AusperBio Reports Sustained Functional Cure up to 15 Months Off All HBV Treatment in Treatment-Naïve and NA-Treated Patients with Chronic Hepatitis B

Long-term follow-up supports AHB-137 as a potential finite-duration therapy; data featured in two late-breaking oral presentations at AASLD The Liver Meeting® 2026

Key Findings

• NA-treated participants: Functional cure was maintained in 16 of 17 evaluable participants at 12 months and 9 of 9 evaluable participants at 15 months after nucleos(t)ide analogue (NA) discontinuation. No participant required NA re-initiation during follow-up.
• Treatment-naïve participants: Of 7 participants who achieved complete response (CR) following 16 weeks of AHB-137 monotherapy, 6 maintained functional cure at 9 months after treatment discontinuation, and all 6 continued to maintain it through 15 months. The seventh participant experienced viral rebound and withdrew.
• Partial responders: Of 6 NA-treated partial responders who discontinued NA, 2 achieved complete response during off-treatment follow-up, suggesting that responses may continue to improve after treatment cessation.
• Safety: No clinical relapse, severe hepatic flares, hepatic decompensation or new safety signals were observed during follow-up in either cohort.

SAN FRANCISCO, Nov. 5, 2026 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (together, "AusperBio"), a biopharmaceutical company developing oligonucleotide therapeutics, today announced long-term follow-up data from Study AB-10-8004 evaluating the durability of functional cure achieved with AHB-137, its investigational antisense oligonucleotide (ASO) therapy for chronic hepatitis B (CHB). The findings show that functional cure can be maintained for up to 15 months after stopping all HBV treatment in both NA-treated and treatment-naïve participants. The data will be presented in two late-breaking oral presentations at The Liver Meeting® 2026, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 5–9 in Denver, Colorado.

"A functional cure only matters if it lasts after treatment stops, and these data show that it can, both in patients coming off NA and in patients who never started it," said Guofeng Cheng, Ph.D., Co-founder and Chief Executive Officer of AusperBio. "That strengthens our conviction in AHB-137 as a potential backbone of finite-duration treatment for CHB. With a Phase 3 trial ongoing in China and global development advancing, we are moving AHB-137 forward with urgency for the approximately 240 million people living with CHB worldwide."

"For patients on long-term NA therapy, the real question is whether they can maintain control of the virus after treatment stops," said Professor Jinlin Hou, Principal Investigator of the study at Southern Medical University. "The continued improvement observed in some participants after treatment discontinuation is particularly encouraging. It suggests that patients' own immune responses may be taking over, and confirming this in larger studies will be an important next step."

"For treatment-naïve patients, achieving functional cure with a finite course of treatment could change the way we treat chronic hepatitis B," said Professor Junqi Niu, Co-Principal Investigator of the study, The First Hospital of Jilin University. "These early findings are encouraging and support further evaluation of this approach in larger studies."

Study Design and Definitions

Study AB-10-8004 (NCT07146100) is a long-term follow-up study evaluating the durability of response and safety in participants who achieved complete response (CR) or partial response (PR) at the end of their respective Phase 2 parent studies.

The NA-treated cohort enrolled 34 participants (21 CR, 13 PR) from AB-10-8002 (NCT06115993) and AB-10-8003 (NCT06550128).
The treatment-naïve cohort enrolled 11 participants (7 CR, 4 PR) from Study AB-10-8008 Part A (NCT06829329), who had received 16 weeks of AHB-137 monotherapy followed by 24 weeks of follow-up without HBV treatment.

For these studies:

• Complete response (CR) was defined as hepatitis B surface antigen (HBsAg) below 0.05 IU/mL and HBV DNA below the lower limit of quantification (LLOQ; below 10 IU/mL).
• Partial response (PR) was defined as HBsAg at or above 0.05 IU/mL and below 10 IU/mL, with HBV DNA below the LLOQ.
• Functional cure was defined as CR maintained for at least 24 weeks without any HBV treatment.

Oral Presentation Details — November 8, 2026

• Abstract 5001: Durability of AHB-137 up to 9 Month Post End-of-Studies in Nucleos(t)ide Analogue Treated Participants with Chronic Hepatitis B: First Long-Term Follow-up Report from the AB-10-8004 Study. Late Breaking Abstract Parallel Session 1, 2:00–2:15 p.m. MT. Presenter: Professor Jinlin Hou, Nanfang Hospital, Southern Medical University.
  
  
• Abstract 5010: Durability of Functional Cure to AHB-137 Monotherapy in Treatment-Naïve Participants with Chronic Hepatitis B: Long-Term Follow-Up Results of the AB-10-8004 Study. Late Breaking Abstract Parallel Session 2, 6:00–6:15 p.m. MT. Presenter: Professor Junqi Niu, The First Hospital of Jilin University.

Late-breaking abstracts are available on the AASLD website.

About Chronic Hepatitis B

Chronic hepatitis B (CHB), caused by persistent hepatitis B virus (HBV) infection, affects approximately 240 million people worldwide, with approximately 1.2 million new infections each year, according to the World Health Organization (WHO) Global Hepatitis Report. In China, approximately 75 million people live with chronic HBV infection, which accounts for approximately 70% of cirrhosis and 80% of primary liver cancer cases and approximately 300,000 deaths each year. Current NA therapies suppress viral replication but rarely achieve functional cure, leaving most patients on long-term or lifelong treatment. Finite-duration therapy that achieves functional cure remains an important unmet medical need.

About AHB-137

AHB-137 is AusperBio's lead investigational unconjugated antisense oligonucleotide (ASO) therapy for chronic hepatitis B (CHB), developed using the Company's proprietary Med-Oligo™ ASO platform. AHB-137 is designed to target HBV RNAs, suppress hepatitis B surface antigen (HBsAg) production, inhibit viral DNA replication, and support the restoration of immune control, with the goal of achieving functional cure for CHB patients. AHB-137 has demonstrated promising clinical results in both NA-treated and treatment-naïve participants and is currently being evaluated in a Phase 3 trial in China, following completion of a global Phase 1 study and multiple Phase 2 studies. The Company is advancing AHB-137 through a coordinated global development strategy toward potential commercialization. AHB-137 is an investigation product candidate and has not been approved by any regulatory authority.

About AusperBio

AusperBio is a biopharmaceutical company focused on developing differentiated oligonucleotide therapeutics and targeted delivery technologies, with an initial focus on achieving a functional cure for chronic hepatitis B. The Company's innovation engine is built on its proprietary Med-Oligo™ ASO and Au-HALO™ targeted delivery platforms, supporting the development of therapies across multiple oligonucleotide modalities. With multiple clinical-stage programs and a growing pipeline, AusperBio is advancing a backbone-based combination strategy for functional cure of CHB while exploring opportunities in additional disease areas with significant unmet medical needs. For more information, visit www.ausperbio.com.

Forward-Looking Statements

This press release has been prepared by AusperBio (the "Company", "We") for informational purposes only. Forward-looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as "anticipate", "expect", "intend", "plan", "believe", "continue", "could", "potential", "may", "will", "goal" or similar expressions and the negatives of those terms. However, not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include, without limitation, statements regarding the potential of AHB-137 as a finite-duration therapy for CHB, the durability of functional cure following treatment discontinuation, the design, progress and timing of the Company's clinical studies, including its Phase 3 trial in China, and the Company's global development and commercialization plans.

These forward-looking statements involve substantial known and unknown risks and uncertainties, including the risk that results in earlier clinical studies may not be indicative of future results and that any product candidates may not ultimately obtain required approvals or meaningfully improve patient outcomes, and other factors that are beyond the Company's control and are difficult to predict and may cause our actual results, timing of results, or achievements to be materially different from the information expressed or implied by these forward-looking statements. We anticipate that subsequent events and developments may cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

All forward-looking statements in this press release speak only as of the date of this press release.

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SOURCE AusperBio Therapeutics Inc.