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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Immunic Inc | NASDAQ:IMUX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.02 | 1.50% | 1.35 | 1.00 | 1.51 | 1.39 | 1.33 | 1.35 | 112,415 | 05:00:11 |
|
|
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
|
56-2358443
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
|
|
Am Klopferspitz 19
|
|
Martinsried, Germany
|
82152
|
(Address of principal executive offices)
|
(Zip Code)
|
Large accelerated filer
|
¨
|
Accelerated filer
|
ý
|
|
|
|
|
Non-accelerated filer
|
¨
|
Smaller reporting company
|
ý
|
|
|
|
|
|
|
Emerging growth company
|
ý
|
Title of each class
|
Trading symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.0001 par value
|
IMUX
|
The Nasdaq Stock Market LLC
|
|
|
Page No.
|
|
||
Item 1.
|
|
|
|
||
|
||
|
||
|
||
|
||
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
|
|
|
|
||
Item 1.
|
||
Item 1A.
|
||
Item 2.
|
Unregistered Sales of Equity Securities
and Use of Proceeds
|
|
Item 4.
|
||
Item 5.
|
||
Item 6.
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
|
(Unaudited)
|
|
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
36,121
|
|
|
$
|
13,072
|
|
Note receivable
|
920
|
|
|
—
|
|
||
Other current assets and prepaid expenses
|
2,452
|
|
|
259
|
|
||
Total current assets
|
39,493
|
|
|
13,331
|
|
||
Property and equipment, net
|
43
|
|
|
40
|
|
||
Goodwill
|
32,970
|
|
|
—
|
|
||
Right of use assets, net
|
68
|
|
|
—
|
|
||
Total assets
|
$
|
72,574
|
|
|
$
|
13,371
|
|
Liabilities, Preferred Stock and Stockholders’ Equity (Deficit)
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,462
|
|
|
$
|
1,400
|
|
Accrued expenses
|
1,586
|
|
|
416
|
|
||
Other current liabilities
|
74
|
|
|
104
|
|
||
Total current liabilities
|
3,122
|
|
|
1,920
|
|
||
Long-term liabilities:
|
|
|
|
||||
Other long-term liabilities
|
41
|
|
|
—
|
|
||
Total long-term liabilities
|
41
|
|
|
—
|
|
||
Total liabilities
|
3,163
|
|
|
1,920
|
|
||
Commitments and contingencies (Note 6)
|
|
|
|
||||
Series A-2 Convertible preferred stock, €1.00 par value, 299,456 shares authorized, issued and outstanding at December 31, 2018
|
—
|
|
|
34,313
|
|
||
Series A-1 Convertible preferred stock, €1.00 par value,13,541 authorized, issued and outstanding at December 31, 2018
|
—
|
|
|
2,879
|
|
||
Stockholders' equity (deficit):
|
|
|
|
||||
Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at June 30, 2019 and December 31, 2018
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value; 130,000,000 and 846,953 shares authorized and 9,986,399 and 846,953 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively
|
1
|
|
|
—
|
|
||
Additional paid-in capital
|
114,137
|
|
|
56
|
|
||
Accumulated other comprehensive loss
|
(722
|
)
|
|
(819
|
)
|
||
Accumulated deficit
|
(44,005
|
)
|
|
(24,978
|
)
|
||
Total stockholders’ equity (deficit)
|
69,411
|
|
|
(25,741
|
)
|
||
Total liabilities, preferred stock and stockholders’ equity (deficit)
|
$
|
72,574
|
|
|
$
|
13,371
|
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
$
|
6,029
|
|
|
$
|
2,157
|
|
|
$
|
9,384
|
|
|
$
|
3,940
|
|
General and administrative
|
8,978
|
|
|
513
|
|
|
10,285
|
|
|
1,017
|
|
||||
Total operating expenses
|
15,007
|
|
|
2,670
|
|
|
19,669
|
|
|
4,957
|
|
||||
Loss from operations
|
(15,007
|
)
|
|
(2,670
|
)
|
|
(19,669
|
)
|
|
(4,957
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Interest income (expense)
|
34
|
|
|
—
|
|
|
34
|
|
|
(1
|
)
|
||||
Other income (expense), net
|
259
|
|
|
—
|
|
|
608
|
|
|
25
|
|
||||
Total other income
|
293
|
|
|
—
|
|
|
642
|
|
|
24
|
|
||||
Net loss
|
$
|
(14,714
|
)
|
|
$
|
(2,670
|
)
|
|
$
|
(19,027
|
)
|
|
$
|
(4,933
|
)
|
|
|
|
|
|
|
|
|
||||||||
Net loss per share, basic and diluted
|
$
|
(1.52
|
)
|
|
$
|
(3.15
|
)
|
|
$
|
(3.60
|
)
|
|
$
|
(5.82
|
)
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average common shares outstanding, basic and diluted
|
9,669,129
|
|
|
846,953
|
|
|
5,282,412
|
|
|
846,953
|
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net loss
|
$
|
(14,714
|
)
|
|
$
|
(2,670
|
)
|
|
$
|
(19,027
|
)
|
|
$
|
(4,933
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
||||||||
Foreign currency translation
|
344
|
|
|
(728
|
)
|
|
97
|
|
|
(700
|
)
|
||||
Total comprehensive loss
|
$
|
(14,370
|
)
|
|
$
|
(3,398
|
)
|
|
$
|
(18,930
|
)
|
|
$
|
(5,633
|
)
|
|
Series A-2 Preferred Stock
|
|
Series A-1 Preferred Stock
|
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Stock subscription not yet issued
|
|
Accumulated
Other Comprehensive Income (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’ Equity (Deficit) |
|||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
Shares
|
|
Amount
|
|
||||||||||||||||||||||||||||
Balance at January 1, 2019
|
299,456
|
|
|
$
|
34,313
|
|
|
13,541
|
|
|
$
|
2,879
|
|
|
|
846,953
|
|
|
$
|
—
|
|
|
$
|
56
|
|
|
$
|
—
|
|
|
$
|
(819
|
)
|
|
$
|
(24,978
|
)
|
|
$
|
(25,741
|
)
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,313
|
)
|
|
(4,313
|
)
|
||||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(247
|
)
|
|
—
|
|
|
(247
|
)
|
||||||||
Stock subscription not yet issued
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
20,531
|
|
|
—
|
|
|
—
|
|
|
20,531
|
|
||||||||
Balance at March 31, 2019
|
299,456
|
|
|
$
|
34,313
|
|
|
13,541
|
|
|
$
|
2,879
|
|
|
|
846,953
|
|
|
$
|
—
|
|
|
$
|
56
|
|
|
$
|
20,531
|
|
|
$
|
(1,066
|
)
|
|
$
|
(29,291
|
)
|
|
$
|
(9,770
|
)
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(14,714
|
)
|
|
(14,714
|
)
|
||||||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
344
|
|
|
—
|
|
|
344
|
|
||||||||
Stock subscription not yet issued
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(20,531
|
)
|
|
—
|
|
|
—
|
|
|
(20,531
|
)
|
||||||||
Conversion of Series A Preferred Stock to common stock
|
(299,456
|
)
|
|
(34,313
|
)
|
|
(13,541
|
)
|
|
(2,879
|
)
|
|
|
5,302,029
|
|
|
1
|
|
|
37,192
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
37,193
|
|
||||||||
Issuance of common stock in pre-closing financing for cash, net of issuance costs of $61
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
2,197,742
|
|
|
—
|
|
|
29,935
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
29,935
|
|
||||||||
Issuance of common stock - Executive bonus agreement
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
460,336
|
|
|
—
|
|
|
6,014
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,014
|
|
||||||||
Issuance of common stock - settlement of contingent payment
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
120,070
|
|
|
—
|
|
|
1,540
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,540
|
|
||||||||
Exchange of common stock in connection with Transaction
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
1,059,269
|
|
|
—
|
|
|
39,400
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
39,400
|
|
||||||||
Balance at June 30, 2019
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
|
9,986,399
|
|
|
$
|
1
|
|
|
$
|
114,137
|
|
|
$
|
—
|
|
|
$
|
(722
|
)
|
|
$
|
(44,005
|
)
|
|
$
|
69,411
|
|
Balance at January 1, 2018
|
299,456
|
|
|
$
|
15,057
|
|
|
13,541
|
|
|
$
|
2,879
|
|
|
|
846,953
|
|
|
$
|
—
|
|
|
$
|
56
|
|
|
$
|
—
|
|
|
$
|
43
|
|
|
$
|
(13,436
|
)
|
|
$
|
(13,337
|
)
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,263
|
)
|
|
(2,263
|
)
|
||||||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
28
|
|
|
—
|
|
|
28
|
|
||||||||
Issuance of preferred stock
|
—
|
|
|
12,564
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Balance at March 31, 2018
|
299,456
|
|
|
$
|
27,621
|
|
|
13,541
|
|
|
$
|
2,879
|
|
|
|
846,953
|
|
|
$
|
—
|
|
|
$
|
56
|
|
|
$
|
—
|
|
|
$
|
71
|
|
|
$
|
(15,699
|
)
|
|
$
|
(15,572
|
)
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,670
|
)
|
|
(2,670
|
)
|
||||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(728
|
)
|
|
—
|
|
|
(728
|
)
|
||||||||
Balance at June 30, 2018
|
299,456
|
|
|
$
|
27,621
|
|
|
13,541
|
|
|
$
|
2,879
|
|
|
|
846,953
|
|
|
$
|
—
|
|
|
$
|
56
|
|
|
$
|
—
|
|
|
$
|
(657
|
)
|
|
$
|
(18,369
|
)
|
|
$
|
(18,970
|
)
|
|
Six Months
Ended June 30, |
||||||
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(19,027
|
)
|
|
$
|
(4,933
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
29
|
|
|
7
|
|
||
Gain on disposal of equipment
|
(26
|
)
|
|
—
|
|
||
Stock-based compensation
|
5,983
|
|
|
—
|
|
||
Contingent payment settled in stock
|
1,540
|
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Other current assets and prepaid expenses
|
(1,862
|
)
|
|
297
|
|
||
Accounts payable
|
(1,423
|
)
|
|
529
|
|
||
Other current liabilities
|
(55
|
)
|
|
(61
|
)
|
||
Accrued expenses
|
(1,463
|
)
|
|
(47
|
)
|
||
Net cash used in operating activities
|
(16,304
|
)
|
|
(4,208
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Proceeds from sale of ELAD assets
|
1,150
|
|
|
—
|
|
||
Cash acquired in connection with the Transaction
|
8,151
|
|
|
—
|
|
||
Purchases of property and equipment
|
(17
|
)
|
|
(7
|
)
|
||
Proceeds from sale of equipment
|
40
|
|
|
—
|
|
||
Net cash provided by (used in) investing activities
|
9,324
|
|
|
(7
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds from issuance of common stock, net of issuance costs of $61
|
29,965
|
|
|
—
|
|
||
Proceeds from issuance of preferred stock
|
—
|
|
|
12,564
|
|
||
Net cash provided by financing activities
|
29,965
|
|
|
12,564
|
|
||
Effect of exchange rate changes on cash and cash equivalents
|
64
|
|
|
(722
|
)
|
||
Net change in cash and cash equivalents
|
23,049
|
|
|
7,627
|
|
||
Cash and cash equivalents, beginning of period
|
13,072
|
|
|
4,504
|
|
||
Cash and cash equivalents, end of period
|
$
|
36,121
|
|
|
$
|
12,131
|
|
Supplemental disclosures for cash flow information:
|
|
|
|
||||
Cash paid for interest
|
$
|
34
|
|
|
$
|
1
|
|
Supplemental disclosure of noncash investing and financing activities:
|
|
|
|
||||
Note receivable from sale of ELAD assets
|
$
|
920
|
|
|
$
|
—
|
|
Conversion of convertible preferred stock to common stock
|
$
|
37,193
|
|
|
$
|
—
|
|
Fair value of net assets acquired in the Transaction
|
$
|
39,400
|
|
|
$
|
—
|
|
|
As of June 30,
|
||||
|
2019
|
|
2018
|
||
Options to purchase common stock
|
16,987
|
|
|
—
|
|
Restricted stock units
|
127,500
|
|
|
—
|
|
Warrants to purchase common stock
|
6,015
|
|
|
—
|
|
Number of shares owned by Vital stockholders (1)
|
1,059,269
|
|
|
RSU's (2)
|
127,500
|
|
|
Total fully-diluted shares
|
1,186,769
|
|
|
Multiplied by the fair value per share of Vital common stock (3)
|
$
|
33.20
|
|
Estimated purchase price
|
$
|
39,400
|
|
(1)
|
The number of shares of
1,059,269
represents the historical
42,369,694
shares of Vital common stock outstanding immediately prior to the closing of the Transaction, adjusted for the Reverse Stock Split.
|
(2)
|
The number of RSUs of
127,500
represents the historical
5,100,000
Vital RSUs to be issued to Vital former officers during the second half of 2019.
|
(3)
|
Based on the last reported sale price of Vital common stock on the Nasdaq Global Market on April 12, 2019, the closing of the Transaction, adjusted for the Reverse Stock Split.
|
|
(in thousands)
|
||
Cash and cash equivalents
|
$
|
8,151
|
|
Prepaid expenses and other assets
|
307
|
|
|
Supplies and working cell banks
|
1,000
|
|
|
Clinical development equipment
|
306
|
|
|
Other property and equipment
|
30
|
|
|
In-process research and development (“IPR&D
”
)
|
764
|
|
|
Accounts payable, accrued expenses and other liabilities
|
(4,128
|
)
|
|
Goodwill
|
32,970
|
|
|
Purchase price
|
$
|
39,400
|
|
Clinical development equipment
|
$
|
306
|
|
Supplies and working cell banks
|
1,000
|
|
|
In process research & development ("IPR&D")
|
764
|
|
|
Total
|
$
|
2,070
|
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
Accrued clinical and related costs
|
$
|
912
|
|
|
$
|
210
|
|
Accrued compensation and related taxes
|
296
|
|
|
—
|
|
||
Accrued other
|
378
|
|
|
206
|
|
||
Total
|
$
|
1,586
|
|
|
$
|
416
|
|
2019
|
|
$
|
15
|
|
2020
|
|
29
|
|
|
2021
|
|
29
|
|
|
Total lease payments
|
|
73
|
|
|
Less: interest portion
|
|
7
|
|
|
Present value of lease obligation
|
|
$
|
66
|
|
|
Fair Value Measurement at June 30, 2019
|
||||||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
5,091
|
|
|
$
|
5,091
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Note receivable
|
$
|
920
|
|
|
$
|
—
|
|
|
$
|
920
|
|
|
$
|
—
|
|
Total assets at fair value
|
$
|
6,011
|
|
|
$
|
5,091
|
|
|
$
|
920
|
|
|
$
|
—
|
|
|
Number of
Shares
|
|
Common stock reserved for issuance for:
|
|
|
Outstanding stock options
|
16,987
|
|
Restricted stock units
|
127,500
|
|
Common stock options available for future grant:
|
|
|
2014 Equity Incentive Plan
|
40,727
|
|
2017 Inducement Equity Incentive Plan
|
46,250
|
|
Common stock reserved for issuance for outstanding warrants
|
6,015
|
|
Total common shares reserved for future issuance
|
237,479
|
|
|
June 30, 2019
|
|
June 30, 2018
|
||||||||||
|
Options
|
|
Exercise Price
|
|
Options
|
|
Exercise Price
|
||||||
Outstanding as of January 1
|
6,937
|
|
|
$
|
—
|
|
|
4,464
|
|
|
$
|
—
|
|
Granted during the period
|
32,177
|
|
|
$
|
—
|
|
|
2,473
|
|
|
$
|
—
|
|
Forfeited during the period
|
—
|
|
|
|
|
—
|
|
|
|
||||
Settled in cash during the period
|
(39,114
|
)
|
|
$
|
—
|
|
|
—
|
|
|
|
||
Expired during the period
|
—
|
|
|
|
|
—
|
|
|
|
||||
Outstanding at June 30
|
—
|
|
|
|
|
6,937
|
|
|
$
|
—
|
|
||
Exercisable at June 30
|
—
|
|
|
|
|
—
|
|
|
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Employees:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
$
|
130
|
|
|
$
|
—
|
|
|
$
|
130
|
|
|
$
|
—
|
|
General and administrative
|
6,361
|
|
|
—
|
|
|
6,361
|
|
|
—
|
|
||||
Total
|
$
|
6,491
|
|
|
$
|
—
|
|
|
$
|
6,491
|
|
|
$
|
—
|
|
Non-employees:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
$
|
1,540
|
|
|
$
|
—
|
|
|
$
|
1,540
|
|
|
$
|
—
|
|
General and administrative
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Total
|
$
|
1,540
|
|
|
$
|
—
|
|
|
$
|
1,540
|
|
|
$
|
—
|
|
|
Options
|
|
Weighted-
Average Exercise Price |
|
Weighted-
Average Remaining Contractual Term (Years) |
|
Aggregate
Intrinsic Value |
|||||
Outstanding as of January 1, 2019
|
—
|
|
|
$
|
—
|
|
|
|
|
|
||
Assumed in the Transaction with Vital
|
17,117
|
|
|
$
|
307.00
|
|
|
|
|
|
||
Granted
|
—
|
|
|
$
|
—
|
|
|
|
|
|
||
Exercised
|
—
|
|
|
$
|
—
|
|
|
|
|
|
||
Forfeited or expired
|
(130
|
)
|
|
$
|
320.00
|
|
|
|
|
|
||
Outstanding as of June 30, 2019
|
16,987
|
|
|
$
|
306.90
|
|
|
2.63
|
|
$
|
—
|
|
Options vested and expected to vest as of June 30, 2019
|
16,987
|
|
|
$
|
306.90
|
|
|
2.63
|
|
$
|
—
|
|
Options exercisable as of June 30, 2019
|
16,987
|
|
|
$
|
306.90
|
|
|
2.63
|
|
$
|
—
|
|
•
|
external research and development expenses incurred under arrangements with third parties, such as CROs, contract manufacturing organizations, consultants, and our scientific advisors; and
|
•
|
internal personnel expenses.
|
|
Three Months Ended June 30,
|
|
Change
|
|||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
|||||||
(dollars in thousands)
|
(unaudited)
|
|||||||||||||
Operating expenses:
|
|
|
|
|||||||||||
Research and development
|
$
|
6,029
|
|
|
$
|
2,157
|
|
|
$
|
3,872
|
|
|
180
|
%
|
General and administrative
|
8,978
|
|
|
513
|
|
|
8,465
|
|
|
1,650
|
%
|
|||
Total operating expenses
|
15,007
|
|
|
2,670
|
|
|
12,337
|
|
|
462
|
%
|
|||
Loss from operations
|
(15,007
|
)
|
|
(2,670
|
)
|
|
(12,337
|
)
|
|
462
|
%
|
|||
Total other income
|
293
|
|
|
—
|
|
|
293
|
|
|
—
|
%
|
|||
Net loss
|
$
|
(14,714
|
)
|
|
$
|
(2,670
|
)
|
|
$
|
(12,044
|
)
|
|
451
|
%
|
|
Six Months Ended June 30,
|
|
Change
|
|||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
|||||||
(dollars in thousands)
|
(unaudited)
|
|||||||||||||
Operating expenses:
|
|
|
|
|||||||||||
Research and development
|
$
|
9,384
|
|
|
$
|
3,940
|
|
|
$
|
5,444
|
|
|
138
|
%
|
General and administrative
|
10,285
|
|
|
1,017
|
|
|
9,268
|
|
|
911
|
%
|
|||
Total operating expenses
|
19,669
|
|
|
4,957
|
|
|
14,712
|
|
|
297
|
%
|
|||
Loss from operations
|
(19,669
|
)
|
|
(4,957
|
)
|
|
(14,712
|
)
|
|
297
|
%
|
|||
Total other income
|
642
|
|
|
24
|
|
|
618
|
|
|
2,575
|
%
|
|||
Net loss
|
$
|
(19,027
|
)
|
|
$
|
(4,933
|
)
|
|
$
|
(14,094
|
)
|
|
286
|
%
|
|
Six Months Ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
(in thousands)
|
(unaudited)
|
||||||
Cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(16,304
|
)
|
|
$
|
(4,208
|
)
|
Investing activities
|
9,324
|
|
|
(7
|
)
|
||
Financing activities
|
29,965
|
|
|
12,564
|
|
•
|
the terms and timing of any strategic alliance, licensing and other arrangements that we may establish;
|
•
|
the initiation and progress of our ongoing pre-clinical studies and clinical trials for our product candidates;
|
•
|
the number of programs we pursue;
|
•
|
the outcome, timing and cost of regulatory approvals;
|
•
|
the cost and timing of hiring new employees to support our continued growth;
|
•
|
the costs involved in patent filing, prosecution, and enforcement; and
|
•
|
the costs and timing of having clinical supplies of our product candidates manufactured.
|
Exhibit
Number
|
Exhibit Title
|
|
|
3.1
|
|
3.2
|
|
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 Database
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
*
|
In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. 33-8238 and 34-47986, Final Rule: Management’s Reports on Internal Control over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act. Such certifications will not be deemed to be incorporated by reference into any filings under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.
|
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