Vigil Neuroscience Reports Second Quarter 2023 Financial Results and Provides Business Update
August 08 2023 - 7:05AM
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,
2023, and provided an update on its recent progress.
“During the quarter, we continued to advance our
lead candidates for ALSP and Alzheimer's Disease and are
well-positioned to deliver on multiple value-driving milestones in
the second half of 2023,” said Ivana Magovčević-Liebisch, Ph.D.,
J.D., President and Chief Executive Officer of Vigil. “Most
notably, we are on track to provide interim data from IGNITE, our
ongoing Phase 2 trial evaluating VGL101 in people living with ALSP.
This interim analysis will include the first six patients following
six months of treatment. Together with data from our ongoing
Natural History Study, ILLUMINATE, this analysis may provide
further observations relating to the trajectory of the disease and
could be instrumental in validating key therapeutic biomarkers to
support proof-of-concept of VGL101.”
“In addition to VGL101, we have also made
significant progress with our novel small molecule TREM2 agonist
for the potential treatment of Alzheimer’s Disease. We are on track
to submit an IND application and initiate a Phase 1 clinical trial
in healthy volunteers in the fourth quarter of 2023,” concluded Dr.
Magovčević-Liebisch. “Driven by our mission to bring transformative
therapies to patients with both rare and common neurodegenerative
diseases, we are thrilled by our continued progress advancing our
pipeline.”
Recent Highlights and Anticipated
Milestones
VGL101, a monoclonal antibody TREM2
agonist
- Added 40
mg/kg dose cohort in ongoing IGNITE Phase 2 clinical
trial: IGNITE, the first-ever interventional trial in
people living with ALSP, is a global Phase 2, open-label clinical
trial designed to evaluate the safety and tolerability of VGL101 in
up to 15 patients with symptomatic ALSP who have
a CSF1R gene mutation. The Company has added a dose
cohort in which patients will receive an intravenous (IV) infusion
of VGL101 at 40 mg/kg approximately every four weeks, for a
treatment duration of one year in addition to the initial dose
cohort of 20 mg/kg.
- First
interim data readout from 20 mg/kg cohort in ongoing IGNITE Phase 2
clinical trial expected in the fourth quarter of
2023: The Phase 2 clinical trial evaluating VGL101
in people living with ALSP is ongoing and the Company remains on
track to report interim data in the fourth quarter of 2023 from the
first 6 patients at 6 months who have received 20 mg/kg of
VGL101.
- Full
data analysis from the VGL101 Phase 1 single and multiple ascending
dose (SAD and MAD) healthy volunteer trial expected in the second
half of 2023: The Company has completed dosing of the
60 mg/kg SAD and MAD cohorts in which VGL101 continued to be safe
and well-tolerated and expects to report the full data analysis
from the Phase 1 clinical trial in the third quarter of 2023 at an
upcoming medical conference.
-
Continued patient-focused initiatives for ALSP
community: As previously disclosed in May 2023, Vigil
launched ALSPAware, a new genetic testing and counseling initiative
designed to enable improved patient diagnosis of ALSP. Developed
with both patients and healthcare providers in mind, the program
includes a single gene confirmatory test for individuals with a
family history of ALSP, as well as a custom gene panel available
for physicians to use in diagnosing adult-onset neurological
diseases, including ALSP.
Small Molecule TREM2 Agonist
Program
-
Continued to progress small molecule TREM2 agonist program
toward clinical development: The Company expects to submit
an Investigational New Drug (IND) application to the U.S. Food and
Drug Administration (FDA) and, subject to FDA clearance of the IND,
initiate clinical development in healthy volunteers for its lead
small molecule TREM2 agonist in the fourth quarter of 2023. The
program will have an initial focus on genetically defined
subpopulations of Alzheimer’s Disease. Vigil’s highly active,
selective and brain-penetrant small molecule agonists are designed
to act as a molecular glue that potentiates the TREM2 signaling
response to natural damage ligands. In preclinical studies, Vigil
has established that its small molecule agonists demonstrate
on-target TREM2 activation across both common and rare TREM2
variants. Additionally, the Company has demonstrated that its small
molecule agonists were able to deliver in vivo TREM2 responses
within the central nervous system at a magnitude and specificity
similar to VGL101.
-
Presented at Keystone Symposia on Molecular and Cellular
Biology – Neurodegeneration: New Biology Guiding the Next
Generation of Therapeutic Development: In May 2023, Vigil
presented a poster and an oral presentation on the unique mechanism
of action of its small molecule TREM2 agonists for the potential
treatment of Alzheimer’s Disease. The presentations can be accessed
on the publications page of the Company’s website.
Corporate
-
Appointment of drug development veteran Christopher J.
Silber, M.D. as Chief Medical Officer: The Company
recently announced the appointment of Christopher J. Silber, M.D.
as Chief Medical Officer. Dr. Silber brings over 30 years of
biopharmaceutical industry experience and a track record of
clinical and regulatory success developing novel therapeutics in
neuroscience.
Second Quarter 2023 Financial
Results
- Cash
Position: Cash, cash equivalents, and marketable
securities were $150.2 million as of June 30, 2023, compared to
$164.5 million as of March 31, 2023. The Company expects its cash,
cash equivalents and marketable securities to fund its operational
plans into the first quarter of 2025.
- Research
and Development (R&D)
Expenses: R&D expenses for the second quarter
ended June 30, 2023, were $14.9 million, compared to $12.1 million
for the same period in 2022. This increase was primarily driven by
increased preclinical activity related to the Company’s small
molecule program, increased clinical trial-related expenses
associated with the continued advancement of the VGL101 program,
and increased headcount to support the Company’s continued
growth.
- General
and Administrative (G&A)
Expenses: G&A expenses for the second quarter
ended June 30, 2023, were $7.0 million, compared to $4.9 million
for the same period in 2022. The increase was primarily
attributable to increases in headcount-related costs to support the
Company’s growth.
- Net
Loss: Loss from operations for the second quarter
ended June 30, 2023, were $20.2 million, compared to $17.0 million
for the same period in 2022.
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. We
are utilizing the tools of modern neuroscience drug development
across multiple therapeutic modalities in our efforts to develop
precision-based therapies to improve the lives of patients and
their families. VGL101, our 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. We are
also developing a novel small molecule TREM2 agonist to treat
common neurodegenerative diseases associated with microglial
dysfunction, with an initial focus on Alzheimer’s disease (AD) in
genetically defined subpopulations.
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements” of Vigil Neuroscience’s
(“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, focus and value of future
milestones; the progress and timing of the preclinical and clinical
development of Vigil’s programs, including the availability of data
and expected timing for reporting interim data from IGNITE Phase 2
clinical trial, filing an IND application for its small molecule
TREM2 agonist program and the initiation of the Phase 1 clinical
trial and reporting full data analysis from its Phase 1 healthy
volunteer trial of VGL101; the success and timing of its
interactions with regulatory authorities; and the Company’s cash
runway into first quarter of 2025. 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 identification and development of product
candidates, including the conduct of research activities and the
initiation and completion of preclinical studies and clinical
trials; uncertainties as to the availability and timing of results
and data from preclinical and clinical studies; the timing of the
Company’s ability to submit and obtain regulatory clearance for
investigational new drug applications and initiate additional
clinical trials; whether results from preclinical studies and
clinical studies will be predictive of the results of later
preclinical studies and clinical trials; the Company’s ability to
initiate and complete its current and expected clinical trials;
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, 2023, its upcoming
Quarterly Report on Form 10-Q for the quarter-ended June 30, 2023
and in 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, 2023 |
|
June 30, 2022 |
|
June 30, 2023 |
|
June 30, 2022 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
$ |
14,903 |
|
|
$ |
12,097 |
|
|
$ |
28,737 |
|
|
$ |
22,462 |
|
General and administrative |
|
|
7,010 |
|
|
|
4,945 |
|
|
|
13,951 |
|
|
|
9,912 |
|
Total operating expenses |
|
|
21,913 |
|
|
|
17,042 |
|
|
|
42,688 |
|
|
|
32,374 |
|
Loss from operations |
|
|
(21,913 |
) |
|
|
(17,042 |
) |
|
|
(42,688 |
) |
|
|
(32,374 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest income, net |
|
|
1,746 |
|
|
|
32 |
|
|
|
2,731 |
|
|
|
34 |
|
Other income (expense), net |
|
|
(7 |
) |
|
|
(5 |
) |
|
|
(12 |
) |
|
|
(9 |
) |
Total other income (expense), net |
|
|
1,739 |
|
|
|
27 |
|
|
|
2,719 |
|
|
|
25 |
|
Net loss |
|
$ |
(20,174 |
) |
|
$ |
(17,015 |
) |
|
$ |
(39,969 |
) |
|
$ |
(32,349 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.52 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.04 |
) |
|
$ |
(1.18 |
) |
Weighted—average common shares
outstanding, basic and diluted |
|
|
38,657,205 |
|
|
|
28,150,051 |
|
|
|
38,601,916 |
|
|
|
27,409,264 |
|
|
|
|
|
|
VIGIL NEUROSCIENCE, INC. |
Selected Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
June 30, 2023 |
|
December 31, 2022 |
Cash, cash equivalents, and marketable securities |
|
$ |
150,164 |
|
$ |
186,605 |
Total assets |
|
|
175,409 |
|
|
200,393 |
Total liabilities |
|
|
21,573 |
|
|
11,312 |
Total stockholders' equity |
|
|
153,836 |
|
|
189,081 |
|
|
|
Investor Contact:
Leah Gibson
Vice President, Investor Relations & Corporate Communications
Vigil Neuroscience, Inc.
lgibson@vigilneuro.com
Media Contact:
Megan McGrath
MacDougall Advisors
mmcgrath@macdougall.bio
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