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].

SOUTH SAN FRANCISCO, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025, being held March 26 - 30, 2025 in Beijing, China. “We are pleased to present preliminary da ...

Financial Performance - The company incurred significant net losses of $131.2 million for the year ended December 31, 2024, and $87.7 million for the year ended December 31, 2023[181]. - As of December 31, 2024, the company had a total stockholders' deficit of $29.0 million[181]. - The company has never generated revenue from product sales and does not anticipate doing so for the next several years[182]. - The company had cash, cash equivalents, and investments of $56.9 million as of December 31, 2024[185]. - The company may require substantial additional financing to achieve its goals, which may not be available on acceptable terms[185]. Funding and Investments - In October 2023 and February 2025, the company closed private investments generating approximately $92.1 million and $105.0 million in gross proceeds, respectively[185]. - The company expects to finance its cash needs through a combination of public or private equity offerings, debt financings, and collaborations[189]. - The company filed a Registration Statement on Form S-3 covering the offering of up to $400.0 million of various securities in November 2024[188]. Drug Development Challenges - The company has invested a significant portion of its resources in research and development activities since its inception[185]. - The company anticipates incurring significant costs associated with commercializing any approved drug candidates[184]. - The company has halted further development of drug candidate ALG-010133 due to insufficient antiviral activity observed in clinical trials[202]. - Development of drug candidate ALG-020572 was discontinued following a serious adverse event involving significant increase in alanine aminotransferase (ALT) levels in patients[202]. - The company is conducting clinical trials for drug candidate ALG-125755, which showed evidence of HBsAg lowering at all evaluated dose levels, but further evaluation is not prioritized due to funding constraints[202]. Regulatory and Compliance Issues - The company has limited experience in preparing and submitting regulatory filings, having not previously submitted a new drug application (NDA) to the FDA[205]. - Regulatory approval processes are lengthy and unpredictable, with no current drug candidates having received approval[213]. - The company plans to seek regulatory approval for its drug candidates in the United States and select foreign countries, which requires compliance with varying regulatory requirements[206]. - The company may face penalties or loss of marketing approval if it fails to comply with regulatory requirements post-approval[266]. - The FDA's review and approval processes can be affected by government funding and other disruptions, potentially delaying the company's product approvals[274]. Market and Competitive Landscape - The company is pursuing treatments for CHB and MASH, with significant investments in drug candidates like ALG-000184 and ALG-055009, respectively[229][232]. - The company faces competition from other firms developing more efficacious therapies for COVID-19, which could impact demand for its products[239]. - The availability of COVID-19 vaccines and oral COVID-19 drugs may reduce the need for potential COVID-19 therapies, negatively impacting commercial opportunities[288]. - The company may face significant delays in obtaining coverage and reimbursement for newly approved drugs, impacting commercial viability[300]. Intellectual Property and Patent Risks - The ability to obtain and maintain sufficient patent protection is critical for the company to compete effectively in the market and commercialize drug candidates[366]. - The company may face challenges in enforcing intellectual property rights, which could allow competitors to develop similar products, impacting its market position[367]. - The company currently holds several U.S. provisional patent applications, which require timely filing of non-provisional applications within 12 months to maintain priority dates[370]. - The company may lose patent protection if it fails to timely file non-provisional applications or if its licensors do not fulfill their obligations under licensing agreements[378]. Operational Risks - The company relies on third parties for clinical trials and studies, and any failure by these parties could substantially harm the business and delay marketing approvals[344]. - The company does not own manufacturing facilities and relies on third parties for drug supplies, increasing the risk of insufficient quantities or delays in development and commercialization efforts[350]. - There is a risk that third-party manufacturers may not be able to scale up production in a timely or cost-effective manner, potentially delaying regulatory approval or commercial launch of drug candidates[351]. Legal and Regulatory Compliance - Compliance with evolving data privacy laws, such as GDPR and CCPA, may impose significant operational challenges and financial penalties for non-compliance[324][323]. - The company must ensure compliance with various healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, to avoid significant operational and financial risks[363]. - The company anticipates ongoing legal complexity and uncertainty regarding international personal data transfers, which could adversely affect financial results[327].