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Assembly Biosciences: Positive Data Of ABI-5366 Brings 2 Fall Program Catalysts
Seeking Alpha· 2025-08-08 20:54
Group 1 - Assembly Biosciences, Inc. (NASDAQ: ASMB) released results from its phase 1b study of ABI-5366, a long-acting helicase-primase inhibitor for treating recurrent genital herpes [2] - The study results are significant for the treatment of patients suffering from recurrent genital herpes, indicating potential advancements in the pharmaceutical sector [2] Group 2 - The Biotech Analysis Central service offers a comprehensive analysis of various pharmaceutical companies, including a library of over 600 articles and a model portfolio of small and mid-cap stocks [2]
Assembly Biosciences Announces Pricing of $175 Million in Equity Financings
Globenewswire· 2025-08-08 12:05
Core Viewpoint - Assembly Biosciences, Inc. has announced a registered offering of common stock and warrants, aiming to raise capital for its innovative therapeutics targeting serious viral diseases [1][4]. Group 1: Offering Details - The offering consists of 5,591,840 shares of common stock and pre-funded warrants for 1,040,820 shares, with a combined price of $19.60 per share and accompanying warrants [1]. - Each pre-funded warrant has a nominal exercise price of $0.001 and is immediately exercisable, while Class A and Class B warrants have an exercise price of $21.60 and specific expiration conditions [1]. - The offering and a private placement with Gilead Sciences, Inc. are expected to close on August 11, 2025, contingent upon customary closing conditions [4]. Group 2: Investor Participation - The offering includes participation from both new and existing investors, such as Commodore Capital, Blackstone Multi-Asset Investing, and Farallon Capital Management [2]. - Gilead will purchase 2,295,920 shares in a private placement at the same price as the offering, which will not be registered under the Securities Act [3]. Group 3: Use of Proceeds - The net proceeds from the offering and private placement will be utilized for general corporate purposes [4]. Group 4: Company Overview - Assembly Biosciences is focused on developing small-molecule therapeutics aimed at serious viral diseases, including herpesvirus and hepatitis infections [7][8].
Assembly Biosciences Reports Positive Interim Results from Phase 1b Clinical Study of Long-Acting Helicase-Primase Inhibitor Candidate ABI-5366 Showing Reductions in Viral Shedding Rate and Genital Lesion Rate in Recurrent Genital Herpes
Globenewswire· 2025-08-08 12:00
– 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 – – 94% reduction in genital lesion rate, also statistically significant, observed with 350 mg weekly oral dose compared to placebo over same period – – Favorable safety and tolerability profile observed in the first two cohorts evaluating weekly oral doses of ABI-5366 – SOUTH SAN FRA ...
Assembly Biosciences(ASMB) - 2025 Q2 - Quarterly Report
2025-08-06 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________to___________. Commission file number: 001-35005 ASSEMBLY BIOSCIENCES, INC. (Exact name of Registrant as specified in its charter) Delaware 20-8729264 (State o ...
Assembly Biosciences(ASMB) - 2025 Q2 - Quarterly Results
2025-08-06 20:10
Exhibit 99.1 Assembly Biosciences Reports Second Quarter 2025 Financial Results and Recent Updates – On track for proof-of-concept Phase 1b data this 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 – SOUTH SAN FRANCISCO, Calif. – August 6, 2025 – Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, to ...
Assembly Biosciences Reports Interim Phase 1a Data from Clinical Study of Oral Entry Inhibitor Candidate ABI-6250 for Hepatitis Delta Virus
Globenewswire· 2025-08-06 20:05
– 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 – – Further pharmacological assessment to be conducted in parallel with Phase 2 preparation – SOUTH SAN FRANCISCO, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting se ...
Assembly Biosciences Reports Second Quarter 2025 Financial Results and Recent Updates
Globenewswire· 2025-08-06 20:05
Core Insights - Assembly Biosciences, Inc. is advancing its clinical programs with significant data expected in 2025 for four development candidates targeting serious viral diseases [2][3] - The company reported positive topline data for ABI-4334 in chronic hepatitis B virus (HBV) and interim data for ABI-6250 in healthy volunteers [1][2] - ABI-5366 and ABI-1179 are on track for proof-of-concept Phase 1b data by fall 2025 for recurrent genital herpes [1][2] Financial Performance - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $75.0 million, down from $91.0 million as of March 31, 2025 [11] - Revenue from collaborative research with Gilead was $9.6 million for the second quarter of 2025, compared to $8.5 million in the same period of 2024 [11] - Research and development expenses were $16.1 million for the second quarter of 2025, slightly down from $16.3 million in the same period of 2024 [11] Clinical Development Updates - ABI-1179 has entered the Phase 1b portion of its trial, with positive topline results for ABI-4334 indicating strong antiviral activity in chronic HBV [6] - ABI-6250's interim data showed pharmacokinetics supportive of a once-daily oral dosing profile and biomarker data indicating target engagement [6] - Upcoming presentations and data releases are scheduled for various international conferences, highlighting the company's ongoing research efforts [6][4] Anticipated Milestones - Key proof-of-concept Phase 1b data for ABI-5366 and ABI-1179 is expected no later than fall 2025 [6] - An abstract for ABI-6250 has been accepted for oral presentation at the International HBV Meeting in September 2025 [6] Company Overview - Assembly Biosciences is focused on developing innovative small-molecule therapeutics for serious viral diseases, including herpesvirus, HBV, and hepatitis delta virus (HDV) [8] - The company is led by a team experienced in virologic drug development, aiming to improve patient outcomes [8]
Assembly Biosciences Presents Data Highlighting Recurrent Genital Herpes Program at STI & HIV 2025 World Congress and International Herpesvirus Workshop
Globenewswire· 2025-07-26 07:00
Core Insights - Assembly Biosciences, Inc. presented Phase 1a clinical and preclinical data for its herpes simplex virus helicase-primase inhibitor candidates ABI-5366 and ABI-1179 at major conferences in July 2025, indicating progress in their development [1][2][4] Group 1: Clinical Data and Presentations - Phase 1a clinical data for ABI-5366 and ABI-1179 were showcased in multiple poster presentations at the STI & HIV 2025 World Congress and the 49th Annual International Herpesvirus Workshop [1][4] - Interim proof-of-concept Phase 1b data for both candidates in participants with recurrent genital herpes is expected in fall 2025 [1] - The late-breaking poster for ABI-1179 included the first scientific presentation of its Phase 1a clinical data, showing no clinically significant food effect [2][4] Group 2: Treatment Potential and Dosing - Both candidates are designed to offer innovative treatment options, potentially allowing for once weekly or once monthly oral dosing, which would significantly reduce the treatment burden compared to current daily therapies [2] - The current standard of care for recurrent genital herpes has not seen new drug approvals in over 25 years, highlighting the need for new treatment options [10] Group 3: Preclinical Insights and Epidemiology - Additional posters reviewed preclinical studies of ABI-5366 and provided methodology for analyzing claims data on genital herpes prevalence and treatment patterns in the U.S. [3] - Epidemiological studies estimate that over four million people in the U.S. and several European countries experience recurrent genital herpes, with most individuals having multiple recurrences annually [10] Group 4: Mechanism of Action - HSV helicase-primase inhibitors target a viral enzyme complex essential for the herpes simplex virus, which has no equivalent in human hosts, suggesting a potentially superior efficacy compared to current nucleoside analog treatments [11] Group 5: Company Overview - Assembly Biosciences is focused on developing innovative small-molecule therapeutics aimed at serious viral diseases, with a commitment to improving patient outcomes [12]
Assembly Biosciences Presents Data Highlighting Recurrent Genital Herpes Program at STI & HIV 2025 World Congress and International Herpesvirus Workshop
GlobeNewswire News Room· 2025-07-26 07:00
Core Insights - Assembly Biosciences, Inc. presented Phase 1a clinical and preclinical data for its herpes simplex virus helicase-primase inhibitor candidates ABI-5366 and ABI-1179 at major conferences in July 2025, indicating progress in their development [1][2][4] Clinical Data - Phase 1a clinical data for ABI-5366 and ABI-1179 showed promising safety and pharmacokinetic profiles in healthy participants, supporting their advancement to Phase 1b evaluation [2][4] - Interim proof-of-concept Phase 1b data for both candidates in participants with recurrent genital herpes is expected in fall 2025 [1] Treatment Innovation - ABI-5366 and ABI-1179 have the potential for less frequent dosing, with ABI-5366 offering once monthly and ABI-1179 once weekly oral dosing, which could significantly reduce the treatment burden compared to current daily therapies [2][10] - The current standard of care for recurrent genital herpes has not seen new drug approvals in over 25 years, highlighting the need for innovative treatments [10] Preclinical Insights - Additional presentations at the STI & HIV 2025 World Congress included preclinical studies and methodologies for estimating genital herpes prevalence and treatment patterns in the U.S. [3][8] Company Background - Assembly Biosciences is focused on developing innovative small-molecule therapeutics for serious viral diseases, including herpesvirus infections [12]
Assembly Biosciences Doses First Participant in Phase 1b Portion of Phase 1a/b Clinical Trial of Investigational Long-Acting Herpes Simplex Virus Helicase-Primase Inhibitor ABI-1179
GlobeNewswire News Room· 2025-06-30 12:00
Core Insights - Assembly Biosciences, Inc. has initiated a Phase 1b study for ABI-1179, a long-acting helicase-primase inhibitor targeting recurrent genital herpes, with the first participant dosed [1][2][3] - The study aims to evaluate the safety and antiviral activity of ABI-1179 over a 29-day treatment period, focusing on viral shedding rates and clinical outcomes [2][6] - ABI-1179 has shown promising interim results in Phase 1a, supporting its once-weekly oral dosing regimen [2][3] Company Developments - The Phase 1b study for ABI-1179 is running concurrently with ABI-5366, both of which have met the company's pharmacokinetic targets in earlier trials [3] - The company has received clearance for an Investigational New Drug (IND) application to expand the Phase 1b study to additional sites in the United States [3] - Interim data from both studies is expected to be reported in fall 2025 [1][3] Industry Context - Recurrent genital herpes affects millions, with current therapies being inadequate in managing the frequency and severity of outbreaks [4][9] - The standard treatment has not seen new drug approvals in over 25 years, highlighting a significant unmet need in the market [9] - Helicase-primase inhibitors like ABI-1179 represent a novel approach that may offer superior efficacy compared to existing nucleoside analogs [10]