Rock Creek Pharmaceuticals Inc
Rock Creek Pharmaceuticals — Investor Presentation (May 2016)
38 slides from Rock Creek Pharmaceuticals's investor presentation, May 16, 2016
Slide 1: Rock Creek Pharmaceuticals, Inc. (OTCQB: RCPI)
May 2016 Rock Creek Pharmaceuticals, Inc. (OTCQB: RCPI)
Slide 2: Forward Looking Statements
Forward Looking Statements Certain statements contained in this presentation constitute forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as "believes," "expects
Slide 3: Overview
Overview 3 Rock Creek Pharmaceuticals is a n emerging drug development company focused on the discovery , development and commercialization of new drugs, formulations and compounds that provide therapies for chronic and acute inflammatory diseases.
Slide 4: Investment Highlights
Investment Highlights • F ocused on discovery, development and commercialization of prescription pharmaceuticals which exploit the recently discovered cholinergic anti - inflammatory system with d istinct ly different mechanism of action compared to NSAIDs, steroids and biologics • Topical safety an
Slide 5: Lead Compound: Anatabine Citrate
5 • Small molecule • Exhibits anti - inflammatory pharmacological characteristics • Crosses blood brain barrier • Excellent bioavailability • Well tolerated as dietary supplement by several hundred thousand users Potential Therapeutic Indications • Dermatology Psoriasis, Atopic Dermatitis • Arthriti
Slide 6: Platform Relevant Data
Platform Relevant Data 6 Anatabine Autoimmune Diseases 2014 2013 2011 2012 Alzheimer’s Disease Inflammation 2014 2013 2013 2015
Slide 7: Intellectual Property
03/01/14 • Thirteen Issued (or in “grant phase”) US /Foreign Anatabine - related patents • Novel Compound: Anatabine Citrate • US Patent #: 8,557,999 Issue Date: 10/15/2013 • Method of Anatabine large - scale synthesis • Twenty US and foreign patents pending for “use” of Anatabine, and salts thereof
Slide 8: Anatabine Signaling Pathways: Mechanism of Action
JAK STAT3 GSK3ß P65 NFkB Activated P65 NFkB P - STAT3 Inflammatory molecule Receptor Inflammatory cytokines TNF - α , IL - 1, IL - 6, etc. Anatabine Signaling Pathways: Mechanism of Action 8
Slide 9: Inhibition of Activated NF-kB with Anatabine
9 Inhibition of Activated NF - k B with Anatabine HIGH RESOLUTION LASER CONFOCAL STUDY (560X Magnification) • Human Inflammatory Cells - Microglia • Treated with TNF a as inflammatory stimulus • Fluoresence Immunostaining showing “green” activated NF k B , in relation to “blue” cell nucleus • Simult
Slide 10: Inhibition of Activated NF-kB with Anatabine
10 Inhibition of Activated NF - k B with Anatabine Control TNFα 25ng/ml TNFα + Anatabine Human Microglia
Slide 11: Experimental Autoimmune Encephalomyelitis (EAE) Model
• Mice injected at 0 hr and 48 hrs with 300 µg of Pertussis toxin • Day 1, 10 Week - old C57Bl6/J Female mice immunized with 300 µg of murine MOG35 - 55 (myelin oligodendrocyte glycoprotein) • Mice randomized into 2 groups: o Placebo group (n=15) receiving regular drinking water o Anatabine group (n
Slide 12: Reduced nerve damage in Anatabine treated EAE mouse spinal cord
Reduced nerve damage in Anatabine treated EAE mouse spinal cord 12 Preclinical Model of Multiple Sclerosis * Paris D, Beaulieu - Abdelahad D, Mullan M, Ait - Ghezala G, Mathura V, et al. (2013) Amelioration of Experimental Autoimmune Encephalomyelitis by Anatabine. PLoS ONE 8(1): e55392. doi:10.1371
Slide 13: Incidence of Hind Limb Paresis
13 0. 17.5 35. 52.5 70. 87.5 0 2 4 6 8 10 12 14 16 18 Incidence of Hind Limb Paresis Day After MOG Vaccination Placebo (n=15) Anatabine (n=15) * Paris D, Beaulieu - Abdelahad D, Mullan M, Ait - Ghezala G, Mathura V, et al. (2013) Amelioration of Experimental Autoimmune Encephalomyelitis by Anatabine
Slide 14: Normalization of Inflammatory Spleen Cytokines in EAE mice
Normalization of Inflammatory Spleen Cytokines in EAE mice by Anatabine 14 Preclinical Model of Multiple Sclerosis Anatabine * Paris D, Beaulieu - Abdelahad D, Mullan M, Ait - Ghezala G, Mathura V, et al. (2013) Amelioration of Experimental Autoimmune Encephalomyelitis by Anatabine. PLoS ONE 8(1): e
Slide 15: Autoimmune Thyroiditis: Human Study
Hashimoto's thyroiditis cytology showing lymphocytes and Hurthle cell metaplasia Lowell R. Schmeltz et al . Anatabine Supplementation Decreases Thyroglobulin Antibodies in Patients With Chronic Lymphocytic Autoimmune (Hashimoto’s) Thyroiditis: A Randomized Controlled Clinical Trial. J Clin Endocrino
Slide 16: Anti-thyroglobulin Antibodies Reduced in Treated Patients
Anti - thyroglobulin Antibodies in Anatabine Citrate Treated Thyroiditis Patients were Reduced 16 Lowell R. Schmeltz et al . Anatabine Supplementation Decreases Thyroglobulin Antibodies in Patients With Chronic Lymphocytic Autoimmune (Hashimoto’s) Thyroiditis: A Randomized Controlled Clinical Trial.
Slide 17: New Zealand Pharmacodynamic Study
New Zealand Pharmacodynamic Study 17 Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal, Healthy Volunteers • New Zealand Ministry of Health Ethics Committee Approval • Determination as to whether a single dose of orally administered anatab
Slide 18: Phase I (PD) and (PK) Data
18 Phase I (PD) and (PK) Data • U.K. Phase I clinical trial approved and regulated by the United Kingdom’s Medicines and Healthcare Products Agency (MHRA) • Three Part Trial; 10 - 14 healthy human subjects; Testing for safety and tolerability; Over 100 doses varied by dose and time release profile •
Slide 19: Focus on Psoriasis and Related Skin Disorders
Focus on Psoriasis and Related Skin Disorders 19 • Establish Proof of Concept • Expedient development pathway (As compared to Alzheimers ’ disease, auto immune thyroiditis and multiple sclerosis) • Lead compound targets biology of Psoriasis ( k eratinocyte hyper - proliferation and inflammation) • W
Slide 20: Psoriasis Pathogenesis
Psoriasis Pathogenesis QRockCreek Normal skin Psoriatic skin Keratinocyte hyper-proliferation Stimulus Keratinocytes Dendritic cells Tells ieyy ra @ Macrophages % Monocytes
Slide 21: Psoriasis: TPA Rodent Model
Control TPA TPA+ Anatabine Topical Psoriasis : TPA Rodent Model 21 Skin Sections: Epidermal staining (arrowed)
Slide 22: NFk-B Activation, Psoriasis: TPA Rodent Model
NF k - B Activation (P - p65NF k - B) 22 Psoriasis : TPA Rodent Model
Slide 23: STAT3 Activation, Psoriasis: TPA Rodent Model
P - STAT3 Immuno - Staining 23 STAT3 Activation (P - STAT3) Psoriasis : TPA Rodent Model
Slide 24: Reduction in Skin TNFα levels with Anatabine
24 Reduction in Skin TNFα levels with Anatabine treatment Psoriasis : TPA Rodent Model
Slide 25: Psoriasis: Imiquimod Rodent Model
25 Psoriasis: Imiquimod Rodent Model • Imiquimod (IMQ): Potent i mmune a ctivator • Clinically recognized m odel of human plaque - type psoriasis • Characterized by: 1. Histological epidermal changes 2. Inflammatory cell infiltration 3. Keratinocyte proliferation 4. Spleen and lymph node enlargement
Slide 26: Psoriasis: Imiquimod Rodent Model Skin Sections
26 Control IMQ IMQ + Placebo IMQ + Antabine Ointment IMQ + Betamethasone Psoriasis: Imiquimod Rodent Model Skin Sections: Epidermal staining (arrowed)
Slide 27: Atopic Dermatitis (Eczema) TMA Rodent Model
Atopic Dermatitis (Eczema) TMA Rodent Model Day 0 Timeline of trimellitic anhydride (TMA) treatments 50µL 5% TMA (Flank skin) Day 5 10µL 5% TMA (Ears) Day 6 to Day 14 (daily treatment) 10µL 2% TMA (Ears) Anatabine cream or ointment (Ears) Timeline of anatabine treatments (cream or ointment) Day 9 to
Slide 28: Atopic Dermatitis TMA Rodent Model Skin Sections
28 Control TMA TMA + Anatabine Cream TMA + Anatabine Ointment Atopic Dermatitis (Eczema) TMA Rodent Model Skin Sections: Epidermal staining (arrowed)
Slide 29: Effect of Anatabine treatments on ear thickness
29 Control (n=8) Anatabine Treatment Begins Atopic Dermatitis (Eczema) TMA Rodent Model TMA alone (n=8) TMA + Anatabine Cream (n=8) TMA + Anatabine Ointment (n=8) Effect of Anatabine treatments on ear thickness
Slide 30: Dermatology Advisors
Professor Christopher Griffiths , MD , FMedSci Foundation Professor of Dermatology at the University of Manchester • P ublished over 530, peer reviewed scientific articles ; Lead editor of Rook’s Textbook of Dermatology • R esearch includes all aspects of psoriasis Professor Vincent Piguet , MD , Ph
Slide 31: Preclinical & Clinical Development: Upcoming Anticipated Milestones
* Timing dependent on capital availability 15 CTA Approved Phase I Trial • Safety, PK, PD studies • Dose/Formulation • Food Effect • 7 D ay Randomized Study Phase IB Tri al Q4 2016 • Mild - Moderate Psoriasis/Topical • Dose Range Study • Clinical Read - Out: Q1 2017 • Proof of Concept/ Conduct ed ex
Slide 32: Financials: 2015 Annual Results
Financials 2015 ANNUAL RESULTS YEAR END 2015 YEAR END 2014 Net Loss (Decrease of $31.7mn from 2014 ) - $ 6,800 ,000 - $ 38 , 5 00,000 GENERAL AND ADMINISTRATION EXPENSES TWELVE MONTHS ENDING DEC 2015 ( Decrease of $20.2 million or 69.6% from 2014 ) 12 MONTHS DEC 2015 $8,800,000 12 MONTHS DEC 2014 $2
Slide 33: $20mn Senior Convertible Notes
$20mn Senior Convertible Notes 33 • Transaction Closed 10/15/2015 • Payable in 20 monthly installments accruing 8% (per annum interest) • Convertible into Company common stock at $1.12 a share (or at a discount to market price, if lower, at time of conversion) • General corporate purposes and ongoin
Slide 34: Capitalization
Capitalization 34 As of March 31 , 201 6 Cash and cash equivalents $ 552,000 Long - term debt $4,170,000 Current Portion of long term debt $12,350,000 Common shares oustanding 15,024,017 Warrants issued after 06/15/15 ( wtd.avg . price of $0.97/share) 4,516,944 W arrants issued before 06/15/15 ( wtd
Slide 35: Experienced Management Team
Experienced Management Team Michael Mullan, MBBS (MD), PhD - Chairman , President & Chief Executive Officer • Recognized authority on Alzheimer's disease and related disorders - "Top 100 Cited Alzheimer Investigators" • Former CEO of The Roskamp Institute, a non - profit research organization, funde
Slide 36: Board of Directors
Robert Scannell , • Co - Founder and General Partner of IASO Advisors, LLC, an investment firm focused on healthcare and biotech • Founder and General Partner of Tradewinds Investment Management ($400mn in assets/20 year track record) • Juris Doctorate from Concord Law School, Los Angeles, CA, MBA F
Slide 37: Investment Highlights
Investment Highlights • F ocused on discovery, development and commercialization of prescription pharmaceuticals which exploit the recently discovered cholinergic anti - inflammatory system with d istinct ly different mechanism of action compared to NSAIDs, steroids and biologics • Topical safety an
Slide 38: For more information, please contact
For more information, please contact: Theodore Jenkins VP, Corporate Strategy & Development 2040 Whitfield Avenue, Suite 300 Sarasota, FL 34243 (941) 251 - 0488
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