This article looks at what neurological diseases Atai Life Sciences Inc. (ATAI) is focused on, its clinical trial progress to date, its latest quarterly financials, the history of its stock price performance, and the price forecasts for the stock over the next 12 months.
An original article by Lorimer Wilson, Managing Editor of munKNEE.com.
About Atai Life Sciences
Atai Life Sciences is a clinical-stage biopharmaceutical company with a market capitalization of $259M and a stock price of $1.56. as of March 3rd, 2023. It is engaged in developing various therapeutic candidates that focus on treatment-resistant depression, cognitive impairment associated with schizophrenia, opioid use disorder, post-traumatic stress disorder, and generalized anxiety disorder.
Research and Development Pipeline – and Progress To Date
Atai has 2 programs in Phase 2 development:
- PCN-101, a subcutaneous formulation of R-ketamine for the treatment of treatment-resistant depression;
- announced January 6th, 2023, that its majority-owned unit Perception Neuroscience’s therapy PCN-101 (R-ketamine) did not meet the main goal of a phase 2a trial for treatment-resistant depression.
- RL-007, a cholinergic, glutamatergic, and GABA-B receptor modulator to treat cognitive impairment associated with schizophrenia;
- announced on March 6th, 2021 that the first patient was recently dosed in a phase 2b study of RL-007 with initial data from the trial are expected in H2 2024.
Atai has another 5 programs in Phase 1:
- KUR-101, an oral formulation of deuterated mitragynine to treat opioid use disorder
- announced on December 23rd, 2022, that the respiratory impact of its candidate for opioid use disorder (OUD) KUR-101 was inconclusive in a Phase 1 trial involving healthy volunteers.
- VLS-01, a formulation of N,N-dimethyltryptamine (DMT) for treating treatment-resistant depression
- announced on October 5th, 2022, that it had dosed the first person in a phase 1 trial of VLS-01 for treatment-resistant depression (TRD);
- EMP-01, an oral formulation of an 3,4-methyl enedioxy methamphetamine (MDMA) for the treatment of post-traumatic stress disorder
- announced on September 27th, 2022, that it had received regulatory and ethics approvals from Medsafe and HDEC to begin participant enrollment;
- DMX-1002, an oral formulation of ibogaine for treating opioid use disorder
- announced on September 21, 2021, that the first subjects have been dosed in a Phase 1/2a clinical trial of DMX-1002;
- GRX-917, an oral formulation of a deuterated version of etifoxine for the generalized anxiety disorder treatment
- announced January 3rd, 2023, that it had received final positive results from a Phase 1 clinical trial of GRX-917
- announced on March 6th, 2023 that the company plans to progress GRX-917 in a phase 2 trial in an anxiety disorder as the next step in clinical development.
- COMP-005: a treatment for treatment-resistant depression
- announced in February the acceleration of a pivotal trial 1, part of a phase 3 program in treatment-resistant depression. Top-line data is expected in the summer of 2024
In addition, Atai has 3 Programs in Pre-Clinical Development
- DMX-1001, an oral formulation of noribogaine for the treatment of opioid use disorder;
- NN-101, a novel intranasal formulation of N-acetylcysteine to treat mild traumatic brain injuries; and
- RLS-01, a formulation of Salvinorin A for treatment-resistant depression.
Go here for a description of the 5 neurological diseases mentioned above.
Q3 Financials Highlights
The Company is still in the product research and development of novel compounds and, as such, has no products and has no revenue, and requires a great deal of money to fund its R&D expenses. For a detailed look at all the financial metrics related to Atai in the last quarter, which ended September 30th, 2022, and for every year going back to 2018 go here.
Read: Atai has reduced its workforce by ~30% as part of a strategic review,
Stock Price History
Atai’s IPO back on June 30th, 2021 was at $18.50 and by the end of 2021 had declined 58.8% and then by another 66.2% in 2022. As bad as that was, it was marginally less than the 70% decline experienced by the other 5 major clinical-stage psychedelic stocks in the munKNEE Psychedelic Drug Stocks Index. The stock continues to decline and as of the close of business on March 24th, 2023, was down 51.5%.
Based on 14 Wall Street analysts (see here) offering 12-month price targets for ATAI Life Sciences in the last 3 months the average price target is $11.88 representing a 647% change from March 24th.
Risks and Offsets
The company reports that its cash position at the end of Q3, 2022, of US$304.1M, combined with committed funding from the Hercules loan facility of up to $175M, is anticipated to provide a cash runway into H1 2026. That being said, however,
- were Atai to experience further setbacks in its various research studies,
- that might cause investors to lose confidence in the eventual success of the company and such negative sentiment could negatively impact its stock price;
- were another company to develop a treatment for one of the 5 disorders before Atai,
- that would most likely negatively impact the stock price, as well and, even more so, if such a competitor were to take the treatment for one of those diseases to market; and
- were one or more of senior management to depart,
- that might cause the company to lose focus which would slow down the progress of its research and development.