UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): February 13, 2019




CALADRIUS BIOSCIENCES, INC.
(Exact Name of Registrant as Specified in Charter)
 
Delaware
(State or Other Jurisdiction
of Incorporation)
001-33650
(Commission
File Number)
22-2343568
(IRS Employer
Identification No.)
 
110 Allen Road, Second Floor, Basking Ridge, NJ 07920
(Address of Principal Executive Offices) (Zip Code)
 
(908) 842-0100
Registrant's Telephone Number
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

o  Emerging growth company

o  If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.







Item 8.01 Other Events.

On February 13, 2019, Caladrius Biosciences, Inc. (the "Company") issued a press release in connection with results announced from The Sanford Project: T-Rex Study, a prospective, randomized, placebo-controlled, double-blind Phase 2a clinical trial of 110 subjects to evaluate the safety and efficacy of the Company’s CLBS03 as a treatment for recent-onset type 1 diabetes (“T1D”) in adolescents. The initial analysis of the one-year follow-up data for all subjects shows that CLBS03 was well-tolerated at the doses tested in the study (targeting 2.5 million cells/kg or 20 million cells/kg); however, no improvement in the primary endpoint of preservation of C-peptide levels vs. placebo at 1 year was observed at the group level (using the standard mixed meal tolerance test). A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.


Item 9.01. Financial Statement and Exhibits.
Exhibit No.
Description
Press release, dated February 13, 2019


SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.



CALADRIUS BIOSCIENCES, INC.

By: /s/ David J. Mazzo            
Name: David J. Mazzo, PhD
Title: President and Chief Executive Officer
Dated: February 13, 2019



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