Assembly Bioscie Stock Price, News & Analysis

Assembly Biosciences (Nasdaq: ASMB) reported positive interim results from the Phase 1a portion of its ongoing Phase 1a/b study evaluating ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate for recurrent genital herpes. Key findings include:

1. ABI-5366 was well-tolerated with a favorable safety profile up to 70 days of exposure.
2. Single doses surpassed target plasma concentrations for antiviral efficacy.
3. Half-life of approximately 20 days supports once-weekly or once-monthly oral dosing.
4. Both weekly and monthly dosing cohorts will be included in Phase 1b.
5. Screening for Phase 1b in participants with recurrent genital herpes has begun.
6. Interim Phase 1b results expected in the first half of 2025.

Assembly Biosciences (ASMB) reported Q2 2024 financial results and updates. Key highlights include:

- Dosing initiated in Phase 1a/b trial for ABI-5366 (genital herpes treatment) and Phase 1b trial for ABI-4334 (chronic HBV treatment)

- Two additional pipeline candidates expected to enter clinic by year-end

- Q2 revenue: $8.5 million; R&D expenses: $16.3 million; Net loss: $11.2 million ($1.98 per share)

- Cash position: $109.2 million as of June 30, 2024, projected to fund operations into Q1 2026

- Upcoming milestones: ABI-5366 Phase 1a interim data in Q3 2024, ABI-4334 Phase 1b interim data by year-end

Assembly Biosciences (Nasdaq: ASMB) presented new preclinical data on its investigational helicase-primase inhibitors for recurrent genital herpes at the International Herpesvirus Workshop. The company highlighted promising results for two candidates: ABI-5366 and ABI-1179.

Key findings for ABI-5366 include low nanomolar activity against HSV-1 and HSV-2, specificity for HSV, and a favorable safety profile. The Phase 1a/b study for ABI-5366 began in May 2024, with interim Phase 1a data expected in Q3 2024.

ABI-1179, licensed from Gilead Sciences, demonstrated potent activity against HSV strains, including acyclovir-resistant isolates, and showed potential for once-weekly oral dosing. Assembly Bio plans to initiate a Phase 1a/b study for ABI-1179 by the end of 2024.

Assembly Biosciences (Nasdaq: ASMB) has dosed the first participant in its Phase 1b clinical trial for ABI-4334, a next-generation capsid assembly modulator (CAM) targeting chronic hepatitis B virus (HBV) infection. The trial aims to evaluate the safety, pharmacokinetics, and efficacy of ABI-4334 over a 28-day period. Interim data is expected by the end of 2024. ABI-4334 has shown promising preclinical results with strong antiviral activity and is optimized to inhibit HBV DNA replication and prevent cccDNA formation. Chronic HBV is a leading cause of chronic liver disease and liver transplants, making this study important for potential therapeutic advancements.

Assembly Biosciences announced the closure of $12.6 million in equity financings from Armistice Capital and Gilead Sciences. The funds will support Assembly's antiviral portfolio, with clinical data readouts expected for ABI-5366 and ABI-4334 in the coming years.

The equity financings involve the sale of common stock and warrants at $15.46 per share with warrants exercisable at $17.00. These transactions extend Assembly's cash runway into Q1 2026 and maintain Gilead's 19.9 percent ownership, with an option to increase up to 29.9 percent.

Assembly intends to use the proceeds for general corporate purposes and further advance its clinical candidates, with significant near-term milestones anticipated.

Assembly Biosciences has initiated a Phase 1a/b clinical trial for ABI-5366, a new helicase-primase inhibitor targeting herpes simplex virus (HSV). The Phase 1a trial involves single ascending doses in healthy participants, with interim data expected by Q3 2024. Phase 1b will start by the end of the year with multiple ascending weekly doses in patients with recurrent genital herpes, with interim data expected in the first half of 2025. ABI-5366 has shown strong potential in preclinical studies, potentially offering a long-acting treatment for HSV-1 and HSV-2. Existing treatments are and not fully effective, highlighting the need for new therapeutic options in this area.

Assembly Biosciences showcased new preclinical data for ABI-6250, an orally bioavailable hepatitis D virus (HDV) entry inhibitor, at the EASL Congress 2024. The data underline ABI-6250's potential to block HDV from entering cells, targeting the NTCP bile acid transporter with high selectivity. The preclinical results showed effective inhibition of HDV infection and NTCP-mediated bile acid uptake, supporting once-daily oral dosing. Clinical trials are expected to begin by the end of 2024. Chronic HDV is a severe viral hepatitis form, leading to liver complications and potential death. ABI-6250 promises to be a significant therapeutic innovation in viral hepatitis treatment.

Assembly Biosciences (Nasdaq: ASMB) will present preclinical data from its HSV and HDV therapeutics at the International Herpesvirus Workshop (July 13-17, 2024) and EASL Congress 2024 (June 5-8, 2024). Data for ABI-5366 and ABI-1179, targeting recurrent genital herpes, will be featured in one oral and two poster presentations. ABI-6250, aimed at treating chronic hepatitis D, will be presented as a poster. The company anticipates starting clinical trials for ABI-5366 mid-year and for ABI-1179 and ABI-6250 by the end of 2024.

Assembly Biosciences, Inc. (Nasdaq: ASMB) reported financial results for Q1 2024, including regulatory clearances for Phase 1 trials for ABI-5366 targeting recurrent genital herpes and ABI-4334 in chronic HBV infection. The company highlighted upcoming clinical milestones, abstract acceptance for ABI-6250 at EASL CongressTM 2024, and financial results showing $113.0 million in cash as of March 31, 2024. Revenues from collaborative research were $5.8 million, with research and development expenses at $11.9 million and a net loss of $9.1 million for Q1 2024.