|
|
|
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)
|
|
|
|
14.
DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
Modification Control Number: jhoffman174729
The purpose of this modification is to:
1. Extend the Period of Performance by 18 months at no cost to the Government.
2. Approve Animal research CRO change from [***].
3. Approve re-allocation of projected cost savings from [***].
4. Approve request to re-budget funds from within [***].
All other terms and conditions remain the same.
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in Sill force and effect. |
||||||||||||||||||
15A
|
NAME AND TITLE OF SIGNER (Type or print)
|
16A NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
ERICA K. SMITH /CONTRACTING OFFICER
TEL: (301) 619-3454 EMAIL: erica.k.smith5.civ@mail.mil
|
||||||||||||||||
15B
|
CONTRACTOR/OFFEROR
/s/ Yakov Kogan
|
15C. DATE SIGNED
|
16B UNITED STATES OF AMERICA
BY
/s/ Erica K. Smith
|
16C
DATE SIGNED
14-Sep-2017
|
||||||||||||||
|
(Signature of person authorized to sign)
|
9/14/2017
|
(Signature of Contracting Officer)
|
|
EXCEPT TO SF 30
APPROVED BY OIRM 11-84 |
30-105-04
|
Standard form 30 (Rev. 10-83)
Prescribed by GSA FAR (48 CFR) 53.243 |
1.
|
Dr. Andrei Gudkov, Co-PI
|
2.
|
Dr. Vadim Krivokrysenko, Co-PI
|
c.
|
The contractor must provide thorough and detailed documentation of the experience, abilities, and background for Key Personnel under this contract in the form of resumes or equivalent statements of qualifications. Such documentation shall include but not be limited to: name, curriculum vitae, type and description of experience.
|
d.
|
The contractor agrees that during the contract performance period, substitution for Key Personnel shall not be permitted unless such substitution is necessitated by sudden illness, death, or termination of employment. In any of these events, the contractor shall promptly notify the Contracting Officer and provide the information required by paragraph (e) below.
|
e.
|
All requests for substitutions must provide a detailed explanation of the circumstances necessitating the proposed substitution(s), a complete resume for the proposed substitute(s), and any other information requested by the Contracting Officer needed to approve or disapprove the proposed substitution(s). All proposed substitutes shall have qualifications that are equal to or higher than the qualifications of the person to be replaced. The Contracting Officer or his authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof
|
f.
|
If any of the listed Key Personnel are subcontractor personnel, the contractor shall include the substance of this clause in any subcontract which he awards under this contract.
|
DELIVERY DATE
|
QUANTITY
|
SHIP TO ADDRESS
|
DODAAC
|
POP 01-SEP-2015 TO 30-NOV-2017
|
N/A
|
FORT DETRICK – CDMRP
FORT DETRICK – CDMRP 1120 FORT DETRICK FREDERICK MD 21702 FOB: Destination |
W91ZSQ
|
DELIVERY DATE
|
QUANTITY
|
SHIP TO ADDRESS
|
DODAAC
|
POP 01-SEP-2015 TO 30-APR-2019
|
N/A
|
FORT DETRICK – CDMRP
FORT DETRICK – CDMRP 1120 FORT DETRICK FREDERICK MD 21702 FOB: Destination |
W91ZSQ
|
DELIVERY DATE
|
QUANTITY
|
SHIP TO ADDRESS
|
DODAAC
|
POP 01-SEP-2015 TO 30-NOV-2017
|
N/A
|
FORT DETRICK – CDMRP
FORT DETRICK – CDMRP 1120 FORT DETRICK FREDERICK MD 21702 FOB: Destination |
W91ZSQ
|
DELIVERY DATE
|
QUANTITY
|
SHIP TO ADDRESS
|
DODAAC
|
POP 01-SEP-2015 TO 30-APR-2019
|
N/A
|
FORT DETRICK – CDMRP
FORT DETRICK – CDMRP 1120 FORT DETRICK FREDERICK MD 21702 FOB: Destination |
W91ZSQ
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Cleveland BioLabs, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Dated: November 14, 2017
|
By:
|
/s/ Yakov Kogan
|
|
|
Yakov Kogan
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive and Principal Financial Officer)
|
1.
|
The Quarterly Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
|
2.
|
The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the period covered by the Quarterly Report.
|
Dated: November 14, 2017
|
By:
|
/s/ Yakov Kogan
|
|
|
Yakov Kogan
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive and Principal Financial Officer)
|
|
|
|
*
|
This certification accompanies the Quarterly Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Quarterly Report). It will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
|