Exhibit 99.1

 

 

Cytori Therapeutics contact

Tiago Girao

+1.858.458.0900

ir@cytori.com

 

 

 

 

 

Cytori Reports First Quarter 2017 Business and Financial Results

SAN DIEGO, May 11, 2017—

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

First quarter 2017 adjusted net loss was $5.9 million, or $0.26 per share, and excludes a $1.7 million non-cash charge for in process research and development expense from the Azaya Therapeutics asset acquisition. Q1 2017 GAAP net loss was $7.5 million, or $0.33 per share. Operating cash burn for the quarter was approximately $4.8 million. Cytori ended the quarter with approximately $6.3 million of cash and cash equivalents, or approximately $15 million pro-forma at March 31, 2017, when considering $8.7 million in net cash proceeds since March 31, 2017 from the issuance of shares under Cytori’s underwritten public offering that closed on April 17, 2017.

Selected Key Recent Highlights:

 

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

 

Received U.S. FDA orphan drug designation for cryopreserved or centrally processed HabeoTM for treatment of hand manifestations of systemic scleroderma.

 

Received U.S. Small Business Designation and related fee reductions.

 

Q1 2017 Financial Performance

 

Q1 2017 operating cash burn was $4.8 million, compared to $5.1 million for Q1 2016.

 

Q1 2017 total revenues were $1.6 million, compared to $2.9 million in Q1 2016.

 

Cash and debt principal balances at March 31, 2017 were approximately $6.3 million and $15.9 million, respectively.

 

Q1 2017 adjusted net loss was $5.9 million or $0.26 per share, compared to a net loss of $5.3 million or $0.41 per share for Q1 2016.

 

Q1 2017 GAAP net loss was $7.5 million or $0.33 per share, compared to a net loss of $5.3 million or $0.41 per share for Q1 2016.

 

“Our areas of primary focus is on stockholder value creation through bringing two valuable late stage products to market,” said Dr. Marc Hedrick, President and CEO of Cytori. “Specifically, our U.S. pivotal STAR trial for HabeoTM Cell Therapy for scleroderma will report top line data in Q3. Also, we currently project completing bulk manufacturing of our nanoparticle doxorubicin oncology product for testing and validation purposes by year end. In parallel, our marketing team is preparing for initial commercial launch of our scleroderma and oncologic products with the goal of obtaining  regulatory approvals in the late 2018 and 2019, respectively. Until then, we will carefully manage our capital resources as we have in prior quarters.”

 

 

Selected Key Anticipated Milestones:

 

 

Complete contracting discussions with BARDA regarding their potential funding of our thermal burn trial (Q2)

 

Report of 48-week US pivotal/phase III trial data for scleroderma hand dysfunction and preparation for US PMA filing (Q3)

 

Complete manufacturing activities required for submission of an MAA to the EMA for our recently acquired nanoparticle doxorubicin (Q4)

 

 


The following information was filed by Cytori Therapeutics, Inc. (CYTX) on Thursday, May 11, 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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