ATAI Life Sciences(ATAI) - 2023 Q4 - Annual Results

2023 Q4 and Full Year Financial and Corporate Highlights atai Life Sciences reported Q4 and full-year 2023 results, emphasizing strategic focus on short-duration psychedelic therapies and a cash runway into 2026 Introduction atai Life Sciences reported Q4 and full-year 2023 results, highlighting its focus on short-duration psychedelic therapies and confirming a cash runway into 2026 - The company is focusing on psychedelic-based therapies that require two hours or less in a clinic, aiming for a combination of short treatment time and durable efficacy to enable accessible treatments at scale[2] - Cash, marketable securities, and committed term loan funding are expected to be sufficient to fund operations into 2026[1] - A key upcoming milestone is the Phase 2b data readout for BPL-003, an intranasal formulation of 5-MeO-DMT, anticipated in the second half of 2024[2][3] Corporate and Clinical Development atai advanced its pipeline with strategic investments and operational streamlining, focusing on short-duration psychedelic therapies for mental health disorders Corporate Highlights atai strategically invested in Beckley Psytech, acquiring a 35.5% stake and clinical assets, while streamlining operations through a subsidiary acquisition - Made a strategic investment in Beckley Psytech, acquiring a 35.5% ownership stake and adding two clinical-stage assets (BPL-003 and ELE-101) to its programs[4] - atai holds a time-limited right of first refusal on a future sale of Beckley Psytech and an indefinite right of first negotiation for BPL-003 and ELE-101[4] - Streamlined operations by acquiring all remaining shares of its subsidiary, DemeRx IB, Inc., and simplifying its organizational structure[4] Clinical Pipeline Highlights atai's clinical pipeline is advancing with key programs like BPL-003 and VLS-01, targeting short-duration treatments for depression, with multiple data readouts expected in 2024-2025 BPL-003: 5-MeO-DMT for Treatment-Resistant Depression (TRD) BPL-003 showed rapid, durable antidepressant effects in Phase 2a, with a Phase 2b study underway and topline data expected in H2 2024 - A Phase 2a open-label study showed a single administration resulted in rapid and durable antidepressant effects, with 45% of patients in remission three months after dosing[5] - The treatment fits the target two-hour in-clinic paradigm, with acute effects resolving on average in less than two hours[5] - Topline data from a controlled Phase 2b study involving 225 TRD patients is anticipated in the second half of 2024[5] VLS-01: N,N-dimethyltryptamine (DMT) for TRD VLS-01, an OTF DMT formulation, initiated Phase 1b dosing to optimize pharmacokinetics, with results anticipated in H2 2024 - Dosing has commenced in a Phase 1b study to evaluate an optimized OTF formulation of VLS-01 compared to intravenous (IV) DMT[6] - Results from the Phase 1b trial are anticipated in the second half of 2024[6] ELE-101: Psilocin for Major Depressive Disorder (MDD) ELE-101, an IV psilocin formulation, aims for a consistent, short treatment, with initial Phase 1/2a results expected in H1 2024 - ELE-101 is an IV formulation of psilocin, aiming to provide therapeutic benefits in a more controllable and shorter treatment paradigm of approximately 2 hours[6][7] - Initial results from the ELE-01 Phase 1/2a study are expected in H1 2024[7] COMP360: Psilocybin Therapy for TRD COMP360's Phase 3 program for TRD anticipates topline data from its first pivotal trial in Q4 2024 and the second in mid-2025 - Pivotal Trial 1 (COMP005) top-line data is expected in the fourth quarter of 2024[7] - Pivotal Trial 2 (COMP006) top-line data is anticipated in mid-2025[7] IBX-210: Ibogaine for Opioid Use Disorder (OUD) atai developed IBX-210, a novel IV ibogaine formulation for improved safety and predictability, with a Phase 1/2a study for OUD planned for H2 2024 - A novel IV formulation of ibogaine (IBX-210) was developed to improve safety, reduce pharmacokinetic variability, and shorten in-clinic time compared to the oral version[8] - A Phase 1/2a study of IBX-210 for the treatment of OUD is anticipated to initiate in the second half of 2024[9] RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS) RL-007 is undergoing a Phase 2b study for CIAS, evaluating two doses against placebo, with topline results expected in mid-2025 - An ongoing Phase 2b study is evaluating 20mg and 40mg doses of RL-007 versus placebo in patients with CIAS[10] - Topline results from the Phase 2b study are expected in mid-2025[10] Financial Results atai reported a significantly reduced net loss for full-year 2023, with decreased R&D and G&A expenses, and maintained a strong cash position Financial Results Summary For full-year 2023, atai significantly reduced its net loss to $40.2 million, with cash and investments at $154.2 million, driven by lower R&D and G&A expenses - Cash, cash equivalents, and short-term investments were $154.2 million as of December 31, 2023, compared to $273.1 million at year-end 2022[11] Research and Development and General and Administrative Expenses | Expense Category | Full Year 2023 (Millions) | Full Year 2022 (Millions) | Change (YoY) (Millions) | | :--- | :--- | :--- | :--- | | R&D Expenses | $62.2 | $74.3 | -$12.1 | | G&A Expenses | $63.6 | $70.4 | -$6.8 | Net Loss Attributable to Shareholders | Metric | Full Year 2023 (Millions) | Full Year 2022 (Millions) | | :--- | :--- | :--- | | Net Loss Attributable to Shareholders | $40.2 | $152.4 | Condensed Consolidated Statements of Operations For full-year 2023, total operating expenses decreased, leading to a narrowed net loss attributable to stockholders of $40.2 million, or ($0.25) per share Condensed Consolidated Statements of Operations | Metric (Thousands, except per share data) | Twelve Months Ended Dec 31, 2023 | Twelve Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Total operating expenses | $125,785 | $145,020 | | Loss from operations | ($125,471) | ($144,787) | | Net loss attributable to stockholders | ($40,224) | ($152,385) | | Net loss per share | ($0.25) | ($0.98) | Condensed Consolidated Balance Sheet As of December 31, 2023, total assets were $293.5 million, with a decrease in cash and cash equivalents but an increase in securities carried at fair value Condensed Consolidated Balance Sheet | Metric (Thousands) | As of Dec 31, 2023 | As of Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $45,034 | $190,613 | | Securities carried at fair value | $109,223 | $82,496 | | Total assets | $293,478 | $305,441 | | Total stockholders' equity | $242,962 | $260,740 |