Multidrug- and Extensively Drug-Resistant (MDR/XDR) Gram-Negative Bacteria Infections Program
-- BRII-693
-- Brii Bio gained exclusive global rights in June 2023 to develop
and commercialize BRII-693, a novel polymyxin for the treatment of
serious gram-negative infections. The Company is seeking strategic
funding partners to expedite development of BRII-693, a novel
antibiotic intended to help tackle the growing worldwide threat of
antimicrobial resistance.
-- In April 2023, Brii Bio submitted a pre-IND to the NMPA of China
for the development of BRII-693, with plans to initiate one Phase
1 PK bridging study in China. Additional clinical PK studies to
enable the initiation of a Phase 3 trial are in planning. These
studies are crucial to support global development efforts. A large,
global Phase 3 registrational trial in hospital-acquired bacterial
pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP),
is expected to begin in 2025.
Human Immunodeficiency Virus (HIV) Infection Program
-- BRII-753 is an internally discovered new chemical entity currently in the
preclinical stage of development. BRII-753 is being developed as a
long-acting subcutaneous injection with the potential for dosing once
monthly, once quarterly, or twice yearly and can be used in combination
therapy for HIV treatment and as monotherapy for pre-exposure prophylaxis
(PrEP).
-- BRII-732 has completed Phase 1 studies with the potential for development
as part of an oral, once-weekly, long-acting combination treatment option
for HIV patients.
Non-Tuberculous Mycobacterial $(NTM.AU)$ Lung Disease Program
-- BRII-658 (Epetraborole): In February 2024, Brii Bio's partner, AN2
Therapeutics, Inc. $(ANTX)$ announced a voluntary pause of its
Phase 3 enrollment in a Phase 2/3 clinical trial for epetraborole
(BRII-658) for the treatment-refractory Mycobacterium avium complex $(MAC)$
lung disease, pending further data review.
Postpartum Depression $(PPD)$ and Major Depressive Disorder (MDD)/Other CNS Disorders
-- BRII-296: In September 2023, the first patient was dosed in the Phase 2
study evaluating BRII-296, a long-acting injectable (LAI) therapy in
development for PPD. The Company expects data readouts from the Phase 2
trial by the second quarter of 2024.
-- BRII-297: Dosing has been completed in a Phase 1 clinical trial for
BRII-297, a long-acting injectable (LAI) being developed to treat anxiety
and depressive disorders. The study aims to evaluate the safety,
tolerability, and PK of BRII-297 in healthy volunteers with data expected
by the second half of 2024.
Full Year 2023 Financial Results
-- Our bank deposits and cash and cash equivalents were RMB2,661.4 million
as of December 31, 2023, representing a decrease of 337.9 million or
11.3%, compared with RMB2,999.3 million as of December 31, 2022. The
decrease was primarily due to payout of daily operations and research and
development activities.
-- Other income was RMB163.7 million for the year ended December 31, 2023,
representing an increase of RMB55.8 million or 51.7%, compared with
RMB107.9 million for the year ended December 31, 2022. This was mainly
due to the increased bank interest income of RMB70.8 million attributable
to the rising interest rates on USD and HKD time deposits. The increase
was partially offset by the decrease in income recognized from PRC
government grants.
-- Research and development expenses were RMB402.7 million for the year
ended December 31, 2023, representing a decrease of RMB37.9 million or
8.6%, compared with RMB440.6 million for the year ended December 31,
2022. The decrease was primarily due to the decrease in discontinuation
of COVID-19 program.
-- Administrative expenses were RMB196.5 million for the year ended December
31, 2023, representing an increase of RMB27.9 million or 16.5%, compared
with RMB168.6 million for the year ended December 31, 2022. The increase
was primarily attributable to the increase in employee cost.
-- Total comprehensive expense for the year ended December 31, 2023, was
RMB159.7 million, representing a decrease of RMB78.8 million or 33.0 %,
compared with RMB238.5 million for the year ended December 31, 2022. The
decrease was primarily attributable to the increase in other gain and
loss, which was partially offset by the decrease in gain arising from the
exchange difference on translation from functional currency to
presentation currency.
Conference Call Information
A live conference call (English session) will be hosted on March 25, 2024 at 8:30 AM U.S. Eastern Time (8:30 PM Hong Kong Time). 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 in advance of 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.
***
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 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 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 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.
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SOURCE Brii Biosciences Limited
/CONTACT: Media Inquiry: media@briibio.com; Investor Inquiry: ir@briibio.com
(END) Dow Jones Newswires
March 22, 2024 07:00 ET (11:00 GMT)
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