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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Caladrius Biosciences Inc | NASDAQ:CLBS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.4264 | 0.4264 | 0.43 | 0 | 01:00:00 |
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
DELAWARE
|
22-2343568
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
|
|
110 Allen Road, 2nd Floor, Basking Ridge, New Jersey
|
07920
|
(Address of principal executive offices)
|
(zip code)
|
Securities registered pursuant to Section 12(b) of the Act:
|
||
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, par value $0.001 per share
|
CLBS
|
The Nasdaq Capital Market
|
Large accelerated filer
o
|
Accelerated filer
o
|
Non-accelerated filer
x
|
Smaller reporting company
x
|
|
Emerging growth company
o
|
Class
|
Outstanding as of August 8th, 2019
|
||
Common stock, $0.001 par value per share
|
10,401,670
|
|
shares
|
•
|
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;
|
•
|
our ability to build and maintain the management and human resources infrastructure necessary to support the growth of our business;
|
•
|
whether a market is established for our cell-based products and services and our ability to capture a meaningful share of this market;
|
•
|
scientific, regulatory and medical developments beyond our control;
|
•
|
our ability to obtain and maintain, as applicable, appropriate governmental licenses, accreditations or certifications or to comply with healthcare laws and regulations or any other adverse effect or limitations caused by government regulation of our business;
|
•
|
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 upon the claims of third-party patents;
|
•
|
whether any potential strategic or financial benefits of various licensing agreements will be realized;
|
•
|
the results of our development activities;
|
•
|
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; and
|
•
|
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 14, 2019, as subsequently amended on March 19, 2019 (our "2018 Form 10-K").
|
|
Page No.
|
|
Financial Statements:
|
||
|
Consolidated Balance Sheets at June 30, 2019 (unaudited) and December 31, 2018
|
|
|
Consolidated Statements of Operations for the three and six months ended June 30, 2019 and 2018 (unaudited)
|
|
|
Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2019 and 2018 (unaudited)
|
|
|
Consolidated Statements of Equity for the three and six months ended June 30, 2019 and 2018 (unaudited)
|
|
|
Consolidated Statements of Cash Flows for the six months ended June 30, 2019 and 2018 (unaudited)
|
|
|
||
|
|
|
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
ASSETS
|
(Unaudited)
|
|
|
||||
Cash and cash equivalents
|
$
|
11,754
|
|
|
$
|
10,299
|
|
Marketable securities
|
21,901
|
|
|
32,754
|
|
||
Prepaid and other current assets
|
1,163
|
|
|
1,053
|
|
||
Total current assets
|
34,818
|
|
|
44,106
|
|
||
Property and equipment, net
|
130
|
|
|
165
|
|
||
Other assets
|
1,402
|
|
|
309
|
|
||
Total assets
|
$
|
36,350
|
|
|
$
|
44,580
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
||
Liabilities
|
|
|
|
|
|
||
Accounts payable
|
$
|
559
|
|
|
$
|
762
|
|
Accrued liabilities
|
5,153
|
|
|
4,857
|
|
||
Total current liabilities
|
5,712
|
|
|
5,619
|
|
||
Other long-term liabilities
|
1,016
|
|
|
1,507
|
|
||
Total liabilities
|
$
|
6,728
|
|
|
$
|
7,126
|
|
Commitments and Contingencies
|
|
|
|
|
|
||
|
|
|
|
||||
Stockholders' Equity
|
|
|
|
|
|||
Preferred stock, authorized, 20,000,000 shares
Series B convertible redeemable preferred stock liquidation value, 0.001 share of common stock, $0.01 par value; 825,000 shares designated; issued and outstanding, 10,000 shares at June 30, 2019 and December 31, 2018, respectively
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value, authorized 500,000,000 shares; issued and outstanding, 10,412,750 and 9,865,735 shares at June 30, 2019 and December 31, 2018, respectively
|
10
|
|
|
10
|
|
||
Additional paid-in capital
|
438,133
|
|
|
436,433
|
|
||
Treasury stock, at cost; 11,080 shares at June 30, 2019 and December 31, 2018
|
(708
|
)
|
|
(708
|
)
|
||
Accumulated deficit
|
(407,546
|
)
|
|
(397,977
|
)
|
||
Accumulated other comprehensive loss
|
—
|
|
|
(32
|
)
|
||
Total Caladrius Biosciences, Inc. stockholders' equity
|
29,889
|
|
|
37,726
|
|
||
Noncontrolling interests
|
(267
|
)
|
|
(272
|
)
|
||
Total stockholders' equity
|
29,622
|
|
|
37,454
|
|
||
Total liabilities and stockholders' equity
|
$
|
36,350
|
|
|
$
|
44,580
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Operating Expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
$
|
2,988
|
|
|
$
|
2,123
|
|
|
$
|
5,026
|
|
|
$
|
4,385
|
|
General and administrative
|
2,358
|
|
|
2,146
|
|
|
4,912
|
|
|
5,043
|
|
||||
Total operating expenses
|
5,346
|
|
|
4,269
|
|
|
9,938
|
|
|
9,428
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Operating loss
|
(5,346
|
)
|
|
(4,269
|
)
|
|
(9,938
|
)
|
|
(9,428
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Investment income, net
|
209
|
|
|
194
|
|
|
436
|
|
|
371
|
|
||||
Interest expense
|
—
|
|
|
(2
|
)
|
|
—
|
|
|
(5
|
)
|
||||
Total other income (expense), net
|
209
|
|
|
192
|
|
|
436
|
|
|
366
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(5,137
|
)
|
|
$
|
(4,077
|
)
|
|
$
|
(9,502
|
)
|
|
$
|
(9,062
|
)
|
Less - net income (loss) attributable to noncontrolling interests
|
3
|
|
|
(1
|
)
|
|
5
|
|
|
(3
|
)
|
||||
Net loss attributable to Caladrius Biosciences, Inc. common stockholders
|
$
|
(5,140
|
)
|
|
$
|
(4,076
|
)
|
|
$
|
(9,507
|
)
|
|
$
|
(9,059
|
)
|
|
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
||||||||
Basic and diluted loss per share
|
|
|
|
|
|
|
|
||||||||
Caladrius Biosciences, Inc. common stockholders
|
$
|
(0.49
|
)
|
|
$
|
(0.42
|
)
|
|
$
|
(0.93
|
)
|
|
$
|
(0.95
|
)
|
|
|
|
|
|
|
|
|
||||||||
Weighted average common shares outstanding
|
|
|
|
|
|
|
|
||||||||
Basic and diluted shares
|
10,393
|
|
|
9,592
|
|
|
10,211
|
|
|
9,577
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net loss
|
$
|
(5,137
|
)
|
|
$
|
(4,077
|
)
|
|
$
|
(9,502
|
)
|
|
$
|
(9,062
|
)
|
|
|
|
|
|
|
|
|
||||||||
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
||||||||
Available for sale securities - net unrealized income (loss)
|
17
|
|
|
28
|
|
|
31
|
|
|
(3
|
)
|
||||
Total other comprehensive income (loss)
|
17
|
|
|
28
|
|
|
31
|
|
|
(3
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss
|
(5,120
|
)
|
|
(4,049
|
)
|
|
(9,471
|
)
|
|
(9,065
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive income (loss) attributable to noncontrolling interests
|
3
|
|
|
(1
|
)
|
|
5
|
|
|
(3
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss attributable to Caladrius Biosciences, Inc. common stockholders
|
$
|
(5,123
|
)
|
|
$
|
(4,048
|
)
|
|
$
|
(9,476
|
)
|
|
$
|
(9,062
|
)
|
|
Series B Convertible
Preferred Stock
|
|
Common Stock
|
|
Additional
Paid in
Capital
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Treasury
Stock
|
|
Total
Caladrius Biosciences,
Inc.
Stockholders'
Equity
|
|
Non-
Controlling
Interest in
Subsidiary
|
|
Total
Equity
|
||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Balance at March 31, 2018
|
10
|
|
|
$
|
—
|
|
|
9,575
|
|
|
$
|
10
|
|
|
$
|
433,138
|
|
|
$
|
(59
|
)
|
|
$
|
(386,793
|
)
|
|
$
|
(708
|
)
|
|
$
|
45,588
|
|
|
$
|
(272
|
)
|
|
$
|
45,316
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,076
|
)
|
|
—
|
|
|
(4,076
|
)
|
|
(1
|
)
|
|
(4,077
|
)
|
|||||||||
Unrealized gain on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
28
|
|
|
—
|
|
|
—
|
|
|
28
|
|
|
—
|
|
|
28
|
|
|||||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
47
|
|
|
—
|
|
|
1,610
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,610
|
|
|
—
|
|
|
1,610
|
|
|||||||||
Net proceeds from issuance of common stock
|
—
|
|
|
—
|
|
|
50
|
|
|
—
|
|
|
288
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
288
|
|
|
—
|
|
|
288
|
|
|||||||||
Proceeds from option exercises
|
—
|
|
|
—
|
|
|
63
|
|
|
—
|
|
|
302
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
302
|
|
|
—
|
|
|
302
|
|
|||||||||
Balance at June 30, 2018
|
10
|
|
|
$
|
—
|
|
|
9,735
|
|
|
$
|
10
|
|
|
$
|
435,338
|
|
|
$
|
(31
|
)
|
|
$
|
(390,869
|
)
|
|
$
|
(708
|
)
|
|
$
|
43,740
|
|
|
$
|
(273
|
)
|
|
$
|
43,467
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
|
Series B Convertible
Preferred Stock
|
|
Common Stock
|
|
Additional
Paid in
Capital
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Treasury
Stock
|
|
Total
Caladrius Biosciences,
Inc.
Stockholders'
Equity
|
|
Non-
Controlling
Interest in
Subsidiary
|
|
Total
Equity
|
||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Balance at March 31, 2019
|
10
|
|
|
$
|
—
|
|
|
10,393
|
|
|
$
|
10
|
|
|
$
|
437,850
|
|
|
$
|
(18
|
)
|
|
$
|
(402,406
|
)
|
|
$
|
(708
|
)
|
|
$
|
34,728
|
|
|
$
|
(270
|
)
|
|
$
|
34,458
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(5,140
|
)
|
|
—
|
|
|
(5,140
|
)
|
|
3
|
|
|
(5,137
|
)
|
|||||||||
Unrealized gain on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
18
|
|
|
—
|
|
|
—
|
|
|
18
|
|
|
—
|
|
|
18
|
|
|||||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
246
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
246
|
|
|
—
|
|
|
246
|
|
|||||||||
Net proceeds from issuance of common stock
|
—
|
|
|
—
|
|
|
20
|
|
|
—
|
|
|
37
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
37
|
|
|
—
|
|
|
37
|
|
|||||||||
Balance at June 30, 2019
|
10
|
|
|
$
|
—
|
|
|
10,413
|
|
|
$
|
10
|
|
|
$
|
438,133
|
|
|
$
|
—
|
|
|
$
|
(407,546
|
)
|
|
$
|
(708
|
)
|
|
$
|
29,889
|
|
|
$
|
(267
|
)
|
|
$
|
29,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series B Convertible
Preferred Stock
|
|
Common Stock
|
|
Additional
Paid in
Capital
|
|
Accumulated
Other
Comprehensive
Loss
|
|
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, 2017
|
10
|
|
|
$
|
—
|
|
|
9,484
|
|
|
$
|
9
|
|
|
$
|
433,044
|
|
|
$
|
(28
|
)
|
|
$
|
(381,810
|
)
|
|
$
|
(708
|
)
|
|
$
|
50,507
|
|
|
$
|
(318
|
)
|
|
$
|
50,189
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(9,059
|
)
|
|
—
|
|
|
(9,059
|
)
|
|
(3
|
)
|
|
(9,062
|
)
|
|||||||||
Unrealized loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3
|
)
|
|
—
|
|
|
—
|
|
|
(3
|
)
|
|
—
|
|
|
(3
|
)
|
|||||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
126
|
|
|
1
|
|
|
1,712
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,713
|
|
|
—
|
|
|
1,713
|
|
|||||||||
Net proceeds from issuance of common stock
|
—
|
|
|
—
|
|
|
50
|
|
|
—
|
|
|
288
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
288
|
|
|
—
|
|
|
288
|
|
|||||||||
Proceeds from option exercises
|
—
|
|
|
—
|
|
|
75
|
|
|
—
|
|
|
342
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
342
|
|
|
—
|
|
|
342
|
|
|||||||||
Change in ownership in subsidiary
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(48
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(48
|
)
|
|
48
|
|
|
—
|
|
|||||||||
Balance at June 30, 2018
|
10
|
|
|
$
|
—
|
|
|
9,735
|
|
|
$
|
10
|
|
|
$
|
435,338
|
|
|
$
|
(31
|
)
|
|
$
|
(390,869
|
)
|
|
$
|
(708
|
)
|
|
$
|
43,740
|
|
|
$
|
(273
|
)
|
|
$
|
43,467
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
|
Series B Convertible
Preferred Stock
|
|
Common Stock
|
|
Additional
Paid in
Capital
|
|
Accumulated
Other
Comprehensive
Loss
|
|
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, 2018
|
10
|
|
|
$
|
—
|
|
|
9,866
|
|
|
$
|
10
|
|
|
$
|
436,433
|
|
|
$
|
(32
|
)
|
|
$
|
(397,977
|
)
|
|
$
|
(708
|
)
|
|
$
|
37,726
|
|
|
$
|
(272
|
)
|
|
$
|
37,454
|
|
Adoption of accounting standard
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(62
|
)
|
|
—
|
|
|
(62
|
)
|
|
—
|
|
|
(62
|
)
|
|||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(9,507
|
)
|
|
—
|
|
|
(9,507
|
)
|
|
5
|
|
|
(9,502
|
)
|
|||||||||
Unrealized gain on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
32
|
|
|
—
|
|
|
—
|
|
|
32
|
|
|
—
|
|
|
32
|
|
|||||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
96
|
|
|
—
|
|
|
663
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
663
|
|
|
—
|
|
|
663
|
|
|||||||||
Net proceeds from issuance of common stock
|
—
|
|
|
—
|
|
|
451
|
|
|
—
|
|
|
1,037
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,037
|
|
|
—
|
|
|
1,037
|
|
|||||||||
Balance at June 30, 2019
|
10
|
|
|
$
|
—
|
|
|
10,413
|
|
|
$
|
10
|
|
|
$
|
438,133
|
|
|
$
|
—
|
|
|
$
|
(407,546
|
)
|
|
$
|
(708
|
)
|
|
$
|
29,889
|
|
|
$
|
(267
|
)
|
|
$
|
29,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
||
Net loss
|
$
|
(9,502
|
)
|
|
$
|
(9,062
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||
Share-based compensation
|
793
|
|
|
2,115
|
|
||
Depreciation and amortization
|
35
|
|
|
169
|
|
||
Gain on disposal of assets
|
—
|
|
|
(1,379
|
)
|
||
Accretion on marketable securities
|
133
|
|
|
155
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
Prepaid and other current assets
|
(110
|
)
|
|
84
|
|
||
Other assets
|
181
|
|
|
158
|
|
||
Accounts payable, accrued liabilities and other liabilities
|
(1,735
|
)
|
|
(4,424
|
)
|
||
Net cash used in operating activities
|
(10,205
|
)
|
|
(12,184
|
)
|
||
Cash flows from investing activities:
|
|
|
|
|
|
||
Purchase of marketable securities
|
(25,969
|
)
|
|
(38,321
|
)
|
||
Sale of marketable securities
|
36,721
|
|
|
36,482
|
|
||
Proceeds from CFC device sale
|
—
|
|
|
2,500
|
|
||
Acquisition of property and equipment
|
—
|
|
|
(11
|
)
|
||
Net cash provided by investing activities
|
10,752
|
|
|
650
|
|
||
Cash flows from financing activities:
|
|
|
|
|
|
||
Proceeds from exercise of options
|
—
|
|
|
342
|
|
||
Tax withholding payments on net share settlement equity awards
|
(130
|
)
|
|
(403
|
)
|
||
Net proceeds from issuance of common stock
|
1,038
|
|
|
288
|
|
||
Repayment of notes payable
|
—
|
|
|
(136
|
)
|
||
Net cash provided by financing activities
|
908
|
|
|
91
|
|
||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
1,455
|
|
|
(11,443
|
)
|
||
Cash, cash equivalents and restricted cash at beginning of period
|
10,299
|
|
|
34,168
|
|
||
Cash and cash equivalents at end of period
|
$
|
11,754
|
|
|
$
|
22,725
|
|
|
|
|
|
||||
Supplemental Disclosure of Cash Flow Information:
|
|
|
|
||||
Cash paid during the period for:
|
|
|
|
||||
Interest
|
$
|
—
|
|
|
$
|
5
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||||||||||||||||||||||||||
|
Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
|
Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
||||||||||||||||
Corporate debt securities
|
$
|
21,901
|
|
|
$
|
3
|
|
|
$
|
(3
|
)
|
|
$
|
21,901
|
|
|
$
|
33,536
|
|
|
$
|
—
|
|
|
$
|
(32
|
)
|
|
$
|
33,504
|
|
Money market funds
|
8,852
|
|
|
—
|
|
|
—
|
|
|
8,852
|
|
|
4,314
|
|
|
—
|
|
|
—
|
|
|
4,314
|
|
||||||||
Total
|
$
|
30,753
|
|
|
$
|
3
|
|
|
$
|
(3
|
)
|
|
$
|
30,753
|
|
|
$
|
37,850
|
|
|
$
|
—
|
|
|
$
|
(32
|
)
|
|
$
|
37,818
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Cash and cash equivalents
|
$
|
8,852
|
|
|
$
|
5,064
|
|
Marketable securities
|
21,901
|
|
|
32,754
|
|
||
Total
|
$
|
30,753
|
|
|
$
|
37,818
|
|
|
June 30, 2019
|
||||||
|
Amortized Cost
|
|
Estimated Fair Value
|
||||
Less than one year
|
$
|
30,753
|
|
|
$
|
30,753
|
|
Greater than one year
|
—
|
|
|
—
|
|
||
Total
|
$
|
30,753
|
|
|
$
|
30,753
|
|
|
June 30,
|
||||
|
2019
|
|
2018
|
||
Stock Options
|
1,101
|
|
|
1,073
|
|
Warrants
|
30
|
|
|
49
|
|
Restricted Stock Units
|
240
|
|
|
45
|
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||||||||||||||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Marketable securities - available for sale
|
|
$
|
—
|
|
|
$
|
21,901
|
|
|
$
|
—
|
|
|
$
|
21,901
|
|
|
$
|
—
|
|
|
$
|
32,754
|
|
|
$
|
—
|
|
|
$
|
32,754
|
|
|
|
$
|
—
|
|
|
$
|
21,901
|
|
|
$
|
—
|
|
|
$
|
21,901
|
|
|
$
|
—
|
|
|
$
|
32,754
|
|
|
$
|
—
|
|
|
$
|
32,754
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Salaries, employee benefits and related taxes
|
$
|
1,293
|
|
|
$
|
1,758
|
|
Operating lease liabilities - current
|
382
|
|
|
—
|
|
||
CIRM upfront funding - current
|
2,743
|
|
|
2,583
|
|
||
Other
|
735
|
|
|
516
|
|
||
Total
|
$
|
5,153
|
|
|
$
|
4,857
|
|
|
June 30, 2019
|
||
Right-of Use Assets:
|
|
||
Other assets
|
$
|
1,093
|
|
Total Right-of-Use Asset
|
$
|
1,093
|
|
|
|
||
Operating Lease Liabilities:
|
|
||
Accrued liabilities
|
$
|
383
|
|
Other long-term liabilities
|
788
|
|
|
Total Operating Lease Liabilities
|
$
|
1,171
|
|
Years ended
|
Operating Leases
|
||
2019
|
$
|
304
|
|
2020
|
403
|
|
|
2021
|
411
|
|
|
2022
|
236
|
|
|
2023
|
27
|
|
|
Total lease payments
|
1,381
|
|
|
Less: Amounts representing interest
|
(210
|
)
|
|
Present value of lease liabilities
|
$
|
1,171
|
|
|
|
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, 2018
|
|
1,018,530
|
|
|
$
|
30.54
|
|
|
5.30
|
|
$
|
3.3
|
|
|
30,000
|
|
|
$
|
5.89
|
|
|
4.19
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Changes during the period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Granted
|
|
209,346
|
|
|
4.86
|
|
|
|
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||||
Exercised
|
|
(240
|
)
|
|
3.54
|
|
|
|
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||||
Forfeited
|
|
(2,610
|
)
|
|
4.63
|
|
|
|
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||||
Expired
|
|
(124,004
|
)
|
|
53.68
|
|
|
|
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||||
Outstanding at June 30, 2019
|
|
1,101,022
|
|
|
$
|
23.12
|
|
|
6.25
|
|
$
|
—
|
|
|
30,000
|
|
|
$
|
5.89
|
|
|
3.70
|
|
$
|
—
|
|
Vested at June 30, 2019
or expected to vest in the future |
|
1,076,348
|
|
|
$
|
23.55
|
|
|
6.18
|
|
$
|
—
|
|
|
30,000
|
|
|
$
|
5.89
|
|
|
3.70
|
|
$
|
—
|
|
Vested at June 30, 2019
|
|
856,547
|
|
|
$
|
28.40
|
|
|
5.39
|
|
$
|
—
|
|
|
30,000
|
|
|
$
|
5.89
|
|
|
3.70
|
|
$
|
—
|
|
|
|
Six Months Ended June 30,
|
||||||
|
|
2019
|
|
2018
|
||||
Number of restricted stock issued
|
|
123,564
|
|
|
127,688
|
|
||
Value of restricted stock issued
|
|
$
|
612
|
|
|
$
|
351
|
|
|
Six Months Ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
Number of restricted stock units issued
|
184,454
|
|
|
34,988
|
|
||
Value of restricted stock units issued
|
$
|
909
|
|
|
$
|
133
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Research and development
|
$
|
50
|
|
|
$
|
341
|
|
|
$
|
174
|
|
|
$
|
381
|
|
General and administrative
|
195
|
|
|
1,627
|
|
|
619
|
|
|
1,734
|
|
||||
Total share-based compensation expense
|
$
|
245
|
|
|
$
|
1,968
|
|
|
$
|
793
|
|
|
$
|
2,115
|
|
|
|
|
|
|
|
|
|
|
Stock Options
|
|
Restricted Stock
|
||||
Unrecognized compensation cost
|
$
|
850
|
|
|
$
|
—
|
|
Expected weighted-average period in years of compensation cost to be recognized
|
2.04
|
|
|
0.00
|
|
|
Stock Options
|
||||||
|
Six Months Ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
Total fair value of shares vested
|
$
|
378
|
|
|
$
|
85
|
|
Weighted average estimated fair value of shares granted
|
$
|
3.18
|
|
|
$
|
2.41
|
|
•
|
Research and development expenses were approximately
$3.0 million
for the
three months ended
June 30, 2019
, compared to
$2.1 million
for the
three months ended
June 30, 2018
, representing an increase of approximately
$0.9 million
, or
41%
. Research and development in both periods focused on the advancement of our ischemic repair platform, and related to (i) expenses associated with our ongoing Phase 2 study of CLBS12 in critical limb ischemia development program in Japan, (ii) expense associated with our ongoing Phase 1b/2a study for CLBS16 in coronary microvascular dysfunction, and (iii) expenses associated with planning our CLBS14 program in NORDA.
|
•
|
General and administrative expenses were approximately
$2.4 million
for the
three months ended
June 30, 2019
, compared to
$2.1 million
for the
three months ended
June 30, 2018
, representing an increase of approximately
$0.2 million
, or
10%
. Our general and administrative expenses focus on general corporate-related activities.
|
•
|
Research and development expenses were approximately
$5.0 million
for the
six months ended
June 30, 2019
, compared to
$4.4 million
for the
six months ended
June 30, 2018
, representing an increase of approximately
$0.6 million
, or
15%
. Research and development in both periods focused on the advancement of our ischemic repair platform, and related to (i) expenses associated with our ongoing Phase 2 study of CLBS12 in critical limb ischemia development program in Japan, (ii) expense associated with our ongoing Phase 1b/2a study for CLBS16 in coronary microvascular dysfunction, and (iii) expenses associated with planning our CLBS14 program in NORDA.
|
•
|
General and administrative expenses were approximately
$4.9 million
for the
six months ended
June 30, 2019
, compared to
$5.0 million
for the
six months ended
June 30, 2018
, representing a decrease of approximately
$0.1 million
, or
3%
. Our general and administrative expenses focus on general corporate-related activities.
|
|
Six Months Ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
Net cash used in operating activities
|
$
|
(10,205
|
)
|
|
$
|
(12,184
|
)
|
Net cash provided by investing activities
|
10,752
|
|
|
650
|
|
||
Net cash provided by financing activities
|
908
|
|
|
91
|
|
|
|
|
|
|
CALADRIUS BIOSCIENCES, INC.
|
August 8, 2019
|
|
By:
/s/ David J. Mazzo, PhD
Name: David J. Mazzo, PhD
Title: President and Chief Executive Officer
(Principal Executive Officer)
|
August 8, 2019
|
|
By:
/s/ Joseph Talamo
Name: Joseph Talamo
Title: Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)
|
*
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
*
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
**
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
**
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase
|
*
|
Filed herewith.
|
**
|
Furnished herewith.
|
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