SEATTLE – Receptor Life Sciences (RLS) today announced the completion of a pre-investigational new drug (preIND) meeting with the U.S. Food and Drug Administration (FDA). The meeting resulted in clear guidance on the regulatory requirements for the development and approval of RLS103 under section 505(b)(2). RLS103 is an investigational inhaled cannabidiol (CBD) designed for the treatment of acute panic attack.

"Alignment on a clear 505(b)(2) development pathway for RLS103 is a significant milestone for the company," said Andrea Leone-Bay, PhD, Chief Scientific Officer of RLS. "Currently no immediate-acting products are available for panic attacks, so RLS103 has the potential to be First-in-Class. We look forward to continuing our dialogue with the FDA and have initiated our IND-enabling studies."

Panic disorder affects approximately 5.4 million adults (2.7% of the population) in the US, according to the National Institute of Mental Health. Benzodiazepines are the most common treatment for panic despite their well-known undesirable side effects, including dependence, sedation, and tolerance. An inhaled CBD formulation holds the potential to treat panic in a safe, effective, and convenient manner.

RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation.

The FDA's 505(b)(2) pathway was established in 1984 to accelerate the development of promising new medications by allowing the use of data based on previously approved drugs.

SEATTLE – Receptor Life Sciences announced today that the Company was granted a Schedule I research license from the United States Drug Enforcement Agency (DEA).

The license is a federal requirement for any scientific or medical personnel who intend to study, prescribe, or otherwise work with Schedule I controlled substances. Under the license, Receptor will research the application of its drug delivery technologies to selected Schedule 1 drugs. This work is ultimately directed to development of prescription therapies to treat a variety of central nervous system disorders.

"This license is an exciting milestone on our path to identifying safe and effective therapies," said Greg Wesner, CEO, Receptor Life Sciences. "We're proud to be a leader in the research and development of cannabinoid prescription medications to treat central nervous system disease."

SEATTLE – Receptor Life Sciences (Receptor) today announced the appointment of Gregory T. Mayes, J.D. to its Board of Directors. Mr. Mayes is an expert in biopharmaceutical industry business strategy and commercialization.

Mr. Mayes comes to Receptor having just ended his tenure as Founder and CEO of Engage Therapeutics. Under Mr. Mayes’ leadership, Engage developed an inhaled alprazolam for the rapid cessation of seizures. Engage recently completed a successful Phase II efficacy study enabling a competitive sale to Belgian pharmaceutical giant UCB.

"Greg’s late stage development and partnering experience will facilitate Receptor’s next stage of growth," said Greg Wesner, CEO, Receptor Life Sciences. "Greg’s 20 plus years of industry experience will help guide us as we apply our validated drug delivery technologies to our pipeline of cannabinoid prescription drug candidates."

Prior to serving as Founder and CEO of Engage, Mr. Mayes served as Chief Operating Officer and Board member of Advaxis Immunotherapies. In this position he was instrumental in establishing major pharma partnerships. He also developed a Phase III registration strategy and clinical development plan for Advaxis's lead product candidate, resulting in an FDA Fast Track Designation.

Prior to Advaxis, Mr. Mayes served as President and General Counsel and Board member for Unigene Laboratories. At Unigene he led out-licensing efforts for a novel oral peptide drug delivery platform. Mr. Mayes also served as Vice President, General Counsel, and Chief Compliance Officer at ImClone Systems, where he contributed significantly to the clinical development and commercialization of ERBITUX® (cetuximab). He was also instrumental to the $6.5 billion-dollar sale of ImClone Systems to Eli Lilly in 2008.

Mr. Mayes also served as Senior Counsel at AstraZeneca Pharmaceuticals LP, where he provided a wide range of legal services in connection with the development and commercialization of five approved products in AstraZeneca's oncology portfolio. Mr. Mayes is a cum laude graduate of Syracuse University where he was recognized as a Remembrance Scholar. He earned his J.D. degree magna cum laude from Temple University School of Law, where he was the Articles Editor on the Temple Law Review.

"We are delighted to have Greg join our Board and welcome his input into our corporate development strategy," said Mr. Wesner.

NEW YORK CITY – Data from an initial proof-of-concept clinical pharmacokinetic study demonstrate that Receptor Life Sciences' research team has found a way to address the bioavailability and variability challenges that have stymied cannabinoid pharmaceutical researchers.

The company is pursuing pathways with the U.S. Food and Drug Administration to bring its investigational therapies to market, using drug delivery platforms already validated by their use in marketed prescription drugs.

"The effectiveness of cannabinoid medicines is negatively impacted by poor bioavailability, highly variable absorption, and erratic time to onset," said Dr. Andrea Leone-Bay, PhD, Chief Scientific Officer and a founder of Receptor Life Sciences. "We are developing solid dosage therapeutics, both oral and inhaled, designed to address these cannabinoid delivery challenges."

Dr. Leone-Bay will present data on the Company's initial oral and inhaled cannabinoidderived product candidates at the 3rd International Cannabinoid Derived Pharmaceuticals Summit.

"Currently available cannabinoid dosage forms attempt to compensate for some of these deficiencies with high doses," said Dr. Leone-Bay. "Unfortunately, higher doses bring the potential to produce undesirable side effects."

Dr. Leone-Bay is an internationally recognized authority on inhaled dry powder and oral drug delivery technologies. She brings unparalleled pharmaceutical development and formulation expertise with 48 publications in peer-reviewed journals and over 100 issued U.S. patents. She previously served as Vice President, Pharmaceutical R&D, Mannkind Corporation.

Researchers believe that cannabinoid medicine has incredible potential that has only recently become a focus of rigorous scientific investigation.

SEATTLE - Receptor Life Sciences ("RLS"), a leading biopharmaceutical company developing FDA regulated oral and inhaled cannabinoid medicines, today announced that the United States Patent and Trademark Office has issued the Company a Patent for compositions comprising cannabinoids and the company's oral absorption enhancing excipients: U.S. Patent No. 10,588,974.

Receptor's excipients increase oral cannabinoid bioavailability, reduce time to onset and can be formulated as either liquid or solid dosage forms. These products are specifically designed to overcome the challenges of poor, highly variable absorption and long time to onset characteristic of currently available oral cannabinoid medicines.

"This patent provides strong patent coverage for RLS' oral delivery technology platform," said Greg Wesner, Founder, CEO, and General Counsel, Receptor Life Sciences. "The patent provides a broad and versatile foundation for the development of a disruptive product line in oral cannabinoid medicines."

"The simplicity and versatility of RLS oral delivery system allows clear differentiation from the numerous traditional approaches prevalent in the industry; and is based on an excipient granted FDA-approval in other products," added Andrea Leone-Bay Founder and Chief Scientific Officer, Receptor Life Sciences.

Dr. Leone-Bay is an internationally recognized authority on inhaled dry powder and oral drug delivery technologies. The new patent is her 111th.

For more information about the company and its clinical product pipeline, please visit www.receptorlife.com.

SEATTLE - Receptor Holdings (RHI) and its subsidiary, Receptor Life Sciences, Inc. (RLS), a leading biopharmaceutical company developing FDA-regulated oral and inhaled cannabinoid medicines, today announced the appointment of James B. Weissman to the Board of Directors of RHI.

Mr. Weissman has more than 30 years' experience in the life sciences industry, with extensive international management experience in biotech and pharmaceutical general management, product development, licensing, business development, marketing and M&A activities.

"We are pleased to welcome Jim to RHI's Board of Directors," said Arthur Rubinfeld, Executive Chairman, Receptor Holdings. "Jim's proven skills in business development, marketing, product development, and strategic planning bring deep pharmaceutical industry guidance to our Board. We look forward to leveraging his unique expertise as we continue to innovate and accelerate the development of our products that have the potential to expedite FDA approvals for the therapeutic use of cannabinoid medicines."

Mr. Weissman is Executive Vice President and Chief Operating Officer of Dicerna Pharmaceuticals, Inc. a position he has held since January 2012. Prior to Dicerna, Mr. Weissman was vice president of business development at MannKind Corporation. Prior to MannKind, Mr. Weissman held leadership positions in both business development and marketing at Pfizer Pharmaceuticals, Inc. in Tokyo. Mr. Weissman holds a Bachelor of Science degree in chemistry from Bates College.

"Interest in the development of safe and effective cannabinoid therapies is strong, and Receptor's technologies offer the potential of significant advantages and differentiation over other approaches," said Mr. Weissman. "I look forward to helping Receptor continue to execute on its business strategy and further the development efforts using the company's unique platform technologies."

SEATTLE - Receptor Life Sciences (RLS), a leader in FDA-regulated cannabinoid medicine drug development using proprietary delivery technologies, today announced the formation of its inaugural Scientific Advisory Board (SAB). The RLS SAB includes international experts in epilepsy, pain management, migraine, anxiety, post-traumatic stress disorder (PTSD), autism spectrum disorder, child psychiatry, sleep disorders, clinical pharmacology and clinical trials.

"The Receptor Life Sciences Scientific Advisory Board includes some of the leading clinicians and researchers in the United States," said Orrin Devinsky, MD, Chief Medical Officer, RLS and Professor of Neurology, Neurosurgery, & Psychiatry at NYU Langone Health. Dr Devinsky was named by Time Magazine as one of the 50 most influential people in health care in 2018 for his work on cannabinoid therapy. "This Board of medical innovators will leverage our oral and inhaled cannabinoid therapies to address unmet medical needs for multiple patient populations."

The SAB includes faculty from leading medical institutions including, Albert Einstein College of Medicine, New York University, University of Minnesota, and University of Indiana, and others. Collectively, the SAB has contributed to more than 2,300 articles in the medical literature.

The SAB will help leverage RLS' pipeline of cannabinoid products for specific indications. The SAB will also guide partnerships with medical research institutions to advance RLS's product portfolio.

In November 2018 Receptor Holdings (RHI), the parent company of RLS, closed over $30 million in a Series A funding round. In addition to Dr Devinsky, the RLS Science Advisory Board members are:

James Cloyd III, Pharm D, Morse Alumni Distinguished Teaching Professor of Pharmacy and Neurology, the Lawrence C. Weaver Endowed Chair in Orphan Drug Development, and Director of the Center for Orphan Drug Research at the University of Minnesota College of Pharmacy.

Daniel Friedman MD, MSc, Associate Professor of Neurology at NYU Langone Health. His expertise includes epilepsy, clinical trial methodology, novel trial designs, and outcomes research.

Brian Hainline, MD, Chief Medical Officer, the National Collegiate Athletic Association, and Clinical Professor of Neurology at Indiana University School of Medicine and NYU School of Medicine. He is an expert in pain management, concussion and sports medicine.

Richard B. Lipton, MD, Edwin S. Lowe Professor and Vice Chair of Neurology, Professor of Epidemiology and Population Health and Professor of Psychiatry and Behavioral Sciences at the Albert Einstein College of Medicine. He directs the Montefiore Headache Center.

Charles R. Marmar, MD, Lucius N. Littauer Professor and Chair of the Department of Psychiatry at NYU Langone Health. Dr. Marmar directs the NYU Center for the Study of Alcohol Use Disorder and Posttraumatic Stress Disorder. He is an international expert in anxiety disorders, PTSD, and mental health in veterans.

SEATTLE - Receptor Life Sciences today announced the appointment of Orrin Devinsky, M.D., as the company’s Chief Medical Officer. Dr. Devinsky joins Andrea Leone-Bay, Ph.D., Receptor’s Chief Scientific Officer. Together Dr. Devinsky and Dr. Leone-Bay will lead the development of Receptor’s best-in-class oral and inhaled cannabinoid products.

Dr. Devinsky is the Director of the NYU Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery. He is also a Professor of Neurology, Neurosurgery, Neuroscience and Psychiatry at NYU School of Medicine. In the field of cannabinoid research, He served as the lead investigator for the development of GW Pharmaceuticals' Epidiolex (cannabidiol, or CBD) for the treatment of convulsive seizures in patients with Dravet Syndrome and drop seizures in patients with Lennox-Gastaut syndrome, rare and severe forms of childhood-onset epilepsy. Dr. Devinsky is a recognized authority on the treatment of epilepsy in adults and children.

Dr. Leone-Bay is the former Vice President and Head of Pharmaceutical Development for MannKind Corporation. She is an internationally recognized authority on dry powder inhalation and oral drug delivery technologies. Dr. Leone-Bay brings unparalleled formulation expertise, nearly 50 publications in peer-reviewed journals, and 93 U.S. patents. She has extensive drug development experience, managing projects from inception through development and commercialization for regulated drug products and drug-device combinations.

"We are delighted to have Orrin and Andrea leading Receptor Life Sciences," said Greg Wesner, CEO of parent company Receptor Holdings. "Orrin’s clinical experience in cannabinoid medicine, together with Andrea’s unparalleled expertise in drug delivery and development, are critical to Receptor’s success in developing and commercializing our products."

"Bringing these proven technologies to market provides patients with treatment options that are precise, consistent, and rapid in onset. These products represent an enormous advance in the clinical value of cannabinoid medicines," said Dr. Devinsky. "Joining the Receptor team will allow me to leverage my experience and knowledge in cannabinoid medicine towards the development of new indications using products with excellent pharmacologic profiles."

"The application of advanced oral and inhaled drug delivery technologies to cannabinoid drugs will provide patients with best-in-class therapies for a variety of clinical indications. I’m excited to be leading these development programs with Dr. Devinsky and look forward to bringing safe and effective treatments to patients in need," said Dr. Leone-Bay.

SEATTLE – Receptor Holdings, Inc. and its wholly-owned subsidiary, Receptor Life Sciences, a biopharmaceutical company developing cannabinoid medicines featuring distinct pharmaceutical drug delivery technologies, today announced that it raised $29 million in a combined convertible debt and Series A round of financing.

Receptor controls patented and disruptive oral and inhaled drug delivery technologies that are validated by their use in FDA-approved products. In initial studies, Receptor’s oral dosage formulations facilitated rapid drug absorption from the GI tract with higher bioavailability than has been reported for existing oral cannabinoid products. Receptor’s inhalation technology combines a simple-to-use, breath-powered inhaler with dry powder cannabinoid formulations that provides ultra-rapid, precise and discreet delivery of cannabinoid medicines to the deep lung.

"The closing of the Series A round will allow us to initiate IND-enabling studies in the United States and to formalize collaborations in Canada and Europe," said Greg Wesner, Chief Executive Officer of Receptor Holdings. "The growing consensus is that cannabinoids have the potential to meet numerous and significant unmet medical needs for indications including epilepsy, chronic pain and post-traumatic stress disorder. By leveraging validated drug delivery technologies, we believe our products have the potential to set the standard of care for cannabinoid medicines in terms of onset of action, bioavailability and consistency."

Receptor Life Sciences, Inc. today announced that it has entered into a collaboration and license agreement with MannKind Corporation.

Pursuant to this agreement multiple inhaled therapeutic products will be developed to explore their potential to treat conditions such as chronic pain, neurologic diseases and inflammatory disorders.

Under the terms of the agreement, MannKind will perform initial formulation studies and will work with Receptor to develop inhaled formulations of certain undisclosed compounds. MannKind will also transfer manufacturing technology to the licensee, who will be responsible for manufacturing and commercialization activities. The parties will collaborate on the clinical development of investigational products, with Receptor being responsible for all development costs. MannKind will be eligible to receive development and commercialization milestones of up to $102.25 million as well as mid-single to low double-digit royalties on net sales of product.

"We are pleased that Receptor Life Sciences has selected our formulation and delivery technology to advance its portfolio of innovative inhaled products," said Matthew Pfeffer, Chief Executive Officer of MannKind. "This collaboration demonstrates the fundamental value of our platform technology while the risk-sharing structure of the transaction allows us to diversify our product opportunities without losing focus on our lead program."