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Voyager Therapeutics Announces Third Quarter 2019 Financial Results and Corporate Highlights
“We are pleased to announce another productive quarter, during which we continued to advance our existing pipeline of wholly-owned and partnered programs,” said
Recent Corporate and Program Updates
- Voyager continues to advance its development programs in connection with
AbbVieand Neurocrine Biosciences, its collaboration partners. Neurocrine Biosciencesand Voyager expect to present final three-year data on all three cohorts of the PD 1101 Phase 1b trial at a medical conference in 2020.
October 2019, Voyager presented data on VY-HTT01 for the treatment of Huntington’s disease at the European Society of Geneand Cell Therapy (ESGCT) Annual Congress. The data showed widespread, dose-dependent and durable huntingtin protein (HTT) lowering in relevant brain regions affected in Huntington’s disease following intraparenchymal administration of VY-HTT01 to non-human primates. VY-HTT01 reduced HTT messenger RNA (mRNA) and protein in a dose-dependent manner resulting in an overall decrease in HTT mRNA (59%) and protein (50%) when measured using quantitative assays from multiple tissue punches sampled throughout the brain.
- Voyager now anticipates, if current preclinical studies are successful, filing an investigational new drug (IND) application for VY-HTT01 for Huntington’s disease during the first half of 2020. This will allow the IND application to include one-year data from preclinical studies instead of the previously planned six-month data. Leveraging its related clinical experience in Parkinson’s disease, Voyager still expects to screen and enroll the first patient in the planned clinical trial during 2020.
Allen Nunnallyhas been promoted to the position of Chief Business Officer from his previous position as Vice President of Corporate and Business Development. Mr. Nunnally played an instrumental role earlier this year in establishing the collaborations with Neurocrine Biosciencesand AbbVie, and in restructuring Voyager’s relationship with Sanofi Genzyme. Prior to joining Voyager in June 2018, Mr. Nunnally held senior positions at Foundation Medicine and the law firm Wilmer Cutler Pickering Hale and Dorr LLP.
Third Quarter 2019 Financial Results
For the third quarter of 2019, Voyager reported:
- A net loss of
$15.0 million, or $0.41per basic share, for the third quarter of 2019, compared to a net loss of $20.3 million, or $0.63per basic share, for the third quarter of 2018.
- Collaboration revenues of
$20.4 millionfor the third quarter of 2019, compared to $2.1 millionfor the third quarter of 2018. This increase reflects the recognition of amounts from the Neurocrine Biosciencesand AbbViealpha-synuclein collaborations, both of which became effective in the first quarter of 2019.
- Operating expenses of
$38.2 millionfor the third quarter of 2019, compared to operating expenses of $23.2 millionfor the third quarter of 2018. The increase in operating expenses related primarily to increased efforts to support Voyager’s preclinical pipeline and clinical program, including increases in research and development and general and administrative headcount.
- Research and development (R&D) expenses of
$29.8 millionfor the third quarter of 2019, compared to R&D expenses of $16.6 millionfor the third quarter of 2018. The increase in R&D expenses related primarily to both external costs and employee-related costs to support Voyager’s clinical and preclinical pipeline programs, including its RESTORE-1 Phase 2 clinical program for VY-AADC.
- General and administrative (G&A) expenses of
$8.5 millionfor the third quarter of 2019, compared to G&A expenses of $6.6 millionfor the third quarter of 2018. The increase in G&A expenses was primarily related to employee and facility costs to support the advancement of Voyager’s pipeline programs and growing operations.
- Cash, cash equivalents, and marketable debt securities as of
September 30, 2019were $307.4 million, as compared to $327.5 millionon June 30, 2019.
Voyager anticipates full-year 2019 operating expenses between
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “might,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “undoubtedly,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the initiation, timing, progress, activities, goals and reporting of results of its preclinical programs and clinical trials and its research and development programs, the potential benefits, timing and future operation of the collaboration agreements with
Chief Financial Officer
|Selected Financial Information
($-amounts in thousands, except per share data)
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Statement of Operations Items:||2019
|Research and development||29,777||16,632||83,184||47,991|
|General and administrative||8,463||6,609||26,444||25,554|
|Total operating expenses||38,240||23,241||109,628||73,545|
|Total other income||2,801||858||6,888||1,997|
|Loss before income taxes||(15,006||)||(20,289||)||(31,023||)||(65,937||)|
|Income tax benefit||—||—||—||180|
|Net loss per share, basic and diluted||$||(0.41||)||$||(0.63||)||$||(0.87||)||$||(2.06||)|
|Weighted-average common shares outstanding, basic and diluted||36,742,993||32,191,475||35,581,408||31,977,670|
|September 30,||December 31,|
|Selected Balance Sheet Items||2019||2018|
|Cash, cash equivalents, and marketable debt securities||$||307,400||$||155,806|
|Accounts payable and accrued expenses||$||20,614||$||10,826|
|Total stockholders’ equity||$||108,156||$||46,446|
Source: Voyager Therapeutics, Inc.