On May 9, 2019 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a late-stage therapeutics development biopharmaceutical company pioneering advancements of cell therapies in select cardiovascular and autoimmune diseases, reported financial results for the three months ended March 31, 2019 and provides highlights of progress within the development pipeline (Press release, Caladrius Biosciences, MAY 9, 2019, View Source [SID1234536130]).

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"I am pleased with the pace of our accomplishments so far in 2019 as we continue to enroll subjects in both our ESCaPE-CMD study in the U.S. for CLBS14-CMD and our CLI study in Japan for CLBS12," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "The preliminary data for both studies are very promising and we expect to report top-line results for ESCaPE-CMD by the end of 2019 and for CLBS12 in the first half of 2020. In addition, we continue to work closely with the U.S Food and Drug Administration on the protocol design for our no-option refractory disabling angina ("NORDA") program and have targeted initiation of that Phase 3 study before the end of 2019."

"We look forward to building on the momentum we have created in advancing our clinical development pipeline and reporting on a number of important, value-creating milestones throughout the balance of this year," concluded Dr. Mazzo.

First Quarter Financial Highlights

Research and development expenses for the first quarter of 2019 were $2.0 million, a 10% decrease compared with $2.3 million for the first quarter of 2018. Research and development in both periods focused on the advancement of our ischemic repair platform and related to (i) expenses associated with our ongoing Phase 2 study of CLBS12 in critical limb ischemia development program in Japan, (ii) expense associated with our ongoing Phase 1b/2a study for CLBS14-CMD in coronary microvascular dysfunction, and (iii) expenses associated with the planning of our CLBS14-NORDA program in refractory angina.

General and administrative expenses, which focus on general corporate related activities, were $2.6 million for the first quarter of 2019, a 12% decrease compared with $2.9 million for the first quarter of 2018.

The net loss for the first quarter of 2019 was $4.4 million, or $0.44 per share, compared with $5.0 million, or $0.52 per share, for the first quarter of 2018.

Balance Sheet Highlights

As of March 31, 2019, Caladrius had cash, cash equivalents and marketable securities of $38.4 million. Based on existing programs and projections, the Company remains confident that its cash balances will allow it to fund its current business plan through the second quarter of 2020.

Conference Call

Caladrius’ management will host a conference call beginning at 4:30 p.m. ET on Thursday, May 9, 2019 to discuss the financial results, provide a company update and answer questions.

Shareholders and other interested parties may participate on the conference call by dialing (866) 595-8403 (domestic) or (706) 758-9979 (international), using the conference ID number: 2576003. The conference call will also be webcast live and can be accessed from the Company’s website at www.caladrius.com/investors/news-events.

For those unable to participate in the live conference call or webcast, an audio recording will be available for replay approximately two hours after the conclusion of the call until 11:59 p.m. ET on May 16, 2019. To access the audio replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide conference ID number: 2576003.

A webcast replay of the conference call will remain available on the Company’s website for 90 days.