Biocardia, Inc. · NASDAQ:BCDA
Biocardia — Investor Presentation (November 2024)
24 slides from Biocardia's investor presentation, November 2024
Slide 1: Corporate Presentation
Developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases Corporate Presentation BioCardia, Inc. (NASDAQ: BCDA) Peter Altman, PhD President and CEO paltman@biocardia.com www.biocardia.com 05295-AL (MKT) Corporate Presentation November 2024 1
Slide 2: Presentation Content and Forward-Looking Statements
Presentation Content and Forward-Looking Statements Presentation Content No part of this presentation or the information herein may be reproduced, photocopied, redistributed or passed on, directly or indirectly, to any other person, or published, in whole or in part, for any purpose without the cons
Slide 3: Executive Summary
Executive Summary Late Stage Cell and Cell Derived Biotherapeutics for Cardiac and Pulmonary Diseases • Phase III CardiAMP® cell therapy for ischemic heart failure with TAM of > $17 Billion in USA1. • Program with FDA breakthrough designation enhancing regulatory process, and CMS reimbursement reduc
Slide 4: Therapeutic and Device Product Pipeline
Therapeutic and Device Product Pipeline Autologous and Allogeneic Cardiac Cell Therapy with leading catheter delivery platforms. 2024 and H1 2025 Platform Candidate Preclinical Phase 1 Phase 2 Phase 3 Anticipated Catalysts Ischemic Heart Failure (HFrEF) Interim CardiAMP HF Ph 3 Data Q1 Japan PMD
Slide 5: Problem: Heart failure is an Enormous Unmet Disease
Problem: Heart failure is an Enormous Unmet Disease • Affects more than 56.2 million people worldwide 1, with 50% mortality at five years 2. • No existing therapies are curative, they currently only slow disease progression. • Recent data shows newer meds only reduce mortality by 0.6%/year (sodium-g
Slide 6: Current Options for Patients - Expensive, Unable to Heal Failing Hearts
Current Options for Patients - Expensive, Unable to Heal Failing Hearts Demonstrating a reduction in mortality without replacing the heart remains a challenge in heart failure. Class I, II. & III Class III Class IV Medications Devices Hemodynamic Transplantation (Tx) Beta-Blockers CRT & CRT-D Su
Slide 7: Potential Solution: CardiAMP Cell Therapy
Potential Solution: CardiAMP Cell Therapy For ischemic HFrEF (BCDA-01) FDA CBER regulated as device system. Medicare reimbursement established for two pivotal trials. 05295-AL (MKT) Corporate Presentation November 2024 7
Slide 8: CardiAMP Cell Therapy is a Significant Advance
CardiAMP Cell Therapy is a Significant Advance The 1st cardiac cell therapy that combines a pre-procedural assay, point of care cell processing system and transendocardial delivery system. How is it unique from other cardiac cell therapies? Precision Medicine Dx High Dose Efficient Delivery Autologo
Slide 9: CardiAMP Cell Therapy Potential Solution in Heart Failure
CardiAMP Cell Therapy Potential Solution in Heart Failure Current Status Breakthrough Device Designation granted by FDA based on results from three trials to date. Reimbursement Code C9782 for CardiAMP Cell Therapy for both treated and control patients (reduced clinical study costs by $25,000 per pa
Slide 10: CardiAMP HF I Phase III Study Interim Safety Outcomes (N=110)
CardiAMP HF I Phase III Study Interim Safety Outcomes (N=110) MACCE = Major Adverse Cardiovascular and Cerebrovascular events LVAD = Left Ventricular Assist Device; MI = myocardial infarction CVA/TIA = Cerebrovascular Accident / Transient Ischemic Attack 05295-AL (MKT) Corporate Presentation Novembe
Slide 11: CardiAMP HF I Phase III Treatment Effectiveness Outcomes (N=110)
CardiAMP HF I Phase III Study Treatment Effectiveness Outcomes (N=110) Primary Outcome All Patients Through Month 24 (p>0.05; n=110) Cardiac Death Non-fatal Six Minute Walk Raval et al THT 2024 Equivalents MACCE Distance Meters (median, ± st dev) Cell Therapy 8.3% 16.7% 2 ± 76 Control 13.2% 18.4% 17
Slide 12: Design of CardiAMP HF II Confirmatory Trial
Design of CardiAMP HF II Confirmatory Trial CardiAMP HF II confirmatory Trial is focused on these patients with Quality of Life as 3rd tier of composite endpoint instead of Six Minute Walk Distance which had p =0.026. Subgroup: Patients with NTproBNP >500 pg/ml Through Month 24 (p=0.026, n=54) Car
Slide 13: Heart Failure II Trial Executive Steering Committee
CardiAMP Heart Failure II Trial Executive Steering Committee Dr. Carl Pepine, University of Florida Professor of Medicine, Division of Cardiovascular Medicine, co-director of CTSI Multi-site Study Support Team at the National Center for Research, has been on the editorial boards of all major cardi
Slide 14: CardiAMP HF Anticipated Timeline
CardiAMP HF Anticipated Timeline CardiAMP HF I Final Japan PMDA accepts Japan commercial 2024 2025 2026 Data for PMDA and submission USA CardiAMP HF II FDA Consultations and Japan PMDA approval fully enrolled Submissions USA CardiAMP HF II USA CardiAMP HF II Enrolling Enrolling Japan approval path
Slide 15: CardiAMP Cell Therapy 2nd Indication: Chronic Myocardial Ischemia with Refractory Angina
CardiAMP Cell Therapy 2nd Indication Chronic Myocardial Ischemia with Refractory Angina 05295-AL (MKT) Corporate Presentation November 2024 15
Slide 16: CardiAMP Cells in Chronic Myocardial Ischemia Trial (BCDA-02)
CardiAMP Cells in Chronic Myocardial Ischemia Trial (BCDA-02) NCT03455725, IDE Trial for Premarket Approval Burden of Illness and Unmet Need Characterized by severe chest pain. Patients suffer from poor perceived health status and psychological distress, have significant impairment in quality of
Slide 17: Chronic Myocardial Ischemia Trial Roll-in Cohort Clinical Results
CardiAMP Cells in Chronic Myocardial Ischemia Trial (BCDA-02) Roll-in Cohort Clinical Results Early results are compelling for both improved angina episode reduction and Exercise Tolerance Time (ETT) which has only been shown with cell therapy. CMS reimbursement can support patient research costs. A
Slide 18: CardiALLO Cell Therapy 2nd Therapeutic Platform Ischemic Heart Failure
CardiALLO Cell Therapy 2nd Therapeutic Platform Ischemic Heart Failure 05295-AL (MKT) Corporate Presentation November 2024 18
Slide 19: Allogeneic Mesenchymal Stem Cells in Heart Failure (BCDA-03)
Allogeneic Mesenchymal Stem Cells in Heart Failure (BCDA-03) CardiALLO MSC, NCT05925608, IND Phase I/II Trial Design: CardiALLO MSC in Heart Failure (BCDA-03) Open Label Roll-in: 3X3 Dose Escalations (N=9) “Off the shelf” cell therapy Randomized Controlled Trial Leverages delivery system (up to
Slide 20: Helix Biotherapeutic Delivery Platform
Helix Biotherapeutic Delivery Platform 05295-AL (MKT) Corporate Presentation November 2024 20
Slide 21: Helix Transendocardial Biotherapeutic Delivery System
Helix Transendocardial Biotherapeutic Delivery System Therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. Helix empowers a seamless transition from bench to commercialization for partners. • Helix provides better Rx retention than surgical delivery
Slide 22: Intellectual Property Overview
Intellectual Property Overview Exclusive rights to over 60 patents and patent applications in USA, Europe, China, India, and Japan with goal to protect the company’s platform and therapeutic initiatives 05295-AL (MKT) Corporate Presentation November 2024 22
Slide 23: Executive Management Team
Executive Management Team Peter Altman, David McClung Debby Edward PhD Holmes- Gillis Higgin CEO CFO VP SVP Clinical Devices Board of Directors: Andrew Blank, Chairman of the Board, CEO Archive America, Board Member Neumentum Jay Moyes, Chairman Audit Committee, Board Member Puma Biotechnology,
Slide 24: Selected Financial Data
Selected Financial Data Nine Months Year Year Year Ended Ended Ended Ended 30-Sep-24 31-Dec-23 31-Dec-22 31-Dec-21 ($mm) ($ mm) ($ mm) ($ mm) Revenues $0.06 $0.5 $1.4 $1.0 Net Loss $5.7 $11.6 $11.9 $12.6 Cash used in operations $5.5 $10.0 $10.6 $10.4 Cash & Equivalents $4.9 $1.1 $7.4 $12.9 Debt N/A