THR-β

Patients with MASH/NASH treated with Rezdiffra experienced clinically meaningful and statistically significant improvements in emotional well-being and health distressStudy results underscore the positive tolerability profile of Rezdiffra CONSHOHOCKEN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today announced the publication of positive patient-reported outcomes data demonstrating Rezdiffra (resmetirom) improved health-related quality of life (HRQL) in patients with NASH with moderate to advanced fibrosis. The results were published in the journal Hepatology. Rezdiffra is a once-daily, oral, liver-directed thyroid hormone receptor (THR)-β agonist designed to target key underlying causes of NASH. It is the first FDA-approved medication for the treatment of NASH. In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and NASH resolution primary endpoints, and 80% of patients treated with Rezdiffra 100 mg experienced improvement or stabilization of fibrosis. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials. Zobair M. Younossi, M.D., MPH, FACP, FACG, AGAF, FAASLD, Professor and Chairman of the Beatty Liver and Obesity Research Program, Inova Health System, the Chairman of the Global NASH Council and lead author of the HRQL analysis stated, “The serious burden of NASH on patient quality of life remains poorly understood and underappreciated by the health system. NASH is associated with significant impairment of HRQL related to fatigue, lack of stamina and other symptoms. Therefore, these results demonstrating that Rezdiffra helped patients achieve clinically meaningful and statistically significantly improvements in multiple domains of HRQL are highly encouraging. Additionally, we found no worsening of HRQL related to potential side effects of Rezdiffra in the MAESTRO-NASH study, which underscores the tolerability profile of the medication.” In the study, changes in HRQL scores from baseline were evaluated in patients receiving Rezdiffra versus placebo and compared between patients with and without biopsy response. By weeks 24 and 52, patients receiving both doses of Rezdiffra experienced improvement of HRQL scores in the Worry domain of the Chronic Liver Disease Questionnaire-NASH. At week 52, Rezdiffra-treated patients who achieved fibrosis improvement or NASH resolution experienced improvement in several HRQL domains, including domains for Worry, Health Distress and Stigma. The improvement in HRQL among Rezdiffra biopsy responders was contrasted by no similar improvement in the placebo group. Biopsy responders with stage F3 fibrosis at baseline had similar or more pronounced improvements of HRQL in comparison to those responders with F2 or F1B fibrosis at baseline. Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH is the leading cause of liver transplant among women and those who get listed for hepatocellular carcinoma in the U.S. and the unpredictable speed of NASH disease progression can cause serious emotional distress for people living with the disease. In addition to the health burden of NASH, patient advocates frequently tell us they worry about the impact of the disease on their families and plans for the future. The introduction of Rezdiffra as the first FDA-approved therapy for NASH has provided hope for patients, and we see this demonstrated in the improvements in health-related quality of life observed in the MAESTRO-NASH trial.” About NASH Nonalcoholic steatohepatitis (NASH) is a more advanced form of nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Additionally, patients with NASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality. Once patients progress to NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically. NASH is rapidly becoming the leading cause of liver transplantation in the U.S. and is already the leading cause in women. Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis. Madrigal plans to focus on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of the liver specialist physicians during the launch of Rezdiffra. NASH is also known as metabolic dysfunction associated steatohepatitis (MASH). In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. Nonalcoholic fatty liver disease (NAFLD) was renamed metabolic dysfunction-associated steatotic liver disease (MASLD); NASH was renamed MASH; and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes). About Rezdiffra What is Rezdiffra? Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. It is not known if Rezdiffra is safe and effective in children (under 18 years old). This indication is approved based on improvement of NASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra. Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you: have any liver problems other than NASH.have gallbladder problems or have been told you have gallbladder problems, including gallstones.are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works.Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Rezdiffra is not recommended in patients taking these medicines.Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol.Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. What are the possible side effects of Rezdiffra? Rezdiffra may cause serious side effects, including: liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice), pain or tenderness in the upper middle or upper right area of your stomach (abdomen).gallbladder problems. Gallbladder problems such as gallstones, inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with NASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting. The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, constipation. These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Madrigal at 1-800-905-0324. Please see the full Prescribing Information, including Patient Information, for Rezdiffra. About Madrigal PharmaceuticalsMadrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH. For more information, visit www.madrigalpharma.com. Forward Looking StatementsThis press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on Madrigal’s beliefs and assumptions and on information currently available to it but are subject to factors beyond its control. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Forward-looking statements include all statements that are not historical facts; statements referenced by forward-looking statement identifiers; and statements regarding: Rezdiffra (resmetirom) and its expected use for treating NASH with moderate to advanced fibrosis. Forward-looking statements can be identified by terms such as “accelerate,” “achieve,” “allow,” “anticipates,” “appear,” “be,” “believes,” “can,” “confidence,” “continue,” “could,” “demonstrates,” ”design,” “estimates,” “expectation,” “expects,” “forecasts,” “future,” “goal,” “help,” “hopeful,” “inform,” “intended,” “intends,” “may,” “might,” “on track,” “planned,” “planning,” “plans,” “positions,” “potential,” “powers,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “will achieve,” “will be,” “would”, “future” or similar expressions and the negatives of those terms. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercial launch of a new product, particularly for a company that does not have commercial experience; risks associated with meeting the objectives of Madrigal’s clinical studies, including, but not limited to Madrigal’s ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal’s studies; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) mechanism of action; enrollment and trial conclusion uncertainties; market demand for and acceptance of our product; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financings on terms similar to those arranged in the past; the ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive studies; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; the timing and outcomes of clinical studies of Rezdiffra (resmetirom); the uncertainties inherent in clinical testing; and uncertainties concerning analyses or assessments outside of a controlled clinical trial. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s submissions filed with the U.S. Securities and Exchange Commission, or SEC, for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 28, 2024, , and Part II, Item 1A of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 7, 2024, and as updated from time to time by Madrigal’s other filings with the SEC. Investor Contact Tina Ventura, IR@madrigalpharma.com Media ContactChristopher Frates, media@madrigalpharma.com

Aligos Therapeutics has announced a midstage metabolic-dysfunction associated steatohepatitis win, though questions remain about data totality and financing for further development. Aligos Therapeutics is heralding a midstage win in metabolic-dysfunction associated steatohepatitis (MASH) after three different doses of its drug candidate significantly slashed liver fat at 12 weeks. Despite the company's enthusiasm, the results failed to impress investors.The oral asset, a thyroid hormone receptor beta agonist called ALG-055009, was evaluated among 102 patients with presumed MASH and stage 1 to 3 liver fibrosis. Top-line results from the phase 2a study, dubbed HERALD, were shared Sept. 19 before U.S. markets opened.Since then, Aligos' stock has slipped about 20%, falling from $14.16 yesterday at close to $11.20 as of 12:15 p.m. ET Thursday. Participants in the phase 2 MASH trial were randomized to one of four dosing arms (0.3, 0.5, 0.7 or 0.9 mg) or to receive placebo once daily for 12 weeks. Only patients weighing more than 85 kg (about 187 pounds) were enrolled in the 0.9-mg dosing cohort, with no other weight restrictions implemented on the other groups.The dosing stratification was used to account for “the wide distribution of body weights among MASH patients,” Aligos President and CEO Lawrence Blatt, Ph.D., said on a Sept. 19 investor call. ALG-055009 hit the study’s primary endpoint, which measured the percent of relative change from baseline in liver fat at Week 12 using a quantitative imaging biomarker scale known as the Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF), plus other noninvasive biomarkers or tests, according to Aligos. The 0.5-mg, 0.7-mg and 0.9-mg trial groups all demonstrated statistically significant reductions in liver fat, with patients in the 0.7-mg cohort seeing the highest placebo-adjusted median relative reduction at 46.2%, Aligos said. Results seen in the lowest dose arm—0.3 mg—were not statistically significant. MASH is a severe form of fatty liver disease that can lead to scarring, cancer or failure of the liver. Up to 70% of participants receiving ALG-055009 had a relative reduction in liver fat of 30% or more compared to baseline, according to Aligos.“I would like to remind everyone that this data is only recently received,” Blatt said on the investor call. “To date, we have evaluated safety and primary efficacy data and a subset of the biomarker data through the treatment period of Week 12. We therefore feel confident reporting the top-line MRI-PDFF, certain biomarkers and the tolerability data today. In the coming weeks, we plan to evaluate additional biomarkers and follow up safety data.” The asset was well tolerated with no serious adverse events or dose reductions reported, according to the California-based biotech. Most treatment-emergent adverse events were mild to moderate in severity, and patients receiving ALG-055009 had a similar incidence of gastrointestinal-related adverse events compared to placebo. The investigational treatment was actually tied to a lower incidence of diarrhea when compared to placebo.ALG-055009 was also tied to significantly lowered levels of atherogenic lipids, such as LDL-C, lipoprotein (a) and apolipoprotein B, the biotech said.In March, Madrigal Pharmaceuticals' resmetirom (brand name Rezdiffra) won accelerated FDA approval for patients with MASH and moderate or severe fibrosis based on a surrogate endpoint measuring the drug's effect on liver inflammation and scarring, also known as fibrosis.  While Aligos didn’t evaluate ALG-055009 in a head-to-head trial with resmetirom, Blatt said the data demonstrate a differentiated profile compared to Madrigal's approved drug.“HERALD data demonstrated a higher placebo adjusted median liver fat reduction at week 12—46.2% for ALG-009 versus 26% placebo adjusted median relative fat reduction reported in the published literature pertaining to the MRI-PDFF Week 12 data for resmetirom,” Blatt said.  Another player in the space is Viking Therapeutics, which shared phase 2b data from its MASH candidate, also an agonist of the thyroid hormone beta receptor, last November. The asset was tied to a median relative reduction from baseline in liver fat up to 51.7%, as measured by MRI-PDFF and depending on dose level. Up to 85% of patients receiving treatment experienced at least a 30% relative reduction in liver fat content.Aligos’ results have prompted the company to plot further clinical development, Blatt said, adding that the biotech plans to wrap up activities necessary to launch a phase 2b study by mid-2025.The company is also in early talks with potential partners and evaluating several options to fund development, according to Blatt. When asked on the Q&A portion of the investor call whether Aligos needed a partner to launch the phase 2b study, Blatt said it depended on the type of partnership offered.“I always like to say, we're not going to give this drug away,” the CEO explained. “So, if partners [are] willing to financially reward the company for the value created, then we'll move forward to partner. If not, we'll find other means to finance the movement forward.” MASH has historically been a tricky indication to crack, with numerous companies—Genfit, Novo Nordisk, Akero Therapeutics and Bristol Myers Squibb, to name a few—failing to get their therapies working both efficiently and safely enough in trials to warrant approvals. The chronic and progressive liver disease is expected to affect some 27 million Americans by 2030, a jump from 16.5 million in 2015. 

ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFFPlacebo-adjusted median relative reductions in liver fat were up to 46.2% with a clear dose responseALG-055009 was well-tolerated with no serious adverse events or dose reductions. Importantly, ALG-055009 dose groups had a similar incidence of gastrointestinal-related adverse events with less diarrhea compared to placeboSignificant reductions in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B were observedConference call scheduled for 8:30am ET/5:30am PT today SOUTH SAN FRANCISCO, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced positive topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. HERALD (NCT06342947) is a randomized, double-blind, placebo-controlled trial that enrolled 102 subjects with presumed MASH and stage 1-3 liver fibrosis (F1-F3). Subjects were randomized to receive one of four doses (0.3, 0.5, 0.7, 0.9 mg) of ALG-055009 or placebo (~20 subjects/arm) given orally once daily for 12 weeks. Only subjects weighing >85 kg were enrolled in the 0.9 mg dose group, with no body weight restrictions implemented in the other dose groups. Key endpoints assessed were safety, tolerability, pharmacokinetics, relative change in liver fat content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF), and other non-invasive biomarkers/tests. Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12, with placebo-adjusted median relative reductions up to 46.2% as measured by MRI-PDFF. Up to 70% of subjects achieved ≥30% relative reduction in liver fat compared to baseline. The MRI-PDFF results are summarized in the figure below. “The robust improvements in liver fat and other clinically relevant biomarkers, such as lipoprotein (a), demonstrate why potency and PK are pertinent when designing molecules aimed at improving patient outcomes,” said Rohit Loomba, MD, MHSc, Chief, Division of Gastroenterology and Hepatology, University of California, San Diego. “This has been an exciting year for the MASH space, which continues with this excellent data from Aligos’ ALG-055009, which has the potential for not only improvement in resolution of MASH, but also fibrosis improvement. In addition, it has potential to improve cardiovascular risk if the non-invasive tests (NIT) data are confirmed in future trials. I look forward to continuing to work with the Aligos team to further develop this program.” ALG-055009 demonstrated a favorable tolerability profile with no serious adverse events (SAEs), or clinical hyper/hypothyroidism. The majority of treatment emergent adverse events (TEAEs) were mild to moderate, with one discontinuation due to worsening insomnia in a subject with pre-existing insomnia. No clinically meaningful findings in laboratory tests, electrocardiograms, vital signs, or physical examinations were observed. Incidence of gastrointestinal-related TEAEs were similar in ALG-055009 dose groups compared to placebo. Specifically, a non-dose-related, lower incidence of diarrhea was observed in ALG-055009 dose groups compared to placebo. Treatment with ALG-055009 resulted in significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a) (LpA), and apolipoprotein B (ApoB). In addition, dose dependent increases in sex hormone binding globulin (SHBG), a marker of THR-β target engagement in the liver, were observed. “When designing ALG-055009, our goal was to create a potential best-in-class THR-β agonist through enhanced potency and a superior PK profile,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “Today’s data demonstrates that these enhanced pharmacologic properties did indeed translate into robust improvements in liver fat reduction. In addition, ALG-055009 demonstrated a favorable tolerability profile, which is important given that MASH medications will likely be administered for prolonged periods of time. We believe ALG-055009 has the potential to help patients better adhere to MASH treatment. These results indicate that ALG-055009 warrants further development. We are currently in early discussions with potential partners and evaluating a variety of options to fund the continued development. We plan to complete the activities required for a Phase 2b study by the middle of 2025 and are assessing potential Phase 2b clinical trial designs.” The company plans to present additional results and analyses at a future scientific meeting later this year. Conference Call & Webcast Details The company will host a conference call and webcast with a slide presentation today at 8:30am ET/5:30am PT. To access the live webcast with slides, please visit the Presentation & Events page on the Aligos website at www.aligos.com. Please register ten minutes prior to its start. Following the live webcast, a replay will be available on the company’s website for 90 days. About MASH One of the effects of improper diet and insufficient exercise is the accumulation of fatty deposits in the liver, referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), which was estimated to occur in approximately 30% of the worldwide population as of 2019. An estimated 1.5% to 6.5% of the global population is believed to have an ongoing inflammatory response to these excess fat deposits, which is referred to as metabolic dysfunction-associated steatohepatitis (MASH). In the United States alone, the prevalence of MASH is projected to increase from approximately 16.5 million in 2015 to 27.0 million in 2030. In the absence of changes in diet and exercise, the inflammation inherent in MASH persists and may result in progressive fibrosis of the liver, which may result in cirrhosis. These fibrotic changes are associated with numerous morbidities including recurrent hospitalization for complications of cirrhosis, hepatocellular carcinoma, need for liver transplant, and death. The first drug to treat this growing patient population, a THR-β agonist, was recently approved. About the HERALD Study HERALD (NCT06342947) is a randomized, double-blind, placebo-controlled trial that enrolled 102 subjects with presumed MASH and stage 1-3 liver fibrosis (F1-F3). Subjects were randomized to receive one of four doses (0.3, 0.5, 0.7, 0.9 mg) of ALG-055009 or placebo (~20 subjects/arm) given orally once daily for 12 weeks. The primary endpoint was relative change in liver fat content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 12. Safety, pharmacokinetics (PK) and other non-invasive biomarkers/tests previously shown to be impacted by treatment with thyroid hormone receptor beta (THR-β) agonists were also evaluated. About ALG-055009 ALG-055009 was designed to be a potential best-in-class thyroid hormone receptor beta (THR-β) agonist discovered by Aligos for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Recent topline data from the Phase 2a HERALD study demonstrated a favorable tolerability profile with significant reductions in liver fat as measured by MRI-PDFF following once a day, low oral dose. About Aligos Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biopharmaceutical company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. For more information, please visit www.aligos.com or follow us on LinkedIn or X. Forward-Looking Statements 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 regarding Aligos’ research and development activities, including Aligos’ goals in designing ALG-055009, MASH medications being administered for prolonged periods of time, ALG-055009’s potential for greater patient adherence, ALG-055009’s results indicating that ALG-055009 warrants future development, Aligos’ discussions with potential partners and evaluation of options to fund the continued development of ALG-055009, Aligos’ plans to complete the activities required for a Phase 2b study and Aligos’ assessment of potential Phase 2b clinical trial designs. 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, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. 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 August 6, 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. Investor ContactAligos Therapeutics, Inc.Jordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media ContactInizio EvokeJake RobisonVice PresidentJake.Robison@inzioevoke.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f305238a-fd16-4b0d-85d9-5bc31c7dacc2