Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

My thoughts/opinions (t/o) have always been aimed at calling it how I see it.

In real time. No more. No less.

HM

So, here are some of my take aways and questions from this weeks video sessions, IF all is to be believed.

My t/o -



HM

1b. Not-so-good- Chris is still in charge

1c. What happened?? Is our new Board Chairman putting the smack down?? Mark for eventual CEO replacement??

My t/o - Chris has never been in charge. He’s been charged with carrying out the wishes of Team Cobra. Simply go back to when he thought it was a good idea to work for Kal Malhi at First Responders Technologies. My best guess is they pressured Doc Williams to do the same. I don’t hink he’s that dumb and arrogant. Which is another reason why I think he initially bailed out of his commitment to Algernon Pharmaceuticals like a step father.

I don’t know if the new COB has full control over Team Cobra, but the numbers suggest he does. The new COB has a previous working relationship with Christopher as does Doc Williams with Christopher. That gives them 3 voices over two Team Cobra members still on the BOD ( Rajpaul Attariwala, David Levine).

However, Kal Malhi may still wield considerable power from the outside as he’s done historically at Breathtec/ Algernon. Riding the remainder of the BOD of Team Cobra would be the true measure of putting a historically horrible and brazenly blatant conflict of interest in the rear view mirror. Unless and until such time, see Edgar Allen Poe’s advice from above.

The return of Doc Williams would suggest there is a renewed effort to get shit done on a timeline on par with legitimate biotechs like Bellus Health. Thus far, Algernon is not a pure comparison to Bellus Health until Algernon starts designing, launching, and completing powered clinical trials.

Will Doc Williams push aside or out Christopher Moreau at the CEO spot is anyone’s guess. My best guess is not a chance unless Moreau opens his piehole and spews something completely outrageous and legally actionable. Time will tell and...



HM

2b. Not-so-good

-You need strong data from 19 of 20 ppl, mimimum, to reach a p-value of <=.05 (we have 14 ppl)

My t/o - My understanding now is that none of the “studies” thus far were designed for statistical significance. I’ll opine further in this post.

HM

2c. ??
- so, did all 14 ppl strongly trend well??

- why is IPF left out of CC study USA??

- Is it for ease and expediency of trial (maybe a faster outcome, like Bellus Health), or insufficiency in IPF data??

-will this now be open for all adults with CC (roughly 11% of American adults)

My t/o - Did all 14 people strongly trend well? We don’t know and we may never know. SWhy is IPF left out of a CC trial targeted for the USA? Because, Chronic Cough is almost never, if ever, coupled with Idiopathic Pulmonary Fibrosis. The CEO admitted that in writing in the news release:

The Company’s pilot IPF and chronic cough Phase 2 trial was neither powered nor intended to show statistical significance but was designed to identify signals and the magnitude of any clinical effects. While chronic cough is a symptom which occurs in a subset of patients with IPF, it is often severe and difficult to treat in IPF patients compared to chronic cough arising from other causes. Typically, IPF patients are excluded from clinical trials in chronic cough patients. A relative reduction of cough count in these patients is being viewed by the Company as encouraging news.

Is it for ease and expediency of trial (maybe a faster outcome, like Bellus Health), or insufficiency in IPF data?? Yes, it’s for ease and efficiency. The question is why didn’t they do/design such a trial in the first place? I have some further thoughts...

HM

-now have freedom to move ifenprodil to countries with whom Japan supplier may not have agreed (for note, Japan and AU have very strict healthcare standards and drug manufacturing and workwell together as countries, in this regard, essentially tops in the world, so would be my guess that Algernon was bound very tightly by Japan supplier, just an educated guess)

My t/o - Whether Algernon places the blame on the manufacturer/supplier or government restrictions, there is absolutely no excuse for sticking the Chronic Cough study inside of the IPF study. Regardless of the ever twisting and changing stories the CEO tells about AU/NZ I will believe none of what I hear. Show it to us in black and white.

HM

4b. Not-so-good

My t/o -Took years and millions of wasted dollars on possibly valueless trials to get here (some data, like safety, IL-6, from Covid study, and trends from IPF/CC may still serve some beneficial purpose)

Perhaps, but we already knew it was a safe drug. It has a 40 year history of safety and is still sold in Japan (a partner of the USA).

HM

5a. Good

Mr. Moreau likes to address "shareholders" in his videos

5b. Not-so-good

He likes to do it with a smarmy smug smirk on his smacker ( figured I'd complete the alliteration).

My t/o - A list of things to permanently ditch in his sales pitch:
Biopub
Constantly looking down at his phone (has done it in many past vids).
Talking out of both sides of his mouth
Wearing a plunging neckline with a suit jacket. He’s probably not wearing any pants either.

HM

And, will he begin to understand that while some of us know what the F we're talking about, and while some of us know nothing about what the F we're talking about, that as the people who are following his company, buying his company's shares and helping to try to build it's value, all of us need to be shown respect, otherwise you get people like M$, myself, and others really PO'd and possibly dumping his companies shares, it's value and it's respectability in this space?? Yes, Kal be damned.

Just start with the truth and keep a straight line from there. Your withholdings, half-truths, and non-truths have come to light over time anyway, so you just look pathetic as a leader when they do.

________

My closing thoughts/opinions:

Excerpt from Management Discussion and Analysis

Dated December 12, 2018

Overview

...Breathtec was formed to propel innovative research in the area of breath analysis as a medical diagnostic tool. The principal goal of the Company is to develop and commercialize non-invasive, affordable, breath analysis devices for early detection of infections and life-threatening diseases such as cancers, liver disease, kidney failure, diabetes, asthma and tuberculosis.

On August 1, 2018, the Company signed a Letter of Intent (“LOI”) to acquire 100% of the issued and outstanding shares of Nash Pharmaceuticals Inc. (“Nash Pharma”), including dilutive securities of NASH, in exchange for securities of Breathtec (the “Transaction”). Nash Pharma is a clinical stage pharmaceutical development company focused on drug repurposing in the areas of non-alcoholic steatohepatitis (NASH), chronic kidney disease (CKD) and inflammatory bowel disease (IBD). Through its ongoing research programs, Nash Pharma has developed data that supports the advancement of up to 7 drug candidates into phase II trials. The Transaction closed on October 19, 2018.

On October 17, 2018, prior to the closing of the Transaction, the Company consolidated its common shares on the basis of 2 pre-consolidation shares for 1 post-consolidation common share. This resulted in the Company having 28,948,678 common shares, 5,739,166 outstanding warrants and 2,147,500 outstanding options. All the figures as to the number of common shares, stock options, warrants, prices of issued shares, exercise prices of stock options and warrants, as well as loss per share in the consolidated financial statements and the MD&A are post-consolidation amounts and the prior year comparatives have been retroactively restated to present the post-consolidation amounts.

Upon the closing of the Transaction on October 19, 2018, the Company acquired all of the issued and outstanding common shares of Nash Pharma in consideration for the issuance by the Company of 15,800,000 common shares of the Company and issued an additional 14,800,000 warrants at a price equal to the exercise price of the Nash Pharma warrants.

Of the “7 drug candidates” that states data supports “Phase 2 trials” what type of trials are being expressed here, and how many of those candidates other than Ifenprodil have thus far been advanced in 3 years time? Common shares stood at 29M Outstanding - 36M Fully Diluted (post split) and FAIMS continued to be talked up as the next best thing in breathalyzer land. Upon acquisition (reverse takeover) of Nash Pharmaceuticals the common shares increased to 47M Outstanding - 70M Fully Diluted.

Common shares to date: 167M Outstanding - 214M Fully Diluted.

In other words - 29M Outstanding to 167M Outstanding.

In other words - 36M Fully Diluted to 214M Fully Diluted.

A 6 Fold Increase of Outstanding and Fully Diluted Shares.

What have we to show for it thus far?

A failed South Korea study.
A failed Romania study.
A failing Australia/New Zealand study.
A share price of historic lows.
A Team Of Cobras.
King Cobra flipping millions of shares to profit another penny stock company.
A couple of new avenues to explore (Stroke/Cancer) courtesy of Doc Williams.
A Shelf Prospectus for $50M CAD locked and loaded for more dilution.
6 of 7 compounds acquired from Nash Pharmaceuticals sitting on a shelf somewhere.

Speaking of compounds, this is what we know for sure:

There were four programs acquired from Nash Pharma at the date of acquisition.

Intangibles Acquired
1 - CKD program
2 - IBD program
3 - NASH program
4 - IPF program

Status of Programs
1 - Clinical results
2 - Clinical results
3 - Clinical results
4 - Anticipated results

Dates Patent Applications were Filed
1 - June 27, 2018
2 - July 6, 2018
3 - July 6, 2018
4 - February 14, 2019

% of Total Value of Nash Pharma
1 - 30%
2 - 30%
3 - 30%
4 - 10%

Acquisition Costs
1 - $ 1,458,827
2 - $ 1,458,827
3 - $ 1,458,827
4 - $ 486,275

TOTAL = 100% $ 4,862,756

Knowing the company has moved onto DMT for Stroke and Ifenprodil for Cancer, does anyone think the remainder of the pipeline will ever see a clinical trial? Does anyone think 90% of the acquisition was worth $4.4M CAD? Or, do you think - You’ve Been Had?

Look at what management chose to do with Ifenprodil out the gate;

NP-120 (Ifenprodil) outperformed Roche’s Pirfenidone and Boehringer Ingelheim‘s Nintedanib in an IPF animal study and Merck’s MK-7264 (Gefapixant) in a recent acute cough animal study.

“We have been working diligently since the close of our last financing to move forward with our plans for our first phase 2 clinical trial,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “NP-120 (Ifenprodil) represents a novel first in class treatment for both IPF and chronic cough and is an appropriate choice to be our lead compound.”

Management knew in advance of combining the IPF and Chronic Cough study that…”Algernon Pharmaceuticals’ NP-120 (Ifenprodil) Outperforms Merck’s Phase 3 Drug MK-7264 (Gefapixant) in an Acute Cough Study by 110%”

Management also knew… “The Company’s pilot IPF and chronic cough Phase 2 trial was neither powered nor intended to show statistical significance but was designed to identify signals and the magnitude of any clinical effects. While chronic cough is a symptom which occurs in a subset of patients with IPF, it is often severe and difficult to treat in IPF patients compared to chronic cough arising from other causes. Typically, IPF patients are excluded from clinical trials in chronic cough patients. A relative reduction of cough count in these patients is being viewed by the Company as encouraging news.”

Management waited 2 years for a complete disaster of the IPF/CC “study” to unfold to explain in crystal clear terms - the study was a hill to climb (time, time, time) before getting to a real world Phase 2 clinical trial powered for statistical significance. What’s even more disturbing is management chose to waste even more time and money by burying the Chronic Cough “study” inside the IPF study - knowing that shit wasn’t a prudent thing to do. We have paid/are paying for that decision in spades (as in grab a shovel and dig yourself a hole).

Just think if management had simply run a Chronic Cough study by itself from the outset? If we are to believe (which I don’t) 14 or so people on a cough machine is enough to file a US FDA Pre-IND Meeting Request - how long do you think it would have taken to do a 20 person “study” followed up by a clinical trial powered for statistical significance?

For a “pure comparison” to Bellus Health - here’s their Chronic Cough timeline;

Phase 1 clinical trial completed in 3 months with 90 participants.

Phase 2 clinical trial terminated after 9 months due to COVID-19 with 68 participants.

Phase 2 clinical trial completed in 9 months with 300 participants.

Bellus Health said it anticipates reporting topline data in the fourth quarter of 2021.

Bellus Health didn’t let COVID-19 bog them down to the depths of hell. They got after it and came out stronger than ever. Their timelines to data eclipses anything Algernon has attempted thus far with it’s tiny number of participants and lack of an endeavor to reach statistical significance. How the CEO brings his lips to suggest Algernon is anywhere in the league of Bellus Health is laughable at best.

Range of valuation: Bellus Health 500 Million to 1 Billion $ market cap reversus Algernon Pharmaceuticals 10 Million to 70 Million $ market cap. NASDAQ versus OTC. Apples and Oranges.

My two biggest regrets about Algernon Pharmaceuticals:

Fixating on the clinical trial timeline management pumped from the start of this disastrous journey.



Anyone with half a brain would understand the chart to mean on average each Clinical Trial Phase 1, 2, 3, averages just over 2 years. However, since management is running Phase 2 “studies” not powered for statistical significance, the timeline F-ing around at Phase 2 is substantially lengthened. In the case of the IPF/CC “study” it’s just a stepping stone to a potential Phase 2 clinical trial powered for statistical significance. Management’s decision to peel the Chronic Cough “study’ out from under the IPF “study” is their way of trying to climb their way out of the gigantic hole they dug. A hole that’ll be filled with more dilution.

My other regret is having early on believed a lot of garbage coming out of the CEO’s mouth.

Including a longtime history of Board Of Directors (less the new COB) working with/for Kal Malhi at various other failed/failing/flailing/on fire penny stock companies.

In-credible rumors of the CEO conducting private webcasts with Dr. KSS of Biopub, who is a Medical and Scientific Advisory Board Member @ Algernon Pharmaceuticals.

A Real Piece Of Art-Work



M$

Outro

PostScript

tcm55

Dr MW may earn the CEO job through future efforts or/and connections. But, I see him as a 'brain guy' and not a 'sharp pencil' guy.

Dr. Mark Williams holds an MBA. Surely he’s pushed a lot of pencils in life. Also, if the rest of the BOD can hold umpteen million job titles throughout Pennyland and wherever else, surely the “brain guy” can hold the CEO/BOD and CSO job which remains vacated since his prior departure from the company.

tcm55

Novotec has been a huge disappointment recruiting the IPF CT. Wish in one hand and reality in the other...GLTA...

In my small world of reality it is management who made the ultimate decision to pigeonhole the IPF/CC “study” in a country they knew had slim pickings for clinical trial participants. The CEO admitted much (late as ever) in one or more webcasts.

The first confirmed cases of COVID-19 in Australia were in January 2020. A full blown Global Pandemic was in full effect thereafter. Thereafter, Algernon methodically walked into a sinkhole:

Algernon Pharmaceuticals Selects NP-120 (Ifenprodil) for its Lead Phase 2 Trial for Idiopathic Pulmonary Fibrosis and Chronic Cough
December 09, 2019

Algernon Pharmaceuticals Appoints Novotech as CRO for First Phase 2 Trial and Announces Novotech’s $220K Equity Investment
January 17, 2020

Algernon Pharmaceuticals Appoints Professor of Respiratory Medicine Dr. Jacky Smith to Its Medical and Scientific Advisory Board
February 07, 2020

Algernon Submits for Ethics Approval for Phase 2 IPF and Chronic Cough Study
March 30, 2020

Algernon Receives First Ethics Approval for Phase 2 Ifenprodil IPF and Chronic Cough Human Study in Australia
May 06, 2020

Algernon Begins Screening Patients for Phase 2 Ifenprodil IPF and Chronic Cough Human Study in Australia
July 07, 2020

Algernon Announces First Patient Dosed in Phase 2 IPF and Chronic Cough Human Trial of Ifenprodil
August 05, 2020

Algernon to Provide Update on its Ifenprodil IPF and Chronic Cough Phase 2 Human Study Featured on BioPub Webcast Hosted by Dr. KSS MD PhD
August 25, 2020 08:00

Commoners bought the Hook.
Commoners bought the Line.
Management bought the S(t)inker.

Australia’s IPF & CC Recruitment Pool



Anyone know/recall a reason given why management didn't recruit for COVID-19 patients in Australia?

Algernon Submits for Ethics Approval in Australia for Multinational Phase 2b/3 Human Study of Ifenprodil for COVID-19
May 15, 2020

Perhaps it’s due to Big Pharma (Killer Whales) wading through a small pool?



My thoughts.
My opinions.
Long Journey (Circa 2016).
Awaiting closure.

What’s Closure?
Participants/Patients not Patience.
A Phase 2 Final Data designed for statistical significance:

3 years
36 months
156 weeks
1096 days
26,304 hours
1,578,240 minutes
94,694,400 seconds
and counting…