On August 3, 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 second quarter 2023 (Press release, Aligos Therapeutics, AUG 3, 2023, View Source [SID1234633733]).

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"We continue to make important progress in advancing our portfolio of drug candidates," said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics. "Phase 2a enabling activities for our lead program in NASH, ALG-055009, are going well and we remain on track to file this important Phase 2a protocol to the US IND in Q4 2023. Additionally, our COVID-19 protease inhibitor, ALG-097558, is now dosing in the clinic in a first in human study and our best-in-class capsid assembly modulator, ALG-000184, continues to generate impressive DNA, RNA, and HBsAg lowering activity as dosing continues in CHB subjects. We look forward to sharing emerging data from these exciting programs at future scientific conferences."

Recent Business Progress

Aligos Portfolio of Drug Candidates

NASH Program (ALG-055009)

Dosing in the Phase 1 first-in-human study is now complete and the database is locked. Data at all dose levels continue to support a favorable risk-benefit profile for ALG-055009
Phase 2a enabling activities (e.g., drug manufacturing, non-clinical studies) are ongoing and on track for a Q4 2023 filing of the Phase 2a protocol
Key design elements/milestones of the Phase 2a study have been formulated and include:
Randomized, double-blind, placebo-controlled trial evaluating dosing for 12 weeks
Evaluation of multiple dose levels of ALG-055009 vs. placebo (gelcap formulation)
Primary endpoint based on change from baseline at 12 weeks in MRI-PDFF
Additional non-invasive biomarkers commonly evaluated in NASH trials will also be assessed
All sites will be in the US
Anticipated top line data: Q4 2024
Stephen Harrison, MD has signed on to be the Phase 2a study’s Principal Investigator
COVID-19 (ALG-097558)

The first-in-human study (ALG-097558-701) clinical trial application was approved in the UK
Dosing in Part 1, which is evaluating single ascending oral doses in healthy volunteers, of this multi-part study is ongoing
Dosing is expected to continue throughout 2023 and early 2024 with topline data anticipated in H1 2024
HBV Programs

Capsid-Assembly Modulator (ALG-000184)

Ongoing cohort data continue to show that 300 mg ALG-000184 + entecavir (ETV) is well tolerated and results in unprecedented HBsAg lowering activity for an oral CHB drug. Specifically, Hou et al., showed at EASL 2023 that a majority of HBeAg positive CHB subjects dosed with 300 mg ALG-000184 + ETV demonstrated declines of ≥0.4 and ≥1.0 log10 IU/mL at 12 and 24 weeks, respectively. The largest HBsAg reduction observed among subjects receiving this regimen was a 2 log10 IU/mL decline in a subject dosed for 36 weeks
Dosing with ALG-000184 + entecavir for up to 96 weeks in HBeAg positive and HBeAg negative CHB subjects is planned
Emerging data will continue to be presented at upcoming scientific conferences
ALG-125755

Dosing in Parts 1 and 2, which evaluated single ascending subcutaneous doses of ALG-125755 in healthy volunteers and virologically suppressed HBeAg negative CHB subjects, respectively, is now complete
Single doses of up to 320 mg ALG-125755:
Were found to be well tolerated with predicted PK
Lowered HBsAg levels across the dose range evaluated, but comparative efficacy data vs. competitor siRNAs are inconclusive
Further clinical evaluation of ALG-125755 is not prioritized with current funding. Further advancement will require partnership of the program.
Corporate

On July 31, 2023, Aligos Therapeutics, Inc. (the "Company") and Janssen Biopharma, LLC ("Janssen") filed a stipulation staying the case in their ongoing legal proceedings. The Company and Janssen have reached an agreement in principle to resolve their disputes and expect to finalize a settlement agreement promptly.
Financial Results for the Second Quarter 2023

Cash, cash equivalents and investments totaled $90.8 million as of June 30, 2023, compared with $125.8 million as of December 31, 2022. 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 June 30, 2023, were $18.8 million or basic and diluted net loss per common share of $(0.43), compared to net losses of $19.9 million or basic and diluted net loss per common share of $(0.47) for the three months ended June 30, 2022.

Research and development (R&D) expenses for the three months ended June 30, 2023, were $16.8 million compared with $16.5 million for the same period of 2022. The increase was primarily due to other costs including facility expenses due to the right-of-use asset impairment, largely offset by a decrease in third party expenses from the reduced manufacturing of drug supply in advance of our NASH program in 2022, and employee-related costs. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2023, was $1.6 million compared with $2.2 million for the same period of 2022.

General and administrative (G&A) expenses for the three months ended June 30, 2023, were $9.2 million compared with $7.6 million for the same period of 2022. The increase in G&A expenses for this comparative period is primarily attributable to an increase in legal and related costs offset by a decrease in facility expenses. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2023, was $1.6 million compared with $1.8 million for the same period of 2022.