Global, pivotal Phase 2-3 program for VY-AADC on track to dose the first patient during the second quarter of 2018
Voyager to host conference call today at 4:30 p.m. EDT
CAMBRIDGE, Mass., Oct. 30, 2017 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, today announced an update to its VY-AADC program for advanced Parkinson's disease. Under Voyager's Collaboration Agreement with Sanofi Genzyme, Sanofi Genzyme had an exclusive option for ex-U.S. development and commercial rights to VY-AADC. Based on Voyager's understanding that because this option did not include rights in the U.S., Sanofi Genzyme informed Voyager that it has decided not to exercise its rights to this program. As a result, Voyager gains full worldwide development and commercial rights to VY-AADC for the treatment of advanced Parkinson's disease.
"We are very pleased to gain full worldwide rights to our Parkinson's disease program that recently demonstrated robust and durable clinical effects from the ongoing Phase 1b trial," said Steven Paul, M.D., Voyager's president and chief executive officer. "Sanofi Genzyme remains an important collaborator for Voyager, and we remain fully committed to progressing our Huntington's disease and Friedreich's ataxia programs under the ongoing collaboration. There is a significant unmet need for Parkinson's disease patients, particularly during the advanced stages of the disease where there are hundreds of thousands of patients globally. With a one-time administration that has been well tolerated, VY-AADC could penetrate the estimated 10,000 deep brain stimulation procedures worldwide each year for Parkinson's disease and the further tens of thousands of advanced patients who do not elect to undergo deep brain stimulation. We are pleased to progress this exciting program towards the planned start of the global, pivotal Phase 2-3 program later this year. We plan to describe our next steps with our Parkinson's program, and other corporate highlights, at our upcoming third quarter conference call."
Voyager's total cash, cash equivalents, and marketable debt securities as of June 30, 2017 were $141.3 million. Based on the company's current operating plan, Voyager continues to expect to end 2017 with total cash, cash equivalents, and marketable debt securities of approximately $90 million to $100 million and continues to project that its existing cash, cash equivalents, and marketable debt securities will be sufficient to fund operating expenses and capital expenditure requirements into 2019.
Conference Call Information
Voyager will host a conference call and live webcast today at 4:30 p.m. EDT. The live call may be accessed by dialing (877) 851-3834 for domestic callers or +1 (631) 291-4595 for international callers, and referencing conference ID number 5894739. A live audio webcast of the conference call will be available online from the Investors & Media section of Voyager's website at www.voyagertherapeutics.com. A replay of the webcast will be archived there for 30 days.
About Voyager Therapeutics
Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for patients suffering from severe neurological diseases. Voyager is committed to advancing the field of adeno-associated virus (AAV) gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. The company's pipeline focuses on severe neurological diseases in need of effective new therapies, including advanced Parkinson's disease, a monogenic form of ALS, Huntington's disease, Friedreich's ataxia, frontotemporal dementia, Alzheimer's disease and severe, chronic pain. Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, and the University of Massachusetts Medical School. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, Massachusetts. For more information, please visit www.voyagertherapeutics.com.
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," "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 and reporting of results of its preclinical programs and clinical trials and its research and development programs; 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 product engine; its ability to add new programs to its pipeline; its ability to develop manufacturing capability for its products; its ability to enter into new partnerships or collaborations; its expected case, cash equivalents and marketable debt securities at the end of a fiscal period and anticipation for how long expected cash, cash equivalents and marketable debt securities will last; and the timing or likelihood of its regulatory filings approvals are forward looking. All forward-looking statements are based on estimates and assumptions by Voyager's management that, although Voyager believes 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 clinical trials and the expectations for regulatory submissions and approvals; the continued development of the product engine; Voyager's scientific approach and general development progress; the availability or commercial potential of Voyager's product candidates; the sufficiency of cash resources; and need for additional financing. 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 and Quarterly Report on 10-Q filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
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