Core Insights - Aligos Therapeutics is progressing with the Phase 2 B-SUPREME study of pevifoscorvir sodium for chronic hepatitis B virus (HBV) infection, with interim analyses scheduled for 2026 [1][2] Study Progress - The Phase 2 B-SUPREME study currently has 144 subjects enrolled globally, with expectations for interim analyses to provide insights on study tracking [2] - The first interim analysis will include approximately 60% (36) of HBeAg- participants who have completed 12 weeks of treatment, expected in the first half of 2026 [3] - A second interim analysis is planned for when about 50% (55) of HBeAg+ participants complete 24 weeks of treatment, anticipated in the second half of 2026 [4] Regulatory Compliance - To maintain study integrity and comply with FDA regulations, the company will remain blinded to subject-level data and will receive insights from the Data Safety Monitoring Board [5] Leadership Update - Hardean Achneck, MD has resigned as Executive Vice President and Chief Medical Officer, and a search for his successor is underway [6] Study Details - The Phase 2 B-SUPREME study is a randomized, double-blind, active-controlled multicenter trial evaluating the safety and efficacy of ALG-000184 monotherapy compared to tenofovir disoproxil fumarate in approximately 200 untreated adult subjects with chronic HBV infection for 48 weeks [7] - The primary endpoint for HBeAg- participants is HBV DNA <LLOQ (10 IU/mL), while for HBeAg+ participants, it is also HBV DNA <LLOQ (10 IU/mL) [7] Product Information - Pevifoscorvir sodium, previously known as ALG-000184, is a potential first-in-class oral small molecule capsid assembly modulator being developed for chronic HBV infection [8] - Phase 1 studies have shown that pevifoscorvir sodium is well-tolerated, with no safety signals and demonstrated linear pharmacokinetics and excellent antiviral activity [8]

Core Insights - Aligos Therapeutics has appointed James Hassard as Executive Vice President and Chief Commercial Officer to enhance its global commercial capabilities [1][2] - The company is advancing the Phase 2 B-SUPREME study of pevifoscorvir sodium and is preparing for its commercial launch [2] - Aligos focuses on developing therapies for liver and viral diseases, with a strong emphasis on chronic hepatitis B virus infection and other high unmet medical needs [3] Company Overview - Aligos Therapeutics, Inc. is a clinical stage biotechnology company dedicated to improving patient outcomes through innovative therapies for liver and viral diseases [3] - The company utilizes a science-driven approach and has a purpose-built pipeline targeting conditions such as chronic hepatitis B virus infection, obesity, metabolic dysfunction-associated steatohepatitis, and coronaviruses [3] Leadership Background - James Hassard brings extensive experience in building commercial organizations across various therapeutic areas, having previously served as Chief Commercial Officer at Crinetics Pharmaceuticals and Arrowhead Pharmaceuticals [2] - His career includes significant roles at Coherus Oncology, Amgen, and Merck, where he launched multiple pharmaceutical products in areas including hepatitis, oncology, and nephrology [2] - Hassard holds a Bachelor of Science in Pharmacology and an MBA, indicating a strong educational background relevant to his new role [2]

Core Insights - Aligos Therapeutics, Inc. announced positive data from four presentations at the HEP-DART 2025 Meeting, showcasing advancements in therapies for liver and viral diseases [1][2] Pevifoscorvir Sodium Data - The Phase 1 monotherapy study of pevifoscorvir sodium for chronic hepatitis B virus (HBV) infection demonstrated its potential as a first-line therapy, with complete 96-week and post-treatment follow-up data indicating continued efficacy [3][6] ALG-055009 Data - New in vivo data from studies on diet-induced obese mice showed that the combination of ALG-055009 with incretin receptor agonists resulted in significant weight loss, with SEMA monotherapy achieving a maximum of 23.9% body weight loss, while the combination with ALG-055009 led to an additional 8.6% decrease for a total of 33% [4][5] - TIRZEP monotherapy resulted in a maximum of 27.1% and 34.4% body weight loss for low and high doses respectively, with combinations yielding up to 40% weight loss [4][5] Synergistic Effects - The combination therapy of ALG-055009 with incretin receptor agonists primarily resulted in fat mass loss without significantly affecting lean mass or food consumption, indicating a beneficial addition to existing therapies for weight loss [5][6] Future Directions - The company expressed enthusiasm for the potential of both pevifoscorvir sodium and ALG-055009, highlighting their commitment to advancing next-generation therapies for chronic HBV and metabolic diseases [6][9]

Core Insights - Aligos Therapeutics has a significant Phase II pipeline, with a focus on hepatitis B treatment through its lead program, pevifoscorvir (previously known as ALG-184) [2][3] - The company is also developing a beta thyroid agonist, ALG-009, which has completed Phase IIa testing, along with preclinical results in obesity [2] - Additionally, Aligos is working on a pan-coronavirus protease inhibitor currently in a Phase II study funded by the MRC in the U.K. [3] Company Pipeline - The lead program, pevifoscorvir, targets chronic hepatitis B virus (HBV) infection, which is recognized as the largest chronic viral infection globally [2][3] - The beta thyroid agonist, ALG-009, has shown promising results in Phase IIa testing [2] - The preclinical portfolio includes an antisense oligonucleotide targeting both hepatitis B and hepatitis delta viruses [3]

Summary of Aligos Therapeutics Conference Call Company Overview - **Company**: Aligos Therapeutics (NasdaqCM:ALGS) - **Event**: Jefferies' London Healthcare Conference - **Date**: November 17, 2025 Key Points on Aligos Therapeutics and its Pipeline Lead Programs - **PEVY/PhosCovir**: Lead program targeting hepatitis B, previously known as ALG-000184 [2][3] - **ALG-009**: A beta thyroid agonist that has completed phase 2A testing, with potential applications in obesity and metabolic diseases [2][20] - **Pan-coronavirus protease inhibitor**: Currently undergoing a phase 2 study in the UK funded by the MRC [2] Hepatitis B Virus (HBV) Insights - **Prevalence**: Approximately 250 million patients globally, with significant populations in China (70 million), the US (2-2.5 million), and Western Europe (14 million) [3] - **Current Treatments**: Standard care includes nucleoside analogs and pegylated interferon, but these have limitations, including progression to end-stage liver disease and liver cancer [4][5] - **Unmet Medical Need**: A study indicated that 4% of patients on nucleoside therapy developed hepatocellular carcinoma over five years, highlighting the need for more effective treatments [4] Mechanism of Action for PEVY - **Capsid Assembly Modulators**: PEVY is designed to block both the replication of HBV and the establishment of cccDNA, which is crucial for the virus's persistence [8][9] - **Pharmacological Improvements**: Oral bioavailability of PEVY was increased from 5% to 80% through laboratory modifications [9] - **Clinical Results**: In early studies, PEVY demonstrated significant reductions in HBV DNA, outperforming standard nucleoside therapies [11][12] Clinical Trial Data - **Efficacy**: By week 48, 60% of E positive patients were below the limit of quantitation for HBV DNA, and 100% of E negative patients achieved similar results [12][13] - **Comparison with Standard Care**: PEVY showed a greater log reduction in HBV DNA compared to tenofovir, a standard nucleoside analog [11][13] - **Safety Profile**: No patients discontinued therapy due to adverse events, indicating a favorable safety profile [15] Future Directions - **Ongoing Studies**: A phase 2 clinical study comparing PEVY to TDF is underway, with an interim analysis expected early next year [17][19] - **Potential for Standard of Care**: PEVY is positioned to become the standard for chronic suppression of HBV, especially for patients not eligible for functional cure therapies [19] ALG-009 Developments - **Potency and Selectivity**: ALG-009 has shown to be significantly more potent than existing beta thyroid agonists, with a favorable pharmacokinetic profile [20][21] - **Phase 2b Readiness**: The drug is ready to enter phase 2b trials, with promising data on fat reduction in liver disease [21] Additional Insights - **Resistance Mechanism**: PEVY has shown no emergence of drug-resistant variants in clinical studies, which is a significant advantage over previous capsid assembly modulators [24][25] - **Regulatory Considerations**: The ability to conduct monotherapy with PEVY is crucial for FDA approval for chronic suppression, differentiating it from previous therapies that required combination treatments [25] This summary encapsulates the critical aspects of Aligos Therapeutics' conference call, focusing on their innovative approaches to treating hepatitis B and metabolic diseases, as well as the promising data from their clinical trials.

Core Insights - Aligos Therapeutics, Inc. announced positive data from eight presentations at the AASLD The Liver Meeting® 2025, showcasing the potential of their therapy for liver and viral diseases [1][2]. Pevifoscorvir Sodium Data - Pevifoscorvir sodium demonstrated significant efficacy in treating chronic hepatitis B virus (HBV) infection, with 75% of HBeAg+ subjects maintaining HBV DNA levels below the lower limit of quantification (LLOQ) after transitioning to nucleos(t)ide analog (NA) monotherapy [2][6]. - In HBeAg- subjects, 100% maintained HBV DNA < LLOQ during the follow-up period, indicating strong viral suppression [2][5]. - The therapy showed a rapid and durable reduction in HBV DNA levels, with 60% of HBeAg+ subjects achieving HBV DNA < LLOQ by Week 48, increasing to 100% by Week 96 [4][6]. Mechanism of Action - Preclinical data indicated that ALG-001075, the active component of pevifoscorvir sodium, can prevent cccDNA formation and HBV DNA integration, suggesting a novel mechanism of action [3][8]. - The therapy's ability to reduce HBV antigens and RNA during NA therapy indicates its potential to inhibit cccDNA establishment [6][7]. Presentation Highlights - The oral presentation by Professor Man-Fung Yuen emphasized the first-in-class potential of pevifoscorvir sodium, reinforcing its impact on the HBV lifecycle [9]. - Multiple poster presentations showcased ongoing research and innovation in HBV treatment, including differentiation of capsid assembly modulators and their effects on HBV core protein [10][11]. Future Directions - The company is advancing the Phase 2 B-SUPREME study and is optimistic about the progress of its HBV ASO program, which has shown promising preclinical results [7][8].

Drug Development - The company is developing three potential best-in-class drug candidates for chronic hepatitis B virus (HBV) infection, obesity, and coronavirus infections, with promising clinical data reported[95][96]. - Pevifoscorvir sodium has shown multi-log10 reductions in HBV DNA and RNA in Phase 1 studies, with 60% of HBeAg+ subjects achieving sustained HBV DNA suppression at Week 48[100][101]. - The ongoing Phase 2 B-SUPREME study aims to evaluate the safety and efficacy of pevifoscorvir sodium compared to tenofovir disoproxil fumarate in approximately 200 subjects with chronic HBV infection[105]. - The company has received positive feedback from the FDA and other regulatory bodies supporting the chronic suppressive therapy pathway for pevifoscorvir sodium[103]. - ALG-055009 has been designed to exhibit approximately 50-fold greater potency compared to resmetirom, positioning it as a strong candidate for treating obesity and metabolic dysfunction-associated steatohepatitis (MASH)[108]. - The Phase 1 study of ALG-055009 showed that it was well tolerated, with no evidence of clinical thyroid dysfunction and low intersubject variability in pharmacokinetics[109][110]. - The company is exploring an antisense oligonucleotide (ASO) platform to potentially treat chronic HBV infection and hepatitis delta virus (HDV) co-infection[106][107]. - Pevifoscorvir sodium has demonstrated a favorable pharmacokinetic profile and antiviral activity, suggesting its potential as a best-in-class treatment for chronic HBV infection[99][104]. - The company plans to present 96-week safety and antiviral activity data for pevifoscorvir sodium at upcoming scientific conferences[104]. - ALG-055009 demonstrated significant synergistic effects in preclinical studies when combined with semaglutide or tirzepatide, showing enhanced antihyperlipidemic effects compared to monotherapy[114]. - The Phase 2 study of ALG-097558 began in 2024, evaluating its efficacy in high-risk COVID-19 patients[118]. Financial Performance - Revenue from collaborations was $0 for the three and nine months ended September 30, 2025, due to the termination of the Merck collaboration agreement[135]. - Revenue from customers decreased by $0.5 million (41%) and $1.0 million (33%) for the three and nine months ended September 30, 2025, compared to the same periods in 2024[136]. - Research and development expenses increased by $7.2 million (43%) for the three months ended September 30, 2025, compared to the same period in 2024[134]. - The total operating expenses for the three months ended September 30, 2025, were $29.1 million, a 36% increase compared to $21.4 million in the same period in 2024[134]. - The net loss for the nine months ended September 30, 2025, was $4.3 million, a 91% decrease compared to a net loss of $49.1 million for the same period in 2024[132]. - The company has incurred net losses since its formation in February 2018, with an accumulated deficit of $622.3 million as of September 30, 2025[132]. - The change in fair value of 2023 common warrants showed a significant increase of 3905% for the three months ended September 30, 2025, compared to the same period in 2024[134]. - Research and development expenses increased by $7.2 million to $23.9 million for the three months ended September 30, 2025, compared to $16.8 million in the same period of 2024[138]. - Total research and development expenses decreased by $1.8 million to $52.4 million for the nine months ended September 30, 2025, compared to $54.2 million in the same period of 2024[139]. - General and administrative expenses increased by $0.5 million to $5.0 million for the three months ended September 30, 2025, compared to $4.5 million in the same period of 2024[141]. - General and administrative expenses decreased by $1.9 million to $14.1 million for the nine months ended September 30, 2025, compared to $16.0 million in the same period of 2024[142]. - Net cash used in operating activities was $60.8 million for the nine months ended September 30, 2025, compared to $62.3 million in the same period of 2024[157]. - The company incurred a net loss of $4.3 million for the nine months ended September 30, 2025, compared to a net loss of $49.1 million in the same period of 2024[146][159]. - The company had an accumulated deficit of $622.3 million as of September 30, 2025, compared to $618.0 million as of December 31, 2024[149]. - The company raised gross proceeds of $105.0 million from a securities purchase agreement in February 2025[148]. - Cash, cash equivalents, and short-term investments totaled $99.1 million as of September 30, 2025, compared to $56.9 million as of December 31, 2024[149]. - The company expects research and development expenses to increase in future periods as it continues to advance clinical trials for pevifoscorvir sodium and MASH[140]. - During the nine months ended September 30, 2024, investing activities used $38.3 million of cash, primarily due to $108.1 million of purchase of short-term investments[161]. - Net cash provided by financing activities during the nine months ended September 30, 2025, was $101.5 million, primarily due to proceeds from the 2025 PIPE financing[162]. - Net cash provided by financing activities during the nine months ended September 30, 2024, was $0.3 million, consisting primarily of proceeds from the ESPP purchase[162]. Contractual Obligations and Accounting Policies - There have been no material changes to contractual obligations and commitments as of September 30, 2025[163]. - The company does not have any off-balance sheet arrangements during the periods presented[164]. - The maximum potential amount of future payments under indemnification agreements is not determinable, and the fair value of these agreements is considered minimal[165]. - There have been no material changes to critical accounting policies and estimates through September 30, 2025, from those discussed in the Form 10-K[167]. - There have been no material changes in market risk during the three and nine months ended September 30, 2025[169].

Financial Performance - Aligos Therapeutics reported a net loss of $31.5 million for Q3 2025, with a basic and diluted net loss per share of $(3.04), compared to a net loss of $19.3 million or $(3.07) per share in Q3 2024[7]. - Revenue from customers for Q3 2025 was $741,000, down from $1.25 million in Q3 2024, while total revenue for the nine months ended September 30, 2025, was $2.02 million compared to $3.01 million for the same period in 2024[15]. Research and Development - Research and development (R&D) expenses increased to $23.9 million in Q3 2025 from $16.8 million in Q3 2024, primarily due to higher third-party expenses for the pevifoscorvir sodium Phase 2a clinical trial[8]. - Total operating expenses for Q3 2025 were $29.1 million, compared to $21.4 million in Q3 2024, reflecting increased R&D and general administrative costs[15]. - The Phase 2 B-SUPREME study of pevifoscorvir sodium is ongoing, with interim data expected in 1H and 2H 2026, and topline data anticipated in 2027[6]. - The company has completed 96 weeks of dosing in the Phase 1 study of pevifoscorvir sodium, with data readouts expected at The Liver Meeting® 2025[6]. Cash and Funding - Cash, cash equivalents, and investments totaled $99.1 million as of September 30, 2025, up from $56.9 million as of December 31, 2024, expected to fund operations into Q3 2026[5]. - Aligos is exploring various funding options for continued development, including potential out-licensing of ALG-055009[6]. General and Administrative Expenses - General and administrative (G&A) expenses rose to $5.2 million in Q3 2025 from $4.6 million in Q3 2024, mainly due to higher legal and related expenses[9]. Development Pipeline - Aligos maintains enthusiasm for its development pipeline, including ALG-055009, which is in discussions with potential partners for obesity and MASH[2].

Core Insights - Aligos Therapeutics, Inc. reported significant progress in its clinical trials and financial results for Q3 2025, focusing on therapies for liver and viral diseases [1][2]. Recent Business Progress - The Phase 2 B-SUPREME study of pevifoscorvir sodium (pevy) is progressing well, with enrollment across multiple countries including the U.S., China, Hong Kong, and Canada, with interim readouts expected in 2026 [2][7]. - The company is optimistic about the potential of pevifoscorvir sodium as a treatment for chronic hepatitis B virus (HBV) infection and is also advancing its pipeline, including ALG-055009 for obesity and MASH [3][4]. Financial Results for Q3 2025 - Cash, cash equivalents, and investments totaled $99.1 million as of September 30, 2025, up from $56.9 million at the end of 2024, providing sufficient funding for operations into Q3 2026 [5]. - The net loss for Q3 2025 was $31.5 million, or $(3.04) per share, compared to a net loss of $19.3 million, or $(3.07) per share, in Q3 2024 [6][16]. Research and Development Expenses - R&D expenses for Q3 2025 were $23.9 million, an increase from $16.8 million in the same period of 2024, primarily due to costs associated with the pevifoscorvir sodium Phase 2a clinical trial [8]. - General and administrative expenses rose to $5.2 million in Q3 2025 from $4.6 million in Q3 2024, mainly due to increased legal and related expenses [9]. Other Financial Metrics - Interest and other income remained stable at $1.1 million for both Q3 2025 and Q3 2024, while the change in fair value of common warrants resulted in a loss of $4.2 million in Q3 2025, compared to a loss of $0.1 million in Q3 2024 [10][16].

Core Insights - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing therapies for liver and viral diseases [4] Group 1: Upcoming Events - Aligos management will present at the Jefferies London Healthcare Conference on November 17, 2025, at 3:00 PM GMT [2] - Aligos will also participate in the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025, at 2:00 PM ET [3] - Presentations will be accessible via the "Investors" page on Aligos' website, with a replay available for at least 30 days [3] Group 2: Company Overview - Aligos Therapeutics aims to improve patient outcomes through best-in-class therapies targeting high unmet medical needs, including chronic hepatitis B virus (HBV) infection, obesity, and metabolic dysfunction-associated steatohepatitis (MASH) [4] - The company utilizes a science-driven approach and deep R&D expertise to advance its therapeutic pipeline [4]