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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Cytocom Inc | NASDAQ:CBLI | 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% | 3.17 | 3.18 | 3.41 | 0 | 01:00:00 |
|
|
|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
DELAWARE
|
20-0077155
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
|
|
73 High Street, Buffalo, New York
|
14203
|
(Address of principal executive offices)
|
(Zip Code)
|
|
Large accelerated filer
|
¨
|
Accelerated filer
|
¨
|
Non-accelerated filer
|
¨
|
Smaller reporting company
|
x
|
Emerging Growth Company
|
¨
|
|
|
|
|
PAGE
|
|
|
||
ITEM 1.
|
|
|
|
||
|
||
|
Consolidated Condensed Statements of Comprehensive
Income (Loss)
|
|
|
||
|
||
|
||
ITEM 2.
|
||
ITEM 3.
|
||
ITEM 4.
|
||
|
|
|
|
||
ITEM 1.
|
||
ITEM 1A.
|
||
ITEM 2.
|
||
ITEM 3.
|
||
ITEM 4.
|
||
ITEM 5.
|
||
ITEM 6.
|
||
|
|
September 30, 2017
|
|
December 31, 2016
|
||||
|
(Unaudited)
|
|
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
4,590,856
|
|
|
$
|
6,901,816
|
|
Short-term investments
|
5,466,185
|
|
|
8,343,657
|
|
||
Accounts receivable
|
444,244
|
|
|
352,700
|
|
||
Other current assets
|
321,109
|
|
|
289,768
|
|
||
Total current assets
|
10,822,394
|
|
|
15,887,941
|
|
||
Equipment, net
|
18,460
|
|
|
37,376
|
|
||
Other long-term assets
|
30,665
|
|
|
30,553
|
|
||
Total assets
|
$
|
10,871,519
|
|
|
$
|
15,955,870
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
380,914
|
|
|
$
|
336,435
|
|
Accrued expenses
|
864,223
|
|
|
1,823,235
|
|
||
Accrued warrant liability
|
1,027,303
|
|
|
949,419
|
|
||
Total current liabilities
|
2,272,440
|
|
|
3,109,089
|
|
||
Commitments and contingencies
|
—
|
|
|
—
|
|
||
Total liabilities
|
2,272,440
|
|
|
3,109,089
|
|
||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $.005 par value; 1,000,000 and 10,000,000 shares authorized as of September 30, 2017 and December 31, 2016, respectively, 0 shares issued and outstanding as of September 30, 2017 and December 31, 2016
|
—
|
|
|
—
|
|
||
Common stock, $.005 par value; 25,000,000 and 160,000,000 shares authorized as of September 30, 2017 and December 31, 2016, respectively, 11,279,834 and 10,987,166 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively
|
56,395
|
|
|
54,932
|
|
||
Additional paid-in capital
|
163,106,400
|
|
|
158,773,753
|
|
||
Other comprehensive loss
|
(521,650
|
)
|
|
(564,559
|
)
|
||
Accumulated deficit
|
(159,277,502
|
)
|
|
(150,740,156
|
)
|
||
Total Cleveland BioLabs, Inc. stockholders’ equity
|
3,363,643
|
|
|
7,523,970
|
|
||
Noncontrolling interest in stockholders’ equity
|
5,235,436
|
|
|
5,322,811
|
|
||
Total stockholders’ equity
|
8,599,079
|
|
|
12,846,781
|
|
||
Total liabilities and stockholders’ equity
|
$
|
10,871,519
|
|
|
$
|
15,955,870
|
|
|
For the Three Months Ended
September 30, |
|
For the Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Grants and contracts
|
$
|
296,881
|
|
|
$
|
1,141,212
|
|
|
$
|
1,078,011
|
|
|
$
|
2,528,737
|
|
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
919,067
|
|
|
1,104,742
|
|
|
3,524,445
|
|
|
4,338,149
|
|
||||
General and administrative
|
575,136
|
|
|
750,603
|
|
|
1,940,848
|
|
|
2,711,276
|
|
||||
Total operating expenses
|
1,494,203
|
|
|
1,855,345
|
|
|
5,465,293
|
|
|
7,049,425
|
|
||||
Loss from operations
|
(1,197,322
|
)
|
|
(714,133
|
)
|
|
(4,387,282
|
)
|
|
(4,520,688
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Interest and other income
|
67,738
|
|
|
42,400
|
|
|
167,461
|
|
|
272,691
|
|
||||
Foreign exchange gain (loss)
|
(447
|
)
|
|
10,744
|
|
|
(12,732
|
)
|
|
90,932
|
|
||||
Gain (loss) on investments
|
—
|
|
|
(32,926
|
)
|
|
—
|
|
|
40,517
|
|
||||
Change in value of warrant liability
|
(166,287
|
)
|
|
1,834,505
|
|
|
(4,411,994
|
)
|
|
2,700,055
|
|
||||
Total other income (expense)
|
(98,996
|
)
|
|
1,854,723
|
|
|
(4,257,265
|
)
|
|
3,104,195
|
|
||||
Net income (loss)
|
(1,296,318
|
)
|
|
1,140,590
|
|
|
(8,644,547
|
)
|
|
(1,416,493
|
)
|
||||
Net loss (income) attributable to noncontrolling interests
|
35,454
|
|
|
(2,136
|
)
|
|
107,201
|
|
|
(10,857
|
)
|
||||
Net income (loss) attributable to Cleveland BioLabs, Inc.
|
$
|
(1,260,864
|
)
|
|
$
|
1,138,454
|
|
|
$
|
(8,537,346
|
)
|
|
$
|
(1,427,350
|
)
|
Net income (loss) attributable to common stockholders per share of common stock, basic and diluted
|
$
|
(0.11
|
)
|
|
$
|
0.10
|
|
|
$
|
(0.76
|
)
|
|
$
|
(0.13
|
)
|
Weighted average number of shares used in calculating net loss per share, basic and diluted
|
11,279,834
|
|
|
10,987,166
|
|
|
11,162,981
|
|
|
10,987,166
|
|
|
For the Three Months Ended
September 30, |
|
For the Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Net income (loss) including noncontrolling interests
|
$
|
(1,296,318
|
)
|
|
$
|
1,140,590
|
|
|
$
|
(8,644,547
|
)
|
|
$
|
(1,416,493
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
||||||||
Unrealized gain (loss) on short-term investments
|
3,226
|
|
|
(1,732
|
)
|
|
(184
|
)
|
|
7,706
|
|
||||
Foreign currency translation adjustment
|
20,732
|
|
|
11,823
|
|
|
62,919
|
|
|
58,188
|
|
||||
Comprehensive income (loss) including noncontrolling interests
|
(1,272,360
|
)
|
|
1,150,681
|
|
|
(8,581,812
|
)
|
|
(1,350,599
|
)
|
||||
Comprehensive loss (gain) attributable to noncontrolling interests
|
28,846
|
|
|
(9,887
|
)
|
|
87,375
|
|
|
(69,053
|
)
|
||||
Comprehensive income (loss) attributable to Cleveland BioLabs, Inc.
|
$
|
(1,243,514
|
)
|
|
$
|
1,140,794
|
|
|
$
|
(8,494,437
|
)
|
|
$
|
(1,419,652
|
)
|
|
Common Stock
|
|
Treasury Stock
|
|
Additional
Paid-In Capital |
||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|||||||||
Balance at December 31, 2016
|
10,987,166
|
|
|
$
|
54,932
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
158,773,753
|
|
Exercise of warrants
|
292,668
|
|
|
1,463
|
|
|
—
|
|
|
—
|
|
|
4,332,647
|
|
|||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Unrealized loss on short-term investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Foreign currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Balance at September 30, 2017
|
11,279,834
|
|
|
$
|
56,395
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
163,106,400
|
|
|
Accumulated Other
Comprehensive Income (Loss) |
|
Accumulated
Deficit |
|
Noncontrolling
Interests |
|
Total
|
||||||||
Balance at December 31, 2016
|
$
|
(564,559
|
)
|
|
$
|
(150,740,156
|
)
|
|
$
|
5,322,811
|
|
|
$
|
12,846,781
|
|
Exercise of warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
4,334,110
|
|
||||
Net loss
|
—
|
|
|
(8,537,346
|
)
|
|
(107,201
|
)
|
|
(8,644,547
|
)
|
||||
Unrealized loss on short-term investments
|
(184
|
)
|
|
—
|
|
|
—
|
|
|
(184
|
)
|
||||
Foreign currency translation
|
43,093
|
|
|
—
|
|
|
19,826
|
|
|
62,919
|
|
||||
Balance at September 30, 2017
|
$
|
(521,650
|
)
|
|
$
|
(159,277,502
|
)
|
|
$
|
5,235,436
|
|
|
$
|
8,599,079
|
|
|
For the Nine Months Ended September 30,
|
||||||
|
2017
|
|
2016
|
||||
Cash flows from operating activities:
|
|
||||||
Net loss
|
$
|
(8,644,547
|
)
|
|
$
|
(1,416,493
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
16,802
|
|
|
53,671
|
|
||
Non-cash investment income
|
(42,687
|
)
|
|
(31,503
|
)
|
||
Gain on equipment disposal
|
(6,727
|
)
|
|
—
|
|
||
Investment loss provision
|
—
|
|
|
42,476
|
|
||
Non-cash compensation
|
—
|
|
|
13,623
|
|
||
Change in value of warrant liability
|
4,411,994
|
|
|
(2,700,055
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable and other current assets
|
(121,633
|
)
|
|
(857,203
|
)
|
||
Other long-term assets
|
—
|
|
|
(3,698
|
)
|
||
Accounts payable and accrued expenses
|
(944,765
|
)
|
|
(393,746
|
)
|
||
Deferred revenue
|
—
|
|
|
(12,677
|
)
|
||
Net cash used in operating activities
|
(5,331,563
|
)
|
|
(5,305,605
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchase of short-term investments
|
(6,133,755
|
)
|
|
(12,807,168
|
)
|
||
Sale of short-term investments
|
9,092,512
|
|
|
15,745,225
|
|
||
Purchase of equipment
|
—
|
|
|
(7,643
|
)
|
||
Proceeds from sale of equipment
|
8,956
|
|
|
16,665
|
|
||
Decrease in restricted cash
|
—
|
|
|
(2,325
|
)
|
||
Net cash provided by investing activities
|
2,967,713
|
|
|
2,944,754
|
|
||
Cash flows from financing activities:
|
|
|
|
||||
Net proceeds from sale of treasury stock
|
—
|
|
|
539,998
|
|
||
Net cash provided by financing activities
|
—
|
|
|
539,998
|
|
||
Effect of exchange rate change on cash and equivalents
|
52,890
|
|
|
(45,599
|
)
|
||
Decrease in cash and cash equivalents
|
(2,310,960
|
)
|
|
(1,866,452
|
)
|
||
Cash and cash equivalents at beginning of period
|
6,901,816
|
|
|
5,918,424
|
|
||
Cash and cash equivalents at end of period
|
$
|
4,590,856
|
|
|
$
|
4,051,972
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Cash paid during the period for interest
|
$
|
—
|
|
|
$
|
—
|
|
Supplemental schedule of non-cash financing activities:
|
|
|
|
||||
Cashless exercise of warrants
|
$
|
4,334,110
|
|
|
$
|
—
|
|
|
Three Months Ended
September 30, |
|
|
|
Nine Months Ended
September 30, |
|
|
||||||||||
Customer
|
2017
|
|
2016
|
|
Variance
|
|
2017
|
|
2016
|
|
Variance
|
||||||
Department of Defense
|
44.3
|
%
|
|
43.8
|
%
|
|
0.5
|
%
|
|
63.2
|
%
|
|
35.8
|
%
|
|
27.4
|
%
|
Russian Government Agencies
|
—
|
%
|
|
40.0
|
%
|
|
(40.0
|
)%
|
|
—
|
%
|
|
43.3
|
%
|
|
(43.3
|
)%
|
Incuron, LLC
|
55.7
|
%
|
|
16.2
|
%
|
|
39.5
|
%
|
|
36.8
|
%
|
|
20.9
|
%
|
|
15.9
|
%
|
Total
|
100.0
|
%
|
|
100.0
|
%
|
|
—
|
%
|
|
100.0
|
%
|
|
100.0
|
%
|
|
—
|
%
|
|
Unrealized loss on available-for-sale securities
|
|
Gains and losses on foreign exchange translations
|
|
Total
|
||||||
Beginning balance
|
$
|
(2,286
|
)
|
|
$
|
(562,273
|
)
|
|
$
|
(564,559
|
)
|
Other comprehensive income (loss) before reclassifications
|
(184
|
)
|
|
43,093
|
|
|
42,909
|
|
|||
Amounts reclassified from accumulated other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|||
Ending balance
|
$
|
(2,470
|
)
|
|
$
|
(519,180
|
)
|
|
$
|
(521,650
|
)
|
|
As of September 30,
|
||||
Common Equivalent Securities
|
2017
|
|
2016
|
||
Warrants
|
925,812
|
|
|
2,148,741
|
|
Options
|
214,987
|
|
|
236,124
|
|
Total
|
1,140,799
|
|
|
2,384,865
|
|
•
|
Level 1 – Observable inputs for identical assets or liabilities such as quoted prices in active markets;
|
•
|
Level 2 – Inputs other than quoted prices in active markets that are either directly or indirectly observable; and
|
•
|
Level 3 – Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect those that a market participant would use.
|
|
As of September 30, 2017
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
1,342,064
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,342,064
|
|
Short-term investments
|
4,604,367
|
|
|
861,818
|
|
|
—
|
|
|
5,466,185
|
|
||||
Total assets
|
$
|
5,946,431
|
|
|
$
|
861,818
|
|
|
$
|
—
|
|
|
$
|
6,808,249
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Accrued warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,027,303
|
|
|
$
|
1,027,303
|
|
|
As of December 31, 2016
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
2,436,589
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,436,589
|
|
Short-term investments
|
7,487,365
|
|
|
856,292
|
|
|
—
|
|
|
8,343,657
|
|
||||
Total assets
|
$
|
9,923,954
|
|
|
$
|
856,292
|
|
|
$
|
—
|
|
|
$
|
10,780,246
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Accrued warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
949,419
|
|
|
$
|
949,419
|
|
|
September 30, 2017
|
|
December 31, 2016
|
||||
Stock Price
|
$
|
3.44
|
|
|
$
|
1.42
|
|
Exercise Price
|
$3.00 - $60.00
|
|
|
$3.00 - $60.00
|
|
||
Term in years
|
0.07 – 3.85
|
|
|
0.17 - 4.60
|
|
||
Volatility
|
57.05% - 188.50%
|
|
|
52.88% - 96.36%
|
|
||
Annual rate of quarterly dividends
|
—
|
%
|
|
—
|
%
|
||
Discount rate- bond equivalent yield
|
.09% - 1.72%
|
|
|
.15% - 1.84%
|
|
|
Three Months Ended
September 30, 2017 |
|
Three Months Ended September 30, 2016
|
||||
|
Accrued
Warrant Liability |
|
Accrued
Warrant Liability |
||||
Beginning Balance
|
$
|
861,016
|
|
|
$
|
3,183,350
|
|
Total (gains) or losses, realized and unrealized, included in earnings (1)
|
166,287
|
|
|
(1,834,505
|
)
|
||
Issuances
|
—
|
|
|
—
|
|
||
Settlements
|
—
|
|
|
—
|
|
||
Ending Balance
|
$
|
1,027,303
|
|
|
$
|
1,348,845
|
|
|
Nine Months Ended September 30, 2017
|
|
Nine Months Ended September 30, 2016
|
||||
|
Accrued
Warrant
Liability
|
|
Accrued
Warrant
Liability
|
||||
Beginning Balance
|
$
|
949,419
|
|
|
$
|
4,048,900
|
|
Total (gains) or losses, realized and unrealized, included in earnings (1)
|
4,411,994
|
|
|
(2,700,055
|
)
|
||
Issuances
|
—
|
|
|
—
|
|
||
Settlements
|
(4,334,110
|
)
|
|
—
|
|
||
Ending Balance
|
$
|
1,027,303
|
|
|
$
|
1,348,845
|
|
(1)
|
Unrealized gains or losses related to the accrued warrant liability were included as change in value of accrued warrant liability. There were
no
realized gains or losses for the
three and nine
months ended
September 30, 2017
and
2016
.
|
|
Total Stock
Options
Outstanding
|
|
Weighted
Average Exercise
Price per Share
|
|||
December 31, 2016
|
233,367
|
|
|
$
|
41.98
|
|
Granted
|
—
|
|
|
—
|
|
|
Vested
|
—
|
|
|
—
|
|
|
Forfeited, Canceled
|
(18,380
|
)
|
|
69.90
|
|
|
September 30, 2017
|
214,987
|
|
|
$
|
39.59
|
|
|
As of September 30, 2017
|
||||||
|
Stock Options
Outstanding
|
|
Vested Stock
Options
|
||||
Quantity
|
214,987
|
|
|
214,987
|
|
||
Weighted-average exercise price
|
$
|
39.59
|
|
|
$
|
39.59
|
|
Weighted Average Remaining Contractual Term (in Years)
|
5.43
|
|
|
5.43
|
|
||
Intrinsic value
|
$
|
18,780
|
|
|
$
|
—
|
|
|
Number of
Warrants |
|
Weighted Average
Exercise Price |
|||
December 31, 2016
|
2,148,741
|
|
|
$
|
11.04
|
|
Granted
|
—
|
|
|
—
|
|
|
Exercised
|
(1,181,235
|
)
|
|
3.64
|
|
|
Forfeited, Canceled
|
(41,694
|
)
|
|
3.00
|
|
|
September 30, 2017
|
925,812
|
|
|
$
|
20.84
|
|
|
April 20, 2017
|
|
||
Stock Price
|
$
|
4.84
|
|
|
Exercise Price
|
$
|
3.64
|
|
|
Term in years
|
4.29
|
|
|
|
Volatility
|
101.93
|
%
|
|
|
Annual rate of quarterly dividends
|
—
|
%
|
|
|
Discount rate- bond equivalent yield
|
1.65
|
%
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
Program
|
|
Three Months Ended September 30,
|
|
|
||||||||
Funding Source
|
2017
|
|
2016
|
|
Variance
|
||||||||
DoD
|
JWMRP Contract (1)
|
|
$
|
130,618
|
|
|
$
|
490,895
|
|
|
$
|
(360,277
|
)
|
DoD
|
PRMRP Contract (2)
|
|
762
|
|
|
8,842
|
|
|
(8,080
|
)
|
|||
MPT
|
Entolimod colorectal cancer (3)
|
|
—
|
|
|
326,014
|
|
|
(326,014
|
)
|
|||
Incuron
|
Service contract
|
|
165,501
|
|
|
184,819
|
|
|
(19,318
|
)
|
|||
|
|
|
296,881
|
|
|
1,010,570
|
|
|
(713,689
|
)
|
|||
MPT
|
Mobilan pre-clinical (3)
|
|
—
|
|
|
130,642
|
|
|
(130,642
|
)
|
|||
|
|
|
$
|
296,881
|
|
|
$
|
1,141,212
|
|
|
$
|
(844,331
|
)
|
(1)
|
The Congressionally Directed Medical Research Programs (CDMRP) Joint Warfighter Medical Research Program (JWMRP) contract was awarded on September 1, 2015.
|
(2)
|
The CDMRP Peer Reviewed Medical Research Program (PRMRP) grant was awarded effective as of September 30, 2015.
|
(3)
|
The grants received from Russian government entities are denominated in Russian Rubles (RUB). The revenue above was calculated using average exchange rates for the periods presented.
|
|
|
|
|
|
|
|
|
As of September 30, 2017
|
||||||||||||||
Funding Source
|
|
Program
|
|
Total Award
Value
|
|
Funded Award
Value
|
|
Cumulative
Revenue
|
|
Funded
Backlog
|
|
Unfunded Backlog
|
||||||||||
DoD
|
|
JWMRP Contract
|
|
$
|
9,226,455
|
|
|
$
|
9,226,455
|
|
|
$
|
2,066,269
|
|
|
$
|
7,160,186
|
|
|
$
|
—
|
|
DoD
|
|
PRMRP Contract
|
|
6,573,992
|
|
|
6,573,992
|
|
|
73,436
|
|
|
6,500,556
|
|
|
—
|
|
|||||
|
|
|
|
$
|
15,800,447
|
|
|
$
|
15,800,447
|
|
|
$
|
2,139,705
|
|
|
$
|
13,660,742
|
|
|
$
|
—
|
|
|
Three Months Ended September 30,
|
|
|
||||||||
|
2017
|
|
2016
|
|
Variance
|
||||||
Entolimod for Biodefense Applications
|
$
|
623,331
|
|
|
$
|
606,186
|
|
|
$
|
17,145
|
|
Entolimod for Oncology Indications
|
72,138
|
|
|
269,545
|
|
|
(197,407
|
)
|
|||
|
695,469
|
|
|
875,731
|
|
|
(180,262
|
)
|
|||
Incuron service contract
|
148,898
|
|
|
137,210
|
|
|
11,688
|
|
|||
Panacela product candidates
|
74,700
|
|
|
91,801
|
|
|
(17,101
|
)
|
|||
Total research and development expenses
|
$
|
919,067
|
|
|
$
|
1,104,742
|
|
|
$
|
(185,675
|
)
|
|
Program
|
|
Nine Months Ended September 30,
|
|
|
||||||||
Funding Source
|
2017
|
|
2016
|
|
Variance
|
||||||||
DoD
|
JWMRP Contract (1)
|
|
$
|
674,806
|
|
|
$
|
859,188
|
|
|
$
|
(184,382
|
)
|
DoD
|
PRMRP Contract (2)
|
|
4,185
|
|
|
46,157
|
|
|
(41,972
|
)
|
|||
DoD
|
DTRA Contract (3)
|
|
1,886
|
|
|
—
|
|
|
1,886
|
|
|||
MPT
|
CBLB612 pre-clinical (4)
|
|
—
|
|
|
304,485
|
|
|
(304,485
|
)
|
|||
MPT
|
Entolimod colorectal cancer (4)
|
|
—
|
|
|
462,257
|
|
|
(462,257
|
)
|
|||
Incuron
|
Service contract
|
|
397,134
|
|
|
528,411
|
|
|
(131,277
|
)
|
|||
|
|
|
1,078,011
|
|
|
2,200,498
|
|
|
(1,122,487
|
)
|
|||
MPT
|
Mobilan pre-clinical (4)
|
|
—
|
|
|
328,239
|
|
|
(328,239
|
)
|
|||
|
|
|
$
|
1,078,011
|
|
|
$
|
2,528,737
|
|
|
$
|
(1,450,726
|
)
|
(1)
|
The Congressionally Directed Medical Research Programs (CDMRP) Joint Warfighter Medical Research Program (JWMRP) contract was awarded on September 1, 2015.
|
(2)
|
The CDMRP Peer Reviewed Medical Research Program (PRMRP) grant was awarded effective as of September 30, 2015.
|
(3)
|
The Defense Threat Reduction Agency (DTRA) contract had additional revenue recognized upon acknowledgment of final annual indirect rates for the fiscal year ended December 31, 2013.
|
(4)
|
The grants received from Russian government entities are denominated in Russian Rubles (RUB). The revenue above was calculated using average exchange rates for the periods presented.
|
|
Nine Months Ended September 30,
|
|
|
||||||||
|
2017
|
|
2016
|
|
Variance
|
||||||
Entolimod for Biodefense Applications
|
$
|
2,776,473
|
|
|
$
|
2,174,445
|
|
|
$
|
602,028
|
|
Entolimod for Oncology Indications
|
247,647
|
|
|
1,561,145
|
|
|
(1,313,498
|
)
|
|||
|
3,024,120
|
|
|
3,735,590
|
|
|
(711,470
|
)
|
|||
Incuron service contract
|
291,469
|
|
|
356,518
|
|
|
(65,049
|
)
|
|||
Panacela product candidates
|
208,856
|
|
|
246,041
|
|
|
(37,185
|
)
|
|||
Total research and development expenses
|
$
|
3,524,445
|
|
|
$
|
4,338,149
|
|
|
$
|
(813,704
|
)
|
•
|
From inception through
September 30, 2017
, we have raised $144.7 million of net equity capital, including amounts received from the exercise of options and warrants;
|
•
|
DoD and BARDA have funded grants and contracts totaling $60.4 million for the development of entolimod for its biodefense indication;
|
•
|
Russian Government Agencies have funded a series of our oncology clinical development contracts totaling $17.3 million, based on the exchange rates in effect on the date of funding. These contracts included a requirement for us to contribute matching funds, which we have satisfied with both the value of developed intellectual property at the time of award and incurred development expenses;
|
•
|
We have been awarded $4.0 million in grants and contracts not described above, all of which have been recognized at
September 30, 2017
;
|
•
|
Incuron was formed to develop and commercialize the Curaxins product line, including its lead oncology drug candidate CBL0137. In 2015, we sold our ownership interest for approximately $4.0 million and retain a 2% royalty interest in the CBL0137 technology; and
|
•
|
Panacela was formed to develop and commercialize preclinical compounds, which were transferred to Panacela through assignment agreements. RUSNANO contributed $9.0 million to Panacela and CBLI contributed $3.0 million plus intellectual property to Panacela. As of the date of this filing, CBLI owns 67.57% of Panacela.
|
|
For the Nine Months Ended
September 30, |
||||||||||
|
2017
|
|
2016
|
|
Variance
|
||||||
Cash flows used in operating activities
|
$
|
(5,331,563
|
)
|
|
$
|
(5,305,605
|
)
|
|
$
|
(25,958
|
)
|
Cash flows provided by investing activities
|
2,967,713
|
|
|
2,944,754
|
|
|
22,959
|
|
|||
Cash flows provided by financing activities
|
—
|
|
|
539,998
|
|
|
(539,998
|
)
|
|||
Effect of exchange rate change on cash and equivalents
|
52,890
|
|
|
(45,599
|
)
|
|
98,489
|
|
|||
Decrease in cash and cash equivalents
|
(2,310,960
|
)
|
|
(1,866,452
|
)
|
|
(444,508
|
)
|
|||
Cash and cash equivalents at beginning of period
|
6,901,816
|
|
|
5,918,424
|
|
|
983,392
|
|
|||
Cash and cash equivalents at end of period
|
$
|
4,590,856
|
|
|
$
|
4,051,972
|
|
|
$
|
538,884
|
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
Item 4.
|
Controls and Procedures
|
Item 1.
|
Legal Proceedings
|
Item 1A.
|
Risk Factors
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
Item 3.
|
Defaults Upon Senior Securities
|
Item 4.
|
Mine Safety Disclosures
|
Item 5.
|
Other Information
|
Item 6.
|
Exhibits
|
(a)
|
The following exhibits are included as part of this report:
|
|
CLEVELAND BIOLABS, INC.
|
|
|
|
|
Dated: November 14, 2017
|
By:
|
/s/ YAKOV KOGAN
|
|
|
Yakov N. Kogan
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer and Principal Financial Officer)
|
|
|
|
1 Year Cytocom Chart |
1 Month Cytocom Chart |
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