ALGS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• and suggested potentially best-in-class potent and durable antiviral activity.

• Further, data presented at AASLD’s The Liver Meeting® 2025 highlighted outcomes for treatment-naïve or currently not treated HBeAg+ and HBeAg- subjects who completed 96 weeks of 300 mg pevifoscorvir sodium monotherapy, followed by 8 weeks of nucleos(t)ide analog (NA) monotherapy. Reductions in HBV D…

• Additionally, preclinical in vitro data demonstrated that ALG-001075, the active parent moiety of pevifoscorvir sodium, can prevent cccDNA formation and HBV DNA integration. This finding was demonstrated by cell-based studies, which showed prevention of cccDNA establishment and HBV DNA integration f…

• Compared to Phase 3 studies with the current standard of care nucleos(t)ide analogs (NAs), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) (Buti et al., Lancet Gastro, 2016; Chen et al., Lancet Gastro 2016), these Phase 1 data to date suggest, subject to confirmation via further …

• With the completion of the 96 week Phase 1 study, we initiated the Phase 2 B-SUPREME study (NCT06963710), which is designed as a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of pevifoscorvir sodium monotherapy compared with tenofovir disoproxil fum…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• Data from this study following an oral daily dose of 300 mg pevifoscorvir sodium monotherapy in HBeAg+ subjects demonstrated sustained HBV DNA suppression (<LLOQ (10 IU/mL, target detected (TD) or target not detected (TND)) in 6/10 (60%)

• Compared to Phase 3 studies with the current standard of care nucleos(t)ide analogs (NAs), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) (Buti et al., Lancet Gastro, 2016; Chen et al., Lancet Gastro 2016), these Phase 1 data to date suggest, subject to confirmation via further …

• Dosing of HBeAg+ and HBeAg- subjects with pevifoscorvir sodium in Phase 1 has been completed and the 96-week safety, PK, antiviral activity, and post-treatment data are expected to be presented at upcoming scientific conferences. In 2024, Aligos announced that the FDA cleared the Company’s investiga…

• The Phase 2 B-SUPREME study (NCT06963710) is designed as a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of pevifoscorvir sodium monotherapy compared with tenofovir disoproxil fumarate for 48 weeks in approximately 200 currently untreated HBeAg+ and…

• We are also exploring additional ways to potentially treat patients with chronic HBV infection, including our antisense oligonucleotide (ASO) platform which utilizes novel monomers that could potentially reduce ASO toxicity and improve ASO liver to kidney ratios.

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We are not currently a party to any material legal proceedings. From time to time, we may be subject to various claims, lawsuits, and other legal and administrative proceedings arising in the ordinary course of business. The outcome of any such matters is inherently uncertain, and some of these matt…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• From time to time, we may become involved in litigation or other legal proceedings. While the outcome of any such proceedings cannot be predicted with certainty, we are not currently involved in any legal proceedings that we believe are, individually or in the aggregate, material to our business, re…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• supply chain. Restrictions resulting from health pandemics or epidemics may at any time disrupt our supply chain and delay or limit our ability to obtain sufficient materials for our drug candidates.

• In addition, our current and planned clinical trials may be affected by any future public health pandemics or epidemics. Site initiation and patient enrollment may be delayed due to prioritization of hospital resources toward the disease, and potential patients may not be able or willing to comply w…

• As a company, we have limited experience in preparing, submitting and prosecuting regulatory filings. Specifically, we have not previously submitted a new drug application (NDA) to the FDA or similar approval filings to a comparable foreign regulatory

• not obtained regulatory approval for any drug candidate and it is possible that none of our current or future drug candidates will ever obtain regulatory approval.

• The U.S. BIOSECURE Act, which was enacted in December 2025, prohibits federal agencies from procuring or using any biotechnology equipment or services from “biotechnology companies of concern”, or entering into, extending, or renewing any

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• In addition, our current and planned clinical trials may be affected by any future public health pandemics or epidemics. Site initiation and patient enrollment may be delayed due to prioritization of hospital resources toward the disease, and potential patients may not be able or willing to comply w…

• interrupting healthcare services, or due to potential patient concerns regarding interactions with medical facilities or staff. Similarly, our ability to recruit and retain principal investigators and site staff who, as healthcare providers, may have heightened exposure to the disease, may be delaye…

• We are evaluating drug candidates in clinical trials in many countries (e.g., United States, Canada, and throughout Asia and Europe). As a company, we have limited experience in preparing, submitting and prosecuting regulatory filings. Specifically, we have not previously submitted a new drug applic…

• Certain Chinese biotechnology companies, CROs and contract development and manufacturing organizations may become subject to trade restrictions, sanctions, other regulatory requirements, or proposed legislation by the U.S. government, which could potentially impact services available for our researc…

• candidates. For example, if such laws or restrictions are passed, they could have the potential to severely restrict the ability of U.S. biotechnology companies like us to purchase services or products from, collaborate with, or otherwise work with certain Chinese biotechnology companies. It is poss…