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Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical-stage biopharmaceutical company headquartered in South San Francisco, California, and founded in 2018. The company is dedicated to developing novel therapeutics to address unmet medical needs in liver and viral diseases. Aligos is particularly focused on treatments for chronic hepatitis B (CHB) and metabolic dysfunction-associated steatohepatitis (MASH), as well as for coronaviruses.
The company’s lead candidate, ALG-010133, is a synthetic oligonucleotide currently in Phase I clinical trial for the treatment of CHB. Other promising candidates in their pipeline include ALG-000184, a capsid assembly modulator also targeting CHB, and ALG-055009, a small molecule thyroid hormone receptor beta (THR-ß) agonist for MASH. Initial studies on ALG-055009 have demonstrated enhanced potency and favorable pharmacokinetics.
Aligos is advancing its clinical programs, including the Phase 2a HERALD study of ALG-055009, which will assess the safety and efficacy of the drug in subjects with MASH, with topline data expected in Q4 2024. The study aims to enroll about 100 subjects and will evaluate multiple non-invasive biomarkers to track liver health improvements.
The company is also actively engaged in collaborations and partnerships to bolster its research efforts. Recently, Aligos presented positive data at the European Association for the Study of the Liver (EASL) Congress 2024, showcasing the sustained antiviral activity of ALG-000184 in both HBeAg-positive and HBeAg-negative CHB subjects. This data represents a significant advancement in viral load suppression and demonstrates Aligos' potential to deliver best-in-class treatments.
Besides its focus on liver diseases, Aligos is developing ALG-097558, a pan-coronavirus protease inhibitor showing promise in preclinical and early clinical trials. ALG-097558 has been well tolerated and does not require ritonavir boosting, addressing a critical need for effective, easily administered antiviral therapies.
Financially, Aligos reported cash, cash equivalents, and investments totaling $112.7 million as of March 31, 2024. The company continues to secure funding to support its operations and further its research projects, with a belief that its current cash balance will sustain operations through the end of 2025.
Aligos’ mission is to leverage its deep expertise and innovative approaches in drug development to become a leader in treating liver and viral diseases, ultimately improving patient outcomes and addressing high unmet medical needs worldwide.
On April 11, 2023, Aligos Therapeutics (Nasdaq: ALGS) announced the presentation of seven posters at the EASL Congress 2023 in Vienna, occurring from June 21 to 24. The posters focus on five liver disease programs, showcasing data that highlights the company's advancements in addressing unmet medical needs in liver and viral diseases. Key presentations include data on Chronic Hepatitis B treatments involving compounds like CAM-E ALG-000184 and siRNA ALG-125755, as well as innovative approaches targeting Hepatocellular Carcinoma. Chairman & CEO Lawrence Blatt expressed optimism about these being potential best-in-class therapies. Detailed information will be made available on their corporate website post-conference.
Aligos Therapeutics (Nasdaq: ALGS) showcased positive results for its thyroid receptor-beta agonist candidate, ALG-055009, during the 15th Paris Hepatology Conference from March 27-29, 2023. The Phase 1 data revealed a favorable safety and pharmacokinetic profile in healthy volunteers and subjects with hyperlipidemia. The study demonstrated low variability and similar bioavailability for both liquid and gelcap formulations, which are set for a Phase 2 study with a regulatory filing anticipated in Q4 2023. These results indicate promising potential for addressing unmet medical needs in liver and viral diseases.
Aligos Therapeutics (Nasdaq: ALGS) announced significant advancements in its drug development pipeline for NASH, COVID-19, and CHB diseases, highlighting progress in clinical trials and positive data from candidate ALG-055009. The company reported a cash balance of $125.8 million as of December 31, 2022, down from $205.8 million in 2021, but sufficient to fund operations through the end of 2024. Net losses decreased to $21.9 million for Q4 2022, compared to $37.7 million in Q4 2021, and annual losses were $96.0 million, down from $128.3 million.
The firm anticipates key data readouts throughout 2023, which could drive shareholder value.