UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 8-K

Current Report 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  March 3, 2016

CYTORI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 

Delaware
001-34375
33-0827593
(State or Other Jurisdiction of Incorporation)
(Commission File
Number)
(I.R.S. Employer Identification Number)

3020 Callan Road, San Diego, California 92121
(Address of principal executive offices, with zip code)

(858) 458-0900
(Registrant's telephone number, including area code)

n/a
(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see  General Instruction A.2. below):
 
 
 □
    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
 □
    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
 □
    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
 □
    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 2.02                          Results of Operations and Financial Condition

On March 3, 2016, Cytori Therapeutics, Inc. (Company) issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2015. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information disclosed under this Item 2.02 in this report, including Exhibit 99.1 hereto, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.


Item 9.01                          Financial Statements and Exhibits

(d)            Exhibits

Exhibit No.     
Description
99.1
Cytori Therapeutics, Inc. Press Release, dated March 3, 2016 *

* Exhibit 99.1 hereto is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.



SIGNATURES


Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.




 
CYTORI THERAPEUTICS, INC.
   
Date:  March 3, 2016
By: /s/ Tiago Girao
 
Tiago Girao
 
VP Finance and Chief Financial Officer












CYTORI THERAPEUTICS CONTACT
Tiago Girao
+1.858.458.0900
ir@cytori.com




Cytori Reports Fourth Quarter and Full Year 2015 Business and Financial Results
SAN DIEGO, March 03, 2016—Cytori Therapeutics (NASDAQ: CYTX) (Cytori or the "Company") today announced its fourth quarter and year-end 2015 financial results and provided updates on its corporate activity and clinical development.
Fourth quarter 2015 net loss allocable to common stockholders was $2.8 million, or a net loss of $5.4 million and $0.03 per share when excluding a non-cash charge of $2.7 million related to the change in fair value of warrant liabilities. Cytori continued to reduce its operating cash burn, spending approximately $4.5 million in the fourth quarter 2015. Cytori ended 2015 with $14.3 million of cash and cash equivalents.
Full year 2015 net loss allocable to common stockholders was $19.4 million, or a net loss of $26.4 million and $0.19 per share when excluding two non-cash charges - a $7.7 million gain related to the change in fair value of warrant liabilities and a $0.7 million charge related to the beneficial conversion feature for convertible preferred stock. Full year 2015 operating cash burn was $20.5 million, compared to $30.3 million in 2014.
"In 2015, the corporate repositioning that began in 2014 is largely completed and we are now enrolling two Phase III studies in scleroderma in the US and Europe, implementing a European patient access program for scleroderma, supporting an approval trial in Japan for SUI, and completing patient follow up for a mid-stage US OA trial," said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. "The challenge for us in 2016 is to continue to build upon the operational and financial performance achieved over this past year and successfully meet or exceed our key milestones this year."

Select Recent Highlights:
·
Presentation of 24 month follow-up data showing sustained benefit of results in investigator-initiated pilot/phase I/II trial for scleroderma hand dysfunction
·
Updated on enrollment status of U.S. pivotal/phase III trial for scleroderma (STAR trial), which is on track to complete around mid-2016
·
Completed and reported interim top-line 6 month data on knee osteoarthritis trial
·
Initiation of enrollment in a phase II investigator initiated trial for fistula from Crohn's disease
·
Publication of investigator-initiated phase I erectile dysfunction trial data in Journal EBioMedicine

Q4 and Year End 2015 Financial Performance
·
Q4 and full-year 2015 operating cash burn of $4.5 million and $20.5 million, compared to $4.9 million and $30.3 million for the same periods in 2014, respectively.
·
Cash and debt principal balances at December 31, 2015 of approximately $14.3 million and $17.7 million, respectively.
·
Q4 and full-year 2015 total revenues of $3.4 million and $11.7 million, compared to $3.8 million and $7.6 million for the same periods in 2014, respectively.
·
Q4 and full-year contribution (profit/loss) from our sales and marketing organization, excluding share based compensation, of a profit of $0.2 million and a loss of $0.8 million, compared to a profit of $0.1 million and a loss of $3.8 million for the same periods in 2014, respectively.
·
Q4 net loss, when excluding non-cash charges related to the change in fair value of warrant liabilities and beneficial conversion feature for convertible preferred stock, was $5.4 million or $0.03 per share, compared to $6 million or $0.07 per share for the same period in 2014, respectively.
·
Full-year net loss, when excluding non-cash charges related to the change in fair value of warrant liabilities and beneficial conversion feature for convertible preferred stock, was $26.4 million or $0.19 per share, compared to $37.7 million and $0.47 per share for the same period in 2014, respectively.
"We succeeded in meeting our internal key financial and operating metrics in 2015. This includes a reduction in our overall cash burn by over 30% while expanding our investment in research and development activities," said Tiago Girao, VP of Finance and CFO of Cytori Therapeutics. "In 2016, we plan to continue to narrow our losses, balancing ongoing capital requirements through a number of targeted activities that include further 'across-the-board' operational efficiency measures, tighter working capital management, increased revenue, and an intense focus on only those activities that we believe will maximize stockholder value creation."


Upcoming Near Term Catalysts:

·
Report of 48-week US pilot/phase IIb ACT-OA trial (94 patients) with data analysis in Q3 2016
·
Complete enrollment of  US  STAR phase III trial (anticipated mid 2016) for scleroderma hand dysfunction
·
Complete enrollment of investigator-initiated EU phase III SCLERADEC-II trial (anticipated in 2016) for scleroderma hand dysfunction
·
File IDE and obtain approval for burn wound therapy trial related to contract with BARDA (anticipated in 2016)

2016 Financial Guidance
·
Operating cash burn within a range of $18 million to $20 million
·
Total revenues (product and contract) within a range of $12 million to $14 million

Management Conference Call Webcast
Cytori will host a management conference call at 5:30 p.m. Eastern Time today to further discuss the Company's 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: 32453785.
About Cytori
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions.  Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair.  As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori's proprietary technologies and products.  For more information: visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements that involve known and unknown risks and uncertainties. All statements, other than historical facts are forward looking statements. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical, pre-clinical and regulatory uncertainties, such as those associated with the ACT-OA, STAR, SCLERADEC-I, SCLERADEC-II, ADRESU trial and possible BARDA wound trial (including risks in the collection and results of clinical data and final clinical outcomes), as well as achievement of financial goals (including 2016 operating cash burn and 2016 total revenues), dependence on third party performance (including performance of investigator-initiated trials), performance and acceptance of our products in the marketplace, unexpected costs and expenses that could adversely impact liquidity, our reliance on key personnel, the right of the Federal Government to cut or terminate further support of the thermal burn injury program (including any decision not to proceed with a wound trial in 2016), our abilities to capitalize on our internal restructuring and achieve profitability, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, included in our annual and quarterly reports.
There may be events in the future that we are unable to predict, or over which we have no control, and our business, financial condition, results of operations and prospects may change in the future. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless we have an obligation under U.S. Federal securities laws to do so.


CYTORI THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)

   
As of December 31,
 
   
2015
   
2014
 
         
Assets
       
Current assets:
       
Cash and cash equivalents                                                                                                                                      
 
$
14,338,000
   
$
14,622,000
 
Accounts receivable, net of reserves of $797,000 and of $1,523,000 in 2015 and 2014, respectively
   
1,052,000
     
1,243,000
 
Inventories, net                                                                                                                                      
   
4,298,000
     
4,829,000
 
Other current assets                                                                                                                                      
   
1,555,000
     
992,000
 
                 
Total current assets                                                                                                                                  
   
21,243,000
     
21,686,000
 
                 
Property and equipment, net                                                                                                                                          
   
1,631,000
     
1,583,000
 
Restricted cash and cash equivalents                                                                                                                                          
   
350,000
     
350,000
 
Other assets                                                                                                                                          
   
1,521,000
     
1,763,000
 
Intangibles, net                                                                                                                                          
   
9,031,000
     
9,415,000
 
Goodwill                                                                                                                                          
   
3,922,000
     
3,922,000
 
                 
Total assets                                                                                                                                  
 
$
37,698,000
   
$
38,719,000
 
                 
Liabilities and Stockholders' Equity (Deficit)
               
Current liabilities:
               
Accounts payable and accrued expenses                                                                                                                                      
 
$
6,687,000
   
$
5,546,000
 
Current portion of long-term obligations, net of discount
   
     
7,363,000
 
Joint Venture purchase obligation
   
1,750,000
     
3,008,000
 
                 
Total current liabilities                                                                                                                                  
   
8,437,000
     
15,917,000
 
                 
Warrant liability
   
     
9,793,000
 
Deferred revenues                                                                                                                                          
   
105,000
     
112,000
 
Long-term deferred rent                                                                                                                                          
   
269,000
     
558,000
 
Long-term obligations, net of discount, less current portion
   
16,681,000
     
18,041,000
 
                 
Total liabilities                                                                                                                                  
   
25,492,000
     
44,421,000
 
                 
Commitments and contingencies
               
Stockholders' equity:
               
Series A 3.6% convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 13,500 shares issued and no shares outstanding in 2015; 13,500 shares issued and 5,311 outstanding in 2014
   
     
 
Common stock, $0.001 par value; 290,000,000 shares authorized; 195,058,395 and 99,348,377 shares issued and outstanding in 2015 and 2014, respectively
   
195,000
     
99,000
 
Additional paid-in capital                                                                                                                                      
   
368,032,000
     
331,772,000
 
Accumulated other comprehensive income
   
996,000
     
700,000
 
Accumulated deficit                                                                                                                                      
   
(357,017,000
)
   
(338,273,000
)
                 
Total stockholders' equity (deficit)                                                                                                                                  
   
12,206,000
     
(5,702,000
)
                 
Total liabilities and stockholders' equity (deficit)                                                                                                                                  
 
$
37,698,000
   
$
38,719,000
 



CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)

   
For the Three Months
Ended December 31,
   
For the Twelve Months
Ended December 31,
 
   
2015
   
2014
   
2015
   
2014
 
                 
 Product revenues  
 
$
1,556,000
   
$
2,469,000
     
4,838,000
     
4,953,000
 
                                 
Cost of product revenues  
   
791,000
     
1,416,000
     
3,186,000
     
2,940,000
 
                                 
Gross profit  
   
765,000
     
1,053,000
     
1,652,000
     
2,013,000
 
                                 
Development revenues:
                               
Government contracts and other  
   
1,820,000
     
1,301,000
     
6,821,000
     
2,645,000
 
     
1,820,000
     
1,301,000
     
6,821,000
     
2,645,000
 
Operating expenses:
                               
Research and development  
   
4,629,000
     
2,999,000
     
19,000,000
     
15,105,000
 
Sales and marketing  
   
603,000
     
1,074,000
     
2,662,000
     
6,406,000
 
General and administrative  
   
2,104,000
     
2,831,000
     
9,765,000
     
15,953,000
 
Change in fair value of warrant liabilities  
   
(2,680,000
)
   
(235,000
)
   
(7,668,000
)
   
(369,000
)
                                 
Total operating expenses  
   
4,656,000
     
6,669,000
     
23,759,000
     
37,095,000
 
                                 
Operating loss  
   
(2,071,000
)
   
(4,315,000
)
   
(15,286,000
)
   
(32,437,000
)
                                 
Other income (expense):
                               
Income (loss) on asset disposal  
   
(3,000
)
   
57,000
     
3,000
     
42,000
 
Loss on debt extinguishment  
   
     
     
(260,000
)
   
 
Interest income  
   
3,000
     
2,000
     
9,000
     
6,000
 
Interest expense  
   
(702,000
)
   
(1,086,000
)
   
(3,379,000
)
   
(4,371,000
)
Other income (expense), net  
   
17,000
     
(413,000
)
   
169,000
     
(608,000
)
                                 
Total other expense  
   
(685,000
)
   
(1,440,000
)
   
(3,458,000
)
   
(4,931,000
)
                                 
Net loss  
 
$
(2,756,000
)
 
$
(5,755,000
)
   
(18,744,000
)
   
(37,368,000
)
             Beneficial conversion feature for
                               
             convertible preferred stock  
   
     
(1,169,000
)
   
(661,000
)
   
(1,169,000
)
             Net loss allocable to common stockholders  
 
$
(2,756,000
)
 
$
(6,924,000
)
   
(19,405,000
)
   
(38,537,000
)
                                 
Basic and diluted net loss per share allocable to common stockholders
 
$
(0.02
)
 
$
(0.08
)
   
(0.14
)
   
(0.48
)
                                 
Basic and diluted weighted average shares used in calculating net loss per share allocable to common stockholders
   
163,418,283
     
91,925,991
     
140,797,316
     
80,830,698
 
                                 
Comprehensive loss:
                               
Net loss  
   
(2,756,000
)
   
(5,755,000
)
   
(18,744,000
)
   
(37,368,000
)
Other comprehensive income (loss) – foreign currency translation adjustments
   
(65,000
)
   
243,000
     
296,000
     
444,000
 
Comprehensive loss  
   
(2,821,000
)
   
(5,512,000
)
   
(18,448,000
)
   
(36,924,000
)
                                 


CYTORI THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)

   
For the Years Ended December 31,
 
   
2015
   
2014
   
2013
 
Cash flows from operating activities:
           
Net loss                                                                                                            
 
$
(18,744,000
)
 
$
(37,368,000
)
 
$
(26,177,000
)
Adjustments to reconcile net loss to net cash used in operating activities:
                       
Depreciation and amortization                                                                                                        
   
1,093,000
     
779,000
     
1,630,000
 
Amortization of deferred financing costs and debt discount
   
979,000
     
1,220,000
     
893,000
 
Joint venture acquisition obligation accretion
   
365,000
     
579,000
     
204,000
 
Provision for doubtful accounts                                                                                                        
   
(105,000
)
   
1,084,000
     
1,141,000
 
Provision for expired enzymes                                                                                                        
   
     
313,000
     
 
Change in fair value of warrants                                                                                                        
   
(7,668,000
)
   
(369,000
)
   
(418,000
)
Change in fair value of option liability                                                                                                        
   
     
     
(2,250,000
)
Stock-based compensation                                                                                                        
   
2,041,000
     
3,101,000
     
3,608,000
 
Equity loss from investment in joint venture
   
     
     
48,000
 
Gain (loss) on asset disposal                                                                                                        
   
8,000
     
(33,000
)
   
257,000
 
Gain on previously held equity interest in Joint Venture
   
     
     
(4,892,000
)
Gain on sale of assets
   
     
     
(4,453,000
)
Loss on debt extinguishment
   
260,000
     
     
708,000
 
Increases (decreases) in cash caused by changes in operating assets and liabilities:
                       
Accounts receivable                                                                                                    
   
328,000
     
2,057,000
     
(1,209,000
)
Inventories                                                                                                    
   
490,000
     
(815,000
)
   
(459,000
)
Other current assets                                                                                                    
   
(637,000
)
   
510,000
     
(24,000
)
Other assets                                                                                                    
   
363,000
     
11,000
     
(854,000
)
Accounts payable and accrued expenses
   
1,045,000
     
(1,147,000
)
   
(409,000
)
Deferred revenues, related party                                                                                                    
   
     
     
(638,000
)
Deferred revenues                                                                                                    
   
3,000
     
(100,000
)
   
(1,223,000
)
Long-term deferred rent                                                                                                    
   
(289,000
)
   
(152,000
)
   
(46,000
)
                         
Net cash used in operating activities                                                                                                
   
(20,468,000
)
   
(30,330,000
)
   
(34,563,000
)
                         
Cash flows from investing activities:
                       
Purchases of property and equipment                                                                                                            
   
(611,000
)
   
(764,000
)
   
(519,000
)
Expenditures for intellectual property                                                                                                            
   
(13,000
)
   
(255,000
)
   
 
Proceeds from sale of assets                                                                                                            
   
11,000
     
76,000
     
5,000,000
 
License agreement termination fee
   
     
(400,000
)
   
(800,000
)
Cash acquired in purchase of joint venture
   
     
     
5,000
 
                         
Net cash (used in) provided by investing activities
   
(613,000
)
   
(1,343,000
)
   
3,686,000
 
                         
Cash flows from financing activities:
                       
Principal payments on long-term debt obligations
   
(25,032,000
)
   
(1,962,000
)
   
(22,304,000
)
Proceeds from long-term obligations                                                                                                            
   
17,700,000
     
     
27,000,000
 
Debt issuance costs and loan fees                                                                                                            
   
(1,854,000
)
   
     
(1,744,000
)
Joint venture purchase payments                                                                                                            
   
(1,623,000
)
   
(2,262,000
)
   
(221,000
)
Proceeds from exercise of employee stock options and warrants and stock purchase plan
   
4,997,000
     
4,151,000
     
225,000
 
Proceeds from issuance of common stock                                                                                                            
   
29,054,000
     
19,001,000
     
18,000,000
 
Proceeds from issuance of preferred stock
   
     
13,500,000
     
 
Costs from sale of common stock                                                                                                            
   
(2,370,000
)
   
(425,000
)
   
(184,000
)
Costs from sale of preferred stock                                                                                                            
   
     
(1,129,000
)
   
 
Dividends paid on preferred stock
   
(75,000
)
   
     
 
                         
Net cash provided by financing activities
   
20,797,000
     
30,874,000
     
20,772,000
 
                         
Effect of exchange rate changes on cash and cash equivalents
   
     
(85,000
)
   
(106,000
)
                         
Net decrease in cash and cash equivalents
   
(284,000
)
   
(884,000
)
   
(10,211,000
)
                         
Cash and cash equivalents at beginning of year
   
14,622,000
     
15,506,000
     
25,717,000
 
                         
Cash and cash equivalents at end of year                                                                                                            
 
$
14,338,000
   
$
14,622,000
   
$
15,506,000