Biocardia, Inc. · NASDAQ:BCDA
Biocardia — Investor Presentation (August 2026)
24 slides from Biocardia's investor presentation, August 2026
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-BA (MKT) Corporate Presentation August 2026 1
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: Proprietary Platforms Overview
Proprietary Platforms Overview CardiAMP® Autologous Mononuclear Cells - lead program for ischemic heart failure of reduced ejection fraction (HFrEF), second program for related indication of chronic myocardial ischemia Pipeline-in-a-Product: Off the Shelf MSC Therapies - Advancing CardiALLO and
Slide 4: Therapeutic Product Pipeline
Therapeutic Product Pipeline Resulting from Platforms Therapeutic Platform Candidate Preclinical Phase 1 Phase 2 Phase 3 CardiAMP® HF BCDA-01α, β, Δ Ischemic Heart Failure with Reduced Ejection Fraction (HFrEF) Autologous Mononuclear Cells CardiAMP® CMI Chronic Myocardial Ischemia with Refractory An
Slide 5: Problem: Heart failure, a disease with enormous unmet need
Problem: Heart failure, a disease with enormous unmet need • 56.2 million people worldwide have HF. 1 • In the United States, HF costs are projected to increase to $70 billion in 2030, half related to hospitalization.1 • In Japan, one million patents have heart failure with 31 to 47% having ischemic
Slide 6: Potential Solution: Enhancing Microvascular Function
Potential Solution: Enhancing Microvascular Function New mechanism of action: o improve microvascular capillary density o reduce fibrosis o prevent adverse remodeling Mechanism driven primarily by cell mediated paracrine signaling Not intended to regenerate new myocardium Silva et al. Tex Hear
Slide 7: CardiAMP Cell Therapy: Lead Program
CardiAMP® Cell Therapy: Lead Program FDA Breakthrough Designation / Has CMS Reimbursement Autologous Cell Therapy For ischemic HFrEF 05295-BA (MKT) Corporate Presentation August 2026 7
Slide 8: CardiAMP System Development Status
CardiAMP System Development Status 200 Procedures and Counting FDA Breakthrough Device Designation granted based on results from Phase I and II trials. CMS Reimbursement Code C9782 for CardiAMP Cell Therapy for both treated and control patients at $20,000 ($35,000 for a treatment and a control) TABM
Slide 9: Phase III CardiAMP HF Trial
Phase III CardiAMP HF Trial 05295-BA (MKT) Corporate Presentation August 2026 9
Slide 10: CardiAMP HF Phase III Results in Patients with NTproBNP/BNP >500 pg/ml
CardiAMP HF Phase III Results in Patients with NTproBNP/BNP >500 pg/ml Composite outcome of three tiers – all benefit treatment A C A C Tier 3 6MWD MLHFQ +14m +0m 9.9 pts improvement WR=1.61 WR=2.02 CI 0.84-3.08 CI 1.01- 4.03 p=0.15 p =0.04 HTx = Heart Transplant; LVAD = Left ventricular Assist Devi
Slide 11: CardiAMP HF Phase III Results: LVEDVi and LVESVi
CardiAMP HF Phase III Results in Patients with NTproBNP/BNP >500 pg/ml Left Ventricular End Diastolic Volume Index (LVEDVi) and Left Ventricular End Diastolic Volume Index (LVESVi) show prevention of negative heart enlargement. This has long been known to align with positive outcomes.** LVEDVi LVESV
Slide 12: CardiAMP Key clinical insights
CardiAMP Key clinical insights Benefit seen across patients in three trials* • Reduced mortality and non-fatal major adverse cardiac events • Improved heart function • Improved quality of life Heart failure patients are heterogeneous Analysis suggests greater benefit in patients with both high c
Slide 13: CardiAMP HF Pathways to Approval and Reimbursement: Japan
CardiAMP HF Pathways to Approval and Reimbursement JAPAN Japan Pharmaceutical and Medical Devices Agency (PMDA) has said they are likely to accept existing evidence of safety and efficacy as sufficient for market release. o Initial indication identical to CardiAMP HF Trial with elevated NTproBNP.
Slide 14: CardiAMP HF Pathways to Approval and Reimbursement: Japan
CardiAMP HF Pathways to Approval and Reimbursement JAPAN Target initial population for CardiAMP cell therapy o In Japan, total ischemic HFrEF patients are ~ 300,000 and anticipate ~20,000 initial reachable patients with unmet need as discussed with PMDA. A cardiac cell therapy patch that is surgic
Slide 15: CardiAMP HF Pathways to Approval and Reimbursement: USA
CardiAMP HF Pathways to Approval and Reimbursement USA Target initial population for CardiAMP cell therapy o Patients with ischemic heart failure, on guideline directed medical therapy but still having biomarker evidence of active heart stress ~ 1 million patients in USA 1, 2 o Reimbursement in US
Slide 16: Ongoing Confirmatory CardiAMP HF II Clinical Trial
Ongoing Confirmatory CardiAMP HF II Clinical Trial Double Blind Procedure Placebo Controlled Randomized (1:1) Trial (NCT06258447) o NYHA Class II and III, EF< 40%, Ischemic etiology, with elevated NTproBNP o Patients on stable Guideline Directed Medical Therapy o One month screening to baseline de
Slide 17: 2nd Platform: Allogeneic Mesenchymal Stem Cells
2nd Platform Allogeneic Mesenchymal Stem Cells being advanced for Cardiac and Pulmonary indications 05295-BA (MKT) Corporate Presentation August 2026 17
Slide 18: CardiALLO Allogeneic Cell Therapy Strategic Optionality
CardiALLO Allogeneic Cell Therapy Strategic Optionality Pipeline-in-a-Product: Off the Shelf MSC Therapies Donor derived mesenchymal cells manufactured and cryopreserved for therapy o Potential advantages Off the shelf availability – reduces clinical procedural logistics No need for performing
Slide 19: Allogeneic Mesenchymal Stem Cells in Heart Failure (BCDA-03) Phase I/II
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 20: 3rd Platform: Helix cardiac biotherapeutic delivery
3rd Platform Helix cardiac biotherapeutic delivery for cell, gene, and protein delivery to the heart 05295-BA (MKT) Corporate Presentation August 2026 20
Slide 21: Delivery as a Differentiator
Delivery as a Differentiator Pipeline-in-a-Product: Local Delivery to the Heart Precision Transendocardial Delivery • Proprietary catheter-based delivery systems • Designed for targeted myocardial injection • Delivery quality recognized as a key variable in cardiac cell therapy outcomes • DeNovo App
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-BA (MKT) Corporate Presentation August 2026 22
Slide 23: Executive Management Team
Executive Management Team Peter Altman David McClung Debby Holmes- Edward Gillis Higgin CEO CFO VP Clinical SVP 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, Inc.
Slide 24: Financial Data and Significant Anticipated Catalysts
Financial Data and Significant Anticipated Catalysts Year Year Year CardiAMP Cell Therapy Ended Ended Ended Q4 ‘26 Peer Reviewed Manuscript 2023 2024 2025 Q4 ‘26 Japan PMDA Submission for Approval ($ mm) ($mm) ($mm) Q4 ‘27 Japan Approval Net Loss $11.6 $7.9 $8.2 Q3 ‘28 HF II completes enrollment Cas