Andrew Tsai

Ritu Baral

Charles Duncan

Judah Frommer

Brian Abrahams

Neena Bitritto-Garg

Patrick Trucchio

Sumant Kulkarni

- ATAI Life Sciences N.V. announced the **closing of its public offering** on **October 20, 2025**, which included the **full exercise of the underwriters' option** to purchase additional common shares.  **[1840904_0001140361-25-038748_ef20057467_ex99-1.htm:1]** **[1840904_0001140361-25-038748_ef20057467_8k.htm:2]** 
- The offering of **27,283,750 common shares** at a price of **$5.48 per share** generated approximately **$149.5 million in aggregate gross proceeds**.  **[1840904_0001140361-25-038748_ef20057467_ex99-1.htm:1]** **[1840904_0001140361-25-038748_ef20057467_8k.htm:2]** 
- The company anticipates that these net proceeds, combined with existing liquid assets, will be sufficient to **fund operations into 2029**.  **[1840904_0001140361-25-038748_ef20057467_ex99-1.htm:1]** **[1840904_0001140361-25-038748_ef20057467_8k.htm:2]** 
- These funds are primarily allocated to advance clinical development, including the **Phase 3 clinical program for BPL-003**, and completing Phase 2 trials for VLS-01 and EMP-01.  **[1840904_0001140361-25-038748_ef20057467_ex99-1.htm:1]** **[1840904_0001140361-25-038748_ef20057467_8k.htm:2]**

ATAI Life Sciences Completes Public Offering and Underwriters' Option Exercise

- **ATAI Life Sciences** and **Beckley Psytech** announced on **October 16, 2025**, that the **U.S. Food and Drug Administration (FDA)** granted **Breakthrough Therapy designation (BTD)** to **BPL-003** (mebufotenin benzoate) nasal spray for adult patients with **treatment-resistant depression (TRD)**.  **[1840904_0001140361-25-038319_ny20057248x2_ex99-1.htm:0]** **[1840904_0001140361-25-038319_ny20057248x2_8k.htm:2]** 
- The BTD expedites development for serious conditions and follows positive topline results from Beckley Psytech's Phase 2b study, which showed **rapid and durable antidepressant effects** from a single dose of BPL-003.  **[1840904_0001140361-25-038319_ny20057248x2_ex99-1.htm:0]** **[1840904_0001140361-25-038319_ny20057248x2_8k.htm:2]** 
- The **Phase 3 clinical program** for BPL-003 is anticipated to initiate in the **second quarter of 2026**, subject to alignment with the FDA.  **[1840904_0001140361-25-038319_ny20057248x2_ex99-1.htm:0]**

ATAI Life Sciences and Beckley Psytech Announce FDA Breakthrough Therapy Designation for BPL-003

- **ATAI Life Sciences** and **Beckley Psytech** announced that the **U.S. FDA granted Breakthrough Therapy designation (BTD) to BPL-003** (mebufotenin benzoate) nasal spray for adult patients with **treatment-resistant depression (TRD)**.  **[1840904_7807dbf1776143708fbc1325fd3bf582_1]** 
- The BTD was granted following **positive topline results from Beckley Psytech’s Phase 2b study**, which demonstrated **rapid and durable antidepressant effects** from a single dose of BPL-003.  **[1840904_7807dbf1776143708fbc1325fd3bf582_1]** 
- This designation is expected to **expedite the development timelines and regulatory reviews** for BPL-003, with **Phase 3 trials anticipated to begin in the second quarter of 2026**.  **[1840904_7807dbf1776143708fbc1325fd3bf582_1]**

ATAI Life Sciences and Beckley Psytech Receive FDA Breakthrough Therapy Designation for BPL-003

- Beckley Psytech Limited reported a **loss for the period of £20,093k** for the six months ended June 30, 2025, an increase from £7,478k in the prior year period, and held **£1.6 million** in cash and cash equivalents as of that date.  **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:0]** **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:3]** 
- The company faces a **material uncertainty regarding its ability to continue as a going concern** without additional financing.  **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:3]**  This is being addressed by **ATAI Life Sciences N.V.'s proposed acquisition** of Beckley Psytech, which is conditional on Atai shareholder approval in Q4 2025.  **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:3]** 
- To support operations, Atai, which already owns **33.6%** of Beckley Psytech, provided a **$10.0 million promissory note** on August 13, 2025, received on August 15, 2025, to fund BPL-003 development.  **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:3]** 
- On July 1, 2025, Beckley Psytech announced **positive topline results from its BPL-003-201 Phase 2b study**, which met its primary and all key secondary endpoints, demonstrating rapid, robust, and durable antidepressant effects.  **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:9]** **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:9]** 
- The company also intends to **spin off its Eleusis CGU** (In Process Research and Development) to existing shareholders, with management exploring alternative indications for this asset.  **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:8]** **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:9]** **[1840904_0001140361-25-037941_ef20056757_ex99-1.htm:9]**

Beckley Psytech Reports H1 2025 Financials, Atai Acquisition Progresses, and BPL-003 Study Shows Positive Results

- ATAI Life Sciences N.V. entered into a Share Purchase Agreement on **June 2, 2025**, to acquire the remaining issued share capital of Beckley Psytech not already owned by ATAI, by issuing **105,044,902 Ordinary Shares** to the sellers.  **[1840904_0001140361-25-036537_ny20050228x7_ex99-2.htm:1]**  The acquisition is expected to close in the **second half of 2025**, after which the combined group will be renamed **"Atai Beckley N.V."**.  **[1840904_0001140361-25-036537_ny20050228x7_ex99-2.htm:1]** 
- The company plans a **Redomiciliation** to Delaware, expected to be completed before the end of **2025** and prior to the acquisition, involving a **one-for-one share exchange** that is not anticipated to materially affect its consolidated financial statements or effective tax rate, with estimated transaction costs of approximately **$3.0 million**.  **[1840904_0001140361-25-036537_ny20050228x7_ex99-2.htm:1]** 
- On **July 1, 2025**, ATAI completed a **PIPE Financing**, raising approximately **$50.0 million** in gross proceeds through the issuance of ordinary shares and pre-funded warrants.  **[1840904_0001140361-25-036537_ny20050228x7_ex99-2.htm:1]**  Additionally, on **August 13, 2025**, ATAI provided a **Promissory Note** of up to **$10.0 million** to Beckley Psytech for BPL-003 development milestones.  **[1840904_0001140361-25-036537_ny20050228x7_ex99-2.htm:1]** 
- The unaudited pro forma net loss per share (basic and diluted) is **$(0.28)** for the **six months ended June 30, 2025**, and **$(2.55)** for the **year ended December 31, 2024**, reflecting these transactions.  **[1840904_0001140361-25-036537_ny20050228x7_ex99-2.htm:7]** **[1840904_0001140361-25-036537_ny20050228x7_ex99-2.htm:8]** **[1840904_0001140361-25-036537_ny20050228x7_ex99-2.htm:28]**

ATAI Life Sciences Announces Acquisition of Beckley Psytech, Redomiciliation, and Recent Financing

- **ATAI Life Sciences** and **Beckley Psytech** announced **positive Phase 2a data** for a **two-dose induction regimen of BPL-003** (intranasal mebufotenin benzoate) in patients with **treatment-resistant depression (TRD)**.  **[1840904_0001140361-25-035777_ef20055927_ex99-1.htm:0]** **[1840904_0001140361-25-035777_ef20055927_8k.htm:1]** **[1840904_0001140361-25-035777_ef20055927_8k.htm:2]** 
- The open-label study demonstrated **rapid, clinically meaningful, and durable antidepressant effects** sustained for up to **3 months**, with the second dose leading to further reductions in MADRS scores.  **[1840904_0001140361-25-035777_ef20055927_ex99-1.htm:0]** **[1840904_0001140361-25-035777_ef20055927_ex99-1.htm:1]** **[1840904_0001140361-25-035777_ef20055927_8k.htm:2]** 
- Key efficacy results include a mean **MADRS reduction of 19.0 points from baseline** one week after the second dose, and **remitter rates doubling to 50% at Week 8** (6 weeks after the second dose).  **[1840904_0001140361-25-035777_ef20055927_ex99-1.htm:1]** **[1840904_0001140361-25-035777_ef20055927_8k.htm:2]** 
- **BPL-003 was generally well-tolerated**, with all adverse events classified as mild to moderate, and patients met discharge readiness criteria within two hours after dosing.  **[1840904_0001140361-25-035777_ef20055927_ex99-1.htm:1]** **[1840904_0001140361-25-035777_ef20055927_8k.htm:2]** 
- **Phase 3 clinical trials** for BPL-003 in TRD are expected to **initiate in the first half of 2026**, pending FDA feedback.  **[1840904_0001140361-25-035777_ef20055927_ex99-1.htm:1]** **[1840904_0001140361-25-035777_ef20055927_8k.htm:2]**

ATAI Life Sciences and Beckley Psytech Report Positive Phase 2a Data for BPL-003 in TRD

- ATAI Life Sciences announced positive Phase 2b data for **BPL-003** in Treatment-Resistant Depression (TRD), demonstrating a **MADRS difference of 6.3** versus subclinical control at day 29.  **[1840904_2146205_0]** 
- The company will proceed with the **8 milligram dose** of BPL-003 for further development, citing similar efficacy but a less favorable safety profile for the 12 milligram dose.  **[1840904_2146205_7]** 
- An end-of-Phase 2 meeting with the FDA for BPL-003 is scheduled for submission this quarter, with Phase 3 study initiation targeted for **early next year** and patient enrollment around mid-next year.  **[1840904_2146205_1]** **[1840904_2146205_3]** 
- The VLS-01 program is facing delays in site activation and recruitment due to limited psychedelic experience sites and challenges with Schedule I license approvals.  **[1840904_2146205_6]** 
- ATAI is exploring EMP-01 for social anxiety disorder, an indication representing a **market of over 13 million individuals**.  **[1840904_2146205_7]**

ATAI Life Sciences (ATAI)