ATAI Life Sciences(ATAI) - 2025 Q2 - Quarterly Results

Management Commentary 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] - The combination adds BPL-003, a late-stage, clinically-validated asset for treatment-resistant depression (TRD), to atai's wholly owned pipeline[3] - Recent fundraising efforts in 2025 totaled nearly $140 million, reflecting strong investor confidence in the company's strategy[3] Key Highlights 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] - Topline data from the eight-week open-label extension of the BPL-003 Phase 2b trial is expected in Q3 2025[4] - The company's cash, securities, and other assets are expected to fund combined operations into the second half of 2027[4] Recent Clinical Highlights and Upcoming Milestones 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) 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] - 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] - The 8 mg dose has been selected for Phase 3 advancement, with an End-of-Phase 2 meeting request planned for Q3 2025[5] VLS-01 (Buccal Film DMT) 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] - The delay is attributed to slower-than-anticipated site activation and patient recruitment[5] EMP-01 (Oral R-MDMA) 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] - Topline data from the Phase 2 study are anticipated in the first quarter of 2026[5] Inidascamine (RL-007) 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] - atai plans to allocate resources to its wholly owned pipeline of psychedelic product candidates focused on affective disorders[10] Novel 5-HT2A Receptor Agonists 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] Corporate Updates 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] - The company has initiated the process to move its corporate domicile to the US for structural simplification and operational efficiencies[10] Consolidated Financial Results 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 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] - The company's cash runway is expected to fund operations for the combined company into the second half of 2027[7] Operating Expenses and Net Loss 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] - 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] Financial Statements 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 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 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 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] - These statements involve risks and uncertainties, including the possibility that proposed transactions may not be completed or their anticipated benefits realized[14] - Investors are urged to read the S-4 Registration Statement and Proxy Statement, when available, for important information about the proposed transactions[16]