Aligos Therapeutics(ALGS) - 2025 Q2 - Quarterly Results

Company Overview Aligos Therapeutics is a clinical-stage biotechnology company focused on developing best-in-class therapies for liver and viral diseases, including chronic HBV, MASH, and coronaviruses Introduction Aligos Therapeutics, a clinical-stage biotechnology company focused on liver and viral diseases, reported its recent business progress and financial results for the second quarter of 2025 - Aligos Therapeutics, Inc. (Nasdaq: ALGS) is a clinical stage biotechnology company[1] - The company focuses on improving patient outcomes through best-in-class therapies for liver and viral diseases[1] - This report covers recent business progress and financial results for the second quarter 2025[1] About Aligos Aligos Therapeutics is a clinical-stage biotechnology company dedicated to developing best-in-class therapies for high unmet medical needs in liver and viral diseases, including chronic HBV, MASH, and coronaviruses, leveraging its science-driven approach and R&D expertise - Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company[13] - Its mission is to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases[13] - The company's pipeline targets chronic hepatitis B virus (HBV) infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses[13] Recent Business Progress Aligos Therapeutics advanced its key pipeline candidates, including the initiation of the Phase 2 B-SUPREME study for ALG-000184 and positive Phase 2a results for ALG-055009, while exploring external funding for ALG-097558 CEO Statement CEO Lawrence Blatt announced the initiation of the Phase 2 B-SUPREME study for ALG-000184, with regulatory approvals and site activations underway, and dosing expected soon. He highlighted ALG-000184's potential to replace standard HBV care and noted ongoing partnership discussions for ALG-055009 - Initiation of the Phase 2 B-SUPREME study of ALG-000184 is well underway with regulatory approvals across multiple countries (US, China, Canada, Taiwan, UK, New Zealand, Moldova)[2] - Dosing for ALG-000184 is expected to commence in the coming weeks[2] - Phase 1 data suggests ALG-000184 has the potential to replace standard of care treatment for chronic suppression of HBV infection and may become the backbone of treatments aimed at a functional cure[2] - ALG-055009 remains in discussions with potential partners[2] Pipeline Updates Aligos provided updates on its key pipeline candidates: ALG-000184 (HBV) is advancing to Phase 2 with promising Phase 1 96-week data, ALG-055009 (MASH) met its primary endpoint in Phase 2a with significant liver fat and lipid reductions, and ALG-097558 (Coronaviruses) is in early-stage studies with future development expected to be externally funded ALG-000184 (Chronic HBV Infection) The Phase 2 B-SUPREME study for ALG-000184, a potential first-/best-in-class small molecule CAM-E for chronic HBV, has initiated regulatory approvals, site activations, and subject screening, with dosing expected soon. The study will evaluate safety and efficacy against tenofovir disoproxil fumarate over 48 weeks. Interim data is expected in 2026, and topline data in 2027. Phase 1 96-week data showed ALG-000184 was well tolerated, had a favorable PK profile, and demonstrated potentially best-in-class antiviral activity, achieving 100% HBV DNA reduction to <LLOQ in HBeAg-negative subjects by Week 96 - ALG-000184 is a potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection[3] - The Phase 2 B-SUPREME study (NCT04746183) recently began obtaining regulatory approvals, activating global sites, and screening subjects, with dosing expected to commence in the coming weeks[3] - The Phase 2 study is designed as a randomized, double-blind, active-controlled multicenter study evaluating ALG-000184 monotherapy compared with tenofovir disoproxil fumarate in approximately 200 untreated HBeAg and HBeAg-negative adult subjects for 48 weeks[3] - The company expects to announce interim data in 2026 and topline data in 2027 for the Phase 2 study[3] - 96-week dosing recently completed in the Phase 1 study, with data readouts planned for scientific conferences this year[3] ALG-000184 Phase 1 Study Results (96 Weeks) | Metric | HBeAg-negative Subjects (300 mg daily) | HBeAg-positive Subjects (300 mg daily) | | :-------------------------------- | :------------------------------------- | :------------------------------------ | | HBV DNA < LLOQ (Week 48) | 60% (6 of 10 subjects) | N/A | | HBV DNA < LLOQ (Week 96) | 100% (9 of 9 subjects) | 100% (8 of 8 subjects) | | HBV DNA < LLOQ (TND) (Week 96) | 5 of 9 subjects | 100% (8 of 8 subjects) | | Tolerability | Well tolerated, no viral breakthrough, no known CAM resistant mutations | Well tolerated, no viral breakthrough, no known CAM resistant mutations | ALG-055009 (MASH) ALG-055009, a potential best-in-class small molecule THR-β agonist for MASH, successfully met its primary endpoint in the Phase 2a HERALD study, demonstrating statistically significant and dose-dependent reductions in liver fat at week 12. The study also showed significant improvements in atherogenic lipids and a favorable tolerability profile. Aligos is exploring out-licensing options for its continued development - ALG-055009 is a potential best-in-class small molecule THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH)[5] - The Phase 2a HERALD data presented at EASL 2025 demonstrated that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at week 12 as measured by MRI-PDFF[10] - Substantial, dose-dependent reductions in liver fat were observed across all key subgroups with 12 weeks of once daily ALG-055009 treatment[10] - Statistically significant improvements in atherogenic lipids (LDL-C, lipoprotein (a), apolipoprotein B) were achieved, even in the context of stable GLP-1 agonist or statin use[10] - ALG-055009 demonstrated a favorable tolerability profile with no evidence of clinical hyper/hypothyroidism and similar rates of GI-related adverse events compared to placebo[10] - The company is continuing to evaluate a variety of options to fund continued development, including potential out-licensing[10] ALG-097558 (Pan-Coronavirus Protease Inhibitor) ALG-097558, a potential best-in-class ritonavir-free small molecule pan-coronavirus protease inhibitor, is currently being assessed in the AGILE platform study for high-risk COVID-19 subjects, which began in 2024. A NIAID-sponsored drug-drug interaction and relative bioavailability study in healthy volunteers commenced dosing in Q2 2025, with future development expected to be funded by external sources - ALG-097558 is a potential best-in-class ritonavir-free small molecule pan-coronavirus protease inhibitor[6] - The AGILE platform study (NCT04746183) assessing ALG-097558 monotherapy or in combination with remdesivir in high-risk subjects with COVID-19 began in 2024[10] - A NIAID-sponsored drug-drug interaction and relative bioavailability study of ALG-097558 in healthy volunteers began dosing in the second quarter of 2025[10] - The company expects any future development of ALG-097558 to be funded by external sources[10] Financial Results for the Second Quarter 2025 Aligos Therapeutics reported a net loss of $15.9 million for Q2 2025, a significant decline from Q2 2024, primarily due to a decrease in common warrant fair value, despite reduced R&D and G&A expenses, with cash reserves extending into H2 2026 Key Financial Highlights Aligos reported a net loss of $15.9 million for Q2 2025, a significant change from a net income of $5.1 million in Q2 2024, primarily due to a substantial decrease in income from the change in fair value of common warrants. R&D expenses decreased by $7.1 million YoY due to the completion of the MASH trial, while G&A expenses also saw a reduction. The company's cash, cash equivalents, and investments increased to $122.9 million, providing funding into the second half of 2026 Cash, Cash Equivalents and Investments (in millions) | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :-------------- | :---------------- | :----- | | Cash, cash equivalents and investments | $122.9 | $56.9 | +$66.0 | - Cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the second half of 2026[7] Net (Loss) Income and EPS (Q2 YoY, in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | Net (Loss) Income | $(15.9) | $5.1 | $(21.0) | | Basic & Diluted Net (Loss) Income per Share | $(1.53) | $0.81 | $(2.34) | Research and Development (R&D) Expenses (Q2 YoY, in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | R&D Expenses | $14.0 | $21.1 | $(7.1) | - The decrease in R&D expenses was primarily due to reduced third-party expenses from the completion of the MASH Phase 2a clinical trial, partially offset by increased spend in the chronic HBV infection program[9] General and Administrative (G&A) Expenses (Q2 YoY, in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | G&A Expenses | $5.6 | $6.4 | $(0.8) | - The decrease in G&A expenses was primarily due to a decrease in third-party expenses, including legal expenses[11] Change in Fair Value of 2023 Common Warrants (Q2 YoY, in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | Income from Warrants | $1.7 | $30.4 | $(28.7) | Condensed Consolidated Statements of Operations The consolidated statement of operations shows a net loss of $15.863 million for Q2 2025, a significant decline from a net income of $5.061 million in Q2 2024, primarily driven by a substantial decrease in the change in fair value of common warrants. For the six months ended June 30, 2025, the company reported a net income of $27.225 million, reversing a net loss of $29.802 million in the prior year period, largely due to a significant increase in the fair value of warrants Condensed Consolidated Statements of Operations (Unaudited, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue from collaborations | $ - | $ - | $ - | $ 292 | | Revenue from customers | $ 965 | $ 1,061 | $ 1,276 | $ 1,755 | | Research and development | $ 13,976 | $ 21,099 | $ 28,478 | $ 37,464 | | General and administrative | $ 5,556 | $ 6,376 | $ 10,608 | $ 13,043 | | Total operating expenses | $ 19,532 | $ 27,475 | $ 39,086 | $ 50,507 | | Loss from operations | $ (18,567) | $ (26,414) | $ (37,810) | $ (48,460) | | Interest and other income, net | $ 1,207 | $ 1,227 | $ 2,087 | $ 2,765 | | Change in fair value of 2023 common warrants | $ 1,682 | $ 30,437 | $ 63,176 | $ 16,106 | | Net (Loss) income | $ (15,863) | $ 5,061 | $ 27,225 | $ (29,802) | | Net (loss) income per share, basic | $ (1.53) | $ 0.81 | $ 2.90 | $ (4.77) | | Net (loss) income per share, diluted | $ (1.53) | $ 0.81 | $ 2.90 | $ (4.77) | Condensed Consolidated Balance Sheets As of June 30, 2025, Aligos' total assets increased significantly to $134.706 million from $70.094 million at December 31, 2024, primarily driven by a substantial increase in short-term investments. Total liabilities decreased, leading to a positive total stockholders' equity of $101.866 million, a reversal from a deficit of $(28.973) million at the end of 2024 Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | Change | | :-------------------------------- | :-------------------------- | :-------------------------- | :----- | | Cash and cash equivalents | $ 18,661 | $ 36,997 | $(18,336) | | Short-term investments | $ 104,284 | $ 19,942 | +$84,342 | | Total current assets | $ 127,944 | $ 62,141 | +$65,803 | | Total assets | $ 134,706 | $ 70,094 | +$64,612 | | Total liabilities | $ 32,840 | $ 99,067 | $(66,227) | | Total stockholders' equity (deficit) | $ 101,866 | $ (28,973) | +$130,839 | Additional Information This section provides important disclaimers regarding forward-looking statements, highlighting inherent risks in drug development and the company's policy on updating such information, alongside investor contact details Forward-Looking Statement This section contains standard forward-looking statements regarding future events, including clinical trial enrollment, potential drug impacts, data releases, funding expectations, and the sufficiency of capital resources. It highlights substantial risks and uncertainties inherent in drug development, regulatory processes, manufacturing, intellectual property, and macroeconomic conditions, with a disclaimer that Aligos undertakes no obligation to update these statements - The press release contains forward-looking statements regarding expected enrollment for ALG-000184, its potential impact, planned data releases, potential benefits and out-licensing of ALG-055009, funding expectations for ALG-097558, and the sufficiency of capital resources into the second half of 2026[15] - Such statements are subject to substantial risks and uncertainties inherent in the drug development process, including clinical-stage development, clinical trial design, regulatory approval, manufacturing, intellectual property, capital resources, reliance on third parties, competitive landscape, and global events[15] - Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events, except as required by law[15] Investor Contact This section provides contact information for investor relations inquiries - Investor Contact: Jordyn Tarazi, Vice President, Investor Relations & Corporate Communications[16] - Contact Details: +1 (650) 910-0427, jtarazi@aligos.com[16]