Stephen F. Flaim, Ph.D., FACC, FAHA steve.flaim@techcoastangels.com - - PowerPoint PPT Presentation

Stephen F. Flaim, Ph.D., FACC, FAHA

steve.flaim@techcoastangels.com flaimsf@nhlbi.nih.gov

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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

OncoFluor’s Technology

MAb directed against the tumor cell-surface antigen Tumor cell-surface antigen (protein molecule unique to cancer cells)

Fluorophore attached to MAb Fluorescent-tagged MAb construct

 Proof-of-concept studies complete  Manufacture/supply plans complete  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

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Sustainable Cardiac Regeneration

• Heart failure leading cause of death in the US (29%)
• 700,000 deaths/yr - 29% of all US death (51% women)
• 50% mortality within 5 years of diagnosis
• Total US cost associated with heart failure >$30B/yr
• >50% total due to re-hospitalization costs
• >1M hospitalizations/yr in US due to HF
• 25% of all re-hospitalizations at 1 month
• Cost of physician office visits = $1.8B (2013)
• Mean patient cost = $23,077
• Unmet medical need - market opportunity = $16B (post-MI)

CardioCreate’s Technology

Modified CPCeP + Marker Control CPCe Marker

Adult Cardiac Stem Cell Nucleus

Pim-1 Gene Overexpression – Adult cardiac stem cells

• 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

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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

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• Half-life of 27 hours
• Orally bioavailable
• 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
• pulmonary hypertension
• fibrotic disorders
• wound healing (2-fold decrease in wound healing time)
• autoimmune disorders
• Funding
• Angel round - $0.5M
• Non-dilutive NIH - $2M

CAR Peptide

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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 (4th 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

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SX-682

Mechanism

• CXCR1/2 receptor inhibitor in neutrophils
• Blocks neutrophil migration to lungs
• Breaks cycle of inflammation/tissue damage
• Potential for first-in-class therapeutic treatment
• Proof-of-concept work complete
• IC50 = 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

SX-682

Stephen F. Flaim, Ph.D., FACC, FAHA

steve.flaim@techcoastangels.com flaimsf@nhlbi.nih.gov

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