Brii Biosciences Announces Annual 2023 Financial Results and Company Update

The hepatitis B cure program will advance to multiple late-stage clinical studies, and the interim results achieved in 2024 and 2025 will inform the company's registration strategy

Integrate R&D, manufacturing and commercial strengths through the acquisition of BRII-179's global intellectual property and expansion of manufacturing footprint

Optimize the company's resources, and the sufficient cash of US$376 million will support the company's operations through 2027

The company will hold a conference call on March 25 at 8:30 a.m. (Hong Kong time) / March 24 at 8:30 p.m. (EST) (in Chinese)

BEIJING, China and DURHAM, NC CAROLINA, March 22, 2024 /PRNewswire/ -- Brii Biosciences Limited ("Brii Biosciences" or the "Company", stock code: 2137. HK), a global company dedicated to developing innovative therapies for unmet patient needs and major public health diseases, today announced its latest progress and annual results for the year ended December 31, 2023.

In 2023, the Company achieved a significant milestone in its focused hepatitis B virus (HBV) program, advancing the development of novel combination therapies for functional cure of HBV while expanding its product portfolio. With formative data from multiple ongoing clinical trials of HBV drug candidates, as well as global intellectual property and manufacturing technology for BRII-179, the Company will initiate multiple combination therapy studies in 2024.

Dr. Zhi Hong, Chairman and Chief Executive Officer of Brii Biosciences, commented, "2023 was a pivotal year for Brii Biosciences, as we gained important insights from multiple Phase 2 studies. Through active clinical studies over the past 5 years, we have gained insight into what is needed to minimize and maintain hepatitis B surface antigen (HBsAg) clearance. Based on BRII-179, we developed strategies to assess and enhance intrinsic immunity in patients with hepatitis B, targeting patients who are most likely to respond while avoiding unnecessary treatment in other patients. These important breakthroughs inform our late-stage clinical combination studies. "

• In February 2024, Brii Bio entered into an agreement with VBI Vaccines, Inc. ("VBI", Nasdaq: VBIV) to acquire BRII-179's global intellectual property and manufacturing technology to expand its future global manufacturing and supply capabilities. Future payments to the VBI related to BRII-179 and PreHevbriTM were also eliminated.
• BRII-179 received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China in November 2023 to accelerate the delivery of innovative therapies to patients with HBV.
• Brii Bio acquired exclusive development and commercialization rights to PreHevbriTM in Greater China and Asia Pacific (excluding Japan) in July 2023 and has submitted two pre-clinical applications (pre-INDs) to CDE for the registration of PreHevbriTM in China. A listing registration application in Hong Kong has also been submitted.
• Brii Bio has optimized its resources to focus on clinical and commercial development of its leading HBV portfolio. The Company is actively pursuing collaboration opportunities to further develop its pipeline with global interests in the areas of its central nervous system (CNS), human immunodeficiency virus (HIV) and multi- and extensively drug-resistant (MDR/XDR) segments.
• Brii Biosciences has appointed Brian A. Johns, Ph.D., as Chief Scientific Officer, responsible for Brii Bio's early discovery programs and developing the company's pipeline strategy for the future. Our new organizational strategy is led by leaders with extensive experience in infectious diseases to ensure that the company's pipeline goals are met.

Key data obtained in 2023 demonstrate that our proprietary therapeutic vaccine, BRII-179, elicits a potent and specific immune response in patients with chronic hepatitis B, which is strongly associated with improved clinical efficacy. Brii Bio and its strategic partners will conduct a series of confirmatory joint studies in 2024 to establish future hepatitis B treatment options centered on BRII-179. To further our commitment to BRII-179, Brii Bio entered into a transaction with VBI for global intellectual property and manufacturing rights. We are working closely with our partners to initiate late-stage clinical studies to clarify the contribution of BRII-179 and BRII-835 (elebsiran) to improving functional cure rates for HBV. In addition, BRII-179 has the potential to identify patients with chronic hepatitis B who can produce a good antibody response and have a higher chance of functional cure.

Key data and development plans

• BRII-179 related research and programs
  • At the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in November 2023, Brii Bio presented two groundbreaking poster presentations on BRII-179 that revealed an important link between HBsAg clearance and hepatitis B surface antibody response. These data point to further functional cure rates and the identification of patients most likely to respond to curative therapies.
    • BRII-179 can induce a functional immune response and improve HBsAg clearance and duration of HBsAg clearance in patients with chronic hepatitis B treated with combination peginterferon α (PEG-IFNα), which may improve the functional cure rate of patients with chronic hepatitis B.
    • Data from a translational study of Brii Bio's Phase 1b/2a study of BRII-179 and BRII-179 in combination with BRII-835 (elebsiran) suggest that BRII-179 may be useful in identifying patients with chronic hepatitis B who are able to generate the necessary HBV-specific immune response, thereby achieving higher functional cure rates in these screened patients while avoiding unnecessary treatment for other patients.
  • Brii Bio plans to initiate multiple pooled studies in the second half of 2024 to validate the ability of BRII-179 to improve functional cure rates for HBV when combined with other therapies.
  • Brii Bio will present data from patients meeting the criteria for discontinuation of a nucleotide reverse transcriptase inhibitor (NRTI) in its ongoing Phase 2 study of BRII-179 in combination with PEG-IFNα in patients with chronic hepatitis B at the 33rd Asia-Pacific Association for the Study of the Liver (APASL) at the 33rd Asia-Pacific Association for Liver Research (APASL) in Kyoto, Japan, March 27-31, 2024.
• BRII-835(E lebsiran ） & BRII-877(T obevibart ） Related research and plan
  • Patient enrollment has been completed in the Phase 2 study of BRII-835 (elebsiran) in combination with PEG-IFNα in the Asia-Pacific region, including Chinese mainland. The study aims to further understand the efficacy of BRII-835 (elebsiran) compared to PEG-IFNα alone in improving the cure rate of HBV and to explore the potential of BRII-179 in screening suitable patients for better efficacy. Initial topline results from the study are expected in the fourth quarter of 2024.
  • Brii Biosciences' partner, Vir Biotechnology, Inc. ("Vir") (Nasdaq: VIR), presented new data from Part B of the MARCH study at the November 2023 AASLD meeting. The data showed that after 24 weeks of treatment with BRII-877 (tobevibart) in the BRII-835 (elebsiran) regimen with or without PEG-IFNα, the response rate increased approximately threefold: 15.0% for BRII-877 (tobevibart) + BRII-835 (elebsiran) + PEG-IFNα and BRII-877 (tobevibart)+ BRII-835 (elebsiran) has a response rate of 14.3%. Cohort data for 48 weeks of treatment will be published in the fourth quarter of 2024.
  • Vir shared preliminary data from a small group of participants with chronic hepatitis D (CHD) in the SOLSTICE study in a breakthrough report at the AASLD meeting in November 2023 and at the 42nd annual J.P. Morgan healthcare conference in January 2024. After 12 weeks of combination treatment with BRII-877 (tobevibart) and BRII-835 (elebsiran), hepatitis D virus ribonucleic acid (HDV RNA) was undetectable in 5 of 6 participants, and HDV RNA was below the lower limit of quantification in 6 of 6 participants. Additional data will be released in the second quarter of 2024, with full 24-week treatment data expected in the fourth quarter of 2024.
  • A Phase 1 study of BRII-877 (tobevibart) is underway in China. Human pharmacokinetic (PK) data for subjects in Chinese mainland will be compared with subjects in Asia Pacific and Europe.

Based on the company's focused HBV project strategy, Brii Bio is seeking opportunities for the subsequent development of the following projects.

Multidrug-resistant and extensively drug-resistant (MDR/XDR) gram-negative infections program

• BRII-693
  • Brii Bio acquired exclusive worldwide rights to develop and commercialize BRII-693, a novel polymyxin for the treatment of severe gram-negative infections, in June 2023. The company is seeking strategic funding partners to accelerate the development of BRII-693, a novel antibiotic designed to help address the growing global threat of antimicrobial resistance.
  • In April 2023, Brii Biosciences submitted a pre-IND application for BRII-693 to the NMPA, with plans to initiate a Phase 1 clinical PK bridging study in China. The Company is planning to conduct additional PK clinical studies to support the initiation of Phase 3 clinical trials. These studies are critical to supporting global development efforts. A large, global Phase 3 registrational clinical trial for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) is expected to begin in 2025.

Human Immunodeficiency Virus (HIV) Project

• BRII-753 It is a new chemical entity developed in-house and is currently in preclinical development. BRII-753 is a long-acting subcutaneous injection that can be administered monthly, quarterly, or twice annually for combination therapy and pre-exposure prophylaxis monotherapy for HIV.
• BRII-732 A Phase 1 study has been completed and has the potential to be developed as part of a once-weekly oral long-acting combination regimen for HIV patients.

Nontuberculous mycobacteria ( NTM) Pulmonary Disease Program

• BRII-658(Epetraborole): In February 2024, Brii Bio's partner, AN2 Therapeutics, Inc. (NASDAQ: ANTX), announced that it has voluntarily suspended patient enrollment in its Phase 2/3 clinical trial of epetraborole (BRII-658) for the treatment of refractory complex mycobacterial (MAC) lung disease, pending further data review.

Postpartum Depression (PPD) and Major Depressive Disorder (MDD) programs

• BRII-296： In September 2023, the first patient was dosed in the Phase 2 study evaluating BRII-296. BRII-296 is a long-acting injectable that is being developed for the treatment of PPD. The Company expects to report Phase 2 trial data in the second quarter of 2024.
• BRII-297 It is a long-acting injectable that is being developed for the treatment of anxiety and depression, and the phase 1 clinical trial of the drug has been dosed to patients. The study is designed to evaluate the safety, tolerability and pharmacokinetics of BRII-297 in healthy volunteers, with data expected in the second half of 2024.

• Bank deposits and cash and cash equivalents were RMB2,661.4 million as of December 31, 2023, a decrease of RMB337.9 million or 11.3% compared to RMB2,999.3 million as of December 31, 2022. The decrease was mainly attributable to expenditure on day-to-day operations and R&D activities.
• For the year ended December 31, 2023, other income was RMB163.7 million, an increase of RMB55.8 million or 51.7% compared to RMB107.9 million for the year ended December 31, 2022. This was mainly attributable to an increase in bank interest income of RMB70.8 million due to higher interest rates on US dollar and Hong Kong dollar time deposits. This increase was partially offset by a decrease in the recognition of Chinese government subsidy revenues.
• For the year ended December 31, 2023, R&D expenditure was RMB402.7 million, a decrease of RMB37.9 million or 8.6% compared to RMB440.6 million for the year ended December 31, 2022. The decrease was primarily due to the termination of the COVID-19 program.
• For the year ended December 31, 2023, administrative expenses amounted to RMB196.5 million, an increase of RMB27.9 million or 16.5% compared to RMB168.6 million for the year ended December 31, 2022. The increase was mainly attributable to higher employee costs.
• For the year ended December 31, 2023, the total comprehensive expenses amounted to RMB159.7 million, a decrease of RMB78.8 million or 33.0% compared to RMB238.5 million for the year ended December 31, 2022. The decrease was mainly attributable to an increase in other gains and losses, partially offset by a decrease in gains arising from exchange differences in functional currencies to presentation currencies.

The Company will host a conference call (in Chinese) on March 25, 2024, at 8:30 a.m. Hong Kong time (8:30 p.m. EST, March 24). Participants must register for the conference call prior to attending the conference call. The registration link can be found here.

All participants must complete online registration via the link above prior to the conference call. In addition, a replay of this conference call will be available after the meeting and will be available by visiting the Investor Relations section of the Company's website.

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This press release involves references to third-party information. Such information should not be incorporated into this press release as a reference. Brii Bio is not responsible for such third-party information.

About Brii Biosciences:

Brii Biosciences (stock code: 2137.HK) HK) is a biotechnology company focused on developing innovative therapies to address significant public health challenges with significant unmet patient needs, limited treatment options, and severe social stigma against patients. With a focus on infectious diseases and central nervous system diseases, the Company is advancing a pipeline of unique drug candidates and developing novel functional cures for hepatitis B virus (HBV) infection through leading programs, as well as first-in-class treatments for postpartum depression (PPD) and major depressive disorder (MDD). Led by a visionary and experienced leadership team, the company operates in key biotechnology hubs in Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, please visit:

The information conveyed in this press release contains certain statements that are, or may be, forward-looking. These statements often contain words such as "will," "expects," "believes," "plans," and "anticipates" and words of similar meaning. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on what will happen in the future. There may be other significant risks that are not currently considered material or of which the Company is not aware. These forward-looking statements are not guarantees of future performance. Against the backdrop of these uncertainties, readers should not rely on these forward-looking statements. Forward-looking statements are subject to change or are modified accordingly in light of future events or developments, and the Company assumes no obligation with respect thereto.

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