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Vitality Biopharma V15

This presentation and our commentary and responses to your questions may contain forward-looking statements, including comments concerning drug development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of our technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our regulatory filings from time to time.

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Vitality Biopharma V15

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  1. 2 Safe Harbor Statement This presentation and our commentary and responses to your questions may contain forward-looking statements, including comments concerning drug development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of our technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our regulatory filings from time to time.

  2. 3 Company Background In 2015, we discovered that stevia UGT enzymes could enable production of a new class of cannabinoid prodrugs Superpositioning of a steviol glycoside with cannabidiol A drug development company, using cannabinoids to treat serious neurological and inflammatory disorders

  3. 4 Leadership entrepreneurial team focused on biotechnology and life sciences Robert Brooke, CEO,Co-founder Former hedge fund analyst at Bristol Capital for over 50 direct healthcare investments; Experienced biotech entrepreneur, Founder of Genesis, now Lion Biotech (NASDAQ:LBIO), Co-Founder of Intervene Immune B.S. in Elec. Eng., Georgia Tech; M.S. in Biomedical /Neuroengineering, UCLA Avtar Dhillon, MD, Chairman & Co- founder Chairman, Inovio Pharmaceuticals, Oncosec Medical, and Arch Therapeutics Raised $200M in public markets over last 10 years Former venture capitalist and family physician for > 10 years Brandon Zipp, PhD, Dir. of Research & Development, Scientific Co-founder >10 years research experience with glucosyltransferase enzymes Developer of UGT biosynthesis platform Ph.D., Biochem & Molecular Biology, Univ. of California Davis Richard McKilligan, JD, MBA, Controller Ex-Morgan, Lewis, & Bockius LLP, State Bars in CA and NY, CPA (inactive) JD from Cornell, MBA from Univ of Chicago, BS in Accounting from Univ of Illinois Anthony Maida, PhD, MBA, Director, Chair of Audit Committee Senior Vice President, Clinical Research, Northwest Bio MBA, MA in Toxicology, PhD in Immunology

  4. 5 Cannabinoids in Medicine Initial skepticism has waned, and widespread acceptance within medical community is leading to many new clinical trials Independent Clinical Trials Inflammatory Bowel Disease Opiate Dependence Epilepsy Schizophrenia Neuropathic Pain Multiple Sclerosis Huntington’s Disease CBD is (a) not psychoactive and has (b) dramatic therapeutic effects when treating severe and drug-resistant seizure disorders in children. Vitality Biopharma takes a similar approach with cannabosides for treatment of IBD. Potential for dramatic benefits with no psychoactivity.

  5. 6 Cannabinoid Drug Companies There are surprisingly few drug development companies in the U.S. capable of obtaining DEA and FDA approvals  GW Pharmaceuticals Plc (NASDAQ:GWPH) Pharma pioneer of cannabis drugs with decent intellectual property position  Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) Topical or transdermal delivery, targeted effect for localized muscle or joint pain relief  Vitality Biopharma, Inc. (OTCQB: VBIO) Targeted delivery through glycosylation for delivery to gut and brain, no psychoactivity

  6. 7 Prodrug Background Cannabosides reduce or avoid entirely the psychoactive side effects through targeted prodrug technology A prodrug is a medication or compound that, after administration, is converted within the body into a pharmacologically active drug. Prodrugs are typically designed to overcome well-known drawbacks of currently available therapies, i.e. cannabis drugs v1.0. Vitality’s prodrug technology enables the selective delivery to specific tissues or organs, including the gut or brain, enabling existing drugs to have a more targeted effect. As of 2015, there were approximately 15 prodrugs that had been classified as blockbusters, defined as having annual sales in excess of $1 billion.

  7. 8 Treatment of Inflammatory Bowel Disease More than half of front-line therapies for induction of remission fail to have a sustained effect, and have severe side effects There is no cure for inflammatory bowel disease, including either Crohn’s disease or ulcerative colitis. Up to 75% of Crohn’s disease patients will require surgery, including colectomies and colostomies.

  8. 9 IBD Case Study: “I’d rather be illegally alive than legally dead.” Coltyn Turner, age 15 A teenager with Crohn’s disease failed all therapies at the Mayo Clinic before his family moved to Colorado to access cannabis. He entered into remission and was able to get his life back… and he’s not the only one.

  9. 10 Treatment of Inflammatory Bowel Disease Clinical data suggests Cannabis can induce remission, even in patients resistant to steroids or biologic TNF-a inhibitors In an independent and placebo-controlled trial, with only 8 weeks of Cannabis treatment, there was a statistically significant change in Crohn’s Disease Activity Index IBD Patients (%) n=56 83.9% Symptoms Improved Abdominal pain Abdominal cramping Joint pain 76.8% 48.2% Diarrhea 28.6% Storr et al., Inflammatory Bowel Diseases, 2014 Naftali et al., Clinical Gastroenterology & Hepatology, 2013

  10. 11 Site-Specific Delivery of THC Enables More Potent Local Effects Current medications deliver psychoactive THC into the bloodstream/brain, so low doses are always required Higher local concentrations of cannabinoids could then enable more potent cannabinoid treatments for pain and inflammation within the gastrointestinal tract. Merrick, Cannabis & Cann. Research, April 2016 Figure 2, Wright, British Jo. of Pharmacology, 2008 “CB2 receptors represent a braking system for… the resolution of inflammation and many of its symptoms.”

  11. 12 The U.S. Opiate Epidemic With 4.6% of the world’s population, we use 80% of the opiates Since 2013, the rates of drug-overdose deaths have exceeded the number of deaths from car accidents. The New England Journal of Medicine has written that the rising death toll has been rivaled in modern history only by that at the peak of the AIDS epidemic in the early 1990s.

  12. 13 Treatment of Narcotic Bowel Syndrome Opiate-induced severe abdominal pain leads to misdiagnosis, escalating dosages, and drug dependence The vicious cycle of narcotic bowel syndrome Up to 81% of opiate users have have functional bowel disorders, but they may hide opiate-induced severe abdominal pain. More than half (58%) report chronic abdominal pain in independently-conducted clinical studies, and 6% develop NBS. Drossman & Szigethy, Am J Gastroenterol Suppl, 2014 Reported quality-of-life for NBS patients is worse than quadriplegia, and opiates are associated with 61% of all drug overdose deaths.

  13. 14 NBS Case Study? “Prince suffered from stomach pains and sore throats in final months” UK Independent, May 2016 At age 57, Prince died of opiate overdose, and was reported to have struggled with abdominal pain and was losing weight in his final months.

  14. 15 Treatment of Narcotic Bowel Syndrome Cannabinoids and opiates have synergistic effects, enabling protocols to reduce pain and wean off or avoid opiate use Even low-dose opiate use can lead to hypersensitivity, and may act by neuroinflammation from glial cells Grunkemeier, Clin Gastroent, 2007 THC (dronabinol) enhances pain relief in chronic users on stable doses of opiates Narang, Journal of Pain, 2009

  15. 16 Clinical Development Pipeline Oral cannabosides - drug formulations including a novel class of cannabinoid glycoside prodrugs (CBD, THC, CBDV, etc.) Drug Clinical Indications Status Inflammatory Bowel Disease, Narcotic Bowel Syndrome Phase 1/2 Studies to initiate in 2017 VB100 Neuropathic Pain, Irritable Bowel Syndrome, Opiate-induced Bowel Dysfunction, Muscle Spasticity in Multiple Sclerosis Phase 1 Studies to initiate in 2017 VB210 Additional Drug Formulations Epilepsy, Schizophrenia, Huntington’s, Guillain-Barré Preclinical  Pursuing drug indications where cannabis has already proven useful  Less regulatory burden and shorter trials through acute dosing regimens

  16. 17 Clinical Development Strategy Low-cost data for initial drug approvals, and simultaneous proof-of-concept in large market disease indications First-in-man clinical studies of proprietary cannabinoid glycosides “cannabosides” Phase 1/2 Trial Designs for Inflammatory Bowel Disease & Narcotic Bowel Syndrome Trial of multiple agents for initial evaluation of pharmacokinetics and symptomatic relief of IBD & NBS (e.g. abdominal pain, cramping, etc.) Symptomatic relief will be pursued, along with secondary endpoints Proprietary molecules and manufacturing process developed internally Use of enzyme biosynthesis process for biotransformation of cannabinoids for production of cannabinoid prodrugs of CBD, THC, CBDV, and more

  17. 18 Internal Drug Manufacturing Capacity Existing company facilities designed to enable large-scale production of small molecule drugs by enzymatic biosynthesis

  18. 19 Platform Technology Enzymatic glycosylation breakthrough leads to novel compositions of matter with improved drug properties Cannabinoids (CBD, THC, etc.) Steviol Cannabinoid Glycosides (Cannaboside Prodrugs) Steviol Glycosides (Reb A, D, M, Next-gen Sweetener)

  19. 20 Cannabinoid Prodrugs Cannaboside prodrugs enable the site-specific delivery of cannabinoids to the large intestine upon oral ingestion

  20. 21 Targeted Drug Delivery Glycoside prodrugs can selectively target different tissues, including the through oral delivery, and also the (I.V.) Distribution of ibuprofen after intravenous injection of ibuprofen and glycoside prodrugs in rats (Chen et. al., 2009) Independent studies have demonstrated reliable targeting to the colon upon oral delivery of glycoside prodrugs, as well as higher permeation of brain tissue upon IV or alternative routes of drug administration.

  21. 22 Cannabinoid Prodrugs Glycosylation has reliably led to improvements in drug solubility and stability in novel class of cannabosides Patents pending for more than 20 novel cannabinoid glycoside prodrugs, known as “cannabosides” Prodrugs of CBD, THC, CBDV, TRPV1 agonists, vanilloids, and many more compounds have also been created…

  22. Intellectual Property New international patent filing with PCT covering compositions of matter for more than 20 cannabinoid prodrugs with modified solubility and stability, including glycoside prodrugs of THC, CBD, and CBDV, with protection that would extend to 2035 or longer with PTEs Manufacturing system for glycosides, geared for low- cost efficient production of steviol and cannabinoid glycosides

  23. Company Highlights Seeking DEA and FDA approval of cannabis pharmaceuticals using a low-cost, low-risk prodrug strategy Intellectual property covering more than 20 cannabinoid prodrugs including modifications of non-psychotropic CBD, THC, and CBDV, a new class of cannabosides Proprietary glycosylation platform enables existing drugs to be tailored for selective delivery to the gut and brain

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