Rock Creek Pharmaceuticals Inc
Rock Creek Pharmaceuticals — Investor Presentation (September 2015)
31 slides from Rock Creek Pharmaceuticals's investor presentation, Sep 4, 2015
Slide 1: September 2015 Investor Presentation
September 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
Investment Highlights • Clinical stage company focused on discovery, development and commercialization of prescription pharmaceuticals which exploit the recently discovered cholinergic anti - inflammatory system • Distinct mechanism of action compared to NSAIDs, steroids and biologics • Platform mec
Slide 4: Rock Creek's Lead Opportunity - Dermatology
Rock Creek’s Lead Opportunity - Dermatology 4 • Initial opportunity to replace/enhance current topical therapeutics in the mild - to - moderate Psoriasis market which is approximately $1.2B worldwide • Potential to avoid many of the treatment - limiting side effects of steroids • Mechanism of action
Slide 5: Why Psoriasis?
Why Psoriasis? 5 • Establish Proof of Concept • Lead compound targets biology of Psoriasis (keratinocyte hyper - proliferation and inflammation) • Well absorbed in skin, allowing direct targeting of psoriatic lesions • Can easily observe changes in molecular drivers in real time with biopsy • Curren
Slide 6: Psoriasis Unmet Need
6 Psoriasis Unmet Need “The main unmet need in Psoriasis is for an agent that is as effective as biologics, but is safe enough to use in the treatment of mild cases of psoriasis, and that is not an injection. Although there is a well stocked R&D pipeline, with drug candidates that go some way to mee
Slide 7: Current Standard of Care: Topical Steroids
7 Current Standard of Care: Topical Steroids: • Mild to high potency, with/without vitamin D analogs • Limited use on face, other sensitive areas or skin folds • Long term or repeat short term use associated with; - Local: skin thinning, striae, bruising, purpura, skin tears, telangiectasia - Steroi
Slide 8: Cholinergic Anti-Inflammatory System
8 Terminal branch of vagus Acetylcholine RCP’s Lead Compound Mimics Acetylcholine Cholinergic Anti - Inflammatory System α7 nAChR brain lung heart liver spleen vagus nerve stomach kidney small/large bowel Macrophages WBC image: blausen.com staff. Blausen gallery 2014. Wikiversity Journal of Medicine
Slide 9: RCP's Lead Compound Mimics Acetylcholine
9 Acetylcholine binding on alpha 7 nicotinic receptor Anatabine binding on alpha 7 nicotinic receptor RCP’s Lead Compound Mimics Acetylcholine
Slide 10: Signaling Pathways: Mechanism of Action
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 Oligomer
Slide 11: Psoriasis Pathogenesis
Psoriasis Pathogenesis Normal skin Stimulus Keratinocytes Macrophages Monocytes Blood vessels a
Slide 12: Topical Formulations: Psoriasis Mouse Model
Control TPA TPA+ Anatabine Topical Topical Formulations: Psoriasis Mouse Model 12
Slide 13: Topical Formulations: Psoriasis Mouse Model (P-p65NFkB)
P - p65NF k B Immuno - Staining 13 Topical Formulations : Psoriasis Mouse Model
Slide 14: Topical Formulations: Psoriasis Mouse Model (P-STAT3)
P - STAT3 Immuno - Staining 14 Topical Formulations: Psoriasis Mouse Model P - STAT3 Immuno - Staining
Slide 15: Skin TNFα Reduction: Topical Formulations
15 Skin TNFα Reduction: Topical Formulations
Slide 16: Keratinocyte Proliferation: Topical Formulations
16 Keratinocyte Proliferation: Topical Formulations
Slide 17: Platform Relevant Data
Platform Relevant Data 17 Anatabine Autoimmune Diseases 2014 2013 2011 2012 Alzheimer’s Disease Inflammation 2014 2013 2013 2015
Slide 18: 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 19: Incidence of Hind Limb Paresis
19 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 20: Reduced nerve damage in Anatabine treated EAE mouse spinal cord
Reduced nerve damage in Anatabine treated EAE mouse spinal cord 20 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 21: Normalization of Inflammatory Spleen Cytokines in EAE mice
Normalization of Inflammatory Spleen Cytokines in EAE mice by Anatabine 21 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 22: 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 Endocrinol
Slide 23: Anti-thyroglobulin Antibodies Reduced in Treated Patients
Anti - thyroglobulin Antibodies in Anatabine Citrate Treated Thyroiditis Patients were Reduced 23 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 24: Intellectual Property
03/01/14 • Six Issued 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 • Six pending US and foreign patents pending for “use” of Anatabine, and salts thereof , its isomers and deri
Slide 25: Upcoming Anticipated Milestones
* Subject to adequate funding 15 Q1 - 15 CTA Approved Phase I Trial • Safety, PK, PD studies • Dose/Formulation • Food Effect • 7 Day, Double Blind Placebo Controlled Phase IB Trial Q1 • Proof of Concept • Mild - Moderate Psoriasis • Topical • Conducted in EU Q2 - 15 Q3 - 15 Q4 - 15 2017 Phase II Tr
Slide 26: Financials: Second Quarter 2015 Results
26 Financials SECOND QUARTER 2015 RESULTS Q2 2015 Q2 2014 Net Loss - $800,000 - $12,700,000 General, and Administrative Expenses $1,600,000 $ 11,200,000 Decrease of $9.6 million or 85.7% yoy (see below) $ 4.2 million: Restructuring C ost S avings Office Consolidation Reduced Headcount Lower Rent Exp
Slide 27: Capitalization
Capitalization 27 As of June 30, 2015 Cash and cash equivalents $2,993,000 Long - term debt $350,000 Common shares outstanding 10,873,863 Warrants outstanding Exercise price of $2.83/share) 1,233,375 Warrants outstanding (Wtd. avg. exercise price of $23.23/share) 1,127,599 Options outstanding (Wtd.
Slide 28: Management Team
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, funded by multiple
Slide 29: Board of Directors
Suni Chundru Samuel, MD, MBA • Chief Executive Officer of Sierra Molecular Corporation • Commercialized and developed medical devices, chemistry, molecular tools, overseen production, developed new product portfolios • Built sales channels with Fortune 500 distributors, and driven intellectual prope
Slide 30: Investment Highlights
Investment Highlights • Clinical stage company focused on discovery, development and commercialization of prescription pharmaceuticals which exploit the recently discovered cholinergic anti - inflammatory system • Distinct mechanism of action compared to NSAIDs, steroids and biologics • Platform mec
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
Rock Creek Pharmaceuticals — Investor Presentation (September 2015) on 6ix