Exhibit 99.1

 

Cytori Reports Third Quarter 2017 Business and Financial Results

 

SAN DIEGO, November 9, 2017—

Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced its third quarter 2017 financial results and provided updates on its corporate activity and clinical development.

Third quarter 2017 net loss was $4.8 million, or $0.14 per share. Operating cash burn for the quarter was approximately $4.0 million. Cytori ended the quarter with approximately $4.8 million of cash and cash equivalents.

 

Selected Key Recent Highlights:

 

U.S. STAR scleroderma clinical trial data accepted for presentation at Systemic Sclerosis World Congress in February 2018.

 

BARDA executed a $13.4 million contract option to fund the U.S. RELIEF burn clinical trial.

 

Received U.S. FDA IDE approval for RELIEF, a thermal burn pilot trial related to ongoing BARDA contract.

 

Q3 2017 Financial Performance

 

Q3 2017 and year-to-date operating cash burn was $4.0 million and $13.9 million, compared to $4.6 million and $15.4 million for the same periods in 2016, respectively.

 

Q3 2017 and year-to-date total revenues were $1.8 million and $4.9 million, compared to $2.6 million and $8.4 million for the same periods in 2016, respectively.

 

Cash and debt principal balances at September 30, 2017 were approximately $4.8 million and $13.0 million, respectively.

 

Q3 2017 net loss was $4.8 million or $0.14 per share, compared to $5.4 million or $0.26 per share for Q3 2016.

 

Year-to-date adjusted net loss was $16.7 million, or $0.57 per share, and excludes a $1.7 million non-cash charge for in-process research and development expense from the Azaya Therapeutics asset acquisition, compared to $17.1 million or $1.06 per share for the same period in 2016.

 

Year-to-date GAAP net loss was $18.4 million or $0.62 per share, compared to $17.1 million or $1.06 per share for the same period in 2016.

 

“Based on the completed analysis of our STAR trial data, including the strong safety profile, clinically meaningful improvements in the diffuse scleroderma subgroup and the lack of approved treatments with this orphan condition, we intend to meet with the U.S. FDA as soon as possible to chart next steps.” said Dr. Marc Hedrick, President and CEO of Cytori. “Simultaneously, manufacturing validation for our recently acquired liposomal doxorubicin chemotherapy drug candidate, ATI-0918, a generic version of Caelyx®, is ongoing and on track for submitting an application to the European Medicines Agency next year while other key cell therapy trials, specifically SCLERADEC-II and ADRESU for scleroderma and stress urinary incontinence, respectively, march toward full enrollment.”

 

Selected Key Near-Term Milestones:

 

 

Pursue meeting with U.S. FDA to determine next steps required to obtain Habeo™ Cell Therapy regulatory approval for scleroderma-associated hand dysfunction.

 

Begin enrollment of BARDA’s funded U.S. RELIEF burn clinical trial.

 

Complete ATI-0918 manufacturing and regulatory activities required to prepare an application for the EMA.

 

Complete enrollment of SCLERADEC-II and ADRESU clinical trials in France and Japan, respectively.

 

2017 Financial Guidance – Updated

The Company expects full year 2017 operating cash burn to be lower than 2016, primarily due to the restructuring announced in September 2017.

 


The following information was filed by Cytori Therapeutics, Inc. (CYTX) on Thursday, November 9, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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