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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) announced the grant of stock options to three new employees, totaling 38,000 shares at an exercise price of $5.79 per share. This incentive is part of the company's strategy to attract talent as they develop therapies targeting hepatitis B virus (HBV). The stock options have a ten-year term and vest over four years. These grants were made under the 2020 Inducement Award Plan and are approved by the Compensation Committee, aligning with Nasdaq Listing Rule 5635(c)(4).
Assembly Biosciences, Inc. (Nasdaq: ASMB) has decided to wind down its microbiome program to concentrate resources on advancing its hepatitis B virus (HBV) therapeutic portfolio. This strategic move aims to enhance the company's focus on developing core inhibitors for chronic HBV treatments. As of September 30, 2020, Assembly Bio reported cash reserves of approximately $238M, projected to sustain operations into the second half of 2022. The decision does not stem from any negative data regarding the microbiome program and is anticipated to conclude by January 31, 2021.
Assembly Biosciences, Inc. (Nasdaq: ASMB), announced the grant of stock options for 14,520 shares to three new employees, with an exercise price of $5.66 per share, based on the closing price on December 1, 2020. The options will vest over four years, with one-fourth vesting after the first year and the remaining in monthly installments. This grant is part of the 2017 Inducement Award Plan and was approved by the Compensation Committee. The new employees do not hold executive positions.
Assembly Biosciences, Inc. (ASMB) announces the appointment of Nicole S. White, PhD, as Senior Vice President of Pharmaceutical Development and Manufacturing. With over 20 years in the field, Dr. White's experience includes leadership roles at Gilead Sciences and Gossamer Bio. She will play a crucial role in advancing the company's pipeline, particularly the core inhibitor vebicorvir, which is set for Phase 3 studies next year. This strategic addition aims to enhance Assembly's capabilities in developing novel therapeutics for hepatitis B virus (HBV) and microbiome-related diseases.
Assembly Biosciences (Nasdaq: ASMB) has entered a two-year exclusive collaboration with Door Pharmaceuticals to develop a novel class of hepatitis B virus (HBV) core protein modulators. The partnership will leverage Door's discovery platform, which targets functions of HBV core proteins that could disrupt viral nucleic acid activity. Assembly Biosciences will fund the research and retains the option to license resulting compounds. Chronic HBV affects over 250 million globally, necessitating innovative therapies to improve cure rates.
Assembly Biosciences, a clinical-stage biotechnology company, reported its HBV core inhibitor programs' data at the AASLD 2020 conference. The findings highlighted the differentiated safety profile of vebicorvir in combination with nucleos(t)ide therapy, potentially offering improved chronic suppressive therapy for HBV patients. Notable outcomes from the studies include a stable safety profile for vebicorvir over 1.5 years and the significance of HBV pgRNA as a biomarker. Upcoming Phase 3 trials are planned for vebicorvir in 2021.
Assembly Biosciences, Inc. (Nasdaq: ASMB) has granted stock options to a new employee, allowing the purchase of 6,520 shares at an exercise price of $14.75 per share, aligning with the company's closing stock price on November 2, 2020. The options, part of the 2020 Inducement Award Plan, vest over four years, with one-fourth vesting on the first anniversary. This grant serves as a material inducement for the employee to join Assembly. The award was approved by an independent Compensation Committee, adhering to Nasdaq Listing Rule 5635(c)(4).
Assembly Biosciences (ASMB) reported its Q3 2020 financial results, highlighting a strong cash position of $237.9 million, sufficient to fund operations into H2 2022. Revenue surged to $34.6 million, up from $4.2 million in Q3 2019, driven by a collaboration agreement with BeiGene. R&D expenses increased to $26.9 million, primarily for the HBV program. Despite a net loss of $3.3 million, a significant reduction from $25 million in the prior year, the company continues to advance its HBV pipeline, anticipating Phase 3 studies for its lead candidate, vebicorvir, in H1 2021.
Assembly Biosciences (ASMB) has released interim results from its Phase 2 Study 211, which assesses the off-treatment response of its core inhibitor vebicorvir (VBR) in chronic HBV patients. The study, however, has not achieved a meaningful sustained virologic response (SVR), with 39 of 41 patients relapsing post-treatment. Specifically, only 4% of HBeAg negative and 6% of HBeAg positive patients maintained SVR. Despite these disappointing outcomes, Assembly Bio plans to proceed with a Phase 3 trial for vebicorvir as a chronic suppressive therapy in partnership with BeiGene, targeting the significant unmet need in HBV treatment.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced that new clinical and preclinical data on its hepatitis B virus (HBV) core inhibitor portfolio will be presented at The Liver Meeting Digital Experience™ from November 13-16, 2020. Four abstracts, including two late-breaking posters, highlight research on the long-term safety of ABI-H0731 and associations between HBV pgRNA and HCC development. Assembly's HBV pipeline includes three core inhibitors, with vebicorvir showing superior antiviral activity in Phase 2 trials. Both vebicorvir and ABI-H2158 have received Fast Track designation from the FDA.