Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company
dedicated to breaking through barriers in gene therapy and
neurology, today reported second quarter 2023 financial and
operating results.
“The introduction today of Voyager’s vectorized anti-Aβ gene
therapy research initiative expands our Alzheimer's disease
portfolio, complementing our anti-tau antibody and tau knock-down
gene therapy programs,” said Alfred W. Sandrock, Jr., M.D., Ph.D.,
Chief Executive Officer of Voyager. “We are encouraged by recent
approvals in Alzheimer’s disease, and we believe this establishes a
path forward for new approaches to existing targets, as well as new
targets, to help address the heterogeneity of the massive
Alzheimer’s disease population. Our anti-tau antibody VY-TAU01
remains on track for IND in the first half of 2024, and we continue
to advance our growing pipeline of wholly-owned and partnered CNS
gene therapies leveraging our neurotropic TRACER capsids.”
Key Milestones Achieved in Q2 2023 and Subsequent
Period:
- Launch of new vectorized anti-Aβ antibody early
research initiative for Alzheimer’s disease: Voyager today
announced an early research initiative investigating a gene therapy
comprising a vectorized anti-Aβ antibody delivered via a TRACER
capsid for the potential one-time treatment of Alzheimer’s disease.
The new initiative leverages Voyager’s vectorized antibody
expertise to express an anti-Aβ antibody to target amyloid plaques.
Preliminary data in mice have shown vectorized antibody target
engagement. This initiative further expands Voyager’s portfolio of
Alzheimer’s programs including its anti-tau antibody program and
siRNA tau knockdown gene therapy research initiative.
- Licensing agreement with Sangamo: In June,
Voyager and Sangamo Therapeutics, Inc. announced a definitive
license agreement for a potential treatment of prion disease. Under
the agreement, Voyager provided Sangamo with access to a TRACER
capsid to be combined with Sangamo’s zinc finger transcriptional
regulators (ZF-TRs) designed to treat prion disease.
- ASGCT 2023 Conference: In May, Voyager shared
seven data presentations at the American Society of Gene and Cell
Therapy’s (ASGCT) Annual Meeting, including data demonstrating
greater than 50% cell transduction in multiple areas of the brain
at a dose of 2E12 vg/kg following intravenous administration of
VCAP-102 in marmosets, as well as data further confirming the
binding of VCAP-102 to a novel receptor, and progress identifying
receptors to additional TRACER-derived capsid families.
- Advancement of anti-tau
antibody program: In April, Voyager received pre-IND
written feedback from the FDA for VY-TAU01, its lead humanized
anti-tau antibody candidate. Voyager continues to expect to
initiate GLP toxicology studies this year to enable an IND filing
in the first half of 2024.
- Presentation of data on
Huntington’s disease (HD) early research initiative: In
April, Voyager presented data on the HD research initiative at the
18th Annual Huntington's Disease Therapeutics Conference held in
Dubrovnik, Croatia. Voyager’s early research initiative for HD
combines an intravenous TRACER capsid with vectorized siRNAs to
enable specific knockdown of mutant HTT and MSH3.
- Key leadership additions: In May, Voyager
announced the appointment of George Scangos, Ph.D., to its Board of
Directors. In July, Voyager announced the appointment of Jacquelyn
Fahey Sandell as Chief Legal Officer.
Key Upcoming Milestones:
- Anti-tau antibody program for Alzheimer’s disease: Voyager
continues to expect to initiate GLP toxicology studies in 2023 to
support an IND in the first half of 2024.
- SOD1 gene therapy program for amyotrophic lateral sclerosis
(ALS): Voyager expects to identify a lead development candidate in
the second half of 2023 to support an IND in mid-2025.
- Voyager and Neurocrine Biosciences collaboration: Voyager and
Neurocrine Biosciences continue to collaboratively advance the GBA1
gene therapy program for Parkinson’s disease and other
GBA1-mediated diseases, as well as the FXN gene therapy program for
Friedreich’s Ataxia.
Second Quarter 2023 Financial Results
- Collaboration
Revenues: Voyager had collaboration revenue of $4.9 million for the
second quarter of 2023, compared to $0.7 million for the same
period in 2022. The increase was primarily due to revenue
recognized during the second quarter of 2023 on the 2023 and
2019 strategic collaborations with Neurocrine
Biosciences.
- Net Loss: Net loss
was $22.2 million for the second quarter of 2023, compared to $19.1
million for the same period in 2022. The difference is
primarily due to the increase in operating expenses discussed
in the two bullets immediately below.
- R&D Expenses:
Research and development expenses were $22.0 million for the second
quarter of 2023, compared to $12.5 million for the same period in
2022. The increase in R&D expenses was primarily a result of
increased program-related spending, and increased compensation
costs driven by headcount increases during the second quarter of
2023.
- G&A Expenses:
General and administrative expenses were $8.3 million for the
second quarter of 2023, compared to $7.6 million for the same
period in 2022. The increase in G&A expenses was primarily a
result of increased compensation costs driven by headcount
increases.
- Cash Position: Cash,
cash equivalents and marketable securities as of June 30, 2023,
were $272.7 million.
Six Months Ended June 30, 2023 Financial
Results
- Collaboration
Revenues: Voyager had collaboration revenue of $155.3 million for
the six months ended June 30, 2023 period, compared to $1.4 million
for the same period in 2022. The increase was primarily due to
revenue recognized during the first quarter of 2023 on the
2023 strategic collaboration with Neurocrine Biosciences, as
well as revenue recognized on the Novartis license of novel TRACER
capsids.
- Net Income (Loss):
Net income was $101.8 million for the six months ended June 30,
2023 period, compared to net loss of $40.4 million for the same
period in 2022. The difference was primarily due to the
revenue increases noted above.
- R&D Expenses:
Research and development expenses were $40.6 million for the six
months ended June 30, 2023 period, compared to $26.9 million for
the same period in 2022. The increase in R&D expenses was
primarily a result of increased program-related spend, and
increased compensation costs driven by headcount increases during
the 2023 period.
- G&A Expenses:
General and administrative expenses were $17.3 million for the six
months ended June 30, 2023 period, compared to $15.2 million for
the same period in 2022. The increase in G&A expenses was
primarily a result of increased compensation costs driven by
headcount increases.
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 and
in future periods. As communicated previously, we expect our cash,
cash equivalents, and marketable securities, along with amounts
expected to be received as reimbursement for development costs
under the Neurocrine collaborations and interest income, to be
sufficient to meet Voyager’s planned operating expenses and capital
expenditure requirements into 2025.
Conference Call
Voyager will host a conference call and webcast today at 8:30
a.m. ET to discuss the second quarter 2023 financial and operating
results. To participate via telephone and join the call live,
please register in advance here. Upon registration, telephone
participants will receive a confirmation email detailing how to
join the conference call, including the dial-in number and a unique
passcode. A live webcast of the call will also be available on the
Investors section of the Voyager website at
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 the TRACER™ Capsid Discovery
PlatformVoyager’s TRACER™ (Tropism Redirection of AAV by
Cell-type-specific Expression of RNA) capsid discovery platform is
a broadly applicable, RNA-based screening platform that enables
rapid discovery of AAV capsids with robust penetration of the
blood-brain barrier and enhanced central nervous system (CNS)
tropism in multiple species, including non-human primates (NHPs).
TRACER generated capsids have demonstrated superior and widespread
gene expression in the CNS compared to conventional AAV capsids as
well as cell- and tissue-specific transduction, including to areas
of the brain that have been traditionally difficult to reach.
Separate results have demonstrated the enhanced ability of certain
capsids to target cardiac muscle and to de-target the dorsal root
ganglia. Voyager is expanding its library of AAV capsids optimized
to deliver diverse therapeutic payloads to address a broad range of
CNS and other diseases. As part of its external partnership
strategy, Voyager has established multiple collaboration agreements
providing access to its next-generation TRACER capsids to
potentially enable its partners’ gene therapy programs to treat a
variety of diseases.
About Voyager TherapeuticsVoyager
Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to
breaking through barriers in gene therapy and neurology. The
potential of both disciplines has been constrained by delivery
challenges; Voyager is leveraging cutting-edge expertise in capsid
discovery and deep neuropharmacology capabilities to address these
constraints. Voyager’s TRACER AAV capsid discovery platform has
generated novel capsids with high target delivery and blood-brain
barrier penetration at low doses, potentially addressing the narrow
therapeutic window associated with conventional gene therapy
delivery vectors. This platform is fueling alliances with Pfizer
Inc., Novartis Pharma AG, Neurocrine Biosciences, Inc., and Sangamo
Therapeutics, Inc., as well as multiple programs in Voyager’s own
pipeline. Voyager’s pipeline includes wholly-owned and
collaborative preclinical programs in Alzheimer’s disease,
amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and other
diseases of the central nervous system, with a focus on validated
targets and biomarkers to enable a path to rapid potential
proof-of-biology. For more information, visit
www.voyagertherapeutics.com.
Voyager Therapeutics® is a registered trademark, and TRACER™ is
a trademark, of Voyager Therapeutics, Inc.
Forward-Looking StatementsThis 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 “may,” “will,” “expect,” “plan,” “believe,” “target,”
“future,” “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; the preclinical development of its potential
development candidates; Voyager’s entitlement to receive option
exercise, milestone and royalty-based fees from Novartis and Pfizer
under the respective license option agreements; Voyager’s ability
to advance gene therapy product candidates under the Neurocrine
collaborations; Voyager’s ability to identify receptors to
additional TRACER-derived capsid families; Voyager’s anticipated
financial results, including the receipt by Voyager of revenues or
reimbursement payments from collaboration partners; and Voyager’s
cash runway and Voyager’s 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. All forward-looking statements are 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 continued development of Voyager’s
technology platforms, including Voyager’s TRACER platform and its
antibody screening technology; the ability to initiate and conduct
preclinical studies in animal models; 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 initiation, timing, conduct and outcomes of Voyager’s
preclinical studies; the possibility or the timing of the exercise
of development, commercialization, license and other options under
the Pfizer and Novartis license option agreements and Neurocrine
collaborations; 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 ability to attract
and retain talented directors, employees, and contractors; and the
sufficiency of 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
InvestorsInvestors@vygr.com
Andrew Funderburkafunderburk@kendallir.com
MediaTrista Morrisontmorrison@vygr.com
Peg Rusconiprusconi@vergescientific.com
Selected Financial Information |
($ amounts in thousands, except per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
Statement of
Operations Items: |
|
2023 |
|
|
2022 |
|
|
2023 |
|
2022 |
|
Collaboration revenue |
|
$ |
4,853 |
|
|
$ |
712 |
|
|
$ |
155,333 |
|
|
$ |
1,371 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
21,985 |
|
|
|
12,527 |
|
|
|
40,553 |
|
|
|
26,876 |
|
General and
administrative |
|
|
8,294 |
|
|
|
7,552 |
|
|
|
17,322 |
|
|
|
15,211 |
|
Total operating expenses |
|
|
30,279 |
|
|
|
20,079 |
|
|
|
57,875 |
|
|
|
42,087 |
|
Operating (loss) income |
|
|
(25,426 |
) |
|
|
(19,367 |
) |
|
|
97,458 |
|
|
|
(40,716 |
) |
Total other income |
|
|
3,277 |
|
|
|
280 |
|
|
|
5,141 |
|
|
|
310 |
|
(Loss) income before income
taxes |
|
|
(22,149 |
) |
|
|
(19,087 |
) |
|
|
102,599 |
|
|
|
(40,406 |
) |
Income tax provision |
|
|
59 |
|
|
|
— |
|
|
|
763 |
|
|
|
— |
|
Net (loss) income |
|
$ |
(22,208 |
) |
|
$ |
(19,087 |
) |
|
$ |
101,836 |
|
|
$ |
(40,406 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share,
basic |
|
$ |
(0.51 |
) |
|
$ |
(0.50 |
) |
|
$ |
2.42 |
|
|
$ |
(1.06 |
) |
Net (loss) income per share,
diluted |
|
$ |
(0.51 |
) |
|
$ |
(0.50 |
) |
|
$ |
2.33 |
|
|
$ |
(1.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding, basic |
|
|
43,520,137 |
|
|
|
38,298,426 |
|
|
|
42,102,101 |
|
|
|
38,183,192 |
|
Weighted-average common shares
outstanding, diluted |
|
|
43,520,137 |
|
|
|
38,298,426 |
|
|
|
43,770,999 |
|
|
|
38,183,192 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
Selected Balance Sheet
Items |
|
2023 |
|
2022 |
|
Cash, cash equivalents, and
marketable debt securities |
|
$ |
272,746 |
|
|
$ |
118,848 |
|
Total assets |
|
$ |
315,536 |
|
|
$ |
159,356 |
|
Accounts payable and accrued
expenses |
|
$ |
10,719 |
|
|
$ |
10,382 |
|
Deferred revenue |
|
$ |
83,049 |
|
|
$ |
65,827 |
|
Total stockholders’
equity |
|
$ |
199,026 |
|
|
$ |
59,020 |
|
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