On August 4, 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 second quarter June 30, 2022 (Press release, Aligos Therapeutics, AUG 4, 2022, View Source [SID1234617544]).
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"In the second quarter, we continued to make strong progress in advancing our drug candidates and discovery programs," said Lawrence Blatt, PhD, MBA, CEO and Chairman of the Board at Aligos. "We completed enrollment in multiple cohorts across our Phase 1 CAM-2 and NASH studies and presented posters for these and other drug candidates and discovery programs at the recent International Liver Congress meeting hosted by the European Association for the Study of the Liver (EASL). We are similarly off to a strong start in Q3, where we have initiated enrollment in a 12-week cohort evaluating the safety and chronic suppressive activity of ALG-000184 in chronic hepatitis B (CHB) patients. We also remain on track to submit a clinical trial application (CTA) this quarter to evaluate our siRNA drug candidate, ALG-125755, in healthy volunteers and CHB patients. We believe our siRNA, which is designed to lower HBsAg levels, is an important addition to our clinical portfolio and has the potential to be a cornerstone of our functional cure strategy."
Recent Business Progress
Aligos Portfolio of Drug Candidates
HBV Programs
ALG-000184 (CAM-2): Enrollment of HBeAg positive subjects in 28-day and 12-week cohorts evaluating various dose levels is ongoing. We plan to share data from HBeAg positive cohorts at a scientific conference in Q4 2022.
ALG-125755 (siRNA): Phase 1 enabling nonclinical studies are nearly complete. We are on track to file a CTA in Q3 2022 to enable the evaluation of the safety, tolerability, pharmacokinetics, and antiviral activity of ALG-125755. Dosing is planned to begin in healthy volunteers in Q4 2022 and in CHB subjects
in Q1 2023.
NASH
ALG-055009: Enrollment of hyperlipidemic subjects in all 4 cohorts of the multiple ascending dose portion of our Phase 1 study is now complete. We are currently analyzing these data and remain on track to share top line data from the single and multiple ascending dose portions of this study in Q3 2022.
COVID-19 3CL Protease Inhibitor (PI) Program
ALG-097558: Evaluation of ALG-097558 in the hamster SARS-CoV-2 infection model indicates that when dosed prior to infection or up to 24 hours post-infection, the compound causes a significant reduction in the levels of infectious virus in the lungs.
Phase 1 enabling nonclinical studies are on track to be initiated in H2 2022. A subsequent CTA filing for a Phase 1 study evaluating the safety and pharmacokinetics of ALG-097558 in healthy volunteers is planned for Q1 2023.
COVID-19 3CL Protease Inhibitor Resistance Profiling
The potential for the emergence of viral resistance to 3CL protease inhibitors used to treat COVID-19 is of considerable concern. Together with our collaborators at KU Leuven, including its Centre for Drug Design and Discovery (CD3), a drug discovery unit and investment fund of KU Leuven, and the Rega Institute for Medical Research, we have begun to investigate the viral resistance profile of our 3CL protease inhibitors. A resistant mutant was derived by incubating SARS-CoV-2 infected cells with an early lead compound, ALG-097161. We identified a combination of 3 amino acid substitutions in the 3CL protease (L50F E166A L167F) that are associated with a greater than 50-fold increase in the EC50 values for ALG-097161 and PF-07321332 (nirmatrelvir) when assessed in a biochemical assay. In contrast, when ALG-097558 was profiled against the L50F E166A L167F resistant mutant, only a 3-fold shift in the EC50 value was observed. Experiments to further evaluate the viral resistance profile of ALG-097558 are currently ongoing.
Financial Results for the Second Quarter 2022
Cash, cash equivalents and investments totaled $159.3 million as of June 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 June 30, 2022, were $19.9 million or basic and diluted net loss per common share of ($0.47), compared to net losses of $29.8 million or basic and diluted net loss per common share of $(0.79) for the three months ended June 30, 2021.
Research and development (R&D) expenses for the three months ended June 30, 2022, were $16.5 million compared with $24.6 million for the same period of 2021. The decrease in R&D expenses for this comparative period is primarily attributable to our continued wind-down related to the discontinuation of our STOPS and ASO programs offset by our expenditures related to the ongoing development and manufacturing activities associated with our CAM and NASH clinical program activities. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2022, was $2.2 million compared with $2.0 million for the same period of 2021.
General and administrative (G&A) expenses for the three months ended June 30, 2022, were $7.6 million compared with $6.6 million for the same period of 2021. The increase in G&A expenses for this comparative period is primarily attributable to routine employee and facility related costs. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2022, was $1.8 million compared with $1.5 million for the same period of 2021.