Atai Life Sciences B.V. Stock Price, News & Analysis

atai Life Sciences (NASDAQ: ATAI) has initiated dosing in its Phase 2 study of EMP-01 (oral R-MDMA) for treating social anxiety disorder (SAD). The exploratory, randomized, double-blind, placebo-controlled trial will evaluate approximately 60 adult patients, who will receive two administrations of either EMP-01 or placebo, four weeks apart.

The study aims to assess safety, tolerability, and efficacy, with symptom monitoring for six weeks after the first dose. In previous Phase 1 studies, EMP-01 showed a unique, dose-dependent profile more similar to classical psychedelics than racemic MDMA. Topline data is expected in Q1 2026.

atai Life Sciences (NASDAQ: ATAI) reported its Q4 and full year 2024 financial results, highlighting significant clinical progress and a strengthened financial position. The company completed an equity offering raising $59.2 million, extending its operational runway into 2027.

Key clinical developments include: dosing the first patient in Phase 2 Elumina trial of VLS-01 for treatment-resistant depression; initiating Phase 2 trial of EMP-01 for social anxiety disorder; and Beckley Psytech completing enrollment in Phase 2b study of BPL-003. Topline data for VLS-01 and EMP-01 are expected in Q1'26, while BPL-003 results are anticipated in mid-2025.

Financial highlights: Cash position of $72.3 million as of December 31, 2024, down from $154.2 million year-over-year. R&D expenses were $55.5 million for 2024, decreased from $62.2 million in 2023. G&A expenses reduced to $47.5 million from $63.6 million. Net loss increased to $149.3 million in 2024 compared to $40.2 million in 2023.

atai Life Sciences (NASDAQ: ATAI) has initiated the Phase 2 Elumina clinical trial for VLS-01, announcing the first patient dosing. VLS-01, a proprietary oral transmucosal film formulation of DMT, is being developed to treat treatment-resistant depression (TRD) affecting approximately 100 million people globally.

The Elumina trial is a multicenter, double-blind, randomized, placebo-controlled study involving about 142 patients. The trial structure includes two treatment periods: First period participants will be randomized 1:1 to receive either 120mg VLS-01 or placebo on Day 1 and Week 2. The primary endpoint measures changes in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 4, with final assessments at Week 14. The second period begins at Week 14, testing two different dose levels (60mg vs 120mg) of VLS-01.

The company expects to report topline results in Q1 2026. VLS-01 is designed to fit within the established two-hour interventional psychiatry treatment paradigm, aiming to provide rapid, robust, and durable antidepressant effects.

atai Life Sciences (NASDAQ: ATAI) has completed enrollment for the core stage of its Phase 2b clinical trial evaluating BPL-003 (mebufotenin benzoate) for treatment-resistant depression (TRD). The trial enrolled 196 patients across 38 sites in six countries, testing 8mg and 12mg doses against a sub-perceptual dose.

The eight-week, quadruple-masked study aims to assess efficacy and safety in patients with moderate-to-severe depression who failed at least two prior treatments. Previous Phase 2a results showed promising outcomes, with 55% of patients achieving remission at Day 29 and 45% at Day 85 after a single 10mg dose. Notably, patients were dischargeable within two hours post-dosing.

An open-label extension stage continues to evaluate a second high dose of BPL-003. Topline results from the core stage are expected in mid-2025, with Phase 3 planning scheduled for the second half of 2025.

atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on mental health disorder treatments, has announced its participation in the TD Cowen 45th Annual Health Care Conference in Boston, MA. The event will take place from March 3-5, 2025.

The company's management team will engage in a fireside chat scheduled for Monday, March 3 at 11:50 A.M. ET, along with one-on-one investor meetings. A webcast of the presentation will be available, with an archived replay accessible on the Investors section of atai's website under Events for up to 90 days.

atai Life Sciences (NASDAQ: ATAI) has successfully completed its public offering of 26,190,477 common shares on February 14, 2025, followed by the underwriter's full exercise of its option to purchase an additional 3,928,571 shares at $2.10 per share on February 17, 2025. The total gross proceeds amounted to approximately $63.25 million.

The company plans to use the net proceeds for general corporate purposes, including working capital and advancing clinical development of its product candidates. Based on the planned use of proceeds and current operating plan, atai projects that its existing cash, short-term securities, public equity holdings, and committed term loan facility will fund operations into 2027. Berenberg acted as the sole bookrunner for the offering.

atai Life Sciences (NASDAQ: ATAI) has announced the pricing of a registered underwritten public offering of 26,190,477 common shares at $2.10 per share. The company expects to raise approximately $55 million in gross proceeds before deducting underwriting costs and other expenses.

The offering includes a 30-day option for the underwriter to purchase up to an additional 3,928,571 common shares. Berenberg is serving as the sole bookrunner for the offering, which is expected to close on February 14, 2025. The proceeds will be used for general corporate purposes, including working capital and advancing clinical development of product candidates and programs.

The offering is being made through an effective shelf registration statement filed with the SEC on July 1, 2022, and declared effective on July 11, 2022.

atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on mental health disorder treatments, has announced a proposed registered underwritten public offering of $55 million in common shares. The company will grant underwriters a 30-day option to purchase up to an additional $8.25 million of common shares.

Berenberg is serving as the sole bookrunner for the offering. The proceeds will be used for general corporate purposes, including working capital and advancing clinical development of product candidates and programs. The offering is being made through an effective shelf registration statement filed with the SEC on July 1, 2022.

atai Life Sciences (NASDAQ: ATAI) announced positive topline results from Beckley Psytech's Phase 2a open-label study of BPL-003, a synthetic intranasal formulation of 5-MeO-DMT benzoate, in treating alcohol use disorder (AUD). The study, involving 12 patients with moderate to severe AUD, demonstrated significant improvements following a single dose combined with relapse prevention therapy:

Key results after 12 weeks include:

• Reduction in daily alcohol consumption from 9.3 to 2.2 units
• Decrease in heavy drinking days from 56% to 13%
• Increase in abstinent days from 33% to 81%
• 50% of patients maintained complete abstinence

The treatment was well-tolerated with only mild to moderate adverse events reported, and patients were typically ready for discharge within two hours. Beckley Psytech plans to evaluate future development options and share additional clinical data throughout 2025.