Vigil Neuroscience, Inc. - VIGL STOCK NEWS

Vigil Neuroscience (Nasdaq: VIGL), a clinical-stage biotech company focusing on microglia-based treatments for neurodegenerative diseases, has announced its participation in two upcoming investor conferences in September 2024:

1. Morgan Stanley 22nd Annual Global Healthcare Conference: A fireside chat scheduled for Thursday, September 5th at 2:35 p.m. ET.

2. H.C. Wainwright 26th Annual Global Investment Conference: Another fireside chat set for Tuesday, September 10th at 10:30 a.m. ET.

Both events will feature live webcasts available on the company's website under the 'Events & Presentations' page in the 'Investors' section. These webcasts will remain accessible for approximately 90 days after the presentations.

Vigil Neuroscience (VIGL) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. A $40 million strategic investment from Sanofi, extending cash runway into 2026.

2. Updated clinical development strategy for iluzanebart, pursuing a potential accelerated approval pathway in ALSP.

3. Interim data from VG-3927 Phase 1 trial supporting continued development for Alzheimer's disease.

4. Q2 2024 financials: $86.7 million in cash and equivalents, $15.5 million in R&D expenses, and $21.2 million net loss.

5. Plans to report final analysis from IGNITE clinical trial in H1 2025 and complete Phase 1 data for VG-3927 in Q1 2025.

Vigil Neuroscience (Nasdaq: VIGL) highlights a new publication in Neurology Genetics on the prevalence of CSF1R gene variants associated with adult-onset leukoencephalopathy with axonal-spheroids and pigmented glia (ALSP). The study suggests ALSP is underreported, with an estimated prevalence of 281 per 1 million in the UK population. This translates to approximately 19,000 cases in the U.S. and 29,000 in the EU and UK, significantly higher than previous estimates. The research indicates there may be over 2 million carriers worldwide. ALSP, a rare neurodegenerative disorder caused by CSF1R mutations, is often misdiagnosed and requires genetic testing for confirmation. This new data emphasizes the need for increased genetic screening and awareness to improve diagnosis and support for ALSP patients.

Vigil Neuroscience (NASDAQ: VIGL) presented data on its small molecule TREM2 agonist program at the 2024 Alzheimer's Association International Conference. The company shared clinical data from single ascending dose (SAD) cohorts in its ongoing Phase 1 trial of VG-3927, demonstrating proof-of-pharmacology with a robust decrease of sTREM2 in the CSF.

Key highlights include:

• In vivo data showing selective activation of downstream function leading to microglial amyloid-beta phagocytosis
• Acute modulation of AD pathophysiology comparable to an approved therapeutic
• In vitro data demonstrating preferential activity on cellular TREM2
• Phase 1 trial design details for VG-3927 in healthy volunteers
• Pharmacological and functional characterization of VG-3927 as a TREM2-specific, highly potent molecule

Vigil believes VG-3927 has the potential to offer a differentiated approach to treating Alzheimer's disease.

Vigil Neuroscience (Nasdaq: VIGL) has announced promising interim data from its ongoing Phase 1 clinical trial of VG-3927, a potential once-daily oral therapy for Alzheimer's disease (AD). The trial, which has enrolled 80 healthy volunteers, demonstrated a favorable safety and tolerability profile, with all adverse events being mild or moderate and resolving without intervention. Key findings include:

1. VG-3927 achieved a robust decrease in sTREM2 in cerebrospinal fluid, indicating clinical proof-of-target engagement.
2. The drug showed a predictable pharmacokinetic profile supporting once-daily dosing.
3. An increase in osteopontin/SPP1, a biomarker associated with neuroprotective microglia, was observed after repeat dosing.

Vigil plans to report complete Phase 1 data, including results from an AD patient cohort, in Q1 2025. The company will present new preclinical and clinical data at the upcoming 2024 Alzheimer's Association International Conference.

Vigil Neuroscience (Nasdaq: VIGL) announced three presentations on its small molecule TREM2 agonist VG-3927 at the 2024 Alzheimer's Association International Conference (AAIC) in Philadelphia. The presentations include:

1. An oral presentation on the characterization of VG-3927 for clinical development in Alzheimer's disease.

2. A poster on the design of a Phase 1, first-in-human study of VG-3927 in healthy volunteers.

3. A poster on the pharmacological and functional characterization of VG-3927 for Alzheimer's treatment.

These presentations highlight Vigil's progress in developing VG-3927 as a potential treatment for Alzheimer's disease, showcasing the company's focus on harnessing microglia for neurodegenerative diseases.

Vigil Neuroscience (Nasdaq: VIGL) has updated its clinical development strategy for iluzanebart in adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) following a Type C Meeting with the FDA. The company will preserve the IGNITE dataset for a final analysis at 12 months, foregoing an interim analysis. This approach aims to leverage their biomarker strategy and pursue a potential accelerated approval pathway.

The FDA has shown openness to considering accelerated approval, requesting additional data to support the proposed development plan. Vigil plans to report the final analysis from the IGNITE clinical trial in the first half of 2025, including all patients dosed with either 20 mg/kg or 40 mg/kg of iluzanebart over 12 months.

Vigil Neuroscience announced a $40 million strategic investment from Sanofi at an as-converted price of $7.44 per common share. Sanofi will acquire 537,634 Series A non-voting preferred shares, convertible into ten shares of common stock each. This investment provides Sanofi with an exclusive right of first negotiation for the license of Vigil's TREM2 agonist program, including VG-3927, currently in phase 1 trials for Alzheimer's treatment.

The funds from this investment will support Vigil's research and development, extending its cash runway into 2026. Vigil's CEO, Ivana Magovčević-Liebisch, emphasized the significance of Sanofi's investment as validation of their precision medicine approach. Sanofi's Global Head of Neurology Development, Erik Wallstroem, highlighted the importance of microglial signaling in neurodegenerative diseases and their commitment to immunoscience and neuroimmunology.

Augustine Therapeutics has secured EUR 17 million ($18.5 million) in the first closing of its Series A funding round. The financing was led by Asabys Partners, with participation from Eli Lilly and Company, and the Charcot-Marie-Tooth Research Foundation, among others.

The funds will advance AGT100216, a selective HDAC6 inhibitor, into a Phase 1/2 clinical trial in 2025, targeting neurological diseases like Charcot-Marie-Tooth and chemotherapy-induced peripheral neuropathies. Additional funds will support pipeline development and expand the executive and R&D team.

Gerhard Koenig has been appointed as Executive Chairman of the Board, while Clara Campàs from Asabys Partners has joined the Board of Directors.