Replies to post #7486 on Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

Ok, now you are losing me in regard to all the DD you stated you did. Here is what you said

The big picture surely involves lots of upside for any biotech company, but also lots of risks. See *all* of the big picture not just the rosy picture where 100% of everything goes right.

So answer me this, are you here for the COVID-19 angle specifically? If so, ok now I get what you just stated. Which is you have a very narrow view of all that is going on with Algernon. Without question, NP-120 is not simply targeting a COVID-19 treatment. NP-120 also targets Acute Lung Injury, Idiopathic Pulmonary Fibrosis, and Chronic Cough. All of those pathways are multi billion dollar markets. The clinical trial in Australia, as of right now is still a go. That's an IPF and Chronic Cough trial. Lest we forget it's the same trial that Novotech put up 220K to be a part of. Novotech has certainly seen it's fair share of clinical trials throughout Asia-Pacific - consisting of 47 countries with a total population of 4.3 Billion people - 60% of the world's population.

A MULTI-AWARD WINNING REGIONAL CONTRACT RESEARCH ORGANIZATION (CRO)

Novotech has been instrumental in the success of over a thousand Phase I - IV clinical trials for biotechnology companies.

https://novotech-cro.com/awards

As I stated in a previous post, COVID-19 found Algernon.

Unlike a plethora of biotechs, Algernon did not go out of it's way to invent/retool a drug/story to go after COVID-19. NP-120 Ifenprodil was already a drug in the pipeline for lung disease(s). I don't believe it was coincidental that Dr. Williams found an independent Ifenprodil study for treating H5N1. Which is the deadliest "Influenza Virus" to date. H5N1 has a mortality rate of 60%. According to Chinese government data, a 55 year-old from Hubei province was likely the first person to have contracted COVID-19 on November 17. The H5N1 study was published on December 10, 2019. The timing could not have been any more precise to the urgent task at hand. Therefore, I don't believe those chain of events were merely coincidental. It's my belief it was fate.

algernonpharmaceuticals.com/independent-ifenprodil-studies/

"Fate is about the present, where every decision an individual has made has led them to their present scenario" - wiki

Finding those studies was Dr. Mark Williams' fate and Algernon's destiny.



COVID-19 has created a warp speed pathway in multiple jurisdictions around the world (Asia, Australia, North America) to dose patients immediately in need. Immediate access to patients in hospitals. Immediate ability to see how Ifenprodil performs in humans. Immediately working through a paper trail process by leaps and bounds. Emergency Use & Expanded Access. That's why COVID-19 is a game changer. Acute Lung Injury (ALI) has been around long before COVID-19, and ALI will be around long after the pandemic. COVID-19 is a critical concern for sure. Nonetheless, it's only one cause of Acute Lung Injury. The Acute Lung Injury market now includes COVID-19. IMO, that's ALL of the big picture.

So let's revisit what you stated here:

See *all* of the big picture not just the rosy picture where 100% of everything goes right.

Regarding Leading Drug NP-120 Ifenprodil

- Algernon has a shot at Acute Lung Injury

- Algernon has a shot at COVID-19 treatment

- Algernon has a shot at Idiopathic Pulmonary Fibrosis

- Algernon has a shot at Chronic Cough

Those four diseases represent "co-primary endpoints" for two separate trials. Meaning, ALI and COVID-19 is one clinical trial with two independent aims/outcomes/data readouts/endpoints. The same applies to IPF and Chronic Cough. One clinical trial with two independent aims/outcomes/data readouts/endpoints. So, think of it as four trials with four independent outcomes. For illustration purposes, let's narrow the lense to focus specifically on the IPF/CC trial. Chris and Mark spoke about the "Probability of success" for the IPF/CC trial in the BioPub webcast dated February 28, 2020.

Here's an excerpt of their tag team closing remarks:

Chris - One final point. I realize that Mark whose done some mathematics and i think there will be a few investors who will be interested in this and i think it's a good way to end our discussion today. I'm going to go back to the third slide where I talked about the probability of a Phase 2 success. With a typical new drug program it's about 50%. We've indicated that we think it's closer to 65% for us with a repurposed drug because you've eliminated the concerns about safety. What Mark didn't mention is that with a co-primary endpoint trial you've got to possibles it's either IPF or Cough if you look at the probability of success Mark just quickly why don't you walk through the math

Mark - This is a purest argument ok so this is not necessarily real world but if you assume that 50% of failures of the 50% of failures 30% is attributed to say safety you could say well if that's the case maybe I could bump up my potential chance of seeing success to about 65% is what Chris was saying because 50% of 30% is 15% so you have about a 65% chance of seeing success on a Phase 2 level is what the argument is now if their truly independent endpoints and Cough and IPF and admittedly there is some overlap but in principle we have dissected the coughing mechanism away from the fibrosis mechanism with the two independent animal studies as I mentioned mice don't cough and guinea pigs in the study that we ran for cough didn't have fibrosis so we feel we parsed out the two biological activities so if you have a 65% chance of success that means the inverse is you got a 1 in 3 chance of failure if they are truly independent events the the probability that both will fail is the probability of the two events multiplied together so that would be a 1 in 3 times a 1 in 3 which is a 1 in 9 now that would be like an 11 12% chance of total failure now I'm not saying that's the case but it's another way to think about how risk has been mitigated again by having two endpoints and by having a safe compound and by having agents that we hopefully have shown to your readers satisfaction are as good as if not better than the standard of care or the lead asset in that space I mean again from a derisk perspective i think we've done all that we can at our stage to do that so that's kind of where I think Chris was wanting us to go

Please forgive the fused sentences. This is not a paid gig. But I digress. The point of it all is to show an illustration of the big picture as it relates to the rosy picture you suggest others are painting. Management believes taking all the factors into consideration Algernon has a 65% chance of success in the IPF/CC clinical trial(s). That's a calculation made 1 week prior to this bombshell news release on March 6, 2020:

Algernon Explores the Use of NP-120 (Ifenprodil) as a Novel Treatment for Coronavirus

The Acute Lung Injury/COVID-19 trial(s), as stated above, has co-primary endpoints just like IPF/CC. Therefore, it's not a stretch, but rather a mathematical probability, that four co-primary endpoints will further increase Algernon's probability of success. Expressly a probability of success above and beyond 65%.

Management also stated in a webcast (I can't recall if it was BioPub or Proactive) all we need is a positive readout for just one primary endpoint. I think that was in relation to all four primary endpoints (ALI/COVID-19/IPF/CC). I mean, any one of them targets a multi-billion dollar market.

Furthermore, not specifically directed at you, but there continues to be wavering about what Algernon's stated goals are as it relates to the success of any of it's lead compounds. Will Algernon advance/further develop a successful Phase 2 drug on it's own? Will Algernon find a partner to advance/further develop a successful Phase 2 drug? What about a buyout? There is no need to guess about Algernon's stated goals. Here are the exact words from Chris Moreau, CEO:

We do believe that we are on the radar screen and certainly with Phase 2 data that's compelling. I didn't mention this earlier, but Mark and I really haven't been envisioning building another global pharma. We do think that while we could carry Phase 2 to a Phase 3, we have those skill sets to run a Phase 3. We do think that if we have really strong data Phase 2 then we are going to be looking at some sort of a licensing or acquisition.

The above quote is from the same BioPub webcast dated February 28, 2020. Does anyone truly believe the repurposed drugs strategy has changed since the announcement of COVID-19 clinical trials? Of course not! If anything, it exponentially ramps up the probability Algernon is a buyout target.

Having said that, some may believe the above is painting a rosy picture.

My reply would be, I don't have the talent of a painter, but if you could see the nose on my face, you would undoubtedly agree, I have no problem with smelling the roses.



Just 1 opinion,

/////AMG

Outro