MMJ International Holdings
Company Name: MMJ International Holdings
Company Website: http://www.mmjih.com
Contact Name: Duane Boise
Contact Email: firstname.lastname@example.org
What is your company's primary cannabis business?: Other
Does your company touch the plant?: No
Do you authorize us to provide the following (Pitch Deck) information to our Members?: No
Company's Bio (Pitch Deck): "Investor Summary"
"A unique, low-risk, extraordinary high return opportunity in the U.S. cannabis industry today."
"MMJ Bio Pharma (MMJ) is seeking a strategic partner/investor to bring to market a"
"highly anticipated, safe, and effective marijuana-based pharmaceutical, offering investors a unique, low risk business model in the U.S. cannabis industry. (See"
"Note below for important information.)"
"Unlike companies dealing in “medical marijuana” it’s in flower state, MMJ is a bio-"
"pharmaceutical company with a pioneering cannabis formulation (a prescribed pharmaceutical) of CBD+THC via purified botanical extract. The ultimate goal is to produce a targeted, personalized dose of a non-addictive, FDA-approved motor cortex and pain management drug as an alternative to the opiates. MMJ has devel- oped a patent-pending product for symptomatic treatment of Huntington’s Dis- ease, Multiple Sclerosis (MS), and several other pain related conditions. The Com-"
"pany initiated an FDA application process for the MS indication in 2018 that will be"
"are two additional pain related targets that are planned for IND application by EOY"
"The long history of cannabinoids use and research, its proven safety and efficacy,"
"lowing FDA conventions; Orphan Status, Fast Track, Priority Review and potentially"
"Breakthrough Therapy, support expedited development. Critical end-of-phase two milestones are expected to be reached for HD in late 2021, and for MS in early"
"MMJ offers investors a “big pharma” return at a fraction of costs and risks typical of such ventures, and by far exceeding the returns of cannabis industry:"
"• Complete legal certainty, by FDA and DEA, unlike any other recreational cannabis business in the U.S. and Canada;"
"• Known safety and efficacy of cannabis for the proposed indications;"
"• Strong barriers of entry for competition from the grow, manufacturing through development;"
"• World-class, highly experienced team and key partnerships;"
"• Extraordinary high profitability and investor returns (more than 100% IRR);"
"Both indications present significant unmet need for an agent able to manage thess"
"(Continued on page 2)"
"MMJ BioPharma LLC"
"Stage: Clinical Development"
"Contributed capital: over"
"1st Round: $15M Equity/Debt"
"Equity Exit Strategy:"
"EOP2 Exit via licensing; HD—2021;"
"Estimated Annual Market:"
"Global Medical Marijuana (MM) Market:"
"$11B in 2015 @ CAGR 17.1%,"
"growing to $55B by 2025;"
"U.S. MM Market:"
"$4.8B in 2017 @ CAGR"
"22.0%, growing to over $22B by 2025"
"Use of Proceeds Operations & R&D: 78% S&M and G&M: 22%"
"MMJ BioPharma LLC"
"spasticity and chorea symptoms. Available agents, such as baclofen, tizanidine, and"
"benzodiazepines lack efficacy in some patients and have significant side effects, e.g., benzodiazepine causes a severe addiction, and tetrabenazine and neuroleptics are known to cause detrimental side effects such as depression."
"The Company intends to develop an efficient, accelerated process for commercial- izing personalized, cannabis-based CBD+THC medications for both chronic and short-term therapeutic relief, addressing smaller but significant patient groups that are currently underserved by the big pharma. There are four keys distinguishing our strategy:"
"1. We are exploring strain by strain nuances for a ‘personalized medicine’ ap- proach. There are multiple sub-strains within both the sativa and indica prima- ry strains that function slightly different as CBD to THC ratios; this approach separates MMJ from the one-size-fits-all associated with recreational or dis- pensary products."
"2. We have integrated the entire supply chain in our foundation business ar- rangements to create a seamless vertical process from the grow stage, through R&D, to commercialization."
"3. While focusing on potential orphan populations (We anticipate uncovering an subset of MS patients that will qualify) we are developing a long-term chronic dosing dossier and Health Economics outcomes that will also facilitate off-label use (expected to be at a minimum, 2X the targeted population)"
"4. We are engaged in developing a RNA diagnostic confirmation of the disease along with HEOR strategy that will summarize the pricing and data require- ment of insurers prior to EOP2 activities so we will know exactly where we stand on reimbursement"
"MMJ has developed a pharmaceutical—cannabinoid (CB) compound in a soft-"
"gelatin capsule dose-form for the treatment of symptoms associated with multiple neurological diseases: Huntington’s Disease chorea (involuntary movements), and spasticity (muscle stiffness) associated with progressive MS. The product is devel- oped as a high quality botanical extract of CBD plus THC along with the ‘tail’ from a chromatography standpoint. We are the first Biopharmaceutical company to en- gage the FDA on this dual-active component product profile and have received ex- cellent feedback to date on this first-in-class approach."
"(Continued on page 3)"
• Lowest risk cannabis business model
• FDA-approved cannabis- based pharmaceuticals
• Unique pharma-grade manufacturing capability
-MMJ’s stakeholder is Schedule I-licensed phar- maceutical manufacturer
• FDA Orphan designation
• Patent-pending formula- tions and FDA’s 7 years exclusivity
• First-class expert team in big pharma, science, medicine, law and tech- nology
Intellectual Property Patents: 2 nonprovisional utility patent applications (US)
Targeting 3 additional patient applications by EOY 2019"
"MMJ currently has few direct competitors among the CB pharma in the U.S. for the"
"aforesaid indications and approaches. However, GW Pharmaceuticals (NASDAQ:GWPH) offers a synthetic CB product (Sativax) for MS spasticity that is not approved for U.S. but sold in 28 other countries. There are several other com- panies (United Pharm., Valeant Pharm. Int., (NASDAQ:VRX), etc.), offering CB phar- maceuticals for other indications that are also not approved for U.S."
"There are several companies that offer synthetic CB products for neuro-pain and spasticity but they cause severe side effects due to the synthesis limitations, not present in natural CB products (Indevus (NASDAQ:IDEV), Zynerba Pharmaceuticals, etc.). Producers of non-CB products used for treatment of the aforesaid diseases may also pose competitive challenges by lowering prices, which appeals to the pay- ers. Besides the business strategies that deter competition, MMJ develops a patent portfolio (2 U.S. nonprovisional utility patents are currently filed), and upon the FDA approval, MMJ will receive 7 years U.S. exclusivity for each medical indication."
"MMJ International Holdings"
"330 3rd Street, Suite 1005 St Petersburg, Fl 33701"
"This document is for infor- mational purposes only and does not constitute an offer or solicitation to sell"
"shares or securities in the Company or any related or associated company. None of the information or anal- yses presented are intend-"
"ed to form the basis for any investment decision, and no specific recommendations are intended. The Company expressly disclaims any and all responsibility"
"for any direct or consequen- tial loss or damage of any kind whatsoever arising directly or indirectly from:"
"(i) reliance on any infor- mation contained in this document, (ii) any error, omission or inaccuracy in any such information or (iii) any action resulting there from."
"More information on the"
"management and FDA study teams:"
" htt p://mmjih.co m/mmj- management"
C-Suite Bio's (Pitch Deck): "Management"
"MMJ has assembled a team of world-known neurologists, genomic experts, bio- informaticians, experts in drug formulation, chemists, clinicians, researchers, and big pharma veterans."
"• Timothy C. Moynahan, Executive Chairman of the Board of Directors"
"Mr. Moynahan is an accomplished attorney who serves as the Chairman of the Ex- ecutive Board of the Global Virus Network—a global authority for the control of viral diseases. Mr. Moynahan also serves on the Advisory Board and Executive Committee of Institute of Human Virology (IHV)—a center of the University of Mar- yland Biotechnology Institute, affiliated with the University of Maryland School of Medicine, dedicated to the research and prevention of chronic viral diseases and virally linked cancers. Director, Robert Gallo, M.D., is the co-discoverer of the AIDS virus."
"• Duane Boise, President & CEO"
"A series entrepreneur, former CEO of Falkirk Hospital (NY), co-founder of the St. Vincent DePaul Homeless Shelter, the first AIDS Hospice in the United States,"
"founder of the EMED—a comprehensive emergency medical evacuation system"
"President & CEO of MMJ Duane Boise is a series entre- preneur with a history of success in his 25 years of medical services industry experience"
"Chairman of the Board"
"Mr. Timothy C. Moynahan Mr. Moynahan serves as the Chairman of the Executive Board of the Global Virus Network, and serves on the Advisory Board and Executive Committee of the Institute of Human Virology (IHV)"
"• Patheon (Thermo Fisher Scientific)"
"• University of South Florida (USF) – Col- lege of Medicine Neurology"
"• ADMERA Health Genomics"
"• University of the West Indies"
"• UBMDNeurol- ogy/Jacobs Neurological Institute"
"• PAREXEL (NASDAQ: PRXL)"
"• Baker Hostetler (BH)"
"years’ experience in the medical services industry. He has a strong international"
"business background and a proven ability to establish relationships and organize operations throughout the world under the most demanding conditions."
"(Continued on page 4)"
"• Brian McIlroy, Ph.D"
"Former Exec. Dir., Buffalo Institute for Genomics and Data Analytics at UB, former GE executive."
"• Lee Rosebush, MBA, Pharm.D., J.D."
"Partner at BH, FDA “orphan drug” expert, Law360’s top life sciences attorneys un- der 40."
"• Elio Mariani, Ph.D"
"Formulation, 40 years’ experience in big pharma leadership with more than 100 developed products."
"• Bianca Weinstock-Guttman, M.D."
"Director of the Jacobs Multiple Sclerosis Center at UBMD, and Exec. Director of NYSMSC."
"• Lance Shea"
"BH Co-Chair Pharmacy Division with over 25 years of experience in law and science."
"• Frank Palumbo, M.D., J.D."
"BH FDA Policy Advisor, Exec. Director Center on Drugs and Public Policy MD School of Pharmacy."
"• Igor Kavalchuk, M.D, Ph.D"
"Prof. at University of Lethbridge, med. doctor, expert in next gen. genome sequenc- ing and analysis."
"• Juan Sanchez Ramos M.D., Ph.D"
"Professor College of Medicine, Neurology, University of South Florida. Director Huntington Disease COE"
"• Marlene Haffner"
"Past Director of the FDA Office of Orphan Drugs and founder of Haffner Associates"
"Robert Soto, MBA"
"Senior Director – Early Phase Development at PAREXEL"
"• Karen Ivester, MSc."
"Senior executive in Global Clinical Operations for biopharma and CRO companies including Covance, Quintiles, PAREXEL and PPD"
"• Kevin Brett"
"VP Business Development MMJ, former Business Development executive at PAREXEL"
"The FDA is presently issuing numerous “cease and desist” orders against compa- nies producing products containing marijuana that claim to be effective against symptoms of various illnesses. In addition, the Attorney General of the United States has effectively withdrawn the effects of the “Cole Memorandum” which per- mitted U.S. Attorneys around the country to choose not to enforce federal marijua- na laws. It is now in the discretion of U.S. Attorneys for each district to enforce the present severe restrictions on the growing and sale of marijuana or any products"
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