Cytori Therapeutics contact

Tiago Girao

+1.858.458.0900

ir@cytori.com

 

 

 

 

Cytori Reports Q1 2018 Business and Financial Results

SAN DIEGO, May 10, 2018—

Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced Q1 2018 financial results and provided updates on corporate development.

Q1 2018 net loss was $4.4 million, or $0.07 per share. Operating cash burn for Q1 was approximately $4.1 million. Cytori ended Q1 with approximately $5.9 million of cash and cash equivalents.

Cytori’s recently acquired nanomedicine facility in San Antonio, Texas is now actively manufacturing validation batches of ATI-0918, pegylated liposomal doxorubicin, in preparation for filing a Marketing Authorization Application with the European Medicines Agency. All key supply chain contracts are being established to produce final drug product. Cytori has also expanded its on-site analytical chemistry evaluation capability to meet all process validation requirements. To prepare commercially, we are having ongoing discussions with potential licensing partners for ATI-0918 distribution in Europe, Asia, and North America. The Company is also actively evaluating potential co-development partners for ATI-1123, protein-stabilized pegylated liposomal docetaxel, a new chemical entity for various cancer types.

 

Regarding Cytori Cell Therapy, Cytori announced the completion of enrollment in the European investigator-initiated clinical trial SCLERADEC-II with a planned data readout in 2H 2018. Cytori also announced completion of enrollment in the Japanese investigator-initiated ADRESU clinical trial for male stress urinary incontinence, for which data 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. The Company is currently in the process of initiating up to 10 sites in the U.S. for RELIEF.

 

“Our major corporate objective is to file for market approval in Europe for ATI-0918, our oncology drug product and a generic version of Caelyx®. Additionally, we are working to define the clinical and regulatory pathways for our nanomedicine products in China, where a substantial opportunity exists based on the evolution of drug standards to mirror those in the U.S.” said Dr. Marc Hedrick, President and CEO of Cytori. “Also, we are preparing for international trial readouts from the SCLERADEC-II scleroderma and ADRESU urinary incontinence trials, in 2018 or early 2019.”

 

Q1 2018 Financial Performance

 

Q1 2018 operating cash burn was $4.1 million, compared to $4.8 million for Q1 2017.

 

Q1 2018 total revenues were $1.6 million.

 

In Q1 2018, consumable utilization in Japan grew by more than 50% as compared to Q1 2017.

 

Cash and debt principal balances at March 31, 2018 were approximately $5.9 million and $13.0 million, respectively.

 

Q1 2018 net loss was $4.4 million or $0.07 per share, compared to a net loss of $7.5 million or $0.33 per share for Q1 2017.

Selected Key Anticipated Milestones:

 

 

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

 

Enroll first patient in the BARDA funded U.S. RELIEF burn clinical trial.

 

Report of 12/24-week European SCLERADEC-II trial data for scleroderma hand dysfunction.

 

Report of 24/48-week Japanese ADRESU trial data for post-surgical 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: 7194327.

 

 


The following information was filed by Cytori Therapeutics, Inc. (CYTX) on Thursday, May 10, 2018 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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