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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 (ASMB) reported Q3 2021 financial results, highlighting a net loss of $18.8 million, or $0.41 per share, compared to $3.3 million, or $0.09 per share, in Q3 2020. Revenue from collaborative research significantly declined to $6.3 million from $34.6 million year-over-year, primarily due to the discontinuation of the ABI-H2158 project. R&D expenses decreased to $18.5 million, reflecting the wind-down of the microbiome program. Assembly Bio aims to advance their core inhibitor ABI-4334 into clinical trials in 2022, and they have two ongoing Phase 2 studies involving their lead candidate vebicorvir (VBR).
Assembly Biosciences (Nasdaq: ASMB) announced its participation in the AASLD The Liver Meeting from November 12-15, 2021, featuring significant clinical data on its HBV core inhibitor program. The company will present findings from three studies: one oral presentation and two poster presentations, including a late-breaking poster on the preclinical candidate ABI-4334. The results aim to enhance the understanding of HBV and demonstrate the potential of core inhibitors for treating chronic HBV infection.
Assembly Biosciences (ASMB) and Antios Therapeutics announced a clinical collaboration to assess a triple combination treatment for chronic hepatitis B (HBV). The Phase 2a ANTT201 trial will evaluate the safety and efficacy of Antios’ ATI-2173, Assembly Bio’s vebicorvir (VBR), and tenofovir disoproxil fumarate in ten treatment-naive patients. The study aims to provide a functional cure for HBV, which affects approximately 270 million people globally, offering hope for improved treatment options.
Assembly Biosciences (Nasdaq: ASMB) announced its participation in two upcoming conferences focused on hepatitis B virus (HBV). The Science of HBV Cure Meeting 2021 will feature Dr. William Delaney presenting on novel capsid inhibitors on October 12. Additionally, CEO Dr. John McHutchison will participate in the H.C. Wainwright 2nd Annual HBV Conference on October 13. These engagements highlight Assembly Bio's commitment to advancing therapies for the estimated 270 million people living with HBV worldwide.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced the grant of stock options to two new employees, allowing the purchase of 16,000 shares at an exercise price of $3.46, the closing price on October 1, 2021. These options have a ten-year term, vesting over four years, and are granted as inducements for accepting employment. The grants comply with Nasdaq Listing Rule 5635(c)(4) and are approved by the independent Compensation Committee. Assembly Bio focuses on developing innovative treatments for hepatitis B virus (HBV).
Assembly Biosciences (ASMB) announced the discontinuation of its ABI-H2158 development after observing elevated alanine transaminase (ALT) levels in a Phase 2 trial, indicating drug-induced hepatotoxicity. Patient safety remains a priority, and the company will focus on advancing ongoing triple combination studies and developing other core inhibitor candidates. The Phase 2 study for ABI-H2158 involved 88 patients, with some suffering significant ALT elevations. The FDA has placed the drug on clinical hold. Assembly Bio aims to extend its cash runway into late 2023 while progressing promising pipeline assets.
Assembly Biosciences, Inc. (Nasdaq: ASMB) has selected a new core inhibitor candidate, ABI-4334, optimized for potency, to advance into clinical development targeting hepatitis B virus (HBV). The company is executing preclinical work with plans to initiate clinical studies in 2022. ABI-4334 shows promising preclinical results, including single-digit nanomolar potency against new virus production and cccDNA formation. The candidate demonstrates pan-genotypic activity, an improved resistance profile, and favorable pharmacokinetics, aiming to offer a finite and curative HBV therapy.
Assembly Biosciences (ASMB) reported its Q2 2021 financial results, highlighting a cash position of $199.1 million. However, revenues plummeted to $0, down from $39.4 million in Q2 2020, due to the termination of its microbiome collaboration with Allergan. R&D expenses decreased to $16.7 million from $23.3 million, while general and administrative costs fell to $6.9 million from $9.5 million. The net loss was $23.6 million, or $0.55 per share, compared to net income of $7.3 million, or $0.21 per share, in the previous year. The company aims to advance its HBV clinical programs.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced the promotions of Jason Okazaki to Chief Operating Officer and Michael Samar to Chief Financial Officer. Okazaki, with 20 years of business and legal experience, has been with Assembly Bio since 2020, while Samar has over 20 years in finance and operations since joining the company in 2017. CEO John McHutchison praised their contributions toward achieving long-term objectives in developing therapies targeted at hepatitis B virus (HBV). The company aims to provide curative treatments for the 270 million HBV-infected individuals globally.
Assembly Biosciences Appoints Dr. Michael Houghton to Board
Assembly Biosciences, Inc. (Nasdaq: ASMB) has appointed Sir Michael Houghton, PhD, a Nobel Prize-winning virologist, to its board of directors. Dr. Houghton, renowned for discovering the hepatitis C virus, brings over 40 years of drug development experience. His expertise is expected to enhance Assembly Bio's efforts towards finite and curative therapies for hepatitis B virus (HBV), targeting over 250 million individuals globally. CEO John McHutchison emphasized the potential impact of Dr. Houghton’s insights on the company's innovative therapeutic pipeline.
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