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Brii Biosciences Provides Corporate Update and Reports Full-Year 2024 Financial Results

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.

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."

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.

Additional Clinical Programs

Brii Bio is actively seeking external partnerships for its therapeutic candidates for HIV, MDR/XDR and central nervous system diseases.

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.

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.

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.