Vigil Neuroscience Reports Second Quarter 2024 Financial Results and Provides Business Update
13 Agosto 2024 - 8:00AM
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 second quarter ended June 30,
2024, and provided an update on recent progress.
“Vigil has made great progress in the first half
of this year as we continue to advance our pipeline of novel
candidates for indications with strong genetic links to microglial
dysfunction,” said Ivana Magovčević-Liebisch, Ph.D., J.D.,
President and Chief Executive Officer of Vigil. “With the recent
strategic investment from Sanofi and our clinical program updates
that support an encouraging regulatory pathway for iluzanebart in
ALSP and the continued development of VG-3927 for the potential
treatment of AD, we believe that we are well-positioned to execute
on our strategy to bring these potentially transformative therapies
to patients and their families.”
Recent Highlights and Anticipated
Milestones
Iluzanebart, Monoclonal Antibody TREM2
Agonist:
- Clinical
development strategy update following Type C Meeting with U.S. Food
and Drug Administration (FDA): In July 2024, the Company
announced that it updated the clinical development strategy for
iluzanebart. This follows a Type C meeting with the FDA where the
Agency stated it was open to considering the accelerated approval
pathway and that the Company should provide additional data to
support the proposed development plan. The updated strategy
includes preserving the IGNITE dataset for a final analysis at 12
months, which the Company believes provides an opportunity to
leverage its biomarker strategy and to pursue the potential
accelerated approval pathway.
- Final
analysis from IGNITE clinical trial planned for first half of
2025: The Company plans to report the final analysis from
the IGNITE clinical trial, including all patients at 12 months
dosed with either 20 mg/kg or 40 mg/kg of iluzanebart in the first
half of 2025.
-
Publication on ALSP Genetic Mutation Prevalence in
Neurology Genetics: In July 2024, a peer-reviewed research
publication reported new data on the prevalence and clinical
significance of CSF1R gene variants in the UK population. The
research, published in the journal Neurology Genetics and conducted
by Wade et al., suggests the estimated prevalence of ALSP is
underreported in the U.S., EU, and UK. Prior to this publication,
it was estimated there may be approximately 10,000 people living
with ALSP in the U.S. with similar prevalence outside of the U.S.
Based on these new data, the Company now estimates U.S. prevalence
of ALSP is approximately 19,000 while the estimated combined EU and
UK prevalence is approximately 29,000.
VG-3927, Small Molecule TREM2 Agonist
- Interim
data from ongoing Phase 1 clinical trial evaluating VG-3927 in
healthy volunteers: In July 2024, the Company reported
interim data from the ongoing Phase 1 SAD/MAD clinical trial
evaluating VG-3927 in healthy volunteers. These data showed that
the safety and tolerability profile observed in individual doses in
six SAD and two MAD cohorts supports continued clinical development
of VG-3927. In addition, VG-3927 demonstrated a predictable PK
profile supportive of once-daily dosing. Importantly, in the SAD
and MAD cohorts, VG-3927 achieved a robust and sustained decrease
of soluble TREM2 in the CSF demonstrating clinical proof-of-target
engagement. VG-3927 also showed an increase in osteopontin/secreted
phosphoprotein 1 (SPP1) after repeat dosing.
- Complete
Phase 1 clinical data in first quarter of 2025: As part of
the Phase 1 clinical trial, the Company has commenced screening for
a cohort of AD patients, including some participants who carry
TREM2 or other disease-related variants to explore the biomarker
response of VG-3927 after a single dose. Vigil expects to use these
data to inform the development strategy for subsequent and larger
trials evaluating VG-3927 in AD. The Company plans to report the
complete Phase 1 clinical data, including data from the AD patient
cohort, in the first quarter of 2025.
Corporate
- $40 million strategic
investment from Sanofi: In June 2024, the Company entered
into a Securities Purchase Agreement with Sanofi, a global
healthcare and pharmaceutical company, pursuant to which Vigil
agreed to issue an aggregate of 537,634 Series A non-voting
preferred shares, each convertible into 10 shares of common stock,
at an as-converted price of $7.44 per common share for gross
proceeds of $40 million. The Company plans to use the proceeds to
fund its research and development activities.
Second Quarter 2024 Financial Results
-
Cash Position: Cash, cash equivalents, and
marketable securities were $86.7 million as of June 30, 2024,
compared to $101.6 million as of March 31, 2024. The Company
expects its cash, cash equivalents and marketable securities,
together with the $40 million gross proceeds received from Sanofi
in July, will fund its operational plans into 2026.
-
Research and Development (R&D)
Expenses: R&D expenses for the second quarter
ended June 30, 2024, were $15.5 million, compared to $14.9 million
for the same period in 2023. This increase was driven by advancing
VG-3927 Phase 1 clinical development and headcount-related costs to
support the Company’s continued growth.
-
General and Administrative (G&A)
Expenses: G&A expenses for the second quarter
ended June 30, 2024, were $6.9 million, consistent with the $7.0
million for the same period in 2023.
-
Net Loss: Loss from operations for the second
quarter ended June 30, 2024, were $21.2 million, compared to $20.2
million for the same period in 2023.
About Vigil NeuroscienceVigil
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)
patients, including some who carry TREM2 and other
disease-associated variants.
Forward-Looking StatementsThis
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 VG-3927, and the expected therapeutic
benefits of such programs as well as the ability to improve the
lives of patients and their families; the estimated prevalence of
ALSP in the US, UK and EU; the progress and timing of the clinical
development of Vigil’s programs, including the availability of, and
expected timing for reporting, data from both the IGNITE Phase 2
clinical trial and the VG-3927 Phase 1 clinical trial; beliefs
about observations made analyzing preclinical study and clinical
trial data to date; the success and timing of the Company’s
interactions with regulatory authorities, including with the FDA
regarding the accelerated approval pathway; 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 related to uncertainties inherent in the development
of product candidates, including the conduct of research activities
and the conduct of clinical trials; uncertainties as to the
availability and timing of results and data from clinical trials;
whether results from prior preclinical studies and clinical trials
will be predictive of the results of subsequent preclinical studies
and clinical trials; the timing and content of additional
regulatory information from the FDA; the Company’s ability to work
with the FDA to successfully remove the partial clinical hold on
VG-3927; whether Vigil’s cash resources will be sufficient to fund
its foreseeable and unforeseeable operating expenses and capital
expenditure requirements; 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 March 31, 2024, its upcoming
Quarterly Report on Form 10-Q for the quarter ended June 30, 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 on this page 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 |
|
Six Months Ended |
|
|
June 30,2024 |
|
June 30,2023 |
|
June 30,2024 |
|
June 30,2023 |
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
15,540 |
|
|
$ |
14,903 |
|
|
$ |
29,866 |
|
|
$ |
28,737 |
|
General and administrative |
|
|
6,938 |
|
|
|
7,010 |
|
|
|
14,027 |
|
|
|
13,951 |
|
Total operating expenses |
|
|
22,478 |
|
|
|
21,913 |
|
|
|
43,893 |
|
|
|
42,688 |
|
Loss from operations |
|
|
(22,478 |
) |
|
|
(21,913 |
) |
|
|
(43,893 |
) |
|
|
(42,688 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income, net |
|
|
1,254 |
|
|
|
1,746 |
|
|
|
2,731 |
|
|
|
2,731 |
|
Other income (expense), net |
|
|
(3 |
) |
|
|
(7 |
) |
|
|
(5 |
) |
|
|
(12 |
) |
Total other income, net |
|
|
1,251 |
|
|
|
1,739 |
|
|
|
2,726 |
|
|
|
2,719 |
|
Net
loss |
|
$ |
(21,227 |
) |
|
$ |
(20,174 |
) |
|
$ |
(41,167 |
) |
|
$ |
(39,969 |
) |
Net
loss per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.52 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.02 |
) |
|
$ |
(1.04 |
) |
Weighted—average common shares outstanding, basic and diluted |
|
|
40,564,580 |
|
|
|
38,657,205 |
|
|
|
40,214,345 |
|
|
|
38,601,916 |
|
|
|
|
|
|
|
|
|
|
VIGIL NEUROSCIENCE, INC. |
Selected Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
June 30, 2024 |
|
December 31, 2023 |
Cash, cash equivalents, and marketable securities |
|
$ |
86,674 |
|
$ |
117,940 |
Total assets |
|
|
108,464 |
|
|
140,858 |
Total liabilities |
|
|
23,192 |
|
|
24,606 |
Total stockholders' equity |
|
|
85,272 |
|
|
116,252 |
|
|
|
|
|
Internet Posting of
InformationVigil 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 GibsonVice President,
Investor Relations & Corporate CommunicationsVigil
Neuroscience, Inc.lgibson@vigilneuro.com
Media Contact:Megan McGrathCTD Comms,
LLCmegan@ctdcomms.com
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