Full Press Release Details
Voyager Therapeutics Announces Fourth Quarter and Full Year 2019 Financial Results and Corporate Updates
Protocol amendment being implemented for ongoing RESTORE-1 trial of VY-AADC (NBIb-1817) for Parkinson's disease; plan to initiate RESTORE-2 trial in 2H 2020
Update on VY-HTT01 for Huntington's disease preclinical program expected in 2Q 2020
Strong financial position with ~$282M of cash at end of 2019 and expected runway into mid-2022
CAMBRIDGE, Mass., March 3, 2020 Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, today reported its fourth quarter and full year 2019 financial results, program progress and corporate updates.
In 2019, we took important steps toward our vision of establishing Voyager as the leader in neurological gene therapy, including forming our strategic collaboration with Neurocrine Biosciences, expanding our partnership with AbbVie, and further progressing our wholly-owned and partnered programs, said Andre Turenne, President and CEO of Voyager. Turning to 2020, we are excited to continue this momentum across all programs. These initiatives include presenting longer-term data from the Parkinson's disease program, advancing our Huntington's disease program, and further leveraging our novel capsid research and expertise in vector engineering and delivery toward additional pipeline programs.
Recent Corporate Highlights and Program Outlook
VY-AADC for Parkinson's Disease
VY-HTT01 for Huntington's Disease
Early Pipeline and Platform
Anticipated Upcoming Milestones
VY-AADC for Parkinson's Disease:
VY-HTT01 for Huntington's Disease:
Early Pipeline and Platform:
Fourth Quarter and Full Year 2019 Financial Results
Conference Call Information
Voyager will host a conference call and webcast today at 4:30 p.m. EST. The conference call may be accessed by dialing (877) 851-3834 for domestic callers, or +1 (631) 291-4595 for international callers. Please reference conference ID number 8461408 to join the call. The conference call will be webcast live from the Investors & Media section of Voyager's website at www.voyagertherapeutics.com and will be archived there following the call for 90 days.
About Voyager Therapeutics
Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe 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 severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, a monogenic form of ALS called SOD1, Friedreich's ataxia, Alzheimer's disease, and other neurodegenerative diseases related to defective or excess aggregation of tau and alpha-synuclein proteins in the brain. Voyager has strategic collaborations with AbbVie and 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.
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 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 AbbVie and Neurocrine Biosciences, including any potential future payments thereunder, its ability to identify and attract parties to participate in research and development collaborations, its ability to advance its AAV-based gene therapies into, and successfully initiate, enroll and complete, clinical trials, the potential clinical utility of its product candidates, its ability to continue to develop its gene therapy platform, its ability to perform under existing collaborations including those with AbbVie and Neurocrine Biosciences, its ability to add new programs to its pipeline, the regulatory pathway of, and the timing or likelihood of its regulatory filings and approvals for, any of its product candidates, its ability to operate its research and development activities efficiently and effectively, the utility and value of Voyager's patent portfolio, and Voyager's anticipated financial results, including Voyager's available cash, cash equivalents and marketable debt securities, the receipt by Voyager of revenues or reimbursement payments from collaboration partners, Voyager's operating expenses, and Voyager's ability to fund its operating expenses with its current cash, cash equivalents and marketable debt securities though a stated time period 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, those related to the initiation and conduct of preclinical studies and clinical trials; the availability of data from preclinical studies and clinical trials; the expectations for regulatory communications, submissions and approvals; the continued development of the gene therapy platform; 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 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.
VP, Investor Relations
Selected Financial Information
($-amounts in thousands, except per share data)
| Three Months Ended | Year Ended | ||||||||||||
| December 31, | December 31, | ||||||||||||
| Statement of Operations Items: | 2019 | 2018 | 2019 | 2018 | |||||||||
| Collaboration revenue | $ | 32,674 | $ | 2,008 | $ | 104,391 | 7,619 | ||||||
| Operating expenses: | |||||||||||||
| Research and development | 36,551 | 16,914 | 119,735 | 64,905 | |||||||||
| General and administrative | 9,891 | 8,255 | 36,335 | 33,809 | |||||||||
| Total operating expenses | 46,442 | 25,169 | 156,070 | 98,714 | |||||||||
| Operating loss | (13,768) | (23,161) | (51,679) | (91,095) | |||||||||
| Total other income | 1,193 | 629 | 8,082 | 2,627 | |||||||||
| Loss before income taxes | (12,575) | (22,532) | (43,597) | (88,468) | |||||||||
| Income tax benefit | 180 | ||||||||||||
| Net loss | $ | (12,575) | $ | (22,532) | $ | (43,597) | $ | (88,288) | |||||
| Net loss per share, basic and diluted | $ | (0.34) | $ | (0.77) | $ | (1.21) | $ | (2.75) | |||||
| Weighted-average common shares outstanding, basic and diluted | 36,838,507 | 29,281,071 | 35,898,266 | 32,065,781 |
| December 31, | |||||||
| Selected Balance Sheet Items | 2019 | 2018 | |||||
| Cash, cash equivalents, and marketable debt securities | $ | 281,533 | $ | 155,806 | |||
| Total assets | $ | 354,760 | $ | 177,029 | |||
| Accounts payable and accrued expenses | $ | 25,586 | $ | 10,826 | |||
| Deferred revenue | $ | 194,493 | $ | 113,046 | |||
| Total stockholders' equity | $ | 99,512 | $ | 46,446 |