ALG-097558

SOUTH SAN FRANCISCO, Calif., May 07, 2024 (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 reported recent business progress and financial results for the first quarter 2024. “We have executed on a number of key deliverables to position Aligos for success,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President & CEO of Aligos Therapeutics. “Importantly, we began dosing in the Phase 2a HERALD study of our THR- drug candidate, ALG-055009, and we expect topline data in Q4 2024. In addition, we recently presented data from our three clinical programs at scientific conferences, showcasing our robust pipeline of potentially best-in-class small molecule drug candidates. In particular, we demonstrated positive safety, tolerability, and antiviral activity data after dosing for up to 64 weeks with our hepatitis B virus capsid assembly modulator, ALG-000184, and positive safety and PK data for our ritonavir-free, pan-coronavirus protease inhibitor, ALG-097558. We remain excited by the potential of these programs and look forward to continuing to deliver for our shareholders.” Recent Business Progress Aligos Portfolio of Drug Candidates ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH Data presented at the Asian Pacific Association for the Study of the Liver (APASL) conference highlighted ALG-055009 Phase 1 data that showed multiple-ascending doses (MAD) over 14 days in hyperlipidemic subjects produced favorable, dose-dependent pharmacodynamic effects on atherogenic lipids and sex hormone binding globulin (SHBG), an indicator of target engagement in the liverThe Phase 2a HERALD study was initiated in Q1 2024 with the first subject dosed in April 2024Topline HERALD data are anticipated in Q4 2024 ALG-000184: Potential first-/best-in-class small molecule CAM-E for CHB Interim data from Parts 3 and 4 of Study ALG-000184-201 were presented at the APASL conference and showed consistent, potent antiviral activity across multiple cohorts of untreated chronic hepatitis B (CHB) patients receiving once daily doses of ALG-000184 as monotherapy or in combination with entecavir (ETV) x ≤ 64 weeksDosing continues in this ongoing Phase 1a/1b study, with subjects planning to dose for up to 96 weeks. Additional interim data readouts are planned to be presented this year at the following conferences: European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD)Phase 2 enabling activities, including regulatory interactions and drug supply manufacturing, are underway ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor Topline data presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Annual Meeting demonstrated single (up to 2000 mg) and multiple (up to 800 mg Q12 for 7 days) doses of ALG-097558 were well tolerated in healthy volunteers with a pharmacokinetic (PK) profile supporting twice daily, ritonavir-free dosing without a food effectReceived an additional $1.3M grant from the National Institutes of Health (NIH)Phase 2 enabling activities, including nonclinical and clinical studies, are underway with financial support from the NIH Financial Results for the First Quarter 2024 Cash, cash equivalents and investments totaled $112.7 million as of March 31, 2024, compared with $135.7 million as of December 31, 2023. Additionally, in October 2023, we raised $92.1 million in gross proceeds in private placement financing, before deducting placement agent’s fees and other expenses. Including the proceeds from the private placement financing, we continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2025. Net losses for the three months ended March 31, 2024 were $34.9 million or basic and diluted net loss per common share of $(0.22), compared to net losses of $23.0 million or basic and diluted net loss per common share of $(0.53) for the three months ended March 31, 2023. Research and development (R&D) expenses for the three months ended March 31, 2024 were $16.4 million, compared with $18.1 million for the same period of 2023. The decrease was primarily due to a decrease in employee related costs, partially offset by an increase in third party expenses. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2024 was $1.4 million, compared with $2.2 million for the same period of 2023. General and administrative (G&A) expenses for the three months ended March 31, 2024 were $6.7 million, compared with $8.5 million for the same period of 2023. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended March 31, 2024 was $1.2 million, compared with $1.5 million for the same period of 2023. Interest and other income (expense), net, for the three months ended March 31, 2024 was an expense of $12.8 million compared with income of $1.0 million for the same period of 2023. The change in interest and other income (expense), net, is primarily due to an increase in the fair value of the Common Warrants liability, which resulted in a non-cash charge, associated with the Securities Purchase Agreement entered into in October 2023 following the private investment in public equity (PIPE) offering. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to Aligos being positioned for success; the potential of the company’s three clinical programs and the company looking forward to continuing to deliver for its shareholders; the expectation of topline Phase 2a HERALD data for ALG-055009 in Q4 2024; the continuation of dosing in the ongoing Phase 1a/1b study for ALG-000184 with subjects planning to dose for up to 96 weeks and the planned presentation of additional interim data readouts at this year’s EASL and AASLD; and the company’s continued belief its cash balance provides sufficient cash to fund planned operations through the end of 2025. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the impact of global events and other macroeconomic conditions on the Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, 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. Aligos Therapeutics, Inc Condensed Consolidated Statements of Operations(In thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023 (Unaudited) (Unaudited) Revenue from Collaborations$292 $2,583 Revenue from Customers 694 140 Operating Expenses: Research and development 16,366 18,135 General and administrative 6,666 8,506 Total operating expenses 23,032 26,641 Loss from operations (22,046) (23,918) Interest and other income (expense), net (12,793) 1,002 Loss before income tax expense (34,839) (22,916) Income tax expense (24) (39)Net loss (34,863) (22,955)Basic and diluted net loss per common share$(0.22)$(0.53)Weighted-average number of shares used in computing basic and diluted net loss per common share 156,154,156 42,910,065 Aligos Therapeutics, Inc. Condensed Consolidated Balance Sheets(In thousands) March 31, 2024 December 31, 2023 (Unaudited) (audited) (1)Assets Current assets: Cash and cash equivalents$24,151 $135,704Short-term investments 88,588 -Prepaid expenses and other current assets 5,325 5,380Total current assets 118,064 141,084Other assets 9,838 10,443Total assets$127,902 $151,527 Liabilities and Stockholders’ Equity Current liabilities$18,880 $23,906Other liabilities, noncurrent 49,226 35,541Total liabilities 68,106 59,447Total stockholders’ equity 59,796 92,080Total liabilities and stockholders’ equity$127,902 $151,527 _____________________________________________ (1) The balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Investor ContactJordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media ContactMichael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com

Data demonstrates a 7-day treatment regimen with the pan-coronavirus protease inhibitor ALG-097558 was well tolerated and does not require ritonavir boosting SOUTH SAN FRANCISCO, Calif., April 25, 2024 (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 an ePoster flash session presentation at the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) 2024, being held April 27-30, 2024 in Barcelona, Spain. The presentation highlights ALG-097558 Phase 1 data showing that single (up to 2000 mg) and multiple (up to 800 mg Q12 for 7 days) doses of this potent, pan-coronavirus protease inhibitor were well tolerated in healthy volunteers with a PK pro twice daily ritonavir-free dosing without a food effect. “We are pleased to present these ALG-097558 data, which further highlight the best-in-class potential of this pan-coronavirus protease inhibitor and its substantial differentiation versus current standard of care coronavirus antiviral drugs like nirmatrelvir/ritonavir (PAXLOVIDTM),” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “These data further demonstrate that Aligos has developed a robust clinical pipeline of three potentially best-in-class drug candidates. We look forward to continuing to advance ALG-097558 for current and potential future pandemics with the financial support of various external funding sources, including government agencies.” Details of the presentation are as follows: ePoster Flash Session Presentation Title: Safety and pharmacokinetics of single and multiple ascending doses of ALG-097558, a pan-coronavirus proteaseinhibitor, in healthy volunteers Presented by Denisa Wilkes, MD, MSc, CPM, Medical Director, Hammersmith Medicines Research April 28, 2024 at 8:30am CEST The presentation will be available on the Scientific Presentations & Conferences section of the Aligos website ( ) after the live event. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. PAXLOVID® is a registered trade mark of Pfizer, Inc. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements, with respect to ALG-097558, that the Phase 1 data supports twice daily ritonavir-free dosing without food effect and highlights best-in-class potential and substantial differentiation versus standard of care coronavirus antiviral drugs; that such data further demonstrate that Aligos has developed a robust clinical pipeline of three potentially best-in-class drug candidates; and that the company is looking forward to continuing to advance ALG-097558 for current and potential future pandemics with the financial support of various external funding sources, including government agencies. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, and the impact of global events and other macroeconomic conditions on the Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, 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. Contacts Company Jordyn Tarazi Vice President, Investor Relations & Corporate Communications (650) 910-0427 jtarazi@Aligos.com Media Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com