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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 (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.
Assembly Biosciences, Inc. (ASMB) reported financial results for Q1 2021, focusing on hepatitis B virus (HBV) therapies. The company initiated two Phase 2 triple combination studies with its lead core inhibitor candidate, vebicorvir (VBR). Financially, cash and equivalents stood at $214.9 million, sufficient to fund operations into 2023. However, revenues fell to $0 due to the wind-down of the microbiome program, while R&D expenses decreased to $18.6 million. The net loss for the quarter was $27.2 million, or $0.69 per share, marginally higher than the previous year.
Assembly Biosciences (Nasdaq: ASMB) announced the grant of stock options to three new employees, totaling 26,000 shares at an exercise price of $5.05 per share. This initiative serves as a material inducement for the new hires to join the company. The options carry a ten-year term and vest over four years, with a quarter vesting on the first anniversary. The grants adhere to Nasdaq Listing Rule 5635(c)(4) and are part of Assembly Bio's 2020 Inducement Award Plan, approved by the Compensation Committee, which comprises only independent directors.
Assembly Biosciences (ASMB) reported its financial results for Q4 and the fiscal year ended December 31, 2020. The company is concentrating on developing finite and curative therapies for chronic hepatitis B, halting Phase 3 studies of vebicorvir as a chronic suppressive treatment. They reported revenues of $79.1 million for 2020, a significant increase from $16.0 million in 2019, largely due to collaborations with BeiGene and Abbvie. R&D expenses rose to $106.8 million, reflecting a growing focus on HBV. The net loss for 2020 was $62.2 million, showing improvement from $97.6 million in 2019.
Assembly Biosciences (ASMB) announced a strategic shift from Phase 3 clinical studies of vebicorvir (VBR) to focus on finite and curative therapies for hepatitis B virus (HBV). This change aims to expedite the development of more potent core inhibitors and novel treatment combinations. The company anticipates extending its cash runway into 2023, bolstered by ongoing clinical studies, including a Phase 2a trial combining VBR with Nucleos(t)ide Analogue Reverse Transcriptase Inhibitors. CEO John McHutchison reaffirms commitment to addressing HBV's unmet medical needs.
Assembly Biosciences (ASMB), a clinical-stage biotechnology firm focused on hepatitis B virus (HBV) therapeutics, announced two investor events. The first is a Key Objectives and Anticipated Progress Conference Call on February 25, 2021, at 5 p.m. ET, coinciding with the release of Q4 and year-end 2020 financial results. The second event is the SVB Leerink 10th Annual Global Healthcare Conference, featuring CEO John McHutchison in a fireside chat on February 26, 2021, at 1:40 p.m. ET. Both events will be accessible via Assembly Bio’s website, with archived webcasts available for replay.