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Company extends BRII-179 license to global rights and introduces preventive vaccine, PreHevbri® in Greater China and Asia Pacific markets New data from BRII-835 + PEG-IFN-α study have demonstrated that robust anti-HBs antibody responses at the end of treatment are associated with sustained HBsAg loss 24 weeks post treatment Company owns exclusive global rights of BRII-693 in development for difficult-to-treat carbapenem-resistant Gram-negative bacterial infections Dr. David Margolis appointed as Chief Medical Officer to lead organization's late-stage clinical programs towards commercialization DURHAM, N.C. and BEIJING, July 5, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" 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 provided updates on its diverse pipeline of infectious disease (ID) and central nervous system (CNS) disease candidates and announced a pivotal leadership transition that will further advance its strategic priorities. "We are proud to announce our latest achievements in advancing our mission to improve patient health and address critical public health issues. With expanded collaborations and acquisitions, including the worldwide license extension of BRII-179, the introduction of PreHevbri® vaccine in Greater China and Asia Pacific markets, and the acquisition of global rights for BRII-693, we are making remarkable progress in our infectious disease portfolio," said Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "Additionally, it is with great pleasure that I introduce Dr. David Margolis as our new Chief Medical Officer. With his extensive experience and expertise both as a licensed ID specialist and a drug developer, Dr. Margolis will play a pivotal role in leading the successful execution of our late-stage clinical programs towards commercialization. Together, these strategic moves align seamlessly with our growth plans and represent important progress for our broader global strategy." Core Clinical Development Updates Hepatitis B Virus (HBV) Led by Brii Bio's team in China and partners, Vir Biotechnology, Inc. ("Vir,"NASDAQ: VIR) and VBI Vaccines, Inc. ("VBI,"NASDAQ: VBIV), the Company is addressing the full range of disease impact for HBV by progressing multiple combination studies to achieve a best-in-class functional cure in broad patient populations, as well as to commercialize a prevention vaccine in Greater China and Asia Pacific region. China and many Asia Pacific countries have the highest prevalence of HBV globally, with over 150 million people impacted by this disease (China ~86 million, Southeast Asia ~69 million HBsAg positive population1). Currently, there is no effective HBV functional cure available, highlighting the urgent need for a better prophylactic vaccine. In July 2023, Brii Bio announced substantial expansion of its HBV portfolio in collaboration with VBI. Under the terms of the agreements, Brii Bio extends its exclusive license to worldwide markets for BRII-179 (VBI-2601). Additionally, Brii Bio also acquires exclusive rights to develop and commercialize PreHevbri® in Greater China and Asia Pacific countries including Australia, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Thailand and Vietnam, among others. PreHevbri® is a clinically differentiated 3-antigen adult HBV prophylactic vaccine recently approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. In June 2023, Vir and VBI presented multiple clinical study results at the European Association for the Study of the Liver (EASL) Congress™ 2023: In follow-up data from Vir's Phase 2 trial of combination 24 or 48 weeks of VIR-2218 (BRII-835) on top of a course of up to 48 weeks of pegylated interferon alpha (PEG-IFN-α), 16% (5/31) of participants demonstrated sustained HBsAg loss 24 weeks after end of treatment. Anti-HBs titers greater than 500 mIU/mL at the end of treatment were associated with sustained HBsAg loss at 24 weeks after the end of treatment. Data from Part A of Vir's Phase 2 MARCH trial evaluating short treatment duration of combinations of VIR-2218 (BRII-835) and VIR-3434 (BRII-877) in chronic HBV participants demonstrated a 2.7-3.1 log10 IU/mL decline in HBsAg levels and 90% of participants achieved HBsAg reduction below 10 IU/mL at the end of treatment. VBI presented follow-up data in a subset of participants from the pivotal Phase 3 study, PROTECT, up to 3.5 years after completion of immunization with PreHevbrio® (also known as PreHevbri® in the European Union/European Economic Area and United Kingdom, and Sci-B-Vac® in Israel), a prophylactic 3-antigen HBV vaccine. The mean anti-HBs titers in participants vaccinated with PreHevbrio® were more than 5x higher than those vaccinated with Engerix-B (1287 vs. 254 mIU/mL) suggesting that T-cell responses of PreHevbrio® may contribute to long lasting and strong humoral immune responses and greater durability compared with Engerix-B. In May 2023, Brii Bio submitted an IND application to the NMPA of China for the development of BRII-877 (VIR-3434), and a Phase 1 clinical study is expected to start by the end of 2023. In the second half of 2023, the Company expects data readouts from two Phase 2 trials: Additional data from the Phase 2 study evaluating BRII-835 (VIR-2218) and BRII-179 (VBI-2601) combination. Topline results from the Phase 2 study evaluating BRII-179 (VBI-2601) in combination with PEG-IFN-α. Brii Bio plans for additional combination studies with the earliest to start in 2H 2023. Postpartum Depression (PPD) and Major Depressive Disorder (MDD)/Other CNS Disorders Brii Bio is developing its internally-discovered BRII-296 therapeutic candidate as a first-of-its-kind one-time injection treatment with the potential to expand the PPD and MDD treatment landscapes for patients in the U.S. In June 2023, Brii Bio announced the dosing of the first subject in a Phase 1 clinical trial for BRII-297, a long-acting injectable (LAI) being developed to treat anxiety and depressive disorders. The study, currently underway, aims to evaluate the safety, tolerability, and pharmacokinetics of BRII-297 in healthy volunteers. Brii Bio is working closely with the U.S. Food and Drug Administration (FDA) to align and agree on a PPD treatment protocol in preparation for its Phase 2 proof-of-concept (POC) study to be initiated in the second half of 2023. Brii Bio is actively working to expand the clinical indications for BRII-296 and plans to initiate additional studies in the U.S. in 2024. Additional Pre-Clinical and Clinical Development Updates Human Immunodeficiency Virus (HIV) Infection In December 2022, Brii Bio successfully lifted the U.S. FDA clinical hold, enabling the conduct of the Company's planned Phase 1 study to investigate a lower oral dose of once-weekly BRII-732, with dosing initiated in 2Q 2023. The Company is exploring partnership opportunities to continue developing BRII-732 as part of a potential oral, once-weekly, long-acting combination treatment option for HIV patients. The Company is pursuing partnership opportunities for BRII-753 as part of a long-acting, subcutaneous injection with potential for dosing once monthly, once quarterly, or twice-yearly combination treatment option for HIV patients. MDR/XDR Gram-Negative Bacteria Infections In June 2023, Brii Bio announced definitive agreements with Qpex Biopharma ("Qpex") to acquire exclusive global rights of BRII-693 (QPX-9003), expanding its existing rights in Greater China. The Company returns its exclusive rights of BRII-636 (QPX-7728 or OMNIvance) and BRII-672 (QPX-7831 or ORAvance) in Greater China to Qpex in connection with the acquisition of Qpex by Shionogi. In April 2023, Brii Bio submitted a pre-IND to the NMPA of China for the development of BRII-693 in China. BRII-693 has a highly differentiated safety and efficacy profile to address the most difficult-to-treat Acinetobacter baumannii and Pseudomonas aeruginosa infections resistant to carbapenem. Nontuberculosis Mycobacteria (NTM) Lung Disease Brii Bio's partner, AN2 Therapeutics, Inc. ("AN2,"NASDAQ: ANTX) is enrolling its Phase 2/3 pivotal trial evaluating once-daily, oral epetraborole (BRII-658) for treatment-refractory MAC lung disease. AN2 reported in May that there were nearly 80 sites active in its pivotal Phase 2/3 trial of epetraborole in treatment-refractory MAC lung disease. Corporate Update Dr. David Margolis has been appointed Chief Medical Officer (CMO) after serving as Brii Bio's Head of Infectious Diseases Therapy Area for nearly three years. As the CMO, Dr. Margolis will play a critical role in the Company's late-stage clinical development towards commercial growth across the pipeline. In addition, he will continue to fulfill existing responsibilities that he previously held as Head of Infectious Diseases Therapy Area. Meanwhile, Dr. Li Yan will leave the company to pursue other interests. Brii Bio expresses sincere gratitude to Dr. Yan for his contributions to the Company in the past 5 years. About Brii Bio Brii Biosciences 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 first-of-its-kind treatment options for 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 . 1 Lancet Gastroenterol Hepatol. 2018; 3(6): 383-403 SOURCE Brii Biosciences Limited

TAMPA, Fla., June 20, 2023 /PRNewswire/ -- Neurolief, a medical neurotechnology innovator, today announced new data released at the 65th Annual Scientific Meeting hosted by the American Headache Society (June 15-18, 2023, Austin, TX). The real-world, open label analysis presents clinically meaningful data on both the acute treatment and prevention of migraine. Relivion MG is a novel wearable digital therapeutic neurostimulation system, intended to treat migraine and reduce the need for drug therapies. Continue Reading "This real-world data is extremely promising," says Roni Sharon, a board-certified neurologist and headache specialist, and assistant professor of neurology at Tel Aviv University's Slackler School of Medicine. "The remarkable results achieved in this subset of more difficult to treat patient population underscore the immense potential of Relivion's innovative technology in helping millions of people living with migraine." "At the heart of our mission lies a deep dedication to our patients," said Scott Drees, Neurolief's CEO. "We will continue to partner with the migraine community to expand access to Relivion and together, we will embark on a journey to help shape the future of migraine care." Tweet this Neurolief's eCOT-NS technology is the first external, combined occipital and trigeminal neurostimulation system (eCOT-NS) which applies electrical impulse to 6 major nerve branches in the head associated with migraine. Combined occipital and trigeminal neurostimulation was previously possible only by an invasive high-risk procedure. Poster 1: Initial Efficacy and Safety Evidence of Long-Term Migraine Preventive Treatment Using External Combined Occipital and Trigeminal Nerve Stimulation (poster #: P-252) This post-hoc analysis included sixteen subjects with high frequency episodic or chronic migraine who self-administered daily treatments with Relivion MG for a 9-month period. Mean Monthly Migraine Days (MMD) decreased by 75%, from 17.8 days per month at baseline to 4.8 days at the end of the third treatment month (p<0.0001). Observed MMDs during treatment months 4-6 were stable despite the reduced frequency of treatment. Mean monthly rescue medication intake days decreased by 80%, from 14 days per month at baseline to 4 days at the end of the third treatment month (p<0.0001). Observed monthly rescue medication intake days during treatment months 4-6 were stable despite the reduced frequency of treatment. No serious adverse events were reported. Poster 2: Real-world Efficacy of Abortive Migraine Treatment with External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) in High-Frequency Episodic and Chronic Migraine by treatment initiation timing (poster #P-255) This post-hoc analysis included analysis of 497 migraine attacks across 56 subjects who self-administered abortive treatment sessions with the eCOT-NS system upon the onset of a migraine and record their migraine outcomes as well as the timing of treatment initiation from migraine onset (<1 hour or >1 hour after pain onset). 78% of treatments which were initiated less than 1 hour after migraine onset achieved relief of migraine pain and 40% of treatments were pain-free. 62% of treatments which were initiated more than 1 hour after migraine onset achieved relief of migraine pain and 25% of treatments were pain-free. There were no reported serious adverse events. "At the heart of our mission lies a deep dedication to our patients" said Scott Drees, Neurolief's CEO. "We will continue to partner with the migraine community to expand access to Relivion and together, we will embark on a journey to help shape the future of migraine care." Relivion MG is cleared by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine for patients 18 years of age and older and has received CE Mark. Neurolief will pursue an expanded indication for the preventive treatment of episodic and chronic migraine. For more information on Relivion MG, visit Relivion.com. About Neurolief Neurolief is a neuromodulation company, dedicated to improving the lives of patients suffering from Neurological and Neuropsychiatric disorders such as migraine and depression. The company has designed and manufactures the Relivion device which is the world's first neuromodulation system designed to concurrently stimulate the occipital and trigeminal nerve branches to modulate brain regions associated with migraine and depression. Currently FDA and CE approved for the acute treatment of migraine, Relivion is intended to provide a highly effective alternative to pharmaceutical therapies. The system also incorporates a patient mobile app and clinical software with cloud enabled data-tracking feature sets, enabling next generation AI incorporation. The company is currently pursuing additional FDA and CE mark approvals for migraine prevention and for treatment of major depression (MDD). SOURCE Neurolief Inc.

The Company’s Nelivabon Program Pairs Novel Compound with Companion Diagnostics to Treat MDD patientsMUNICH, Germany, June 20, 2023 (GLOBE NEWSWIRE) -- HMNC Brain Health (‘‘HMNC’’ or the ‘‘Company’’), a global clinical-stage biopharmaceutical company pioneering the development of personalized therapies in psychiatry, announced today that the first patient has been enrolled in the Olive trial, a randomized, double-blind, placebo-controlled trial in more than 300 patients with Major Depressive Disorder (MDD) conducted in eight countries in Europe. The Olive trial is a crucial component of the Nelivabon program, aimed at developing BH-200, a potent vasopressin V1b receptor antagonist, for improved treatment of patients with MDD who have underlying HPA-axis (Hypothalamus‐pituitary‐adrenal axis) dysfunction. The neuropeptide vasopressin plays a critical role in coordinating hormonal and behavioral adaptation to stress, and its elevated activity in the brain following repeated stressors may increase anxiety and depressive symptoms. BH-200 directly targets the HPA-axis dysfunction and has demonstrated promising tolerability in previous clinical trials. The Olive trial will evaluate the efficacy and safety of BH-200 in depressed patients. Moreover, it will test the predictive capabilities of the V1b polygenic score, which the company aims to eventually develop into a companion diagnostic for BH-200. As this genetic in-vitro diagnostic test is still under development, the Olive trial will recruit every patient regardless of genetic status, and a post-hoc analysis will be performed. The hypothesis is that patients with a high V1b polygenic score, which is estimated to be around 30% of the population, will benefit the most from BH-200. ‘‘The initiation of the Olive trial for the Nelivabon program marks an important milestone in our pursuit of providing innovative and personalized treatments for patients suffering from stress-axis-related MDD,’’ said Dr. Maximilian Doebler, Chief Business Officer of HMNC Brain Health. ‘‘We remain committed to advancing our clinical research pipeline to address unmet needs in mental health care and ultimately bring new treatment options to patients suffering from mental health disorders such as MDD.’’ ‘‘The development of the predictive companion diagnostic as part of the Nelivabon program reflects HMNC Brain Health's focus on targeted and personalized treatments. By identifying patients with a specific dysfunction of the HPA-axis, the program aims to provide tailored and efficient treatment options, furthering the company's goal of delivering personalized healthcare solutions,’’ said Dr. Hans Eriksson, Chief Medical Officer of HMNC Brain Health. ‘‘The commencement of our Phase 2 study is a crucial step in validating the safety and efficacy of this innovative treatment strategy. We are very confident that our precision psychiatry approach for the treatment of MDD will prove its noteworthy potential addressing a large patient population.’’ If the Nelivabon program receives clinical validation, it could represent a significant advancement in the treatment of stress-axis-related MDD, a potential breakthrough in mental health treatment, supporting HMNC Brain Health’s commitment to innovation. The initial results of the Olive trial are expected in H2 2024. ABOUT HMNC BRAIN HEALTH HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, leading to higher remission rates. The Company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The Company has presence in both Germany and the US and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. The Company now enters the next stage of its development with a large-scale licensing and fundraising agenda. ABOUT THE NELIVABON PROGRAM The Nelivabon program is focused on developing BH-200, a vasopressin V1b receptor antagonist, to treat Major Depressive Disorder (MDD) related to dysfunction in the human body's stress system, called HPA-axis (Hypothalamus‐pituitary‐adrenal axis). BH-200 targets the elevated activity of vasopressin in the brain caused by repeated stressors, potentially reducing anxiety and depressive symptoms. The neuropeptide vasopressin coordinates hormonal and behavioral adaptation to stress, but repeated stressors can cause an overactive vasopressin system that leads to an increase in anxiety and the development of depressive symptoms. To identify depressed patients with underlying dysfunction of the HPA-axis, who may benefit from treatment with BH-200, the program includes a matching molecular diagnostic test. While the diagnostic test is still in early development, data stemming from this trial is expected to significantly improve its accuracy. BH-200 has shown to be well-tolerated in clinical trials. The program is entering a Phase-II proof-of-concept study in H1 2023 and once clinically validated, could represent an efficient treatment option for patients suffering from stress-axis-related MDD. Media contacts (U.S.):Anne Donohoe+1212.896.1265hmncbrain@kcsa.com Investor Contacts (U.S.):Sophia Bashford+1 347-487-6788sbashford@kcsa.com