Voyager Therapeutics Announces Third Quarter 2020 Financial Results and Corporate Updates – GlobeNewswire

Posted: November 10, 2020 at 2:00 pm

CAMBRIDGE, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ: VYGR) today reported its third quarter 2020 financial results, program progress and corporate updates.

During the third quarter, we took important steps to advance our lead programs for Parkinsons disease and Huntingtons disease with the presentation of positive long-term clinical results and the filing of an IND, respectively. Together with our partner, Neurocrine, we are currently focused on resuming enrollment in the RESTORE-1 clinical trial for Parkinsons disease pending the requested review and assessment of patient imaging data by the DSMB. For our Huntingtons disease program, the FDA has provided clarity regarding the additional information it is requesting pursuant to our IND filing. We plan to work with the FDA to respond to these requests to allow for an IND clearance and the start of VY-HTT01s clinical evaluation, said Andre Turenne, President and CEO of Voyager. We look forward to continuing our progress on these two important programs, along with our broadening AAV gene therapy portfolio to treat severe neurological diseases.

Recent Program and Corporate Highlights

VY-AADC (NBIb-1817) for Parkinsons Disease

VY-HTT01 for Huntingtons Disease

Novel AAV Capsid Discovery Program

Recent Corporate Updates

Third Quarter 2020 Financial Results

Financial Guidance

About Voyager TherapeuticsVoyager 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. Voyagers wholly owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinsons disease, Huntingtons disease, Friedreichs ataxia, and other severe neurological diseases. For more information on Voyager Therapeutics, please visit the companys website at or follow @VoyagerTx on Twitter and LinkedIn.

Voyager Therapeutics is a registered trademark, and TRACER is a trademark, of Voyager Therapeutics, Inc.

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 Voyagers ability to deliver patient imaging data to the DSMB for the RESTORE-1 Phase 2 clinical trial, the review of such data by the DSMB prior to year-end, and pending the DSMBs evaluation of such data the resumption of enrollment in the RESTORE-1 Phase 2 clinical trial; the submission by Neurocrine Biosciences of an expedited safety report relating to the RESTORE-1 clinical trial in a timely manner; Voyagers efforts to work with the FDA to resolve additional information requests relating to the IND application for VY-HTT01, the clearance of the VY-HTT01 IND application by the FDA and the initiation of a Phase 1b clinical trial of VY-HTT01; Voyagers continuing efforts in the discovery and engineering of novel AAV capsids, including progressing non-human primate studies of selected novel capsids; the contributions that will be made to Voyager by key senior level officers and a new member to the Voyager Board of Directors; the timing, progress, activities, goals and reporting of results of Voyagers preclinical programs and clinical trials and its research and development programs; the potential clinical utility of its product candidates; Voyagers 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; Voyagers anticipated financial results, including Voyagers available cash, cash equivalents and marketable debt securities; Voyagers ability to fund its operating expenses with its current cash, cash equivalents and marketable debt securities through a stated time period; and 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 are forward looking statements.

All forward-looking statements are based on estimates and assumptions by Voyagers 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 to provide imaging data to the DSMB for the RESTORE-1 Phase 2 clinical trial, and the ability for the DSMB to complete its evaluation and to resolve questions that may exist regarding such patient data; the ability for Voyager to meet the information requests of, and to resolve questions raised by, the FDA relating to the IND application for VY-HTT01; the ability of Voyager to progress its research and engineering program for novel capsids and to conduct non-human primate studies; the initiation and conduct of preclinical studies and clinical trials; the availability of data from preclinical studies and clinical trials, and the ability to effectively present such data; Voyagers 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; the commercial potential of Voyagers product candidates; the severity and length of the COVID-19 health crisis, the imposition of governmental controls and guidance addressing the COVID health crisis; and the financial and human resources available to Voyager to manage the COVID-19 health crisis. These statements are also subject to a number of material risks and uncertainties that are described in Voyagers 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.

Investors:Paul CoxVP, Investor

Media:Sheryl Seapy

Selected Financial Information($-amounts in thousands, except per share data)(Unaudited)

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Voyager Therapeutics Announces Third Quarter 2020 Financial Results and Corporate Updates - GlobeNewswire

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