On May 7, 2024 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), 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 first quarter 2024 (Press release, Aligos Therapeutics, MAY 7, 2024, View Source [SID1234642755]).
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"We have executed on a number of key deliverables to position Aligos for success," stated Lawrence Blatt, Ph.D., MBA, Chairman, President & CEO of Aligos Therapeutics. "Importantly, we began dosing in the Phase 2a HERALD study of our THR- drug candidate, ALG-055009, and we expect topline data in Q4 2024. In addition, we recently presented data from our three clinical programs at scientific conferences, showcasing our robust pipeline of potentially best-in-class small molecule drug candidates. In particular, we demonstrated positive safety, tolerability, and antiviral activity data after dosing for up to 64 weeks with our hepatitis B virus capsid assembly modulator, ALG-000184, and positive safety and PK data for our ritonavir-free, pan-coronavirus protease inhibitor, ALG-097558. We remain excited by the potential of these programs and look forward to continuing to deliver for our shareholders."
Recent Business Progress
Aligos Portfolio of Drug Candidates
ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH
Data presented at the Asian Pacific Association for the Study of the Liver (APASL) conference highlighted ALG-055009 Phase 1 data that showed multiple-ascending doses (MAD) over 14 days in hyperlipidemic subjects produced favorable, dose-dependent pharmacodynamic effects on atherogenic lipids and sex hormone binding globulin (SHBG), an indicator of target engagement in the liver
The Phase 2a HERALD study was initiated in Q1 2024 with the first subject dosed in April 2024
Topline HERALD data are anticipated in Q4 2024
ALG-000184: Potential first-/best-in-class small molecule CAM-E for CHB
Interim data from Parts 3 and 4 of Study ALG-000184-201 were presented at the APASL conference and showed consistent, potent antiviral activity across multiple cohorts of untreated chronic hepatitis B (CHB) patients receiving once daily doses of ALG-000184 as monotherapy or in combination with entecavir (ETV) x ≤ 64 weeks
Dosing continues in this ongoing Phase 1a/1b study, with subjects planning to dose for up to 96 weeks. Additional interim data readouts are planned to be presented this year at the following conferences: European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD)
Phase 2 enabling activities, including regulatory interactions and drug supply manufacturing, are underway
ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor
Topline data presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Annual Meeting demonstrated single (up to 2000 mg) and multiple (up to 800 mg Q12 for 7 days) doses of ALG-097558 were well tolerated in healthy volunteers with a pharmacokinetic (PK) profile supporting twice daily, ritonavir-free dosing without a food effect
Received an additional $1.3M grant from the National Institutes of Health (NIH)
Phase 2 enabling activities, including nonclinical and clinical studies, are underway with financial support from the NIH
Financial Results for the First Quarter 2024
Cash, cash equivalents and investments totaled $112.7 million as of March 31, 2024, compared with $135.7 million as of December 31, 2023. Additionally, in October 2023, we raised $92.1 million in gross proceeds in private placement financing, before deducting placement agent’s fees and other expenses. Including the proceeds from the private placement financing, we continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2025.
Net losses for the three months ended March 31, 2024 were $34.9 million or basic and diluted net loss per common share of $(0.22), compared to net losses of $23.0 million or basic and diluted net loss per common share of $(0.53) for the three months ended March 31, 2023.
Research and development (R&D) expenses for the three months ended March 31, 2024 were $16.4 million, compared with $18.1 million for the same period of 2023. The decrease was primarily due to a decrease in employee related costs, partially offset by an increase in third party expenses. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2024 was $1.4 million, compared with $2.2 million for the same period of 2023.
General and administrative (G&A) expenses for the three months ended March 31, 2024 were $6.7 million, compared with $8.5 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 March 31, 2024 was $1.2 million, compared with $1.5 million for the same period of 2023.
Interest and other income (expense), net, for the three months ended March 31, 2024 was an expense of $12.8 million compared with income of $1.0 million for the same period of 2023. The change in interest and other income (expense), net, is primarily due to an increase in the fair value of the Common Warrants liability, which resulted in a non-cash charge, associated with the Securities Purchase Agreement entered into in October 2023 following the private investment in public equity (PIPE) offering.