Assembly Biosciences Q1 2024 Financial Results and Highlights

Assembly Biosciences, Inc., a biotechnology company specializing in therapeutics for severe viral diseases, has reported its financial outcomes and notable developments for the first quarter ending March 31, 2024. The company announced the successful clearance of clinical trial applications for two of its leading investigational therapies, ABI-5366 and ABI-4334. Phase 1a/1b trials for ABI-5366, targeting recurrent genital herpes, and Phase 1b trials for ABI-4334, aimed at chronic hepatitis B virus (HBV) infection, are on track to commence by mid-2024. Interim first-in-human data for ABI-5366 from the Phase 1a trial is anticipated in the third quarter of 2024, while interim data for ABI-4334 from the Phase 1b trial is expected by the end of the year.

Jason Okazaki, CEO and President of Assembly Bio, expressed satisfaction with the regulatory clearances, emphasizing their significance in reaching critical clinical milestones in the company's antiviral pipeline. He highlighted the expertise and dedication of the Assembly Bio team in advancing treatment options for patients suffering from serious viral infections.

Key achievements in the first quarter of 2024 include:
1. Regulatory green light for two clinical trial applications:
- ABI-5366: Initiation of Phase 1a/1b clinical studies in both healthy volunteers and individuals with recurrent genital herpes.
- ABI-4334: Initiation of a Phase 1b study in individuals with chronic HBV infection.
2. An abstract for ABI-6250, an oral HBV/hepatitis delta virus (HDV) entry inhibitor candidate, has been accepted for a poster presentation at the European Association for the Study of the Liver (EASL) Congress in June 2024.

The milestones anticipated for 2024 include the commencement of studies for ABI-5366 and ABI-4334 by mid-year. Specifically, Phase 1a interim clinical data for ABI-5366 is expected in Q3 2024, with Phase 1b interim data to follow in the first half of 2025. For ABI-4334, Phase 1b interim clinical data is anticipated by the year’s end. Additionally, two more candidates are expected to enter clinical trials by year-end: ABI-1179, a long-acting HSV helicase-primase inhibitor from Gilead Sciences, and ABI-6250, a small molecule HDV entry inhibitor.

Financial results for the first quarter of 2024 are as follows:
- Cash, cash equivalents, and marketable securities were reported at $113.0 million as of March 31, 2024, down from $130.2 million on December 31, 2023. This cash position is projected to sustain operations into the second half of 2025.
- Collaborative research revenues amounted to $5.8 million for the quarter ending March 31, 2024. There were no revenues recognized for the same period in 2023. The reported revenue was primarily from the collaboration with Gilead Sciences.
- Research and development expenses were $11.9 million for the quarter, compared to $14.5 million for the same period in 2023. Despite increased expenses for the development of ABI-1179 and ABI-6250, overall costs decreased due to the discontinuation of other programs and reduced employee and contractor-related expenses.
- General and administrative expenses were $4.6 million, down from $5.0 million in the same period last year, mainly due to a reduction in non-cash stock-based compensation expense.
- The net loss attributable to common stockholders was $9.1 million, or $1.66 per share, compared to $19.0 million, or $4.46 per share, for the same quarter in 2023.

Assembly Biosciences remains dedicated to the development of innovative small-molecule therapeutics to alter the course of serious viral diseases and improve patient outcomes globally. Backed by a seasoned team of leaders in virologic drug development, the company continues to prioritize the advancement of treatment options for herpesvirus, HBV, and HDV infections.