On August 8, 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 and six months ended June 30, 2019 and provides highlights of progress within the development pipeline (Press release, Caladrius Biosciences, AUG 8, 2019, View Source [SID1234538495]).

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"I am delighted to announce that, after close collaboration with the U.S. Food and Drug Administration, we have finalized the protocol design for a confirmatory Phase 3 trial of CLBS14 in no-option refractory disabling angina ("NORDA"). We now plan to initiate enrollment in this trial in early 2020," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "The protocol defines a prospective, randomized, double blind, ~400 total subject trial with a primary endpoint of total exercise time at the 6-month follow-up visit."

Dr. Mazzo continued, "We also recently announced that the European Medicines Agency granted CLBS12 the Advanced Therapy Medicinal Product classification for the treatment of critical limb ischemia ("CLI"). As a result, we now have the opportunity to work closely with the European regulators to define a path forward that would accelerate the approval of CLBS12’s registration to treat CLI in Europe. Finally, the preliminary data from our clinical programs studying our CD34+ cell therapy platform for coronary microvascular dysfunction ("CMD") in the United States and CLI in Japan, continue to trend positively and we reiterate our expectations to report top-line data by the end of 2019 and early 2020, respectively."

Second Quarter Financial Highlights

Research and development expenses for the second quarter of 2019 were $3.0 million, a 41% increase compared with $2.1 million for the second 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 CLI development program in Japan, (ii) expense associated with our ongoing clinical study for CLBS16 in CMD, and (iii) expenses associated with the planning and preparation for Phase 3 enrollment initiation of our CLBS14 program in NORDA.

General and administrative expenses, which focus on general corporate related activities, were $2.4 million for the second quarter of 2019, a 10% increase compared with $2.1 million for the second quarter of 2018.

The net loss for the second quarter of 2019 was $5.1 million, or $0.49 per share, compared with $4.1 million, or $0.42 per share, for the second quarter of 2018.

Six Month Financial Highlights

Research and development expenses for the first six months of 2019 were $5.0 million, a 15% increase compared with $4.4 million for the first six months 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 CLI development program in Japan, (ii) expense associated with our ongoing Phase 2 clinical study

for CLBS16 in CMD, and (iii) expenses associated with the planning and preparation for Phase 3 enrollment initiation of our CLBS14 program in NORDA.

General and administrative expenses, which focus on general corporate related activities, were $4.9 million for the first six months of 2019, a 3% decrease compared with $5.0 million for the first six months of 2018.

The net loss for the first six months of 2019 was $9.5 million, or $0.93 per share, compared with $9.1 million, or $0.95 per share, for the first six months of 2018.

Balance Sheet Highlights

As of June 30, 2019, Caladrius had cash, cash equivalents and marketable securities of $33.7 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 for the investment community beginning at 4:30 p.m. ET on Thursday, August 8, 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: 4491545. 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 August 15, 2019. To access the audio replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide conference ID number: 4491545.

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