Articles from Assembly Biosciences, Inc.

SOUTH SAN FRANCISCO, Calif., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (“Assembly Bio”) (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced the pricing of an underwritten, registered offering (the “offering”) of an aggregate of 5,591,840 shares of common stock and pre-funded warrants to purchase up to 1,040,820 shares of common stock, together with accompanying Class A and Class B warrants to purchase up to an aggregate of 6,632,660 shares of common stock at a combined price per share of common stock and accompanying Class A warrant and Class B warrant of $19.60 and a combined price per pre-funded warrant and accompanying Class A warrant and Class B warrant of $19.599. Each pre-funded warrant will have a nominal exercise price of $0.001 per share of common stock and will be immediately exercisable. Each accompanying Class A warrant will have an exercise price of $21.60 per share of common stock, will be immediately exercisable and will expire on the earlier of (i) five years from the date of issuance (August 11, 2030) and (ii) the date that is 30 days after the public announcement that Assembly Bio has completed enrollment (of at least 200 patients total) for its Phase 2 clinical study evaluating ABI-5366 vs. valacyclovir. Each accompanying Class B warrant will have an exercise price of $21.60 per share of common stock, will be exercisable on or after November 15, 2026 and will expire on December 31, 2026, provided that each Class B warrant will automatically terminate in full and be extinguished and shall no longer be exercisable in the event that Assembly Bio publicly announces prior to November 15, 2026 that it has received at least $75.0 million in the aggregate of non-dilutive capital in connection with a collaboration agreement.

– 94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort evaluating 350 mg weekly oral dose compared to placebo over 29-day evaluation period –

– On track for proof-of-concept Phase 1b data no later than this fall in participants with recurrent genital herpes for long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidates, ABI-5366 and ABI-1179 –

– Data to date in single- and multiple-ascending dose cohorts of healthy participants demonstrate a four-day half-life for ABI-6250, supporting target daily oral dosing profile and dose-dependent elevations in biomarker of target engagement –

– Phase 1a clinical data in healthy participants presented for both ABI-5366 and ABI-1179, novel long-acting herpes simplex virus helicase-primase inhibitor candidates –

– Study will evaluate safety and antiviral activity of ABI-1179 in participants with recurrent genital herpes –

– Favorable safety and tolerability profile, as well as pharmacokinetics supporting once-daily oral dosing, continued to be observed in final 400 mg cohort –

SOUTH SAN FRANCISCO, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that Jason Okazaki, chief executive officer and president, and Anuj Gaggar, MD, PhD, chief medical officer, will present in a fireside chat during the Jefferies 2025 Global Healthcare Conference at 8:45 a.m. Eastern Time on June 4, 2025. A live webcast will be available on the Events and Presentations section of Assembly Bio’s website and a replay will be accessible following the event. To register for the live webcast and replay, please visit: https://investor.assemblybio.com/events-presentations.

– Ongoing clinical studies for four candidates on track with data expected in 2025, including interim Phase 1b data for long-acting helicase-primase inhibitors ABI-5366 and ABI-1179 anticipated in fall 2025 –

– Late-breaker poster highlights preclinical profile of ABI-6250, currently in Phase 1a with data anticipated in Q3 2025 –

– Clinical and preclinical data supporting dosing profile and tolerability for ABI-5366, a novel long-acting helicase-primase inhibitor candidate, featured in two poster presentations –

– Four development candidates in clinical studies with data anticipated this year, continuing rapid progress of antiviral pipeline –

– Phase 1a study will evaluate single and multiple ascending doses of ABI-6250 in healthy participants with data expected in Q3 2025 –

– ABI-1179 was well-tolerated, with a half-life of approximately four days and high exposure across the dose range evaluated supporting the potential for once-weekly oral administration at a low dose –

– ABI-4334 was well-tolerated with a favorable safety profile and half-life supporting once-daily oral dosing observed –

—Assembly Bio to receive approximately $20.1 million equity investment and $10 million in accelerated funding under the collaboration, extending cash runway to mid-2026—

SOUTH SAN FRANCISCO, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent updates for the third quarter ended September 30, 2024.

– ABI-5366 was well-tolerated, with a favorable safety profile observed with exposure of up to 70 days –

SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent updates for the second quarter ended June 30, 2024.

– Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented –

– Phase 1b study will evaluate safety, pharmacokinetic and efficacy endpoints in participants with chronic hepatitis B virus infection with interim data expected by the end of 2024 –

— Funding supports advancement of antiviral portfolio, including four candidates in clinical development, and extends cash runway into Q1 2026 —

– Phase 1a study portion of single ascending dosing in healthy participants will inform the development of ABI-5366 with interim data expected in Q3 2024 –

-- Poster highlights promising preclinical profile of ABI-6250 ahead of entry into the clinic, expected by end of 2024 --

-- Preclinical data from both ABI-5366 and ABI-1179, Assembly Bio’s long-acting helicase-primase inhibitor candidates targeting recurrent genital herpes, featured in poster and oral presentations at the International Herpesvirus Workshop --

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent highlights for the first quarter ended March 31, 2024.

SOUTH SAN FRANCISCO, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2023.

– Assembly Bio common stock expected to begin trading on a split-adjusted basis on February 12, 2024 –

SOUTH SAN FRANCISCO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today provided an outline of the anticipated milestones and progress for its clinical pipeline during 2024.

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced a grant of inducement awards to its chief medical officer, Anuj Gaggar, MD, PhD on November 8, 2023.

--Poster highlights potential of oral small molecule IFNAR agonist program to engage the IFNα pathway through a liver-focused approach to improve tolerability--

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today reported financial results for the third quarter ended September 30, 2023, and recent corporate updates.

-- Dr. Gaggar is an experienced industry executive with substantial infectious disease expertise and proven record of successfully leading early- and clinical-stage antiviral programs --

-- One poster and one oral presentation selected, with the poster highlighting new preclinical data from the Company’s interferon-α receptor agonist program --

− ABI-6250 demonstrated low nanomolar potency against hepatitis D virus and selective inhibition of NTCP in preclinical studies with once-daily dosing projected –

-- Two oral presentations and one poster will feature new data from the Company’s hepatitis B/hepatitis D entry inhibitor, capsid assembly modulator ABI-4334, and interferon-alpha receptor agonist programs --

SOUTH SAN FRANCISCO, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today reported financial results and recent updates for the second quarter ended June 30, 2023.

-- First presentation of preclinical data describing the activity, pharmacokinetics and safety profile of ABI-5366, supporting planned clinical entry in 1H 2024 --

SOUTH SAN FRANCISCO, Calif., June 21, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced data from its hepatitis D virus (HDV) and hepatitis B virus (HBV) antiviral pipeline featured in five poster presentations at the International Liver Congress™, the Annual Meeting of the European Association for the Study of the Liver (EASL) taking place in Vienna, Austria, on June 21-24, 2023, including one selected for inclusion in the Best of EASL Congress summary.

-- International Herpesvirus Workshop will feature oral and poster presentations of preclinical data from ABI-5366, Assembly Bio’s first herpesvirus development candidate --

SOUTH SAN FRANCISCO, Calif., May 23, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced that Jason Okazaki, chief executive officer and president, and William Delaney, PhD, chief scientific officer, will present in a fireside chat during the 2023 Jefferies Healthcare Conference at 4:00 p.m. Eastern Time on June 7, 2023. A live webcast will be available on the Events and Presentations section of Assembly Bio’s website and a replay will be accessible following the event. To register for the live webcast and replay, please visit: https://investor.assemblybio.com/events-presentations.

SOUTH SAN FRANCISCO, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today reported financial results and recent highlights for the first quarter ended March 31, 2023.

SOUTH SAN FRANCISCO, Calif., April 18, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today provided an update of results from the final multiple-dose cohort in the ongoing Phase 1a study of its investigational next-generation, highly potent hepatitis B virus (HBV) core inhibitor, ABI-4334 (4334), and announced it will evaluate partnering opportunities for its core inhibitor portfolio and prioritize its expanded virology pipeline.

SOUTH SAN FRANCISCO, Calif., March 22, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today provided an update on its investigational next-generation hepatitis B virus (HBV) core inhibitors, ABI-H3733 (3733) and ABI-4334 (4334), and reported financial results and recent highlights for the fourth quarter and year ended December 31, 2022.

−ABI-5366 Demonstrates Favorable Profile for a Long-Acting Therapeutic in Preclinical Studies

SOUTH SAN FRANCISCO, Calif., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative, investigational therapeutics targeting hepatitis B virus (HBV) and other viral diseases, today announced promising interim efficacy, safety and pharmacokinetic (PK) results from two ongoing clinical studies of its investigational next-generation HBV core inhibitors, a Phase 1b clinical study of ABI-H3733 (3733) and a Phase 1a clinical study of ABI-4334 (4334).

Healthy volunteer study will inform development of 4334 for treatment of hepatitis B virus

Phase 1a Trial of Next-Generation Core Inhibitor, ABI-4334, Now Underway Following Clinical Trial Application (CTA) Clearance

Data demonstrating nanomolar potency of core inhibitor ABI-4334 to disrupt the hepatitis B virus (HBV) life cycle at multiple points supports advancement into clinical studies

Four poster presentations, including two late breaking, highlight breadth and promise of virology portfolio

Dr. McHutchison will continue to provide strategic counsel as board member and chairman of the Science & Technology Committee of the board