The Company remains on track to report VGL101 Phase 1 healthy volunteer topline data and initiate a Phase 2 proof-of-concept trial in adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) patients in the fourth quarter of 2022: Vigil recently completed dosing of the 20 mg/kg multiple ascending dose cohort without any safety signals in its U.S. Phase 1 trial of VGL101 in healthy volunteers. The Company also initiated dosing of VGL101 at 30 mg/kg in its Phase 1 trial in healthy volunteers in Australia in an effort to maintain optionality to support patients with rare and common neurodegenerative diseases beyond ALSP.

VGL101 received U.S. Food and Drug Administration (FDA) orphan drug designation: In July, the FDA granted orphan drug designation to VGL101 for the treatment of patients with ALSP. The FDA’s Orphan Drug Designation program provides orphan designation to drugs and biologics that are intended to treat, diagnose or prevent rare diseases affecting fewer than 200,000 people in the U.S. This designation provides the potential to obtain certain benefits, including financial incentives to support clinical development and seven years of marketing exclusivity upon FDA approval.

Vigil presented key findings demonstrating the high frequency of initial misdiagnosis of ALSP at the 8^th Congress of the European Academy of Neurology (EAN): Vigil presented a poster entitled, “Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP): Initial Misdiagnosis,” at EAN highlighting the frequency of initial misdiagnosis of ALSP through a comprehensive, systematic literature review. The findings of this systematic review demonstrated a high incidence of initial misdiagnosis of ALSP and confirmed the need for early, accurate diagnosis to allow rapid therapeutic intervention for potential cessation or slowing of the progression of this devastating disorder and improvement of survival time. This poster can be accessed on the Publications page of the Company’s website.

Vigil presented two posters at the Alzheimer’s Association International Conference (AAIC) further supporting the evaluation of VGL101 as a potential therapeutic for ALSP: Vigil presented a poster entitled, “VGL101 Rescues CSF1R Dysfunction in Human Microglia and Macrophages: Evaluation of In Vitro TREM2 Agonism in Models of a CSF1R-dependent Leukodystrophy,” demonstrating that TREM2 agonism by VGL101 was able to compensate for CSF1R dysfunction in in vitro ALSP models utilizing healthy, human monocyte derived macrophages (hMDM) and induced pluripotent stem cell derived human microglia (iMGL). Vigil also presented a poster entitled, “Phenotypic Features of Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP): Presenting Symptoms and Clinical Course,” summarizing its systematic literature review of published case studies on the clinical and genetic features of ALSP to better understand the phenotypic characteristics of ALSP. Data from a cohort of 292 patients, representing the largest case series to date of ALSP, confirmed and expanded the previous, smaller case reports on the phenotypic characteristics of ALSP. These posters can be accessed on the Publications page of the Company’s website.

IND-enabling studies in small molecule TREM2 agonist program are progressing: The Company’s first-in-class, orally available and highly CNS penetrant small molecule program is designed to activate TREM2 for the treatment of common neurodegenerative diseases. Vigil has established that its small molecules have a different mechanism of action and bind to a different location than VGL101, providing the potential for additional optionality in positioning these molecules in different patient populations and potential differentiation from TREM2 antibody therapeutics. Based on these findings, the Company no longer believes that the originally planned Phase 1b biomarker trial of VGL101 will inform clinical development of the small molecule in Alzheimer’s Disease (AD) and is no longer planning to conduct this biomarker trial. The Company continues to expect to file an Investigational New Drug (IND) application with an initial focus in genetically defined AD subpopulations in 2023.

Prioritization of development studies extends cash runway: Vigil has elected to prioritize VGL101 in ALSP and its small molecule TREM2 agonist programs. The Company no longer plans to conduct the Phase 1b biomarker trial of VGL101 in AD and plans to defer the initiation of the planned Phase 2 clinical trial of VGL101 for the treatment of cerebral adrenoleukodystrophy (cALD). This strategic prioritization is expected to extend the Company’s cash runway through the end of the second quarter of 2024.

Further strengthened Board of Directors: Vigil recently appointed Suzanne Bruhn, Ph.D. to its Board of Directors. Dr. Bruhn brings over 20 years of executive leadership experience in the biopharmaceutical industry with deep operational and global regulatory experience. In addition, her extensive knowledge of the rare disease and neuroscience space and proven track record of developing and commercializing therapies for serious diseases will be invaluable as the Company advances the clinical development of its pipeline candidates.

Cash Position: Cash and cash equivalents were $148.9 million as of June 30, 2022. The Company expects its cash and cash equivalents to fund its operational plans through the end of the second quarter of 2024.

R&D Expenses: Research and development expenses for the second quarter ended June 30, 2022, were $12.1 million, compared to $8.6 million for the same period in 2021. The increase was primarily attributable to the continued advancement of our pipeline programs and increases in headcount to support our continued growth.

G&A Expenses: General and administrative expenses for the second quarter ended June 30, 2022, were $4.9 million, compared to $2.1 million for the same period in 2021. The increase was primarily attributable to increases in headcount-related costs and professional service fees associated with operating as a public company.

Net Loss: Loss from operations for the second quarter ended June 30, 2022, were $17.0 million, compared to $11.4 million for the same period in 2021. The increase was primarily attributable to higher operating costs in the current period to support the advancement of the Company’s pipeline as well as increased costs associated with operating as a public company.

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