|
|
|
|
|
|
|
|
|
|
|
|
Delaware
|
|
|
|
(State or other jurisdiction of incorporation)
|
|
||
001-37590
|
|
|
|
45-0705648
|
(Commission File Number)
|
|
|
|
(IRS Employer Identification No.)
|
540 Gaither Road, Suite 400, Rockville, Maryland 20850
(Address of principal executive offices) (Zip Code)
|
||
Registrant’s Telephone Number, Including Area Code: (410) 522-8707
|
¨
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
¨
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
¨
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
¨
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.001 Par Value
|
CERC
|
Nasdaq Capital Market
|
|
(i)
|
accrued benefits under his Employment Agreement;
|
(ii)
|
subject to complying with obligations set forth in his Employment Agreement, continued payment of the executive’s base salary for 18 consecutive months;
|
(iii)
|
100% of the annual bonus earned in the year in which the termination occurs, payable when such annual bonuses are paid to other executive employees of Cerecor;
|
(iv)
|
full vesting of options awarded by Cerecor; and
|
(v)
|
if he timely elects and remains eligible for continued coverage under COBRA, the COBRA premiums necessary to continue the health insurance coverage in effect for the executive and his covered dependents prior to the date of termination, until the earliest of (x) the first anniversary of his termination, (y) expiration of the executive’s continuation coverage under COBRA, or (z) the date when the executive is eligible for substantially equivalent health insurance.
|
(i)
|
Audited Consolidated Financial Statements for Aevi Genomic Medicine, Inc. as of December 31, 2018 and 2017.
|
(ii)
|
Unaudited Condensed Consolidated Financial Statements for Aevi Genomic Medicine, Inc. as of
|
(i)
|
Unaudited pro forma condensed combined balance sheet as of September 30, 2019.
|
(ii)
|
Unaudited pro forma condensed combined statement of operations for the nine months ended September 30, 2019.
|
(iii)
|
Unaudited pro forma condensed combined statement of operations for the year ended December 31, 2018.
|
Exhibit No.
|
|
Description
|
|
|
|
10.1
|
|
|
|
|
|
10.2
|
|
|
|
|
|
10.3
|
|
|
|
|
|
10.4
|
|
|
|
|
|
23.1
|
|
|
|
|
|
99.1
|
|
|
|
|
|
99.2
|
|
|
|
|
|
99.3
|
|
|
|
|
|
99.4
|
|
|
|
|
|
99.5
|
|
|
|
|
|
|
|
|
|
|
|
|
CERECOR INC.
|
|
|
|
|
Date: February 3, 2020
|
|
|
/s/ Joseph M. Miller
|
|
|
|
Joseph M. Miller
|
|
|
|
Chief Financial Officer
|
|
|
|
|
|
|
|
|
CERECOR INC.
|
|
|
|
|
By: /s/ Joseph M. Miller
|
|
|
|
|
Name: Joseph M. Miller
|
|
|
|
|
Title: Chief Financial Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMERICAN STOCK TRANSFER & TRUST COMPANY, LLC
|
|
|
|
|
By: /s/ Michael Legregin
|
|
|
|
|
Name: Michael Legregin
|
|
|
|
|
Title: Senior Vice President, Corporate Actions
|
|
|
540 Gaither Road
|
|||
Rockville, MD 20850
|
||||
|
||||
|
||||
|
||||
|
|
|
|
|
|
CERECOR INC.
|
|
|
|
|
/s/ Joseph M. Miller
|
|
|
|
|
Joseph M. Miller
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Michael Cola
|
|
|
|
|
Michael Cola
|
|
|
|
|
|
|
|
|
|
|
540 Gaither Road
|
|||
Rockville, MD 20850
|
||||
|
||||
|
||||
|
||||
|
|
|
|
|
|
CERECOR INC.
|
|
|
|
|
/s/ Joseph M. Miller
|
|
|
|
|
Joseph M. Miller
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Garry Neil
|
|
|
|
|
Garry Neil
|
|
|
|
|
|
|
|
|
|
/s/ Ernst & Young LLP
|
|
Philadelphia, PA
|
February 3, 2020
|
•
|
Commitment to Rare Pediatric and Orphan Diseases: Cerecor continues its commitment to becoming an R&D-focused biopharmaceutical company with a robust pipeline of rare pediatric and orphan disease programs. This transaction expands the number of clinical programs in development at Cerecor while creating depth of focus in rare pediatric and orphan diseases.
|
•
|
Pipeline Assets: The emerging clinical-stage pipeline consists of six medicines with compelling biological rationale in orphan autoimmune, metabolic and oncology indications, with the potential for multiple product launches through 2023:
|
◦
|
CERC-002 (formerly AEVI-002), a fully-human, anti-LIGHT monoclonal antibody for Pediatric Onset Crohn’s Disease
|
◦
|
CERC-006 (formerly AEVI-006), a potent, orally-available mTORC1/2 inhibitor for complex Lymphatic Malformations
|
◦
|
CERC-007 (formerly AEVI-007), a fully-human, anti-IL-18 monoclonal antibody for auto-inflammatory diseases, including Adult Onset Still’s Disease (AOSD) and Multiple Myeloma)
|
◦
|
CERC-801, an ultra-pure, D-Galactose substrate replacement therapy for PGM1-CDG
|
◦
|
CERC-802, an ultra-pure, D-Mannose substrate replacement therapy for MPI-CDG
|
◦
|
CERC-803, an ultra-pure, L-Fucose substrate replacement therapy for SLC35C1-CDG
|
|
|
|
Page
|
|
|
December 31,
|
|
|
Note
|
2018
|
2017
|
ASSETS
|
|
|
|
CURRENT ASSETS:
|
|
|
|
Cash and cash equivalents
|
3
|
$12,076
|
$33,729
|
Prepaid expenses and other current assets
|
|
170
|
893
|
Total current assets
|
|
12,246
|
34,622
|
LONG‑TERM ASSETS:
|
|
|
|
Lease deposits
|
6(d)
|
11
|
11
|
Property and equipment, net
|
4
|
20
|
85
|
Other long‑term assets
|
|
—
|
43
|
Total long‑term assets
|
|
31
|
139
|
Total assets
|
|
$12,277
|
$34,761
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
Trade payables
|
|
$1,582
|
$943
|
Other accounts payable and accrued expenses
|
5
|
2,763
|
3,197
|
Total current liabilities
|
|
4,345
|
4,140
|
Total liabilities
|
|
4,345
|
4,140
|
COMMITMENTS AND CONTINGENCIES
|
6
|
|
|
STOCKHOLDERS’ EQUITY:
|
7
|
|
|
Common stock—$0.0001 par value; 200,000,000 shares authorized; 64,766,882 shares issued and outstanding at December 31, 2018; 59,332,265 shares issued and outstanding at December 31, 2017
|
|
7
|
6
|
Additional paid‑in capital
|
|
253,678
|
245,593
|
Accumulated deficit
|
|
(245,753)
|
(214,978)
|
Total stockholders’ equity
|
|
7,932
|
30,621
|
Total liabilities and stockholders’ equity
|
|
$12,277
|
$34,761
|
|
|
Year ended December 31,
|
|
|
Note
|
2018
|
2017
|
Research and development expenses
|
|
$22,299
|
$25,176
|
General and administrative expenses
|
|
8,663
|
9,524
|
Operating loss
|
|
(30,962)
|
(34,700)
|
Financial expenses
|
|
(1)
|
(41)
|
Financial income
|
|
188
|
27
|
Loss before taxes on income
|
|
(30,775)
|
(34,714)
|
Taxes on income
|
8
|
—
|
—
|
Net loss
|
|
$(30,775)
|
$(34,714)
|
Basic loss per share
|
10
|
$(0.500)
|
$(0.830)
|
Diluted loss per share
|
10
|
$(0.500)
|
$(0.830)
|
Weighted average number of shares of common stock used in computing basic loss per share
|
|
61,381,611
|
41,675,814
|
Weighted average number of shares of common stock used in computing diluted loss per share
|
|
61,381,611
|
41,675,814
|
|
Common stock
|
Additional
paid‑in |
Accumulated
|
Total
stockholders’ |
|
|
Shares
|
Amount
|
capital
|
deficit
|
equity
|
Balance as of December 31, 2016
|
37,103,843
|
$4
|
$215,008
|
$(180,034)
|
34,978
|
Issuance of common stock at $1.26 per share, net
|
22,222,222
|
2
|
26,968
|
—
|
26,970
|
Stock‑based compensation related to options and warrants granted to consultants, directors and employees
|
—
|
—
|
3,368
|
—
|
3,368
|
Exercise of warrants and options
|
6,200
|
(*)
|
19
|
—
|
19
|
Cumulative‑effect adjustment from adoption of ASU 2016‑09
|
—
|
—
|
230
|
(230)
|
—
|
Net loss
|
—
|
—
|
—
|
(34,714)
|
(34,714)
|
Balance as of December 31, 2017
|
59,332,265
|
$6
|
$245,593
|
$(214,978)
|
30,621
|
Issuance of common stock at an average of $0.97 per share, net
|
5,426,151
|
1
|
4,961
|
—
|
4,962
|
Stock‑based compensation related to options and warrants granted to consultants, directors and employees
|
—
|
—
|
3,090
|
—
|
3,090
|
Exercise of warrants and options
|
8,466
|
(*)
|
34
|
—
|
34
|
Net loss
|
—
|
—
|
—
|
(30,775)
|
(30,775)
|
Balance as of December 31, 2018
|
64,766,882
|
$7
|
$253,678
|
$(245,753)
|
7,932
|
(*)
|
Represents an amount lower than $1.
|
|
%
|
Computers and peripheral equipment
|
33
|
Leasehold improvements
|
The shorter of term of the lease or the useful life of the asset
|
|
2018
|
2017
|
Dividend yield
|
0%
|
0%
|
Expected volatility
|
77.5 ‑ 77.9%
|
72.0 ‑ 78.6%
|
Risk‑free interest rate
|
2.7 ‑ 3.1%
|
2.2 ‑ 2.5%
|
Suboptimal exercise factor
|
1.5 ‑ 2.5
|
1.5 ‑ 2.5
|
Contractual life (years)
|
10
|
10
|
Exit rate
|
6%
|
6 ‑ 8%
|
|
2018
|
2017
|
Dividend yield
|
0%
|
0%
|
Expected volatility
|
77.9 ‑ 77.9%
|
78.0 ‑ 78.6%
|
Risk‑free interest rate
|
2.7 ‑ 2.7%
|
2.3 ‑ 2.4%
|
Contractual life (years)
|
9.7 ‑ 9.8
|
9.0 ‑ 9.9
|
|
December 31,
|
|
|
2018
|
2017
|
Cost:
|
|
|
Furniture and office equipment
|
$—
|
$—
|
Computers and peripheral equipment
|
35
|
35
|
Laboratory equipment
|
—
|
—
|
Leasehold improvements
|
157
|
157
|
Total cost
|
192
|
192
|
Total accumulated depreciation
|
172
|
107
|
Depreciated cost
|
$20
|
$85
|
|
December 31,
|
|
|
2018
|
2017
|
Employees and payroll accruals
|
$47
|
$1,297
|
R&D accruals
|
2,222
|
1,539
|
Accrued expenses, other
|
494
|
361
|
Other accounts payable and accrued expenses
|
$2,763
|
$3,197
|
|
Total
|
Less than
1 Year |
1 ‑ 3
Years |
3 ‑ 5
Years |
More than
5 Years and Thereafter |
Operating lease obligations
|
$44
|
$44
|
$—
|
$—
|
$—
|
|
Number of
options and warrants |
Weighted
average exercise price |
Weighted
average remaining contractual terms (years) |
Aggregate
intrinsic value |
Outstanding at December 31, 2017
|
11,110,362
|
$4.34
|
6.43
|
$1
|
Granted
|
2,943,930
|
$1.54
|
|
|
Exercised
|
(17,334)
|
$1.24
|
|
|
Forfeited
|
(3,728,630)
|
$3.51
|
|
|
Outstanding at December 31, 2018
|
10,308,328
|
$3.84
|
6.85
|
$—
|
Vested and expected to vest, December 31, 2018
|
10,308,328
|
$3.84
|
6.85
|
$—
|
Exercisable at December 31, 2018
|
6,158,796
|
$4.85
|
5.50
|
$—
|
|
Number of
options and warrants |
Weighted
average exercise price |
Weighted
average remaining contractual terms (years) |
Aggregate
intrinsic value |
Outstanding at December 31, 2017
|
160,000
|
$3.62
|
2.45
|
$—
|
Granted
|
40,000
|
$1.52
|
|
|
Exercised
|
—
|
$—
|
|
|
Forfeited
|
(190,000)
|
$3.12
|
|
|
Outstanding at December 31, 2018
|
10,000
|
$4.82
|
7.84
|
$—
|
Exercisable at December 31, 2018
|
10,000
|
$4.82
|
7.84
|
$—
|
|
Year ended
December 31, |
|
|
2018
|
2017
|
Research and development expenses
|
$1,260
|
$1,515
|
General and administrative expenses
|
1,830
|
1,853
|
|
$3,090
|
$3,368
|
|
|
As of December 31, 2018
|
||
Options / Warrants
|
Exercise
Price per Share ($) |
Shares to be
Issued upon Exercise of Options and Warrants Outstanding |
Shares to be
Issued upon Exercise of Options and Warrants Exercisable |
Weighted Average
Remaining Contractual Terms of Options and Warrants Outstanding (in years) |
Options:
|
|
|
|
|
Granted to Employees and Directors
|
1.07 ‑ 2.66
|
3,619,280
|
447,641
|
9.1
|
|
3.14 ‑ 4.91
|
4,403,900
|
3,564,632
|
5.9
|
|
5.22 ‑ 8.80
|
2,143,938
|
2,005,313
|
5.2
|
|
|
10,167,118
|
6,017,586
|
|
Granted to Consultants
|
4.82
|
10,000
|
10,000
|
7.8
|
Total Shares to be Issued upon Exercise of Options
|
|
10,177,118
|
6,027,586
|
|
Warrants:
|
|
|
|
|
Issued to Employees and Directors
|
2.84
|
141,210
|
141,210
|
3.8
|
Issued to Investors
|
2.84
|
3,812,694
|
3,812,694
|
3.8
|
Total Shares to be Issued upon Exercise of Warrants
|
|
3,953,904
|
3,953,904
|
|
Total Shares to be Issued upon Exercise of Options and Warrants
|
|
14,131,022
|
9,981,490
|
|
|
December 31,
|
|
|
2018
|
2017
|
Rate reconciliation:
|
|
|
Federal income tax benefit at statutory rate
|
21.0%
|
35.0%
|
State and local tax, net of federal benefit
|
5.7%
|
5.3%
|
Loss in earning of subsidiaries
|
0.0%
|
(1.00)%
|
Permanent differences
|
(0.90)%
|
(1.30)%
|
Tax credits
|
1.6%
|
2.1%
|
Tax attribute revaluations
|
(7.70)%
|
0.0%
|
Impact of tax reform
|
0.0%
|
(50.60)%
|
Change in valuation allowance
|
(19.70)%
|
10.5%
|
Effective Income tax rate
|
0.0%
|
0.0%
|
|
December 31,
|
|
|
2018
|
2017
|
Deferred tax assets:
|
|
|
Net operating loss and credit carryforwards
|
$55,184
|
$45,548
|
Stock Compensation
|
4,969
|
7,065
|
Accrued Expenses
|
—
|
1,497
|
Other
|
36
|
23
|
Total deferred tax assets before valuation allowance
|
60,189
|
54,133
|
Valuation allowance
|
(60,189)
|
(54,133)
|
Net deferred tax asset
|
$—
|
$—
|
|
Year ended
December 31, |
|
|
2018
|
2017
|
Financial expenses:
|
|
|
Bank charges
|
(1)
|
$(3)
|
Foreign currency remeasurement adjustments
|
—
|
(4)
|
Others
|
—
|
(34)
|
|
(1)
|
$(41)
|
Financial income:
|
|
|
Foreign currency remeasurement adjustments
|
—
|
$—
|
Interest on cash equivalents, short‑term bank deposits
|
207
|
22
|
Others
|
(19)
|
5
|
|
188
|
$27
|
|
Year ended December 31,
|
|
|
2018
|
2017
|
Weighted‑average anti‑dilutive shares related to:
|
|
|
Outstanding stock options
|
10,221,139
|
11,105,065
|
Outstanding warrants
|
4,386,288
|
4,830,901
|
|
14,607,427
|
15,935,966
|
|
Three Months Ended
(Unaudited) |
|||
|
March 31
|
June 30
|
September 30
|
December 31
|
2018:
|
|
|
|
|
R&D expenses
|
$(6,561)
|
$(5,747)
|
$(5,125)
|
$(4,866)
|
G&A expenses
|
$(2,174)
|
$(2,504)
|
$(2,174)
|
$(1,811)
|
Operating loss
|
$(8,735)
|
$(8,251)
|
$(7,299)
|
$(6,677)
|
Financial income (expense)
|
$26
|
$60
|
$50
|
$51
|
Net loss
|
$(8,709)
|
$(8,191)
|
$(7,249)
|
$(6,626)
|
Basic loss per share
|
$(0.150)
|
$(0.140)
|
$(0.120)
|
$(0.100)
|
Diluted loss per share
|
$(0.150)
|
$(0.140)
|
$(0.120)
|
$(0.100)
|
Weighted average number of shares used in computing basic loss per share
|
59,334,821
|
59,338,255
|
62,019,780
|
64,766,882
|
Weighted average number of shares used in computing diluted loss per share
|
59,334,821
|
59,338,255
|
62,019,780
|
64,766,882
|
2017:
|
|
|
|
|
R&D expenses
|
$(7,947)
|
$(5,667)
|
$(6,299)
|
$(5,263)
|
G&A expenses
|
$(2,988)
|
$(2,369)
|
$(2,270)
|
$(1,897)
|
Operating loss
|
$(10,935)
|
$(8,036)
|
$(8,569)
|
$(7,160)
|
Financial income (expense)
|
$18
|
$3
|
$(36)
|
$1
|
Net loss
|
$(10,917)
|
$(8,033)
|
$(8,605)
|
$(7,159)
|
Basic loss per share
|
$(0.290)
|
$(0.220)
|
$(0.230)
|
$(0.130)
|
Diluted loss per share
|
$(0.290)
|
$(0.220)
|
$(0.230)
|
$(0.130)
|
Weighted average number of shares used in computing basic loss per share
|
37,108,261
|
37,110,043
|
37,110,043
|
55,225,985
|
Weighted average number of shares used in computing diluted loss per share
|
37,108,261
|
37,110,043
|
37,110,043
|
55,225,985
|
|
|
|
Page
|
|
September 30,
2019 |
December 31,
2018 |
|
Unaudited
|
Audited
|
ASSETS
|
|
|
CURRENT ASSETS:
|
|
|
Cash and cash equivalents
|
$2,381
|
$12,076
|
Prepaid expenses and other current assets
|
403
|
170
|
Total current assets
|
2,784
|
12,246
|
LONG‑TERM ASSETS:
|
|
|
Lease deposits
|
11
|
11
|
Property and equipment, net
|
1
|
20
|
Total long‑term assets
|
12
|
31
|
Total assets
|
$2,796
|
$12,277
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
CURRENT LIABILITIES:
|
|
|
Trade payables
|
$123
|
$1,582
|
Other accounts payable and accrued expenses
|
4,130
|
2,763
|
Total current liabilities
|
4,253
|
4,345
|
LONG‑TERM LIABILITIES:
|
|
|
Royalty agreement liability
|
2,000
|
—
|
Total long‑term liabilities
|
2,000
|
—
|
Total liabilities
|
6,253
|
4,345
|
STOCKHOLDERS’ EQUITY:
|
|
|
Common stock—$0.0001 par value; 200,000,000 shares authorized; 64,766,882 shares issued and outstanding at September 30, 2019 and December 31, 2018
|
$7
|
$7
|
Additional paid‑in capital
|
254,815
|
253,678
|
Accumulated deficit
|
(258,279)
|
(245,753)
|
Total stockholders’ equity
|
(3,457)
|
7,932
|
Total liabilities and stockholders’ equity
|
$2,796
|
$12,277
|
|
Nine months ended
September 30, |
Three months ended
September 30, |
||
|
2019
|
2018
|
2019
|
2018
|
|
Unaudited
|
Unaudited
|
||
Research and development expenses
|
$7,902
|
$17,433
|
$2,499
|
$5,125
|
General and administrative expenses
|
4,643
|
6,852
|
1,543
|
2,174
|
Operating loss
|
(12,545)
|
(24,285)
|
(4,042)
|
(7,299)
|
Financial income, net
|
19
|
136
|
—
|
50
|
Net loss
|
$(12,526)
|
$(24,149)
|
$(4,042)
|
$(7,249)
|
Basic and diluted loss per share
|
$(0.190)
|
$(0.400)
|
$(0.060)
|
$(0.120)
|
Weighted average number of common stock used in computing basic and diluted loss per share
|
64,766,882
|
60,240,787
|
64,766,882
|
62,019,780
|
|
For the Three Months ended September 30, 2019 and 2018
|
||||
|
Common stock
|
Additional
|
|
Total
|
|
|
Shares
|
Amount
|
paid‑in
capital |
Accumulated
deficit |
stockholders’
equity |
Balance as of June 30, 2018
|
59,340,731
|
$6
|
$247,162
|
$(231,878)
|
$15,290
|
Stock‑based compensation related to options and warrants granted to directors and employees
|
—
|
—
|
750
|
—
|
750
|
Issuance of common stock at an average of $0.97 per share, net
|
5,426,151
|
(*)
|
4,961
|
—
|
4,961
|
Net loss
|
—
|
—
|
—
|
(7,249)
|
(7,249)
|
Balance as of September 30, 2018
|
64,766,882
|
$6
|
$252,873
|
$(239,127)
|
$13,752
|
Balance as of June 30, 2019
|
64,766,882
|
$7
|
$254,562
|
$(254,237)
|
$332
|
Stock‑based compensation related to options and warrants granted to directors and employees
|
—
|
—
|
253
|
—
|
253
|
Net loss
|
—
|
—
|
—
|
(4,042)
|
(4,042)
|
Balance as of September 30, 2019
|
64,766,882
|
$7
|
$254,815
|
$(258,279)
|
$(3,457)
|
|
For the Nine Months ended September 30, 2019 and 2018
|
||||
|
Common stock
|
Additional
|
|
Total
|
|
|
Shares
|
Amount
|
paid‑in
capital |
Accumulated
deficit |
stockholders’
equity |
Balance as of December 31, 2017
|
59,332,265
|
$6
|
$245,593
|
$(214,978)
|
$30,621
|
Stock‑based compensation related to options and warrants granted to directors and employees
|
—
|
—
|
2,285
|
—
|
2,285
|
Exercise of warrants and options
|
8,466
|
(*)
|
34
|
—
|
34
|
Issuance of common stock at an average of $0.97 per share, net
|
5,426,151
|
(*)
|
4,961
|
—
|
4,961
|
Net loss
|
—
|
—
|
—
|
(24,149)
|
(24,149)
|
Balance as of September 30, 2018
|
64,766,882
|
$6
|
$252,873
|
$(239,127)
|
$13,752
|
Balance as of December 31, 2018
|
64,766,882
|
$7
|
$253,678
|
$(245,753)
|
$7,932
|
Stock‑based compensation related to options and warrants granted to directors and employees
|
—
|
—
|
1,137
|
—
|
1,137
|
Net loss
|
—
|
—
|
—
|
(12,526)
|
(12,526)
|
Balance as of September 30, 2019
|
64,766,882
|
$7
|
$254,815
|
$(258,279)
|
$(3,457)
|
(*)
|
Represents an amount lower than $1.
|
a.
|
Aevi Genomic Medicine Inc. (the “Company”) was incorporated in January 2000 in Delaware as Medgenics, Inc. The Company has two wholly‑owned subsidiaries (the “Subsidiaries”): Medgenics Medical Israel Ltd. (the “Israeli Subsidiary”), which was incorporated in Israel in March 2000 and Aevi Genomics Medicine Europe BVBA/SPRL, which was incorporated in Belgium in December 2018. The Company is a clinical stage biopharmaceutical company with an emphasis on identifying the drivers of disease and applying this understanding to the pursuit of differentiated novel therapies primarily for pediatric onset, life‑altering diseases, including rare and orphan diseases.
|
b.
|
As reflected in the accompanying financial statements, the Company incurred a net loss and negative cash flow from operating activities for the nine‑month period ended September 30, 2019 of $12,526 and $11,695, respectively. The accumulated deficit as of September 30, 2019 was $258,279. As of September 30, 2019, the Company had cash and cash equivalents of $2,381 which it believes will provide funding for its operations into the fourth quarter of 2019. The Company and the Subsidiaries have not yet generated revenues from product sales. See Note 3 below, for additional information regarding liquidity risks and management’s plans. See Note 4 below, for additional information regarding that certain outstanding note payable to CHOP in cash.
|
c.
|
The Children’s Hospital of Philadelphia Foundation (the “CHOP Foundation”) is the Company’s largest stockholder. As of September 30, 2019, the CHOP Foundation and certain related parties beneficially owned 21,311,586 shares of the Company’s Common Stock. The shares of Common Stock beneficially owned by the CHOP Foundation and certain related parties represent approximately 31.5% of the Company’s outstanding shares of Common Stock.
|
a.
|
The accompanying unaudited condensed financial statements of the Company, have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and the rules of the Securities and Exchange Commission (“SEC”) and should be read in conjunction with the audited financial statements and notes thereto included in the Annual Report on Form 10‑K for the year ended December 31, 2018 (“2018 Form 10‑K”) as filed with the SEC. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim periods presented have been reflected herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that would substantially duplicate the disclosure contained in the audited financial statements for the most recent fiscal year as reported in the 2018 Form 10‑K have been omitted.
|
b.
|
Recently issued accounting pronouncements:
|
a.
|
On September 10, 2019, the Company obtained approval of an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s outstanding Common Stock by a ratio of not less than one‑for‑twenty and not more than one‑for‑sixty, with the exact ratio to be set within this range by the Company’s Board of Directors in its sole discretion, at any time prior to December 31, 2019, the implementation and timing of which shall be subject to the discretion of the Company’s Board of Directors.
|
b.
|
Issuance of stock options and warrants to employees and directors:
|
|
Nine months ended September 30, 2019
|
|||
|
Number of
options and warrants |
Weighted
average exercise price |
Weighted
average remaining contractual terms (years) |
Aggregate
intrinsic value |
Outstanding at December 31, 2018
|
10,308,328
|
$3.84
|
6.85
|
$—
|
Granted
|
—
|
$—
|
|
|
Exercised
|
—
|
$—
|
|
|
Forfeited
|
(1,441,913)
|
$3.61
|
|
|
Outstanding at September 30, 2019
|
8,866,415
|
$3.88
|
5.92
|
$—
|
Vested and expected to vest at September 30, 2019
|
8,866,415
|
$3.88
|
5.92
|
$—
|
Exercisable at September 30, 2019
|
7,482,805
|
$4.24
|
5.47
|
$—
|
c.
|
Issuance of options and warrants to consultants:
|
|
Nine months ended September 30, 2019
|
|||
|
Number of
options and warrants |
Weighted
average exercise price |
Weighted
average remaining contractual terms (years) |
Aggregate
intrinsic value |
Outstanding at December 31, 2018
|
10,000
|
$4.82
|
7.84
|
$—
|
Granted
|
—
|
$—
|
|
|
Exercised
|
—
|
$—
|
|
|
Forfeited
|
—
|
$—
|
|
|
Outstanding at September 30, 2019
|
10,000
|
$4.82
|
7.09
|
$—
|
Exercisable at September 30, 2019
|
10,000
|
$4.82
|
7.09
|
$—
|
d.
|
Stock‑based compensation expense:
|
e.
|
Summary of shares to be issued upon exercise of options and warrants:
|
|
|
As of September 30, 2019
|
||
Options / Warrants
|
Exercise
price per share ($) |
Shares to be issued
upon exercise of options and warrants outstanding |
Shares to be issued
upon exercise of options and warrants exercisable |
Weighted average
remaining contractual terms of options and warrants (in years) |
Options:
|
|
|
|
|
Granted to employees and directors
|
1.07 ‑ 2.66
|
2,914,667
|
1,717,057
|
8.3
|
|
3.14 ‑ 4.91
|
3,993,000
|
3,807,000
|
5.0
|
|
5.22 ‑ 8.80
|
1,817,538
|
1,817,538
|
4.4
|
|
|
8,725,205
|
7,341,595
|
|
Granted to consultants
|
4.82
|
10,000
|
10,000
|
7.1
|
Total shares to be issued upon exercise of options
|
|
8,735,205
|
7,351,595
|
|
Warrants:
|
|
|
|
|
Issued to employees and directors
|
2.84
|
141,210
|
141,210
|
3.0
|
Issued to investors
|
2.84
|
3,812,694
|
3,812,694
|
3.0
|
Total shares to be issued upon exercise of warrants
|
|
3,953,904
|
3,953,904
|
|
Total shares to be issued upon exercise of options and warrants
|
|
12,689,109
|
11,305,499
|
|
|
Nine months ended
September 30, |
Three months ended
September 30, |
||
|
2019
|
2018
|
2019
|
2018
|
Weighted‑average anti‑dilutive shares related to:
|
|
|
|
|
Outstanding stock options
|
9,797,536
|
10,219,710
|
9,294,613
|
10,623,655
|
Outstanding warrants
|
3,953,904
|
4,532,000
|
3,953,904
|
3,953,904
|
Total weighted‑average anti‑dilutive shares
|
13,751,440
|
14,751,710
|
13,248,517
|
14,577,559
|
Contractual Obligations
|
Total
|
Less than
1 Year |
1 ‑ 3 Years
|
3 ‑ 5 Years
|
More than
5 Years and Thereafter |
||||||
Operating lease obligations
|
|
$44,000
|
|
|
$44,000
|
|
$—
|
|
$—
|
$—
|
|
Purchase obligations
|
|
$7,125,000
|
|
|
$4,750,000
|
|
|
$2,375,000
|
|
$—
|
$—
|
Total
|
|
$7,169,000
|
|
|
$4,794,000
|
|
|
$2,375,000
|
|
$—
|
$—
|
•
|
Cerecor’s sale of its rights title and interest in, assets relating to its Pediatric Portfolio, namely Aciphex® Sprinkle™, Cefaclor for Oral Suspension, Karbinal™ ER, Flexichamber™, Poly‑Vi‑Flor® and Tri‑Vi‑Flor™ (the “Pediatric Portfolio”), as well as the corresponding commercial infrastructure consisting of the right to offer employment to Cerecor’s sales force and the assignment of supporting commercial contracts (collectively, the “Aytu Divestiture”) on November 1, 2019;
|
•
|
Cerecor's acquisition of Ichorion Therapeutics, Inc. (“Ichorion”) on September 25, 2018; and
|
•
|
Cerecor's acquisition of the Pediatrics Business ("Avadel Pediatrics Business") from Avadel Pharmaceuticals PLC (“Avadel”) on February 16, 2018.
|
•
|
the accompanying notes to the unaudited pro forma condensed combined financial statements;
|
•
|
Cerecor’s financial statements and related notes for the three and nine months ended September 30, 2019, contained within Cerecor's Form 10-Q filed on November 14, 2019;
|
•
|
Aevi’s financial statements and related notes for the three and nine months ended September 30, 2019, filed as Exhibit 99.3 within this Form 8-K;
|
•
|
Cerecor’s audited financial statements and related notes for the year ended December 31, 2018, contained within Cerecor's Annual Report on Form 10-K filed on March 18, 2019;
|
•
|
Aevi’s audited financial statements and related notes for the year ended December 31, 2018, filed as Exhibit 99.2 within this Form 8-K; and
|
•
|
the previously filed unaudited pro forma condensed combined financial statements contained within the Previous Report, which include a pro forma condensed combined balance sheet as of September 30, 2019, a pro forma condensed combined statement of operation for the year ended December 31, 2018 and the nine months ended September 30, 2019, and the notes related thereto, filed by Cerecor on December 9, 2019.
|
|
|
|
|
Cerecor Previously Reported
|
|
|
Historical Cerecor
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
|
Historical Cerecor
|
|
Pro Forma Adjustments
|
|
|
as adjusted for Previous Transactions
|
|
|
Historical
Aevi
|
|
Aevi
Pro Forma Adjustments
|
|
|
|
Pro Forma Cerecor Combined
|
|
||||||||||||
|
|
|
|
Note 4
|
|
|
|
|
|
|
|
Note 3
|
|
|
|
|
|
||||||||||||
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cash and cash equivalents
|
|
$
|
5,251
|
|
|
$
|
3,821
|
|
|
|
$
|
9,072
|
|
|
|
$
|
2,381
|
|
|
$
|
(4,138
|
)
|
a)
|
|
|
$
|
7,315
|
|
|
Accounts receivable, net
|
|
4,956
|
|
|
—
|
|
|
|
4,956
|
|
|
|
—
|
|
|
—
|
|
|
|
|
4,956
|
|
|
||||||
Other receivables
|
|
208
|
|
|
(208
|
)
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
||||||
Inventory, net
|
|
402
|
|
|
(377
|
)
|
|
|
25
|
|
|
|
—
|
|
|
—
|
|
|
|
|
25
|
|
|
||||||
Prepaid expenses and other current assets
|
|
1,670
|
|
|
(1,230
|
)
|
|
|
440
|
|
|
|
403
|
|
|
—
|
|
|
|
|
843
|
|
|
||||||
Restricted cash, current portion
|
|
102
|
|
|
|
|
|
102
|
|
|
|
—
|
|
|
—
|
|
|
|
|
102
|
|
|
|||||||
Total current assets
|
|
12,589
|
|
|
2,006
|
|
|
|
14,595
|
|
|
|
2,784
|
|
|
(4,138
|
)
|
|
|
|
13,241
|
|
|
||||||
Property and equipment, net
|
|
1,497
|
|
|
—
|
|
|
|
1,497
|
|
|
|
1
|
|
|
—
|
|
|
|
|
1,498
|
|
|
||||||
Intangible assets, net
|
|
26,595
|
|
|
(23,834
|
)
|
|
|
2,761
|
|
|
|
—
|
|
|
680
|
|
b)
|
|
|
3,441
|
|
|
||||||
Goodwill
|
|
16,411
|
|
|
(2,667
|
)
|
|
|
13,744
|
|
|
|
—
|
|
|
—
|
|
|
|
|
13,744
|
|
|
||||||
Restricted cash, net of current portion
|
|
—
|
|
|
10,000
|
|
|
|
10,000
|
|
|
|
11
|
|
|
—
|
|
|
|
|
10,011
|
|
|
||||||
Investment in Aytu
|
|
102
|
|
|
—
|
|
|
|
102
|
|
|
|
—
|
|
|
—
|
|
|
|
|
102
|
|
|
||||||
Total assets
|
|
$
|
57,194
|
|
|
$
|
(14,495
|
)
|
|
|
$
|
42,699
|
|
|
|
$
|
2,796
|
|
|
$
|
(3,458
|
)
|
|
|
|
$
|
42,037
|
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Accounts payable
|
|
$
|
826
|
|
|
$
|
—
|
|
|
|
$
|
826
|
|
|
|
$
|
123
|
|
|
$
|
—
|
|
|
|
|
$
|
949
|
|
|
Accrued expenses and other current liabilities
|
|
13,134
|
|
|
(3,267
|
)
|
|
|
9,867
|
|
|
|
4,130
|
|
|
750
|
|
c)
|
|
|
14,747
|
|
|
||||||
Income taxes payable
|
|
1,015
|
|
|
—
|
|
|
|
1,015
|
|
|
|
—
|
|
|
—
|
|
|
|
|
1,015
|
|
|
||||||
Long-term debt, current portion
|
|
1,050
|
|
|
(1,050
|
)
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
||||||
Contingent consideration, current portion
|
|
1,237
|
|
|
(1,237
|
)
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
||||||
Total current liabilities
|
|
17,262
|
|
|
(5,554
|
)
|
|
|
11,708
|
|
|
|
4,253
|
|
|
750
|
|
|
|
|
16,711
|
|
|
||||||
Long-term debt, net of current portion
|
|
14,255
|
|
|
(14,255
|
)
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
||||||
Contingent consideration, net of current portion
|
|
6,236
|
|
|
(6,236
|
)
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
||||||
Deferred tax liability, net
|
|
98
|
|
|
—
|
|
|
|
98
|
|
|
|
—
|
|
|
—
|
|
|
|
|
98
|
|
|
||||||
Other long-term liabilities
|
|
1,122
|
|
|
—
|
|
|
|
1,122
|
|
|
|
2,000
|
|
|
—
|
|
|
|
|
3,122
|
|
|
||||||
Total liabilities
|
|
38,973
|
|
|
(26,045
|
)
|
|
|
12,928
|
|
|
|
6,253
|
|
|
750
|
|
|
|
|
19,931
|
|
|
||||||
Stockholders’ equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Common stock
|
|
44
|
|
|
—
|
|
|
|
44
|
|
|
|
7
|
|
|
(2
|
)
|
d)
|
|
|
49
|
|
|
||||||
Preferred stock
|
|
3
|
|
|
—
|
|
|
|
3
|
|
|
|
—
|
|
|
|
|
|
|
3
|
|
|
|||||||
Additional paid-in capital
|
|
134,086
|
|
|
(70
|
)
|
|
|
134,016
|
|
|
|
254,815
|
|
|
(238,704
|
)
|
d)
|
|
|
150,127
|
|
|
||||||
Accumulated deficit
|
|
(115,912
|
)
|
|
11,620
|
|
|
|
(104,292
|
)
|
|
|
(258,279
|
)
|
|
234,498
|
|
e)
|
|
|
(128,073
|
)
|
|
||||||
Total stockholders’ equity
|
|
18,221
|
|
|
11,550
|
|
|
|
29,771
|
|
|
|
(3,457
|
)
|
|
(4,208
|
)
|
|
|
|
22,106
|
|
|
||||||
Total liabilities and stockholders’ equity
|
|
$
|
57,194
|
|
|
$
|
(14,495
|
)
|
|
|
$
|
42,699
|
|
|
|
$
|
2,796
|
|
|
$
|
(3,458
|
)
|
|
|
|
$
|
42,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerecor Previously Reported
|
|
|
Historical Cerecor
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
|
Historical Cerecor
|
|
Pro Forma Adjustments
|
|
|
as adjusted for Previous Transactions
|
|
|
Historical
Aevi |
|
Aevi
Pro Forma Adjustments |
|
|
|
Pro Forma Cerecor Combined
|
|
||||||||||||
|
|
|
|
Note 4
|
|
|
|
|
|
|
|
Note 3
|
|
|
|
|
|
||||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Product revenue, net
|
|
$
|
15,374
|
|
|
$
|
(9,264
|
)
|
|
|
$
|
6,110
|
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
$
|
6,110
|
|
|
License and other revenue
|
|
100
|
|
|
—
|
|
|
|
100
|
|
|
|
—
|
|
|
—
|
|
|
|
|
100
|
|
|
||||||
Total revenues, net
|
|
15,474
|
|
|
(9,264
|
)
|
|
|
6,210
|
|
|
|
—
|
|
|
—
|
|
|
|
|
6,210
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cost of product sales
|
|
3,241
|
|
|
(3,853
|
)
|
|
|
(612
|
)
|
|
|
—
|
|
|
—
|
|
|
|
|
(612
|
)
|
|
||||||
Research and development
|
|
8,857
|
|
|
—
|
|
|
|
8,857
|
|
|
|
7,902
|
|
|
—
|
|
|
|
|
16,759
|
|
|
||||||
General and administrative
|
|
7,779
|
|
|
(269
|
)
|
|
|
7,510
|
|
|
|
4,643
|
|
|
302
|
|
g)
|
|
|
12,455
|
|
|
||||||
Sales and marketing
|
|
8,676
|
|
|
(7,740
|
)
|
|
|
936
|
|
|
|
—
|
|
|
—
|
|
|
|
|
936
|
|
|
||||||
Amortization expense
|
|
3,195
|
|
|
(2,191
|
)
|
|
|
1,004
|
|
|
|
—
|
|
|
255
|
|
h)
|
|
|
1,259
|
|
|
||||||
Impairment of intangible assets
|
|
1,449
|
|
|
(1,449
|
)
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
||||||
Change in fair value of contingent consideration
|
|
(1,009
|
)
|
|
(247
|
)
|
|
|
(1,256
|
)
|
|
|
—
|
|
|
—
|
|
|
|
|
(1,256
|
)
|
|
||||||
Total operating expenses
|
|
32,188
|
|
|
(15,749
|
)
|
|
|
16,439
|
|
|
|
12,545
|
|
|
557
|
|
|
|
|
29,541
|
|
|
||||||
(Loss) income from operations
|
|
(16,714
|
)
|
|
6,485
|
|
|
|
(10,229
|
)
|
|
|
(12,545
|
)
|
|
(557
|
)
|
|
|
|
(23,331
|
)
|
|
||||||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Change in fair value of warrant liability and unit purchase option liability
|
|
7
|
|
|
—
|
|
|
|
7
|
|
|
|
—
|
|
|
—
|
|
|
|
|
7
|
|
|
||||||
Other (expense) income, net
|
|
(24
|
)
|
|
—
|
|
|
|
(24
|
)
|
|
|
19
|
|
|
—
|
|
|
|
|
(5
|
)
|
|
||||||
Interest (expense) income, net
|
|
(614
|
)
|
|
714
|
|
|
|
100
|
|
|
|
—
|
|
|
—
|
|
|
|
|
100
|
|
|
||||||
Total other (expense) income, net
|
|
(631
|
)
|
|
714
|
|
|
|
83
|
|
|
|
19
|
|
|
—
|
|
|
|
|
102
|
|
|
||||||
Net (loss) income before taxes
|
|
(17,345
|
)
|
|
7,199
|
|
|
|
(10,146
|
)
|
|
|
(12,526
|
)
|
|
(557
|
)
|
|
|
|
(23,229
|
)
|
|
||||||
Income tax expense
|
|
349
|
|
|
(40
|
)
|
|
|
309
|
|
|
|
—
|
|
|
—
|
|
|
|
|
309
|
|
|
||||||
Net (loss) income
|
|
$
|
(17,694
|
)
|
|
$
|
7,239
|
|
|
|
$
|
(10,455
|
)
|
|
|
$
|
(12,526
|
)
|
|
$
|
(557
|
)
|
|
|
|
$
|
(23,538
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Net loss attributable to common shareholders
|
|
$
|
(13,239
|
)
|
|
|
|
|
|
$
|
(7,823
|
)
|
|
|
|
|
|
|
|
|
|
|
$
|
(18,083
|
)
|
|
|||
Weighted-average shares of common stock, basic and diluted
|
|
42,454
|
|
|
|
|
|
42,454
|
|
|
|
|
|
4,899
|
|
i)
|
|
|
47,353
|
|
|
||||||||
Net loss per share of common stock, basic and diluted
|
|
$
|
(0.31
|
)
|
|
|
|
|
$
|
(0.18
|
)
|
|
|
|
|
|
|
|
|
$
|
(0.38
|
)
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Net loss attributable to preferred shareholders
|
|
$
|
(4,455
|
)
|
|
|
|
|
$
|
(2,632
|
)
|
|
|
|
|
|
|
|
|
$
|
(5,455
|
)
|
|
||||||
Weighted-average shares of preferred stock, basic and diluted
|
|
2,857
|
|
|
|
|
|
2,857
|
|
|
|
|
|
—
|
|
|
|
|
2,857
|
|
|
||||||||
Net loss per share of preferred stock, basic and diluted
|
|
$
|
(1.56
|
)
|
|
|
|
|
$
|
(0.92
|
)
|
|
|
|
|
|
|
|
|
$
|
(1.91
|
)
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerecor Previously Reported
|
|
|
Historical Cerecor
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
|
Historical Cerecor
|
|
Pro Forma Adjustments
|
|
|
as adjusted for Previous Transactions
|
|
|
Historical
Aevi |
|
Aevi
Pro Forma Adjustments |
|
|
|
Pro Forma
Cerecor Combined
|
|
||||||||||||
|
|
|
|
Note 4
|
|
|
|
|
|
|
|
Note 3
|
|
|
|
|
|
||||||||||||
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Product revenue, net
|
|
$
|
17,871
|
|
|
$
|
(11,165
|
)
|
|
|
$
|
6,706
|
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
$
|
6,706
|
|
|
Sales force revenue
|
|
456
|
|
|
—
|
|
|
|
456
|
|
|
|
—
|
|
|
—
|
|
|
|
|
456
|
|
|
||||||
Total revenues, net
|
|
18,327
|
|
|
(11,165
|
)
|
|
|
7,162
|
|
|
|
—
|
|
|
—
|
|
|
|
|
7,162
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cost of product sales
|
|
7,478
|
|
|
(4,051
|
)
|
|
|
3,427
|
|
|
|
—
|
|
|
—
|
|
|
|
|
3,427
|
|
|
||||||
Research and development
|
|
5,787
|
|
|
2,342
|
|
|
|
8,129
|
|
|
|
22,299
|
|
|
—
|
|
|
|
|
30,428
|
|
|
||||||
Acquired in-process research and development
|
|
18,724
|
|
|
—
|
|
|
|
18,724
|
|
|
|
—
|
|
|
23,781
|
|
f)
|
|
|
42,505
|
|
|
||||||
General and administrative
|
|
10,678
|
|
|
1,283
|
|
|
|
11,961
|
|
|
|
8,663
|
|
|
—
|
|
|
|
|
20,624
|
|
|
||||||
Sales and marketing
|
|
8,522
|
|
|
(8,018
|
)
|
|
|
504
|
|
|
|
—
|
|
|
—
|
|
|
|
|
504
|
|
|
||||||
Amortization expense
|
|
4,532
|
|
|
(2,648
|
)
|
|
|
1,884
|
|
|
|
—
|
|
|
340
|
|
h)
|
|
|
2,224
|
|
|
||||||
Impairment of intangible assets
|
|
1,862
|
|
|
—
|
|
|
|
1,862
|
|
|
|
—
|
|
|
—
|
|
|
|
|
1,862
|
|
|
||||||
Change in fair value of contingent consideration
|
|
58
|
|
|
(169
|
)
|
|
|
(111
|
)
|
|
|
—
|
|
|
—
|
|
|
|
|
(111
|
)
|
|
||||||
Total operating expenses
|
|
57,641
|
|
|
(11,261
|
)
|
|
|
46,380
|
|
|
|
30,962
|
|
|
24,121
|
|
|
|
|
101,463
|
|
|
||||||
Loss (income) from operations
|
|
(39,314
|
)
|
|
96
|
|
|
|
(39,218
|
)
|
|
|
(30,962
|
)
|
|
(24,121
|
)
|
|
|
|
(94,301
|
)
|
|
||||||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Change in fair value of warrant liability and unit purchase option liability
|
|
25
|
|
|
—
|
|
|
|
25
|
|
|
|
—
|
|
|
—
|
|
|
|
|
25
|
|
|
||||||
Other income, net
|
|
14
|
|
|
—
|
|
|
|
14
|
|
|
|
187
|
|
|
—
|
|
|
|
|
201
|
|
|
||||||
Interest (expense) income, net
|
|
(812
|
)
|
|
828
|
|
|
|
16
|
|
|
|
—
|
|
|
—
|
|
|
|
|
16
|
|
|
||||||
Total other (expense) income, net
|
|
(773
|
)
|
|
828
|
|
|
|
55
|
|
|
|
187
|
|
|
—
|
|
|
|
|
242
|
|
|
||||||
Net (loss) income before taxes
|
|
(40,087
|
)
|
|
924
|
|
|
|
(39,163
|
)
|
|
|
(30,775
|
)
|
|
(24,121
|
)
|
|
|
|
(94,059
|
)
|
|
||||||
Income tax benefit
|
|
(34
|
)
|
|
16
|
|
|
|
(18
|
)
|
|
|
—
|
|
|
—
|
|
|
|
|
(18
|
)
|
|
||||||
Net (loss) income
|
|
$
|
(40,053
|
)
|
|
$
|
908
|
|
|
|
$
|
(39,145
|
)
|
|
|
$
|
(30,775
|
)
|
|
$
|
(24,121
|
)
|
|
|
|
$
|
(94,041
|
)
|
|
Net (loss) income attributable to common shareholders
|
|
$
|
(41,710
|
)
|
|
$
|
908
|
|
|
|
$
|
(40,802
|
)
|
|
|
$
|
(30,775
|
)
|
|
$
|
(24,121
|
)
|
|
|
|
$
|
(95,698
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Weighted-average shares of common stock, basic and diluted
|
|
34,774
|
|
|
5,693
|
|
|
|
40,467
|
|
|
|
|
|
4,899
|
|
i)
|
|
|
45,366
|
|
|
|||||||
Net loss per share of common stock, basic and diluted
|
|
$
|
(1.20
|
)
|
|
|
|
|
$
|
(1.01
|
)
|
|
|
|
|
|
|
|
|
$
|
(2.11
|
)
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
a)
|
Cash and cash equivalents- In August 2019, Aevi obtained the right to exercise an exclusive license from MedImmune Limited to develop and commercialize a Phase 2‑ready fully human monoclonal antibody that targets interleukin 18, or IL‑18, AEVI‑007, for consideration of $3.5 million in cash and $2.5 million in equity (“AZ Option”).
|
b)
|
Intangible assets, net- This adjustment reflects the preliminary estimate of the assembled workforce intangible asset recorded as part of purchase accounting (which we have preliminarily recorded for pro forma purposes as an asset acquisition-see note f) for more information regarding this preliminary conclusion). The assembled workforce represents the total estimated replacement cost of the acquired Aevi workforce, including recruiting fees, training costs and loss of productivity costs. For purposes of these unaudited pro forma condensed combined financial statements, management estimated each of these costs based on estimated replacement costs as a percentage of the acquired Aevi workforce’s compensation. We preliminarily assigned a two‑year useful life to the assembled workforce intangible asset.
|
c)
|
Accrued expenses and other current liabilities- The $0.8 million net adjustment reflects (1) removal of the CHOP Note (defined below), which will be converted to common stock immediately prior to the consummation of the Merger and (2) accrual of estimated transaction costs directly attributable to the Merger.
|
d)
|
Additional paid-in capital and common stock- The $238.7 million net reduction to additional paid‑in capital reflects the elimination of historical Aevi equity balances of $254.8 million partially offset by the estimated Cerecor common stock to be issued upon consummation of the Merger based on the Estimated Adjusted Purchase Price of $16.1 million. Similarly, the small net reduction to common stock reflects the elimination of the par value of historical Aevi equity partially offset by the estimated par value of the estimated Cerecor shares to be issued subsequent to consummation of the Merger (for this purpose using the closing stock price on September 30, 2019 to estimate the number of shares to be issued).
|
e)
|
Accumulated deficit- The $234.5 million increase to accumulated deficit within the unaudited pro forma condensed consolidated balance sheet as of September 30, 2019 represents the removal of Aevi’s historical accumulated deficit of $258.3 million offset by the recognition of the estimated IPR&D expense of $23.8 million related to the asset accounting treatment of the Merger. Refer to note f) for more information regarding the preliminary purchase accounting performed.
|
f)
|
Acquired in-process research and development- Cerecor preliminarily determined the Merger will be recorded as an asset purchase as opposed to a business combination because management preliminarily concluded that substantially all of the value received is related to one group of similar identifiable assets, namely the acquired IPR&D for the two rare and orphan disease assets (AEVI‑006 and AEVI‑007). Accordingly, this adjustment immediately expenses the estimated value attributable to IPR&D asset of $23.1 million within the unaudited pro forma condensed combined statement of operations for the year ended December 31, 2018. The preliminary estimated value to the acquired IPR&D asset (in thousands) is calculated as follows:
|
g)
|
General and administrative- Immediately following the completion of the Merger, the current Chief Executive Officer of Aevi is expected to be appointed as the Chief Executive Officer (“CEO”) of Cerecor and the current Chief Scientific Officer of Aevi is expected to be appointed as the Chief Medical Officer (“CMO”) of Cerecor. The employment agreements for these executives will be effective upon closing. The CMO’s salary is anticipated to match his current salary at Aevi.
|
h)
|
Amortization expense- Reflects amortization expense related to the intangible asset of assembled workforce that was recorded as a part of the preliminary asset acquisition accounting as if the acquisition had occurred on January 1, 2018. As described in further detail in note b), the assembled workforce was recorded to intangible assets and has a preliminary useful life of two years.
|
i)
|
Weighted-average shares of common stock, basic and diluted- Adjustment reflects the 4.9 million shares estimated to be issued as part of the Merger. Pursuant to the Merger Agreement, at the Merger Effective Time, all outstanding common stock of Aevi (other than canceled shares or dissenting shares) will be converted into the right to receive (i) the fraction of a share
|
•
|
Cerecor's sale of its Pediatric Portfolio (the Aytu Divestiture), as well as the corresponding commercial infrastructure consisting of the right to offer employment to Cerecor’s sales force and the assignment of supporting commercial contracts on November 1, 2019;
|
•
|
Cerecor's acquisition of Ichorion on September 25, 2018; and
|
•
|
Cerecor's acquisition of Avadel Pediatric Business on February 16, 2018.
|
|
|
Cerecor Previously Reported
|
|
Cerecor Reversal of Previously Reported
|
|
Cerecor Reversal of Certain Previously Reported
|
|
Cerecor Previously Reported
|
|
Cerecor Previously Reported
|
||||||||||
|
|
Historical Avadel Pediatric Business and Historical Ichorion
and related Pro Forma Adjustments
|
|
Historical
Avadel Pediatric Business and related Pro Forma Adjustments
|
|
Ichorion Pro Forma Adjustment
|
|
Aytu Divestiture
Pro Forma Adjustments
|
|
Pro Forma Adjustments
|
||||||||||
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Product revenue, net
|
|
$
|
1,705
|
|
|
$
|
(1,705
|
)
|
|
$
|
—
|
|
|
$
|
(11,165
|
)
|
|
$
|
(11,165
|
)
|
Sales force revenue
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total revenues, net
|
|
1,705
|
|
|
(1,705
|
)
|
|
—
|
|
|
(11,165
|
)
|
|
(11,165
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of product sales
|
|
355
|
|
|
(355
|
)
|
|
—
|
|
|
(4,051
|
)
|
|
(4,051
|
)
|
|||||
Research and development
|
|
2,342
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,342
|
|
|||||
Acquired in-process research and development
|
|
(18,724
|
)
|
|
—
|
|
|
18,724
|
|
|
—
|
|
|
—
|
|
|||||
General and administrative
|
|
3,294
|
|
|
(1,846
|
)
|
|
—
|
|
|
(165
|
)
|
|
1,283
|
|
|||||
Sales and marketing
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,018
|
)
|
|
(8,018
|
)
|
|||||
Amortization expense
|
|
302
|
|
|
(246
|
)
|
|
—
|
|
|
(2,704
|
)
|
|
(2,648
|
)
|
|||||
Impairment of intangible assets
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Change in fair value of contingent consideration
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(169
|
)
|
|
(169
|
)
|
|||||
Total operating expenses
|
|
(12,431
|
)
|
|
(2,447
|
)
|
|
18,724
|
|
|
(15,107
|
)
|
|
(11,261
|
)
|
|||||
Loss (income) from operations
|
|
14,136
|
|
|
742
|
|
|
(18,724
|
)
|
|
3,942
|
|
|
96
|
|
|||||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Change in fair value of warrant liability and unit purchase option liability
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Other income, net
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Interest (expense) income, net
|
|
(125
|
)
|
|
125
|
|
|
—
|
|
|
828
|
|
|
828
|
|
|||||
Total other (expense) income, net
|
|
(125
|
)
|
|
125
|
|
|
—
|
|
|
828
|
|
|
828
|
|
|||||
Net (loss) income before taxes
|
|
14,011
|
|
|
867
|
|
|
(18,724
|
)
|
|
4,770
|
|
|
924
|
|
|||||
Income tax benefit
|
|
—
|
|
|
—
|
|
|
—
|
|
|
16
|
|
|
16
|
|
|||||
Net (loss) income
|
|
$
|
14,011
|
|
|
$
|
867
|
|
|
$
|
(18,724
|
)
|
|
$
|
4,754
|
|
|
$
|
908
|
|
Net (loss) income attributable to common shareholders
|
|
$
|
14,011
|
|
|
$
|
867
|
|
|
$
|
(18,724
|
)
|
|
$
|
4,754
|
|
|
$
|
908
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Weighted-average shares of common stock, basic and diluted
|
|
5,693
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,693
|
|