Core Insights - Assembly Biosciences, Inc. is developing ABI-5366, a long-acting helicase-primase inhibitor for recurrent genital herpes, with interim proof-of-concept data expected in fall 2025 [1][5] - The company presented data on ABI-5366 at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases, highlighting its potential as a once-weekly or once-monthly oral treatment option [1][2][8] Clinical Data - ABI-5366 was well tolerated in a Phase 1a study, with no serious adverse events reported at doses up to 350 mg, and a half-life of approximately 20 days supports infrequent dosing [3][4] - Preclinical studies demonstrated broad activity against HSV-1 and HSV-2, reinforcing the potential for weekly or monthly oral dosing [4] Genital Herpes Prevalence and Treatment Patterns - A retrospective analysis estimated 262,457 total genital herpes cases and 148,067 recurrent cases in 2023 among healthcare-engaged individuals in the U.S., with a projected 1.35 million individuals experiencing recurrent genital herpes nationwide [6][7] - Among recurrent cases, 97% received pharmacologic treatment, with 57% on suppressive therapy, indicating a significant opportunity for improved treatment strategies [7] Company Overview - Assembly Biosciences focuses on innovative therapeutics for serious viral diseases, including herpesvirus and hepatitis infections, aiming to enhance patient outcomes [12]

Core Viewpoint - Assembly Biosciences (ASMB) is experiencing significant selling pressure, with a 22.6% decline over the past four weeks, but is now positioned for a potential trend reversal due to being in oversold territory and positive earnings expectations from Wall Street analysts [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. - ASMB's current RSI reading is 20.23, suggesting that heavy selling may be exhausting itself, indicating a potential bounce back towards equilibrium in supply and demand [5]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that ASMB's earnings estimates for the current year have increased by 11.4% over the last 30 days, which often correlates with near-term price appreciation [7]. - ASMB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the stock's potential for a turnaround [8].

Core Viewpoint - Assembly Biosciences (ASMB) has received a Zacks Rank 2 (Buy) upgrade due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Correlation - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, particularly influenced by institutional investors who adjust their valuations based on these estimates [4][6]. - Rising earnings estimates for Assembly Biosciences indicate an improvement in the company's underlying business, suggesting potential for stock price appreciation [5]. Recent Performance and Projections - Assembly Biosciences is projected to earn -$6.78 per share for the fiscal year ending December 2025, reflecting a year-over-year change of -1.4% [8]. - Over the past three months, the Zacks Consensus Estimate for Assembly Biosciences has increased by 11.4%, indicating positive revisions in earnings estimates [8]. Zacks Rating System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating, highlighting superior earnings estimate revisions [9][10]. - The upgrade of Assembly Biosciences to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Commission File Number: 001-35005 ASSEMBLY BIOSCIENCES, INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from __________ to __________ (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Inc ...

Exhibit 99.1 Assembly Biosciences Reports Year End 2024 Financial Results and Recent Highlights – Four development candidates in clinical studies with data anticipated this year, continuing rapid progress of antiviral pipeline – – Interim Phase 1b proof-of-concept data, including initial efficacy measures, anticipated in fall 2025 for ABI- 5366 and ABI-1179, long-acting helicase-primase inhibitor candidates for recurrent genital herpes – SOUTH SAN FRANCISCO, Calif., March 20, 2025 – Assembly Biosciences, In ...

– Four development candidates in clinical studies with data anticipated this year, continuing rapid progress of antiviral pipeline – – Interim Phase 1b proof-of-concept data, including initial efficacy measures, anticipated in fall 2025 for ABI- 5366 and ABI-1179, long-acting helicase-primase inhibitor candidates for recurrent genital herpes – SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics ...

– Phase 1a study will evaluate single and multiple ascending doses of ABI-6250 in healthy participants with data expected in Q3 2025 – – Biomarker of ABI-6250 target engagement, serum bile acids, will be assessed in addition to safety and pharmacokinetic measures – SOUTH SAN FRANCISCO, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the first participant has ...

Core Insights - Assembly Biosciences, Inc. announced positive interim Phase 1a results for ABI-1179, a long-acting helicase-primase inhibitor targeting recurrent genital herpes [1][4] - The drug demonstrated a mean half-life of approximately four days, supporting a once-weekly oral dosing regimen, and was well-tolerated with a favorable safety profile [2][7][9] - The company plans to advance ABI-1179 into Phase 1b studies concurrently with ABI-5366, another investigational candidate, with interim data expected in fall 2025 [3][10] Study Overview - The Phase 1a study (ABI-1179-101) is a randomized, blinded, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of ABI-1179 in healthy participants [5] - Dosing has been completed for three cohorts (50 mg, 100 mg, and 300 mg), with a randomized allocation of 6:2 between ABI-1179 and placebo [5] Safety and Efficacy - ABI-1179 was well-tolerated across all evaluated doses, with mild treatment-emergent adverse events and no serious adverse events reported [9] - A self-limited grade 2 alanine transaminase elevation was noted in the highest dose cohort, but no significant ECG abnormalities or severe laboratory issues were observed [9] Future Plans - The Phase 1b study will evaluate multiple ascending doses of ABI-1179 in participants with recurrent genital herpes, focusing on safety, tolerability, pharmacokinetics, and antiviral activity [10][11] - The study will assess changes in viral parameters and clinical outcomes, including lesion recurrence rates [11] Industry Context - Recurrent genital herpes affects millions, with current treatments being only partially effective; no new drugs have been approved for over 25 years [13] - The helicase-primase inhibition mechanism has shown potential for superior efficacy compared to existing nucleoside analogs [14]

– ABI-4334 was well-tolerated with a favorable safety profile and half-life supporting once-daily oral dosing observed – – In the first 150 mg dose cohort, ABI-4334 showed strong antiviral activity with a mean reduction of 2.9 log IU/mL in plasma HBV DNA over 28 days of treatment – – Enrollment in final cohort of 400 mg ongoing with data anticipated in 1H 2025 – SOUTH SAN FRANCISCO, Calif., Dec. 26, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB), a biotechnology company developing innova ...

Core Insights - Assembly Biosciences, Inc. announced a $20.1 million equity investment from Gilead Sciences, increasing Gilead's ownership stake to 29.9% [1][5] - The collaboration includes an additional $10 million in accelerated funding to support the development of Assembly Bio's antiviral pipeline, particularly for hepatitis D virus candidate ABI-6250 [1][6] - The funding and investment are expected to extend Assembly Bio's cash runway to mid-2026 [6] Funding and Investment Details - Gilead's equity investment will raise its ownership from approximately 19.9% to 29.9% [5] - The $10 million accelerated funding is part of option-related payments for ABI-6250 and will be credited against future payments under the collaboration agreement [5] - The amendment to the collaboration agreement adjusts the option timepoints and payment structure for ABI-6250 to support accelerated development strategies [3][5] Clinical Pipeline Progress - The funding will support the advancement of Assembly Bio's clinical pipeline for antiviral candidates targeting herpesviruses, hepatitis D virus, and hepatitis B virus [2] - Assembly Bio plans to release data from multiple ongoing clinical studies, including interim Phase 1b data for ABI-5366 expected in the first half of 2025 [2] - Since the collaboration began in October 2023, Assembly Bio has initiated clinical studies for four antiviral candidates [4] Strategic Implications - The additional investment is seen as a strengthening of Assembly Bio's balance sheet, allowing for key clinical data readouts in 2025 [4] - The updated clinical plan for ABI-6250 aims to significantly reduce the development timeline for the compound [4] - The collaboration highlights the collective efforts of both organizations to change the treatment paradigm for serious viral diseases [4]