“The need has never been more urgent. More than 50 million adults in the U.S. are living with chronic pain at an estimated annual cost of $560 billion in medical care, lost productivity and disability programs, according to federal data. Unlike acute pain—the sharp, instantaneous sensation that alerts the body to injury or trauma— chronic pain can persist long after normal healing, lasting for months or years….” - A New Prognosis for Pain Care - WSJ, February 6, 2019 Exxel Pharma Investor Presentation
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Overview Development stage pharmaceutical company preparing for the first clinical trial and human proof of concept • Commercializing novel, patented, non-addictive endocannabinoid-boosting therapeutics. • The therapeutics were developed at the University of California, Irvine and result from over $10M in past R&D spending. • Targeting significant unmet medical needs in multi-billion dollarmarkets. • Supported by non-dilutive grant funding. • Expecting to be in clinical testing within 9 months. • Managed by a team of experienced biotech executives and entrepreneurs. Exxel Pharma is currently raising capital to complete a phase I clinical trial, and ready the Company for an exit or out licensing opportunity 3
Company Focus: Chronic Pain Peripheral Neuropathic Pain The Problem • Neuropathic pain (NP) is a chronic pain condition that affects 7-10% of the general population, with symptoms ranging from numbness to debilitating pain. • Peripheral NP is caused by injury to peripheral nerves (nerves that reside outside the CNS) or pathological change in the peripheral nervous system. • Common forms include diabetic peripheral neuropathy, chemotherapy-induced peripheral neuropathy, HIV- associated neuropathy and post-herpetic neuropathy. • First line therapies are estimated to provide pain relief in less that 50% of patients. • Opioid type drugs are not typically recommended, but are used as second line therapies. The Solution • URB937 – A peripheral FAAH inhibitor drug for safe and non-addictive treatment of chronic and acute pain. Exxel Pharma’s URB937 has potential as a safe therapeutic for chronic and acute pain. 4
Company Focus: PTSD Post Traumatic Stress Disorder The Problem • PTSD develops in some people who have experienced a shocking, scary or dangerous event. • An estimated 8 million Americans, or 3.5% of the US population, suffer from PTSD at any given time. • For veterans, the prevalence was estimated to 26.9-30.9% for the Vietnam war, 12.1% for the Gulf war, and 13.8% for the Operation Iraqi Freedom (Iraqi/Afghan wars). • Sertraline (Zoloft) and Paroxetine (Paxil) are currently approved by the FDA for treatment of PTSD; these only provide relief from symptoms in some patients, leaving a significant unmet medical need for new therapeutics. The Solution • URB597 – A global FAAH inhibitor drug for treatment of PTSD, anxiety and other diseases of the central nervous system. Exxel Pharma’s URB597 has potential as a safe therapeutic for PTSD and substance use disorders. 5
Our Therapeutic Target: The Endocannabinoid System The human endocannabinoid system (ECS) is biological system necessary for maintaining overall health and homeostasis. The Endocannabinoid System functions throughout the body The ECS impacts: • Pain • Mood • Anxiety • Appetite • Inflammation • Insomnia • Substance addiction 6
The Endocannabinoid System: A Natural Opportunity FAAH inhibitors boost Anandamide’s The Endocannabinoid System therapeutic effects • The Endocannabinoid System (ECS) consists of • FAAH breaks down Anandamide, limiting its therapeutic effects, making FAAH an attractive pharmaceutical target I. Endocannabinoids II. Cannabinoid receptors • Inhibition of FAAH results in elevated Anandamide levels, which produces multiple therapeutic effects III. FAAH • Endocannabinoids are neurotransmitters that activate the Ana cannabinoid receptors; where and when needed • Cannabinoid receptors 1 and 2 (CB1 & CB2) are GPCRs found throughout the body Anandamide Arachidonic acid FAAH Ana • The body’s main endocannabinoid is called Anandamide and is produced in response to different types of stress and pain • FAAH (fatty acid amide hydrolase) metabolizes Anandamide Ethanolamine FAAH inhibitor limiting its effects and duration 7
Human Proof of Concept – FAAH in the News “She’d been told that childbirth was going to be painful. But as the hours wore on, nothing bothered her — even without an epidural”. “The study of rare families with inherited pain insensitivity can “We’ve never come across a patient like this,” said John Wood, the identify new human-validated analgesic drug targets. Here, a 66- head of the Molecular Nociception Group at University College London. yr-old female presented with nil requirement for postoperative analgesia after a normally painful orthopaedic hand surgery Eventually he found what he was looking for on a gene the scientists (trapeziectomy). Further investigations revealed a lifelong history call FAAH-OUT. All of us have this gene. But in Ms. Cameron’s, “the of painless injuries, such as frequent cuts and burns, which were patient has a deletion that removes the front of the gene,” he said. observed to heal quickly”... In this example, a patient without FAAH shows pain insensitivity and lack of anxiety, mirroring Exxel’s animal data and supporting the extraordinary therapeutic and commercial potential of targeting FAAH. 8
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