Rock Creek Pharmaceuticals Inc
Rock Creek Pharmaceuticals — Investor Presentation (June 2015)
31 slides from Rock Creek Pharmaceuticals's investor presentation, Jun 11, 2015
Slide 1: June 2015 Investor Presentation
June 2015 Investor Presentation (NASDAQ: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: Investment Highlights
• Focused on discovery, development and commercialization of prescription pharmaceuticals for chronic inflammatory diseases and neurological disorders • Lead drug candidate, Anatabine Citrate, is a novel small molecule, cholinergic agonist o Phase I clinical trial underway – data expected 3Q 2015 o
Slide 4: Anatabine Citrate: Key Attributes
• Small molecule • Exhibits anti - inflammatory pharmacological characteristics via Cholinergic Receptor Binding • Excellent bioavailability • Crosses blood brain barrier • Well tolerated as dietary supplement by several hundred thousand users Anatabine Citrate : Key Attributes 4
Slide 5: Potential Therapeutic Applications
Potential Therapeutic Applications 5 Anatabine Autoimmune Diseases 2014 2013 2011 2012 Alzheimer’s Disease Inflammation 2013 2013
Slide 6: Anatabine Citrate: NF-kB Signaling Pathways
Anatabine Inflammatory Molecules: TNF - α, IL - 1, IL - 6, IFN - γ, Cox - 2 Amyloid, etc. α - 7 nAChR Antabine Citrate: NF - ƙB Signaling Pathways 6
Slide 7: Signaling Pathways: Mechanism of Action
7 Anatabine JAK IKK STAT3 P - STAT3 P65 NFkB * * Signaling Pathways: Mechanism of Action Daniel Paris, David Beaulieu - Abdelahad, Ghania Ait - Ghezala , Venkat Mathura , , Megha Verma, Alex E Roher, Jon Reed , Fiona Crawford 1, Michael Mullan , (2015) Anatabine Attenuates Tau Phosphorylation and Ol
Slide 8: Anatabine Citrate: Proposed MOA
Proposed Common Mechanism(s) of Action across Different CNS and non - CNS Conditions Suppression of inflammatory activity (via NF - kB, STAT3) Activation of alpha 7 nAChR on microglia, macrophage, monocytes, B - cells, T - cells Reduced inflammatory cytokine release Reduced tissue damage Reduced org
Slide 9: Evaluating Anatabine Citrate in Human Thyroid Health
Hashimoto's thyroiditis cytology showing lymphocytes and Hurthle cell metaplasia Lowell R. Schmeltz et al, (2014) Anatabine Supplementation Decreases Thyroglobulin Antibodies in Patients With Chronic Lympho cyt ic Autoimmune (Hashimoto’s) Thyroiditis: A Randomized Controlled Clinical Trial. J Clin E
Slide 10: Autoimmune Thyroiditis: Human Study
Anti - thyroglobulin Antibodies in Anatabine Citrate Treated Thyroiditis Patients were Reduced Lowell R. Schmeltz et al, (2014) Anatabine Supplementation Decreases Thyroglobulin Antibodies in Patients With Chronic Lympho cyt ic Autoimmune (Hashimoto’s) Thyroiditis: A Randomized Controlled Clinical T
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: Incidence of Hind Limb Paresis
12 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 Encepha lomyelitis by Anatabin
Slide 13: Preclinical Model of Multiple Sclerosis
• Reduced nerve damage in Anatabine treated EAE mouse spinal cord 13 Preclinical Model of Multiple Sclerosis * Paris D, Beaulieu - Abdelahad D, Mullan M, Ait - Ghezala G, Mathura V, et al. (2013) Amelioration of Experimental Autoimmune Encepha lomyelitis by Anatabine. PLoS ONE 8(1): e55392. doi:10.1
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 * Paris D, Beaulieu - Abdelahad D, Mullan M, Ait - Ghezala G, Mathura V, et al. (2013) Amelioration of Experimental Autoimmune Encepha lomyelitis by Anatabine. PLoS ONE 8(1): e55392. do
Slide 15: Anatabine Citrate: Psoriasis Indication
15 Anatabine Citrate: Psoriasis Indication TPA Induced Epidermal Hyperplasia (Psoriasis Mouse Model)
Slide 16: Topical Anatabine: Psoriasis Mouse Model
Control TPA TPA+ Anatabine Topical Topical Anatabine: Psoriasis Mouse Model 16
Slide 17: Topical Anatabine: Psoriasis Mouse Model
P<0.001 P<0.001 17 Topical Anatabine: Psoriasis Mouse Model 0. 27.5 55. 82.5 110. 137.5 Control (n=8) TPA (n=8) TPA+Anatabine (n=8) Acanthosis (µm)
Slide 18: P-p65NFkB Immuno-Staining
18 P - p65NFkB Immuno - Staining Topical Anatabine : Psoriasis Mouse Model
Slide 19: P-p65NFkB Reduction
19 0. 3.25 6.5 9.75 13. Control (n=8) TPA (n=8) TPA+Anatabine topical (n=8) P - p65NFkB Burden (%) P<0.001 P<0.001 P - p65NFkB Reduction Topical Anatabine: Psoriasis Mouse Model TPA (n=8)
Slide 20: P-STAT3 Immuno-Staining
20 P - STAT3 Immuno - Staining Topical Anatabine in Psoriasis Mouse Model P - STAT3 Immuno - Staining
Slide 21: P-STAT3 Reduction
0. 3.5 7. 10.5 14. Control (n=8) TPA (n=8) TPA+Anatabine Topical (n=8) Skin P - STAT3 Burden (%) P<0.001 P<0.001 Topical Anatabine : Psoriasis Mouse Model P - STAT3 Reduction 21
Slide 22: Anatabine Citrate: Regulatory Strategy
• Phase 1 underway in EU o Clinical Trial Application (CTA) approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK (January 2015) o Trial being conducted by CRO Quotient Clinical in Nottingham, UK o Study Completion expected in Third Quarter/2015 • Investigational New D
Slide 23: Anatabine Citrate: Phase I Trial Design
• Initial dosing of first cohort of 14 healthy subjects began in Feb . 2015 • Primary outcome measures : safety and tolerability • Secondary outcome measures : pharmacokinetic parameters • Exploratory outcome measures : pharmacodynamic (PD) assessment (impact of the drug on inflammatory processes) •
Slide 24: Potential Therapeutic Indications
• Dermatology (Psoriasis) • Arthritic Conditions (Osteoarthritis) • Inflammatory Bowel Disorders (Ulcerative Colitis, Crohn’s) • Auto - Immune Disorders (Thyroiditis) • CNS (Alzheimer’s, Multiple Sclerosis) Potential Therapeutic Indications 24 Initial Clinical Targets: Psoriasis & Osteoarthritis
Slide 25: Intellectual Property
03/01/14 • Six Issued US/Foreign Anatabine related patents: o Anatabine Citrate - Novel Compound ; US Patent 8,557,999 o Method of Anatabine synthesis • Six pending US and foreign patents pending for “use” of Anatabine, its isomers and derivatives for inflammatory conditions Intellectual Property 25
Slide 26: Upcoming Milestones
15 Q1 - 15 CTA Approval Phase I under CTA Safety, PK, PD data Drug Formulation development Phase IIA POC studies Q2 - 15 Q3 - 15 Q4 - 15 2016 Phase II studies CTA Phase I Complete Ongoing US IND Protocol Development Upcoming Milestones 26
Slide 27: Management Team
Management Team Michael Mullan, MBBS (MD), PhD - Chairman and 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, funded by multiple agencies
Slide 28: Scott P. Sensenbrenner • President and CEO of Enzymedica, Inc. • Executive experience in
Scott P. Sensenbrenner • President and CEO of Enzymedica, Inc. • Executive experience in marketing, supply chain, operations and financial management in the natural products industry • Overseen sales and marketing programs in public and private companies • Previously Group Director, Nutrition Divisi
Slide 29: Capitalization
Capitalization 29 As of March 31, 2015 ($000s) Cash and cash equivalents $91 Insurance proceeds receivable $3,529 Long - term debt $350 Common shares outstanding 8,111,700 Warrants outstanding (Wtd. avg. exercise price of $29.20/share) 1,119,840 Options outstanding (Wtd. avg. exercise price of $52.9
Slide 30: Investment Highlights
• Focused on discovery, development and commercialization of prescription pharmaceuticals for chronic inflammatory diseases and neurological disorders • Lead drug candidate, Anatabine Citrate, is a novel small molecule, cholinergic agonist o Phase I clinical trial underway – data expected 3Q 2015 o
Slide 31: 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 31
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