Vigil Neuroscience Reports First Quarter 2023 Financial Results and Provides Business Update
10 Mai 2023 - 1:00PM
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 first quarter ended March 31,
2023, and provided an update on recent progress.
“We continue to make considerable progress in advancing VGL101
and our small molecule TREM2 agonist program and believe we are
well-positioned to execute on multiple value enhancing milestones
in 2023. Our IGNITE Phase 2 trial evaluating VGL101 in patients
with ALSP is enrolling as expected and we plan to report our first
interim update from the first six patients treated for six months
with VGL101 in the fourth quarter of this year. We also remain on
track to present the full data analysis from the VGL101 Phase 1
trial in the second half of this year. In addition, we are proud of
the recent launch of ALSPAware as part of our continued efforts to
support the ALSP community. Given that only one-third of those
living with ALSP receive a correct initial diagnosis, we believe
this new program will help both physicians and individuals reach an
accurate diagnosis earlier,” said Ivana Magovčević-Liebisch, Ph.D.,
J.D., President and Chief Executive Officer of Vigil. “We have also
continued to advance our lead small molecule candidate toward the
clinic and expect to submit an IND and initiate a Phase 1 trial in
healthy volunteers in the fourth quarter of 2023. We are committed
to achieving these important milestones as part of our
patient-centered mission of developing potentially transformative
treatments for rare and common neurodegenerative diseases.”
Recent Highlights and Anticipated
Milestones
VGL101, Monoclonal Antibody TREM2 Agonist
- Announced FDA lifted partial clinical hold on doses
greater than 20 mg/kg for VGL101: In
March 2023, Vigil announced that the U.S. Food and Drug
Administration (FDA) lifted its partial clinical hold on doses
greater than 20 mg/kg for VGL101 in its ongoing and future clinical
trials in patients with adult-onset leukoencephalopathy with axonal
spheroids and pigmented glia (ALSP).
- Presented multiple presentations on ALSP at the 2023
American Academy of Neurology (AAN) Annual Meeting: In
April 2023, Vigil presented three oral presentations and two poster
presentations on ALSP, including previously reported VGL101 Phase 1
interim top-line data and the ILLUMINATE natural history study
interim data. The Company also presented key findings on the
diverse phenotype, radiological features, and reasons for
misdiagnosis and disease progression of ALSP. These presentations
can be accessed on the publications page of the Company’s
website.
- Launched ALSPAware
program to provide access to no-cost genetic testing and
counseling for ALSP: 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. By increasing
access to genetic testing for both individuals and healthcare
providers, we believe ALSPAware has the potential to help reduce
initial misdiagnosis of this disease, while also providing
appropriate disease management services for those living with
ALSP.
- On track to present the full data analysis from the
Phase 1 single and multiple ascending dose (SAD and MAD) healthy
volunteer trial in the second half of 2023: The Company
has completed dosing of the 60 mg/kg SAD and MAD cohorts in
Australia in which VGL101 continued to be safe and well tolerated
and expects to report the full data analysis from the Phase 1 trial
during the second half of 2023.
- First interim data readout from ongoing IGNITE Phase 2
clinical trial expected in the fourth quarter of 2023:
IGNITE, the first-ever interventional trial in ALSP, is a global
Phase 2, open-label trial designed to evaluate the safety and
tolerability of VGL101 in up to 15 patients with symptomatic ALSP
who have a CSF1R gene mutation. Patients enrolled in the trial
receive an intravenous (IV) infusion of 20 mg/kg of VGL101
approximately every four weeks, for a treatment duration of one
year. The Company expects to report six-month interim data from the
first six patients in the trial in the fourth quarter of 2023.
Small Molecule TREM2 Agonist Program
- Presented small molecule TREM2 agonist program
preclinical data at the AD/PD, Alzheimer’s & Parkinson’s
Diseases International Conference: In April 2023, Vigil
presented an oral presentation highlighting preclinical data from
the characterization of its small molecule TREM2 agonist program
supporting further development as a potential treatment of
Alzheimer’s disease (AD). This presentation can be accessed on the
publications page of the Company’s website.
- Continued advancement of small molecule TREM2 agonist
program toward the clinic: 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. 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. The
Company expects to submit an Investigational New Drug (IND)
application to the FDA and, subject to FDA clearance of the IND,
initiate clinical development for its lead small molecule TREM2
agonist, with an initial focus in genetically defined Alzheimer’s
disease subpopulations, in the fourth quarter of 2023.
Corporate
- Added distinguished leader in biopharmaceutical
industry to Board of Directors: In May 2023, Vigil
appointed Samantha Budd Haeberlein, Ph.D. to its Board of
Directors. Dr. Budd Haeberlein brings more than 20 years of
biopharmaceutical industry experience across research,
translational medicine, and clinical development with a focus on
CNS indications, including rare and common neurological
disorders.
Upcoming Events
Vigil plans to participate at the following investor
conferences:
- Mizuho Neuroscience Summit on May 16, 2023
- Jefferies Healthcare Conference from June 7-9, 2023
First Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents, and
marketable securities were $164.5 million as of March 31, 2023,
compared to $186.6 million as of December 31, 2022. 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 first quarter ended
March 31, 2023, were $13.8 million, compared to $10.4 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 advancing the VGL101 program into a phase 2
clinical trial, and increased headcount to support the Company’s
continued growth.
- General and Administrative (G&A)
Expenses: G&A expenses for the first quarter ended
March 31, 2023, were $6.9 million, compared to $5.0 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 first
quarter ended March 31, 2023, were $19.8 million, compared to $15.3
million for the same period in 2022.
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. 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 candidate, is a fully
human monoclonal antibody agonist targeting human triggering
receptor expressed on myeloid cells 2 (TREM2) and is in a Phase 2
proof-of-concept trial in patients with adult-onset
leukoencephalopathy with axonal spheroids and pigmented glia
(ALSP), a rare and fatal neurodegenerative disease. We are also
conducting IND-enabling studies with a novel small molecule TREM2
agonist program to treat common neurodegenerative diseases
associated with microglial dysfunction, with an initial focus on
Alzheimer’s disease (AD) in genetically defined subpopulations.
Forward-Looking StatementsThis 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 and
focus; the potential design, access, benefits and success of
ALSPAware, including the belief that the program will ease the
diagnostic journey for patients and their families; 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 in
the fourth quarter of 2023, filing an IND application for its small
molecule TREM2 agonist program and the initiation of the Phase 1
clinical trial in the fourth quarter of 2023 and reporting full
data analysis from its Phase 1 healthy volunteer trial of VGL101 in
the second half of 2023; the success and timing of its interactions
with regulatory authorities; expectations regarding the development
of VGL101 in ALSP and other indications, its small molecule TREM2
agonist program in AD, and the development of other pipeline
candidates, including its expected therapeutic benefits as well as
its safety and tolerability profile; the Company’s cash runway into
first quarter of 2025; expectations regarding the use of capital,
expenses and other financial results in the future. 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 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; uncertainties associated with the impact
of the COVID-19 pandemic on its business and operations; as well as
the risks and uncertainties identified in the Company’s filings
with the Securities and Exchange Commission (SEC), including
Vigil’s Annual Report on Form 10-K for the year ended December 31,
2022 and in any subsequent filings it may make 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 |
|
|
March 31,2023 |
|
March 31,2022 |
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
13,834 |
|
|
$ |
10,365 |
|
General and administrative |
|
|
6,941 |
|
|
|
4,967 |
|
Total operating expenses |
|
|
20,775 |
|
|
|
15,332 |
|
Loss
from operations |
|
|
(20,775 |
) |
|
|
(15,332 |
) |
Other
income (expense): |
|
|
|
|
Interest income, net |
|
|
985 |
|
|
|
2 |
|
Other income (expense), net |
|
|
(5 |
) |
|
|
(4 |
) |
Total other expense, net |
|
|
(980 |
) |
|
|
(2 |
) |
Net loss
and comprehensive loss |
|
$ |
(19,795 |
) |
|
$ |
(15,334 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.51 |
) |
|
$ |
(0.58 |
) |
Weighted—average common shares outstanding, basic, and diluted |
|
|
38,546,012 |
|
|
|
26,660,246 |
|
VIGIL NEUROSCIENCE, INC. |
Selected Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
Cash, cash equivalents, and marketable securities |
|
$ |
164,480 |
|
$ |
186,605 |
Total
assets |
|
|
192,361 |
|
|
200,393 |
Total
liabilities |
|
|
21,021 |
|
|
11,312 |
Total
stockholders' equity |
|
|
171,340 |
|
|
189,081 |
Investor Contact:Stern Investor
Relationsinvestors@vigilneuro.com
Media Contact:Megan McGrath
MacDougall Advisorsmmcgrath@macdougall.bio
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