Aligos Therapeutics, Inc. (NASDAQ:ALGS): A Promising Biotech Tackling Unmet Needs in Liver Diseases and Viral Infections

Published on September 24, 2024 | Ticker: ALGS

Aligos Therapeutics, Inc. (NASDAQ:ALGS) is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver diseases and viral infections. The company has a diverse pipeline of drug candidates, including potential best-in-class treatments for metabolic dysfunction-associated steatohepatitis (MASH), chronic hepatitis B (CHB), and coronavirus infections.

Business Overview

Aligos is devoting substantial efforts to the research and development of its drug candidates. The company's primary area of focus is MASH, a complex, chronic liver disease that is a leading cause of liver-related morbidity. Aligos has developed ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, as a potential best-in-class treatment for MASH. The drug candidate recently completed a successful Phase 1 study and has now initiated a Phase 2a trial.

In the CHB space, Aligos is pursuing a portfolio of differentiated drug candidates, including a small molecule Capsid Assembly Modulator that results in the production of empty viral capsids (CAM-E), ALG-000184. ALG-000184 has demonstrated potentially best-in-class antiviral activity in early-stage clinical trials. The company is also exploring small molecule inhibitors of the Programmed Cell Death Ligand 1 (PD-L1) as a way to boost immune responses in CHB patients.

Aligos' third area of focus is the development of pan-coronavirus antiviral therapies, including ALG-097558, a small molecule coronavirus 3CL protease inhibitor that has shown broad activity against SARS-CoV-2 variants and other coronaviruses in preclinical studies. The company is currently conducting Phase 1 trials for ALG-097558 and plans to seek additional external funding to advance this program.

Financials

For the full year 2023, Aligos reported annual net income of -$87.7 million, annual revenue of $15.5 million, annual operating cash flow of -$79.0 million, and annual free cash flow of -$79.0 million.

In the first quarter of 2024, the company generated revenue of $986,000, consisting of $292,000 from collaborations and $694,000 from customers. Research and development expenses were $16.4 million, while general and administrative expenses were $6.7 million, resulting in a net loss of $34.9 million for the quarter. Operating cash flow was -$22.7 million, and free cash flow was also -$22.7 million.

The company ended the first quarter of 2024 with $112.7 million in cash, cash equivalents, and investments, providing runway to fund operations for at least the next 12 months.

Pipeline Progress

Aligos' lead drug candidate, ALG-055009 for MASH, recently initiated a Phase 2a trial. The company expects to report topline safety and 12-week MRI-PDFF data from this study in the fourth quarter of 2024.

For ALG-000184 in CHB, Aligos is currently conducting additional Phase 1b cohorts evaluating the safety, pharmacokinetics, and antiviral activity of the drug candidate. Preliminary data have been presented at scientific conferences, indicating a potentially best-in-class antiviral profile.

In the coronavirus program, ALG-097558 has completed Phase 1 studies, demonstrating a favorable safety and pharmacokinetic profile. Aligos is now seeking additional external funding to advance this program, including planned Phase 2 enabling activities.

Risks and Challenges

As a clinical-stage biopharmaceutical company, Aligos faces several risks and challenges common to the industry, including the inherent uncertainty of drug development, the need for substantial additional financing, and intense competition in its target markets.

The company's success will depend on its ability to advance its drug candidates through clinical trials, obtain regulatory approvals, and ultimately commercialize successful products. Failures or delays in these processes could significantly harm Aligos' business and prospects.

Additionally, Aligos operates in a highly competitive environment, with numerous companies developing therapies for MASH, CHB, and coronavirus infections. The company's drug candidates will need to demonstrate superior efficacy, safety, and commercial viability to succeed in these crowded markets.

Liquidity

As of March 31, 2024, Aligos had $112.7 million in cash, cash equivalents, and investments, which the company believes will enable it to fund operations for at least the next 12 months. However, the company will likely need to raise additional capital through public or private equity offerings, debt financings, collaborations, or other arrangements to support its ongoing research and development activities and potential commercialization efforts.

Conclusion

Aligos Therapeutics is a promising clinical-stage biopharmaceutical company with a diverse pipeline of drug candidates targeting significant unmet needs in liver diseases and viral infections. The company's lead programs in MASH, CHB, and coronavirus infections have demonstrated encouraging early-stage results, positioning Aligos as a potential leader in these therapeutic areas. While the company faces the inherent risks and challenges of drug development, its strong financial position and experienced management team suggest it is well-equipped to navigate the path to potential commercialization and value creation for shareholders.

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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.