Biocardia, Inc. · NASDAQ:BCDA
Biocardia — Next Generation Cardiovascular Drug Development Summit (April 2023)
24 slides from Biocardia's conference presentation, Apr 28, 2023
Slide 1: Clinical Development Synergies of Autologous and Allogeneic Bone Marrow Derived Cell Therapies for Ischemic Heart Failure
Clinical Development Synergies of Autologous and Allogeneic Bone Marrow Derived Cell Therapies for Ischemic Heart Failure Peter Altman, PhD President and CEO paltman@biocardia.com www.biocardia.com www.cardiamp.com 1 05782-A (MKT) Auto and Allogenic Cell Therapy Synergies in iHFrEF 2023. Copyright B
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: Three Platforms, Four Clinical Stage Product Candidates for Cardiovascular and Pulmonary Diseases
Three Platforms, Four Clinical Stage Product Candidates for Cardiovascular and Pulmonary Diseases Product 2023 Platform Candidate Preclinical Phase 1 Phase 2 Phase 3 Anticipated Catalysts Recent Significant Events CardiAMP® for Ischemic Heart Failure (HFrEF) Q2’23: Submission Japan BCDA-01 and DSMB
Slide 4: The Problem – Great Advances But Still Unable to Heal Failing Hearts
The Problem – Great Advances But Still 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/re
Slide 5: Potential Solution – Cell Based Therapy
Potential Solution – Cell Based Therapy 5 05782-A (MKT) Auto and Allogenic Cell Therapy Synergies in iHFrEF 2023. Copyright BioCardia.
Slide 6: Potential Solution: Cell Based Therapy
Potential Solution: Cell Based Therapy ▪ Two basic approaches: 1. Deliver cells to repopulate damaged heart tissue with contractile heart cells ▪ Studies repopulating the heart using embryonic or induced pluripotent stem cells are beginning ▪ No safety or efficacy results in humans are available 2.
Slide 7: Potential Solution: ABM MNC & Allo MSC Therapy Mechanism of Action
Potential Solution: ABM MNC & Allo MSC Therapy Mechanism of Action ▪ Autologous bone marrow mononuclear cells (ABM MNC) 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 r
Slide 8: 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 Cell Therapy Modified from Decision Making in Advanced Heart Failure A Scientific Statement From the American Heart Association, Circ 2012 8 05782-A (MKT) Auto and Allogenic
Slide 9: BioCardia Cell Rx Development History in Ischemic HFrEF
BioCardia Cell Rx Development History in Ischemic HFrEF TABMMI Ph I TAC-HFT-MNC Ph I/II CardiAMP Phase III (N=20) (N=34) N=260 Trial NCT BM Rx Patients TAC-HFT-MSC Ph II Excluded TABMMI 00507468 Auto MNC (N=34) TACHFT-BMC 00768066 Auto MNC Due to CPA CardiAMP 02438306 Auto MNC TRIDENT 02013674 Allo
Slide 10: CardiAMP Autologous Cell Based Therapy
CardiAMP Autologous Cell Based Therapy 10 05782-A (MKT) Auto and Allogenic Cell Therapy Synergies in iHFrEF 2023. Copyright BioCardia.
Slide 11: CardiAMP Phase III Study Design
CardiAMP Phase III Study Design ▪ Multi-center prospective, randomized, double-blind (RCT) trial to evaluate autologous bone marrow mononuclear cell (ABM MNC) therapy delivered using the CardiAMP Cell Therapy System in subjects with ischemic heart failure and left ventricular systolic dysfunction ▪
Slide 12: CardiAMP Autologous Cell Therapy Overview
CardiAMP Autologous Cell Therapy Overview 12 05782-A (MKT) Auto and Allogenic Cell Therapy Synergies in iHFrEF 2023. Copyright BioCardia.
Slide 13: CardiAMP Autologous Cell Therapy: Pre-Procedure Cell Screening
CardiAMP Autologous Cell Therapy: Pre-Procedure Cell Screening Selects 70% anticipated to be most likely to respond based on therapeutic potential of their bone marrow ▪ Personalized approach to treatment using cell therapy with goal to treat the patients whose own cells, based on previous studies,
Slide 14: CardiAMP Autologous Cell Therapy Step 1: Cell Harvest
CardiAMP Autologous Cell Therapy Step 1: Cell Harvest Only 60 ml of marrow is taken immediately before step 2 cell processing. 05782-A (MKT) Auto and Allogenic Cell Therapy Synergies in iHFrEF 2023. Copyright BioCardia.
Slide 15: CardiAMP Autologous Cell Therapy Step 2: Cell Processing
CardiAMP Autologous Cell Therapy Step 2: Cell Processing ▪ Provides for a 5cc dosage form with a target dosage of 200 million cells. ▪ Excellent recovery of mesenchymal stem cells and endothelial progenitor cells1 ▪ During cell processing, patient is prepared for cardiac catheterization which follow
Slide 16: CardiAMP Autologous Cell Therapy Step 3: Delivery System
CardiAMP Autologous Cell Therapy Step 3: Delivery System • Cells are delivered transendocardially to 10 pre-specified target sites in myocardial wall surrounding the infarct zone • Pre-procedure echocardiography is used to target sites • Navigation using fluoroscopy, with biplane recommended but not
Slide 17: CardiAMP Autologous Cell Therapy Step 3: Delivery Targeting
CardiAMP Autologous Cell Therapy Step 3: Delivery Targeting Annotated anatomical overlays and echo wall motion / thickness bullseye targeting. 17 05782-A (MKT) Auto and Allogenic Cell Therapy Synergies in iHFrEF 2023. Copyright BioCardia.
Slide 18: CardiAMP Cell Therapy Potential Solution in Heart Failure 2022 Updates (BCDA-01)
CardiAMP Cell Therapy Potential Solution in Heart Failure 2022 Updates (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, Eurointerventio
Slide 19: 100% Survival, Patient Benefits and Positive Cardiac Remodeling; 2-Year Results from CardiAMP in HFrEF
100% Survival, Patient Benefits and Positive Cardiac Remodeling; 2-Year Results from CardiAMP in HFrEF Phase III Roll In Cohort (BCDA-01) Six Minute Walk Distance Sources of data and additional resources: Cell Potency Assay: Johnston P et al Circ Res, 2018. Phase I: De la Fuente LM, et al. EuroInter
Slide 20: CardiALLO NK1R+ MSC Cell Based Therapy
CardiALLO NK1R+ MSC Cell Based Therapy 20 05782-A (MKT) Auto and Allogenic Cell Therapy Synergies in iHFrEF 2023. Copyright BioCardia.
Slide 21: CardiALLO NK1R+ MSC Phase I/II Study Design
CardiALLO NK1R+ MSC Phase I/II Study Design ▪ Multi-center prospective, randomized, double-blind (RCT) trial to evaluate allogeneic Neurokinin 1 receptor positive mesenchymal stem cells (NK1R+ MSC) therapy delivered using in subjects with ischemic heart failure and left ventricular systolic dysfunct
Slide 22: CardiALLO Allogeneic NK1R+ MSC
CardiALLO Allogeneic NK1R+ MSC The specific MSCs used in BioCardia’s allogenic cell therapy are NK1 receptor positive. NK1 binds to substance P, an important neuropeptide associated with inflammation throughout the body and a primary mediator of inflammation in the airways. Manufactured at BioCardia
Slide 23: CardiALLO Allogeneic NK1R+ Mesenchymal Stem Cells Targeting heart failure patients excluded from CardiAMP HFrEF
CardiALLO Allogeneic NK1R+ Mesenchymal Stem Cells Targeting heart failure patients excluded from CardiAMP HFrEF Treats patients not eligible for CardiAMP autologous program due to nature of cells. Technical and logistic development synergies ▪ Delivery ▪ Clinical design ▪ Patients ▪ Physicians and C
Slide 24: Thank you
Thank you Peter Altman, PhD President and CEO paltman@biocardia.com www.biocardia.com www.cardiamp.com 05782-A (MKT) Auto and Allogenic Cell Therapy Synergies in iHFrEF 2023. Copyright BioCardia.
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