CSE: AGN | OTCQB: AGNPF | XFRA: AGW
https://algernonpharmaceuticals.com/
Clinical stage drug development company that focuses on repurposing existing drugs for new applications. This significantly reduces their pipeline and investment requirements from inception to market.
What they are working on: Quotes are from their website
NP-120 (Ifenprodil):
The Company’s lead compound in its idiopathic pulmonary fibrosis (IPF) research program, is a drug called Ifenprodil, an orally delivered small molecule, which was originally developed by Sanofi to treat peripheral circulatory disorders. Algernon conducted two independent studies showing that NP-120 (Ifenprodil) outperformed the world’s leading two treatments for IPF, Nintedanib and Pirfenidone in a recent pre-clinical in vivo animal study, reducing fibrosis by 56% with statistical significance.
Since NP-120 (Ifenprodil) is already approved with an established safety history, Algernon intends to move the drug directly into a phase II human trial. The Algernon business model is to repurpose safe approved drugs that are not available in the US or Europe, screen them in globally accepted animal models for new diseases, file new intellectual property rights and then move them into an off label phase II trial in the country where they were originally approved. Once a signal is established in a human trial, the company will begin to advance the repurposed drug through a USFDA registration.
They've started phase II trials already, and based on this site (https://pact.lungfoundation.com.au/find-a-trial/) it looks like it's a 13 week trial. They estimated in their management discussion on Jan 29, 2021 that they would expect early data from these trials in Q2 of this year and final data in Q3.
In addition to this, they have announced:
On March 6th, 2020, Algernon announced that it was going to explore the potential of using NP-120 (Ifenprodil) as a novel treatment for COVID-19, also known as the coronavirus. An independent research study found that Ifenprodil significantly reduced acute lung injury and improved survivability in an animal study with H5N1 infected mice. H5N1 is the most lethal form of influenza known to date with an over 50% mortality rate.
On June 4, 2020 Algernon received clearance from the U.S. FDA for its IND application for a 150 patient multi-national Phase 2b/3 clinical study of Ifenprodil & COVID-19 and enrolled its first patient on August 3.
On December 24, 2020, Algernon announced that the last patient from the Phase 2b part of the Ifenprodil COVID-19 study had completed both the treatment period and two week follow up and has announced that the final data set will be available at the end of February.
The release date for the data has been pushed back to sometime around the 5th of March, but I just found this news report from Feb 5, and based on that the outcomes seem really good, so I'm very hopeful for postive results:
https://wsvn.com/news/special-reports/breath-of-hope-south-florida-doctors-lead-way-against-treating-severe-lung-damage-caused-by-covid-19/
They also got approved by the data safety board to continue with phase 3, so minimally results from phase 2b are good enough that it's worth any health risk participants are exposed to.
https://www.globenewswire.com/news-release/2021/01/19/2160593/0/en/Algernon-Pharmaceuticals-Receives-Green-Light-from-DSMB-to-Conduct-Phase-3-Study-of-Ifenprodil-for-COVID-19.html
The company is also working with AP-188 (DMT):
Algernon has started a clinical research program for stroke focused on AP-188 (“N,N-Dimethyltryptamine or DMT”), a known psychedelic compound that is part of the tryptamine family (other drugs in the tryptamine family include psilocybin and psilocin). Algernon plans to be the first Company globally to pursue DMT for stroke in humans and is planning to begin a clinical trial soon as possible in 2021.
You can read a bunch more about their DMT pipeline on their website (including timelines and clinical trial pipelines), way more than what I can fit into a post here, but the long and short of it is that they are going to try and repair brain damage caused by stroke by microdosing patients with sub-hallucinogenic amounts of DMT. They are planning to file breakthrough therapy applications with the FDA soon and they just awarded a contract to manufacture AP-188 to Dalton Pharma Services. They have retained a CRO (Charles River Laboratories) to help them with preclinical studies, and they have filed a bunch of patents, but beyond that this seems like the ground floor for this type of treatment. I want to stress for the DMT stuff, this is a LONG TERM play. There aren't great existing treatment options at this point for stroke, and the market is valued at $8 billion as of 2018, projected to grow to $15 billion by 2027. If they get the lock on this it's going to be lucrative, but given that they're at the preclinical stage of things right now it's going to take a while.
Catalyst:
They've finished the stage 2b clinical trial for their ifenprodil as a treatment for covid/lung scarring. They are now saying they expect the data to be locked on March 5, and I would expect results for covid treatment to follow shortly, with separate results for the lung scarring to follow after that.
Here's the article which goes over that:
https://finance.yahoo.com/news/algernon-pharmaceuticals-provides-covid-19-124800972.html
Now that we know what they do, and when they're planning to do it, what does the company itself look like?
Company Overview/Financials:
Company profile on OTC: https://www.otcmarkets.com/stock/AGNPF/quote
Highlights: 152m shares outstanding 45m market cap 1m average volume (30D)
Share price has been hovering between .15-.30 USD for the majority of the last year. Their financial situation isn't great on account of them not having revenue because they're a drug development company without a drug. It looks like their working capital is only 4 million, with short term expenses of 1 million, so not great with no revenue but doesn't seem immediately dire. The upside there is that they don't face the costly process of getting new drugs FDA approved, and if the results of the Ifenprodil are promising in March I suspect their financial situation could change pretty quickly. They could also just get straight up acquired, which would be fantastic for the stock price at least. I would guess there is at least a risk of dilution here though if they don't bring something to market or make some kind of deal with someone who can in the next year.
Competitors:
The only other DMT stock I could find was LMLLF, I did a bit of research and they seem to be kind of all over the place, there's no mention of DMT on their actual website but I found press releases saying they were applying for orphan drug status for DMT with the FDA. They're also into cannabis and shrooms on the recreational side, it looks like they might be making some revenue from selling shrooms in NL markets.
On the IPF/Chronic Cough side of things there is more competition, there are competing drugs from Evotech/Roche, Merck, Genentech, and Boehringer. The larger companies drugs don't seem to perform as well though (see e.g., https://www.cbj.ca/algernon-pharmaceuticals-np-120-ifenprodil-outperforms-mercks-phase-3-drug-mk-7264-gefapixant-in-an-acute-cough-study-by-110/ for chronic cough and https://pulmonaryfibrosisnews.com/2019/08/02/repurposed-anti-fibrotic-medication-np-120-set-for-phase-2-trial-algernon-says/ for IPF) but the big issue apparently has been that they are sucking up all of the patients for clinical trials and that has slowed things down quite a bit for AGNPF. That said it looks like they're making progress now and results are coming out soon so hopefully the worst of that is behind them.
Hype From Others:
With regards to what other people know/think about the stock, there is only 1 other post on this subreddit about this company in the last few weeks, and only 2 posts in the last few months. There are less than 600 people following it on stocktwits. I've seen virtually no coverage of this company whatsoever. Volume has been pretty stable/down for the last few months. I think this company has fallen through the cracks and few have noticed it yet, but the short term covid play plus serious long term research into treating stroke victims and people with lung issues could mean big $$ for early investors. On the other hand if no one knows about the stock no one will buy it so maybe that's a negative? I think more people will start to hear about it once the results from their clinical trial comes out though.
Position:
I personally hold 6k shares @ .28. I'm excited about the research this company is doing, I think better COVID treatments will become more critical as more and more mutations start showing up (they just found another in California apparently), and I think the possibility of repairing brain damage is amazing. Bonus points to the company for doing research with psychedelics... that might help make it more popular, DMT isn't some boring drug no one has ever heard of.
Concerns:
The finances are the big one for me, especially if the ifenprodil results aren't good. If that happens then I would probably expect some measure of stock dilution while they try to raise capital for the next few years of clinical trials.
There's always the risk that even if the ifenprodil results are good, they can't get a licensing deal to get the drug sold... I think I'm less worried about this though, especially if the follow up data on scar tissue in lungs looks good. I think with the damage COVID does to lungs people will be clamoring to get this drug to market. Regardless, the risk is always there.
Like all biotech/pharma plays that rely on trial results, this is something of a gamble, and one that you need to do your own DD on. Don't invest what you aren't willing to lose. Bad trial results can tank the stock, as can a lot of other things. I'm not your financial advisor, I'm mostly writing this so people poke holes in my analysis and find things I may have missed.
Price targets:
I have no idea how people make them. I'm not going to pretend to know. I'm going to pull a number out of my butt and guess $1 in the run-up to them releasing the Ifenprodil data. $3 afterwards if the results look good, $.2 if the results look bad. If their DMT stuff works out too, $25-1,000. Rocket ship rocket ship star diamond emoji. Again, I have no idea how people make accurate price targets, and I'm pretty convinced at this point no one actually knows how to because I don't think I've ever seen one be right. Don't trust price targets.
In Conclusion:
That's my DD, I hope you enjoyed it. Please tear it to shreds in the comments section, I want to know what I'm overlooking. On the off chance I didn't miss anything and this actually is the gem I think it is, I hope we all make boatloads of money!
https://www.reddit.com/r/pennystocks/comments/lsc8kt/agnpf_overlooked_pharma_company_with_several/