Voyager Therapeutics Announces Strategic Shift and Leadership Transitions

• Company focusing on rapidly moving VY-HTT01 into clinical development for Huntington’s disease and maximizing opportunities created by TRACERTM gene therapy technology platform and next-generation targeted AAV capsids
• Board members Michael Higgins and Glenn Pierce, M.D., Ph.D., join leadership team

CAMBRIDGE, Mass., May 19, 2021 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for serious neurological diseases, today announced key leadership transitions and a strategic shift toward a refocused pipeline and expanded investment in its innovative, next-generation AAV capsid platform, TRACER (Tropism Redirection of AAV by Cell-type-specific Expression of RNA). The Company expects its TRACER technology platform to enable development of novel gene therapy candidates for serious neurological diseases that have been challenging to address with conventional approaches.

Michael Higgins, chairman of the board of directors, will assume the role of interim chief executive officer (CEO) and Glenn Pierce, M.D., Ph.D., board director, will assume the role of interim chief scientific officer (CSO). Mr. Higgins succeeds Andre Turenne, who has decided to step down from his roles as president and CEO and as a board director, effective in early June, to pursue new opportunities. Mr. Turenne will support the Company in an advisory capacity as the Company searches for a permanent CEO. Voyager also announced that Omar Khwaja, M.D., Ph.D., has resigned from his role as chief medical officer (CMO) and head of research and development, effective at the end of May. Dr. Khwaja will be returning to Europe to pursue a new scientific and clinical leadership opportunity. Maria Lopez-Bresnahan, M.D., SVP of translational medicine and clinical development, will continue to lead the Company’s clinical development programs, including the Company’s program for Huntington’s disease.

“On behalf of the entire Board, I want to thank Andre and Omar for their significant and dedicated contributions to the Company. We wish them success with their next endeavors,” said Michael Higgins, incoming CEO.

“I am proud of our collective accomplishments, especially in the development of Voyager’s platform technology and the progress made in moving VY-HTT01 toward clinical studies. I have great confidence in the outstanding team at Voyager and wish them all the best in their important work developing new treatments for severe neurological diseases,” said Mr. Turenne. “It has been a privilege to be part of Voyager, and I look forward to the Company’s continued progress towards delivering solutions for patients in need.”

Mr. Higgins added, “This is a transformational time for Voyager. We believe that our TRACER technology platform has the potential to generate novel capsids that will enable the treatment of a broad range of diseases that today cannot be safely and effectively addressed with current AAV delivery. We believe the novel capsids will allow Voyager to create highly differentiated, next-generation AAV gene therapies for serious neurological diseases and enable licensing and partnership opportunities both inside and outside of the neurology space. We anticipate an eventful year ahead with the initiation of our planned Phase 1/2 clinical trial for VY-HTT01 for Huntington’s disease, the expected advancement of our earlier stage pipeline programs powered by our novel capsids, further investment in TRACER and other vector engineering technology, and potential strategic partnership and licensing deals.”

“Voyager has made tremendous progress identifying innovative gene therapy approaches for serious neurological diseases, including the ability to deliver diverse therapeutic payloads directly to targeted areas of the brain,” said Dr. Khwaja. “I am particularly excited by the possibilities created by the TRACER platform, and by the appointment of Glenn Pierce, a widely respected expert in gene therapy development, to lead Voyager’s team of world-class scientists and clinicians as they advance these technologies and programs towards the clinic.”

At the recent ASGCT meeting, the Company presented key data in non-human primates (NHPs) demonstrating that one of its novel capsids, 9P801, after intravenous dosing, resulted in more than 1,000-fold or higher transgene expression in the brain, and 100-fold higher transgene expression in the spinal cord, compared to AAV9. Data showed the Company’s novel capsid variants effectively penetrated the blood brain barrier and achieve widespread biodistribution and transduction of multiple regions of the brain including the cortex, thalamus, striatum, cerebellum, brainstem and spinal cord. These results arose from the first of many libraries screened in NHPs, and the Company is rapidly processing additional NHP campaigns from AAV9 and other parental capsids.

The Company also recently announced IND clearance of VY-HTT01, its gene therapy candidate for the treatment of Huntington’s disease and confirmed its expectation to proceed with VYTAL, its planned Phase 1/2 clinical trial, in the fourth quarter of 2021.

Incoming Interim Leadership

Michael Higgins has served on Voyager’s board of directors since July 2015 and has been chair of the board since June 2019. He is also the chair of the board of Pulmatrix and a board member for Genocea Biosciences, Nocion Therapeutics, Camp4 Therapeutics and Sea Pharmaceuticals. Previously, Michael served as entrepreneur-in-residence at Polaris Partners, senior vice president and chief operating officer of Ironwood Pharmaceuticals and held a variety of senior business positions at Genzyme. Michael has a B.S. from Cornell University and an M.B.A. from the Amos Tuck School of Business Administration at Dartmouth College.

Glenn Pierce, M.D., Ph.D., has been a member of the board of directors since January 2017. He serves as entrepreneur-in-residence at Third Rock Ventures. At Third Rock Ventures, he co-founded Ambys Medicines and serves as interim chief medical officer. Glenn previously served in a number of roles at Biogen, most recently as chief medical officer leading the hematology, cell and gene therapies division. Prior to Biogen, he served in small and large, public and private biopharmaceutical firms, including Bayer, Inspiration, Avigen, Selective Genetics and Amgen in the areas of tissue regeneration and hematology. Glenn is the co-author of more than 150 scientific papers and has received more than 15 patents. He currently serves on the boards of directors of Global Blood Therapeutics and the World Federation of Hemophilia as the vice president, Medical. Dr. Pierce received an M.D. and a Ph.D. in immunology, both from Case Western Reserve University in Cleveland, and completed his postgraduate training in pathology and hematology research at Washington University in St. Louis.

The Company’s Board has commenced a search process to identify a permanent chief executive officer and chief scientific officer.

About Voyager Therapeutics
Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for serious 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. For more information on Voyager Therapeutics, please visit the company’s website at www.voyagertherapeutics.com 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 the effective date for the resignation of Mr. Turenne and Dr. Khwaja from their current roles at Voyager; the assumption of interim roles by Mr. Higgins and Dr. Pierce at Voyager; the capabilities of Voyager’s novel capsids to treat a broad range of diseases; the initiation of the planned phase 1/2 clinical trial for VY-HTT01 for Huntington's disease; the expected advancement of earlier stage pipeline programs; the potential for TRACER to prove on an ongoing basis its ability to advance gene therapy approaches; the ability of Voyager's differentiated technology to provide strategic opportunities; and the ability for the Voyager to successfully recruit a new chief executive officer and chief scientific officer, in each instance are forward looking statements.

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, the severity and length of the COVID-19 health crisis; the ability of Voyager’s interim executive officers to successfully transition to their new roles; the ability of Voyager to recruit experienced and expert senior executive officers in a competitive environment; the ability of Voyager to continue development of the TRACER system; the success of the TRACER system to identify AAV novel capsids that have utility in gene therapy for the treatment of neurological diseases and for other diseases; the ability to engage investigators, to recruit patients meeting eligibility requirements, to manage COVID-19 restrictions and to generate clinical outcomes and data in a timely manner for the VYTAL study; the ability of Voyager to manage the business disruptions resulting from COVID-19 health crisis; the ability of Voyager to create research and development programs combining sufficient levels of scientific interest and applied expertise to be attractive in recruiting and maintaining researchers and scientists; Voyager’s scientific approach and general development progress; the ability to create and protect intellectual property; and the sufficiency of cash resources to support Voyager’s programs.

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 for the year ended December 31, 2020, 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.

Investor Inquiries:
investors@voyagertherapeutics.com

Media Inquiries:
Lissette Steele
Verge Scientific Communications
202.930.4762 x 409
lsteele@vergescientific.com