|View printer-friendly version|
Voyager Therapeutics Announces First Quarter 2020 Financial Results and Corporate Updates
Announced 14 presentations at upcoming
Ended Q1 2020 with over
“Our goal is to develop life-changing therapies for people living with severe neurological disease, and despite the ongoing COVID-19 health crisis, we ended the first quarter of 2020 in a strong position and expect to provide important progress updates across our programs over the course of 2020,” said
Recent Corporate Highlights and Program Outlook
VY-AADC (NBIb-1817) for Parkinson’s Disease
- The protocol of the RESTORE-1 clinical trial of VY-AADC (NBIb-1817) for Parkinson’s disease is being amended to make the previously announced protocol modifications. Patient screening is expected to resume once trial sites are able to accept study participants in the context of COVID-19.
- Voyager and Neurocrine Biosciences continue preparations for the initiation of the RESTORE-2 registrational study in Parkinson’s disease planned for the second half of 2020.
- Voyager and Neurocrine Biosciences expect to report final three-year data on all three cohorts (15 total patients) of the PD-1101 Phase 1b trial, as well as two-year data from the PD-1102 Phase 1 posterior trajectory trial (8 total patients), in the second half of 2020.
- Results from an intravenous (IV) levodopa sub-study from the PD-1101 trial were recently published in Movement Disorders, in an article titled “Aromatic L-Amino Acid Decarboxylase Gene Therapy Enhances Levodopa Response in Parkinson’s Disease.” In the sub-study of 13 patients from the trial, VY-AADC (NBIb-1817) administration improved the magnitude, speed of onset, and duration of Unified Parkinson’s Disease Rating Scale (UPDRS) motor responses to low and high dose of IV levodopa, across all cohorts.
VY-HTT01 for Huntington’s Disease
- Voyager is currently engaged in the ongoing conduct and review of preclinical studies for its Huntington’s disease program, VY-HTT01. Pending this review, Voyager is planning for the potential initiation of both a first-in-human Phase 1 study of VY-HTT01 and a prospective observational study of patients with late prodromal and early manifest Huntington’s disease. Voyager anticipates providing an update on the program in mid-2020.
- Voyager plans to present updated VY-HTT01 preclinical data at the upcoming ASGCT 23rd Annual Meeting taking place virtually on
May 12-15, 2020.
Early Pipeline and Platform
- Voyager continues to advance its earlier-stage research efforts, including wholly-owned and partnered programs with AbbVie and Neurocrine Biosciences. These initiatives include Friedreich’s ataxia, SOD1 ALS, vectorized antibodies, novel AAV capsids, and new discovery activities on novel targets.
- Voyager plans to present multiple progress updates on these efforts as well as its manufacturing platform at the upcoming ASGCT Annual Meeting.
- Voyager recently formed a new
Scientific Advisory Board(SAB) of industry leading experts in neuroscience and genetic medicine, including: chairperson Guangping Gao, Ph.D., a co-founder of Voyager and Co-Director of the Li Weibo Institute for Rare Diseases Research, and Director of the Horae Gene Therapy Centerand Viral Vector Core, University of Massachusetts Medical School(UMMS); Beverly Davidson, Ph.D., Professor of Pathology and Laboratory Medicine and Professor of Genetics, University of Pennsylvania Perelman School of Medicine, and Director of the Raymond G. Perelman Center for Cellular and Molecular Therapeuticsand Chief Scientific Strategy Officer at Children’s Hospital of Philadelphia; David Liu, Ph.D., the Richard Merkin Professor and Vice-Chair of the Faculty at the Broad Institute of Harvardand MIT, and Professor of Chemistry and Chemical Biology at Harvard University; Dinah Sah, Ph.D., Voyager’s former Chief Scientific Officer; and Phillip Zamore, Ph.D., a co-founder of Voyager, the Gretchen Stone Cook Professor of Biomedical Sciences and Chair of the RNA Therapeutics Institute, UMMS.
Expansion of Technical Operations and Manufacturing Facilities
- Voyager has entered into a lease agreement to expand its operations with a 32,000 square foot facility located in
Lexington, MA.The Company expects the new state-of-the-art facility currently under construction to be ready for occupancy in late 2020. The facility includes both office and lab space and will house the Company’s growing manufacturing capabilities to support the current and future pipeline programs.
Anticipated Upcoming Milestones
VY-AADC (NBIb-1817) for Parkinson’s Disease:
- Report 3-year results from PD-1101 trial (2H 2020)
- Report 2-year results from PD-1102 trial (2H 2020)
- Initiate RESTORE-2 registration trial (2H 2020)
VY-HTT01 for Huntington’s Disease:
- Provide update on program and clinical plans (mid-2020)
- Present additional results from preclinical studies (2H 2020)
Early Pipeline and Platform:
- Provide progress updates on Friedreich’s ataxia program, new discovery programs, as well as vectorized antibody and novel capsid efforts (2020)
First Quarter 2020 Financial Results
- Collaboration Revenues: Voyager had collaboration revenue of
$18.1 millionfor the first quarter of 2020, compared to collaboration revenue of $5.2 millionfor the same period of 2019. The increase in collaboration revenue was largely due to efforts related to the Neurocrine Biosciences and AbbVie alpha-synuclein collaborations, which were entered into in the first quarter of 2019.
- Net Loss: Net loss was
$24.3 millionfor the first quarter of 2020, compared to a net loss of $27.2 millionfor the same period of 2019.
- R&D Expenses: Research and development expenses were
$32.3 millionfor the first quarter of 2020, compared to $24.8 millionfor the same period in 2019. The increase in R&D expenses was primarily related to employee-related, external and facility costs to support Voyager’s clinical and preclinical pipeline programs, including the VY-AADC (NBIb-1817) and VY-HTT01 programs.
- G&A Expenses: General and administrative expenses were
$10.2 millionfor the first quarter of 2020, compared to $9.7 millionfor the same period in 2019. The increase in G&A expenses was primarily related to employee costs to support the advancement of Voyager’s pipeline programs and operations, partially offset by a reduction in legal and other administrative costs.
- Cash Position: Cash, cash equivalents and marketable debt securities as of
March 31, 2020were $250.9 million.
- Based on the Company’s current operating plan, Voyager anticipates cash, cash equivalents and marketable debt securities will be between
$150 millionand $170 millionat the end of 2020.
- Voyager expects that its cash, cash equivalents and marketable debt securities, as well as amounts expected to be received for reimbursement of development costs from Neurocrine Biosciences, will be sufficient to meet Voyager’s projected operating expenses and capital expenditure requirements into mid-2022.
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “might,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “undoubtedly,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the ability of Voyager to maintain a high level of business critical activity and maintain a level of scientific leadership during the COVID-19 health crisis, the continued operation and effect of the
VP, Investor Relations
Selected Financial Information
($-amounts in thousands, except per share data)
|Three Months Ended|
|Statement of Operations Items:||2020||2019|
|Research and development||32,294||24,831|
|General and administrative||10,206||9,659|
|Total operating expenses||42,500||34,490|
|Total other income||170||2,123|
|Net loss per share, basic and diluted||$||(0.66||)||$||(0.81||)|
|Weighted-average common shares outstanding, basic and diluted||36,963,255||33,353,061|
|Selected Balance Sheet Items||2020||2019|
|Cash, cash equivalents, and marketable debt securities||$||250,931||$||281,533|
|Accounts payable and accrued expenses||$||22,308||$||25,586|
|Total stockholders’ equity||$||79,757||$||99,512|
Source: Voyager Therapeutics, Inc.