[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 ...

Though psychedelic therapies and related psychedelic stocks have fallen out of favor recently, there’s still tremendous research and insight happening beneath the surface. Even Elon Musk uses ketamine as a depression therapeutic. While it isn’t technically a psychedelic, it’s often lumped into the same non-standard treatment protocols associated with psychedelic stocks.Johns Hopkins is committing to more than $55 million in psychedelic research funding. However, the hospital center is just one of many such ...

Core Insights - The biotech sector focused on psychedelics has faced significant challenges since mid-2021, with stocks of leading companies down over 75% compared to three years ago, but 2024 is expected to bring new opportunities for investors willing to take risks [1] Industry Developments - Late 2023 saw three key developments that could lead to a transformative year for the psychedelics industry, particularly in treating PTSD, which affects approximately 13 million people in the U.S. [2] - Compass Pathways reported positive early results from its phase 2 clinical trial of COMP360, a psilocybin therapy for PTSD, indicating good tolerance among patients [3] - Compass is also set to release data from a phase 3 trial for treatment-resistant depression (TRD) in summer 2024, which could serve as a significant catalyst for the company and its peers [4] Regulatory Milestones - The Multidisciplinary Association for Psychedelic Studies (MAPS) submitted a request to the FDA for approval of MDMA combined with psychotherapy for PTSD, marking a potential first for psychedelic-derived treatments [5] - The FDA is expected to decide on the priority review request by February 12, 2024, which could lead to a decision on approval within six months [6] - The approval of MDMA therapy would represent a major milestone for the industry, likely boosting share prices across clinical-stage competitors and reducing perceived risks associated with psychedelic biotech stocks [7] Investment Considerations - Investors are encouraged to consider the potential for significant derisking events in the psychedelics industry, as successful outcomes from the described catalysts could lead to increased approval rates for additional therapies [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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 No ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q n (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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 A ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q n (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 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 ...

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, 2022 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 ...