Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2025 Financial Results

On March 5, 2026 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported recent business progress and financial results for the fourth quarter and full year 2025.

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"Our team has made tremendous progress recently in the global Phase 2 B-SUPREME study of pevifoscorvir sodium," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "With the completion of the planned enrollment in the HBeAg- cohort, we are continuing to enroll participants in the HBeAg+ cohort and look forward to the interim analyses in the first and second half of 2026. Additionally, the Phase 2 B-SUPREME study may demonstrate that pevifoscorvir sodium affects the three pillars of HBV disease pathogenesis: replication, integration, and maintenance of the viral reservoir. We are also excited to announce the advancement, in partnership with Xiamen Amoytop Biotech Co., Ltd. ("Amoytop"), of ALG-170675, a dual mechanism antisense oligonucleotide (ASO) into IND-enabling studies. Lastly, adding James Hassard as Executive Vice President, Chief Commercial Officer has allowed us to begin laying the groundwork for the future of our best-in-class programs."

Recent Business Progress

Pipeline Updates

Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

The Phase 2 B-SUPREME study (NCT06963710) of pevifoscorvir sodium in subjects with chronic HBV infection completed the planned enrollment of 60 HBeAg- participants in January 2026. HBeAg+ participants continue to enroll in the study.
The first protocol defined interim analysis includes approximately 60% (or 36) HBeAg- participants that complete 12 weeks of the treatment period, with this enrollment threshold reached in Q4 2025.
A second protocol defined interim analysis is planned when approximately 50% (or 55) HBeAg+ participants complete 24 weeks of the treatment period, with this enrollment threshold reached in January 2026.
Topline data for both the HBeAg- and HBeAg+ cohorts are expected in 2027.
96-weeks of dosing have been completed in the Phase 1 study (NCT04536337) with post-treatment data expected to be presented at upcoming scientific meetings.
ALG-170675: Potential best-in-class antisense oligonucleotide (ASO) for chronic hepatitis B virus (HBV) infection

Along with our partner Xiamen Amoytop Biotech Co., Ltd. (Amoytop), ALG-170675 was recently selected to proceed into IND-enabling studies. Current costs for development in China are being funded by Amoytop, who maintain rights in China, Taiwan, Hong Kong and Macau.
This next-generation ASO works via two mechanisms of action. It targets and destroys HBsAg mRNA and activates the immune response through TLR-8 agonism.
ALG-055009: Potential best-in-class small molecule THR-β for obesity, MASH

Recently presented in vivo data in diet induced obese (DIO) mice treated with semaglutide (SEMA), tirzepatide (TIRZEP), or a combination of ALG-055009 and SEMA or TIRZEP for 28 days demonstrated synergistic weight loss in the combination groups compared to monotherapy groups. SEMA monotherapy resulted in a maximum of 23.9 ±2.6% body weight loss, while the combination of SEMA and ALG-055009 had an additional 8.6% decrease for a maximum 33% body weight loss. The low and high doses of TIRZEP led to a maxima of 27.1 ±2.7% and 34.4 ±1.6% body weight loss, respectively. Combination of TIRZEP (low) or TIRZEP (high) with ALG-055009 induced an additional 11.7% and 5.8% decrease for a maximum of 39% and 40% body weight loss respectively.
Furthermore, the additional weight loss in the combination therapy of either incretin receptor agonist and ALG-055009 was mainly due to additional loss of fat mass, with no significant effect on lean mass or food consumption as compared to incretin receptor agonist monotherapy. The data suggest the potential for a significant benefit of adding ALG-055009 to an incretin receptor agonist therapy for weight loss, especially in combination with a low-dose of a potent incretin receptor agonist, such as tirzepatide.
Evaluation of a variety of options to fund continued development, including potential out-licensing is ongoing.
Business Updates

James Hassard was appointed Executive Vice President, Chief Commercial Officer to build the Company’s global commercial capabilities.
Financial Results for the Fourth Quarter and Full Year 2025

Cash, cash equivalents and investments totaled $77.8 million as of December 31, 2025, compared with $56.9 million as of December 31, 2024. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the third quarter of 2026.

Net loss for the three months ended December 31, 2025 was $19.9 million or basic and diluted net loss per common share of $(1.91), compared to net loss of $82.2 million or basic and diluted net loss per common share of $(13.08) for the three months ended December 31, 2024.

Net loss for the year ended December 31, 2025 was $24.2 million or basic and diluted net loss per common share of $(2.45), compared to net loss of $131.2 million or basic and diluted net loss per common share of $(20.94) for the year ended December 31, 2024.

Research and development (R&D) expenses for the three months ended December 31, 2025 were $17.0 million, compared with $16.0 million for the same period of 2024. The increase was primarily due to an increase in third-party expenses for the pevifoscorvir sodium Phase 2 clinical trial. Total R&D stock-based compensation expense incurred for the three months ended December 31, 2025 was $0.7 million, compared with $1.0 million for the same period of 2024.

R&D expenses for the year ended December 31, 2025 were $69.5 million, compared with $70.3 million for the same period of 2024. The decrease was due to increased government funds received for the coronavirus program which offset related costs.

General and administrative (G&A) expenses for the three months ended December 31, 2025 were $4.9 million, compared with $5.2 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in legal and other related expenses. Total G&A stock-based compensation expense incurred for the three months ended December 31, 2025 was $0.6 million, compared with $0.7 million for the same period of 2024.

G&A expenses for the year ended December 31, 2024 were $20.7 million, compared with $22.8 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third party expenses including legal expenses.

Interest and other income, net, for the three months ended December 31, 2025 was income of $0.8 million compared with income of $0.6 million for the same period in 2024.

Interest and other income, net, for the year ended December 31, 2025 was income of $3.9 million compared with income of $4.4 million for the same period of 2024.

Change in fair value of 2023 common warrants for the three months ended December 31, 2025, was income of $1.2 million compared with a loss of $62.1 million for the same period of 2024.

Change in fair value of common warrants for the year ended December 31, 2025, was income of $60.2 million compared with a loss of $46.1 million for the same period of 2024.

(Press release, Aligos Therapeutics, MAR 5, 2026, View Source [SID1234663291])