Aligos Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 6, 2026
ALGS$4.07-9.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001193125-26-212001
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001193125-26-336851
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 136 previous paragraphs and 135 current paragraphs.
94 unchanged; 27 reworded; 13 added; 15 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
In addition, newly presented data showed that among participants with a baseline HBsAg ≥3,000 IU/mL, 40% (4/10) achieved HBsAg <3,000 IU/mL at 48 weeks, suggesting eligibility for a functional cure regimen, which may include an antisense oligonucleotide (ASO) agent (Yuen, et al. EASL 2026). In clinical trials conducted to date, certain ASO agents under development for chronic HBV infection have seen 19% functional cure rates in a patient population of HBsAg <3,000 IU/mL (Hou, et al. N Engl J Med. 2026), which is estimated to be ~30-40% of all patients with chronic HBV infection.
Current report
Topline data are expected to be available in late Q3 2027.
Current report
ALG‑170675: Potential best‑in‑class antisense oligonucleotide (ASO) for chronic hepatitis B virus infection
Current report
ALG-170675 is a next-generation ASO we discovered as part of a research collaboration with Amoytop, who maintain rights in Greater China. Novel intellectual property has been filed for this candidate, which has shown improved RNase H mediated in vivo activity over GSK-836 (bepirovirsen) with similar hTLR8 agonist activity observed in vitro and in vivo. In addition, ALG-170675 utilizes novel monomers that could potentially reduce ASO toxicity and improve ASO liver to kidney ratios.
Current report
ALG-170675 was designed to reduce the production of HBsAg by targeting and degrading HBV RNA transcripts inside infected hepatocytes. ALG-170675 selectively binds to the HBV transcripts and induces RNase H-mediated degradation of viral RNA, lowering antigen burden and potentially enabling restoration of antiviral immune responses (Hong, et al. EASL 2026).
Current report
In addition, ALG-170675 may have advantages compared with GSK-836 with better in vitro safety, enhanced liver exposure, liver to kidney ratio, and improved in vivo efficacy in mice. Additionally, nonclinical studies have shown additive to synergistic effects when combined with a CAM-E.
Current report
Amoytop recently received IND approval in China and is expected to advance the program into the clinic with a Phase 1 study in healthy volunteers. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALG-170675 following single (SAD) and multiple (MAD) ascending doses. The SAD portion plans to enroll approximately 32 healthy participants across four dose cohorts of 75 mg, 150 mg, 300 mg, and 450 mg. Following completion of the 300 mg SAD cohort, the MAD portion of the study is expected to begin and would enroll approximately 24 healthy participants. The study design also includes a cohort of approximately 16 participants with chronic HBV infection, which is expected to initiate following completion of the 150 mg MAD cohort in Q4 2026.
Current report
Under our agreement with Amoytop, we may utilize data from these studies for regulatory filings and other purposes. We have the potential to conduct a Phase 2 study in 2028. Each party is responsible for their own development costs.
Current report
License revenue includes recognition of revenue from the upfront payment from license agreements.
Current report
fees and expenses paid to institutions that conduct our clinical trials and to clinical trial-related service providers;
Current report
Revenue
Current report
Revenue from customers increased by $1.6 million for the six months ended June 30, 2026, when compared to the same period in 2025 related to a milestone payment. Revenue from customers decreased by $1.0 million for the three months ended June 30, 2026, when compared to the same period in 2025 due to the completion of the work on the original and extended Amoytop agreement.
Current report
Revenue from licensing agreements increased by $27.8 million for the three and six months ended June 30, 2026, related to the Amoytop license agreement. There was no revenue from licensing agreements in the three and six months ended June 30, 2025.
Removed paragraphs (15)
Previous report
The study design for the Phase 2 B-SUPREME study includes pre-specified sample size re-estimations for both Parts 1a and 2a to ensure sufficient power to demonstrate a statistically significant treatment effect at the primary endpoint. The first interim analysis occurred in April 2026, which was performed after approximately 60% of HBeAg- participants (N=34, Part 2a) reached Week 12 or later. In addition, safety data was reviewed for all participants enrolled in the study (N=174) at the time the interim analysis was performed.
Previous report
Findings from the first interim analysis include:
Previous report
The Data Safety Monitoring Board (DSMB) recommended increasing the sample size of Part 2a from 74 currently enrolled to 100 participants. A futility analysis was performed; the prespecified futility criteria was not met, per the statistical analysis plan.
Previous report
The study drugs were well-tolerated with no clinically concerning laboratory, physical examination, vital sign, or ECG abnormalities. No viral breakthrough related to study drugs has been observed in the study to date.
Previous report
A second protocol defined interim analysis is planned when approximately 50% of HBeAg+ participants complete 24 weeks of the treatment period. This enrollment milestone occurred in January 2026. This interim analysis is expected to occur in the second half of 2026. To preserve study integrity and comply with FDA regulatory requirements, we will remain blinded to subject-level data and will receive insights from the independent DSMB on protocol-specified assessments, including the potential for sample size re-estimation at each interim analysis.
Previous report
We expect topline data for the Phase 2 B-SUPREME study in 2027.
Previous report
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. Along with our partner Amoytop, ALG-170675 was selected and is currently in IND-enabling studies. Current costs for development in China are being funded by Amoytop, who maintain rights in China, Taiwan, Hong Kong and Macau. This next-generation ASO works via two mechanisms of action. It targets and destroys HBsAg-encoding mRNA and activates the immune response through TLR-8 agonism.
Previous report
Additionally, we are pursuing a novel strategy for a potential cure for hepatitis delta virus (HDV) coinfection by utilizing a proprietary ASO approach targeting the destruction of the viral genome. Ongoing work is aimed at the selection of a clinical development candidate.
Previous report
ALG‑097558: Potential best-in-class small molecule ritonavir-free protease inhibitor for pan-coronavirus
Previous report
Another area of focus is to develop drug candidates with pan-coronavirus antiviral activity, including against Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19. In this area of focus, we are exploring small molecule coronavirus 3CL protease inhibitors (PIs) in collaboration with the Rega Institute at Katholieke Universiteit Leuven (KU Leuven), the Center for Innovation and Stimulation of Drug Discovery (CISTIM) and the Centre for Drug Design and Discovery (CD3). This collaboration led to the discovery of ALG‑097558 which has completed a Phase 1 first-in-human evaluation in HVs and advanced into a clinical trial evaluating the compound in high-risk COVID-19 patients.
Previous report
ALG‑097558 has been shown in preclinical studies to be at least 3-fold more potent than nirmatrelvir and other PIs in clinical development against a panel of SARS-CoV-2 variants (including Omicron). It also has demonstrated broad pan‑coronavirus activity, including against SARS-CoV-1 and MERS-CoV in preclinical studies. In the first-in-human Phase 1 clinical study, single doses up to 2000 mg and multiple doses up to 800 mg Q12H for 7 days were well tolerated with an acceptable PK profile that suggests ritonavir boosting may not be required. Furthermore, the absence of a clinically relevant DDI with midazolam suggests that ALG‑097558 may be shown to be appropriate for co-administration with CYP3A4 substrates (NCT05840952). Based on these Phase 1 data (Wilkes et al., RespiDart, 2024), the projected efficacious dose range to treat SARS-CoV-2 is 200-600 mg ALG‑097558 Q12 x 5 days, without the need for ritonavir coadministration.
Previous report
A Phase 2 study of ALG‑097558 began in 2024. The AGILE trial, a United Kingdom government-supported platform trial (MRC and Wellcome Trust funding), is sponsoring and performing a study in standard and high‑risk COVID‑19 patients evaluating ALG‑097558 as monotherapy or in combination with remdesivir (NCT04746183). We expect that future development of ALG‑097558 will be funded by external sources, including public funding sources as described below.
Previous report
Preclinical activities for our coronavirus program were partially funded through a grant from the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern program through the Metropolitan AntiViral Drug Accelerator (MAVDA) consortium. Specific clinical and nonclinical studies for the ALG-097558 program are now also being funded with federal funds from the NIAID, NIH, Department of Health and Human Services, under Contract No. 75N93023C00052. We filed an IND in the third quarter of 2024. We expect to receive approximately $15.3 million in funds across these two NIH awards and contracts to support these activities. To date, these funds have not been impacted by any changes at the NIH or NIAID. We are also seeking additional external funding (e.g., from governmental agencies) and/or collaborations (e.g., platform trials) to support future studies as we advance ALG‑097558 for the treatment of COVID‑19 and future coronavirus pandemics.
Previous report
Revenue from customers
Previous report
Revenue from customers increased by $2.5 million for the three months ended March 31, 2026, when compared to the same period in 2025. The increase was due to a milestone payment received from Amoytop, due to a candidate entering GLP toxicology studies in the first quarter of 2026. We expect to recognize additional revenue from customers in 2026 in connection with the upfront payment received under our April 2026 license agreement with Amoytop.
Reworded paragraphs (27)
Previous wording
We are a clinical-stage biotechnology company focused on developing novel therapeutics to address unmet medical needs in liver diseases and viral infections, including in the areas of chronic hepatitis B virus (HBV) infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronavirus infections as well as obesity. The Aligos team has a demonstrated track record of success in drug development and medicinal chemistry in liver and viral diseases, resulting in three potential best‑in‑class drug candidates currently in clinical development.
Current wording
We are a clinical-stage biotechnology company focused on developing novel therapeutics to address unmet medical needs in liver diseases and viral infections, including in the areas of chronic hepatitis B virus (HBV) infection, metabolic dysfunction-associated steatohepatitis (MASH), and obesity. The Aligos team has a demonstrated track record of success in drug development and medicinal chemistry in liver and viral diseases, resulting in multiple potential best‑in‑class drug candidates currently in clinical development.
Previous wording
Our pipeline of drug candidates includes pevifoscorvir sodium (previously known as ALG‑000184) for chronic HBV infection, ALG‑055009 for MASH and obesity, ALG‑097558 for coronavirus infections, and a portfolio of preclinical programs. Pevifoscorvir sodium is our potential best‑/first‑in‑class Capsid Assembly Modulator (CAM‑E) for chronic HBV infection which has shown in pre-clinical testing to have enhanced pharmacologic properties vs. competitor CAM‑E drugs and greater HBV DNA suppression compared to the standard of care, nucleos(t)ide analogs (NAs), and has shown multi-log 10 reductions in viral antigens in Phase 1 clinical studies conducted to date. Pevifoscorvir sodium recently received Fast Track Designation from the Food and Drug Administration (FDA) in chronic HBV infection. ALG‑055009 is our potential best‑in‑class thyroid hormone receptor beta (THR‑β) agonist for MASH and obesity with pharmacologic properties that appear to be enhanced based on data to date vs. competitor THR-β agonists. Phase 2a topline data demonstrated that ALG‑055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFF in subjects with presumed MASH. Recently presented nonclinical data suggests synergistic fat mass loss in combination with incretin receptor agonists in diet induced obese (DIO) mice. ALG‑097558 is our potential best‑in‑class small molecule pan-coronavirus 3CL protease inhibitor (PI), which has been at least 3-fold more potent in cell-based assays of coronavirus infection than other approved CoV PIs and we believe can be dosed twice daily without the requirement for ritonavir co-dosing based on Phase 1 clinical studies conducted to date.
Current wording
Our pipeline of drug candidates includes pevifoscorvir sodium (previously known as ALG‑000184) for chronic HBV infection, ALG‑170675 for chronic HBV infection, ALG‑055009 for MASH and obesity, and a portfolio of preclinical programs. Pevifoscorvir sodium is our potential best‑/first‑in‑class Capsid Assembly Modulator (CAM‑E) for chronic HBV infection which has shown in pre-clinical testing to have enhanced pharmacologic properties vs. competitor CAM‑E drugs and greater HBV DNA suppression compared to the standard of care, nucleos(t)ide analogs (NAs), and has shown multi-log 10 reductions in viral antigens in Phase 1 clinical studies conducted to date. Pevifoscorvir sodium recently received Fast Track Designation from the Food and Drug Administration (FDA) and Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of chronic HBV infection. ALG‑170675 is our potential next-generation best-in-class antisense oligonucleotide (ASO) under development for the treatment of chronic HBV infection with improved RNase H mediated in vivo activity and similar hTLR8 agonist activity observed in vitro and in vivo compared to competitor compounds. ALG‑170675 recently received IND approval in China and is expected to enter the clinic in Q3 2026 in China, with clinical trials sponsored and performed by our partner Xiamen Amoytop Biotech Co., Ltd (Amoytop). ALG‑055009 is our potential best‑in‑class thyroid hormone receptor beta (THR‑β) agonist for MASH and obesity with pharmacologic properties that appear to be enhanced based on data to date vs. competitor THR-β agonists. Phase 2a topline data demonstrated that ALG‑055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFF in subjects with presumed MASH. Recently presented nonclinical data suggests synergistic fat mass loss in combination with incretin receptor agonists in diet induced obese (DIO) mice.
Previous wording
Our primary area of focus seeks to enhance the viral suppression and rate of functional cure for chronic HBV infection, which often results in life-threatening conditions such as cirrhosis, end-stage liver disease, and the most common form of liver cancer, hepatocellular carcinoma (HCC). To achieve this, we are developing a portfolio of differentiated chronic HBV infection drug candidates, including a small molecule CAM that results in the production of empty viral capsids.
Current wording
Our primary area of focus seeks to enhance the viral suppression (near term goal) and rate of functional cure (long term goal) for chronic HBV infection, which often results in life-threatening conditions such as cirrhosis, end-stage liver disease, and the most common form of liver cancer, hepatocellular carcinoma (HCC). To reduce the burden of disease associated with chronic HBV infection, we are developing a portfolio of differentiated drug candidates, including a small molecule CAM that results in the production of empty viral capsids.
Previous wording
In 2018, we in‑licensed a lead drug candidate (GLP‑26) and the associated IP for a CAM‑E from the laboratory of Professor Raymond Schinazi at Emory University. Our scientists optimized this lead drug candidate to discover the highly potent CAM‑E, ALG‑001075, which was further optimized to the prodrug pevifoscorvir sodium. Based on pre-clinical data to date, pevifoscorvir sodium has superior DMPK properties with enhanced absorption and high liver uptake, with a ~2-300-fold improvement in in vitro potency compared to other known CAMs. CAM‑Es are a class of small molecule antiviral agents that accelerate HBV capsid assembly and inhibit pgRNA encapsidation (1st MOA), resulting in empty viral capsids and lower circulating HBV DNA and RNA levels. CAM-Es have the potential to prevent HBV DNA integration by blocking the conversion of pgRNA to dslDNA, the form which integrates into the host chromosome. CAM‑Es are also believed to prevent the establishment and replenishment of cccDNA (2nd MOA), a major factor for the persistence of HBV infection which can be assessed by circulating HBV antigen levels (HBsAg, HBcrAg, and HBeAg). These three drivers, replication, integration, and the reservoir, comprise the disease pathogenesis which can lead to end-stage liver disease and liver cancer. We believe that effective therapies for chronic HBV infection must address all three drivers. In preclinical studies and clinical trials conducted to date, pevifoscorvir sodium has demonstrated the potential to not only block HBV replication and prevent HBV DNA integration, but also reduce the cccDNA reservoir, all clinically relevant markers that improve outcomes in chronic HBV infection.
Current wording
In 2018, we in‑licensed a lead drug candidate (GLP‑26) and the associated IP for a CAM‑E from the laboratory of Professor Raymond Schinazi at Emory University. Our scientists optimized this lead drug candidate to discover the highly potent CAM‑E, ALG‑001075, which was further optimized to the prodrug pevifoscorvir sodium. Based on pre-clinical data to date, pevifoscorvir sodium has superior DMPK properties with enhanced absorption and high liver uptake, with a ~2- to 300-fold improvement in in vitro potency compared to other known CAMs. CAM‑Es are a class of small molecule antiviral agents that accelerate HBV capsid assembly and inhibit pgRNA encapsidation (1st MOA), resulting in empty viral capsids and lower circulating HBV DNA and RNA levels. CAM-Es have the potential to prevent HBV DNA integration by blocking the conversion of pgRNA to dslDNA, the form which integrates into the host chromosome. CAM‑Es are also believed to prevent the establishment and replenishment of cccDNA (2nd MOA), a major factor for the persistence of HBV infection which can be assessed by circulating HBV antigen levels (HBsAg, HBcrAg, and HBeAg). These three drivers, replication, integration, and the reservoir, comprise the disease pathogenesis which can lead to end-stage liver disease and liver cancer. We believe that effective therapies for chronic HBV infection must address all three drivers. In preclinical studies and clinical trials conducted to date, pevifoscorvir sodium has demonstrated the potential to not only block HBV replication and prevent HBV DNA integration, but also reduce the cccDNA reservoir, each of which we believe are clinically relevant markers that improve outcomes in chronic HBV infection.
Previous wording
A multi-part Phase 1 study is complete, with evaluation of the safety, tolerability, and pharmacokinetic profile of pevifoscorvir sodium in HVs. Additionally, a dose-ranging phase assessing the safety, pharmacokinetics (PK), and antiviral activity of 10‑300 mg doses of pevifoscorvir sodium administered over 28 days in untreated HBeAg+/- subjects with chronic HBV infection has also been completed. In these study phases, pevifoscorvir sodium was found to be well tolerated with a favorable PK profile and demonstrated potentially best-in-class multi-log 10 HBV DNA and RNA reductions at all doses tested, as well as HBV surface antigen (HBsAg) reductions in a subset of HBeAg+ subjects receiving 100 mg or 300 mg of pevifoscorvir sodium (Hou et al, AASLD 2022). Based on the favorable profile observed with dosing up to 300 mg of pevifoscorvir sodium for 28 days, additional Phase 1 studies evaluated the risk-benefit profile of pevifoscorvir sodium at doses of 300 mg, with or without entecavir (ETV) therapy, for up to 96 weeks in HBeAg+ and HBeAg- subjects with chronic HBV infection. Data from these cohorts (Yuen et al., AASLD 2025) have been presented, showing that pevifoscorvir sodium, administered for up to 96 weeks, was well tolerated, exhibited a favorable PK profile, and suggested potentially best-in-class potent and durable antiviral activity.
Current wording
A multi-part Phase 1 study is complete, with evaluation of the safety, tolerability, and pharmacokinetic profile of pevifoscorvir sodium in HVs. Additionally, a dose-ranging phase assessing the safety, pharmacokinetics (PK), and antiviral activity of 10‑300 mg doses of pevifoscorvir sodium administered over 28 days in untreated HBeAg+/- subjects with chronic HBV infection has also been completed. In these study phases, pevifoscorvir sodium was found to be well tolerated with a favorable PK profile and demonstrated potentially best-in-class multi-log 10 HBV DNA and RNA reductions at all doses tested, as well as HBV surface antigen (HBsAg) reductions in a subset of HBeAg+ subjects receiving 100 mg or 300 mg of pevifoscorvir sodium (Yuen, et al, Lancet Gastro.
Previous wording
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 DNA, HBV antigens, and HBV RNA were largely maintained during the NA-only 8-week follow-up period. Notably, viral biomarkers such as HBV antigens and HBV RNA are typically unaffected by NA therapy, suggesting that pevifoscorvir sodium may reduce the cccDNA pool through engagement of its secondary mechanism of action (Yuen et al., AASLD 2025).
Current wording
Further, data presented at The European Association for the Study of the Liver’s 2026 Congress highlighted outcomes for treatment-naïve or currently not treated HBeAg+ subjects who completed 96 weeks of 300 mg pevifoscorvir sodium monotherapy, followed by ≥24 weeks of nucleos(t)ide analog (NA) monotherapy. Among HBeAg+ subjects, 9 of 10 subjects transitioned to NA monotherapy; of these, 4 (44%) maintained HBV DNA levels below the lower limit of quantification (LLOQ; 10 IU/mL, target detected [TD] or target not detected [TND]) throughout the NA only ≥24-week follow-up period. Reductions in HBV antigens and HBV RNA were maintained during the NA only ≥24-week follow-up period. Notably, these viral biomarkers, such as HBV antigens and HBV RNA, are typically unaffected by NA therapy, suggesting that pevifoscorvir sodium may reduce the cccDNA reservoir through engagement of its secondary mechanism of action (Mak, et al. EASL 2026).
Previous wording
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 following treatment with ALG-001075 (Verheyen, et. al. AASLD 2025).
Current wording
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 following treatment with ALG-001075 (Verheyen, et. al. AASLD 2025). Preclinical in vitro data also demonstrated that long-term treatment with ALG-001075 resulted in profound suppression of HBeAg, HBsAg and intracellular HBV RNAs which was durable after treatment withdrawal in HBV-infected HepaRG cells, suggesting a potential reduction in cccDNA level and/or transcriptional activity (Debing, et al. EASL 2026).
Previous wording
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 study, that pevifoscorvir sodium treatment may be superior to NAs in HBeAg+/- subjects in achieving HBV DNA levels < LLOQ (10 IU/mL) after 48 weeks on treatment. Chronic suppressive therapy of HBV DNA levels is a validated approval pathway in chronic HBV infection (Food and Drug Administration (FDA) Guidance, Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment Guidance for Industry, April 2022 – Section III.B.1.a). We have received affirmative feedback from the FDA, the Committee for Medicinal Products for Human Use (CHMP: EU) and the National Medical Products Administration (NMPA: China) supporting subsequent studies utilizing the chronic suppressive therapy pathway for pevifoscorvir sodium. Our ongoing Phase 2 B-SUPREME study is being conducted to test superiority to standard of care NA treatment (HBV DNA levels <LLOQ (10 IU/ml, TD or TND) in HBeAg+ subjects and HBV DNA levels < LLOQ (10 IU/ml, TND) in HBeAg- subjects) after 48 weeks of monotherapy treatment. Furthermore, when combined with other mechanisms of action, including other candidates in our chronic HBV infection portfolio, pevifoscorvir sodium dosing regimens have the potential to contribute to achieving higher rates of functional cure, subject to testing such endpoint, as compared with currently approved agents.
Current wording
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), the Company’s Phase 1 data to date suggest, subject to confirmation via further study, that pevifoscorvir sodium treatment may be superior to NAs in HBeAg+/- subjects in achieving HBV DNA levels < LLOQ (10 IU/mL) after 48 weeks on treatment. Chronic suppressive therapy of HBV DNA levels is a validated approval pathway in chronic HBV infection (Food and Drug Administration (FDA) Guidance, Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment Guidance for Industry, April 2022 – Section III.B.1.a). We have received affirmative feedback from the FDA, the Committee for Medicinal Products for Human Use (CHMP: EU) and the National Medical Products Administration (NMPA: China) supporting subsequent studies utilizing the chronic suppressive therapy pathway for pevifoscorvir sodium. Our ongoing Phase 2 B-SUPREME study is being conducted to test superiority to standard of care NA treatment (HBV DNA levels <LLOQ (10 IU/ml, TD or TND) in HBeAg+ subjects and HBV DNA levels < LLOQ (10 IU/ml, TND) in HBeAg- subjects) after 48 weeks of monotherapy treatment. Furthermore, when combined with other mechanisms of action, including other candidates in our chronic HBV infection portfolio, pevifoscorvir sodium dosing regimens have the potential to contribute to achieving higher rates of functional cure, subject to testing such endpoint, as compared with currently approved agents.
Previous wording
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 fumarate for 48 weeks in approximately 200 currently untreated HBeAg+ and HBeAg- adult subjects with chronic HBV infection. The primary endpoint in the HBeAg+ arm is HBV DNA <LLOQ (10 IU/mL, TD or TND) and the primary endpoint in the HBeAg- arm is HBV DNA <LLOQ (10 IU/mL, TND). The study is also evaluating safety, PK, and other secondary and exploratory HBV biomarkers, including reductions in HBV antigens and other markers of HBV infection. The Phase 2 study has obtained regulatory approvals to move forward in every country included in the study and is currently enrolling subjects. As of April 2026, there were 74 participants enrolled in the HBeAg- cohort (Part 2a), with 103 participants enrolled in the HBeAg+ cohort (Part 1a).
Current wording
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 fumarate for 48 weeks in approximately 250 currently untreated HBeAg+ and HBeAg- adult subjects with chronic HBV infection. The primary endpoint in the HBeAg+ arm is HBV DNA <LLOQ (10 IU/mL, TD or TND) and the primary endpoint in the HBeAg- arm is HBV DNA <LLOQ (10 IU/mL, TND). The study is also evaluating safety, PK, and other secondary and exploratory HBV biomarkers, including reductions in HBV antigens and other markers of HBV infection. Enrollment has been completed with 131 participants in the HBeAg+ Part 1a and 114 participants in the HBeAg- Part 2a.
Previous wording
In April 2026, we announced that we entered an exclusive license deal with Xiamen Amoytop Biotech Co., Ltd. (Amoytop) to develop and commercialize pevifoscorvir sodium in Mainland China, Taiwan, Hong Kong, and Macau for chronic HBV infection with Amoytop for an upfront payment of $25 million and up to $420 million in clinical, regulatory, and sales milestones, along with tiered, high single-digit royalties. The closing of the transaction was conditional and automatically effective upon Amoytop receiving approval at a Shareholder’s Meeting, which occurred on May 7, 2026.
Current wording
In May 2026, we entered an exclusive license deal with Amoytop to develop and commercialize pevifoscorvir sodium in Mainland China, Taiwan, Hong Kong, and Macau (Greater China) for chronic HBV infection for an upfront payment of $25.0 million, net of tax, (which was received in July 2026) and up to $420 million in clinical, regulatory, and sales milestones, along with tiered, high single-digit royalties.
Previous wording
Customer revenue includes recognition of revenue generated from research and development services under third-party contracts with customers. In order to record customer revenue, we utilize an input method to recognize revenue over time as costs are incurred.
Current wording
Customer revenue includes recognition of revenue generated from research and development services under third-party contracts with customers.
Previous wording
Comparison of the three months ended March 31, 2026 and 2025
Current wording
Comparison of the three and six months ended June 30, 2026 and 2025
Previous wording
The following table summarizes our operating expenses for the three months ended March 31, 2026 and 2025 (in thousands):
Current wording
The following table summarizes our operating expenses for the three and six months ended June 30, 2026 and 2025 (in thousands):
Previous wording
Research and development expenses increased by $8.9 million during the three months ended March 31, 2026, compared to the same period in 2025. The increase in the three-month period was primarily due to a $6.2 million increase in third-party expenses due to increased clinical study costs as a result of the beginning of enrollment and dosing in the pevifoscorvir sodium Phase 2 B‑SUPREME clinical trial. Further, there was a $2.2 million increase in employee-related costs, and a $0.4 million increase in facility and other expenses.
Current wording
Research and development expenses increased by $10.1 million and $18.9 million, respectively, during the three and six months ended June 30, 2026 compared to the same periods in 2025. The increase was primarily due to a $8.8 million and $14.9 million, respectively, increase in third-party expenses due to increased clinical study costs as a result of the enrollment and dosing in the pevifoscorvir sodium Phase 2 B‑SUPREME clinical trial. Further, there were increases in employee-related costs, and facility and other expenses in both periods.
Previous wording
General and administrative expenses increased by $1.4 million during the three months ended March 31, 2026, compared to the same period in 2025. This was primarily due to a $0.7 million increase in employee-related costs, as well as a $0.4 million increase in third party expenses due to increased legal and intellectual property spend.
Current wording
General and administrative expenses remained flat and increased by $1.4 million during the three and six months ended June 30, 2026, compared to the same periods in 2025. The increase in the six-month period was primarily due to a $1.2 million increase in employee-related costs, as well as a $0.4 million increase in third party expenses due to increased legal and intellectual property spend, offset by a $0.2 million decrease in facility and other expenses.
Previous wording
Interest and other income, net remained relatively flat during the three months ended March 31, 2026 as compared to the same period in the prior year.
Current wording
Interest and other income, net decreased by $1.0 million and $1.1 million, respectively, during the three and six months ended June 30, 2026 as compared to the same period in the prior year. This was primarily due to a decreasing short-term investments balance.
Previous wording
The change in fair value of 2023 Common Warrants was a decrease of $58.1 million for the three months ended March 31, 2026 compared to the same period ended March 31, 2025. The change was due to a change in the fair value of the 2023 Common Warrants measured using the Black Scholes option pricing model remeasured at each reporting period, principally due to a change in the stock price between reporting periods.
Current wording
The change in fair value of 2023 Common Warrants was an increase of $1.3 million and a decrease of $56.8 million for the three and six months ended June 30, 2026, compared to the same period ended June 30, 2025. The change was due to a change in the fair value of the 2023 Common Warrants measured using the Black Scholes option pricing model remeasured at each reporting period, principally due to a change in the stock price between reporting periods.
Previous wording
We have incurred net losses in each year since inception. Our net losses were $23.0 million for the three months ended March 31, 2026 and $24.2 million for the year ended December 31, 2025. As of March 31, 2026, we had an accumulated deficit of $665.2 million.
Current wording
We have incurred operating losses in each year since inception. Our cash and cash equivalents were $30.4 million as of June 30, 2026. As of June 30, 2026, we had an accumulated deficit of $666.7 million.
Previous wording
Our operations have been financed primarily by net proceeds from the sale and issuance of our convertible preferred stock, proceeds from public offerings, revenue from customer and collaboration agreements, and proceeds from private placements of our common stock, warrants and pre-funded warrants, and the issuance of convertible debt.
Current wording
Our operations have been financed primarily by net proceeds from the sale and issuance of our convertible preferred stock, proceeds from public offerings, revenue from customers, collaboration and license agreements, and proceeds from private placements of our common stock, warrants and pre-funded warrants, and the issuance of convertible debt.
Previous wording
In February 2025, we entered into a securities purchase agreement (the 2025 Securities Purchase Agreement) with certain investors named therein (the Purchasers) pursuant to which we issued (i) 2,103,307 shares of our common stock (the Common Stock), consisting of 1,427,000 shares of voting Common Stock and 676,307 shares of non-voting Common Stock, (ii) pre‑funded warrants (the 2025 Pre-Funded Warrants) to purchase up to an aggregate of 1,922,511 shares of voting Common Stock, and (iii) accompanying common warrants (the 2025 Common Warrants and, together with the 2025 Pre-Funded Warrants, the 2025 Warrants) to purchase up to an aggregate of 2,012,909 shares of Common Stock. Each Warrant is exercisable for one share of Common Stock (the 2025 Private Placement). We received gross proceeds of $105.0 million. In connection with the 2025 Private Placement, we also entered into a registration rights agreement with the Purchasers, pursuant to which we agreed to register for resale the shares of Common Stock sold to the Purchasers, as well as the shares of Common Stock underlying the 2025 Warrants sold to the Purchasers, on the terms set forth therein. We also entered into a registration rights agreement with Baker Brothers Life Sciences, L.P. (together with its affiliates, the Lead Investor), pursuant to which we agreed to file a resale registration statement with the Securities and Exchange Commission following demand by the Lead Investor to register the resale of shares of Common Stock and any Common Stock issued or issuable upon the exercise or conversion of non-voting Common Stock and any of our other securities held by the Lead Investor.
Current wording
In February 2025, we entered into a securities purchase agreement (the 2025 Securities Purchase Agreement) with certain investors named therein (the Purchasers) pursuant to which we issued (i) 2,103,307 shares of our common stock (the Common Stock), consisting of 1,427,000 shares of voting Common Stock and 676,307 shares of non-voting Common Stock, (ii) pre‑funded warrants (the 2025 Pre-Funded Warrants) to purchase up to an aggregate of 1,922,511 shares of voting Common Stock, and (iii) accompanying common warrants (the 2025 Common Warrants and, together with the 2025 Pre-Funded Warrants, the 2025 Warrants) to purchase up to an aggregate of 2,012,909 shares of Common Stock (the 2025 Private Placement). Each Warrant is exercisable for one share of Common Stock. We received gross proceeds of $105.0 million. In connection with the 2025 Private Placement, we also entered into a registration rights agreement with the Purchasers, pursuant to which we agreed to register for resale the shares of Common Stock sold to the Purchasers, as well as the shares of Common Stock underlying the 2025 Warrants sold to the Purchasers, on the terms set forth therein. We also entered into a registration rights agreement with Baker Brothers Life Sciences, L.P. (together with its affiliates, the Lead Investor), pursuant to which we agreed to file a resale registration statement with the Securities and Exchange Commission following demand by the Lead Investor to register the resale of shares of Common Stock and any Common Stock issued or issuable upon the exercise or conversion of non-voting Common Stock and any of our other securities held by the Lead Investor.
Previous wording
As of March 31, 2026, we had an accumulated deficit of $665.2 million, and cash, cash equivalents and short-term investments of $54.9 million. Our current operating plan and projected cash outflows for the upcoming periods raise doubt about our ability to continue as a going concern for at least 12 months from the issuance of the financial statements included elsewhere in this Quarterly Report. We plan to raise additional capital to fund continued operations beyond the fourth quarter of 2026. We are taking steps to identify access to future capital and expect to be able to access capital in the future. However, there can be no assurance that any additional funding will be available to us on acceptable terms, if at all. If events or circumstances occur such that we do not obtain additional funding, it may be necessary to significantly reduce the scope of operations to reduce the current rate of spending, which could include reductions in staff and the need to delay, limit, reduce or terminate current or future product development, which could have a material adverse effect on our business, results of operations and financial condition. Moreover, even if financing efforts are successful and additional capital is obtained, available liquidity may still be insufficient to eliminate the aforementioned substantial doubt regarding our ability to continue as a going concern.
Current wording
As of June 30, 2026, we had an accumulated deficit of $666.7 million, and cash and cash equivalents of $30.4 million. Our current operating plan and projected cash outflows for the upcoming periods raise substantial doubt about our ability to continue as a going concern for at least 12 months from the issuance of the financial statements included elsewhere in this Quarterly Report. We plan to raise additional capital to fund continued operations beyond the fourth quarter of 2026. We are taking steps to identify access to future capital and expect to be able to access capital in the future. However, there can be no assurance that any additional funding will be available to us on acceptable terms, if at all. If events or circumstances occur such that we do not obtain additional funding, it may be necessary to significantly reduce the scope of operations to reduce the current rate of spending, which could include reductions in staff and the need to delay, limit, reduce or terminate current or future product development, which could have a material adverse effect on our business, results of operations and financial condition. Moreover, even if financing efforts are successful and additional capital is obtained, available liquidity may still be insufficient to eliminate the aforementioned substantial doubt regarding our ability to continue as a going concern.
Previous wording
Our primary use of cash is to fund operating expenses, which consist primarily of research and development costs related to our drug candidates and our discovery programs, and to a lesser extent, general and administrative expenditures. Our current operating plan and projected cash outflows for the upcoming periods raise doubt about our ability to continue as a going concern for at least 12 months from the issuance of the financial statements. If we are successful with our ability to access additional funding, we expect our expenses to increase substantially in connection with our ongoing clinical development activities related to our chronic HBV infection drug candidate pevifoscorvir sodium, for which has an ongoing Phase 2 trial, as well as our research and development of our other drug candidates.
Current wording
Our primary use of cash is to fund operating expenses, which consist primarily of research and development costs related to our drug candidates and our discovery programs, and to a lesser extent, general and administrative expenditures. Our current operating plan and projected cash outflows for the upcoming periods raise substantial doubt about our ability to continue as a going concern for at least 12 months from the issuance of the financial statements. If we are successful with our ability to access additional funding, we expect our expenses to increase substantially in connection with our ongoing clinical development activities related to our chronic HBV infection drug candidate pevifoscorvir sodium, for which we have an ongoing Phase 2 trial, as well as our research and development of our other drug candidates.
Previous wording
Net cash used in operating activities of $23.1 million and $20.9 million for the three months ended March 31, 2026 and 2025, respectively, was largely due to ongoing research and development activities, specifically our Phase 2 B‑SUPREME study, and general administrative expenses to support those activities. Net losses for the three months ended March 31, 2026 and 2025 included, among other items, non-cash charges of stock-based compensation, non-cash lease expense, and depreciation, offset by non-cash credits including the change in the fair value of the 2023 Common Warrants and accretion of discount on investments.
Current wording
Net cash used in operating activities of $48.1 million and $36.4 million for the six months ended June 30, 2026 and 2025, respectively, was largely due to ongoing research and development activities, specifically our Phase 2 B‑SUPREME study, and general administrative expenses to support those activities. Net (loss) income for the six months ended June 30, 2026 and 2025 included, among other items, non-cash charges of stock-based compensation, non-cash lease expense, and depreciation, offset by non-cash change in the fair value of the 2023 Common Warrants and accretion of discount on investments.
Previous wording
During the three months ended March 31, 2026, investing activities provided $34.9 million of cash, primarily due to $35.0 million related to maturities of short-term investments.
Current wording
During the six months ended June 30, 2026, investing activities provided $59.9 million of cash, primarily due to $60.0 million related to maturities of short-term investments.
Previous wording
During the three months ended March 31, 2025, investing activities used $44.1 million of cash, primarily due to $64.0 million of purchase of short-term investments partially offset by $20.0 million related to maturities of short-term investments.
Current wording
During the six months ended June 30, 2025, investing activities used $83.5 million of cash, primarily due to $103.3 million of purchase of short-term investments, partially offset by $20.0 million related to maturities of short-term investments.
Previous wording
During the three months ended March 31, 2026, net cash used by financing activities was $62.0 thousand, primarily due to payments on finance leases.
Current wording
During the six months ended June 30, 2026, net cash provided by financing activities was $0.2 million, primarily due to proceeds from the ESPP purchase.
Previous wording
During the three months ended March 31, 2025, net cash provided by financing activities was $101.7 million, primarily due to proceeds from the 2025 PIPE financing.
Current wording
During the six months ended June 30, 2025, net cash provided by financing activities was $101.6 million, primarily due to proceeds from the 2025 PIPE financing.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
& Hep., 2026). Based on the favorable profile observed with dosing up to 300 mg of pevifoscorvir sodium for 28 days, additional Phase 1 studies evaluated the risk-benefit profile of pevifoscorvir sodium at doses of 300 mg, with or without entecavir (ETV) therapy, for up to 96 weeks in HBeAg+ and HBeAg- subjects with chronic HBV infection. Data from these cohorts (Yuen et al., AASLD 2025) have been presented, showing that pevifoscorvir sodium, administered for up to 96 weeks, was well tolerated, exhibited a favorable PK profile, and suggested potentially best-in-class potent and durable antiviral activity.