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Working to solve the historical challenges of cardiac cell therapy
So heart failure patients can thrive
Peter Altman, PhD
Chief Executive Officer
BioCardia (NASDAQ: BCDA)
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▪ Cardiovascular regenerative medicine company with best in class autologous and allogenic cell therapies.
▪ CardiAMP autologous cell therapy system represents novel, rapid and personalized approach to autologous cell therapy with robust ongoing late-stage clinical activity for the treatment of two enormous unmet needs of heart failure and chronic myocardial ischemia.
▪ CardiALLO allogeneic Neurokinin-1 Receptor Positive “off the shelf” culture expanded immune privileged mesenchymal stem cell therapy follow-on program with potential orphan indication
▪ Enabling FDA approved and CE Marked products partnered with five other therapeutic programs.
▪ Extensive intellectual property portfolio
Highlights
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▪ A global pandemic affecting more than 26 million people worldwide, 5.7 million people in U.S., with 50% mortality at five years.
▪ No existing therapies are curative, they only slow disease progression.
▪ Cell therapy holds promise to rejuvenate the heart, yet no cardiac cell therapy has been FDA-cleared to date despite decades of research.
The Problem of Heart Failure
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Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr; 3(1): 7–11.
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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?
Our 1st Solution for Heart Failure: CardiAMP cell therapy
Patient Selection1st test for a cardiac cell therapy that identifies likely responders pre-treatment
High DoseHighest dose cell therapy using bone-marrow derived cells (BMDCs) to provoke body’s healing response
Efficient DeliveryProprietary delivery system shown to be safest and most effective in helping heart retain cells
Low CostBedside cell processing that eliminates costly off-site manufacturing
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Medications▪ ACE Inhibitors/ARBs▪ Beta-Blockers▪ Aldosterone Antagonists▪ Hydralazine and nitrates▪ Ivabradine (AMGEN)
NYHA II & III ▪ LCZ696 (Novartis)
Devices▪ CRT & CRT-D▪ Mitral valve
repair/replacement▪ Pressure monitoring
Hemodynamic Support▪ IV Inotropes▪ Left Ventricular
Assist Devices (LVAD)
Transplantation (Tx)▪ Immuno-
suppression
Class I, II. & III Class III Class IV
Images from Cleveland Clinic
Current Options for Patients - Expensive, Unable to Heal Failing Hearts
Each of these is a multi billion dollar market today.
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PA Pressure Monitoring
LVAD/TX
MV repair
CRT
Future Potential of CardiAMP Cell Therapy
Role of Cell Therapy in Clinical Course of Heart Failure
Modified from Decision Making in Advanced Heart Failure A Scientific Statement From the American Heart Association, Circ 2012
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CardiAMP cell therapy: mechanistic basis for regenerationTransplanted cells are hypothesized to benefit the heart through direct and indirect pathways.
▪ Indirect Regeneration: Transplanted cells secrete stimulatory cytokines to instigate an innate regenerative response from resident stem cells.
▪ Accelerating a natural process:Cells from bone marrow home to injury in the heart. CD34, CD133, and CD19 cells are primary drivers of benefit.
▪ Data: Preclinical studies support reduced fibrotic scar and enhanced micro vessel density, and benefit of higher dosages delivered intramyocardially. Clinical studies support enhanced heart function, functional capacity, and quality of life with no significant safety issues.
Afzal MR et al Adult Bone Marrow Cell Therapy for Ischemic Heart Disease, Circulation Research. 2015.
Fisher SA et al. Meta-Analysis of Cell Therapy Trials for Patients with Heart Failure. Circulation Research 2015.
Takahashi, M. et al. (2006) Am J Physiol Heart Circ Physiol. 291:H886-H893.
Silva, GV. et al. (2011) Tex Heart Inst J. 38(3):219-24
Behfar, A. et al. (2014) Nat. Rev. Cardiol. 11: 232–246
Vignozzi R. J. et al. An acute immune response underlies the benefit of cardiac stem-cell therapy, Nature, 2019.
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Cardiac cell therapy: learnings from previous trials
▪ Effective Dose matters: Inefficient delivery of circulating investigational product (IP) into the coronary arteries, results in minor first pass targeting of the heart. Most IP passes straight through the heart and are effectively systemic administration. Higher absolute cell dosage coupled with higher efficiency delivery results in CardiAMP having the highest effective dosage.
▪ Patients phenotypes matter: For autologous cell therapy, each patient can be different and selecting patients with prequalified cells enhances probability of technical success for CardiAMP, which is the first autologous cell therapy to include a selection companion diagnostic strategy.
▪ Safety of delivery matters: Significant safety issues have occurred with other delivery approaches, with one approach having a 5% treatment emergent major adverse cardiac event rate, and this data is incorporated into the composite efficacy endpoints.
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Investigational CardiAMP Cell Therapy System
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FDA CBER regulated as device system.
Medicare reimbursement established for two pivotal trials.
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▪ CardiAMP Potency Assay bone marrow biomarker panel analysis at core lab:
▪ One marker is CD34+ cell count, which has shown therapeutic benefit in clinical trials for CMI (Henry EHJ, 2018).
▪ Personalized approach to autologous cell therapy:
— Can reduce problematic patient-to-patient variation in bone marrow cells
— Can significantly lower cost of therapy by enabling point of care treatment and excluding patients from therapy not likely to respond
— Potentially attractive to patients, physicians and payors
CardiAMP Pre-procedure Screening Selects Patients Likely to Respond,Assay Performed in CLIA/CAP Laboratory
Anticipated to select 70% most likely to respond based on
therapeutic potentialof their bone marrow
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CardiAMP Cell Collection is Performed with BioCardia Procedure Kit using FDA cleared devices
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Heterogeneous cell populationLymphocytesMonocytesHematopoietic stem and progenitor cellsMesenchymal stem cells
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CardiAMP Cell Processing for Transfer at Point of Care with proprietary FDA cleared devices
Provides for a 5cc dosage form with a target dosage of 200 million MNCs.Superior recovery of mesenchymal stem cells and endothelial progenitor cells.
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0
5,000
10,000
15,000
20,000
25,000
Mesenchymal Cells(CFU-F / Output)
MSC Recovery and Viability
CardiAMP CS Ficoll
Performance of CardiAMP Cell Processing
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0
50,000
100,000
150,000
200,000
250,000
HematopoeticStem Cells (CFU -GEMM/ Output)
HSC Recovery and Viability
CardiAMP CS Ficoll
0
10
20
30
40
50
60
70
80
90
100
Mononuclear cellrecovery (%)
MNC Recovery and Viability
CardiAMP CS Ficoll
BioResearch Open Access, Volume 4.1, 2015
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CardiAMP Cell Delivery to Damaged Regions of Heart with Proprietary Helix System, Approved in Europe
Target dosage is delivered to ten sites in the heart around the infarct zone.
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Performance of CardiAMP Cell Delivery with Proprietary Helix
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Mitsutake et al, Int.Heart J. (2017)Duckers H et al, Transcatheter Therapeutics 2018.
0
1
2
3
4
5
6
% Treatment Emergent Major AdverseCardiac Eevents
Superior Safety with Lowest % Treatment Emergent MACE
CardiAMP Helix Stop Flow
Myostar Celyad
0
5
10
15
20
% Dosage Retained
Superior Efficiency of Delivery, Results in Increased
Effective Dosage
CardiAMP Helix
Stop Flow
Myostar
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CardiAMP HF Phase I Open Label Trial Results
Transendocardial Autologous Bone Marrow in Myocardial Infarction (TABMMI) NCT00507468Safety: No Treatment Emergent-MACE
De la Fuente LM, et al. EuroIntervention 2011, 7: 805-812.
Improved LV Ejection Fraction
Improvement at 12 & 24M:
~ +7 %, p=0.000006, p=0.00005, N=20
Improved survival at 3 and 5 year follow-up
1st 10 patients – No death
All 20 patients – 2 deaths:
D177 Elective heart transplant D695 Unknown causes
Exercise Tolerance Time
Improvement at 12 & 24M:
~ +125 sec, p=0.006, N= 20
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*NS: not significant
SecondaryEfficacy
Endpoints
Active(Mean)
Placebo(Mean)
Treat. Difference
FavorsCardiAMP Therapy
P-value
6 minute walk (meters)N=28, Mean ± St Dev
+14.3 ± 59.6
-42.0± 18.1
+56.3 ✓ 0.049
MLHF quality of life (pts)N= 29, Mean ± St Dev
-7.7± 17.8
+9.7± 24.8
-17.4 ✓ 0.038
Maximum Oxygen Use (mL/kg·min)
+0.16 -0.870 +1.03 ✓ 0.321NS*
NY Heart Association Class
-0.42 -0.25 -0.17 ✓ 0.638NS
LV End Systolic Volume (ml)
+3.2 +47.2 -44 ✓ 0.129NS
LV End Diastolic Volume (ml)
+4.5 +51.2 -46.7 ✓ 0.149NS
LV Ejection Fraction (%) +0.97 -2.38 +3.35 ✓ 0.252NS
▪ TACHFT-BMC were results superior to TACHFT-MSC ▪ Primary safety endpoint met: no treatment emergent MACE at 30 days▪ No death or MACE in BMC treatment group at one year follow-up▪ All secondary efficacy endpoints at one year follow-up favor therapy (below)▪ Multiple endpoints that are statistically significant and clinically meaningful
Wong Po Foo et al, World Congress of Regenerative Medicine, 2015.Heldman A et al, JAMA 2013.
CardiAMP HF Phase 2 Randomized Placebo Controlled Trial Results
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CardiAMP HF Phase 2 Randomized Placebo Controlled Trial ResultsRelative to other heart failure therapies
▪ CRT = Cardiac Resynchronization Therapy or Biventricular Pacing, a $3Bn US Market
▪ 50% of patients in CardiAMP placebo controlled Phase II already had AICD or CRT devices
▪ 6MW has been used for approval in PAH, and CRT
▪ This data is from trials used for CRT product registration
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1 CRT, Miracle-ICD, JAMA, 20032 Cells, REVASCOR, Circ Res 20053 CRT, Contak CD, JACC, 20034 CRT, PAVE, JCE 20055 CRT, Miracle, Circ, 20036 CRT, Path CHF, JACC, 20027 Cells, CardiAMP, JAMA 2013, WCRM 20158 CRT, Mustic, JACC, 20029 Entresto Paradigm HF, NEJM 2014 – No Six Minute Walk
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▪ Changes from Phase II are NYHA Class I patients are eliminated and potency assay is implemented with intent to enhance response to therapy
▪ Primary endpoint:
o Superiority with respect to functional capacity as measured by six minute walk test at one-year post-procedure (efficacy)
▪ Secondary hierarchical endpoints will have p values and will be on labelling if achieved:
o Non-inferiority with respect to survival (safety)
o Non-inferiority with respect to MACE (safety)
o Superiority with regard to quality of life as measured by the MLHFQ (efficacy)
o Time to first heart failure (HF)-related major adverse cardiac events (efficacy)
o Superiority with respect to survival (efficacy)
This is substantially equivalent to the Finkelstein-Schoenfeld statistical analysis plan which would not change the power (>95%) if used based on the Phase II data.
250 Ischemic Heart Failure Patients
20% ≤ EF ≤ 40%
NYHA Class II and III
CardiAMP Potency Assay Meets Thresholds
150 Patients @200M Cells 100 Patients SHAM
CardiAMP HF : Phase 3 Pivotal Trial to Support FDA Approval
Achieved in Phase II
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CardiAMP HF Phase 3 Pivotal Trial Results To Date
▪ Data Safety Monitoring Board (DSMB) pre-specified interim analysis of safety outcomes for the first 74 patients treated in the Phase 3 trial of its investigational CardiAMP cell therapy product no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned.
▪ Results from CardiAMP-HF Study Roll-In Phase: 12-month follow-up results compared to baseline (shown as mean ±sem). N=10 for baseline, 3 months, and 6 months; N=9 for 9 months where one patient was hospitalized, N = 10 for 12 months. Results compared to improvements in Phase II TAC-HFT Study.
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Johnston, American Heart Association, November 12, 2018Wong Po Foo, TACHFT Study, World Congress Regen Med 2015.
TACHFT
+7.5 pts
TACHFT
+0.97 %
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10
5
10
0
2
4
6
8
10
12
14
3 Months 6 Months 9 Months 12 Months
Po
ints
Imp
rove
men
t
Improvement in Quality of Life Self Assessment (MLHFQ) Versus Baseline
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CardiAMP HF Phase 3 Pivotal Trial Results To Date
+1.0
+4.1
0
2
4
6
8
Baseline 6 Months 12 Months
Ch
an
ge i
n L
VE
F (
%)
Change in LV Function
Echo Core Lab (Yale School of Medicine
p=0.49
p=0.18
Change in Akinetic Wall Segments
ΔA
kin
eti
c S
eg
me
nts -1.1
-1.9
-4
-3
-2
-1
0
Baseline 6 Months 12 Months
p=0.08
*p=0.04
Change in Wall Motion Score
-3.0
-5.9
-10
-8
-6
-4
-2
0
Baseline 6 Months 12 Months
ΔW
all M
oti
on
Sc
ore
**p=0.01
**p=0.01
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CardiAMP HF Phase 3 Pivotal Trial Status
The Company recently received FDA approval for an IDE supplement for the Phase III pivotal CardiAMP™ Heart Failure Trial of its lead therapeutic candidate. This will enable patients in the control group to cross over to CardiAMP treatment once their follow-up for the CardiAMP Trial has been completed. The IDE supplement is intended to enable BioCardia to cover all out-of-pocket insurance co-pays for patients with Medicare coverage. These two areas were previously barriers to participation for patients.
These changes, coupled with site-specific action plans, are being actively rolled out and are expected to further accelerate trial enrollment, which currently stands at 74 patients enrolled at 25 world class active U.S. centers. We have been excited by the significant uptick in the number of patient informed consents received for participation in the CardiAMP Heart Failure trial in March 2020 and by the number of new centers becoming fully active, however this solid progress has been delayed by COVID-19.
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Sources of data: Povsic T. et al EHJ 2018
CardiAMP 2nd Indication: Chronic Myocardial Ischemia (BCDA-02)
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▪ Patients suffer from poor perceived health status and psychological distress, have significant impairment in quality of life, and represent a burden to the healthcare system due to significant use of resources
▪ Estimated that between 600,000 and 1.8 million patients suffer from RA, with approximately 75,000 new cases diagnosed each year
Burden of Illness and Unmet Need
▪ Current therapies have limitations or are associated with minimal reduction in angina
Minimal Treatment Options
▪ Reachable market estimated as 200,000 patients in the United States per year, 500,000 worldwide. Of note, Ranexa from Gilead Sciences sales estimated as $800M/Year
Market Opportunity
Characterized by significant debilitating chest pain that greatly reduces quality of life.
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CardiAMP 2nd Indication: Chronic Myocardial Ischemia (BCDA-02)Approved by FDA, Anticipated to treat First Patient Q2 2020
CardiAMP Chronic Myocardial Ischemia Trial, NCT03455725, IDE Trial for Premarket Approval
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40 center, 343 Chronic Myocardial Ischemia Patients
Open Label Roll In
200M Cells (N=10)
Randomized Sham Controlled Therapy at 200M cells
to Treatment (N=333) 2:1
10 peri-infarct injection sites
Helix System
Primary endpoint change from baseline in total exercise time.
Hierarchical secondary endpoints of MACE, survival.
▪ Adaptive statistical analysis plan with anticipated read out at 100 patients.
▪ Trial is reimbursed by Medicare.
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Sources of data: American Heart Association and American Association of HF Nurses Certification Board 2013. McMurray, JJV et. At., 2005. The Lancet, 365, pp 1877-1889
Go, A.S. et al., Heart Disease and Stroke Statistics 2013 Update:, A Report From the American Heart AssociationPovsic T. et al EHJ 2018
Alternate HF Therapy: CardiALLO Cell Therapy (BCDA-03)Initially Targeting Ischemic Heart Failure Patients Excluded from CardiAMP
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▪ Chronic disease with 50% mortality at five years, impacts 1 in 5 adults over age of 40.
▪ Annual cost estimated to be $39 billion, projected to increase to $70 billion in 2030, half related to hospitalization
Burden of Illness and Unmet Need
▪ Despite advances in pharmaceutical chemistry and device development, options are limited.
▪ BCDA-3 appropriate for 30% of patients who do not meet cell potency assay.
Minimal Treatment Options
▪ Targeting patients excluded from CardiAMP HF based on cell potency, may be approximately 200K patients in USA.
▪ Potential to be advanced for other indications.
Market Opportunity
Characterized by a large spherical heart that has lost pumping capacity.
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Alternate HF Therapy: CardiALLO Cell Therapy (BCDA-03)Clinical Results and Development Strategy
▪ Similar benefits and risks between allogeneic to autologous MSC delivered with Helix
▪ High dose allogeneic MSC delivered with Helix more effective vs. low dose
▪ Submitted IND in heart failure to follow these three trials, with enhanced approach using Neurokinin 1 R+ cells, initially in patients excluded from BCDA-01 by potency assay
Florea V, et al, TRIDENT, Circ Research, 2017.
Three BCDA co-sponsored Phase 1 / 2 culture expanded mesenchymal cell trials in heart failure have been completed:
Conclusions
CardiALLO Nerokinin 1 R+ Mesenchymal Stem Cells
These are believed to be highly potent cells that respond to the primary mediator of injury and pain - Substance P.
Hare J et al, POSEIDON, JAMA 2012.
Heldman A et al, TAC-HFT, JAMA 2013.
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Product Candidate
(Pathway) Preclinical Phase 1 Phase 2 Phase 3
BCDA-01
BCDA-02
BCDA-03
Helix Partner-01Cell Pro Thera
Helix Partner-02University of Milan
Helix Partner -03
Helix Partner -04
Helix Partner -05
CardiAMP®: Ischemic Heart Failure
CardiAMP®: Chronic Myocardial Ischemia with Refractory Angina
CardiALLO™: Ischemic Heart Failure
Acute Infarction
Heart Failure
Advanced Biotherapeutic Pipeline
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Heart Failure
Heart Failure
Acute Infarction
Fundedby Medicare
Funded by partners
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▪ Regulated and manufactured as a procedure kit with anticipated low cost of goods and long shelf life
▪ For both leading indications, CardiAMP fits into standard interventional cardiology device channels
▪ All components approved in EU and/or USA.
▪ The stem cells that respond to pain
▪ Treats patients not possible to be treated with CardiAMP
▪ Potential orphan indication
▪ “Off the shelf” cell therapy
▪ Leverages delivery system
Three Commercially Viable and Potentially Pivotal Programs
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CardiAMP cell therapy system (BCDA-01, 02)
CardiALLO cell therapy system (BCDA-03)
CardiALLO
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▪ Exclusive rights to over 65 patents and patent applications in USA, Europe, China, India, and Japan covering CardiAMP Cell Therapy System, CardiALLO Cell Therapy System, Helix biotherapeutic delivery system and Morph vascular access catheter products.
▪ Most recently issued USA patents are below with expiration excluding any potential patent term extensions.
Intellectual Property Overview
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US Patent No. Patent Title Expiration on or after
10,520,505 Methods of measuring therapeutic potency potential and defining dosages for autologous cell therapy
2034
10,071,226 Radial and trans-endocardial delivery catheter 2034
10,035,982 Method of preparing autologous cells and methods of use for therapy 2029
9,945,854 Methods of measuring therapeutic potency potential and defining dosages for autologous cell therapy
2034
9,752,123 Method of Preparing Autologous Cells and Methods of Use for Therapy 2029
9,517,199 Treatment for chronic myocardial infarct 2027
9,504,642 Treatment for chronic myocardial infarct 2027
9,301,975 Method of preparing autologous cells and method of use for therapy 2029
8,496,926 Treatment for chronic myocardial infarction 2027
Additional nonexclusive rights from partnering agreements have been secured.
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Year EndedDecember 31, 2019
Year EndedDecember 31, 2018
Revenues $710,000 $625,000
Net Loss $14.7M $14.0M
Cash used in operations $9.4M $11.1M
Cash & Equivalents $5.6M $5.4M
Debt N/A N/A
BCDA Financial Snapshot
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Common shares o/s 6,848,355Public float: 3.5 million sharesInstitutional ownership % N/A
04589-P (MKT) Q1 2020
▪ Q1 2020 CardiAMP Heart Failure DSMB Review- Safety (BCDA-01)
▪ Q2 2020 Phase III pivotal trial commencement/first sites activated in CardiAMP Chronic Myocardial Ischemia (CMI) Trial, the second Phase III pivotal trial of CardiAMP (BCDA-02)
▪ Q2 2020 FDA acceptance of Investigational New Drug application for CardiALLO Neurokinin-1 Receptor Positive Mesenchymal Stem Cell Therapy (BCDA-03), the Company’s second therapeutic platform
▪ Q4 2020 Pre-specified Data Safety Monitoring Board Review of all patients enrolled, including futility analysis, based on sixty (60) patients that will have reached the primary one-year follow-up endpoint at the time of analysis (BCDA-01)
▪ Q4 2020 Pre-specified Data Safety Monitoring Board Review of safety data from roll-in cohort in CardiAMP CMI Trial (BCDA-02)
Anticipated Catalysts
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Leadership team advancing autologous and allogenic cell therapies and partnering delivery technologies to enable others
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Peter Altman, PhD
David McClung
Eric Duckers, MD, PhD
Ian McNiece, PhD
Sujith Shetty, MD
Phil Pesta Jeff Emery, PhD
CEO Chief Financial Officer
Chief Medical Officer
Chief Scientific Officer
VP Clin Reg VP Operations
VP Development
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▪ Cardiovascular regenerative medicine company with best in class autologous and allogenic cell therapies
▪ CardiAMP autologous cell therapy system represents novel, rapid and personalized approach to autologous cell therapy with robust ongoing late-stage clinical activity for the treatment of two enormous unmet needs of heart failure and chronic myocardial ischemia
▪ CardiALLO allogeneic Neurokinin-1 Receptor Positive “off the shelf” culture expanded immune privileged mesenchymal stem cell therapy follow-on program with potential orphan indication
▪ Enabling FDA approved and CE Marked products partnered with other programs
▪ Extensive intellectual property portfolio
Highlights
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This presentation includes forward-looking statements. All statements other than statements of historical facts included in this presentation that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies and prospects regarding, among other things, our CardiAMP™ Cell Therapy System, our cell-based therapy product pipeline, our enabling and delivery product portfolio, our market opportunity, enrollment and the availability of data in our clinical trials, FDA product clearances, the efficacy and safety of our products and therapies, the achievement of anticipated milestones, financial condition and results of operations. Although we believe that we have a reasonable basis for forward-looking statements contained in this presentation, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations, clinical development programs, regulatory approvals and business environment, all of which are difficult to predict and many of which are beyond our control. The known risks, uncertainties and factors are described in detail under the caption “Risk Factors” in our Form 10-K for the fiscal year ended December 31, 2019, filed with the Securities and Exchange Commission on April 9, 2020.
As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Therefore, our actual results may differ materially from those expressed or implied by forward-looking statements in this presentation. All forward-looking statements included in this presentation are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
Disclaimer Regarding Forward-Looking Statements
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Thank you.
Peter Altman, PhD
Chief Executive Officer
NASDAQ: BCDA
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