UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): August 7, 2018

 

 

Voyager Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

Registrant’s telephone number, including area code (857) 259-5340

 

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

 

 

Item 2.02. Results of Operations and Financial Condition.

On August 7, 2018, Voyager Therapeutics, Inc. (the “Company”) announced second quarter 2018 financial results and corporate highlights. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits

(d)    Exhibits

 

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

 

 

EXHIBIT INDEX

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Voyager Therapeutics Announces Second Quarter 2018 Financial Results and Corporate Highlights

 

Clinical data updates and regulatory feedback for VY-AADC during the quarter support planned pivotal program for Parkinson’s disease

 

Pipeline programs progressing with updated preclinical data from ALS and Huntington’s disease programs expected during the fourth quarter of this year

 

Conference call scheduled for today at 4:30 p.m. EDT

 

 

Cambridge, Mass., August 7, 2018 – Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases today reported its second quarter 2018 results, recent progress and corporate updates and will host a conference call and webcast today at 4:30 p.m. EDT to discuss these results. 

 

“The significant progress made during the second quarter with our lead program VY-AADC for Parkinson’s disease and our pipeline programs positions Voyager to potentially achieve important milestones for the remainder of this year and into 2019,” said Andre Turenne, president and chief executive officer of Voyager Therapeutics. “These include enrolling our pivotal program for VY-AADC for Parkinson’s disease and providing longer-term results from the Phase 1 trials as well as presenting preclinical data on our programs targeting ALS SOD-1 and Huntington’s disease. In addition, we continue to advance our collaboration with AbbVie targeting vectorized monoclonal antibodies directed against tau for the treatment of Alzheimer’s disease and other neurodegenerative diseases.”

 

Recent Clinical and Preclinical Program Highlights

 

VY-AADC for Parkinson’s disease:

 

 

 

 

 

Preclinical programs for ALS SOD-1, Huntington’s disease, Friedreich’s ataxia and tau for Alzheimer’s and other neurodegenerative diseases:

 

 

Management Updates

 

Voyager recently announced the appointment of Andre Turenne as president and chief executive officer of Voyager and member of the Voyager Board of Directors. Mr. Turenne joins Voyager with extensive strategic business development and commercial leadership experience, including nearly 12 years at Genzyme and Sanofi where he most recently served as Sanofi’s senior vice president, global head, business development and licensing responsible for partnering activities across all of Sanofi’s business units.

 

Voyager today announced the resignation of Bernard Ravina, M.D., M.S., Voyager’s chief medical officer, as he pursues a new career opportunity at a private biotechnology company. Voyager has initiated a retained search for this role. Dr. Ravina will continue to serve as a Clinical Advisor to Voyager. Steven M. Paul, M.D., Voyager’s former president and chief executive officer, will continue to serve on Voyager’s Board of Directors and as a member of Voyager’s Science & Technology Committee and as a Senior Advisor to Voyager.

 

“Since joining Voyager over four and a half years ago, Bernard played an integral role in advancing the Parkinson’s disease program and in leading our medical activities,” said Andre Turenne, president and chief executive officer of Voyager Therapeutics. “With VY-AADC entering a robust pivotal program based on the positive Phase 1 clinical trial data and receiving RMAT designation and the positive Type C meeting feedback from the FDA, Bernard’s departure occurs during a natural transition point, and we are highly confident in the strong medical team that he has assembled to continue to execute on our priorities. We wish Bernard success in his next endeavor and are very pleased that he will continue to contribute to Voyager as a Clinical Advisor.”

 

Second Quarter 2018 Financial Results

 

Voyager reported a GAAP net loss of $25.5 million, or $0.80 per share, for the second quarter ended June 30, 2018, compared to a GAAP net loss of $18.9 million, or $0.73 per share, for the same period in 2017.

 

Collaboration revenues of $2.6 million for the second quarter of 2018 compared to $1.2 million for the second quarter of 2017. Collaboration revenues reflect recognition of payment for research and development services provided by Voyager for various programs under the collaboration agreements with Sanofi Genzyme and AbbVie. The increase in collaboration revenues for the second quarter of 2018 compared to the same period in 2017 primarily reflects the recognition of revenue related to research services performed under the AbbVie collaboration agreement that was announced in February 2018.  These amounts were offset primarily by a reduction in revenue recognized under the Sanofi Genzyme collaboration resulting from the adoption of certain accounting rules related to revenue recognition. 

 

Research and development (R&D) expenses of $16.5 million for the second quarter ended June 30, 2018 compared to $15.3 million for the same period in 2017. The increase in R&D expenses related primarily to expenditures associated with increased personnel, facility and external costs to support the advancement of VY-AADC into the randomized, placebo-controlled Phase 2 trial, as well as expenditures related to support Voyager’s preclinical pipeline programs.

 

General and administrative (G&A) expenses of $11.8 million for the second quarter 2018 compared to $4.5 million for the same period in 2017. The increase in G&A expenses was primarily due to personnel costs including an increase in non-cash stock-based compensation expenses and higher professional fees.

   

Cash, cash equivalents, and marketable debt securities as of June 30, 2018 were $197.0 million. Based on the Company’s current operating plan, Voyager continues to expect to end 2018 with total cash, cash equivalents and marketable debt securities of approximately $125 million to $135 million and projects that its existing cash, cash equivalents and marketable debt securities will be sufficient to fund operating expenses and capital expenditure requirements into early 2020.

 

Conference Call Information

 

Voyager will host a conference call and webcast today at 4:30 p.m. ET.  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 8498509.  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.  The webcast will be archived for 30 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 pipeline focuses on severe neurological diseases in need of effective new therapies, including Parkinson’s disease, a monogenic form of ALS called SOD1, Huntington’s disease, Friedreich’s ataxia, neurodegenerative diseases related to defective or excess aggregation of tau protein in the brain including Alzheimer’s disease and severe, chronic pain. Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, AbbVie, 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.

 

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 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 gene therapy platform, its ability to develop manufacturing capability for its products and successfully transition its manufacturing process, its ability to perform under existing collaborations with, among others, Sanofi Genzyme and AbbVie and to add new programs to its pipeline, its ability to enter into new partnerships or collaborations, the sufficiency of its cash resources and the timing or likelihood of its regulatory filings and 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, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of the gene therapy platform; Voyager’s scientific approach and general development progress; 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 most recent 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. 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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Investor Relations:

Matt Osborne

Vice President of Investor Relations & Corporate Communications

857-259-5353

mosborne@vygr.com  

 

Media:

Josie Butler

W2O/Pure Communications, Inc.

910-239-5099

jbutler@w2ogroup.com

 Selected Financial Information

($-amounts in thousands, except per share data)

(Unaudited)