Fluoropharma Medical Inc · OTC:FPMI
Fluoropharma Medical — Investor Presentation (July 2016)
50 slides from Fluoropharma Medical's investor presentation, Jul 18, 2016
Slide 1: Molecular Imaging to Enhance Patient Outcomes in Cardiovascular Disease
Fluenenia. _— Pharma Molecular Imaging to Enhance Patient Outcomes in Cardiovascular Disease
Slide 2: Forward-Looking Statements
Forward-Looking Statements Fluor < Pharma This presentation contains “forward-looking statements’ within the meaning of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which are intended to be covered
Slide 3: Experienced Management Team and Advisors
Experienced Management Team and Advisors Fluoro — Pharma Thomas H. Tulip, Ph.D. President and CEO + Healthcare executive with >30 years medical industry experience + Former Executive at Navidea, Alseres, Lantheus and Bristol-Myers Squibb : and ardiolite Edward L. Lyons, Jr. Vice President, Developme
Slide 4: Agenda
Agenda * Background on FPMI —Company —Medical Need —CardioPET and BFPET + Value: Current and Prospective + GFP Merger Plans + Potential Product: mFBG * Summary
Slide 5: Imaging Agent Success Case Study
Imaging Agent Success Case Study NUCLEAR CARDIOLOGY
Slide 6: Nuclear Cardiology: Dramatic Growth
Nuclear Cardiology: Dramatic Growth 1 Million US Blood Flow Studies Cardiolite introduced * Tc-99m SPECT* agent 8 Million US Blood Flow Studies * Tc-99m agent US end- user revenue: $1.3B ~$70/dose *SPECT=Single Photon Computed Tomography | | ion | i | | aiid p 196 187 1058 80 2000 OH Nuclear Perfusi
Slide 7: Nuclear Cardiology: Reasons for Success
Imaging Agent Success Case Study Fluorg Pharma Nuclear Cardiology: Reasons for Success ° Clearly addressed unmet needs (ischemia, blood flow) * Demonstrably impacted patient management ° Prognosis as well as diagnosis « Embraced by referring Cardiologists * Many acquired cameras and performed studie
Slide 8: Nuclear Cardiology: What's Changing
Nuclear Cardiology: What’s C! +» Patients and symptoms —Diabetes, Obesity, Women, Heart Failure + 40% of today’s patients underserved by SPECT technology + New generation of heart imaging agents needed + Higher resolution, quantifiable, less prone to misleading artifacts + Focused on more than just
Slide 9: PET Can Provide Better Answers
PET Can Provide Better Answers = Pharma + Easier to interpret Higher * Older agent artifacts Peaciition eliminated images. a oD + Patients and staff + More than 100 distribution centers and 3000 PET cameras www.FluoroPharma.com
Slide 10: Molecular Imaging Allows 3D Imaging and Cardiac Motion
Molecular Imaging Allows 3D Imaging and Cardiac Motion = Pharma yww.FluoroPharma.com
Slide 11: Nuclear Cardiology: Perfusion and Beyond
Nuclear Cardiology PERFUSION AND BEYOND
Slide 12: Why Focus on Heart Disease?
Why Focus on Heart Disease? ee People will die of heart disease BL ae ...Anew heart attack occurs seconds ..A cardiac perfusion scan is performed www.FluoroPharma.com
Slide 13: Why Focus on Heart Disease?
y Focus on Heart Disease? Pharma * 69% of US adults are overweight or obese * Only half of Americans meet physical activity guidelines + More than 100 M adults have high cholesterol + 80 M adults have high blood pressure * Cardiovascular procedures and operations increased 28% from 2000 to 2010 Amer
Slide 14: Cardiovascular Disease: Major Global Health Burden
Cardiovascular Disease; Major Global Health Burden Fluoro aeae High Blood Pressure Blood Chemistry Coronary Artery Disease (CAD) &. = Stable Angina L WHO: “Neglected Global Epidemic” 16.7 M deaths WW: 1/3 of all : ‘Acute Myocardial | / deaths, 78% from low/middle income Key facts US esate S__Infaret
Slide 15: Heart Failure Reaching Epidemic Proportions
Heart Failure Reaching Epidemic Proportions OL Pharma HF Cost, US Na arog exeactry swore agyiis yoni 50%) mn die wthin 5 = « HF prevalence is expected to increase 48% from 2012 t0 2020 ro) 127% Total US cost in 2012 was $31 8 40 20 ° + Pacemaker rates rising dramatically Hospitalization rates increa
Slide 16: Greatest Areas for Cost Reduction
Greatest Areas for Cost Reduction Fluor < ~ Appropriate therapeutics aimed to prevent and best treat disease related to diabetes, obesity and heart disease hold greatest promise : i bi i It driven medicine offer best route to reducing the overall costs of healthcare Medical Concerns that Present Bes
Slide 17: Drivers of Referrals to Cardiac PET
Drivers of Referrals to Cardiac PET Fluoro — Pharma Drivers and Benefits @ Lowers Radiation Dose + With improved diagnostic accuracy @© Allows fusion of anatomical and biochemical studies » Superior image quality * Improved quantification @ Enables more precise approach for patients...the best test
Slide 18: Nuclear Cardiology Beyond Blood Flow: CardioPET and BFPET
Nuclear Cardiology Beyond Blood Flow CardioPET and BFPET
Slide 19: FPMI Development Portfolio
FPMI Development Portfolio patients with Artery Disease (CAD) and metabolic disorders, 19 million potential patients Modified fatty acid designed to enable metabolic imaging Detects regions of fatty acid uptake with CAD Phase 1 (US) Phase 2A (Europe; recruitment complete) Phase 2B (US) planned 2016
Slide 20: CardioPET (FCPHA) Results
CardioPET (FCPHA) Results Normal CAD Subject Subject Fatty acid analog that detects regions of metabolic insufficiency PHASE | TRIAL COMPLETED - Incl, 6 CAD pts. Results; + CardioPET promising safety with no AEs detected + Clinical findings consistent with SPECT + Quality of CardioPET images visuall
Slide 21: Cardiac Metabolism: A Delicate Balance
Cardiac Metabolism: A Delicate Balance Glucose oxidation + Provides 10% to 40% of energy + More 02 efficient pathway ATP/0,=: Energy (ATP) ‘Schematic representation of Myocardial Use of FA and CHO in the Human Heart Myocardial FAICHO Fuel Mix + | Physiological ——————> | Glucotoxic Fluoro Pharma Fatt
Slide 22: Fatty Acid Metabolism
Fatty Acid Metabolism Fluoro F The Intersection of Diabetes and Heart Failure Diabetes and obesity Heart failure Identify metabolic oe ‘4 FA delivery linpaired FA oxidation Medically APPAR activity modulate FA and glucose oxidation Contractile dysfunction www.FluoroPharma.com
Slide 23: Trends for Pacemaker Placement 1990-2002
ns for Pacemaker Placeme: 1990-2002 Chart 16-2. ic Survey. AV indicates atrioventricular. Data derived from Birnie eta” Pacemaker placements rose to nearly 400,000 per year in the US in 2010 (from 180,000 per year in 1979) www.FluoroPharma.com ‘Mozatfarian et al. Circulation 2016 23,
Slide 24: BFPET: Nuclear Cardiology Beyond Blood Flow
BFPET Nuclear Cardiology Beyond Blood Flow
Slide 25: Tetraphenylphosphonium salts penetrate mitochondria
Tetraphenylphosphonium salts penetrate the hydrophobic barriers of mitochondria Recognized markers of mitochondrial membrane electric and kinetic potential Mitochondrial damage contributes to a wide range of diseases; including cancers, di: degenerative di: and the pathophysiology of aging First pro
Slide 26: BFPET: Preliminary Results
BFPET: Preliminary Results Pharma Or cl Lipophilic compound that tracks coronary blood flow and cell membrane integrity Phase | trial completed (12 Normal Healthy Volunteers) * 6/12 whole body scans/dosimetry + No adverse events + Rapid extraction, stable heart uptake BFPETICT fusion images ina 60-y
Slide 27: Example of Performance
Example of Performance BFPET images demonstrated than SPECT On SPECT this patient appeared ...while BFPET clearly showed to have a defect... that patient’s myocardium was healthy Source: R PLA 201 9, China www.FluoroPharma.com
Slide 28: Mitochondrial Membrane Integrity
ial Membrane Integrity Pharma Q aig Ny (i> \A wy, Ave @® 30-6omv ° 510% Nucleus) sym 150-180 mV Plasma membrane
Slide 29: Disorders of Heart Rhythm
Disorders of Heart Rhythm Fluoro - Pharma + Bradycardia + Atrio-ventricular (AV) Block + Sinus node dysfunction + Supra-ventricular tachycardia (SVT) : inical Atrial Tachyarrhy ¢ Ventricular Tachycardia (VT) + Atrial Fibrillation and Atrial Flutter (AF)
Slide 30: Atrial Fibrillation Prevalence
+ Estimates of AF ranged as high as 6.1 million in the US in 2010, and is expected to rise to 12.1 million in 2030 * In Europe, the prevalence of AF in adults was estimated to be 8.8 million in 2010, and is expected to rise to 17.9 million in 2060 + The global prevalence of AF is estimated at 33.5 m
Slide 31: Invasive Radiofrequency Ablation
Invasive Radiofrequency Ablation is increasingly being used to treat more complex arrhythmias The success of ablation treatments and subsequent device implantations depends upon precise localization of the nodal sources of rhythm disturbances Invasive Electro-Anatomic Mapping (EAM) is being used to
Slide 32: 18-F FTPP Feasibility Study
48-F FTPP Feasibility Study Fluor a Objective: Describe a new i jive method to itati measure and image myocardial membrane potential Methods: 3 pigs; 2 normal and 1 with experimentally-induced infarct were studied with dynamic PET imaging. The total volume (V, ) of 18-F FTPP was measured in voxels b
Slide 33: BFPET Summary
BFPET Summary + Rhythm disorders of the heart driving device utilization higher worldwide Atrial Fibrillation (AF) is associated with increased mortality in individuals with other cardiovascular conditions, including HF, MI, CABG and stroke The use of pacemakers and invasive ablative therapies are i
Slide 34: Extended Scientific Advisory Board
Extended Scientific Advisory Board Timothy M. Bateman, MO Hetien sehetbe sical Professor of Calfornia-Keck Medicine edieine Joost Naraa, HO H. Wiliam Strauss, MD Professor of Mean, ing P Radiology and Gerdiology Associate Dean for Giobal Sinai Hosptal, New = Pharma www.FluoroPharma.com
Slide 35: Letter of Intent to Merge with Ground Floor Pharma
LETTER OF INTENT TO MERGE With Ground Fluor Pharma
Slide 36: NEWCO
NEWCO Fluoro Pharma We believe that a merger of FluoroPharma Medical Inc. and Ground Fluor Pharma, with three low risk, 1st- and best-in-class advanced imaging assets primed for success in the established, multi-billion dollar cardiovascular and oncolgy imaging markets, would represent a very attrac
Slide 37: NEWCO Executive Summary
NEWCO Executive Summary Pharma Acombination of Fluoro Pharma Medical, Inc. (FPMI) and Ground Floor Pharma ( GFP) which would produce a vibrant new entry in the rapidly advancing, Positron Emission Tomography (PET) space. This entity would feature: An (SWIFT) focused on a central need in the industri
Slide 38: NEWCO Portfolio Summary - GFP
Fluoro NEWCO Portfolio Summary - GFP = Pharma Platform ‘*F- production technology + Long lasting, world wide IP from U. of Nebraska and MGH + mFBG + Superior to current standard of care - $500M US opportunity + Pioneer Orphan indication for Pediatric Neuroblastoma + Favorable FDA attention : Expedit
Slide 39: 18F-mFBG (meta-Fluorobenzylguanidine) From Ground Floor Pharma
Fluoro Pharma 18F-mFBG (meta-Fluorobenzylguanidine) From Ground Fluor Pharma
Slide 40: 18F mFBG
18F mFBG Fluoro - Pharma * Success in Phase I/II human studies ¢ Improved imaging agent for orphan indication — Commercial revenues within 2 years ¢ Follow-on re-purposing to large unmet need in cardiology provides significant growth potential
Slide 41: Current Product: 123I-mIBG
Current Product: +23|-mIBG Imaging pheochromocytoma and neuroblastoma + FDA-approved product for diagnosing and monitoring these cancers: AdreView (125 mlBG) from GE Healthcare: +» Annual US revenue: $15 -20 M + Price ~$4000/dose * 5,000 scans per year in U.S. » Pediatric patients have numerous mIBG
Slide 42: mFBG
mFBG + '8F PET performance better than '*| SPECT, enabling better patient management + Improved target to background * Improved accuracy in identifying small lesions « Improved laboratory efficiency and patient convenience —Imaging at 2 rather than 24 hours * Traditional mFBG manufacturing hampered
Slide 43: FDA Guidance: Enhanced Development
DA Guidance: Enhanced development * Orphan Drug Status + Pediatric Neuroblastoma * Favorable attention « Expedited review * Fees waived « Favorable attention * Acceptance of much of mIBG data as applicable * Limited numer of patients for pivotal study « Result: expected approval 1018
Slide 44: Developing mFBG for Cardiology
Developing mFBG for Cardiology A significant opportunity
Slide 45: Assessment of Cardiac Innervation
Assessment of Cardiac Innervation Q - Pharma Impaired NET in HF prevents reuptake of NE plays a critical role in cardiac autonomic function irculating NE Poros Srna Prone ee P @. 3 a, » 4 ww High levels of circulating NE have long been associated with poor survival in heart failure yt “Plasma NE pai
Slide 46: Pivotal Study: 2018-19
* Pivotal Study: 2018-19 * 250 patients + $20M * Approval: 2020 + Market opportunity: $500 M (US Only) « Gross margins: greater than 65% igre: CRM Dee Markt, by Product Tpe, Goal (USO), 2040-2016 2a enon Rereh Gog ne Global device market approaching $108
Slide 47: Potential Catalysts
Potential Catalysts Frequent News Flow
Slide 48: Near-term value-creating milestones
Fluoro Near-term value-creating milestones Pharma — Initial International Partnerships China, Canada — Merger Proposal — New, Exciting Story — Camera and Pharmacy Company Partnerships 2-4Q16 — BFPET Phase 2A initiation 2Q16 — CardioPET Phase 2B Initiation 2H16 — mFBG Phase 3 Initiation 2H16 — BFPET
Slide 49: Multiple Exit / Monetization Opportunities
Multiple Exit / Monetization Opportunities Fluoro — Pharma — Completion of BFPET Phase 2A — Completion of CardioPET Phase 2B — Initiation of BFPET Phase 2B — Completion of mFBG Phase 3 — mFBG NDA Submission — mFBG NDA Approval — Initiation of CardioPET Phase 3 — Initiation of BFPET Phase 2B — Comple
Slide 50: Summary
Fluoro ~ Summary Pharma * Breakout proprietary Oncology, Neurology and Cardiovascular imaging technologies * Low risk in many di i Technical, Execution, Cc + Short study timeli gulatory pathway . i from platform + Potential to improve di: i di costs in large + Well-established worldwide IP + Multi-b
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