|
ý
|
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
|
|
33-0903395
|
(State or Other Jurisdiction of Incorporation or Organization)
|
|
(I.R.S. Employer Identification No.)
|
|
|
|
2505 Meridian Parkway, Suite 100
|
|
|
Durham, North Carolina
|
|
27713
|
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, par value $0.001 per share
|
CMRX
|
The Nasdaq Global Market
|
Large accelerated filer
o
|
|
Accelerated filer
x
|
Non-accelerated filer
o
|
|
Smaller reporting company
x
|
|
|
Emerging growth company
o
|
|
Page
|
|
|
|
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
ASSETS
|
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
|
||
Cash and cash equivalents
|
|
$
|
21,644
|
|
|
$
|
81,106
|
|
Short-term investments, available-for-sale
|
|
136,755
|
|
|
105,424
|
|
||
Accounts receivable
|
|
774
|
|
|
330
|
|
||
Prepaid expenses and other current assets
|
|
2,200
|
|
|
2,598
|
|
||
Total current assets
|
|
161,373
|
|
|
189,458
|
|
||
Property and equipment, net of accumulated depreciation
|
|
1,054
|
|
|
1,210
|
|
||
Operating lease right-of-use assets
|
|
969
|
|
|
—
|
|
||
Other long-term assets
|
|
45
|
|
|
46
|
|
||
Total assets
|
|
$
|
163,441
|
|
|
$
|
190,714
|
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
|
||
Accounts payable
|
|
$
|
1,832
|
|
|
$
|
4,691
|
|
Accrued liabilities
|
|
11,954
|
|
|
8,275
|
|
||
Total current liabilities
|
|
13,786
|
|
|
12,966
|
|
||
Lease-related obligations
|
|
537
|
|
|
144
|
|
||
Total liabilities
|
|
14,323
|
|
|
13,110
|
|
||
|
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
|
|
|
||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at June 30, 2019 and December 31, 2018; no shares issued and outstanding as of June 30, 2019 and December 31, 2018
|
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2019 and December 31, 2018; 51,230,916 and 50,735,279 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively
|
|
51
|
|
|
51
|
|
||
Additional paid-in capital
|
|
740,547
|
|
|
733,907
|
|
||
Accumulated other comprehensive gain (loss), net
|
|
125
|
|
|
(92
|
)
|
||
Accumulated deficit
|
|
(591,605
|
)
|
|
(556,262
|
)
|
||
Total stockholders’ equity
|
|
149,118
|
|
|
177,604
|
|
||
Total liabilities and stockholders’ equity
|
|
$
|
163,441
|
|
|
$
|
190,714
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Contract revenue
|
|
$
|
1,438
|
|
|
$
|
1,193
|
|
|
$
|
3,794
|
|
|
$
|
1,983
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development
|
|
13,827
|
|
|
13,712
|
|
|
27,342
|
|
|
28,071
|
|
||||
General and administrative
|
|
6,312
|
|
|
6,650
|
|
|
13,998
|
|
|
13,388
|
|
||||
Total operating expenses
|
|
20,139
|
|
|
20,362
|
|
|
41,340
|
|
|
41,459
|
|
||||
Loss from operations
|
|
(18,701
|
)
|
|
(19,169
|
)
|
|
(37,546
|
)
|
|
(39,476
|
)
|
||||
Other (expense) income:
|
|
|
|
|
|
|
|
|
||||||||
Unrealized loss on equity investment
|
|
(22
|
)
|
|
(78
|
)
|
|
(30
|
)
|
|
(212
|
)
|
||||
Interest income and other, net
|
|
1,073
|
|
|
634
|
|
|
2,233
|
|
|
1,249
|
|
||||
Net loss
|
|
(17,650
|
)
|
|
(18,613
|
)
|
|
(35,343
|
)
|
|
(38,439
|
)
|
||||
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain on debt investments, net
|
|
77
|
|
|
225
|
|
|
217
|
|
|
122
|
|
||||
Comprehensive loss
|
|
$
|
(17,573
|
)
|
|
$
|
(18,388
|
)
|
|
$
|
(35,126
|
)
|
|
$
|
(38,317
|
)
|
Per share information:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss, basic and diluted
|
|
$
|
(0.35
|
)
|
|
$
|
(0.39
|
)
|
|
$
|
(0.69
|
)
|
|
$
|
(0.81
|
)
|
Weighted-average shares outstanding, basic and diluted
|
|
51,130,104
|
|
|
47,811,552
|
|
|
51,009,935
|
|
|
47,725,209
|
|
|
Common
Stock |
|
Additional
Paid-in Capital |
|
Accumulated Other
Comprehensive Gain (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity (Deficit) |
||||||||||
Balance, December 31, 2018
|
$
|
51
|
|
|
$
|
733,907
|
|
|
$
|
(92
|
)
|
|
$
|
(556,262
|
)
|
|
$
|
177,604
|
|
Share-based compensation
|
—
|
|
|
4,073
|
|
|
—
|
|
|
—
|
|
|
4,073
|
|
|||||
Exercise of stock options
|
—
|
|
|
13
|
|
|
—
|
|
|
—
|
|
|
13
|
|
|||||
Employee stock purchase plan purchases
|
—
|
|
|
170
|
|
|
—
|
|
|
—
|
|
|
170
|
|
|||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrealized gain on investments, net
|
—
|
|
|
—
|
|
|
140
|
|
|
—
|
|
|
140
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(17,693
|
)
|
|
(17,693
|
)
|
|||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
(17,553
|
)
|
|||||||||
Balance, March 31, 2019
|
$
|
51
|
|
|
$
|
738,163
|
|
|
$
|
48
|
|
|
$
|
(573,955
|
)
|
|
$
|
164,307
|
|
Share-based compensation
|
—
|
|
|
2,367
|
|
|
—
|
|
|
—
|
|
|
2,367
|
|
|||||
Exercise of stock options
|
—
|
|
|
17
|
|
|
—
|
|
|
—
|
|
|
17
|
|
|||||
Employee stock purchase plan purchases
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock, net of issuance costs
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrealized gain on investments, net
|
—
|
|
|
—
|
|
|
77
|
|
|
—
|
|
|
77
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(17,650
|
)
|
|
(17,650
|
)
|
|||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
(17,573
|
)
|
|||||||||
Balance, June 30, 2019
|
$
|
51
|
|
|
$
|
740,547
|
|
|
$
|
125
|
|
|
$
|
(591,605
|
)
|
|
$
|
149,118
|
|
|
Common
Stock |
|
Additional
Paid-in Capital |
|
Accumulated Other
Comprehensive Gain (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity (Deficit) |
||||||||||
Balance, December 31, 2017
|
$
|
47
|
|
|
$
|
709,514
|
|
|
$
|
(963
|
)
|
|
$
|
(486,788
|
)
|
|
$
|
221,810
|
|
Share-based compensation
|
1
|
|
|
3,391
|
|
|
—
|
|
|
—
|
|
|
3,392
|
|
|||||
Exercise of stock options
|
—
|
|
|
60
|
|
|
—
|
|
|
—
|
|
|
60
|
|
|||||
Employee stock purchase plan purchases
|
—
|
|
|
358
|
|
|
—
|
|
|
—
|
|
|
358
|
|
|||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrealized loss on investments, net
|
—
|
|
|
—
|
|
|
(103
|
)
|
|
—
|
|
|
(103
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(19,826
|
)
|
|
(19,826
|
)
|
|||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
(19,929
|
)
|
|||||||||
Balance, March 31, 2018
|
$
|
48
|
|
|
$
|
713,323
|
|
|
$
|
(1,066
|
)
|
|
$
|
(506,614
|
)
|
|
$
|
205,691
|
|
Share-based compensation
|
—
|
|
|
4,035
|
|
|
—
|
|
|
—
|
|
|
4,035
|
|
|||||
Exercise of stock options
|
—
|
|
|
55
|
|
|
—
|
|
|
—
|
|
|
55
|
|
|||||
Employee stock purchase plan purchases
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock, net of issuance costs
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrealized loss on investments, net
|
—
|
|
|
—
|
|
|
225
|
|
|
—
|
|
|
225
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(18,613
|
)
|
|
(18,613
|
)
|
|||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
(18,388
|
)
|
|||||||||
Balance, June 30, 2018
|
$
|
48
|
|
|
$
|
717,413
|
|
|
$
|
(841
|
)
|
|
$
|
(525,227
|
)
|
|
$
|
191,393
|
|
|
|
Six Months Ended June 30,
|
||||||
|
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||
Net loss
|
|
$
|
(35,343
|
)
|
|
$
|
(38,439
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
||
Depreciation of property and equipment
|
|
306
|
|
|
487
|
|
||
Amortization of discount/premium on investments
|
|
(1,205
|
)
|
|
(171
|
)
|
||
Share-based compensation
|
|
6,440
|
|
|
7,427
|
|
||
Unrealized loss on equity investment
|
|
30
|
|
|
212
|
|
||
Lease-related amortization
|
|
(36
|
)
|
|
(24
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
||
Accounts receivable
|
|
(444
|
)
|
|
1,463
|
|
||
Prepaid expenses and other assets
|
|
399
|
|
|
24
|
|
||
Accounts payable and accrued liabilities
|
|
302
|
|
|
(3,529
|
)
|
||
Net cash used in operating activities
|
|
(29,551
|
)
|
|
(32,550
|
)
|
||
|
|
|
|
|
||||
Cash flows from investing activities:
|
|
|
|
|
|
|
||
Purchases of property and equipment
|
|
(150
|
)
|
|
(96
|
)
|
||
Purchases of short-term investments
|
|
(107,149
|
)
|
|
(18,117
|
)
|
||
Purchases of long-term investments
|
|
—
|
|
|
(6,031
|
)
|
||
Proceeds from sales of short-term investments
|
|
—
|
|
|
22,000
|
|
||
Proceeds from maturities of short-term investments
|
|
77,210
|
|
|
43,500
|
|
||
Net cash (used in) provided by investing activities
|
|
(30,089
|
)
|
|
41,256
|
|
||
|
|
|
|
|
||||
Cash flows from financing activities:
|
|
|
|
|
|
|
||
Proceeds from exercise of stock options
|
|
30
|
|
|
115
|
|
||
Proceeds from employee stock purchase plan
|
|
171
|
|
|
358
|
|
||
Payments of deferred offering costs
|
|
(23
|
)
|
|
(280
|
)
|
||
Net cash provided by financing activities
|
|
178
|
|
|
193
|
|
||
Net (decrease) increase in cash and cash equivalents
|
|
(59,462
|
)
|
|
8,899
|
|
||
Cash and cash equivalents:
|
|
|
|
|
||||
Beginning of period
|
|
81,106
|
|
|
18,548
|
|
||
End of period
|
|
$
|
21,644
|
|
|
$
|
27,447
|
|
•
|
Level 1
— Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.
|
•
|
Level 2
— Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly.
|
•
|
Level 3
— Valuations based on inputs that are unobservable and significant to the overall fair value measurement.
|
|
Fair Value Measurements
|
||||||||||||||
|
June 30, 2019
|
||||||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Cash equivalents
|
|
|
|||||||||||||
Money market funds
|
$
|
11,906
|
|
|
$
|
11,906
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Commercial paper
|
5,835
|
|
|
—
|
|
|
5,835
|
|
|
—
|
|
||||
Total cash equivalents
|
17,741
|
|
|
11,906
|
|
|
5,835
|
|
|
—
|
|
||||
Short-term investments
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
38,405
|
|
|
38,405
|
|
|
—
|
|
|
—
|
|
||||
Common stock of U.S. corporation
|
8
|
|
|
8
|
|
|
—
|
|
|
—
|
|
||||
Commercial paper
|
45,673
|
|
|
—
|
|
|
45,673
|
|
|
—
|
|
||||
Corporate bonds
|
52,669
|
|
|
—
|
|
|
52,669
|
|
|
—
|
|
||||
Total short-term investments
|
136,755
|
|
|
38,413
|
|
|
98,342
|
|
|
—
|
|
||||
Total assets
|
$
|
154,496
|
|
|
$
|
50,319
|
|
|
$
|
104,177
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
|
Fair Value Measurements
|
||||||||||||||
|
December 31, 2018
|
||||||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Cash equivalents
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
30,726
|
|
|
$
|
30,726
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. treasury securities
|
11,482
|
|
|
11,482
|
|
|
—
|
|
|
—
|
|
||||
Commercial paper
|
29,677
|
|
|
—
|
|
|
29,677
|
|
|
—
|
|
||||
Corporate bonds
|
4,008
|
|
|
—
|
|
|
4,008
|
|
|
—
|
|
||||
Total cash equivalents
|
75,893
|
|
|
42,208
|
|
|
33,685
|
|
|
—
|
|
||||
Short-term investments
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
12,589
|
|
|
12,589
|
|
|
—
|
|
|
—
|
|
||||
Common stock of U.S. corporation
|
38
|
|
|
38
|
|
|
—
|
|
|
—
|
|
||||
Commercial paper
|
60,114
|
|
|
—
|
|
|
60,114
|
|
|
—
|
|
||||
Corporate bonds
|
32,683
|
|
|
—
|
|
|
32,683
|
|
|
—
|
|
||||
Total short-term investments
|
105,424
|
|
|
12,627
|
|
|
92,797
|
|
|
—
|
|
||||
Total assets
|
$
|
181,317
|
|
|
$
|
54,835
|
|
|
$
|
126,482
|
|
|
$
|
—
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Accrued research and development expenses
|
$
|
6,378
|
|
|
$
|
4,525
|
|
Accrued compensation
|
4,154
|
|
|
2,469
|
|
||
Other accrued liabilities
|
1,422
|
|
|
1,281
|
|
||
Total accrued liabilities
|
$
|
11,954
|
|
|
$
|
8,275
|
|
|
|
June 30, 2019
|
||||||||||||||
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
||||||||
Corporate bonds
|
|
$
|
52,595
|
|
|
$
|
74
|
|
|
$
|
—
|
|
|
$
|
52,669
|
|
U.S. treasury securities
|
|
38,379
|
|
|
27
|
|
|
(1
|
)
|
|
38,405
|
|
||||
Commercial paper
|
|
45,649
|
|
|
25
|
|
|
(1
|
)
|
|
45,673
|
|
||||
Total investments
|
|
$
|
136,623
|
|
|
$
|
126
|
|
|
$
|
(2
|
)
|
|
$
|
136,747
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
December 31, 2018
|
||||||||||||||
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
||||||||
Corporate bonds
|
|
$
|
32,724
|
|
|
$
|
—
|
|
|
$
|
(41
|
)
|
|
$
|
32,683
|
|
Commercial paper
|
|
60,159
|
|
|
—
|
|
|
(45
|
)
|
|
60,114
|
|
||||
U.S. treasury securities
|
|
12,592
|
|
|
—
|
|
|
(3
|
)
|
|
12,589
|
|
||||
Total investments
|
|
$
|
105,475
|
|
|
$
|
—
|
|
|
$
|
(89
|
)
|
|
$
|
105,386
|
|
|
|
June 30, 2019
|
||||||||||||||||||||||
|
|
Less than 12 Months
|
|
Greater than 12 Months
|
|
Total
|
||||||||||||||||||
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Commercial paper
|
|
$
|
6,955
|
|
|
$
|
(1
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,955
|
|
|
$
|
(1
|
)
|
U.S. treasury securities
|
|
9,980
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
9,980
|
|
|
(1
|
)
|
||||||
Total
|
|
$
|
16,935
|
|
|
$
|
(2
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
16,935
|
|
|
$
|
(2
|
)
|
Number of securities with unrealized losses
|
|
|
|
4
|
|
|
|
|
—
|
|
|
|
|
4
|
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
|
December 31, 2018
|
||||||||||||||||||||||
|
|
Less than 12 Months
|
|
Greater than 12 Months
|
|
Total
|
||||||||||||||||||
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Corporate bonds
|
|
$
|
32,683
|
|
|
$
|
(41
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
32,683
|
|
|
$
|
(41
|
)
|
Commercial paper
|
|
60,114
|
|
|
(45
|
)
|
|
—
|
|
|
—
|
|
|
60,114
|
|
|
(45
|
)
|
||||||
U.S. treasury securities
|
|
12,589
|
|
|
(3
|
)
|
|
—
|
|
|
—
|
|
|
12,589
|
|
|
(3
|
)
|
||||||
Total
|
|
$
|
105,386
|
|
|
$
|
(89
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
105,386
|
|
|
$
|
(89
|
)
|
Number of securities with unrealized losses
|
|
|
|
36
|
|
|
|
|
—
|
|
|
|
|
36
|
|
Maturing in one year or less
|
$
|
136,747
|
|
Maturing after one year through two years
|
—
|
|
|
Total debt investments
|
136,747
|
|
|
Common stock of U.S. corporation
|
8
|
|
|
Total investments
|
$
|
136,755
|
|
Assets
|
|
||
Operating Lease Right-of-Use Assets
|
$
|
969
|
|
|
|
||
Liabilities
|
|
||
Operating Lease Short-term Liabilities (recorded within Accrued liabilities)
|
$
|
618
|
|
Operating Lease Long-term Liabilities (recorded within Lease-related obligations)
|
519
|
|
|
Total Operating Lease Liabilities
|
$
|
1,137
|
|
Years Ending December 31,
|
As of June 30, 2019
|
||
2019
|
$
|
365
|
|
2020
|
719
|
|
|
2021
|
182
|
|
|
Total future minimum rental payments
|
$
|
1,266
|
|
Less amount of lease payments representing interest
|
129
|
|
|
Total present value of lease payments
|
$
|
1,137
|
|
Years Ending December 31,
|
As of December 31, 2018
|
||
2019
|
$
|
786
|
|
2020
|
797
|
|
|
2021
|
235
|
|
|
Total future minimum rental payments
|
$
|
1,818
|
|
Years Ending December 31,
|
As of June 30, 2019
|
||
2019
|
$
|
39
|
|
2020
|
81
|
|
|
2021
|
14
|
|
|
Total future minimum sublease rentals
|
$
|
134
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Research and development expense
|
|
$
|
1,000
|
|
|
$
|
1,536
|
|
|
$
|
2,270
|
|
|
$
|
2,856
|
|
General and administrative expense
|
|
1,367
|
|
|
2,500
|
|
|
4,170
|
|
|
4,571
|
|
||||
Total share-based compensation expense
|
|
$
|
2,367
|
|
|
$
|
4,036
|
|
|
$
|
6,440
|
|
|
$
|
7,427
|
|
|
|
Employee Termination Benefits
|
|
Clinical Trial Close-out Costs
|
|
Other Development Costs
|
|
Total
|
||||
Research and development
|
|
1,426
|
|
|
2,837
|
|
|
315
|
|
|
4,578
|
|
General and administrative
|
|
1,909
|
|
|
—
|
|
|
—
|
|
|
1.909
|
|
Total restructuring expenses
|
|
3,335
|
|
|
2,837
|
|
|
315
|
|
|
6,487
|
|
|
|
Employee Termination Benefits
|
|
Clinical Trial Close-out Costs
|
|
Other Development Costs
|
|
Total
|
||||
Balance at March 31, 2019
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Accruals
|
|
3,335
|
|
|
2,131
|
|
|
315
|
|
|
5,781
|
|
Payments
|
|
(1,551
|
)
|
|
(69
|
)
|
|
—
|
|
|
(1,620
|
)
|
Balance at June 30, 2019
|
|
1,784
|
|
|
2,062
|
|
|
315
|
|
|
4,161
|
|
•
|
fees paid to consultants and contract research organizations (CROs), including in connection with preclinical and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis;
|
•
|
salaries and related overhead expenses, which include stock option, restricted stock units and employee stock purchase program compensation and benefits, for personnel in research and development functions;
|
•
|
payments to third-party manufacturers, which produce, test and package drug substance and drug product (including continued testing of process validation and stability);
|
•
|
costs related to legal and compliance with regulatory requirements; and
|
•
|
license fees for and milestone payments related to licensed products and technologies.
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Direct research and development expenses
|
|
$
|
7,264
|
|
|
$
|
7,716
|
|
|
$
|
14,948
|
|
|
$
|
15,428
|
|
Research and development personnel costs - excluding stock-based compensation
|
|
4,637
|
|
|
2,857
|
|
|
8,259
|
|
|
6,775
|
|
||||
Research and development personnel costs - stock-based compensation
|
|
1,000
|
|
|
1,536
|
|
|
2,270
|
|
|
2,856
|
|
||||
Indirect research and development expenses
|
|
926
|
|
|
1,603
|
|
|
1,865
|
|
|
3,012
|
|
||||
Total research and development expenses
|
|
$
|
13,827
|
|
|
$
|
13,712
|
|
|
$
|
27,342
|
|
|
$
|
28,071
|
|
|
|
Three Months Ended June 30,
|
|
Dollar Change
|
|
% Change
|
|||||||||
|
|
2019
|
|
2018
|
|
Increase/(Decrease)
|
|||||||||
Contract revenue
|
|
$
|
1,438
|
|
|
$
|
1,193
|
|
|
$
|
245
|
|
|
20.5
|
%
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
|
13,827
|
|
|
13,712
|
|
|
115
|
|
|
0.8
|
%
|
|||
General and administrative
|
|
6,312
|
|
|
6,650
|
|
|
(338
|
)
|
|
(5.1
|
)%
|
|||
Total operating expenses
|
|
20,139
|
|
|
20,362
|
|
|
(223
|
)
|
|
(1.1
|
)%
|
|||
Loss from operations
|
|
(18,701
|
)
|
|
(19,169
|
)
|
|
468
|
|
|
(2.4
|
)%
|
|||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|||||||
Unrealized loss on equity investment
|
|
(22
|
)
|
|
(78
|
)
|
|
56
|
|
|
(71.8
|
)%
|
|||
Interest income and other, net
|
|
1,073
|
|
|
634
|
|
|
439
|
|
|
69.2
|
%
|
|||
Net loss
|
|
$
|
(17,650
|
)
|
|
$
|
(18,613
|
)
|
|
$
|
963
|
|
|
(5.2
|
)%
|
•
|
an increase of $1.2 million in compensation and severance expenses;
|
•
|
an increase of $0.9 million related to oral and IV BCV program costs mainly attributable to the acceleration of closeout costs; offset by
|
•
|
a decrease of $0.8 million in expenses related to the smallpox program;
|
•
|
a decrease of $0.8 million in legal fees and operational expenses;
|
•
|
a decrease of $0.5 million in expenses related to our development of early stage compounds.
|
•
|
a decrease of $1.5 million in commercial readiness and operational expenses; offset by
|
•
|
an increase of $0.7 million related to legal and consulting fees incurred in the pursuit of external opportunities to build our pipeline; and
|
•
|
an increase of $0.5 million in compensation and severance expenses.
|
|
|
Six Months Ended June 30,
|
|
Dollar Change
|
|
% Change
|
|||||||||
|
|
2019
|
|
2018
|
|
Increase/(Decrease)
|
|||||||||
Contract revenue
|
|
$
|
3,794
|
|
|
$
|
1,983
|
|
|
$
|
1,811
|
|
|
91.3
|
%
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|||||
Research and development
|
|
27,342
|
|
|
28,071
|
|
|
(729
|
)
|
|
(2.6
|
)%
|
|||
General and administrative
|
|
13,998
|
|
|
13,388
|
|
|
610
|
|
|
4.6
|
%
|
|||
Total operating expenses
|
|
41,340
|
|
|
41,459
|
|
|
(119
|
)
|
|
(0.3
|
)%
|
|||
Loss from operations
|
|
(37,546
|
)
|
|
(39,476
|
)
|
|
1,930
|
|
|
(4.9
|
)%
|
|||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|||||||
Unrealized loss on equity investment
|
|
(30
|
)
|
|
(212
|
)
|
|
182
|
|
|
(85.8
|
)%
|
|||
Interest income and other, net
|
|
2,233
|
|
|
1,249
|
|
|
984
|
|
|
78.8
|
%
|
|||
Net loss
|
|
$
|
(35,343
|
)
|
|
$
|
(38,439
|
)
|
|
$
|
3,096
|
|
|
(8.1
|
)%
|
•
|
a decrease of $1.6 million in expenses related to development of early stage compounds; and
|
•
|
a decrease of $1.2 million in legal fees and operational expenses; offset by
|
•
|
an increase of $1.2 million in expenses related to oral and IV BCV program costs mainly attributable to the acceleration of closeout costs; and
|
•
|
an increase of $0.9 million in compensation and severance expenses.
|
•
|
an increase of $1.8 million related to compensation and severance expenses; and
|
•
|
an increase of $1.2 million related to legal and consulting fees incurred in the pursuit of external opportunities to build our pipeline; offset by
|
•
|
a decrease of $2.4 million in expenses related to commercial readiness and operational expenses.
|
|
|
Six Months Ended June 30,
|
||||||
|
|
2019
|
|
2018
|
||||
Cash sources and uses:
|
|
|
|
|
|
|
||
Net cash used in operating activities
|
|
$
|
(29,551
|
)
|
|
$
|
(32,550
|
)
|
Net cash (used in) provided by investing activities
|
|
(30,089
|
)
|
|
41,256
|
|
||
Net cash provided by financing activities
|
|
178
|
|
|
193
|
|
||
Net (decrease) increase in cash and cash equivalents
|
|
$
|
(59,462
|
)
|
|
$
|
8,899
|
|
•
|
initiate development and manufacturing activities of CX-01 for the treatment of AML and other potential indications;
|
•
|
terminate our development activities of BCV for indications other than smallpox, including closing the AdAPT and IV studies of BCV;
|
•
|
continue the development of brincidofovir for the treatment of smallpox as a medical countermeasure;
|
•
|
obtain regulatory approvals for brincidofovir and CX-01;
|
•
|
scale-up manufacturing capabilities to commercialize brincidofovir and CX-01 in the event we receive regulatory approval;
|
•
|
identify and in-license additional product candidates to expand our research and development pipeline;
|
•
|
maintain, expand and protect our intellectual property portfolio; and
|
•
|
continue our internal research and development efforts and seek to discover additional product candidates.
|
•
|
obtaining favorable results for and advancing the development of brincidofovir for the treatment of smallpox and CX-01 for the treatment of AML;
|
•
|
obtaining United States and foreign regulatory approval(s) for brincidofovir and CX-01;
|
•
|
generating, licensing or otherwise acquiring a pipeline of product candidates which progress to clinical development, regulatory approval, and commercialization.
|
•
|
significantly delay, scale back or discontinue the development or commercialization of brincidofovir or any other product candidate;
|
•
|
seek corporate partners for brincidofovir, CX-01, or any other product candidate at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or
|
•
|
relinquish or license on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves.
|
•
|
acceptance of data from our studies of oral brincidofovir in animal models, including data necessary to bridge to a recommended human dose, by the FDA and foreign regulatory bodies;
|
•
|
reaching agreement with the FDA on the design and conduct of a pivotal Phase 3 clinical trial to support approval of CX-01;
|
•
|
receipt of marketing approvals from the FDA and corresponding regulatory authorities outside the United States;
|
•
|
establishing manufacturing capabilities necessary for a registration trial and commercialization of CX-01;
|
•
|
establishing commercial manufacturing capabilities for brincidofovir;
|
•
|
acceptance of the product, if approved for marketing;
|
•
|
effectively competing with other therapies;
|
•
|
a continued acceptable safety profile of the product following approval; and
|
•
|
obtaining, maintaining, enforcing and defending intellectual property rights and claims.
|
•
|
regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
|
•
|
animal efficacy studies of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us to conduct additional animal efficacy studies or abandon development programs;
|
•
|
we might be required to change one of our clinical research organizations (CROs) during ongoing clinical programs;
|
•
|
the number of subjects required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate or subjects may drop out of these clinical trials at a higher rate than we anticipate;
|
•
|
our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
•
|
we may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the subjects are being exposed to unacceptable health risks;
|
•
|
regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
|
•
|
the cost of clinical trials of our product candidates may be greater than we anticipate;
|
•
|
we may encounter agency or judicial enforcement actions which impact our clinical trials;
|
•
|
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; or
|
•
|
our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators to suspend or terminate the trials.
|
•
|
inability to raise funding necessary to initiate or continue a trial;
|
•
|
delays in obtaining, or failure to obtain, regulatory approval of Investigational New Drug applications or to commence a trial;
|
•
|
delays in reaching agreement with the FDA and foreign health authorities on final trial design;
|
•
|
imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities;
|
•
|
delays caused by disagreements with existing CROs and/or clinical trial sites;
|
•
|
delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
|
•
|
delays in obtaining, or failure to obtain, required IRB or ethics committee (EC) approvals covering each site;
|
•
|
delays in recruiting suitable patients to participate in a trial;
|
•
|
delays in having subjects complete participation in a trial or return for post-treatment follow-up;
|
•
|
delays caused by subjects dropping out of a trial due to side effects or otherwise;
|
•
|
clinical sites declining to participate or dropping out of a trial to the detriment of enrollment;
|
•
|
agency or judicial enforcement actions against us;
|
•
|
time required to add new clinical sites; and
|
•
|
delays by our contract manufacturers to produce and deliver sufficient supply of clinical trial materials.
|
•
|
regulatory authorities may approve the product only with a risk evaluation and mitigation strategy (REMS), potentially with restrictions on distribution and other elements to assure safe use (ETASU);
|
•
|
regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in a form of a modified REMS;
|
•
|
regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
|
•
|
we may be required to change the way the product is administered or to conduct additional clinical studies;
|
•
|
we could be sued and held liable for harm caused to patients; and
|
•
|
our reputation may suffer.
|
•
|
issue an untitled or warning letter asserting that we are in violation of the law;
|
•
|
seek an injunction or impose civil or criminal penalties or monetary fines;
|
•
|
suspend or withdraw regulatory approval;
|
•
|
suspend any ongoing clinical trials;
|
•
|
refuse to approve a pending application or supplements to an application submitted by us;
|
•
|
recall and/or seize product; or
|
•
|
refuse to allow us to enter into supply contracts, including government contracts.
|
•
|
the federal healthcare anti-kickback statute which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid;
|
•
|
the federal civil and criminal false claims laws and the Federal Civil Monetary Penalties Act, including the Federal Civil False Claims Act (False Claims Act) which permit private individuals to bring a civil action on behalf of the federal government to enforce certain of these laws thought civil whistleblower or
qui tam
actions, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent or from knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which, among other things, imposes criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly or willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statement in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their implementing regulations, and as amended again by the final HIPAA omnibus rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to HIPAA, published in January 2013, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as health plans, healthcare clearinghouses and certain healthcare providers, as well as their business associates;
|
•
|
the General Data Protection Regulation (GDPR), which impose obligations on companies in relation to the handling of personal data of individuals within the EU, along with related national legislation;
|
•
|
mandated physician payments reporting laws and/or requirements throughout global jurisdictions, including EU member states, in which we conduct research and development and/or other business activities;
|
•
|
the FDCA which prohibits, among other things, the adulteration or misbranding of drugs and devices;
|
•
|
the federal transparency law, enacted as part of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), and its implementing regulations, which requires manufacturers of drugs, devices, biologicals and medical supplies to report to the Centers for Medicare & Medicaid Services (CMS) information related to payments and other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
|
•
|
analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by state governmental and non-governmental third-party payers,
|
•
|
inability to meet our product specifications and quality requirements consistently;
|
•
|
delay or inability to procure or expand sufficient manufacturing capacity;
|
•
|
manufacturing and product quality issues related to scale-up of manufacturing;
|
•
|
costs and validation of new equipment and facilities required for scale-up;
|
•
|
failure to comply with cGMP and similar foreign standards;
|
•
|
inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;
|
•
|
termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;
|
•
|
reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our product candidates in a timely fashion, in sufficient quantities or under acceptable terms;
|
•
|
lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;
|
•
|
operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier;
|
•
|
carrier disruptions or increased costs that are beyond our control; and
|
•
|
failure to deliver our products under specified storage conditions and in a timely manner.
|
•
|
demonstration of clinical safety and efficacy in our clinical trials;
|
•
|
relative convenience, ease of administration and acceptance by physicians, patients, pharmacists and health care payers;
|
•
|
prevalence and severity of any AEs;
|
•
|
limitations or warnings contained in the FDA-approved labeling from Regulatory Authorities such as the FDA and EMA for the relevant product candidate;
|
•
|
availability, efficacy and safety of alternative treatments;
|
•
|
price and cost-effectiveness;
|
•
|
effectiveness of our or any future collaborators’ or competitor’s sales and marketing strategies;
|
•
|
ability to obtain hospital formulary approval;
|
•
|
ability to ensure availability for product through appropriate channels;
|
•
|
ability to maintain adequate inventory; and
|
•
|
ability to obtain and maintain sufficient third-party coverage and adequate reimbursement, which may vary from country to country.
|
•
|
recruiting and retaining talented people;
|
•
|
training employees that we recruit;
|
•
|
establishing compliance standards;
|
•
|
setting the appropriate system of incentives;
|
•
|
managing additional headcount;
|
•
|
ensuring that appropriate support functions are in place to support sales force organizational needs; and
|
•
|
integrating a new business unit into an existing corporate architecture.
|
•
|
different regulatory requirements for drug approvals in the EU and other foreign countries;
|
•
|
reduced protection for intellectual property rights;
|
•
|
unexpected changes in tariffs, trade barriers and regulatory and labor requirements;
|
•
|
economic weakness, including inflation, or political instability in particular foreign economies and markets;
|
•
|
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
•
|
foreign taxes, including withholding of payroll taxes;
|
•
|
foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;
|
•
|
differing payer reimbursement regimes, governmental payers or patient self-pay systems and price controls;
|
•
|
workforce uncertainty in countries where labor unrest is more common than in the United States;
|
•
|
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
|
•
|
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires; and
|
•
|
regulatory and compliance risks that relate to maintaining accurate information and control over activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions or its anti‑bribery provisions, or similar anti‑bribery or anti‑corruption laws and regulations.
|
•
|
discover and develop medicines that are superior to other products in the market;
|
•
|
demonstrate through our clinical trials that our product candidates, including brincidofovir and CX-01, are differentiated from existing and future therapies;
|
•
|
attract qualified scientific, product development and commercial personnel;
|
•
|
obtain and successfully defend and enforce patent and/or other proprietary protection for our medicines and technologies;
|
•
|
obtain required regulatory approvals;
|
•
|
successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines;
|
•
|
deliver a competitive value proposition compared to established competition and/or competitors who will enter the market before or after any of our product candidates, including brincidofovir and CX-01; and
|
•
|
negotiate competitive pricing and reimbursement with third-party payers.
|
•
|
our research methodology or that of our collaboration partners may be unsuccessful in identifying potential product candidates;
|
•
|
our potential product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval; and
|
•
|
our collaboration partners may change their development profiles for potential product candidates or abandon a therapeutic area.
|
•
|
audit and object to any BARDA contract-related costs and fees on grounds that they are not allowable under the FAR, and require us to reimburse all such costs and fees;
|
•
|
suspend or prevent us for a set period of time from receiving new contracts or extending our existing contract based on violations or suspected violations of laws or regulations;
|
•
|
claim nonexclusive, nontransferable rights to product manufactured and intellectual property developed under the BARDA contract and may, under certain circumstances, such as circumstances involving public health and safety, license such inventions to third parties without our consent;
|
•
|
cancel, terminate or suspend our BARDA contract based on violations or suspected violations of laws or regulations;
|
•
|
terminate our BARDA contract in whole or in part for the convenience of the government for any reason or no reason, including if funds become unavailable to the applicable governmental agency;
|
•
|
reduce the scope and value of our BARDA contract;
|
•
|
decline to exercise an option to continue the BARDA contract;
|
•
|
direct the course of a development program in a manner not chosen by the government contractor;
|
•
|
require us to perform the option segments even if doing so may cause us to forego or delay the pursuit of other opportunities with greater commercial potential;
|
•
|
take actions that result in a longer development timeline than expected; and
|
•
|
change certain terms and conditions in our BARDA contract.
|
•
|
FAR, and agency-specific regulations supplements to the FAR, which comprehensively regulate the procurement, formation, administration and performance of government contracts and implement federal procurement policy in numerous areas, such as employment practices, protection of the environment, accuracy and retention periods of records, recording and charging of costs, treatment of laboratory animals and human subject research;
|
•
|
business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act and the Foreign Corrupt Practices Act;
|
•
|
export and import control laws and regulations; and
|
•
|
laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.
|
•
|
termination of contracts;
|
•
|
forfeiture of profits;
|
•
|
suspension of payments;
|
•
|
fines; and
|
•
|
suspension or prohibition from conducting business with the U.S. government.
|
•
|
impairment of our business reputation and significant negative media attention;
|
•
|
withdrawal of participants from our clinical studies;
|
•
|
significant costs to defend the related litigation and related litigation;
|
•
|
distraction of management’s attention from our primary business;
|
•
|
substantial monetary awards to patients or other claimants;
|
•
|
inability to commercialize our product candidates, including brincidofovir and CX-01; and
|
•
|
decreased demand for our product candidates, if approved for commercial sale.
|
•
|
results of clinical trials of our product candidates or those of our competitors;
|
•
|
any delay in filing an application for any of our product candidates and any adverse development or perceived adverse development with respect to regulatory review of that application;
|
•
|
failure to successfully develop and commercialize our product candidates, including brincidofovir and CX-01;
|
•
|
termination of any of our license or collaboration agreements;
|
•
|
any agency or judicial enforcement actions against us;
|
•
|
inability to obtain additional funding;
|
•
|
regulatory or legal developments in the United States and other countries applicable to our product candidates;
|
•
|
adverse regulatory decisions;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
inability to obtain adequate product supply for our product candidates, or the inability to do so at acceptable prices;
|
•
|
introduction of new products, services or technologies by our competitors;
|
•
|
failure to meet or exceed financial projections we provide to the public;
|
•
|
failure to meet or exceed the estimates and projections of the investment community;
|
•
|
changes in the market valuations of similar companies;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or recommendations;
|
•
|
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
|
•
|
significant lawsuits (including patent or stockholder litigation), and disputes or other developments relating to proprietary rights (including patents, litigation matters and our ability to obtain patent protection for our technologies);
|
•
|
additions or departures of key scientific or management personnel;
|
•
|
sales of our common stock by us or our stockholders in the future;
|
•
|
trading volume of our common stock;
|
•
|
general economic, industry and market conditions; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors;
|
•
|
allowing the authorized number of our directors to be changed only by resolution of our board of directors;
|
•
|
limiting the removal of directors;
|
•
|
creating a staggered board of directors;
|
•
|
requiring that stockholder actions must be effected at a duly called stockholder meeting and prohibiting stockholder actions by written consent;
|
•
|
eliminating the ability of stockholders to call a special meeting of stockholders; and
|
•
|
establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at duly called stockholder meetings.
|
Number
|
|
Description
|
3.1(1)
|
|
|
|
|
|
3.2(1)
|
|
|
|
|
|
4.1(2)
|
|
|
|
|
|
10.1(3)
|
|
|
|
|
|
10.2(3)
|
|
|
|
|
|
10.3
|
|
|
|
|
|
10.4*
|
|
|
|
|
|
10.5
|
|
|
|
|
|
31.1
|
|
|
|
|
|
31.2
|
|
|
|
|
|
32.1
|
|
|
|
|
|
32.2
|
|
|
|
|
|
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.
|
*
|
Certain confidential information contained in this exhibit, marked by brackets, has been omitted pursuant to Item 601 of Regulation S-K.
|
(1)
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867), filed with the SEC on April 16, 2013.
|
(2)
|
Incorporated by reference to Chimerix, Inc.’s Registration Statement on Form S-1 (No. 333-187145), as amended.
|
(3)
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867), filed with the SEC on April 10, 2019.
|
|
CHIMERIX, INC.
|
|
|
|
|
August 8, 2019
|
By:
|
/s/ Michael A. Sherman
|
|
|
Michael A. Sherman
|
|
|
President and Chief Executive Officer
|
|
|
|
August 8, 2019
|
By:
|
/s/ Michael T. Andriole
|
|
|
Michael T. Andriole
|
|
|
Chief Business and Financial Officer
|
e.
|
Rights Employee may have under the provisions of this Release; and
|
5.
|
General Release.
|
14.
|
ADEA Acknowledgements.
Employee acknowledges the following:
|
1)
|
The class, unit, or group of individuals whose employment is being terminated as part of the same employment termination program (if any), the eligibility factors for this program, and any time limits applicable to the program; and
|
2)
|
The job titles and ages of all individuals covered under the termination program and the ages of all individuals in the same job classification or organizational unit who are not covered.
|
Grant Date
|
Type of Award
|
Total Shares Underlying Outstanding Awards
|
Exercise Price per Share
|
Shares Vested as of Separation Date May 31, 2019
|
Shares Vested Accelerated Pursuant to Severance Plan
|
Total Vested Shares as of Seperation Date May 31,2019
|
07-Apr-2011
|
Options (ISO)
|
42,680
|
$2.35
|
127
|
0
|
127
|
07-Apr-2011
|
Options (NQ)
|
126,334
|
$2.35
|
78,334
|
0
|
78,334
|
28-Jan-2014
|
Options (ISO)
|
55,400
|
$18.75
|
44,734
|
0
|
44,734
|
28-Jan-2015
|
Options (ISO)
|
3,342
|
$39.41
|
3,342
|
0
|
3,342
|
28-Jan-2015
|
Options {NO)
|
61,658
|
$39.41
|
61,658
|
0
|
61,658
|
08-Jan-2016
|
Options (ISO)
|
9,495
|
$8.06
|
5,787
|
3,708
|
9,495
|
08-Jan-2016
|
Options (NQ)
|
168,505
|
$8.06
|
142,546
|
25,959
|
168,505
|
24-Jan-2017
|
Options (ISO)
|
13,746
|
$5.14
|
1
|
5,287
|
5,288
|
24-Jan-2017
|
Options (NQ)
|
37,004
|
$5.14
|
29,603
|
7,401
|
37,004
|
24-Jan-2017
|
Share Units (RSU)
|
25,375
|
$0.00
|
0
|
6,343
|
6,343
|
25-Jan-2018
|
Options (ISO)
|
24,205
|
$4.68
|
0
|
1,046
|
1,046
|
25-Jan-2018
|
Options (NQ)
|
117,545
|
$4.68
|
47,250
|
34,391
|
81,641
|
23-Jan-2019
|
Options (ISO)
|
39,428
|
$2.41
|
1
|
0
|
1
|
23-Jan-2019
|
Options (NQ)
|
136,572
|
$2.41
|
14,666
|
44,000
|
58,666
|
05-Feb-2019
|
Share Units (RSU)
|
100,000
|
$0.00
|
0
|
100,000
|
100,000
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/P00057
|
PAGE OF
|
||||||
2
|
2
|
|||||||
NAME OF OFFEROR OR CONTRACTOR
CHIMERIX, INC. 1377270
|
||||||||
ITEM NO.
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||
|
May 2020, at no additional cost to the Government.
3. The following within scope change is hereby added to CLIN 0004 Only as Paragraph 5.3.3 based on FDA Feedback and is necessary for the full completion of CLIN 4 under the contract.
5.3.3 Conduct [*] Study with a [*].
The above non-clinical efforts cannot be performed until the receipt and approval of all required Protocols by BARDA inclusive of any required approved OLAW Assurances and IIA approvals from OLAW.
4. Under G.3 Key Personnel, Dr. Garrett Nichols hereby replaces Dr. Mauricio Vargas-Cortes as Principal Investigator under the contract.
5.
The total amount, scope and period of performance of all other CLINs that are currently being performed under the contract remain unchanged. This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract. In addition, the total amount, scope and period of performance of all unexercised Option CLINs under the contract remain unchanged. This modification also confirms that all activities under the base period of performance CLIN 0001 were completed as of 31 May 2013 and confirms that all activities under the Option 1/CLIN 0002 period of performance were completed as of 30 April 2015.
B. This is a no cost bilateral modification. All other terms and conditions of Contract Number HHSO100201100013C remain unchanged.
Period of Performance: 02/16/2011 to 05/31/2020
|
Optionholder:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of Shares Subject to Option:
|
|
Exercise Price (Per Share):
|
|
Total Exercise Price:
|
|
Expiration Date:
|
|
Vesting Schedule
:
|
One-fourth
(
1/4
th
) of the shares vest one year after the Vesting Commencement Date; the balance of the shares vest in a series of thirty-six (36) successive equal monthly installments measured from the first anniversary of the Vesting Commencement Date, subject to Optionholder’s Continuous Service as of each such date and the potential vesting acceleration described in Section 1 of the Option Agreement.
|
Type of option (check one):
|
Nonstatutory
|
Stock option dated:
|
_______________
|
Number of Shares as
to which option is exercised: |
_______________
|
Certificates to be
issued in name of: |
_______________
|
Total exercise price:
|
$______________
|
Cash payment delivered
herewith: |
$______________
|
Value of ________ Shares delivered herewith:
|
$______________]
|
Value of ________ Shares pursuant to net exercise
2
:
|
$______________]
|
Regulation T Program (cashless exercise
3
):
|
$______________]
|
Date:
|
August 8, 2019
|
/s/ Michael A. Sherman
|
|
|
Michael A. Sherman
|
|
|
President & Chief Executive Officer
|
Date:
|
August 8, 2019
|
/s/ Michael T. Andriole
|
|
|
Michael T. Andriole
|
|
|
Chief Business and Financial Officer
|
Date:
|
August 8, 2019
|
/s/ Michael A. Sherman
|
|
|
Michael A. Sherman
|
|
|
President & Chief Executive Officer
|
Date:
|
August 8, 2019
|
/s/ Michael T. Andriole
|
|
|
Michael T. Andriole
|
|
|
Chief Business and Financial Officer
|