On November 6, 2024 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biopharmaceutical 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 third quarter 2024 (Press release, Aligos Therapeutics, NOV 6, 2024, View Source [SID1234647798]).
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"This quarter we reached a key milestone when we announced the positive topline HERALD data in MASH subjects," stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "With placebo-adjusted median relative reductions in liver fat of up to 46.2%, we continue to believe ALG-055009 has best-in-class potential. We are completing Phase 2b enabling studies and evaluating a variety of options to fund continued development, including potential partnering where discussions are underway. In addition, we are progressing ALG-000184 for CHB towards a Phase 2 study next year. Lastly, we expect to begin externally funded clinical studies for ALG-097558 later this year in COVID subjects. 2024 has been an exciting year for the company, and we believe we are laying the groundwork for important future successes in 2025 and beyond."
Recent Business Progress
Aligos Portfolio of Drug Candidates
ALG-000184: Potential first-/best-in-class small molecule CAM-E for CHB
Dosing continues in this ongoing Phase 1a/1b study, with subjects expected to dose for up to 96 weeks. Additional interim data readouts are planned to be presented this year at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM) 2024
Received positive feedback from the FDA and the National Medical Products Administration in China to move forward with sustained HBV DNA suppression as the primary efficacy endpoint for future studies designed to support the potential registration of ALG-000184 for the treatment of hepatitis B infection
Announced a clinical collaboration with Xiamen Amoytop Biotech Co., Ltd.
Amoytop agreed to sponsor and perform a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING (mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China
Phase 2 enabling activities are underway, including drug supply manufacturing
ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH
Topline HERALD data were presented in September 2024, demonstrating that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFF
Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12, with placebo-adjusted median relative reductions up to 46.2% as measured by MRI-PDFF. Up to 70% of subjects achieved ≥30% relative reduction in liver fat compared to baseline
ALG-055009 demonstrated a favorable tolerability profile with no clinical hyper/hypothyroidism. Incidence of gastrointestinal-related treatment emergent adverse events were similar in ALG-055009 dose groups compared to placebo. Specifically, a non-dose-related, lower incidence of diarrhea was observed in ALG-055009 dose groups compared to placebo
Treatment with ALG-055009 resulted in significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a) (LpA), and apolipoprotein B (ApoB). In addition, dose dependent increases in sex hormone binding globulin (SHBG), a marker of THR-β target engagement in the liver, were observed
Additional data readouts are planned to be presented this year at AASLD’s The Liver Meeting (TLM) 2024
ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor
Three additional clinical studies are expected to begin in 2024
AGILE University of Liverpool, a UK-government supported platform trial (with MRC and Wellcome Trust funding), has agreed to sponsor and perform a study in high-risk COVID patients evaluating ALG-097558 as monotherapy or in combination with remdesivir
The NIAID has agreed to sponsor clinical studies evaluating pharmacokinetic (PK) differences in special populations (renal/hepatic impairment subjects)
Phase 2 enabling activities, including nonclinical and clinical studies, are underway with financial support from the NIH
Financial Results for the Third Quarter 2024
Cash, cash equivalents and investments totaled $74.9 million as of September 30, 2024, compared with $135.7 million as of December 31, 2023. We continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2025.
Net loss for the three months ended September 30, 2024 were $19.3 million or basic and diluted net loss per common share of $(3.07), compared to net losses of $18.0 million or basic and diluted net loss per common share of $(10.37) for the three months ended September 30, 2023.
Research and development (R&D) expenses for the three months ended September 30, 2024 were $16.8 million, compared with $15.9 million for the same period of 2023. The increase was primarily due to an increase in third party expenses for the clinical trials. Total R&D stock-based compensation expense incurred for the three months ended September 30, 2024 was $1.2 million, compared with $1.6 million for the same period of 2023.
General and administrative (G&A) expenses for the three months ended September 30, 2024 were $4.6 million, compared with $6.4 million for the same period of 2023. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended September 30, 2024 was $0.9 million, compared with $1.6 million for the same period of 2023.
Interest and other income, net, for the three months ended September 30, 2024 was income of $1.0 million compared with income of $1.1 million for the same period of 2023.