On August 6, 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 second quarter 2024 (Press release, Aligos Therapeutics, AUG 6, 2024, View Source [SID1234645405]).
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"This quarter we continued to execute on our key clinical programs," stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "We completed enrollment ahead of schedule for the Phase 2a HERALD study of our THR-β agonist drug candidate, ALG-055009, and we expect topline data in early Q4 2024. In addition, we presented data from ALG-000184 at the EASL Congress 2024, including new data from the HBeAg-negative cohort, that demonstrated no viral breakthrough and unprecedented reductions in viral markers of CHB. We also received positive regulatory feedback from the FDA supporting subsequent studies of chronic suppressive therapy with sustained HBV DNA suppression as the primary approvable endpoint. We look forward to continuing to develop our drug candidates for patients in need of better outcomes."
Recent Business Progress
Aligos Portfolio of Drug Candidates
ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH
The Phase 2a HERALD study completed enrollment in May 2024
Topline HERALD data are anticipated in early 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 European Association for the Study of the Liver (EASL) Congress 2024 and showed consistent, potent antiviral activity across multiple cohorts of untreated chronic hepatitis B (CHB) patients
Data from ≤ 72 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (
Received positive feedback from the FDA regarding future studies with sustained HBV DNA suppression as the primary efficacy endpoint, leading to the potential registration of ALG-000184 for the treatment of hepatitis B infection
Phase 2 enabling activities, including 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
Phase 2 enabling activities, including nonclinical and clinical studies, are underway with financial support from the NIH
Financial Results for the Second Quarter 2024
Cash, cash equivalents and investments totaled $94.5 million as of June 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 income for the three months ended June 30, 2024 was $5.1 million or basic and diluted net income per common share of $0.03, compared to net losses of $18.8 million or basic and diluted net loss per common share of $(0.43) for the three months ended June 30, 2023. Net income for the three months ended June 30, 2024 was primarily due to a decrease in the fair value of the Company’s warrant liability, which resulted in non-cash income of $30.5 million, or $0.19 per share, associated with the warrants issued in October 2023 as part of the private investment in public equity (PIPE) offering.
Research and development (R&D) expenses for the three months ended June 30, 2024 were $21.1 million, compared with $16.8 million for the same period of 2023. The increase was primarily due to an increase in third party expenses for clinical trials. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2024 was $1.2 million, compared with $1.6 million for the same period in 2023.
General and administrative (G&A) expenses for the three months ended June 30, 2024 were $6.4 million, compared with $9.2 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 June 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 June 30, 2024 was income of $31.7 million compared with income of $1.1 million for the same period of 2023. The change in interest and other income, net, is primarily due to a decrease of $30.5 million in the fair value of the company’s warrant liability, which resulted in non-cash income.