Core Insights - Atai Beckley N.V. is a clinical-stage biopharmaceutical company focused on developing effective and rapid-acting mental health treatments [2] - The company was formed through the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025 [2] - Key products in Atai Beckley's pipeline include BPL-003, VLS-01, and EMP-01, all of which are in Phase 2 clinical development targeting treatment-resistant depression and social anxiety disorder [2] Company Participation - Srinivas Rao, M.D., Ph.D., and Kevin Craig, M.D. will participate in the Jefferies Global Healthcare Conference in London [1] - The format will include a fireside chat and one-on-one investor meetings scheduled for November 20 at 11:30 A.M. GMT [1] - An archived replay of the event will be available on the company's website for up to 90 days [1]

Financial Performance - Total revenue for the three months ended September 30, 2025, was $749,000, compared to $40,000 for the same period in 2024, indicating a significant increase[23] - The net loss attributable to Atai Beckley N.V. stockholders for the three months ended September 30, 2025, was $61.074 million, compared to a loss of $26.286 million for the same period in 2024, reflecting an increase in losses[23] - For the three months ended September 30, 2025, the net loss was $61,098 thousand, compared to a net loss of $26,311 thousand for the same period in 2024, representing an increase of 132%[25] - For the nine months ended September 30, 2025, the net loss was $115,309 thousand, slightly higher than the net loss of $111,058 thousand for the same period in 2024, indicating a 4% increase[25] - The comprehensive loss attributable to Atai Beckley N.V. stockholders for the three months ended September 30, 2025, was $61,104 thousand, compared to $27,249 thousand for the same period in 2024, reflecting a 124% increase[25] - The total comprehensive loss for the nine months ended September 30, 2025, was $117,807 thousand, compared to $111,754 thousand for the same period in 2024, marking a 5% increase[25] Assets and Liabilities - Total current assets increased to $130.666 million as of September 30, 2025, up from $80.125 million on December 31, 2024, representing a growth of 63%[20] - Cash and cash equivalents rose to $30.402 million as of September 30, 2025, compared to $17.505 million on December 31, 2024, marking a 73% increase[20] - Total liabilities increased to $79.912 million as of September 30, 2025, from $42.833 million on December 31, 2024, representing an increase of 86%[20] - The company reported a total stockholders' equity of $159.908 million as of September 30, 2025, up from $116.554 million on December 31, 2024, indicating a growth of 37%[20] Cash Flow and Funding - Cash flows used in operating activities amounted to $55.2 million for the nine months ended September 30, 2025, slightly improved from $58.1 million in the prior year[32] - The company expects its existing cash and cash equivalents and short-term securities will be sufficient to fund operating expenses for at least the next 12 months[45] - The company raised $118.2 million from equity offerings during the nine months ended September 30, 2025[32] - The company raised approximately $50.0 million through the July 2025 PIPE Financing by issuing 18,264,840 common shares at a price of $2.19 per share[176] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $37.1 million, slightly up from $36.5 million in the same period of 2024[23] - The company is focused on developing a pipeline of interventional psychiatric product candidates aimed at treating difficult-to-treat mental health conditions[35] - The company has not generated any revenues from its core psychedelic product candidates and does not anticipate doing so until successful development and regulatory approval[44] Acquisitions and Investments - The company completed the acquisition of Beckley Psytech Limited on November 5, 2025, enhancing its capabilities in psychedelic-based medicines[42] - The company acquired IntelGenx Corp. in October 2024, which has since been rebranded to Nualtis Corp., focusing on novel oral thin film products[43] - The Company acquired Nualtis Corp. on October 2, 2024, for a total consideration of $5.7 million, which was the fair value of the discharged debt[93] - The estimated fair value of the net assets acquired from Nualtis at the acquisition date totaled $5.384 million, with goodwill recognized at $0.331 million[94] Stockholder Equity and Shares - The weighted average common shares outstanding attributable to Atai Beckley N.V. stockholders increased to 217,601,496 for the three months ended September 30, 2025, compared to 160,621,817 for the same period in 2024[23] - The company issued 30,119,048 common shares, net of issuance costs of $4.1 million, resulting in an increase of $59,117 thousand in additional paid-in capital[29] Financial Challenges - The company expects to continue incurring losses for the foreseeable future and may never achieve profitability, highlighting ongoing financial challenges[10] - The accumulated deficit as of September 30, 2025, was $815,441 thousand, up from $661,249 thousand as of September 30, 2024, indicating a significant increase in losses[29] Revenue Recognition - For the three and nine months ended September 30, 2025, the Company did not recognize revenue from its primary operations and does not expect to do so for at least the next several years[74] - The Company recognized $0.2 million of license revenue pursuant to the Rizafilm Asset Purchase Agreement during the nine months ended September 30, 2025[78] - The Company recognized $0.7 million and $2.8 million in revenue from research and development services for the three and nine months ended September 30, 2025, respectively[79] Digital Assets - The Company expects to hold its digital assets as a long-term investment, classifying them as non-current assets as of September 30, 2025[60] - The Company held digital assets valued at approximately $10.0 million, consisting exclusively of Bitcoin[196] - The Company recognized a gain of $0.2 million and $1.4 million for the three and nine months ended September 30, 2025, respectively, related to the change in fair value of its digital assets[150] Lease Obligations - The company recognized operating lease right-of-use assets of $2,662,000 and lease liabilities of $2,958,000 as of September 30, 2025, compared to $1,334,000 and $1,209,000 respectively at December 31, 2024[205] - The weighted-average remaining lease term for the company's operating leases is 4.5 years, with a weighted-average discount rate of 10.2% as of September 30, 2025[205]

Core Insights - Proactive provides fast, accessible, and actionable business and finance news content to a global investment audience [2] - The company focuses on medium and small-cap markets while also covering blue-chip companies and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, mining, oil and gas, and emerging technologies [3] Technology Adoption - 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 does not provide any relevant content regarding company or industry insights [1]

Financial Performance - AtaiBeckley reported a net loss of $61.1 million for Q3 2025, compared to a net loss of $26.3 million in Q3 2024, reflecting a significant increase in losses[14] - General and administrative (G&A) expenses rose to $14.5 million in Q3 2025, compared to $10.3 million in Q3 2024, largely due to increased legal and professional service expenses[12] - Research and development (R&D) expenses increased to $14.7 million in Q3 2025 from $12.4 million in the same period last year, driven by higher clinical program costs[11] Cash and Securities - The company had cash, cash equivalents, and short-term securities of $114.6 million as of September 30, 2025, up from $72.3 million at the end of 2024, primarily due to $148.8 million in net proceeds from equity issuances[10] - AtaiBeckley closed a public offering of common shares, generating approximately $150 million in gross proceeds, expected to fund operations into 2029[13] - Cash and cash equivalents rose to $30.40 billion, compared to $17.51 billion in December 2024, marking a 73.5% increase[23] Assets and Equity - Total assets increased to $239.82 billion as of September 30, 2025, up from $159.39 billion in December 2024, representing a growth of 50.4%[23] - Total stockholders' equity attributable to Atai Beckley N.V. stockholders increased to $159.75 billion from $116.30 billion, reflecting a growth of 37.3%[23] - Other investments held at fair value increased to $34.41 billion from $28.89 billion, a growth of 19.2%[23] Liabilities - Accounts payable increased to $5.37 billion, up from $2.62 billion, indicating a rise of 104.5%[23] - Pre-funded warrant liabilities reached $57.43 billion, with no previous balance reported in December 2024[23] - Current portion of long-term debt decreased to $0 from $6.37 billion, indicating a significant reduction in short-term liabilities[23] - Noncurrent portion of lease liabilities increased to $2.43 billion from $0.73 billion, reflecting a rise of 232.9%[23] Clinical Developments - BPL-003 received Breakthrough Therapy designation from the FDA for treatment-resistant depression, with positive Phase 2b data indicating sustained antidepressant effects after a second dose[4] - The company completed enrollment in the Phase 2a trial of EMP-01 for social anxiety disorder and anticipates topline results in Q1 2026[7] - The company is scheduled to have an End-of-Phase 2 meeting with the FDA for BPL-003, with guidance on the Phase 3 clinical program expected in Q1 2026[7] Grants and Funding - A multi-year grant worth up to $11.4 million was awarded by the National Institute on Drug Abuse to support the development of novel 5-HT2A/2C receptor agonists for opioid use disorder[8] Shareholder Information - The weighted average common shares outstanding attributable to AtaiBeckley N.V. stockholders increased to 217,601,496 in Q3 2025 from 160,621,817 in Q3 2024[21]

Core Insights - AtaiBeckley has established itself as a global leader in transformative mental health therapies, particularly focusing on rapid-acting psychedelic treatments [2][3] - The FDA granted Breakthrough Therapy designation for BPL-003, indicating its potential to significantly improve treatment for patients with treatment-resistant depression (TRD) [3][4] - The company has made substantial progress in its clinical pipeline, including positive Phase 2a and Phase 2b data for BPL-003 and advancements in other therapies [2][3] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and short-term securities of $114.6 million, an increase from $72.3 million at the end of 2024, primarily due to $148.8 million in net proceeds from equity issuances [7][9] - The net loss for the three months ended September 30, 2025, was $61.1 million, compared to $26.3 million for the same period in 2024, with a significant portion attributed to non-cash expenses [12][18] - Research and development expenses increased to $14.7 million for the third quarter of 2025, up from $12.4 million in the prior year, reflecting higher costs associated with clinical programs [10][11] Clinical Developments - BPL-003, a mebufotenin nasal spray, has shown positive topline results in Phase 2b studies, demonstrating sustained antidepressant effects after a second dose [3][4] - The company completed enrollment in the Phase 2a trial of EMP-01 for social anxiety disorder and received a grant from NIDA to support the development of novel 5-HT2A/2C receptor agonists for opioid use disorder [3][8] - An End-of-Phase 2 meeting with the FDA is scheduled to discuss the Phase 3 clinical program for BPL-003, with guidance expected in the first quarter of 2026 [3][8] Corporate Updates - The strategic combination of atai Life Sciences and Beckley Psytech has created AtaiBeckley, enhancing its position in the mental health treatment landscape [2][13] - The company appointed Scott Braunstein, M.D., as Vice Chairman and Lead Independent Director, bringing extensive experience in the biopharmaceutical industry [8] - AtaiBeckley plans to redomicile to the U.S. by the end of 2025, pending satisfaction of closing conditions [8]

Group 1 - The conference call is focused on the Atai Beckley BPL-003 phase IIb open-label extension study data [1] - The call includes forward-looking statements that are subject to risks and uncertainties [1] - The company does not undertake any obligation to revise or update forward-looking statements unless required by law [1] Group 2 - Factors that could cause actual results to differ from forward-looking statements are discussed in detail in the recently filed 10-K [2]

Core Insights - Proactive provides fast, accessible, and actionable business and finance news content to a global investment audience [2] - The company focuses on medium and small-cap markets while also covering blue-chip companies and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, mining, oil and gas, and emerging technologies [3] Technology Adoption - 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]

Summary of Atai Life Sciences Conference Call Company Overview - **Company**: Atai Life Sciences (NasdaqGM: ATAI) - **Event**: Conference call regarding the TyBeckley BPL003 Phase IIb open label extension study data - **Date**: November 10, 2025 Key Industry and Company Insights Study Results - **BPL003 Phase IIb Trial**: Focused on patients with Treatment Resistant Depression (TRD) - **Dosage**: A second dose of 12 mg administered eight weeks after the initial 12 mg dose resulted in rapid and clinically meaningful additional antidepressant effects [6][7] - **Response and Remission Rates**: - Response rate of 63% and remission rate of 48% in subjects receiving either 8 mg or 12 mg in the core study [7] - Sustained effects for up to eight weeks post-dosing [7] - **Safety Profile**: - Well tolerated with over 99% of treatment-emergent adverse events classified as mild or moderate [15] - No serious adverse events reported throughout the trial [15] Regulatory Designation - **Breakthrough Therapy Designation**: Granted by the US FDA for BPL003, recognizing its potential to deliver substantial improvement over existing therapies for TRD [7] Study Design and Methodology - **Core Study**: Included 193 participants randomized to three dosing arms (0.3 mg, 8 mg, and 12 mg) [9] - **Assessment Schedule**: Participants assessed on days 1, 2, 8, 29, and 57, with a primary endpoint at day 29 [10] - **Open Label Extension**: 126 participants completed the core study, with 107 receiving a second dose and followed for another eight weeks [19] Efficacy Observations - **Responder Rates**: Approximately 81% responder rate observed after the second dose [25] - **Remission Rates**: 67% remission rate at day 57 after the second dose [26] - **Time to Discharge**: Majority of patients deemed ready for discharge within 90 minutes post-dose, aligning with the two-hour treatment paradigm [18][32] Competitive Landscape - **Comparison with Spravato**: - Spravato achieved blockbuster status in 2024, exceeding $1 billion in sales in 2025 [35] - BPL003 aims to leverage a similar two-hour in-clinic treatment paradigm, potentially improving patient quality of life and treatment scalability [37] Future Development Plans - **Phase III Studies**: Anticipated initiation in the second quarter of next year, pending FDA feedback from the end of Phase II meeting [32] - **Pipeline Assets**: - VLS01 (buccal DMT for TRD) in Phase 2b trial, results expected in the second half of next year [39] - EMT1 (oral RMDMA for social anxiety disorder) in Phase 2a trial, results expected in the first quarter of next year [39] Additional Important Insights - **Adverse Events**: One serious adverse event related to a patient with a history of depression and suicidal ideation, which resolved the next day [29][51] - **Dosing Strategy**: Future studies will likely focus on the 8 mg dose, with discussions ongoing regarding the potential for redosing paradigms [58][62] - **Patient Discharge Protocol**: Emphasis on structured assessments to ensure patient readiness for discharge, with a focus on minimizing the time spent in the clinic [70][82] This summary encapsulates the critical points discussed during the conference call, highlighting the company's advancements in the treatment of TRD and its strategic positioning within the competitive landscape.

BPL-003 Phase 2b Clinical Trial Results - The open-label extension of the BPL-003 Phase 2b clinical trial demonstrated additional and durable antidepressant effects after a second dose[11] - Patients who received an active dose (either 8 mg or 12 mg) of BPL-003 in the core study achieved a response rate of 63% and a remission rate of 48% at Week 8 (Week 16 of the Phase 2b clinical trial)[11] - In the core study, statistically significant MADRS difference was observed at Day 29 (Week 4) following a single 8 mg or 12 mg dose vs 0.3 mg[21] - In the core study, 8 mg dose demonstrated comparable efficacy to 12 mg, suggesting it may be sufficient to achieve maximal therapeutic benefit[21] - In the OLE study, patients who received an active dose in the core study showed a mean reduction in MADRS score of 19.0 points at Day 57 compared to baseline at the start of the Phase 2b clinical trial[36] - In the OLE study, responder rates continued to improve following a second dose of BPL-003[37] - In the OLE study, remission rates continued to improve following a second dose of BPL-003[40] Safety and Tolerability - BPL-003 was generally well-tolerated, with the majority of TEAEs occurring on the day of dosing, classified as mild or moderate, and transient in nature[11] - In the core study, 78% of participants experienced any TEAE[24] - In the OLE study, 86% of participants experienced any TEAE[43] Market Opportunity - Spravato achieved blockbuster status and established the 2-hour in-clinic interventional psychiatry treatment paradigm[50] - Spravato reported global annual sales of $1.047 billion in Q1-Q3 2025[51]