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Assembly Biosciences, Inc. (NASDAQ: ASMB) is a public clinical-stage biotechnology company dedicated to advancing innovative therapies for serious viral diseases. The company focuses on two key platform programs: the treatment of Hepatitis B virus (HBV) infection and the development of novel oral live biotherapeutics for disorders associated with the microbiome.
In the HBV program, Assembly Biosciences is pioneering a new class of oral therapeutics aimed at increasing cure rates for patients with chronic HBV. The company has developed several drug candidates that inhibit various steps in the HBV lifecycle, including novel core protein allosteric modulators (CpAMs). These small molecules target and modulate the HBV core protein, a crucial component in the virus's replication process.
The microbiome program is designed to address diseases linked to dysbiosis, an imbalance in the microbial community of the gut. Assembly Biosciences employs a robust strain identification and selection process, methods for strain isolation and growth under Good Manufacturing Practices (GMP), and a patent-pending delivery system known as GEMICEL®. This system ensures targeted delivery of live biotherapeutics to specific areas in the gastrointestinal tract.
Recent achievements for Assembly Biosciences include a long-term partnership with Gilead Sciences to accelerate the development of their antiviral pipeline. This collaboration is expected to enhance the company's financial and scientific resources, positioning them to achieve critical milestones and deliver innovative treatments to patients.
Financial results for the third quarter of 2023 highlighted the company's ongoing progress, including the advancement of multiple antiviral candidates targeting herpesviruses, HBV, and hepatitis delta virus (HDV). Assembly Biosciences also announced leadership enhancements, including the appointment of Dr. Anuj Gaggar as Chief Medical Officer.
Looking ahead, Assembly Biosciences plans to have four candidates in clinical studies by the end of 2024. These include the initiation of trials for ABI-5366, a long-acting herpes simplex virus helicase-primase inhibitor, and the development of ABI-6250, an orally bioavailable small molecule for treating chronic HDV.
For more information, visit assemblybio.com.
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.
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.
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