BioCardia, Inc. · NASDAQ:BCDA
BioCardia — Investor Presentation (March 2024)
27 slides from BioCardia's investor presentation, March 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-AD (MKT) Corporate Presentation March 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: Therapeutic and Device Product Pipeline
Therapeutic and Device Product Pipeline Rx 2024 Platform Candidate Preclinical Phase 1 Phase 2 Phase 3 Anticipated Catalysts F Interim CardiAMP HF Ph 3 Data Final CardiAMP HF Ph 3 Data CardiAMP® BCDA-01 CardiAMP® for Ischemic Heart Failure (HFrEF) Enrollment in CardiAMP HF II 2nd Ph 3 Autolo
Slide 4: Selected Financial Data
Selected Financial Data BioCardia, Inc. (NASDAQ: BCDA) Year Year 9M Ended Ended Ended 30-Sep-23 31-Dec-22 31-Dec-21 ($ mm) ($ mm) ($ mm) Revenues $0.5 $1.4 $1.0 Net Loss $9.5 $11.9 $12.6 Cash used in operations $8.1 $10.6 $10.4 Cash & Equivalents $1.8 $7.4 $12.9 Debt N/A N/A N/A Additional cash rais
Slide 5: Problem: Heart failure is an Enormous Unmet Disease
Problem: Heart failure is an Enormous Unmet Disease • Affects more than 26 million people worldwide, with 50% mortality at five years. • No existing therapies are curative, they currently only slow disease progression. • Recent data shows newer meds only reduce mortality by 0.3%/year (sodium glucose
Slide 6: Current Options for Patients - Expensive, Unable to Heal Failing Hearts
Current Options for Patients - Expensive, Unable to Heal Failing Hearts Class I, II. & III Class III Class IV Medications Devices Hemodynamic Transplantation (Tx) Beta-Blockers CRT & CRT-D Support Immuno- Mineralocorticoid Mitral valve • IV Inotropes suppression receptor antagonists repair
Slide 7: Potential Solution: Cell-Based Therapy Role in Continuum of HF Care
Potential Solution: Cell-Based Therapy Role in Continuum of HF Care LVAD/TX PA Pressure Monitoring MV repair CRT Potential of CardiAMP Cell Therapy Modified from Decision Making in Advanced Heart Failure A Scientific Statement From the American Heart Association, Circ 2012 7 05295-AD (MKT) Corporate
Slide 8: CardiAMP & CardiALLO Cell Rx Mechanism of Action
Potential Solution: CardiAMP & CardiALLO Cell Rx Mechanism of Action Marrow cells home to heart in injury In preclinical studies, ABM MNC have: 1. reduced inflammation 2. reduced oxidative stress 3. reduced cell apoptosis 4. increased angiogenesis 5. limited reactive fibrosis 6. prevented advers
Slide 9: Potential Solution: Cell-Based Therapy
Potential Solution: Cell-Based Therapy BioCardia CardiAMP BioCardia CardiALLO Autologous Cells Allogeneic Cells Mechanism of action Paracrine release; Paracrine release; microvascular microvascular enhancement enhancement/ immunomodulatory Patients treated to date ~204 ~46 Arrhythmias safety Yes Yes
Slide 10: Autologous Mononuclear Cells: CardiAMP Cell Therapy
Autologous Mononuclear Cells: CardiAMP Cell Therapy For ischemic HFrEF (BCDA-01) and for Chronic Myocardial Ischemia (BCDA-02) FDA CBER regulated as device system. Medicare reimbursement established for two pivotal trials. 05295-AD (MKT) Corporate Presentation March 2024 10
Slide 11: 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? 1st test for a cardiac cell therapy that Patient Selection
Slide 12: CardiAMP Cell Therapy Potential Solution in Heart Failure (BCDA-01)
CardiAMP Cell Therapy Potential Solution in Heart Failure (BCDA-01) Breakthrough Device Designation granted by FDA based on results from three trials to date: • Improved exercise tolerance/distance • Improved heart function References: • TABMMI Trial, de la Fuente et al, Eurointervention 2011. • Imp
Slide 13: CardiAMP HF Phase III Study: Trial Design and Demographics
CardiAMP HF Phase III Study (BCDA-01) NCT02438306, IDE Trial Design and Demographics Trial Design: Open Label Roll-in: 200M Cells (N=10) Randomized Controlled Trial (N=250) 18 centers Primary endpoint is FS composite of heart death, major adverse cardiac and cerebrovascular events, and six- minute w
Slide 14: CardiAMP HF Phase III Study: Interim Safety Outcomes
CardiAMP HF Phase III Study (BCDA-01) NCT02438306, IDE Trial Interim Safety Outcomes MACCE = Major Adverse Cardiovascular and Cerebrovascular events LVAD = Left Ventricular Assist Device CVA/TIA – Cerebrovascular Accident/ Transient Ischemic Attack 05295-AD (MKT) Corporate Presentation March 2024 14
Slide 15: CardiAMP HF Phase III Study: Interim Safety Outcomes
CardiAMP HF Phase III Study (BCDA-01) NCT02438306, IDE Trial Interim Safety Outcomes VT = Ventricular Tachyarrhythmia 05295-AD (MKT) Corporate Presentation March 2024 15
Slide 16: CardiAMP HF Phase III Study: Treatment Effectiveness Outcomes
CardiAMP HF Phase III Study (BCDA-01) NCT02438306, IDE Trial Treatment Effectiveness Outcomes INTERIM ADAPTIVE TRIAL ANALYSIS Through Month 24 (p>0.05; n=92 at Month 24 at time of analysis) Cardiac Death Non-fatal 6MWD change Equivalents MACCE from baseline, M Cell Therapy 8.3% 16.7% 2 ± 76 Control
Slide 17: CardiAMP HF Phase III Study: Treatment Effectiveness Outcomes
CardiAMP HF Phase III Study (BCDA-01) NCT02438306, IDE Trial Treatment Effectiveness Outcomes SUBGROUP ANALYSES: NTproBNP >500 pg/ml at Screening/Baseline (n=54 at time of analysis) Through Month 24 (3-tiers include 6MWD change from baseline, p=0.073) Cardiac Death Non-fatal 6MWD change Equivalents
Slide 18: CardiAMP HF II Confirmatory Phase III Study Trial Design
CardiAMP HF II Confirmatory Phase III Study (BCDA-01) Trial Design Approved by FDA in Q4 2023 Approved by CMS for Reimbursement in Q1 2024 Randomized Controlled Trial (N=250) Up to 40 centers Primary endpoint is Finkelstein Schoenfeld composite of heart death, major adverse cardiac and cer
Slide 19: 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 20: 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 (up to Leverages delivery system
Slide 21: Allogeneic Mesenchymal Stem Cells in ARDS (BCDA-04)
Allogeneic Mesenchymal Stem Cells in ARDS (BCDA-04) NCT05491681, IND Phase I/II Trial IND Approved by FDA April 2022 with initial focus on patients recovering from Acute Respiratory Distress (ARDS). Trial On Hold Pending External Funding The anti-inflammatory effects of MSC have been well-docume
Slide 22: Helix Biotherapeutic Delivery System Platform
Helix Biotherapeutic Delivery System Platform 3 Approved in EU, Investigational in USA & Canada Partnering with other firms for cell, gene, exosome, and protein-based therapies Published results from clinical studies show enhanced safety Published results from preclinical studies show enhanc
Slide 23: Morph Steerable Introducer Products
Morph Steerable Introducer Products = Platform 4 Initially Developed for Helix System Morph DNA Steerable Guide & Avance Transeptal Steerable Introducers FDA Cleared 510(k) for 5Fr to 8Fr Morph DNA Steerable Introducers Targeted for Summer 2024. 05295-AD (MKT) Corporate Presentation March 2024 23
Slide 24: Morph Potential Markets
Morph Potential Markets large and synergistic with other products Indication Procedures/ Year (est. in 000s) 2027E Peripheral 1900 Renal 1000 Endovascular Aortic Repair (EVAR) 215 Carotid 100 Structural Heart 200 Transseptal Left Heart Access 500 Radial Access 200 05295-AD (MKT) Corporate Presentati
Slide 25: 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-AD (MKT) Corporate Presentation March 2024 25
Slide 26: Executive Management Team
Executive Management Team Peter Altman, David Debby Edward PhD McClung Holmes- Gillis Higgin CEO CFO VP SVP Clinical Devices 05295-AD (MKT) Corporate Presentation March 2024 26
Slide 27: Therapeutic and Device Product Pipeline
Therapeutic and Device Product Pipeline Rx 2024 Platform Candidate Preclinical Phase 1 Phase 2 Phase 3 Anticipated Catalysts F Interim CardiAMP HF Ph 3 Data CardiAMP® for Ischemic Heart Failure (HFrEF) Final CardiAMP HF Ph 3 Data CardiAMP® BCDA-01 Enrollment in CardiAMP HF II 2nd Ph 3 Funded