Replies to post #6961 on Algernon Pharmaceuticals Inc (AGNPF)

[smoki]

Algernon Pharmaceuticals.com will answer your question’s DD!

[Money $hot]

Management’s Discussion and Analysis

Dated January 28, 2020

BUSINESS MODEL

The Company is engaged in advancing a number of repurposed genericized drugs into phase II clinical trials for the global disease areas of NASH, CKD, IBD and IPF. The compounds being advanced by the Company have all performed equal to or better than the positive controls used in the Company’s widely accepted pre-clinical in vivo animal research studies.

Algernon’s business strategy is to fast track a number of its lead compounds into phase II clinical trials as quickly and as inexpensively as possible by leveraging the currently existing regulatory approval in the country of origin where the drugs were originally approved. Conducting off label phase II trials in the drugs’ currently approved market would save the company from conducting all of the preclinical toxicology work. This additional work would in comparison, add significant time and costs to the Company’s development timeline and budget. The next step post positive phase II results would be to begin the USFDA approval process.

At present, the Company does not plan to develop a sales team to advance the marketing sales and distribution of any of its lead compounds if such compounds achieve regulatory approval in any given market. The Company’s strategy is to look for moments of inflection where the potential exists to be able to consummate the best possible licensing or partnering deal or acquisition transaction.

ALGERNON IS A LICENSING AND/OR ACQUISITION PLAY FOR ALL LEAD COMPOUNDS (IPF, CKD. NASH. IBD, CHRONIC COUGH, ALI - Coronavirus). ALGERNON IS NOT ATTEMPTING TO BE IN THE FULL BLOWN BUSINESS OF PUMPING OUT PILLS. THERFORE, THE COMPANY CAN RUN ON A SHOESTRING BUDGET WITH AN EXCEPTIONALLY COMPETENT AND CAPABLE CHIEF EXECUTIVE OFFICER AND CHIEF SCIENCE OFFICER.

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[Money $hot]

Dr. Mark Williams is the "brainchild" behind the repurposed drugs strategy. His years of research targeted 11 compounds. Ultimately narrowing down the field to 4 leading candidates. All preclinical and clinical trials are conducted by Contract Research Organizations (CRO). The overall business model is lean, mean, and ingenious. The only necessary persons to run such a business model is Chris Moreau (CEO), and Dr. Mark Williams (CSO). Given that Algernon is on the brink of Phase II clinical trials for IPF, Chronic Cough, and Acute Lung Injury (ALI) as a result of the COVID-19 pandemic, it's hard to argue the business model is flawed. There is no shortage of communications with shareholders - a plethora of news releases. If that's not enough information, review the CEO interview in the ibox above - attached here for your convenience:

Right out of the gate (the first minute and ten seconds) it's established that Algernon has a different business model than most biotechs.

We're not advancing "new" chemical entities. Our focus is to take genericized drugs that have never been approved in US or Europe, find if they have efficacy in new diseases...so our focus is different and we have a very capital efficient model of trying to find new uses for safe older drugs. - Chris Moreau, CEO

Here is what CRO's can do for you:

A contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance.

CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant.[citation needed] CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.).[1]

Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[2][3] CROs range from large, international full-service organizations to small, niche specialty groups.

CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval,[4] without the drug sponsor having to maintain a staff for these services.[5]

CRO infographic



References:
en.wikipedia.org/wiki/Contract_research_organization

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Outro

[Money $hot]

P.S. I forgot about this guy being part of management team.

Michael Sadhra CA
Chief Financial Officer & Director
Mr. Sahdra was a Former Senior Tax Manager at KPMG and is currently aTax Partner Sadhra Chow LLP. He has Served as CFO and as Director of Numerous Public Companies.

He doesn't have a corporate photo on the corporate website. So I usually forget to put him in the picture.

Add the 4 Medical Advisory Board doctors and that rounds out the frame.

smoki gave you some good advice. Take some time to go over the website. Also, read some filings at SEDAR. Pennyland is already the ultimate risk. Why invest in something you know very little about? Failing to do some basic due diligence puts your risk tolerance on roids.

/////AMG