On May 4, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported recent business progress and financial results for the first quarter March 31, 2022 (Press release, Aligos Therapeutics, MAY 4, 2022, View Source [SID1234613587]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"From the very beginning, we designed Aligos to be a company with a diverse portfolio of drug candidates across a broad range of indications," said Lawrence Blatt, PhD, MBA, Chairman & CEO of Aligos. "This approach has allowed us to continue to advance promising new drug candidates from our portfolio even in the face of the recent discontinuation of our STOPS and antisense oligonucleotide (ASO) HBV programs in Q1. Our teams remain focused on advancing our pipeline and we look forward to achieving important milestones this year, including top line data for ALG-000184, our Class II CAM for HBV, and ALG-055009, our THR-β agonist for NASH. In addition, we are on track to file a clinical trial application in second half of 2022 to conduct a first in human study evaluating ALG-125755, our HBV siRNA. Finally, we are excited to see ALG-097558, a broad-spectrum coronavirus inhibitor that was identified in our collaboration with KU Leuven, advance towards the clinic."
Recent Business Progress
Aligos Portfolio of Drug Candidates:
HBV Programs
ALG-000184 (Class II CAM) – dosing in the 10-300 mg range for 28 days in chronic hepatitis B (CHB) patients continued in Q1 and is set to complete in Q3 2022. Cohorts evaluating doses of 10-300 mg given over 12 weeks are also set to begin in Q3. We plan to share top line results for 28 day and 12-week cohorts in Q2 and Q4 2022, respectively.
ALG-125755 (siRNA) – first in human enabling nonclinical studies continued in Q1 and are set to complete in Q3 2022 when we plan to file a clinical trial application (CTA) to enable dosing in healthy volunteers beginning in Q4 2022.
Our STOPS and ASO programs were terminated in Q1 due to insufficient antiviral activity and poor tolerability, respectively, being observed in Phase 1 studies.
NASH Programs
ALG-055009 (THR- β) – dosing in healthy volunteers (HVs) and subjects with hyperlipidemia continued in Q1 and is set to complete in Q2. Preliminary data after single and multiple oral doses will be shared as a poster presentation (Abstract #3109) at the upcoming EASL ILC meeting 22-26 June 2022. Topline results from this Phase 1 proof of concept study remain on track for release in Q3 2022.
Significant progress has been made in the nonalcoholic steatohepatitis (NASH) oligonucleotide research collaboration with Merck with respect to the two undisclosed targets, utilizing Aligos’ know-how and our proprietary oligonucleotide chemistry platform. Both collaboration programs are currently advancing further into lead optimization.
COVID Protease Inhibitor (PI) Program
ALG-097558 – we recently announced that we selected this broad-spectrum coronavirus protease inhibitor to move forward into development. ALG-097558 has shown superior potency compared to nirmatrelvir (PF-07321332) against SARS-CoV-2 and multiple resistant variants in all cell-based and biochemical assays tested to date. ALG-097558 is 7 to 20-fold more active than nirmatrelvir, depending on the variant. ALG-097558 exerts potent broad-spectrum activity against alpha and beta coronaviruses, and its highly conserved target site indicates a high probability that it will retain potent activity against potential future SARS-CoV-2 variants that may emerge. Projected efficacious doses of ALG-097558 can be achieved in humans without ritonavir boosting. Aligos expects to file a Phase 1 clinical trial application in second half of 2022.
Financial Results for the First Quarter 2022
Cash, cash equivalents and marketable securities totaled $183.2 million as of March 31, 2022, compared with $205.8 million as of December 31, 2021. We continue to believe our cash balance provides sufficient cash to fund planned operations into the first half of 2024.
Net losses for the three months ended March 31, 2022, were $35.6 million or basic and diluted net loss per common share of $0.84 compared to net losses of $27.7 million or basic and diluted net loss per common share of $0.74 for the three months ended March 31, 2021.
Research and development (R&D) expenses for the three months ended March 31, 2022, were $31.7 million compared with $22.9 million for the same period of 2021. The increase in R&D expenses for this comparative period is primarily attributable to an increase in third-party expenses primarily due to our continued increase in expenditures related to research, development and manufacturing activities associated with our CAM clinical trial activities as well as costs related to our NASH program, and our discontinued STOPS and ASO programs, leading to write off charges for non-cancelable purchase obligations. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2022, was $2.0 million compared with $1.7 million for the same period for 2021.
General and administrative (G&A) expenses for the three months ended March 31, 2022, were $6.5 million compared with $5.8 million for the same period of 2021. The increase in G&A expenses for this comparative period is primarily attributable to an increase in ordinary routine employee-related costs partially offset by a decrease in in third-party expenses primarily due to decreased legal and accounting service costs. Total G&A stock-based compensation expense incurred for the three months ended March 31, 2022, was $1.8 million compared with $1.0 million for the same period of 2021.