Clinical Trials - Positive Phase 1 data for VG-3927 indicates a robust and dose-dependent reduction of sTREM2 by up to approximately 50% in the cerebral spinal fluid, supporting its advancement to Phase 2 trial[6] - The final analysis from the IGNITE Phase 2 clinical trial for iluzanebart is planned for the second quarter of 2025, with an intention to pursue an accelerated approval pathway[3] - The company plans to initiate the Phase 2 trial for VG-3927 in Q3 2025, marking it as the first and only Phase 2-ready oral small molecule TREM2 agonist[2] - The Phase 1 trial for VG-3927 included 115 participants, with 89 receiving the drug, demonstrating a favorable safety and tolerability profile[6] - The company expects to present Phase 1 data at the AD/PD™ 2025 International Conference on Alzheimer's and Parkinson's Disease in April 2025[6] Financial Performance - Cash, cash equivalents, and marketable securities were $97.8 million as of December 31, 2024, down from $111.3 million as of September 30, 2024, expected to fund operations into 2026[6] - Research and Development (R&D) expenses increased to $62.3 million for the year ended December 31, 2024, compared to $60.9 million in 2023, driven by increased clinical activity[6] - General and Administrative (G&A) expenses decreased to $27.4 million for the year ended December 31, 2024, from $27.9 million in 2023, attributed to lower external professional service fees[6] - Net loss for the fourth quarter was $23.8 million, compared to $22.2 million for the same period in 2023, with a total net loss of $84.3 million for the year ended December 31, 2024[6] - Total assets decreased to $117.7 million as of December 31, 2024, from $140.9 million in 2023, while total liabilities increased to $46.1 million from $24.6 million[13]

Core Insights - Vigil Neuroscience announced positive Phase 1 clinical trial data for VG-3927, a potential treatment for Alzheimer's Disease, and plans to initiate a Phase 2 trial in Q3 2025 [1][2] - The company is on track to report final analysis from the IGNITE Phase 2 clinical trial for iluzanebart in ALSP in Q2 2025 [1][2] Recent Developments - Positive Phase 1 data for VG-3927 supports its advancement as a Phase 2-ready oral small molecule TREM2 agonist, potentially offering a new therapy for Alzheimer's disease [2][4] - The IGNITE Phase 2 trial for iluzanebart is expected to provide critical data for a potential breakthrough therapy for ALSP [2][4] Financial Performance - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $97.8 million, down from $111.3 million as of September 30, 2024 [8][13] - Research and Development (R&D) expenses for Q4 2024 were $18.7 million, compared to $16.8 million in Q4 2023, driven by increased clinical activity [8][11] - General and Administrative (G&A) expenses decreased to $6.4 million in Q4 2024 from $7.1 million in Q4 2023, attributed to lower external professional service fees [8][11] Clinical Trial Details - The Phase 1 trial for VG-3927 included 115 participants, demonstrating a favorable safety profile and a robust dose-dependent reduction of sTREM2 in cerebral spinal fluid [4][8] - The company plans to present Phase 1 data at the AD/PD™ 2025 International Conference on Alzheimer's and Parkinson's Disease in April 2025 [4][8]

Company Overview - Vigil Neuroscience, Inc. is a clinical-stage biotechnology company focused on developing treatments for neurodegenerative diseases by restoring the function of microglia, the immune cells of the brain [3] - The company is developing precision-based therapies to improve the lives of patients and their families, utilizing modern neuroscience drug development tools across multiple therapeutic modalities [3] Lead Clinical Candidates - Vigil's lead clinical candidate, Iluzanebart, is a fully human monoclonal antibody agonist targeting TREM2, aimed at treating adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare and fatal neurodegenerative disease [3] - The company is also developing VG-3927, a novel small molecule TREM2 agonist, with an initial focus on Alzheimer's disease (AD) [3] Upcoming Events - Management will participate in a fireside chat at the Stifel 2025 Virtual CNS Forum on March 19, 2025, at 9:00 a.m. ET [1] - A live webcast of the event will be available, and an archived version will be accessible for approximately 90 days following the event [2]

Company Overview - Vigil Neuroscience, Inc. is a clinical-stage biotechnology company focused on developing treatments for neurodegenerative diseases by restoring the function of microglia, the immune cells of the brain [3] - The company is developing precision-based therapies to improve the lives of patients and their families, utilizing modern neuroscience drug development tools across multiple therapeutic modalities [3] Key Developments - Vigil Neuroscience will participate in a fireside chat at the Guggenheim Securities SMID Cap Biotech Conference on February 6, 2025, at 10:30 a.m. ET [1] - The company's lead clinical candidate, Iluzanebart, is a fully human monoclonal antibody agonist targeting TREM2 for treating adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare neurodegenerative disease [3] - Vigil is also developing VG-3927, a novel small molecule TREM2 agonist aimed at treating common neurodegenerative diseases, with an initial focus on Alzheimer's disease [3] Investor Relations - Vigil Neuroscience encourages investors to regularly check the "Investors" section of its website for important information [4] - The company provides contact information for investor relations and media inquiries, indicating a commitment to transparency and communication with stakeholders [5]

Core Insights - Vigil Neuroscience Inc. has released data from its completed Phase 1 trial for VG-3927, a potential treatment for Alzheimer's disease [1] Group 1: Clinical Trial Results - The Phase 1 clinical trial demonstrated a robust and dose-dependent reduction of sTREM2 of up to approximately 50% in the cerebral spinal fluid (CSF) [6] - The company plans to advance a once-daily oral dose of 25mg and expects to initiate the Phase 2 trial in Q3 2025 [3] - The trial showed consistent target engagement across participant groups, with cohort means showing reductions in sTREM2 ranging from 20% to 25% in the highest three dose levels [3][4] Group 2: Safety and Tolerability - The trial demonstrated a favorable safety and tolerability profile across all cohorts, including the elderly cohort, with all adverse events being mild or moderate and self-resolving [6] - No serious adverse events were reported during the trial [6] Group 3: Market and Valuation - Vigil's market capitalization is lower than the cash reported at the end of Q3 last year, indicating the company is significantly undervalued compared to its potential [4] - Analyst Sarah Schram views the trial results as encouraging preliminary support for target engagement, maintaining an Outperform rating for the stock [3][4] - Following the news, VIGL stock increased by 21.40%, reaching $2.47 [4]

Core Insights - Vigil Neuroscience announced positive Phase 1 clinical trial results for VG-3927, a potential once-daily oral therapy for Alzheimer's disease (AD) [1][2] - The company plans to advance VG-3927 into a Phase 2 trial in Q3 2025, selecting a 25mg QD oral dose that fully engages desired pharmacology [1][4] Group 1: Clinical Trial Results - The Phase 1 trial included 115 participants across 14 cohorts, evaluating safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) [2][5] - VG-3927 demonstrated a favorable safety and tolerability profile, with all adverse events being mild or moderate and self-resolving [5][6] - A robust and dose-dependent reduction of sTREM2 of up to approximately 50% in the cerebral spinal fluid (CSF) was achieved, indicating strong PK/PD relationship and sustained target engagement [5][6] Group 2: Drug Profile and Mechanism - VG-3927 is a potent orally bioavailable small molecule TREM2 agonist designed to enhance protective microglial responses without increasing inflammation [6] - The drug's novel mode of action as both an agonist and a positive allosteric modulator (PAM) may lead to greater neuroprotection by amplifying functional responses around sites of pathology [6] - VG-3927 does not bind to sTREM2, maximizing receptor activation and microglial function, which differentiates it from antibody TREM2 agonists [6] Group 3: Future Developments - Vigil expects to present additional data at the AD/PD™ 2025 International Conference on Alzheimer's and Parkinson's Disease in April 2025 [5] - The company is focused on developing precision-based therapies for neurodegenerative diseases, with VG-3927 being a key candidate for AD treatment [7]

Core Insights - Vigil Neuroscience is on track to report data from the Phase 1 clinical trial of VG-3927 for Alzheimer's disease in the first quarter of 2025 and final analysis from the IGNITE Phase 2 clinical trial of iluzanebart in ALSP is planned for the second quarter of 2025 [1][12] 2024 Key Achievements - The company secured a $40 million strategic investment from Sanofi to fund research and development activities [5] - Completed enrollment of 20 patients for the IGNITE Phase 2 clinical trial, exceeding the initial target of 15 patients [6] - Surpassed enrollment of 50 participants in the ILLUMINATE natural history study of ALSP, providing critical insights on MRI and NfL biomarkers [6] - Reported interim data from the ongoing Phase 1 clinical trial of VG-3927, demonstrating safety, tolerability, and pharmacokinetic profiles [6] - FDA removed the partial clinical hold on the Phase 1 clinical trial of VG-3927 based on a complete response submitted by the company [6] - Presented new preclinical data on VG-3927 at the Alzheimer’s Association International Conference, highlighting its differentiated mechanism of action compared to antibody TREM2 agonists [6] 2025 Milestones - The company plans to report key data for both VG-3927 and iluzanebart in the first half of 2025, which are expected to support efforts to bring transformative therapies to patients with ALSP and Alzheimer's disease [9] - The final analysis of the IGNITE Phase 2 clinical trial is planned for the second quarter of 2025, with the company pursuing an accelerated approval pathway for iluzanebart in ALSP [12]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |------------------------------------------------------------------------------------------------------|------------------------------------------------| | | | | For the t ...

Financial Performance - Vigil Neuroscience reported a net loss of $19.3 million for Q3 2024, a decrease from a net loss of $20.5 million in Q3 2023[6]. - Total operating expenses for Q3 2024 were $20.7 million, compared to $22.3 million for Q3 2023[10]. - Vigil's total liabilities increased to $42.7 million as of September 30, 2024, compared to $24.6 million at the end of 2023[11]. Cash and Securities - Cash, cash equivalents, and marketable securities increased to $111.3 million as of September 30, 2024, up from $86.7 million as of June 30, 2024[6]. Research and Development - Research and Development (R&D) expenses for Q3 2024 were $13.8 million, down from $15.4 million in Q3 2023, reflecting a decrease in manufacturing activities for iluzanebart[6]. - Interim data from the Phase 1 clinical trial of VG-3927 showed a robust decrease in soluble TREM2 in the CSF, indicating clinical proof-of-target engagement[5]. - Vigil expects to report complete Phase 1 clinical data for VG-3927, including data from the Alzheimer's disease patient cohort, in the first quarter of 2025[5]. Clinical Trials - The final analysis from the IGNITE Phase 2 clinical trial for iluzanebart is planned for the first half of 2025[4]. - The FDA removed the partial clinical hold on the Phase 1 clinical trial of VG-3927 in September 2024[5]. Market Insights - The estimated U.S. prevalence of ALSP is now approximately 19,000, up from a previous estimate of 10,000[4].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (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, 2024 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 001-41200 VIGIL NEUROSCIENCE, INC. (Exact name of Registrant as specified in its Charter) Del ...