|
|
þ
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
for the quarterly period ended March 31, 2020
|
|
OR
|
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
(State of incorporation)
|
45-0705648
(I.R.S. Employer Identification No.)
|
540 Gaither Road, Suite 400
Rockville, Maryland 20850
(Address of principal executive offices)
|
(410) 522‑8707
(Registrant’s telephone number,
including area code)
|
Title of each class
|
Trading Symbol
|
Name of each exchange on which registered
|
Common Stock, $0.001 par value
|
CERC
|
Nasdaq Capital Market
|
Large accelerated filer ¨
|
|
Accelerated filer þ
|
Non-accelerated filer ¨
|
|
Smaller reporting company þ
|
Emerging growth company þ
|
|
|
|
|
|
March 31, 2020
|
|
December 31, 2019
|
||||
|
|
(unaudited)
|
|
|
||||
Assets
|
|
|
|
|
||||
Current assets:
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
5,659,384
|
|
|
$
|
3,609,438
|
|
Accounts receivable, net
|
|
2,194,983
|
|
|
1,001,645
|
|
||
Other receivables
|
|
2,063,981
|
|
|
4,240,572
|
|
||
Inventory, net
|
|
16,276
|
|
|
21,334
|
|
||
Prepaid expenses and other current assets
|
|
777,442
|
|
|
706,968
|
|
||
Restricted cash, current portion
|
|
64,643
|
|
|
17,535
|
|
||
Investment in Aytu
|
|
14,708,768
|
|
|
7,628,947
|
|
||
Current assets of discontinued operations
|
|
—
|
|
|
497,577
|
|
||
Total current assets
|
|
25,485,477
|
|
|
17,724,016
|
|
||
Property and equipment, net
|
|
1,416,832
|
|
|
1,447,663
|
|
||
Intangible assets, net
|
|
2,695,675
|
|
|
2,426,258
|
|
||
Goodwill
|
|
14,409,088
|
|
|
14,409,088
|
|
||
Restricted cash, net of current portion
|
|
112,549
|
|
|
101,945
|
|
||
Total assets
|
|
$
|
44,119,621
|
|
|
$
|
36,108,970
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
||||
Current liabilities:
|
|
|
|
|
||||
Accounts payable
|
|
$
|
2,725,998
|
|
|
$
|
2,077,524
|
|
Accrued expenses and other current liabilities
|
|
6,194,205
|
|
|
5,640,252
|
|
||
Income taxes payable
|
|
—
|
|
|
551,671
|
|
||
Current liabilities of discontinued operations
|
|
6,409,668
|
|
|
3,891,012
|
|
||
Total current liabilities
|
|
15,329,871
|
|
|
12,160,459
|
|
||
Royalty obligation
|
|
2,000,000
|
|
|
—
|
|
||
Deferred tax liability, net
|
|
106,701
|
|
|
85,981
|
|
||
Other long-term liabilities
|
|
1,094,307
|
|
|
1,111,965
|
|
||
Long-term liabilities of discontinued operations
|
|
—
|
|
|
1,755,000
|
|
||
Total liabilities
|
|
18,530,879
|
|
|
15,113,405
|
|
||
Stockholders’ equity:
|
|
|
|
|
||||
Common stock—$0.001 par value; 200,000,000 shares authorized at March 31, 2020 and December 31, 2019; 59,560,252 and 44,384,222 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
|
|
59,560
|
|
|
44,384
|
|
||
Preferred stock—$0.001 par value; 5,000,000 shares authorized at March 31, 2020 and December 31, 2019; 1,257,143 and 2,857,143 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
|
|
1,257
|
|
|
2,857
|
|
||
Additional paid-in capital
|
|
160,935,648
|
|
|
135,238,941
|
|
||
Accumulated deficit
|
|
(135,407,723
|
)
|
|
(114,290,617
|
)
|
||
Total stockholders’ equity
|
|
25,588,742
|
|
|
20,995,565
|
|
||
Total liabilities and stockholders’ equity
|
|
$
|
44,119,621
|
|
|
$
|
36,108,970
|
|
|
|
Three Months Ended
|
||||||
|
|
March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
Revenues:
|
|
|
|
|
||||
Product revenue, net
|
|
$
|
2,753,865
|
|
|
$
|
2,576,369
|
|
Total revenues, net
|
|
2,753,865
|
|
|
2,576,369
|
|
||
|
|
|
|
|
||||
Operating expenses:
|
|
|
|
|
||||
Cost of product sales
|
|
66,558
|
|
|
752,548
|
|
||
Research and development
|
|
4,767,750
|
|
|
3,401,189
|
|
||
Acquired in-process research and development
|
|
25,549,344
|
|
|
—
|
|
||
General and administrative
|
|
2,675,613
|
|
|
2,675,610
|
|
||
Sales and marketing
|
|
676,527
|
|
|
396,276
|
|
||
Amortization expense
|
|
430,583
|
|
|
334,748
|
|
||
Change in fair value of contingent consideration
|
|
—
|
|
|
20,940
|
|
||
Total operating expenses
|
|
34,166,375
|
|
|
7,581,311
|
|
||
Loss from continuing operations
|
|
(31,412,510
|
)
|
|
(5,004,942
|
)
|
||
Other income (expense):
|
|
|
|
|
||||
Change in fair value of Investment in Aytu
|
|
7,079,821
|
|
|
—
|
|
||
Change in fair value of warrant liability and unit purchase option liability
|
|
11,280
|
|
|
(47,577
|
)
|
||
Other expense, net
|
|
—
|
|
|
(9,400
|
)
|
||
Interest income, net
|
|
9,790
|
|
|
30,217
|
|
||
Total other income (expense), net from continuing operations
|
|
7,100,891
|
|
|
(26,760
|
)
|
||
Loss from continuing operations before taxes
|
|
(24,311,619
|
)
|
|
(5,031,702
|
)
|
||
Income tax (benefit) expense
|
|
(2,156,855
|
)
|
|
130,672
|
|
||
Loss from continuing operations
|
|
$
|
(22,154,764
|
)
|
|
$
|
(5,162,374
|
)
|
Income (loss) from discontinued operations, net of tax
|
|
1,037,658
|
|
|
(2,291,674
|
)
|
||
Net loss
|
|
$
|
(21,117,106
|
)
|
|
$
|
(7,454,048
|
)
|
|
|
|
|
|
||||
Net (loss) income per share of common stock, basic and diluted:
|
|
|
|
|
||||
Continuing operations
|
|
$
|
(0.36
|
)
|
|
$
|
(0.09
|
)
|
Discontinued operations
|
|
0.02
|
|
|
(0.04
|
)
|
||
Net loss per share of common stock, basic and diluted
|
|
$
|
(0.34
|
)
|
|
$
|
(0.13
|
)
|
|
|
|
|
|
||||
Net (loss) income per share of preferred stock, basic and diluted:
|
|
|
|
|
||||
Continuing operations
|
|
$
|
(1.78
|
)
|
|
$
|
(0.46
|
)
|
Discontinued operations
|
|
0.08
|
|
|
(0.21
|
)
|
||
Net loss per share of preferred stock, basic and diluted
|
|
$
|
(1.70
|
)
|
|
$
|
(0.67
|
)
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
Operating activities
|
|
|
|
|
||||
Net loss
|
|
$
|
(21,117,106
|
)
|
|
$
|
(7,454,048
|
)
|
Adjustments to reconcile net loss used in operating activities:
|
|
|
|
|
||||
Depreciation and amortization
|
|
453,016
|
|
|
1,098,478
|
|
||
Stock-based compensation
|
|
1,116,323
|
|
|
596,693
|
|
||
Acquired in-process research and development, including transaction costs
|
|
25,549,344
|
|
|
—
|
|
||
Deferred taxes
|
|
20,720
|
|
|
5,941
|
|
||
Amortization of inventory fair value associated with acquisition of TRx and Avadel's pediatric products
|
|
—
|
|
|
22,603
|
|
||
Change in fair value of Investment in Aytu
|
|
(7,079,821
|
)
|
|
—
|
|
||
Change in fair value of warrant liability and unit purchase option liability
|
|
(11,280
|
)
|
|
47,577
|
|
||
Change in value of Guarantee
|
|
(1,755,000
|
)
|
|
—
|
|
||
Change in fair value of contingent consideration
|
|
—
|
|
|
180,402
|
|
||
Other
|
|
—
|
|
|
21,412
|
|
||
Changes in assets and liabilities:
|
|
|
|
|
||||
Accounts receivable, net
|
|
(695,761
|
)
|
|
439,159
|
|
||
Other receivables
|
|
(1,962,812
|
)
|
|
(62,014
|
)
|
||
Inventory, net
|
|
5,058
|
|
|
41,195
|
|
||
Prepaid expenses and other assets
|
|
22,676
|
|
|
281,051
|
|
||
Accounts payable
|
|
250,970
|
|
|
(196,671
|
)
|
||
Income taxes payable
|
|
(551,671
|
)
|
|
(217,608
|
)
|
||
Accrued expenses and other liabilities
|
|
(141,873
|
)
|
|
2,074,278
|
|
||
Lease liability, net
|
|
157,143
|
|
|
—
|
|
||
Net cash used in operating activities
|
|
(5,740,074
|
)
|
|
(3,121,552
|
)
|
||
Investing activities
|
|
|
|
|
||||
Net cash paid in merger with Aevi
|
|
(1,250,650
|
)
|
|
—
|
|
||
Purchase of property and equipment
|
|
—
|
|
|
(165,969
|
)
|
||
Net cash used in investing activities
|
|
(1,250,650
|
)
|
|
(165,969
|
)
|
||
Financing activities
|
|
|
|
|
||||
Proceeds from exercise of stock options and warrants
|
|
74,207
|
|
|
94,177
|
|
||
Proceeds from registered direct offering, net
|
|
5,136,184
|
|
|
—
|
|
||
Proceeds from sale of shares pursuant to common stock private placement, net
|
|
3,887,991
|
|
|
—
|
|
||
Proceeds from underwritten public offering, net
|
|
—
|
|
|
8,975,960
|
|
||
Payment of contingent consideration
|
|
—
|
|
|
(228,678
|
)
|
||
Payment of long-term debt
|
|
—
|
|
|
(24,342
|
)
|
||
Net cash provided by financing activities
|
|
9,098,382
|
|
|
8,817,117
|
|
||
Increase in cash, cash equivalents and restricted cash
|
|
2,107,658
|
|
|
5,529,596
|
|
||
Cash, cash equivalents, and restricted cash at beginning of period
|
|
3,728,918
|
|
|
10,746,756
|
|
||
Cash, cash equivalents, and restricted cash at end of period
|
|
$
|
5,836,576
|
|
|
$
|
16,276,352
|
|
Supplemental disclosures of cash flow information
|
|
|
|
|
||||
Cash paid for interest
|
|
$
|
—
|
|
|
$
|
262,500
|
|
Cash paid for taxes
|
|
$
|
316,000
|
|
|
$
|
378,025
|
|
Supplemental disclosures of non-cash activities
|
|
|
|
|
||||
Issuance of common stock in Aevi Merger
|
|
$
|
15,495,578
|
|
|
$
|
—
|
|
Leased asset obtained in exchange for new operating lease liability
|
|
$
|
—
|
|
|
$
|
743,025
|
|
|
|
March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
5,659,384
|
|
|
$
|
16,121,388
|
|
Restricted cash, current
|
|
64,643
|
|
|
77,846
|
|
||
Restricted cash, non-current
|
|
112,549
|
|
|
77,118
|
|
||
Total cash, cash equivalents and restricted cash
|
|
$
|
5,836,576
|
|
|
$
|
16,276,352
|
|
|
Common stock
|
|
Preferred Stock
|
|
Additional paid‑in
|
|
Accumulated
|
Total stockholders’
|
|||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
capital
|
|
deficit
|
|
equity
|
||||||||||||
Three Months Ended March 31, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Balance, December 31, 2018
|
40,804,189
|
|
|
$
|
40,804
|
|
|
2,857,143
|
|
|
$
|
2,857
|
|
|
$
|
119,082,157
|
|
|
$
|
(98,218,070
|
)
|
|
$
|
20,907,748
|
|
Issuance of shares of common stock in underwritten public offering, net of offering costs
|
1,818,182
|
|
|
1,818
|
|
|
|
|
—
|
|
|
8,974,142
|
|
|
—
|
|
|
8,975,960
|
|
||||||
Exercise of stock options and warrants
|
31,288
|
|
|
31
|
|
|
|
|
—
|
|
|
94,146
|
|
|
—
|
|
|
94,177
|
|
||||||
Stock-based compensation
|
|
|
—
|
|
|
|
|
—
|
|
|
596,693
|
|
|
—
|
|
|
596,693
|
|
|||||||
Restricted Stock Units vested during period
|
100,000
|
|
|
101
|
|
|
|
|
—
|
|
|
(101
|
)
|
|
—
|
|
|
—
|
|
||||||
Net loss
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
(7,454,048
|
)
|
|
(7,454,048
|
)
|
|||||||
Balance, March 31, 2019
|
42,753,659
|
|
|
$
|
42,754
|
|
|
2,857,143
|
|
|
$
|
2,857
|
|
|
$
|
128,747,037
|
|
|
$
|
(105,672,118
|
)
|
|
$
|
23,120,530
|
|
Three Months Ended March 31, 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Balance, December 31, 2019
|
44,384,222
|
|
|
$
|
44,384
|
|
|
2,857,143
|
|
|
$
|
2,857
|
|
|
$
|
135,238,941
|
|
|
$
|
(114,290,617
|
)
|
|
$
|
20,995,565
|
|
Conversion of preferred stock to common stock
|
8,000,000
|
|
|
8,000
|
|
|
(1,600,000
|
)
|
|
(1,600
|
)
|
|
(6,400
|
)
|
|
—
|
|
|
—
|
|
|||||
Issuance of shares related to Aevi Merger
|
3,893,361
|
|
|
3,894
|
|
|
|
|
—
|
|
|
15,491,684
|
|
|
—
|
|
|
15,495,578
|
|
||||||
Issuance of shares pursuant to registered direct offering, net of offering costs
|
1,306,282
|
|
|
1,306
|
|
|
|
|
—
|
|
|
5,134,878
|
|
|
—
|
|
|
5,136,184
|
|
||||||
Issuance of shares pursuant to common stock private placement, net of offering costs
|
1,951,219
|
|
|
1,951
|
|
|
|
|
—
|
|
|
3,886,040
|
|
|
—
|
|
|
3,887,991
|
|
||||||
Exercise of stock options and warrants
|
25,168
|
|
|
25
|
|
|
|
|
—
|
|
|
74,182
|
|
|
—
|
|
|
74,207
|
|
||||||
Stock-based compensation
|
|
|
—
|
|
|
|
|
—
|
|
|
1,116,323
|
|
|
—
|
|
|
1,116,323
|
|
|||||||
Net loss
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
(21,117,106
|
)
|
|
(21,117,106
|
)
|
|||||||
Balance, March 31, 2020
|
59,560,252
|
|
|
$
|
59,560
|
|
|
1,257,143
|
|
|
$
|
1,257
|
|
|
$
|
160,935,648
|
|
|
$
|
(135,407,723
|
)
|
|
$
|
25,588,742
|
|
|
|
March 31, 2020
|
|
December 31,
|
||||
|
|
(unaudited)
|
|
2019
|
||||
Assets
|
|
|
|
|
||||
Current assets:
|
|
|
|
|
||||
Accounts receivable, net
|
|
$
|
—
|
|
|
$
|
497,577
|
|
Total current assets of discontinued operations
|
|
—
|
|
|
497,577
|
|
||
|
|
|
|
|
||||
Liabilities
|
|
|
|
|
||||
Current liabilities:
|
|
|
|
|
||||
Accounts payable
|
|
—
|
|
|
387,975
|
|
||
Accrued expenses and other current liabilities
|
|
6,409,668
|
|
|
3,503,037
|
|
||
Total current liabilities of discontinued operations
|
|
6,409,668
|
|
|
3,891,012
|
|
||
Other long-term liabilities
|
|
—
|
|
|
1,755,000
|
|
||
Total long-term liabilities of discontinued operations
|
|
—
|
|
|
1,755,000
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
Product revenue, net
|
|
$
|
(717,342
|
)
|
|
$
|
2,835,074
|
|
|
|
|
|
|
||||
Operating expenses:
|
|
|
|
|
||||
Cost of product sales
|
|
—
|
|
|
1,195,344
|
|
||
General and administrative
|
|
—
|
|
|
41,374
|
|
||
Sales and marketing
|
|
—
|
|
|
2,712,626
|
|
||
Amortization expense
|
|
—
|
|
|
744,099
|
|
||
Change in fair value of contingent consideration
|
|
—
|
|
|
159,462
|
|
||
Total operating expenses
|
|
—
|
|
|
4,852,905
|
|
||
Other income (expense):
|
|
|
|
|
||||
Change in value of Guarantee
|
|
1,755,000
|
|
|
—
|
|
||
Interest expense, net
|
|
—
|
|
|
(238,158
|
)
|
||
Total other income (expense)
|
|
1,755,000
|
|
|
(238,158
|
)
|
||
Income (loss) from discontinued operations before tax
|
|
1,037,658
|
|
|
(2,255,989
|
)
|
||
Income tax expense
|
|
—
|
|
|
35,685
|
|
||
Income (loss) from discontinued operations, net of tax
|
|
$
|
1,037,658
|
|
|
$
|
(2,291,674
|
)
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
Operating activities
|
|
|
|
|
||||
Amortization
|
|
$
|
—
|
|
|
$
|
744,099
|
|
Stock-based compensation, excluding amount included within gain on sale of Pediatric Portfolio
|
|
—
|
|
|
49,364
|
|
||
Change in fair value of contingent consideration liability
|
|
—
|
|
|
159,462
|
|
||
Change in value of Guarantee
|
|
(1,755,000
|
)
|
|
—
|
|
|
|
Three Months Ended
|
||||||||||||||
|
|
March 31, 2020
|
||||||||||||||
|
|
Common stock
|
|
Preferred stock
|
||||||||||||
|
|
Continuing Operations
|
|
Discontinued Operations
|
|
Continuing Operations
|
|
Discontinued Operations
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
|
||||||||
Allocation of undistributed net (loss) income
|
|
$
|
(19,204,480
|
)
|
|
$
|
899,476
|
|
|
$
|
(2,950,284
|
)
|
|
$
|
138,182
|
|
Denominator:
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares
|
|
53,934,760
|
|
|
53,934,760
|
|
|
1,657,143
|
|
|
1,657,143
|
|
||||
Basic and diluted net (loss) income per share
|
|
$
|
(0.36
|
)
|
|
$
|
0.02
|
|
|
$
|
(1.78
|
)
|
|
$
|
0.08
|
|
|
|
Three Months Ended
|
||||||||||||||
|
|
March 31, 2019
|
||||||||||||||
|
|
Common stock
|
|
Preferred stock
|
||||||||||||
|
|
Continuing Operations
|
|
Discontinued Operations
|
|
Continuing Operations
|
|
Discontinued Operations
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
|
||||||||
Allocation of undistributed net loss
|
|
$
|
(3,835,249
|
)
|
|
$
|
(1,702,538
|
)
|
|
$
|
(1,327,125
|
)
|
|
$
|
(589,136
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares
|
|
41,284,168
|
|
|
41,284,168
|
|
|
2,857,143
|
|
|
2,857,143
|
|
||||
Basic and diluted net loss per share
|
|
$
|
(0.09
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(0.21
|
)
|
|
|
Three Months Ended
|
||
|
|
March 31,
|
||
|
|
2020
|
|
2019
|
Stock options
|
|
7,712,680
|
|
4,345,305
|
Warrants on common stock
|
|
4,024,708
|
|
4,024,708
|
Restricted Stock Units
|
|
267,500
|
|
345,000
|
Underwriters' unit purchase option
|
|
40,000
|
|
40,000
|
•
|
Level 1—inputs to the valuation methodology are quoted prices (unadjusted) for an identical asset or liability in an active market.
|
•
|
Level 2—inputs to the valuation methodology include quoted prices for a similar asset or liability in an active market or model‑derived valuations in which all significant inputs are observable for substantially the full term of the asset or liability.
|
•
|
Level 3—inputs to the valuation methodology are unobservable and significant to the fair value measurement of the asset or liability.
|
|
|
March 31, 2020
|
||||||||||
|
|
Fair Value Measurements Using
|
||||||||||
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
||||||
|
|
active markets for
|
|
observable
|
|
unobservable
|
||||||
|
|
identical assets
|
|
inputs
|
|
inputs
|
||||||
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||
Assets
|
|
|
|
|
|
|
||||||
Investments in money market funds*
|
|
$
|
4,436,860
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Investment in Aytu
|
|
$
|
—
|
|
|
$
|
14,708,768
|
|
|
$
|
—
|
|
Liabilities
|
|
|
|
|
|
|
||||||
Warrant liability**
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
760
|
|
Unit purchase option liability**
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,014
|
|
|
|
December 31, 2019
|
||||||||||
|
|
Fair Value Measurements Using
|
||||||||||
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
||||||
|
|
active markets for
|
|
observable
|
|
unobservable
|
||||||
|
|
identical assets
|
|
inputs
|
|
inputs
|
||||||
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||
Assets
|
|
|
|
|
|
|
||||||
Investments in money market funds*
|
|
$
|
2,240,230
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Investment in Aytu
|
|
$
|
—
|
|
|
$
|
7,628,947
|
|
|
$
|
—
|
|
Liabilities
|
|
|
|
|
|
|
||||||
Warrant liability**
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,460
|
|
Unit purchase option liability**
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,594
|
|
|
|
Warrant
|
|
Unit purchase
|
|
Contingent
|
|
|
||||||||
|
|
liability
|
|
option liability
|
|
consideration
|
|
Total
|
||||||||
Balance at December 31, 2019
|
|
$
|
3,460
|
|
|
$
|
10,594
|
|
|
$
|
—
|
|
|
$
|
14,054
|
|
Change in fair value
|
|
(2,700
|
)
|
|
(8,580
|
)
|
|
—
|
|
|
(11,280
|
)
|
||||
Balance at March 31, 2020
|
|
$
|
760
|
|
|
$
|
2,014
|
|
|
$
|
—
|
|
|
$
|
2,774
|
|
|
|
Warrant
|
|
Unit purchase
|
|
Contingent
|
|
|
||||||||
|
|
liability
|
|
option liability
|
|
consideration
|
|
Total
|
||||||||
Balance at December 31, 2018
|
|
$
|
2,950
|
|
|
$
|
7,216
|
|
|
$
|
1,256,210
|
|
|
$
|
1,266,376
|
|
Change in fair value
|
|
14,800
|
|
|
32,777
|
|
|
20,940
|
|
|
68,517
|
|
||||
Balance at March 31, 2019
|
|
$
|
17,750
|
|
|
$
|
39,993
|
|
|
$
|
1,277,150
|
|
|
$
|
1,334,893
|
|
|
|
As of
|
||||||
|
|
March 31, 2020
|
|
December 31, 2019
|
||||
Research and development expenses
|
|
$
|
1,873,361
|
|
|
$
|
920,901
|
|
Compensation and benefits
|
|
1,413,014
|
|
|
1,591,964
|
|
||
General and administrative
|
|
1,035,454
|
|
|
120,056
|
|
||
Sales and marketing
|
|
207,950
|
|
|
360,016
|
|
||
Sales returns and allowances
|
|
1,361,410
|
|
|
2,284,175
|
|
||
Medicaid rebates
|
|
95,410
|
|
|
118,271
|
|
||
Other
|
|
207,606
|
|
|
244,869
|
|
||
Total accrued expenses and other current liabilities
|
|
$
|
6,194,205
|
|
|
$
|
5,640,252
|
|
Number of shares
|
|
Exercise price
|
|
Expiration
|
||
underlying warrants
|
|
per share
|
|
date
|
||
22,328*
|
|
$
|
8.40
|
|
|
October 2020
|
2,380*
|
|
$
|
8.68
|
|
|
May 2022
|
4,000,000
|
|
$
|
12.50
|
|
|
June 2024
|
4,024,708
|
|
|
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
Research and development
|
|
$
|
381,769
|
|
|
$
|
57,376
|
|
General and administrative
|
|
679,600
|
|
|
469,125
|
|
||
Sales and marketing
|
|
54,954
|
|
|
20,828
|
|
||
Total stock-based compensation, continuing operations
|
|
1,116,323
|
|
|
547,329
|
|
||
Total stock-based compensation, discontinued operations
|
|
—
|
|
|
49,364
|
|
||
Total stock-based compensation
|
|
$
|
1,116,323
|
|
|
$
|
596,693
|
|
|
|
Options Outstanding
|
|||||||||||
|
|
Number of shares
|
|
Weighted average exercise price per share
|
|
Weighted average grant date fair value per share
|
|
Weighted average remaining contractual term (in years)
|
|||||
Balance at December 31, 2019
|
|
4,180,606
|
|
|
$
|
4.80
|
|
|
$
|
2.67
|
|
|
7.9
|
Granted
|
|
3,550,583
|
|
|
$
|
3.97
|
|
|
$
|
2.51
|
|
|
|
Exercised
|
|
(25,168
|
)
|
|
$
|
2.95
|
|
|
$
|
1.90
|
|
|
|
Forfeited
|
|
(125,000
|
)
|
|
$
|
5.28
|
|
|
$
|
2.85
|
|
|
|
Expired
|
|
(168,341
|
)
|
|
$
|
6.16
|
|
|
$
|
3.35
|
|
|
|
Balance at March 31, 2020
|
|
7,412,680
|
|
|
$
|
4.37
|
|
|
$
|
2.58
|
|
|
8.5
|
Exercisable at March 31, 2020
|
|
2,104,285
|
|
|
$
|
4.43
|
|
|
$
|
2.50
|
|
|
5.9
|
|
|
Options Outstanding
|
|||||||||||
|
|
Number of shares
|
|
Weighted average exercise price per share
|
|
Weighted average remaining contractual term (in years)
|
|
Aggregate intrinsic value (1)
|
|||||
Balance at December 31, 2019
|
|
300,000
|
|
|
$
|
4.98
|
|
|
9.4
|
|
|
||
Granted
|
|
—
|
|
|
|
|
|
|
|
|
|||
Balance at March 31, 2020
|
|
300,000
|
|
|
$
|
4.98
|
|
|
9.2
|
|
$
|
—
|
|
Exercisable at March 31, 2020
|
|
—
|
|
|
|
|
|
|
|
Service-based options
|
|
|
Expected dividend yield
|
|
—%
|
Expected volatility
|
|
69.9% - 71.5%
|
Expected life (in years)
|
|
5.0 - 6.25
|
Risk-free interest rate
|
|
0.37 - 1.48%
|
|
|
|
|
RSUs Outstanding
|
|||||
|
|
Number of shares
|
|
Weighted average grant date fair value
|
|||
Unvested RSUs at December 31, 2019
|
|
267,500
|
|
|
$
|
4.92
|
|
Granted
|
|
—
|
|
|
|
|
|
Unvested RSUs at March 31, 2020
|
|
267,500
|
|
|
|
|
|
As of
|
||||||
|
|
March 31, 2020
|
|
December 31, 2019
|
||||
Property and equipment, net
|
|
$
|
710,230
|
|
|
$
|
718,626
|
|
Other current liabilities
|
|
$
|
166,403
|
|
|
$
|
155,815
|
|
Other long-term liabilities
|
|
$
|
1,094,307
|
|
|
$
|
1,111,965
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
Operating lease cost*
|
|
$
|
54,508
|
|
|
$
|
54,506
|
|
|
|
|
||
|
|
Undiscounted Cash Flows
|
||
April 1, 2020 through December 31, 2020
|
|
$
|
124,285
|
|
2021
|
|
169,510
|
|
|
2022
|
|
173,748
|
|
|
2023
|
|
178,092
|
|
|
2024
|
|
182,544
|
|
|
2025
|
|
187,108
|
|
|
Thereafter
|
|
813,638
|
|
|
Total lease payments
|
|
$
|
1,828,925
|
|
Less implied interest
|
|
$
|
(568,215
|
)
|
Total
|
|
$
|
1,260,710
|
|
•
|
Advancing our pipeline of compounds through development and to regulatory approval;
|
•
|
Acquiring or licensing rights to targeted, complementary differentiated preclinical and clinical stage assets;
|
•
|
Developing the go-to-market strategy to quickly and effectively market, launch, and distribute each of our assets that receive marketing approval;
|
•
|
Opportunistically out-licensing rights to indications or geographies; and
|
•
|
Opportunistically out-licensing rights or sale of non-core assets.
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Preclinical expenses
|
|
$
|
1,245
|
|
|
$
|
879
|
|
Clinical expenses
|
|
596
|
|
|
1,590
|
|
||
CMC expenses
|
|
1,166
|
|
|
435
|
|
||
Internal expenses not allocated to programs:
|
|
|
|
|
||||
Salaries, benefits and related costs
|
|
1,313
|
|
|
435
|
|
||
Stock-based compensation expense
|
|
382
|
|
|
57
|
|
||
Other
|
|
66
|
|
|
5
|
|
||
|
|
$
|
4,768
|
|
|
$
|
3,401
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Salaries, benefits and related costs
|
|
$
|
1,012
|
|
|
$
|
1,230
|
|
Legal, consulting and other professional expenses
|
|
784
|
|
|
887
|
|
||
Stock-based compensation expense
|
|
706
|
|
|
469
|
|
||
Other
|
|
174
|
|
|
90
|
|
||
|
|
$
|
2,676
|
|
|
$
|
2,676
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Salaries, benefits and related costs
|
|
$
|
134
|
|
|
$
|
185
|
|
Stock-based compensation expense
|
|
55
|
|
|
21
|
|
||
Advertising and marketing expense
|
|
481
|
|
|
190
|
|
||
Other
|
|
7
|
|
|
—
|
|
||
|
|
$
|
677
|
|
|
$
|
396
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Amortization of intangible assets
|
|
$
|
431
|
|
|
$
|
335
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Change in fair value of Investment in Aytu
|
|
$
|
7,080
|
|
|
$
|
—
|
|
Change in fair value of warrant liability and unit purchase option liability
|
|
11
|
|
|
(48
|
)
|
||
Other expense, net
|
|
—
|
|
|
(9
|
)
|
||
Interest income, net
|
|
10
|
|
|
30
|
|
||
|
|
$
|
7,101
|
|
|
$
|
(27
|
)
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Income tax (benefit) expense
|
|
$
|
(2,157
|
)
|
|
$
|
131
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
|
|
(in thousands)
|
||||||
Net cash provided by (used in):
|
|
|
|
|
||||
Operating activities
|
|
$
|
(5,740
|
)
|
|
$
|
(3,122
|
)
|
Investing activities
|
|
(1,251
|
)
|
|
(166
|
)
|
||
Financing activities
|
|
9,098
|
|
|
8,817
|
|
||
Net increase in cash and cash equivalents
|
|
$
|
2,107
|
|
|
$
|
5,529
|
|
Exhibit
Number
|
|
Description of Exhibit
|
|
|
|
10.1
|
|
|
|
|
|
10.2#
|
|
|
|
|
|
10.3#
|
|
|
|
|
|
10.4
|
|
|
|
|
|
10.5#+
|
|
|
|
|
|
10.6
|
|
|
|
|
|
10.7
|
|
|
|
|
|
10.8#
|
|
|
|
|
|
10.9*
|
|
|
|
|
|
10.10
|
|
|
|
|
|
10.11*
|
|
|
|
|
|
10.12*
|
|
|
|
|
|
10.13*
|
|
|
|
|
|
10.14*
|
|
|
|
|
|
10.15
|
|
|
|
|
|
10.16
|
|
|
|
|
|
10.17
|
|
|
|
|
|
10.18
|
|
|
|
|
|
10.19
|
|
|
|
|
|
10.20*
|
|
|
|
|
|
10.21
|
|
|
|
|
|
10.22
|
|
|
|
|
|
10.23*
|
|
|
|
|
|
10.24*
|
|
|
|
|
|
31.1+
|
|
|
|
|
|
31.2+
|
|
|
|
|
|
32.1+†
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document.
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document.
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
SIGNATURES
|
|||
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|||
|
|
|
|
Cerecor Inc.
|
|||
|
|
|
|
Date: May 7, 2020
|
|
/s/ Christopher Sullivan
|
|
|
|
|
Christopher Sullivan
|
|
|
|
Interim Chief Financial Officer
|
|
|
|
(on behalf of the registrant and as the registrant’s principal financial officer and principal accounting officer)
|
|
|
|
(a)
|
General. Executive may provide written notice to the Company at least thirty
|
|
|
|
|
EXECUTIVE:
|
|
COMPANY:
|
|
|
|
|
|
By: /s/ Michael Cola
|
|
By: /s/ Joseph M. Miller
|
|
Michael Cola
|
|
Joseph M. Miller
|
|
March 11, 2020
|
|
Chief Financial Officer
|
|
|
|
March 11, 2020
|
|
|
|
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Cerecor Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us 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 our 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 our 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.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
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.
|
Date: May 7, 2020
|
|
/s/ Michael Cola
|
|
|
|
|
Michael Cola
|
|
|
|
Chief Executive Officer
|
|
|
|
(Registrant’s principal executive officer)
|
|
|
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Cerecor Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us 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 our 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 our 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.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
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.
|
Date: May 7, 2020
|
|
/s/ Christopher Sullivan
|
|
|
|
|
Christopher Sullivan
|
|
|
|
Interim Chief Financial Officer
|
|
|
|
(Registrant’s principal financial officer and principal accounting 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 and results of operations of the Registrant.
|
Date: May 7, 2020
|
|
/s/ Michael Cola
|
|
|
|
|
Michael Cola
|
|
|
|
Chief Executive Officer
|
|
|
|
(Registrant’s principal executive officer)
|
Date: May 7, 2020
|
|
/s/ Christopher Sullivan
|
|
|
|
|
Christopher Sullivan
|
|
|
|
Interim Chief Financial Officer
|
|
|
|
(Registrant’s principal financial officer and principal accounting officer)
|
|