Stephen F. Flaim, Ph.D., FACC, FAHA steve.flaim@techcoastangels.com flaimsf@nhlbi.nih.gov 1
Smart Imaging for the Oncologic Surgeon Human Breast Cancer White Light Blue Light • 20% of lumpectomies require redo surgeries at $6-8K/surgery • MAb-fluorescent tag construct – directly visible light • Inject IV 24-48 hrs prior to tumor resection surgery • Improves visible detection of tumor margin and mets • IP – tissue avid compound + fluorescent tag emitting light in visible range & used under direct visualization conditions 2
OncoFluor’s Technology Fluorophore Fluorescent-tagged MAb construct attached to MAb Tumor cell-surface antigen (protein molecule unique to cancer cells) Proof-of-concept studies complete MAb directed against the tumor cell-surface Manufacture/supply plans complete antigen Pre-IND meeting with FDA Tool indication, definitive path forward Final project plans and contractors for first-in-man study Patents issued (national phase) assigned to OncoFluor Rights to 6 MAbs covering 90% of surgically resectable tumors Friends & family round complete - $0.5M Total addressable market for breast cancer alone - $1.7B Series A round – IND enabling studies & first-in-man 3
Sustainable Cardiac Regeneration • Heart failure leading cause of death in the US (29%) o 700,000 deaths/yr - 29% of all US death (51% women) o 50% mortality within 5 years of diagnosis • Total US cost associated with heart failure >$30B/yr o >50% total due to re-hospitalization costs o >1M hospitalizations/yr in US due to HF o 25% of all re-hospitalizations at 1 month o Cost of physician office visits = $1.8B (2013) o Mean patient cost = $23,077 • Unmet medical need - market opportunity = $16B (post-MI) 4
CardioCreate’s Technology Pim-1 Gene Overexpression – Adult cardiac stem cells Control CPCe Marker Modified CPCeP + Marker Adult Cardiac Stem Cell Nucleus • Pim-1 enzyme is cardioprotective • CPCePs home, engraft and divide • Asymmetric division – “stemness” preserved • Daughter cells are cardiac and vascular • Presence sustained for 32 weeks or more • Significant improvement in cardiac function • Functional benefit sustained for > 8 months • Angel round + non-dilutive NIH funding ($21M) • Launching Series A – first-in-man trial
Problem • Pulmonary arterial hypertension (PAH) • Unmet medical need – progressive & highly fatal • Current therapies have adverse side-effects • Other potential indications CAR Peptide Solution • CARSKNKDC (CAR) peptide • CAR binds to diseased glycocalyx • Promotes enhanced drug delivery • Increases selectivity & efficacy of co-administered therapeutics 6
CAR Peptide • Half-life of 27 hours o Orally bioavailable o No side-effects found • 2-3 fold increase in localized drug activity • No commercially available products using this approach • Can reduce unwanted side effects of systemic therapies • May have multiple disease targets o pulmonary hypertension o fibrotic disorders o wound healing (2-fold decrease in wound healing time) o autoimmune disorders • Funding o Angel round - $0.5M o Non-dilutive NIH - $2M 7
Chronic Obstructive Pulmonary Disease (COPD) Combination of small airway disease (chronic bronchitis) and parenchymal destruction (emphysema) 12.7 million U.S. adults diagnosed with COPD – will increase with aging population (4 th leading cause of death worldwide by 2020) COPD Market Opportunity Global market is expected to be greater than $15B by 2019 Top therapies for COPD had sales of over $1B in 2012 Current COPD Therapies Improve COPD management but not progression or mortality (treat symptoms) An effective anti-inflammatory agent could reduce the frequency and severity of exacerbations and inhibit the functional decline of lungs of COPD patients Significant competitive advantage over current marketed COPD therapies 8
SX-682 Mechanism CXCR1/2 receptor inhibitor in neutrophils Blocks neutrophil migration to lungs SX-682 Breaks cycle of inflammation/tissue damage Potential for first-in-class therapeutic treatment Proof-of-concept work complete IC 50 = 55 nM in isolated human neutrophils 1 mg/kg potently inhibits neutrophil influx in rat model of pulmonary inflammation Once daily, orally bioavailable Funding Status and Plans $6.2M non-dilutive to date – NIH Launching Series A round CMC, IND enabling studies, first-in-man clinical trial Exit via acquisition 9
Stephen F. Flaim, Ph.D., FACC, FAHA steve.flaim@techcoastangels.com flaimsf@nhlbi.nih.gov 10
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