VYGR Voyager Therapeutics Inc.

11.27
-0.02  -0%
Previous Close 11.29
Open 11.23
52 Week Low 6.26
52 Week High 22.13
Market Cap $421,847,686
Shares 37,431,028
Float 25,846,620
Enterprise Value $221,787,203
Volume 128,125
Av. Daily Volume 301,694
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Upcoming Catalysts

Drug Stage Catalyst Date
VY-AADC02
Advanced Parkinson’s disease
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
VY-AADC02 (RESTORE-1)
Parkinson's Disease
Phase 2
Phase 2
Phase 2 trial to re-enroll 2H 2020. Phase 3 trial to commence 1H 2021.

Latest News

  1.                             Plans to present three-year Phase 1b results of VY-AADC (NBIb-1817) in patients with Parkinson's disease at the Movement Disorder Society (MDS) Virtual Congress 2020

    Expects screening and enrollment in RESTORE-1 trial of VY-AADC (NBIb-1817) to resume during 2H 2020

    Intends to submit Investigational New Drug (IND) application of VY-HTT01 for Huntington's disease during 2H 2020

    CAMBRIDGE, Mass., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today reported its second quarter 2020 financial results, program progress and corporate updates.

    "We anticipate making important progress across our lead programs in the coming months, including presenting long-term clinical results from our Parkinson's disease gene therapy program, resuming patient screening and enrollment in our RESTORE-1 trial for Parkinson's patients, and moving our wholly-owned gene therapy for Huntington's disease toward the clinic with an IND filing," said Andre Turenne, President and CEO of Voyager. "We're also excited to continue momentum on our next generation capsids, which we believe have the potential to substantially enhance and expand the therapeutic potential of AAV gene therapy to treat severe neurological diseases."

    Corporate Highlights and Program Outlook

    VY-AADC (NBIb-1817) in Parkinson's Disease

    • Voyager and Neurocrine Biosciences plan to present the final three-year data on all three cohorts of the PD-1101 Phase 1b trial, as well as two-year data from the PD-1102 Phase 1 trial, at the MDS Virtual Congress 2020 being held in September. In total, these data will represent more than 60 years of patient experience following VY-AADC treatment and will include a range of patient-reported, physician-assessed and objective endpoints.  
    • Voyager and Neurocrine Biosciences expect patient screening and enrollment to resume at clinical sites in the RESTORE-1 Phase 2 clinical trial during the second half of 2020. Trial sites had temporarily suspended patient screening and enrollment activity in response to the COVID-19 pandemic and the implementation of protocol amendments.
    • Voyager and Neurocrine Biosciences plan to initiate the RESTORE-2 Phase 3 global registrational clinical study of VY-AADC (NBIb-1817) in Parkinson's disease during the first half of 2021.
    • Voyager and collaborators recently published a review of the evolution of novel techniques to overcome the challenges of surgical delivery of gene therapies to target brain regions, in an article titled "Data-Driven Evolution of Neurosurgical Gene Therapy Delivery in Parkinson's Disease" in the Journal of Neurology, Neurosurgery and Psychiatry.

    VY-HTT01 in Huntington's Disease

    • Huntington's disease is a fatal genetic disease affecting approximately 40,000 people in the U.S. that results in the progressive decline of motor and cognitive functions. There are currently no approved treatments targeting the underlying cause of the disease.
    • Voyager is developing VY-HTT01 as a one-time AAV-based gene therapy treatment designed to knock down expression of the HTT gene. Voyager's approach is focused on delivering VY-HTT01 directly into the brain and targeting a reduction of the levels of mutated protein in the striatum and cortex to potentially slow the progression of both motor and cognitive symptoms.
    • Voyager recently completed IND-enabling preclinical studies and is finalizing an IND application for VY-HTT01 in Huntington's disease, which it expects to file with the U.S. Food and Drug Administration (FDA) in the second half of 2020.
    • In non-human primate studies, one-time administration of VY-HTT01 resulted in robust and durable knockdown of HTT mRNA and protein, with knockdown stabilization between 6 and 12 months, and widespread distribution of VY-HTT01 vector genome across the striatum and cortex.
    • VY-HTT01 treatment demonstrated robust knockdown of HTT mRNA and protein in the YAC128 and BACHD transgenic mouse models of Huntington's disease, with significant improvements in motor function. The Company plans to present preclinical data from the IND-enabling studies at a future scientific congress in the first half of 2021.
    • Following clearance of the IND by the FDA, the Company expects to begin the first-in-human clinical trial of VY-HTT01 in Huntington's disease patients.
    • Voyager and collaborators recently published an article titled "Clinical Outcomes and Selection Criteria for Prodromal Huntington's Disease Trials" in Movement Disorders. The publication analyzed the use of the normalized prognostic index (PIN) score to improve selection of pre-diagnosis Huntington's disease patients for future clinical trials and identified outcome measures that show robust longitudinal change for measuring treatment efficacy and reducing trial size.

    Novel AAV Capsid Discovery Program

    • Voyager continues to progress its efforts in the discovery and engineering of novel AAV capsids with the potential to overcome the limitations of existing capsids, including greater blood-brain barrier (BBB) penetrance following IV administration. Voyager is leveraging its proprietary TRACER™ platform to facilitate the selection of AAV capsids with significantly improved BBB crossing and cell-specific transduction properties for therapeutic applications.
    • Voyager has presented in vivo proof-of-concept data for capsids identified using its TRACER platform. Voyager is currently engaged in non-human primate studies to further characterize and select novel AAV capsids with improved properties and potential for therapeutic applications.

    Corporate Updates

    • Voyager recently appointed Maria Lopez-Bresnahan, MD, MBA, FAAN, as Senior Vice President, Translational Medicine and Clinical Development. Dr. Lopez-Bresnahan brings more than two decades of industry experience in neurological drug development, including prior clinical leadership roles at Alkermes plc, Vertex Pharmaceuticals, and Pfizer Inc.
    • Following the recent conclusion of the tau and alpha-synuclein vectorized antibody collaborations with AbbVie, Voyager has regained full rights to the vectorization technology and certain novel vectorized antibodies developed as part of the collaborations.

    Anticipated Upcoming Milestones

    VY-AADC (NBIb-1817) for Parkinson's Disease:

    • Report 3-year results from PD-1101 trial (September 2020)
    • Report 2-year results from PD-1102 trial (September 2020)
    • Resume patient screening and enrollment in RESTORE-1 Phase 2 clinical trial (2H 2020)
    • Initiate RESTORE-2 Phase 3 registrational clinical trial (1H 2021)

    VY-HTT01 for Huntington's Disease:

    • IND application and Phase 1 trial initiation (update post-FDA clearance)
    • Present IND-enabling preclinical results at a scientific congress (1H 2021)

    Early Pipeline and Platform:

    • Provide progress updates on earlier-stage research programs, including novel capsid discovery efforts

    Second Quarter 2020 Financial Results

    • Collaboration Revenues: Voyager had collaboration revenue of $28.7 million for the second quarter of 2020, compared to collaboration revenue of $46.1 million for the same period of 2019. The decrease in collaboration revenue primarily reflects the termination of the Sanofi-Genzyme Collaboration in June 2019, which resulted in the recognition of $28.7 million of previously deferred amounts. The reduction in revenue from the termination of the Sanofi Genzyme Collaboration was offset by an increase in revenue related to research services and cost reimbursements from the collaborations with Neurocrine and AbbVie in the second quarter of 2020 compared to the same period of 2019.
    • Net Loss: Net loss was $8.7 million for the second quarter of 2020, compared to net income of $11.2 million for the same period of 2019.
    • R&D Expenses: Research and development expenses were $29.4 million for the second quarter of 2020, compared to $28.6 million for the same period in 2019. The increase in R&D expenses was primarily related to employee-related, external and facility costs to support Voyager's clinical and preclinical pipeline programs.
    • G&A Expenses: General and administrative expenses were $8.2 million for the second quarter of 2020, compared to $8.3 million for the same period in 2019.
    • Cash Position: Cash, cash equivalents and marketable debt securities as of June 30, 2020 were $229.7 million.

    Financial Guidance

    • Based on the Company's current operating plan, Voyager continues to anticipate cash, cash equivalents and marketable debt securities will be between $150 million and $170 million at the end of 2020.
    • Voyager expects that its cash, cash equivalents and marketable debt securities, as well as amounts expected to be received for reimbursement of development costs from Neurocrine Biosciences, will be sufficient to meet Voyager's projected operating expenses and capital expenditure requirements into mid-2022.

    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 wholly owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, Friedreich's ataxia, and other severe neurological diseases. For more information, please visit www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and 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 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 presenting long-term medical data for patients treated in Voyager's Parkinson's disease clinical trials in September, 2020; resuming patient screening in Voyager's RESTORE-1 Phase 2 clinical trial prior to year-end and initiating the RESTORE-2 Phase 3 clinical trial during the first half of 2021; submitting an IND filing to the FDA for VY-HTT01 before year-end; presenting preclinical data from Voyager's VY-H TT01 preclinical studies, and obtaining clearance by the FDA of Voyager's IND filing for VY-HTT01 and initiating a Phase 1b clinical trial thereafter, continuing to progress its novel capsids discovery program, including the conclusion of non-human primate studies to identify novel AAV capsids; meeting selected development milestones for Voyager's programs for Parkinson's disease, Huntington's disease and technology platform research; maintaining a high level of business critical activity during the COVID-19 health crisis; the initiation, timing, progress, activities, goals and reporting of results of its preclinical programs and clinical trials and its research and development programs; the potential benefits, timing and future operation of the collaboration agreement with Neurocrine Biosciences, identifying and attracting parties to participate in research and development collaborations; advancing AAV-based gene therapies into, and successfully initiating, enrolling and completing, clinical trials; the potential clinical utility of its product candidates, continuing to develop its gene therapy platform; adding 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; and Voyager's anticipated financial results, including Voyager's available cash, cash equivalents and marketable debt securities; the receipt by Voyager of revenues or reimbursement payments from collaboration partners; Voyager's operating expenses, and Voyager's ability to fund its operating expenses with its current cash, cash equivalents and marketable debt securities through a stated time period are forward looking. 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 initiation and conduct of preclinical studies and clinical trials; the availability of data from preclinical studies and clinical trials; the sufficiency of preclinical and clinical data to support applications for additional studies and marketing approval of its drug development candidates;  the ability to effectively present such data by means of conference proceedings conducted virtually in response to the COVID-19 health crisis; the expectations for regulatory communications, submissions and approvals; the decisions of regulatory authorities, including the FDA's review of Voyager's IND application for VY-HTT01 and other drug development activities; the changing priorities of collaboration partners; the continued development of the gene therapy platform; Voyager's 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 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; the sufficiency of cash resources; the possibility or the timing of the exercise of development, commercialization, license and other options under collaborations; 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 Annual Report on Form 10K, Voyager's Quarterly Reports on Form 10-Q and other reports filed by Voyager with the Securities and Exchange Commission, as may be 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 Cox

    VP, Investor Relations

    857-201-3463

    Media:

    Sheryl Seapy

    W2Opure

    949-903-4750



    Selected Financial Information

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

    (Unaudited)

                  
      Three Months Ended  Six Months Ended  
      June 30,  June 30,  
    Statement of Operations Items: 2020 2019 2020 2019 
    Collaboration revenue $28,681  $46,087 $46,748  $51,284  
    Operating expenses:             
    Research and development  29,423   28,576  61,718   53,407  
    General and administrative  8,239   8,322  18,444   17,981  
    Total operating expenses  37,662   36,898  80,162   71,388  
    Operating (loss) income  (8,981)  9,189  (33,414)  (20,104) 
    Total other income  300   1,964  470   4,087  
    Net (loss) income $(8,681) $11,153 $(32,944) $(16,017) 
                  
    Net (loss) income per share, basic $(0.23) $0.30 $(0.89) $(0.46) 
    Net (loss) income per share, diluted $(0.23) $0.29 $(0.89) $(0.46) 
                  
    Weighted-average common shares outstanding, basic  37,029,524   36,610,918  36,996,390   34,990,989  
    Weighted-average common shares outstanding, diluted  37,029,524   37,941,257  36,996,390   34,990,989  



      June 30,  December 31,  
    Selected Balance Sheet Items 2020 2019 
    Cash, cash equivalents, and marketable debt securities $229,670 $281,533 
    Total assets $297,455 $354,760 
    Accounts payable and accrued expenses $20,199 $25,586 
    Deferred revenue $166,767 $194,493 
    Total stockholders' equity $76,884 $99,512 

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  2. CAMBRIDGE, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, will report its second quarter 2020 financial results and corporate updates on Monday, August 10, 2020, before the open of the U.S. financial markets.

    Additionally, the company will participate in the following virtual investor conferences in August:

    • BTIG Virtual Biotechnology Conference
      Monday, August 10 at 3:30 p.m. ET

    • Wedbush PacGrow Healthcare Virtual Conference
      Tuesday, August 11 at 1:10 p.m. ET

    • Canaccord Genuity 40th Annual Growth Conference
      Wednesday, August 12 at 3:30 p.m. ET

    The webcast sessions may be accessed from the Investors…

    CAMBRIDGE, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, will report its second quarter 2020 financial results and corporate updates on Monday, August 10, 2020, before the open of the U.S. financial markets.

    Additionally, the company will participate in the following virtual investor conferences in August:

    • BTIG Virtual Biotechnology Conference

      Monday, August 10 at 3:30 p.m. ET



    • Wedbush PacGrow Healthcare Virtual Conference

      Tuesday, August 11 at 1:10 p.m. ET



    • Canaccord Genuity 40th Annual Growth Conference

      Wednesday, August 12 at 3:30 p.m. ET

    The webcast sessions may be accessed from the Investors & Media section of Voyager's website at www.voyagertherapeutics.com. Replays of the webcasts will be archived on the Company's website for at least 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 wholly owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, Friedreich's ataxia, and other severe neurological diseases. For more information, please visit www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and LinkedIn.

    Investor Relations:   

    Paul Cox

    VP, Investor Relations

    857-201-3463

       

    Media:

    Sheryl Seapy

    W2Opure

    949-903-4750

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  3. CAMBRIDGE, Mass., Aug. 03, 2020 (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 the termination of its tau and alpha-synuclein vectorized antibody collaborations with AbbVie. Voyager retains full rights to the vectorization technology and certain novel vectorized antibodies developed as part of the collaborations.

    "Our efforts to harness AAV-based gene therapy to produce antibodies directly in the brain and overcome major limitations with delivery of current biologics across the blood-brain barrier have been highly productive," said Omar Khwaja, M.D., Ph.D., Chief Medical Officer and Head of…

    CAMBRIDGE, Mass., Aug. 03, 2020 (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 the termination of its tau and alpha-synuclein vectorized antibody collaborations with AbbVie. Voyager retains full rights to the vectorization technology and certain novel vectorized antibodies developed as part of the collaborations.

    "Our efforts to harness AAV-based gene therapy to produce antibodies directly in the brain and overcome major limitations with delivery of current biologics across the blood-brain barrier have been highly productive," said Omar Khwaja, M.D., Ph.D., Chief Medical Officer and Head of R&D at Voyager. "Through the tau and alpha-synuclein collaborations, we believe we have made considerable progress against targets for neurodegenerative diseases with this novel approach, reinforcing our enthusiasm for its potential to deliver therapeutically efficacious levels of biologics to the brain and central nervous system. We believe our continued work on discovery and design of novel AAV capsids with substantially improved blood-brain barrier penetrance will also considerably broaden the potential of AAV-based gene therapy, including vectorized antibodies or other biologics, for the treatment of severe neurological diseases."

    The tau and alpha-synuclein research collaborations were formed in 2018 and 2019, respectively. Under the terms of the collaboration agreements, Voyager received upfront payments to perform research and preclinical development of vectorized antibodies directed against tau and alpha-synuclein. With the conclusion of the collaborations, Voyager has regained full clinical development and commercialization rights to certain product candidates developed within the context of the collaboration for the tau program. Voyager is free to pursue vectorized antibody programs for tau and alpha-synuclein alone or in collaboration with another partner.

    Voyager does not anticipate any changes to its cash runway guidance due to the termination of the agreements. As of March 31, 2020, the Company had cash, cash equivalents and marketable debt securities of $250.9 million, which, along with amounts expected to be received for reimbursement of development costs from Neurocrine Biosciences, is expected to be sufficient to meet Voyager's projected operating expenses and capital expenditure requirements into mid-2022.

    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 wholly owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, Friedreich's ataxia, and other severe neurological diseases. For more information, please visit www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and 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 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 ability of Voyager to maintain research and development activities currently included within the collaboration agreements with AbbVie; Voyager's ability to advance its AAV-based gene therapies and its ability to continue to develop its gene therapy platform; the scope of the intellectual property rights and other rights that will be available to Voyager following the termination of the AbbVie collaboration agreements;  the anticipated effects of the termination of the AbbVie collaboration agreements on Voyager's anticipated financial results, including Voyager's available cash, cash equivalents and marketable debt securities; and Voyager's ability to fund its operating expenses with its current cash, cash equivalents and marketable debt securities through a stated time period are forward looking. 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 continued cooperation of AbbVie in activities arising from the termination of the AbbVie collaboration agreements, the development of the gene therapy platform; Voyager's scientific approach and general development progress; Voyager's ability to create and protect its intellectual property; and the sufficiency of Voyager's cash resources. 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 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 Cox

    VP, Investor Relations

    857-201-3463

    Media:

    Sheryl Seapy

    W2Opure

    949-903-4750

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  4. CAMBRIDGE, Mass, June 16, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, has entered into an employment agreement with a newly hired employee that, among other things, provides for the grant of a non-qualified stock option and of restricted stock units as inducements material to her entering into employment with Voyager. The inducement awards were approved by the Compensation Committee of Voyager's Board of Directors in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The option award became effective on June 15, 2020 and the restricted stock unit award is scheduled to become effective on July…

    CAMBRIDGE, Mass, June 16, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, has entered into an employment agreement with a newly hired employee that, among other things, provides for the grant of a non-qualified stock option and of restricted stock units as inducements material to her entering into employment with Voyager. The inducement awards were approved by the Compensation Committee of Voyager's Board of Directors in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The option award became effective on June 15, 2020 and the restricted stock unit award is scheduled to become effective on July 1, 2020.

    The employee received a non-qualified stock option to purchase an aggregate of 36,000 shares of Voyager's common stock and will receive a restricted stock unit award of 6,000 Voyager's common stock. The stock option has a ten-year term and an exercise price of $12.82 per share, which is equal to the closing price of Voyager's common stock on the effective date of grant. The stock option vests over four years, with 25% of the shares underlying the stock option vesting on the first anniversary of the effective date of grant and 75% of the shares underlying the stock option vesting in 36 equal monthly installments following the first anniversary of the effective date of grant. The restricted stock units will vest annually in equal installments over three years beginning on the first anniversary of the effective date of grant date. Vesting of the stock option and restricted stock units will be subject to the employee's continued employment with Voyager. The stock option is, and upon the effectiveness of the grant the restricted stock units will be, subject to the terms and conditions of equity award agreements.

    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 wholly-owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, a monogenic form of ALS called SOD1, Friedreich's ataxia, Alzheimer's disease, and other neurodegenerative diseases related to defective or excess aggregation of tau and alpha-synuclein proteins in the brain. Voyager has strategic collaborations with AbbVie and Neurocrine Biosciences. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager is headquartered in Cambridge, Massachusetts. For more information, please visit www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and LinkedIn.

    Investors:       

    Paul Cox

    VP, Investor Relations

    857-201-3463

    Media:

    Sheryl Seapy

    W2Opure

    949-903-4750

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  5. Announced 14 presentations at upcoming American Society of Gene and Cell Therapy (ASGCT) Virtual Annual Meeting highlighting Huntington's disease, ALS SOD1, vectorized antibodies, novel capsids, and manufacturing

    Formed new Scientific Advisory Board with industry-leading expertise

    Ended Q1 2020 with over $250M of cash and equivalents with expected runway into mid-2022

    CAMBRIDGE, Mass., May 06, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today reported its first quarter 2020 financial results, program progress and corporate updates.

    "Our goal is to develop life-changing therapies for people living with severe neurological disease, and despite the ongoing COVID-19 health crisis, we ended the first quarter of 2020 in a strong…

    Announced 14 presentations at upcoming American Society of Gene and Cell Therapy (ASGCT) Virtual Annual Meeting highlighting Huntington's disease, ALS SOD1, vectorized antibodies, novel capsids, and manufacturing

    Formed new Scientific Advisory Board with industry-leading expertise

    Ended Q1 2020 with over $250M of cash and equivalents with expected runway into mid-2022

    CAMBRIDGE, Mass., May 06, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today reported its first quarter 2020 financial results, program progress and corporate updates.

    "Our goal is to develop life-changing therapies for people living with severe neurological disease, and despite the ongoing COVID-19 health crisis, we ended the first quarter of 2020 in a strong position and expect to provide important progress updates across our programs over the course of 2020," said Andre Turenne, President and Chief Executive Officer of Voyager. "As we advance our pioneering work for both rare and common neurological diseases, we are privileged to have assembled a distinguished group of advisors, comprised of some of the world's leaders in genetic medicine and neuroscience. Moving forward, their scientific expertise will be invaluable in supporting our efforts for patients in need."

    Recent Corporate Highlights and Program Outlook

    VY-AADC (NBIb-1817) for Parkinson's Disease

    • The protocol of the RESTORE-1 clinical trial of VY-AADC (NBIb-1817) for Parkinson's disease is being amended to make the previously announced protocol modifications. Patient screening is expected to resume once trial sites are able to accept study participants in the context of COVID-19.
    • Voyager and Neurocrine Biosciences continue preparations for the initiation of the RESTORE-2 registrational study in Parkinson's disease planned for the second half of 2020.
    • Voyager and Neurocrine Biosciences expect to report final three-year data on all three cohorts (15 total patients) of the PD-1101 Phase 1b trial, as well as two-year data from the PD-1102 Phase 1 posterior trajectory trial (8 total patients), in the second half of 2020.
    • Results from an intravenous (IV) levodopa sub-study from the PD-1101 trial were recently published in Movement Disorders, in an article titled "Aromatic L-Amino Acid Decarboxylase Gene Therapy Enhances Levodopa Response in Parkinson's Disease." In the sub-study of 13 patients from the trial, VY-AADC (NBIb-1817) administration improved the magnitude, speed of onset, and duration of Unified Parkinson's Disease Rating Scale (UPDRS) motor responses to low and high dose of IV levodopa, across all cohorts.

    VY-HTT01 for Huntington's Disease

    • Voyager is currently engaged in the ongoing conduct and review of preclinical studies for its Huntington's disease program, VY-HTT01. Pending this review, Voyager is planning for the potential initiation of both a first-in-human Phase 1 study of VY-HTT01 and a prospective observational study of patients with late prodromal and early manifest Huntington's disease. Voyager anticipates providing an update on the program in mid-2020.
    • Voyager plans to present updated VY-HTT01 preclinical data at the upcoming ASGCT 23rd Annual Meeting taking place virtually on May 12-15, 2020.

    Early Pipeline and Platform

    • Voyager continues to advance its earlier-stage research efforts, including wholly-owned and partnered programs with AbbVie and Neurocrine Biosciences. These initiatives include Friedreich's ataxia, SOD1 ALS, vectorized antibodies, novel AAV capsids, and new discovery activities on novel targets.
    • Voyager plans to present multiple progress updates on these efforts as well as its manufacturing platform at the upcoming ASGCT Annual Meeting. 

    Formation of New Scientific Advisory Board

    • Voyager recently formed a new Scientific Advisory Board (SAB) of industry leading experts in neuroscience and genetic medicine, including: chairperson Guangping Gao, Ph.D., a co-founder of Voyager and Co-Director of the Li Weibo Institute for Rare Diseases Research, and Director of the Horae Gene Therapy Center and Viral Vector Core, University of Massachusetts Medical School (UMMS); Beverly Davidson, Ph.D., Professor of Pathology and Laboratory Medicine and Professor of Genetics, University of Pennsylvania Perelman School of Medicine, and Director of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics and Chief Scientific Strategy Officer at Children's Hospital of Philadelphia; David Liu, Ph.D., the Richard Merkin Professor and Vice-Chair of the Faculty at the Broad Institute of Harvard and MIT, and Professor of Chemistry and Chemical Biology at Harvard University; Dinah Sah, Ph.D., Voyager's former Chief Scientific Officer; and Phillip Zamore, Ph.D., a co-founder of Voyager, the Gretchen Stone Cook Professor of Biomedical Sciences and Chair of the RNA Therapeutics Institute, UMMS.

    Expansion of Technical Operations and Manufacturing Facilities

    • Voyager has entered into a lease agreement to expand its operations with a 32,000 square foot facility located in Lexington, MA. The Company expects the new state-of-the-art facility currently under construction to be ready for occupancy in late 2020. The facility includes both office and lab space and will house the Company's growing manufacturing capabilities to support the current and future pipeline programs.

    Anticipated Upcoming Milestones

    VY-AADC (NBIb-1817) for Parkinson's Disease:

    • Report 3-year results from PD-1101 trial (2H 2020)
    • Report 2-year results from PD-1102 trial (2H 2020)
    • Initiate RESTORE-2 registration trial (2H 2020)

    VY-HTT01 for Huntington's Disease:

    • Provide update on program and clinical plans (mid-2020)
    • Present additional results from preclinical studies (2H 2020)

    Early Pipeline and Platform:

    • Provide progress updates on Friedreich's ataxia program, new discovery programs, as well as vectorized antibody and novel capsid efforts (2020)

    First Quarter 2020 Financial Results

    • Collaboration Revenues: Voyager had collaboration revenue of $18.1 million for the first quarter of 2020, compared to collaboration revenue of $5.2 million for the same period of 2019. The increase in collaboration revenue was largely due to efforts related to the Neurocrine Biosciences and AbbVie alpha-synuclein collaborations, which were entered into in the first quarter of 2019.
    • Net Loss: Net loss was $24.3 million for the first quarter of 2020, compared to a net loss of $27.2 million for the same period of 2019.
    • R&D Expenses: Research and development expenses were $32.3 million for the first quarter of 2020, compared to $24.8 million for the same period in 2019. The increase in R&D expenses was primarily related to employee-related, external and facility costs to support Voyager's clinical and preclinical pipeline programs, including the VY-AADC (NBIb-1817) and VY-HTT01 programs.
    • G&A Expenses: General and administrative expenses were $10.2 million for the first quarter of 2020, compared to $9.7 million for the same period in 2019. The increase in G&A expenses was primarily related to employee costs to support the advancement of Voyager's pipeline programs and operations, partially offset by a reduction in legal and other administrative costs. 
    • Cash Position: Cash, cash equivalents and marketable debt securities as of March 31, 2020 were $250.9 million.

    Financial Guidance

    • Based on the Company's current operating plan, Voyager anticipates cash, cash equivalents and marketable debt securities will be between $150 million and $170 million at the end of 2020.
    • Voyager expects that its cash, cash equivalents and marketable debt securities, as well as amounts expected to be received for reimbursement of development costs from Neurocrine Biosciences, will be sufficient to meet Voyager's projected operating expenses and capital expenditure requirements into mid-2022.

    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 wholly-owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, a monogenic form of ALS called SOD1, Friedreich's ataxia, Alzheimer's disease, and other neurodegenerative diseases related to defective or excess aggregation of tau and alpha-synuclein proteins in the brain. Voyager has strategic collaborations with AbbVie and Neurocrine Biosciences. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager is headquartered in Cambridge, Massachusetts. For more information, please visit www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and 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 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 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, the continued operation and effect of the Scientific Advisory Board on Voyager's research and development activities, the completion of construction projects to expand Voyager's facilities and to establish operations in the new facilities, the ability to maintain a Scientific Advisory Board, and to retain as members of the Scientific Advisory Board individuals of recognized scientific prominence, the initiation, timing, progress, activities, goals and reporting of results of its preclinical programs and clinical trials and its research and development programs, the potential benefits, timing and future operation of the collaboration agreements with AbbVie and Neurocrine Biosciences, its ability to identify and attract parties to participate in research and development collaborations, 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 perform under existing collaborations including those with AbbVie and Neurocrine Biosciences, its 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, its ability to operate its research and development activities efficiently and effectively, the utility and value of Voyager's patent portfolio, and Voyager's anticipated financial results, including Voyager's available cash, cash equivalents and marketable debt securities, the receipt by Voyager of revenues or reimbursement payments from collaboration partners, Voyager's operating expenses, and Voyager's ability to fund its operating expenses with its current cash, cash equivalents and marketable debt securities through a stated time period are forward looking. 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 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; the inability of Voyager to create research and development programs combining sufficient levels of scientific interest and applied expertise to be attractive in recruiting and maintaining renown scientists to serve as members of a Scientific Advisory Board; 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 by means of conference proceedings conducted virtually in response to the COVID-19 health crisis; the expectations for regulatory communications, submissions and approvals; the continued development of the gene therapy platform; Voyager's 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; 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 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 Cox
    VP, Investor Relations
    857-201-3463

    Media:
    Sheryl Seapy
    W2Opure
    949-903-4750
    s


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

                   
        Three Months Ended  
        March 31,   
    Statement of Operations Items:   2020     2019    
    Collaboration revenue   $  18,067     $  5,197    
    Operating expenses:              
    Research and development      32,294        24,831    
    General and administrative      10,206        9,659    
    Total operating expenses      42,500        34,490    
    Operating loss      (24,433 )      (29,293 )  
    Total other income      170        2,123    
    Net loss   $  (24,263 )   $  (27,170 )  
    Net loss per share, basic and diluted   $  (0.66 )   $  (0.81 )  
    Weighted-average common shares outstanding, basic and diluted      36,963,255        33,353,061    


                   
        March 31,    December 31,   
    Selected Balance Sheet Items   2020   2019  
    Cash, cash equivalents, and marketable debt securities   $  250,931   $  281,533  
    Total assets   $  322,610   $  354,760  
    Accounts payable and accrued expenses   $  22,308   $  25,586  
    Deferred revenue   $  186,150   $  194,493  
    Total stockholders' equity   $  79,757   $  99,512  

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