still be owned by Algernon Pharmaceuticals. The company hopes to raise funds for research and development for its DMT clinical studies of patients who have had either a stroke or a traumatic brain injury.

Class A common shares will be offered at US$1 per share and require a minimum investment of US$1000. The company is also offering bonus shares at the following prices: US$15,000 for 5% bonus shares, US$25,000 for 10% bonus shares, US$100,000 for 15% bonus shares, or US$250,000 for 20% bonus shares.

The marketing for the offering will be focused on using primarily on-line and digital communications.

New Legislation on Psychedelics

Psychedelic substances have seen recent acceptance from state legislative bodies. As of January 1, 2023, Oregon has become the first state to legalize psychedelics and plans to set up clinics across the state. Other states, such as Massachusetts, Illinois, and Utah, are also considering bills that would legalize psychedelics, and Virginia is considering legislation that would move psychedelics to a lower schedule, and Arizona has put forth funding for research.

Australia's Therapeutic Goods Administration (TGA) has approved psychedelic substances to be used in medications. Specifically, Australia has approved psilocybin and MDMA for prescription by psychiatrists who are approved by a human research ethics committee under the Authorized Prescriber Scheme. The shift in legislation has come as conventional treatments have been unable to keep pace with the rising rate of mental illness following the pandemic.

Algernon on the Move

According to Clive Maund, Algernon Pharma is a company that bears watching: "Algernon Pharmaceuticals Inc. has two things going for it. One is that it could come out with positive news at any time that could get the stock moving... it is likely to result in big percentage gains."

According to Clive Maund, Algernon Pharma is a company that bears watching.

Algernon has a number of short-term catalysts to report. The company is engaged in a Phase 1 DMT study for brain injuries.

Algernon NeuroScience also represents a catalyst that bears watching as they continue their research into DMT. As stated above, the company recently filed a Form 1-A offering statement. The offering of 37.5% of the company's common shares will fund research, development, and management.

The company is expecting final data from its Phase 1 Study for DMT in Q3, 2023 and is planning a Phase 2a stroke and a Phase 2a traumatic brain injury study to start in Q2 2024. The company is also planning to file a US FDA IND filing for a Phase 2b chronic cough study.

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.

The company reports that it has CA$689K in the bank as of the quarter ending November 30, 2022, and that its burn rate is approximately CA$80k net of clinical trials and research costs.

According to Market Watch, the company has 9.7 million shares outstanding and trades in the 52-week range between .24 and 1.46.

Disclosure:
1) Amanda Duvall wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She or members of her household own securities of the following companies mentioned in the article: none. She or members of her household are paid by the following companies mentioned in this article: none. His/her company has a financial relationship with the following companies referred to in this article: None. 

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