On March 14, 2019 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a late-stage therapeutics development biopharmaceutical company committed to the development of innovative products that have the potential to restore the health of people with chronic illnesses and with a focus on select cardiovascular indications, reported financial results for the three and twelve months ended December 31, 2018 (Press release, Caladrius Biosciences, MAR 14, 2019, View Source [SID1234534335]).

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"2018 was an exciting and productive year for Caladrius, featuring a number of significant developments. Specifically, we made great progress advancing and expanding our clinical CD34+ cell technology platform while maintaining strong fiscal prudence," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "Notably, we initiated the ESCaPE-CMD phase 2 study in the U.S. for CLBS14-CMD and subsequently acquired a data license for our no-option refractory disabling angina program, CLBS14-NORDA, for which we plan to initiate a phase 3 trial in the fall of this year pending finalization of the protocol with the U.S Food and Drug Administration. We continue to expect to report top-line data in the ESCaPE-CMD trial by the end of 2019 or early 2020, and we continue to enroll in our CLI study in Japan for CLBS12 for which we expect to report topline data in the first half of 2020.

"We are excited about what lies ahead in 2019 and expect the momentum to continue as we advance our clinical development pipeline and achieve a number of important development milestones throughout the balance of the year," concluded Dr. Mazzo.

Fourth Quarter Financial Highlights

Research and development expenses for the fourth quarter of 2018 were $1.5 million, a 68% decrease compared with $4.7 million for the fourth quarter of 2017. Expenses in the fourth quarter of 2018 principally comprised costs in our ischemic repair programs for CLBS12 and CLBS14-CMD and preparation for our CLBS14-NORDA program. Conversely, the prior year quarter expenses were focused primarily on our T-Rex study for CLBS03, which completed enrollment in December 2017.

General and administrative expenses for the fourth quarter of 2018 were $2.3 million, a 14% decrease compared with $2.7 million for the fourth quarter of 2017, due to lower corporate-related activities compared with the prior year period.

The net loss from continuing operations for the fourth quarter of 2018 was $3.6 million, or $0.36 per share, compared with $4.0 million, or $0.40 per share, for the fourth quarter of 2017.

2018 Financial Highlights

Research and development expenses for 2018 were $7.6 million, a 52% decrease compared with $15.8 million for 2017. The current year expenses were principally comprised of costs related to our ischemic repair programs for CLBS12 and CLBS14-CMD as well as initial preparation for our CLBS14-NORDA program. Conversely, the prior year expenses were focused primarily on our T-Rex study for CLBS03, which trial completed enrollment in December 2017.

General and administrative expenses for 2018 were $9.4 million, a 20% decrease compared with $11.8 million for 2017. The decrease was due to lower corporate-related activities compared with the prior year period, along with the sale of our counter-flow centrifugation system to Hitachi in the second quarter of 2018, which resulted in a one-time $1.4 million gain included in general and administrative expenses.

Net loss from continuing operations for the twelve months ended December 31, 2018 was $16.2 million, or $1.67 per share, compared with $16.2 million, or $1.78 per share, for the same period of 2017.

Balance Sheet Highlights

As of December 31, 2018, Caladrius had cash, cash equivalents and marketable securities of $43.1 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 mid-2020.

Conference Call

Caladrius’ management will host a conference call for the investment community beginning at 4:30 p.m. ET on Thursday, March 14, 2019 to discuss the financial results, provide a company update and answer questions.

Shareholders and other interested parties may participate in the conference call by dialing (866) 595-8403 (domestic) or (706) 758-9979 (international), using the conference ID number: 2168777. 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 of the call will be available for replay approximately two hours after the conclusion of the call until 11:59 p.m. ET on March 21, 2019. To access the audio replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide conference ID number: 2168777.

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