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 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].

Core Viewpoint - Aligos Therapeutics, Inc. has announced that eight abstracts have been accepted for poster presentations at the European Association for the Study of the Liver (EASL) Congress 2025, highlighting its focus on innovative therapies for liver and viral diseases [1]. Group 1: Abstracts on Chronic Hepatitis B Virus (HBV) - Abstract 861 discusses the monotherapy with the novel capsid assembly modulator ALG-000184, showing profound and sustained HBV DNA suppression in untreated subjects over 96 weeks [2]. - Abstract 856 presents the safety and antiviral effect of oral daily 300 mg ALG-000184 in combination with Entecavir for untreated HBeAg-positive subjects, also over 96 weeks [3]. - Abstract 1924 reveals a high barrier of resistance to ALG-000184 based on viral kinetics and sequence analysis from a phase I monotherapy study [3]. Group 2: Abstracts on Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Abstract 302 highlights that ALG-055009, a novel thyroid hormone receptor beta agonist, significantly reduces atherogenic lipids/lipoproteins in patients with presumed MASH in the Phase 2a HERALD study [4]. - Abstract 2185 indicates robust reductions in liver fat at Week 12 across subgroups, including GLP-1 receptor agonist users in non-cirrhotic MASH patients [4]. - Abstract 2152 discusses population pharmacokinetic/pharmacodynamic modeling of ALG-055009, showing a statistically significant correlation between exposure and key efficacy endpoints [5]. Group 3: Preclinical Research - Abstract 2105 presents next-generation hepatitis B virus antisense oligonucleotides with significantly improved properties compared to current clinical candidates [6]. Company Overview - Aligos Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing best-in-class therapies for liver and viral diseases, leveraging its R&D expertise to address high unmet medical needs [6].

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 ...

Company Performance - Aligos Therapeutics reported a quarterly loss of $3.41 per share, significantly worse than the Zacks Consensus Estimate of a loss of $1.91, representing an earnings surprise of -78.53% [1] - The company's revenues for the quarter ended December 2024 were $0.63 million, missing the Zacks Consensus Estimate by 51.62%, and down from $2.68 million a year ago [2] - Over the last four quarters, Aligos Therapeutics has surpassed consensus EPS estimates only once and has topped consensus revenue estimates just once [2] Stock Movement and Outlook - Aligos Therapeutics shares have declined approximately 67.5% since the beginning of the year, contrasting with the S&P 500's decline of -1.9% [3] - The company's future stock performance will largely depend on management's commentary during the earnings call and the revisions of earnings estimates [3][4] - The current consensus EPS estimate for the upcoming quarter is -$2.04 on $1 million in revenues, and for the current fiscal year, it is -$8.94 on $4 million in revenues [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Aligos Therapeutics belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Aligos Therapeutics' stock performance [5][6]

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].

Financial Performance - Aligos Therapeutics reported a net loss of $82.2 million for Q4 2024, compared to a net loss of $27.9 million in Q4 2023, resulting in a basic and diluted net loss per share of $(13.08) versus $(5.50) in the prior year[8][20]. - For the full year 2024, the net loss was $131.2 million, compared to $87.7 million in 2023, with a basic and diluted net loss per share of $(20.94) compared to $(34.20) in 2023[9][20]. - Cash, cash equivalents, and investments totaled $56.9 million as of December 31, 2024, down from $135.7 million at the end of 2023; following a $105 million private placement completed in February 2025, funding is expected to last into the second half of 2026[7][5]. - General and administrative (G&A) expenses for Q4 2024 were $5.2 million, compared to $6.4 million in Q4 2023, with total G&A expenses for the year at $22.8 million, down from $30.6 million in 2023[12][13]. Research and Development - Research and development (R&D) expenses for Q4 2024 were $16.0 million, down from $22.3 million in Q4 2023, while total R&D expenses for the year were $70.3 million, slightly down from $73.0 million in 2023[10][11]. - Interim data from a Phase 1 study of ALG-000184 showed 100% sustained HBV DNA suppression in HBeAg-positive subjects by Week 48, with no viral breakthrough or known CAM resistant mutations observed[5][10]. - The Phase 2 clinical study for ALG-000184 is expected to begin in mid-2025, with the potential to replace standard care for chronic hepatitis B virus infection[2][5]. - ALG-055009 demonstrated statistically significant reductions in liver fat of up to 46.2% at Week 12, with 70% of subjects achieving a ≥30% relative reduction compared to baseline[5][12]. - Aligos commenced three additional clinical trials for ALG-097558 in 2024, with ongoing studies evaluating its efficacy in high-risk COVID-19 patients[6][12]. Funding and Development Strategy - The company is evaluating options for continued development funding, including potential out-licensing of its products[12][14].

Core Insights - Aligos Therapeutics reported significant business progress and financial results for Q4 and full year 2024, highlighting advancements in their clinical pipeline and financial activities [1][2]. Recent Business Progress - The company is advancing ALG-000184 towards a Phase 2 clinical study expected to begin in mid-2025, with the potential to replace standard care for chronic hepatitis B virus infection [2][3]. - ALG-055009 demonstrated statistically significant reductions in liver fat in a Phase 2a study, with up to 70% of subjects achieving a ≥30% relative reduction in liver fat compared to baseline [5][15]. - The company completed a $105 million private placement financing in February 2025, enhancing its financial position for ongoing operations [5]. Financial Results - As of December 31, 2024, cash, cash equivalents, and investments totaled $56.9 million, down from $135.7 million a year prior, but expected to fund operations into the second half of 2026 following the recent financing [7]. - The net loss for Q4 2024 was $82.2 million, compared to a net loss of $27.9 million in Q4 2023, with a basic and diluted net loss per share of $(13.08) [8][20]. - For the full year 2024, the net loss was $131.2 million, compared to $87.7 million in 2023, with a basic and diluted net loss per share of $(20.94) [9][20]. Research and Development Expenses - R&D expenses for Q4 2024 were $16.0 million, down from $22.3 million in Q4 2023, primarily due to decreased third-party expenses for clinical trials [10]. - For the full year 2024, R&D expenses totaled $70.3 million, slightly down from $73.0 million in 2023, with reductions in employee-related costs offset by increases in third-party expenses [11]. General and Administrative Expenses - G&A expenses for Q4 2024 were $5.2 million, down from $6.4 million in Q4 2023, attributed to decreased third-party expenses [12]. - For the full year 2024, G&A expenses were $22.8 million, compared to $30.6 million in 2023, reflecting a reduction in legal and other third-party expenses [13].

Company Overview - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing best-in-class therapies for liver and viral diseases [2] - The company aims to improve patient outcomes through its science-driven approach and deep R&D expertise [2] Financial Announcement - Aligos Therapeutics will report its fourth quarter 2024 financial results on March 10, 2025, before the U.S. financial markets open [1] Pipeline and Therapeutic Focus - The company is advancing a pipeline of therapeutics targeting high unmet medical needs, including chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses [2]