The BPL-003 Phase 2a trial is an open-label study investigating BPL-003 as both monotherapy and adjunctive to SSRIs in patients with Treatment Resistant Depression.Initial results from the recently completed monotherapy Part 1 of the study were shared in March 2024, and showed that a single dose of BPL-003 was safe and well-tolerated, with a rapid and durable antidepressant effect lasting up to 12-weeks post-dose. Part 2 of the study will investigate a single dose of BPL-003 in patients who are currently on ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Core Insights - atai Life Sciences announced the publication of Phase 1 results for BPL-003, a novel intranasal formulation of 5-MeO-DMT, indicating its safety and potential for treating mental health disorders [1][4] Group 1: Study Results - BPL-003 was evaluated in a double-blind, placebo-controlled Phase 1 study involving 44 healthy volunteers, demonstrating safety and tolerability with no serious adverse events reported [2] - The pharmacokinetics showed rapid absorption and elimination, with systemic exposure increasing dose-proportionally, and subjective psychedelic effects onset within minutes, resolving in less than two hours [2][3] - 60% of participants experienced a 'complete mystical experience' at doses of 10 mg and 12 mg, with 87% expressing willingness to accept the same or higher doses in the future [3] Group 2: Future Development - BPL-003 is currently under investigation in Phase 2a studies for Alcohol Use Disorder and Treatment Resistant Depression, with initial results from a Phase 2b study expected in H2 2024 [4] - The findings from Phase 1 could support a scalable treatment model that aligns with existing interventional treatment paradigms [2][4] Group 3: Company Background - Beckley Psytech is developing BPL-003, a short-duration psychedelic tryptamine associated with improvements in mood and anxiety, and is reported to produce mystical experiences comparable to high doses of psilocybin [5] - atai Life Sciences holds a 35.5% ownership stake in Beckley Psytech and has strategic plans for collaboration on digital therapeutics and market access activities [6]

atai Life Sciences (NASDAQ:ATAI, ETR:9VC) made significant strides in advancing its innovative mental health therapies in 2023, with a focus on psychedelic-based treatments for depression.   CEO and co-founder Florian Brand joined Proactive to discuss the company’s recent milestones including encouraging clinical trial results, what to expect from its ongoing research programs and upcoming catalysts for both the company and the broader psychedelics sector. Proactive: In 2023, there was a big focus on psyche ...

Momentum investing revolves around the idea of following a stock's recent trend in either direction. In the 'long' context, investors will be essentially be "buying high, but hoping to sell even higher." With this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving that way. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.While many investors like to look for moment ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO . Commission File Number: 001-40493 ATAI Life Sciences N.V. (Exact name of registrant as specified in its charter) The Netherlands Not Applicable (State or other ...

[2023 Q4 and Full Year Financial and Corporate Highlights](index=1&type=section&id=atai%20Life%20Sciences%20Reports%20Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results%20and%20Provides%20Corporate%20and%20Clinical%20Highlights) 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](index=1&type=section&id=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](index=2&type=chunk) - Cash, marketable securities, and committed term loan funding are expected to be sufficient to fund operations into **2026**[1](index=1&type=chunk) - 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](index=2&type=chunk)[3](index=3&type=chunk) [Corporate and Clinical Development](index=1&type=section&id=Corporate%20and%20Clinical%20Development) atai advanced its pipeline with strategic investments and operational streamlining, focusing on short-duration psychedelic therapies for mental health disorders [Corporate Highlights](index=1&type=section&id=Corporate%20Highlights) 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](index=4&type=chunk) - 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](index=4&type=chunk) - Streamlined operations by acquiring all remaining shares of its subsidiary, DemeRx IB, Inc., and simplifying its organizational structure[4](index=4&type=chunk) [Clinical Pipeline Highlights](index=2&type=section&id=Clinical%20Highlights) 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)](index=2&type=section&id=BPL-003%3A%205-MeO-DMT%20for%20Treatment-Resistant%20Depression%20%28TRD%29) 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](index=5&type=chunk) - The treatment fits the target two-hour in-clinic paradigm, with acute effects resolving on average in **less than two hours**[5](index=5&type=chunk) - Topline data from a controlled Phase 2b study involving **225 TRD patients** is anticipated in the **second half of 2024**[5](index=5&type=chunk) [VLS-01: N,N-dimethyltryptamine (DMT) for TRD](index=2&type=section&id=VLS-01%3A%20N%2CN-dimethyltryptamine%20%28DMT%29%20for%20TRD) 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](index=6&type=chunk) - Results from the Phase 1b trial are anticipated in the **second half of 2024**[6](index=6&type=chunk) [ELE-101: Psilocin for Major Depressive Disorder (MDD)](index=2&type=section&id=ELE-101%3A%20Psilocin%20for%20Major%20Depressive%20Disorder%20%28MDD%29) 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](index=6&type=chunk)[7](index=7&type=chunk) - Initial results from the ELE-01 Phase 1/2a study are expected in **H1 2024**[7](index=7&type=chunk) [COMP360: Psilocybin Therapy for TRD](index=2&type=section&id=COMP360%3A%20Psilocybin%20Therapy%20for%20TRD) 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](index=7&type=chunk) - Pivotal Trial 2 (COMP006) top-line data is anticipated in **mid-2025**[7](index=7&type=chunk) [IBX-210: Ibogaine for Opioid Use Disorder (OUD)](index=2&type=section&id=IBX-210%3A%20Ibogaine%20for%20Opioid%20Use%20Disorder%20%28OUD%29) 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](index=8&type=chunk) - A Phase 1/2a study of IBX-210 for the treatment of OUD is anticipated to initiate in the **second half of 2024**[9](index=9&type=chunk) [RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)](index=4&type=section&id=RL-007%3A%20Pro-Cognitive%20Neuromodulator%20for%20Cognitive%20Impairment%20Associated%20with%20Schizophrenia%20%28CIAS%29) 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](index=10&type=chunk) - Topline results from the Phase 2b study are expected in **mid-2025**[10](index=10&type=chunk) [Financial Results](index=4&type=section&id=Consolidated%20Financial%20Results) 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](index=4&type=section&id=Financial%20Results%20Summary) 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](index=11&type=chunk) 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](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) 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](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEET) 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 |

The Phase 1b trial of VLS-01 investigates the pharmacokinetics, pharmacodynamics, safety and tolerability of atai's proprietary, optimized oral transmucosal formulation of DMTVLS-01 is being developed as a rapid-acting and durable antidepressant for treatment resistant depression, which affects approximately 100 million people globallyVLS-01 is designed to induce a short psychedelic experience, allowing for a total in-clinic treatment of 2-hours, consistent with an established commercial paradigm in interve ...

Group 1 - atai Life Sciences is a clinical-stage biopharmaceutical company focused on transforming the treatment of mental health disorders [1][2] - The company will participate in a panel discussion at the TD Cowen conference in Boston on March 4, 2024, at 12:50pm ET [1] - A live audio webcast of the panel discussion will be available on the company's website, with a replay accessible after the event [1] Group 2 - atai aims to pool resources and best practices to accelerate the development of new medicines for mental health [2] - The company's vision is to heal mental health disorders, enabling individuals to live more fulfilled lives [2]

NEW YORK and BERLIN, Feb. 06, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ:ATAI) ("atai" or "Company") today announced that Anne Johnson, the Company's interim Chief Financial Officer since October 2023 and Chief Accounting Officer since August 2022, has been named Chief Financial Officer (CFO). Anne succeeds Stephen Bardin as the Company's CFO while Stephen will continue in an advisory role until March 31, 2024 to support the transition. "Anne has been an integral member of our team for over three y ...