atai Life Sciences N.V. (NASDAQ: ATAI) Q4 2021 Earnings Highlights
CEO Florian Brand:
“…2021 was a truly transformative year for atai. We made important progress across our programs, expanded our diverse pipeline with multiple shots on goal, and secured approximately US$410 million in financing. This allowed us to enter 2022 with US$362 million in cash, putting us into a very, very strong position to work up towards our strategic goal, achieving clinically meaningful and sustained behavioral change in mental health patients.
To achieve this goal, we will focus on three strategic pillars. One rapid acting intervention; two, ongoing digital support; and three, biomarker driven precision mental health.
Let’s turn to the first pillar, rapid acting intervention. This pillar is really about developing our first, second and third generation compounds in the most effective and most efficient way. We anticipate these compounds to be highly differentiated to show rapid acting improvements in mental health disorders.
And we’re especially interested in compounds with strong neuroplastic properties that open a therapeutic window to initiate behavioral change in patients. To give you an example, in the context of depression, this first pillar is really about lifting a patient out of depression in a quick and meaningful way, but then we want this patient to stay out of depression.
And this leads me to our second pillar, ongoing digital support. This pillar is about keeping mental health patients in state of remission. And it is grounded in innovative digital care provided patients before, during and after treatment.
While these tools are especially relevant for the psychedelic-assisted therapies that we’re developing, we see great potential to apply digital support across our entire drug development pipeline.
We believe pairing digital therapeutics with a rapid acting pharmacological agent from pillar one will allow us to achieve sustained behavioral change in mental health patients. What works for one patient, though, might not work for another. As we all know, the mental health patient population is highly heterogeneous.
Which brings me to our third strategic pillar, biomarker driven precision mental health. When it comes to mental health, there is no one size fits all approach. So, this pillar is about identifying patient subtypes using biological and digital biomarkers to treat patients with a therapy that is right for them at the right moment in time. We believe this will reduce the need for trial and error and give each patient the best chance of receiving the treatment that works for her or him.
Each of these pillars has a true disruptive potential on its own. But it’s by combining them that we can really unleash their full potential, allowing a true leap forward for mental health patients by achieving clinically meaningful and sustained behavioral change.
And we have already laid the groundwork for all three pillars, for example, by building out our digital, data and biomarker teams, and we will continue to be highly active in all of these three pillars.
That said, our focus for the next few years will remain on pillar one, rapid acting intervention, generating value by executing and further expanding our drug development programs and by further strengthening the robust patent portfolio of our compounds.
Let’s now have a closer look at our achievements in our first pillar since January 2021 and then look ahead what we can expect over the next two years.
Since January 2021, we launched eight new programs, including three programs dedicated to drug discovery. This brings our total number of drug discovery and development programs to 13 as of today. It goes without saying that we intend to stay highly active in business development this year and also beyond.
From an R&D perspective, we also achieved many meaningful milestones in 2021. Allow me to highlight just a few of them. We saw positive Phase IIb data for COMP360. The results of this groundbreaking trial in treatment resistant depression, or TRD, led us to increase our stake in Compass Pathways to 22.8%.
We also shared positive Phase IIa proof of mechanism data for RL-007. This compound is being developed to treat cognitive impairment associated with schizophrenia, a condition that today has no approved treatment options.
And in September 2021, we initiated the Phase IIa proof of concept trial with PCN-101 in TRD. We anticipate top line data for this trial by the end of this year. And we also recently received IND clearance from the FDA to run our first clinical study with this compound in the United States.
So, as you can tell, we made a lot of progress here. And as we look ahead to the upcoming two years, we’re anticipating at least 14 R&D catalysts.
Alongside these exciting R&D milestones, we saw further validation of our approach to capture the value of our programs. In March 2021, we were thrilled to announce a collaboration with Otsuka Pharmaceuticals. This significant licensing deal for PCN-101 represents the first major partnership between a biopharmaceutical company developing psychedelics and large pharma.
When it comes to capturing the value or monetizing our programs, we have a high degree of optionality. And with the IPO of Compass Pathways and the licensing deal with Otsuka, we have already successfully demonstrated some of the ways in which we intend to capture value in the future. We will decide the best and most viable option of capturing value, including self-commercialization, for each of our assets on a case by case basis….”