Atai Life Sciences Q4 And Full-Year 2023 Results: Steep Cash Drain Yet 2026 Target Remains, Update On Psychedelic Pipeline

Clinical-stage psychedelics biotech Atai Life Sciences ATAI announced its consolidated financial results for the fourth quarter and full year 2023.

The Numbers:

• Cash, cash equivalents and short-term investments of $154.2 million by December 31, 2023, as compared to $273.1 million by December 31, 2022. 
• Quarterly and full-year R&D expenses of $14.2 million and $62.2 million, respectively, as compared to $21.9 million and $74.3 million for the same periods in 2022. 
• Quarterly and full-year General and Administrative (G&A) expenses of $19.4 million and $63.6 million, respectively, as compared to $15.7 million and $70.4 million in the same periods in 2022. 
• Quarterly and full-year net loss of $18.3 million and $40.2 million, respectively, as compared to $45.0 million and $152.4 million in the comparable 2022 periods.

The report states that the decrease of $118.9 million in the company's cash position is primarily due to the $84.1 million net cash used in operating activities, $25.0 million for the Beckley Psytech investment, and $15.0 million of additional investments to advance its development programs. 

Nonetheless, the Atai team still expects its cash, marketable securities and committed term loan facility with Hercules Capital for $175 million will be enough to fund operations into 2026.

Now Read: Atai Life Sciences’ Q3 Earnings: Near $20M Burned QoQ, Says Funding ‘Sufficient’ To Streamline 2026

January's strategic investment in Beckley Psytech added two clinical-stage assets, BPL-003 and ELE-101, to Atai's programs. The company now owns 35.5% of Beckley Psytech, plus a time-limited right of first refusal on a future sale of the company, asset sales or other transfer of commercial rights and an indefinite right of first negotiation for both compounds.

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‘Continued Commitment To Transforming Mental Healthcare'

The clinical-stage biopharma company is dedicated to developing innovative therapeutics to treat depression, anxiety, addiction and other mental health disorders. By pooling resources and best practices, Atai's stated aim is to responsibly accelerate the development of new medicines to achieve "clinically meaningful and sustained behavioral change" in mental health patients.

During the period, Atai reportedly underwent operational efficiencies "by simplifying and optimizing its organizational structure" in line with its revised business and pipeline priorities.

"In 2023, we demonstrated our continued commitment to transforming mental health care for those most in need. Much of our recent focus has centered on psychedelic-based therapies for depression -such as BPL-003, an intranasal formulation of 5-MeO-DMT- that require two hours or less in a clinic,” CEO and co-founder Florian Brand said. We believe that the combination of a short treatment time and durable efficacy has the potential to enable accessible and convenient interventional treatments at scale."

BPL-003 has recently shown positive initial results on a Phase 2a clinical study for Treatment-Resistant Depression (TRD,) including "rapid and durable" antidepressant effects, with 45% of patients in remission three months, following a single dose. 

The compound will now be assessed in a multi-site Phase 2b study in 225 patients with TRD, of which topline data is expected in the second half of 2024. Plus, data from a separate Phase 2a study of BPL-003 in Alcohol Use Disorder (AUD) patients is expected mid-2024.

The other pipeline asset targeting a two-hour in-clinic treatment is VLS-01, an oral transmucosal film formulation of DMT also targeting TRD. The compound is currently being assessed in a Phase 1b study evaluating the safety and tolerability of the OTF formulation of VLS-01 as compared to intravenous DMT. Results from this study are also anticipated for H2 2024.

Other psychedelic assets in the company's portfolio with updates in the yearly period include:

• ELE-101, an IV formulation of psilocin targeting Major Depressive Disorder (MDD) potentially offering psilocybin's therapeutic benefits "in a more consistent, controllable, and shorter treatment paradigm" (approx. 2 hours.) The compound is currently in a Phase 1/2a study of which results are expected by mid-2024.
• COMP360, COMPASS Pathways' CMPS synthetic psilocybin therapy, is currently under evaluation in several trials. Most noticeably within a Phase 3 program in TRD patients (topline data to come in Q4 2024 and mid-2025,) but also in a Phase 2 trial in PTSD patients (efficacy data expected by Spring 2024.)
• IBX-210, an IV formulation of semi-synthetic ibogaine targeting Opioid Use Disorder (OUD), showed some mixed results in a Phase 1 study in 2023. Atai's novel IV formulation of ibogaine aims to improve safety, minimize changes in how it is processed in the body, and achieve a shorter and more predictable in-clinic time. A Phase 1/2a study of IBX-210 on OUD would begin in the second half of 2024.

Looking ahead, Brand said the company anticipates several important milestones in the coming year.

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Photo courtesy of Fabian Blank on Unsplash.