Slide 1: Developing cellular and cell-derived therapeutics
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-AX (MKT) Corporate Presentation March 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: 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 • Despite guideline directed medical therapy: • High mortality: 50% mortality at
Slide 4: Potential Solution: Enhancing Microvascular Function
Potential Solution: Enhancing Microvascular Function Therapies design to 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 Heart Ins
Slide 5: Proprietary Regenerative Medicine Platform Overview
Proprietary Regenerative Medicine Platform Overview CardiAMP® Autologous Mononuclear Cells (lead program, utilizes delivery) CardiALLO Allogeneic Mesenchymal Cells (earlier stage, also utilizes delivery) Proprietary Delivery Systems Transendocardial catheter-based local delivery technology 052
Slide 6: CardiAMP Cell Therapy: Lead Program
CardiAMP® Cell Therapy: Lead Program Autologous Cell Therapy For ischemic HFrEF 05295-AX (MKT) Corporate Presentation March 2026 6
Slide 7: CardiAMP Key clinical insights
CardiAMP Key clinical insights Benefit seen across patients in three trials (189 procedures)* • 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
Slide 8: Ongoing CardiAMP Clinical Strategy in HFrEF
Ongoing CardiAMP Clinical Strategy in HFrEF CardiAMP HF II randomized, controlled design o Composite endpoint including: Mortality Major adverse cardiac events Quality of life measures o Up to 250 patients at up to 40 centers o Designed as confirmatory trial o Power of 80% with 160 patients
Slide 9: CardiALLO Allogeneic Cell Therapy Strategic Optionality
CardiALLO Allogeneic Cell Therapy Strategic Optionality Donor derived mesenchymal cells manufactured and cryopreserved for therapy o Potential advantages Off the shelf availability – reduces clinical procedural logistics No need for performing a tissue collection on treatment day Limits pati
Slide 10: Delivery as a Differentiator
Delivery as a Differentiator 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 05295-AX (MKT) Corporate Presentation March 2026 10
Slide 11: CardiAMP Market Opportunity
CardiAMP Market Opportunity Target initial population for CardiAMP cell therapy o Patients with HFrEF, on guideline directed medical therapy but still having biomarker evidence of active heart stress = ~ 1 million patients in USA 1, 2 o Current USA CMS reimbursement in trials is $35,000 for a trea
Slide 12: CardiAMP HF Pathways to Approval and Reimbursement
CardiAMP HF Pathways to Approval and Reimbursement United States (FDA) – working with 3rd party legal group o Past: FDA Breakthrough Designation o FDA active regulatory engagement on approvability based on existing data as a low-risk medical device system. 1st Helix Transendocardial Delivery Sys
Slide 13: HF Pathways to Approval and Reimbursement
CardiAMP HF Pathways to Approval and Reimbursement Japan (PMDA) – working with independent regulatory leaders o PMDA leadership in cell therapy supportive of regenerative therapies o More significant unmet need in Japan due to reduced use of heart transplantation and left ventricular assist device
Slide 14: Selected Financial Data and Significant Near-Term Catalysts
Selected Financial Data and Significant Near -Term Catalysts Nine Year Year Months Ended Ended Ended 31-Dec-23 31-Dec-24 30-Sep-25 ($ mm) ($mm) ($mm) Net Loss $11.6 $7.9 $6.2 Cash used in CardiAMP $10.0 $8.0 $4.9 operations CMI Data Cash & Helix FDA Oral $1.1 $2.4 $5.3 substantive Presentation Equiv
Slide 15: Appendix 1: CardiAMP Clinical Development Details
Appendix 1: CardiAMP Clinical Development Details 05295-AX (MKT) Corporate Presentation March 2026 15
Slide 16: CardiAMP System Development Status
CardiAMP System Development Status 189 Procedures and Counting FDA Breakthrough Device Designation granted based on results from trials to date. CMS Reimbursement Code C9782 for CardiAMP Cell Therapy for both treated and control patients for Calendar Year (CY) 2025, is assigned to APC 1590 (New Tech
Slide 17: Phase I Study -- TABMMI
CardiAMP Phase I Study -- TABMMI Transendocardial Autologous Bone Marrow in Myocardial Infarction (TABMMI) NCT00507468 Safety: No Treatment Emergent-MACE 20 Ischemic Heart Failure Patients LVEF<40% NYHA Class I, II, and III Open Label Safety Study 100 Million BMC 10 peri-infarct injection sites - He
Slide 18: Phase II Study – TAC-HFT
CardiAMP Phase II Study – TAC-HFT Transendocardial Autologous Cells in Heart Failure Trial (TAC-HFT), NCT00768066 Primary safety endpoint was met: no treatment-emergent MACE at 30 days pp; no death or MACE in BMC treatment group and 20% MACE in control group at one year follow-up All secondary eff
Slide 19: Phase II Study – TAC-HFT
CardiAMP Phase II Study – TAC-HFT All echocardiographic and MRI imaging outcomes favor therapy No., Mean Treated (n=19) Placebo Treatment (SD), [95% CI] (n =10) Differences (all benefits) LVEF % n = 17, 0.97 (6.60) n = 9, -2.38 (7.55) +3.25% [-2.42 –4.36] [-8.18 –3.42] EDV ml n = 17, 4.47 (27.36) n
Slide 20: CardiAMP HF Phase III Study
CardiAMP HF Phase III Study 05295-AX (MKT) Corporate Presentation March 2026 20
Slide 21: CardiAMP HF Phase III Clinical Results
CardiAMP HF Phase III Clinical Results 115 Patients Double Blind and Randomized Primary outcome is a Finkelstein Shoenfeld (FS) 3 tier composite of cardiac death, nonfatal major adverse cardiac events, and six-minute-walk distance (6MWD) or quality of life (QoL) in the 3rd tier. This FS outcome stat
Slide 22: CardiAMP HF Phase III Clinical Results
CardiAMP HF Phase III Clinical Results 115 Patients Double Blind and Randomized Like Phase II, the echocardiographic These treatment effects were also parameters improved in treated versus reflected in the biomarker for heart control patients. This was assessed in stress, NTproBNP, which decreased i