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Share Name | Share Symbol | Market | Type |
---|---|---|---|
ArQule Inc | NASDAQ:ARQL | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 20.00 | 19.99 | 19.50 | 0 | 01:00:00 |
|
DELAWARE
(STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION) |
| |
04-3221586
(I.R.S. EMPLOYER IDENTIFICATION NO.) |
|
|
(TITLE OF EACH CLASS) |
| |
NAME OF EACH EXCHANGE
ON WHICH REGISTERED |
|
|
COMMON STOCK, $.01 PAR VALUE
|
| |
The NASDAQ Stock Market LLC
(NASDAQ Global Market) |
|
|
Large accelerated filer ☐
Non-accelerated filer ☐ |
| |
Accelerated filer ☒
Smaller reporting company ☒ Emerging growth company ☐ |
|
| | |
Page
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PART I | | | | | | | |
| | | | 4 | | | |
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| | | | 5 | | | |
| | | | 6 | | | |
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| | | | 11 | | | |
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| | | | 21 | | | |
| | | | 42 | | | |
| | | | 42 | | | |
| | | | 42 | | | |
| | | | 42 | | | |
PART II | | | | | | | |
| | |
|
| | ||
| | | | 43 | | | |
| | | | 44 | | | |
| | |
|
| | ||
| | | | 55 | | | |
| | | | 56 | | | |
| | | | 56 | | | |
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|
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| | | | 84 | | | |
| | | | 84 | | | |
| | | | 85 | | | |
| | | | 85 | | | |
| | | | 85 | | | |
PART III | | | | | | | |
| | | | 86 | | | |
| | | | 86 | | | |
| | |
|
| | ||
| | | | 86 | | | |
| | | | 86 | | | |
PART IV | | | | | | | |
| | | | 86 | | | |
| | | | 86 | | | |
| | | | 86 | | | |
| | | | 87 | | | |
| | |
|
| |
NAME
|
| |
AGE
|
| |
POSITION
|
|
Paolo Pucci
|
| |
57
|
| | Chief Executive Officer and a Director | |
Peter S. Lawrence
|
| |
55
|
| | President and Chief Operating Officer | |
Robert J. Weiskopf
|
| |
68
|
| | Chief Financial Officer and Treasurer | |
Dr. Brian Schwartz
|
| |
57
|
| | Chief Medical Officer | |
| | |
12/31/13
|
| |
12/31/14
|
| |
12/31/15
|
| |
12/31/16
|
| |
12/31/17
|
| |
12/31/18
|
| ||||||||||||||||||
ArQule, Inc.
|
| | | | 100.00 | | | | | | 56.74 | | | | | | 100.93 | | | | | | 58.60 | | | | | | 76.74 | | | | | | 128.84 | | |
NASDAQ Market (U.S. Companies) Index
|
| | | | 100.00 | | | | | | 112.46 | | | | | | 113.00 | | | | | | 127.70 | | | | | | 155.01 | | | | | | 146.57 | | |
NASDAQ Biotechnology Index
|
| | | | 100.00 | | | | | | 134.40 | | | | | | 150.22 | | | | | | 118.15 | | | | | | 143.71 | | | | | | 130.97 | | |
Plan Category
|
| |
Number of Shares of
Common Stock to be Issued Upon Exercise of Outstanding Options |
| |
Weighted-Average
Exercise Price of Outstanding Options |
| |
Weighted-Average
Remaining Contractual Term (in years) |
| |
Number of Shares of
Common Stock Remaining Available for Future Issuance Under Equity Compensation Plans |
| ||||||||||||
Equity compensation plans approved by stockholders
|
| | | | 10,748,157 | | | | | $ | 2.90 | | | | | | 6.08 | | | | | | 4,610,616 | | |
Equity compensation plans not approved by stockholders
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
| | |
YEAR ENDED DECEMBER 31,
|
| |||||||||||||||||||||||||||
| | |
2018
|
| |
2017
|
| |
2016
|
| |
2015
|
| |
2014
|
| |||||||||||||||
STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS DATA:
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Revenue: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development revenue(a)
|
| | | $ | 25,764 | | | | | $ | — | | | | | $ | 4,709 | | | | | $ | 11,239 | | | | | $ | 11,254 | | |
Costs and expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development(b)
|
| | | | 28,710 | | | | | | 19,468 | | | | | | 20,042 | | | | | | 15,561 | | | | | | 22,271 | | |
General and administrative
|
| | | | 10,753 | | | | | | 7,551 | | | | | | 7,563 | | | | | | 9,830 | | | | | | 12,154 | | |
Restructuring and other costs(c)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,099 | | |
Total costs and expenses
|
| | | | 39,463 | | | | | | 27,019 | | | | | | 27,605 | | | | | | 25,391 | | | | | | 35,524 | | |
Loss from operations
|
| | | | (13,699 ) | | | | | | (27,019 ) | | | | | | (22,896 ) | | | | | | (14,152 ) | | | | | | (24,270 ) | | |
Interest income
|
| | | | 1,435 | | | | | | 238 | | | | | | 178 | | | | | | 101 | | | | | | 272 | | |
Interest expense
|
| | | | (1,666 ) | | | | | | (1,520 ) | | | | | | — | | | | | | — | | | | | | (35 ) | | |
Other income (expense)(d)
|
| | | | (1,552 ) | | | | | | (902 ) | | | | | | — | | | | | | 277 | | | | | | 642 | | |
Loss before income taxes
|
| | | | (15,482 ) | | | | | | (29,203 ) | | | | | | (22,718 ) | | | | | | (13,774 ) | | | | | $ | (23,391 ) | | |
Provision for income taxes
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Net loss
|
| | | | (15,482 ) | | | | | | (29,203 ) | | | | | | (22,718 ) | | | | | | (13,774 ) | | | | | | (23,391 ) | | |
Unrealized gain (loss) on marketable securities
|
| | | | (79 ) | | | | | | (18 ) | | | | | | (1 ) | | | | | | 13 | | | | | | (77 ) | | |
Comprehensive loss
|
| | | $ | (15,561 ) | | | | | $ | (29,221 ) | | | | | $ | (22,719 ) | | | | | $ | (13,761 ) | | | | | $ | (23,468 ) | | |
Basic and diluted net loss per share
|
| | | $ | (0.16 ) | | | | | $ | (0.39 ) | | | | | $ | (0.33 ) | | | | | $ | (0.22 ) | | | | | $ | (0.37 ) | | |
Weighted average common shares outstanding—basic and diluted
|
| | | | 99,035 | | | | | | 74,813 | | | | | | 69,714 | | | | | | 62,808 | | | | | | 62,627 | | |
Cash, cash equivalents and marketable securities(e)
|
| | | $ | 99,558 | | | | | $ | 48,036 | | | | | $ | 31,126 | | | | | $ | 38,772 | | | | | $ | 59,208 | | |
Marketable securities-long term
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 2,058 | | |
| | | | $ | 99,558 | | | | | $ | 48,036 | | | | | $ | 31,126 | | | | | $ | 38,772 | | | | | $ | 61,266 | | |
Working capital(e)
|
| | | $ | 91,788 | | | | | $ | 38,824 | | | | | $ | 23,248 | | | | | $ | 28,661 | | | | | $ | 42,824 | | |
Notes payable
|
| | | | 14,760 | | | | | | 14,607 | | | | | | — | | | | | | — | | | | | | — | | |
Total assets
|
| | | | 106,676 | | | | | | 48,902 | | | | | | 32,380 | | | | | | 40,004 | | | | | | 63,394 | | |
Total stockholders’ equity(e)
|
| | | | 78,968 | | | | | | 14,181 | | | | | | 23,680 | | | | | | 29,179 | | | | | | 40,545 | | |
| | |
December 31,
|
| |
% increase (decrease)
|
| ||||||||||||||||||||||||
| | |
2018
|
| |
2017
|
| |
2016
|
| |
2017 to 2018
|
| |
2016 to 2017
|
| |||||||||||||||
| | |
(in millions)
|
| | | |||||||||||||||||||||||||
Cash, cash equivalents and marketable securities short-term
|
| | | $ | 99.6 | | | | | $ | 48.0 | | | | | $ | 31.1 | | | | | | 107 % | | | | | | 54 % | | |
Working capital
|
| | | | 91.8 | | | | | | 38.8 | | | | | | 23.2 | | | | | | 136 % | | | | | | 67 % | | |
| | |
Year Ended December 31,
|
| |||||||||||||||
| | |
2018
|
| |
2017
|
| |
2016
|
| |||||||||
| | |
(in millions)
|
| |||||||||||||||
Cash flow from: | | | | | |||||||||||||||
Operating activities
|
| | | $ | (13.0 ) | | | | | $ | (25.2 ) | | | | | $ | (22.9 ) | | |
Investing activities
|
| | | | (53.3 ) | | | | | | (11.9 ) | | | | | | 8.9 | | |
Financing activities
|
| | | | 65.3 | | | | | | 42.1 | | | | | | 15.4 | | |
| | |
Payment due by period
|
| |||||||||||||||||||||||||||
Contractual Obligations
|
| |
Total
|
| |
Less than
1 year |
| |
1–3 years
|
| |
3–5 years
|
| |
More than
5 years |
| |||||||||||||||
Notes payable
|
| | | $ | 15,900 | | | | | $ | 1,667 | | | | | $ | 10,000 | | | | | $ | 4,233 | | | | | $ | — | | |
Interest on notes payable
|
| | | | 3,461 | | | | | | 1,143 | | | | | | 1,322 | | | | | | 996 | | | | | | — | | |
Operating lease obligations
|
| | | | 819 | | | | | | 523 | | | | | | 296 | | | | | | — | | | | | | — | | |
Purchase obligations
|
| | | | 8,497 | | | | | | 8,497 | | | | | | — | | | | | | — | | | | | | — | | |
Total
|
| | | $ | 28,677 | | | | | $ | 11,830 | | | | | $ | 11,618 | | | | | $ | 5,229 | | | | | $ | — | | |
|
| | | | | |
% increase (decrease)
|
| ||||||||||||||||||||||||
| | |
2018
|
| |
2017
|
| |
2016
|
| |
2017 to 2018
|
| |
2016 to 2017
|
| |||||||||||||||
| | |
(in millions)
|
| | | |||||||||||||||||||||||||
Research and development revenue
|
| | | $ | 25.8 | | | | | $ | — | | | | | $ | 4.7 | | | | | | 100 % | | | | | | (100 )% | | |
| | | | | |
% increase (decrease)
|
| ||||||||||||||||||||||||
| | |
2018
|
| |
2017
|
| |
2016
|
| |
2017 to 2018
|
| |
2016 to 2017
|
| |||||||||||||||
| | |
(in millions)
|
| | | |||||||||||||||||||||||||
Research and development
|
| | | $ | 28.7 | | | | | $ | 19.5 | | | | | $ | 20.1 | | | | | | 47 % | | | | | | (3 )% | | |
Clinical Phase
|
| |
Estimated Completion Period
|
|
Phase 1
|
| |
1–2 years
|
|
Phase 2
|
| |
2–3 years
|
|
Phase 3
|
| |
2–4 years
|
|
| | | | | |
% increase (decrease)
|
| ||||||||||||||||||||||||
| | |
2018
|
| |
2017
|
| |
2016
|
| |
2017 to 2018
|
| |
2016 to 2017
|
| |||||||||||||||
| | |
(in millions)
|
| | | |||||||||||||||||||||||||
General and administrative
|
| | | $ | 10.8 | | | | | $ | 7.6 | | | | | $ | 7.6 | | | | | | 42 % | | | | | | — % | | |
| | | | | |
% increase (decrease)
|
| ||||||||||||||||||||||||
| | |
2018
|
| |
2017
|
| |
2016
|
| |
2017 to 2018
|
| |
2016 to 2017
|
| |||||||||||||||
| | |
(in thousands)
|
| | | |||||||||||||||||||||||||
Interest income
|
| | | $ | 1,435 | | | | | $ | 238 | | | | | $ | 178 | | | | | | 503 % | | | | | | 34 % | | |
Interest expense
|
| | | | (1,666 ) | | | | | | (1,520 ) | | | | | | — | | | | | | 10 % | | | | | | 100 % | | |
Other income (expense)
|
| | | | (1,552 ) | | | | | | (902 ) | | | | | | — | | | | | | 72 % | | | | | | 100 % | | |
| | |
Page
|
| |||
| | | | 57 | | | |
| | | | 59 | | | |
| | | | 60 | | | |
| | | | 61 | | | |
| | | | 62 | | | |
| | | | 63 | | |
| | |
December 31,
|
| |||||||||
| | |
2018
|
| |
2017
|
| ||||||
| | |
(IN THOUSANDS,
EXCEPT SHARE AND PER SHARE DATA) |
| |||||||||
ASSETS | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | $ | 19,236 | | | | | $ | 20,229 | | |
Marketable securities-short term
|
| | | | 80,322 | | | | | | 27,807 | | |
Contract receivables
|
| | | | 5,984 | | | | | | — | | |
Prepaid expenses
|
| | | | 861 | | | | | | 547 | | |
Total current assets
|
| | | | 106,403 | | | | | | 48,583 | | |
Property and equipment, net
|
| | | | 69 | | | | | | 115 | | |
Other assets
|
| | | | 204 | | | | | | 204 | | |
Total assets
|
| | | $ | 106,676 | | | | | $ | 48,902 | | |
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | |
Accounts payable and accrued expenses
|
| | | $ | 12,948 | | | | | $ | 8,259 | | |
Notes payable-current portion
|
| | | | 1,667 | | | | | | — | | |
Deferred revenue
|
| | | | — | | | | | | 1,500 | | |
Total current liabilities
|
| | | | 14,615 | | | | | | 9,759 | | |
Long-term liabilities: | | | | | | | | | | | | | |
Notes payable-long term
|
| | | | 13,093 | | | | | | 14,607 | | |
Warrant liability
|
| | | | — | | | | | | 1,512 | | |
Total liabilities
|
| | | | 27,708 | | | | | | 25,878 | | |
Commitments and contingencies (Note 13) | | | | | | | | | | | | | |
Preferred stock, convertible, Series A $0.01 par value; 1,000,000, shares
authorized; zero and 8,370 shares issued and outstanding at December 31, 2018 and 2017, respectively |
| | | | — | | | | | | 8,843 | | |
Stockholders’ equity: | | | | | | | | | | | | | |
Common stock, $0.01 par value; 200,000,000 shares authorized; 109,003,637 and 87,110,202 shares issued and outstanding at December 31, 2018 and 2017, respectively
|
| | | | 1,090 | | | | | | 871 | | |
Additional paid-in capital
|
| | | | 625,993 | | | | | | 547,364 | | |
Accumulated other comprehensive loss
|
| | | | (95 ) | | | | | | (16 ) | | |
Accumulated deficit
|
| | | | (548,020 ) | | | | | | (534,038 ) | | |
Total stockholders’ equity
|
| | | | 78,968 | | | | | | 14,181 | | |
Total liabilities, preferred stock and stockholders’ equity
|
| | | $ | 106,676 | | | | | $ | 48,902 | | |
|
| | |
YEAR ENDED DECEMBER 31,
|
| |||||||||||||||
| | |
2018
|
| |
2017
|
| |
2016
|
| |||||||||
| | |
(IN THOUSANDS, EXCEPT
PER SHARE DATA) |
| |||||||||||||||
Revenue: | | | | | | | | | | | | | | | | | | | |
Research and development revenue
|
| | | $ | 25,764 | | | | | $ | — | | | | | $ | 4,709 | | |
Costs and expenses: | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | 28,710 | | | | | | 19,468 | | | | | | 20,042 | | |
General and administrative
|
| | | | 10,753 | | | | | | 7,551 | | | | | | 7,563 | | |
| | | | | 39,463 | | | | | | 27,019 | | | | | | 27,605 | | |
Loss from operations
|
| | | | (13,699 ) | | | | | | (27,019 ) | | | | | | (22,896 ) | | |
Interest income
|
| | | | 1,435 | | | | | | 238 | | | | | | 178 | | |
Interest expense
|
| | | | (1,666 ) | | | | | | (1,520 ) | | | | | | — | | |
Other expense
|
| | | | (1,552 ) | | | | | | (902 ) | | | | | | — | | |
Loss before income taxes
|
| | | | (15,482 ) | | | | | | (29,203 ) | | | | | | (22,718 ) | | |
Provision for income taxes
|
| | | | — | | | | | | — | | | | | | — | | |
Net loss
|
| | | | (15,482 ) | | | | | | (29,203 ) | | | | | | (22,718 ) | | |
Unrealized loss on marketable securities
|
| | | | (79 ) | | | | | | (18 ) | | | | | | (1 ) | | |
Comprehensive loss
|
| | | $ | (15,561 ) | | | | | $ | (29,221 ) | | | | | $ | (22,719 ) | | |
Basic and diluted net loss per common share: | | | | | | | | | | | | | | | | | | | |
Net loss per common share
|
| | | $ | (0.16 ) | | | | | $ | (0.39 ) | | | | | $ | (0.33 ) | | |
Weighted average basic and diluted common shares outstanding
|
| | | | 99,035 | | | | | | 74,813 | | | | | | 69,714 | | |
|
| | |
PREFERRED STOCK
|
| | |
COMMON STOCK
|
| |
ADDITIONAL
PAID-IN CAPITAL |
| |
ACCUMULATED
OTHER COMPREHENSIVE INCOME/(LOSS) |
| |
ACCUMULATED
DEFICIT |
| |
TOTAL
STOCK- HOLDERS’ EQUITY |
| ||||||||||||||||||||||||||||||
| | |
SHARES
|
| |
AMOUNT
|
| | |
SHARES
|
| |
PAR
VALUE |
| ||||||||||||||||||||||||||||||||||||
Balance at December 31, 2015
|
| | | | — | | | | | $ | — | | | | | | | 62,939,780 | | | | | $ | 629 | | | | | $ | 510,664 | | | | | $ | 3 | | | | | $ | (482,117 ) | | | | | $ | 29,179 | | |
Issuance of common stock and options
from stock offering, net |
| | | | | | | | | | | | | | | | | 8,027,900 | | | | | | 80 | | | | | | 15,094 | | | | | | | | | | | | | | | | | | 15,174 | | |
Stock option exercises and issuance of common stock
|
| | | | | | | | | | | | | | | | | 97,498 | | | | | | 1 | | | | | | 112 | | | | | | | | | | | | | | | | | | 113 | | |
Restricted shares issued net of forfeitures and shares redeemed for taxes
|
| | | | | | | | | | | | | | | | | 29,828 | | | | | | — | | | | | | | | | | | | | | | | | | | | | | | | — | | |
Employee stock purchase plan
|
| | | | | | | | | | | | | | | | | 51,203 | | | | | | 1 | | | | | | 67 | | | | | | | | | | | | | | | | | | 68 | | |
Stock based compensation expense
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1,865 | | | | | | | | | | | | | | | | | | 1,865 | | |
Change in unrealized loss on marketable
securities |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (1 ) | | | | | | | | | | | | (1 ) | | |
Net loss
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (22,718 ) | | | | | | (22,718 ) | | |
Balance at December 31, 2016
|
| | | | — | | | | | | — | | | | | | | 71,146,209 | | | | | $ | 711 | | | | | $ | 527,802 | | | | | | 2 | | | | | $ | (504,835 ) | | | | | $ | 23,680 | | |
Issuance of preferred stock and preferred warrants from stock offerings, net
|
| | | | 8,370 | | | | | | 8,843 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Issuance of common stock and common warrants from stock offering, net
|
| | | | | | | | | | | | | | | | | 15,938,651 | | | | | | 160 | | | | | | 17,764 | | | | | | | | | | | | | | | | | | 17,924 | | |
Restricted shares issued net of forfeitures and shares redeemed for taxes
|
| | | | | | | | | | | | | | | | | 5,380 | | | | | | — | | | | | | | | | | | | | | | | | | | | | | | | — | | |
Employee stock purchase plan
|
| | | | | | | | | | | | | | | | | 19,962 | | | | | | — | | | | | | 17 | | | | | | | | | | | | | | | | | | 17 | | |
Stock based compensation expense
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1,434 | | | | | | | | | | | | | | | | | | 1,434 | | |
Issuance of warrants from notes payable
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | 347 | | | | | | | | | | | | | | | | | | 347 | | |
Change in unrealized loss on marketable
securities |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (18 ) | | | | | | | | | | | | (18 ) | | |
Net loss
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (29,203 ) | | | | | | (29,203 ) | | |
Balance at December 31, 2017
|
| | | | 8,370 | | | | | $ | 8,843 | | | | | | | 87,110,202 | | | | | $ | 871 | | | | | $ | 547,364 | | | | | $ | (16 ) | | | | | $ | (534,038 ) | | | | | $ | 14,181 | | |
Issuance of preferred stock and
warrants due to conversion of preferred stock to common stock and preferred warrants to common warrants |
| | | | (8,370 ) | | | | | | (8,843 ) | | | | | | | 8,370,000 | | | | | | 83 | | | | | | 11,823 | | | | | | | | | | | | | | | | | | 11,906 | | |
Issuance of common stock from stock offering, net
|
| | | | | | | | | | | | | | | | | 12,650,000 | | | | | | 127 | | | | | | 64,435 | | | | | | | | | | | | | | | | | | 64,562 | | |
Stock option exercises and issuance of common stock
|
| | | | | | | | | | | | | | | | | 603,851 | | | | | | 6 | | | | | | 750 | | | | | | | | | | | | | | | | | | 756 | | |
Shares issued from exercise of warrants
|
| | | | | | | | | | | | | | | | | 269,584 | | | | | | 3 | | | | | | (2 ) | | | | | | | | | | | | | | | | | | 1 | | |
Stock based compensation expense
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1,503 | | | | | | | | | | | | | | | | | | 1,503 | | |
Warrants issued upon debt
extension |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | 120 | | | | | | | | | | | | | | | | | | 120 | | |
Change in unrealized loss on marketable
securities |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (79 ) | | | | | | | | | | | | (79 ) | | |
Increase to opening accumulated deficit
upon adoption of new accounting standard |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1,500 | | | | | | 1,500 | | |
Net loss
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (15,482 ) | | | | | | (15,482 ) | | |
Balance at December 31, 2018
|
| | | | — | | | | | $ | — | | | | | | | 109,003,637 | | | | | $ | 1,090 | | | | | $ | 625,993 | | | | | $ | (95 ) | | | | | $ | (548,020 ) | | | | | $ | 78,968 | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | |
YEAR ENDED DECEMBER 31,
|
| |||||||||||||||
| | |
2018
|
| |
2017
|
| |
2016
|
| |||||||||
| | |
(IN THOUSANDS)
|
| |||||||||||||||
Cash flows from operating activities: | | | | | | | | | | | | | | | | | | | |
Net loss
|
| | | $ | (15,482 ) | | | | | $ | (29,203 ) | | | | | $ | (22,718 ) | | |
Adjustments to reconcile net loss to net cash used in operating
activities: |
| | | | | | | | | | | | | | | | | | |
Depreciation and amortization
|
| | | | 46 | | | | | | 65 | | | | | | 101 | | |
Amortization of premium (discount) on marketable securities
|
| | | | 691 | | | | | | (28 ) | | | | | | 48 | | |
Amortization of debt discount
|
| | | | 322 | | | | | | 330 | | | | | | — | | |
Change in fair value of warrant liability
|
| | | | 1,552 | | | | | | 902 | | | | | | — | | |
Non-cash stock compensation
|
| | | | 1,503 | | | | | | 1,434 | | | | | | 1,865 | | |
Changes in operating assets and liabilities:
|
| | | | | | | | | | | | | | | | | | |
Contract receivables
|
| | | | (5,984 ) | | | | | | — | | | | | | — | | |
Prepaid expenses and other assets
|
| | | | (314 ) | | | | | | 322 | | | | | | (108 ) | | |
Accounts payable and accrued expenses
|
| | | | 4,690 | | | | | | (497 ) | | | | | | 2,466 | | |
Deferred revenue
|
| | | | — | | | | | | 1,500 | | | | | | (4,591 ) | | |
Net cash used in operating activities
|
| | | | (12,976 ) | | | | | | (25,175 ) | | | | | | (22,937 ) | | |
Cash flows from investing activities: | | | | | | | | | | | | | | | | | | | |
Purchases of marketable securities
|
| | | | (112,580 ) | | | | | | (41,971 ) | | | | | | (30,975 ) | | |
Proceeds from sale or maturity of marketable securities
|
| | | | 59,295 | | | | | | 30,033 | | | | | | 39,856 | | |
Purchases of property and equipment
|
| | | | — | | | | | | — | | | | | | (15 ) | | |
Net cash provided by (used in) investing activities
|
| | | | (53,285 ) | | | | | | (11,938 ) | | | | | | 8,866 | | |
Cash flows from financing activities: | | | | | | | | | | | | | | | | | | | |
Proceeds from notes payable and warrants
|
| | | | — | | | | | | 15,000 | | | | | | — | | |
Debt issuance costs associated with notes payable and warrants
|
| | | | (49 ) | | | | | | (376 ) | | | | | | — | | |
Proceeds from common stock offerings and warrants, net
|
| | | | 64,561 | | | | | | 17,951 | | | | | | 15,174 | | |
Proceeds from convertible preferred stock offering and warrants, net
|
| | | | — | | | | | | 9,483 | | | | | | — | | |
Proceeds from stock option exercises and employee stock plan purchases
|
| | | | 756 | | | | | | 17 | | | | | | 181 | | |
Net cash provided by financing activities
|
| | | | 65,268 | | | | | | 42,075 | | | | | | 15,355 | | |
Net increase (decrease) in cash and cash equivalents
|
| | | | (993 ) | | | | | | 4,962 | | | | | | 1,284 | | |
Cash and cash equivalents, beginning of period
|
| | | | 20,229 | | | | | | 15,267 | | | | | | 13,983 | | |
Cash and cash equivalents, end of period
|
| | | $ | 19,236 | | | | | $ | 20,229 | | | | | $ | 15,267 | | |
|
| | |
2018
|
| |
2017
|
| |
2016
|
| |||||||||
Research and development
|
| | | $ | 369 | | | | | $ | 359 | | | | | $ | 514 | | |
General and administrative
|
| | | | 1,134 | | | | | | 1,075 | | | | | | 1,351 | | |
Total stock-based compensation expense
|
| | | $ | 1,503 | | | | | $ | 1,434 | | | | | $ | 1,865 | | |
|
| | |
2018
|
| |
2017
|
| |
2016
|
|
Dividend yield(1)
|
| |
0.0%
|
| |
0.0%
|
| |
0.0%
|
|
Weighted average expected volatility factor(2)
|
| |
62%
|
| |
62%
|
| |
63%
|
|
Risk free interest(3)
|
| |
2.4–2.9%
|
| |
1.9–2.1%
|
| |
1.2–1.8%
|
|
Expected term, excluding options issued pursuant to the Employee Stock Purchase Plan(4)
|
| |
5.6–7.2 years
|
| |
6.1–7.1 years
|
| |
5.8–7.2 years
|
|
Expected term—Employee Stock Purchase Plan(5)
|
| |
6 months
|
| |
6 months
|
| |
6 months
|
|
December 31, 2018
|
| |
Amortized
Cost |
| |
Gross
Unrealized Gains |
| |
Gross
Unrealized Losses |
| |
Fair
Value |
| ||||||||||||
Security type | | | | | | | | | | | | | | | | | | | | | | | | | |
Corporate debt securities-short term
|
| | | $ | 80,417 | | | | | $ | 2 | | | | | $ | (97 ) | | | | | $ | 80,322 | | |
Total available-for-sale marketable securities
|
| | | $ | 80,417 | | | | | $ | 2 | | | | | $ | (97 ) | | | | | $ | 80,322 | | |
|
December 31, 2017
|
| |
Amortized
Cost |
| |
Gross
Unrealized Gains |
| |
Gross
Unrealized Losses |
| |
Fair
Value |
| ||||||||||||
Security type | | | | | | | | | | | | | | | | | | | | | | | | | |
Corporate debt securities-short term
|
| | | $ | 27,823 | | | | | $ | 1 | | | | | $ | (17 ) | | | | | $ | 27,807 | | |
Total available-for-sale marketable securities
|
| | | $ | 27,823 | | | | | $ | 1 | | | | | $ | (17 ) | | | | | $ | 27,807 | | |
|
| | |
December 31,
2018 |
| |
Quoted Prices in
Active Markets (Level 1) |
| |
Significant
Other Observable Inputs (Level 2) |
| |
Significant
Unobservable Inputs (Level 3) |
| ||||||||||||
Cash equivalents
|
| | | $ | 14,444 | | | | | $ | 14,444 | | | | | $ | — | | | | | $ | — | | |
Corporate debt securities-short term
|
| | | | 80,322 | | | | | | — | | | | | | 80,322 | | | | | | — | | |
Total
|
| | | $ | 94,766 | | | | | $ | 14,444 | | | | | $ | 80,322 | | | | | $ | — | | |
|
| | |
December 31,
2017 |
| |
Quoted Prices in
Active Markets (Level 1) |
| |
Significant
Other Observable Inputs (Level 2) |
| |
Significant
Unobservable Inputs (Level 3) |
| ||||||||||||
Cash equivalents
|
| | | $ | 19,889 | | | | | $ | 19,889 | | | | | $ | — | | | | | $ | — | | |
Corporate debt securities-short term
|
| | | | 27,807 | | | | | | — | | | | | | 27,807 | | | | | | — | | |
Total
|
| | | $ | 47,696 | | | | | $ | 19,889 | | | | | $ | 27,807 | | | | | $ | — | | |
|
| | |
December 31,
2017 |
| |
Quoted Prices in
Active Markets (Level 1) |
| |
Significant
Other Observable Inputs (Level 2) |
| |
Significant
Unobservable Inputs (Level 3) |
| ||||||||||||
Warrant liability
|
| | | $ | 1,512 | | | | | $ | — | | | | | $ | — | | | | | $ | 1,512 | | |
|
| | |
2017
|
|
Warrant stock price
|
| |
$1.75
|
|
Exercise price
|
| |
1.65
|
|
Expected volatility
|
| |
53.3%
|
|
Risk-free interest
|
| |
2.07%
|
|
Expected term
|
| |
3.85 years
|
|
Dividends
|
| |
none
|
|
| | |
Amount
|
| |||
Warrant liability as of December 31, 2017
|
| | | $ | 1,512 | | |
Change in fair value
|
| | | | 1,552 | | |
Conversion of preferred stock warrants to common stock warrants
|
| | | | (3,064 ) | | |
Warrant liability as of December 31, 2018
|
| | | $ | — | | |
|
| | |
USEFUL
LIFE ESTIMATED (YEARS) |
| |
2018
|
| |
2017
|
| |||||||||
Machinery and equipment
|
| | | | 5 | | | | | $ | 1,611 | | | | | $ | 1,939 | | |
Leasehold improvements
|
| | | | 3–5 | | | | | | 232 | | | | | | 232 | | |
Furniture and fixtures
|
| | | | 7 | | | | | | 40 | | | | | | 40 | | |
Computer equipment
|
| | | | 3 | | | | | | 2,496 | | | | | | 2,497 | | |
| | | | | | | | | | | 4,379 | | | | | | 4,708 | | |
Less: Accumulated depreciation and amortization
|
| | | | | | | | | | 4,310 | | | | | | 4,593 | | |
Net property and equipment
|
| | | | | | | | | $ | 69 | | | | | $ | 115 | | |
|
| | |
2018
|
| |
2017
|
| ||||||
Security deposits
|
| | | $ | 204 | | | | | $ | 204 | | |
Total other assets
|
| | | $ | 204 | | | | | $ | 204 | | |
|
| | |
2018
|
| |
2017
|
| ||||||
Accounts payable
|
| | | $ | 1,329 | | | | | $ | 537 | | |
Accrued payroll
|
| | | | 1,971 | | | | | | 1,448 | | |
Accrued outsourced preclinical and clinical fees
|
| | | | 8,497 | | | | | | 5,409 | | |
Accrued professional fees
|
| | | | 666 | | | | | | 492 | | |
Other accrued expenses
|
| | | | 485 | | | | | | 373 | | |
| | | | $ | 12,948 | | | | | $ | 8,259 | | |
|
|
2019
|
| | | $ | 1,667 | | |
|
2020
|
| | | | 5,000 | | |
|
2021
|
| | | | 5,000 | | |
|
2022
|
| | | | 3,333 | | |
| | | | | $ | 15,000 | | |
|
Stock Options
|
| |
Number
of Shares |
| |
Weighted Average
Exercise Price |
| ||||||
Outstanding as of December 31, 2017
|
| | | | 10,622,455 | | | | | $ | 3.01 | | |
Granted
|
| | | | 1,911,770 | | | | | | 2.78 | | |
Exercised
|
| | | | (1,104,706 ) | | | | | | 3.22 | | |
Cancelled
|
| | | | (681,362 ) | | | | | | 3.71 | | |
Outstanding as of December 31, 2018
|
| | | | 10,748,157 | | | | | $ | 2.90 | | |
Exercisable as of December 31, 2018
|
| | | | 5,973,658 | | | | | $ | 3.71 | | |
|
| | |
Options Outstanding
|
| |
Options Exercisable
|
| ||||||||||||||||||||||||
Range of Exercise Prices
|
| |
Number
Outstanding at December 31, 2018 |
| |
Weighted Average
Remaining Contractual Life |
| |
Weighted Average
Exercise Price |
| |
Exercisable as of
December 31, 2018 |
| |
Weighted Average
Exercise Price |
| |||||||||||||||
$0.95–1.41
|
| | | | 2,352,567 | | | | | | 7.46 | | | | | $ | 1.05 | | | | | | 753,988 | | | | | $ | 1.17 | | |
1.42–2.35
|
| | | | 3,329,745 | | | | | | 7.71 | | | | | | 1.69 | | | | | | 1,234,325 | | | | | | 1.71 | | |
2.36–3.80
|
| | | | 2,636,207 | | | | | | 4.96 | | | | | | 2.73 | | | | | | 2,001,207 | | | | | | 2.80 | | |
3.81–5.60
|
| | | | 626,750 | | | | | | 7.07 | | | | | | 4.81 | | | | | | 186,250 | | | | | | 4.12 | | |
5.61–8.40
|
| | | | 1,802,888 | | | | | | 2.56 | | | | | | 7.13 | | | | | | 1,797,888 | | | | | | 7.13 | | |
| | | | | 10,748,157 | | | | | | 6.08 | | | | | $ | 2.90 | | | | | | 5,973,658 | | | | | $ | 3.71 | | |
|
| | |
Options
|
| |
Weighted-Average
Exercise Price |
| |
Weighted-Average
Remaining Contractual Term (in years) |
| |
Aggregate
Intrinsic Value |
| ||||||||||||
Vested and unvested expected to vest at December 31, 2018
|
| | | | 10,560,209 | | | | | $ | 2.90 | | | | | | 6.08 | | | | | $ | 8,112 | | |
Exercisable at December 31, 2018
|
| | | | 5,973,658 | | | | | $ | 3.71 | | | | | | 4.26 | | | | | $ | 2,823 | | |
| | |
2018
|
| |
2017
|
| |
2016
|
| |||||||||
Income tax (benefit) expense at statutory rate
|
| | | $ | (3,251 ) | | | | | $ | (9,929 ) | | | | | $ | (7,724 ) | | |
State tax (benefit) expense, net of Federal tax (benefit) expense
|
| | | | (938 ) | | | | | | (1,452 ) | | | | | | (1,146 ) | | |
Permanent items
|
| | | | 75 | | | | | | 508 | | | | | | 263 | | |
Effect of change in valuation allowance and State NOL expiration
|
| | | | 4,542 | | | | | | (39,972 ) | | | | | | 8,837 | | |
Tax credits
|
| | | | (132 ) | | | | | | (544 ) | | | | | | (228 ) | | |
Change in tax rate on beginning assets
|
| | | | — | | | | | | 51,445 | | | | | | — | | |
Other
|
| | | | (296 ) | | | | | | (56 ) | | | | | | (2 ) | | |
Tax expense (benefit)
|
| | | $ | — | | | | | $ | — | | | | | $ | — | | |
|
| | |
2018
|
| |
2017
|
| ||||||
Deferred tax assets: | | | | | | | | | | | | | |
Net operating loss carryforwards
|
| | | $ | 103,855 | | | | | $ | 100,421 | | |
Tax credit carryforwards
|
| | | | 26,880 | | | | | | 26,771 | | |
Equity based compensation
|
| | | | 4,361 | | | | | | 3,381 | | |
Book depreciation in excess of tax
|
| | | | 56 | | | | | | 49 | | |
Reserves and accruals
|
| | | | 178 | | | | | | 171 | | |
Other
|
| | | | 21 | | | | | | 16 | | |
| | | | | 135,351 | | | | | | 130,809 | | |
Valuation allowance
|
| | | | (135,351 ) | | | | | | (130,809 ) | | |
Deferred tax liabilities
|
| | | | — | | | | | | — | | |
Net deferred tax assets
|
| | | $ | — | | | | | $ | — | | |
|
YEAR ENDING DECEMBER 31,
|
| |
OPERATING LEASES
|
| |||
2019
|
| | | $ | 523 | | |
2020
|
| | | | 296 | | |
Thereafter
|
| | | | — | | |
Total minimum lease payments
|
| | | $ | 819 | | |
|
| | |
FIRST
QUARTER |
| |
SECOND
QUARTER |
| |
THIRD
QUARTER |
| |
FOURTH
QUARTER |
| ||||||||||||
2018 | | | | | | | | | | | | | | | | | | | | | | | | | |
Net revenues
|
| | | $ | 4,138 | | | | | $ | 13,706 | | | | | $ | 4,979 | | | | | $ | 2,941 | | |
Net income (loss)
|
| | | | (6,532 ) | | | | | | 5,156 | | | | | | (5,619 ) | | | | | | (8,487 ) | | |
Basic and diluted net income (loss) per share: | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic net income (loss) per share
|
| | | $ | (0.07 ) | | | | | $ | 0.06 | | | | | $ | (0.05 ) | | | | | $ | (0.08 ) | | |
Diluted net income (loss) per share
|
| | | $ | (0.07 ) | | | | | $ | 0.05 | | | | | $ | (0.05 ) | | | | | $ | (0.08 ) | | |
| | |
FIRST
QUARTER |
| |
SECOND
QUARTER |
| |
THIRD
QUARTER |
| |
FOURTH
QUARTER |
| ||||||||||||
2017 | | | | | | | | | | | | | | | | | | | | | | | | | |
Net revenues
|
| | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | | |
Net loss
|
| | | | (7,576 ) | | | | | | (7,201 ) | | | | | | (6,666 ) | | | | | | (7,760 ) | | |
Basic and diluted net loss per share: | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss per share
|
| | | $ | (0.11 ) | | | | | $ | (0.10 ) | | | | | $ | (0.09 ) | | | | | $ | (0.09 ) | | |
| A r Q ule , I nc . | | | |||||
| By: | | | / s / P aolo P ucci | | | ||
| | | | Paolo Pucci | | | ||
| | | | Chief Executive Officer | | | ||
| Date: March 7, 2019 | | | | |
|
SIGNATURE
|
| |
TITLE
|
| |
DATE
|
|
|
/
s
/ P
aolo
P
ucci
Paolo Pucci
|
| |
Chief Executive Officer and Director
(Principal Executive Officer) |
| |
March 7, 2019
|
|
|
/
s
/ P
eter
S. L
awrence
Peter S. Lawrence
|
| |
President and Chief Operating Officer
(Principal Financial Officer) |
| |
March 7, 2019
|
|
|
/
s
/ R
obert
J. W
eiskopf
Robert J. Weiskopf
|
| |
Chief Financial Officer and Treasurer
(Principal Accounting Officer) |
| |
March 7, 2019
|
|
|
/
s
/ P
atrick
J. Z
enner
Patrick J. Zenner
|
| | Director—Chairman of the Board | | |
March 7, 2019
|
|
|
/
s
/ T
imothy
C. B
arabe
Timothy C. Barabe
|
| | Director | | |
March 7, 2019
|
|
|
/
s
/ S
usan
L. K
elley
Susan L. Kelley
|
| | Director | | |
March 7, 2019
|
|
|
/
s
/ R
onald
M. L
indsay
Ronald M. Lindsay
|
| | Director | | |
March 7, 2019
|
|
|
/
s
/ M
ichael
D. L
oberg
Michael D. Loberg
|
| | Director | | |
March 7, 2019
|
|
|
/
s
/ W
illiam
G. M
essenger
William G. Messenger
|
| | Director | | |
March 7, 2019
|
|
|
/
s
/ R
an
N
ussbaum
Ran Nussbaum
|
| | Director | | |
March 7, 2019
|
|
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