Qnovia, Inc. Announces the Appointment of Four New Members to its Scientific Advisory Board

Qnovia, Inc., a pharmaceutical company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRx^TM, today announced the appointment of four new members to its Scientific Advisory Board (SAB). The new members include Neal Benowitz, MD, Professor at University of California at San Francisco, Ian M. Fearon, PhD, independent consultant, Darla E. Kendzor, PhD, Professor at University of Oklahoma Health Sciences Center, and Nicole Nollen, PhD, Professor at University of Kansas.

“Our newly appointed advisors bring world-class scientific and multi-disciplinary expertise and reaffirm our commitment to advance novel therapies for the millions of people who seek to quit smoking,” said Brian Quigley, Chief Executive Officer of Qnovia, Inc. “We are grateful for the leadership of the Chair and founding member of our SAB, Dr. Jasjit S. Ahluwalia, a professor at Brown University, who has been instrumental in shaping the direction of our SAB over the past year. The expansion of our SAB complements the regulatory expertise of our policy and regulatory strategy advisor, Mitch Zeller, who served a prior appointment as director of FDA’s Center for Tobacco Products.”

“Looking ahead, our SAB will serve a critical role as we advance the clinical development of our lead asset, QN-01, towards FDA and MHRA approval,” Quigley said. “We believe our proprietary drug-device combination platform has the potential to be a first-in-class and best-in-class treatment for smoking cessation. Last fall, QN-01 demonstrated a superior pharmacokinetic profile compared to existing nicotine replacement therapies in our first-in-human Phase 1 clinical trial. We plan to submit our IND and CTA to the regulatory bodies and look forward to commencing our Phase 1/2 clinical study this year. Overall, we are highly encouraged by the data we have generated to date and believe that 2024 is going to be a pivotal year for Qnovia,” he added.

“The cigarette smoking epidemic is one of the largest threats to public health today with no new smoking cessation therapies approved in two decades in the U.S. Qnovia’s therapy has a novel and differentiated approach as the world’s first breath-actuated, multi-orientation, portable nebulizer in development,” said Dr. Jasjit S. Ahluwalia, Chair and founding member of Qnovia’s SAB. “I am pleased to welcome four highly distinguished experts in their field to our growing SAB. Each member brings a wealth of experience to the table, encompassing diverse areas ranging from nicotine addiction, toxicology, digital technologies, clinical development, regulatory affairs, and behavioral science. Collectively, we believe that we can drive meaningful advancements in fighting the leading cause of preventable death and disease in the world.”

Members of the Scientific Advisory Board consist of:

Jasjit S. Ahluwalia, MD, MPH, MS, Professor at Brown University

Chair and founding member

• Dr. Ahluwalia has over 30 years of experience as a practicing physician, faculty member, department chair, Associate Dean and Center Director in medical schools, and a School of Public Health Dean. Dr. Ahluwalia is a Professor of Behavioral and Social Sciences at Brown University’s School of Public Health and of Medicine at the Alpert Medical School and is a leader in studying nicotine addiction and cessation with over 400 peer-reviewed publications in leading scientific journals. He has received over $120m in extramural grants and has published more than 400 manuscripts. Additionally, Dr. Ahluwalia has served a three-year term on the U.S. Federal Government’s Interagency Committee on Tobacco and Health, chaired by the U.S. Surgeon General. He also served a three-year term on the Board of the Society for Research on Nicotine and Tobacco.

Neal Benowitz, MD, Professor Emeritus at University of California at San Francisco (UCSF)

• Dr. Benowitz has been a practicing physician at San Francisco General Hospital for over 50 years. The hospital has a partnership with UCSF, where Dr. Benowitz also serves as an emeritus faculty member in the Department of Medicine. He was the Chief of the Division of Clinical Pharmacology at UCSF for 35 years. His research focuses on the human pharmacology of nicotine, individual differences in vulnerability to tobacco-related disease, and the use of pharmacologic data as a basis for public health policies to prevent and reduce such disease. He has served on a number of national and international committees addressing issues in tobacco-related diseases and smoking cessation, including several sponsored by the Institute of Medicine. He has served as president of the American Society for Clinical Pharmacology and Therapeutics and the Society for Research on Nicotine and Tobacco. He has authored over 800 publications, including a state-of-the-art review on nicotine addiction in the New England Journal of Medicine in June 2010. He maintains an active clinical practice in cardiology and medical toxicology.

Ian M. Fearon, PhD

• Dr. Fearon is an independent consultant with over 20 years of experience and expertise in regulatory and scientific aspects of nicotine and tobacco products. His deep understanding of regulatory submissions in the United States and Europe will allow Qnovia to navigate the regulatory landscape. Dr. Fearon received his PhD in Cardiovascular Research from the University of Leeds. Dr. Fearon has authored more than 60 publications, including more than 20 on tobacco/nicotine product assessment, which have generated more than 3,200 citations. His consulting work focuses on advising manufacturers on regulatory requirements for e-cigarettes as both consumer goods and medicinally licensed products, in the US, UK and Europe. He specializes in the biological and psychological effects of nicotine, clinical and behavioral studies to assess the individual and population impact of electronic cigarettes and tobacco heating devices, and the scientific basis for regulation. Prior to independent consulting, Ian worked for JUUL Labs as Senior Director of Clinical and Regulatory Affairs EMEA, and previously he was Director of Tobacco Research at Celerion, a provider of clinical research capabilities and regulatory expertise to the tobacco and e-cigarette industries.

Darla E. Kendzor, PhD, MA, Professor at University of Oklahoma Health Sciences Center

• Dr. Kendzor has over 15 years of research experience focused on tobacco use and cessation, cancer prevention, and health disparities. Dr. Kendzor received her PhD in clinical psychology from Louisiana State University and has authored over 150 peer reviewed publications. Her work emphasizes the application of contingency management to real-world settings, as well as tobacco cessation interventions for vulnerable populations and mobile health. Her current NIH-funded trials focus on evaluating clinic- and smartphone-based incentive interventions for socioeconomically disadvantaged adults. This research also aims to identify treatment mechanisms and other contextual factors that influence cessation via smartphone-based ecological momentary assessment. She collaborates on several other NIH-funded smartphone-based intervention trials for populations experiencing health disparities including pregnant women, low-income adults, individuals experiencing homelessness, and adults with minority race/ethnicity. Other ongoing research focuses on tobacco harm reduction interventions for people experiencing homelessness and understanding medical cannabis use among adults with cancer.

Nicole Nollen, PhD, MA, Professor at University of Kansas

• Dr. Nollen has been a Professor in the Department of Population Health at the University of Kansas Cancer Center for over 20 years. Dr. Nollen received her PhD in counseling psychology from the University of Missouri at Kansas City and has authored over 105 peer reviewed publications. The long-term goal of Dr. Nollen’s research is to reduce tobacco-related morbidity and mortality for low income and racial/ethnic minority populations. Her specific research interests are in eliminating tobacco-related health disparities in low income and racial/ethnic minority communities by evaluating promising behavioral and pharmacotherapy treatments for racial/ethnic minority adult smokers interested in quitting and examining novel electronic nicotine delivery products for adult smokers unwilling or unable to quit combustible cigarettes.

About Smoking Cessation

Smoking continues to be the leading cause of preventable death and disease in the world, leading to almost 8 million direct and indirect deaths annually. More than half of the nearly 30 million smokers in America and 6 million smokers in the UK attempt to quit every year. However, very few of these quit attempts are successful, and existing pharmacotherapies are under-utilized due to the lack of real-world efficacy. As a result, quitting “cold turkey” remains the most popular way to quit smoking, though this is also the least effective option. QN-01 is designed to meet the urgent need for a safe and effective pharmacotherapy with the potential to be a breakthrough in meeting the urgent need of millions of smokers who want to quit but can’t.

About Qnovia, Inc.

Qnovia, Inc., formerly Respira Technologies, Inc., is a pharmaceutical company focused on developing and commercializing proprietary inhalation device technologies to improve patient outcomes across a growing range of indication areas. The company’s drug delivery platform is the first multi orientation, portable vibrating mesh nebulizer that effectively operates in any position held by the patient. Qnovia sees significant opportunity to utilize its drug delivery technologies to improve the treatment of asthma, COPD, vaccine delivery, pain management, and infectious diseases using generic and select investigational new drugs. The company was founded by Mario Danek in 2018 to build cutting-edge drug delivery platforms that improve patient outcomes through superior device technologies. The company can be found at www.qnovia.com.

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