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): March 15, 2017

 

 

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))

 

 

 

Item 2.02. Results of Operations and Financial Condition.

On March 15, 2017,  Voyager Therapeutics, Inc. (the “Company”) announced financial results for the quarter and year ended December 31, 2016. 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:

 

 

 

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.

 

 

 

EXHIBIT INDEX

 

 

 

Voyager Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Corporate Highlights

 

Lead program VY-AADC01 for advanced Parkinson’s disease on track to report 6-month data from Cohort 3 and longer-term data from Cohorts 1 and 2 in mid-year 2017

 

VY-AADC01 Phase 1b data accepted as emerging (late-breaking) oral presentation at the upcoming American Academy of Neurology (AAN) meeting

 

Three investigational new drug (IND) applications planned within the next 24 months for gene therapy pipeline programs targeting devastating CNS diseases

 

Cambridge, Mass., March 15, 2017 – Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company developing life-changing treatments for severe diseases of the central nervous system (CNS), today reported its fourth quarter and full year 2016 financial results, and provided corporate highlights, goals and financial guidance.

 

“Voyager’s exceptional performance and accomplishments during 2016 created strong momentum for the company for 2017 and beyond as we continue to focus our efforts on developing gene therapies for devastating diseases of the CNS,” said Steven Paul, M.D., president and chief executive officer of Voyager Therapeutics. “The positive interim Phase 1b data we provided late last year for VY-AADC01 for advanced Parkinson’s disease provided proof-of-concept that a one-time, targeted delivery of a gene therapy was well tolerated and could enhance patients’ sensitivity to levodopa while at the same time generate durable, dose-related, and clinically meaningful improvements in patients’ motor function. Additional data from this trial mid-year from more patients for longer duration will inform the design of a double-blind, placebo-controlled trial expected to start later this year. Our pipeline programs are rapidly progressing with three INDs planned within the next 24 months for our monogenic ALS, Huntington’s disease, and Friedreich’s ataxia programs. During the year, we allocated capital wisely towards our manufacturing capabilities and vector engineering platform providing us with a strong foundation for the transformative years ahead.”

 

2016 and Recent Key Pipeline and Corporate Highlights

 

Lead program highlights:

 

 

 

 

 

Pipeline program highlights:

 

 

 

Recent corporate highlights:

 

 

 

 

 

 

Corporate Goals and 2017 Financial Guidance

 

Voyager remains committed to becoming the leading gene therapy company focused on severe diseases of the CNS with expertise in discovery, development, manufacturing and commercialization of gene therapy products for people living with these devastating diseases. The significant accomplishments achieved during 2016 provide a solid foundation for continued progress during 2017 and beyond, as measured by the planned achievements of the following corporate goals and 2017 financial guidance:

 

 

 

 

 

 

 

Fourth Quarter and Full Year 2016 Financial Results

 

Voyager reported a GAAP net loss of $14.7 million, or $0.57 per share, for the fourth quarter ended December 31, 2016, compared to a GAAP net loss of $8.8 million, or $0.67 per share, for the same period in 2015. The Company reported a net loss of $40.2 million, or $1.59 per share, for the full-year ended December 31, 2016, compared to a net loss of $38.3 million, or $9.14 per share, for the same period in 2015.  

 

Collaboration revenues of $2.4 million for the fourth quarter of 2016 compared to collaboration revenues of $4.9 million for the fourth quarter of 2015. Collaboration revenues of $14.2 million for the full year end December 31, 2016, compared to collaboration revenues of $17.3 million for the full year ended December 31, 2015. Collaboration revenues reflect reimbursement for research and development services provided by Voyager for various programs under the Sanofi-Genzyme collaboration agreement. The decrease in collaboration revenues for the fourth quarter and full year 2016 compared to the same periods in 2015 reflect deprioritized development of VY-SMN101 for spinal muscular atrophy and a reduction of certain services provided by Sanofi-Genzyme.

 

Research and development (R&D) expenses of $12.7 million for the fourth quarter ended December 31, 2016, compared to $9.2 million for the same period in 2015. R&D expenses were $42.2 million for the year ended December 31, 2016 compared to $27.7 million for the same period in 2015. The increase in R&D expenses was largely due to expenditures associated with the development of Voyager’s pipeline and product engine, increased facility expenses and personnel costs to support the advancement of the pipeline programs.

 

General and administrative (G&A) expenses were $3.5 million for the fourth quarter ended December 31, 2016, compared to $3.2 million for the same period in 2015. G&A expenses were $13.3 million for the year ended December 31, 2016 compared to $9.9 million for the same period in 2015. The increase in G&A expenses was primarily due to personnel costs to support Voyager’s growth, and facility costs. 

 

Cash, cash equivalents, and marketable debt securities as of December 31, 2016 were $174.4 million.

 

Conference Call Information

 

Voyager will host a conference call and webcast today at 8:30 a.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 83618016. 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 Parkinson’s Disease and VY-AADC01

 

Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease that affects approximately 700,000 people in the U.S.1 and seven to 10 million people worldwide2. It is estimated that up to 15% of the prevalent population with Parkinson’s disease, or approximately 100,000 patients in the U.S., have motor fluctuations that are refractory, or not well-controlled, with levodopa. While the underlying cause of Parkinson's disease in most patients is unknown, the motor symptoms of the disease arise from a loss of neurons in the midbrain that produce the neurotransmitter dopamine. Declining levels of dopamine in this particular region of the brain leads to the motor symptoms associated with Parkinson’s disease including tremors, slow movement or loss of movement, rigidity, and postural instability. Motor symptoms during the advanced stages of the disease include falling, gait freezing, and difficulty with speech and swallowing, with patients often requiring the daily assistance of a caregiver.

 

There are currently no therapies that effectively slow or reverse the progression of Parkinson’s disease. Levodopa remains the standard of care treatment, with its beneficial effects on symptom control having been discovered over 40 years ago3. Patients are generally well-controlled with oral levodopa in the early stages of the disease, but become less responsive to treatment as the disease progresses. Patients experience longer periods of reduced mobility and stiffness termed off-time, or the time when medication is no longer providing benefit, and shorter periods of on-time when their medication is effective.

 

The progressive motor symptoms of Parkinson’s disease are largely due to the death of dopamine neurons in the substantia nigra, a part of the midbrain that converts levodopa to dopamine, in a single step catalyzed by the enzyme AADC. Neurons in the substantia nigra release dopamine into the putamen where the receptors for dopamine reside. In advanced Parkinson’s disease, neurons in the substantia nigra degenerate and the enzyme AADC is markedly reduced in the putamen, which limits the brain’s ability to convert oral levodopa to dopamine4. The intrinsic neurons in the putamen, however, do not degenerate in Parkinson’s disease5 6. VY-AADC01, comprised of the adeno-associated virus-2 capsid and a cytomegalovirus promoter to drive AADC transgene expression, is designed to deliver the AADC gene directly into neurons of the putamen where dopamine receptors are located, bypassing the substantia nigra neurons and enabling the neurons of the putamen to express the AADC enzyme to convert levodopa into dopamine. The approach with VY-AADC01, therefore, has the potential to durably enhance the conversion of levodopa to dopamine and provide clinically meaningful improvements in motor symptoms following a single administration.  

 

 

1 Willis et al, Neuroepidemiology.2010;34:143–151

2 www.pdf.org/en/parkinson_statistics

3 Poewe W, et al, Clinical Interventions in Aging.2010;5:229-238.

4 Lloyd, J Pharmacol Exp Ther. 1975;195:453-464, Nagatsu, J Neural Transm Suppl.2007

5 Cold Spring Harb Perspect Med 2012;2:a009258

6 Braak et al, Cell Tissue Res.2004;318:121-134

About Voyager Therapeutics

 

Voyager Therapeutics is a clinical-stage gene therapy company developing life-changing treatments for severe diseases of the CNS. 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. The Company’s pipeline focuses on severe CNS diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of ALS, Friedreich’s ataxia, Huntington’s disease, 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. Follow Voyager on 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 law. 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 complete, clinical trials, its ability to continue to develop its product engine, its ability to add new programs to its pipeline, ability to enter into new partnerships or collaborations, its expected cash, cash equivalents and marketable securities at the end of a fiscal year and anticipation for how long expected cash, cash equivalents and marketable securities will last, 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. These statements are also subject to a number of material risks and uncertainties that are described in Voyager’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as updated by its future 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

Head of Investor Relations & Corporate Communications

857-259-5353

mosborne@vygr.com

 

Media:

Josephine Butler

Pure Communications, Inc.

910-337-0707

jbutler@purecommunications.com 

 

 

 

 

 

 

 

 

Selected Financial Information

(amounts in thousands, except per share data)

(Unaudited)