SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 -
Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company dedicated to developing advanced therapies for
liver and viral diseases, has shared updates on its recent business activities and financial performance for the third quarter of 2024.
Dr. Lawrence Blatt, Chairman, President, and CEO of Aligos Therapeutics, highlighted the significant milestone achieved with the announcement of positive topline data from the HERALD study in MASH subjects. The data showed placebo-adjusted median relative reductions in liver fat of up to 46.2%, reinforcing the potential of
ALG-055009 to become a leading treatment. The company is finalizing Phase 2b enabling studies and exploring various funding options, including potential partnerships, to continue its development. Additionally, the company is advancing
ALG-000184 for
chronic hepatitis B (CHB) towards a Phase 2 study next year and plans to initiate externally funded clinical studies for
ALG-097558 in
COVID-19 patients by the end of the year. Blatt expressed excitement about 2024 and the company's future success prospects in 2025 and beyond.
### Recent Business Developments
**Aligos Portfolio of Drug Candidates**
**ALG-000184**: A promising small molecule CAM-E for CHB, currently undergoing a Phase 1a/1b study with dosing expected to last up to 96 weeks. Additional interim data presentations are planned for the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM) 2024. The FDA and China's National Medical Products Administration have provided positive feedback to proceed with sustained HBV DNA suppression as the primary efficacy endpoint for future studies aimed at potential registration of ALG-000184 for hepatitis B treatment. A clinical collaboration with Xiamen Amoytop Biotech Co., Ltd. has been announced, where Amoytop will sponsor and conduct a Phase 1b exploratory study in China evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (mipeginterferon alfa-2b) in CHB patients. Phase 2 enabling activities, including drug supply manufacturing, are underway.
**ALG-055009**: This small molecule THR-β agonist for MASH has shown promising results in the HERALD study, with significant reductions in liver fat at 12 weeks as measured by MRI-PDFF. Doses ranging from 0.5 mg to 0.9 mg demonstrated up to 46.2% placebo-adjusted median relative reductions in liver fat. Up to 70% of subjects achieved a 30% or greater reduction in liver fat compared to baseline. ALG-055009 exhibited a positive tolerability profile without clinical hyper/hypothyroidism and a lower incidence of gastrointestinal-related adverse events compared to placebo. Notably, treatment led to significant reductions in atherogenic lipids and dose-dependent increases in SHBG, a marker of THR-β target engagement in the liver. Further data presentations are planned for AASLD’s The Liver Meeting (TLM) 2024.
**ALG-097558**: This small molecule pan-coronavirus protease inhibitor is set to enter three additional clinical studies in 2024. The AGILE University of Liverpool has agreed to sponsor and conduct a study in high-risk COVID-19 patients evaluating ALG-097558 as monotherapy or in combination with remdesivir. The NIAID will sponsor studies assessing pharmacokinetic differences in special populations. Phase 2 enabling activities, supported by NIH funding, are progressing.
### Financial Highlights for Q3 2024
As of September 30, 2024, Aligos reported $74.9 million in cash, cash equivalents, and investments, compared to $135.7 million as of December 31, 2023. The company maintains that its cash reserves are sufficient to fund planned operations through the end of 2025.
For the third quarter of 2024, Aligos reported a net loss of $19.3 million, or $(3.07) per common share, compared to a net loss of $18.0 million, or $(10.37) per common share, for the same period in 2023. Research and development expenses increased to $16.8 million from $15.9 million in the same quarter of the previous year, primarily due to higher third-party clinical trial expenses. General and administrative expenses decreased to $4.6 million from $6.4 million, mainly due to lower third-party costs, including legal expenses. Interest and other income totaled $1.0 million, compared to $1.1 million for the same period in 2023.
### About Aligos Therapeutics
Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company aiming to enhance patient outcomes by developing superior therapies for liver and viral diseases. The company leverages its scientific approach and extensive R&D expertise to advance its pipeline of treatments for conditions like metabolic dysfunction-associated steatohepatitis (MASH) and high unmet medical need viruses such as hepatitis B and coronaviruses.
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