ALGS Aligos Therapeutics Inc.

28.74
+0.68  (+2%)
Previous Close 28.06
Open 28.11
52 Week Low 12.82
52 Week High 37.5099
Market Cap $1,095,508,733
Shares 38,117,910
Float 34,859,283
Enterprise Value $985,044,479
Volume 84,953
Av. Daily Volume 166,228
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Upcoming Catalysts

Drug Stage Catalyst Date
ALG-000184
Hepatitis B
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
ALG-01013
Hepatitis B
Phase 1
Phase 1
Phase 1 trial initiated August 2020 (New Zealand).

Latest News

  1. SOUTH SAN FRANCISCO, Calif., Feb. 03, 2021 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company will deliver four poster presentations at the 30th Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL), taking place virtually from February 4 through February 6, 2021.

    "We are proud to show progress for two of our clinical candidates from our chronic hepatitis B portfolio," said Aligos CEO Lawrence Blatt, Ph.D., MBA. "Both candidates are currently being evaluated in Phase 1a/b umbrella studies where we will evaluate each for antiviral…

    SOUTH SAN FRANCISCO, Calif., Feb. 03, 2021 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company will deliver four poster presentations at the 30th Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL), taking place virtually from February 4 through February 6, 2021.

    "We are proud to show progress for two of our clinical candidates from our chronic hepatitis B portfolio," said Aligos CEO Lawrence Blatt, Ph.D., MBA. "Both candidates are currently being evaluated in Phase 1a/b umbrella studies where we will evaluate each for antiviral activity in CHB patients following demonstration of safety and tolerability in healthy volunteers. These trials are part of a larger plan to develop highly effective treatments using combinations of multiple novel drugs from our portfolio. We look forward to advancing our other lead candidates targeting other viral mechanisms of action into the clinic alongside ALG-010133 and ALG-000184."

    Three of the presentations highlight encouraging data from Aligos' two most advanced CHB candidates for development toward a combination therapy for chronic hepatitis B (CHB): STOPS™ (ALG-010133), a proprietary oligonucleotide designed to inhibit hepatitis B virus (HBV) S-antigen (or HBsAg) replication, and ALG-000184, a capsid assembly modulator (CAM), designed to inhibit HBV replication.

    The first presentation, titled "Preclinical Efficacy and Pharmacokinetics of ALG-010133, an S-Antigen Transport-inhibiting Oligonucleotide Polymers (STOPS) for the Treatment of Chronic Hepatitis B (CHB)", demonstrated that Aligos' lead STOPS candidate inhibited S-antigen release from cells in several lines of human hepatocytes. In vivo, ALG-010133 demonstrated high, rapid and sustained exposure in the liver following single subcutaneous injections given to nonclinical species, predicting once-weekly dosing in humans. Further, a nonclinical multiple dosing study in which animals were given three weekly subcutaneous doses demonstrated sufficient concentrations in the liver sufficient for projected efficacy in human CHB patients. Together, the combination of excellent in vitro efficacy and a favorable pharmacokinetic profile in vivo has justified ALG-010133's progression to a Phase 1a/b trial for evaluation as a potential treatment for CHB.

    A second presentation, "Safety, tolerability and pharmacokinetics of single ascending doses of ALG-000184, a Class II Capsid Assembly Modulator for the treatment of Chronic Hepatitis B (CHB), in healthy volunteers (HV)", outlined preliminary data supporting further evaluation of Aligos' small molecule candidate ALG-000184 in healthy volunteers and in CHB patients, as planned in the ongoing Phase 1a/b trial. At single oral doses of up to 500 mg, ALG-000184 was safe, well-tolerated and demonstrated a linear pharmacokinetic profile supporting once-daily oral dosing. Doses of 100 mg or higher resulted in plasma concentrations of active compound that are projected to result in antiviral activity in CHB patients.

    Two other poster presentations entitled "Excellent preclinical characteristics of ALG-000184, a prodrug of the HBV capsid assembly modulator ALG-001075" and "ALG-020572, a next generation hepatitis B virus (HBV) antisense oligonucleotide (ASO) with bridged nucleic acid chemistry, has a significantly improved preclinical profile" highlight the nonclinical characteristics of ALG-000184 and its parent compound, ALG-001075, and ALG-020572, Aligos' ASO candidate for chronic hepatitis B that significantly improves upon other ASOs in terms of nonclinical safety and efficacy.

    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 viral infections and liver diseases. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos' strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

    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 regarding our plan to evaluate each of our clinical candidates for antiviral activity in CHB patients following demonstration of safety and tolerability in healthy volunteers; our plan to develop highly effective treatments using combinations of multiple novel drugs from our portfolio; our advancing our other lead candidates targeting other viral mechanisms of action into the clinic alongside ALG-010133 and ALG-000184; ALG-010133's progression to a Phase 1a/b trial for evaluation as a potential treatment for CHB following excellent in vitro efficacy and a favorable pharmacokinetic profile in vivo; and further evaluation of Aligos' small molecule candidate ALG-000184 in healthy volunteers and in CHB patients as planned in the ongoing Phase 1a/b trial. 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's 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's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. 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's prospectus filed with the Securities and Exchange Commission on October 19, 2020, and its future periodic reports to be filed 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

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    LifeSci Communications

    +1 315 879 8192

     

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    LifeSci Advisors

    +1 212 915 2577

     



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  2. SOUTH SAN FRANCISCO, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that CEO Lawrence Blatt, Ph.D., MBA, will present at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 3:40 p.m. ET/12:40pm PT. The presentation will be followed by a virtual Q&A session.

    A recording of the webcast presentation will be available within 24 hours of the presentation and will be available for 30 days through the Investors section of the Aligos website. https://investor.aligos.com

    About Aligos

    Aligos Therapeutics, Inc. is a clinical stage…

    SOUTH SAN FRANCISCO, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that CEO Lawrence Blatt, Ph.D., MBA, will present at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 3:40 p.m. ET/12:40pm PT. The presentation will be followed by a virtual Q&A session.

    A recording of the webcast presentation will be available within 24 hours of the presentation and will be available for 30 days through the Investors section of the Aligos website. https://investor.aligos.com

    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 viral infections and liver diseases. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos' strategy is to harness the deep expertise and decades of drug development experience its team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

    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". 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's 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's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. 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's prospectus filed with the Securities and Exchange Commission on October 19, 2020, and its future periodic reports to be filed 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

    Amy Jobe, Ph.D.

    LifeSci Communications

    +1 315 879 8192

    Investor Contact

    Corey Davis, Ph.D.

    LifeSci Advisors

    +1 212 915 2577



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  3. SOUTH SAN FRANCISCO, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company delivered an oral and poster presentation today at the RespiDART & Emerging Viruses 2020 meeting. The presentation highlighted the company's progress with developing a SARS-CoV-2 therapeutic candidate, as well as the development of a screening method to assess potential candidates. Aligos performed all research in collaboration with Belgian University KU Leuven, in particular its Centre for Drug Design and Discovery (CD3), and the Rega Institute for Medical Research…

    SOUTH SAN FRANCISCO, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company delivered an oral and poster presentation today at the RespiDART & Emerging Viruses 2020 meeting. The presentation highlighted the company's progress with developing a SARS-CoV-2 therapeutic candidate, as well as the development of a screening method to assess potential candidates. Aligos performed all research in collaboration with Belgian University KU Leuven, in particular its Centre for Drug Design and Discovery (CD3), and the Rega Institute for Medical Research.

    The presentation, titled "Structure-based discovery of potent and selective SARS-CoV-2 3-chymotrypsin-like cysteine protease inhibitors using a multiplex screening platform," describes the authors' mass spectrometry-based assay developed to assess putative coronaviral 3-chymotrypsin-like cysteine protease (3CLpro) inhibitors in development for therapeutic use against SARS-CoV-2, including Aligos' own 3CLpro inhibitor candidate, ALG-097111. Coronaviral 3CLpro is a promising therapeutic target, as it is essential and conserved among coronaviruses but is not found in humans.

    Aligos and collaborators launched a structure-based approach to identify novel coronaviral 3CLpro inhibitors that were evaluated in the in-house developed multiplex SARS-CoV-2 3CLpro/human rhinovirus 3C (HRV3C) protease assay to assess their specificity and selectivity.

    Unlike all other SARS-CoV-2 3CLpro compounds tested with the screening platform to date, Aligos' lead compound ALG-097111 demonstrated potent SARS-CoV-2 3CLpro inhibition, without inhibiting human cathepsin L protease activity up to the highest concentration tested (IC50 > 10 µM). Cathepsin L has been shown to be involved in a highly redundant entry pathway of SARS-CoV-2 into different cell types. As the competition between the viral 3CLpro and the host cathepsin L might eventually act as a decoy mechanism in vivo, the identification of potent inhibitors selective for the viral 3CLpro represents an important breakthrough.

    "We are pleased that our work with CD3 and the Rega Institute has yielded a platform that we can use to optimize our SARS-CoV-2 3CLpro inhibitors," said Pierre J.M.B. Raboisson, Pharm.D. Ph.D., Vice President, Head of Small Molecule Medicinal Chemistry and European Site Head at Aligos. "A highly specific, selective small molecule anti-coronaviral therapeutic will likely be indispensable as part of an effective treatment regimen against SARS-CoV-2, whereas treatments repurposed from other viral indications may fall short. We are encouraged to see potent protease inhibition activity with ALG-097111 and we continue to refine the candidate's chemistry for optimal potency."

    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 viral infections and liver diseases. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos' strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

    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 regarding the ability to use the platform arising from the collaboration with CD3 and the Rega Institute to optimize SARS-CoV-2 3CLpro inhibitors; the likelihood of specific, selective small molecule anti-coronaviral therapeutic being indispensable as part of an effective treatment regimen against SARS-CoV-2; and the continued refinement of the chemistry of ALG-097111 for optimal potency. 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's 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's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. 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's prospectus filed with the Securities and Exchange Commission on October 19, 2020, and its future periodic reports to be filed 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

    Amy Jobe, Ph.D.

    LifeSci Communications

    +1 315 879 8192

    Investor Contact

    Corey Davis, Ph.D.

    LifeSci Advisors

    +1 212 915 2577



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  4. SOUTH SAN FRANCISCO, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS) today announced that it has entered into an Exclusive License and Research Collaboration Agreement with Merck, known as MSD outside the United States and Canada, under which Merck and Aligos will apply Aligos' oligonucleotide platform technology to discover, research, optimize and develop oligonucleotides directed against a non-alcoholic steatohepatitis (NASH) target and up to one additional target of interest in the cardiometabolic/fibrosis space.

    "We have assembled a team of scientists and medical professionals with significant experience in oligonucleotide-based drug discovery and we have developed a proprietary oligonucleotide chemistry…

    SOUTH SAN FRANCISCO, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS) today announced that it has entered into an Exclusive License and Research Collaboration Agreement with Merck, known as MSD outside the United States and Canada, under which Merck and Aligos will apply Aligos' oligonucleotide platform technology to discover, research, optimize and develop oligonucleotides directed against a non-alcoholic steatohepatitis (NASH) target and up to one additional target of interest in the cardiometabolic/fibrosis space.

    "We have assembled a team of scientists and medical professionals with significant experience in oligonucleotide-based drug discovery and we have developed a proprietary oligonucleotide chemistry platform that has broad applicability across diverse therapeutic areas," said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. "Given the imperative to find new innovative treatments for NASH, a chronic liver disease that can progress to fibrosis, cirrhosis, end-stage liver disease and hepatocellular carcinoma, we are pleased to collaborate with Merck to advance the development of potentially effective therapeutic regimens."

    Aligos is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver diseases, including chronic hepatitis B (CHB) and NASH. The company has extensive expertise and resources necessary to develop oligonucleotide candidates for liver diseases, including STOPS™ molecules as well as antisense oligonucleotide (ASO) and small interfering RNA (siRNA) candidates in development for Aligos' program in CHB.

    "NASH continues to represent a serious unmet need and will likely require multiple targeted therapeutic approaches," said Dr. Ajay Chawla, Vice President, Cardiometabolic Disease Discovery, Merck Research Laboratories. "We look forward to working with the scientists at Aligos to apply their novel oligonucleotide-based platform."

    Under the terms of the agreement, Aligos will receive an upfront payment from Merck as well as an additional payment upon designation of a second target for the collaboration. With respect to each collaboration target, Aligos will be eligible for up to $458M in development and commercialization milestones as well as tiered royalties on net sales. Aligos will be primarily responsible for designing, preparing and evaluating the oligonucleotide molecules and delivering optimized lead molecules, and Merck will be responsible for subsequent research, clinical development and commercialization efforts.

    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 viral infections and liver diseases. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos' strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

    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 regarding the advancement of the development of potentially effective therapeutic regimens for NASH, Aligos' eligibility on receiving development and commercialization milestones and royalties from Merck as well as Aligos' strategy to advance its own pipeline of potentially best-in-class molecules. 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's 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's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. 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's prospectus filed with the Securities and Exchange Commission on October 19, 2020, and its future periodic reports to be filed 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

    Amy Jobe, Ph.D.

    LifeSci Communications

    +1 315 879 8192

    Investor Contact

    Corey Davis, Ph.D.

    LifeSci Advisors

    +1 212 915 2577



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  5. SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company has delivered six poster presentations and an oral presentation at this year's American Association for the Study of Liver Diseases (AASLD) Liver Meeting Digital Experience™ (TLMdX) 2020, held virtually on November 13-16, 2020. The data presented includes updates from three of Aligos' assets in its lead chronic hepatitis B (CHB) combination therapy platform, as well as data from the company's nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC) programs…

    SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company has delivered six poster presentations and an oral presentation at this year's American Association for the Study of Liver Diseases (AASLD) Liver Meeting Digital Experience™ (TLMdX) 2020, held virtually on November 13-16, 2020. The data presented includes updates from three of Aligos' assets in its lead chronic hepatitis B (CHB) combination therapy platform, as well as data from the company's nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC) programs.

    "We are proud of the progress we have made for the Aligos' liver disease programs as outlined in our presentations during this year's AASLD Liver Meeting," said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. "We are working towards producing a combination regimen of promising therapeutics that have the potential to lead to functional cures for patients living with chronic hepatitis B. Additionally, our team has made substantial progress on ALG-055009, a potent and selective purpose built THR beta agonist for the treatment of NASH. Two of our drug candidates, ALG-010133 (STOPS™) and ALG-000184 (CAM), aimed at the treatment of chronic hepatitis B have already begun Phase 1 clinical trials and we look forward to advancing the remainder of our liver disease portfolio towards clinical development over the coming year."

    Chronic hepatitis B

    Antisense oligonucleotide (ASO)

    Title: Development of a Best-in-Class HBV ASO, ALG-020572, for the Treatment of Chronic Hepatitis B: Potential for Combination with other Anti-HBV Agents

    Authors: Jin Hong, et al.

    Presentation type: Oral presentation

    Summary: Aligos' ASO candidates for chronic hepatitis B significantly improve upon other ASOs in terms of nonclinical safety. ALG-020572, which targets the open reading frame (ORF) of the small HBsAg, demonstrates excellent in vivo potency and safety profiles in an AAV-HBV mouse efficacy model. ALG-020572 or its unconjugated form demonstrated additive to synergistic activity when combined with other anti-HBV agents in vivo or in vitro.

    Capsid assembly modulator (CAM)

    Title: Best-in-class preclinical characteristics of ALG-000184, a prodrug of the capsid assembly modulator ALG-001075 for the treatment of chronic hepatitis B

    Abstract number: 0823

    Presentation type: Poster

    Authors: Andreas Jekle, et al.

    Summary: The in vitro antiviral profile and ADME characteristics of ALG-000184, Aligos' capsid assembly modulator (CAM) candidate for chronic hepatitis B, are described. ALG-001075 is a class-II CAM with broad and potent anti-HBV activity.

    In cell-based assays, both compounds inhibited HBV DNA with nanomolar EC50 values. ALG-001075 had broad antiviral activity against 37 clinical isolates of the hepatitis B virus and retained activity against 6 known CAM resistance mutations, while T33N reduced ALG-001075's antiviral activity 28-fold.

    Oral administration of ALG-000184 in a tablet formulation at doses of 1 to 12.6 mg/kg resulted in complete oral absorption and high exposure to ALG-001075.

    S-antigen Transport-inhibiting Oligonucleotide Polymer (STOPS™)

    Title: ALG-010133, a Representative S-Antigen Transport-inhibiting Oligonucleotide Polymer (STOPS™) Effectively Inhibits Hepatitis B Surface Antigen (HBsAg) Secretion in Multiple Hepatitis B Virus (HBV) Cell Models

    Abstract number: 0821

    Presentation type: Poster

    Authors: Yuchun Nie et al.

    Summary: ALG-010133 demonstrated robust inhibition of HBsAg release in multiple cell lines and infected liver cells across HBV genotypes, with enhanced activity compared to the structurally similar clinical-stage nucleic acid polymer REP-2139. Additionally, intracellular HBsAg was also reduced, suggesting that HBsAg was degraded inside the cell rather than trapped intracellularly.

    ALG-010133 inhibited HBsAg release with the following EC50 values in respective cell models:

    • 3.9 nM in HepG2.2.15
    • 23.7 nM in PLC/PRF 5
    • 3.2 nM in HBV-infected HepG2-NTCP cells
    • 5.9 nM in HBV-infected PHH cells

    Title: The S-Antigen Transport-Inhibiting Oligonucleotide Polymer (STOPS™) ALG-010133 Demonstrates a Favorable Preclinical Profile for the Treatment of Chronic Hepatitis B

    Abstract number: 0831

    Presentation type: Poster

    Authors: Vikrant Gohil, et al.

    Summary: Aligos' STOPS candidate for use in chronic hepatitis B, currently in a Phase 1a/b trial, was evaluated for pharmacokinetic and overall safety profile in nonclinical species through subcutaneous or intravenous dosing.

    Results included the following:

    • 2-week repeat dose studies with weekly SC dosing in nonclinical species showed that ALG-010133 was well tolerated to up to the highest dose tested (50 mg/kg).
    • Rapid uptake and long half-life were demonstrated, with significant recovery in all tissues four weeks after the final dose in nonclinical species.

    NASH

    Title: Characterization of Thyroid Hormone Receptor (THR) Agonists for the Treatment of Non-Alcoholic Steatohepatitis (NASH) by Quantification of Gene Transcription in Human Hepatocytes

    Abstract number: 1665

    Presentation type: Poster

    Authors: Xuan Luong, et al.

    Summary: A fast, high-throughput strategy to rank THR agonist compound efficacy was implemented by using human-derived hepatocytes and quantifying changes in the hepatocytes' transcription of specific genes specific to cholesterol and fatty acid biosynthesis and metabolism directly downstream of THR binding and activation. The ability of three THR agonists to modulate the expression of genes specific to cholesterol and fatty acid biosynthesis and metabolism were compared to one another in vitro and replicated in vivo in a high fat diet-fed rat model for confirmation. Using human-derived hepatocytes provides more biologically relevant data compared to biochemical or non-hepatocyte screening assays.

    Title: ALG-055009, a Potent and Selective THR Beta Agonist for the Treatment of NASH, Demonstrates Significant Cholesterol Reduction in a Diet-Induced Obese (DIO) Mouse Efficacy Model

    Abstract number: 1656

    Presentation type: Poster

    Authors: Kusum Gupta, et al.

    Summary: Aligos' THR-β agonist candidate ALG-055009 in development for NASH is highly efficacious in a diet-induced obese mouse model. With its high and selective potency combined with projected low doses in humans, ALG-055009 has the potential to be a best-in-class THR-β agonist for the treatment of NASH.

    In DIO mouse models, the minimum efficacious dose of 0.15 mg/kg/dose twice daily resulted in 17% and 34% reductions in total and LDL cholesterol, respectively. None of the doses induced any significant changes in gene expression in the heart, indicating a potentially wide safety margin.

    Hepatocellular carcinoma

    Title: Tumor Regression in a Mouse Model of Hepatocellular Carcinoma Upon Treatment with the STING Agonist ALG-031048

    Abstract number: 1118

    Authors: Andreas Jekle, et al.

    Summary: Aligos' novel STING agonist ALG-031048 was evaluated in the Hepa1-6 HCC mouse model, for potential use in the treatment of advanced hepatocellular carcinoma.

    Three intratumorally administrated doses of ALG-031048 induced robust dose-dependent anti-tumor activity, resulting in an average 14% tumor reduction (TR) at 25 μg dosing, with tumor regression achieved in 7 of 10 mice; and 88% tumor regression at 100 μg dosing, with tumor regression achieved in all 10 mice. Both were an improvement over single agent anti-PD-1 treatment.

    After intratumoral and subcutaneous administration in CT26 and MC38-hPD-L1 murine models of colon carcinoma, ALG-031048 showed strong anti-tumor activity, which was augmented in combination with antibodies against the immune checkpoint inhibitor CTLA-4 in the CT26 model or in combination with the anti-PD-L1 antibody, atezolizumab, in the MC38-hPD-L1 model.

    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 viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos' strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

    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 our working towards producing a combination regimen of therapeutics that may lead to functional cures for patients living with CHB and our looking forward to advancing the remainder of our liver disease portfolio towards clinical development over the coming year. 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's 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's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. 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's prospectus filed with the Securities and Exchange Commission on October 19, 2020, and its future periodic reports to be filed 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

    Amy Jobe, Ph.D.

    LifeSci Communications

    +1 315 879 8192

    Investor Contact

    Corey Davis, Ph.D.

    LifeSci Advisors

    +1 212 915 2577



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