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Assembly Biosciences, Inc. reports developments for a clinical-stage biotechnology business focused on small-molecule therapeutics for serious viral diseases. Its recurring updates center on investigational antiviral candidates for herpes simplex virus, hepatitis delta virus and hepatitis B virus, including helicase-primase inhibitors ABI-5366 and ABI-1179, the HDV entry inhibitor ABI-6250 and the HBV capsid assembly modulator ABI-4334.
Company news also covers clinical data presentations, financial results, research and collaboration revenue, the Gilead collaboration and licensing activity, and equity financing transactions that support pipeline development.
Assembly Biosciences (Nasdaq: ASMB) participated in key conferences addressing hepatitis B virus (HBV). On October 5, 2020, Chief Scientific Officer William Delaney discussed critical gaps in HBV cure biomarkers. This was followed by a presentation from CEO John McHutchison at the H.C. Wainwright HBV Mini-Conference on October 20, 2020. The company aims to develop innovative therapies for HBV, which affects over 250 million globally. Current treatments only suppress the virus, highlighting the urgent need for effective therapies.
Assembly Biosciences, Inc. (ASMB) announced the grant of stock options to two new employees, totaling 31,520 shares at an exercise price of $17.29 per share, which was the closing price on October 1, 2020. These options have a ten-year term and vest over four years. The awards, approved by the Compensation Committee, are part of the 2020 Inducement Award Plan, as a material inducement for employment acceptance. The company is focused on developing therapeutics for hepatitis B virus (HBV) and microbiome-related diseases.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced grants of stock options totaling 86,000 shares to five new employees, priced at $20.14 per share, the closing stock price on September 1, 2020. These options serve as material inducements for accepting employment at the company. The options have a ten-year term, vesting over four years with specific conditions for continued service and potential acceleration upon certain events. The compensation committee, comprised solely of independent directors, approved these awards outside of the stockholder-approved equity incentive plans.
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.