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Medical-stage psychedelics biotech Atai Life Sciences ATAI introduced its consolidated monetary outcomes for the fourth quarter and full yr 2023.
The Numbers:
- Money, money equivalents and short-term investments of $154.2 million by December 31, 2023, as in comparison with $273.1 million by December 31, 2022.
- Quarterly and full-year R&D bills of $14.2 million and $62.2 million, respectively, as in comparison with $21.9 million and $74.3 million for a similar intervals in 2022.
- Quarterly and full-year Common and Administrative (G&A) bills of $19.4 million and $63.6 million, respectively, as in comparison with $15.7 million and $70.4 million in the identical intervals in 2022.
- Quarterly and full-year internet lack of $18.3 million and $40.2 million, respectively, as in comparison with $45.0 million and $152.4 million within the comparable 2022 intervals.
The report states that the lower of $118.9 million within the firm’s money place is primarily as a result of $84.1 million internet money utilized in working actions, $25.0 million for the Beckley Psytech funding, and $15.0 million of extra investments to advance its growth packages.
Nonetheless, the Atai workforce still expects its money, marketable securities and committed term loan facility with Hercules Capital for $175 million can be sufficient to fund operations into 2026.
Now Learn: Atai Life Sciences’ Q3 Earnings: Near $20M Burned QoQ, Says Funding ‘Sufficient’ To Streamline 2026
January’s strategic funding in Beckley Psytech added two clinical-stage belongings, BPL-003 and ELE-101, to Atai’s packages. The corporate now owns 35.5% of Beckley Psytech, plus a time-limited proper of first refusal on a future sale of the corporate, asset gross sales or different switch of economic rights and an indefinite proper of first negotiation for each 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 Part 1 research in 2023. Atai’s novel IV formulation of ibogaine goals to enhance security, decrease modifications in how it’s processed within the physique, and obtain a shorter and extra predictable in-clinic time. A Part 1/2a research of IBX-210 on OUD would start within the second half of 2024.
Wanting forward, Model mentioned the corporate anticipates a number of necessary milestones within the coming yr.
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Photograph courtesy of Fabian Blank on Unsplash.
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