☒
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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DELAWARE
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33-0827593
|
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(State or Other Jurisdiction of Incorporation or Organization)
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(I.R.S. Employer Identification No.)
|
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3020 CALLAN ROAD, SAN DIEGO, CALIFORNIA
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92121
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Name of each exchange on which registered
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Common stock, par value $0.001
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NASDAQ Stock Market LLC
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Large Accelerated Filer
☐
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Accelerated Filer
☒
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Non-Accelerated Filer
☐
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Smaller reporting company
☐
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(Do not check if a smaller reporting company)
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Page
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|||
PART I | |||
Item 1.
|
3
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||
Item 1A.
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13
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||
Item 1B.
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28
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||
Item 2.
|
29
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||
Item 3.
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29
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||
Item 4.
|
29
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||
PART II | |||
Item 5.
|
30
|
||
Item 6.
|
32
|
||
Item 7.
|
34
|
||
Item 7A.
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48
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||
Item 8.
|
49
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||
Item 9.
|
80
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||
Item 9A.
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80
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||
Item 9B.
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81
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||
PART III | |||
Item 10.
|
82
|
||
Item 11.
|
82
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||
Item 12.
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82
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||
Item 13.
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82
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||
Item 14.
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82
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||
PART IV | |||
Item 15.
|
83
|
·
|
Hand dysfunction assessed by the CHFS, showed a 62% reduction in hand dysfunction at two years (p<0.001).
|
· | Raynaud’s Condition Score decreased by an average of 89% over baseline at two years (p<0.001). |
· | Hand pain, as measured by a 100 mm Visual Analogue Scale, and the Scleroderma Health Assessment Questionnaire (SHAQ) score at two years both showed improvement of 50% over baseline (p=0.01 and p<0.001 respectively). |
· | Improvement of 20% in grip strength and 330% in pinch strength at two years (p=0.05 and p=0.004 respectively) |
· | Continued reduction in the number of ulcers from 15 at baseline to 9 at one year and 6 at two years. |
· | The randomization is relatively balanced among the three treatment groups; low dose, high dose, and placebo. |
· | Intra-articular application of a single dose of ECCO-50 appears to be safe and feasible in an outpatient day-surgery setting. No complications occurred related to the fat harvest, cell processing or cell delivery. |
· | A significant placebo response was observed, similar to that demonstrated in other OA trials. |
· | The pre-specified primary endpoint, pain on walking at 12 weeks, as measured by a single question from the Knee Injury and Osteoarthritis Outcome Score (KOOS) did not obtain statistical significance. |
· | Key secondary endpoints include the total and sub-scores of the KOOS, patient self-assessments (knee pain, knee stability, osteoarthritis activity and osteoarthritis damage), use of as-needed pain medication, pain while walking 50 feet and health status as measured by the SF-36. Consistent trends were observed suggesting improvement in the cell treated group relative to the placebo group at the 12 and 24 week time periods for patient reported outcomes; however, in general, between-group differences were small. |
· | Both high dose and low dose of ECCO-50 performed similarly. |
· | Supported enrollment in the ACT-OA (osteoarthritis) and STAR (scleroderma) trials; |
· | Supported ongoing preclinical and other research activities towards BARDA contract milestones; |
· | Continued patient follow-up and data analysis from the Athena trials and European ADVANCE trial; |
· | Prepared and submitted multiple regulatory filings in the United States, Europe, Japan, and other regions related to various cell and tissue processing systems under development; |
· | Developed new configurations and expanded functionality of our Celution ® platform to address the current Japan approval as a medical device (Japan Class I) and other markets; |
· | Conducted adipose derived regenerative cells (ADRC) viability and transport studies in support of clinical trial requirements; |
· | Conducted, presented, and published research efforts related to ADRC characterization and potency to further establish scientific leadership in the field; and |
· | Continued to optimize and develop the Celution ® System family of products and next-generation devices, single-use consumables and related instrumentation. |
Region
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Clinical Applications
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Regulatory Status
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Japan
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Cell Banking
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Approved
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Celution® Centrifuge, Celbrush
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Class I Notification
|
|
China
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Celution 800/IV, Celase, Intravase
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Class I Notification
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Europe
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Celution® 800: Cell Processing for re-implantation or re-infusion into same patient (General Processing)
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CE Mark
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Celution® 800: Breast reconstruction and other cosmetic procedures
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CE Mark
|
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Celution® 800: Crohn’s fistula
|
CE Mark
|
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Intravase® for use with Celution® 800
|
CE Mark
|
|
Cell Concentration
|
CE Mark
|
|
U.S.
|
Osteoarthritis
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ACT-OA IDE trial completed in June 2015
|
U.S.
|
Scleroderma
|
STAR (full IDE approval granted in January 2015) - enrolling
|
U.S.
|
Refractory Heart Failure
|
ATHENA and ATHENA II IDE trial enrolled
|
Australia
|
Celution 800 Cell Processing for re-implantation or re-infusion into same patient (general/plastic reconstruction)
|
ARTG Certificate
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Croatia
|
Celution 800 Cell Processing for re-implantation or re-infusion into same patient (general/plastic reconstruction)
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Approval Certificated from the Croatia Agency for Medicinal Products and Medical Devices
|
New Zealand
|
Celution 800
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WAND Registered
|
Russia
|
Celution 800 Cell Processing for re-implantation or re-infusion into same patient (general/plastic reconstruction)
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Roszdravnadzor Certificate (Federal Service for Control of Healthcare and Social Development)
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Serbia
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Celution 800 Cell Processing for re-implantation or re-infusion into same patient (general/plastic reconstruction)
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ALIMS (Medicines and Medical Devices Agency of Serbia)
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Singapore
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Celution 800 Cell Processing for re-implantation or re-infusion into same patient (general/plastic reconstruction)
|
HSA approved, SMDR Registered
|
· | causing us to use a larger portion of our cash flow to fund interest and principal payments, reducing the availability of cash to fund working capital and capital expenditures and other business activities; |
· | making it more difficult for us to take advantage of significant business opportunities, such as acquisition opportunities, and to react to changes in market or industry conditions; and |
· | limiting our ability to borrow additional monies in the future to fund working capital, capital expenditures and other general corporate purposes. |
· | By mid-March, 2016, we shall have filed our definite proxy for a stockholders meeting which includes a request to approve a reverse stock split to bring our stock priced above $1; |
· | On or before May 10, 2016, we shall have held a stockholders meeting at which the stockholders approve a reverse stock sufficient to demonstrate compliance with Nasdaq’s minimum $1 bid price requirement; |
· | On or before May 31, 2016, we shall have demonstrated a closing bid price of $1 or more for a minimum of ten consecutive trading days. |
· | we would be forced to seek to be traded on a less recognized or accepted exchange or market such as the OTC Bulletin Board or the “pink sheets;” |
· | the trading price of our common stock would be adversely affected, including an increased spread between the “bid” and “asked” prices quoted by market makers; |
· | the liquidity and marketability of shares of our common stock would be adversely affected, thereby reducing the ability of holders of our common stock to purchase or sell our shares as quickly and as inexpensively as they have done historically (if our stock is traded as a “penny stock,” transactions in our stock would be more difficult and cumbersome); |
· | our ability to access capital on terms favorable to us (or at all) would be adversely affected, as companies trading on the OCT Bulletin Board or “pink sheets” are viewed as less attractive investments with materially higher associated risks, such that existing or prospective institutional investors may be less interested in, or prohibited from, investing in our common stock (which may also cause the market price of our common stock to decline). |
• | restrictions on our products or manufacturing processes; |
• | warning letters; |
• | withdrawal of the products from the market; |
• | voluntary or mandatory recall; |
• | fines; |
• | suspension or withdrawal of regulatory approvals; |
• | suspension or termination of any of our ongoing clinical trials; |
• | refusal to permit the import or export of our products; |
• | refusal to approve pending applications or supplements to approved applications that we submit; |
• | product seizure; |
• | injunctions; or |
• | imposition of civil or criminal penalties. |
• | clinical results may not meet prescribed endpoints for the studies or otherwise provide sufficient data to support the efficacy of our products; |
• | clinical and nonclinical test results may reveal side effects, adverse events or unexpected safety issues associated with the use of our products; |
• | regulatory review may not find a product safe or effective enough to merit either continued testing or final approval; |
• | regulatory review may not find that the data from preclinical testing and clinical trials justifies approval; |
• | regulatory authorities may require that we change our studies or conduct additional studies which may significantly delay or make continued pursuit of approval commercially unattractive; |
• | a regulatory agency may reject our trial data or disagree with our interpretations of either clinical trial data or applicable regulations; |
• | the cost of clinical trials required for product approval may be greater than what we originally anticipate, and we may decide to not pursue regulatory approval for such a product; |
• | a regulatory agency may identify problems or other deficiencies in our existing manufacturing processes or facilities, or the existing processes or facilities of our collaborators, our contract manufacturers or our raw material suppliers; |
• | a regulatory agency may change its formal or informal approval requirements and policies, act contrary to previous guidance, adopt new regulations or raise new issues or concerns late in the approval process; |
• | a product candidate may be approved only for indications that are narrow or under conditions that place the product at a competitive disadvantage, which may limit the sales and marketing activities for such products or otherwise adversely impact the commercial potential of a product; or |
• | a regulatory agency may ask the company to put a clinical study on hold pending additional safety data; there is no guarantee that the company will be able to satisfy the regulator agencies requests in a timely manner, which can lead to significant uncertainty in the completion of a clinical study. |
· | political unrest, terrorism and economic or financial instability; |
· | unexpected changes and uncertainty in regulatory requirements; |
· | nationalization programs that may be implemented by foreign governments; |
· | import-export regulations; |
· | difficulties in enforcing agreements and collecting receivables; |
· | difficulties in ensuring compliance with the laws and regulations of multiple jurisdictions; |
· | changes in labor practices, including wage inflation, labor unrest and unionization policies; |
· | longer payment cycles by international customers; |
· | currency exchange fluctuations; |
· | disruptions of service from utilities or telecommunications providers, including electricity shortages; |
· | difficulties in staffing foreign branches and subsidiaries and in managing an expatriate workforce, and differing employment practices and labor issues; and |
· | potentially adverse tax consequences. |
· | audit or object to our contract-related costs and fees, and require us to reimburse all such costs and fees; |
· | suspend or prevent us for a set period of time from receiving new contracts or extending our existing contracts based on violations or suspected violations of laws or regulations; |
· | cancel, terminate or suspend our contracts based on violations or suspected violations of laws or regulations; |
· | terminate our contracts if in the Government’s best interest, including if funds become unavailable to the applicable governmental agency; |
· | reduce the scope and value of our contracts; and |
· | change certain terms and conditions in our contracts. |
· | termination of contracts; |
· | forfeiture of profits; |
· | suspension of payments; |
· | fines; and |
· | suspension or prohibition from conducting business with the U.S. Government. |
· | fluctuations in our operating results or the operating results of our competitors; |
· | changes in estimates of our financial results or recommendations by securities analysts; |
· | variance in our financial performance from the expectations of securities analysts; |
· | changes in the estimates of the future size and growth rate of our markets; |
· | changes in accounting principles or changes in interpretations of existing principles, which could affect our financial results; |
· | conditions and trends in the markets we serve; |
· | changes in general economic, industry and market conditions; |
· | success of competitive products and services; |
· | changes in market valuations or earnings of our competitors; |
· | announcements of significant new products, contracts, acquisitions or strategic alliances by us or our competitors; |
· | the outcome of clinical trials involving the use of our products, including our sponsored trials; |
· | our continuing ability to list our securities on an established market or exchange; |
· | the timing and outcome of regulatory reviews and approvals of our products; |
· | the commencement or outcome of litigation involving our company, our general industry or both; |
· | changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; |
· | actual or expected sales of our common stock by the holders of our common stock; and |
· | the trading volume of our common stock. |
• | authorize our Board of Directors to issue without stockholder approval up to 5,000,000 shares of preferred stock, the rights of which will be determined at the discretion of the Board of Directors; |
• | require that stockholder actions must be effected at a duly called stockholder meeting and cannot be taken by written consent; |
• | establish advance notice requirements for stockholder nominations to our Board of Directors or for stockholder proposals that can be acted on at stockholder meetings; and |
• | limit who may call stockholder meetings. |
Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities |
High
|
Low
|
|||||||
2014
|
||||||||
Quarter ended March 31, 2014
|
$
|
3.47
|
$
|
2.44
|
||||
Quarter ended June 30, 2014
|
$
|
2.88
|
$
|
2.14
|
||||
Quarter ended September 30, 2014
|
$
|
2.52
|
$
|
0.66
|
||||
Quarter ended December 31, 2014
|
$
|
0.70
|
$
|
0.36
|
||||
2015
|
||||||||
Quarter ended March 31, 2015
|
$
|
1.37
|
$
|
0.44
|
||||
Quarter ended June 30, 2015
|
$
|
1.35
|
$
|
0.56
|
||||
Quarter ended September 30, 2015
|
$
|
0.55
|
$
|
0.30
|
||||
Quarter ended December 31, 2015
|
$
|
0.42
|
$
|
0.19
|
Plan Category
|
Number of securities to be issued upon exercise of outstanding options, warrants and rights
|
Weighted-average exercise price of outstanding options, warrants and rights
|
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column(a))
|
|||||||||
(a)
|
(b)
|
(c)
|
||||||||||
Equity compensation plans approved by security holders (1)
|
221,800
|
$
|
5.68
|
—
|
||||||||
Equity compensation plans not approved by security holders (2)
|
6,023,846
|
$
|
3.84
|
—
|
||||||||
Equity compensation plans not approved by security holders (3)
|
2,816,500
|
$
|
0.46
|
5,576,623
|
||||||||
Equity compensation plans not approved by security holders (4)
|
1,000,000
|
$
|
—
|
1,000,000
|
||||||||
Total
|
10,062,146
|
$
|
2.84
|
6,576,623
|
(1) | The 1997 Stock Option and Stock Purchase Plan expired in October 2007. |
(2) | The 2004 Stock Option and Stock Purchase Plan expired in August 2014. |
(3) | See Notes to the Consolidated Financial Statements included elsewhere herein for a description of our 2014 Equity Incentive Plan. |
(4) | See Notes to the Consolidated Financial Statements included elsewhere herein for a description of our 2015 New Employee Incentive Plan. |
For the year ended December 31
|
||||||||||||||||||||
2015
|
2014
|
2013
|
2012
|
2011
|
||||||||||||||||
Statements of Operations Data:
|
||||||||||||||||||||
Product revenues:
|
||||||||||||||||||||
Sales to related party
|
$
|
—
|
$
|
—
|
$
|
1,845
|
$
|
—
|
$
|
—
|
||||||||||
Sales to third parties
|
4,838
|
4,953
|
5,277
|
8,709
|
7,983
|
|||||||||||||||
4,838
|
4,953
|
7,122
|
8,709
|
7,983
|
||||||||||||||||
Cost of product revenues
|
3,186
|
2,940
|
3,421
|
4,000
|
3,837
|
|||||||||||||||
Gross profit
|
1,652
|
2,013
|
3,701
|
4,709
|
4,146
|
|||||||||||||||
Development revenues:
|
||||||||||||||||||||
Development, related party
|
—
|
—
|
638
|
2,882
|
1,992
|
|||||||||||||||
Development
|
—
|
—
|
1,179
|
2,529
|
—
|
|||||||||||||||
Government contracts and other
|
6,821
|
2,645
|
3,257
|
381
|
21
|
|||||||||||||||
6,821
|
2,645
|
5,074
|
5,792
|
2,013
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||||||
Research and development
|
19,000
|
15,105
|
17,065
|
13,628
|
10,904
|
|||||||||||||||
Sales and marketing
|
2,662
|
6,406
|
9,026
|
9,488
|
13,560
|
|||||||||||||||
General and administrative
|
9,765
|
15,953
|
16,031
|
15,672
|
14,727
|
|||||||||||||||
Change in fair value of warrants
|
(7,668
|
)
|
(369
|
)
|
(418
|
)
|
(209
|
)
|
(4,360
|
)
|
||||||||||
Change in fair value of option liabilities
|
—
|
—
|
(2,250
|
)
|
340
|
740
|
||||||||||||||
Total operating expenses
|
23,759
|
37,095
|
39,454
|
38,919
|
35,571
|
|||||||||||||||
Total operating loss
|
(15,286
|
)
|
(32,437
|
)
|
(30,679
|
)
|
(28,418
|
)
|
(29,412
|
)
|
||||||||||
Other income (expense):
|
||||||||||||||||||||
Gain (loss) on asset disposal
|
3
|
42
|
(257
|
)
|
—
|
—
|
||||||||||||||
Loss on debt extinguishment
|
(260
|
)
|
—
|
(708
|
)
|
—
|
—
|
|||||||||||||
Interest income
|
9
|
6
|
4
|
4
|
9
|
|||||||||||||||
Interest expense
|
(3,379
|
)
|
(4,371
|
)
|
(3,396
|
)
|
(3,386
|
)
|
(2,784
|
)
|
||||||||||
Other income (expense), net
|
169
|
(608
|
)
|
(438
|
)
|
(314
|
)
|
(55
|
)
|
|||||||||||
Gain on Puregraft divestiture
|
—
|
—
|
4,453
|
—
|
—
|
|||||||||||||||
Gain on previously held equity interest in JV
|
—
|
—
|
4,892
|
—
|
—
|
|||||||||||||||
Equity loss in investments
|
—
|
—
|
(48
|
)
|
(165
|
)
|
(209
|
)
|
||||||||||||
Net loss
|
$
|
(18,744
|
)
|
$
|
(37,368
|
)
|
$
|
(26,177
|
)
|
$
|
(32,279
|
)
|
$
|
(32,451
|
)
|
|||||
Beneficial conversion feature for convertible preferred stock
|
(661
|
)
|
(1,169
|
)
|
—
|
—
|
—
|
|||||||||||||
Net loss allocable to common stockholders
|
$
|
(19,405
|
)
|
$
|
(38,537
|
)
|
$
|
(26,177
|
)
|
$
|
(32,279
|
)
|
$
|
(32,451
|
)
|
|||||
Basic and diluted net loss per share allocable to common stockholders
|
$
|
(0.14
|
)
|
$
|
(0.48
|
)
|
$
|
(0.39
|
)
|
$
|
(0.55
|
)
|
$
|
(0.61
|
)
|
|||||
Basic and diluted weighted average shares used in calculating net loss per share allocable to common stockholders
|
140,797,316
|
80,830,698
|
67,781,364
|
58,679,687
|
53,504,030
|
|||||||||||||||
Statements of Cash Flows Data:
|
||||||||||||||||||||
Net cash used in operating activities
|
$
|
(20,468
|
)
|
$
|
(30,330
|
)
|
$
|
(34,563
|
)
|
$
|
(32,193
|
)
|
$
|
(35,323
|
)
|
|||||
Net cash provided by(used in) investing activities
|
(613
|
)
|
(1,343
|
)
|
3,686
|
(1,204
|
)
|
(560
|
)
|
|||||||||||
Net cash provided by financing activities
|
20,797
|
30,874
|
20,772
|
22,192
|
20,137
|
|||||||||||||||
Effect of exchange rate changes on cash and cash equivalents
|
—
|
(85
|
)
|
(106
|
)
|
—
|
—
|
|||||||||||||
Net decrease in cash
|
(284
|
)
|
(884
|
)
|
(10,211
|
)
|
(11,205
|
)
|
(15,746
|
)
|
||||||||||
Cash and cash equivalents at beginning of year
|
14,622
|
15,506
|
25,717
|
36,922
|
52,668
|
|||||||||||||||
Cash and cash equivalents at end of year
|
$
|
14,338
|
$
|
14,622
|
$
|
15,506
|
$
|
25,717
|
$
|
36,922
|
||||||||||
Balance Sheet Data:
|
||||||||||||||||||||
Cash, cash equivalents and short-term investments
|
$
|
14,338
|
$
|
14,622
|
$
|
15,506
|
$
|
25,717
|
$
|
36,922
|
||||||||||
Working capital
|
12,806
|
5,769
|
9,671
|
16,366
|
35,516
|
|||||||||||||||
Total assets
|
37,698
|
38,719
|
42,060
|
43,250
|
51,534
|
|||||||||||||||
Deferred revenues, related party
|
—
|
—
|
—
|
638
|
3,520
|
|||||||||||||||
Deferred revenues
|
105
|
112
|
212
|
2,635
|
5,244
|
|||||||||||||||
Warrant liabilities, long-term
|
—
|
9,793
|
—
|
—
|
627
|
|||||||||||||||
Option liabilities
|
—
|
—
|
—
|
2,250
|
1,910
|
|||||||||||||||
Long-term deferred rent
|
269
|
558
|
710
|
756
|
504
|
|||||||||||||||
Long-term obligations, less current portion
|
16,681
|
18,041
|
23,100
|
12,903
|
21,962
|
|||||||||||||||
Total stockholders’ equity (deficit)
|
$
|
12,206
|
$
|
(5,702
|
)
|
$
|
3,132
|
$
|
6,455
|
$
|
9,946
|
Years ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Related party
|
$
|
—
|
$
|
—
|
$
|
1,845,000
|
||||||
Third party
|
4,838,000
|
4,953,000
|
5,277,000
|
|||||||||
Total product revenues
|
$
|
4,838,000
|
$
|
4,953,000
|
$
|
7,122,000
|
Years ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Cost of product revenues
|
$
|
3,107,000
|
$
|
2,856,000
|
$
|
3,338,000
|
||||||
Share-based compensation
|
79,000
|
84,000
|
83,000
|
|||||||||
Total cost of product revenues
|
$
|
3,186,000
|
$
|
2,940,000
|
$
|
3,421,000
|
||||||
Total cost of product revenues as % of product revenues
|
66
|
%
|
59
|
%
|
48
|
%
|
Years ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Government contract (BARDA) and other
|
$
|
6,821,000
|
$
|
2,645,000
|
$
|
3,257,000
|
||||||
Development (Olympus)
|
—
|
—
|
638,000
|
|||||||||
Development (Senko)
|
—
|
—
|
1,179,000
|
|||||||||
Total development revenues
|
$
|
6,821,000
|
$
|
2,645,000
|
$
|
5,074,000
|
Years ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Research and development
|
$
|
18,442,000
|
$
|
14,527,000
|
$
|
16,444,000
|
||||||
Development milestone (Joint Venture)
|
—
|
—
|
16,000
|
|||||||||
Stock-based compensation
|
558,000
|
578,000
|
605,000
|
|||||||||
Total research and development expenses
|
$
|
19,000,000
|
$
|
15,105,000
|
$
|
17,065,000
|
Years ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Sales and marketing
|
$
|
2,552,000
|
$
|
5,946,000
|
$
|
8,329,000
|
||||||
Stock-based compensation
|
110,000
|
460,000
|
697,000
|
|||||||||
Total sales and marketing
|
$
|
2,662,000
|
$
|
6,406,000
|
$
|
9,026,000
|
Years ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
General and administrative
|
$
|
8,471,000
|
$
|
13,974,000
|
$
|
13,808,000
|
||||||
Stock-based compensation
|
1,294,000
|
1,979,000
|
2,223,000
|
|||||||||
Total general and administrative expenses
|
$
|
9,765,000
|
$
|
15,953,000
|
$
|
16,031,000
|
Years ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Cost of product revenues
|
$
|
79,000
|
$
|
84,000
|
$
|
83,000
|
||||||
Research and development related
|
558,000
|
578,000
|
605,000
|
|||||||||
Sales and marketing related
|
110,000
|
460,000
|
697,000
|
|||||||||
General and administrative related
|
1,294,000
|
1,979,000
|
2,223,000
|
|||||||||
Total stock-based compensation
|
$
|
2,041,000
|
$
|
3,101,000
|
$
|
3,608,000
|
Years ended December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Change in fair value of warrant liability
|
$
|
(7,668,000
|
)
|
$
|
(369,000
|
)
|
$
|
(418,000
|
)
|
Years ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Change in fair value of option liability
|
$
|
—
|
$
|
—
|
$
|
(2,250,000
|
)
|
Years ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Gain (loss) on asset disposal
|
$
|
3,000
|
$
|
42,000
|
$
|
(257,000
|
)
|
|||||
Loss on debt extinguishment
|
(260,000
|
)
|
—
|
(708,000
|
)
|
|||||||
Interest income
|
9,000
|
6,000
|
4,000
|
|||||||||
Interest expense
|
(3,379,000
|
)
|
(4,371,000
|
)
|
(3,396,000
|
)
|
||||||
Other income (expense), net
|
169,000
|
(608,000
|
)
|
(438,000
|
)
|
|||||||
Gain on Puregraft divestiture
|
—
|
—
|
4,453,000
|
|||||||||
Gain on previously held equity interest in joint venture
|
—
|
—
|
4,892,000
|
|||||||||
Equity loss from investment in joint venture
|
—
|
—
|
(48,000
|
)
|
||||||||
Beneficial conversion feature for convertible preferred stock
|
(661,000
|
)
|
(1,169,000
|
)
|
—
|
|||||||
Total
|
$
|
(4,119,000
|
)
|
$
|
(6,100,000
|
)
|
$
|
4,502,000
|
· | In connection with the May 2015 and June 2013 Loan Agreements, losses on debt extinguishment were recorded that relate to the payoff of the prior loan obligations. See Note 11 to the Consolidated Financial Statements for further information. |
· | Interest expense decreased for the year ended December 31, 2015 as compared to 2014, due to pay down and refinance of principal loan balance. |
· | Interest expense increased for the year ended December 31, 2014 as compared to 2013, due to cash interest and non-cash amortization of debt and warrant costs related to our $27.0 million Term Loan executed in June 2013, and increased accretion expense related to our Joint Venture liability. |
· | The changes in other income (expense) in 2015, 2014 and 2013 resulted primarily from changes in exchange rates related to transactions in foreign currency. |
· | Refer to Note 5 of the Notes to Consolidated Financial Statements for discussion of gain on Puregraft divestiture. |
· | Refer to Note 4 of the Notes to Consolidated Financial Statements for discussion of gain on previously held equity interest in joint venture. |
· | We recorded a beneficial conversion feature of $661,000 and $1,169,000 in December of 2015 and 2014, respectively, related to the issuance of our Series A 3.6% Convertible Preferred Stock. The fair value of the common stock into which the Series A 3.6% Preferred Stock was convertible on the respective dates of issuance of the preferred stock exceeded the proceeds allocated to the Series A 3.6% Convertible Preferred Stock, resulting in a beneficial conversion feature . |
As of December 31,
|
||||||||
2015
|
2014
|
|||||||
Cash and cash equivalents
|
$
|
14,338,000
|
$
|
14,622,000
|
||||
Current assets
|
$
|
21,243,000
|
$
|
21,686,000
|
||||
Current liabilities
|
8,437,000
|
15,917,000
|
||||||
Working capital
|
$
|
12,806,000
|
$
|
5,769,000
|
· | In January 2013, Lazard Capital Markets, LLC (underwriter) exercised its overallotment option and as a result we sold an additional 1,053,000 shares raising approximately $3.0 million in gross proceeds before deducting underwriting discounts and commissions and other offering expenses payable by us. |
· | On June 28, 2013 we entered into the Loan Agreement with Oxford Finance LLC and Silicon Valley Bank (together, the “Lenders”), pursuant to which the Lenders funded an aggregate principal amount of $27.0 million (the “Term Loan”), subject to the terms and conditions set forth in the loan agreement. The Term Loan accrues interest at a fixed rate of 9.75% per annum. In connection with the Term Loan, on June 28, 2013, we issued to the Lenders warrants to purchase up to an aggregate of 596,553 shares of our common stock at an exercise price of $2.26 per share. These warrants are immediately exercisable and will expire on June 28, 2020. In connection with the Loan Agreement, we prepaid all outstanding amounts under the prior loan agreement, at which time our obligations under the prior loan agreement immediately terminated. The net proceeds of the Term Loans, after payment of lender fees and expenses and prepaying all the outstanding amounts relating to the prior loan agreement, were approximately $7.8 million. |
· | On July 30, 2013, we entered into a Sale and Exclusive License/Supply Agreement with Bimini Technologies LLC (“Bimini”), pursuant to which we sold to Bimini substantially all of the assets (other than certain retained rights and licenses) of our Puregraft® product line, a series of standalone fat transplantation products that were developed to improve the predictability of outcomes for autologous fat grafting and aesthetic body contouring. The aggregate value of the consideration paid by Bimini at the execution of the agreement was $5.0 million. |
· | On October 29, 2013, we entered into a partnership with Lorem Vascular, to commercialize Cytori Cell Therapy (OICH-D3) for the cardiovascular, renal and diabetes markets, in China, Hong Kong, Malaysia, Singapore and Australia (the “License/Supply Agreement”), and a Common Stock Purchase Agreement. On January 30, 2014 we entered into the Amended and Restated License/Supply Agreement with Lorem Vascular (the “Restated Agreement”) expanding the licensed field to all uses excepting alopecia (hair loss). Under the Restated Agreement, Lorem Vascular committed to pay up to $500 million in license fees in the form of revenue milestones. In addition, Lorem is required to pay us 30% of their gross profits in China, Hong Kong and Malaysia for the term of the Restated Agreement. Cytori Cell Therapy is derived from our Celution® System, which enables access to a patient’s own adipose-derived regenerative cells (ADRCs) at the point-of-care. In addition, Lorem Vascular agreed to purchase our Celution® System and consumables under the Restated Agreement. Pursuant to the related Common Stock Purchase Agreement, we received $24.0 million in exchange for 8.0 million shares of our common stock issued to Lorem Vascular at $3.00 per share. The equity purchased was closed in two equal installments, in November 2013 and January 2014. |
· | In May 2014, we and 47 holders of warrants to purchase a total of 3,156,238 shares of our common stock issued in a private offering in May 2009, agreed to extend the expiration date of the warrants from May 14, 2014 to May 14, 2015 and increase the exercise price of the warrants from $2.62 per share to $3.50 per share pursuant to an Amendment to Warrant to Purchase Common Stock. One holder of warrants did not agree to the Amendment, and their warrants, covering 38,500 shares of Common Stock, expired unexercised on May 14, 2014 in accordance with the original terms. |
· | In May 2014, we entered into subscription agreements with certain institutional investors pursuant to which we sold a total of 4,048,584 units, with each unit consisting of one share of common stock and one warrant to purchase one share of common stock at a purchase price of $2.47 per unit, in a registered direct offering. Each warrant had an exercise price of $3.00 per share, was exercisable immediately after issuance and expires five years from the date of issuance. The transaction was completed on June 4, 2014 raising approximately $10.0 million in gross proceeds before deducting any offering expenses or fees payable by us. Under the terms of our Placement Agent Agreement, we granted WBB Securities, LLC warrants to purchase 202,429 shares of common stock. The placement agent warrants have the same terms as the warrants issued to the purchasers in the offering, except that such warrants have an exercise price of $3.09. |
· | In September 2014, we and 13 holders of warrants dated June 4, 2014 to purchase a total of 4,032,389 shares of our common stock agreed to amend the warrants in order to reduce the exercise price from $3.00 per share to $1.00 per share and change the expiration date from June 4, 2019 to September 10, 2014. We received proceeds of approximately $4.1 million from the exercise of the warrants. In addition, pursuant to the terms of the amendment, upon each holder’s exercise of all warrants for cash prior to the amended expiration date, we issued additional warrants for the same number of common shares to the holders. The additional warrants have an exercise price of $2.00 per share, and are exercisable on the date that is six months and one day from the date of issuance and expire five years from the date of issuance. For those investors participating in the October 2014 issuance of Series A 3.6% Convertible Preferred Stock, we agreed to reduce the exercise price of 3,384,601 warrants from $2.00 per share to $0.5771 per share, conditioned upon shareholder approval which was obtained in January 2015. |
· | In September 2014, we entered into a 2 nd Amendment to the Loan Agreement with the Lenders pursuant to the amended Loan Agreement, under which we were provided a conditional waiver of principal payments subject to meeting certain capital raise requirements, which we achieved in October. The waiver of principal payments continues from November 1, 2014 through April 1, 2015 and thereafter we are required to make payments of principal and accrued interest in equal monthly installments of $1.0 million, sufficient to amortize the Term Loans through the maturity date. |
· | In October, 2014, we entered into a Securities Purchase Agreement with certain institutional investors pursuant to which we sold a total of 13,500 units for a purchase price of $1,000 per unit, with each unit consisting of one share of our Series A 3.6% Convertible Preferred Stock, which was convertible into shares of our common stock with a conversion price of $0.52, and warrants to purchase up to a number of shares of common stock equal to 100% of the conversion shares under the shares of preferred stock, in a registered direct offering. Each warrant had an exercise price of $0.5771 per share, was exercisable six months after the date of issuance and expires five years from the date on which it is initially exercisable. The preferred stock and the warrants were immediately separable and were issued separately. As of December 31, 2015, all units had been converted into shares of common stock. |
· | On May 5, 2015, we entered into a Securities Purchase Agreement with certain institutional investors pursuant to which the Company agreed to sell up to $25 million of units, with each unit consisting of its common stock and one warrant to purchase one share of its common stock, in a registered direct offering. The purchase and sale of the units is took place in two separate closings. At the initial closing, which took place on May 8, 2015, the Company received approximately $17.7 million in net proceeds from the sale of units. The purchase price for each unit sold at the initial closing was $0.77. Each warrant issued as part of the units at the initial closing had an initial exercise price of $1.02 per share, and was exercisable during the period commencing six months and one day after the date of issuance and expiring five years from the date on which it was initially exercisable. The second closing of the purchase and sale of the units occurred on August 27, 2015 upon satisfaction of certain conditions, including, without limitation, stockholder vote, and the Company received approximately $2.2 million in net proceeds from the sale of 7,499,993 units of the 14,999,993 units available for sale at the second closing. The purchase price for each unit sold at the second closing was $0.3263 and each warrant issued had an initial exercise price of $0.401 and expire five years from the date of issuance. As of December 31, 2015, all units had been converted into shares of common stock. |
Payments due by period
|
||||||||||||||||||||
Contractual Obligations
|
Total
|
Less than 1
year
|
1 – 3 years
|
3 – 5 years
|
More than
5 years
|
|||||||||||||||
Long-term obligations
|
$
|
18,789,000
|
$
|
—
|
$
|
14,160,000
|
$
|
4,629,000
|
$
|
—
|
||||||||||
Interest commitment on long-term obligations
|
3,684,000
|
1,611,000
|
1,980,000
|
93,000
|
—
|
|||||||||||||||
Operating lease obligations
|
4,109,000
|
2,240,000
|
1,842,000
|
27,000
|
—
|
|||||||||||||||
Minimum purchase obligation
|
6,163,000
|
1,069,000
|
2,147,000
|
2,947,000
|
—
|
|||||||||||||||
Joint Venture purchase obligation*
|
1,750,000
|
1,750,000
|
—
|
—
|
—
|
|||||||||||||||
Clinical research study obligations
|
6,739,000
|
6,243,000
|
496,000
|
—
|
—
|
|||||||||||||||
Total
|
$
|
41,234,000
|
$
|
12,913,000
|
$
|
20,625,000
|
$
|
7,696,000
|
$
|
—
|
Years Ended
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Net cash used in operating activities
|
$
|
(20,468,000
|
)
|
$
|
(30,330,000
|
)
|
$
|
(34,563,000
|
)
|
|||
Net cash (used in) provided by investing activities
|
(613,000
|
)
|
(1,343,000
|
)
|
3,686,000
|
|||||||
Net cash provided by financing activities
|
20,797,000
|
30,874,000
|
20,772,000
|
· | initial consulting services; |
· | license rights and standard operating procedures; |
· | equipment and supplies; |
· | installation services; |
· | training services; |
· | database hosting services; |
· | technical support services; and |
· | maintenance services. |
Page
|
|
Reports of KPMG LLP, Independent Registered Public Accounting Firm
|
50
|
Consolidated Balance Sheets as of December 31, 2015 and 2014
|
52
|
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2015, 2014 and 2013
|
53
|
Consolidated Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2015, 2014 and 2013
|
54
|
Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2014 and 2013
|
55
|
Notes to Consolidated Financial Statements
|
57
|
Item 1.
|
Financial Statements
|
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
|
For the Years Ended December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Product revenues:
|
||||||||||||
Related party
|
$
|
—
|
$
|
—
|
$
|
1,845,000
|
||||||
Third party
|
4,838,000
|
4,953,000
|
5,277,000
|
|||||||||
4,838,000
|
4,953,000
|
7,122,000
|
||||||||||
Cost of product revenues
|
3,186,000
|
2,940,000
|
3,421,000
|
|||||||||
Gross profit
|
1,652,000
|
2,013,000
|
3,701,000
|
|||||||||
Development revenues:
|
||||||||||||
Development, related party
|
—
|
—
|
638,000
|
|||||||||
Development
|
—
|
—
|
1,179,000
|
|||||||||
Government contracts and other
|
6,821,000
|
2,645,000
|
3,257,000
|
|||||||||
6,821,000
|
2,645,000
|
5,074,000
|
||||||||||
Operating expenses:
|
||||||||||||
Research and development
|
19,000,000
|
15,105,000
|
17,065,000
|
|||||||||
Sales and marketing
|
2,662,000
|
6,406,000
|
9,026,000
|
|||||||||
General and administrative
|
9,765,000
|
15,953,000
|
16,031,000
|
|||||||||
Change in fair value of warrants
|
(7,668,000
|
)
|
(369,000
|
)
|
(418,000
|
)
|
||||||
Change in fair value of option liability
|
—
|
—
|
(2,250,000
|
)
|
||||||||
Total operating expenses
|
23,759,000
|
37,095,000
|
39,454,000
|
|||||||||
Operating loss
|
(15,286,000
|
)
|
(32,437,000
|
)
|
(30,679,000
|
)
|
||||||
Other income (expense):
|
||||||||||||
Gain (loss) on asset disposal
|
3,000
|
42,000
|
(257,000
|
)
|
||||||||
Loss on debt extinguishment
|
(260,000
|
)
|
—
|
(708,000
|
)
|
|||||||
Interest income
|
9,000
|
6,000
|
4,000
|
|||||||||
Interest expense
|
(3,379,000
|
)
|
(4,371,000
|
)
|
(3,396,000
|
)
|
||||||
Other income (expense), net
|
169,000
|
(608,000
|
)
|
(438,000
|
)
|
|||||||
Gain on Puregraft divestiture
|
—
|
—
|
4,453,000
|
|||||||||
Gain on previously held equity interest in joint venture
|
—
|
—
|
4,892,000
|
|||||||||
Equity loss from investment in joint venture
|
—
|
—
|
(48,000
|
)
|
||||||||
Total other income (expense)
|
(3,458,000
|
)
|
(4,931,000
|
)
|
4,502,000
|
|
||||||
Net loss
|
(18,744,000
|
)
|
(37,368,000
|
)
|
(26,177,000
|
)
|
||||||
Beneficial conversion feature for convertible preferred stock
|
(661,000
|
)
|
(1,169,000
|
)
|
—
|
|||||||
Net loss allocable to common stockholders
|
(19,405,000
|
)
|
(38,537,000
|
)
|
(26,177,000
|
)
|
||||||
Basic and diluted net loss per share allocable to common stockholders
|
$
|
(0.14
|
)
|
$
|
(0.48
|
)
|
$
|
(0.39
|
)
|
|||
Basic and diluted weighted average shares used in calculating net loss per share allocable to common stockholders
|
140,797,316
|
80,830,698
|
67,781,364
|
|||||||||
Comprehensive loss:
|
||||||||||||
Net loss
|
$
|
(18,744,000
|
)
|
$
|
(37,368,000
|
)
|
$
|
(26,177,000
|
)
|
|||
Other comprehensive income – foreign currency translation adjustments
|
296,000
|
444,000
|
256,000
|
|||||||||
Comprehensive loss
|
$
|
(18,448,000
|
)
|
$
|
(36,924,000
|
)
|
$
|
(25,921,000
|
)
|
Convertible Preferred Stock
|
Common Stock
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Accumulated
Other
Comprehensive
Income (Loss)
|
Total
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||
Balance at December 31, 2012
|
—
|
—
|
65,914,050
|
$
|
66,000
|
$
|
281,117,000
|
$
|
(274,728,000
|
)
|
—
|
$
|
6,455,000
|
|||||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
—
|
—
|
$
|
3,608,000
|
—
|
—
|
$
|
3,608,000
|
||||||||||||||||||||||
Issuance of common stock under stock option plan and employee stock purchase plan
|
—
|
—
|
338,325
|
—
|
$
|
225,000
|
—
|
—
|
$
|
225,000
|
||||||||||||||||||||||
Sale of common stock, net
|
—
|
—
|
5,053,000
|
$
|
5,000
|
$
|
17,811,000
|
—
|
—
|
$
|
17,816,000
|
|||||||||||||||||||||
Allocation of fair value for debt-related warrants
|
—
|
—
|
—
|
—
|
$
|
949,000
|
—
|
—
|
$
|
949,000
|
||||||||||||||||||||||
Accumulated other comprehensive income (loss)
|
—
|
—
|
—
|
—
|
—
|
—
|
$
|
256,000
|
$
|
256,000
|
||||||||||||||||||||||
Net loss for the year ended December 31, 2013
|
—
|
—
|
—
|
—
|
—
|
$
|
(26,177,000
|
)
|
—
|
$
|
(26,177,000
|
)
|
||||||||||||||||||||
Balance at December 31, 2013
|
—
|
—
|
71,305,375
|
$
|
71,000
|
$
|
303,710,000
|
$
|
(300,905,000
|
)
|
$
|
256,000
|
$
|
3,132,000
|
||||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
—
|
—
|
$
|
3,101,000
|
—
|
—
|
$
|
3,101,000
|
||||||||||||||||||||||
Issuance of common stock under stock option plan and employee stock purchase plan
|
—
|
—
|
204,288
|
—
|
$
|
92,000
|
—
|
—
|
$
|
92,000
|
||||||||||||||||||||||
Sale of common stock, net
|
—
|
—
|
8,048,584
|
$
|
8,000
|
$
|
18,582,000
|
—
|
—
|
$
|
18,590,000
|
|||||||||||||||||||||
Issuance of Series A 3.6% Convertible Preferred Stock, net
|
13,500
|
—
|
—
|
—
|
$
|
2,235,000
|
—
|
—
|
$
|
2,235,000
|
||||||||||||||||||||||
Conversion of Series A 3.6% Convertible Preferred Stock into common stock
|
(8,189
|
)
|
—
|
15,747,397
|
$
|
16,000
|
—
|
—
|
—
|
$
|
16,000
|
|||||||||||||||||||||
Issuance of common stock under stock warrant agreement
|
—
|
—
|
4,042,733
|
$
|
4,000
|
$
|
4,052,000
|
—
|
—
|
$
|
4,056,000
|
|||||||||||||||||||||
Accumulated other comprehensive income (loss)
|
—
|
—
|
—
|
—
|
—
|
—
|
$
|
444,000
|
$
|
444,000
|
||||||||||||||||||||||
Net loss for the year ended December 31, 2014
|
—
|
—
|
—
|
—
|
—
|
$
|
(37,368,000
|
)
|
—
|
$
|
(37,368,000
|
)
|
||||||||||||||||||||
Balance at December 31, 2014
|
5,311
|
—
|
99,348,377
|
$
|
99,000
|
$
|
331,772,000
|
$
|
(338,273,000
|
)
|
$
|
700,000
|
$
|
(5,702,000
|
)
|
|||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
—
|
—
|
$
|
2,041,000
|
—
|
—
|
$
|
2,041,000
|
||||||||||||||||||||||
Issuance of common stock under stock option plan and employee stock purchase plan
|
231,558
|
—
|
27,000
|
$
|
27,000
|
|||||||||||||||||||||||||||
Conversion of Series A 3.6% Convertible Preferred Stock into common stock
|
(5,311
|
)
|
—
|
10,214,143
|
$
|
10,000
|
$
|
(12,000
|
)
|
—
|
—
|
$
|
(2,000
|
)
|
||||||||||||||||||
Issuance of common stock under stock warrant agreement, net
|
—
|
—
|
46,853,649
|
$
|
47,000
|
$
|
22,766,000
|
—
|
—
|
$
|
22,813,000
|
|||||||||||||||||||||
Sale of common stock, net
|
—
|
—
|
38,410,668
|
$
|
39,000
|
$
|
10,662,000
|
—
|
—
|
$
|
10,701,000
|
|||||||||||||||||||||
Allocation of fair value for debt-related warrants
|
—
|
—
|
—
|
—
|
$
|
776,000
|
—
|
—
|
$
|
776,000
|
||||||||||||||||||||||
Accumulated other comprehensive income (loss)
|
—
|
—
|
—
|
—
|
—
|
—
|
$
|
296,000
|
$
|
296,000
|
||||||||||||||||||||||
Net loss for the year ended December 31, 2015
|
—
|
—
|
—
|
—
|
—
|
$
|
(18,744,000
|
)
|
—
|
$
|
(18,744,000
|
)
|
||||||||||||||||||||
Balance at December 31, 2015
|
—
|
—
|
195,058,395
|
$
|
195,000
|
$
|
368,032,000
|
$
|
(357,017,000
|
)
|
$
|
996,000
|
$
|
12,206,000
|
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
|
For the Years Ended December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Supplemental disclosure of cash flows information:
|
||||||||||||
Cash paid during period for:
|
||||||||||||
Interest
|
$
|
1,994,000
|
$
|
2,588,000
|
$
|
2,252,000
|
||||||
Final payment fee on long-term debt
|
1,839,000
|
—
|
1,078,000
|
|||||||||
Supplemental schedule of non-cash investing and financing activities:
|
||||||||||||
Conversion of preferred stock into common stock
|
$ |
10,000
|
$
|
16,000
|
$
|
—
|
||||||
Declared dividend related to preferred stock
|
3,000
|
72,000
|
—
|
|||||||||
Fair value of warrants allocated to additional paid-in capital
|
776,000
|
—
|
949,000
|
|||||||||
Fair value of intangible assets acquired
|
—
|
—
|
9,394,000
|
|||||||||
Fair value of tangible assets acquired
|
—
|
—
|
260,000
|
|||||||||
Joint venture purchase obligation
|
—
|
—
|
4,709,000
|
|||||||||
Fair value of previously held equity interest at acquisition date
|
—
|
—
|
4,928,000
|
1. | Organization and Operations |
2. | Summary of Significant Accounting Policies |
December 31, 2015
|
||||
Other intangibles, net:
|
||||
Beginning balance
|
$
|
9,415,000
|
||
Increase
|
13,000
|
|||
Amortization
|
(397,000
|
)
|
||
Ending balance
|
9,031,000
|
|||
Goodwill, net:
|
||||
Beginning balance
|
3,922,000
|
|||
Increase (decrease)
|
—
|
|||
Ending balance
|
3,922,000
|
|||
Total goodwill and other intangibles, net
|
$
|
12,953,000
|
December 31, 2014
|
||||
Other intangibles, net:
|
||||
Beginning balance
|
$
|
9,345,000
|
||
Acquisition of JV Intangible
|
255,000
|
|||
Amortization
|
(185,000
|
)
|
||
Ending balance
|
9,415,000
|
|||
Goodwill, net:
|
||||
Beginning balance
|
3,922,000
|
|||
Increase (decrease)
|
—
|
|||
Ending balance
|
3,922,000
|
|||
Total goodwill and other intangibles, net
|
$
|
13,337,000
|
As of
December 31, 2014
|
||||
October 2014 Warrants
|
||||
Expected term
|
5.3 years
|
|||
Common stock market price
|
$
|
0.49
|
||
Risk-free interest rate
|
1.65
|
%
|
||
Expected volatility
|
90.00
|
%
|
||
Resulting fair value (per warrant)
|
$
|
0.38
|
● | initial consulting services; |
● | license rights and standard operating procedures; |
● | equipment and supplies; |
● | installation services; |
● | training services; |
● | database hosting services; |
● | technical support services; and |
● | maintenance services. |
Years ended
|
||||||||||||||||||||||||
2015
|
2014
|
2013
|
||||||||||||||||||||||
Product
Revenues
|
% of
Total
|
Product
Revenues
|
% of
Total
|
Product
Revenues
|
% of
Total
|
|||||||||||||||||||
Americas
|
$
|
982,000
|
20
|
%
|
$
|
1,224,000
|
25
|
%
|
$
|
1,152,000
|
16
|
%
|
||||||||||||
Japan
|
2,394,000
|
50
|
%
|
3,068,000
|
62
|
%
|
1,450,000
|
21
|
%
|
|||||||||||||||
Europe
|
675,000
|
14
|
%
|
649,000
|
13
|
%
|
1,948,000
|
27
|
%
|
|||||||||||||||
Asia Pacific
|
787,000
|
16
|
%
|
12,000
|
0
|
%
|
2,572,000
|
36
|
%
|
|||||||||||||||
Total product revenues
|
$
|
4,838,000
|
100
|
%
|
$
|
4,953,000
|
100
|
%
|
$
|
7,122,000
|
100
|
%
|
3. | Agreement with Lorem Vascular |
4. | Transactions with Olympus Corporation |
Useful Life
(in years)
|
Estimated
Fair Value
|
|||||||
Intangible assets:
|
||||||||
Developed technology
|
7
|
$
|
9,394,000
|
Estimated
Fair Value
|
||||
Current assets
|
$
|
236
|
||
Property and equipment
|
260
|
|||
Intangible assets
|
9,394
|
|||
Total assets acquired
|
9,890
|
|||
Accrued and other current liabilities
|
(33
|
)
|
||
Total fair value of the Joint Venture
|
$
|
9,857
|
5. | Sale and Exclusive License/Supply Agreement with Bimini Technologies |
6.
|
Fair Value Measurements
|
Balance as of
|
Basis of Fair Value Measurements
|
|||||||||||||||
December 31, 2014
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash equivalents
|
$
|
8,144,000
|
$
|
8,144,000
|
$
|
—
|
$
|
—
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant liability
|
$
|
9,793,000
|
$
|
—
|
$
|
—
|
$
|
9,793,000
|
Warrant liability
|
December 31, 2015
|
December 31, 2014
|
||||||
Beginning balance
|
$
|
9,793,000
|
$
|
—
|
||||
Additions to warrant liability
|
15,979,000
|
10,162,000
|
||||||
Exercised warrants
|
(18,104,000
|
)
|
—
|
|||||
Change in fair value
|
(7,668,000
|
)
|
(369,000
|
)
|
||||
Ending balance
|
$
|
—
|
$
|
9,793,000
|
7.
|
Fair Value
|
December 31, 2015
|
December 31, 2014
|
|||||||||||||||
Fair Value
|
Carrying Value
|
Fair Value
|
Carrying Value
|
|||||||||||||
Fixed rate long-term debt
|
$
|
16,844,000
|
$
|
16,681,000
|
$
|
25,206,000
|
$
|
25,373,000
|
8.
|
Thin Film Japan Distribution Agreement
|
9. | Composition of Certain Financial Statement Captions |
December 31,
|
||||||||
2015
|
2014
|
|||||||
Raw materials
|
$
|
1,009,000
|
$
|
1,715,000
|
||||
Work in process
|
816,000
|
1,301,000
|
||||||
Finished goods
|
2,473,000
|
1,813,000
|
||||||
$
|
4,298,000
|
$
|
4,829,000
|
December 31,
|
||||||||
2015
|
2014
|
|||||||
Prepaid insurance
|
$
|
300,000
|
$
|
200,000
|
||||
Prepaid supplies and other, current
|
995,000
|
675,000
|
||||||
Other receivables
|
260,000
|
117,000
|
||||||
$
|
1,555,000
|
$
|
992,000
|
December 31,
|
||||||||
2015
|
2014
|
|||||||
Manufacturing and development equipment
|
$
|
5,464,000
|
$
|
5,674,000
|
||||
Office and computer equipment
|
1,939,000
|
2,006,000
|
||||||
Leasehold improvements
|
3,391,000
|
3,271,000
|
||||||
10,794,000
|
10,951,000
|
|||||||
Less accumulated depreciation and amortization
|
(9,163,000
|
)
|
(9,368,000
|
)
|
||||
$
|
1,631,000
|
$
|
1,583,000
|
December 31,
|
||||||||
2015
|
2014
|
|||||||
Deposits
|
$
|
525,000
|
$
|
540,000
|
||||
Prepaid supplies, long-term
|
996,000
|
1,223,000
|
||||||
$
|
1,521,000
|
$
|
1,763,000
|
December 31,
|
||||||||
2015
|
2014
|
|||||||
Accrued legal fees
|
$
|
372,000
|
$
|
544,000
|
||||
Accrued R&D studies
|
1,117,000
|
273,000
|
||||||
Accounts payable
|
1,009,000
|
949,000
|
||||||
Accrued vacation
|
573,000
|
577,000
|
||||||
Accrued payroll and bonus
|
1,058,000
|
876,000
|
||||||
Accrued expenses
|
2,022,000
|
2,006,000
|
||||||
Deferred rent
|
221,000
|
191,000
|
||||||
Accrued accounting fees
|
315,000
|
130,000
|
||||||
$
|
6,687,000
|
$
|
5,546,000
|
10.
|
Commitments and Contingencies
|
Years Ending December 31,
|
Operating
Leases
|
|||
2016
|
$
|
2,240,000
|
||
2017
|
1,789,000
|
|||
2018
|
53,000
|
|||
2019
|
27,000
|
|||
Total
|
$
|
4,109,000
|
Years Ending December 31,
|
Minimum
Purchase
Obligation
|
|||
2016
|
$
|
1,069,000
|
||
2017
|
1,074,000
|
|||
2018
|
1,074,000
|
|||
2019
|
1,473,000
|
|||
2020
|
1,473,000
|
|||
Total
|
$
|
6,163,000
|
11. | Long-term Obligations |
Origination Date
|
Original Loan
Amount
|
Interest
Rate**
|
Current
Monthly
Payment*
|
Original Term
|
Remaining
Principal
(Face Value)
|
||||||||||||
May 2015
|
$
|
17,700,000
|
8.95
|
%
|
$
|
136,413
|
48 Months
|
$
|
17,700,000
|
Origination Date
|
Original Loan
Amount
|
Interest
Rate
|
Current
Monthly
Payment*
|
Original Term
|
Remaining
Principal
(Face Value)
|
||||||||||||
June 2013
|
$
|
27,000,000
|
9.75
|
%
|
$
|
203,434
|
48 Months
|
$
|
25,038,125
|
*
|
Current monthly payment is inclusive of interest only
|
** | 3 month LIBOR rate with a floor of 1% plus 7.95% |
Years Ending December 31,
|
||||
2016
|
$
|
—
|
||
2017
|
7,080,000
|
|||
2018
|
7,080,000
|
|||
2019
|
4,629,000
|
|||
Total
|
$
|
18,789,000
|
12. | Income Taxes |
2015
|
2014
|
2013
|
||||||||||
Income tax expense (benefit) at federal statutory rate
|
(34.00
|
)%
|
(34.00
|
)%
|
(34.00
|
)%
|
||||||
Income tax expense (benefit) at state statutory rate
|
(4.40
|
)%
|
(3.52
|
)%
|
(3.54
|
)%
|
||||||
Gain on previously held equity interest in joint venture
|
0.00
|
%
|
0.00
|
%
|
(7.02
|
)%
|
||||||
Mark to market permanent adjustment
|
(13.91
|
)%
|
(0.37
|
)%
|
(2.15
|
)%
|
||||||
Change in valuation allowance
|
(7.45
|
)%
|
27.12
|
%
|
80.13
|
%
|
||||||
Change in state rate
|
(0.09
|
)%
|
0.02
|
%
|
(1.01
|
)%
|
||||||
Permanent interest adjustments
|
6.25
|
%
|
4.17
|
%
|
0.00
|
%
|
||||||
Stock compensation
|
20.43
|
%
|
0.00
|
%
|
0.00
|
%
|
||||||
Transfer pricing
|
18.49
|
%
|
0.00
|
%
|
0.00
|
%
|
||||||
Debt refinance permanent adjustment
|
0.00
|
%
|
3.92
|
%
|
0.00
|
%
|
||||||
Acquired NOL’s/Intangibles from joint venture
|
0.00
|
%
|
0.00
|
%
|
(33.40
|
)%
|
||||||
Research credit
|
(2.37
|
)%
|
(0.74
|
)%
|
(3.75
|
)%
|
||||||
Foreign rate differential
|
0.69
|
%
|
0.00
|
%
|
2.48
|
%
|
||||||
NOLs expiring and adjustments to NOL
|
13.92
|
%
|
0.00
|
%
|
0.00
|
%
|
||||||
Other, net
|
2.44
|
%
|
3.40
|
%
|
2.26
|
%
|
||||||
0.00
|
%
|
0.00
|
%
|
0.00
|
%
|
2015
|
2014
|
|||||||
Deferred tax assets:
|
||||||||
Allowances and reserves
|
$
|
673,000
|
$
|
825,000
|
||||
Accrued expenses
|
951,000
|
502,000
|
||||||
Deferred revenue and gain-on-sale
|
39,000
|
32,000
|
||||||
Stock based compensation
|
4,547,000
|
7,786,000
|
||||||
Net operating loss carryforwards
|
119,000,000
|
117,258,000
|
||||||
Income tax credit carryforwards
|
7,437,000
|
6,993,000
|
||||||
Property and equipment, principally due to differences in depreciation
|
683,000
|
926,000
|
||||||
Other,net
|
16,000
|
77,000
|
||||||
133,346,000
|
134,399,000
|
|||||||
Valuation allowance
|
(131,187,000
|
)
|
(132,583,000
|
)
|
||||
Total deferred tax assets, net of allowance
|
2,159,000
|
1,816,000
|
||||||
Deferred tax liabilities:
|
||||||||
Intangibles
|
(2,159,000
|
)
|
(1,816,000
|
)
|
||||
Total deferred tax liability
|
(2,159,000
|
)
|
(1,816,000
|
)
|
||||
Net deferred tax assets (liability)
|
$
|
—
|
$
|
—
|
2015
|
2014
|
2013
|
||||||||||
Unrecognized Tax Benefits – Beginning
|
$
|
1,852,000
|
$
|
1,723,000
|
$
|
1,394,000
|
||||||
Gross increases – tax positions in prior period
|
—
|
—
|
69,000
|
|||||||||
Gross decreases – tax positions in prior period
|
—
|
—
|
—
|
|||||||||
Gross increase – current-period tax positions
|
135,000
|
129,000
|
260,000
|
|||||||||
Settlements
|
—
|
—
|
—
|
|||||||||
Lapse of statute of limitations
|
—
|
—
|
—
|
|||||||||
Unrecognized Tax Benefits – Ending
|
$
|
1,987,000
|
$
|
1,852,000
|
$
|
1,723,000
|
13. | Employee Benefit Plan |
14. | Stockholders’ Equity |
15. | Stock-based Compensation |
● | 12/48 of a granted award will vest after one year of service, while an additional 1/48 of the award will vest at the end of each month thereafter for 36 months, or |
● | 1/48 of the award will vest at the end of each month over a four-year period. |
Options
|
Weighted
Average
Exercise Price
|
|||||||
Balance as of January 1, 2015
|
9,115,348
|
$
|
3.93
|
|||||
Granted
|
2,168,000
|
$
|
0.46
|
|||||
Exercised
|
—
|
$
|
—
|
|||||
Expired
|
(445,151
|
)
|
$
|
3.85
|
||||
Cancelled/forfeited
|
(2,232,292
|
)
|
$
|
4.23
|
||||
Balance as of December 31, 2015
|
8,605,905
|
$
|
2.99
|
Options
|
Weighted
Average
Exercise Price
|
Weighted
Average
Remaining
Contractual
Term (years)
|
Aggregate
Intrinsic Value
|
|||||||||||||
Balance as of December 31, 2015
|
8,605,905
|
$
|
2.99
|
6.69
|
$
|
—
|
||||||||||
Vested and expected to vest at December 31, 2015
|
8,470,861
|
$
|
3.02
|
6.65
|
$
|
—
|
||||||||||
Exercisable at December 31, 2015
|
5,368,247
|
$
|
4.04
|
5.39
|
$
|
—
|
Years ended December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Expected term
|
6.0 years
|
6.0 years
|
6.0 years
|
|||||||||
Risk-free interest rate
|
1.58
|
%
|
1.86
|
%
|
1.12
|
%
|
||||||
Volatility
|
75.07
|
%
|
77.52
|
%
|
75.27
|
%
|
||||||
Dividends
|
—
|
—
|
—
|
|||||||||
Resulting weighted average grant date fair value
|
$
|
0.30
|
$
|
1.35
|
$
|
1.72
|
Restricted
Stock Awards
|
Weighted
Average Grant
Date Fair Value
|
|||||||
Balance as of January 1, 2015
|
199,223
|
$
|
3.09
|
|||||
Granted
|
541,377
|
$
|
0.68
|
|||||
Exercised/Released
|
(152,682
|
)
|
$
|
3.13
|
||||
Expired
|
(108,877
|
)
|
$
|
0.73
|
||||
Cancelled/forfeited
|
(11,100
|
)
|
$
|
1.84
|
||||
Balance as of December 31, 2015
|
467,941
|
$
|
0.81
|
Restricted
Stock Awards
|
Weighted
Average Grant
Date Fair Value
|
Weighted
Average
Remaining
Contractual
Term (years)
|
||||||||||
Balance as of December 31, 2015
|
467,941
|
$
|
0.81
|
0.94
|
||||||||
Vested and expected to vest at December 31, 2015
|
279,897
|
$
|
0.90
|
1.21
|
||||||||
Outstanding at December 31, 2015
|
18,241
|
$
|
3.21
|
6.82
|
Years ended December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Total compensation cost for share-based payment arrangements recognized in the statement of operations (net of tax of $0)
|
$
|
2,041,000
|
$
|
3,101,000
|
$
|
3,608,000
|
16.
|
Related Party Transactions
|
17.
|
Quarterly Information (unaudited)
|
For the three months ended
|
||||||||||||||||
March 31,
2015
|
June 30,
2015
|
September 30,
2015
|
December 31,
2015
|
|||||||||||||
Product revenues
|
$
|
902,000
|
$
|
1,614,000
|
$
|
766,000
|
$
|
1,556,000
|
||||||||
Gross profit
|
305,000
|
318,000
|
264,000
|
765,000
|
||||||||||||
Development revenues
|
1,444,000
|
1,847,000
|
1,710,000
|
1,820,000
|
||||||||||||
Operating expenses
|
(22,745,000
|
)
|
3,626,000
|
16,000
|
(4,656,000
|
)
|
||||||||||
Other income (expense)
|
(961,000
|
)
|
(1,342,000
|
)
|
(470,000
|
)
|
(685,000
|
)
|
||||||||
Net income (loss)
|
$
|
(21,957,000
|
)
|
$
|
4,449,000
|
$
|
1,520,000
|
$
|
(2,756,000
|
)
|
||||||
Beneficial conversion feature for convertible preferred stock
|
(661,000
|
)
|
—
|
—
|
—
|
|||||||||||
Net income (loss) allocable to common stock holders
|
(22,618,000
|
)
|
4,449,000
|
1,520,000
|
(2,756,000
|
)
|
||||||||||
Basic and diluted net loss per share
|
$
|
(0.21
|
)
|
$
|
0.03
|
$
|
0.01
|
$
|
(0.02
|
)
|
For the three months ended
|
||||||||||||||||
March 31,
2014
|
June 30,
2014
|
September 30,
2014
|
December 31,
2014
|
|||||||||||||
Product revenues
|
$
|
1,031,000
|
$
|
935,000
|
$
|
518,000
|
$
|
2,469,000
|
||||||||
Gross profit
|
610,000
|
169,000
|
181,000
|
1,053,000
|
||||||||||||
Development revenues
|
403,000
|
356,000
|
585,000
|
1,301,000
|
||||||||||||
Operating expenses
|
(10,560,000
|
)
|
(11,210,000
|
)
|
(8,656,000
|
)
|
(6,669,000
|
)
|
||||||||
Other income (expense)
|
(853,000
|
)
|
(1,143,000
|
)
|
(1,495,000
|
)
|
(1,440,000
|
)
|
||||||||
Net loss
|
$
|
(10,400,000
|
)
|
$
|
(11,828,000
|
)
|
$
|
(9,385,000
|
)
|
$
|
(5,755,000
|
)
|
||||
Beneficial conversion feature for convertible preferred stock
|
—
|
—
|
—
|
(1,169,000
|
)
|
|||||||||||
Net loss allocable to common stock holders
|
(10,400,000
|
)
|
(11,828,000
|
)
|
(9,385,000
|
)
|
(6,924,000
|
)
|
||||||||
Basic and diluted net loss per share
|
$
|
(0.14
|
)
|
$
|
(0.15
|
)
|
$
|
(0.12
|
)
|
$
|
(0.08
|
)
|
18. | Subsequent Events |
(a) | Evaluation of Disclosure Controls and Procedures |
(b) | Management’s Report on Internal Control Over Financial Reporting |
● | Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; |
● | Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures are being made only in accordance with authorizations of management and our Board of Directors; and |
● | Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. |
(c) | Changes in Internal Control over Financial Reporting |
Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
(a) (1)
|
Financial Statements
|
Page
|
|
Reports of KPMG LLP, Independent Registered Public Accounting Firm
|
51
|
||
Consolidated Balance Sheets as of December 31, 2015 and 2014
|
53
|
||
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2015, 2014 and 2013
|
54
|
||
Consolidated Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2015, 2014 and 2013
|
55
|
||
Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2014 and 2013
|
57
|
||
Notes to Consolidated Financial Statements
|
59
|
(a) (2)
|
Financial Statement Schedules
|
Balance at
beginning of
year
|
Additions (A)
|
Deductions (B)
|
Other (C)
|
Balance at
end of year
|
||||||||||||||||
Allowance for doubtful accounts
|
||||||||||||||||||||
Year ended December 31, 2015
|
$
|
1,523
|
$
|
—
|
$
|
(709
|
)
|
$
|
(17
|
)
|
$
|
797
|
||||||||
Year ended December 31, 2014
|
$
|
1,445
|
$
|
1,084
|
$
|
(995
|
)
|
$
|
(11
|
)
|
$
|
1,523
|
||||||||
Year ended December 31, 2013
|
$
|
278
|
$
|
1,141
|
$
|
(16
|
)
|
$
|
42
|
$
|
1,445
|
(A) | Includes charges to costs and expenses. |
(B) | Deductions for uncollectible accounts receivable includes payments collected and devices recovered from customers. |
(C) | Miscellaneous activity. |
(a) (3)
|
Exhibits |
(b)
|
Exhibits |
CYTORI THERAPEUTICS, INC.
|
||
By:
|
/s/ Marc H. Hedrick, MD
|
|
Marc. H. Hedrick, MD
|
||
President & Chief Executive Officer
|
||
March 11, 2016
|
SIGNATURE
|
TITLE
|
DATE
|
||
/s/ David M. Rickey
|
Chairman of the Board of Directors
|
March 11, 2016
|
||
David M. Rickey
|
||||
/s/ Marc H. Hedrick, MD
|
President & Chief Executive Officer (Principal Executive Officer)
|
March 11, 2016
|
||
Marc H. Hedrick, MD
|
||||
/s/ Tiago M. Girão
|
VP of Finance and Chief Financial Officer (Principal Financial Officer)
|
March 11, 2016
|
||
Tiago M. Girão
|
||||
/s/ Paul W. Hawran
|
Director
|
March 11, 2016
|
||
Paul W. Hawran
|
||||
/s/ Gail K. Naughton, PhD
|
Director
|
March 11, 2016
|
||
Gail K. Naughton, PhD
|
||||
/s/ Richard J. Hawkins
|
Director
|
March 11, 2016
|
||
Richard J. Hawkins
|
||||
/s/ Tommy G. Thompson
|
Director
|
March 11, 2016
|
||
Tommy G. Thompson
|
/s/ Gary A. Lyons
|
Director
|
March 11, 2016
|
||
Gary A. Lyons
|
CYTORI THERAPEUTICS, INC.
|
|||||
Exhibit Number
|
Exhibit Title
|
Filed with this Form 10-K
|
Incorporated by Reference
|
||
Form
|
File No.
|
Date Filed
|
|||
Composite Certificate of Incorporation.
|
X
|
||||
3.2
|
Amended and Restated Bylaws of Cytori Therapeutics, Inc.
|
10-Q
|
000-32501
Exhibit 3.2
|
08/14/2003
|
|
3.3
|
Amendment to Amended and Restated Bylaws of Cytori Therapeutics, Inc.
|
8-K
|
001-34375
|
05/06/2014
|
|
3.4
|
Certificate of Designation of Preferences, Rights and Limitations of Series A 3.6% Convertible Preferred Stock
|
8-K
|
001-034375
|
10/08/2014
|
|
4.1
|
Warrant to Purchase Common Stock issued by the Company on October 14, 2008 in favor of Silicon Valley Bank, pursuant to the Loan and Security Agreement dated October 14, 2008.
|
10-K
|
000-32501
Exhibit 10.62
|
03/06/2009
|
|
4.2
|
Warrant to Purchase Common Stock issued by the Company on June 11, 2010 in favor of GE Capital Equity Investments, Inc., pursuant to the Amended and Restated Loan and Security Agreement dated June 11, 2010.
|
8-K
|
001-34375
Exhibit 10.73
|
06/17/2010
|
|
4.3
|
Warrant to Purchase Common Stock issued by the Company on June 11, 2010 in favor of Silicon Valley Bank, pursuant to the Amended and Restated Loan and Security Agreement dated June 11, 2010.
|
8-K
|
001-34375
Exhibit 10.74
|
06/17/2010
|
|
4.4
|
Warrant to Purchase Common Stock issued by the Company on June 11, 2010 in favor of Oxford Financial Corporation, pursuant to the Amended and Restated Loan and Security Agreement dated June 11, 2010.
|
8-K
|
001-34375
Exhibit 10.75
|
06/17/2010
|
|
4.5
|
Warrant to Purchase Common Stock issued by the Company on September 9, 2011 in favor of GE Capital Equity Investments, Inc., pursuant to the Amended and Restated Loan and Security Agreement dated September 9, 2011.
|
8-K
|
001-34375
Exhibit 10.84
|
09/15/2011
|
|
4.6
|
Warrant to Purchase Common Stock issued by the Company on September 9, 2011 in favor of Silicon Valley Bank, pursuant to the Amended and Restated Loan and Security Agreement dated September 9, 2011.
|
8-K
|
001-34375
Exhibit 10.85
|
09/15/2011
|
|
4.7
|
Warrant to Purchase Common Stock issued by the Company on September 9, 2011 in favor of Oxford Financial Corporation, pursuant to the Amended and Restated Loan and Security Agreement dated September 9, 2011.
|
8-K
|
001-34375
Exhibit 10.86
|
09/15/2011
|
|
4.8
|
Warrant to Purchase Common Stock issued by the Company on September 9, 2011 in favor of Oxford Financial Corporation, pursuant to the Amended and Restated Loan and Security Agreement dated September 9, 2011.
|
8-K
|
001-34375
Exhibit 10.87
|
09/15/2011
|
|
4.9
|
Warrant to Purchase Common Stock issued by the Company on June 28, 2013 in favor of Oxford Finance LLC pursuant to the Loan and Security Agreement dated June 28, 2013.
|
10-Q
|
001-34375
Exhibit 4.17
|
08/09/2013
|
|
4.10
|
Warrant to Purchase Common Stock issued by the Company on June 28, 2013 in favor of Oxford Finance LLC pursuant to the Loan and Security Agreement dated June 28, 2013.
|
10-Q
|
001-34375
Exhibit 4.18
|
08/09/2013
|
|
4.12
|
Warrant to Purchase Common Stock issued by the Company on June 28, 2013 in favor of Oxford Finance LLC pursuant to the Loan and Security Agreement dated June 28, 2013.
|
10-Q
|
001-34375
Exhibit 4.19
|
08/09/2013
|
|
4.13
|
Warrant to Purchase Common Stock issued by the Company on June 28, 2013 in favor of Oxford Finance LLC pursuant to the Loan and Security Agreement dated June 28, 2013.
|
10-Q
|
001-34375
Exhibit 4.20
|
08/09/2013
|
|
4.14
|
Warrant to Purchase Common Stock issued by the Company on June 28, 2013 in favor of Silicon Valley Bank pursuant to the Loan and Security Agreement dated June 28, 2013.
|
10-Q
|
001-34375
Exhibit 4.21
|
08/09/2013
|
|
4.15
|
Form of Warrant to Purchase Common Stock for Investors in the Units
|
8-K
|
001-34375
|
05/30/2014
|
4.16
|
Form of Warrant to Purchase Common Stock for Placement Agent of the Units
|
8-K
|
001-34375
|
05/30/2014
|
|
4.17
|
Form of Amendment to Warrant to Purchase Common Stock.
|
8-K
|
001-34375
|
09/08/2014
|
|
4.18
|
Form of Warrant to Purchase Common Stock.
|
8-K
|
001-34375
|
09/08/2014
|
|
4.19
|
Form of Warrant for Purchasers in the Units
|
8-K
|
001-034375
|
10/08/2014
|
|
4.20
|
Form of Initial Warrant to Purchase Common Stock
|
8-K
|
001-034375
|
05/05/2015
|
|
4.21
|
Form of Additional Warrant to Purchase Common Stock
|
8-K
|
001-034375
|
05/05/2015
|
|
4.22
|
Form of Pre-Funded Warrant to Purchase Common Stock
|
8-K
|
001-034375
|
05/05/2015
|
|
Amendment to Common Stock Purchase Warrant
|
X
|
||||
Amendment to Series A-1 Warrant to Purchase Common Stock
|
X
|
||||
Amendment to Series A-2 Warrant to Purchase Common Stock
|
X
|
||||
10.1#
|
Amended and Restated 1997 Stock Option and Stock Purchase Plan.
|
10
|
000-32501
Exhibit 10.1
|
03/30/2001
|
|
10.1.1#
|
Board of Directors resolution adopted November 9, 2006 regarding determination of fair market value for stock option grant purposes (incorporated by reference to Exhibit 10.10.1 filed as Exhibit 10.10.1 to our Form 10-K Annual Report, as filed on March 30, 2007 and incorporated by reference herein)
|
10-K
|
000-32501
Exhibit 10.10.1
|
03/30/2007
|
|
10.2
|
2004 Equity Incentive Plan of Cytori Therapeutics, Inc
|
8-K
|
000-32501
Exhibit 10.1
|
08/27/2004
|
|
10.3#
|
Board of Directors resolution adopted November 9, 2006 regarding determination of fair market value for stock option grant purposes.
|
10-K
|
000-32501
Exhibit 10.10.1
|
03/30/2007
|
|
10.4#
|
Notice and Agreement for Stock Options Grant Pursuant to Cytori Therapeutics, Inc. 1997 Stock Option and Stock Purchase Plan; (Nonstatutory).
|
10-Q
|
000-32501
Exhibit 10.19
|
11/15/2004
|
|
10.5#
|
Notice and Agreement for Stock Options Grant Pursuant to Cytori Therapeutics, Inc. 1997 Stock Option and Stock Purchase Plan; (Nonstatutory) with Cliff.
|
10-Q
|
000-32501
Exhibit 10.20
|
11/15/2004
|
|
10.6#
|
Notice and Agreement for Stock Options Grant Pursuant to Cytori Therapeutics, Inc. 1997 Stock Option and Stock Purchase Plan; (Incentive).
|
10-Q
|
000-32501
Exhibit 10.21
|
11/15/2004
|
|
10.7#
|
Notice and Agreement for Stock Options Grant Pursuant to Cytori Therapeutics, Inc. 1997 Stock Option and Stock Purchase Plan; (Incentive) with Cliff.
|
10-Q
|
000-32501
Exhibit 10.22
|
11/15/2004
|
|
10.8#
|
Form of Options Exercise and Stock Purchase Agreement Relating to the 2004 Equity Incentive Plan.
|
10-Q
|
000-32501
Exhibit 10.23
|
11/15/2004
|
|
10.9#
|
Form of Notice of Stock Options Grant Relating to the 2004 Equity Incentive Plan.
|
10-Q
|
000-32501
Exhibit 10.24
|
11/15/2004
|
|
10.10
|
Sublease Agreement dated May 24, 2005, between Biogen Idec, Inc. and the Company.
|
10-Q
|
000-32501
Exhibit 10.21
|
08/15/2005
|
|
10.11+
|
License & Royalty Agreement, effective August 23, 2007, by and between Olympus-Cytori, Inc.
and Cytori Therapeutics, Inc.
|
10-Q
|
000-32501
Exhibit 10.49
|
11/13/2007
|
|
10.69
|
Lease Agreement entered into on April 2, 2010, between HCP Callan Rd, LLC. and Cytori Therapeutics, Inc.
|
10-Q
|
001-34375
Exhibit 10.69
|
05/06/2010
|
|
10.76
|
Common Stock Purchase Agreement, dated December 6, 2010, by and among Cytori Therapeutics, Inc. and Astellas Pharma Inc.
|
8-K
|
001-34375
Exhibit 10.76
|
12/09/2010
|
|
10.77
|
Form of Notice and Restricted Stock Award Agreement for grants of performance-based restricted stock awards under the 2004 Equity Incentive Plan.
|
8-K
|
001-34375
Exhibit 10.1
|
03/04/2011
|
10.88
|
First Amendment to Lease Agreement entered into on November 4, 2011, between HCP Callan Rd, LLC. and the Company.
|
10-Q
|
001-34375
Exhibit 10.88
|
11/08/2011
|
|
10.89#
|
2011 Employee Stock Purchase Plan
|
DEF 14A
|
001-34375
Appendix A
|
05/02/2011
|
|
10.90+
|
Contract HHSO100201200008C dated September 27, 2012, by and between the Company and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (portions of the exhibit have been omitted pursuant to a request for confidential treatment).
|
8-K
|
001-34375
Exhibit 10.90
|
10/03/2012
|
|
10.91
|
Joint Venture Termination Agreement dated May 8, 2013 by and between the Company and Olympus Corporation.
|
10-Q
|
001-34375
Exhibit 10.91
|
05/10/2013
|
|
10.93+
|
Puregraft Sale-License-Supply Agreement, dated July 30, 2013, by and among the Company and Bimini Technologies LLC.
|
10-Q/A
|
001-34375
Exhibit 10.93
|
11/12/2013
|
|
10.94+
|
Amended and Restated License and Supply Agreement dated January 30, 2014, by and between the Company and Lorem Vascular Pty. Ltd.
|
8-K
|
001-34375
|
02/04/2014
|
|
10.95
|
Sales Agreement, dated May 12, 2014, by and between Cytori Therapeutics, Inc. and Cowen and Company, LLC.
|
8-K
|
001-34375
|
05/12/2014
|
|
10.98
|
Cytori Therapeutics, Inc. 2014 Equity Incentive Plan.
|
DEF 14A
|
001-34375
|
06/12/2014
|
|
10.99
|
Contract HHSO100201200008C Amendment No. 1 dated August 13, 2014, by and between the Company and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority.
|
8-K
|
001-34375
|
08/19/2014
|
|
10.103
|
Confidential Separation Agreement and General Release of all claims dated October 2, 2014, by and among the Company, and Clyde Shores.
|
10-Q
|
001-34375
|
11/06/2014
|
|
10.104
|
Form of Securities Purchase Agreement by and between Cytori Therapeutics, Inc. and the Purchasers (as defined therein), dated as of October 8, 2014.
|
8-K
|
001-034375
|
10/08/2014
|
|
10.105
|
Placement Agency Agreement, dated October 8, 2014, between Cytori Therapeutics, Inc. and Roth Capital Partners, LLC.
|
8-K
|
001-034375
|
10/08/2014
|
|
10.106
|
Amendment One to the Securities Purchase Agreement, dated March 16, 2015, between the Company and certain institutional investors
|
10-Q
|
001-034375
|
05/11/2015
|
|
10.107
|
Form of Securities Purchase Agreement, dated May 5, 2015, by and among Cytori Therapeutics, Inc. and the investors named therein
|
8-K
|
001-034375
|
05/05/2015
|
|
10.108
|
Placement Agency Agreement, dated May 5, 2015, by and between Cytori Therapeutics, Inc. and Mizuho Securities USA Inc.
|
8-K
|
001-034375
|
05/05/2015
|
|
10.109
|
Amendment One to Joint Venture Termination Agreement, dated April 30, 2015, by and between Cytori Therapeutics, Inc. and Olympus Corporation
|
8-K
|
001-034375
|
05/05/2015
|
|
10.110
|
Loan and Security Agreement, dated May 29, 2015, by and between Cytori Therapeutics, Inc. and Oxford Finance, LLC
|
10-Q
|
001-034375
|
08/10/2015
|
|
Amendment One to the Securities Purchase Agreement between the Company and certain institutional investors dated May 5, 2015
|
X
|
||||
10.112#
|
2015 New Employee Incentive Plan
|
8-K
|
001-034375
|
01/0 5/ 2016
|
|
Form of Agreement for Acceleration and/or Severance
|
X
|
||||
Consent of KPMG LLP, Independent Registered Public Accounting Firm
|
X
|
||||
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X
|
||||
Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X
|
Certifications Pursuant to 18 U.S.C. Section 1350/ Securities Exchange Act Rule 13a-14(b), as adopted pursuant to Section 906 of the Sarbanes - Oxley Act of 2002
|
X
|
||||
101.INS
|
XBRL Instance Document
|
X
|
|||
101.SCH
|
XBRL Schema Document
|
X
|
|||
101.CAL
|
XBRL Calculation Linkbase Document
|
X
|
|||
101.DEF
|
XBRL Definition Linkbase Document
|
X
|
|||
101.LAB
|
XBRL Label Linkbase Document
|
X
|
|||
*
|
XBRL Presentation Linkbase Document
|
X
|
+
|
Confidential treatment has been granted with respect to certain portions of this exhibit.
|
#
|
Indicates management contract or compensatory plan or arrangement.
|
CorpAmerica, Inc.
|
|
2711 Centerville Road, Suite 400
|
|
Wilmington, DE 19808
|
|
County of New Castle
|
Company:
|
Holder:
|
||||
Cytori Therapeutics Inc.
|
[Name of Holder]
|
||||
By:
|
By:
|
||||
Name:
|
Name:
|
||||
Title:
|
Title:
|
Company:
|
Holder:
|
||||
Cytori Therapeutics Inc.
|
[Name of Holder]
|
||||
By:
|
By:
|
||||
Name:
|
Name:
|
||||
Title:
|
Title:
|
Company:
|
Holder:
|
||||
Cytori Therapeutics Inc.
|
[Name of Holder]
|
||||
By:
|
By:
|
||||
Name:
|
Name:
|
||||
Title:
|
Title:
|
A. | Section 4(p) of the Agreement is hereby amended and restated in its entirety to read as follows: |
1 | This Amendment shall enter into force as of the Effective Date. |
2 | All capitalized terms used but not defined herein shall have the meaning set forth in the Agreement. |
3 | In consideration of the foregoing amendment, the Company agrees that for the period commencing on the date hereof and ending on February 5, 2016, the Company shall not directly or indirectly issue, offer, sell, grant any option or right to purchase, or otherwise dispose of (or announce any issuance, offer, sale, grant of any option or right to purchase or other disposition of) any equity security or any equity-linked or related security (including, without limitation, any “equity security” (as that term is defined under Rule 405 promulgated under the 1933 Act), provided, however , that the foregoing shall not apply to any issuances of any Excluded Securities (as defined in the Agreement). |
4 | Except as otherwise expressly provided herein, the Agreement shall otherwise remain in full force and effect. |
5 | This Amendment, together with the Agreement (to the extent not amended hereby) and all exhibits thereto and references therein, constitute the entire agreement among the parties and shall supersede any and all previous contracts, arrangements or understandings between the parties with respect to the subject matter herein . |
6 | Each party to this Amendment hereby agrees to perform any further acts and to execute and deliver any further documents that may be necessary or required to carry out the intent and provisions of this Amendment and the transactions contemplated hereby. |
7 | This Amendment may not be altered, amended or modified in any way unless done so in accordance with Section 9(e) of the Agreement. |
8 | This Amendment may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument, and such counterparts may be delivered electronically by the parties. |
CYTORI THERAPEUTICS, INC. | ||
By |
/s/ Tiago Girao
|
|
Name: Tiago Girao
|
||
Title: CFO
|
Facsimile Number of Authorized Signatory:
|
Number of Underlying Securities as of the Effective Date:
|
Name of Purchaser: ProMed Partners, LP
|
Signature of Authorized Signatory of Purchaser
: /s/ David B. Musket
|
Name of Authorized Signatory: David B. Musket
|
Title of Authorized Signatory: Managing Member
|
Email Address of Authorized Signatory: dmasket@promedmgmt.com
|
Facsimile Number of Authorized Signatory: 8572638359
|
Number of Underlying Securities as of the Effective Date:
|
Name of Purchaser: David B. Musket
|
Signature of Authorized Signatory of Purchaser
: /s/ David B. Musket
|
Name of Authorized Signatory:
|
Title of Authorized Signatory:
|
Email Address of Authorized Signatory: dmasket@promedmgmt.com
|
Facsimile Number of Authorized Signatory: 8572638359
|
Number of Underlying Securities as of the Effective Date:
|
Name of Purchaser: Alpha Capital Austalt
|
Signature of Authorized Signatory of Purchaser
: /s/ Konrad Ackermann
|
Name of Authorized Signatory: Konrad Ackermann
|
Title of Authorized Signatory: Director
|
Email Address of Authorized Signatory:
|
Facsimile Number of Authorized Signatory:
|
Number of Underlying Securities as of the Effective Date:
|
Name of Purchaser: Intracoastal Capital, LLC
|
Signature of Authorized Signatory of Purchaser
: /s/ Keith A. Goodman
|
Name of Authorized Signatory: Konrad Ackermann
|
Title of Authorized Signatory:
|
Email Address of Authorized Signatory: kgoodman@cranshirecapital.com
|
Facsimile Number of Authorized Signatory: 847-562-9031
|
Number of Underlying Securities as of the Effective Date: 2,969,850
|
1. | Stock Option Acceleration . |
2. | Severance Contingency; Definitions . |
3. | Other Termination . |
4. | General Release . |
5. | At-Will Employment . |
6. | Dispute Resolution . |
7. | Miscellaneous . |
Executive:
|
|||||
Dated:
|
|||||
Company | |||||
CYTORI THERAPEUTICS, INC., a Delaware corporation | |||||
By:
|
Dated:
|
||||
Name: Marc H. Hedrick | |||||
Title: President/Chief Executive Officer |
Executive:
|
|||
Dated: |
|
||
Company:
|
|||
CYTORI THERAPEUTICS, INC., a Delaware corporation
|
Dated: |
|
By:
|
Name:
|
Title:
|
/s/ KPMG LLP
|
|
San Diego, California
|
|
March 11, 2016
|
1.
|
I have reviewed this annual report on Form 10-K of Cytori Therapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
Date: March 11, 2016
|
|
/s/ Marc H. Hedrick, MD
|
|
Marc. H. Hedrick,
|
|
President & Chief Executive Officer
|
1. | I have reviewed this annual report on Form 10-K of Cytori Therapeutics, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
Date: March 11, 2016
|
|
/s/ Tiago M. Girão
|
|
Tiago M. Girão,
|
|
VP of Finance and Chief Financial Officer
|
1. | The Form 10-K report of Cytori Therapeutics, Inc. that this certification accompanies fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934. |
2. | The information contained in the Form 10-K report of Cytori Therapeutics, Inc. that this certification accompanies fairly presents, in all material respects, the financial condition and results of operations of Cytori Therapeutics, Inc. |
By:
|
/s/ Marc H. Hedrick, MD
|
|
Dated: March 11, 2016
|
Marc H. Hedrick, MD
|
|
President & Chief Executive Officer
|
||
By:
|
/s/ Tiago M. Girão
|
|
Dated: March 11, 2016
|
Tiago M. Girão
|
|
VP of Finance and Chief Financial Officer
|