Vigil Neuroscience Reports Third Quarter 2023 Financial Results and Provides Business Update
07 November 2023 - 1:05PM
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 third quarter ended September
30, 2023, and provided an update on recent progress.
“We continue to make significant progress in
advancing our novel TREM2 agonist candidates - VGL101 in ALSP and
VG-3927 in Alzheimer’s disease, and believe we are well-positioned
to become a leader in neurodegenerative drug development,” said
Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief
Executive Officer of Vigil. “Importantly, we are diligently
advancing our Phase 2 IGNITE trial, the first interventional study
in ALSP, and expect to report our interim results from the first
six patients treated for six months with VGL101 this quarter. In
September, we also proudly introduced our oral small molecule TREM2
agonist candidate, VG-3927, with the opening of our IND. We dosed
our first participant in our Phase 1 clinical trial in healthy
volunteers last month and expect to share interim results in
mid-2024.”
“As the only company known to have two TREM2
modalities, we have achieved critical milestones to support our
mission to bring transformative therapies to patients with both
rare and common neurodegenerative diseases,” added Dr.
Magovčević-Liebisch. “With our unique precision medicine approach
and dedicated team of industry leaders, we look forward to the
continued development of our clinical programs to serve patient
populations with high unmet need.”
Recent Highlights and Anticipated
Milestones
VGL101, A Fully Human Monoclonal
Antibody TREM2 Agonist
- First
interim data readout from 20 mg/kg cohort in ongoing IGNITE Phase 2
clinical trial on track for this quarter: The Phase 2
clinical trial evaluating VGL101 in adult-onset leukoencephalopathy
with axonal spheroids and pigmented glia (ALSP) is ongoing and the
Company remains on track to report interim data this quarter from
the first 6 patients at 6 months who have received 20 mg/kg of
VGL101.
-
Presented complete data analysis from Phase 1 single and
multiple ascending dose (SAD and MAD) healthy volunteer trial and
Phase 2 study design via two posters at ANA 2023: In
September 2023, the Company presented the complete data analysis
from its Phase 1 healthy volunteer trial, showing that VGL101
demonstrated a favorable safety and tolerability profile in SAD and
MAD cohorts at doses up to 60 mg/kg. VGL101 showed linear and
predictable pharmacokinetic (PK) characteristics and an observed
half-life that supports monthly dosing. Target engagement and
downstream pharmacodynamic responses of VGL101 at 20 mg/kg and 40
mg/kg support evaluating these doses in the ongoing IGNITE Phase 2
trial in ALSP. The Company also presented the trial design for its
ongoing Phase 2 IGNITE study, a global, open-label clinical trial
evaluating VGL101 in approximately 15 patients with symptomatic
ALSP who have a confirmed CSF1R gene mutation. These presentations
can be accessed on the publications page of the Company’s
website.
- Granted
Orphan Drug Designation for VGL101 from the European Medicines
Agency (EMA): In October 2023, the European Commission
granted orphan drug designation for VGL101 for the treatment of
CSF1R-related leukoencephalopathy, which includes ALSP. In July
2022, VGL101 was granted orphan drug designation by the U.S. Food
and Drug Administration (FDA) for ALSP.
-
Continued patient-focused initiatives for ALSP
community: In October, the Company added a new section for
healthcare providers (HCPs) on ALSPinfo.com, a disease education
website for ALSP. Prior to the update, ALSPinfo.com included
information and resources for those living with ALSP and their
caregivers. By expanding the website to include an HCP section, the
Company hopes to continue to raise awareness for ALSP, lower the
frequency of misdiagnosis, and encourage the utilization of genetic
testing for diagnostic purposes.
VG-3927, An Oral Small Molecule TREM2
Agonist
- First
participant dosed in ongoing Phase 1 clinical trial in healthy
volunteers: In October 2023, the first participant was
dosed in the Phase 1 clinical trial in healthy volunteers
evaluating VG-3927. VG-3927 is the first and only oral small
molecule TREM2 agonist in clinical development for the potential
treatment of Alzheimer’s disease (AD). The Company expects to
report interim Phase 1 topline data for VG-3927 in healthy
volunteers in mid-2024.
-
Update on small molecule program and hosted R&D
Event: In September 2023, the Company was informed by the
FDA that the Investigational New Drug (IND) application for VG-3927
was open and the Phase 1 clinical trial in healthy volunteers was
allowed to proceed with a partial clinical hold related to maximum
exposure limit. The FDA subsequently indicated that additional
non-clinical data is needed in order to exceed the maximum exposure
limit set by the FDA in the Phase 1 clinical trial. The Company is
in the process of obtaining additional PK data and will work with
the FDA to address the partial clinical hold. Based on preclinical
studies, the Company believes that the maximum exposure limit
exceeds the predicted efficacious dose of VG-3927. At this time,
the Company does not anticipate delays in the current clinical
development plans for VG-3927. In September 2023, the Company
hosted an R&D Event to share details on VG-3927 with KOL guest
participation from Marco Colonna, M.D. and Samuel Gandy, M.D. The
event highlighted new preclinical data for VG-3927, discussed
current treatment approaches for AD, and Vigil’s TREM2-focused
clinical approach for treating AD guided by its precision medicine
strategy. A recording of the event can be accessed on the Events
& Presentations page of the Investors Section of the Company’s
website.
Third Quarter 2023 Financial
Results
- Cash
Position: Cash, cash equivalents, and marketable
securities were $133.6 million as of September 30, 2023, compared
to $150.2 million as of June 30, 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 third quarter
ended September 30, 2023, were $15.4 million, compared to $12.8
million for the same period in 2022. The increase was primarily
driven by increased manufacturing-related expenses associated with
the VGL101 program, increased clinical activity associated with
advancing the VG-3927 program into a Phase 1 clinical trial, and
increased headcount to support the Company’s continued growth.
- General
and Administrative (G&A)
Expenses: G&A expenses for the third quarter
ended September 30, 2023, were $6.9 million, compared to $4.8
million for the same period in 2022. The increase was primarily
attributable to increases in headcount-related costs and
professional service fees to support the Company’s growth.
- Net
Loss: Loss from operations for the third quarter
ended September 30, 2023, were $20.5 million, compared to $17.5
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 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) in
genetically defined subpopulations.
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 progress and
timing of the clinical development of Vigil’s programs, including
the availability of, and expected timing for reporting, interim
data from both the IGNITE Phase 2 clinical trial and the VG-3927
Phase 1 clinical trial; the anticipated impact of the VG-3927
partial clinical hold on the Company’s clinical development plans,
regulatory progress and clinical progress for VG-3927; the success
and timing of the Company’s 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 conduct of clinical trials;
uncertainties as to the availability and timing of results and data
from clinical trials; whether results from preclinical studies and
clinical trials will be predictive of the results of later
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 June 30, 2023,
its upcoming Quarterly Report on Form 10-Q for the quarter ended
September 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.
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.
VIGIL NEUROSCIENCE, INC. |
Consolidated Statements of Operations |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, 2023 |
|
September 30, 2022 |
|
September 30, 2023 |
|
September 30, 2022 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
15,415 |
|
|
$ |
12,791 |
|
|
$ |
44,152 |
|
|
$ |
35,253 |
|
General and administrative |
|
6,906 |
|
|
|
4,846 |
|
|
|
20,857 |
|
|
|
14,758 |
|
Total operating expenses |
|
22,321 |
|
|
|
17,637 |
|
|
|
65,009 |
|
|
|
50,011 |
|
Loss
from operations |
|
(22,321 |
) |
|
|
(17,637 |
) |
|
|
(65,009 |
) |
|
|
(50,011 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
Interest income, net |
|
1,829 |
|
|
|
163 |
|
|
|
4,560 |
|
|
|
197 |
|
Other income (expense), net |
|
(3 |
) |
|
|
(26 |
) |
|
|
(15 |
) |
|
|
(35 |
) |
Total other income (expense), net |
|
1,826 |
|
|
|
137 |
|
|
|
4,545 |
|
|
|
162 |
|
Net
loss |
$ |
(20,495 |
) |
|
$ |
(17,500 |
) |
|
$ |
(60,464 |
) |
|
$ |
(49,849 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
$ |
(0.53 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.70 |
) |
Weighted—average common shares outstanding, basic and diluted |
|
38,809,109 |
|
|
|
33,303,345 |
|
|
|
38,671,739 |
|
|
|
29,395,548 |
|
|
|
|
|
|
|
|
|
VIGIL NEUROSCIENCE, INC. |
Selected Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
September 30, 2023 |
|
December 31, 2022 |
Cash, cash equivalents, and marketable securities |
$ |
133,643 |
|
|
$ |
186,605 |
|
Total
assets |
|
159,156 |
|
|
|
200,393 |
|
Total
liabilities |
|
23,320 |
|
|
|
11,312 |
|
Total
stockholders' equity |
|
135,836 |
|
|
|
189,081 |
|
|
|
|
|
Investor Contact:Leah Gibson
Vice President, Investor Relations & Corporate Communications
Vigil Neuroscience, Inc.lgibson@vigilneuro.com
Media Contact:Megan McGrath
MacDougall Advisorsmmcgrath@macdougall.bio
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