GlobeNewswire Inc | Nov 10, 2020 08:30AM EST

November 10, 2020

BASKING RIDGE, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (Caladrius or the Company), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, announces its presentation at American Heart Associations (AHA) Scientific Sessions, being held virtually November 13-17, 2020.

AHAVirtual Scientific Sessions 2020

Session Abstract Poster SessionType:Session COVID-19: Mechanism and ObservationsTitle:Abstract Autologous CD34+ Cells (CLBS119) for Repair of Covid-19 InducedTitle: Microvascular Lung Damage: Rationale and Study DesignPresenter: Douglas W. Losordo, M.D., FACC, FAHA, Chief Medical Officer of Caladrius Biosciences

Note: This session is OnDemand and will be available via AHA Scientific Sessions virtual platform on November 13, 2020 at 9:00 a.m. (CST) until November 17, 2020 at 8:30 p.m. (CST).

Evidence from research by others indicates that severe cases of COVID-19 are accompanied by damage to the pulmonary endothelium.1,2 These data indicate SARS-CoV2 is particularly avid for the lung microvascular endothelium, destroying microvascular integrity. Destruction of microvascular integrity appears to be one of the mechanisms by which COVID-19 causes severe loss of lung function that appears to persist after acute recovery. CD34+ cells have pre-programmed tissue repair effects mediated by pro-angiogenic functions.3 Restoration of the microvasculature by pro-angiogenic therapies has been associated with regeneration of damaged organ function.4-9

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease. We are developing first-in-class cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.

The Companys current product candidates include: HONEDRA (formerly CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (CLI) based on the results of an ongoing clinical trial; CLBS14, a Regenerative Medicine Advanced Therapy (RMAT) designated therapy for which the Company has finalized with the U.S. Food and Drug Administration (the FDA) a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina (NORDA); CLBS16, the subject of a recently completed positive Phase 2a clinical trial in the U.S. for the treatment of coronary microvascular dysfunction (CMD); and CLBS119, an emergent CD34+ stem cell therapy responding to the COVID-19 pandemic and the potentially permanent damage the virus inflicts on the lungs of many patients. For more information on the company, please visit www.caladrius.com.

Contact:

Investors:Caladrius Biosciences, Inc.John MendittoVice President, Investor Relations and Corporate CommunicationsPhone:+1-908-842-0084Email:jmenditto@caladrius.com

Media:W2O GroupChristiana PascalePhone: +1-212-257-6722Email:cpascale@w2ogroup.com

-- Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, and Moch H, Endothelial cell infection and endotheliitis in COVID-19. Lancet, 2020. 395(10234): p. 1417-1418. -- Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, and Jonigk D, Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med, 2020. -- Berenson RJ, Andrews RG, Bensinger WI, Kalamasz D, Knitter G, Buckner CD, and Bernstein ID, Antigen CD34+ marrow cells engraft lethally irradiated baboons. J Clin Invest, 1988. 81(3): p. 951-955. -- Kawamoto A, Katayama M, Handa N, Kinoshita M, Baba R, Takano H, Kihara Y, Morioka S, Fukushima M, and Asahara T, Safety and efficacy is sustained up to one year after transplantation of autologous CD34+ cells in no-option patients with chronic critical limb ischemia. Circulation, 2006. 114(18 Supplement): p. II-264 Abstract. -- Losordo DW, Schatz RA, White CJ, Udelson JE, Veereshwarayya V, Durgin M, Poh KK, Weinstein R, Kearney M, Chaudhry M, Burg A, Eaton L, Heyd L, Thorne T, Shturman L, Hoffmeister P, Story K, Zak V, Dowling D, Traverse JH, Olson RE, Flanagan J, Sodano D, Murayama T, Kawamoto A, Kusano KF, Wollins J, Welt F, Shah P, Soukas P, Asahara T, and Henry TD, Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Circulation, 2007. 115(25): p. 3165-3172. -- Kawamoto A, Katayama M, Handa N, Kinoshita M, Takano H, Horii M, Sadamoto K, Yokoyama A, Yamanaka T, Onodera R, Kuroda A, Baba R, Kaneko Y, Tsukie T, Kurimoto Y, Okada Y, Kihara Y, Morioka S, Fukushima M, and Asahara T, Intramuscular transplantation of G-CSF-mobilized CD34(+) cells in patients with critical limb ischemia: a phase I/IIa, multicenter, single-blinded, dose-escalation clinical trial. Stem Cells, 2009. 27(11): p. 2857-2864. -- Losordo DW, Henry TD, Davidson C, Sup Lee J, Costa MA, Bass T, Mendelsohn F, Fortuin FD, Pepine CJ, Traverse JH, Amrani D, Ewenstein BM, Riedel N, Story K, Barker K, Povsic TJ, Harrington RA, Schatz RA, and Investigators AC, Intramyocardial, autologous CD34+ cell therapy for refractory angina. Circ Res, 2011. 109(4): p. 428-436. -- Losordo DW, Kibbe MR, Mendelsohn F, Marston W, Driver VR, Sharafuddin M, Teodorescu V, Wiechmann BN, Thompson C, Kraiss L, Carman T, Dohad S, Huang P, Junge CE, Story K, Weistroffer T, Thorne TM, Millay M, Runyon JP, and Schainfeld R, A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv, 2012. 5(6): p. 821-830. -- Ohtake T, Mochida Y, Ishioka K, Oka M, Maesato K, Moriya H, Hidaka S, Higashide S, Ioji T, Fujita Y, Kawamoto A, Fukushima M, and Kobayashi S, Autologous Granulocyte Colony-Stimulating Factor-Mobilized Peripheral Blood CD34 Positive Cell Transplantation for Hemodialysis Patients with Critical Limb Ischemia: A Prospective Phase II Clinical Trial. Stem Cells Transl Med, 2018. 7(11): p. 774-782.