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About Assembly Biosciences, Inc. (ASMB)
Assembly Biosciences, Inc. (Nasdaq: ASMB) is a clinical-stage biotechnology company dedicated to developing innovative therapeutics targeting serious viral diseases. Headquartered in South San Francisco, California, the company focuses on advancing small-molecule antiviral therapies and live biotherapeutics to address unmet medical needs in chronic viral infections and microbiome-associated disorders. Assembly Bio operates at the forefront of biotechnology, leveraging cutting-edge science and strategic collaborations to transform the treatment landscape for patients worldwide.
Core Therapeutic Platforms
1. Hepatitis B Virus (HBV) Program: Assembly Bio is developing a pipeline of next-generation capsid assembly modulators (CAMs) designed to inhibit multiple steps of the HBV lifecycle. These CAMs aim to increase cure rates for chronic HBV infection, a leading cause of liver disease globally. The company's most advanced candidate, ABI-4334, has shown potent antiviral activity and is undergoing Phase 1b clinical trials to evaluate its safety and efficacy. Assembly Bio’s innovative approach targets both HBV DNA replication and the formation of cccDNA, the viral reservoir, positioning it as a potential best-in-class therapy.
2. Herpes Simplex Virus (HSV) Program: Assembly Bio is advancing long-acting helicase-primase inhibitors, including ABI-5366 and ABI-1179, for the treatment of recurrent genital herpes. These candidates are designed to provide superior efficacy compared to existing nucleoside analogs and offer the potential for weekly or monthly oral dosing. With no new therapies approved for genital herpes in over 25 years, Assembly Bio’s HSV program represents a significant step forward in addressing this chronic condition.
3. Hepatitis D Virus (HDV) Program: The company is developing ABI-6250, an orally bioavailable small-molecule inhibitor targeting the NTCP transporter, a clinically validated mechanism for HDV infection. ABI-6250 aims to provide a convenient, once-daily oral therapy for chronic HDV, the most severe form of viral hepatitis, which currently has limited treatment options.
Innovative Technology and Delivery Systems
Assembly Bio’s research and development efforts are underpinned by proprietary technologies, including their GEMICEL® platform for targeted oral delivery of live biotherapeutics. This platform enables the precise delivery of therapeutic agents to specific regions of the gastrointestinal tract, enhancing efficacy and patient outcomes in microbiome-related diseases.
Strategic Collaborations
Assembly Bio has established a long-term partnership with Gilead Sciences, Inc., a global leader in antiviral therapies. This collaboration provides financial support, accelerates clinical development, and validates the company’s scientific approach. Gilead’s equity investment and collaborative research efforts underscore the potential of Assembly Bio’s pipeline to address critical gaps in the treatment of viral diseases.
Market Position and Competitive Landscape
Operating in the highly competitive biotechnology sector, Assembly Bio differentiates itself through its focus on innovative mechanisms of action, such as helicase-primase inhibition and NTCP targeting. By addressing unmet medical needs in chronic HBV, HDV, and HSV infections, the company is positioned as a disruptive force in its market segments. Its emphasis on oral therapies and long-acting formulations provides a competitive edge over traditional treatment modalities.
Commitment to Patients and Innovation
Assembly Biosciences is driven by a mission to improve the lives of patients suffering from serious viral diseases. With a robust pipeline, strategic industry partnerships, and a focus on scientific excellence, the company is well-positioned to deliver transformative therapies that address significant unmet medical needs.
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.
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