On March 9, 2023 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, reported recent business progress and financial results for the fourth quarter and full year 2022 (Press release, Aligos Therapeutics, MAR 9, 2023, View Source [SID1234628405]).

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"Last year was very productive for our team," said Lawrence Blatt, PhD, MBA, Chairman & CEO of Aligos. "We made great progress advancing our NASH, COVID-19, and CHB drug candidates. In particular, our drug candidate for NASH, ALG-055009, continued to generate positive data in the clinic that differentiates it from other THR-beta agonists in development. Additionally, important nonclinical advances were made for ALG-097558, our protease inhibitor for COVID-19, which is anticipated to enter the clinic in the first half of this year. Finally, our CAM-E, ALG-000184, continues to generate potentially best-in-class antiviral activity data, including HBsAg reductions that are significantly more substantial than competitor CAM-E drugs, suggesting that it may be an important component in future treatments for CHB. Taken together, we expect these programs to have multiple important data readouts as we continue to advance them throughout 2023. These data have the potential to be important drivers of shareholder value and we look forward to sharing them as they emerge."

Recent Business Progress

Aligos Portfolio of Drug Candidates

NASH Program

ALG-055009 – Evaluation of single and multiple ascending doses (SAD, MAD) in healthy volunteers and subjects with hyperlipidemia was completed and MAD data were presented in November at The Liver Meeting (AASLD). Data from this Phase 1 study continue to be favorable and are positively differentiated compared to competitor drugs in the same class. We remain on track to submit a Phase 2 clinical trial filing by the end of 2023.
COVID-19

ALG-097558 – First-in-human-enabling nonclinical studies are ongoing. We anticipate initiating the clinical evaluation of single and multiple ascending doses of this drug candidate in healthy volunteers in Q2 2023, with top line safety and PK data available by Q4 2023.
HBV Programs

ALG-000184 (CAM-E) – Evaluation of a range of doses given over 28 days to both HBeAg positive and HBeAg negative CHB subjects was completed. Additionally, new interim data from cohorts evaluating dosing durations of up to 48 weeks in HBeAg positive subjects were presented by Professor Hou, Nanfang Medical University, China at the Asian Pacific Association for the Study of the Liver meeting (APASL) in February 2023. This presentation demonstrated favorable safety and antiviral activity for up to 12 weeks of dosing, including notable reductions in HBsAg levels. We anticipate sharing additional safety and antiviral activity data for up to 48 weeks of dosing from these and other ongoing cohorts at scientific conferences throughout 2023.

ALG-125755 (siRNA) – The SAD evaluation of ALG-125755 in healthy volunteers was completed and doses up to 200 mg were found to have a favorable safety and PK profile (Gane et al., APASL 2023). As a result, SAD cohorts in CHB subjects are now being evaluated. We anticipate sharing emerging data from these cohorts at scientific conferences throughout 2023.
Financial Results for the Fourth Quarter and Full Year 2022

Cash, cash equivalents and investments totaled $125.8 million as of December 31, 2022, compared with $205.8 million as of December 31, 2021. We continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2024.

Net losses for the three months ended December 31, 2022, were $21.9 million or basic and diluted net loss per common share of $(0.51), compared to net losses of $37.7 million or basic and diluted net loss per common share of $(0.89) for the three months ended December 31, 2021.

Net losses for the year ended December 31, 2022, were $96.0 million or basic and diluted net loss per common share of $(2.25), compared to net losses of $128.3 million or basic and diluted net loss per common share of $(3.22) for the year ended December 31, 2021.

Research and development (R&D) expenses for the three months ended December 31, 2022, were $19.1 million compared with $28.6 million for the same period of 2021. The decrease in R&D expenses for this comparative period is primarily attributable to a decrease in third-party expenses due to our continued wind down related to the discontinuation of our STOPS and ASO programs, and the manufacturing of drug supply in advance of our clinical and nonclinical activities. Total R&D stock-based compensation expense incurred for the three months ended December 31, 2022, was $1.9 million compared with $1.9 million for the same period of 2021.

R&D expenses for the year ended December 31, 2022 were $85.1 million, compared with $104.2 million for the same period of 2021. The decrease in R&D expenses for this comparative period is primarily attributable to a decrease in third-party expenses due to our continued wind down related to the discontinuation of our STOPS and ASO programs, and the manufacturing of drug supply in advance of our clinical and nonclinical activities. Total R&D stock-based compensation expense incurred in the year ended December 31, 2022, was $8.0 million, compared with $7.6 million for the same period of 2021.

General and administrative (G&A) expenses for the three months ended December 31, 2022, were $7.1 million compared with $9.7 million for the same period of 2021. The decrease in G&A expenses for this comparative period is primarily attributable to facility costs and outside services costs. Total G&A stock-based compensation expense incurred for the three months ended December 31, 2022, was $1.6 million compared with $1.7 million for the same period of 2021.

General and administrative (G&A) expenses for the year ended December 31, 2022, were $26.4 million compared with $28.5 million for the same period of 2021. The decrease in G&A expenses for this comparative period is primarily attributable to facility costs and outside services costs. Total G&A stock-based compensation expense incurred for the year ended December 31, 2022, was $6.7 million compared with $5.9 million for the same period of 2021.