Pharmaceutical Company Sets Gold Standard for New Drugs

Algernon Pharmaceuticals Inc. (CSE:AGN; OTCQB:AGNPF; XFRA:AGW0) has announced that it has received a notice from the U.S. Patent Office regarding one of its lead development research programs and released news about the development of another drug. 

Algernon is a publicly traded drug development company that works in the areas of RRC, stroke, traumatic brain injuries, Idiopathic Pulmonary Fibrosis (IPF), and CKD and NASH. The CEO is Christopher J. Moreau, and the CFO is James Kindly.

Repirinast Patent and Ifenprodil Development

Algernon Pharmaceuticals recently announced that it had received an allowance from the United States Patent and Trademark Office (USPTO) for the patent application it filed for a chronic kidney disease drug, Repirinast, and its use to treat NASH, a common co-morbidity of CKD. The company also filed patents in Canada, Europe, China, and Japan.

According to Christopher J. Moreau, the CEO of Algernon Pharmaceuticals, "This is the first allowance notice received from the USPTO by Algernon for one of the drugs being investigated under our innovated drug repurposing program and is further validation of our intellectual property strategy." Algernon's strategy for the patent application includes the method of use, dosing, and formulations for new composition of matter patents based on novel salt forms.

According to Dr. Smith, "To see effects of this magnitude in an IPF population, where other drugs have failed to demonstrate a benefit, is notable."

Repirinast claims a method of use to treat NASH. According to the data from Algernon, Repirinast reduced hepatic fibrosis by 57%, and reduced the NAFLD score by 31%. In comparison, telmisartan, the current standard of care for NASH, only reduced fibrosis by 27%.

Based on the data, Repirinast is the company's leading treatment for CKD. Patients with CKD are at an increased risk of NASH even when controlling for other co-morbidities.

Algernon has also announced that it is planning a Phase 2b RCC study for a drug known as Ifenprodil. A geometric mean analysis of the data from the completed Phase 2a RCC study showed that if the drug is administered three times daily for a period of three months, it can reduce cough counts by about 40% from the established baseline. Dr. Jacky Smith, Algernon's chief scientific and medical advisor and an expert on coughs, conducted the statistical review.

According to Dr. Smith, "The additional analysis confirms my initial positive impression of the study. The NMDA receptor has always been an interesting target for cough, but other agents have been poorly tolerated. To see effects of this magnitude in an IPF population, where other drugs have failed to demonstrate a benefit, is notable."

Ifenprodil is also notable because it affects central signaling and works by targeting the brain instead of the lungs, but it has zero reported cases of taste disturbance, which was a reported side effect of the Merck drug.

Pharmaceuticals Focusing on Research and Development

According to Evaluate Vantage, spending on pharmaceutical research has largely held steady after the uptick in funding related to the COVID-19 pandemic. The biggest spenders in 2022 were Roche, overtaking Pfizer, who was first in 2021. Bristol and Johnson and Johnson cut their spending in 2022 by 5% and 4% each. Astrazeneca increased its spending by 19%, citing the acquisition of Alexion as the reason for the uptick in funding for research and development. Moderna and Regeneron have reinvested some of the profit they received last year into research.

Johnson and Johnson provided a positive earnings report this week. The reported revenue exceeded previous estimates at US$13.4 billion in pharmaceutical sales, with a growth of 4.0% year over year. While this is good news for the company, and continued growth is expected, it is still not enough to meet the company's goal of US$60 billion by 2025, in part because pharmaceutical patents is an extremely competitive market.

The Future at Algernon

There are a number of catalysts working in Algernon's favor. The company achieved positive Phase 2a data related to research on Idiopathic Pulmonary Fibrosis and chronic cough.

According to technical analyst Clive Maund, Algernon is an obvious choice for investors.

According to technical analyst Clive Maund, Algernon is an obvious choice for investors: "It is thus worth taking into consideration that the company has brought a highly effective drug / treatment to the late stages of development . . . and it would seem from the price / volume action in Algernon over the past week that some investors are starting to join the dots and figure out what this means for Algernon . . . Algernon has developed a highly effective product, and its stock price is silly cheap and so a good investment."

Algernon has also received coverage from Streetwise in the past related to its research into using DMT to treat brain injuries and is currently engaged in a Phase 1 study in the Netherlands. Algernon has established Algernon NeuroScience and filed a Form 1-A offering statement with the U.S. Securities and Exchange Commission (SEC) in relation to the DMT clinical trials in order to raise US$10 million.

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

In terms of institutions, the Canadian firm Alpha North Asset Management owns 13.15% with 1.27 million shares of the company. Palos Management Inc. owns 1.24% with 0.12 million shares. Algernon reports no strategic investors.

As of March 1, 2023, Algernon has CA$0.5 million dollars. The company reports a monthly burn rate of CA$80k, which goes to clinical trials and research costs.

Algernon has 9.65 million shares outstanding and 9.28 million free-float traded shares. There are 2,769,768 warrants and 931,000 options. The company has a market cap of CA$1.93 million. Algernon trades in the 52-week period between CA$0.24 and CA$1.46.

On March 21, 2023, Algernon announced it was undertaking a rights offering to raise gross proceeds of approximately $2,416,747. The company has offered 9,666,988 rights to holders of its Class A common shares as of the close of business on the record date of March 29, 2023, on the basis of one right for each one share held. Each one right will entitle the holder to subscribe for one unit at the subscription price of 25 cents per unit.

The rights are trading on the Canadian Securities Exchange under the symbol AGN.RT and will trade until 9 am. Pacific Time on or about April 27, 2023. The rights will expire at 2 p.m. on April 27, 2023, after which time unexercised rights will be void and of no value.

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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