Voyager Reports Third Quarter 2024 Financial and Operating Results
Voyager Therapeutics (VYGR) reported Q3 2024 financial results with collaboration revenue of $24.6 million, up from $4.6 million in Q3 2023. Net loss decreased to $9.0 million from $25.9 million year-over-year. The company completed enrollment in its VY7523 anti-tau antibody trial for Alzheimer's, with top-line data expected H1 2025. Voyager secured a new $15 million upfront payment from Novartis for a TRACER capsid license and received a $3 million milestone payment from Neurocrine. Cash position stands at $345.4 million, providing runway into 2027.
Voyager Therapeutics (VYGR) ha riportato i risultati finanziari del terzo trimestre del 2024, con ricavi da collaborazioni di 24,6 milioni di dollari, in aumento rispetto ai 4,6 milioni di dollari del terzo trimestre del 2023. La perdita netta è diminuita a 9,0 milioni di dollari dai 25,9 milioni di dollari dell'anno precedente. L'azienda ha completato l'arruolamento nello studio clinico del suo anticorpo anti-tau VY7523 per l'Alzheimer, con i dati preliminari attesi nella prima metà del 2025. Voyager ha ottenuto un nuovo pagamento anticipato di 15 milioni di dollari da Novartis per una licenza del capsidi TRACER e ha ricevuto un pagamento per traguardi di 3 milioni di dollari da Neurocrine. La posizione di cassa ammonta a 345,4 milioni di dollari, garantendo liquidità fino al 2027.
Voyager Therapeutics (VYGR) reportó los resultados financieros del tercer trimestre de 2024, con ingresos por colaboración de 24,6 millones de dólares, en comparación con los 4,6 millones de dólares en el tercer trimestre de 2023. La pérdida neta se redujo a 9,0 millones de dólares desde los 25,9 millones de dólares en el año anterior. La empresa completó la inscripción en su ensayo de anticuerpos anti-tau VY7523 para el Alzheimer, con datos preliminares esperados para la primera mitad de 2025. Voyager aseguró un nuevo pago por adelantado de 15 millones de dólares de Novartis por una licencia de cápsula TRACER y recibió un pago por hitos de 3 millones de dólares de Neurocrine. La posición de efectivo se sitúa en 345,4 millones de dólares, asegurando recursos hasta 2027.
보이저 테라퓨틱스 (VYGR)는 2024년 3분기 재무 결과를 보고했으며, 협력 수익은 2,460만 달러로, 2023년 3분기 460만 달러에서 증가했습니다. 순손실은 전년 대비 9.0백만 달러로 감소하였고, 이전에는 2,590만 달러였습니다. 회사는 알츠하이머에 대한 VY7523 항 타우 항체 임상시험의 등록을 완료하였으며, 주요 데이터는 2025년 상반기에 예상됩니다. 보이저는 노바티스에서 TRACER 캡시드 라이센스에 대해 1,500만 달러의 선불금을 확보했으며, 신경크라인으로부터 300만 달러의 마일스톤 지급을 받았습니다. 현금 보유액은 3억 4,540만 달러로 2027년까지의 자금을 지원합니다.
Voyager Therapeutics (VYGR) a annoncé les résultats financiers du troisième trimestre 2024, avec des revenus de collaboration de 24,6 millions de dollars, en hausse par rapport à 4,6 millions de dollars au troisième trimestre 2023. La perte nette a diminué à 9,0 millions de dollars par rapport à 25,9 millions de dollars l'année précédente. L'entreprise a terminé l'inscription à son essai d'anticorps anti-tau VY7523 pour la maladie d'Alzheimer, avec des données préliminaires attendues au premier semestre 2025. Voyager a obtenu un nouveau paiement initial de 15 millions de dollars de Novartis pour une licence de capsides TRACER et a reçu un paiement d'étape de 3 millions de dollars de Neurocrine. La position de trésorerie s'élève à 345,4 millions de dollars, offrant une marge de manœuvre jusqu'en 2027.
Voyager Therapeutics (VYGR) hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, mit Kooperationsumsätzen von 24,6 Millionen Dollar, ein Anstieg von 4,6 Millionen Dollar im dritten Quartal 2023. Der Nettoverlust verringerte sich auf 9,0 Millionen Dollar, nachdem er im Vorjahr bei 25,9 Millionen Dollar lag. Das Unternehmen hat die Einschreibung in seine VY7523-Antikörperstudie gegen Tau für Alzheimer abgeschlossen, mit den erwarteten Hauptdaten in der ersten Hälfte von 2025. Voyager sicherte sich eine neue Vorauszahlung von 15 Millionen Dollar von Novartis für eine TRACER-Kapsel-Lizenz und erhielt eine Meilensteinzahlung von 3 Millionen Dollar von Neurocrine. Die Zahlungsmittelposition beträgt 345,4 Millionen Dollar, was einen finanziellen Spielraum bis 2027 gewährleistet.
- Collaboration revenue increased significantly to $24.6M from $4.6M YoY
- Net loss reduced substantially to $9.0M from $25.9M YoY
- Strong cash position of $345.4M providing runway into 2027
- New Novartis deal with $15M upfront payment and up to $305M in milestone payments
- Additional $3M milestone payment received from Neurocrine partnership
- R&D expenses increased to $30.2M from $25.9M YoY
- Initial tau PET imaging data for VY7523 not expected until H2 2026
Insights
The Q3 results reveal significant financial progress with
The Novartis deal, worth up to
The completion of enrollment in VY7523's single ascending dose trial marks a important milestone in Voyager's Alzheimer's program. The preclinical data showing significant tau reduction with their C-terminal directed antibody approach, particularly compared to failed N-terminal directed competitors, suggests a potentially differentiated therapeutic strategy.
The ambitious 2025-2026 pipeline progression, including three IND filings for CNS gene therapies (SOD1 ALS, GBA1 Parkinson's and Friedreich's ataxia) and advancement of both antibody and gene therapy approaches for tau, positions Voyager well in the neurogenetic medicine space. The dual-modality strategy targeting tau through both antibody and gene therapy approaches provides multiple shots on goal for Alzheimer's treatment.
- Enrollment and dosing complete in single ascending dose clinical trial of anti-tau antibody VY7523 for Alzheimer’s; on track to generate top-line data H1 2025 -
- Recent third-party clinical data establish that an antibody can inhibit tau accumulation in the human brain; provide support for use of an antibody to target tau in Alzheimer’s -
- Continued partnership progress in Q3 2024 evidenced by new capsid license and new gene therapy development candidate selection -
- INDs on track for three CNS gene therapies in 2025 in SOD1 ALS, GBA1 Parkinson’s and other GBA1-mediated disease, and Friedreich’s ataxia programs -
LEXINGTON, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today reported third quarter 2024 financial and operating results.
“An increasing body of clinical evidence implicates tau as a critical target in Alzheimer’s disease,” said Alfred W. Sandrock, Jr., M.D., Ph.D., Chief Executive Officer of Voyager. “Recent third-party clinical data give us increasing confidence that an antibody targeting the appropriate epitope of tau can slow the accumulation of tau in the brain of Alzheimer’s patients, and that this slowing may offer a clinically significant benefit in some patients. These encouraging data build on previous positive third-party clinical data with a tau silencing program and, we believe, support Voyager’s prioritization of both an anti-tau antibody and a tau silencing gene therapy. Our clinical-stage anti-tau antibody VY7523 is expected to generate initial tau PET imaging data in patients in H2 2026, and our tau silencing gene therapy is advancing toward IND in 2026. Our strong cash position of
Third Quarter 2024 and Recent Highlights
- Licensed TRACER™ capsid to Novartis in 5th partnered program: Voyager agreed to license to Novartis AG a novel TRACER capsid for use in a gene therapy program against an undisclosed rare neurologic disease target. This is the fifth partnered program between the two companies. Voyager received an upfront payment of
$15 million in October and is eligible for up to$305 million in milestone payments, as well as royalties. - Achieved 3rd development candidate in partnership with Neurocrine: The joint steering committee with collaborator Neurocrine Biosciences, Inc. selected a development candidate in a gene therapy program for the potential treatment of an undisclosed neurological disease, triggering a
$3 million milestone payment to Voyager, which was received in October. This follows recent development candidate selections in programs for GBA1-mediated disorders and Friedreich’s ataxia. - VY7523 anti-tau antibody for Alzheimer’s disease: Enrollment and dosing completed in the single ascending dose (SAD) clinical trial, with top-line safety and pharmacokinetic data expected in H1 2025.
- Presented head-to-head preclinical data for murine surrogate of VY7523 vs. murine surrogates of other anti-tau antibodies: Murine surrogate of VY7523 (C-terminal directed) demonstrated significant reduction in spread of human pathological tau in p301S mouse seeding model, as did murine surrogate of bepranemab (mid-domain directed). No significant reduction was seen for murine surrogates of two N-terminal directed antibodies that previously failed their primary endpoints in clinical trials. These data are expected to be presented at a future conference.
Anticipated Upcoming Milestones
- H1 2025: Initial safety and pharmacokinetic data expected from VY7523 SAD clinical trial
- Mid-2025: U.S. IND and Canadian clinical trial application (CTA) filings expected with SOD1 silencing gene therapy VY9323 in ALS patients, subsequent clinical trial has potential to generate proof-of-concept based on biomarkers
- 2025: Initiation of Multiple Ascending Dose (MAD) clinical trial in AD patients expected with VY7523
- 2025: IND filings anticipated with NBIX-partnered GBA-1 and Friedreich’s ataxia gene therapies
- 2026: U.S. IND and Canadian CTA filings anticipated with tau silencing gene therapy for Alzheimer’s disease
- H2 2026: Initial tau PET imaging data expected in MAD clinical trial of VY7523 in Alzheimer’s disease
Third Quarter 2024 Financial Results
- Collaboration Revenues: Voyager had collaboration revenue of
$24.6 million for the third quarter of 2024, compared to$4.6 million for the same period in 2023. The increase was primarily due to increased revenue recognized under our Novartis and Neurocrine agreements. - Net Loss: Net loss was
$9.0 million for the third quarter of 2024, compared to net loss of$25.9 million for the same period in 2023. The decrease is primarily due to increased collaboration revenue recognized during the third quarter of 2024, as discussed above. - R&D Expenses: Research and development expenses were
$30.2 million for the third quarter of 2024, compared to$25.9 million for the same period in 2023. The increase in R&D expenses was primarily a result of increased targeted development team hires to support our advancing pipeline, along with increased facilities costs related to our lease for additional laboratory and office space. - G&A Expenses: General and administrative expenses were
$8.2 million for the third quarter of 2024, compared to$8.3 million for the same period in 2023. The consistent spend reflects continued disciplined expense management. - Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2024, were
$345.4 million . This does not include the$15.0 million upfront payment from Novartis or the$3.0 million milestone payment from Neurocrine, both of which were received in October 2024.
Financial Guidance
Voyager is committed to maintaining a strong balance sheet that supports the advancement and growth of its platform and pipeline. Voyager continues to assess its planned cash needs both during the current period and in future periods. We expect our cash, cash equivalents, and marketable securities, along with amounts expected to be received as reimbursement for development costs under the Neurocrine and Novartis collaborations and interest income, to be sufficient to meet Voyager’s planned operating expenses and capital expenditure requirements into 2027.
Conference Call
Voyager will host a conference call and webcast today at 4:30 p.m. ET to discuss third quarter 2024 financial and operating results. A live webcast of the call will be available on the Investors section of the Voyager website at https://ir.voyagertherapeutics.com/, and a replay of the call will be available at the same link approximately two hours after its completion. The replay will be available for at least 30 days following the conclusion of the call.
About Voyager Therapeutics
Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.voyagertherapeutics.com.
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 “expect,” “believe,” “anticipate,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements.
For example, all statements Voyager makes regarding Voyager’s ability to advance its AAV-based gene therapy programs and tau antibody program, including expectations for Voyager’s achievement of preclinical and clinical development milestones for its potential development candidates such as the identification of lead development candidates, IND filings, the initiation of clinical trials, clinical trial enrollment, and the generation of clinical data and proof-of-concept; the potential for an antibody targeting tau to slow the accumulation of tau in the brain of Alzheimer’s patients and for this slowing to offer a clinically significant benefit in some patients; the potential for third-party clinical data to inform Voyager’s clinical development plans; Voyager’s ability to advance gene therapy product candidates under the Neurocrine collaboration; Voyager’s anticipated financial results, including the anticipated receipt by Voyager of revenues or reimbursement payments from collaboration partners; and Voyager’s cash runway and ability to generate sufficient cash resources to enable it to continue its business and operations 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 and 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 expectations and decisions of regulatory authorities; the timing, initiation, conduct and outcomes of Voyager’s preclinical and clinical studies; the availability of data from clinical trials; the availability or commercial potential of product candidates under collaborations; the success of Voyager’s product candidates; the willingness and ability of Voyager's collaboration partners to meet obligations under collaboration agreements with Voyager; the continued development of Voyager’s technology platforms, including Voyager’s TRACER platform and its antibody screening technology; Voyager’s scientific approach and program development progress, and the restricted supply of critical research components; the development by third parties of capsid identification platforms that may be competitive to Voyager’s TRACER capsid discovery platform; Voyager’s ability to create and protect intellectual property rights associated with the TRACER capsid discovery platform, the capsids identified by the platform, and development candidates for Voyager’s pipeline programs; the possibility or the timing of Voyager’s receipt of program reimbursement, development or commercialization milestones, option exercise, and other payments under Voyager’s existing licensing or collaboration agreements; the ability of Voyager to negotiate and complete licensing or collaboration agreements with other parties on terms acceptable to Voyager and the third parties; the success of programs controlled by third-party collaboration partners in which Voyager retains a financial interest; the ability to attract and retain talented directors, employees, and contractors; and the sufficiency of Voyager’s cash resources to fund its operations and pursue its corporate objectives.
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. 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.
Contacts
Trista Morrison, NACD.DC, tmorrison@vygr.com
Investors: Michael Hencke, mhencke@kendallir.com
Media: Brooke Shenkin, brooke@scientpr.com
| Selected Financial Information | ||||||||||||||||
| ($ amounts in thousands, except per share data) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| Statement of Operations Items: | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Collaboration revenue | $ | 24,629 | $ | 4,614 | $ | 73,723 | $ | 159,947 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 30,241 | 25,863 | 91,785 | 66,416 | ||||||||||||
| General and administrative | 8,168 | 8,258 | 26,926 | 25,580 | ||||||||||||
| Total operating expenses | 38,409 | 34,121 | 118,711 | 91,996 | ||||||||||||
| Operating (loss) income | (13,780 | ) | (29,507 | ) | (44,988 | ) | 67,951 | |||||||||
| Total other income | 4,779 | 3,429 | 14,554 | 8,570 | ||||||||||||
| (Loss) income before income taxes | (9,001 | ) | (26,078 | ) | (30,434 | ) | 76,521 | |||||||||
| Income tax provision (benefit) | 43 | (177 | ) | 81 | 586 | |||||||||||
| Net (loss) income | $ | (9,044 | ) | $ | (25,901 | ) | $ | (30,515 | ) | $ | 75,935 | |||||
| Net (loss) income per share, basic | $ | (0.16 | ) | $ | (0.59 | ) | $ | (0.53 | ) | $ | 1.85 | |||||
| Net (loss) income per share, diluted | $ | (0.16 | ) | $ | (0.59 | ) | $ | (0.53 | ) | $ | 1.78 | |||||
| Weighted-average common shares outstanding, basic | 57,851,110 | 43,864,838 | 57,564,413 | 40,962,116 | ||||||||||||
| Weighted-average common shares outstanding, diluted | 57,851,110 | 43,864,838 | 57,564,413 | 42,610,724 | ||||||||||||
| September 30, | December 31, | ||||||
| Selected Balance Sheet Items | 2024 | 2023 | |||||
| Cash, cash equivalents, and marketable securities | $ | 345,360 | $ | 230,875 | |||
| Total assets | $ | 426,041 | $ | 351,281 | |||
| Accounts payable and accrued expenses | $ | 14,602 | $ | 18,427 | |||
| Deferred revenue | $ | 34,782 | $ | 75,240 | |||
| Total stockholders’ equity | $ | 330,310 | $ | 236,320 | |||
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