Summary of Assembly Biosciences FY Conference Call Company Overview - **Company**: Assembly Biosciences (NasdaqGS: ASMB) - **Focus**: Originally a capsid assembly modulator company targeting Hepatitis B Virus (HBV), now expanded to include herpes virus treatments, particularly for recurrent genital herpes [3][4] Recent Developments - **Pipeline Expansion**: The company has developed two lead compounds for recurrent genital herpes, 5366 and 1179, both currently in phase 1b trials [3][4] - **Positive Data**: Recently announced positive interim data for 5366, showing significant efficacy in reducing viral shedding and lesions [10][12][13] Market Opportunity - **Unmet Need**: There is a significant unmet need in the genital herpes market, with the last treatment approval nearly 20 years ago. Many patients experience multiple recurrences annually, and current treatments are inadequate [5][6] - **Patient Population**: Focus on patients with three to ten lesions per year, who often rely on daily suppressive therapy with valacyclovir, which has a high failure rate [5][6] Product Details - **5366**: A helicase-primase inhibitor, 400 times more potent than valacyclovir, with a 20-day half-life, designed for long-acting oral or injectable use [8][9] - **1179**: Discovered at Gilead, approximately 1,000 times more potent than valacyclovir, with a four-day half-life, supporting potential once-a-week treatment [8][9] Clinical Data Highlights - **Efficacy Results**: In the phase 1b trial for 5366, there was over a 90% reduction in shedding rates and a 98% reduction in high viral load swabs compared to placebo. Additionally, there was a greater than 90% reduction in lesions [12][13] - **Safety Data**: Upcoming unblinded safety data for 5366 will be shared in December, with expectations of confirming its well-tolerated profile [17][22] Future Plans - **Phase 2 Trials**: Plans to conduct head-to-head trials against valacyclovir, focusing on longer duration studies to evaluate efficacy and safety [26][31] - **Market Potential**: Estimated market size for recurrent genital herpes treatment in the U.S. is around 1.3-1.4 million patients, with over 800,000 on chronic suppressive therapy, indicating a multi-billion dollar market opportunity [33] Additional Programs - **Hepatitis Delta**: Development of an oral small molecule (6250) targeting the same mechanism as Gilead's Bulevirtide, with promising phase 1 results [36][39] - **Hepatitis B**: Ongoing development of a capsid assembly modulator (4334) with high antiviral effects, awaiting Gilead's review for potential opt-in [42][43] Financial Position - **Cash Reserves**: The company reported a cash position of over $230 million, expected to last until at least the end of 2027, with additional contributions from Gilead anticipated [43][44] Conclusion - **Strategic Collaboration**: The partnership with Gilead provides optionality for advancing both HSV and HBV programs, with a focus on bringing effective treatments to market quickly [44]

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 September 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 (St ...

Financial Performance - Assembly Biosciences reported a net loss of $9.2 million, or $0.72 per share, for Q3 2025, compared to a net loss of $9.6 million, or $1.51 per share, in Q3 2024[12]. - Cash, cash equivalents, and marketable securities totaled $232.6 million as of September 30, 2025, compared to $75.0 million as of June 30, 2025, providing a cash runway projected to fund operations into late 2027[8]. - Assembly Biosciences raised $175 million in gross proceeds from equity financing, enhancing its financial position to support ongoing and future clinical development[3]. - Research and development expenses increased to $16.6 million for Q3 2025, compared to $13.5 million in Q3 2024, primarily due to spending on the HSV program[12]. - Total operating expenses for Q3 2025 were $21.7 million, up from $17.8 million in the same period in 2024[12]. Research and Development - Revenue from collaborative research with Gilead was $10.8 million for Q3 2025, up from $6.8 million in the same period in 2024, reflecting increased research and development activities[12]. - Positive interim results were released from the Phase 1b study of ABI-5366, showing significant reductions in HSV-2 shedding and genital lesion rates in participants with recurrent genital herpes[4]. - Enrollment was completed in the ongoing Phase 1b studies for both ABI-5366 and ABI-1179, with additional data updates expected by the end of the year[4]. - The Phase 1a study of ABI-6250 demonstrated a pharmacokinetic profile supporting once-daily dosing, leading to its progression into Phase 2 evaluation[9]. - The initiation of a Phase 2 clinical study of ABI-5366 is anticipated in mid-2026[9].

Core Insights - Assembly Biosciences, Inc. reported significant progress in its clinical pipeline, particularly with positive interim results for its long-acting helicase-primase inhibitor candidate ABI-5366 in recurrent genital herpes [1][3] - The company raised $175 million in gross proceeds from equity financing, enhancing its financial position to support ongoing and future clinical developments [1][13] Herpes Simplex Virus (HSV) Developments - Positive Phase 1b interim results for ABI-5366 showed significant reductions in viral shedding and genital lesion rates in participants with recurrent genital herpes [1][7] - Enrollment in the Phase 1b study for ABI-5366 and two cohorts for ABI-1179 has been completed, with additional data expected by the end of the year [1][3][7] Hepatitis D Virus (HDV) Developments - Interim results from a Phase 1a study of ABI-6250, an oral HDV entry inhibitor, support progression to Phase 2 evaluation [1][7] - The pharmacokinetic profile of ABI-6250 indicates potential for once-daily dosing, with dose-dependent increases in a biomarker of target engagement [1][7] Financial Performance - Cash, cash equivalents, and marketable securities totaled $232.6 million as of September 30, 2025, compared to $75.0 million as of June 30, 2025, providing a cash runway into late 2027 [13] - Revenue from collaborative research with Gilead was $10.8 million for the three months ended September 30, 2025, an increase from $6.8 million in the same period in 2024 [13] - Research and development expenses rose to $16.6 million for the third quarter of 2025, up from $13.5 million in the same period in 2024, primarily due to increased spending on the HSV program [13]

Core Insights - Assembly Biosciences, Inc. announced positive Phase 1b clinical data for its investigational capsid assembly modulator ABI-4334, showcasing a favorable safety profile and significant reductions in viral nucleic acids [1][2][3] Group 1: Clinical Data - The Phase 1b study involved two cohorts of predominantly HBeAg-negative subjects, evaluating 150 mg and 400 mg oral doses of ABI-4334 administered once daily for 28 days [3] - ABI-4334 demonstrated well-tolerated results at both dose levels, with multi-log declines in hepatitis B virus (HBV) DNA and pregenomic RNA (pgRNA) observed, indicating effective suppression of viral replication [3] - The study results support the potential of ABI-4334 to maximize antiviral activity as part of multi-drug combination regimens targeting chronic hepatitis B infection [2][3] Group 2: Presentation and Collaboration - The complete Phase 1b data was presented in a late-breaking poster at the American Association for the Study of Liver Diseases (AASLD) conference, marking the first scientific presentation of these findings [1][2] - Under a collaboration agreement with Gilead Sciences, Gilead has the option to obtain an exclusive license for further development and commercialization of ABI-4334 after reviewing the data package post-Phase 1b study [4]

Core Insights - Assembly Biosciences, Inc. (NASDAQ:ASMB) is highlighted as a top long-term biotechnology stock to consider for investment [1] - H.C. Wainwright has reaffirmed a Buy rating and a price target of $50 for Assembly Biosciences following promising interim data for ABI-5366, an oral treatment for recurrent genital herpes [2] Company Overview - Assembly Biosciences focuses on developing and commercializing small-molecule therapies for serious viral diseases, particularly chronic hepatitis B virus (HBV) and herpesviruses [2] Clinical Development - The interim data presented for ABI-5366 demonstrated strong antiviral activity, favorable tolerability, and a dosing profile that supports weekly or monthly administration [2] - These results are seen as a validation of Assembly's helicase-primase inhibitor platform, reducing the risk associated with advancing ABI-5366 into Phase 2 trials [2] - The company plans to initiate Phase 2 clinical studies by mid-2026, indicating ongoing progress in its antiviral pipeline [2]

Core Insights - The article highlights stocks reaching new 52-week highs, indicating market recognition of strong fundamentals and potential catalysts for growth [1][2]. Company Summaries Cogent Biosciences Inc. (COGT) - Cogent Biosciences plans to file its first New Drug Application for Bezuclastinib by the end of 2025, targeting non-advanced systemic mastocytosis [3]. - A phase III trial comparing Bezuclastinib with Sutent is ongoing, with results expected in the second half of 2025 [4]. - The stock reached a 52-week high of $16.99, up from $7.25 when last featured [5]. Assembly Biosciences Inc. (ASMB) - Assembly Biosciences is advancing four key development programs, with ABI-5366 expected to enter phase 2 studies in mid-2026 [6]. - Interim data for ABI-1179 is anticipated this fall, while ABI-6250 is in a phase 1a trial [7]. - The stock hit a 52-week high of $28, up from $14.53 when last featured [8]. Compass Therapeutics Inc. (CMPX) - Compass Therapeutics is conducting a phase 2/3 study of Tovecimig for advanced biliary tract cancer, with analyses of secondary endpoints expected in Q1 2026 [9][10]. - The stock reached a 52-week high of $4.39, up from $2.91 when last featured [11]. NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam Pharma is developing Obicetrapib as a cholesterol-lowering therapy, with positive data from the BROADWAY trial [12][13]. - The company has completed two additional phase III trials and submitted marketing applications to the EMA [16]. - The stock reached a 52-week high of $39.76, up from $21.56 when last featured [17]. Mineralys Therapeutics Inc. (MLYS) - Mineralys is developing Lorundrostat for uncontrolled hypertension, with a pivotal phase III trial achieving its primary endpoint [19]. - A phase II trial for overweight participants with OSA is ongoing, with topline results expected in 1H 2026 [20]. - The stock hit a 52-week high of $43.88, up from $10.34 when last featured [20]. Kymera Therapeutics Inc. (KYMR) - Kymera is set to report data from its phase I trial of KT-621 this quarter, with phase 2b studies planned for late 2025 and early 2026 [21][22]. - The stock reached a 52-week high of $60, up from $40 when last featured [22]. Insmed Inc. (INSM) - Insmed has two approved drugs and is conducting a phase 3 trial of Arikayce, with topline results expected in 1H 2026 [24][25]. - The stock hit a high of $166.54, up from $76.54 when last featured [26]. Adaptive Biotechnologies Corp. (ADPT) - Adaptive Biotechnologies expects MRD revenue between $190 million and $200 million for 2025, up from $145.5 million in 2024 [28][29]. - The stock reached a 52-week high of $15.94, up from $9.80 when last featured [29]. BridgeBio Pharma Inc. (BBIO) - BridgeBio has upcoming topline results from the FORTIFY and CALIBRATE studies expected in Fall 2025 [30]. - The stock reached a 3-year high of $56.24, up from $25.10 when last featured [31]. Tarsus Pharmaceuticals Inc. (TARS) - Tarsus reported strong sales for Xdemvy, with Q2 2025 sales of $102.7 million, compared to $40.8 million in Q2 2024 [32]. - The stock hit an all-time high of $70.15, up from $25.01 when last featured [34]. Palvella Therapeutics Inc. (PVLA) - Palvella's QTORIN is under development for various skin diseases, with a phase 2 trial expected to report data in mid-December 2025 [35][36]. - The stock reached a 52-week high of $76.76, up from $25 when last featured [36]. Merus N.V. (MRUS) - Merus agreed to be acquired by Genmab for $97 per share, with the deal expected to close in early Q1 2026 [37]. - The stock was at $39.71 when last featured [39]. Nephros Inc. (NEPH) - Nephros reported net revenue of $4.4 million for Q2 2025, marking its third consecutive quarter of profitability [40][41]. - The stock hit a 52-week high of $5.98, up from $2.93 when last featured [42].

Core Insights - Assembly Biosciences, Inc. is participating in two upcoming investor conferences to discuss its innovative therapeutics targeting serious viral diseases [1][2][3] Group 1: Upcoming Events - Anuj Gaggar, MD, PhD, the chief medical officer, will present a pre-recorded fireside chat at the H.C. Wainwright Liver Disease Virtual Conference on October 21, 2025, starting at 7 a.m. Eastern Time [2] - Jason Okazaki, CEO and president, along with Dr. Gaggar, will present during the Guggenheim 2nd Annual Healthcare Innovation Conference on November 12, 2025, at 11 a.m. Eastern Time [3] - Webcast registration for both events is available on Assembly Biosciences' website, with replays accessible after each event [3] Group 2: Company Overview - Assembly Biosciences is focused on developing small-molecule therapeutics aimed at serious viral diseases, particularly targeting herpesvirus, hepatitis B virus (HBV), and hepatitis delta virus (HDV) infections [4] - The company is led by a team experienced in virologic drug development, emphasizing its commitment to improving patient outcomes [4]

Core Insights - Assembly Biosciences, Inc. presented interim Phase 1b clinical data for its HSV helicase-primase inhibitor candidate ABI-5366 at the IUSTI Congress, highlighting its potential to improve treatment for recurrent genital herpes [1][2] Clinical Data Summary - The interim data showed significant antiviral activity, with a 94% reduction in HSV-2 shedding rate, a 98% decrease in high viral load shedding rate, and a 94% reduction in genital lesion rate in the 350 mg weekly dosing cohort compared to placebo [3][9] - ABI-5366 was well tolerated at both the 30 mg and 350 mg doses evaluated in the study [2][3] Future Development Plans - A monthly dosing regimen of ABI-5366 is currently under evaluation, and interim data from both ABI-5366 and ABI-1179 studies are expected to be shared later this fall [4][9] - The company plans to initiate Phase 2 clinical studies of ABI-5366 in mid-2026 [4] Collaboration and Licensing - Under a collaboration agreement with Gilead Sciences, Gilead has the option to obtain an exclusive license for further development and commercialization of the helicase-primase inhibitor program after reviewing the data package post-Phase 1b studies [6][7] Market Context - Recurrent genital herpes affects over four million people in the U.S. and several European countries, with current treatment options being limited and no new therapies approved in over two decades [8][10] - The current standard of care is nucleoside analogs, which are only partially effective in preventing recurrences and reducing transmission [10][11]

Core Insights - Four biotechnology stocks have surged into the top 10th percentile for momentum ranking, indicating strong technical strength and price action [1][2] Group 1: Momentum Ranking - Arrowhead Pharmaceuticals Inc. (ARWR), Assembly Biosciences Inc. (ASMB), Atara Biotherapeutics Inc. (ATRA), and Corcept Therapeutics Inc. (CORT) have shown significant momentum percentile increases, making them stand out in the competitive biotech sector [2][5] - Joining the top decile for momentum ranking means these stocks are outperforming 90% of all tracked stocks in terms of price appreciation and volatility-adjusted returns [5] Group 2: Individual Stock Performance - ARWR's momentum percentile increased from 89.87 to 93.79, with a week-on-week gain of 3.92 percentage points; the stock has risen by 66.92% year-to-date and 69.33% over the year [7] - ASMB moved from 87.58 to 93.13, posting a 5.55 percentage point increase; it is up 43.85% YTD and 62.95% over the year [7] - ATRA climbed from 88.24 to 92.76, translating to a weekly gain of 4.52 percentage points; the stock has declined 2.97% YTD but advanced 69.00% over the year [8] - CORT advanced from 88.05 to 90.50, achieving a week-on-week improvement of 2.45 percentage points; it has risen by 67.84% YTD and 81.22% over the year [8]