Assembly Biosciences Announces Q3 2024 Financials and Updates

Assembly Biosciences, Inc., a biotechnology firm committed to developing novel treatments for severe viral diseases, announced its financial results for the third quarter ending September 30, 2024, along with key recent updates. CEO and President Jason Okazaki expressed satisfaction with the company's progress in advancing four therapeutic candidates targeting significant viral diseases and anticipated the release of two interim data sets by year-end.

The company revealed positive interim Phase 1a data for ABI-5366, a long-acting HSV helicase-primase inhibitor candidate aimed at recurrent genital herpes, which has led to the commencement of dosing in the Phase 1b part of the trial. The Phase 1a data indicated that ABI-5366 was well-tolerated, showcasing a positive safety profile with exposure durations up to 70 days and a half-life of around 20 days when administered orally. The ongoing Phase 1b study is set to explore both once-weekly and once-monthly oral dosing, with interim results anticipated in the first half of 2025.

Additionally, regulatory clearance has been obtained for a Phase 1a/b study for ABI-1179, also a product of collaboration with Gilead Sciences, Inc. This candidate is another long-acting HSV helicase-primase inhibitor. Anuj Gaggar, MD, PhD, and William Delaney, PhD, presented at the H.C. Wainwright 5th Annual Viral Hepatitis Virtual Conference, outlining the company's advancements. Moreover, preclinical data for ABI-6250, a small molecule entry inhibitor targeting HBV/HDV, were highlighted at the International HBV Meeting.

Looking ahead, the company anticipates several key milestones. Interim clinical data for ABI-5366's Phase 1b trial involving participants with recurrent genital herpes are expected in the first half of 2025. For ABI-4334, a highly potent capsid assembly modulator candidate for chronic HBV, interim data from its Phase 1b trial is expected by the end of 2024. Both ABI-1179 and ABI-6250 are on schedule to enter clinical trials by the end of the year.

Financially, Assembly Biosciences reported $95.0 million in cash, cash equivalents, and marketable securities as of September 30, 2024, down from $109.2 million at the end of the previous quarter. This financial position is projected to support operations into the first quarter of 2026. The company recorded $6.8 million in revenue from collaborative research for the third quarter, compared to no revenue in the same period of 2023. This revenue was attributed to the collaboration with Gilead.

Research and development expenses rose to $13.5 million, up from $10.8 million in the same quarter of 2023, reflecting the increased number of candidates in development. General and administrative expenses remained steady at $4.3 million. The net loss attributable to common stockholders for the quarter was $9.6 million, or $1.51 per share, an improvement from the $14.4 million loss, or $3.29 per share, in the same period of 2023.

Assembly Biosciences continues to focus on developing innovative small-molecule therapeutics to address serious viral diseases, including herpesvirus, hepatitis B virus (HBV), and hepatitis delta virus (HDV). The company's leadership team is dedicated to improving patient outcomes through advanced virologic drug development.