x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
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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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22-2343568
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(State or other jurisdiction of
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(I.R.S. Employer
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incorporation or organization)
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Identification No.)
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|
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106 ALLEN ROAD, FOURTH FLOOR BASKING RIDGE, NJ
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07920
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(Address of principal executive offices)
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(zip code)
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Large accelerated filer
o
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Accelerated filer
x
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
x
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•
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our ability to obtain sufficient capital or strategic business arrangements to fund our operations and expansion plans, including meeting our financial obligations under various licensing and other strategic arrangements, the funding of our clinical trials for product candidates, and the commercialization of the relevant technology;
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•
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our ability to build and maintain the management and human resources infrastructure necessary to support the growth of our business;
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•
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our ability to integrate our acquired businesses successfully and grow such acquired businesses as anticipated, including expanding our PCT business;
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•
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whether a market is established for our cell-based products and services and our ability to capture a meaningful share of this market;
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•
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scientific and medical developments beyond our control;
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•
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our ability to obtain and maintain, as applicable, appropriate governmental licenses, accreditations or certifications or comply with healthcare laws and regulations or any other adverse effect or limitations caused by government regulation of our business;
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•
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whether any of our current or future patent applications result in issued patents, the scope of those patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business; and our ability to commercialize products without infringing the claims of third party patents;
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•
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whether any potential strategic or financial benefits of various licensing agreements will be realized;
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•
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the results of our development activities;
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•
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our ability to complete our other planned clinical trials (or initiate other trials) in accordance with our estimated timelines due to delays associated with enrolling patients due to the novelty of the treatment, the size of the patient population and the need of patients to meet the inclusion criteria of the trial or otherwise;
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•
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our ability to satisfy our obligations under our loan agreement; and
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•
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other factors discussed in "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 15, 2016 (our "2015 Form 10-K").
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Page No.
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Financial Statements:
|
||
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Consolidated Balance Sheets at June 30, 2016 and December 31, 2015
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|
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Consolidated Statements of Operations for the three and six months ended June 30, 2016 and 2015
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Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2016 and 2015
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Consolidated Statements of Equity for the six months ended June 30, 2016 and 2015
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Consolidated Statements of Cash Flows for the six months ended June 30, 2016 and 2015
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|
|
|
|
|
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|
|
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June 30,
2016 |
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December 31,
2015 |
||||
ASSETS
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(Unaudited)
|
|
(Unaudited)
|
||||
Current Assets
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
17,699,686
|
|
|
$
|
20,318,411
|
|
Accounts receivable, net of allowances of $0 at June 30, 2016 and December 31, 2015
|
2,892,467
|
|
|
2,566,101
|
|
||
Deferred costs
|
5,149,777
|
|
|
2,911,743
|
|
||
Prepaid expenses and other current assets
|
3,512,007
|
|
|
3,476,177
|
|
||
Total current assets
|
29,253,937
|
|
|
29,272,432
|
|
||
Property, plant and equipment, net
|
17,039,880
|
|
|
17,064,900
|
|
||
Goodwill
|
7,013,315
|
|
|
7,013,315
|
|
||
Intangible assets, net
|
2,592,880
|
|
|
2,877,880
|
|
||
Other assets
|
812,888
|
|
|
976,768
|
|
||
Total assets
|
$
|
56,712,900
|
|
|
$
|
57,205,295
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
||
Current Liabilities
|
|
|
|
|
|
||
Accounts payable
|
$
|
2,903,221
|
|
|
$
|
4,107,388
|
|
Accrued liabilities
|
6,202,343
|
|
|
6,198,488
|
|
||
Long-term debt, current
|
5,007,851
|
|
|
4,171,456
|
|
||
Notes payable, current
|
1,012,393
|
|
|
1,192,666
|
|
||
Unearned revenues
|
7,231,005
|
|
|
5,345,225
|
|
||
Total current liabilities
|
22,356,813
|
|
|
21,015,223
|
|
||
Long-term Liabilities
|
|
|
|
|
|
||
Deferred income taxes
|
1,032,994
|
|
|
932,662
|
|
||
Notes payable
|
321,375
|
|
|
583,041
|
|
||
Unearned revenues - long-term
|
3,812,998
|
|
|
—
|
|
||
Long-term debt
|
3,643,502
|
|
|
10,828,544
|
|
||
Other long-term liabilities
|
508,590
|
|
|
562,001
|
|
||
Total liabilities
|
$
|
31,676,272
|
|
|
$
|
33,921,471
|
|
Commitments and Contingencies (see Note 15)
|
|
|
|
|
|
||
Redeemable Securities
|
19,400,000
|
|
|
—
|
|
||
EQUITY
|
|
|
|
|
|
||
Stockholders' Equity*
|
|
|
|
|
|||
Preferred stock, authorized, 20,000,000 shares
Series B convertible redeemable preferred stock liquidation value, 1 share of common stock, $.01 par value; 825,000 shares designated; issued and outstanding, 10,000 shares at June 30, 2016 and December 31, 2015 |
100
|
|
|
100
|
|
||
Common stock, $.001 par value, authorized 500,000,000 shares; issued and outstanding, 5,926,749 and 5,673,302 shares, at June 30, 2016 and December 31, 2015, respectively
|
5,927
|
|
|
5,673
|
|
||
Additional paid-in capital
|
398,699,991
|
|
|
396,547,401
|
|
||
Treasury stock, at cost; 10,999 shares at June 30, 2016 and December 31, 2015, respectively
|
(707,637
|
)
|
|
(707,637
|
)
|
||
Accumulated deficit
|
(391,948,123
|
)
|
|
(372,132,490
|
)
|
||
Accumulated other comprehensive income
|
—
|
|
|
486
|
|
||
Total Caladrius Biosciences, Inc. stockholders' equity
|
6,050,258
|
|
|
23,713,533
|
|
||
Noncontrolling interests
|
(413,630
|
)
|
|
(429,709
|
)
|
||
Total equity
|
5,636,628
|
|
|
23,283,824
|
|
||
Total liabilities and equity
|
$
|
56,712,900
|
|
|
$
|
57,205,295
|
|
*Adjusted to reflect the impact of the 1:10 reverse stock split that became effective on July 28, 2016
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Revenues
|
$
|
8,300,439
|
|
|
$
|
5,866,963
|
|
|
$
|
15,789,918
|
|
|
$
|
9,039,242
|
|
|
|
|
|
|
|
|
|
||||||||
Costs and expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of revenues
|
7,051,546
|
|
|
5,798,796
|
|
|
13,279,802
|
|
|
9,167,408
|
|
||||
Research and development
|
4,027,965
|
|
|
7,600,744
|
|
|
9,904,143
|
|
|
14,404,376
|
|
||||
Impairment of intangible assets
|
—
|
|
|
9,400,000
|
|
|
—
|
|
|
9,400,000
|
|
||||
Selling, general, and administrative
|
4,705,879
|
|
|
8,736,373
|
|
|
11,164,210
|
|
|
19,824,272
|
|
||||
Total operating costs and expenses
|
15,785,390
|
|
|
31,535,913
|
|
|
34,348,155
|
|
|
52,796,056
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Operating loss
|
(7,484,951
|
)
|
|
(25,668,950
|
)
|
|
(18,558,237
|
)
|
|
(43,756,814
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Other income (expense), net
|
6,860
|
|
|
5,354,845
|
|
|
12,545
|
|
|
4,808,818
|
|
||||
Interest expense
|
(359,725
|
)
|
|
(547,275
|
)
|
|
(1,286,542
|
)
|
|
(1,098,239
|
)
|
||||
|
(352,865
|
)
|
|
4,807,570
|
|
|
(1,273,997
|
)
|
|
3,710,579
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Loss before provision for income taxes and noncontrolling interests
|
(7,837,816
|
)
|
|
(20,861,380
|
)
|
|
(19,832,234
|
)
|
|
(40,046,235
|
)
|
||||
Provision (benefit) for income taxes
|
46,954
|
|
|
(3,703,363
|
)
|
|
100,332
|
|
|
(3,656,730
|
)
|
||||
Net loss
|
(7,884,770
|
)
|
|
(17,158,017
|
)
|
|
(19,932,566
|
)
|
|
(36,389,505
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Less - loss attributable to noncontrolling interests
|
(50,054
|
)
|
|
(31,757
|
)
|
|
(116,933
|
)
|
|
(76,349
|
)
|
||||
Net loss attributable to Caladrius Biosciences, Inc. common stockholders
|
$
|
(7,834,716
|
)
|
|
$
|
(17,126,260
|
)
|
|
$
|
(19,815,633
|
)
|
|
$
|
(36,313,156
|
)
|
|
|
|
|
|
|
|
|
||||||||
Basic and diluted loss per share attributable to Caladrius Biosciences, Inc. common stockholders
|
$
|
(1.33
|
)
|
|
$
|
(3.84
|
)
|
|
$
|
(3.39
|
)
|
|
$
|
(8.83
|
)
|
Weighted average common shares outstanding*
|
5,907,013
|
|
|
4,457,480
|
|
|
5,839,963
|
|
|
4,110,413
|
|
||||
|
|
|
|
|
|
|
|
||||||||
*Adjusted to reflect the impact of the 1:10 reverse stock split that became effective on July 28, 2016
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Net loss
|
$
|
(7,884,770
|
)
|
|
$
|
(17,158,017
|
)
|
|
$
|
(19,932,566
|
)
|
|
$
|
(36,389,505
|
)
|
|
|
|
|
|
|
|
|
||||||||
Other comprehensive loss:
|
|
|
|
|
|
|
|
||||||||
Available for sale securities - net unrealized (loss) gain
|
—
|
|
|
1,866
|
|
|
(486
|
)
|
|
537
|
|
||||
Total other comprehensive loss
|
—
|
|
|
1,866
|
|
|
(486
|
)
|
|
537
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss
|
(7,884,770
|
)
|
|
(17,156,151
|
)
|
|
(19,933,052
|
)
|
|
(36,388,968
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss attributable to noncontrolling interests
|
(50,054
|
)
|
|
(31,757
|
)
|
|
(116,933
|
)
|
|
(76,349
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss attributable to Caladrius Biosciences, Inc. common stockholders
|
$
|
(7,834,716
|
)
|
|
$
|
(17,124,394
|
)
|
|
$
|
(19,816,119
|
)
|
|
$
|
(36,312,619
|
)
|
|
Series B Convertible
Preferred Stock
|
|
Common Stock*
|
|
Additional
Paid in
Capital*
|
|
Accumulated
Other
Comprehensive
Income
|
|
Accumulated
Deficit
|
|
Treasury
Stock
|
|
Total
Caladrius Biosciences,
Inc.
Stockholders'
Equity
|
|
Non-
Controlling
Interest in
Subsidiary
|
|
Total
Equity
|
||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Balance at December 31, 2014
|
10,000
|
|
|
$
|
100
|
|
|
3,678,386
|
|
|
$
|
3,678
|
|
|
$
|
350,462,009
|
|
|
$
|
1,329
|
|
|
$
|
(291,246,538
|
)
|
|
$
|
(705,742
|
)
|
|
$
|
58,514,836
|
|
|
$
|
(441,047
|
)
|
|
$
|
58,073,789
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36,313,156
|
)
|
|
—
|
|
|
(36,313,156
|
)
|
|
(76,349
|
)
|
|
(36,389,505
|
)
|
|||||||||
Unrealized gain/loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
537
|
|
|
—
|
|
|
—
|
|
|
537
|
|
|
—
|
|
|
537
|
|
|||||||||
Equity-based compensation expense
|
—
|
|
|
—
|
|
|
90,334
|
|
|
90
|
|
|
8,132,016
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,132,106
|
|
|
—
|
|
|
8,132,106
|
|
|||||||||
Proceeds from issuance of common stock
|
—
|
|
|
—
|
|
|
1,776,582
|
|
|
1,777
|
|
|
36,134,637
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
36,136,414
|
|
|
—
|
|
|
36,136,414
|
|
|||||||||
Change in Ownership in Subsidiary
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(88,928
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(88,928
|
)
|
|
88,928
|
|
|
—
|
|
|||||||||
Balance at June 30, 2015
|
10,000
|
|
|
$
|
100
|
|
|
5,545,302
|
|
|
$
|
5,545
|
|
|
$
|
394,639,734
|
|
|
$
|
1,866
|
|
|
$
|
(327,559,694
|
)
|
|
$
|
(705,742
|
)
|
|
$
|
66,381,809
|
|
|
$
|
(428,468
|
)
|
|
$
|
65,953,341
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
|
Series B Convertible
Preferred Stock
|
|
Common Stock*
|
|
Additional
Paid in
Capital*
|
|
Accumulated
Other
Comprehensive
Income
|
|
Accumulated
Deficit
|
|
Treasury
Stock
|
|
Total
Caladrius Biosciences,
Inc.
Stockholders'
Equity
|
|
Non-
Controlling
Interest in
Subsidiary
|
|
Total
Equity
|
||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Balance at December 31, 2015
|
10,000
|
|
|
$
|
100
|
|
|
5,673,302
|
|
|
$
|
5,673
|
|
|
$
|
396,547,401
|
|
|
$
|
486
|
|
|
$
|
(372,132,490
|
)
|
|
$
|
(707,637
|
)
|
|
$
|
23,713,533
|
|
|
$
|
(429,709
|
)
|
|
$
|
23,283,824
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(19,815,633
|
)
|
|
—
|
|
|
(19,815,633
|
)
|
|
(116,933
|
)
|
|
(19,932,566
|
)
|
|||||||||
Unrealized gain/loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(486
|
)
|
|
—
|
|
|
—
|
|
|
(486
|
)
|
|
—
|
|
|
(486
|
)
|
|||||||||
Equity-based compensation expense
|
—
|
|
|
—
|
|
|
95,355
|
|
|
95
|
|
|
1,235,049
|
|
|
—
|
|
|
—
|
|
|
|
|
1,235,144
|
|
|
—
|
|
|
1,235,144
|
|
||||||||||
Proceeds from issuance of common stock
|
—
|
|
|
—
|
|
|
158,092
|
|
|
159
|
|
|
1,050,553
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,050,712
|
|
|
—
|
|
|
1,050,712
|
|
|||||||||
Change in Ownership in Subsidiary
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(133,012
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(133,012
|
)
|
|
133,012
|
|
|
—
|
|
|||||||||
Balance at June 30, 2016
|
10,000
|
|
|
$
|
100
|
|
|
5,926,749
|
|
|
$
|
5,927
|
|
|
$
|
398,699,991
|
|
|
$
|
—
|
|
|
$
|
(391,948,123
|
)
|
|
$
|
(707,637
|
)
|
|
$
|
6,050,258
|
|
|
$
|
(413,630
|
)
|
|
$
|
5,636,628
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
*Adjusted to reflect the impact of the 1:10 reverse stock split that became effective on July 28, 2016
|
|
Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
||
Net loss
|
$
|
(19,932,566
|
)
|
|
$
|
(36,389,505
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||
Equity-based compensation expense
|
1,235,143
|
|
|
8,132,106
|
|
||
Depreciation and amortization
|
1,422,011
|
|
|
1,254,305
|
|
||
Change in acquisition-related contingent consideration
|
—
|
|
|
(4,800,000
|
)
|
||
Impairment of intangible assets
|
—
|
|
|
9,400,000
|
|
||
Loss on disposal of assets
|
591,307
|
|
|
—
|
|
||
Bad debt recovery
|
—
|
|
|
(2,641
|
)
|
||
Deferred income taxes
|
100,332
|
|
|
(3,656,730
|
)
|
||
Accretion on marketable securities
|
—
|
|
|
33,054
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
Prepaid expenses and other current assets
|
(35,830
|
)
|
|
368,620
|
|
||
Accounts receivable
|
(326,366
|
)
|
|
1,816,376
|
|
||
Deferred costs
|
(2,238,034
|
)
|
|
(406,498
|
)
|
||
Unearned revenues
|
5,698,778
|
|
|
308,912
|
|
||
Other assets
|
163,393
|
|
|
(8,005
|
)
|
||
Accounts payable, accrued liabilities and other liabilities
|
(1,253,723
|
)
|
|
2,122,987
|
|
||
Net cash used in operating activities
|
(14,575,555
|
)
|
|
(21,827,019
|
)
|
||
Cash flows from investing activities:
|
|
|
|
|
|
||
Purchase of marketable securities
|
—
|
|
|
(3,013,157
|
)
|
||
Sale of marketable securities
|
—
|
|
|
7,049,000
|
|
||
Acquisition of property, plant and equipment
|
(1,703,297
|
)
|
|
(1,802,607
|
)
|
||
Net cash (used in) provided by investing activities
|
(1,703,297
|
)
|
|
2,233,236
|
|
||
Cash flows from financing activities:
|
|
|
|
|
|
||
Net proceeds from issuance of common stock
|
1,050,712
|
|
|
36,136,414
|
|
||
Repayment of long-term debt
|
(6,348,646
|
)
|
|
—
|
|
||
Proceeds from notes payable
|
368,615
|
|
|
1,089,611
|
|
||
Repayment of notes payable
|
(810,554
|
)
|
|
(594,979
|
)
|
||
Sale of ownership interest in subsidiary
|
19,400,000
|
|
|
—
|
|
||
Net cash provided by financing activities
|
13,660,127
|
|
|
36,631,046
|
|
||
Net increase (decrease) in cash and cash equivalents
|
(2,618,725
|
)
|
|
17,037,263
|
|
||
Cash and cash equivalents at beginning of period
|
20,318,411
|
|
|
19,174,061
|
|
||
Cash and cash equivalents at end of period
|
$
|
17,699,686
|
|
|
$
|
36,211,324
|
|
|
|
|
|
||||
Supplemental Disclosure of Cash Flow Information:
|
|
|
|
||||
Cash paid during the period for:
|
|
|
|
||||
Interest
|
$
|
1,200,364
|
|
|
$
|
744,811
|
|
Entity
|
|
Percentage of Ownership
|
|
Location
|
Caladrius Biosciences, Inc.
|
|
100%
|
|
United States of America
|
NeoStem Therapies, Inc.
|
|
100%
|
|
United States of America
|
Stem Cell Technologies, Inc.
|
|
100%
|
|
United States of America
|
Amorcyte, LLC
|
|
100%
|
|
United States of America
|
PCT, LLC, a Caladrius Company (1)
|
|
80.1%
|
|
United States of America
|
NeoStem Family Storage, LLC (1)
|
|
80.1%
|
|
United States of America
|
Athelos Corporation (2)
|
|
97.9%
|
|
United States of America
|
PCT Allendale, LLC (1)
|
|
80.1%
|
|
United States of America
|
NeoStem Oncology, LLC
|
|
100%
|
|
United States of America
|
•
|
persuasive evidence of an arrangement exists;
|
•
|
delivery has occurred or the services have been rendered;
|
•
|
the fee is fixed or determinable; and
|
•
|
collection is probable.
|
|
June 30, 2016
|
|
December 31, 2015
|
||||||||||||||||||||||||||||
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
||||||||||||||||
Certificate of deposits
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
249.0
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
249.0
|
|
Corporate debt securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,047.2
|
|
|
—
|
|
|
—
|
|
|
1,047.2
|
|
||||||||
Money market funds
|
2,567.0
|
|
|
—
|
|
|
—
|
|
|
2,567.0
|
|
|
837.7
|
|
|
—
|
|
|
—
|
|
|
837.7
|
|
||||||||
Municipal debt securities
|
5,725.0
|
|
|
—
|
|
|
—
|
|
|
5,725.0
|
|
|
4,740.9
|
|
|
0.8
|
|
|
—
|
|
|
4,741.7
|
|
||||||||
Total
|
$
|
8,292.0
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8,292.0
|
|
|
$
|
6,874.8
|
|
|
$
|
0.8
|
|
|
$
|
—
|
|
|
$
|
6,875.6
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Cash and cash equivalents
|
$
|
8,292.0
|
|
|
$
|
6,875.6
|
|
Marketable securities
|
—
|
|
|
—
|
|
||
Total
|
$
|
8,292.0
|
|
|
$
|
6,875.6
|
|
|
June 30, 2016
|
||||||
|
Amortized Cost
|
|
Estimated Fair Value
|
||||
Less than one year
|
$
|
8,292.0
|
|
|
$
|
8,292.0
|
|
Greater than one year
|
—
|
|
|
—
|
|
||
Total
|
$
|
8,292.0
|
|
|
$
|
8,292.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||||||||||||||||||
|
Useful Life
|
|
Gross
|
|
Accumulated Amortization
|
|
Net
|
|
Gross
|
|
Accumulated Amortization
|
|
Net
|
||||||||||||
Customer list
|
10 years
|
|
$
|
1,000.0
|
|
|
$
|
(545.1
|
)
|
|
$
|
454.9
|
|
|
$
|
1,000.0
|
|
|
$
|
(495.1
|
)
|
|
$
|
504.9
|
|
Manufacturing technology
|
10 years
|
|
3,900.0
|
|
|
(2,125.9
|
)
|
|
1,774.1
|
|
|
3,900.0
|
|
|
(1,930.9
|
)
|
|
1,969.1
|
|
||||||
Tradename
|
10 years
|
|
800.0
|
|
|
(436.1
|
)
|
|
363.9
|
|
|
800.0
|
|
|
(396.1
|
)
|
|
403.9
|
|
||||||
Total Intangible Assets
|
|
|
$
|
5,700.0
|
|
|
$
|
(3,107.1
|
)
|
|
$
|
2,592.9
|
|
|
$
|
5,700.0
|
|
|
$
|
(2,822.1
|
)
|
|
$
|
2,877.9
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Cost of revenue
|
$
|
77.7
|
|
|
$
|
79.2
|
|
|
$
|
157.3
|
|
|
$
|
153.9
|
|
Research and development
|
19.8
|
|
|
27.1
|
|
|
37.7
|
|
|
58.7
|
|
||||
Selling, general and administrative
|
45.0
|
|
|
45.0
|
|
|
90.0
|
|
|
90.0
|
|
||||
Total
|
$
|
142.5
|
|
|
$
|
151.3
|
|
|
$
|
285.0
|
|
|
$
|
302.6
|
|
2016
|
$
|
285
|
|
2017
|
570.0
|
|
|
2018
|
570.0
|
|
|
2019
|
570.0
|
|
|
2020
|
570.0
|
|
|
Thereafter
|
27.9
|
|
|
Total
|
$
|
2,592.9
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Salaries, employee benefits and related taxes
|
$
|
3,160.8
|
|
|
$
|
2,771.2
|
|
Professional fees
|
342
|
|
|
480.7
|
|
||
Other
|
2,699.6
|
|
|
2,946.5
|
|
||
Total
|
$
|
6,202.4
|
|
|
$
|
6,198.4
|
|
Years Ending December 31,
|
(in millions)
|
||
2016
|
$
|
0.4
|
|
2017
|
6.8
|
|
|
2018
|
3.0
|
|
|
Total
|
$
|
10.2
|
|
|
|
Stock Options
|
|
Warrants
|
||||||||||||||||||||||
|
|
Shares
|
|
Weighted Average Exercise Price
|
|
Weighted Average Remaining Contractual Term (Years)
|
|
Aggregate Intrinsic Value (In Thousands)
|
|
Shares
|
|
Weighted Average Exercise Price
|
|
Weighted Average Remaining Contractual Term (Years)
|
|
Aggregate Intrinsic Value (In Thousands)
|
||||||||||
Outstanding at December 31, 2015
|
|
666,348
|
|
|
$
|
64.60
|
|
|
6.88
|
|
$
|
0.1
|
|
|
321,404
|
|
|
$
|
137.20
|
|
|
1.26
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Changes during the period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Granted
|
|
169,038
|
|
|
6.20
|
|
|
|
|
|
|
141,845
|
|
|
122.60
|
|
|
|
|
|
||||||
Exercised
|
|
—
|
|
|
—
|
|
|
|
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||||
Forfeited
|
|
(56,024
|
)
|
|
35.90
|
|
|
|
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||||
Expired
|
|
(87,030
|
)
|
|
46.50
|
|
|
|
|
|
|
(3,200
|
)
|
|
147.50
|
|
|
|
|
|
||||||
Outstanding at June 30, 2016
|
|
692,332
|
|
|
$
|
55.00
|
|
|
7.34
|
|
$
|
18.9
|
|
|
460,049
|
|
|
$
|
98.00
|
|
|
1.06
|
|
$
|
—
|
|
Vested at June 30, 2016 or expected to vest in the future
|
|
675,324
|
|
|
$
|
56.00
|
|
|
7.29
|
|
$
|
18.4
|
|
|
460,049
|
|
|
$
|
98.00
|
|
|
1.06
|
|
$
|
—
|
|
Vested at June 30, 2016
|
|
489,652
|
|
|
$
|
71.00
|
|
|
6.55
|
|
$
|
9.0
|
|
|
460,300
|
|
|
$
|
98.00
|
|
|
1.06
|
|
$
|
—
|
|
|
|
Six Months Ended June 30,
|
||||||
|
|
2016
|
|
2015
|
||||
Number of Restricted Stock Issued
|
|
107,719
|
|
|
127,606
|
|
||
Value of Restricted Stock Issued
|
|
$
|
651.7
|
|
|
$
|
4,029.5
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Cost of goods sold
|
$
|
11.7
|
|
|
$
|
378.2
|
|
|
$
|
136.0
|
|
|
$
|
495.1
|
|
Research and development
|
6.0
|
|
|
1,104.2
|
|
|
98.3
|
|
|
1,526.9
|
|
||||
Selling, general and administrative
|
317.8
|
|
|
2,933.9
|
|
|
1,000.8
|
|
|
6,110.1
|
|
||||
Total share-based compensation expense
|
$
|
335.5
|
|
|
$
|
4,416.3
|
|
|
$
|
1,235.1
|
|
|
$
|
8,132.1
|
|
|
|
|
|
|
|
|
|
|
Stock Options
|
|
Restricted Stock
|
||||
Unrecognized compensation cost
|
$
|
1,696.8
|
|
|
$
|
551.0
|
|
Expected weighted-average period in years of compensation cost to be recognized
|
2.09
|
|
|
2.02
|
|
|
Stock Options
|
|
Warrants
|
||||||||||||
|
Six Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Total fair value of shares vested
|
$
|
1,153.1
|
|
|
$
|
4,915.3
|
|
|
$
|
—
|
|
|
$
|
14.0
|
|
Weighted average estimated fair value of shares granted
|
$
|
4.02
|
|
|
$
|
2.17
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Years ended
|
|
Operating Leases
|
||
2016
|
|
$
|
1,041.7
|
|
2017
|
|
1,866.9
|
|
|
2018
|
|
1,037.1
|
|
|
2019
|
|
990.1
|
|
|
2020 and thereafter
|
|
960.2
|
|
|
Total minimum lease payments
|
|
$
|
5,896.0
|
|
|
Three Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
Clinical Services
|
$
|
4,767.9
|
|
|
$
|
4,017.6
|
|
Clinical Services Reimbursables
|
2,112.0
|
|
|
856.1
|
|
||
Processing and Storage Services
|
1,333.6
|
|
|
993.3
|
|
||
Other
|
87.0
|
|
|
—
|
|
||
|
$
|
8,300.4
|
|
|
$
|
5,867.0
|
|
•
|
Clinical Services were approximately
$4.8 million
for the
three months ended
June 30, 2016
compared to
$4.0 million
for the
three months ended
June 30, 2015
, representing an increase of approximately
$0.8 million
or
19%
, and was comprised of the following:
|
◦
|
Process Development Revenue -
Process development revenues were approximately
$0.4 million
for the
three months ended
June 30, 2016
compared to
$1.9 million
for the
three months ended
June 30, 2015
. In accordance with our revenue recognition policy, process development revenue is recognized upon contract completion (
i.e.
, when the services under a particular contract are completed). Process development revenue will continue to fluctuate from period to period as a result of our process development revenue recognition policy, and the timing upon when services for a contract are completed. Accordingly, unearned revenue relating to process development contracts increased from
$4.2 million
as of
March 31, 2016
and
$5.4 million
as of
June 30, 2016
, representing billings on contracts that have not been completed.
|
◦
|
Clinical Manufacturing Revenue
- Clinical manufacturing revenues were approximately
$4.4 million
for the
three months ended
June 30, 2016
compared to
$2.2 million
for the
three months ended
June 30, 2015
. The increase is primarily due to an increase in the number of patients our customers have enrolled and treated in clinical trials, which number varies depending on the stage of the clinical trial.
|
•
|
Clinical Services Reimbursables were approximately
$2.1 million
for the
three months ended
June 30, 2016
compared to
$0.9 million
for the
three months ended
June 30, 2015
, representing an increase of approximately
$1.3 million
, or
147%
. Generally, clinical services reimbursables correlate with clinical services revenues. However, differences in the cost of supplies to be reimbursed can vary greatly from contract to contract based on the cost of supplies needed for each client's manufacturing and development process and may impact this correlation. In addition, our terms for billing reimbursable expenses do not include a significant mark-up in the acquisition cost of such consumables, and as a result, changes in this revenue category have little impact on our gross margin and net loss.
|
•
|
Processing and Storage Services were approximately
$1.3 million
for the
three months ended
June 30, 2016
compared to
$1.0 million
for the
three months ended
June 30, 2015
, representing an increase of approximately
$0.3 million
or
34%
. The increase was primarily due to higher volume for our oncology stem cell processing services.
|
|
Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
Clinical Services
|
$
|
10,068.8
|
|
|
$
|
5,480.6
|
|
Clinical Services Reimbursables
|
3,373.1
|
|
|
1,384.6
|
|
||
Processing and Storage Services
|
2,243.2
|
|
|
2,054.1
|
|
||
Other
|
104.8
|
|
|
120.0
|
|
||
|
$
|
15,789.9
|
|
|
$
|
9,039.2
|
|
•
|
Clinical Services were approximately
$10.1 million
for the
six months ended
June 30, 2016
compared to
$5.5 million
for the
six months ended
June 30, 2015
, representing an increase of approximately
$4.6 million
, or
84%
, and was comprised of the following:
|
◦
|
Process Development Revenue -
Process development revenues were approximately
$1.7 million
for the
six months ended
June 30, 2016
compared to
$2.0 million
for the
six months ended
June 30, 2015
. In accordance with our revenue recognition policy, process development revenue is recognized upon contract completion (
i.e.
, when the services under a particular contract are completed). Process development revenue will continue to fluctuate from period to period as a result of our process development revenue recognition policy, and the timing upon when services for a contract are completed. Accordingly, unearned revenue relating to process development contracts increased from
$4.2 million
as of
December 31, 2015
to
$5.4 million
as of
June 30, 2016
, representing billings on contracts that have not been completed.
|
◦
|
Clinical Manufacturing Revenue
- Clinical manufacturing revenues were approximately
$8.4 million
for the
six months ended
June 30, 2016
compared to
$3.5 million
for the
six months ended
June 30, 2015
. The increase is primarily due to an increase in the number of patients our customers have enrolled and treated in clinical trials, which number varies depending on the stage of the clinical trial.
|
•
|
Clinical Services Reimbursables were approximately
$3.4 million
for the
six months ended
June 30, 2016
compared to
$1.4 million
for the
six months ended
June 30, 2015
, representing an increase of approximately
$2.0 million
, or
144%
. Generally, clinical services reimbursables correlate with clinical services revenues. However, differences in the cost of supplies to be reimbursed can vary greatly from contract to contract based on the cost of supplies needed for each client's manufacturing and development process and may impact this correlation. In addition, our terms for billing reimbursable expenses do not include a significant mark-up in the acquisition cost of such consumables, and as a result, changes in this revenue category have little impact on our gross margin and net loss.
|
•
|
Processing and Storage Services were approximately
$2.2 million
for the
six months ended
June 30, 2016
compared to
$2.1 million
for the
six months ended
June 30, 2015
, representing an increase of approximately
$0.2 million
, or
9%
. The increase was primarily due to higher volume for our oncology stem cell processing services.
|
•
|
Cost of revenues were approximately
$7.1 million
for the
three months ended
June 30, 2016
compared to
$5.8 million
for the
three months ended
June 30, 2015
, representing an increase of
$1.3 million
, or
22%
. Overall, gross margin for the
three months ended
June 30, 2016
was
$1.2 million
, or
15%
, compared to
$0.1 million
, or
1%
for the
three months ended
June 30, 2015
. Gross margin percentages generally will increase/decrease as Clinical Services revenue increases/
|
•
|
Research and development expenses were approximately
$4.0 million
for the
three months ended
June 30, 2016
compared to
$7.6 million
for the
three months ended
June 30, 2015
, representing a decrease of approximately
$3.6 million
, or
47%
.
|
◦
|
Immune Modulation -
Immune modulation expenses, including our recently initiated Phase 2 T1D, were
$1.8 million
for the
three months ended
June 30, 2016
, representing an increase of
$0.7 million
compared to the
three months ended
June 30, 2015
.
|
◦
|
Immuno-oncology -
Immuno-oncology expenses, which are primarily associated with the close-out activities for the Intus Phase 3 clinical trial for the immunotherapy product candidate CLBS20, were
$1.2 million
for the
three months ended
June 30, 2016
, representing a decrease of
$2.0 million
compared to the
three months ended
June 30, 2015
. In January 2016, we discontinued the clinical development of CLBS20. Accordingly, we expect expenses to decrease to zero as close-out activities are completed.
|
◦
|
Ischemic Repair -
Ischemic repair expenses were
$0.8 million
for the
three months ended
June 30, 2016
, representing a decrease of approximately
$1.1 million
compared to the
three months ended
June 30, 2015
. The decrease is primarily due to lower program expenses associated with the decision to only conduct clinical study activity for a critical limb ischemia development program in Japan with a partner, and lower expenses associated with the close-out activities of the PreSERVE-AMI Phase 2 study for CLBS10. Expenses associated with CLBS10 are expected to decrease to zero as close-out activities are completed.
|
◦
|
Other -
Other research and development expenses were
$0.3 million
for the
three months ended
June 30, 2016
, representing a decrease of approximately
$1.2 million
compared to the
three months ended
June 30, 2015
. The decrease was primarily due to approximately
$1.1 million
of lower equity-based compensation expenses during the
three months ended
June 30, 2016
compared to the prior year.
|
•
|
Impairment of intangible assets for the
three months ended
June 30, 2015
relates to the full impairment of IPR&D associated with CLBS10 valued at
$9.4 million
, based on the Company's decision that it will not pursue further development of CLBS10 upon completion of the ongoing PreSERVE-AMI Phase 2 clinical study.
|
•
|
Selling, general and administrative expenses were approximately
$4.7 million
for the
three months ended
June 30, 2016
compared to
$8.7 million
for the
three months ended
June 30, 2015
, representing a decrease of approximately
$4.0 million
, or
46%
. Equity-based compensation included in selling, general and administrative expenses for the
three months ended
June 30, 2016
was approximately
$0.4 million
, compared to approximately
$2.9 million
for the
three months ended
June 30, 2015
, representing a decrease of
$2.5 million
. Equity-based compensation expense is expected to fluctuate in future quarters as equity-linked instruments are used to compensate employees, consultants and other service providers. Non-equity-based general and administrative expenses for the
three months ended
June 30, 2016
were approximately
$4.3 million
, compared to approximately
$5.8 million
for the
three months ended
June 30, 2015
, representing a decrease of
$1.5 million
. The decrease was primarily related to operational and compensation-related cost reductions compared to the prior year period.
|
•
|
Cost of revenues were approximately
$13.3 million
for the
six months ended
June 30, 2016
compared to
$9.2 million
for the
six months ended
June 30, 2015
, representing an increase of
$4.1 million
, or
45%
. Overall, gross margin for the
six months ended
June 30, 2016
was
$2.5 million
, or
16%
, compared to negative gross margin for the
six months ended
June 30, 2015
of
$0.1 million
, or
1%
. Gross margin percentages generally will increase/decrease as Clinical Service revenue increases/decreases. However, gross margin percentages will also fluctuate from period to period due to the mix of service and reimbursable revenues and costs.
|
•
|
Research and development expenses were approximately
$9.9 million
for the
six months ended
June 30, 2016
compared to
$14.4 million
for the
six months ended
June 30, 2015
, representing a decrease of approximately
$4.5 million
, or
31%
.
|
◦
|
Immune Modulation -
Immune modulation expenses, including our efforts focused on initiating our Phase 2 study of CLBS03 in T1D, were
$3.7 million
for the
six months ended
June 30, 2016
, representing an increase of
$1.4 million
compared to the
six months ended
June 30, 2015
.
|
◦
|
Immuno-oncology -
Immuno-oncology expenses, which are primarily associated with the Intus Phase 3 clinical trial for our lead immunotherapy product candidate CLBS20, were
$2.5 million
for the
six months ended
June 30, 2016
, representing a decrease of
$2.6 million
compared to the
six months ended
June 30, 2015
. In January 2016, we discontinued the clinical development of CLBS20. Accordingly, we expect expenses to decrease to zero as close-out activities are completed.
|
◦
|
Ischemic Repair -
Ischemic repair expenses were
$2.0 million
for the
six months ended
June 30, 2016
, representing a decrease of approximately
$2.5 million
compared to the
six months ended
June 30, 2015
. The decrease is primarily due to lower program expenses associated with the decision to only conduct clinical study activity for a critical limb ischemia development program in Japan with a partner, and lower expenses associated with the close-out activities of the PreSERVE-AMI Phase 2 study for CLBS10. Expenses associated with CLBS10 are expected to decrease to zero as close-out activities are completed.
|
◦
|
Other -
Other research and development expenses were
$1.8 million
for the
six months ended
June 30, 2016
, representing a decrease of approximately
$0.8 million
compared to the
six months ended
June 30, 2015
. The decrease was primarily due to approximately
$1.4 million
of lower equity-based compensation expenses and lower non-core research and development expenses, which was partially offset by
$1.2 million
in one-time restructuring costs for severance and loss on disposal of assets during the
six months ended
June 30, 2016
compared to the prior year.
|
•
|
Impairment of intangible assets for the
six months ended
June 30, 2015
relates to the full impairment of IPR&D associated with CLBS10 valued at
$9.4 million
, based on the Company's decision that it will not pursue further development of CLBS10 upon completion of the ongoing PreSERVE-AMI Phase 2 clinical study.
|
•
|
Selling, general and administrative expenses were approximately
$11.2 million
for the
six months ended
June 30, 2016
compared to
$19.8 million
for the
six months ended
June 30, 2015
, representing a decrease of approximately
$8.7 million
, or
44%
. Equity-based compensation included in selling, general and administrative expenses for the
six months ended
June 30, 2016
was approximately
$1.0 million
, compared to approximately
$6.1 million
for the
six months ended
June 30, 2015
, representing a decrease of
$5.2 million
. Equity-based compensation expense is expected to fluctuate in future quarters as equity-linked instruments are used to compensate employees, consultants and other service providers. Non-equity-based general and administrative expenses for the
six months ended
June 30, 2016
were approximately
$10.2 million
, compared to approximately
$13.7 million
for the
six months ended
June 30, 2015
, representing a decrease of
$3.5 million
. The decrease was primarily related to operational and compensation-related cost reductions compared to the prior year period.
|
|
Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
Net cash used in operating activities
|
$
|
(14,575.6
|
)
|
|
$
|
(21,827.0
|
)
|
Net cash (used in) provided by investing activities
|
(1,703.3
|
)
|
|
2,233.2
|
|
||
Net cash provided by financing activities
|
13,660.1
|
|
|
36,631.0
|
|
•
|
During the
six months ended
June 30, 2016
, we spent approximately $
1.7 million
for property and equipment.
|
•
|
During the
six months ended
June 30, 2015
, we spent approximately $
1.8 million
for property and equipment, and sold (net of purchases) approximately
$4.0 million
in marketable securities.
|
•
|
Hitachi Chemical purchased a 19.9% membership interest in PCT for
$19.4 million
.
|
•
|
We raised
$1.0 million
in a private placement through the issuance of
141,844
shares of common stock and two-year warrants to purchase up to an aggregate of
141,844
shares our common stock, at an exercise price of
$10.00
per share.
|
•
|
Upon execution of the Hitachi Transaction, we paid
$6.3 million
in principal payments on our long term debt to Oxford Finance LLC.
|
•
|
We raised $28.8 million (or $26.5 million in net proceeds after deducting underwriting discounts and commissions and offering expenses) through an underwritten offering of
1.4 million
shares of common stock at a public offering price of
$20.00
per share.
|
•
|
We raised gross proceeds of approximately
$9.4 million
through the issuance of approximately
296,977
shares of common stock under the provisions of our equity line of credit with Aspire Capital.
|
|
|
|
|
|
CALADRIUS BIOSCIENCES, INC.
|
August 9, 2016
|
|
By:
/s/ David J. Mazzo, PhD
Name: David J. Mazzo, PhD
Title: Chief Executive Officer
(Principal Executive Officer)
|
August 9, 2016
|
|
By:
/s/ Joseph Talamo
Name: Joseph Talamo
Title: Senior Vice President and Chief Financial
Officer (Principal Financial and Accounting Officer)
|
*
|
Filed herewith.
|
**
|
Furnished herewith.
|
1.
|
The designation of the series;
|
2.
|
The number of shares initially constituting such series;
|
3.
|
The increase, and the decrease to a number not less than the number of the outstanding shares of such series, of the number of shares constituting such series theretofore fixed;
|
4.
|
The rate or rates and the times and conditions under which dividends on the shares of such series shall be paid, and, (i) if such dividends are payable in preference to, or in relation to, the dividends payable on any other class or classes of stock, the terms and conditions of such payment, and (ii) if such dividends shall be cumulative, the date or dates from and after which they shall accumulate;
|
5.
|
Whether or not the shares of such series shall be redeemable, and, if such shares shall be redeemable, the terms and conditions of such redemption, including, but not limited to, the date or dates upon or after which such shares shall be redeemable and the amount per share which shall be payable upon such redemption, which amount may vary under conditions and at different redemption dates;
|
6.
|
The amount payable on the shares of such series in the event of the dissolution of, or upon any distribution of the assets of, the Corporation;
|
7.
|
Whether or not the shares of such series may be convertible into, or exchangeable for, shares of any other class or series and the price or prices and the rates of exchange and the terms of any adjustments to be made in connection with such conversion or exchange;
|
8.
|
Whether or not the shares of such series shall have voting rights in addition to the voting rights provided by law, and, if such shares shall have such voting rights, the terms and conditions thereof, including but not limited to, the right of the holders of such shares to vote as a separate class either alone or with the holders of shares of one or more other series of Preferred Stock and the right to have more or less than one vote per share;
|
9.
|
Whether or not a purchase fund shall be provided for the shares of such series, and, if such a purchase fund shall be provided, the terms and conditions thereof;
|
10.
|
Whether or not a sinking fund shall be provided for the redemption of the shares of such series and if such a sinking fund shall be provided, the terms and conditions thereof; and
|
11.
|
Any other powers, preferences and relative, participating, optional, or other special rights, and qualifications, limitations or restrictions thereof, as shall not be inconsistent with the provisions of this Article FOURTH or the limitations provided by law.
|
1.
|
Subject to the rights of the Preferred stockholders, the holders of the Common Stock shall be entitled to receive such dividends as may be declared thereon by the Board of Directors of the Corporation in its discretion, from time to time, out of any funds or assets of the Corporation lawfully available for the payment of such dividends.
|
2.
|
In the event of any liquidation, dissolution or winding up of the Corporation, or any reduction of its capital, resulting in a distribution of its assets to its stockholders, whether voluntary or involuntary, then, after there shall have been paid or set apart for the holders of the Preferred Stock the full preferential amounts to which they are entitled, the holders of the Common Stock shall be entitled to receive as a class, pro rata, the remaining assets of the Corporation available for distribution to its stockholders.
|
3.
|
For any and all purposes of this Certificate of Incorporation, neither the merger or consolidation of the Corporation into or with any other corporation, nor the merger or consolidation of any other corporation into or with the Corporation, nor a sale, transfer or lease of all or substantially all of the assets of the Corporation, or any other transaction or series of transactions having the effect of a reorganization shall be deemed to be a liquidation, dissolution or winding-up of the Corporation.
|
4.
|
Except as otherwise expressly provided by, law or in a resolution of the Board of Directors providing voting rights to the holders of the Preferred Stock, the holders of the Common Stock shall possess exclusive voting power for the election of directors and for all other purposes and each holder thereof shall be entitled to one vote for each share thereof.
|
/s/ David J. Mazzo
|
/s/ Robert Preti
|
/s/ Douglas W. Losordo
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 as amended; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition of the Company as of the dates presented and the results of operations of the Company for the periods presented.
|
|
/s/ David J. Mazzo, PhD
|
|
David J. Mazzo, PhD
|
|
Chief Executive Officer (Principal Executive Officer)
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 as amended; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition of the Company as of the dates presented and the results of operations of the Company for the periods presented.
|
|
/s/ Joseph Talamo
|
|
Joseph Talamo
|
|
Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)
|