Friulimicin B

First patient dosed in a PEG-IFN-α controlled BRII-835 + PEG-IFN-α combination Phase 2 study for HBV functional cureFirst of several studies to investigate the potential of BRII-179 in enriching patients with strong intrinsic anti-HBsAg responses for curative treatments to start before the end of 2023Regulatory submissions and preparation for launches of PreHevbri® in APAC countries and regions are underwayNear-term revenue opportunities with PreHevbri® and strong balance sheet supporting operations through 2026Company to host earnings call on August 22 at 8:00 PM ET / August 23 at 8:00 AM HKT and an HBV R&D Day on August 24 from 1:00-2:30 PM HKT DURHAM, N.C. and BEIJING, Aug. 22, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," "we," or the "Company," stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today announced a corporate update and reported its interim results for the first six months ended June 30, 2023. Infectious Disease Therapeutic Area Continue Reading Recently, Brii Bio executed two strategic transactions with VBI Vaccines Inc. (Nasdaq: VBIV), gaining exclusive global rights to BRII-179 and introducing PreHevbri®, a clinically differentiated prophylactic hepatitis B vaccine, to APAC countries and regions. The addition of PreHevbri® complements Brii Bio's existing functional cure portfolio, further advancing solutions to reduce the transmission of HBV across Greater China and the other Asia Pacific countries and regions. The Company is actively working towards the preparation for launches of PreHevbri® in APAC markets, prioritizing countries and regions where additional trials may not be required. A Market Authorization Application has been filed in Hong Kong, and the Company expects a regulatory decision in the near future. In June, Brii Bio's strategic partner, Vir Biotechnology, Inc. (Nasdaq: VIR), shared data from Part A of its Phase 2 MARCH trial of VIR-2218 (BRII-835) and VIR-3434 (BRII-877) at the 2023 European Association for the Study of the Liver (EASL) Congress, demonstrating significant declines in HBsAg levels and 90% achievement of HBsAg level below 10 IU/mL in chronic HBV participants, suggesting promising potential of VIR-3434 (BRII-877) in chronic HBV treatment. On the heels of these data, Brii Bio obtained Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China for a Phase 1 study of BRII-877 (VIR-3434) in August 2023. Additionally, compelling data highlights the potential of BRII-835 (VIR-2218)/PEG-IFN-α combination as a best-in-class functional curative treatment for chronic HBV infections. Findings show that robust anti-HBs antibody responses at the end of treatment were associated with sustained HBsAg loss 24 weeks post-treatment, pointing to the important role of patients' humoral immunity in achieving sustained immune control of HBV infections. Building upon this critical insight, Brii Bio has initiated a randomized and active-controlled BRII-835 + PEG-IFN-α Phase 2 study, following regulatory approvals from multiple regulatory authorities in APAC including the NMPA in mainland China. The primary objective of the study is to compare the functional cure rate of BRII-835/PEG-IFN-α combination versus PEG-IFN-α alone. Furthermore, the Company intends to include patients in the study who were previously exposed to BRII-179 and who had documented anti-HBsAg responses. The Company believes that BRII-179 has the unique ability to distinguish patients who have significant intrinsic humoral immunity versus those who do not. Planning of additional studies are also underway to investigate the role of BRII-179 as a primer to elicit stronger antibody responses and in enriching patients for curative treatments such as BRII-835/PEG-IFN-α as well as other combinations in broad HBV patient populations. In a separate transaction with Qpex, Brii Bio acquired exclusive global rights to BRII-693 (also previously known as QPX9003), a potentially best-in-class synthetic lipopeptide IV antibiotic for combating difficult-to-treat multi-drug- and extremely-drug-resistant (MDR/XDR) gram-negative bacterial infections (especially carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa), reinforcing the Company's commitment to addressing antibiotic resistance challenges while strengthening financial support. Central Nervous System Disease Therapeutic Area Following an agreement with U.S. Food and Drug Administration, the Company will start a Phase 2 study of BRII-296 in postpartum depression (PPD) investigating the first-of-its-kind, long-acting, single treatment option in the third quarter of 2023. BRII-296 represents a paradigm shift in patient care with the potential to provide rapid and sustained relief of depressive symptoms for new mothers. It is estimated that approximately 500,000 mothers suffer from PPD in the U.S. alone, and globally, close to 20 million women are affected by PPD. Additionally, the Company continues to advance a second long-acting injectable, BRII-297, in a first-in-human Phase 1 study, expanding the potentially groundbreaking treatment paradigm for various anxiety and depressive disorders or indications. 1H 2023 Financial Results Other Income was RMB85.9 million for 1H 2023, representing an increase of RMB47.7 million, or 124.9%, compared with RMB38.2 million for 1H 2022. The increase was mainly due to the increased bank interest income of RMB36.1 million attributable to the additional placement of time deposits with original maturity over three months and the increased income recognized from PRC government grants of RMB11.6 million. Research and development expenses were RMB202.2 million for 1H 2023, representing a decrease of RMB56.3 million, or 21.8%, compared with RMB258.5 million for 1H 2022. The decrease was primarily due to the reduced third-party contracting fees from COVID-19 programs after the Company decided to terminate these programs. Administrative expenses were RMB102.8 million for 1H 2023, representing an increase of RMB7.3 million, or 7.6%, compared with RMB95.5 million for 1H 2022. The increase was primarily attributable to the increase in employee headcounts and computer software fees. Total comprehensive expense for 1H 2023 was RMB104.0 million, representing a decrease of RMB113.7 million, or 52.2%, compared with RMB217.7 million for 1H 2022. The decrease was primarily due to the increase in other income and decrease in the research and development expenses. Conference Call Information A live conference call will be hosted on August 23, 2023, at 8:00 AM Hong Kong time (August 22, 2023, at 8:00 PM U.S. Eastern Time). To participate, please make sure to register in advance. For the registration link, please click here. About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a commercial stage 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 and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B viral infection (HBV), postpartum depression (PPD), and major depressive disorder (MDD). 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 . 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 are 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. SOURCE Brii Biosciences Limited

Company acquires exclusive global rights of the novel lipopeptide BRII-693 for the difficult to treat MDR/XDR gram-negative bacterial infections Company returns Greater China rights to Qpex Biopharma of beta-lactamase inhibitor QPX7728-based products Company to receive ~$24M upfront cash payments DURHAM, N.C. and BEIJING, June 25, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, today announced that it entered into definitive agreements with Qpex Biopharma ("Qpex") and third parties in connection with the acquisition of Qpex by Shionogi. Under the terms of the agreement, Brii Bio will acquire exclusive global rights for the development and commercialization of BRII-693 (also known as QPX9003) to expand from its existing rights in Greater China. All existing cost-share, milestone and royalty payments associated with BRII-693 to Qpex are eliminated. The Company will return its exclusive rights to QPX7728-based products BRII-636 and BRII-672 in Greater China to Qpex and Brii will no longer be responsible for cost-share, milestone and royalty payments to Qpex associated with these products. In association with the return of QPX7728-based program rights to Qpex, Qpex will complete a merger through acquisition by Shionogi. Brii Bio will receive approximately $24 million upon closing of the acquisition as a Qpex shareholder and the return of the QPX7728 product rights, with potential contingency payments for future milestone events in the US. BRII-693 is a novel synthetic lipopeptide in development for the treatment of critically ill patients with MDR/XDR gram-negative bacterial infections, especially carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa. In October 2019, Brii Bio entered into a licensing agreement with Qpex to develop and commercialize BRII-693 and the QPX7728-based products in Greater China. "With the demonstrated antibacterial mechanism and improved safety profile, BRII-693 has the potential to be the safest and most effective polymyxin for the treatment of critically ill patients with gram-negative bacterial infections," said Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio, "Given the microbiological and clinical profile of BRII-693, we are very excited about this opportunity to prioritize and focus on the global development of this agent." In April 2023, Brii Bio submitted a pre-IND to the National Medical Products Administration (NMPA) for the development of BRII-693 (QPX9003) in China. About BRII-693 BRII-693 is a novel lipopeptide antimicrobial that was discovered under the directions of Professor Jian Li of the Biomedicine Drug Discovery Institute of Monash University in Australia. BRII-693's discovery was supported in part by funds from the U.S. National Institutes of Allergy and Infectious Diseases (NIAID; RO1 AI098771 and AI132154). The discovery of BRII-693 and preclinical studies were described in 2022 in the journal Nature Communications and show improved potency and less toxicity compared to older polymyxin antimicrobial agents. BRII-693 has the potential to be an important advance in the treatment of gram-negative infections, including MDR/XDR strains, with improved renal safety compared to currently available polymyxin antibiotics. In 2021, the US FDA designated QPX-9003 (BRII-693) to be a Qualified Infectious Disease Product (QIDP). The QIDP designation provides incentives for the development of BRII-693 in the US, including priority review and eligibility for FDA's Fast Track Designation; there is also the potential for extension of regulatory and market exclusivity in the US. In October 2022, the interim Phase 1 results from a completed first-in-human clinical study conducted in the US presented at ID Week in Washington DC demonstrated that BRII-693 is safe and well-tolerated at all doses tested. An end of Phase 1 meeting was convened with the US FDA in December 2022 and these results along with approaches for a future Phase 3 program were discussed with the agency. About Brii Bio Brii Biosciences ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address some of the world's most common diseases where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs to develop a novel functional cure for hepatitis B viral infection (HBV) and a first-of-its-kind treatment for postpartum depression (PPD). 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 . SOURCE Brii Biosciences Limited