University of Ferrara

MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces that Federico Mingozzi, Ph.D., is joining the Board of Directors of Sensorion as a Non-Executive Director by way of co-optation, effective as of today. Dr. Federico Mingozzi previously worked at Spark Therapeutics, where he served as Chief Science and Technology Officer. Federico brings over 25 years of experience in gene therapy, immunology, as well as biochemistry and molecular biology in academia and industry. He is well known for his significant contributions to the development of gene therapies various diseases. Furthermore, he has played a key role in advancing our understanding of the interactions between gene therapy vectors and the host immune system, as well as in the formulation of strategies to overcome immune responses to anti-AAV vectors. Federico has participated in numerous clinical trials targeting metabolic and neuromuscular diseases, hereditary blindness, and coagulation disorders. Prior to joining Spark Therapeutics, Federico Mingozzi was Head of the Immunology and Liver Gene Transfer Unit at Genethon, Research Director at INSERM, the French National Institute of Health and Medical Research, and Director at the Children’s Hospital of Philadelphia. Federico holds a bachelor’s degree in biology and his Ph.D. in biochemistry and molecular biology from the University of Ferrara in Italy, and his M.B.A. from Drexel University. Khalil Barrage, ad interim Chair of Sensorion's Board of Directors, said: "We are delighted to welcome Federico Mingozzi as new director. His pioneering research, contribution and recognized scientific success in the field of gene therapy will be extremely valuable to Sensorion.” Dr Federico Mingozzi, Non-Executive Director of Sensorion, said: “I am looking forward to joining Sensorion's Board of Directors and to using my experience to contribute to the development of Sensorion, a company recognized for its pioneering research in the development of gene therapies for hearing disorders. The development of this research represents an exciting challenge.” About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT), currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2022 full year financial report published on March 30, 2023, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. View source version on businesswire.com: Contacts Investor Relations Noemie Djokovic, Investor Relations and Communications Associate ir.contact@sensorion-pharma.com International Media Relations Ulysse Communication Pierre-Louis Germain / 00 33 (0)6 64 79 97 51 plgermain@ulysse-communication.com Nicolas Entz / 06 33 67 31 54 nentz@ulysse-communication.com Bruno Arabian / 00 00(0)6 87 88 47 26 barabian@ulysse-communication.com Source: Sensorion View this news release online at:

LONDON, UK I June 07, 2023 I GSK plc (LSE/NYSE: GSK) today announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been granted European Marketing Authorisation. The first launches are planned ahead of the 2023/2024 RSV season which typically starts in the autumn. Tony Wood, Chief Scientific Officer, GSK, said: “Thousands of older adults across Europe suffer serious respiratory illness due to RSV each year. This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation. Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the vaccine as countries begin to launch.” RSV is a common, contagious respiratory virus that leads to over 270,000 hospitalisations and approximately 20,000 in-hospital deaths each year in adults aged 60 years and over in Europe. 1 An estimated 3 million cases of RSV acute respiratory infection (ARI) are reported in this population each year, and the impact on healthcare systems is expected to increase as the population ages. 1 Those with underlying medical conditions, such as diabetes and chronic heart and lung disease, drive the majority of RSV hospitalisations. 2, 3 Dr Alberto Papi, Full Professor of Respiratory Medicine and Head at the University of Ferrara, said: “For most, RSV causes cold-like symptoms. For older adults and those with underlying medical conditions however, it can lead to severe disease and is a leading cause of serious respiratory infections. As scientists, we have been trying to find a solution for over 60 years. I am proud to have been part of the innovation that has resulted in a vaccine now being available to help protect eligible older adults across Europe from severe RSV disease for the first time.” The authorisation is based on GSK’s landmark positive pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial data. In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs 40 of 12,494) against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. In addition, efficacy was 94.6% (95% CI, 65.9–99.9, 1 of 4,937 vs 18 of 4,861) in older adults with at least one underlying medical condition of interest, such as certain cardiorespiratory and endocrine-metabolic conditions. The vaccine was generally well tolerated. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. These were generally mild to moderate and transient. The European Commission’s decision follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) positive opinion in April 2023. GSK’s marketing authorisation application was reviewed under the accelerated assessment mechanism because prevention of RSV disease in the older adult population is considered a major public health interest. Arexvy was the world’s first RSV vaccine to be approved for older adults when, in May 2023, it was approved by the US Food and Drug Administration. Later this month, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the US. Regulatory reviews are ongoing in Japan and several other countries. About Arexvy (Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)) Respiratory syncytial virus vaccine, adjuvanted, contains recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01 E adjuvant. Indication The European Commission has authorised Arexvy for active immunisation for the prevention of LRTD caused by RSV in adults aged 60 years and older. It is also approved in the US. The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees. The vaccine is not approved anywhere else in the world. The proposed trade name remains subject to regulatory approval in other markets. The Arexvy EMA Reference Information, including a full list of adverse events and the complete important safety information in the EU, will shortly be available at this link: www.ema.europa.eu/medicines/human//EPAR/arexvy A clinical trial investigating RSV vaccination in adults aged 50-59, including participants with underlying comorbidities, is fully recruited. Results are expected in 2023, together with additional results from the AReSVi-006 phase III efficacy trial and the AReSVi-004 immunogenicity trial. These trials continue to evaluate an annual revaccination schedule and protection/immunogenicity over multiple seasons following one dose of the RSV vaccine. The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. About AReSVi-006 This is a randomised, placebo-controlled, observer-blind, multi-country phase III trial to demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 vaccine in adults aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries. Initial results were published in the New England Journal of Medicine in February 2023. About RSV in older adults RSV is a common contagious virus affecting the lungs and breathing passages. Older adults are at high risk for severe disease due in part to age-related decline in immunity. Older adults with underlying medical conditions are at even greater risk for severe disease. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death. In Europe, RSV leads to over 270,000 hospitalisation and approximately 20,000 in-hospital deaths each year in adults aged 60 years and over. 1 Adults with underlying conditions are more likely to seek medical services and have higher hospitalisation rates than adults without these conditions. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include but are not limited to those described under Item 3.D 'Risk factors” in the company's Annual Report on Form 20-F for 2022, GSK’s Q1 Results for 2023 and any impacts of the COVID-19 pandemic. Notes * The European Commission has the authority to approve medicines for European Union member states, as well as in the European Economic Area (EEA) countries Iceland, Norway and Liechtenstein. References [1] Savic M, Penders Y, Shi T, Branche A, Pirçon J-Y. Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: a systematic literature review and meta-analysis. Influenza Other Respir Viruses 2022 November 11. Available at: https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/full/10.1111/irv.13031 [2] Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. Accessed March 2023. Available at: www.cdc.gov/rsv/high-risk/older-adults.html [3] Tseng HF, Sy LS, Ackerson B, et al. Severe morbidity and short- and mid- to long-term mortality in older adults hospitalized with respiratory syncytial virus infection. J Infect Dis. 2020;222(8):1298-1310. doi:10.1093/infdis/jiaa361.   Available at: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/32591787/ SOURCE: GlaxoSmithKline

Phase II sham-controlled randomized trial met its primary endpoint with statistical significance; treatment slowed cognitive decline by 82% over 6 months in the treated population compared to sham with no safety issues Key secondary measures of cognitive function also reached statistical significance, including a 108% difference in function as measured by ADCS-ADL Trial results published in the peer-reviewed neurology journal Brain Company was formed to develop SinaptiStim™ – AD System based on the hypothesis tested in the Phase II trial and plans to evaluate its investigational device in a pivotal trial beginning in 2023 CAMBRIDGE, Mass., Oct. 25, 2022 (GLOBE NEWSWIRE) -- Sinaptica Therapeutics, Inc., a clinical-stage company leading the development of a new class of personalized electromagnetic therapeutics to treat neurodegenerative diseases, today announced the publication of a Phase II trial conducted independently under the leadership of its co-founders, which yielded positive results demonstrating that precision-delivered noninvasive brain stimulation has the potential to slow the progression of cognitive and functional decline in patients with mild-to-moderate dementia due to Alzheimer’s disease. The findings have been published in the peer-reviewed neurology journal Brain. Fifty patients were enrolled in the Phase II randomized, double-blind, sham-controlled trial. The patients underwent a novel diagnostic assessment using both transcranial magnetic stimulation (TMS) and electroencephalogram (EEG) to personalize key treatment parameters to each patient. The trial included a 24-week treatment period, with an initial 2-week intensive course during which repetitive transcranial magnetic stimulation (rTMS) or sham was applied over the precuneus daily (five times per week), followed by a 22-week maintenance phase during which the same stimulation was applied weekly. rTMS was given as an add-on to standard treatment with acetylcholinesterase inhibitors. The primary outcome measure was the change at 24 weeks from baseline of the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) score (scores range from 0 to 18, with higher scores indicating worse cognition and daily function). Over the course of the trial, patients in the treatment group showed a stable performance while patients in the sham (placebo) group showed a general worsening of cognitive performance. Specifically, the precision-delivered rTMS treatment slowed cognitive decline, compared to the sham intervention, by 82% at 6 months, representing a treatment difference in the CDR-SB score of 1.3 points (p=0.009). Treatment was well tolerated, and no serious adverse events were observed in patients treated with rTMS for 6 months. “We are very encouraged by the statistically significant and clinically meaningful results of our precision-delivered noninvasive neurostimulation approach in patients with mild-to-moderate Alzheimer’s disease,” said lead investigator Giacomo Koch, MD, PhD, co-founder of Sinaptica Therapeutics, Full Professor of Physiology at University of Ferrara, Italy and Director, Non-invasive Brain Stimulation Laboratory, at Santa Lucia Foundation, IRCCS in Rome, Italy, which is where the Phase II trial was conducted. “The results are particularly notable because they were achieved in patients already showing symptoms of mild-to-moderate dementia, in which cognitive decline progresses more rapidly and is less responsive to drug interventions. As one of the largest trials of brain stimulation ever conducted in Alzheimer’s disease resulting in a therapeutic benefit and the first to use a precision-delivered protocol targeting the precuneus, we have validated the potential of our novel approach to be a new therapeutic tool in the treatment of Alzheimer’s disease and potentially other neurodegenerative diseases.” Patients in the treatment group also showed better performance compared to the sham group in three key secondary outcome measures, which reached statistical significance. In the Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) scale, treatment showed an improvement in cognitive function compared to sham with an estimated mean change in ADCS-ADL scores of -0.7 for the treatment group and 7.5 for the sham group, demonstrating a 108% difference between the treatment and sham groups at 6 months. The Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) also demonstrated a slowing of functional decline, with an estimated mean change in ADAS-Cog score of -0.67 for the treatment group and -4.2 for the sham group and an estimated mean change in MMSE score of 0.30 for the treatment group and 1.8 for the sham group. In addition, neurophysiological results showed that precuneus cortical excitability remained unchanged after 6 months in the treatment group, whereas it was significantly reduced in the sham group as a reflection of pathological decline of brain activity, suggesting a neuroprotective treatment effect. “Alzheimer’s disease patients develop alterations to the Default Mode Network, or DMN, a key network responsible for episodic memory for which the precuneus is a key region,” said study investigator Emiliano Santarnecchi, PhD, co-founder of Sinaptica Therapeutics, Associate Professor of Radiology at Harvard Medical School, as well as Director, Precision Neuroscience & Neuromodulation Program and Director, Network Control Laboratory, at Massachusetts General Hospital in Boston, MA. “In this Phase II trial, we have shown that the DMN can be targeted by precision-delivered noninvasive therapeutic interventions that utilize electromagnetic brain stimulation to improve plasticity and stabilize network connectivity. We believe this is an important development with the potential to address the staggering unmet need in the treatment of Alzheimer’s disease and warrants further evaluation.” Dr. Koch and Dr. Santarnecchi founded Sinaptica Therapeutics to further develop, test, and translate the groundbreaking science into real-world therapeutic solutions, including the development of an investigational precision-delivered noninvasive neurostimulation device for treating mild-to-moderate Alzheimer’s disease. “Sinaptica Therapeutics is pioneering a new class of electromagnetic therapeutics that integrate AI-derived protocols, brain modeling and network targeting to achieve a personalized and precision-delivered approach to slowing the progression of cognitive and functional decline in Alzheimer’s disease,” said Rich Macary, President of Sinaptica Therapeutics. “These unprecedented peer-reviewed clinical results demonstrate the potential for this new class of personalized electromagnetic therapeutics to treat cognitive and functional decline safely and noninvasively in Alzheimer’s disease patients. We look forward to confirming the significant Phase II results and obtaining additional clinical data in a larger, multi-center, pivotal trial using our patent-pending investigational SinaptiStim™ – AD System, which has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration.” About Sinaptica Therapeutics Sinaptica Therapeutics is a clinical-stage electromagnetic therapeutics company pioneering a personalized noninvasive brain stimulation approach with the potential to revolutionize the treatment of Alzheimer’s disease (AD). The company’s personalized, noninvasive brain stimulation platform is underpinned by significant clinical trial results showing an unprecedented reduction in cognitive decline and improved function in mild-to-moderate Alzheimer’s disease patients. The investigational SinaptiStim™ – AD System integrates electromagnetic stimulation of the brain with powerful proprietary artificial intelligence-derived protocols, brain modeling, and network targeting to create a personalized and precision-delivered therapeutic approach. The company plans to advance this promising science with a pivotal, randomized, controlled clinical trial. It seeks to create a new, more efficient treatment paradigm for the staggering unmet need and burden of AD, as well as other neurodegenerative disorders. The company has received Breakthrough Device Designation from the U.S. Food and Drug Administration for the patent-pending SinaptiStim™ – AD System. For more information, please visit . The SinaptiStim™ – AD System is for investigational use only. It has not been approved by the U.S. Food and Drug Administration and is not available for commercial sale. Media Contact Tony Plohoros 6 Degrees tplohoros@6degreespr.com Business Contact Rich Macary Sinaptica Therapeutics, Inc. rich@sinapticatx.com