PART I. FINANCIAL INFORMATION This section presents unaudited consolidated financial statements, detailing financial position, operations, equity, and cash flows [Item 1. Financial Statements (Unaudited)](index=9&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited consolidated financial statements, including balance sheets, income, equity, and cash flows, with accompanying notes [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$134.7 million**, liabilities decreased, and stockholders' equity turned positive, driven by investments and warrant liability changes | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $18,661 | $36,997 | | Short-term investments | $104,284 | $19,942 | | Total current assets | $127,944 | $62,141 | | Total assets | $134,706 | $70,094 | | 2023 common warrants liability | $9,191 | $72,367 | | Total liabilities | $32,840 | $99,067 | | Total stockholders' equity (deficit) | $101,866 | $(28,973) | [Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20(Loss)%20Income) Net income for the six months ended June 30, 2025, was **$27.2 million**, a significant improvement from a prior year loss, driven by a gain from warrant fair value changes | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 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) | | 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) | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) Total stockholders' equity increased significantly to **$101.866 million** by June 30, 2025, driven by a **$105.004 million** PIPE offering and net income | Metric (in thousands) | Balance as of Dec 31, 2024 | Balance as of June 30, 2025 | | :-------------------- | :------------------------- | :-------------------------- | | Total Stockholders' Equity (Deficit) | $(28,973) | $101,866 | | Issuance of common stock, pre-funded warrants and common warrants in connection with 2025 PIPE offering | - | $105,004 | | Net income (Q1 2025) | - | $43,088 | | Net loss (Q2 2025) | - | $(15,863) | [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by financing activities was **$101.6 million** for the six months ended June 30, 2025, significantly offsetting cash used in operations and investing | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Net cash and cash equivalents used in operating activities | $(36,413) | $(42,239) | | Net cash and cash equivalents used in investing activities | $(83,488) | $(48,649) | | Net cash and cash equivalents provided by financing activities | $101,565 | $262 | | Net decrease in cash, cash equivalents, and restricted cash | $(18,336) | $(90,626) | | Cash, cash equivalents, and restricted cash, end of period | $18,771 | $45,148 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes to the unaudited condensed consolidated financial statements, covering organization, accounting policies, and various financial components [1. Organization and basis of presentation](index=14&type=section&id=1.%20Organization%20and%20basis%20of%20presentation) Aligos Therapeutics is a clinical-stage biotechnology company focused on liver and viral diseases, with sufficient cash to fund operations for at least 12 months - Aligos is a clinical-stage biotechnology company developing novel therapeutics for chronic hepatitis B virus (HBV) infection, metabolic dysfunction associated steatohepatitis (MASH), and coronaviruses[32](index=32&type=chunk) - The company has incurred substantial losses and negative cash flows since inception, with an accumulated deficit of **$590.8 million** as of June 30, 2025[37](index=37&type=chunk) - As of June 30, 2025, the company had **$122.9 million** in cash, cash equivalents, and investments, which is expected to fund operations for at least 12 months[38](index=38&type=chunk)[39](index=39&type=chunk) [2. Summary of significant accounting policies](index=16&type=section&id=2.%20Summary%20of%20significant%20accounting%20policies) The financial statements adhere to U.S. GAAP for interim reporting, with no material changes to accounting policies from the 2024 Form 10-K - The company's unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP and SEC interim reporting requirements[34](index=34&type=chunk) - No material changes were made to the company's significant accounting policies from its 2024 Form 10-K[44](index=44&type=chunk) - The company has elected the extended transition period for complying with new or revised financial accounting standards as an 'emerging growth company'[45](index=45&type=chunk) [3. Balance sheet components](index=17&type=section&id=3.%20Balance%20sheet%20components) Property and equipment, net, and total accrued liabilities decreased from December 31, 2024, to June 30, 2025 | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Property and equipment, net | $2,063 | $2,362 | | Accrued R&D expenses | $3,824 | $5,029 | | Accrued compensation | $4,421 | $6,387 | | Total Accrued liabilities | $12,209 | $15,557 | [4. Investments](index=17&type=section&id=4.%20Investments) Short-term investments significantly increased to **$104.284 million** by June 30, 2025, leading to increased interest income | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Short-term investments (Fair Value) | $104,284 | $19,942 | | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Interest income | $400 | $300 | $1,200 | $900 | [5. Fair value measurement](index=18&type=section&id=5.%20Fair%20value%20measurement) The 2023 common warrants liability, a Level 3 financial instrument, significantly decreased to **$9.191 million** by June 30, 2025 | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Available for sale securities (Level 2) | $104,284 | $19,942 | | 2023 common warrants liability (Level 3) | $(9,

[Company Overview](index=1&type=section&id=Company%20Overview) 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](index=1&type=section&id=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](index=1&type=chunk) - The company focuses on improving patient outcomes through best-in-class therapies for liver and viral diseases[1](index=1&type=chunk) - This report covers recent business progress and financial results for the second quarter 2025[1](index=1&type=chunk) [About Aligos](index=3&type=section&id=About%20Aligos) 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](index=13&type=chunk) - Its mission is to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases[13](index=13&type=chunk) - The company's pipeline targets chronic hepatitis B virus (HBV) infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses[13](index=13&type=chunk) [Recent Business Progress](index=1&type=section&id=Recent%20Business%20Progress) 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](index=1&type=section&id=CEO%20Statement) 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](index=2&type=chunk) - Dosing for ALG-000184 is expected to commence in the coming weeks[2](index=2&type=chunk) - 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](index=2&type=chunk) - ALG-055009 remains in discussions with potential partners[2](index=2&type=chunk) [Pipeline Updates](index=1&type=section&id=Pipeline%20Updates) 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)](index=1&type=section&id=ALG-000184_HBV) 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk) - The company expects to announce interim data in 2026 and topline data in 2027 for the Phase 2 study[3](index=3&type=chunk) - 96-week dosing recently completed in the Phase 1 study, with data readouts planned for scientific conferences this year[3](index=3&type=chunk) 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)](index=2&type=section&id=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](index=5&type=chunk) - 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](index=10&type=chunk) - Substantial, dose-dependent reductions in liver fat were observed across all key subgroups with 12 weeks of once daily ALG-055009 treatment[10](index=10&type=chunk) - 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](index=10&type=chunk) - 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](index=10&type=chunk) - The company is continuing to evaluate a variety of options to fund continued development, including potential out-licensing[10](index=10&type=chunk) [ALG-097558 (Pan-Coronavirus Protease Inhibitor)](index=2&type=section&id=ALG-097558_Coronaviruses) 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](index=6&type=chunk) - 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](index=10&type=chunk) - 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](index=10&type=chunk) - The company expects any future development of ALG-097558 to be funded by external sources[10](index=10&type=chunk) [Financial Results for the Second Quarter 2025](index=2&type=section&id=Financial%20Results%20for%20the%20Second%20Quarter%202025) 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](index=2&type=section&id=Key%20Financial%20Highlights) 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 | **+$66.0** | - Cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the second half of 2026[7](index=7&type=chunk) Net (Loss) Income and EPS (Q2 YoY, in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | Net (Loss) Income | **$(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](index=9&type=chunk) 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](index=11&type=chunk) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=3&type=section&id=Additional%20Information) 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](index=3&type=section&id=Forward-Looking%20Statement) 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](index=15&type=chunk) - 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](index=15&type=chunk) - 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](index=15&type=chunk) [Investor Contact](index=3&type=section&id=Investor%20Contact) This section provides contact information for investor relations inquiries - Investor Contact: Jordyn Tarazi, Vice President, Investor Relations & Corporate Communications[16](index=16&type=chunk) - Contact Details: +1 (650) 910-0427, jtarazi@aligos.com[16](index=16&type=chunk)

Core Viewpoint - Aligos Therapeutics, Inc. is advancing its clinical pipeline, particularly focusing on the Phase 2 B-SUPREME study of ALG-000184 for chronic HBV infection, while also reporting significant financial results for Q2 2025 [1][2][7]. Recent Business Progress - The Phase 2 B-SUPREME study of ALG-000184 has received regulatory approvals in multiple countries, including the US, China, and the UK, with site activations and subject screenings currently in progress [2][3]. - The study aims to evaluate the safety and efficacy of ALG-000184 compared to tenofovir disoproxil fumarate in approximately 200 untreated adult subjects with chronic HBV infection over 48 weeks [3]. - Phase 1 data presented at the EASL meeting indicates that ALG-000184 has the potential to replace standard care for chronic HBV suppression, with promising results showing 100% of subjects achieving HBV DNA < LLOQ after 96 weeks of treatment [2][3]. Pipeline Updates - ALG-055009 is being evaluated for metabolic dysfunction-associated steatohepatitis (MASH) and has shown statistically significant reductions in liver fat and improvements in atherogenic lipids after 12 weeks of treatment [5][12]. - ALG-097558, a pan-coronavirus protease inhibitor, is in a study assessing its efficacy in high-risk COVID-19 subjects, with funding expected from external sources [6][12]. Financial Results for Q2 2025 - Cash, cash equivalents, and investments totaled $122.9 million as of June 30, 2025, a significant increase from $56.9 million at the end of 2024, providing sufficient funding for operations into the second half of 2026 [7]. - The net loss for Q2 2025 was $15.9 million, or $(1.53) per share, compared to a net income of $5.1 million, or $0.81 per share, in Q2 2024 [8][18]. - Research and development expenses decreased to $14.0 million from $21.1 million in the same period of 2024, primarily due to reduced clinical study costs [9][18].

SOUTH SAN FRANCISCO, Calif., July 30, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biotechnology company focused on improving patient outcomes through best- in-class therapies for liver and viral diseases, today announced that it will report the Company's second quarter 2025 financial results on Wednesday, August 6, 2025, after the close of the U.S. financial markets. About Aligos Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biopharmaceutical company fo ...

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]