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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. (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.
Assembly Biosciences (ASMB), a clinical-stage biotechnology company, announced the grant of stock options to three new employees for a total of 21,520 shares at an exercise price of $3.82. The options have a ten-year term and will vest over four years. This grant is part of Assembly Bio's 2020 Inducement Award Plan and aims to support the hiring of new talent as part of their commitment to developing innovative therapeutics for hepatitis B virus (HBV). The approval was made by the Compensation Committee, consisting of independent directors.
Assembly Biosciences (Nasdaq: ASMB) presented data from its core inhibitor programs during the International Liver Congress™ 2021, focusing on hepatitis B virus (HBV) therapies.
CEO John McHutchison highlighted the promising efficacy of their lead candidate, vebicorvir (VBR), alongside next-generation candidates ABI-H2158 and ABI-H3733. These drugs aim for deeper virologic suppression in HBV patients. The data showed significant plasma concentrations above effective levels, indicating potential improved outcomes. However, no sustained virologic response was observed in patients stopping VBR treatment.
Assembly Biosciences (Nasdaq: ASMB) announced that three abstracts related to their hepatitis B virus (HBV) therapeutics will be presented at the International Liver Congress™ 2021 from June 23-26, 2021. The company will showcase findings on its core inhibitor programs, vebicorvir (VBR), ABI-H2158, and ABI-H3733. Key presentations include an oral discussion on the enhanced potency of the next-generation inhibitors and two posters revealing resistance data and treatment response following therapy discontinuation.
Chronic HBV affects approximately 270 million people worldwide, highlighting the urgent need for effective treatments.
Assembly Biosciences (Nasdaq: ASMB) announced stock options granted to six new employees, totaling 106,520 shares at an exercise price of $4.03, the closing price on June 1, 2021. These options serve as inducements for employment and have a ten-year term with a four-year vesting schedule. The options were approved by the Compensation Committee as per Nasdaq regulations and fall under the 2017 Inducement Award Plan. Assembly Bio focuses on innovative therapeutics for hepatitis B, aiming to develop curative therapies for the 270 million global patients.
Assembly Biosciences, Inc. (Nasdaq: ASMB) has appointed Dr. Lisa Johnson-Pratt to its board of directors. With over 20 years in drug development, she previously led commercial strategies at Ionis Pharmaceuticals and GlaxoSmithKline. Dr. Johnson-Pratt will contribute her expertise in clinical programs and commercialization as Assembly Bio advances its hepatitis B virus (HBV) treatment pipeline. Her appointment comes as the company aims to provide innovative, curative therapies for the 270 million individuals suffering from HBV globally.
Assembly Biosciences, Inc. (ASMB) announced the granting of stock options to three new employees, totaling 25,000 shares at an exercise price of $4.16 per share. This measure is designed to attract talent, with options vesting over four years and subject to continued employment. The options were approved by the Compensation Committee, adhering to Nasdaq Listing Rule 5635(c)(4). Assembly Bio is focused on innovative therapies for hepatitis B virus (HBV), aiming to provide curative solutions to the estimated 270 million people affected globally.
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