Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical-stage biotechnology company that has established itself as a rising star in the field of liver and viral disease treatments. Founded in 2018, the company's mission is to improve patient outcomes by developing best-in-class therapies for these critical therapeutic areas.
Business Overview and History Aligos Therapeutics was incorporated in the state of Delaware in February 2018. The company quickly expanded its footprint, forming subsidiaries in Belgium, Australia, and China to support its global R&D efforts. Aligos' founders and management team have a proven track record of success in drug development and medicinal chemistry, particularly in the areas of liver and viral diseases.
In its early years, Aligos established a pipeline of drug candidates targeting chronic hepatitis B (CHB) infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronavirus infections. The company's most advanced programs included ALG-000184, a capsid assembly modulator (CAM-E) for CHB, and ALG-055009, a thyroid hormone receptor beta (THRβ) agonist for MASH.
Aligos went public through an initial public offering on the Nasdaq exchange in 2020, using the proceeds to advance its pipeline and initiate clinical trials for ALG-000184 and ALG-055009. Despite the challenges of the COVID-19 pandemic, the company made progress on its programs, reporting positive data from early-stage studies.
By 2023, Aligos had expanded its collaboration efforts, signing deals with partners like Merck and Amoytop Biotech. However, the company also faced setbacks, such as halting development of its STOPS drug candidate ALG-010133 and discontinuing its ASO drug candidate ALG-020572 due to lack of efficacy or safety concerns. Despite these challenges, Aligos continued to advance its lead programs, ALG-000184 and ALG-055009, through additional clinical studies.
The company's pipeline of drug candidates is centered around three key areas: chronic hepatitis B (CHB) infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronavirus infections. Aligos' lead CHB drug candidate, ALG-000184, is a potentially best-in-class capsid assembly modulator (CAM-E) that has demonstrated compelling antiviral activity in early-stage clinical trials. For MASH, the company's lead asset, ALG-055009, is a potential best-in-class thyroid hormone receptor beta (THRβ) agonist that achieved positive topline data in a recent Phase 2a study. Furthermore, Aligos is developing ALG-097558, a potential best-in-class small molecule coronavirus 3CL protease inhibitor (PI), to address COVID-19 and other coronavirus infections.
Aligos has strategically in-licensed key technologies and intellectual property to bolster its pipeline, including agreements with Emory University, Luxna Biotech, and KU Leuven. These partnerships have provided the company with a robust foundation for its drug discovery and development efforts.
Financials As of December 31, 2024, Aligos reported cash, cash equivalents, and investments of $56.9 million, providing a solid financial runway. The company has been able to raise significant capital, including a $92.1 million private placement in October 2023 and a $105 million private placement in February 2025, which are expected to fund the advancement of its pipeline, including the planned initiation of a Phase 2 study for ALG-000184 in mid-2025.
For the full year 2024, Aligos reported total revenue of $3.94 million, with the majority coming from collaboration agreements. The company's net loss for the year was $131.21 million, reflecting its ongoing investment in research and development activities. Aligos' cash burn rate, as measured by its annual free cash flow, was $80.87 million in 2024.
In the most recent quarter (Q4 2024), Aligos reported revenue of $629,000, representing a 42% decrease compared to the same quarter in the prior year. The company's net loss for the quarter was $82.15 million, a 51% increase from the previous year's quarter. Operating cash flow and free cash flow data for the quarter were not available.
As a small-cap company, Aligos primarily operates in the United States and does not break out performance by geographic markets. The biotechnology and pharmaceutical industries have seen a compound annual growth rate (CAGR) of approximately 7-8% over the past 5 years, providing a favorable environment for companies like Aligos to grow and develop their pipeline.
Liquidity Aligos Therapeutics has maintained a strong liquidity position through strategic fundraising efforts. The company's successful private placements in 2023 and 2025 have significantly bolstered its cash reserves, providing the necessary financial resources to advance its clinical programs. With $56.9 million in cash, cash equivalents, and investments as of December 31, 2024, Aligos has demonstrated its ability to secure funding and manage its cash burn rate effectively.
The company's debt-to-equity ratio of -0.29 indicates that it has more equity than debt on its balance sheet. As of December 31, 2024, Aligos had $37 million in cash and cash equivalents. The company's current ratio and quick ratio are both 2.86, indicating strong liquidity and the ability to meet short-term obligations.
Key Pipeline Developments Chronic Hepatitis B (CHB): Aligos' lead CHB drug candidate, ALG-000184, is a potentially best-in-class CAM-E that has demonstrated superior antiviral activity compared to the current standard of care, nucleoside/nucleotide analogs (NAs), in early-stage clinical trials. The company recently announced that the U.S. FDA has cleared the Investigational New Drug (IND) application for a Phase 1 drug-drug interaction (DDI) study of ALG-000184, paving the way for a planned Phase 2 study in mid-2025.
The multi-part Phase 1 study of ALG-000184 is currently ongoing, with completed evaluation of safety, tolerability, and pharmacokinetic profile in healthy volunteers. A dose-ranging Phase 1 study assessing safety, pharmacokinetics, and antiviral activity of 10-300 mg doses administered over 28 days in untreated HBeAg-negative subjects with chronic HBV infection has also been completed. ALG-000184 was found to be well-tolerated with a favorable pharmacokinetic profile and demonstrated potentially best-in-class multi-log 10 HBV DNA and RNA reductions at all doses tested, as well as HBsAg reductions in a subset of HBeAg-positive subjects receiving the 300 mg dose.
Additional ongoing Phase 1 cohorts are evaluating the safety and efficacy of daily doses up to 300 mg of ALG-000184, with or without entecavir (ETV), for up to 96 weeks in both HBeAg-positive and HBeAg-negative subjects with chronic HBV infection. Preliminary data from several of these cohorts have shown that ALG-000184, administered for up to 92 weeks, was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated potentially best-in-class antiviral activity.
The antiviral activity data has indicated that ALG-000184 may be inhibiting the establishment of cccDNA, which is an important component of maintaining the HBV life cycle and the disruption of which may enhance the rates of functional cure. Dosing in HBeAg-positive and HBeAg-negative subjects will continue through 2025, with 96-week safety, pharmacokinetic, and antiviral activity data to be presented at upcoming scientific conferences. An exploratory combination study with peginterferon alfa-2b is also expected to begin in 2025.
Metabolic Dysfunction-Associated Steatohepatitis (MASH): Aligos' lead MASH drug candidate, ALG-055009, is a potential best-in-class THRβ agonist that has demonstrated robust reductions in liver fat content in a recent Phase 2a study. The company is now completing Phase 2b-enabling activities and evaluating various options, including potential out-licensing, to fund the continued development of this promising asset.
ALG-055009 has been designed to exhibit significantly greater potency, approximately 50-fold higher compared to the approved THRβ agonist resmetirom, and enhanced β-selectivity, along with optimized pharmacologic properties to deliver an improved pharmacokinetic profile.
A first-in-human Phase 1 study of ALG-055009 in healthy volunteers (single ascending doses and multiple ascending doses) has been completed. The clinical data showed that ALG-055009 was well-tolerated, had dose proportional pharmacokinetics with low inter-subject variability, and demonstrated the expected thyromimetic effects without any clinical evidence of thyroid dysfunction.
Based on the promising Phase 1 data, Aligos initiated the Phase 2a HERALD study, a 12-week randomized, double-blind, placebo-controlled trial evaluating 4 doses (0.30 mg, 0.50 mg, 0.70 mg, and 0.90 mg) of ALG-055009 versus placebo in 102 subjects with presumed MASH and liver fibrosis at stages 1-3 (F1-F3). The study met the primary endpoint, with the ALG-055009 dose groups demonstrating statistically significant reductions in liver fat content at Week 12 as measured by MRI-PDFF, with placebo-adjusted median relative reductions up to 46.2%. Additionally, up to 70% of subjects achieved a 30% relative reduction in liver fat compared to baseline, a positive prognostic indicator of histological improvements in MASH resolution and fibrosis reduction.
Phase 2b enabling activities are currently underway, with expected completion in mid-2025. Aligos is also assessing potential Phase 2b clinical trial study designs with key opinion leaders and evaluating a variety of options to fund continued development of ALG-055009, including potential out-licensing.
Coronavirus Infections: Aligos is developing ALG-097558, a potential best-in-class small molecule coronavirus 3CL PI, to address COVID-19 and other coronavirus infections. The company has completed a Phase 1 study in healthy volunteers, which showed the drug candidate was well-tolerated and had an acceptable pharmacokinetic profile. Aligos has initiated additional clinical trials, including a study in high-risk COVID-19 patients, with funding support from the National Institutes of Health (NIH) and other public sources.
ALG-097558 has been shown to be at least 3-fold more potent than nirmatrelvir and other PIs in clinical development against a panel of SARS-CoV-2 variants, including Omicron. It has also demonstrated broad pan-coronavirus activity, including against SARS-CoV-1 and MERS-CoV.
In a first-in-human Phase 1 clinical study, single doses up to 2000 mg and multiple doses up to 800 mg Q12H for 7 days were well-tolerated with an acceptable pharmacokinetic profile that indicates ritonavir boosting is not required and an absence of a clinically relevant drug-drug interaction with midazolam, suggesting ALG-097558 can be co-administered with CYP3A4 substrates. Based on these Phase 1 data, the projected efficacious dose range to treat SARS-CoV-2 is 200-600 mg ALG-097558 Q12H for 5 days, without the need for ritonavir co-administration.
ALG-097558 has begun three additional clinical trials in 2024. The AGILE study, sponsored by the University of Liverpool and funded by the UK government, is evaluating ALG-097558 as monotherapy or in combination with remdesivir in high-risk COVID-19 patients. Additionally, two clinical studies evaluating pharmacokinetics in special populations (renal and hepatic impairment) are ongoing, funded by a contract with the National Institute of Allergy and Infectious Diseases (NIAID). NIAID is also sponsoring a drug-drug interaction and relative bioavailability study in healthy volunteers, expected to start in the second quarter of 2025.
Aligos expects that future development of ALG-097558, including ongoing Phase 2 enabling activities, will be funded by external sources, including public funding sources. Preclinical activities for the coronavirus program were partially funded through grants from the National Institutes of Health (NIH) and NIAID, and specific clinical and nonclinical studies for ALG-097558 and a follow-up compound are now being funded under a contract with NIAID.
Risks and Challenges As a clinical-stage biotechnology company, Aligos faces several risks and challenges common to the industry, including the inherent uncertainty of drug development, regulatory hurdles, competition from larger pharmaceutical players, and the need to secure additional financing to advance its pipeline. The company's success will depend on its ability to navigate these obstacles and successfully develop, obtain regulatory approval for, and commercialize its drug candidates.
Outlook and Conclusion Aligos Therapeutics has positioned itself as a promising player in the liver and viral disease treatment landscape. The company's diversified pipeline, led by potentially best-in-class drug candidates in CHB, MASH, and coronavirus infections, has generated significant interest and momentum. With the recent clearance of the IND application for ALG-000184 and the positive topline data for ALG-055009, Aligos is poised to take the next steps in advancing its clinical programs and unlocking value for shareholders.
Despite the inherent risks and challenges facing the biotechnology industry, Aligos' experienced management team, strategic partnerships, and strong financial position provide a solid foundation for the company's long-term growth and success. As Aligos continues to execute on its development plans and navigate the regulatory landscape, investors will closely watch the company's progress in bringing its innovative therapies to patients in need.
The company's focus on developing novel therapeutics to address significant unmet medical needs in chronic hepatitis B, metabolic dysfunction-associated steatohepatitis, and coronavirus infections demonstrates Aligos' commitment to tackling challenging and impactful areas of medicine. The advancement of these programs, particularly the promising data for ALG-000184 in chronic hepatitis B and ALG-055009 in MASH, highlights Aligos' capabilities in drug discovery and development and positions the company for potential future success in the biotechnology industry.