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Bringing Hope to People Living with Neurodegenerative Diseases

Dave Jackson Dave Jackson, Stockhouse
0 Comments| October 25, 2021

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Alpha Cognition Inc. (TSX-V.ACOG, OTCMKTS: ACOGF, Forum) is a clinical stage, biopharmaceutical company dedicated to developing treatments for under-served neurodegenerative diseases. Stockhouse Media’s Dave Jackson caught up recently with Company CEO Michael McFadden to get shareholders and investors up-to-date with this cutting-edge biopharma company.

(Click image to play video)


SH: To start off with, can you tell us a little bit about yourself and the history of the company?

MM: Sure, first myself 30 years biopharma, I spent my first decade in large cap pharma, Eli Lilly, Pfizer Pharmacy, and my last 20 years have all been spinning startups, very similar to Alpha Cognition. So Amylin, Avenir Eurovan are among several companies that I've worked for all in the R&D and commercial space. So please really to do it again with this very special company Alpha Cognition, the company actually has been around for a number of years through different names and different renditions as a lot of biopharmaceutical companies have. Recently we've entered the public markets to an RTO with a Crystal Bridge, and we're now traded on the TSXV and OTC markets and we have progressed our programs to the point where I would consider us a late stage biopharmaceutical company. Although we have some early stage compounds as well.

SH: Can you update our investor audience and your Alpha Cognition shareholders on any new company developments, especially in the wake of COVID-19?

MM: That is a great question. First let me talk about the impact of the company with COVID. We're a virtual company. So we border two continents, Canada and the United States and we're based in many cities around each. As a virtual company, we've actually been unaffected by COVID from an operational aspect. It's allowed us to continue to move our programs forward and we've actually accelerated that work in 2021. The new developments with the company, I think put us at the precipice of one of the most exciting years in company history. So we have four developmental programs, Alpha 1062 for Alzheimer's alpha, 1062 plus amendment teen also for Alzheimer's and then we have two early stage programs, one for mild traumatic brain injury and then a second for ALS. ALS is otherwise known as Lou Gehrig's disease and we have a gene therapy program otherwise known as alpha 602 for that disease.

SH: Michael, what exactly are ALPHA-1062 and ALPHA-602, how do they work, and can you expand on the clinical-stage trials to date?

MM: Sure. Alpha-1062. Let me start with that program. Alpha-1062 is a pro-drug of a drug called Galantamine, otherwise known as Razadyne. It was a J&J drug approved back in the mid two thousands. The drug had some modicum of success but it was limited by a fairly high tolerability issue, very high adverse events that occurred when patients took the drug and that limited its uptake into the market. Alpha-1062 is a pro drug of that drug and we formulated it to be a best in class, minimizing the side effects, allowing patients to get to an optimal therapeutic dose and we believe it will be a drug that will provide long-term outcomes for patients. The drug also, we have a different formulation for it, Alpha-1062 in a nasal, it's a drug device delivery for our MTBI program. So it's a drug with wide utility across multiple disease states. Alpha-602 is a pro granulin gene therapy. That is a full link pro granulin, pro granulin is a protein chain and that drug has shown applicability for a number of disease states. We're focused on ALS and what we believe could be a curative option for ALS as a disease that's life-ending for all patients and it has no real good therapeutic options for those patients. So we're hopeful that our current clinical trials will allow us to move forward with that program.

SH: You’ve recently announced the closing of $14.4 million Canadian dollar public offering. This may be news to many investors. Can you unpack the benefits of it?

MM: Sure. So when I joined the company in April, we immediately embarked upon an extensive review of our compounds and then we complemented that with market research in the market to look at the value of the compounds, what the potential could be and what we discovered through all of that work is the market value for 1062 is far greater than we anticipated. That was validated by our scientific experts and validated by patient and caregiver research that we completed. that gave us confidence that we can move the program forward and ultimately commercialize the program in the US and in other markets. So to do so, we needed to provide additional capital to further our clinical programs, to ready us for commercialization And we'll use some of those dollars also for a patient tolerability trial that allow us to differentiate the compound in our label, which will be very important for commercialization.

SH: The Company looks set for strong growth in 2022. How are you placed to expand operations?

MM: Sure. So we have a lean operational model. We are virtual, we have minimal resources that we're utilizing to optimize shareholder value and minimize shareholder spin. We'll continue that model through the course of 22 that said, we'll need to expand as we move closer to commercialization and NDA file, which we expect to happen for 1062 in 2022. So we'll be adding key resources throughout the company, mostly on the R&D side, and then some on the G&A side to make sure that we are fulfilling our requirements for the FDA and that we're able to take and progress our programs as appropriately for that company.

SH: Why did the company take a 505-B2 path toward approval and what does the company have to demonstrate to be approved?

MM: Great question. So we're often asked this question of why a 505 B2 approach 505 B2 for those in the audience who may be unfamiliar with that term is a bioequivalence program. So our drug has to show bioequivalence versus a comparator drug in our case, that is Galantamine and we have to demonstrate AUC area under the curve and C-Max, that are relative to that compared to drug. The benefits of the program is it allows us to move much faster with a much lower cost of capital toward approval. Now we're supplementing that with patient data and the patient data is a tolerability and dosing trial, which will allow us to change or modify our label with the FDA. So the two together allow us to achieve the same thing that a much more expensive $70 million five-year study would do had we taken the traditional route. So it's a very innovative approach to push drug to market demonstrate data that is sufficient and appropriate for physicians and ultimately patients.

SH: Why would ALPHA-1062 work for Traumatic Brain Injury?

MM: Great question. So traumatic brain injury is one of our early stage programs. In fact, we have that trial underway this quarter and we'll announce results of that trial in Q1 of 2022. So why to your question, why would it Alpha-1062 work? So Alpha-1062 has shown benefits to demonstrate cognitive clearing and also reduce brain inflammation. Those are two hallmark characteristics that patients with a traumatic brain injury might suffer from and cognitive clearing allows them to think clearer and faster and reduction in brain inflammation does just what you would think it would do when you hit your head or you have some type of impact to the skull, there is inflammation that occurs as a response to that impact. We believe that our drug may be able to reduce that inflammation a much faster rate or set another way, restore brain to normality but we'll see what the data says. We're still waiting on that data and that trial to complete and we'll be very pleased and excited to announce that data in Q1 of 2022.

SH: What separates ACI from the competition and makes your business model unique?

MM: Yeah, our business model is unique. In a couple of ways, one is it's very unusual for a company our size to have the breadth and depth of scientific programs that this company has. We have a late stage program. We have multiple early stage program. We have a program in between that allow the company to deliver shareholder value in a way most early stage companies or small companies cannot. Number two, we've taken a lean operational approach to minimize shareholder capital burn. So we are taking a lean approach to deliver value for shareholders but not having to take a tremendous number of years and a lot of capital to get there. So we're unique I think in the industry to be able to deliver that. then third we're tackling some of the really hard diseases. Alzheimer's affects 6 million people in the United States, additional half million to almost a million in Canada, a lot of impact disease but not very good options and we believe we've discovered and have a product that can really solve many of the issues that patients suffer with. Same thing for ALS, same thing for MTBI. So we're conquering big things, but doing it in a very smart, efficient way.

SH: I have to mention your stock has had a very nice bump over the last three months…nearly doubling in value since mid-July…even though you’re not expecting to be generating revenue until 2023. What can you tell our investor audience regarding the current valuation of your stock and why you think it’s still a good buy right now?

Click to enlargeMM: Yeah, it's a great question. So I think most CEOs would say this, our stock is undervalued but let me explain my rationale on why I believe that and it's ultimately up to the investors to decide. We're a company with a late stage program in a market that is sized at $5 billion US in mild to moderate Alzheimer's. So that means each SharePoint in the market is a $50 million SharePoint. We believe our product is poised to take share from the other agents. Now we released data that will provide inflection points for shareholders along the way and those inflection points are our VABE study results we'll announce in Q1 of 2022, we'll be filing NDA in mid 2022 and then ultimately, we hope to have FDA approval on that program in 2023. So along the way a lot of shareholder inflection points that should provide more value as risk is reduced for the company.

Secondly, in our early stage programs MTBI and in our gene therapy program for ALS again, data will be announced in 2022, the results of those programs, which will allow us to progress rapidly to additional trials and have additional inflection points as risk is taken off the table for our investors And you're able to see good data sets that support your investment thesis, our clinical thesis on moving those programs forward. So we think great opportunities for investors to see inflection points in 2022 and great opportunities for us to see improvement and advancement in our clinical programs.

SH: What’s the long-term strategy for the company moving forward and what should retail and institutional investors be looking out for?

MM: So I think with our company, it's very unusual for a company with a late stage compound to be valued in the CNS arena at a sub $100 million valuation we are but we have the capabilities and resources because we have a very focused, targeted drug approval and likewise, a very focused, targeted commercialization strategy to move toward commercialization. So we can burn small amounts of capital but have big benefit. We think that's a positive for any investor who would have an interest in our company. Number two, we're looking at two disease areas, MTBI and ALS have no approved therapy or very limited number of therapies that can affect disease and so we hold the opportunity for investors to realize inflection points on those programs that should be highly interesting to strategics. That should be highly interesting to additional investors as those programs that advance. We think that will benefit both the company and investors allow for a very good 2022 of results and hopefully we hope return.

SH: Michael, can you tell our audience a little bit about your corporate management and board teams, along with the experience and innovative ideas they bring to the biopharma space?

MM: Yes. so our corporate team and I'll say this in general for biopharmaceutical companies, it's difficult to be successful without a team that can develop drugs successfully and a team that has a commercial experience to launch drugs successfully. Our development team, over 250 drug approvals to their credit. So they have been there, they've done this and they've done it in many therapeutic areas. Our commercial team, 50 years experience over 20 commercial launches, half those have been billion dollar plus launches. So can we commercialize the drug? You betcha. Our team has done it many, many times in multiple therapeutic areas and I think are surrounding that with our entire team, a real depth of experience in CNS and real depth of experience in Alzheimer's disease. So we bring to the table, great capability, and great experience in that disease areas But we supplement that with scientific advisory board that guides our thinking and guides, our thought processes around our clinical programs. Every good company should have that and we do.

SH: And finally, Michael, if there’s anything I’ve overlooked please feel free to elaborate.

MM: Yeah, I'll just say in summary, I'm really excited about the company. I hope you hear that in my answers to your questions and I'm excited because we have a great pipeline of assets that we're bringing forward to the market and we're poised in 2022 to make it one of the most exciting years for the company but also the investors who have invested in our company. It also at the end of the day is important for patients. So we offer the opportunity to bring a new therapy that could be impactful to patients and caregivers And that's why we get up and do our work every day is we want to bring solutions that can affect disease and then ultimately affect families who suffer from the disease or affected by that disease. So that's why we do what we do but in the course of a work that we do there's a great opportunity for investor reward and those who follow our story, we're excited to keep you informed on our progress.

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FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.

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