Strategic Acquisition of Intellectual Property of BRII-179, a Wholly Owned Phase 2b Asset Capable of Combining with Multiple HBV Treatment Modalities for Cure
Data from Multiple Ongoing Late-Stage Studies Reinforce Brii Bio's HBV Functional Cure Strategy of Optimized Combination Regimens to Target Patient Populations
4 Abstracts Including 2 Oral Presentations with Data from the Ongoing Phase 2 ENSURE Study at the Upcoming APASL (March 26-30)
Strong Cash Reserves of US$335.7 Million to Propel Operations into 2028
Actively Seeking Partnership Opportunities for Non-HBV Programs
Conference Call (English Session) Scheduled for March 31 at 8:30 PM HKT / 8:30 AM ET
DURHAM, N.C. and BEIJING, China, March 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 needs provided a corporate update today and reported its financial results for the year ended December 31, 2024.
(PRNewsfoto/Brii Biosciences Limited)
In 2024, Brii Bio advanced its core hepatitis B virus (HBV) functional cure program, gaining valuable data from ongoing Phase 2 trials that support its goal of achieving higher functional cure rates for patients through combined immunomodulation and surface antigen reduction approaches. These data support BRII-179 (a recombinant protein-based HBV immunotherapeutic) as a key differentiator through identifying patients who are potentially more susceptible to curative therapies. Two Phase 2b studies, ENRICH and ENHANCE, are fully enrolled to confirm these important findings. End-of-treatment (EOT) data from its ENSURE study suggests a direct role of elebsiran (an HBV-targeting siRNA) in achieving a higher HBV functional cure rate. Elebsiran is currently being evaluated in multiple ongoing trials with Brii Bio's other assets, including ongoing trials of tobevibart (a broadly neutralizing monoclonal antibody targeting HBV) run by Vir Biotechnology, Inc. ("Vir Biotechnology," Nasdaq: VIR). Upcoming 2025 data readouts from these studies will guide Brii Bio's late-stage development and registration strategy. Brii Bio remains well-funded with a cash position of US$335.7 million, sufficient to support the Company through late-stage development plans for HBV functional cure.
"The critical milestones we achieved in 2024 have strengthened our HBV portfolio of multiple mechanisms of action at both the clinical and strategic level," stated Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "Data from multiple ongoing combination studies with our highly differentiated HBV assets continue to show that our multi-modal approach has the potential to produce higher functional cure rates across broader HBV patient groups. With the strategic acquisition of BRII-179 and data from three ongoing Phase 2b studies throughout this year and next, we are creating multiple curative treatment options for patients with chronic HBV infection."
Clinical Development Update
Brii Bio is actively advancing its innovative product pipeline, with a primary focus on the late-stage clinical development of its flagship HBV program.
HBV Program
The Company is progressing multiple ongoing combination studies with its differentiated HBV candidates, including elebsiran, an HBV-targeting siRNA; BRII-179, a recombinant protein-based HBV immunotherapeutic. The Company's partner, Vir Biotechnology, is also progressing multiple combination studies with elebsiran and tobevibart, a broadly neutralizing monoclonal antibody targeting HBV surface antigen.
By addressing HBV from these three distinct therapeutic perspectives in varying combinations with each other, Brii Bio aims to determine the best curative regimens to address different population subsets and the most efficient regulatory path to approval. Upcoming pivotal data sets from the Company's ongoing ENRICH (BRII-179 in priming HBV-specific immunity and enriching patients with competent immunity) and ENSURE (elebsiran in combination with PEG-IFNα versus PEG-IFNα alone) studies are expected throughout 2025-2026 and will further inform late-stage studies as Brii Bio advances toward determining HBV functional cure.
Brii Bio completed enrollment in its ENHANCE study in January 2025. The ENHANCE study is a Phase 2b, randomized, double-blind study evaluating the clinical efficacy and safety of the combination therapy of BRII-179, elebsiran, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.
Brii Bio presented 48-week EOT data from its Phase 2 ENSURE study at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in a late-breaking oral presentation in November 2024. Data showed patients treated with elebsiran in combination with PEG-IFNα achieved a higher rate of HBV surface antigen loss (HBsAg) than patients treated with PEG-IFNα alone. The ENSURE study data marks the industry's first evidence delineating the contribution of siRNA (elebsiran) toward functional cure on top of PEG-IFNα therapy through head-to-head comparison with PEG-IFNα alone, highlighting elebsiran's potential to make a substantial impact on producing higher HBV functional cure rates. Brii Bio plans to present additional key data readouts in the first half of 2025.
The ENSURE study is also investigating patients with prior experience of receiving BRII-179. Based on early data from Cohort 4 of the ENSURE study (data to be released at APASL 2025), the ENRICH study was fully enrolled in November 2024, evaluating the role of BRII-179 in priming HBV-specific immunity as part of a curative regimen and as a tool to identify immuno-responsive patients with a higher probability of achieving functional cure.
Brii Bio's development partner, Vir Biotechnology, presented data from its Phase 2 MARCH and SOLSTICE studies at AASLD's The Liver Meeting in November 2024.
Vir Biotechnology recently commenced a Phase 3 registrational clinical program (ECLIPSE) to evaluate the tobevibart and elebsiran combination in people living with chronic hepatitis delta (CHD).
Vir Biotechnology was granted Fast Track designation for tobevibart and elebsiran for the treatment of CHD in June 2024 by the U.S. Food and Drug Administration (FDA), followed by Orphan designation by the European Medicines Agency (EMA) in November 2024, and FDA Breakthrough Therapy Designation and EMA Prime Designation in December 2024.
The CDE granted Breakthrough Therapy Designations (BTD) for tobevibart and elebsiran in May 2024.
Additional Clinical Programs
Brii Bio is actively seeking external partnerships for its therapeutic candidates for HIV, MDR/XDR and central nervous system diseases.
In October 2024, Brii Bio received IND approval from CDE of NMPA for a Phase 1 PK bridging study in China with BRII-693, a novel polymyxin for the treatment of serious gram-negative infections. Previous phase 1 data has been published on Antimicrobial Agents and Chemotherapy in December 2024, supporting future global Phase 3 registrational trial in patients with hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Brii Bio holds exclusive global rights to develop and commercialize BRII-693.
Full Year 2024 Corporate Highlights and Recent Update
In December 2024, Brii Bio announced the approval of a HK$60 million share-buyback program, or 10% of its total outstanding shares, underscoring the Company's confidence in its prospects. As of March 21, 2025, the Company had repurchased approximately 4,433,000 shares on the Hong Kong Stock Exchange for a consideration of approximately HK$5.3 million.
In December 2024, Brii Bio signed an asset purchase agreement with VBI Vaccines, Inc. ("VBI") and its associated subsidiaries to acquire full intellectual property rights and other assets relating to BRII-179 for a total consideration of $18 million. The agreement eliminates future payments to VBI related to BRII-179 and PreHevbriTM and dissolves the prior agreement announced on February 14, 2024. The purchase brings Brii Bio additional commercial upside while ensuring the uninterrupted clinical supply of BRII-179 as the Company continues to develop this asset with ongoing studies that support BRII-179's potential to increase HBV patients' response to curative treatments.
Full Year 2024 Financial Results
Our bank deposits and cash and cash equivalents were RMB2,413.4 million as of December 31, 2024, representing a decrease of 248 million or 9.3% compared with RMB2,661.4 million as of December 31, 2023. The decrease was primarily due to payout of daily operations and research and development activities.
Other income was RMB141.4 million for the year ended December 31, 2024, representing a decrease of RMB22.3 million or 13.6%, compared with RMB163.7 million for the year ended December 31, 2023. This was mainly due to the decrease in bank interest income of RMB20.8 million attributable to the declining interest rates on USD and HKD time deposits and the decrease in income recognized from PRC government grants.
Research and development expenses were RMB249.8 million for the year ended December 31, 2024, representing a decrease of RMB152.9 million or 38.0%, compared with RMB402.7 million for the year ended December 31, 2023. The decrease was primarily attributable to the decrease in third-party contracting cost of RMB79.3 million and the decrease in employee cost of RMB67.7 million, which were primarily due to pipeline prioritization and organizational optimization during the year.
Administrative expenses were RMB153.2 million for the year ended December 31, 2024, representing a decrease of RMB43.3 million or 22.0%, compared with RMB196.5 million for the year ended December 31, 2023. The decrease was primarily attributable to the decrease in employee cost of RMB39.7 million, which was primarily attributable to pipeline prioritization and organizational optimization during the year.
Loss for the year was RMB512.4 million for the year ended December 31, 2024, representing an increase of RMB328.0 million or 177.9%, compared with RMB184.4 million for the year ended December 31, 2023. The increase in loss was primarily attributable to investment-related losses of RMB126.1 million and impairment losses of RMB90.3 million, partially offset by the decrease in research and development expenses and administrative expenses. In contrast to the prior year, which benefited from a significant gain on the one-time sale of assets of RMB131.8 million and the increase in the share price of an equity investment of RMB129.2 million, the current year was impacted by a decline in the fair value of the same equity investment.
Conference Call Information
A live conference call (English session) will be hosted on March 31, 2025 at 08:30 AM U.S. Eastern Time (8:30 PM Hong Kong Time) when the management team will provide an annual update including data to be presented at the APASL conference on March 26-30. All participants are required to register in advance of the call. For the registration link, please click here.
All participants shall use the link provided above to complete the online registration process prior to the conference call. Upon registering, each participant will receive an email with important details for this call, including the call date, time and access link. This link is to be kept confidential and not shared with other participants. Additionally, a replay of the conference call will be available after the call and can be accessed by visiting the Company's website at www.briibio.com under the Investor Relations section.
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This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release. Brii Bio disclaims responsibility for such third-party information.
About Brii Bio
Brii Biosciences Limited ("Brii Bio," stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit www.briibio.com.
Forward-Looking Statement
The information communicated in this press release contains certain statements that are or may be forward-looking. These statements typically contain words such as "will," "expects," "believes," "plans" and "anticipates," and words of similar import. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company is unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
