BRII BIOSCIENCS LTD U/ADR - BRIBY STOCK NEWS

Brii Biosciences Limited reported its fiscal year 2022 results, highlighting a revenue increase to RMB51.6 million due to the COVID-19 therapy commercialization in China. The company is focused on advancing its clinical programs for hepatitis B and depression, with Phase 2 trials set for 2023. Financially, R&D expenses decreased by 10.9% to RMB440.6 million, while total comprehensive expense fell by 94.4% to RMB238.5 million. Brii Bio discontinued its COVID-19 antibody program to prioritize its main clinical projects and remains well-funded through 2025.

Brii Biosciences announced significant clinical development updates, focusing on two lead programs for hepatitis B and postpartum depression. The company completed patient enrollment in Phase 2 trials for both areas, revealing promising preliminary results. Notably, the U.S. FDA lifted the clinical hold on BRII-732, allowing a restart of trials for a potential HIV treatment. While the company aims to address high unmet medical needs, it also plans to explore partnerships for its discontinued HIV candidate, BRII-778.

Brii Biosciences announced promising results from two Phase 1 studies evaluating BRII-732 and BRII-778 for HIV treatment. Both candidates showed safety and tolerability, suggesting potential for a once-weekly oral combination therapy. Data presented at IDWeek 2022 highlighted their favorable pharmacokinetic profiles, which may enhance adherence compared to daily regimens. Brii aims to advance these compounds through clinical development, addressing the needs of over 38 million people living with HIV globally.

Brii Biosciences announced the top-line results from its Phase 1 study of BRII-296, a long-acting, single-injection therapy for postpartum depression (PPD). The 600 mg dosage was shown to be safe and well-tolerated, with a favorable pharmacokinetic profile. These findings position BRII-296 as a potential one-time outpatient treatment for PPD, addressing the needs of the 900,000 individuals affected in the U.S. annually. The company plans to move forward with a Phase 2 clinical trial by the end of 2022, focusing on patient-centered development.

Brii Biosciences Limited has appointed Dr. Taiyin Yang to its Board of Directors as co-chair of the newly expanded Audit and Risk Committee, effective September 1, 2022. Dr. Yang, a seasoned expert from Gilead Sciences, brings extensive experience in product development and manufacturing. Separately, non-executive board member Dr. Axel Bouchon will depart on September 30, 2022, to pursue new opportunities but will continue as an advisor. With these changes, Brii now has a diverse board of eight directors, enhancing its governance and oversight capabilities.

Brii Biosciences Limited has strengthened its global leadership team in preparation for strategic growth. The company has launched its long-acting COVID-19 therapy in China, marking a significant transition to a commercial stage. Its pipeline includes over 10 innovative candidates targeting HBV, CNS, HIV, and MDR/XDR infections. Financially, the company reported a total comprehensive expense reduction of 92.5%, while R&D expenses surged by 64% to RMB258.5 million. With ample funds to support operations through 2025, Brii Bio is poised for significant advancements in its clinical programs.

Brii Biosciences has appointed Eleanor de Groot as Chief Technology Officer and Aleksandar Skuban as Central Nervous System (CNS) Diseases Therapy Area Head. Both leaders bring extensive experience in biotech and pharmaceutical development. Dr. de Groot has over 20 years of experience in global operations and clinical development, while Dr. Skuban has 25 years in R&D, focusing on CNS diseases. The leadership changes are aimed at strengthening Brii Bio's capabilities in addressing significant health challenges, particularly in CNS and mental health therapies.