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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):  November 5, 2015

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 November 5, 2015, Cytori Therapeutics, Inc. (Company) issued a press release announcing its financial results for the third quarter ended September 30, 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 November 5, 2015 *
 
* 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:  November 5, 2015
By: /s/ Tiago Girao
 
Tiago Girao
 
VP Finance and Chief Financial Officer

Exhibit Index
 
Exhibit No.
Description

Cytori Therapeutics, Inc. Press Release, dated November 5, 2015 *

Exhibit 99.1
 
 

CYTORI THERAPEUTICS CONTACT
Tiago Girao
+1.858.458.0900
ir@cytori.com
 
Cytori Reports Third Quarter 2015 Business and Financial Results

SAN DIEGO, November 05, 2015—Cytori Therapeutics (NASDAQ: CYTX) today announced its third quarter financial results and provided updates on its corporate activity and clinical development.

Third quarter 2015 net income allocable to common stockholders was $1.5 million, or a net loss of $5.8 million and $0.04 per share when excluding a non-cash charge of $7.3 million related to the change in fair value of warrant liabilities. Cytori continued to reduce its operating cash burn, spending approximately $6.1 million in the third quarter 2015. Cytori ended the second quarter of 2015 with $19 million of cash and cash equivalents.

“This has been a good quarter for us; our trials are progressing on schedule and we have a number of anticipated milestones over the next 12 months related to our lead programs in scleroderma and osteoarthritis,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “In parallel, we are preparing for commercial success through expansion of our market access activities in Europe for scleroderma, broadening our business development efforts and strengthening our leadership team. Also, we are analyzing additional opportunities to cost effectively expand our clinical pipeline and better develop the technology platform upon which it is based.”

Select Q3 Highlights:

· Publication of extended follow-up data showing sustained benefit of results in pilot/phase I/II trial for scleroderma hand dysfunction

· Initiated enrollment in two late stage trials for scleroderma hand dysfunction in both the US (STAR trial) and Europe (SCLERADEC-II trial)

· Initiated enrollment of Japanese pivotal/phase III trial for stress urinary incontinence (ADRESU trial)

· Publication of twelve-month follow up data in patients with intractable inflammatory bowel disease

Q3 and Year-To-Date Financial Performance

· Q3 and year-to-date operating cash burn of $6.1 million and $15.9 million, compared to $7.2 million and $25.4 million for the same periods in 2014, respectively.

· Cash and debt principal balances at September 30, 2015 of approximately $19 million and $17.7 million, respectively.

· Q3 and year-to-date product revenues of $0.8 million and $3.3 million, compared to $0.5 million and $2.5 million for the same periods in 2014, respectively.

· Q3 and year-to-date contribution (profit/loss) from our sales and marketing organization, excluding share based compensation, of a loss of $0.3 million and $1.1 million, compared to a loss of $1.2 million and $4.0 million for the same periods in 2014, respectively.

· Q3 and year-to-date contract revenue of $1.7 million and $5.0 million, compared to $0.6 million and $1.3 million for the same periods in 2014, respectively.

· Q3 and year-to-date net loss/income allocable to common stockholders was a net income of $1.5 million (or $0.01 per share, or a net loss of $5.8 million and $0.04 per share when excluding a non-cash charge of $7.3 million related to the change in fair value of warrant liabilities) and a net loss of $16.6 million (or $0.12 per share, or $21.6 million and $0.16 per share when excluding a non-cash charge of $5 million related to the change in fair value of warrant liabilities), compared to a net loss of $9.4 million (or $0.12 per share, or $9.5 million and $0.12 per share when excluding a non-cash charge of $0.1 million related to the change in fair value of warrant liabilities) and $31.6 million (or $0.41 per share, or $31.7 million and $0.41 per share when excluding a non-cash charge of $0.1 million related to the change in fair value of warrant liabilities) for the same periods in 2014, respectively.

“We continue to seek to hold the overall cash burn down while expanding the overall spending in research and development,” said Tiago Girao, VP of Finance and CFO of Cytori Therapeutics. “We have been successful at this thus far through the implementation of ‘across-the-board’ operational efficiencies, tighter management of working capital, better support from key stakeholders and service providers, and ultimately by maintaining a clear company-wide focus on only those activities than management feels will bring shareholder value in the most compressed time frame possible.”
 
 
Upcoming Near Term Catalysts:

· Evaluate and release 24-week data from 94 patient US pilot/phase IIb ACT-OA trial (anticipated Q1 2016) and identify partner for late stage US clinical development

· Complete enrollment of  US  STAR trial (anticipated mid 2016) for scleroderma hand dysfunction

· Complete enrollment of EU pivotal/phase III SCLERADEC-II trial (anticipated mid 2016) for scleroderma hand dysfunction

· Complete enrollment of Japanese pivotal/phase III ADRESU trial (anticipated 2017) for stress urinary incontinence

· Work with FDA to plan a burn wound therapy trial related to contract with BARDA (anticipated in 2016)
 
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: 58684057.

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 Trial, STAR, SCLERADEC-I and SCLERADEC-II clinical trials, including risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, 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, 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.
 
2
 
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS

(UNAUDITED)
   
As of September
30, 2015
    
As of December
31, 2014
  
Assets
        
Current assets:
        
Cash and cash equivalents
  
$
18,970,000
    
$
14,622,000
  
Accounts receivable, net of reserves of $900,000 and of $1,523,000 in 2015 and 2014, respectively
    
1,134,000
      
1,243,000
  
Inventories, net
    
4,612,000
      
4,829,000
  
Other current assets
    
1,314,000
      
992,000
  
                 
Total current assets
    
26,030,000
      
21,686,000
  
                 
Property and equipment, net
    
1,734,000
      
1,583,000
  
Restricted cash and cash equivalents
    
350,000
      
350,000
  
Other assets
    
1,214,000
      
1,763,000
  
Intangibles, net
    
9,196,000
      
9,415,000
  
Goodwill
    
3,922,000
      
3,922,000
  
                 
Total assets
  
$
42,446,000
    
$
38,719,000
  
                 
Liabilities and Stockholders’ Equity (Deficit)
                
Current liabilities:
                
Accounts payable and accrued expenses
  
$
6,279,000
    
$
5,546,000
  
Current portion of long-term obligations, net of discount
    
1,446,000
      
7,363,000
  
Joint venture purchase obligation
    
1,725,000
      
3,008,000
  
                 
Total current liabilities
    
9,450,000
      
15,917,000
  
                 
Deferred revenues
    
143,000
      
112,000
  
Warrant liabilities, long-term
    
12,527,000
      
9,793,000
  
Long-term deferred rent and other
    
348,000
      
558,000
  
Long-term obligations, net of discount, less current portion
    
14,978,000
      
18,041,000
  
                 
Total liabilities
    
37,446,000
      
44,421,000
  
                 
Commitments and contingencies
                
Stockholders’ equity (deficit):
                
Series A 3.6% convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 13,500 shares issued; 0 and 5,311 outstanding in 2015 and 2014, respectively
    
—
      
—
  
Common stock, $0.001 par value; 290,000,000 shares authorized; 158,468,645 and 99,348,377 shares issued and outstanding in 2015 and 2014, respectively
    
159,000
      
99,000
  
Additional paid-in capital
    
358,035,000
      
331,772,000
  
Accumulated other comprehensive income
    
1,061,000
      
700,000
  
Accumulated deficit
    
(354,255,000
)
    
(338,273,000
)
                 
Total stockholders’ equity (deficit)
    
5,000,000
      
(5,702,000
)
                 
Total liabilities and stockholders’ equity (deficit)
  
$
42,446,000
    
$
38,719,000
  

3

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

(UNAUDITED)

   
For the Three Months
Ended September 30,
    
For the Nine Months
Ended September 30,
  
   
2015
    
2014
    
2015
    
2014
  
                 
Product revenues
  
$
766,000
    
$
518,000
    
$
3,281,000
    
$
2,484,000
  
                                 
Cost of product revenues
    
502,000
      
337,000
      
2,395,000
      
1,524,000
  
                                 
Gross profit
    
264,000
      
181,000
      
886,000
      
960,000
  
                                 
Development revenues:
                                
Government contracts and other
    
1,711,000
      
585,000
      
5,002,000
      
1,345,000
  
     
1,711,000
      
585,000
      
5,002,000
      
1,345,000
  
Operating expenses:
                                
Research and development
    
4,352,000
      
3,140,000
      
14,363,000
      
12,106,000
  
Sales and marketing
    
566,000
      
1,471,000
      
2,059,000
      
5,332,000
  
General and administrative
    
2,370,000
      
4,179,000
      
7,662,000
      
13,121,000
  
Change in fair value of warrant liabilities
    
(7,310,000
)
    
(134,000
)
    
(4,988,000
)
    
(134,000
)
                                 
Total operating expenses
    
(22,000
)
    
8,656,000
      
19,096,000
      
30,425,000
  
                                 
Operating income (loss)
    
1,997,000
      
(7,890,000
)
    
(13,208,000
)
    
(28,120,000
)
                                 
Other income (expense):
                                
Income (loss) on asset disposal
    
(3,000
)
    
(14,000
)
    
6,000
      
(15,000
)
Loss on debt extinguishment
    
—
      
—
      
(260,000
)
    
—
  
Interest income
    
3,000
      
1,000
      
6,000
      
4,000
  
Interest expense
    
(669,000
)
    
(1,260,000
)
    
(2,677,000
)
    
(3,286,000
)
Other income (expense), net
    
199,000
      
(222,000
)
    
152,000
      
(195,000
)
                                 
Total other expense
    
(470,000
)
    
(1,495,000
)
    
(2,773,000
)
    
(3,492,000
)
                                 
Net income (loss)
  
$
1,527,000
    
$
(9,385,000
)
  
$
(15,981,000
)
  
$
(31,612,000
)
Beneficial conversion feature for
                                
convertible preferred stock
    
—
      
—
      
(661,000
)
    
—
  
Net income (loss) allocable to common stockholders
  
$
1,527,000
    
$
(9,385,000
)
  
$
(16,642,000
)
  
$
(31,612,000
)
                                 
Net income (loss) per share allocable to common stockholders
                                
Basic
  
$
0.01
    
$
(0.12
)
  
$
(0.12
)
  
$
(0.41
)
Diluted
  
$
0.01
    
$
(0.12
)
  
$
(0.12
)
  
$
(0.41
)
                                 
Weighted average shares used in calculating net income (loss) per share allocable to common stockholders
                                
Basic
    
153,798,471
      
80,430,061
      
133,174,133
      
77,091,624
  
Diluted
    
157,968,958
      
80,430,061
      
133,174,133
      
77,091,624
  
                                 
Comprehensive income (loss):
                                
Net income (loss)
  
$
1,527,000
    
$
(9,385,000
)
  
$
(15,981,000
)
  
$
(31,612,000
)
Other comprehensive income (loss) – foreign currency translation adjustments
    
110,000
      
58,000
      
361,000
      
201,000
  
Comprehensive income (loss)
  
$
1,637,000
    
$
(9,327,000
)
  
$
(15,620,000
)
  
$
(31,411,000
)

4

 
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(UNAUDITED)
   
For the Nine Months Ended September 30,
  
   
2015
    
2014
  
Cash flows from operating activities:
        
Net loss
  
$
(15,981,000
)
  
$
(31,612,000
)
Adjustments to reconcile net loss to net cash used in operating activities:
                
Depreciation and amortization
    
761,000
      
525,000
  
Amortization of deferred financing costs and debt discount
    
714,000
      
961,000
  
Joint Venture acquisition obligation accretion
    
340,000
      
362,000
  
Provision for doubtful accounts
    
—
      
1,126,000
  
Provision for expired enzyme
    
—
      
313,000
  
Change in fair value of warrants
    
(4,988,000
)
    
(134,000
)
Stock-based compensation expense
    
1,617,000
      
2,566,000
  
Loss on asset disposal
    
5,000
      
15,000
  
Loss on debt extinguishment
    
260,000
      
—
  
Increases (decreases) in cash caused by changes in operating assets and liabilities:
                
Accounts receivable
    
131,000
      
2,505,000
  
Inventories
    
(10,000
)
    
(1,158,000
)
Other current assets
    
(258,000
)
    
(19,000
)
Other assets
    
762,000
      
(124,000
)
Accounts payable and accrued expenses
    
870,000
      
(666,000
)
Deferred revenues
    
41,000
      
47,000
  
Long-term deferred rent
    
(210,000
)
    
(81,000
)
                 
Net cash used in operating activities
    
(15,946,000
)
    
(25,374,000
)
                 
Cash flows from investing activities:
                
Purchases of property and equipment
    
(544,000
)
    
(792,000
)
Expenditures for intellectual property
    
(13,000
)
    
(255,000
)
License agreement termination fee
    
—
      
(400,000
)
                 
Net cash used in investing activities
    
(557,000
)
    
(1,447,000
)
                 
Cash flows from financing activities:
                
Principal payments on long-term obligations
    
(25,032,000
)
    
(1,303,000
)
Proceeds from long-term obligations
    
17,700,000
      
—
  
Debt issuance costs and loan fees
    
(1,854,000
)
    
—
  
Joint Venture purchase payments
    
(1,623,000
)
    
(2,236,000
)
Proceeds from exercise of employee stock options and warrants
    
4,986,000
      
4,066,000
  
Proceeds from sale of common stock, net
    
26,749,000
      
18,650,000
  
Dividends paid on preferred stock
    
(75,000
)
    
—
  
                 
Net cash provided by financing activities
    
20,851,000
      
19,177,000
  
                 
Effect of exchange rate changes on cash and cash equivalents
    
—
      
(13,000
)
                 
Net increase (decrease) in cash and cash equivalents
    
4,348,000
      
(7,657,000
)
                 
Cash and cash equivalents at beginning of period
    
14,622,000
      
15,506,000
  
                 
Cash and cash equivalents at end of period
  
$
18,970,000
    
$
7,849,000
  
 
5