Roth%Conference% March%16,%2016%...
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Roth Conference March 16, 2016 NEMUS Bioscience OTCQB: NMUS
Transcript of Roth%Conference% March%16,%2016%...
Roth Conference March 16, 2016
NEMUS Bioscience OTCQB: NMUS
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Forward Looking Statement
This presenta-on contains “forward-‐looking statements” within the meaning of the “safe harbor” provisions of the Private Securi-es Li-ga-on Reform Act of 1995. All of the statements in this presenta-on, whether wriGen or oral, that refer to expected or an-cipated future ac-ons and results of NEMUS Bioscience, Inc. (NEMUS) are forward-‐looking statements. These forward-‐looking statements reflect the beliefs and expecta-ons of the management of NEMUS as of the date of this presenta-on. NEMUS cannot give any assurance that such forward-‐looking statements will prove to be correct. The reader is cau-oned not to place undue reliance on these forward-‐looking statements. The informa-on provided in this presenta-on does not iden-fy or include any risk or exposures, of NEMUS that would materially adversely affect the performance or risk of the company. For a descrip-on of the risks and uncertain-es related to the business of NEMUS, see our Annual Report on Form 10-‐K filed with the Securi-es and Exchange Commission and our subsequent periodic reports filed with the Securi-es and Exchange Commission. All informa-on contained in this presenta-on is provided as of the date of the presenta-on and is subject to change without no-ce. Neither NEMUS, nor any other person undertakes any obliga-on to update or revise publicly any of the forward-‐looking statements set out herein, whether as a result of new informa-on, future events or otherwise, except as required by law. This presenta-on does not convey an offer of any type and is not intended to be, and should not be construed as, an offer to sell, or the solicita-on of an offer to buy, any securi-es of NEMUS.
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OTCQB NMUS
Price (3/15/16) $0.785
Market Cap (3/15/16) $15.6 M
Shares Outstanding 19.9 M common & 4500 PS, 25.5 M if 100% converted
% Ownership by Directors & Employees
31.4% shares 1.2 M op-ons
Warrants Outstanding 10.9 M (Avg. Strike @ $1.15)
Founded 2012
Base of Opera-ons Costa Mesa, California & Oxford, Mississippi
Company Overview
NEMUS Bioscience is a publicly traded, life-‐science biotech company, focused on developing regulatory-‐approved, cannabinoid-‐based therapies, for a
spectrum of diseases, especially those of unmet medical need
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NEMUS Value ProposiNon
• NEMUS is focused on developing cannabinoid molecules for the treatment and management of acute and chronic diseases, especially those of unmet medical need
• NEMUS is the sole development and commercializaNon partner of the University of Mississippi, drawing on 47 years of intellectual capital in cannabinoid chemistry and physiology from the only enNty with a Federal license to directly study cannabinoids
• NEMUS is advancing therapeuNcs for medical applicaNons in global mulN-‐billion dollar markets including:
ü A cannabinoid franchise in ophthalmology in glaucoma and re6nal diseases
ü Pallia6ve care in oncology (CINV and CIPN)
ü An6-‐infec6ves, especially in strains developing resistance to an6bio6cs (MRSA)
• Proprietary product pipeline led by a pro-‐drug of tetrahydrocannibinol (THC) and novel deriva-ves of cannabidiol (CBD)
• NEMUS management team has proven track-‐record in drug research, pharmaceu-cal & biotech development, and public company experience on a global scale
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Recent Milestones
• August, 2015: Comple-on of Series B $5 million financing round
• September, 2015: globally-‐recognized glaucoma expert Dr. Robert N. Weinreb joins NEMUS Scien-fic Advisory Board
• October, 2015: Patent issued in Japan for NB1111 (THC prodrug)
• December, 2015: NEMUS in-‐licenses CBD deriva-ves from UM and ini-ates research into chemotherapy induced periphernal neuropathy (CIPN)
• January, 2016: interna-onally recognized cancer expert Dr. Donald I. Abrams joins NEMUS Scien-fic Advisory Board
• January, 2016: NEMUS announces valida-on of NB1111 data in glaucoma with 45% decline in IOP
• January, 2016: NEMUS announces ini-a-on of development program for chemotherapy-‐induced nausea and vomi-ng (CINV) and expects to request a pre-‐IND mee-ng with FDA in H1’16
• February, 2016: NEMUS signs agreement with AMRI to manufacture proprietary API for glaucoma (NB1111) and CINV (NB1222) programs
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NEMUS Cannabinoid Prodrug Programs Hold CompeNNve Advantages Orally administered cannabinoids (both pill and spray delivery mechanisms) hold a variety of disadvantages for paNents: • Poor bioavailability vs other routes of administraNon • Irregular pharmacokineNcs secondary to GI absorpNon • SuscepNble to significant first-‐pass metabolism by the liver
– “Due to extensive first-‐pass metabolism and high lipid
solubility, a frac-on of the drug reaches the circula-on”1
– “The pharmacologic effects of Marinol are dose-‐related and subject to considerable inter-‐pa-ent variability”1
– “Intoxica-on type reac-ons appear dose-‐related due to great inter-‐pa-ent drug level variability” 2
– “The pharmacokine-c data show great inter-‐subject variability”3
1) Marinol Summary Basis of Approval 2) Sa6vex Product Labelling -‐ Black Box Warning 3) Sa6vex Product Labelling
NEMUS prodrug technology designed to capitalize on the use of proprietary formulaNons that could allow for alternaNve delivery methods miNgaNng risk of unpredictable plasma levels that can compromise safety and efficacy
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InnovaNve Cannabinoid FormulaNons Designed for Improved Drug Delivery
-‐
• Ocular delivery: Glaucoma & re-nal diseases • Transmucosal delivery: CINV & CIPN (suppository &
buccal patch)
• Transmembranous delivery: An--‐infec-ves (An--‐MRSA) (nasal/transdermal)
All NEMUS licensed delivery opNons opNmize our prodrug cannabinoid technology by enhancing bioavailability through
avoiding first-‐pass liver metabolism and offering more predictable pharmacokineNcs
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• The University of Mississippi (UM) is the only enNty in the US authorized by NIDA and the DEA to cul-vate cannabis on behalf of the federal government
• The University of Mississippi has a con-nuous 45+ year regulatory history in dealing with FDA, DEA, NIDA, NIH, etc.
• NEMUS has exclusive, perpetual, worldwide exclusivity for all compounds and targets we are working on with UM for key fields of delivery
• NEMUS has:
• Recurring op6on agreements for unique THC and CBD deriva6ve molecules including patent 8,809,261 issued August, 2014 covering NCE of cannabinoid prodrug esters
• Mul6ple method of delivery agreements including ocular, transmembranous, transmucosal
• Mul6ple research agreements including CIPN and MRSA
The Only Federally-‐Approved Source of Cannabis-‐Derived Compounds
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Development Pipeline: OpNmizing THC and CBD Delivery Through Unique FormulaNons
Drug Name Target Delivery Research Pre-‐clinical Phase 1 Phase 2/3
NB1222 (THC-‐based)
Chemotherapy-‐induced nausea & vomiNng (CINV)
Suppository & Buccal Patch
NB1111 (THC-‐based)
Glaucoma/Ophthalmology Targets
Sustained Ocular
ID pending (CBD-‐based)
Chemotherapy-‐induced peripheral neuropathy (CIPN)
Trans-‐membranous
ID pending
Methicillin-‐Resistant Staph Aureus (MRSA)
Topical & Transdermal
Target indicaNons are mulN-‐billion dollar global markets of urgent medical need
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NB1222
Treatment of Chemotherapy-‐Induced
Nausea and Vomi-ng (CINV)
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NB1222: Chemotherapy-‐Induced Nausea and VomiNng (CINV)
• There are an es-mated 15 million cancer cases globally according to the Interna-onal Agency for Research on Cancer
• 25%-‐30% of pa-ents receive chemotherapy; of the chemotherapy recipients, 70%-‐80% experience CINV
• The global CINV market exceeds $1.3 B
• Dronabinol is an orally administered synthe-c version of THC approved for cachexia in HIV and nausea/vomi-ng in CINV with annual sales for CINV in excess of $110 MM (Source: IMS Health)
• NEMUS plans to develop a suppository version of our proprietary prodrug of THC, NB 1222, for use in CINV by filing an NDA via the expedited regulatory pathway of 505(b)(2)
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NB1222 Advantages Versus Dronabinol in CINV
-‐1
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PD 1 3 5 7 9 11 13 15 17 19 21 23
Plasma Co
ncen
traN
ons (ng/
ml)
Timepoint (h)
A Comparison of THC Plasma ConcentraNons From ProDrug THC Suppository* vs. dronabinol in Humans
Dronabinol 10 mg THC 10 mgEg
• Bioavailability: Dronabinol has been found to have a bioavailability of 6%-‐15% while a prodrug of THC administered via suppository yielded a bioavailability of roughly 70%*
• AbsorpNon: Orally administered dronabinol can have erra-c absorp-on from the gut coupled to varying plasma levels due to first-‐pass metabolism in the liver; a suppository avoids the upper GI tract and thereby de-‐risks the nega-ve effect of first-‐pass metabolism on the drug pharmacokine-cs
• Adverse Events: Oral dronabinol has been associated with nausea and vomi-ng adverse events; a suppository route of administra-on mi-gates that side effect
• PharmacokineNcs: THC prodrug dosing using a suppository allows greater drug exposure (graph above) and maintenance within the therapeu-c window versus peak/trough PK with oral dosing
Source: NEMUS Internal Data
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NB1111 For the Treatment of
Glaucoma
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Visual Field Defect in Glaucoma How the World is Seen With Glaucoma
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The Glaucoma Market
• $8 billion globally and growing with aging popula-ons • A leading cause of blindness in the US • $2.3 billion US market (32 MM Rx) • Regulatory pathway well-‐defined • Regulatory strategy: Poten-al for “urgent medical need” and “breakthrough therapy” FDA designa-ons;
• Glaucoma as a “Non-‐responder” market presents greater opportuni-es; >50% of pa*ents on 2 or more Rx
• Cannabinoids have shown neuroprotec-ve quali-es in vitro and in vivo (mul-ple animal species)
• Licensing and acquisiNons in the glaucoma market occur predominantly earlier in development (pre-‐clin, phase 1)
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NB1111 (Glaucoma/Ophthalmology)
Sustained release treatment with a proprietary THC prodrug could bring a new therapeuNc class directly to the target organ, avoiding systemic exposure
OCULAR FEATURES OF NB1111 • Penetrates all chambers of the eye • Produces a 45% reduc-on in Intra-‐Ocular Pressure (IOP) in glaucoma animal model (THC has been shown to lower IOP in previous human tes-ng) • ReducNon of IOP is the only proven method to treat glaucoma • Sustained release via implantable delivery vehicle enhance compliance • PotenNally first medicaNon to exert direct neuroprotec-on of the op-c nerve (re-nal ganglion cells; RGCs) by inhibi-ng apoptosis pathway • NeuroprotecNon is the “holy grail” of glaucoma
The proprietary formulaNon allows THC to be absorbed across membranes that are normally barriers to absorpNon
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THC Lowers IOP in Humans; PredicNve Animal Model Consistent with Human Experience
• The acNve moiety of NB1111, THC, has been shown to lower IOP in mul-ple human studies • THC delivered by inhala-on (smoking) or edible lowered IOP 40% to 65% but compromises blood flow to re-na via systemic vasodila-on and dosing complicated by short half-‐life
• The NEMUS prodrug NB1111 achieved a 45%-‐50% reduc-on in IOP in validated rabbit glaucoma model tes-ng conducted at UM • New formulaNon tesNng of NB1111 will confront the compliance issue of topical drops (eyedrops) by development of implantable sustained release device • Next stage tesNng:
• Canine/primate studies looking at IOP lowering effect as single dose and mul--‐dose via implantable device
• In vitro and in vivo studies assessing neuroprotec-ve biomarkers
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THC Can Address MulNple MOAs in Lowering IOP and Preserving ReNnal Ganglion Cells (RGCs) Therapy Class
Mechanism of Ac-on (MOA)
Increased flow trabecular mesh
Increased flow uveoscleral pathway
Decreased fluid produc-on
Direct neuroprotec-ve
quali-es
Prostaglandins (50% mkt share)
X
β-‐ adrenergic blockers (30%)
X
α-‐ adrenergic agonists (10%)
X X
Carbonic anhydrase inhibitors (<5%)
X
Cholinergic agonists (<5%)
X
Pro-‐drug THC (NB1111)
X X X X
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CHEMOTHERAPY-‐INDUCED PERIPHERAL NEUROPATHY (CIPN)
CBD DERIVATIVES
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Chemotherapy-‐Induced Peripheral Neuropathy (CIPN): Market Data • CIPN is a dose-‐dependent complica-on associated with many types of
chemotherapeu-c agents
• In addiNon to severe, someNmes unremimng pain, it can also lead to premature discon-nua-on of chemotherapy which in turn can compromise responses to cancer treatment
• No agents have been shown to prevent CIPN and currently there is a significant unmet medical need for therapies that can mi-gate the pain without complica-ons associated with addicNon and gastrointesNnal obstrucNon
• The CIPN market in the United States exceeds $500 MM (LifeSci Advisors, 2013) and the parallel opioid-‐induced cons-pa-on market is es-mated to be $600 MM globally (GlobalData, 2015)
• NEMUS has signed a research agreement with UM to test CBD-‐related deriva-ves in validated animal models of CIPN
• NEMUS expects to complete proof-‐of-‐concept in vivo and in vitro tesNng in 2016 with basic science data presented at appropriate scien-fic mee-ngs
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METHICILLIN-‐RESISTANT STAPHYLOCOCCUS AUREUS
MULTIPLE CANNABINOID
DERIVATIVES
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MRSA Has Become a Global Urgent Health Concern
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Methicillan-‐Resistant Staph Aureus (MRSA)
MRSA FACTS & CURRENT MEDICAL LANDSCAPE • First described in 1961 now a pandemic • CDC: prevalence of MRSA in ICU sevng approaching 60% • 1960’s: one gene-c MRSA muta-on/clone; currently six MRSA gene-c clones; 15 clones in China • 2010 hospital survey: 61.8% of pa-ents admiGed to ICU were MRSA colonized1
• 50% of screened pa-ents had healthcare-‐associated infec-ons1 • 11,000 deaths annually; 80,000 invasive infec-ons/yr.2 • Annual costs in the US: $3.2 -‐ $4 billion2
1) Jarvis WR et al; Am J Infect Control 2012; 40(3): 194-‐200 2) Pew Trust MRSA Survey; April 3, 2012
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Methicillan-‐Resistant Staph Aureus (MRSA)
NEMUS is Assessing a New Class of AnN-‐InfecNves to Combat the Threat of AnNbioNc Resistance
CANNABINOID EXPERIENCE IN MRSA1
• Select cannabinoids have been known to possess some an-bacterial proper-es 1 • AnN-‐bacterial properNes can be leveraged to address newly developed strains exhibi-ng an-bio-c resistance to current meds • NEMUS intends to seek IP protecNon concerning the use of transmembrane enhancing formulaNons of cannabinoids to facilitate bacteriocidal ac-vity • A spectrum of gram-‐posi-ve organisms will be screened in addiNon to MRSA
1) J Nat Prod. 2008 Aug;71(8):1427-‐30. doi: 10.1021/np8002673. Epub 2008 Aug 6. -‐ An-bacterial cannabinoids from Cannabis sa-va: a structure-‐ac-vity study
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Upcoming InflecNon Point Timelines
2016 Developmental Goals
H1-‐2016 • Contract API manufacturer
for THC-‐val-‐HS • Ini-ate 2yr stability study API • Ini-ate in vivo MRSA studies • Ini-ate CIPN in vivo studies • Complete ini-al canine/
primate study • Hold FDA pre-‐IND mee-ng:
NB1222 (CINV)
H2-‐2016 • Hold FDA pre-‐IND mee-ng: NB1111
(Glaucoma) • Ini-ate primate sustained release
glaucoma study: NB1111 • Ini-ate IND enabling studies: NB1111 • Complete MRSA in vivo studies • Ini-ate MRSA tox studies • Ini-ate CINV tox bridging studies:
NB1222 • Ini-ate human BA-‐PK study in CINV • Ini-ate formula-on work on new CBD
formula-on for CIPN
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NEMUS Bioscience, Inc. (OTCQB: NMUS)
• NEMUS is focused on developing cannabinoid molecules for the treatment and management of acute and chronic diseases, especially those of unmet medical need
• NEMUS cannabinoid molecules are engineered to enhance trans-‐membrane transport resulNng in: ü Enhanced bioavailability ü Permits routes of administra6on that avoid first-‐pass metabolism by the liver ü Resul6ng in more predictable pharmacokine6cs ü Patent issued in August, 2014 allows long IP runway with broad claims and reach for
the delivery of molecules and condi6ons that can be treated
• NEMUS is the sole development and commercializaNon partner of the University of Mississippi, drawing on 47 years of intellectual capital in cannabinoid chemistry and physiology
• NEMUS is advancing therapeuNcs for medical applica-ons in global mul--‐billion dollar markets including a cannabinoid franchise in ophthalmology, palliaNve care in oncology, and anN-‐infecNve medicines, especially in strains developing resistance to an-bio-cs
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Management
BRIAN MURPHY, MD, MPH, MBA – Chief ExecuNve Officer; Chief Medical Officer, Director Dr. Murphy has almost two decades of experience in drug development and evalua-on, both from the academic and industry perspec-ve. He most recently served as the CMO of Eiger Biosciences. Previously, Dr. Murphy was CMO at Valeant Pharmaceu-cals Interna-onal (VRX) where his responsibili-es also included oversight of Global Medical Affairs and Pharmacovigilance. Dr. Murphy also served as Medical Director, then VP of Marke-ng and Commercial Strategy of Hepatology for InterMune, Inc. (ITMN). Prior to InterMune, Dr. Murphy was Medical Director of North America for An-virals/Interferons at Hoffmann-‐LaRoche. Murphy is board-‐cer-fied in internal medicine and completed his residency at Tuws-‐New England Medical Center. He went on to complete parallel fellowship tracts at Harvard Medical School and the MassachuseGs General Hospital. Dr. Murphy earned his MD, MPH (general public health), and MS (pharmacology) degrees from New York Medical College and is a graduate of the Harvard School of Public Health (MPH in Health Policy and Management). He earned his MBA at the Columbia University Graduate School of Business.
LIZ BERECZ, MA, CPA -‐ Chief Financial Officer Elizabeth Berecz is a seasoned financial execu-ve with over 20 years of experience holding senior level posi-ons in both private and public companies. She has proven success in leading strategic planning, financial repor-ng, and global system implementa-ons for companies of various sizes. Liz started her career at Price Waterhouse Silicon Valley where she spent five years audi-ng several high profile public companies in the technology industry. She then spent 10 years holding key leadership posi-ons in various publicly held Companies including Quantum Corpora-on (Corporate Controller), Business Objects (VP Finance and Administra-on), and Excite (VP Finance), followed by 10 years of key leadership roles in privately held Companies including CFO posi-ons with Op-cal Shop Interna-onal, StarTrac Inc., Power Balance Technologies, Inc. and most recently Bentley Mills, Inc. She also serves as an Adjunct Professor of Accoun-ng and Finance at the University of San Francisco. Elizabeth received her BA in Economics from Stanford University and a MA in Sports Management from University of San Francisco.
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Management
COSMAS N. LYKOS, ESQ – Co-‐founder, Officer & Board Member – ExecuNve Chairman Cosmas Lykos co-‐founded NEMUS in 2012 and has served as its Chairman of the Board of Directors since August 2014. Awer gradua-ng with Honors from Duke University School of Law in 1993, Mr. Lykos began his career at Gibson Dunn & Crutcher, LLP, an interna-onal full-‐service law firm, as a corporate associate un-l 1998. From 1998 to 2004, Mr. Lykos served as Vice President of Business Affairs, General Counsel, Secretary and Chief Compliance Officer of RemedyTemp, Inc., a NASDAQ publicly-‐traded temporary staffing firm with over 250 directly-‐owned and franchised offices na-onwide. From 2004 un-l 2008, Mr. Lykos served as Vice President of Business Development, Chief Legal Officer, Secretary and Chief Compliance Officer of Oakley, Inc., a NYSE publicly-‐traded sports and technical eyewear, apparel, accessories and retail company. In January of 2008, he became Co-‐owner and President of the Op-cal Shop Interna-onal, a designer and distributor of licensed eyewear brands, including Chrome Hearts and Blinde, through two wholly-‐owned foreign subsidiaries with a direct and distributor sales network in over 60 countries around the world. Primary responsibili-es included developing and implemen-ng OSI’s vision and strategies and the management of its foreign subsidiaries, sales, legal, human resources, finance and administra-ve func-ons. In 2011, Mr. Lykos nego-ated and consummated the sale of OSI to its primary licensor, Chrome Hearts LLC and con-nues to provide consul-ng services. Mr. Lykos has extensive public and private company board of directors experience. As Chief Compliance and Legal Officer and Secretary of both Oakley, Inc. and RemedyTemp, Inc., Mr. Lykos aGended all board of director mee-ngs and board commiGee mee-ngs. As an angel investor, Mr. Lykos has made minority investments in various private companies and has served on their Board of Directors.
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BOD & Strategic Advisors
MAHMOUD A. ELSOHLY, PHD ScienNfic Advisor World’s foremost expert on the science of cannabinoids. 300+ scien-fic publica-ons . Research professor at The University of Mississippi.
JERRY MCLAUGHLIN, MBA Strategic Advisor, Board of Directors -‐ Member CEO of AgeneBio; 25 year veteran execu-ve in pharmaceu-cal medical device and healthcare related industries (Endo Pharma, Merck, MBA-‐ Villanova University,BA-‐ Dickinson College).
TOM GEORGE Board of Directors – Chairman of Audit Commitee
30 year senior execu-ve in corporate finance and accoun-ng; CFO of Deckers Brands ( Ophthonix, Oakley, Coopers & Lybrand). Graduate of University of Southern California.
DOUGLAS S. INGRAM, ESQ Board of Directors – Vice Chairman, Chairman of CompensaNon Commitee 25 year senior execu-ve in healthcare, Past President of Allergan, former AGorney at Gibson, Dunn & Crutcher, LLP. Summa cum laude and Order of the Coif graduate of the Univ. of Arizona school of law.
ROBERT N. WEINREB, M.D. ScienNfic Advisor Chair, Ophthalmology Advisory Board Globally recognized expert on glaucoma and eye diseases. 1000+ scien-fic publica-ons. Dis-nguished Professor of Ophthalmology; University of California San Diego.
DONALD I. ABRAMS, M.D. ScienNfic Advisor Chief, Hematology/Oncology at UCSF Cancer and Integra-ve Medicine specialist with research interests in the development of an--‐cancer therapeu-cs and pallia-ve care medicines.
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Contact
650 Town Center Drive, Suite 1770
Costa Mesa, CA 92626 949-‐396-‐0330
[email protected] www.nemusbioscience.com
Investor RelaNons: Adam Holdsworth PCG Advisory Group Tel: 646-‐862-‐4607 [email protected]
Company: Brian Murphy, MD, MPH, MBA CEO -‐ CMO Tel: 949-‐355-‐1140 [email protected]
