What did growth look like for PsychoGenics in 2022?

2022 was quite a good year. As a reminder, there are three sides to PsychoGenics: a contract research organization (CRO), a drug discovery company, and partnerships. In the CRO, we work for companies on a fee-for-service basis utilizing disease models and extensive preclinical capabilities to help them identify treatments for all CNS conditions which include psychiatric disorders, neurodegenerative conditions, and orphan disorders. In 2022, we grew the CRO business by over 20%, we hired a lot of research staff, we worked for 128 companies worldwide, and repeat business accounted for 80% of the total revenue.

Our approach to drug discovery is phenotypic where we test compounds in mice and evaluate their behavioral responses with AI/ machine learning to extract complex behavioral signatures. Using this approach together with our library of diverse active compounds we initiated several discovery programs and identified development candidates for depression and agitation, now ready to enter IND tox studies.

Finally, our partnered programs also progressed, and we expect to hear shortly the outcome of multiple Phase 3 schizophrenia trials for Ulotaront, a compound discovered in partnership with Sunovion. We also extended our partnership with Karuna.

How do you see demand for your Cube Technology shaping in 2023?

There’s a lot of interest in our Cube platforms for several reasons. First, there is growing interest in psychiatric disorders, as it is a huge unmet need, and data from psychedelic drugs is very promising. This resurgence in CNS is reflected in the growth of the business.

In addition, companies are more receptive to phenotypic drug discovery. The target-based approach to drug discovery has not been very successful in CNS in general, largely due to the complexity of the poorly defined conditions with multiple susceptibility genes, epigenetics, and the environment playing a role. And finally, the approach we take is very efficient. We typically identify a development candidate after testing less than 300 compounds, compared to an average of 2,500 compounds in a target-based approach. This means we are delivering development candidates faster and at a fraction of the cost.

Can you touch upon the breakthrough potential of Ulotaront?

We discovered Ulotaront in partnership with Sunovion by screening a library of diverse compounds predicted to have CNS activity. The goal was to find a treatment for schizophrenia that did not target dopamine D2, which we did. Our work demonstrated that Ulotaront had a better side effect profile when compared to existing drugs and had effects on negative symptoms (apathy, social withdrawal, flat affect), all effects that were confirmed in phase 2 clinical trial. The compound has been in Phase 3 trials for some time and is expected to read out this year. We are very excited about Ulotaront, as it has the potential to be the first AI-discovered novel drug to be marketed.

Are you seeing widespread adoption of AI by the pharma industry?

AI is so broad: it can be leveraged throughout the drug discovery process to assess genomic data and find new targets, to find novel treatments and improve the properties of compounds using computational chemistry, to mine the literature to generate new hypotheses, as well as supporting systems and operations to improve workflow and efficiency. However, there is hype around AI that led to several claims that are not yet validated.

How has the mental health picture evolved in the US since the pandemic?

There is a mental health crisis made worse by Covid-19, especially in adolescents. As a society, we need to do a lot more to support mental health which affects one in five in the US. This is why Ulotaront is exciting, it could be on the market as early as 2024 to address symptoms of schizophrenia that are not adequately addressed, and the improved side effect profile will hopefully improve drug compliance.

What will be the growth priorities for PsychoGenics in 2023?

We will continue to add capabilities and disease models to the CRO side. On the drug discovery side, we are committed to finding better treatments for patients suffering from severely disabling neuropsychiatric conditions. Our goal is to advance all programs which we have self-funded to date and will seek investment to support clinical development as needed.