On November 2, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported recent business progress and financial results for the third quarter, September 30, 2022 (Press release, Aligos Therapeutics, NOV 2, 2022, View Source [SID1234623119]).
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"We continue to make important progress in advancing our portfolio of drug candidates targeting chronic hepatitis B (CHB), COVID-19, and NASH," said Lawrence Blatt, PhD, MBA, Chairman and CEO of the Board at Aligos. "For our capsid assembly modulator (CAM), ALG-000184, we have observed a favorable safety and antiviral activity profile after 28 days of dosing and, as a result, have recently initiated longer term dosing cohorts. These cohorts will evaluate up to 48 weeks of treatment with ALG-000184 and will further define the potential role of this drug candidate in achieving chronic suppression and functional cure in CHB. We also recently began clinical evaluation in healthy volunteers of ALG-125755, our siRNA targeting HBsAg production. We anticipate evaluating this drug in CHB subjects in Q1 2023."
"For our NASH thyroid hormone receptor beta agonist program, we will be sharing new safety and pharmacodynamic data after multiple doses of ALG-055009 in subjects with hyperlipidemia at The Liver Meeting (AASLD). The emerging safety and anti-lipid activity data appear favorable and support advancing this drug into phase 2 development."
"As with our development programs, our discovery projects are also making important progress," said Leonid Beigelman, PhD, President of Aligos. "ALG-097558, our potent, pan-coronavirus protease inhibitor that doesn’t require boosting with ritonavir is currently undergoing Phase 1 enabling non-clinical studies and we plan to initiate clinical evaluation of this important drug candidate in Q2 2023."
Recent Business Progress
Aligos Portfolio of Drug Candidates
HBV Programs
ALG-000184 (CAM) – Evaluation of a range of doses given over 28 days to both HBeAg positive and HBeAg negative CHB subjects is largely complete. New data from cohorts evaluating 100 and 300 mg in HBeAg positive CHB subjects will be presented at The Liver Meeting (AASLD) in November. Based on the favorable safety and antiviral activity profile from these cohorts, the Study Review Committee (SRC) recommended the evaluation of 100 mg and 300 mg in HBeAg positive CHB subjects for up to 48 weeks. We anticipate sharing antiviral activity data from these new cohorts throughout 2023.
ALG-125755 (siRNA) – Single ascending doses (SAD) of ALG-125755 are currently being evaluated in healthy volunteers in New Zealand. If the safety profile is favorable, we anticipate initiating cohorts evaluating SAD in CHB subjects in Q1 2023 and sharing data at scientific conferences throughout 2023.
NASH Program
ALG-055009 – Evaluation of single and multiple ascending doses (SAD, MAD) in healthy volunteers and subjects with hyperlipidemia is complete and MAD data will be presented in November at The Liver Meeting (AASLD). Data from this Phase 1 study continue to be favorable.
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.
Financial Results for the Third Quarter 2022
Cash, cash equivalents, and investments totaled $142.3 million as of September 30, 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 into the first half of 2024.
Net losses for the three months ended September 30, 2022, were $18.6 million or basic and diluted net loss per common share of $(0.44), compared to net losses of $33.1 million or basic and diluted net loss per common share of $(0.78) for the three months ended September 30, 2021.
Research and development (R&D) expenses for the three months ended September 30, 2022, were $17.8 million compared with $28.1 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 primarily to our continued winddown related to the discontinuation of our STOPS and ASO programs, and the manufacturing of drug supply in advance of our clinical trial activity for our CAM and siRNA programs. Total R&D stock-based compensation expense incurred for the three months ended September 30, 2022, was $1.9 million compared with $1.9 million for the same period of 2021.
General and administrative (G&A) expenses for the three months ended September 30, 2022, were $5.3 million compared with $6.5 million for the same period of 2021. The decrease in G&A expenses for this comparative period is primarily attributable to facility costs and updated expense allocations. Total G&A stock-based compensation expense incurred for the three months ended September 30, 2022, was $1.5 million compared with $1.7 million for the same period of 2021.