[Management Commentary](index=1&type=section&id=Management%20Commentary) Management highlights the transformative Beckley Psytech combination, solidifying atai's leadership in psychedelic mental health and advancing its clinical pipeline with strong investor confidence - The planned strategic combination with Beckley Psytech is expected to establish atai as a **global leader** in psychedelic mental health[3](index=3&type=chunk) - The combination adds **BPL-003**, a late-stage, clinically-validated asset for treatment-resistant depression (TRD), to atai's wholly owned pipeline[3](index=3&type=chunk) - Recent fundraising efforts in 2025 totaled nearly **$140 million**, reflecting strong investor confidence in the company's strategy[3](index=3&type=chunk) [Key Highlights](index=1&type=section&id=Key%20Highlights) Positive topline data for BPL-003 in TRD demonstrated rapid, durable effects, with cash expected to fund operations into H2 2027, and key milestones anticipated in Q3 2025 - Positive topline data from the **Phase 2b trial of BPL-003** in TRD met primary and key secondary endpoints, showing single-dose effects for up to **8 weeks**[4](index=4&type=chunk) - Topline data from the eight-week open-label extension of the BPL-003 Phase 2b trial is expected in **Q3 2025**[4](index=4&type=chunk) - The company's cash, securities, and other assets are expected to fund combined operations into the **second half of 2027**[4](index=4&type=chunk) [Recent Clinical Highlights and Upcoming Milestones](index=2&type=section&id=Recent%20Clinical%20Highlights%20and%20Upcoming%20Milestones) Updates on key clinical programs include positive BPL-003 Phase 2b results, VLS-01 data delay to H2 2026, ongoing EMP-01 enrollment, and Inidascamine's Phase 2b trial not meeting its primary endpoint [BPL-003 (Intranasal Mebufotenin)](index=2&type=section&id=BPL-003) BPL-003's Phase 2b study in TRD met all endpoints, showing rapid, durable antidepressant effects for up to 8 weeks, with the 8 mg dose selected for Phase 3 - The Phase 2b study met its primary endpoint, demonstrating rapid and durable antidepressant effects for up to **8 weeks** with a single dose[5](index=5&type=chunk) - BPL-003 was generally well-tolerated, with **99%** of treatment-emergent adverse events being mild or moderate, and no drug-related serious adverse events[5](index=5&type=chunk) - The **8 mg dose** has been selected for Phase 3 advancement, with an End-of-Phase 2 meeting request planned for **Q3 2025**[5](index=5&type=chunk) [VLS-01 (Buccal Film DMT)](index=2&type=section&id=VLS-01) Topline data for VLS-01 in TRD is delayed to H2 2026 due to slower site activation and patient recruitment in its Phase 2 trial - Topline data from the Phase 2 trial of VLS-01 in TRD patients is now anticipated in the **second half of 2026**[5](index=5&type=chunk) - The delay is attributed to slower-than-anticipated site activation and patient recruitment[5](index=5&type=chunk) [EMP-01 (Oral R-MDMA)](index=2&type=section&id=EMP-01) Enrollment continues for the Phase 2 study of EMP-01 for social anxiety disorder, with topline data expected in Q1 2026 - Patient enrollment continues in the Phase 2 study of EMP-01 for social anxiety disorder (SAD)[5](index=5&type=chunk) - Topline data from the Phase 2 study are anticipated in the **first quarter of 2026**[5](index=5&type=chunk) [Inidascamine (RL-007)](index=3&type=section&id=Inidascamine) Inidascamine's Phase 2b trial for CIAS did not meet its primary endpoint, leading atai to reallocate resources to its wholly owned psychedelic programs - The Phase 2b trial of inidascamine for CIAS did not meet its primary endpoint with statistical significance[10](index=10&type=chunk) - atai plans to allocate resources to its wholly owned pipeline of psychedelic product candidates focused on affective disorders[10](index=10&type=chunk) [Novel 5-HT2A Receptor Agonists](index=2&type=section&id=Novel%205-HT2A%20Receptor%20Agonists) Novel 5-HT2A receptor agonists with non-hallucinogenic potential in rodent studies are undergoing further optimization and evaluation for therapeutic use - Discovered novel **5-HT2A receptor agonists** that maintain non-hallucinogenic potential in rodent drug discrimination studies[6](index=6&type=chunk) [Corporate Updates](index=3&type=section&id=Corporate%20Updates) atai is advancing its strategic combination with Beckley Psytech for Q4 2025 shareholder approval and initiating US redomiciliation for structural and operational efficiencies - The planned strategic combination with Beckley Psytech is expected to proceed to shareholder approval in **Q4 2025**[10](index=10&type=chunk) - The company has initiated the process to move its corporate domicile to the US for structural simplification and operational efficiencies[10](index=10&type=chunk) [Consolidated Financial Results](index=3&type=section&id=Consolidated%20Financial%20Results) Q2 2025 net loss significantly narrowed to $27.7 million, cash increased to $95.9 million, R&D expenses decreased, and G&A expenses rose due to strategic transactions [Financial Position and Liquidity](index=3&type=section&id=Financial%20Position%20and%20Liquidity) As of June 30, 2025, cash and equivalents totaled $95.9 million, an increase driven by $89.2 million in equity issuances, funding operations into H2 2027 Cash, Cash Equivalents, and Short-Term Securities | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Cash, cash equivalents and short-term securities | $95.9 million | $72.3 million | - The **$23.6 million** increase in cash is primarily due to **$89.2 million** in net proceeds from equity issuances, offset by cash used in operations and debt payoff[7](index=7&type=chunk) - The company's cash runway is expected to fund operations for the combined company into the **second half of 2027**[7](index=7&type=chunk) [Operating Expenses and Net Loss](index=3&type=section&id=Operating%20Expenses%20and%20Net%20Loss) Q2 2025 saw R&D expenses decrease to $11.1 million, G&A expenses increase to $14.9 million, and net loss narrow significantly to $27.7 million Operating Expenses and Net Loss (Q2) | Expense Category | 2025 (Millions USD) | 2024 (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | R&D Expenses | $11.1 | $12.6 | ($1.5) | | G&A Expenses | $14.9 | $13.4 | +$1.5 | | Net Loss | ($27.7) | ($57.3) | $29.6 | - The decrease in R&D expenses was primarily due to lower personnel-related expenses and consulting services[8](index=8&type=chunk) - The increase in G&A expenses was largely due to legal and professional service costs related to the planned Beckley Psytech combination and US redomiciliation[9](index=9&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) Condensed consolidated financial statements detail a Q2 2025 net loss of $27.7 million, with total assets of $189.2 million and stockholders' equity of $143.9 million [Condensed Consolidated Statements of Operations](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Q2 2025 statements show revenue of $0.7 million, total operating expenses of $26.0 million, and a net loss of $27.7 million, or ($0.14) per share Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Metric | 2025 (unaudited) | 2024 | | :--- | :--- | :--- | | Revenue (Thousands USD) | $719 | $273 | | Total operating expenses (Thousands USD) | $25,992 | $26,002 | | Loss from operations (Thousands USD) | ($25,273) | ($25,729) | | Net loss attributable to stockholders (Thousands USD) | ($27,729) | ($57,312) | | Net loss per share — basic and diluted (USD) | ($0.14) | ($0.36) | [Condensed Consolidated Balance Sheet](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEET) As of June 30, 2025, the balance sheet reports total assets of $189.2 million, total liabilities of $45.3 million, and stockholders' equity of $143.9 million Condensed Consolidated Balance Sheet (Thousands USD) | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $61,940 | $17,505 | | Total assets | $189,204 | $159,387 | | Total liabilities | $45,279 | $42,833 | | Total stockholders' equity | $143,925 | $116,554 | [Legal Disclaimers and Forward-Looking Statements](index=4&type=section&id=Legal%20Disclaimers) This section outlines forward-looking statements regarding business strategy, clinical development, the Beckley Psytech transaction, and financial projections, all subject to significant risks and uncertainties - The press release includes forward-looking statements regarding business strategy, product candidate development, the proposed transaction with Beckley Psytech, and cash runway[13](index=13&type=chunk) - These statements involve risks and uncertainties, including the possibility that proposed transactions may not be completed or their anticipated benefits realized[14](index=14&type=chunk) - Investors are urged to read the S-4 Registration Statement and Proxy Statement, when available, for important information about the proposed transactions[16](index=16&type=chunk)

Core Insights - The planned strategic combination with Beckley Psytech is expected to establish atai Life Sciences as a global leader in psychedelic-based mental health therapies, particularly for treatment-resistant depression [2][12] - The company reported positive Phase 2b results for BPL-003, indicating its potential as a fast-acting and durable treatment option for patients [2][4] - Recent fundraising efforts have raised nearly $140 million in 2025, reflecting strong investor confidence in the company's strategy [2] Clinical Highlights and Upcoming Milestones - BPL-003 demonstrated rapid and durable antidepressant effects for up to 8 weeks with a single dose in a Phase 2b clinical trial involving 193 patients [3][4] - The company plans to submit an End-of-Phase 2 meeting request to the FDA in the third quarter of 2025 [5] - Topline data from the eight-week open-label extension stage of the Phase 2b trial is expected in Q3 2025 [3][4] Financial Performance - As of June 30, 2025, the company had cash, cash equivalents, and short-term securities totaling $95.9 million, an increase from $72.3 million at the end of 2024 [10] - The net loss attributable to stockholders for Q2 2025 was $27.7 million, a significant decrease from $57.3 million in Q2 2024 [16][25] - Research and development expenses for Q2 2025 were $11.1 million, down from $12.6 million in the same period last year [14] Corporate Updates - The strategic combination with Beckley Psytech is expected to progress to the shareholder approval stage in Q4 2025 [12] - The company is in the process of relocating its corporate domicile to the U.S. to enhance operational efficiency [12] - atai is focusing on its wholly owned pipeline of psychedelic product candidates aimed at addressing affective disorders [12]

Group 1 - Atai Life Sciences (NASDAQ: ATAI) reported results from its phase 2b study of inidascamine for treating cognitive impairment associated with schizophrenia, indicating a negative outcome [2] - The company is part of the Biotech Analysis Central service, which provides extensive analysis and a model portfolio of biotech stocks [2] Group 2 - The article emphasizes the importance of informed decision-making for healthcare investors through detailed analysis and news reports [2]

Core Insights - Recognify Life Sciences announced that its Phase 2b clinical trial for inidascamine did not meet its primary endpoint for cognitive improvement in patients with cognitive impairment associated with schizophrenia [1][2] - Despite not achieving statistical significance, inidascamine showed consistent numerical improvements across various cognitive measures, including Symbol Coding and Verbal Learning [2][4] - The drug demonstrated a favorable safety profile, with no significant side effects commonly associated with schizophrenia treatments [3][4] Company Overview - Recognify Life Sciences is a clinical-stage biotech company focused on developing pro-cognitive treatments for mental health and neurodegenerative disorders [10] - The company is a strategic investment of atai Life Sciences, which is also involved in developing psychedelic-based therapies for mental health [11] Clinical Trial Details - The Phase 2b trial enrolled 242 patients across the United States and Europe, evaluating the efficacy, safety, and tolerability of inidascamine over a six-week period [4] - The study's primary endpoint was based on the MCCB neurocognitive composite score, which did not show statistical significance, but secondary and exploratory endpoints are still under analysis [2][4] Future Directions - Recognify Life Sciences plans to present additional results from the study at scientific meetings and will evaluate strategic options for inidascamine based on the complete data set [5][6] - The ongoing analysis aims to identify potential responder populations and mechanistic insights that could guide future development [4][5] Industry Context - Cognitive impairment associated with schizophrenia affects approximately 80% of patients, representing a significant unmet clinical need, as there are currently no effective pharmaceutical treatments approved for this condition [9] - The global prevalence of schizophrenia is over 21 million, with around 2.4 million cases in the United States [9]

Core Viewpoint - atai Life Sciences N.V. (ATAI) has been upgraded to a Zacks Rank 1 (Strong Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the importance of changing earnings estimates, which are closely correlated with near-term stock price movements [4][6]. - Rising earnings estimates for atai Life Sciences indicate an improvement in the company's underlying business, likely leading to an increase in stock price [5][10]. Zacks Rating System - The Zacks Rank stock-rating system categorizes stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7][9]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions [9][10]. Recent Earnings Estimate Revisions - For the fiscal year ending December 2025, atai Life Sciences is expected to earn -$0.54 per share, unchanged from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for atai Life Sciences has increased by 27.9% [8].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, and has prepared detailed reports on more than 1,000 companies [1]

Core Insights - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Technology Adoption - Proactive is recognized for being a forward-looking and enthusiastic adopter of technology [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Findings - Atai Life Sciences and Beckley Psytech Limited announced successful topline results from the Phase 2b trial of BPL-003, achieving primary and key secondary endpoints in patients with treatment-resistant depression [1][3][4] Efficacy Results - A single 12 mg dose of BPL-003 resulted in a statistically significant mean reduction of 11.1 points in depressive symptoms on the MADRS scale at Day 29, compared to a 5.8 point reduction in the 0.3 mg comparator group (p = 0.0038) [3][4] - The 8 mg dose also showed significant improvement with a mean MADRS score reduction of 12.1 points at Day 29 (p = 0.0025) [4] - Both 8 mg and 12 mg doses demonstrated significant efficacy as early as Day 2, with mean reductions of 8.8 points and 8.9 points, respectively, compared to a 3.9 point reduction in the 0.3 mg group [6] - Durable effects were observed, with the 8 mg group showing a mean reduction of 10.8 points at Day 57 [7] Safety Findings - More than 99% of treatment-emergent adverse events were mild or moderate, with no serious adverse events reported [8] - The 8 mg dose was better tolerated than the 12 mg dose, with dose-related increases in discomfort and other mild side effects [8] - No instances of treatment-emergent suicidal intent or behavior were observed in the 8 mg or 12 mg groups [9] Future Developments - The study includes an ongoing eight-week open-label extension to evaluate the safety and efficacy of a second 12 mg dose, with data expected in Q3 2025 [9][10] - Atai Life Sciences announced a private placement of 18.3 million shares, raising approximately $50 million in gross proceeds [10] Transaction Update - The companies plan to combine in an all-share transaction, contingent on the success of the Phase 2b trial, expected to close in the second half of 2025 [2] Market Reaction - Following the announcement, ATAI stock rose by 28.3% to $2.81 in premarket trading [10]

Summary of Atai Life Sciences (ATAI) Update / Briefing July 01, 2025 Company Overview - **Company**: Atai Life Sciences - **Focus**: Development of psychedelic therapies for mental health, specifically targeting treatment-resistant depression with the drug BPL-three Key Industry Insights - **Market Context**: Treatment-resistant depression is a significant public health issue, affecting millions globally and is the second leading cause of disability worldwide [12][12] - **Competitor Analysis**: SPRAVATO, a leading treatment in this space, achieved blockbuster status with approximately $930 million in sales in the U.S. in the previous year [47][47] Core Findings from Phase 2B Trial of BPL-three - **Trial Success**: The Phase 2b trial of BPL-three exceeded expectations, meeting both primary and secondary endpoints, demonstrating rapid and durable antidepressant effects [6][6][10][10] - **Efficacy**: - Significant reductions in MADRS scores were observed with both 8 mg and 12 mg doses compared to the active comparator (0.3 mg) [7][7] - The drug showed a robust effect lasting at least two months post-administration [42][42] - Approximately one-third of subjects were responders by day eight, maintaining this response through day 57 [27][27] - **Safety Profile**: - The drug was well tolerated, with 99% of adverse events being mild or moderate, and no serious drug-related adverse events reported [8][8][32][32] - No suicide-related safety signals were detected, which is critical given the population studied [36][36] Dosing and Administration Insights - **Dosing Strategy**: The 8 mg dose was identified as potentially optimal, showing comparable efficacy to the 12 mg dose with fewer side effects [25][25][30][30] - **Administration Time**: The treatment requires a short in-clinic time of approximately two hours, allowing for rapid discharge post-treatment, which aligns with the interventional psychiatry model [10][10][34][34] Future Development Plans - **Phase 3 Readiness**: The company is preparing to advance BPL-three into Phase 3 trials, with an end-of-phase 2 meeting with the FDA anticipated in Q3 2025 [45][45] - **Redosing Strategy**: Future studies will explore a potential redosing paradigm, likely within a two to three-month window, which would significantly improve treatment convenience compared to SPRAVATO [68][68] Competitive Advantages - **Unique Positioning**: Atai Life Sciences is positioned uniquely with BPL-three and VLS-one, both designed for a two-hour treatment paradigm, contrasting with competitors requiring multiple doses over extended periods [51][51][52][52] - **Commercial Scalability**: The single administration model with a two-hour follow-up is expected to enhance commercial scalability and patient convenience [51][51] Upcoming Milestones - **Data Releases**: Additional data from ongoing studies, including an open-label extension study, are expected in the near future, which will further inform the efficacy and safety profile of BPL-three [44][44] - **Regulatory Engagement**: The company plans to engage with regulatory bodies regarding potential breakthrough designations and the national review voucher program for expedited approval processes [117][117] Conclusion - **Overall Assessment**: The Phase 2b trial results for BPL-three indicate a promising new treatment option for patients with treatment-resistant depression, with a favorable safety profile and significant efficacy, setting the stage for further development and potential market entry [62][62]