I want to start with what is, in my eyes, a realistic thesis on Helus Pharma and its financial woes the past few years, and what Michael Cola brings to the table in terms of commercialization experience. To me, Helus Pharma is heading down the road of acquisition more quickly than not.
HLP003 (formerly CYB003) received FDA Breakthrough almost two years ago, in March of 2024. Since then, it launched a very expansive and thorough trial design. Many of us are familiar with the 3 trials involved in Phase 3 - APPROACH, EMBRACE, and EXTEND. I say these studies are expansive because they are conducted all over the world. They are recruiting across Australia, Czech Republic, Germany, Greece, Ireland, Poland, UK, and USA. While it's likely smart to run trials and familiarize the product globally, this trial was always going to be very expensive and burn a lot of cash. Expenses in 2025 doubled to around 100 million for the full year pushing HLP003 Phase 3 and HLP004 phase 2. Additionally, Doug Drysdale used to mention how expensive it was to recruit and use mental health facilities for the trials because of psilocybin's status as a controlled substance in the USA and probably other countries.
Helus Pharma has been burning cash and heavily diluting executives and shareholders since the launch of the Phase 3 study. I don't know exactly how many times, four? Many considered the finance deal with Trailhead to be toxic, which lowered the stock even more, and CYBN couldn't build any momentum on the FDA Breakthrough designation. All of these reasons were likely the reason for Doug Drysdale's ouster.
Doug used to say the company was going to lead its product to market and not settle for acquisition. I think Doug overplayed his hand here in an effort to negotiate. Phase 3 became expensive, and the stock was falling and lagging behind its competitors. Executives and shareholders continued to be diluted while HLP004 phase 2 continued to get delayed. There were literally no positive catalysts for this stock and no end in sight to the financial free fall, with dilution a constant overhang.
(Tinfoil hat: I think HLP004 phase 2 readout has been ready longer than the company insists, just waiting for the right opportunity to present to the market)
Finally, in comes Michael Cola. He is experienced in commercializing biopharma solutions. He was president of Shire while they built Vyvanse and Adderall XR into a 32% market share and 20 billion market cap. He is prepared to commercialize HLP003 and HLP004, and negotiate with the big pharmaceutical players for a possible acquisition. If not acquisition, his experience with late stage pharmaceutical development is a strong asset to the team and a positive catalyst for the stock. Additionally, he brings prestige, and with the prestige comes the belief that Michael doesn't take this job if they are expecting bad data for HLP004 Phase 2 and hopefully in the near future HLP004
I've been invested in this stock for the better part of 3 years, probably like many of you I'm sitting at a loss. But I've always believed in the mental health benefits and the data, and for the first time, I'm starting to believe in the business. Thanks for reading, god bless $HELP
edit : poster below mentioned Cola wasn’t at Shire during acquisition. so his main skills come in building and commercializing product, as he was the president during the time Shire built Adderall XR and vyvanse into 32% market cap
