Corporate Presentation June OTCQB: VBIO

Transcription

1 Corporate Presentation June OTCQB: VBIO

2 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.

3 3 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 Iovance Biotherapeutics (NASDAQ:IOVA), Co-Founder of Intervene Immune B.S. in Elec. Eng., Georgia Tech; M.S. in Biomedical /Neuroengineering, UCLA Avtar Dhillon, MD, Chairman & Cofounder 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 & Counsel 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 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 Autism Chronic / Neuropathic Pain Epilepsy Schizophrenia Multiple Sclerosis CBD is (a) not psychoactive and has (b) dramatic therapeutic effects when treating severe and drug-resistant seizure disorders in children. Vitality has a similar approach with THC prodrugs for pediatric IBD. Potential for dramatic benefits with no psychoactivity. 4

5 5 Cannabinoid Drug Companies There are surprisingly few drug development companies in the U.S. capable of obtaining DEA licensing and FDA approvals GW Pharmaceuticals Plc (NASDAQ:GWPH) Pharma pioneer of cannabis drugs with decent intellectual property position Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) Developing synthetic CB2 cannabinoid receptor agonists Vitality Biopharma, Inc. (OTCQB: VBIO) Targeted delivery through glycosylation for delivery to gut and brain, no psychoactivity

6 Comparator Chart GW Pharma s Epidiolex (cannabidiol) for Treatment of Drugresistant Pediatric Epilepsy, One Path to a >$4B Mkt Cap 6 VBIO today? Targeting clinical proof-of-concept for GI disorders using THC prodrug

7 Vitality Bio Developed a Novel Class of Cannabinoids Cannabosides are cannabinoids that have been glycosylated (bound to glucose) via proprietary enzymatic biosynthesis methods 7

8 Cannabosides Limit THC s Psychoactivity with Targeted Delivery Upon oral ingestion, THC prodrug transits through digestive tract before decoupling to release THC exclusively within intestinal tract 8 VBX-100 Site-specific release of THC occurs in the intestinal tract. There is no psychoactivity because THC is not absorbed, so there is no entry of THC into the bloodstream and brain.

9 GI-Targeted Delivery Vitality s cannabinoid prodrugs enable the site-specific delivery of THC to the large intestine upon oral ingestion 9

10 New Treatment Options VBX-100 s delivery mechanism may enable widespread use of THC in sensitive populations including pediatric and elderly 10

11 Prodrug Background Cannabosides avoids psychoactivity and also the adverse effects of systemic immunosuppressant drugs A prodrug is a medication or compound that, after administration, is converted within the body into a pharmacologically active drug. Prodrugs overcome well-known drawbacks of currently available therapies. Vitality s prodrug technology enables the targeted delivery to the GI tract, harnessing the therapeutic effects of THC locally while avoiding psychoactivity. Colon-targeting also avoids the adverse systemic effects of immunosuppressive IBD therapies (such as TNFalpha inhibitors, corticosteroids, etc.). As of 2015, there were approximately 15 prodrugs that had been classified as blockbusters, defined as having annual sales in excess of $1 billion. 11

12 Treatment of Inflammatory Bowel Disease (IBD), Crohn s & colitis >50% of front-line Rx fail to have a sustained effect, and most 2 nd & 3 rd line agents have potential for severe adverse effects There is no cure for IBD. >$10B pharma market. Black Box Warning: Patients at increased risk for developing serious infections that may lead to hospitalization or death. 12

13 13 Pediatric 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.

14 Clinical Treatment of IBD Early clinical data suggests THC could induce remission even in severe disease resistant to steroids or biologic TNF-a inhibitors 14 IBD Symptoms Improved Abdominal pain Abdominal cramping Patients (%) n= % 76.8% Joint pain 48.2% Independent, placebo-controlled clinical trial, with 8 weeks of THC treatment. Diarrhea 28.6% Storr et al., Inflammatory Bowel Diseases, 2014 Naftali et al., Clinical Gastroenterology & Hepatology, 2013

15 Role of Cannabinoids in the Gastrointestinal Tract CB1 and CB2 receptors are found throughout the GI tract on intestinal epithelium, enteric neurons, and immune cells 15 CB1 and CB2 Receptors Modulate: Inflammation Motility Secretion Immune activation Gut barrier function Sharkey & Wiley, Gastroenterology 2016

16 CB1 Receptors Reduce Colonic Motility via Cholinergic Neurons Delivery of THC reduces colonic transit or motility, which means it can prevent diarrhea in IBD and IBS 16 Mayo Clinic, Camilleri, Neurogastroenterology & Motility, 2018

17 CB2 Receptors Act as Braking System for Inflammation Current medications deliver psychoactive THC into the bloodstream/brain, so low doses are always required 17 THC is an agonist of both CB1 and CB2 receptors, providing relief of both pain and inflammation within the gastrointestinal tract. Figure 2, Wright, British Jo. of Pharmacology, 2008

18 Colorectal Cancer & Colonic C. difficile Superbug Infections Direct anti-microbial and anti-cancer effects emerging Colorectal cancer: March 2017, data reported on how CBD universally inhibited cell growth at concentrations similar to established chemotherapeutics in colorectal cancer cell lines. In 2017, American Cancer Society estimates that 50,260 deaths will occur due to colorectal cancer. C. difficile infections: In May 2017, new antimicrobial activity using cannabinoids discovered against C. difficile, MRSA, and other WHO priority pathogens. C. difficile superbug infected almost 500,000 Americans in 2015 and responsible for 15,000 deaths Conditions often are comorbid with Crohn s & colitis, providing opportunities to benefit patients in multiple ways, e.g. treatment of C.diff-associated diarrhea and colitis (potential for stronger efficacy) 18

19 19 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.

20 20 Treatment of Narcotic Bowel Syndrome with VBX-100 Opiate-induced severe abdominal pain leads to misdiagnosis, escalating dosages, and drug dependence Up to 81% of opiate users have functional bowel disorders, but they may hide opiateinduced severe abdominal pain. More than half (58%) report chronic abdominal pain in independently-conducted clinical studies, and 6% develop NBS. The vicious cycle of narcotic bowel syndrome 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.

21 Treatment of Narcotic Bowel Syndrome Cannabinoids and opiates have synergistic effects, enabling protocols to reduce pain and wean off or avoid opiate use 21 THC (dronabinol) enhances pain relief in chronic users on stable doses of opiates, Narang, Journal of Pain, 2009

22 Mechanism of Action of Narcotic Bowel Syndrome Treatments Cannabinoids could reduce peripheral neuroinflammation within spinal cord and enteric nervous system Even low-dose opiate use can lead to hypersensitivity, and may act by neuroinflammation from glial cells, Grunkemeier, Clin Gastroent, 2007

23 Clinical Development Pipeline VBX-100 is a GI-targeted prodrug of d9-thc, also known as Marinol or dronabinol, which avoids psychoactivity Drug Clinical Indications Status VBX-100 Ulcerative Colitis (induction) Irritable Bowel Syndrome C.diff-associated Diarrhea and Colitis Narcotic Bowel Syndrome Phase 1 Trial 2H VBX-210 Additional Cannabinoid Formulations Irritable Bowel Syndrome Ulcerative Colitis (maintenance) Chronic Pain Colorectal Cancer Refractory Pain Autism Spectrum Disorder Preclinical Discovery Less regulatory burden and shorter trials through acute dosing regimens and referencing of safety data available at FDA for d9-thc (dronabinol)

24 24 Clinical Development & Approval Focus Low-cost data for initial drug approvals, and simultaneous proof-of-concept in large market disease indications Phase 2 Trial Design for Inducing Remission of Ulcerative Colitis Trial for initial evaluation of pharmacokinetics and tolerability of cannabosides, as well as targeting efficacy for ulcerative colitis 505(b)(2) regulatory path may enable expedited trials and FDA approval THC, also known as Marinol or dronabinol, has been approved since 1986 with a long track record of safety. Existing data may enable VBX-100 to enter Phase 2 trials more quickly and reduce trial requirements for eventual approval.

25 25 DEA-Approved Drug Manufacturing Capacity Federally-compliant facilities designed to enable large-scale production of small molecule cannabinoid drugs by enzymatic biosynthesis

26 Cannabinoid Prodrugs Glycosylation has reliably led to improvements in drug solubility and stability in novel class of cannabosides 26 Patents pending for more than 20 novel cannabinoid glycoside prodrugs, known as cannabosides Prodrugs of THC, CBD, CBDV, TRPV1 agonists, vanilloids, and additional compounds have been created

27 Intellectual Property International PCT filing covering compositions of matter for cannabinoid prodrugs designed to enable targeted delivery Versatile platform with glycoside prodrugs of THC, CBD, and CBDV, with protection that upon grant would extend to 2035 Manufacturing system for glycosides, geared for lowcost efficient production of steviol and cannabinoid glycosides

28 Company Highlights Received DEA site approval and now seeking FDA approval of VBX- prodrug strategy Intellectual property covering more than 20 cannabinoid prodrugs including modifications of nonpsychotropic THC (VBX-100), CBD, and CBDV, a new class of OTCQB: VBIO Proprietary glycosylation platform enables cannabinoids to be modified to enable therapeutic effects without psychoactivity