Assembly Bioscie Stock Price, News & Analysis

Assembly Biosciences (Nasdaq: ASMB) presented crucial clinical data on its HBV core inhibitors vebicorvir (VBR) and ABI-H2158 during EASL's Digital International Liver Congress. Vebicorvir showed a favorable safety profile, achieving significant reductions in HBV DNA and pgRNA in patients with chronic HBV infections. Approximately 88% of participants in its Phase 2 study are projected to meet criteria for stopping therapy. ABI-H2158 exhibited improved potency against cccDNA formation. Both drugs have received Fast Track designation from the FDA.

Assembly Biosciences (Nasdaq: ASMB) announced the grant of stock options totaling 13,000 shares to two new employees at an exercise price of $23.08 per share, as of August 3, 2020. The options, which are part of the 2020 Inducement Award Plan, have a ten-year term and will vest over four years. This move aims to incentivize the new hires and is compliant with Nasdaq's regulations. The company focuses on developing therapeutics for hepatitis B virus and microbiome-related diseases.

Assembly Biosciences, Inc. (Nasdaq: ASMB) reported strong financial results for Q2 2020, highlighting a significant increase in collaborative research revenue to $39.4 million, up from $3.1 million in 2019, driven by a $36 million deferred revenue recognition. The company initiated key collaborations, notably with BeiGene, receiving $40 million upfront, with potential total payments of $500 million. Net income attributable to common stockholders was $7.5 million, marking a significant improvement from a net loss of $18.5 million the previous year. Cash reserves stood at $226.7 million, projected to fund operations into H2 2022.

Assembly Biosciences has partnered with BeiGene for the exclusive development and commercialization of three clinical-stage core inhibitors for hepatitis B virus (HBV) in China. This collaboration includes an upfront payment of $40 million for Assembly, with potential milestone payments up to $500 million, plus royalties on sales. The drugs, ABI-H0731 and ABI-H2158, are in Phase 2 trials, while ABI-H3733 is in Phase 1. Both companies aim to address the significant unmet medical need for HBV treatments in a region with nearly 90 million infected individuals.

Assembly Biosciences, Inc. (Nasdaq: ASMB) announced that the FDA has granted Fast Track designation to ABI-H2158 for treating chronic HBV infection, potentially expediting its development and approval. This second-generation core inhibitor is currently in a global Phase 2 trial, complementing the company's first-generation drug ABI-H0731, which also holds Fast Track designation. The company emphasized the significance of providing innovative treatments for the over 250 million people affected by HBV globally.

Assembly Biosciences (Nasdaq: ASMB) announced the grant of stock options for 112,600 shares to ten new employees, with an exercise price of $23.30 per share. This move aims to incentivize new hires and is in accordance with Nasdaq Listing Rule 5635(c)(4). The options are part of a ten-year term, vesting over four years. None of the new employees hold executive positions. The stock options were approved by the Compensation Committee and granted outside of the standard equity incentive plans, aligning with the company's strategy to enhance talent acquisition.

Assembly Biosciences (Nasdaq: ASMB) has initiated a Phase 2 trial for its second-generation core inhibitor, ABI-H2158, targeting chronic hepatitis B infection. This randomized, placebo-controlled trial will involve 80 treatment-naïve patients, comparing 2158 with entecavir against a placebo. The trial aims to evaluate HBV DNA reduction and safety over 72 weeks. Previous Phase 1b results showed that 2158 was well tolerated and demonstrated significant antiviral activity. Clinical data from this trial will be presented at the upcoming EASL congress in August 2020.

Assembly Biosciences (ASMB) announced preclinical data from its immuno-oncology microbiome program showcased at the American Association for Cancer Research Virtual Annual Meeting II. The poster highlights the discovery of a live biotherapeutic product (LBP) targeting solid tumors, revealing single bacterial strains with significant anti-tumor activity. The program aims to enhance the efficacy of checkpoint inhibitors. Assembly’s lead candidate, ABI-M201, is in a Phase 1b trial for ulcerative colitis, while ABI-M301 is in preclinical stages for Crohn's disease.

Assembly Biosciences, Inc. (Nasdaq: ASMB) has regained worldwide rights to its microbiome gastrointestinal programs previously licensed to AbbVie, which has terminated their collaboration agreement. No safety or efficacy concerns were cited. The Company plans to explore strategic alternatives for ongoing development of its microbiome programs, including ABI-M201, currently in Phase 1b trials for ulcerative colitis. Assembly anticipates its cash reserves of $249.1 million will fund operations into 2022. The transition is expected to complete by Q4 2020.