David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global...

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Corporate Presentation David J. Mazzo, PhD President and Chief Executive Officer June 2019 | NASDAQ: CLBS

Transcript of David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global...

Page 1: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Corporate PresentationDavid J. Mazzo, PhD

President and Chief Executive Officer

June 2019 | NASDAQ: CLBS

Page 2: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Forward-looking statements advisory

This Investor Presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this presentation, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this Investor Presentation are forward-looking statements. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to differ materially from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 14, 2019, as subsequently amended on March 19, 2019, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Investor Presentation. Caladrius does not intend, and disclaims any obligation, to update or revise any forward-looking information contained in this Investor Presentation or with respect to the matters described herein.

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Page 3: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

▪Late-stage therapeutics development company

▪ Pioneering advancements of cell therapies in cardiovascular disease

▪ Three principal development programs; 2 designated “breakthrough”*

▪ CLBS12*, CLBS16 (aka CLBS14-CMD), CLBS14* (aka CLBS14-NORDA)

▪Financially stable and debt-free

▪ Strong balance sheet (~$38 million cash as of March 31, 2019)

▪ Low operating cash burn (cash projected through 2Q 2020)

▪Multiple value creating events within the next ~12 months

▪ Key regulatory and data milestones across the pipeline

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Caladrius Biosciences: Uniquely positioned for near-term success

Page 4: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Accomplished executive team with broad domain-specific expertise

David J. Mazzo, PhD President and Chief Executive Officer

35+ years of experience in all aspects of large pharma (Merck, Baxter, RPR, HMR,

Schering-Plough) and emerging biopharma (Chugai USA, Regado); successful

international drug development across all therapeutic areas, international capital

raising and business transactions; Director and former Chairman of EyePoint Pharma

Douglas W. Losordo, MD Executive VP, Global Head of R&D and

Chief Medical Officer

25+ years of experience as a leader in cell therapy research and development;

renowned clinician with noteworthy academic (Tufts, Northwestern, NYU) and industry

(Baxter) credentials; pioneer of CD34+ cell therapy

Joseph Talamo, CPA, MBASenior VP and Chief Financial Officer

25+ years of experience as a versatile finance executive with strong accounting/audit

background (KPMG) and leadership roles in publicly traded pharmaceutical

development and commercial-stage companies (OSI Pharmaceuticals, BMS)

Todd Girolamo, JD, MBASenior VP, General Counsel and

Corporate Secretary

25+ years of legal experience as a practicing attorney (Cahill, Gordon & Reindel; Reid

& Priest) as well as finance and biotechnology industry experience (Oppenheimer,

CIBC, Leerink Swann)

John D. MendittoVice President,

Investor Relations and Corporate Communications

25+ years of experience as an investor relations and corporate communications

professional with a major focus on healthcare and life science (Novartis, Medco Health

Solutions, Argos Therapeutics)

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Page 5: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Distinguished, committed cardiovascular disease Scientific Advisory Board

Michael Gibson, MD

Baim Institute for Clinical ResearchChief Executive Officer of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School.

Timothy Henry, MD

The Christ HospitalLindner Family Distinguished Chair in Clinical Research and Medical Director of The Carl and Edyth Lindner Center for

Research at The Christ Hospital, Cincinnati.

Thomas Povsic, MD, PhD

Duke UniversityHead of the advanced biomarkers group at Duke Clinical Research Institute and Associate Professor of Medicine at

Duke University with an additional appointment to the Durham VA Medical Center.

Arshed Quyyumi, MD

Emory UniversityProfessor of Medicine in the Division of Cardiology at Emory University School of Medicine and Director at Emory

Clinical Cardiovascular Research Institute.

Richard Schatz, MD

Scripps ClinicResearch Director of cardiovascular interventions at the Heart, Lung, and Vascular Center at Scripps Clinic and

Director of cell therapy.

Christopher White, MD

Ochsner Medical CenterProfessor & Chairman of Medicine and Cardiology, The Ochsner Clinical School, Univ. Queensland, AU and Medical

Director of Value Based Healthcare & System Chairman of Cardiovascular Diseases for the Ochsner Health System.

Joseph Wu, MD, PhD

Stanford UniversityDirector of the Stanford Cardiovascular Institute and Simon H. Stertzer, MD, Professor of Medicine and Radiology.

Andreas Zeiher, MD

University of FrankfurtChairman of Medicine, Dept. of Cardiology, Angiology & Nephrology at the J.W. Goethe Univ. of Frankfurt, German.

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Page 6: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Autologous CD34+ Cells Treat

Microvascular Insufficiency

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Page 7: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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Normal microvasculatureAugmented microvasculature

post-CD34+ cells treatmentCompromised microvasculature

ArteryVein

ArteryVein

Capillaries CapillariesCapillaries

ArteryVein

CD34+ cells promote angiogenesis of the microvasculature

▪ CD34+ cells are endothelial progenitor cells

▪ Naturally reside in the bone marrow

▪ Induce capillary growth to regenerate damaged microcirculation1

1Mackie, A.R. et al., Tex Heart Inst J 2011, 38(5), 474-485

Page 8: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

▪ >700 subjects in randomized double-blind placebo-controlled trials

▪ Consistent evidence of therapeutic benefit and tolerance

▪ Single treatment elicits therapeutic effect

▪ No cell-related adverse events reported

▪ Multiple sites, investigators, countries and indications

▪ Refractory Angina (improved mortality & exercise time, reduced angina)1

▪ Critical Limb Ischemia (reduced amputation & pain; ulcer healing)2

▪ Claudication (improved functionality)3

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1Povsic, T. et al. JACC Cardiovasc Interv, 2016.2Losordo, D.W. et al. Circ Cardiovasc Interv, 2012.3U.S. study; Pending publication

CD34+ cell therapy supported by a plethora of compelling clinical data

Page 9: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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Cells returned to same

patient by injection; site

indication dependent

Isolation, concentration

and formulation of

CD34+/CXCR4+ cells

Sample collection via

apheresis on day 5 of

GCSF mobilization

ShipmentShipment

Simple, rapid, scalable and economical autologous cell therapy process

Day 1 Day 2 Day 3 or 4

▪ GCSF mobilization eliminates need for surgical bone marrow aspiration

▪ Four days or less from donation to treatment

▪ Well characterized, reliable GMP process – easily scaled to meet increasing demand

Page 10: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

CD34+ cell therapy patent estate provides for long-term exclusivity

▪ 7 U.S. patents granted and 2 U.S. patents pending

▪ 23 foreign patents granted and 3 foreign patents pending

▪ Japan, Russia, Canada, and the EU5 countries-France, Germany, Great Britain, Italy, and Spain

▪ Key claims cover:

▪ Pharmaceutical composition of non-expanded CD34+/CXCR4+ stem cells

▪ Therapeutic concentration range

▪ Stabilizing serum

▪ Repair of injury caused by vascular insufficiency

▪ Issued and pending claims applicable to broad array of ischemic conditions

▪ CLI, CMD, NORDA, AMI, CHF and ischemic brain injury, among others

▪ Expiries of granted patents range from 2031 – 2039 including patent term extension

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“Composition of matter” protection to 2031+

Page 11: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

CLBS12Critical Limb Ischemia (CLI)

(Japan)

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Page 12: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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CLI Represents a Multi-billion Dollar Global Market Opportunity*

Japan USA Europe*

No-option CLI pts. eligible for CLBS12 (R4 or R5) (not eligible for revascularization)

~51,000 ~300,000 ~560,000

*Europe:

*Independent third-party analysis; Report available upon request

▪ Initiation in Japan prompted by early definition of accelerated path to regulatory approval

▪ Estimated >$100M initial commercial opportunity based on significant pharmaco-eco benefits

▪ CLBS12 could be a marketed product in Japan as early as 2021

▪ Positive results from ongoing trial in Japan should support expedited development in USA/EU

CLI represents an expedited commercial opportunity in Japan

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4.6%12.1%

35.3%

67.3%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

R 1-3 R 4 R 5 R 6

18.9%

37.7%

52.2%

63.5%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

R 1-3 R 4 R 5 R 6

4 Year Amputation Rates 4 Year Mortality Rates

Source: Reinecke H., European Heart Journal, 2015 Apr 14;36(15):932-8.

Retrospective outcomes analysis based upon

Rutherford (“R”) classification (n=41,882)

R 1-3: CLI-free

R 4: Debilitating rest pain

R 5: Minor tissue loss non-healing ulcer; focal gangrene with diffuse pedal ischemia

R 6: Functional foot no longer salvageable

CLI amputation and mortality rates increase with disease severity

Page 14: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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Source: Kinoshita et al, Atherosclerosis 224 (2012) 440-445

Week 12 Post-treatment

Before Treatment

Actual CLI Patient

Laser Doppler Image

Single CD34+ cell therapy administration appears to reverse CLI

Prospective, single blind, open label clinical trial (n=17) - Japan

Rutherford Scale (arteriosclerosis + Buerger’s Disease patients)

Rutherford 4 or 5Rutherford 3 or less

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

pre 4 8 12 24 52 104 156 208

Incid

en

ce

Weeks

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Single CD34+ cell therapy administration increases amputation free survival

Randomized, double-blind, placebo-controlled clinical trial (n=28) - USA

1×106 cells/kg

Placebo

Source: Losordo, D.W. et al, Circulation 2012

p = 0.014

Page 16: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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Design ▪ Prospective, open label, controlled, randomized trial (1:1 w/SOC) CLI patients

Primary Endpoint ▪ Time to continuous CLI-free status (2 consecutive monthly visits, adjudicated independently)

Study Size ▪ 30 pts. with no-option CLI + 5 Buerger’s Disease pts.; all R4 or R5; ~10 centers in Japan

Dose ▪ Up to 106 autologous CD34+ cells/kg (CLBS12) per affected limb

Control/Comparator

▪ Standard of Care: wound care plus drugs approved in Japan

▪ Including antimicrobials, antiplatelets, anticoagulants and vasodilators

▪ Choice of pharmacotherapy will be made by the investigators according to protocol

Mode of administration

▪ Intramuscular, 20 injections in affected lower limb in single administration

Timing/Cost▪ Top-line results expected 1H2020

▪ Study funded to completion in current budget projections

CLBS12 eligible for early conditional approval in Japan based on ongoing study

Awarded SAKIGAKE (“breakthrough”) designation with priority review

Page 17: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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Preliminary Buerger’s Disease cohort results in Japan are extraordinary

Pre 1 30 60 90 120 150 180 210 240 270 300 330 365

1

2

3

4

5

6 A

Patient

Days

▪ Natural evolution of Buerger’s Disease is continual progression

▪ Surgery typically is ineffective & existing pharmacotherapies do not prevent amputation (A)1

▪ To date, CLBS12 treatment has resulted in 50% of patients achieving a positive outcome

CLI-free Continuous CLI-freeRutherford 6Rutherford 4 or 5 Follow-up ongoing

1Cacione DG, et al, Pharm. treatment of Buerger’s Disease, Cochrane Database of Systematic Reviews, 2016, (3) CD011033

Page 18: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

CLBS16Coronary Microvascular Dysfunction (CMD)

(USA)

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Page 19: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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1 www.heart.org/en/health-topics/heart-attack/angina-chest-pain/coronary-microvascular-disease-mvd2 Loffler and Bourque, Curr Cardiol Rep. 2016 Jan; 18(1): 13 Kenkre, T.S. et al., Circ: CV Qual & Outcomes 2017, 10(12) 1-94 Collins P. British heart journal (1993) 69(4), 279–281

▪ CMD

▪ Is heart disease affecting the walls and inner lining of tiny coronary

artery blood vessels with an absence of large vessel blockage1

▪ Only recently readily recognized and diagnosed

▪ Previously known as “Cardiac Syndrome X”

▪ Affects women more frequently, especially younger women1

▪ Portends a poor prognosis in patients with the condition2

▪ Significantly elevated risk of all-cause mortality in women3

▪ Now can be diagnosed by measuring Coronary Flow Reserve (CFR)

▪ CFR is the ratio of maximal to resting coronary blood flow4

Coronary Microvascular Dysfunction (CMD) is a relatively unknown killer

Page 20: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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▪ Nearly 50% of patients with Coronary Artery Disease have a CMD component

▪ Multi-billion dollar global opportunity based on significant pharmaco-eco benefits

USA2,3 Europe4 Japan5,6

~8,300,000 ~6,000,000 ~1,000,000

Patients Potentially Eligible for CLBS16Estimates are 30% - 70% have CMD1

Europe:

CMD is an unmet medical need with significant market potential

1Alrifai, A. et al., U.S. Card. Rev., 12(1) 2018, Pages 41-45 2Mittal, S.R.; Indian Heart Journal, Volume 66, 2014, Pages 678–6813Cleveland Clinic/AHA (American Heart Association)4Townsend, N, et al.; EHJ, Volume 37, Issue 42, 7 November 2016, Pages 3232–32455Kita, T; EHJ Supplements, Volume 6, Issue suppl_A, 1 March 2004, Pages A8–A116Ueshima, H, et al.; AHA Journal, December 16/23, 2008, Volume 118, Issue 25

Page 21: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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Design ▪ Interventional, open label, proof-of-concept trial

Primary Endpoint ▪ Safety and the evaluation of adverse events

Secondary Endpoints▪ Changes from baseline to 6 months for coronary flow reserve, endothelial-dependent

microvascular function, time to angina; other cardiovascular metrics

Study Size ▪ 20 patients at 2 centers in the USA (Cedars Sinai, Los Angeles & Mayo Clinic, Rochester)

Dose ▪ Up to 300 x 106 CD34+ cells

Control ▪ No control arm

Mode of administration ▪ Single intracoronary infusion

Timing/Cost▪ Top-line results expected by end of 2019

▪ Study funded to completion in current budget projections (NIH grant)

CLBS16 proof-of-concept study (ESCaPE-CMD)Enrollment completion expected in May 2019

Page 22: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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Preliminary ESCaPE-CMD results are extremely encouraging

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

Baseline Day 180C

oro

nary

Flo

w R

ese

rve

p = 0.01675

▪ Patient follow-up to date (n=6)

▪ Coronary flow reserve (CFR)

▪ Ratio of maximal to resting

coronary blood flow1

▪ Increased CFR correlates with

improvement in symptoms

▪ Full results expected end of 2019

1 Collins, P., British heart journal (1993) 69(4), 279–281

Page 23: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

CLBS14No Option Refractory Disabling Angina (NORDA)

(USA)

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Page 24: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Patients Eligible for CLBS14*

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Europe:

USA Europe Japan

<100K ~50K ~30K

▪ Patients with NORDA

▪ have large vessel disease which has been treated but continue to have angina

▪ have failed all available approved treatment options

▪ continuously burden the healthcare system pharmacoeconomically

*Independent Third-party analysis; Full third-party report available upon request

NORDA presents a multi-billion dollar global market opportunity

Page 25: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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▪ CLBS holds an open and active IND

▪ Data license to previous clinical studies avoids need to repeat Phases 1 & 2

▪ CLBS owns all germane IP for product and its use

▪ RMAT (Regen. Medicine Advanced Therapy) designation awarded 2Q18

▪ Therapy must show preliminary evidence of addressing serious unmet medical need

▪ Includes potential for priority review and accelerated approval

▪ Phase 3 (registration) protocol discussions with FDA reaching conclusion

▪ Single phase 3 trial with total exercise time at 6 months as primary endpoint

▪ Finalization expected 2Q19 with first patient targeted for fall 2019

▪ Supported by a rigorous and compelling clinical database

CLBS14 Phase 3 development status

Page 26: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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Source: Losordo, D.W., et al., Circ Res, 2011

Randomized, double blind, placebo-controlled Phase 2 study (n=168)

Single treatment of CLBS14 significantly improves exercise time*

P=0.014P=0.017

6 Months 12 Months

*Total exercise

time at 6 months

will be the phase 3

primary endpoint

Page 27: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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ase

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ekly

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ue

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CI)

Placebo CLBS14-NORDA

6 months 12 months

Source: Losordo, D.W. et al, Circ Res 2011

p = 0.0421 p = 0.0109

Randomized, double blind, placebo-controlled Phase 2 study (n=168)

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Single treatment of CLBS14 significantly reduces angina frequency

Page 28: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Randomized, double blind, placebo-controlled Phase 2 study (n=168)

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Single treatment of CLBS14 significantly reduces mortality

Source: Losordo, D.W., Circ Res 2011

Placebo

p = 0.0065

Page 29: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

▪ Phases 1, 2, & partial 3 studies1,2,3

completed (combined n=304)

▪ Same NORDA definition in all studies

▪ Two independent compelling patient-

level pooled-analyses:

▪ European Heart Journal, January 2018

(Henry, et al)

▪ Cardiovascular Revascularization

Medicine, June 2018 (Velagapudi, et al)

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1 Losordo, D.W., et al, Circulation 2007, 115(25) pp. 3165-31722 Losordo, D.W., et al, Circ Res 2011, 109(4) pp. 428-36.3 Povsic, T.J., et al, JACC Cardiovasc Interv, 2016 9(15) pp. 1576-85.

Change in Angina Frequency

P=0.03 P=0.01 P=0.01

ITT Population

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ve

Fre

qu

en

cy o

f A

ng

ina

(95

% C

I)

1.5

1.0

0.5

0.0

3M 6M 12M

Timepoint

Combined CLBS14 clinical database corroborates success potential

Page 30: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

▪ Phases 1, 2, & partial 3 clinical studies1,2,3 completed (combined n=304)

▪ Same NORDA definition in all studies

▪ Two independent compelling patient-level pooled-analyses: European Heart Journal, January 2018 (Henry, et al);

Cardiovascular Revascularization Medicine, June 2018 (Velagapudi, et al)

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Mortality and Major Cardiac Adverse Events (MACE)

Combined CLBS14 clinical database corroborates success potential

1 Losordo, D.W., et al, Circulation, 2007 115(25) pp. 3165-3172 2 Losordo, D.W., et al, Circ Res, 2011 109(4) pp. 428-363 Povsic, T.J., et al, JACC Cardiovasc Interv, 2016 9(15) pp.1576-85

Page 31: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Pre-Clinical Phase 1 Phase 2 Phase 3

Country: USA(ongoing)

Country: USA(ongoing)

Country: Japan(ongoing)

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Registration eligible trialCD34+ Cell Therapy Platform

(Ischemic Repair)

T Regulatory Cell Therapy Platform

(Immune Modulation)

CLBS03 Recent Onset Type 1 Diabetes

CLBS14-NORDA No Option Refractory Disabling Angina Country: USA(initiation targeted fall 2019)

Results of comprehensive

analysis of 1-year patient

level data in conjunction with

2-year follow-up data (end

2019) will determine next

development steps

CLBS14 No Option Refractory Disabling Angina

CLBS16 Coronary Microvascular Dysfunction

CLBS12 Critical Limb Ischemia

CLBS03 Recent Onset Type 1 Diabetes

Innovative multi-product pipeline based on proprietary technology platforms

Page 32: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Program 2019 2020

Phase 2 (registration)

Topline Data Expected

Target Enrollment

Completion

Phase 3 Clinical Development

Plan Finalized with FDA

Phase 2 Topline Data

Expected

Phase 3 Clinical Trial

Initiation Target

Target Enrollment

Completion

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CLBS12 ---------------------------------------------------------------------------------------------------------------------------------------(Critical Limb Ischemia)

CLBS14 ---------------------------------------------------------------------------------------------------------------------------(No Option Refractory Disabling Angina)

CLBS16 -------------------------------------------------------------------------------------------------------------------------------(Coronary Microvascular Dysfunction)

Timeline of key development milestones by principal development program

Page 33: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

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Cash & Investments at March 31, 2019: $38m

1Q2019 Operating Cash Burn: $5m

Cash Runway Based on Current Plan:(Including CLBS14 Phase 3 Clinical Initiation Costs)

through 2Q 2020

Debt: $0

Common Shares Outstanding at March 31, 2019: ~10.4m shares

Options Outstanding as of March 31, 2019:Exercise Price < $5.00 = 687,000 sharesExercise Price < $10.00 = 125,000 sharesExercise Price > $10.00 = 402,000 shares

~1.2m shares

Key CLBS financial information

Page 34: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

▪Late-stage therapeutics development company

▪ Pioneering advancements of cell therapies in cardiovascular disease

▪ Three principal development programs; 2 designated “breakthrough”*

▪ CLBS12*, CLBS16 (aka CLBS14-CMD), CLBS14* (aka CLBS14-NORDA)

▪Financially stable and debt-free

▪ Strong balance sheet (~$38 million cash as of March 31, 2019)

▪ Low operating cash burn (cash projected through 2Q 2020)

▪Multiple value creating events within the next ~12 months

▪ Key regulatory and data milestones across the pipeline

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Caladrius Biosciences: Uniquely positioned for near-term success

Page 35: David J. Mazzo, PhD President and Chief Executive Officer · Multi-billion dollar global opportunity based on significant pharmaco-eco benefits USA2,3 Europe4 Japan5,6 ~8,300,000

Investor Relations Contact

John D. Menditto

Phone: (908) 842-0084

Email: [email protected]

www.caladrius.com

NASDAQ: CLBS