8-K: Aligos Therapeutics Reports Business Progress and Year-End 2024 Financial Results

Aligos Therapeutics announced recent business progress, including a $105 million private placement, and financial results for the fourth quarter and full year 2024, highlighting advancements in their pipeline programs.

Summary

• Aligos Therapeutics reported its recent business progress and financial results for Q4 and the full year 2024.
• A key highlight was the completion of a $105 million private placement financing on February 13, 2025.
• Lesley Ann Calhoun was promoted to Executive Vice President, Chief Operating Officer and Chief Financial Officer.
• The company's lead drug candidate, ALG-000184, is moving closer to a Phase 2 clinical study expected to begin in mid-2025.
• Interim data from the Phase 1 study of ALG-000184 showed sustained HBV DNA suppression in HBeAg-positive subjects.
• ALG-055009 demonstrated statistically significant reductions in liver fat in the Phase 2a HERALD data.
• Three additional clinical trials evaluating ALG-097558 commenced in 2024.
• Cash, cash equivalents, and investments totaled $56.9 million as of December 31, 2024, compared to $135.7 million as of December 31, 2023.
• The company believes its cash, cash equivalents and investments, inclusive of the private placement, will fund planned operations into the second half of 2026.
• Net loss for the year ended December 31, 2024, was $131.2 million, compared to a net loss of $87.7 million for the year ended December 31, 2023.

Sentiment

Score: 6

Explanation: The sentiment is neutral to slightly positive. While the company reported increased losses and a decreased cash position, the successful private placement and progress in clinical trials provide a balanced outlook.

Positives

• The $105 million private placement provides Aligos with additional funding to advance its pipeline.
• ALG-000184 shows promise as a potential firstand best-in-class treatment for chronic hepatitis B.
• ALG-055009 demonstrated significant reductions in liver fat, a positive indicator for MASH resolution.
• ALG-055009 demonstrated a dose-dependent reduction from baseline of up to 26.8% at Week 12 for lipoprotein (a).
• The company's cash position is expected to fund operations into the second half of 2026.

Negatives

• The company reported a net loss of $131.2 million for the year ended December 31, 2024, which is higher than the $87.7 million loss in 2023.
• Cash, cash equivalents, and investments decreased from $135.7 million at the end of 2023 to $56.9 million at the end of 2024.

Risks

• The company is in the clinical stage of development, and drug development is inherently risky.
• Aligos relies on third parties for manufacturing and development efforts.
• Changes in the competitive landscape could impact Aligos' business.
• The company is evaluating options to fund continued development of ALG-055009, including potential out-licensing, which may not be successful.
• Future development of ALG-097558 is expected to be funded by external sources, which may not be available.

Future Outlook

Aligos anticipates initiating a Phase 2 clinical study for ALG-000184 in mid-2025 and expects its current cash reserves to fund operations into the second half of 2026. The company also plans to continue development and out-licensing for ALG-05509 and future development of ALG-097558.

Management Comments

• 2024 was a pivotal year for the company, paving the way for the future of Aligos, stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics.
• That future looks bright as we move ALG-000184 closer towards a Phase 2 clinical study, which is expected to begin in mid-2025.
• We continue to believe our CAM-E has the potential to be a firstand best-in-class candidate, by acting as a disease modifying agent for patients in need of better outcomes.
• Our recent fundraising is backed by investors supportive of our vision for ALG-000184, which has the potential to replace standard of care and become the backbone of treatment for next-generation therapies for chronic hepatitis B virus infection.

Industry Context

Aligos is operating in the competitive biotechnology industry, focusing on liver and viral diseases. The company's pipeline targets areas with high unmet medical needs, such as chronic hepatitis B, MASH, and coronaviruses. The progress of ALG-000184 and ALG-055009 is particularly relevant given the increasing focus on developing effective treatments for these conditions.

Comparison to Industry Standards

• The sustained HBV DNA suppression observed with ALG-000184 monotherapy is a positive sign, potentially positioning it as a competitive treatment option compared to existing therapies like entecavir and tenofovir.
• The liver fat reductions achieved with ALG-055009 in MASH patients are comparable to results seen with other THR-β agonists in development, such as Viking Therapeutics' VK2809 and Madrigal Pharmaceuticals' resmetirom.
• The 26.8% reduction in lipoprotein (a) is notable, as this lipid has been resistant to statin therapy, and this result could position ALG-055009 as a potential treatment for cardiovascular disease.

Management Changes

Stakeholder Impact

• Shareholders will be impacted by the increased net loss and dilution from the private placement.
• Employees may be affected by potential out-licensing or external funding of certain programs.
• Patients with chronic hepatitis B, MASH, and coronavirus infections could benefit from the development of new therapies.
• Investors are impacted by the $105 million private placement.

Next Steps

• Initiate Phase 2 clinical study for ALG-000184 in mid-2025.
• Present 96-week data readouts for ALG-000184 at upcoming scientific conferences.
• Continue development and evaluate out-licensing options for ALG-055009.
• Continue clinical studies evaluating PK in special populations for ALG-097558.
• NIAID to start dosing in a drug-drug interaction and relative bioavailability study in healthy volunteers in the second quarter of 2025.

Key Dates