Biocardia, Inc. · NASDAQ:BCDA
Biocardia — Forum for Innovative Regenerative Medicine 2019
27 slides from Biocardia's conference presentation, Feb 4, 2019
Slide 1: BioCardia - Forum for Innovative Regenerative Medicine
BIOCARDIA’ Forum for Innovative Regenerative Medicine Regenerative Medicine Cross Roads Nihonbashi Life Science Building Tokyo, Japan January 28, 2019 Peter Altman, PhD, FAHA Chief Executive Officer 5090(MKT)-A
Slide 2: Note Regarding Forward-Looking Statements
atterary Note Regarding Forward-Looking Statements These slides and any accompanying oral presentation contain forward-looking statements as that term is defined under the Private Securities Litigation Reform ‘Act of 1995. Such forward-looking statements include, among other things, references to de
Slide 3: Introduction to BioCardia
eiiotecion to BioCardia Headquarters near San Francisco, California = Founded in 1999 = 30 Employees = Publicly traded OTC:BCDA = 12 clinicaltrials to date (completed, ongoing, or approved) USA Rest of World = Jvs-01 = NORTHERN = STOP HF = TABMMI = TAC-HFT = RECARDIO = TRIDENT = EXCELLENT = POSEIDON
Slide 4: Highlights
Highlights = Cardiovascular regenerative medicine company with a potential first-in-class therapy for heart failure = CardiAMP autologous cell therapy system represents novel, rapid and personalized approach to autologous cell therapy = Robust ongoing late-stage clinical activity — CardiAMP Phase 3
Slide 5: Advanced Clinical Pipeline
Advanced Clinical Pipeline Product Candidate (Pathway) Preclinical Phase 1 Phase 2 Phase3 Approved BCDx 01 paieyemolngieUssies BCDA-02 Reactor an + Pivotal/ Phase3 has CMS reimbursement BCDA-03 CardiALLO: Ischemic Heart Failure ‘+ IND submission Q1 2019 anticipated Helix Partner-01 Cell Pro Thera He
Slide 6: Heart Failure: Burden of Illness and Unmet Need
"atl Heart Failure ARE Burden of Illness and Unmet Need ® Chronic disease with 50% mortality at five years, impacts 1 in 5 adults over age of 40 in USA. * Annual cost estimated to be $39 billion annually, projected to increase to $70 billion in 2030, half related to hospitalization in USA « Estimate
Slide 7: Cardiac cell therapy: mechanistic basis for regeneration
diac cell therapy: mechanistic basis for regeneration Transplanted cells are hypothesized to benefit the heart through direct and indirect pathways. Vascular 6% New blood = Direct Regeneration: Transplanted progenitor ©5050 °-~ = mp vessels : ae 3 pool °O' al cells actively home to injury sites ' ct
Slide 8: Investigational CardiAMP Cell Therapy System
P Pier investigational CardiAMP Cell Therapy System Pre-procedure Post-procedure Screening Patient leaves hospital the next day Small amount of bone marrow collected from hipbone and sent to lab for testing my i Cell Collection y aa Small amount of bone marr . obtained from hipbone —— a , Card iAMP™
Slide 9: Pre-procedure Screening Selects Patients Likely to Respond to CardiAMP
probpfiredure Screening Selects Patients Likely to Respond to CardiAMP = CardiAMP Potency Assay bone marrow biomarker panel analysis at core lab: Anticipated to select 70% most likely to eee e@ @ @ @ t t t t t t t respond based on therapeutic potential of their bone marrow = One marker is CD34+ cell
Slide 10: What's Involved? Step 1: Cell Collection
< ; What’s Involved? Procedure — Step 1: Cell Collection Clinician draws 60 cc bone marrow from the iliac crest (hip bone) Procedure performed under local anesthesia and conscious sedation, and takes *20 minutes Bone Marrow Mononuclear Cells <o. ECT to 800 ew ®e%a0 ee o*%— 2% @ @~@ 5090(MKT)-A
Slide 11: What's Involved? Step 2: Cell Processing
_ What’s Involved? Procedure — Step 2: Cell Processing Cell processing platform prepares proprietary dosage at point of care while patientis prepared for cell delivery - takes approximately 25 minutes 5090(MKT)-A
Slide 12: What's Involved? Step 3: Cell Therapy Delivered
a What’s Involved? Procedure — Step 3: Cell Therapy Delivered to Injured Heart Cell therapy injected into the heart tissue using minimally-invasive delivery system Procedure takes 30-45 minutes Delivery System CardiAMP Cells 5090(MKT)-A 2
Slide 13: Helix Animation
Helix Animation BIO C 5090(MKT)-A 13
Slide 14: BCDA-01: CardiAMP Heart Failure Phase I Trial Design and Results
BCDA-01: CardiAMP Heart Failure Phase | Trial Design and Results Transendocardial Autologous Bone Marrow in Myocardial Infarction (TABMMI) NCT00507468 Safety: No Treatment Emergent-MACE 20 Ischemic Heart Failure Patients LVEF<40% NYHA Class I, Il, and III Open Label Safety Study 100 Million BMC 10 p
Slide 15: BCDA-01: CardiAMP Heart Failure Phase II Trial Design
— BCDA-01: CardiAMP Heart Failure Phase 2 Trial Design Transendocardial Autologous Cells in Heart Failure Trial (TAC-HFT), NCT00768066 34 Ischemic Heart Failure Patients LVEF<50% 3 Bone Marrow Mononuclear Cells NYHA Class I, II, and III , . 92, Oe Open Label Dose Escalation 100 M to 200M Cells (N=4)
Slide 16: CardiAMP Heart Failure Phase II Efficacy Results in Six Minute Walk
BC rdiAMP Heart Failure Ph 2 Efficacy Results in Six Minute Walk elative to other CRT and Entresto heart failure therapies Improvementin Meters over Control wavaurune Entresto Para‘ 5090(MKT)-A Six Minute Walk CRT, Miracle-ICD, JAMA, 2003 Cells, REVASCOR, Cire Res 2005 CRT, Contak CD, JACC, 2003 CRT
Slide 17: BCDA-01: Phase 3 Trial Design
- BCDA-01: Phase 3 Trial Design CardiAMP Heart Failure Trial, NCT02438306, IDE Trial for Premarket Approval 40 center, 260 Ischemic Heart Failure . Patients LVEF<40% NYHA Class Il and III New in Phase 3: oO Focus on NYHA Class Il & Ill Patients with cell potency assay inclusion criteria Open Label R
Slide 18: CardiAMP Heart Failure Trial: Efficacy Outcomes from Roll-In Phase
ardiAMP Heart Failure Trial: acy Outcomes from Roll-In Phase ster V. Johnston’, Henricus J. Duckers?, Amish N. aval’, Thomas D. Cook’, Jay H. Traverse, William T. Abraham, Peter A. Altman?, Carl J. Pepine® ‘ins University, Baltimore, MD, 2.Biocardia, Inc, San Carlos, CA, isconsin, Madison, WI, 4. Mi
Slide 19: BCDA-01 Phase 3 Roll In Cohort Safety and Efficacy Results
al BCDA-01 Phase 3 Roll In Cohort Safety and Efficacy Results Points Improvement Data Safety Monitoring Board (DSMB) pre- ied interim analysis of safety outcomes for t 10 patients treated in the Phase 3 trial of ional CardiAMP cell therapy product no significant safety concerns with the CardiAMP stu
Slide 20: Pre-specified Secondary Endpoint: Recruitment of Myocardial Segments
Pre-specified Secondary Endpoint: Recruitment of Myocardial Segments ry JOHNS HOPKINS BIOCARDIV’ cine. Akinetic Myocardial Segments Change in Akinetic Myocardial Segments 0,08 0,08 8 ° e) a Bs 4 | ¥ 31% HE B 4 3 Ss 3 2 3 Eas zo 4 Baseline 6 Months 12Months Baseline 6 Months 12Months * In 8 out of 10
Slide 21: CardiAMP Cell Therapy System Product
CardiAMP Cell Therapy System Product CardiAMP Cell Therapy System Components Approvals CardiAMP Cell Processing Platform* v v v Helix Biotherapeutic Delivery System * v Morph Universal Deflectable Guide Catheter v v |+ Caution: Investigational Device for Cardiac Indications. Limited by United States
Slide 22: BCDA-02: CardiAMP Cell Therapy System Targeting Chronic Myocardial Ischemia
BCDA- ardiAMP Cell Therapy System Targeting Chronic Myocardial Ischemia Burden of Illness an met Need ® Patients suffer from poor perceived health status and psychological distress, have significant impairment in quality of life, and represent a burden to the healthcare system due to significant use
Slide 23: BCDA-02: Phase 3 Trial Design, Chronic Myocardial Ischemia
Pm BCDA-02: Phase 3 Trial Design 40 center, 343 Ischemic Heart Failure Patients LVEF<40% NYHA Class Il and III Open Label Roll In Target 200M Cells (N=10) Randomized Sham Controlled Therapy at 200M cells to Treatment (N=333) 2:1 10 peri-infarct injection sites Helix System Primary endpoint change fr
Slide 24: BCDA-03: CardiALLO Cell Therapy System Targeting Ischemic Heart Failure
Minimal Treatment Options BCDA-03: CardiALLO Cell Therapy System Targeting Ischemic Heart Failure @® Chronic disease with 50% mortality at five e Ss . years, impacts 1 in 5 adults over age of 40. a - @® Annualcost estimated to be $39 billion annually, projected to increase to $70 billionin 2030, hal
Slide 25: BCDA-03: Clinical Results and Development Strategy
BCDA-03: Clinical Results and Development Strategy Three BCDA co-sponsored Phase 1/2 culture expanded mesenchymal cell trials in heart failure have been completed: CardiALtO cells as.cultured — patentpending ‘Comparison of Al mneic vs Aut Banani cetemeccend tem Cells Eee rasan Roane inate ut tera Ca
Slide 26: Partnering Opportunities
er vities Seek partners for = CardiAMP Phase 3 pivotal trial for the treatment of heart failure = CardiAMP Phase 3 pivotal trial for chronic myocardial ischemia with refractory angina = CardiALLO Phase 2 NK1+ cell therapy for heart failure and other in indications (stroke, diabetes, osteo arthritis,
Slide 27: Thank you
BIOCARDIA’ Thank you 5090(MKT}-A
BioCardia — Forum for Innovative Regenerative Medicine 2019 on 6ix