Voyager Therapeutics Q1 2024 Financial and Operating Results

Voyager Therapeutics, Inc., a biotechnology firm focused on neurogenetic medicines, has announced its financial and operational results for the first quarter of 2024. The company, traded under the Nasdaq symbol VYGR, made significant strides in various therapeutic programs and maintained a robust financial position.

Voyager has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for VY-TAU01, an anti-tau antibody aimed at treating Alzheimer's disease. The company plans to soon initiate a single ascending dose trial in healthy volunteers. This development marks a crucial step forward in their efforts to combat Alzheimer's.

In terms of its gene therapy pipeline, Voyager has selected development candidates for its GBA1 and Friedreich’s Ataxia programs in partnership with Neurocrine Biosciences. Additionally, the company is advancing its wholly-owned SOD1-ALS program, with IND filings expected for all three gene therapy programs in 2025.

Voyager has appointed Dr. Toby Ferguson as its Chief Medical Officer. Dr. Ferguson brings significant experience in the field of neurology clinical development, enhancing Voyager's leadership team.

The company reported a strong cash position, with approximately $400 million as of March 31, 2024. This financial stability is expected to support their operations and multiple clinical data readouts through 2027.

Key highlights from the first quarter of 2024 include the successful clearance of the IND application for VY-TAU01, the selection of development candidates for the GBA1 and FXN gene therapy programs, and strategic collaborations. Voyager entered into a strategic collaboration and capsid license agreement with Novartis Pharma AG to develop potential gene therapies for Huntington’s disease and spinal muscular atrophy. This agreement included an $80 million upfront payment and an additional $20 million for newly issued Voyager equity, with potential for up to $1.2 billion in milestone payments and tiered royalties.

Voyager also completed a public offering, raising approximately $100 million in gross proceeds. This funding will further support their developmental and operational goals.

The company presented significant data at key conferences. At the 2024 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2024), Voyager showcased robust reductions in human tau mRNA and protein levels across the brain following a single IV administration of a tau silencing gene therapy candidate in mice. Additionally, VY-TAU01 showed positive tolerance levels in non-human primates. At the American Society of Gene & Cell Therapy’s (ASGCT) 27th annual meeting, Voyager presented new data demonstrating enhanced brain tropism of second-generation TRACER-derived AAV capsids, showing promising translatability and activity against therapeutic targets in Alzheimer’s and ALS.

Looking ahead, Voyager anticipates dosing the first subject in a Phase 1a trial for VY-TAU01 shortly, with plans for a Phase 1b multiple ascending dose trial in early Alzheimer's patients in 2025. The VY9323SOD1 gene therapy program for ALS is expected to file an IND in mid-2025, followed by a Phase 1 clinical trial.

Financially, Voyager reported collaboration revenue of $19.5 million for Q1 2024, a significant drop from $150.5 million in Q1 2023, primarily due to the large recognition of revenue from prior agreements with Neurocrine and Novartis in the previous year. The net loss for Q1 2024 was $11.3 million, compared to a net income of $124.0 million in Q1 2023, reflecting the decrease in collaboration revenue. Research and development expenses were $27.1 million, up from $18.6 million in the same period last year, driven by increased spending on various programs.

Voyager remains committed to advancing its gene therapy programs and maintaining a solid financial foundation to support its long-term goals. With a strategic focus on key therapeutic areas and robust partnerships, Voyager is well-positioned to continue its progress in developing innovative treatments for neurological diseases.