Company Overview - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing therapies for liver and viral diseases [3] - The company aims to improve patient outcomes through its science-driven approach and deep R&D expertise [3] Leadership Appointment - Kieron Wesson, PhD, has been appointed as Vice President, Head of Chemistry Manufacturing Controls (CMC) at Aligos, effective immediately [1] - Dr. Wesson brings over 20 years of experience in pharmaceutical development, having previously held leadership roles at Kezar Life Sciences and AN2 Therapeutics [2] - His expertise will provide leadership and oversight on all CMC-related matters as Aligos prepares to begin its Phase 2 study of ALG-000184 in mid-2025 [2] Pipeline and Research Focus - Aligos is advancing a purpose-built pipeline targeting high unmet medical needs, including chronic hepatitis B virus infection and metabolic dysfunction-associated steatohepatitis (MASH) [3] - The company is set to initiate a Phase 2 clinical study for its therapeutic candidate ALG-000184 in mid-2025 [2]

Summary of Oligos Therapeutics Conference Call Company Overview - **Company**: Oligos Therapeutics - **CEO**: Lawrence Blatt - **Focus**: Development of therapies for chronic hepatitis B (HBV) and other conditions Key Points on Pipeline and Products - **Pipeline Status**: Transitioning into Phase II studies, particularly for ALG184, a capsid assembly modulator for chronic hepatitis B treatment [2][49] - **Other Products**: - ALG184 for chronic hepatitis B [2] - ALG-nine for NASH, with completed Phase II study and ongoing outlicensing discussions [3] - Coronavirus protease inhibitor funded by external sources [3] Chronic Hepatitis B Insights - **Prevalence**: Approximately 300 million people infected globally [5] - **Current Treatments**: - Nucleoside analogs block virus replication but do not fully suppress HBV DNA, leading to disease progression [5][6] - Pegylated interferons can achieve functional cures in a subset of patients [6] - **Clinical Data**: - Study in Taiwan showed 4% of patients on nucleoside analogs developed hepatocellular carcinoma over five years [6] - Incomplete suppression of HBV DNA correlates with poor outcomes [8][10] ALG184 Mechanism and Efficacy - **Mechanism**: ALG184 blocks encapsulation of pre-genomic RNA and transport of rcDNA into the nucleus, effectively suppressing all viral markers [11] - **Clinical Trial Results**: - In a Phase 1b study, 60% of E antigen positive patients achieved HBV DNA levels below 10 international units by week 48, and 100% by week 96 [17] - E antigen negative patients also showed rapid reductions in HBV DNA [18] - **Comparison with Standard Care**: ALG184 demonstrated superior efficacy compared to Gilead's TAF and TDF in achieving undetectable HBV DNA levels [19] Safety and Regulatory Pathway - **Safety Profile**: No emergence of resistant variants or significant toxicity observed over two years of treatment [25][26] - **Regulatory Guidance**: FDA and other regulatory bodies have indicated that chronic suppression is an acceptable endpoint for approval [57][58] Market Potential - **Economic Burden**: The cumulative cost of HBV to the healthcare system is estimated at $45 billion, highlighting the need for effective treatments [45] - **Market Differentiation**: ALG184 is positioned as a once-daily oral therapy, contrasting with injectable therapies that are difficult to administer and store [41][48] - **Potential Revenue**: The U.S. market potential for ALG184 exceeds $1 billion, with significant interest from payers due to the economic burden of untreated HBV [46][48] Future Milestones - **Upcoming Studies**: Initiation of Phase II study (B Supreme) expected soon, with interim analysis planned for 2026 [49][66] - **Data Presentation**: Off-therapy data from the Phase 1b study will be presented at ASLD [50] Conclusion - **Positioning**: ALG184 is expected to replace nucleoside analogs as the standard of care for chronic HBV suppression and serve as a backbone for future functional cure therapies [37][48]

Core Points - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing therapies for liver and viral diseases [3] - The company will present at the Jefferies Global Healthcare Conference on June 5, 2025 [1] - A live webcast of the presentation will be available on Aligos' website, with a replay accessible for at least 30 days [2] Company Overview - Aligos Therapeutics aims to improve patient outcomes through best-in-class therapies targeting high unmet medical needs such as chronic hepatitis B virus infection and metabolic dysfunction-associated steatohepatitis (MASH) [3] - The company utilizes a science-driven approach and has deep R&D expertise to advance its therapeutic pipeline [3]

Core Insights - Aligos Therapeutics, Inc. has appointed Laura Kavanaugh as Vice President, Head of Legal, effective immediately, bringing over 25 years of experience in the biotechnology and pharmaceutical industries [1][2][3] Company Overview - Aligos Therapeutics is a clinical stage biotechnology company focused on developing therapies for liver and viral diseases, aiming to improve patient outcomes [3] - The company is dedicated to addressing high unmet medical needs, including chronic hepatitis B virus infection and metabolic dysfunction-associated steatohepatitis (MASH) [3] Leadership Appointment - Laura Kavanaugh's previous roles include Vice President, Corporate Law & Privacy Officer at Codexis and independent legal consultant for various biotech firms [2] - Kavanaugh's expertise is expected to enhance Aligos' legal oversight and support its mission [2]

Core Insights - Aligos Therapeutics, Inc. announced positive data from eight presentations at the EASL Congress 2025, highlighting advancements in therapies for liver and viral diseases [1][2] Group 1: ALG-000184 for Chronic Hepatitis B - The 96-week data from the monotherapy cohort receiving 300 mg ALG-000184 showed that all subjects in both HBeAg+ and HBeAg- cohorts achieved HBV DNA viral suppression below the lower limit of quantification (LLOQ) [2][3] - In HBeAg+ subjects, 60% achieved HBV DNA < LLOQ at Week 48, which increased to 100% at Week 96, with HBV DNA levels declining to < LLOQ in 5 of 9 subjects [3] - All HBeAg- subjects (100%) experienced rapid HBV DNA suppression by Week 24, maintaining suppression for up to 96 weeks [4] - No viral breakthrough was observed in any subjects receiving ALG-000184 for up to 96 weeks, and no known resistant mutations were identified [5] Group 2: ALG-055009 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) - ALG-055009 demonstrated significant reductions in liver fat content, with placebo-adjusted median relative reductions up to 46.2% at Week 12 [8] - The treatment was well-tolerated, with gastrointestinal-related adverse events similar to placebo [8] - Statistically significant improvements in atherogenic lipids were observed, indicating potential cardiovascular benefits alongside liver fat reduction [9][10] Group 3: Presentation Details - Key presentations included data on ALG-000184's antiviral effects and safety, as well as ALG-055009's impact on liver fat and lipid profiles [10][11][12] - Notable presenters included experts from the University of Hong Kong and Southern Medical University, showcasing the clinical significance of the findings [10][11] Group 4: Company Overview - Aligos Therapeutics is focused on developing best-in-class therapies for liver and viral diseases, leveraging its R&D expertise to address high unmet medical needs [15]

Company Performance - Aligos Therapeutics reported a quarterly loss of $2.11 per share, which was better than the Zacks Consensus Estimate of a loss of $2.80, and an improvement from a loss of $5.50 per share a year ago, indicating a 24.64% earnings surprise [1] - The company posted revenues of $0.31 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 68.90%, and down from $0.99 million in the same quarter last year [2] - Over the last four quarters, Aligos Therapeutics has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2] Stock Performance - Aligos Therapeutics shares have declined approximately 87.3% since the beginning of the year, contrasting with the S&P 500's decline of 3.9% [3] - The current consensus EPS estimate for the upcoming quarter is -$2.74 on $1 million in revenues, and for the current fiscal year, it is -$8.66 on $39.5 million in revenues [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Aligos Therapeutics belongs, is currently ranked in the top 31% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Aligos Therapeutics' stock performance [5][6]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 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: 001-39617 Aligos Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-4724808 (State or other jurisd ...

Financial Performance - Net income for Q1 2025 was $43.1 million, with a basic net income per share of $5.12, compared to a net loss of $34.9 million in Q1 2024[6]. - The change in fair value of common warrants resulted in income of $61.5 million for Q1 2025, compared to a loss of $14.4 million in Q1 2024[11]. - Cash, cash equivalents, and investments totaled $137.9 million as of March 31, 2025, up from $56.9 million as of December 31, 2024, providing funding into the second half of 2026[5]. - Total liabilities decreased to $34.3 million as of March 31, 2025, from $99.1 million as of December 31, 2024[18]. Research and Development - Aligos raised over $100 million to initiate a Phase 2 study of ALG-000184 for chronic hepatitis B virus infection, with dosing expected to begin by mid-2025[2]. - Research and development expenses decreased to $14.5 million in Q1 2025 from $16.4 million in Q1 2024, primarily due to reduced clinical trial costs[7]. - ALG-000184 demonstrated 100% sustained HBV DNA suppression in HBeAg subjects after 48 weeks of treatment[3]. - The Phase 2 B-SUPREME study for ALG-000184 is expected to enroll approximately 200 untreated adult subjects with chronic HBV infection[3]. - ALG-055009 showed statistically significant liver fat reductions of up to 46.2% at week 12 in MASH patients, with 70% of subjects achieving a ≥30% relative reduction[10]. Operating Expenses - General and administrative expenses fell to $5.1 million in Q1 2025 from $6.7 million in Q1 2024, attributed to lower third-party expenses[8].

Core Insights - Aligos Therapeutics is advancing its clinical development plans for therapies targeting liver and viral diseases, having raised over $100 million for its Phase 2 study of ALG-000184 in chronic hepatitis B virus infection [2][3] - The company reported significant financial progress, with a net income of $43.1 million for Q1 2025, a substantial improvement from a net loss of $34.9 million in Q1 2024 [7][10] Recent Business Progress - Aligos is on track to begin dosing for the Phase 2 study of ALG-000184 by mid-2025, following positive FDA correspondence [2] - Data presented at the APASL meeting indicated that ALG-000184 has the potential to be a first-line treatment for chronic HBV infection, with a well-tolerated profile and promising antiviral activity [5][12] - The Phase 2 B-SUPREME study will evaluate ALG-000184 against tenofovir disoproxil fumarate in approximately 200 untreated adult subjects with chronic HBV infection [5] Pipeline Updates - ALG-000184 is positioned as a potential first-/best-in-class small molecule for chronic hepatitis B virus infection [3] - ALG-055009, a THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH), has shown best-in-class potential, with significant reductions in liver fat observed in clinical trials [4][12] - The company is in discussions for potential partnerships regarding ALG-055009 with multinational pharmaceutical companies [2] Financial Results for Q1 2025 - Cash, cash equivalents, and investments totaled $137.9 million as of March 31, 2025, compared to $56.9 million at the end of 2024, providing sufficient funding into the second half of 2026 [6] - Research and development expenses decreased to $14.5 million from $16.4 million year-over-year, primarily due to reduced third-party clinical trial expenses [8] - General and administrative expenses also decreased to $5.1 million from $6.7 million, reflecting lower third-party costs [9]

Core Viewpoint - Aligos Therapeutics, Inc. is set to report its first quarter 2025 financial results on May 6, 2025, before the U.S. financial markets open, indicating ongoing developments in its clinical-stage biotechnology efforts focused on liver and viral diseases [1]. Company Overview - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company dedicated to improving patient outcomes through the development of best-in-class therapies for liver and viral diseases [2]. - The company utilizes a science-driven approach and extensive R&D expertise to advance its pipeline of therapeutics targeting high unmet medical needs, including chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses [2].