Assembly Bio reports positive results from HBV drug trial

SOUTH SAN FRANCISCO - Assembly Biosciences, Inc. (NASDAQ:ASMB), a $131 million market cap biotech company, announced positive topline results from its Phase 1b study of ABI-4334, an investigational capsid assembly modulator (CAM) for chronic hepatitis B virus (HBV) infection. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it’s currently experiencing rapid cash burn.

The 28-day trial evaluated two dosage cohorts, showing mean HBV DNA reductions of 2.9 log10 IU/mL in the 150 mg cohort and 3.2 log10 IU/mL in the 400 mg cohort. For participants with detectable HBV RNA at baseline, mean declines of 2.5 and 2.3 log10 U/mL were observed in the respective cohorts. The stock has shown strong momentum, with a 17% return over the past six months.

According to the company, the data suggests the 150 mg dose achieves "saturated inhibition of viral replication," while the 400 mg dose provides higher exposure levels that could potentially maximize inhibition of cccDNA formation, a viral reservoir.

The drug demonstrated a favorable safety profile with no serious adverse events or discontinuations due to adverse events. Pharmacokinetic data supported once-daily oral dosing.

"These data support the ability of ABI-4334 to effectively inhibit viral replication at the lower 150 mg dose, while offering the potential to dose higher for purposes of maximizing inhibition of cccDNA formation," said Anuj Gaggar, chief medical officer of Assembly Bio.

The completion of this trial triggers an opt-in decision point for Gilead Sciences, Inc., which has rights to license ABI-4334 for further development and commercialization after reviewing the study data package. Analysts maintain a strong buy consensus on ASMB with price targets ranging from $29 to $31. Track this and other biotech opportunities with InvestingPro, which offers exclusive insights and real-time analysis of the healthcare sector.

The investigational drug has not been approved for use, and its safety and efficacy have not been established. The company stated that the information is based on a press release statement.

In other recent news, Assembly Biosciences announced several significant developments following its Annual Meeting of Stockholders. The company expanded its stock plans by amending the 2018 Stock Incentive Plan, increasing the number of shares reserved for issuance to 1,478,333, and adding an additional 225,000 shares subject to performance-based vesting. Additionally, the Employee Stock Purchase Plan was amended to increase the number of shares reserved for issuance from 164,500 to 225,000. In a key management change, Jeanette M. Bjorkquist has been appointed as the principal financial officer, succeeding Jason A. Okazaki, who remains the principal executive officer. Bjorkquist has been with the company since 2019 and recently served as VP, Finance. The Annual Meeting also saw the election of all director nominees to the Board of Directors until the 2026 meeting. Stockholders approved the compensation of the company’s named executive officers on a non-binding advisory basis. Ernst & Young LLP was ratified as the independent registered public accounting firm for the fiscal year ending December 31, 2025.

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