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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 (ASMB) reported its Q4 and full-year 2021 financial results, highlighting a net loss of $129.9 million, up from $62.2 million in 2020. The cash position decreased to $174.6 million as of December 31, 2021. Revenues dropped significantly to $6.3 million, compared to $79.1 million in 2020, primarily due to prior collaborations. R&D expenses decreased to $68.5 million, while general and administrative expenses fell to $28.8 million. The company aims to advance its pipeline with key studies expected in 2022, including the initiation of trials for new core inhibitor candidates.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced that CEO John McHutchison will speak at the SVB Leerink 11th Annual Global Healthcare Conference on February 17, 2022, at 3:40 p.m. ET. The virtual fireside chat will be accessible via webcast on Assembly Bio's website, with a replay available for 30 days. Assembly Bio focuses on innovative therapies for hepatitis B virus (HBV) and aims to develop curative treatments for the 270 million people affected worldwide. Its portfolio includes next-generation core inhibitors targeting HBV replication.
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company, announced the grant of stock options to two new employees, allowing the purchase of 7,000 shares at an exercise price of $2.45 each. The options have a ten-year term and vest over four years. This action aims to attract talent through financial incentives and follows Nasdaq Listing Rule requirements. Assembly Bio focuses on developing therapies targeting hepatitis B virus, aiming to provide innovative treatments for the 270 million infected globally.
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company focused on hepatitis B virus (HBV) therapies, announced that CEO John McHutchison will present at the HC Wainwright Virtual BIOCONNECT Conference from January 10-13, 2022. The presentation will be available for on-demand viewing starting January 10, 2022, at 7:00 a.m. EST on the company's website. Assembly Bio aims to develop curative therapies for the 270 million people worldwide living with HBV, leveraging its innovative oral core inhibitors and combination studies.
Assembly Biosciences, a clinical-stage biotechnology company listed on Nasdaq under the symbol ASMB, has outlined its development pipeline for 2022, focusing on hepatitis B virus (HBV) treatments. Key milestones include sharing preliminary data from three Phase 2 studies of vebicorvir (VBR) and advancing ABI-H3733 and ABI-4334 clinical trials. The company aims to explore new antiviral mechanisms while managing risks related to clinical study timelines and financial resource allocation. The CEO expressed optimism about the company's strategy and research potential.
Assembly Biosciences (Nasdaq: ASMB) has announced the grant of stock options for 21,000 shares to three new employees, priced at $2.24 per share—the closing price on December 1, 2021. These stock options are intended as inducements for employment and have a ten-year term, vesting over four years. The grants were made outside of stockholder-approved plans, in accordance with Nasdaq Listing Rule 5635(c)(4), providing transparency in the induction process.
Assembly Biosciences (Nasdaq: ASMB) announced promising preclinical and clinical data at the AASLD conference. New core inhibitor candidate, ABI-4334, showed single-digit nanomolar potency against pgRNA encapsidation and cccDNA formation. Phase 1a study results for ABI-H3733 indicated favorable pharmacokinetics and safety, with Phase 1b planned for 2022. Additionally, vebicorvir (VBR) demonstrated enhanced viral suppression in combination with NrtIs. An oral presentation on VBR's role in HBV treatment is scheduled for November 14.
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.
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