Voyager Therapeutics Announces First Quarter 2021 Financial Results and Corporate Updates
May 10 2021 - 7:30AM
Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene
therapy company focused on developing life-changing treatments for
patients suffering from serious neurological diseases, today
reported its first quarter 2021 financial results, program progress
and corporate updates.
“We are very pleased with the progress we’ve made in the first
few months of this year, including receiving IND clearance for our
VY-HTT01 program for Huntington’s disease as well as presenting
important new results at the ASGCT conference from our next
generation, blood brain barrier penetrant AAV capsid program which
opens up numerous potential opportunities in CNS diseases,” said
Andre Turenne, President and CEO of Voyager. “We look forward to
providing updates on these and other programs at our upcoming
investor event in July and over the coming months, particularly as
we prepare to initiate our planned VYTAL Phase 1/2 clinical trial
in Huntington’s disease later this year.”
Recent Corporate Highlights and Pipeline
Updates
VY-HTT01 for Huntington’s Disease
- In April 2021, the Company announced FDA clearance of its
Investigational New Drug (IND) application for VY-HTT01, the
Company’s gene therapy candidate for the treatment of Huntington’s
disease, and plans to initiate the VYTAL Phase 1/2 clinical trial
of VY-HTT01 at multiple US sites in the fourth quarter.
- The planned VYTAL Phase 1/2 clinical trial is designed as a
randomized, open-label study with a concurrent delayed-start
control. The trial will evaluate the safety and tolerability of
VY-HTT01 in patients with early manifest Huntington’s disease.
Secondary endpoints include disease biomarkers and clinical outcome
measures.
- Huntington’s disease is caused by toxic gain-of-function
mutations in the huntingtin, or HTT, gene. Preclinical data for
VY-HTT01 have shown strong reduction in mutant HTT protein in
transgenic animal models of Huntington’s disease, resulting in
improvement in disease phenotype. Additional data in non-human
primates have demonstrated widespread distribution of VY-HTT01
across the striatum and cortex, which are core areas of disease
pathology, and robust and durable reduction of HTT mRNA and
protein.
- The Company expects to initiate the planned VYTAL Phase 1/2
clinical trial by the end of 2021 and anticipates providing initial
topline safety, tolerability and biomarker data in 2022.
Novel AAV Capsid Discovery Program
- Voyager has developed a series of novel adeno-associated virus
(AAV) capsids which, following intravenous administration, achieve
up to 1000-fold higher RNA expression in the brain and 100-fold
higher expression in the spinal cord of non-human primates than
AAV9, the current natural AAV serotype with the best ability to
ability to cross the blood brain barrier. The Company
believes these capsids may allow for significantly enhanced gene
delivery to specific types of cells in the brain at lower
doses.
- The Company believes its TRACERTM technology and novel capsid
discoveries have the potential to support a significant number of
CNS programs, both for the Company’s own development pipeline and
for the enablement of programs by other companies, through
potential future licensing and collaboration arrangements. The
TRACER platform has the potential to be flexibly applied to
discover capsids with improved tropism to other tissues and to
overcome other limitations of current AAV capsids.
- The Company plans to present new data on these novel blood
brain barrier penetrant capsids at the ASGCT conference on May 11,
2021 (see detail below).
VY-AADC (NBIb-1817) for Parkinson’s
Disease
- As previously announced, Neurocrine Biosciences provided notice
of its decision to terminate that portion of the Company’s
collaboration agreement related to the VY-AADC (NBIb-1817) program
for Parkinson’s disease, effective August 2, 2021. Voyager
intends to support Neurocrine, the clinical study sponsor and IND
holder for the RESTORE-1 clinical trial of VY-AADC (NBIb-1817), on
ongoing matters related to the completion of imaging and clinical
assessments requested by the trial’s Data Safety and Monitoring
Board (DSMB). Although Neurocrine remains the study sponsor of the
RESTORE-1 clinical trial, the underlying technology licenses for
the VY-AADC program will revert to the Company in accordance with
the collaboration agreement on August 2, 2021.
- The Company continues to believe that the VY-AADC program holds
significant promise for Parkinson’s disease patients as evidenced
by the positive multi-year safety and efficacy data from the two
Phase 1b clinical trials presented in September 2020 at the MDS
Virtual Congress. However, as a result of the prioritization of new
programs enabled by novel capsids in the Company’s preclinical
portfolio and its focus on the clinical efforts for the VY-HTT01
program to treat Huntington’s disease, the Company has determined
that it will not advance the VY-AADC program on its own following
the termination of that portion of the collaboration agreement.
Instead, the Company expects to turn the future development and
commercialization of VY-AADC over to a partner once the potential
path forward for the program is determined.
Corporate Updates and Other Anticipated
Milestones
Upcoming Presentations and Updates
- The Company recently announced that it will have eight
presentations and posters at the ASGCT 24th Annual Meeting, taking
place May 11-14, 2021. Oral presentations are expected to highlight
data from Voyager’s novel capsid, preclinical and manufacturing
efforts. The Company also intends to host an Industry Sponsored
Symposium titled "Advancing AAV Gene Therapy for CNS Disease,” at
this year’s ASGCT Meeting. Details of the presentation schedule can
be found here.
- At an upcoming virtual investor and analyst event planned for
July 2021, the Company expects to provide additional updates on
multiple platform and program advances on the planned VYTAL Phase
1/2 clinical trial for Huntington’s disease, the novel capsid
program, and the preclinical pipeline.
First Quarter 2021 Financial Results
- Collaboration Revenues: Collaboration revenue
was $6.5 million for the first quarter of 2021, compared to
collaboration revenue of $18.1 million for the same period of 2020.
The decrease in collaboration revenue was largely due to a
reduction of revenue related to research services and cost
reimbursements from the collaborations with Neurocrine and AbbVie.
The collaborations with AbbVie were terminated in August 2020.
- Net Loss: Net loss was $21.6 million for the
first quarter of 2021, compared to a net loss of $24.3 million for
the same period of 2020.
- R&D Expenses: Research and development
expenses were $22.3 million for the first quarter of 2021, compared
to $32.3 million for the same period in 2020. The decrease in
R&D expenses was primarily related to lower manufacturing and
external clinical expenses for the VY-AADC program.
- G&A Expenses: General and administrative
expenses were $9.7 million for the first quarter of 2021, compared
to $10.2 million for the same period in 2020. The decrease in
G&A expenses was primarily related to lower intellectual
property expenses.
- Cash Position: Cash, cash equivalents and
marketable debt securities as of March 31, 2021 were $153.1
million.
About Voyager Therapeutics
Voyager Therapeutics is a clinical-stage gene therapy company
focused on developing life-changing treatments for serious
neurological diseases. Voyager is committed to advancing the field
of AAV gene therapy through innovation and investment in vector
engineering and optimization, manufacturing, and dosing and
delivery techniques. Voyager’s wholly-owned and partnered pipeline
focuses on serious neurological diseases for which effective new
therapies are needed. Voyager has a strategic collaboration with
Neurocrine Biosciences. Founded by scientific and clinical leaders
in the fields of AAV gene therapy, expressed RNA interference and
neuroscience, Voyager is headquartered in Cambridge, Massachusetts.
For more information, please visit www.voyagertherapeutics.com or
follow @VoyagerTx on Twitter and LinkedIn.
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 “may,” “might,” “will,” “would,” “should,”
“expect,” “plan,” “anticipate,” “believe,” “estimate,”
“undoubtedly,” “project,” “intend,” “future,” “potential,” or
“continue,” and other similar expressions are intended to identify
forward-looking statements. For example, all statements Voyager
makes regarding the initiation of the planned VYTAL Phase 1/2
clinical trial of VY-HTT01 in Huntington disease in the fourth
quarter of 2021 and the release of data from the planned VYTAL
clinical trial in 2022; Voyager’s continuing efforts in the
discovery and engineering of novel AAV capsids; the presentation of
data at conferences demonstrating the characteristics and
performance of novel AAV capsids developed by Voyager; the
continuing progress by Voyager in developing new novel AAV capsids;
the ability of Voyager’s novel capsid discoveries to support a
significant number of central nervous system programs and the
ability of Voyager’s novel capsid discoveries to support programs
sponsored by third parties by means of licensing or collaboration
arrangements; the completion of imaging and clinical assessments by
Neurocrine Biosciences for participants of the RESTORE-1 clinical
study; the decision of Voyager to not advance on its own the
VY-AADC program for Parkinson’s disease; Voyager’s ability to
identify and attract parties to participate in research and
development collaborations, including any potential collaboration
for the VY-AADC program; Voyager’s initiation, timing, progress,
activities, goals and reporting of the results of its preclinical
programs and its research and development programs; the potential
benefits, timing and future operation of the collaboration
agreement with Neurocrine Biosciences; Voyager’s ability to add new
programs to its pipeline; Voyager’s ability to operate its research
and development activities efficiently and effectively; and the
utility and value of Voyager’s patent portfolio 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 ability of Neurocrine Biosciences and
Voyager to obtain imaging data for patients treated as part of the
RESTORE-1 clinical trial; the ability of Voyager to effectively
present its novel capsid data by means of virtual conference
proceedings in response to the COVID-19 health crisis; the ability
of Voyager to progress its research and engineering program for
novel capsids, and to procure sufficient numbers of non-human
primates to conduct non-human primate studies; the interest of
third parties in Voyager’s novel capsids, and the ability of
Voyager to negotiate and complete licensing or collaboration
agreements on terms acceptable to Voyager and such third parties;
with respect to the VYTAL clinical trial, the ability of Voyager to
successfully establish clinical sites, to engage investigators, to
recruit patients meeting eligibility requirements, to manage
COVID-19 restrictions and to generate clinical outcomes and data in
a timely manner; the ability of Voyager to manage the business
disruptions resulting from the COVID-19 health crisis; the ability
of Voyager to create research and development programs combining
sufficient levels of scientific interest and applied expertise to
be attractive in recruiting and maintaining researchers and
scientists; the outcomes and consequences associated with
regulatory communications, submissions, approvals and
non-approvals; Voyager’s scientific approach and general
development progress; the ability to attract and retain talented
contractors and employees; the ability to create and protect
intellectual property; the sufficiency of cash resources; the
possibility or the timing of the exercise of development,
commercialization, license and other options under collaborations;
and the availability or commercial potential of Voyager’s product
candidates.
These statements are also subject to a number of material risks
and uncertainties that are described in Voyager’s Annual Report on
Form 10-K for the year ended December 31, 2020, filed with the
Securities and Exchange Commission, as updated by its subsequent
filings 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.
Investor
Inquiries: investors@voyagertherapeutics.com
Media
Inquiries: Lissette
SteeleVerge Scientific Communications202.930.4762 x
409lsteele@vergescientific.com
Selected Financial
Information($-amounts in thousands, except per share
data)(Unaudited)
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
Statement of
Operations Items: |
2021 |
|
2020 |
Collaboration revenue |
$ |
6,501 |
|
|
$ |
18,067 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
22,346 |
|
|
|
32,294 |
|
General and administrative |
|
9,744 |
|
|
|
10,206 |
|
Total operating expenses |
|
32,090 |
|
|
|
42,500 |
|
Operating loss |
|
(25,589 |
) |
|
|
(24,433 |
) |
Total other income |
|
3,940 |
|
|
|
170 |
|
Net loss |
$ |
(21,649 |
) |
|
$ |
(24,263 |
) |
Net loss per share, basic and
diluted |
$ |
(0.58 |
) |
|
$ |
(0.66 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
37,501,065 |
|
|
|
36,963,255 |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
Selected Balance Sheet
Items |
2021 |
|
2020 |
Cash, cash equivalents, and
marketable debt securities |
$ |
153,050 |
|
|
$ |
174,782 |
|
Total assets |
$ |
237,717 |
|
|
$ |
261,584 |
|
Accounts payable and accrued
expenses |
$ |
13,712 |
|
|
$ |
14,839 |
|
Deferred revenue |
$ |
40,057 |
|
|
$ |
43,817 |
|
Total stockholders’
equity |
$ |
136,208 |
|
|
$ |
154,320 |
|
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