CYTORI THERAPEUTICS, INC. (NASDAQ:CYTX) Files An 8-K Entry into a Material Definitive Agreement

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CYTORI THERAPEUTICS, INC. (NASDAQ:CYTX) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry Into a Material Definitive Agreement.

On May 26, 2017, Cytori Therapeutics, Inc., a Delaware corporation (the “Company”) received notice from the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, that BARDA had agreed to an Amendment of Solicitation/Modification of Contract (Amendment No. 0008) (the “Eighth Amendment”) of the Contract HHSO100201200008C, dated September 27, 2012 (as amended, the “BARDA Agreement”).   to the Eighth Amendment, BARDA exercised its unilateral right to exercise Option 2 of the BARDA Agreement, which provides for the assessment of Cytori® Cell Therapy™, or DCCT-10, as an adjunct therapy in thermal burn injury through the Company’s RELIEF pilot clinical trial (the “Pilot Trial”).  Although the Company received formal notice of BARDA’s option exercise on May 26, 2017, the Eight Amendment is deemed effective as of May 23, 2017, which is the date BARDA signed the Eighth Amendment.

Option 2 was previously amended in a separate Amendment of Solicitation/Modification of Contract (Amendment No. 0007), dated May 19, 2017, by and between the Company and BARDA (the “Seventh Amendment” and together with the Eighth Amendment, the “Amendments”).   to the Amendments, Option 2 of the BARDA Agreement was amended  to (i) revise the statement of work setting forth the clinical, regulatory and other activities relating to the Pilot Trial and (ii) set forth and provide the additional funding, and terms thereof, for the execution of the activities outlined in Option 2.  

In accordance with the terms of the Amendments, BARDA will provide the Company with reimbursement of costs incurred, plus payment of a fixed fee, in the aggregate amount of up to approximately $13.4 million (the “Funding Amount”).  The Company is responsible for further costs in excess of the Funding Amount, if any, to meet the objectives of the Pilot Trial. The Amendments also extend the term of the BARDA Agreement and the period of performance of Option 2 of the BARDA Agreement to November 30, 2020.  

The foregoing is only a brief description of the material terms of the Amendments and does not purport to be a complete description of the rights and obligations of the parties thereunder. The foregoing description is qualified in its entirety by reference to the Amendments, which will be filed as exhibits to the Company’s next Quarterly Report on Form 10-Q.


About CYTORI THERAPEUTICS, INC. (NASDAQ:CYTX)

Cytori Therapeutics, Inc. (Cytori) is a biotechnology company engaged in the development of treatments and devices for a range of disorders using cells as a key part of the therapy. The Company develops cellular therapeutics formulated and optimized for specific diseases and medical conditions and related products. It is focused on developing primary product, Cytori Cell Therapy, for patients with scleroderma hand dysfunction, orthopedic disorders, cardiovascular disease, urinary incontinence and thermal burns, including those complicated by radiation. Its cellular therapeutics are collectively known by the name, Cytori Cell Therapy, which consists of a heterogeneous population of specialized cells, including stem cells that are involved in response to injury, repair and healing. These cells are extracted from an adult patient’s own adipose tissue using its automated, enzymatic, sterile Celution System devices and consumable sets at the place where the patient is receiving their care.

CYTORI THERAPEUTICS, INC. (NASDAQ:CYTX) Recent Trading Information

CYTORI THERAPEUTICS, INC. (NASDAQ:CYTX) closed its last trading session 00.000 at 0.980 with 416,479 shares trading hands.