Voyager Reports Third Quarter 2024 Financial and Operating Results
12 November 2024 - 10:01PM
Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company
dedicated to advancing neurogenetic medicines, today reported third
quarter 2024 financial and operating results.
“An increasing body of clinical evidence
implicates tau as a critical target in Alzheimer’s disease,” said
Alfred W. Sandrock, Jr., M.D., Ph.D., Chief Executive Officer of
Voyager. “Recent third-party clinical data give us increasing
confidence that an antibody targeting the appropriate epitope of
tau can slow the accumulation of tau in the brain of Alzheimer’s
patients, and that this slowing may offer a clinically significant
benefit in some patients. These encouraging data build on previous
positive third-party clinical data with a tau silencing program
and, we believe, support Voyager’s prioritization of both an
anti-tau antibody and a tau silencing gene therapy. Our
clinical-stage anti-tau antibody VY7523 is expected to generate
initial tau PET imaging data in patients in H2 2026, and our tau
silencing gene therapy is advancing toward IND in 2026. Our strong
cash position of $345 million is expected to provide runway into
2027, enabling multiple data readouts.”
Third Quarter 2024 and Recent
Highlights
- Licensed
TRACER™ capsid to Novartis in 5th
partnered program: Voyager agreed to license to
Novartis AG a novel TRACER capsid for use in a gene therapy program
against an undisclosed rare neurologic disease target. This is the
fifth partnered program between the two companies. Voyager
received an upfront payment of $15 million in October and is
eligible for up to $305 million in milestone payments, as
well as royalties.
- Achieved
3rd development candidate in
partnership with Neurocrine: The joint steering committee
with collaborator Neurocrine Biosciences, Inc. selected a
development candidate in a gene therapy program for the potential
treatment of an undisclosed neurological disease, triggering
a $3 million milestone payment to Voyager, which was
received in October. This follows recent development candidate
selections in programs for GBA1-mediated disorders and Friedreich’s
ataxia.
- VY7523
anti-tau antibody for Alzheimer’s disease: Enrollment and
dosing completed in the single ascending dose (SAD) clinical trial,
with top-line safety and pharmacokinetic data expected in H1
2025.
-
Presented head-to-head preclinical data for murine
surrogate of VY7523 vs. murine surrogates of other anti-tau
antibodies: Murine surrogate of VY7523 (C-terminal
directed) demonstrated significant reduction in spread of human
pathological tau in p301S mouse seeding model, as did murine
surrogate of bepranemab (mid-domain directed). No significant
reduction was seen for murine surrogates of two N-terminal directed
antibodies that previously failed their primary endpoints in
clinical trials. These data are expected to be presented at a
future conference.
Anticipated Upcoming
Milestones
- H1 2025: Initial safety and
pharmacokinetic data expected from VY7523 SAD clinical trial
- Mid-2025: U.S. IND and Canadian
clinical trial application (CTA) filings expected with SOD1
silencing gene therapy VY9323 in ALS patients, subsequent clinical
trial has potential to generate proof-of-concept based on
biomarkers
- 2025: Initiation of Multiple
Ascending Dose (MAD) clinical trial in AD patients expected with
VY7523
- 2025: IND filings anticipated with
NBIX-partnered GBA-1 and Friedreich’s ataxia gene therapies
- 2026: U.S. IND and Canadian CTA
filings anticipated with tau silencing gene therapy for Alzheimer’s
disease
- H2 2026: Initial tau PET imaging
data expected in MAD clinical trial of VY7523 in Alzheimer’s
disease
Third Quarter 2024 Financial
Results
- Collaboration
Revenues: Voyager had collaboration revenue of $24.6
million for the third quarter of 2024, compared to $4.6 million for
the same period in 2023. The increase was primarily due to
increased revenue recognized under our Novartis and Neurocrine
agreements.
- Net
Loss: Net loss was $9.0 million for the third quarter of
2024, compared to net loss of $25.9 million for the same period in
2023. The decrease is primarily due to increased collaboration
revenue recognized during the third quarter of 2024, as discussed
above.
-
R&D Expenses: Research and development
expenses were $30.2 million for the third quarter of 2024, compared
to $25.9 million for the same period in 2023. The increase in
R&D expenses was primarily a result of increased targeted
development team hires to support our advancing pipeline, along
with increased facilities costs related to our lease for additional
laboratory and office space.
- G&A Expenses:
General and administrative expenses were $8.2 million for the third
quarter of 2024, compared to $8.3 million for the same period in
2023. The consistent spend reflects continued disciplined expense
management.
- Cash
Position: Cash, cash equivalents and marketable securities
as of September 30, 2024, were $345.4 million. This does not
include the $15.0 million upfront payment from Novartis or the $3.0
million milestone payment from Neurocrine, both of which were
received in October 2024.
Financial Guidance
Voyager is committed to maintaining a strong
balance sheet that supports the advancement and growth of its
platform and pipeline. Voyager continues to assess its planned cash
needs both during the current period and in future periods. We
expect our cash, cash equivalents, and marketable securities, along
with amounts expected to be received as reimbursement for
development costs under the Neurocrine and Novartis collaborations
and interest income, to be sufficient to meet Voyager’s planned
operating expenses and capital expenditure requirements into
2027.
Conference Call
Voyager will host a conference call and webcast
today at 4:30 p.m. ET to discuss third quarter 2024 financial and
operating results. A live webcast of the call will be available on
the Investors section of the Voyager website at
https://ir.voyagertherapeutics.com/, and a replay of the call will
be available at the same link approximately two hours after its
completion. The replay will be available for at least 30 days
following the conclusion of the call.
About Voyager Therapeutics
Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a
biotechnology company dedicated to leveraging the power of human
genetics to modify the course of – and ultimately cure –
neurological diseases. Our pipeline includes programs for
Alzheimer’s disease, amyotrophic lateral sclerosis (ALS),
Parkinson’s disease, and multiple other diseases of the central
nervous system. Many of our programs are derived from our TRACER™
AAV capsid discovery platform, which we have used to generate novel
capsids and identify associated receptors to potentially enable
high brain penetration with genetic medicines following intravenous
dosing. Some of our programs are wholly owned, and some are
advancing with partners including Alexion, AstraZeneca Rare
Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and
Sangamo Therapeutics, Inc. For more information, visit
www.voyagertherapeutics.com.
Voyager Therapeutics® is a registered trademark,
and TRACER™ is a trademark, of Voyager Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking
statements for the purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995 and other federal
securities laws. The use of words such as “expect,” “believe,”
“anticipate,” “potential,” or “continue,” and other similar
expressions are intended to identify forward-looking
statements.
For example, all statements Voyager makes
regarding Voyager’s ability to advance its AAV-based gene therapy
programs and tau antibody program, including expectations for
Voyager’s achievement of preclinical and clinical development
milestones for its potential development candidates such as the
identification of lead development candidates, IND filings, the
initiation of clinical trials, clinical trial enrollment, and the
generation of clinical data and proof-of-concept; the potential for
an antibody targeting tau to slow the accumulation of tau in the
brain of Alzheimer’s patients and for this slowing to offer a
clinically significant benefit in some patients; the potential for
third-party clinical data to inform Voyager’s clinical development
plans; Voyager’s ability to advance gene therapy product candidates
under the Neurocrine collaboration; Voyager’s anticipated financial
results, including the anticipated receipt by Voyager of revenues
or reimbursement payments from collaboration partners; and
Voyager’s cash runway and ability to generate sufficient cash
resources to enable it to continue its business and operations are
forward looking.
All forward-looking statements are based on
estimates and assumptions by Voyager’s management that, although
Voyager believes such forward-looking statements to be reasonable,
are inherently uncertain and subject to risks and uncertainties
that may cause actual results to differ materially from those that
Voyager expected. Such risks and uncertainties include, among
others, the expectations and decisions of regulatory authorities;
the timing, initiation, conduct and outcomes of Voyager’s
preclinical and clinical studies; the availability of data from
clinical trials; the availability or commercial potential of
product candidates under collaborations; the success of Voyager’s
product candidates; the willingness and ability of Voyager's
collaboration partners to meet obligations under collaboration
agreements with Voyager; the continued development of Voyager’s
technology platforms, including Voyager’s TRACER platform and its
antibody screening technology; Voyager’s scientific approach and
program development progress, and the restricted supply of critical
research components; the development by third parties of capsid
identification platforms that may be competitive to Voyager’s
TRACER capsid discovery platform; Voyager’s ability to create and
protect intellectual property rights associated with the TRACER
capsid discovery platform, the capsids identified by the platform,
and development candidates for Voyager’s pipeline programs; the
possibility or the timing of Voyager’s receipt of program
reimbursement, development or commercialization milestones, option
exercise, and other payments under Voyager’s existing licensing or
collaboration agreements; the ability of Voyager to negotiate and
complete licensing or collaboration agreements with other parties
on terms acceptable to Voyager and the third parties; the success
of programs controlled by third-party collaboration partners in
which Voyager retains a financial interest; the ability to attract
and retain talented directors, employees, and contractors; and the
sufficiency of Voyager’s cash resources to fund its operations and
pursue its corporate objectives.
These statements are also subject to a number of
material risks and uncertainties that are described in Voyager’s
most recent Annual Report on Form 10-K filed with the Securities
and Exchange Commission. All information in the press release is as
of the date of this press release, and any forward-looking
statement speaks only as of the date on which it was made. Voyager
undertakes no obligation to publicly update or revise this
information or any forward-looking statement, whether as a result
of new information, future events or otherwise, except as required
by law.
Contacts
Trista Morrison, NACD.DC, tmorrison@vygr.com
Investors: Michael Hencke, mhencke@kendallir.com Media: Brooke
Shenkin, brooke@scientpr.com
Selected Financial Information |
($ amounts in thousands, except per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
Statement of
Operations Items: |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
Collaboration revenue |
|
$ |
24,629 |
|
|
$ |
4,614 |
|
|
$ |
73,723 |
|
|
$ |
159,947 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
30,241 |
|
|
|
25,863 |
|
|
|
91,785 |
|
|
|
66,416 |
|
General and administrative |
|
|
8,168 |
|
|
|
8,258 |
|
|
|
26,926 |
|
|
|
25,580 |
|
Total operating expenses |
|
|
38,409 |
|
|
|
34,121 |
|
|
|
118,711 |
|
|
|
91,996 |
|
Operating (loss) income |
|
|
(13,780 |
) |
|
|
(29,507 |
) |
|
|
(44,988 |
) |
|
|
67,951 |
|
Total other income |
|
|
4,779 |
|
|
|
3,429 |
|
|
|
14,554 |
|
|
|
8,570 |
|
(Loss) income before income
taxes |
|
|
(9,001 |
) |
|
|
(26,078 |
) |
|
|
(30,434 |
) |
|
|
76,521 |
|
Income tax
provision (benefit) |
|
|
43 |
|
|
|
(177 |
) |
|
|
81 |
|
|
|
586 |
|
Net (loss) income |
|
$ |
(9,044 |
) |
|
$ |
(25,901 |
) |
|
$ |
(30,515 |
) |
|
$ |
75,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share,
basic |
|
$ |
(0.16 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.53 |
) |
|
$ |
1.85 |
|
Net (loss) income per share,
diluted |
|
$ |
(0.16 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.53 |
) |
|
$ |
1.78 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding, basic |
|
|
57,851,110 |
|
|
|
43,864,838 |
|
|
|
57,564,413 |
|
|
|
40,962,116 |
|
Weighted-average common shares
outstanding, diluted |
|
|
57,851,110 |
|
|
|
43,864,838 |
|
|
|
57,564,413 |
|
|
|
42,610,724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
Selected Balance Sheet
Items |
|
2024 |
|
2023 |
|
Cash, cash equivalents, and
marketable securities |
|
$ |
345,360 |
|
$ |
230,875 |
|
Total assets |
|
$ |
426,041 |
|
$ |
351,281 |
|
Accounts payable and accrued
expenses |
|
$ |
14,602 |
|
$ |
18,427 |
|
Deferred revenue |
|
$ |
34,782 |
|
$ |
75,240 |
|
Total stockholders’
equity |
|
$ |
330,310 |
|
$ |
236,320 |
|
Voyager Therapeutics (NASDAQ:VYGR)
Historical Stock Chart
Von Okt 2024 bis Nov 2024
Voyager Therapeutics (NASDAQ:VYGR)
Historical Stock Chart
Von Nov 2023 bis Nov 2024