Biocardia, Inc. · NASDAQ:BCDA
Biocardia — Investor Presentation (March 2025)
31 slides from Biocardia's investor presentation, March 2025
Slide 1: Corporate Presentation
Developing cellu la r a n d cell-derived th era peu tics for th e trea tm en t of ca rdiova s cu la r a n d pu lm on a ry dis ea s es Corporate Presentation BioCardia, Inc. (NASDAQ: BCDA) Peter Altman, PhD President and CEO paltman@biocardia.com www.biocardia.com 05295-AN (MKT) Corporate Presentatio
Slide 2: Presentation Content and Disclaimer
Presentation Content and Disclaimer 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 consent of BioCardia
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 Product Pipeline
Therapeutic Product Pipeline Autologous and Allogeneic Cardiac Cell Therapy for Cardiac and Pulmonary Disease. Th e r a p e u t ic Pla t fo r m Ca n d id a t e Pr e clin ica l Ph a s e 1 Ph a s e 2 Ph a s e 3 CardiAMP® HF BCDA-01α, β, Δ Ischemic Heart Failure with Reduced Ejection Fraction (HFrEF) A
Slide 5: Enabling Biotherapeutic Delivery Systems and Commercial Devices
Enabling Biotherapeutic Delivery Systems and Commercial Devices Th e r a p e u t ic Pla t fo r m Im a ge St a t u s In ve stiga tio n a l u se with Ca rd iAMP HF, Ca rd iAMP CMI, a n d Ca rd iALLO HF Helix Transendocardial clin ica l tria ls. Biotherapeutic Delivery Device (uses Pa rtn e re d with C
Slide 6: Heart failure: a Disease with Enormous Unmet Need
Heart failure: a Disease with Enormous Unmet Need • 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-glu
Slide 7: 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 8: 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-AN (MKT) Corporate Presentation March 2025 8
Slide 9: Mechanism of Action of Cells
Mechanism of Action of Cells Pre therapy Post therapy 2X Increased Capillary Density 80% Decreased Fibrosis Silva et al. Tex Heart Inst J (2011);38(3):219-24. Takahashi, M. et al. (2006) Am J Physiol Heart Circ 291:H886-H893. 05295-AN (MKT) Corporate Presentation March 2025 9
Slide 10: 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 11: CardiAMP HF Current Status
CardiAMP HF 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 patient). Interim Results: Phase III Clinical Tr
Slide 12: 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 Raval et al THT 2024 05295-AN (MKT) Corporate
Slide 13: CardiAMP HF I Phase III Study Treatment Effectiveness Outcomes
CardiAMP HF I Phase III Study Treatment Effectiveness Outcomes Composite endpoint with three tiers 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
Slide 14: Design of CardiAMP HF II Trial
Design of CardiAMP HF II Trial CardiAMP HF II Trial is focused on these patients with Quality of Life as 3rd tier of composite outcome instead of Six Minute Walk Distance which resulted in p=0.026. Subgroup: Patients with NTproBNP >500 pg/ml Through Month 24 (p=0.026, n=54) Cardiac Death Non-fatal
Slide 15: CardiAMP 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 16: CardiAMP HF Anticipated Timeline is Driven by Data
CardiAMP HF Anticipated Timeline is Driven by Data 2025 CardiAMP HF I Top Line Data Potential CardiAMP HF 2026 FDA/ Japan PMDA Meetings approval in Japan assuming Late Breaking Data presentation 2025 submission 3/30/25 at American College of Cardiology CardiAMP HF II enrolling CardiAMP HF II Enrolli
Slide 17: CardiAMP Cell Therapy 2nd Indication: Chronic Myocardial Ischemia with Refractory Angina
CardiAMP Cell Therapy 2nd Indication Chronic Myocardial Ischemia with Refractory Angina 05295-AN (MKT) Corporate Presentation March 2025 17
Slide 18: 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 19: CardiAMP Cells in Chronic Myocardial Ischemia Trial (BCDA-02) 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 increase in exercise tolerance time (ETT) which has only been shown with cell therapy. Last open label roll in cohort patient reac
Slide 20: CardiALLO Cell Therapy 2nd Therapeutic Platform Ischemic Heart Failure
CardiALLO Cell Therapy 2nd Therapeutic Platform Ischemic Heart Failure 05295-AN (MKT) Corporate Presentation March 2025 20
Slide 21: Allogeneic Mesenchymal Stem Cells in Heart Failure (BCDA-03) CardiALLO MSC
Allogeneic Mesenchymal Stem Cells in Heart Failure (BCDA-03) CardiALLO MSC “Off the shelf” cell therapy based on cells from a single donor to treat many patients, using the same delivery system as CardiAMP programs. Has advantages for patients who do not qualify for CardiAMP because of their cel
Slide 22: Phase I/II TRIDENT Clinical Study, NCT02013674
Allogeneic Mesenchymal Stem Cells in Heart Failure (BCDA-03) Phase I/II TRIDENT Clinical Study, NCT02013674 Allogeneic MSC at 20M and 100M cells (N= 30) delivered at ten sites with Helix. Primary outcome measures: thirty-day post catheterization incidence of predefined treatment-emergent serious adv
Slide 23: CardiALLO MSC, NCT05925608, IND Phase I/II
Allogeneic Mesenchymal Stem Cells in Heart Failure (BCDA-03) CardiALLO MSC, NCT05925608, IND Phase I/II Trial Design: The clinical trial will be testing prospectively an optimized Open Label Roll-in: 3X3 Dose dosage and delivery of allogeneic MSC in patients with Escalations (N=9) ischemic inflammat
Slide 24: Helix Biotherapeutic Delivery Platform
Helix Biotherapeutic Delivery Platform 05295-AN (MKT) Corporate Presentation March 2025 24
Slide 25: 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 26: Morph DNA Steerable Introducers
Morph DNA Steerable Introducers Approved Q3 2024 in a wide variety of configurations and commercially available. 05295-AN (MKT) Corporate Presentation March 2025 26
Slide 27: Commercializing FDA Approved Enabling Products
Commercializing FDA Approved Enabling Products See brochure at www.biocardia.com 05295-AN (MKT) Corporate Presentation March 2025
Slide 28: 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-AN (MKT) Corporate Presentation March 2025 28
Slide 29: 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 30: 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
Slide 31: Anticipated Near Term Catalysts Q1 and Q2 2025
Anticipated Near Term Catalysts Q1 and Q2 2025 BCDA -01 CardiAMP HF with two randomized placebo-controlled trials o HF 1: Late Breaking Presentation at American College of Cardiology March 30, 2025 o Japan PMDA Clinical Consultation request/submission o FDA Meeting request/submission o HF 2: Joini