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SOUTH SAN FRANCISCO, Calif., March 27, 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 three oral presentations and one poster presentation at the 33rd Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2024, being held March 27-31, 2024 in Kyoto, Japan. The poster presentation highlights 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 liver. The three oral presentations provide interim data from Parts 3 and 4 of Aligos’ ALG-000184 Phase 1 extended dosing study showing consistent, potent antiviral activity across different cohorts of untreated CHB patients receiving once daily doses of ALG-000184 as monotherapy or in combination with entecavir (ETV). “We are pleased to present these additional Phase 1 data for ALG-055009 and ALG-000184 at APASL 2024. After the recent initiation of our Phase 2a HERALD study of ALG-055009 in MASH subjects, we remain encouraged by the data presented showing a favorable safety profile and strong evidence of target engagement, as shown by induction of sex hormone binding globulin and lowering of atherogenic lipids. We continue to believe our molecule has the potential to be best-in-class,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “In addition, the three ALG-000184 oral presentations demonstrate a consistent effect in the reduction of key viral markers. These promising results affirm our belief that this compound will play an essential role in the future treatment of hepatitis B.” Details of the presentations are as follows: ALG-055009: Potential best-in-class small molecule THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH) Poster Presentation Title: Pharmacodynamics of Multiple Ascending Oral Doses of ALG-055009, a THR-β Agonist, in Hyperlipidemic Subjects Presented by Megan Fitzgerald, Ph.D.March 28, 2024 at 5:10pm GMT+9 ALG-000184: Potential best-in-class small molecule CAM-E for chronic hepatitis B (CHB) Oral Presentation Title: ALG-000184 (300mg) ± Entecavir Results in Substantial HBV Antigen Declines in Untreated HBeAg-Positive Subjects with CHB Presented by Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong KongMarch 28, 2024 at 9:30am GMT+9 Oral Presentation Title: ALG-000184 (100 mg) + ETV Leads to Stronger Antiviral Effects Compared to ETV Alone in HBeAg-Positive CHB Presented by Professor Jinlin Hou, MD, Director and Professor of the Hepatology Unit and Department of Infectious Diseases, Nanfang Hospital, Southern Medical UniversityMarch 28, 2024 at 9:48am GMT+9 Oral Presentation Title: ALG-000184 Has Favorable Antiviral Effect & Safety in Untreated Asian/Non-Asian HBeAg-Negative CHB Subjects Presented by Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong KongMarch 28, 2024 at 9:57am GMT+9 The presentations can be found on the Scientific Presentations & Conferences section of the Aligos website (www.aligos.com) after the live event. About AligosAligos 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 chronic hepatitis B (CHB) 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, with respect to ALG-055009, statements that the company remains encouraged by the data presented showing a favorable safety profile and strong evidence of target engagement and continues to believe the molecule has the potential to be best-in-class; and with respect to ALG-000184, statements around the promising results contained in the three oral presentations demonstrating consistent effect in the reduction of key viral models, which results affirm the company’s belief that this compound will play an essential role in the future treatment of hepatitis B. 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’ Annual 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 CompanyJordyn TaraziVice President, Investor Relations & Corporate Communications(650) 910-0427jtarazi@Aligos.com MediaMichael Fitzhugh LifeSci Communications (628) 234-3889mfitzhugh@lifescicomms.com

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, delivered oral presentations of clinical data for its capsid assembly modulator-empty (CAM-E), ALG-000184, and its thyroid hormone receptor-beta (THR-β) drug candidate, ALG-055009, at the Hep-DART 2023 meeting, held in Cabo San Lucas, Mexico, from December 3 – 7, 2023. The presentations can be found on the “Scientific Presentations & Conferences” section of the Aligos website (www.aligos.com). “We’re greatly encouraged by the substantial and consistent reductions in HBV viral markers observed during prolonged dosing of ALG-000184 and are grateful for the opportunity to share these results with the scientific community at the Hep-DART 2023 meeting,” said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics. “Consistent with the data that we recently presented at this year’s AASLD meeting, these promising results, including ALG-000184’s unique ability to affect cccDNA antigen expression, affirm our belief that it may have the potential to play a central role in enhancing rates of chronic suppression and/or functional cure in HBV.” Dr. Blatt continued: “We are also pleased for the opportunity to present findings from the Phase 1 trial of our THR-β agonist, ALG-055009, including favorable safety, lipid-lowering activity and differentiated pharmacology and pharmacokinetics, compared to competitor THR-β agonists. As presented at AASLD, ALG-055009 appears to have best-in-class potential. We look forward to the opportunity to demonstrate this promise for patients with NASH in the Phase 2a study, expected to begin in Q1 2024.” Presentation details: Title: Long-term Dosing with ALG-000184 in HBeAg Positive Subjects Results in Unprecedented Multi-log Reductions in HBV Markers Including HBsAg Presenter: Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics Key Highlights: Oral dosing with 300 mg of ALG-000184 ± entecavir (ETV) for up to 48 weeks in untreated HBeAg positive chronic hepatitis B patients demonstrated a favorable safety profile and greater suppression of HBV DNA and RNA versus ETV aloneNo viral breakthroughs occurred when ALG-000184 was given as a monotherapy for up to 44 weeksDose dependent, multi-log reductions were seen in HBsAg, HBeAg and HBcrAgALG-000184 appeared to lower cccDNA levels via 1st and 2nd mechanisms of action of CAM-E drugsALG-000184 may play an important role in enhancing rates of chronic suppression and/or functional cure in CHB patients Title: Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of ALG-055009, a Thyroid Hormone Receptor Beta Agonist, in Hyperlipidaemic Subjects and Relative Bioavailability/Food Effect of a Solid Formulation in Healthy Volunteers Presenter: Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics Key Highlights: In the Phase 1 study, ALG-055009 was well tolerated with a favorable PK profile that is differentiated from VK-2809 and resmetiromExpected thyromimetic effects were observed: dose-dependent increases in sex hormone binding globulin levels (SHBG) and decreases in lipid levelsNo food effect using Phase 2a gel cap formulation in healthy volunteersDemonstrates best-in-class properties as a THR-β agonist 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 nonalcoholic steatohepatitis (NASH) and viruses with high unmet medical need such as coronaviruses and chronic hepatitis B (CHB). 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, with respect to ALG-000184, statements around the company being encouraged by the substantial and consistent reductions in HBV viral markers observed during prolonged dosing of ALG-000184, including ALG-000184’s unique ability to affect cccDNA antigen expression, all of which affirm the company’s belief that it may have the potential to play a central role in enhancing rates of chronic suppression and/or achieving a functional cure in HBV and, with respect to ALG-055009, statements around ALG-055009 appearing to have best-in-class potential, based on higher levels of β-selectivity, compared to other THR-β agonist programs and the company looking forward to demonstrate this promise for patients with NASH in the Phase 2a study, expected to begin in Q1 2024. 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, the risks and uncertainties associated with market conditions, 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-Q filed with the Securities and Exchange Commission on November 2, 2023 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. Media Contact Veronica EamesLifeSci Communicationsveames@lifescicomms.com Investor ContactCorey Davis, Ph.D.LifeSci Advisors+1 212 915 2577cdavis@lifesciadvisors.com

RALEIGH, N.C., Dec. 6, 2023 /PRNewswire/ -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announces the launch of its KYZATREX® HERO campaign that aims to empower men to "Be the Hero of Your Life Again." KYZATREX is an oral prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. The advertising campaign seeks to educate patients who are appropriate candidates for treatment and their physicians on how KYZATREX can help men restore testosterone levels to reinvigorate their natural vitality. The world is currently facing a men's health crisis: Men account for 69% of suicides, 10.8 million men globally are living with prostate cancer, and testicular cancer is the most common cancer among men aged 15-39.1 Additionally, men's testosterone levels are declining, with testosterone deficiency having a prevalence of 20% among adolescent and young adult males.2 Research also indicates that nearly 40% of men over the age of 45 suffer from low testosterone, yet men may not realize the effect it can have on their overall health.3 Through the HERO campaign, Marius Pharmaceuticals wants to help men reveal their inner hero. One of the ways they can do that is to prioritize their own health. Marius believes that every man should be asking their healthcare provider to check their testosterone levels – specifically total testosterone, free testosterone, and sex hormone binding globulin (SHBG), which all contribute to a full understanding of a man's comprehensive metabolic health. In a clinical efficacy study of 127 hypogonadal patients, 96% of patients taking KYZATREX had normal testosterone levels at Day 90. (Based on end of clinical study completers (n=127). Worst case scenario (WCS) was used as a basis for the assessment of primary efficacy endpoint per label. WCS efficacy calculation was 88%, excluding Site 104 (n=139)).4,5 Mean free testosterone levels doubled in the same time period, while mean SHBG levels declined by 30%.5 The only adverse event seen in more than 2% of patients receiving KYZATREX in the clinical trials was hypertension (2.6% of patients).5 "We hope the HERO campaign will help raise awareness for what is possible with safe, effective, and convenient testosterone replacement therapy; how KYZATREX can help get hypogonadal men back to feeling like themselves again," said Shalin Shah, CEO of Marius Pharmaceuticals. "Too many men are silently suffering the daily effects of Testosterone Deficiency, and we want to change that narrative by empowering them to be their own HERO, realizing how the responsible use of testosterone therapy can drive clinically beneficial outcomes for men living with Low T." The HERO campaign is a part of Marius Pharmaceuticals' ongoing comprehensive effort to raise awareness about testosterone deficiency or hypogonadism. The company is committed to educating individuals, including veterans and active-duty service members, about the impact of low testosterone on overall health and well-being. The initiative continues to expand its content and resources to provide valuable information on this critical topic. To learn more about the KYZATREX, visit . About KYZATREX® (testosterone undecanoate) KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Please see additional Important Safety Information for KYZATREX below, including Boxed Warning for potential increased blood pressure, or visit . About Marius Pharmaceuticals Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit . Important Safety Information for KYZATREX® (testosterone undecanoate) Use KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women. Important Safety Information for KYZATREX® KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure. If your blood pressure cannot be controlled, KYZATREX may need to be stopped. Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX. Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age). Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines. KYZATREX may cause other serious side effects including: Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases. If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow. Increased risk of prostate cancer. Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects. In large doses, KYZATREX may lower your sperm count. Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain). Swelling of your ankles, feet, or body (edema), with or without heart failure. Enlarged or painful breasts. Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above. The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels. These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040. Keep KYZATREX and all medicines out of the reach of children. See Full Prescribing Information and Medication Guide for KYZATREX. References: Men's Health is in Crisis. Movember. Accessed November 30, 2023. Lokeshwar SD, Patel P, Fantus RJ, et al. Decline in Serum Testosterone Levels Among Adolescent and Young Men in the USA. Eur Urol Focus. 2021 Jul;7(4):886-889.doi: 10.1016/j.euf.2020.02.006. Mulligan T, Frick MF, Zuraw QC, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul 1; 60(7): 762–769. doi: 10.1111/j.1742-1241.2006.00992.x KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals. Data on File. Raleigh, NC: Marius Pharmaceuticals, 2020. Media Contact: 5W Public Relations [email protected] 212-999-5585 SOURCE Marius Pharmaceuticals