Neal Koller Presents Alphyn Biologics at LSI Europe '23

Transcription

Neal Koller  0:05  
Good afternoon, everyone. I'm Neal Koller chairman and CEO of Alphyn Biologics. I'm here today to tell you why we started alpha and what our mission is and why three Life Science investment funds have invested in Alphen. To quote, the managing director of our lead investor, I've never seen an investment opportunity that could build to a trillion dollar market potential. So let me give you the whys in the house. We're starting with atopic dermatitis, why atopic dermatitis, it's devastating. Over 60% of patients still complained a very, very severe itch, over 50% complained that their disease is just not under control. Some 67% of children 33% of adults complained of lost sleep, the quality of life is just awful. Adults report 11 days per year of lost work due to atopic dermatitis, and the drugs that are available to treat them both the legacy drugs and the new drugs have significant problems. They have efficacy and side effects shortfalls. They do not treat the bacterial component of atopic dermatitis and none of them are truly worryfree long term use, we deal with all of those points. This is a US NIH study that underlines the bacteria component of atopic dermatitis as bacteria goes up on the skin, the atopic dermatitis gets worse. And we're the only drug that treats the bacterial component and the immune component. This is how our lead investor got to a trillion dollar market opportunity. It's reported that AD affects 10% of the population. So in an 8 billion person world, you have 800 million AD sufferers. We treat all of those sufferers the big round red circle is all of the ad patients including the immune component and the bacterial flare component. And that smaller gray circle is the infected atopic dermatitis component, we treat all three of those the only drug to do that now. We looked at the market a little bit differently and we factored in access to drugs Access to Care Reimbursement, we get ourselves to 119 billion in revenue and an 11% annual growth rates in the market today. Dupixent is there in its fourth year of sales supporting that market size, 7 billion in revenue this year is targeted, and that just using us shares 1.5% Dupixent. In its seventh quarter of sales, annualized is at 320 million. So very, very strong sales supporting market size, the exit comparables, as you see two exits at over a billion dollars in atopic dermatitis and 2021 Deravant did a deal just in Japan at 113 million. So the exit comparables are very, very exciting. What do we have, we have a very unique drug substance which is a platform the drug itself has multiple bioactive compounds, multiple mechanisms of action, therefore multiple ways to treat the target disease and multiple diseases that it can treat. It has a very, very strong safety and side effect profile, and a very fast path through regulatory approval. To underline that, our phase two trials started at age two. And we formed the company and raised our first round in March of 2020. And here we are three and a half years later completing two phase two trials very, very fast progress. The results of our phase two trials point to us being the drug of choice. Now there are a number of different endpoints in an atopic dermatitis trial, we've organized them into three categories, the urgency to fix the top priorities to fix the critical to fix and the standard to fix. And as you can see from this slide, and I'll just go to the next slide at the bottom, which has numbers for those of you like numbers. We were the best at the top priorities. We are the only that treats the critical priorities and we did excellently well, in the standard priorities for the numbers. The dark green is where we were the best and the light green is where we were as good as anybody else. That puts us we think in an area all by ourselves all the way to the top and to the right. All the way to the top because of our safety profile and all the way to the right because we treat the immune system and the bacterial component. We had a number of inputs from patients from our clinical trial this is this is just one and this is from a mom whose daughter was in the trial. And that dark gray area says nothing has managed to produce the normal skin like she had in the trial. And this was an email to say, is there another trial when is the drug available? How can we get it. Moving to the team, I've got full career and life sciences first half, large pharma large device within the wired system. Second half of career, all early stage Life Science. My last exit was a 16 exit. Our chief scientific officer, Dr. Pico, first big project out of his PhD program was bringing a drug called Bactrim ban to market Bhature ban today, at least in the States is still the number one drug to treat Mersa or MRSA skin infections. In terms of market protections, we have four key market protections. Our patent applications because the company is so new are still applications, but if granted will take us at least to 2042. We have for regulatory exclusivity on date of approval, 10 year potential in the US 10 year potential in Europe, eight year potential in Japan. At least in the US, there's no generic path for a drug to duplicate what we're doing using our drug substance, they must go through human clinical trials. And the supply of our raw material we expect will have a 15 year Headstart exclusivity in the marketplace. We've raised 9.1 million to date three different rounds. This is our series B round for we're looking for $18,000,000. Two key milestones one is for atopic dermatitis through the next larger trial, phase two B which we're hopeful to convince the health authorities will be one of the pivotal phase threes and we're hopeful that we'll get the second milestone, our second drug an orphan drug, and Epidermolysis. below the below says through its phase two trial. We're also out now talking to commercial partners and looking for partner potential. So if I summarize our competitive advantage leads us for a commercial partner to be a flagship product drug of choice, the data points to drug of choice but Beyond the Data. Key things are we treat the best the top priorities that need to be treated for atopic dermatitis. We are heading to be the only atopic dermatitis drug that has worryfree for continuous long term use. We're not a me too drug. When you look into the pipeline, there are lots of the same type of drugs, same type of mechanism or multi target therapeutics, very novel and very unique. We expect we have a long period of exclusivity. We know that topicals are 90% of this market, because people like topicals and we're well positioned there. We've already talked to us insurers and they already tell us that we will be second tier above the basic legacy products. And first in line in the second tier if our promise continues with the clinical trial results, and they expect will be reimbursable at about $1,000 per two very, very good price. So we're powerful. We're differentiated and I would love to talk to anybody who would like to invest or be a partner. So thank you very much, and hope you had a good conference.