On November 2, 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 third quarter 2023 (Press release, Aligos Therapeutics, NOV 2, 2023, View Source [SID1234636725]).
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"Over this quarter, we raised approximately $92 million in a private placement financing allowing the advancement of our NASH THR-ß and CHB CAM-E programs. Additionally, we successfully received clearance for Aligos’ first US IND (for ALG-055009) and secured an $8.5 million contract with the NIAID to advance our coronavirus protease inhibitor into Phase 2 clinical trials. We are proud to have achieved these critical milestones," noted Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics. "With these achievements in hand, our team is well positioned to execute on our priorities, which include conducting a Ph2a MRI-PDFF study in NASH with ALG-055009, conducting Phase 2 enabling activities for our promising CAM-E, ALG-000184, in CHB, and advancing our potentially best-in-class coronavirus protease inhibitor, ALG-097558. Over the next quarter our research team will continue to identify promising novel small molecule drug candidates as backup molecules for our lead clinical programs as well as discover new small molecules targeting novel molecular pathways in viral and liver diseases."
Recent Business Progress
Aligos Portfolio of Drug Candidates
NASH (THR-ß; ALG-055009)
The US IND was cleared by the FDA, which now enables execution of a planned Phase 1 statin drug-drug interaction study in Q4 2023, prior to filing the Phase 2a protocol to the IND in Q4 2023
In the meantime, Phase 2a startup activities were initiated and are now underway
A preliminary Phase 2a study design was formulated in close collaboration with the study’s Principal Investigator, Dr. Stephen Harrison. The final study design is subject to feedback from the FDA which is expected in early Q1 2024
The final Phase 1 FIH study data were accepted as a poster presentation (Poster #2900-A) at the AASLD Liver Meeting in November 2023
CHB (CAM-E, ALG-000184)
Dosing and enrollment in ongoing Study ALG-000184-201 continues. The total dosing duration now exceeds 48 weeks in some subjects in this Phase 1a/1b study
Data from long term dosing cohorts in Study ALG-000184-201, including a late breaking poster
(Poster #5028-C) summarizing the effects of ALG-000184 on various viral markers, will be presented at the AASLD Liver Meeting in November 2023
With the recent completion of the PIPE, we plan to initiate Ph2 enabling activities, including manufacturing of drug supply, in the near future
Coronavirus (PI, ALG-097558)
Dosing continues in the ongoing first in human study, ALG-097558-701. Dosing is ongoing in the single ascending dose portion of the study and is due to start soon in the multiple ascending dose portion. We continue to project having topline data from this important safety and pharmacokinetics study in H1 2024
The NIAID awarded Aligos an $8.5M contract to conduct Phase 2 enabling activities, which includes multiple nonclinical and clinical studies. These studies will be initiated in H1 2024 and topline data are expected in H2 2025. The ALG-097558 program has been awarded over $11M across two NIH grants and contracts and we plan to seek additional external funding from both public and private sources to further advance this important program
Financial Results for the Third Quarter 2023
Cash, cash equivalents and investments totaled $70.4 million as of September 30, 2023, compared with $125.8 million as of December 31, 2022. Additionally, we raised in private placement financing approximately $92 million in gross proceeds, before deducting placement agent’s fees and other expenses, in October 2023. Including the expected net proceeds from the private placement, we believe our cash balance provides sufficient cash to fund planned operations through the end of 2025.
Net losses for the three months ended September 30, 2023 were $18.0 million or basic and diluted net loss per common share of $(0.41), compared to net losses of $18.6 million or basic and diluted net loss per common share of $(0.44) for the three months ended September 30, 2022.
Research and development (R&D) expenses for the three months ended September 30, 2023 were $15.9 million, compared with $17.8 million for the same period of 2022. The decrease was primarily due to employee-related costs and other costs including facility expenses, partially offset by an increase in third party expenses due to the milestone payments made as a result of dosing the first patient in a clinical trial. Total R&D stock-based compensation expense incurred for the three months ended September 30, 2023 was $1.6 million, compared with $1.9 million for the same period of 2022.
General and administrative (G&A) expenses for the three months ended September 30, 2023 were $6.4 million, compared with $5.3 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. Total G&A stock-based compensation expense incurred for the three months ended September 30, 2023 was $1.6 million, compared with $1.5 million for the same period of 2022.