Vigil Neuroscience Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Recent Business Updates

Rhea-AI Summary

Vigil Neuroscience (VIGL) reported its Q4 and full year 2024 financial results, highlighting significant progress in its TREM2 programs. The company announced positive Phase 1 data for VG-3927, their oral small molecule TREM2 agonist for Alzheimer's Disease, demonstrating favorable safety and up to 50% reduction in sTREM2 in cerebral spinal fluid. A Phase 2 trial is planned for Q3 2025.

The company's financial position shows cash reserves of $97.8 million as of December 31, 2024, expected to fund operations into 2026. R&D expenses increased to $62.3 million for 2024 (from $60.9M in 2023), while G&A expenses decreased to $27.4 million (from $27.9M). Net loss for 2024 was $84.3 million.

The company expects to report final analysis from the IGNITE Phase 2 trial of iluzanebart for ALSP in Q2 2025, pursuing an accelerated approval pathway.

Positive

• Positive Phase 1 data for VG-3927 showing strong safety profile and efficacy
• Substantial cash position of $97.8M funding operations into 2026
• Advancing to Phase 2 trials for VG-3927 in Q3 2025
• Pursuing accelerated approval pathway for iluzanebart in ALSP

Negative

• Increased net loss to $84.3M in 2024 from $82.6M in 2023
• Higher R&D expenses at $62.3M compared to $60.9M in 2023

Insights

Biotechnology Analyst

Vigil Neuroscience's latest results reveal significant progress in its TREM2-targeting neurodegenerative disease platform. The positive Phase 1 data for VG-3927 in Alzheimer's represents a important milestone, demonstrating favorable safety, strong CNS penetration, and robust target engagement with ~50% reduction in soluble TREM2 in cerebrospinal fluid. The once-daily 25mg oral dosing profile represents a significant competitive advantage in Alzheimer's treatment, where patient compliance is critical for chronic therapy.

What distinguishes VG-3927 is its position as the first and only Phase 2-ready oral small molecule TREM2 agonist, targeting microglial function to potentially address both neuroinflammation and impaired clearance mechanisms central to Alzheimer's pathology. This mechanistic approach offers a differentiated strategy in the evolving Alzheimer's treatment landscape.

For iluzanebart in ALSP (Adult-onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia), the upcoming Q2 2025 Phase 2 readout represents a critical inflection point. The company's pursuit of an accelerated approval pathway suggests confidence in the preliminary data. ALSP, being an ultra-rare disease with no approved therapies, provides a potentially streamlined regulatory path that could make this Vigil's first commercial product.

The cash position of $97.8 million funds operations into 2026, comfortably covering both the VG-3927 Phase 2 initiation and iluzanebart's Phase 2 completion - the two most significant near-term value-creating events. While R&D expenses increased modestly year-over-year to $62.3 million, this reflects appropriate investment in advancing two parallel clinical programs.

– Announced positive data from Phase 1 clinical trial evaluating VG-3927 for potential treatment of Alzheimer’s Disease (AD); plans to initiate Phase 2 clinical trial in Q3 2025 –

– On track to report final analysis from IGNITE Phase 2 clinical trial evaluating iluzanebart in ALSP in Q2 2025 –

WATERTOWN, Mass., March 13, 2025 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided updates on recent progress.

“We are entering 2025 with strong momentum, driven by significant progress in the development of our TREM2 programs, VG-3927 and iluzanebart,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. “We recently reported positive Phase 1 data for VG-3927 that support the advancement of this differentiated clinical candidate, and we plan to initiate the Phase 2 trial in the third quarter of 2025. As the first and only, Phase 2-ready oral small molecule TREM2 agonist, VG-3927 has the potential to provide a novel, next-generation therapy for Alzheimer’s disease. Additionally, with the upcoming Phase 2 data readout for iluzanebart in ALSP in the second quarter we are excited to advance closer to providing a potential breakthrough therapy for this devastating disease with serious unmet need. With a number of upcoming catalysts for our two TREM2 agonist programs, 2025 is set to be a pivotal year for Vigil.”

Recent Business Highlights and Upcoming Milestones

Iluzanebart, Monoclonal Antibody TREM2 Agonist

Final analysis from IGNITE Phase 2 clinical trial planned for second quarter of 2025:

• The Company plans to report the final analysis from the IGNITE Phase 2 clinical trial, including all patients at 12 months dosed with either 20 mg/kg or 40 mg/kg of iluzanebart in the second quarter of 2025.
• The Company intends to pursue an accelerated approval pathway for iluzanebart in ALSP and expects to share an update on its progress when the final analysis is reported.

VG-3927, Small Molecule TREM2 Agonist

Positive Phase 1 data from VG-3927:

• In January 2025, the Company reported positive data from its completed Phase 1 clinical trial evaluating VG-3927 for the potential treatment of AD. The Phase 1 single and multiple ascending dose (SAD/MAD) trial assessed the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VG-3927 across 14 cohorts, including 8 SAD cohorts of healthy volunteers up to a 140 mg dose and 4 MAD cohorts of healthy volunteers up to a 50 mg dose. The trial also included a multiple dose elderly cohort and a single dose cohort of AD patients, including some participants who carry TREM2 or other genetic risk factors for AD. The trial enrolled a total of 115 participants with 89 participants receiving VG-3927, including 34 participants that were 55 years of age and older.
• These data demonstrated a favorable safety and tolerability profile across all cohorts, including the elderly cohort. All related adverse events were mild or moderate in severity and self-resolving without drug discontinuations. No serious AEs were reported.
• VG-3927 was observed to be highly CNS penetrant with a favorable and predictable PK profile that supports once-daily dosing. Importantly, VG-3927 achieved a robust and dose-dependent reduction of sTREM2 of up to approximately 50% in the cerebral spinal fluid (CSF) demonstrating a strong PK/PD relationship, sustained target engagement and TREM2 agonist activity.
• Vigil will present the Phase 1 data in an oral presentation at the AD/PD™ 2025 International Conference on Alzheimer’s and Parkinson’s Disease taking place April 1-5, 2025, in Vienna, Austria and virtually.
• The Company plans to advance a once-daily oral dose of 25 mg that fully engages the desired pharmacology and expects to initiate the Phase 2 trial in the third quarter of 2025.
  

Fourth Quarter and Full Year 2024 Financial Results:

• Cash Position: Cash, cash equivalents, and marketable securities were $97.8 million as of December 31, 2024, compared to $111.3 million as of September 30, 2024. The Company expects its cash, cash equivalents and marketable securities will fund its operational plans into 2026.
• Research and Development (R&D) Expenses: R&D expenses were $18.7 million for the fourth quarter and $62.3 million for the year ended December 31, 2024, compared to $16.8 million and $60.9 million for the same periods in 2023. The annual year-over-year increase was primarily driven by increased clinical activity related to the initiation of the VG-3927 Phase 1 clinical trial in the fourth quarter of 2023 and increased headcount-related costs to support the advancement of the Company’s clinical development programs. The increases were partially offset by decreases in the Company’s iluzanebart program driven by the timing of manufacturing activities and completion of the Phase 1 clinical trial.
• General and Administrative (G&A) Expenses: G&A expenses were $6.4 million for the fourth quarter and $27.4 million for the year ended December 31, 2024, compared to $7.1 million and $27.9 million for the same periods in 2023. The annual year-over-year decrease was primarily attributed to a decrease in external professional service fees, partially offset by an increase in headcount-related costs to support the Company’s growth.
• Net Loss: The Company had net losses of $23.8 million for the fourth quarter and $84.3 million for the year ended December 31, 2024, compared to $22.2 million and $82.6 million for the same periods in 2023.

About Vigil Neuroscience

Vigil Neuroscience is a clinical-stage biotechnology company focused on developing treatments for both rare and common neurodegenerative diseases by restoring the vigilance of microglia, the sentinel immune cells of the brain. Vigil is utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities in its efforts to develop precision-based therapies to improve the lives of patients and their families. Iluzanebart, Vigil’s lead clinical candidate, is a fully human monoclonal antibody agonist targeting human triggering receptor expressed on myeloid cells 2 (TREM2) in people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare and fatal neurodegenerative disease. Vigil is also developing VG-3927, a novel small molecule TREM2 agonist, to treat common neurodegenerative diseases associated with microglial dysfunction, with an initial focus on Alzheimer’s disease (AD).

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements” of Vigil Neuroscience (“Vigil” or the “Company”) that are made pursuant to the safe harbor provisions of the federal securities laws, including, without limitation, express or implied statements regarding: the Company’s strategy, business plans and focus; the potential therapeutic benefit of the Company’s product candidates, including iluzanebart and VG-3927; the progress and timing of the clinical development of Vigil’s programs, including the availability of, and expected timing for reporting, the final analysis from the IGNITE Phase 2 clinical trial and the timing to advance VG-3927 into a Phase 2 clinical trial; beliefs about observations made analyzing clinical trial data to date, including with respect to VG-3927; the Company’s intention to seek the accelerated approval pathway for iluzanebart and anticipated timing and outcomes of regulatory interactions; and the expectation that the Company’s cash runway will be sufficient into 2026. Forward-looking statements are based on Vigil’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties inherent in the development of product candidates, including the conduct of research activities and clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; whether Vigil’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and the timing and content of additional regulatory information from the FDA; as well as the risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission (SEC), including Vigil’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, its upcoming Annual Report on Form 10-K for the year ended December 31, 2024, and any subsequent filings Vigil makes with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Vigil undertakes no duty to update such information except as required under applicable law. Readers should not rely upon the information in this press release as current or accurate after its publication date.

VIGIL NEUROSCIENCE, INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
		Three Months Ended								Year Ended
		December  31, 2024				December  31, 2023				December  31, 2024				December  31, 2023
Operating expenses:
Research and development		$	18,668			$	16,782			$	62,306			$	60,934
General and administrative			6,446				7,075				27,377				27,932
Total operating expenses			25,114				23,857				89,683				88,866
Loss from operations			(25,114	)			(23,857	)			(89,683	)			(88,866	)
Other income (expense):
Interest income, net			1,277				1,681				5,418				6,241
Other income (expense), net			6				2				9				(13	)
Total other income, net			1,283				1,683				5,427				6,228
Net loss		$	(23,831	)		$	(22,174	)		$	(84,256	)		$	(82,638	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.57	)		$	(0.57	)		$	(2.07	)		$	(2.13	)
Weighted—average common shares outstanding, basic and diluted			41,657,259				38,832,292				40,668,444				38,712,207

VIGIL NEUROSCIENCE, INC.
Selected Balance Sheet Data
(in thousands)
(unaudited)
		December 31, 2024			December 31, 2023
Cash, cash equivalents, and marketable securities		$	97,795		$	117,940
Total assets			117,691			140,858
Total liabilities			46,056			24,606
Total stockholders' equity			71,635			116,252

Internet Posting of Information
Vigil Neuroscience routinely posts information that may be important to investors in the 'Investors' section of its website at https://www.vigilneuro.com. The company encourages investors and potential investors to consult our website regularly for important information about Vigil Neuroscience.

Investor Contact:
Leah Gibson
Vice President, Investor Relations & Corporate Communications
Vigil Neuroscience, Inc.
lgibson@vigilneuro.com 

Media Contact:
Megan McGrath
CTD Comms, LLC
megan@ctdcomms.com 

FAQ

What were the key findings from VIGL's Phase 1 trial of VG-3927 for Alzheimer's Disease?

The trial showed favorable safety profile, once-daily dosing potential, and up to 50% reduction in sTREM2 in cerebral spinal fluid, demonstrating strong target engagement.

When will Vigil Neuroscience (VIGL) report Phase 2 results for iluzanebart in ALSP?

Final analysis from the IGNITE Phase 2 trial is expected in Q2 2025, including 12-month dosing data for both 20 mg/kg and 40 mg/kg doses.

What is VIGL's cash runway based on their Q4 2024 financial results?

With $97.8 million in cash and equivalents as of December 31, 2024, VIGL expects to fund operations into 2026.

How much did Vigil Neuroscience's (VIGL) net loss increase in 2024 compared to 2023?

Net loss increased by $1.7 million, from $82.6 million in 2023 to $84.3 million in 2024.

When will VIGL begin Phase 2 trials for VG-3927 in Alzheimer's Disease?

VIGL plans to initiate Phase 2 trials with a 25mg once-daily oral dose in Q3 2025.