ATAI Life Sciences(ATAI)
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ATAI Life Sciences(ATAI) - 2023 Q2 - Quarterly Report
2023-08-09 16:00
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 ...
ATAI Life Sciences(ATAI) - 2023 Q1 - Quarterly Report
2023-05-10 16:00
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 ...
ATAI Life Sciences(ATAI) - 2022 Q4 - Annual Report
2023-03-23 16:00
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 ...
ATAI Life Sciences(ATAI) - 2022 Q3 - Earnings Call Transcript
2022-11-11 15:02
Financial Data and Key Metrics Changes - The company's Q3 operating cash use was $28 million, aligning with expectations, and no surprises were reported [4] - At the end of Q3, the company had $304 million in cash, supplemented by a debt facility with Hercules providing access to up to $175 million, ensuring a strong capital position and a cash runway extending into 2025 [4] Business Line Data and Key Metrics Changes - Atai has 8 drug development programs in clinical stages and 4 enabling technologies, all targeting major neuropsychiatric indications [6] - Positive initial Phase 1 results were reported for GRX-917 and KUR-101, indicating promising pharmacokinetic and pharmacodynamic results [6] Market Data and Key Metrics Changes - The company is focused on treatment-resistant depression (TRD) with its PCN-101 program, which has completed enrollment in a Phase 2a proof-of-concept study [7] Company Strategy and Development Direction - Atai aims to achieve clinically meaningful and sustained behavioral change in mental health patients, with a focus on at-home administration of treatments [6][9] - The company is positioning itself to leverage upcoming efficacy datasets as potential value inflection points [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving objectives based on existing preclinical and clinical data, emphasizing the importance of demonstrating a greater therapeutic index compared to other approved treatments [25] - The anticipated data readout for PCN-101 is expected to be a significant event for the company, targeting at-home therapy for TRD [47] Other Important Information - The company is exploring the integration of digital therapeutics to enhance treatment scalability and standardization, aiming to harness behavioral plasticity for durable responses [38] Q&A Session Summary Question: Can you provide a summary of recent progress and upcoming milestones? - The company has 8 drug development programs and 4 enabling technologies, with several programs having achieved proof of concept or a path to efficacy data within the next two years [6] Question: What is the target clinical profile for PCN-101? - The plan is for unsupervised at-home administration with rapid onset of effect and an intermittent dosing regimen [9] Question: How did you decide on the efficacy bar for PCN-101? - The target was based on triangulating data from other trials, aiming for a 5-point improvement compared to placebo at hour 24 [20][21] Question: What would cause a reassessment of moving forward with PCN-101? - Efficacy below clinically meaningful thresholds would lead to a reassessment of the clinical development plan [25] Question: How did you select the doses for the Phase 2a trial of RL007? - Doses were selected based on previous biomarker studies showing clinically meaningful pro-cognitive effects [43]
ATAI Life Sciences(ATAI) - 2022 Q2 - Earnings Call Transcript
2022-08-15 17:20
Atai Life Sciences N.V. (NASDAQ:ATAI) Q2 2022 Earnings Conference Call August 15, 2022 8:30 AM ET Company Participants Greg Weaver – Chief Financial Officer Stephen Bardin – Deputy Chief Financial Officer Florian Brand – Chief Executive Officer Srini Rao – Chief Scientific Officer Conference Call Participants Judah Frommer – Credit Suisse Andrew Tsai – Jefferies LLC Greg Weaver Hi, everyone. Welcome and thanks for joining us for the Atai Second Quarter Earnings Call. I’m Greg Weaver, CFO of Atai Life Scienc ...
ATAI Life Sciences(ATAI) - 2022 Q1 - Earnings Call Transcript
2022-05-16 18:02
Financial Data and Key Metrics Changes - The total cash used in Q1 2022 was $27 million, with a cash position of $335 million at the end of the quarter, providing a runway into 2024 [3] Business Line Data and Key Metrics Changes - The company is focused on developing a diverse pipeline in neuropsychiatry, with a unique model aimed at de-risking assets and providing multiple shots on goal [8][9] Market Data and Key Metrics Changes - The biotech equity markets are currently turbulent, with the XBI biotech index trading below levels seen five years ago, presenting both challenges and opportunities for investment [6][7] Company Strategy and Development Direction - The company aims to leverage its strong cash position to acquire complementary assets and continue its pipeline development, particularly in the neuropsychiatry space, which has seen little innovation [7][9] - The strategy includes integrating digital therapeutics with pharmacological agents to enhance treatment efficacy for mental health disorders [11][12] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the current challenges in the biotech market but expresses optimism about the company's ability to weather the storm due to its strong treasury and disciplined cash management [46][47] - The company is focused on reaching key clinical milestones and remains optimistic about both near-term and long-term prospects [47] Other Important Information - The company has over a thousand licensed clinics in the U.S. that can administer SPRAVATO, which may serve as a foundation for its own product rollout [17] Q&A Session Summary Question: How is atai navigating the turbulent biotech equity markets? - Management sees the current market conditions as an opportunity to invest in undervalued biotech assets and remains active in screening for new opportunities [6][9] Question: How does the digital therapeutics initiative fit into the company's strategy? - The digital therapeutics are integral to the treatment of mental health disorders, and the company is committed to fully funding this unit to support clinical trials [11][12] Question: What lessons have been learned from the SPRAVATO launch? - The company aims to differentiate its product from SPRAVATO by focusing on at-home use and leveraging existing clinic infrastructure [16][17] Question: What are the key takeaways from COMPASS Pathways' Phase 2b data? - Management highlighted the rapidity of onset and durability of effect as critical factors and expressed interest in COMPASS's Phase 3 plans [24][25] Question: How does the company view the role of GABAergic mechanisms in anxiety disorders? - The company believes its GABAergic candidate offers a unique mechanism that may provide a better safety profile compared to traditional benzodiazepines [36][38]