BASKING RIDGE, N.J., (March 17, 2017) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a cell therapy company with a select therapeutic development pipeline focused on immune modulation and a subsidiary, PCT, a development and manufacturing partner for the cell therapy industry, announced financial results for the three and twelve months ended December 31, 2016.
2016 and 2017 Year to Date Highlights
PCT:
Executed a global collaboration and license agreement between PCT and Hitachi Chemical Co., Ltd. in connection with the sale of 19.9% of PCT to Hitachi Chemical Co. America, Ltd. (“Hitachi America”) for $19.4 million; and
Entered into a definitive agreement with Hitachi America whereby Hitachi America agreed to purchase Caladrius’ remaining 80.1% membership interest in PCT for $75 million, subject to potential adjustments, including based on PCT’s cash and outstanding indebtedness as of the closing of the sale, and a potential future milestone payment.
CLBS03:
Awarded a grant from the California Institute for Regenerative Medicine (CIRM) for the development of CLBS03 for an aggregate amount of up to $12.2 million, payable upon the achievement of certain milestones, for the Company’s investigational cell therapy currently being evaluated as a treatment for recent onset type 1 diabetes (T1D);
Initiated a Phase 2 trial, the Sanford Project: T-Rex Study (T-Rex Study), for CLBS03;
Completed enrollment of the initial cohort of 18 subjects of the T-Rex Study and, following a favorable safety recommendation from the Data Safety Monitoring Board, resumed enrollment of the second and final cohort of the study;
Received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for CLBS03; and
Expanded the strategic collaboration with Sanford Research beyond operational support for the CLBS03 clinical program.
CLBS12:
Reached agreement with Japanese regulators on a development plan for CD34 cell therapy for critical limb ischemia (CLBS12) which would qualify the product for early conditional commercial approval upon successful execution.
Fourth Quarter Financial Highlights
Total revenues for the fourth quarter of 2016 increased 35% to $10.2 million compared with $7.6 million in the fourth quarter of 2015, primarily due to higher reported Clinical Services revenues at PCT.
Research and development (R&D) expenses for the fourth quarter of 2016 decreased 19% to $2.6 million compared with $3.2 million for the fourth quarter of 2015, primarily related to the discontinuation of non-core R&D programs announced at the beginning of 2016 and related reductions in R&D staffing and departmental costs, partially offset by costs related to the ongoing Phase 2 T-Rex Study.
Selling, general and administrative (SG&A) expenses were approximately $4.3 million for the fourth quarter of 2016 compared with $5.0 million for the same period in 2015, primarily due to lower operational and compensation-related costs during the 2016 fourth quarter.
The net loss attributable to Caladrius common stockholders for the three months ended December 31, 2016 was $6.0 million or $0.73 per share, compared to $33.2 million or $5.92 per share for same period in 2015.
Net loss for the fourth quarter of 2015 included the impairment of in-process R&D (IPR&D) valued at $34.3 million related to the Company’s decision to discontinue its Phase 3 study of CLBS20 in metastatic melanoma. This impairment was partially offset by the reversal of a related deferred tax liability and the reversal of a related contingent consideration milestone obligation. The net impact for these changes was a $24.7 million increase in net loss.
Full Year Financial Highlights
Total revenues for 2016 of $35.3 million represented an increase of 57% compared with $22.5 million for 2015. R&D expenses in 2016 were $15.1 million compared with $23.9 million in 2015. SG&A expenses for 2016 were $20.4 million compared with $30.0 million for 2015.
The net loss attributable to Caladrius common stockholders for 2016 was $32.7 million or $4.99 per share based on 6.5 million shares outstanding, compared to $80.9 million or $16.67 per share based on 4.9 million shares outstanding for 2015.
Net loss for 2015 included the impairments of IPR&D associated with our CLBS20 and CLBS10 clinical programs, valued at $43.7 million. These impairments were partially offset by reversals of related deferred tax liabilities, and the reversals of related contingent considerations obligations. The net impact for these changes was a $24.7 million increase in 2015 net loss.
Balance Sheet and Cash Flow Highlights
As of December 31, 2016, Caladrius had cash and cash equivalents of $14.7 million. The net cash used in operating activities for 2016 was $23.7 million. During 2016, the Company invested $2.8 million in capital expenditures primarily related to equipment and improvements for PCT’s Allendale, N.J. and Mountain View, CA manufacturing facilities.
Conference Call
Caladrius’ management will host a conference call for the investment community today, March 17, 2017, beginning at 8:30 a.m. Eastern time to review the financial results, provide a Company update and answer questions.
Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 95709222. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events.
The webcast will be archived on the Company’s website for 90 days.
