On November 05, 2015 Caladrius Biosciences, Inc. (NASDAQ:CLBS) ("Caladrius"), a company combining a leading cell therapy service provider with a development pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and ischemic repair, reported financial results for the three months ended September 30, 2015 (Filing, 8-K, Caladrius Biosciences, NOV 9, 2015, View Source [SID:1234508122]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Business Highlights
• Total revenues for the third quarter of 2015 increased 43% to $5.9 million when compared with $4.1 million in the year-ago third quarter, driven by increases in Clinical Service revenue at the Company’s PCT subsidiary, an external development and manufacturing partner for the growing cell therapy industry
• PCT entered into a long-term dedicated capacity agreement with IRX Therapeutics, Inc. to support their anticipated clinical trial manufacturing needs including the manufacture of EU-compliant cell therapy product, adding to a growing list of immuno-oncology clients with similar arrangements including Kite Pharma and ImmunoCellular Therapeutics
• Continued patient enrollment in a Phase 3 clinical study of lead product candidate CLBS20 for the treatment of recurrent Stage III or Stage IV metastatic melanoma
• Presented data elucidating the mechanism of action of CLBS20, suggesting correlations between a distinct immune response triggered by CLBS20 and overall survival of melanoma patients
• Received an initial award of $300,000 out of a potential award of up to $2.3 million from the National Cancer Institute to fund the first phase of a project for process optimization of CLBS20
• Entered into a collaboration agreement with Sanford Research to develop CLBS03, the Company’s T regulatory cell therapy product candidate, for the treatment of adolescents with recent-onset type 1 diabetes, which the Company expects to advance to a Phase 2 clinical study in early 2016
• Promoted Joseph Talamo to Chief Financial Officer and Todd Girolamo to General Counsel.
Management Commentary
"PCT continues to post strong revenue growth, which we expect to continue as the immuno-oncology sector is experiencing industry-wide advances and there are increasing numbers of such products on the market and in development. We expect PCT to continue to capitalize on its unmatched cell development and manufacturing expertise as industry demand for cell therapy services continues to grow," said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. "In addition, we continued to advance our own clinical development programs in immuno-oncology (CLBS20) and immune modulation (CLBS03), while maintaining financial discipline that allowed us to lower our cash burn."
2015 Third Quarter Financial Highlights
Total revenue for the third quarter of 2015 increased 43% to $5.9 million compared with $4.1 million for third quarter of 2014, primarily due to higher reported Clinical Services revenues at PCT.
Research and development expenses in the third quarter of 2015 decreased 24% to $6.3 million compared with $8.5 million for the third quarter of 2014. The decrease was primarily related to lower costs associated with the Company’s ischemic repair and immune modulation programs. The lower costs were partially offset by increased expenses associated with the Intus Phase 3 clinical trial that initiated in 2015.
Selling, general and administrative expenses were approximately $5.1 million for the third quarter of 2015 compared with $7.9 million for same period in 2014. The decrease was primarily due to lower equity-based compensation expenses in the current quarter compared with a year ago and, to a lesser extent, lower expenses associated with other general and administrative activities.
The net loss for the third quarter of 2015 was approximately $11.4 million or $0.21 per share, compared with a net loss of $17.2 million or $0.48 per share for same period in 2014.
As of September 30, 2015, Caladrius had cash, cash equivalents and marketable securities of $29.4 million.