Neumora Therapeutics(NMRA) - 2023 Q4 - Annual Results

Company Overview and 2023 Highlights Neumora Therapeutics achieved significant milestones in 2023, including going public and advancing key clinical programs, setting the stage for a data-rich 2024 2023 Achievements and 2024 Outlook Neumora Therapeutics successfully became a public company in 2023, advancing navacaprant to three Phase III studies and NMRA-266 into clinical trials, with 2024 expected to be data-rich - 2023 was a landmark year for Neumora, successfully going public and advancing navacaprant into three Phase III studies, with NMRA-266 entering clinical trials ahead of schedule[3] - The company anticipates a data-rich 2024, including navacaprant Phase III data in MDD and NMRA-266 Phase I data, alongside plans to initiate several key clinical studies[3] About Neumora Therapeutics Neumora Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing brain disease crises through innovative, precision medicine approaches, with seven neuroscience programs - Neumora Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for brain diseases[15] - The company has seven clinical and preclinical neuroscience programs targeting novel mechanisms of action for various neuropsychiatric and neurodegenerative disorders with unmet needs[15] - Utilizing integrated translational, clinical, and computational tools, the company aims to develop next-generation therapies through a precision medicine approach to improve patient outcomes and quality of life[15] Key Pipeline Highlights Neumora's pipeline features navacaprant in Phase III for MDD, NMRA-266 for schizophrenia, and NMRA-511 for Alzheimer's agitation, with significant data readouts anticipated Navacaprant (NMRA-140) for Major Depressive Disorder (MDD) Navacaprant (NMRA-140), a highly selective KOR antagonist, is in Phase III for MDD with data expected in 2024-2025, and a Phase II BPD trial planned for H1 2024 - Navacaprant (NMRA-140) is a highly selective KOR antagonist being developed as a monotherapy for MDD, with the KOR antagonist approach clinically validated in three independent studies[5] - Topline data for the KOASTAL-1 study is anticipated in H2 2024, with data for KOASTAL-2 and KOASTAL-3 studies expected in H1 2025[7] - The company plans to initiate a Phase II clinical trial for Bipolar Depression (BPD) in H1 2024[7] - The FDA has confirmed that no further physical dependence studies for navacaprant are required[7] NMRA-266 for Schizophrenia NMRA-266, a selective M4 PAM, is in Phase I for schizophrenia with data expected mid-2024, and a Phase Ib study planned for H2 2024 - NMRA-266 is a highly selective M4 muscarinic receptor positive allosteric modulator (PAM) being developed for the treatment of schizophrenia[8] - The Phase I study is ongoing, with data from healthy adult participants expected in mid-2024[12] - The company anticipates initiating a Phase Ib study for schizophrenia in H2 2024, with data expected in 2025[12] NMRA-511 for Alzheimer's Disease Agitation NMRA-511, a highly selective V1aR antagonist, is planned for Alzheimer's disease agitation, with a Phase Ib study starting H1 2024 and data expected in 2025 - NMRA-511 is a highly selective vasopressin 1a receptor (V1aR) antagonist, with vasopressin playing a role in aggression, affiliation, stress, and anxiety responses[9] - The company expects to initiate a Phase Ib study for Alzheimer's disease agitation in H1 2024, with data anticipated in 2025[9] Business Updates Neumora strengthened its leadership team with key appointments in R&D, legal, and commercial functions, enhancing its strategic capabilities Key Leadership Appointments Neumora announced key leadership appointments from Q4 2023 to early 2024, strengthening R&D, legal, and commercial capabilities - In October 2023, Dr Robert Lenz joined Neumora as Executive Vice President and Head of R&D, bringing over two decades of neuroscience drug development experience[13] - In December 2023, Jason Duncan was appointed Chief Legal Officer, with over two decades of legal, compliance, development, and operational experience in the life sciences industry[13] - In January 2024, Kaya Pai Panandiker was appointed Chief Commercial Officer, bringing over two decades of commercialization experience, including successful launches of blockbuster products like TRINTELLIX® and REXULTI®[13] Fourth Quarter and Full Year 2023 Financial Results Neumora reported increased operating expenses and net losses for Q4 and full-year 2023, while maintaining a cash position expected to fund operations into 2026 Cash Position and Financial Guidance As of December 31, 2023, Neumora held $463.8 million in cash, cash equivalents, and marketable securities, projected to fund operations into 2026 Cash, Cash Equivalents, and Marketable Securities | Metric | December 31, 2023 (Millions of USD) | December 31, 2022 (Millions of USD) | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | 463.8 | 395.4 | - The company expects its cash, cash equivalents, and marketable securities as of December 31, 2023, to fund its operating plan into 2026[13] Operating Expenses Analysis Neumora's R&D and G&A expenses significantly increased in Q4 and full-year 2023, driven by clinical program advancement, navacaprant Phase III activities, IPR&D costs, and personnel-related expenses Research and Development Expenses (Millions of USD) | Period | Q4 2023 | Q4 2022 | Full Year 2023 | Full Year 2022 | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | 38.9 | 23.5 | 142.7 | 91.7 | | Growth Rate (YoY) | 65.5% | - | 55.6% | - | - The increase in R&D expenses was primarily due to the advancement of clinical and preclinical programs and initiation activities for the navacaprant Phase III clinical trials[13] - Full-year 2023 R&D expenses included $63.9 million in non-cash in-process research and development (IPR&D) acquisition costs, compared to $13.0 million in 2022[13] General and Administrative Expenses (Millions of USD) | Period | Q4 2023 | Q4 2022 | Full Year 2023 | Full Year 2022 | | :--- | :--- | :--- | :--- | :--- | | G&A Expenses | 11.2 | 7.2 | 45.5 | 31.1 | | Growth Rate (YoY) | 55.6% | - | 46.3% | - | - The increase in G&A expenses was primarily due to personnel-related costs, including stock-based compensation, and professional services supporting the expansion of administrative functions[13] Net Loss Neumora reported significantly expanded net losses for Q4 and full-year 2023, primarily driven by increased operating expenses Net Loss (Millions of USD) | Period | Q4 2023 | Q4 2022 | Full Year 2023 | Full Year 2022 | | :--- | :--- | :--- | :--- | :--- | | Net Loss | (108.7) | (28.1) | (235.9) | (130.9) | | Growth Rate (YoY) | 286.8% | - | 80.2% | - | Net Loss Per Share (USD) | Period | Q4 2023 | Q4 2022 | Full Year 2023 | Full Year 2022 | | :--- | :--- | :--- | :--- | :--- | | Net Loss Per Share | (0.71) | (0.99) | (3.63) | (4.81) | Unaudited Consolidated Statements of Operations and Comprehensive Loss This table presents Neumora Therapeutics' unaudited consolidated statements of operations and comprehensive loss, detailing operating expenses, other income, net loss, and comprehensive loss for Q4 and full-year 2023 versus 2022 Unaudited Consolidated Statements of Operations and Comprehensive Loss (Amounts in thousands, except per share amounts) | | Three Months Ended December 31 | | | | | | Year Ended December 31 | | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | | 2023 | | 2022 | 2023 | | 2022 | | | Operating Expenses: | | | | | | | | | | Research and development expenses | $ 38,864 | | $ 23,523 | | $ 142,719 | $ 91,749 | | | Acquired in-process research and development | 63,904 | | — | | 63,904 | 13,000 | | | General and administrative expenses | 11,236 | | 7,195 | | 45,475 | 31,121 | | | Total operating expenses | 114,004 | | 30,718 | | 252,098 | 135,870 | | | Loss from operations | (114,004) | | (30,718) | | (252,098) | (135,870) | | | Other income (expense): | | | | | | | | | | Interest income | 5,646 | | 2,285 | | 16,611 | 4,561 | | | Other income (expense), net | (104) | | 287 | | (170) | 405 | | | Total other income | 5,542 | | 2,572 | | 16,441 | 4,966 | | | Loss before income taxes | (108,462) | | (28,146) | | (235,657) | (130,904) | | | Income tax provision | 268 | | — | | 268 | — | | | Net loss | (108,730) | | (28,146) | | (235,925) | (130,904) | | | Other comprehensive income (loss): | | | | | | | | | | Unrealized gain (loss) on available-for-sale securities | 235 | | 380 | | 698 | (774) | | | Comprehensive loss | $(108,495) | | $(27,766) | | $(235,227) | $(131,678) | | | Net loss per share, basic and diluted | $ (0.71) | | $ (0.99) | | $ (3.63) | $ (4.81) | | | Weighted-average shares outstanding, basic and diluted | 152,832 | | 28,293 | | 65,021 | 27,207 | Unaudited Condensed Consolidated Balance Sheets This table presents Neumora Therapeutics' unaudited condensed consolidated balance sheets, detailing key assets, liabilities, and stockholders' equity as of December 31, 2023, and 2022 Unaudited Condensed Consolidated Balance Sheets (Amounts in thousands of USD) | | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $ 463,827 | $ 395,395 | | Total assets | 496,195 | 426,234 | | Total liabilities | 27,119 | 29,397 | | Stockholders' equity (deficit) | 469,076 | (446,850) | Cautionary Note Regarding Forward-Looking Statements This section provides a cautionary note on forward-looking statements, highlighting inherent risks and uncertainties in Neumora's future projections Forward-Looking Statements This press release contains forward-looking statements by Neumora Therapeutics regarding future operations, financial performance, clinical programs, and cash resources, subject to risks and uncertainties - This press release contains forward-looking statements regarding Neumora's future operations, financial performance, therapeutic program advancements, clinical trial timelines, regulatory interactions, and cash resource sufficiency[16] - These statements are subject to various risks and uncertainties that could cause actual results to differ materially, including inherent uncertainties in clinical drug development, unpredictable regulatory approvals, reliance on third parties, and intellectual property risks[16] - The company undertakes no obligation to update or revise these forward-looking statements, except as required by law[16]