[Executive Summary](index=1&type=section&id=Executive%20Summary) Assembly Biosciences reported its second quarter 2025 financial results, highlighting significant progress in its clinical pipeline for herpes simplex virus (HSV), hepatitis B virus (HBV), and hepatitis delta virus (HDV) programs, with key data readouts anticipated in 2025 [Q2 2025 Overview](index=1&type=section&id=Q2%202025%20Overview) Assembly Biosciences reported its second quarter 2025 financial results, highlighting significant progress in its clinical pipeline for herpes simplex virus (HSV), hepatitis B virus (HBV), and hepatitis delta virus (HDV) programs, with key data readouts anticipated in 2025 - On track for proof-of-concept Phase 1b data for long-acting HSV helicase-primase inhibitor candidates, **ABI-5366** and **ABI-1179**, no later than fall 2025[1](index=1&type=chunk)[2](index=2&type=chunk) - Delivered positive topline data from Phase 1b study of **ABI-4334** (HBV) and interim data from Phase 1a study of **ABI-6250** (HDV), supporting target engagement[2](index=2&type=chunk) [Recent Business Highlights and Clinical Development](index=1&type=section&id=Second%20Quarter%202025%20and%20Recent%20Highlights) Assembly Bio made significant clinical progress in Q2 2025, reporting positive Phase 1b data for ABI-4334 (HBV), favorable interim Phase 1a data for ABI-6250 (HDV), and initiating Phase 1b dosing for ABI-1179 (HSV), with key data readouts expected in fall 2025 [Key Clinical Trial Progress](index=1&type=section&id=Key%20Clinical%20Trial%20Progress) Assembly Bio reported positive topline Phase 1b results for ABI-4334 in chronic HBV, demonstrating strong antiviral activity. Interim Phase 1a data for ABI-6250 in HDV showed favorable pharmacokinetics for once-daily dosing and biomarker evidence of target engagement. Dosing for ABI-1179 in its Phase 1b HSV trial was initiated, with IND clearance for US expansion - Positive topline Phase 1b data reported for **ABI-4334** (HBV) met target clinical profile, showing strong antiviral activity[4](index=4&type=chunk)[5](index=5&type=chunk) - Interim Phase 1a data for **ABI-6250** (HDV) in healthy volunteers showed pharmacokinetics supportive of once-daily oral dosing and biomarker data indicating engagement of its NTCP target[4](index=4&type=chunk)[5](index=5&type=chunk) - Initiated dosing in the Phase 1b portion of the ongoing Phase 1a/b trial for **ABI-1179** (HSV) and received IND clearance for study expansion to US sites[5](index=5&type=chunk) [Anticipated Milestones and Events](index=2&type=section&id=Anticipated%20Milestones%20and%20Events) The company anticipates reporting interim efficacy, safety, and PK data from Phase 1b studies for HSV candidates ABI-5366 and ABI-1179 in fall 2025. Preclinical profiling of ABI-6250 has been accepted for oral presentation at the International HBV Meeting in September 2025 - Interim efficacy, safety, and PK data from Phase 1b studies for **ABI-5366** and **ABI-1179** (HSV) are expected in fall 2025, evaluating weekly (and monthly for ABI-5366) oral dosing over a 28-day period[9](index=9&type=chunk) - An abstract describing preclinical profiling of **ABI-6250** has been accepted for oral presentation at the International HBV Meeting, September 8-12, 2025[9](index=9&type=chunk) - **ABI-1179** was contributed by Gilead Sciences, Inc. under the collaboration between Assembly Bio and Gilead[7](index=7&type=chunk) [Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Assembly Bio reported a reduced net loss in Q2 2025, driven by increased collaboration revenue and controlled R&D expenses, with sufficient cash to fund operations into mid-2026 [Q2 2025 Financial Results Summary](index=2&type=section&id=Q2%202025%20Financial%20Results%20Summary) Assembly Bio reported a net loss of $10.2 million for Q2 2025, an improvement from $11.2 million in Q2 2024. Collaboration revenue increased, while R&D expenses slightly decreased due to reduced spending on ABI-6250. The company's cash position is projected to fund operations into mid-2026 Q2 2025 Key Financial Highlights | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :-------------------------------- | :-------------------- | :-------------------- | :----------- | | Cash, cash equivalents & marketable securities (as of period end) | $75.0 (June 30) | $91.0 (March 31) | -$16.0 | | Collaboration Revenue (Gilead) | $9.6 | $8.5 | +$1.1 | | Research and Development Expenses | $16.1 | $16.3 | -$0.2 | | General and Administrative Expenses | $4.6 | $4.5 | +$0.1 | | Net Loss attributable to common stockholders | $10.2 | $11.2 | -$1.0 | | Net Loss per basic and diluted share | $1.33 | $1.98 | -$0.65 | - Cash, cash equivalents and marketable securities were **$75.0 million** as of June 30, 2025, projected to fund operations into mid-2026[10](index=10&type=chunk) - Research and development expenses decreased primarily due to a decrease in spending on **ABI-6250**, which had significant preclinical and Phase 1a start-up activities in 2024[10](index=10&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2025, total assets decreased to $80.78 million from $119.17 million at December 31, 2024, primarily driven by a reduction in cash, cash equivalents, and marketable securities. Total liabilities also decreased, while stockholders' equity saw a reduction Condensed Consolidated Balance Sheets (Key Figures) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $24,006 | $38,344 | -$14,338 | | Marketable securities | $50,974 | $73,735 | -$22,761 | | Total current assets | $77,467 | $115,503 | -$38,036 | | Total assets | $80,780 | $119,168 | -$38,388 | | Total liabilities | $62,680 | $85,809 | -$23,129 | | Total stockholders' equity | $18,100 | $33,359 | -$15,259 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) For the three months ended June 30, 2025, collaboration revenue increased by 12.8% year-over-year, while total operating expenses remained relatively flat. The net loss decreased to $10.2 million from $11.2 million in the prior year period, and net loss per share improved significantly Condensed Consolidated Statements of Operations (Q2 2025 vs Q2 2024) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------- | | Collaboration revenue | $9,626 | $8,533 | +$1,093 (12.8%) | | Research and development expenses | $16,125 | $16,259 | -$134 (-0.8%) | | General and administrative expenses | $4,594 | $4,477 | +$117 (2.6%) | | Total operating expenses | $20,719 | $20,736 | -$17 (-0.1%) | | Loss from operations | $(11,093) | $(12,203) | +$1,110 | | Net loss | $(10,198) | $(11,152) | +$954 | | Net loss per share, basic and diluted | $(1.33) | $(1.98) | +$0.65 | Condensed Consolidated Statements of Operations (Six Months Ended June 30, 2025 vs 2024) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :----------------------------- | :----------------------------- | :----------- | | Collaboration revenue | $19,045 | $14,318 | +$4,727 (33.0%) | | Research and development expenses | $30,976 | $28,138 | +$2,838 (10.1%) | | General and administrative expenses | $9,103 | $9,112 | -$9 (-0.1%) | | Total operating expenses | $40,079 | $37,250 | +$2,829 (7.6%) | | Loss from operations | $(21,034) | $(22,932) | +$1,898 | | Net loss | $(19,016) | $(20,229) | +$1,213 | | Net loss per share, basic and diluted | $(2.51) | $(3.64) | +$1.13 | [Additional Information](index=3&type=section&id=About%20Assembly%20Biosciences) This section provides an overview of Assembly Biosciences, its therapeutic focus, forward-looking statement disclaimers, and contact information [About Assembly Biosciences](index=3&type=section&id=About%20Assembly%20Biosciences) Assembly Biosciences is a biotechnology company focused on developing innovative small-molecule therapeutics to address serious viral diseases, specifically herpesvirus, hepatitis B virus (HBV), and hepatitis delta virus (HDV) infections - Assembly Biosciences is a biotechnology company developing innovative small-molecule therapeutics for serious viral diseases[12](index=12&type=chunk) - The company is committed to improving outcomes for patients with herpesvirus, hepatitis B virus (HBV), and hepatitis delta virus (HDV) infections[12](index=12&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains standard forward-looking statements, highlighting various risks and uncertainties that could cause actual results to differ materially. These include the company's ability to maintain financial resources, realize benefits from its collaboration with Gilead, initiate and complete clinical studies, and the potential impact of regulatory changes - Forward-looking statements are subject to risks and uncertainties, including the ability to maintain financial resources, secure additional funding, and realize benefits from the Gilead collaboration[13](index=13&type=chunk) - Risks also include the ability to initiate and complete clinical studies in anticipated timeframes, and that safety and efficacy data may not warrant further development or differentiate product candidates[13](index=13&type=chunk) - Such statements are intended to be covered by the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934[13](index=13&type=chunk) [Contacts](index=4&type=section&id=Contacts) This section provides contact information for investor relations and media inquiries - Investor and Corporate Contact: Shannon Ryan, SVP, Investor Relations, Corporate Affairs and Alliance Management, (415) 738-2992, investor_relations@assemblybio.com[14](index=14&type=chunk) - Media Contact: Alyssa Kuciunas, Sam Brown Healthcare Communications, (331) 481-3751, ASMBMedia@sambrown.com[14](index=14&type=chunk)

Core Insights - Assembly Biosciences, Inc. announced interim data from the Phase 1a clinical trial of ABI-6250, a small molecule hepatitis delta virus (HDV) entry inhibitor, showing a mean half-life of four days and supporting a target daily oral dosing profile [1][2][4] Study Overview - The ongoing Phase 1a study, ABI-6250-101, is randomized, blinded, and placebo-controlled, evaluating safety, tolerability, and pharmacokinetics (PK) of ABI-6250 with dosing completed in various cohorts [5][6] - Doses evaluated include single doses of 5 mg and 25 mg, and multiple doses of 0.05 mg, 0.2 mg, and 1 mg, with multiple-dose cohorts receiving repeat daily dosing over 10 days [5] Pharmacokinetics - A mean half-life of approximately four days was observed for ABI-6250, supporting once-daily oral dosing [7] - Accumulation was noted in multiple-dose cohorts, with exposures on the last day of dosing reaching 6- to 7-fold higher than after the first dose [7] Biomarkers - Dose-dependent elevations of total serum bile acids (TBA) were observed in both single-dose cohorts, indicating NTCP target engagement [8][9] - In the highest single-dose cohort of 25 mg, elevated levels of coproporphyrin I (CP-1) were also noted, suggesting off-target engagement [8][11] Safety Profile - Treatment-emergent adverse events (AEs) were primarily grade 1 or 2, with no serious AEs reported [10] - One grade 2 alanine transaminase (ALT) elevation was observed in the highest single-dose cohort, with all elevations being self-limited and not associated with bilirubin or other liver injury markers [11] Future Plans - The company plans to further explore ABI-6250's pharmacologic and biologic profile in preparation for Phase 2 clinical studies, addressing the critical need for new treatment options for chronic HDV infection [4][12]

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]

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]

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]

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]

Core Insights - Assembly Biosciences, Inc. announced positive topline results from a Phase 1b study of ABI-4334, demonstrating favorable safety, tolerability, and pharmacokinetics for once-daily oral dosing in chronic hepatitis B virus (HBV) infection [1][3][4] Efficacy and Safety - In the 400 mg cohort, mean plasma HBV DNA reductions of 3.2 logs IU/mL were observed over 28 days, consistent with the 150 mg cohort, indicating effective viral replication inhibition [1][2][10] - ABI-4334 showed a favorable safety profile with no serious adverse events reported, and only two grade three treatment-emergent lab abnormalities were noted, both of which resolved [8][9] Pharmacokinetics - The pharmacokinetic data indicated that ABI-4334 maintained exposure levels significantly above those required for potent antiviral activity and inhibition of cccDNA formation, supporting its once-daily dosing regimen [4][10] - Slightly higher than dose-proportional increases in clinical pharmacokinetic exposures were observed from the 150 mg to the 400 mg dose [10] Collaboration and Future Steps - The completion of the trial triggers an opt-in point for Gilead Sciences, Inc. to review the option data package for potential exclusive licensing of ABI-4334 for further development and commercialization [1][5] - Discussions regarding the next steps for ABI-4334 will be supported by the trial results as Gilead evaluates its options [3][5]

Assembly Biosciences (ASMB) 2025 Conference June 04, 2025 08:45 AM ET Speaker0 Good morning everyone. Welcome to the Jefferies Healthcare Conference. My name is Anthea Lee, part of the Healthcare Research Team here at Jefferies. We're very fortunate to have Assembly Biosciences with us today. We have Jason Okazaki, CEO, and CMO Anuj Ghajar. Welcome. For those that are new to the story, perhaps we just start with a quick overview of the company, the pipeline and key catalysts that you see coming up for the r ...

Company Overview - Assembly Biosciences, Inc. is a biotechnology company focused on developing innovative small-molecule therapeutics aimed at serious viral diseases, including herpesvirus, hepatitis B virus (HBV), and hepatitis delta virus (HDV) infections [2] Upcoming Event - Jason Okazaki, CEO, and Anuj Gaggar, CMO, will present in a fireside chat at the Jefferies 2025 Global Healthcare Conference on June 4, 2025, at 8:45 a.m. Eastern Time [1] - A live webcast of the event will be available on Assembly Bio's website, with a replay accessible afterward [1] Leadership and Commitment - The company is led by a team experienced in virologic drug development, demonstrating a commitment to improving patient outcomes affected by chronic viral infections [2]

Core Viewpoint - Assembly Biosciences reported a quarterly loss of $1.17 per share, significantly better than the Zacks Consensus Estimate of a loss of $2.01, indicating a positive earnings surprise of 41.79% [1] Financial Performance - The company posted revenues of $9.42 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 21.38%, compared to $5.79 million in the same quarter last year [2] - Over the last four quarters, Assembly Biosciences has surpassed consensus EPS estimates four times and topped consensus revenue estimates three times [2] Stock Performance - Assembly Biosciences shares have declined approximately 21.4% since the beginning of the year, contrasting with the S&P 500's decline of 4.3% [3] - The company's current Zacks Rank is 2 (Buy), suggesting that the shares are expected to outperform the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$1.59 on revenues of $8.19 million, and for the current fiscal year, it is -$6.78 on revenues of $33.7 million [7] - The trend of estimate revisions for Assembly Biosciences is currently favorable, which could influence future stock movements [5][6] Industry Context - The Medical - Generic Drugs industry, to which Assembly Biosciences belongs, is currently ranked in the top 18% of over 250 Zacks industries, indicating a strong industry performance potential [8]