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]

Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, The Canberra Times, and... Read more Abou ...

Core Insights - Atai Life Sciences announced positive topline data from Beckley Psytech's Phase 2a study of BPL-003, indicating a rapid and durable antidepressant effect for treatment-resistant depression when administered with SSRIs [1][2][6] - BPL-003 was well-tolerated, with patients able to be discharged within an average of less than two hours after dosing [1][3] - The Phase 2b study results are expected in mid-2025, with 196 patients enrolled, marking it as the largest controlled clinical study for mebufotenin [7] Study Findings - A single dose of BPL-003 resulted in a mean MADRS reduction of 18 points from baseline the day after dosing, 19 points one month later, and 18 points three months post-dosing [4] - The open-label Phase 2a study involved 12 patients with moderate-to-severe depression who had not responded to at least two prior treatments [2][6] Treatment Context - BPL-003 is designed as a rapid and durable treatment for treatment-resistant depression and is administered via an intranasal spray [8] - The findings support the potential for BPL-003 to fit within the current interventional psychiatric care model, similar to Spravato® [5] Company Background - Atai Life Sciences is focused on developing effective mental health treatments, with a pipeline that includes other psychedelic-based therapies for various mental health conditions [12] - Beckley Psytech, in which Atai holds a significant stake, is dedicated to developing rapid-acting psychedelic medicines for neuropsychiatric disorders [11]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents the unaudited condensed consolidated financial statements for Q1 2025, including balance sheets, operations, and cash flows [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets grew to $195.8 million, driven by a significant increase in cash from a recent equity offering Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $48,287 | $17,505 | | Total current assets | $115,978 | $80,125 | | Digital assets | $4,788 | $— | | **Total assets** | **$195,783** | **$159,387** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $28,501 | $24,951 | | Total liabilities | $43,509 | $42,833 | | Total stockholders' equity | $152,274 | $116,554 | | **Total liabilities and stockholders' equity** | **$195,783** | **$159,387** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported its first-ever revenue of $1.6 million and a stable net loss of $26.4 million for Q1 2025 Condensed Consolidated Statements of Operations (in thousands, except per share data) | | For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue | $1,555 | $— | | Research and development | $11,328 | $11,530 | | General and administrative | $10,597 | $12,555 | | **Loss from operations** | **($20,370)** | **($24,085)** | | **Net loss attributable to ATAI Life Sciences N.V. stockholders** | **($26,431)** | **($26,713)** | | Net loss per share — basic and diluted | ($0.15) | ($0.17) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Financing activities provided $59.6 million, leading to a net cash increase of $30.8 million for the quarter Condensed Consolidated Statements of Cash Flows (in thousands) | | For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,841) | ($22,573) | | Net cash provided by (used in) investing activities | ($11,014) | $11,471 | | Net cash provided by financing activities | $59,605 | $— | | **Net increase (decrease) in cash, cash equivalents and restricted cash** | **$30,782** | **($11,166)** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Details key events including the IGX acquisition, a $59.1M equity offering, and a corporate restructuring - The acquisition of IntelGenx Corp (IGX) in October 2024 is the source of the company's **newly reported license and R&D revenue**[38](index=38&type=chunk)[39](index=39&type=chunk) - The company invested approximately **$5.0 million in Bitcoin** in March 2025 as part of a treasury reserve diversification strategy[47](index=47&type=chunk)[169](index=169&type=chunk) - A public offering of common shares in February 2025 resulted in **net proceeds of approximately $59.1 million**[199](index=199&type=chunk)[200](index=200&type=chunk) - A corporate restructuring in March 2025 eliminated approximately **25% of the global workforce**, incurring $1.1 million in related costs[247](index=247&type=chunk)[248](index=248&type=chunk) - Management expects existing cash and securities of **$108.2 million** will be sufficient to fund operations for at least the next 12 months[39](index=39&type=chunk)[40](index=40&type=chunk) - On May 2, 2025, the company **paid off its outstanding loan with Hercules Capital of approximately $21.8 million**, terminating the loan agreement[260](index=260&type=chunk)[384](index=384&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=56&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Discusses pipeline advancements, financial results including first-ever revenue, and an extended cash runway to 2027 - The company is advancing its pipeline with key programs **VLS-01 (DMT for TRD) and EMP-01 (R-MDMA for SAD) now in Phase 2 trials**, with topline data expected in Q1 2026[280](index=280&type=chunk) - Strategic investments are expected to yield near-term data, with topline results from **Beckley Psytech's BPL-003 and Recognify's RL-007 Phase 2b studies anticipated in mid-2025**[280](index=280&type=chunk)[282](index=282&type=chunk) - The company's cash, cash equivalents, and short-term securities are expected to **fund operations into 2027**, bolstered by the ~$59.2 million net proceeds from the February 2025 equity offering[360](index=360&type=chunk)[361](index=361&type=chunk) Comparison of Operating Results (in thousands) | | For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue | $1,555 | $— | | Research and development | $11,328 | $11,530 | | General and administrative | $10,597 | $12,555 | | **Net loss** | **($26,465)** | **($27,378)** | [Our Pipeline](index=59&type=section&id=Our%20Pipeline) Outlines the clinical pipeline, highlighting key programs in Phase 2 and anticipated data readouts in 2025 Key Clinical Program Status & Milestones | Program | Indication | Status | Anticipated Milestone | | :--- | :--- | :--- | :--- | | VLS-01 (DMT) | TRD | Phase 2 | Topline data in Q1 2026 | | EMP-01 (R-MDMA) | SAD | Phase 2 | Topline data in Q1 2026 | | BPL-003 (Beckley) | TRD | Phase 2b | Topline data in mid-2025 | | RL-007 (Recognify) | CIAS | Phase 2b | Topline data in mid-2025 | [Results of Operations](index=68&type=section&id=Results%20of%20Operations) Details Q1 2025 results, including $1.6M in revenue, reduced operating expenses, and a loss on investments - Revenue of **$1.6 million in Q1 2025** was generated by the IGX subsidiary, with $1.4 million from R&D services and $0.2 million from licensing[321](index=321&type=chunk)[322](index=322&type=chunk) - General and administrative expenses **decreased by $2.0 million (16%) YoY**, mainly due to a $1.3 million reduction in personnel costs and lower professional fees[331](index=331&type=chunk) - Change in fair value of assets and liabilities resulted in a **net loss of $5.5 million**, driven by a $6.3 million loss on the COMPASS investment[338](index=338&type=chunk) Research and Development Expenses by Category (in thousands) | Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Direct Program Costs | $6,287 | $5,782 | $505 | | Unallocated R&D Expenses | $5,041 | $5,743 | ($702) | | **Total R&D Expenses** | **$11,328** | **$11,530** | **($202)** | [Liquidity and Capital Resources](index=73&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity was bolstered by a $59.2M offering, ensuring a cash runway into 2027 - The company raised **net proceeds of approximately $59.2 million** from a public offering of common shares in February 2025[358](index=358&type=chunk)[360](index=360&type=chunk) - Based on the current operating plan, the company estimates its existing capital will be **sufficient to fund operations into 2027**[361](index=361&type=chunk) - On May 2, 2025, the company voluntarily **prepaid and terminated its Hercules Loan Agreement**, paying off the outstanding amount of approximately $21.8 million[384](index=384&type=chunk) Liquidity Position as of March 31, 2025 (in millions) | Item | Amount | | :--- | :--- | | Cash and cash equivalents | $48.3 | | Restricted cash | $10.0 | | Short-term securities | $49.9 | | **Total** | **$108.2** | [Quantitative and Qualitative Disclosures About Market Risk](index=83&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks from interest rates and foreign currency are not expected to have a material impact - The company's main market risks are **interest rate sensitivity** on its cash and securities portfolio and **foreign currency exchange risk** from its international operations[390](index=390&type=chunk) - A hypothetical **100 basis point change in interest rates** or a **10% change in foreign exchange rates** would not have a material effect on the company's financial position[391](index=391&type=chunk)[395](index=395&type=chunk) [Controls and Procedures](index=84&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes in the quarter - Management concluded that the company's **disclosure controls and procedures were effective** as of March 31, 2025[398](index=398&type=chunk) - **No material changes** in internal control over financial reporting occurred during the first quarter of 2025[399](index=399&type=chunk) [PART II. OTHER INFORMATION](index=85&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=85&type=section&id=Item%201.%20Legal%20Proceedings) Ongoing legal proceedings are not expected to have a material adverse effect on the company's financials - The company is party to various claims and legal proceedings arising in the ordinary course of business, but **does not anticipate a material adverse effect** from them[400](index=400&type=chunk) [Risk Factors](index=86&type=section&id=Item%201A.%20Risk%20Factors) No material changes have been made to the risk factors disclosed in the company's latest Form 10-K - There have been **no material changes** to the risk factors described in the company's Form 10-K for the year ended December 31, 2024[402](index=402&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=87&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - The company did not conduct any unregistered sales of equity securities during the period[404](index=404&type=chunk) [Other Information](index=87&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - No director or officer adopted or terminated a **Rule 10b5-1 trading arrangement** during the three months ended March 31, 2025[406](index=406&type=chunk) [Exhibits](index=88&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with the report, including officer certifications and XBRL data files - Key exhibits filed include **CEO and CFO certifications** (31.1, 31.2, 32.1, 32.2) and Inline XBRL documents[407](index=407&type=chunk)

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 has bureaus and studios in key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Group 2 - The company is focused on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4] - Automation and software tools, including generative AI, are used, but all content is edited and authored by humans [5]

atai Life Sciences First Quarter 2025 Report [Corporate and Pipeline Highlights](index=1&type=section&id=Corporate%20and%20Pipeline%20Highlights) atai Life Sciences advanced its clinical pipeline in Q1 2025, initiating EMP-01 Phase 2 and anticipating mid-year data for BPL-003 and RL-007, supported by a strong cash runway into 2027 - The company's **cash, cash equivalents, short-term securities, and public equity holdings** are expected to fund operations into **2027**[2](index=2&type=chunk) - Key upcoming data readouts are anticipated **mid-year 2025** for **BPL-003** in treatment-resistant depression (TRD) and **RL-007** in cognitive impairment associated with schizophrenia (CIAS)[3](index=3&type=chunk) - The first patient was dosed in the **Phase 2 study of EMP-01** (oral R-MDMA) for social anxiety, with topline data expected in **Q1 2026**[4](index=4&type=chunk) - Chairman Christian Angermayer has continued to personally increase his investment in atai, signaling **strong internal conviction**[3](index=3&type=chunk) [Clinical Pipeline and Program Updates](index=2&type=section&id=Recent%20Clinical%20Highlights%20and%20Upcoming%20Milestones) atai is advancing a diverse clinical pipeline, with VLS-01 and EMP-01 in Phase 2, and key mid-2025 data readouts expected for BPL-003 and RL-007 - **VLS-01** (buccal film DMT): Enrollment continues in the **Phase 2 trial** for TRD, with topline data anticipated in **Q1 2026**[6](index=6&type=chunk) - **EMP-01** (oral R-MDMA): The first patient was dosed in a **Phase 2 study** for social anxiety disorder (SAD), with topline data expected in **Q1 2026**[6](index=6&type=chunk) - **BPL-003** (intranasal mebufotenin): Topline results from a large **Phase 2b study** in TRD are on track for **mid-year 2025**[6](index=6&type=chunk) - **RL-007** (pro-cognitive neuromodulator): Topline data from the **Phase 2b study** in patients with CIAS are expected in **mid-2025**[13](index=13&type=chunk) - The company is advancing a discovery program of **novel, non-hallucinogenic 5-HT2A receptor agonists** for TRD[6](index=6&type=chunk) [Corporate and Financial Updates](index=3&type=section&id=Corporate%20and%20Financial%20Updates) atai strengthened its financial position in Q1 2025 by repaying debt, increasing cash to **$108.2 million** via equity financing, and reducing operating expenses, resulting in a stable net loss - On May 2, 2025, the company fully repaid **$21.8 million in debt**, saving approximately **$2.1 million** in future interest payments[7](index=7&type=chunk) | Metric (in millions) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term securities | $108.2 | $72.3 | - The increase in cash was driven by **$59.1 million** in net proceeds from equity financings, partially offset by **$17.8 million** used in operations and a **$5.0 million** investment in digital assets[8](index=8&type=chunk) | Expense Category (in millions) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | R&D Expenses | $11.3 | $11.5 | | G&A Expenses | $10.6 | $12.6 | - Net loss attributable to stockholders for Q1 2025 was **$26.4 million**, compared to **$26.7 million** for Q1 2024[11](index=11&type=chunk) Financial Statements [Condensed Consolidated Statements of Operations](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) atai reported **$1.56 million** revenue in Q1 2025, with operating expenses decreasing to **$21.9 million**, leading to a net loss of **$26.4 million** or **($0.15)** per share, a slight improvement from Q1 2024 | Metric (in thousands) | Three Months Ended March 31, 2025 (unaudited) | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue | $1,555 | $— | | Loss from operations | $(20,370) | $(24,085) | | Net loss attributable to stockholders | $(26,431) | $(26,713) | | Net loss per share — basic and diluted | $(0.15) | $(0.17) | [Condensed Consolidated Balance Sheet](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEET) As of March 31, 2025, atai's total assets increased to **$195.8 million**, driven by cash and securities, with stockholders' equity rising to **$152.1 million** from equity financing | Key Balance Sheet Items (in thousands) | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $48,287 | $17,505 | | Total assets | $195,783 | $159,387 | | **Liabilities & Equity** | | | | Total liabilities | $43,509 | $42,833 | | Total stockholders' equity | $152,053 | $116,297 |

Core Viewpoint - atai Life Sciences is advancing its position in the mental health treatment sector through a robust pipeline of psychedelic-based therapies aimed at addressing significant unmet needs in mental health conditions [2][3]. Financial Overview - As of March 31, 2025, the company reported cash, cash equivalents, and short-term securities totaling $108.2 million, an increase from $72.3 million at the end of 2024, primarily due to $59.1 million in net proceeds from equity financings [10]. - Research and development (R&D) expenses for Q1 2025 were $11.3 million, slightly down from $11.5 million in the same period the previous year [11]. - General and administrative (G&A) expenses decreased to $10.6 million from $12.6 million year-over-year, reflecting ongoing cost management efforts [12]. - The net loss attributable to stockholders for Q1 2025 was $26.4 million, compared to a loss of $26.7 million in Q1 2024 [13]. Clinical Developments - The company has initiated an exploratory Phase 2 study of EMP-01 for social anxiety disorder, marking a significant milestone in its clinical pipeline [3][6]. - Topline data for BPL-003 in treatment-resistant depression and RL-007 in cognitive impairment associated with schizophrenia are expected mid-year 2025 and in Q1 2026, respectively [3][6]. - VLS-01, an investigational DMT formulation, is currently in a Phase 2 study with topline data anticipated in Q1 2026 [7]. Strategic Positioning - atai is focused on developing innovative, science-driven solutions to address the growing mental health crisis, positioning itself as a leader in mental health innovation [3][4]. - The company has repaid $21.8 million in outstanding debt, saving approximately $2.1 million in interest, which reflects a commitment to financial prudence [9]. - The ongoing development of novel 5-HT2A receptor agonists aims to create non-hallucinogenic treatments for mental health conditions, further diversifying the company's therapeutic offerings [8][14].

Core Insights - atai Life Sciences has initiated a Phase 2 study for EMP-01, an oral formulation of R-MDMA, targeting social anxiety disorder (SAD) [1][2][3] - The Phase 2 study aims to evaluate the safety, tolerability, and efficacy of EMP-01 in approximately 60 adults with SAD, with topline data expected in Q1 2026 [2][3] Company Overview - atai Life Sciences is a clinical-stage biopharmaceutical company focused on developing effective mental health treatments, including EMP-01 for SAD and VLS-01 for treatment-resistant depression [4] - The company is advancing a drug discovery program for novel, non-hallucinogenic 5-HT2AR agonists aimed at addressing complex mental health issues [4] Study Details - The Phase 2 study is randomized, double-blind, and placebo-controlled, with patients receiving either EMP-01 or placebo in a 1:1 ratio [2] - The primary objective is to assess safety and tolerability, while the secondary objective focuses on improvements in social anxiety symptoms compared to placebo [2][3]

Core Insights - atai Life Sciences is focusing on four major clinical readouts in 2025, including VLS-01, BPL-003, RL-007, and EMP-01 [1][2] Clinical Trials - The VLS-01 trial for treatment-resistant depression has commenced, with the first patient dosed and results expected in Q1 of next year [2][5] - BPL-003 trial has completed enrollment, with readouts anticipated in the middle of this year [3][9] - RL-007 trial, addressing cognitive impairment associated with schizophrenia, is also expected to have readouts in the middle of this year [3][9] - EMP-01 trial for social anxiety disorder has been initiated, with results expected around a year from now [3][10] Financial Position - The company has recently raised capital, extending its financial runway into 2027, providing a buffer for future fundraising [4] Unique Aspects of Trials - VLS-01 utilizes a short-duration psychedelic formulation that is easy to administer, resembling a Listerine strip [5][6] - The trial will explore the incremental benefit of a re-dose, with a primary endpoint at four weeks and a long blinded period extending to twelve weeks [7][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's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging 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]