Cytori Reports Q1 2019 Business and Financial Results

On May 14, 2019 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported Q1 2019 financial results and provided updates on corporate activities (Press release, Cytori Therapeutics, MAY 14, 2019, View Source [SID1234536262]).

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Q1 2019 net loss was $3.2 million, or $0.18 per share. Operating cash burn for Q1 was approximately $3.3 million. Cytori ended Q1 with approximately $3.9 million of cash and cash equivalents.

Cytori is developing two clinical stage chemotherapy drugs. ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, is the lead product candidate. The Company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year based on a successful bioequivalence study completed against the European reference drug. The Company is in the process of completing manufacturing-related activities to support the MAA and is evaluating commercial partners for ATI-0918 with a focus on Europe, which has a current estimated market size of over $120 million.

Cytori is also developing ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel. The Company recently received an orphan drug designation from the U.S. FDA for small cell lung cancer and is seeking FDA’s 505(b)(2) new drug application (NDA) and Accelerated Approval pathway.

"The Company’s recent divestiture of its cell therapy businesses allows us to fundamentally reposition and refocus of the Company around our nanotechnology and oncology drug development," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. We intend to begin communicating our plan later in Q2.

Q1 2019 Financial Performance

Q1 2019 operating cash burn was $3.3 million, compared to $4.1 million for Q1 2018.

Q1 2019 product revenues were $0.7 million, compared to $0.7 million for Q1 2018.

Q1 2019 contract revenues were $0.7 million, compared to $0.9 million for Q1 2018.

Q1 2019 Celution consumable utilization grew by approximately 20% as compared to Q1 2018.

Cash and debt principal balances at March 31, 2019 were approximately $3.9 million and $13.0 million, respectively.

Q1 2019 net loss was $3.2 million or $0.18 per share, compared to a net loss of $4.4 million or $0.73 per share for Q1 2018.