Biocardia, Inc. · NASDAQ:BCDA
Biocardia — IPO Roadshow (October 2015)
17 slides from Biocardia's IPO roadshow presentation, Oct 6, 2015
Slide 1: BioCardia Partnering Presentation, October 2015
Filed Pursuant Issuer Relating Registration ARM BIOCARDIA OctoberPartnering Free 7, to 2015 Writing Preliminary No.to333-205003 Presentation Rule Prospectus 433 Prospectus under dated the dated October Securities July 6, 13, Act 2015 2015 of 1933
Slide 2: Disclaimer Regarding Forward-Looking Statements
Disclaimer Any company’s (including, statements 2materially BIOCARDIA statements from included products, but Regarding not made anticipated limited herein the about Forward-Looking ability to, are results. the statements made company’s of theascompany ofStatements that the anticipated contain date t
Slide 3: Free Writing Prospectus Legend
Freereview BioCardia, Before may prospectus 3To BIOCARDIA get Writing you these aif Inc. invest, filed Prospectus you documents (the copy request you “Company”) of should Legend it our forbyfree current read calling by has the visiting registration filed 1-800-624-1179. prospectus a registration EDG
Slide 4: BioCardia Strengths
BioCardia CARDIAMP**, 4*nØ BIOCARDIA From Only Leading >10,000 Ongoing Blinded Companion PMA 275 Published patients Phase company concept CBER intramyocardial cardiovascular Strengths randomized **safety, III No diagnostic treated regulatory to EXCELLENT**, heart we patients pivotal efficiency, aret
Slide 5: BioCardia's Clinical and Preclinical Programs
BioCardia’s Preclinical Phase Enrolling Nine IND CardiALLO™ Two Feasibility EU CardiAMP™ Helix™ ‡Morph® +Caution: COMPLETED 5*Note: BIOCARDIA Investigational USA studies for patients I all II IIITransendocardial aAccess Universal STATUS first Phase models Investigational Preclinical cell completed t
Slide 6: CardiAMP Procedure Overview
1Pre-procedure Small Patient Post-procedure ~60 3CardiAMP™ CardiAMP 2~15 Proprietary ~ 6Initiating BIOCARDIA Delivery Cell 15tominutes amount Collection Processing 90 30 leaves FDA minute minutes cell cells biomarker dosage hospital of Marrow accepted therapy infused marrow procedure prepared panel
Slide 7: CardiAMP: Proprietary Biomarkers
CardiAMP: Proprietary Biomarkers Score Assay One CD45 3.96% 0.44% 82.36% 13.25% 100 101 102 103 104 Estimated CD34 0P 200 400 600 800 1000 1200 Negative Repair Late TimeAMI BM Preserve FOCUS ACT34 CardiAMP 7Modified BIOCARDIA ositive 101 CMI of Time of PE cell performed AMI our CMI trial HF 102 1AMI
Slide 8: CardiAMP Procedure Step 1: Bone Marrow Collection
CardiAMP The Bone Endothelial 81Mesenchymal BIOCARDIA Loffredo clinician procedure MarrowFS Procedure Progenitor draws Mononuclear Stem et is al performed Stem ~60cc Cells Step Cells Cell. of 1:under Cells bone Cell 2011;8:389-98. Collection local marrow anesthesia from theand iliac conscious crest
Slide 9: CardiAMP Procedure Step 2: Cell Processing
CardiAMP Biomet The Cells CardiaAMP for Cell CE Nucleated 9Red BIOCARDIA cell CardiAMP system Blood Poor aretherapy Biologics. processed Plasma Cell Cells Procedure includes TMConcentrate cell System while processing a Step single-use, the 2: patient Cell platform sterile, Processing is prepared pre
Slide 10: CardiAMP Procedure Step 3: Delivery with Helix
Cells infused CardiAMP Morph Helix 10 BIOCARDIA is available Procedure cells Cells using are forHelix™ injected partnering Step 3:system into Delivery with thetoheart other patients tissue biotherapeutic heart using ourprograms. proprietary Helix biotherapeutic delivery system by a cardiologist in a
Slide 11: TABMMI Results
CardiAMP: NYHA 20 No Cells Two-dimensional Results Ejection Baseline 30.0 35.0 40.0 45.0 50.0 155.0 01.2 0.2 0.4 0.6 TABMMI Cumulative *BMC: Years De 11 BIOCARDIA .81patients Ischemic la control 2 3were Fuente 4Class showed bone Fraction 1W 5 (All (1st prepared arm @Survival survival Phase Heart et
Slide 12: CardiAMP Phase II Trial Design
CardiAMP: Patients 68 --CardiAMP 4100M 10 20 Primary Endpoints: Secondary imaging, *BMC: 12 BIOCARDIA Patients Ischemic Patients tobone Randomized was 200M computer dose efficacy PBS 200M Phase Heart ARM-- safety: marrow escalation BMC Placebo BMC MSC II Failure tomography, :30 Trial Six into mononu
Slide 13: CardiAMP Phase II Efficacy Results
CardiAMP: CardiAMP Cells compared Secondary Active Placebo Treat. 6Favors P-value Minnesota 0.049 +56.3 -42.0 +14.3 Maximum 0.038 -17.4 +9.7 -7.7 0.321 +1.03 -0.870 +0.16 NY 0.638 -0.17 -0.25 -0.42 0.129 -44 +47.2 +3.2 0.149 -46.7 +51.2 +4.5 LV 0.252 +3.35 -2.38 +0.97 *NS: Wong BIOCARDIA 13minute En
Slide 14: Six Minute Walk Distance and Quality of Life
CardiAMP: Six Distance 500 Change Minnesota Score 65 12 Baseline Placebo Worse BMC Better Improved Treatment Wong BIOCARDIA 14 55 Months Minute 45045 (points) Poin 400 (Meters) 35 Foo functional Quality vs. functional quality Living Walk Phase 25 350 placebo et15 al300 Distance of with II2015. Trial
Slide 15: CardiAMP Phase III Trial Design
CardiAMP: 250 20% NYHA CardiAMP 150 100 Changes Primary Secondary Non-inferiority Time Superiority 15 BIOCARDIA Ischemic Patients EF toClass first endpoint: 40% from hierarchical Potency with Phase @200M SHAM heart II Heart Phase with and regard respect failure IIIAssay Failure III respect IICells T
Slide 16: BioCardia Current Value Propositions
Current VALUE BioCardia Teva/Mesoblast Celyad Cells Someone Patients Trials 22 45 43 1: Expected BLA Number 2Two Pivotal Time Functional CardiAMP No Yes Superior Companion PMA 1Expect BIOCARDIA 16:Phase xX Loffredo Phase 240 250 trials: (two Approval to (one toto Trial C-CURE Phase major own treated
Slide 17: Contact: Peter Altman, CEO
Peter Altman Contact: www.BioCardia.com BIOCARDIA BioCardia, CEO 650-226-0120 paltman@biocardia.com Inc.