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Company Overview
Assembly Biosciences, Inc. (ASMB) is a clinical-stage biotechnology company dedicated to the discovery and development of novel oral therapeutics designed to address serious viral diseases. With a dual-platform strategy focused on innovative approaches, the company is advancing a new class of oral antiviral therapeutics for hepatitis B virus (HBV) infection as well as pioneering oral live biotherapeutics aimed at restoring the health of dysbiotic microbiomes.
Innovative Therapeutic Platforms
The company’s strategic development is built on two core programs:
- HBV Therapeutics: Assembly Biosciences is developing investigational small-molecule compounds that target critical phases of the HBV lifecycle. These candidates aim to overcome the limitations of current chronic HBV treatments by targeting multiple steps in viral replication and reducing the viral reservoir, which has historically resulted in low cure rates.
- Microbiome Therapeutics: Leveraging a fully integrated platform, Assembly Biosciences has created a proprietary approach for identifying, isolating, and cultivating beneficial microbial strains. This platform, complemented by a patent-pending delivery technology, is designed to formulate oral live biotherapeutics that may address disorders associated with microbiome dysregulation.
Clinical Development and Research Focus
Assembly Biosciences operates at the forefront of antiviral drug development. Its clinical-stage programs are rigorously designed to assess safety, tolerability, and pharmacokinetics across multiple investigational candidates. The company’s robust pipeline is anchored by its commitment to advancing therapies that target the underlying mechanisms of viral infections, with research spanning from preclinical studies to early-stage clinical trials. The emphasis on oral delivery systems not only supports ease of administration but also reflects modern trends in patient-centric care.
Scientific Rationale & Differentiation
The research and development efforts are underscored by thorough mechanistic studies and innovative drug design strategies. By directly targeting key viral proteins and pathways, Assembly Biosciences aims to disrupt viral replication effectively. The incorporation of state-of-the-art strain selection methods in its microbiome program further highlights the company’s technical expertise. This combination of antiviral and microbiome-focused strategies provides a unique platform differentiating Assembly Biosciences from other entities in the competitive biotechnology landscape.
Market Position & Value Proposition
Positioned in a challenging segment of the biotechnology industry, Assembly Biosciences addresses significant unmet medical needs in the treatment of chronic viral infections. The company’s approach leverages long-standing expertise in virologic drug development and integrates rigorous clinical protocols with innovative oral delivery mechanisms. This has facilitated progress across multiple investigational therapies, which are being evaluated through well-designed clinical studies. The strategic emphasis on high-impact diseases such as HBV and conditions linked to microbiome imbalances establishes a clear value proposition to the public health sector.
Research Infrastructure and Strategic Collaborations
Assembly Biosciences benefits from an accomplished leadership team with extensive expertise in antiviral therapeutics and clinical research. Strategic collaborations with renowned partners further strengthen its research and development capabilities. This collaborative approach not only enhances the technical and clinical knowledge base but also provides a robust framework for addressing the safety and efficacy challenges associated with novel drug candidates.
Commitment to Innovation and Scientific Excellence
Underpinned by a deep commitment to scientific rigor and innovation, Assembly Biosciences continuously refines its therapeutic strategies by integrating advanced pharmacokinetic modeling, comprehensive preclinical assessments, and early-stage clinical data. The company’s methodical approach ensures that all therapeutic candidates are evaluated meticulously, thereby promoting a balanced view of potential benefits while maintaining high standards of safety and research integrity. This dedication forms the basis for sustained research excellence and positions Assembly Biosciences as a trusted informational resource in the biotechnology sector.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced that new clinical and preclinical data on its hepatitis B virus (HBV) core inhibitor portfolio will be presented at The Liver Meeting Digital Experience™ from November 13-16, 2020. Four abstracts, including two late-breaking posters, highlight research on the long-term safety of ABI-H0731 and associations between HBV pgRNA and HCC development. Assembly's HBV pipeline includes three core inhibitors, with vebicorvir showing superior antiviral activity in Phase 2 trials. Both vebicorvir and ABI-H2158 have received Fast Track designation from the FDA.
Assembly Biosciences (Nasdaq: ASMB) announced the appointment of Gina Consylman to its board of directors, effective October 20, 2020. Ms. Consylman brings over 25 years of experience in finance and accounting, currently serving as CFO at Ironwood Pharmaceuticals. Her extensive background includes roles at global biotech firms like Biogen and Ernst & Young LLP. With a solid foundation in finance and corporate strategy, her addition aims to strengthen Assembly's leadership team as it develops therapeutics targeting hepatitis B virus and microbiome-related diseases.
Assembly Biosciences (Nasdaq: ASMB) announced that Dr. John McHutchison has received the Advance 2020 Global Impact award for his significant contributions to curative therapies for hepatitis C virus (HCV). His dedication over 30 years has led to innovations now aimed at treating hepatitis B virus (HBV), affecting around 250 million people worldwide. Dr. McHutchison expressed his honor in receiving the award, emphasizing the need for better outcomes for HBV patients. The Advance Awards recognize global Australians contributing to diverse fields, including healthcare and technology.
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.
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