Capricor Therapeutics, Inc. · NASDAQ:CAPR
Capricor Therapeutics — Q3 2014 Earnings Presentation
21 slides from Capricor Therapeutics's earnings presentation, Nov 12, 2014
Slide 1: Quarterly Conference Call 3rd Quarter, 2014
QUARTERLY CONFERENCE CALL 3 rd Quarter, 2014 November 12, 2014 4:30p.m. EST / 1:30p.m. PST
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward - looking statements and information that are based on the beliefs of the management of Capricor Therapeutics, Inc. (Capricor) as well as assumptions made by and information currently available to Capricor. Statements in this presentation
Slide 3: Capricor Therapeutics Overview
Capricor Therapeutics Overview Clinical - stage biotechnology company with a diversified pipeline and near - term focus on cardiovascular diseases including orphan indications Peptide therapy for heart failure ( Cenderitide ) Cardiac - derived stem cells (CDCs) Micro - RNA Platform (Exosomes) 3
Slide 4: Quarterly Financial Highlights
Balance Sheet Highlights (approximate) 9.30.14 12.31.13 Cash (Includes restricted cash and marketable securities) $13.8M $3.5M Outstanding Common Shares 11,703,774 11,687,747 P&L Highlights (approximate) Three months ended 9.30.14 Three months Ended 9.30.13 Income $1.3M $0.1M R&D Expenses $2.0M $1.0
Slide 5: Notable AHA Presentations
Notable AHA Presentations American Heart Association Scientific Sessions Chicago, IL (November 15 - 19) Mon. 11/17 4:00pm – 6:00pm South Hall - A2 ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR): the One Year Phase I Results Mon. 11/17 4:00pm – 6:00pm South Hall - A2 Heart -
Slide 6: Clinical Update
Leeeniaey Therapeutics Clinical Update
Slide 7: CDCs: Clinical Development Post Myocardial Infarction
CDCs: Clinical Development Post Myocardial Infarction (30 days – 1 year after MI) ALLSTAR Clinical Trial NYHA Class III or ambulatory Class IV heart failure DYNAMIC Clinical Trial IND granted, Phase II currently enrolling IND granted, Phase I plan to commence in 2014 Phase I – 14 patients Phase II –
Slide 8: ALLSTAR Phase I 12-Month MRI Analysis
ALLSTAR Phase I – 12 month MRI Analysis ▪ ALLSTAR Phase I ▪ Met safety endpoint (1 month) ▪ No control group ▪ Preliminary 12 month MRI analysis on Phase II equivalent population (defined by tissue type compatibility) ▪ Ejection fraction improved by 5.2% ▪ Relative reduction in scar size of 20.7% ▪
Slide 9: ALLSTAR: Phase II Clinical Trial
ALLSTAR: Phase II Clinical Trial ▪ Ejection Fraction ≤ 45% and Infarct Size ≥ 15 % (MRI ) ▪ Primary Endpoint – Infarct Size by MRI at 1 year ▪ Secondary Endpoints – multiple; EF, volumes, quality of life, etc. ▪ Phase II: Est. 300 patients – currently enrolling ▪ 23 sites activated ALL ogeneic heart
Slide 10: New Indication: Duchenne Muscular Dystrophy
New Indication: Duchenne Muscular Dystrophy
Slide 11: Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy ▪ Affects 1 in 3,500 male births worldwide ▪ ~20,000 male children affected in the US (~275,000 worldwide) ▪ The disease is usually fatal; a majority of deaths occur due to cardiomyopathy ▪ Compelling pre - clinical data to be presented at AHA in November 2014 ▪ Targeting
Slide 12: Upcoming Conference Call
Upcoming Conference Call ▪ Tuesday – November 18, 2014 ▪ 9:30AM (EST) ▪ Hosted by Dr. Linda and Eduardo Marbán ▪ Topic: Cardiosphere - derived Cells and their Exosomes Improve Function, Restore Mitochondrial Integrity and Reverse Degenerative Changes in the Hearts of Mdx Mice ▪ Data to be presented
Slide 13: Cenderitide Update
DD eapnicen Therapeutics Cenderitide Update
Slide 14: Cenderitide: A Unique Protein Drug
Cenderitide: A Unique Protein Drug - S - S - K L L D R I G S M S G L G G F C C K G S L G NH 2 P S L R D P R P N A P S T S A CD - NP ▪ Developed by scientists at the Mayo Clinic and derived from the venom of the green mamba snake ▪ Cenderitide : ▪ Cardiac unloading ▪ Renal function preserved ▪ Aldost
Slide 15: Annual U.S. Cenderitide Market Opportunity
Annual U.S. Cenderitide Market Opportunity Reference: Go AS et al., Circulation , 2013, Desai AS et al., Circulation ,2012 ▪ Heart failure - leading cause of hospitalizations among adults older than 65 years of age in the US ▪ Costs $17 billion annually ▪ Responsible for over 1 million hospital admi
Slide 16: The Post-Acute Hospitalization Period (90 days)
The Post - Acute Hospitalization Period (90 days): When the Rate of Re - hospitalization and Death are Highest 0% 20% 40% 60% - 60 120 180 240 300 360 Percent of Patients Days After Hospital Admission for Heart Failure % of Patients with Death or Re - hospitalization after admission for Acute HF Ref
Slide 17: Continuous Subcutaneous Infusion Using Insulet Omnipod Technology
Continuous Subcutaneous Infusion Using the Insulet Omnipod ® Technology ▪ Entered into a Research Support Agreement with Insulet Corporation (NASDAQ: PODD ) ▪ Insulet will supply Omnipod ® for planned clinical trial: ▪ Engage in product development ▪ Project management ▪ D esign control activities S
Slide 18: Acquisition of Medtronic IP
Acquisition of Medtronic IP ▪ Entered into an agreement to acquire patent rights from Medtronic, Inc. (NYSE: MDT ) ▪ Related to the formulation and pump delivery of natriuretic peptides. ▪ Assigned to Capricor all of its right, title and interest in all natriuretic peptide patents and patent applica
Slide 19: Cenderitide as a Potential Treatment for Post-Acute Heart Failure
Cenderitide as a Potential T reatment for Post - Acute Heart Failure Target Indicatio n Treatmen t Duration 90 days of out - patient treatment after hospital discharge for acute decompensated heart failure Drug Delivery FDA Status Subcutaneous infusion using the Insulet Omnipod ® validated technolog
Slide 20: Anticipated Milestones
Anticipated Milestones ▪ 2014 ▪ Report additional ALLSTAR Phase I results (AHA) ▪ Initiate DYNAMIC clinical trial ▪ 2015 ▪ Initiate Duchenne Muscular Dystrophy trial ▪ Initiate Cenderitide trial ▪ Report initial Cenderitide results ▪ Report initial DYNAMIC results 20
Slide 21: Thank you
DD eapnicen Therapeutics ™ Thank you
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