On August 14, 2018 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported Q2 2018 financial results and provided updates on corporate activities (Press release, Cytori Therapeutics, AUG 14, 2018, View Source [SID1234529752]).

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Q2 2018 net loss was $3.7 million, or $0.59 per share. Operating cash burn for Q2 was approximately $2.7 million. Cytori ended Q2 with approximately $3.1 million of cash and cash equivalents, or approximately $8.8 million pro-forma at June 30, 2018, when considering $5.7 million in net cash proceeds received from a public rights offering which closed on July 25, 2018.

Cytori is developing for manufacture its lead chemotherapeutic drug, ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, with the goal of demonstrating bioequivalence to the European reference drug. Our Nanomedicine team in San Antonio, Texas continues to complete activities in support of a Marketing Authorization Application (MAA) to be filed with the European Medicines Agency (EMA) next year. The Company also continues to engage potential commercial partners for ATI-0918 in Europe, Middle East, North Africa, North America, and Asia Pacific. Furthermore, for Cytori’s ATI-1123 chemotherapy drug product candidate, an albumin-stabilized pegylated liposomal docetaxel, the Company has requested an orphan drug designation from FDA for small cell lung cell cancer and is evaluating the FDA’s 505(b)(2) new drug application (NDA) pathway in the U.S. which may offer accelerated and lower cost development.

Our Cell Therapy team is awaiting data readouts from clinical trials in scleroderma and urinary incontinence and is actively conducting a clinical trial in thermal burns. 6 month data from the 40 patient, French SCLERADEC II clinical trial (scleroderma) is expected before the end of 2018 and 1 year data from the 45 patient, Japanese ADRESU clinical trial (urinary incontinence) is expected in early 2019. Finally, U.S. FDA has approved a protocol amendment for the RELIEF thermal burn injury trial sponsored by BARDA intended to facilitate enrollment. Cytori completed a successful In-Process Review meeting with BARDA this past June. Thus far, Cytori and BARDA have initiated 2 of 8-10 anticipated U.S. clinical sites.

In Japan, Cytori continues to see favorable growth trends in the use of its commercially approved cell therapy products in the aesthetic and orthopedic markets. The Company remains on track to see continued double digit year over year growth in consumable utilization.

"Our primary corporate objective is to file for European market approval for ATI-0918, our lead oncology drug product. We have also expanded the development of our pipeline drug, ATI-1123, in the U.S. and we are priming it for phase II evaluation." said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "We are also pleased with the quarter-over-quarter and year-over-year results of our commercial Cell Therapy efforts in Japan that are primarily focused on consumable utilization. This provides a growing business and infrastructure in anticipation of the SCLERADEC-II and ADRESU trials, in 2018 and 2019, respectively."

Q2 2018 and year-to-date Financial Performance

Q2 2018 and year-to-date operating cash burn was $2.7 million and $6.8 million, compared to $5.0 million and $9.9 million for the same periods in 2017, respectively.
Q2 2018 and year-to-date total revenues were $1.6 million and $3.2 million, compared to $1.5 million and $3.1 million for the same periods in 2017, respectively.
Q2 2018 and year-to-date consumable utilization in Japan grew by over 70% and 60%, when comparing to the same periods in 2017, respectively.
Cash and debt principal balances at June 30, 2018 were approximately $3.1 million and $13.0 million, respectively.
Q2 2018 net loss was $3.7 million or $0.59 per share, compared to a net loss of $6.0 million or $1.94 per share for Q2 2017.
Year-to-date net loss was $8.1 million or $1.32 per share, compare to an adjusted net loss of $13.6 million or $5.04 per share for the same period in 2017, respectively.
Selected Key Anticipated Milestones:

Complete ATI-0918 development and manufacturing required to prepare and file a MAA with the EMA.
Receive Orphan Drug Designation and 505(b)(2) pathway feedback from the U.S. FDA for ATI-1123.
Enroll burn patients in BARDA-funded U.S. RELIEF clinical trial.
Report 3 and 6 month French SCLERADEC II clinical trial data for scleroderma hand dysfunction.
Report 1 year Japanese ADRESU clinical trial data for post-surgical male stress urinary incontinence.
Management Conference Call Webcast

Cytori will host a management conference call at 5:30 p.m. Eastern Time today to further discuss its progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori’s website. If you are unable to access the webcast, you may dial in to the call at +1.877.402.3914, Conference ID: 4075028.