nemus bioscience inc. investor presentation (062915)

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Investor Presentation June 2015 OTCQB: NMUS

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Page 1: Nemus Bioscience Inc. Investor Presentation (062915)

Investor PresentationJune 2015

OTCQB: NMUS

Page 2: Nemus Bioscience Inc. Investor Presentation (062915)

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Forward Looking Statement

This presentation is for informational purposes only. This presentation 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 solicitation of an offer to buy, any interest in any fund or any other investment or investment vehicle. All information contained in this presentation is provided as of the date of the presentation (or the earlier date, if any, set forth in this presentation), and is subject to change without notice. Opinions expressed herein are subject to change without notice and any investment views expressed herein represent the views of NEMUS Bioscience, Inc. (NEMUS), as of the date of preparation of this presentation only and not as of any future date. The information provided in this presentation does not identify or include any risk or exposures, of which NEMUS may or may not be aware, and that would materially adversely affect the performance or risk of the company. In addition, any business strategies employed by the company may involve, among other techniques, licensing, wholesale and various derivatives, each of which entails separate and distinct risks. More generally, this presentation does not, and is not intended to, provide a discussion of the risk factors to which the company is subject. Neither this presentation nor any part of this presentation may be modified, manipulated, reproduced, or distributed without the prior written authorization of NEMUS. Any modification, manipulation, reproduction, or distribution of any of the contents of this presentation may constitute a violation of securities laws/or other laws. None of NEMUS, any company, any affiliate of the foregoing, and any personnel, principals, or agents of any of the foregoing shall be liable for any errors (to the fullest extent permitted by law in the absence of willful misconduct) in the production or contents of this presentation. By accepting this presentation, the recipient acknowledges and agrees that all of the information contained in this presentation shall be kept strictly confidential.

This presentation contains, or may contain, “forward-looking statements.” Generally, the words “intend,” “believe,” “anticipate,” ”expect,” “may,” “should,” “could,” “will,” and other future-oriented terms identify forward-looking statements. Forward-lookingstatements include, but are not limited to, statements relating to the distribution of NEMUS products. These forward-looking statements are based upon the current beliefs and expectations of the management of NEMUS and involve risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Many of these risks and uncertainties relate to factors that are beyond NEMUS’ ability to control or estimate precisely. NEMUS is also subject to general business risks and other risks and uncertainties. NEMUS cannot give any assurance that such forward-looking statements will prove to have been correct. The reader is cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this announcement. Neither NEMUS, nor any other person undertakes any obligation to update or revise publicly any of the forward-looking statements set out herein, whether as a result of new information, future events or otherwise.

Page 3: Nemus Bioscience Inc. Investor Presentation (062915)

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OTCQB NMUS

Price (3/31/15) $4.25

Market Cap (3/31/15) $69.28 M

Shares Outstanding 16.3 M

% Ownership by Directors & Employees

25.81% shares1.77 M options

Warrants Outstanding 4.05 M (Avg. Strike @ $1.00)

Founded 2012

Base of OperationsCosta Mesa, California & Oxford, Mississippi

Company Overview

VISION - To offer physicians and patients the medical benefits of "condition-specific" cannabinoids to alleviate symptoms associated with a range of debilitating diseases

MISSION - To become the premier developer of cannabis-based pharmaceuticals to address unmet medical needs on a global basis

Page 4: Nemus Bioscience Inc. Investor Presentation (062915)

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NEMUS Investment Highlights

• Proprietary product pipeline led by a new chemical entity, a pro-drug of THC

• Patent issued for composition of matter and any formulations/combinations

• The lead compound, NB1111 is a first in class in the treatment for glaucoma

• NEMUS is the only partner of the University of Mississippi for discovery, research and commercialization of cannabis-derived medicines

• The University of Mississippi is the only U.S. entity authorized by the Federal government to cultivate cannabis for research

• A management team with proven pharmaceutical, biotech development and public company experience on a global scale

Page 5: Nemus Bioscience Inc. Investor Presentation (062915)

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Currently approved cannabinoids have poor bioavailability

Oral cannabinoids (both pill and spray delivery mechanisms) are subject to high patient to patient variability

• Metabolism varies on individuals genetic metabolic profile

• Plasma levels influenced by other medications

• Drug levels impacted by what a patient has eaten

– “Due to extensive first-pass metabolism and high lipid solubility, a fraction of the drug reaches the circulation”1

– “The pharmacologic effects of Marinol are dose-related and subject to considerable interpatient variability”1

– “Intoxication type reactions appear dose-related due to great inter-patient drug level variability” 2

– “The pharmacokinetic data show great inter-subject variability”3

1) Marinol Summary Basis of Approval2) Sativex Product Labelling - Black Box Warning3) Sativex Product Labelling

NEMUS will capitalize on the use of proprietary formulations that may allow for alternative delivery methods

Page 6: Nemus Bioscience Inc. Investor Presentation (062915)

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Goal: To Deliver The Benefits More Predictably

NEMUS has licensed a new chemical entity and formulations that may allow for improved delivery of cannabinoids

Ocular Trans-mucosal Rectal

-1

4

9

PD 1 3 5 7 9 11 13 15 17 19 21 23

Pla

sma

Co

nce

ntr

atio

ns

(ng/

ml)

Timepoint (h)

A Comparison of THC Plasma Concentrations From The DHS Suppository* vs. Marinol

Marinol 10 mg THC 10 mgEg

Source: NEMUS Internal Data - *NEMUS has not licensed the particular DHS suppository formulation used in this comparison.

All NEMUS licensed delivery options avoid

bioavailability-compromising first-pass metabolism by the liver

Page 7: Nemus Bioscience Inc. Investor Presentation (062915)

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NEMUS and the University of Mississippi have entered into multiple agreements

Recurring Option Agreement for the NCEUM 5050 – THC Ester – Recurring option agreement on any use of THC ester. (Patent issued in Aug, 2014)

Method of Delivery AgreementsUM 4718 – Suppository Delivery of Dronabinol Hemisuccinate (DHS) – Exclusive worldwide license to intellectualproperty, proprietary data and know-how related to a suppository dosage form containing DronabinolHemisuccinate and other esters. (“NPC 4718”) and development through FDA.

UM 1490 – TransMucosal Delivery of Cannabinoids – Exclusive worldwide license to intellectual property,proprietary data and know-how related to transmucosal delivery of cannabinoids (“UM1490”) and developmentthrough FDA.

UM 8790 – Ocular Delivery of Cannabinoids – Exclusive worldwide license to intellectual property, proprietary dataand know-how related to ocular delivery of cannabinoids (“UM 8790”) and development through FDA.

Research AgreementUM 5070 – MRSA – Exclusive worldwide option to license intellectual property, proprietary data and know-howrelated to the treatment of methicillin-resistant Staphylococcus aureus infections using cannabinoids (“UM5070”) and development through FDA.

Page 8: Nemus Bioscience Inc. Investor Presentation (062915)

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NEMUS Licensed the Rights from UOM

US Patent : 8,809,261

• Issued Aug 19, 2014 to University of Mississippi.

• Compositions containing delta-9-THC-amino acid esters and process of preparation.

• Consists of 66 claims:

– Amino acid, hemi-succinate, hemi-gluturate forms of THC.

– Preparation of several forms of amino acid, hemi-succinate, and hemi-gluturate forms of THC.

– Compositions that contain forms of amino acid, hemisuccinate, and hemi-gluturate forms of THC.

– “Any condition that can respond to the prodrugsof delta-9-THC in a pharmaceutically acceptable carrier.”

- The claims are both wide and deep. -

Page 9: Nemus Bioscience Inc. Investor Presentation (062915)

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Visual Field Defect in Glaucoma

9

How the world is seen with glaucoma

Page 10: Nemus Bioscience Inc. Investor Presentation (062915)

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Our Strategic Asset Management evaluation concluded that glaucoma was the most attractive first target

• $8 billion globally and growing with aging populations

• Leading cause of blindness in the US

• $2.3 billion US market (32 MM Rx)

• Regulatory pathway well-defined

• Potential for “urgent medical need” and “breakthrough therapy”

• Non-responder market presents opportunities for study alternatives increasing the likelihood of success

• Licensing and acquisitions in the glaucoma market occur predominantly earlier in development (pre-clin, phase 1)

Page 11: Nemus Bioscience Inc. Investor Presentation (062915)

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NB1111 - Glaucoma

Topical treatment with a NEMUS formulation could bring a new therapeutic class directly to the target organ, avoiding systemic exposure

FEATURES OF THE NEMUS LEAD COMPOUND

• Penetrates all chambers of the eye

• Produces a reduction in Intra-Ocular Pressure (IOP) in glaucoma animal model

• Reduction of IOP is the only proven method to treat glaucoma

• No systemic THC detected post ocular administration

• QD to BID dosing objective

• Potentially first medication to target the optic nerve through two mechanisms in addition to relieving IOP

The proprietary formulation allows THC to be absorbed across membranes that are normally barriers to absorption.

Page 12: Nemus Bioscience Inc. Investor Presentation (062915)

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Page 13: Nemus Bioscience Inc. Investor Presentation (062915)

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Only NB1111 addresses all four MOAs

Therapy Class

Mechanism ofAction (MOA)

Increased flow Trabecular mesh

Increased flow uveoscleral

pathwayDecreased fluid

production

Directneuroprotective

qualities

Prostaglandins X

β- adrenergic blockers

X

α- adrenergicagonists

X X

Carbonic anhydrase inhibitors

X

Cholinergic agonists

X

Pro-drug THC(NB1111)

X X X X

Page 14: Nemus Bioscience Inc. Investor Presentation (062915)

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THC has been shown to lower IOP in humans

• Active moiety of pro-drug has been shown to lower IOP in human testing

• Testing conducted by leading universities, the NIH, and the US Army

• THC component of pro-drug lowered IOP in human glaucoma up to 65% - better than any currently approved compound

• The NEMUS pro-drug formulation achieved a 45%-50% reduction in IOP in a rabbit glaucoma model – better than any currently approved compound

• Rabbit glaucoma model presented at AAPS meeting November, 2014 by University of Mississippi

• Novel formulation of pro-drug will enhance half-life and effect of the drug

Page 15: Nemus Bioscience Inc. Investor Presentation (062915)

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Rabbit Model: THC-Prodrug Outperforms THCin Intensity and Time of Maximum Effect *

15

* Bhagav P, et al. Development of Δ9-tetrahydrocannabinol prodrug and improved IOP lowering efficacy; AAPS Poster Session, November, 2014

Page 16: Nemus Bioscience Inc. Investor Presentation (062915)

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THC-val-HS outperforms timolol and pilocarpine in IOP reduction*

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* Bhagav P, et al. Development of Δ9-tetrahydrocannabinol prodrug and improved IOP lowering efficacy; AAPS Poster Session, November, 2014

Page 17: Nemus Bioscience Inc. Investor Presentation (062915)

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Unlike many licensing deals, optho deals are often done early in development

0

10

20

30

40

50

60

70

80

Ophthalmology deals Related to Pharmaceuticalsn=265 2007-2014

Acq/purchase

License

Of 408 deals related to ophthalmology revealed in SEC documents, 265 were related to pharmaceuticals, from early to late stage.

Page 18: Nemus Bioscience Inc. Investor Presentation (062915)

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With on-going success, the NPV grows, as does the NEMUS share of the value

Page 19: Nemus Bioscience Inc. Investor Presentation (062915)

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Value grows after Phase 1 and again after Phase 2(ex, glaucoma @ $750MM peak year)

Page 20: Nemus Bioscience Inc. Investor Presentation (062915)

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Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017 Q3 2017

NB1111 Development Timeline: Glaucoma

CMC & Formulation

Clinical Batch Production

IND Enabling Studies

File IND

FPI

Clinical Site Contracting

Phase 1b/2a Study

LPO

Page 21: Nemus Bioscience Inc. Investor Presentation (062915)

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Use of proceeds

ACTIVITY PROJECTED COST

CMC*-FORMULATION $2.6 million

IND** ENABLING STUDIES & FILING $3.2 million

CLINICAL PHASE 1b/2a Study $1.8 million

PROJECTED TOTAL $7.6 million

Page 22: Nemus Bioscience Inc. Investor Presentation (062915)

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Developing Cannabis-Derived Medicine Has Challenges

INCB

NIDA

DEA

FDA

HIGHLY REGULATED

• Conducting clinical research using marijuana typically involves interactions with three federal agencies: FDA, DEA and NIDA

• Cannabis cultivation and trade are the subject of restrictions under the Single Convention on Narcotic Drugs, an international treaty

• DEA authorization is one condition for legally cultivating cannabis in the U.S.

DIFFICULT RESEARCH ENVIRONMENT

• Limited numbers of clinical sites for recruiting patients

HARDER IMPORTATION REQUIREMENTS

• Importation of cannabinoid products also involves multiple agencies beyond the FDA

Page 23: Nemus Bioscience Inc. Investor Presentation (062915)

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The Only Federally-Approved Source of Cannabis

• The Single Convention treaty requires member nations (over 100) to designate a single entity eligible to cultivate cannabis for research purposes

• The University of Mississippi is the only entity in the US that is authorized by NIDA and the DEA to cultivate cannabis on behalf of the federal government

• The University of Mississippi has a continuous 35+ year regulatory history in dealing with FDA, DEA, NIDA, NIH, etc.

• A January 22, 2013, U.S. Court of Appeals for the District of Columbia Circuit upheld DEA’s continued classification of cannabis as a Schedule I controlled substance, subject to stringent regulation

• In March, 2015, NIDA once again granted the 5yr contract to the University

• This also presents hurdles to the development, commercialization and importation of products into the U.S.

Page 24: Nemus Bioscience Inc. Investor Presentation (062915)

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Key Partnership With University Of Mississippi

• NEMUS has licensed the rights to a novel THC pro-drug. The recently issued patent contains claims for composition of matter, formulation, delivery and method of use

• NEMUS has entered into multiple license agreements and a research agreement for specific formulations and corresponding delivery methods

• NEMUS has perpetual, worldwide exclusivity for all compounds and targets we are working on with UM

• UM provides over 45 years of knowledge and experience in the science of cannabinoids

• NEMUS has leased a lab in the UM state-of-the-art incubator adjacent to the natural products labs

• NEMUS has access to a large number of globally recognized scientists and thought leaders in cannabinoid medicine

• NEMUS has partnered with UM to further develop and, if approved, commercialize cannabis derived products that UM has developed, including those progressing through a discovery pipeline

Page 25: Nemus Bioscience Inc. Investor Presentation (062915)

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Drug Pipeline

Drug Name Target Research Pre-clinical Phase 1 Phase 2 Phase 3

NB1111 Glaucoma

NB2221Multiple SclerosisSpasticity

NB51R1 Anxiety

NB23R1 Epilepsy

NB31R1Methicillin-Resistant Staph Aureus

In parallel to the THC program which is entering preclinical IND-enabling studies, NEMUS is also preparing development tracts for other biologically active cannabinoids, including but not limited to CBD

Page 26: Nemus Bioscience Inc. Investor Presentation (062915)

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Candidate - Methicillan-Resistant Staph Aureus (MRSA)

MRSA FACTS & CURRENT MEDICAL LANDSCAPE

• First described in 1961 and has progressively grown as a global health crisis

• CDC: prevalence of MRSA in ICU setting approaching 60%

• 1960’s: one genetic MRSA mutation/clone; currently six MRSA genetic clones

• 2010 hospital survey: 61.8% of patients admitted to ICU were MRSA colonized1

• 50% of screened patients had healthcare-associated infections1

• 11,000 deaths annually; 80,000 invasive infections/yr.2

• Annual costs in the US: $3.2 - $4 billion2

1) Jarvis WR et al; Am J Infect Control 2012; 40(3): 194-2002) Pew Trust MRSA Survey; April 3, 2012

Page 27: Nemus Bioscience Inc. Investor Presentation (062915)

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Candidate - Methicillan-Resistant Staph Aureus (MRSA)

NEMUS is assessing a new class of anti-infectives to combat the threat of antibiotic resistance

CANNABINOID EXPERIENCE IN MRSA1

• Cannabis has long been known to contain antibacterial cannabinoids, whose potential to address antibiotic resistance

• All five major cannabinoids showed potent activity against a variety of MRSA strains of current clinical relevance

• Activity was remarkably tolerant to the nature of the prenyl moiety, to its relative position compared to the n-pentyl moiety (abnormal cannabinoids)

• Methylation and acetylation of the phenolic hydroxyls, esterification of the carboxylic group of pre-cannabinoids, and introduction of a second prenyl moiety were all detrimental for antibacterial activity and reproduction

1) J Nat Prod. 2008 Aug;71(8):1427-30. doi: 10.1021/np8002673. Epub 2008 Aug 6. - Antibacterial cannabinoids from Cannabis sativa: a structure-activity study

Page 28: Nemus Bioscience Inc. Investor Presentation (062915)

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Manufacturing Partnership & Raw Materials

NATURAL(UM PARTNERSHIP)

SYNTHETIC(LAB PARTNERSHIP)

EXTRACT(UM PARTNERSHIP)

• NEMUS and our partners at UM have more than 40 years of combined experience in cannabis genetics including developing specific strains for selected characteristics, cloning and tissue culture in the laboratory, maturing plants both in greenhouses and outdoors, and optimizing cannabinoid production

• NEMUS has leased an on-site facility at UM, where it expects to extract cannabinoids subject to authorization from federal, state, and local regulators

• UM has an existing inventory of cannabis extracts that it plans to supply to NEMUS, subject to authorization from federal, state, and local regulators, for immediate start-up and as a buffer. NEMUS believes this potential for immediate supply is a distinct access advantage over prospective competitors.

• NEMUS plans to assist UM to further develop state of the art growing and manufacturing processes, and plans to innovate via the identification and isolation of cannabinoid, the development of synthetic-based cannabinoid-like compounds, and the development of new combinations thereof

• NEMUS plans to enter into a supply agreement with UM to obtain raw materials for current and future needs, subject to authorization from federal, state, and local regulators

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Commercialization Strategy

NEMUS will initially operate through a strategically aligned network of vendors and partners

• Strategic direction• Clinical/regulatory responsibility• Legal/IP• Management of partners• Business development• Commercialization in selected

markets

• Raw material and IPUniversity of Mississippi

• Extraction, drug candidates and knowledge

Private MS-based lab

• Develop and execute IP strategyLegal/IP Partner

• Drug developmentAtheln and/or

other out-sourced CMO/CRO firm

• ManufacturingAPI

• CommercializationPharma/Biotech

Page 30: Nemus Bioscience Inc. Investor Presentation (062915)

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World Class Management and Partners

Management Team Representing 80+ Years Experience From

World Class Partners

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Management

COSMAS N. LYKOS, ESQ – Co-founder, Officer & Board Member – Executive Chairman Cosmas Lykos co-founded Nemus in 2012 and has served as its Chairman of the Board of Directors since August2014. After graduating with Honors from Duke University School of Law in 1993, Mr. Lykos began his career at GibsonDunn & Crutcher, LLP, an international full-service law firm, as a corporate associate until 1998. From 1998 to 2004, Mr.Lykos served as Vice President of Business Affairs, General Counsel, Secretary and Chief Compliance Officerof RemedyTemp, Inc., a NASDAQ publicly-traded temporary staffing firm with over 250 directly-owned and franchisedoffices nationwide. From 2004 until 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 Optical Shop International,a designer and distributor of licensed eyewear brands, including Chrome Hearts and Blinde, through two wholly-ownedforeign subsidiaries with a direct and distributor sales network in over 60 countries around the world. Primaryresponsibilities included developing and implementing OSI’s vision and strategies and the management of its foreignsubsidiaries, sales, legal, human resources, finance and administrative functions. In 2011, Mr. Lykos negotiated andconsummated the sale of OSI to its primary licensor, Chrome Hearts LLC and continues to provide consulting services. Mr.Lykos has extensive public and private company board of directors experience. As Chief Compliance and Legal Officer andSecretary of both Oakley, Inc. and RemedyTemp, Inc., Mr. Lykos attended all board of director meetings and boardcommittee meetings. As an angel investor, Mr. Lykos has made minority investments in various private companies and hasserved on their Board of Directors.

JOHN B. HOLLISTER, MBA – CEO & Board Member John Hollister brings over 25 years of leadership experience ranging from large pharma to start-up. His experience includes all facets of the product lifecycle from pre-human to phase IV management and leading cross-functional teams. John has led multiple pharmaceutical product launches at SmithKline Beecham as a Senior Product Manager for Pediatric Vaccines and with Amgen as the Global Commercial Leader for Oncology. John led Global Commercial teams to bring products into first in human studies all the way through Phase III (AMGEN). As a strategic consultant, he has worked with a variety of early stage companies to refine their plans. Two of these resulted in senior positions: CEO for a device company, EEG Spectrum, and Senior VP for a diagnostic company, Tethys Bioscience. He has a strong working knowledge of all facets of drug development and commercialization. He received his BA in Economics from Stanford University and his MBA from the Drucker Center at the Claremont Graduate University.

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Management

BRIAN MURPHY, MD, MPH, MBA - Chief Medical OfficerDr. Murphy has more than 15 years experience in drug development and evaluation, both from the academic and industry perspective. He most recently served as the CMO of Eiger Biosciences. Previously, Dr. Murphy was CMO at Valeant Pharmaceuticals International (VRX) where his responsibilities also included oversight of Global Medical Affairs and Pharmacovigilance. Dr. Murphy also served as Medical Director, then VP of Marketing and Commercial Strategy of Hepatologyfor InterMune, Inc. (ITMN). Prior to InterMune, Dr. Murphy was Medical Director of North America for Antivirals/Interferons at Hoffmann-LaRoche. Murphy is board-certified in internal medicine and completed his residency at Tufts-New England Medical Center. He went on to complete parallel fellowship tracts at Harvard Medical School and the Massachusetts 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 OfficerElizabeth Berecz is a seasoned financial executive with over 20 years of experience holding senior level positions in both private and public companies. She has proven success in leading strategic planning, financial reporting, and global system implementations for companies of various sizes. Liz started her career at Price Waterhouse Silicon Valley where she spent five years auditing several high profile public companies in the technology industry. She then spent 10 years holding key leadership positions in various publically held Companies including Quantum Corporation (Corporate Controller), Business Objects (VP Finance and Administration), and Excite (VP Finance), followed by 10 years of key leadership roles in privately held Companies including CFO positions with Optical Shop International, StarTrac Inc., Power Balance Technologies, Inc. and most recently Bentley Mills, Inc. She also serves as an Adjunct Professor of Accounting 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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BOD & Strategic Advisors

MAHMOUD A. ELSOHLY, PHD Scientific Advisor

World’s foremost expert on the science of Cannabis. 300+ scientific publications . Research professor at UM.

JERRY MCLAUGHLIN, MBA Strategic Advisor, Board of Directors - Member

25 year veteran executive in pharmaceutical medical device and healthcare related industries (AgeneBio, Merck, Endo Pharma, Villanova University, Dickinson College).

DAVID SKIBINSKI, MBAStrategic Advisor

25 year health care industry experience (GlaxoSmithKline, 12+ Early Stage Companies).

TOM GEORGEBoard of Directors – Chairman of Audit Committee

30 year senior executive in corporate finance and accounting (Deckers Brands, Ophthonix, Oakley).

DOUGLAS S. INGRAM, ESQBoard of Directors – Vice Chairman, Chairman of Compensation Committee

25 year senior executive in healthcare, Past President of Allergan, former Attorney at Gibson, Dunn & Crutcher, LLP. Summa cum laude and Order of the Coif graduate of the Univ. of Arizona school of law.

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Contact

650 Town Center Drive, Suite 1770Costa Mesa, CA 92626

(949) [email protected]

www.nemusbioscience.com

Investor RelationsMike Cole, Vice President MZ North AmericaTel: [email protected]

CompanyJohn Hollister, CEOTel: [email protected]