Multiple Ongoing Phase 2b Studies Advancing HBV Functional Cure Strategy

Greater China Partnership with Joincare to Accelerate Development of Critical Care Antibiotic soralimixin

Strong Cash Position to Pursue New Discovery Opportunities and Partnership Strategy

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DURHAM, N.C., and BEIJING, Aug. 21, 2025 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," or the "Company," stock code: 2137.HK), a biotechnology company developing therapies to improve patient health across diseases with high unmet medical need, today provided a corporate update and reported its financial results for the six-month period ended June 30, 2025.

In the first half of 2025, Brii Bio rapidly advanced its core hepatitis B virus (HBV) functional cure program through multiple confirmatory Phase 2b trials, including ENRICH and ENHANCE studies, seeking combination regimens with higher HBV functional cure rates. Encouraged by promising data from Cohort 4 of the ENSURE study, presented at both the Asian Pacific Association for the Study of the Liver (APASL) and the European Association for the Study of the Liver (EASL) Congress 2025 supporting the potential of its patient enrichment strategy through BRII-179 induced anti-HBs response, the Company initiated a new cohort in an amended protocol within the ENHANCE study. This amendment evaluates a new triple regimen cohort with BRII-179 and elebsiran combination treatment followed by an added short-course pegylated interferon alpha (PEG-IFN<ALPHA>) treatment. This new cohort was fully enrolled in July 2025. Beyond its HBV pipeline, Brii Bio entered into a strategic license collaboration with Joincare Pharmaceutical Group Industry Co., Ltd ("Joincare Group") for the development of soralimixin (BRII-693) in the Greater China region. The Company has expanded its new discovery efforts to further broaden its portfolio and will continue to pursue partnership to extend the cash runway.

With effective cost control measures in place, Brii Bio remains well-capitalized, maintaining a cash position of US$289.9 million, which is sufficient to support its late-stage development plans for its core HBV functional cure program and early discovery initiatives.

"We made significant strides in our HBV cure program during the first half of 2025, highlighted by encouraging data from Cohort 4 of the ENSURE study and the rapid advancement of ENRICH and ENHANCE studies." said Dr. Zhi Hong, Chairman and Chief Executive Officer of Brii Bio, "These achievements reflect Brii's experience and commitment to discovering innovative curative treatments for patients with chronic HBV infection. Meanwhile, the out-licensing of soralimixin in Greater China and our continued investment in early-stage discovery programs reinforce our strategy of combining internal innovation with strategic external collaborations to drive sustainable growth."

Corporate and Clinical Updates

HBV Program

Brii Bio continues to advance its HBV pipeline with a strong focus on achieving higher rates of HBV functional cure through novel combination regimens. The Company is progressing multiple ongoing Phase 2b combination studies (ENSURE, ENRICH and ENHANCE) with its differentiated HBV candidates, including elebsiran, an HBV-targeting siRNA, and BRII-179, a recombinant protein-based HBV immunotherapeutic.

   -- BRII-179 demonstrated encouraging results in the Cohort 4 of ENSURE study, 
      with key data presented at APASL and EASL 2025: 
 
          -- At Week 48 (end of treatment [EOT]), 61% (11/18) of patients who 
             previously responded to BRII-179 achieved HBsAg seroclearance, 
             compared to 10% (1/10) of non-responders. Among responders, 91% 
             (10/11) developed anti-HBs titers >=100 IU/L. 
 
          -- BRII-179-experienced participants achieved faster HBsAg loss, with 
             83% (10/12) achieving loss by Week 24, versus 55% (6/11) in 
             BRII-179 naïve participants. 

The ENSURE study results demonstrate that prior treatment with BRII-179 and elebsiran can induce robust anti-HBs responses and enrich for patients more likely to achieve HBsAg loss. These data also suggest that most HBsAg loss may be achievable with a shorter PEG-IFN<ALPHA> treatment duration (24 weeks).

The 24-week follow-up data of Cohort 4 of ENSURE study are expected in 2H 2025 and will be presented at a scientific conference.

   -- To further define BRII-179's role in HBV treatment and identify the 
      optimal combination regimen for advancement into a registrational study, 
      the Company is assessing BRII-179 in two additional Phase 2b trials: 
 
          -- ENRICH Study: Evaluates the role of BRII-179 in priming 
             HBV-specific immunity and/or identifying immuno-responsive 
             patients with a higher likelihood of achieving functional cure. We 
             continue to believe that BRII-179 may play a unique role as part 
             of the curative regimens. 
 
          -- ENHANCE Study:Evaluates a triple combination treatment regimen of 
             BRII-179 and elebsiran plus PEG-IFN<ALPHA> to enhance the 
             functional cure rate.Based on insight from ENSURE Cohort 4, we 
             amended the protocol to evaluate a simplified triple combination 
             regimen aimed at shortening PEG-IFN<ALPHA> treatment duration to 
             24 weeks.All studies have been fully enrolled. EOT data from 
             ENRICH and ENHANCE are expected to be presented at a scientific 
             conference in the first half of 2026. 
 
   -- The Company has engaged with CDE of NMPA on potential Phase 3 study 
      design and primary endpoints. The results from the ongoing ENRICH and 
      ENHANCE studies will inform which final combination regimen will be taken 
      forward to potential registrational studies. 

Additional Clinical Programs

Brii Bio is actively seeking external partnerships to advance the development and commercialization of its therapeutic candidates for HIV and multidrug-resistant/extensively drug-resistant (MDR/XDR) infections.

   -- In July 2025, the Company announced the strategic out-licensing agreement 
      with Joincare Group for the research, development, and commercialization 
      of soralimixin (BRII-693) in Greater China region. This collaboration 
      will leverage Joincare Group's strong capabilities in anti-infective 
      therapeutics to accelerate the development and maximize the commercial 
      potential of soralimixin (BRII-693). The Company will continue to seek 
      non-dilutive funding or partnership opportunities for rights outside of 
      Greater China. 

Outlook

Looking ahead, Brii Bio remains committed to delivering innovative therapies for infectious diseases, with a continued focus on achieving a functional cure for HBV.

With key data readouts from its HBV functional cure program expected in the first half of 2026, the Company is well-positioned to make informed decisions that will shape the next phase of its HBV functional cure clinical strategy.

Following the appointment of its new CSO last year, Brii Bio has further expanded its internal discovery team and capabilities, complementing the continued advancement of its core HBV program. Brii Bio will continue to scale up its early discovery efforts to strengthen its innovation engine and reinforce its position at the forefront of biotech breakthroughs.

Interim 2025 Financial Results

   -- The Company maintains a strong cash position to support its operations 
      through 2028. Our bank deposits and cash and cash equivalents were 
      RMB2,075.3 million as of June 30, 2025, representing a decrease of 
      RMB338.1 million or 14.0% compared with RMB2,413.4 million as of December 
      31, 2024. The decrease was primarily due to payout of research and 
      development activities and daily operations. 
 
   -- Through pipeline prioritization, resource optimization, internalization 
      of certain clinical development activities, and cost-saving measures of 
      third-party contractors, we have effectively controlled our operational 
      expenses. Research and development expenses were RMB117.0 million for the 
      six months ended June 30, 2025, representing a decrease of RMB9.2 million 
      or 7.3%, compared with RMB126.2 million for the six months ended June 30, 
      2024. The decrease reflected disciplined pipeline prioritization and 
      organizational streamlining, while maintaining continued investment in 
      core programs during the first half of 2025. 
 
   -- Administrative expenses were RMB58.2million for the six months ended June 
      30, 2025, representing a decrease of RMB20.4 million or 26.0%, compared 
      with RMB78.6 million for the six months ended June 30, 2024. The decrease 
      was primarily attributable to the decrease in employee cost of RMB9.5 
      million and the decrease in facility-related costs and professional 
      service fees of RMB8.4 million, which was primarily attributable to 
      organizational optimization and effective cost control. 
 
   -- Other income was RMB28.1 million for the six months ended June 30, 2025, 
      representing a decrease of RMB42.8 million or 60.4%, compared with 
      RMB70.9 million for the six months ended June 30, 2024. This was mainly 
      due to the decrease in bank interest income of RMB21.6 million 
      attributable to the declining interest rates on CNY and HKD time deposits, 
      reallocation of short-term deposits to money market fund investments, and 
      the decrease in income recognized from PRC government grants. 

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