Biocardia, Inc. · NASDAQ:BCDA
Biocardia — Q1 2025 Earnings Presentation
38 slides from Biocardia's earnings presentation, May 14, 2025
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-AQ (MKT) Corporate Presentation May 2025 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: Executive Summary
Executive Summary Late-Stage Cell and Cell Derived Biotherapeutics for Cardiac and Pulmonary Diseases • CardiAMP® cell therapy for ischemic heart failure with TAM of > $17 Billion in USA1. • Granted FDA breakthrough designation and CMS reimbursement in place. • CardiAMP-HF Phase 3 trial showed incre
Slide 4: Therapeutic Product Pipeline
Therapeutic Product Pipeline Autologous and Allogeneic Cardiac Cell Therapy for Cardiac and Pulmonary Disease. 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 Car
Slide 5: Enabling Biotherapeutic Delivery Systems and Commercial Devices
Enabling Biotherapeutic Delivery Systems and Commercial Devices Therapeutic Platform Image Status Investigational use with CardiAMP HF, CardiAMP CMI, and CardiALLO HF Helix Transendocardial clinical trials. Biotherapeutic Delivery Device (uses Partnered with CellProThera Morph DNA) and StemCardia. A
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-AQ (MKT) Corporate Presentation May 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-AQ (MKT) Corporate Presentation May 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 at $20,000. Final Results: Presented as late breaking clinical trial at the American College
Slide 12: A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF
A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP- HF Trial Primary Outcome • Comparison b/t groups of the hierarchical composite ranking of: Tier 1. All cause death, cardiac transplant, LVAD Tier 2. All non-fatal HF
Slide 13: Patient Flow
Patient Flow 0 lost-to- 1 lost-to-FU 2 lost-to-FU n=10 roll-in cases; FU cells placed Active n=73/74 n=73/74 n=72/74 Treatment N=74 (98.6%) (98.6%) (97.3%) N=303 N=115 patients Enrolled & Randomized 3:2; screened at Randomized at stratified by clinical 24-m 30-d FU 12-m 25 sites in 18 sites site and
Slide 14: Safety Outcomes
Safety Outcomes NO device-related or procedure-related all-cause death, stroke, systemic embolism or need for open cardiac surgery or major endovascular surgical repair at 30 days 05295-AQ (MKT) Corporate Presentation May 2025 14
Slide 15: Primary Efficacy Outcome through Month 24
Primary Efficacy Outcome through Month 24 Treatment (n=74) Patient Pairs N=3,034 Control (n=41) Wins Ties Losses % of decisions Tier 1: death, transplant, LVAD 464 2,217 353 27% Tier 2: non-fatal MACCE 353 149 (stroke, heart attack and hosp) 1,715 17% 707 5 1003 Tier 3: 6MWT (both improved) 56% Tota
Slide 16: MACE-Free Survival
MACE-Free Survival nEvents A – 15/74 (20.3%) nEvents C – 13/41 (31.7%) p-value = 0.170 number at risk number at risk 05295-AQ (MKT) Corporate Presentation May 2025 16
Slide 17: Major Adverse Cardiovascular Events (MACE)
Major Adverse Cardiovascular Events (MACE) Treatment Control All MACE All-cause death, LVAD, Heart… All-cause death Heart transplant LVAD Nonfatal MACE Hospitalization for progression of… Myocardial Infarction Stroke 0% 5% 10% 15% 20% 25% 30% 35% 05295-AQ (MKT) Corporate Presentation May 2025 17
Slide 18: Analysis of Efficacy for Secondary Outcome
Analysis of Efficacy for Secondary Outcome Modified Outcome Measure Treatment (n=74) Patient Pairs N=3,034 Control (n=41) Wins Ties Losses % of decisions Tier 1: death, transplant, LVAD 464 2,217 35 3 27% Tier 2: non-fatal MACE 353 1,715 14 9 17% Tier 3: MLHFQ (QoL) 933 753 29 56% Total Wins = 1,750
Slide 19: Post-hoc Sub-Group Analysis
Post-hoc Sub-Group Analysis Elevated NTproBNP or BNP at Baseline Treatment (n=35) Patient Pairs N=770 Control (n=22) Wins Ties Losses Wins Ties Losses Tier 1: death, transplant, LVAD 492 39% 492 193 85 193 85 Tier 2: non-fatal MACE 103 333 56 22% 103 333 56 Tier 3: MLHFQ (left) 78 168 87 39% 147 51
Slide 20: CardiAMP HF Conclusions
CardiAMP HF Conclusions • A point-of-care approach to treating patients with ischemic heart failure selected for favorable cell characteristics (62% of population) was safe but this study did not meet its primary efficacy outcome using 6MWT as 3rd F-S tier. • Favorable outcomes in additional analyse
Slide 21: Design of CardiAMP HF II Pivotal Trial
Design of CardiAMP HF II Pivotal Trial FDA Approved protocol for up to 250 patients at up to 40 centers Focused on NYHA II and III ischemic HFrEF with NTproBNP >500 pg/ml Primary endpoint is Finkelstein Schoenfeld composite of heart death, major adverse cardiac and cerebrovascular events, and
Slide 22: 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 23: CardiAMP HF Anticipated Timeline is Driven by Data
CardiAMP HF Anticipated Timeline is Driven by Data 2025 CardiAMP HF Top Manuscript Potential CardiAMP HF 2026 FDA/ Japan PMDA Meetings approval in Japan assuming CardiAMP HF II Enrolling 2025 submission CardiAMP HF II enrolling Japan approval pathway may have greater potential for near term approv
Slide 24: CardiAMP Cell Therapy 2nd Indication: Chronic Myocardial Ischemia with Refractory Angina
CardiAMP Cell Therapy 2nd Indication Chronic Myocardial Ischemia with Refractory Angina 05295-AQ (MKT) Corporate Presentation May 2025 24
Slide 25: 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 26: CardiAMP Cells in 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 increase in exercise tolerance time (ETT) which has only been shown with cell therapy. Last open label roll-in cohort patient reac
Slide 27: CardiALLO Cell Therapy 2nd Therapeutic Platform Ischemic Heart Failure
CardiALLO Cell Therapy 2nd Therapeutic Platform Ischemic Heart Failure 05295-AQ (MKT) Corporate Presentation May 2025 27
Slide 28: 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 29: 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 30: 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 31: Helix Biotherapeutic Delivery Platform
Helix Biotherapeutic Delivery Platform 05295-AQ (MKT) Corporate Presentation May 2025 31
Slide 32: 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 33: Morph DNA Steerable Introducers
Morph DNA Steerable Introducers FDA Approved in a wide variety of configurations and commercially available. 05295-AQ (MKT) Corporate Presentation May 2025 33
Slide 34: Commercializing FDA Approved Enabling Products
Commercializing FDA Approved Enabling Products See brochure at www.biocardia.com 05295-AQ (MKT) Corporate Presentation May 2025 34
Slide 35: 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-AQ (MKT) Corporate Presentation May 2025 35
Slide 36: 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 37: Selected Financial Data
Selected Financial Data Year Year Year Year Ended Ended Ended Ended 31-Dec-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 $7.9 $11.6 $11.9 $12.6 Cash used in operations $8.0 $10.0 $10.6 $10.4 Cash & Equivalents $2.4 $1.1 $7.4 $12.9 Debt N/A N/A N/A
Slide 38: Potential Catalysts
Potential Catalysts BCDA -01 CardiAMP HF with two randomized placebo-controlled trials o CardiAMP HF Manuscript o Japan PMDA Approval Milestones o Japan Distribution Deal o FDA Approval Milestones o CardiAMP HF II – additional sites and enrollment BCDA-02 CardiAMP Chronic Myocardial Ischemia wit