Delaware
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47-3116175
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Large accelerated filer
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o
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Accelerated filer
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o
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Non-accelerated filer
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o
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(Do not check if a smaller reporting company)
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Smaller reporting company
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ý
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Emerging growth company
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ý
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Page No.
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PART I. FINANCIAL INFORMATION
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||
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Item 1.
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Financial Statements
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Condensed Consolidated Balance Sheets as of March 31, 2018 (Unaudited) and December 31, 2017
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Condensed Consolidated Statements of Operations for the three months ended March 31, 2018 and 2017 (Unaudited)
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Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2018 and 2017 (Unaudited)
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Condensed Consolidated Statement of Changes in Stockholders’ Equity for the three months ended March 31, 2018 (Unaudited)
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Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2018 and 2017 (Unaudited)
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Notes to Condensed Consolidated Financial Statements (Unaudited)
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Item 2.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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Item 3.
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Quantitative and Qualitative Disclosures About Market Risk
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Item 4.
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Controls and Procedures
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PART II. OTHER INFORMATION
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Item 1.
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Legal Proceedings
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Item 1A.
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Risk Factors
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Item 2.
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Unregistered Sales of Equity Securities and Use of Proceeds
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Item 3.
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Defaults Upon Senior Securities
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Item 4.
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Mine Safety Disclosures
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Item 5.
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Other Information
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Item 6.
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Exhibits
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Signatures
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•
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the timing of the ongoing and expected clinical trials of our product candidates, including statements regarding the timing of completion of the trials and the respective periods during which the results of the trials will become available;
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•
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our ability to obtain adequate financing to meet our future operational and capital needs;
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•
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the timing of and our ability to obtain marketing approval of our product candidates, and the ability of our product candidates to meet existing or future regulatory standards;
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•
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our ability to comply with government laws and regulations;
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•
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our commercialization, marketing and manufacturing capabilities and strategy;
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•
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our estimates regarding the potential market opportunity for our product candidates;
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•
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the timing of or our ability to enter into partnerships to market and commercialize our product candidates;
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•
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the rate and degree of market acceptance of any product candidate for which we receive marketing approval;
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•
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our intellectual property position;
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•
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our estimates regarding expenses, future revenues, capital requirements and needs for additional funding;
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•
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the success of competing treatments;
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•
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our competitive position; and
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•
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our expectations regarding the time during which we will be an “emerging growth company” under the Jumpstart Our Business Startups Act of 2012.
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As of
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As of
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||||
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March 31, 2018
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December 31, 2017
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||||
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(Unaudited)
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||||
Assets
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Current assets:
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Cash and cash equivalents
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$
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28,350
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$
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28,823
|
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Restricted cash
|
|
403
|
|
|
402
|
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||
Marketable securities
|
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2,994
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|
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2,996
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Prepaid expenses and other current assets
|
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3,016
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|
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3,359
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Total current assets
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34,763
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35,580
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Restricted cash, non-current
|
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150
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|
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150
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Other non-current assets
|
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40
|
|
|
54
|
|
||
Property and equipment, net
|
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935
|
|
|
1,026
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Total assets
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$
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35,888
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|
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$
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36,810
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Liabilities and Stockholders’ Equity
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|
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Current liabilities:
|
|
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Accounts payable
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$
|
4,593
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|
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$
|
3,853
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Accrued research and development
|
|
2,987
|
|
|
1,785
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Accrued expenses
|
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816
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|
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1,441
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Total current liabilities
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8,396
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|
7,079
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Common stock warrant liability
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25,275
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|
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32,325
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Total liabilities
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33,671
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39,404
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Commitments and contingencies
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Stockholders’ equity:
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Common stock, $0.01 par value per share; 125,000,000 shares authorized, 57,369,165 and 56,899,353 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively, 289,269 shares paid for and to be issued at December 31, 2017
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574
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|
|
569
|
|
||
Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at March 31, 2018 and December 31, 2017
|
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—
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|
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—
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Additional paid-in capital
|
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176,862
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176,151
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Accumulated other comprehensive loss
|
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(5
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)
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|
(4
|
)
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||
Accumulated deficit
|
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(175,214
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)
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(179,310
|
)
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Total stockholders’ equity
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2,217
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|
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(2,594
|
)
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Total liabilities and stockholders’ equity
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$
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35,888
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$
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36,810
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Three Months Ended
March 31, |
||||||
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2018
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2017
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||||
Operating expenses:
|
|
|
|
|
|
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Research and development
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$
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6,380
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|
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$
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3,337
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General and administrative
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2,112
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1,446
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Total operating expenses
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8,492
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4,783
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Loss from operations
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(8,492
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)
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(4,783
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)
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||
Change in fair value of common stock warrant liability
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7,050
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(14,387
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)
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||
Interest and other income, net
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99
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|
|
27
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|
||
Pre-tax loss
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(1,343
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)
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(19,143
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)
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||
Income tax benefit
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5,439
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|
|
—
|
|
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Net income (loss)
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$
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4,096
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|
|
$
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(19,143
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)
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Weighted average shares outstanding:
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|
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||
Basic
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57,059,686
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31,934,253
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Diluted
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72,100,690
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31,934,253
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Net income (loss) per share:
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|
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|
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||
Basic
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$
|
0.07
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|
|
$
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(0.60
|
)
|
Diluted
|
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$
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(0.04
|
)
|
|
$
|
(0.60
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)
|
|
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Three Months Ended March 31,
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|
||||||
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2018
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|
2017
|
|
||||
Net income (loss)
|
|
$
|
4,096
|
|
|
$
|
(19,143
|
)
|
|
Other comprehensive income
|
|
|
|
|
|
|
|
||
Unrealized losses on available-for-sale marketable securities
|
|
(1
|
)
|
|
—
|
|
|
||
Total other comprehensive loss
|
|
(1
|
)
|
|
—
|
|
|
||
Comprehensive income (loss)
|
|
$
|
4,095
|
|
|
$
|
(19,143
|
)
|
|
|
|
Common Stock
|
|
Additional
|
|
Accumulated
Other
Comprehensive
|
|
Accumulated
|
|
Total
Stockholders’
|
|||||||||||||
|
|
Shares
|
|
Amount
|
|
Paid in Capital
|
|
Loss
|
|
Deficit
|
|
Equity
|
|||||||||||
December 31, 2017
|
|
56,899,353
|
|
|
$
|
569
|
|
|
$
|
176,151
|
|
|
$
|
(4
|
)
|
|
$
|
(179,310
|
)
|
|
$
|
(2,594
|
)
|
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,096
|
|
|
4,096
|
|
|||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
—
|
|
|
(1
|
)
|
|||||
Warrant exercises
|
|
289,269
|
|
|
3
|
|
|
(3
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation
|
|
180,543
|
|
|
2
|
|
|
714
|
|
|
—
|
|
|
—
|
|
|
716
|
|
|||||
March 31, 2018
|
|
57,369,165
|
|
|
$
|
574
|
|
|
$
|
176,862
|
|
|
$
|
(5
|
)
|
|
$
|
(175,214
|
)
|
|
$
|
2,217
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||
Net income (loss)
|
|
$
|
4,096
|
|
|
$
|
(19,143
|
)
|
Adjustments to reconcile net income (loss) to net cash used in operating activities:
|
|
|
|
|
|
|
||
Change in fair value of common stock warrant liability
|
|
(7,050
|
)
|
|
14,387
|
|
||
Accretion and amortization of discounts and premiums on marketable securities, net
|
|
1
|
|
|
—
|
|
||
Stock based compensation
|
|
716
|
|
|
729
|
|
||
Depreciation
|
|
91
|
|
|
99
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
||
Prepaid expenses and other current assets
|
|
343
|
|
|
(111
|
)
|
||
Other non-current assets
|
|
14
|
|
|
582
|
|
||
Accounts payable, accrued research and development, and accrued expenses
|
|
1,345
|
|
|
(200
|
)
|
||
Net cash used in operating activities
|
|
(444
|
)
|
|
(3,657
|
)
|
||
Cash flows from investing activities:
|
|
|
|
|
|
|
||
Proceeds from sale of marketable securities
|
|
—
|
|
|
2,458
|
|
||
Net cash provided by investing activities
|
|
—
|
|
|
2,458
|
|
||
Cash flows from financing activities:
|
|
|
|
|
|
|
||
Payment of offering expenses related to the PIPE offering
|
|
(28
|
)
|
|
—
|
|
||
Proceeds received from exercise of warrants
|
|
—
|
|
|
520
|
|
||
Payment of offering expenses related to the secondary offering
|
|
—
|
|
|
(235
|
)
|
||
Net cash (used in) provided by financing activities
|
|
(28
|
)
|
|
285
|
|
||
|
|
|
|
|
||||
Net change in cash, cash equivalents and restricted cash
|
|
(472
|
)
|
|
(914
|
)
|
||
Cash, cash equivalents and restricted cash at beginning of period
|
|
29,375
|
|
|
14,910
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
|
$
|
28,903
|
|
|
$
|
13,996
|
|
|
|
|
|
|
|
|
||
Non-cash financing activities:
|
|
|
|
|
|
|
||
Conversion of warrant liability to common stock upon exercise of warrants
|
|
$
|
—
|
|
|
$
|
702
|
|
•
|
The risk that the Company will not achieve success in its research and development efforts, including clinical trials conducted by it or its potential collaborative partners.
|
•
|
The expectation that the Company will experience operating losses for the next several years.
|
•
|
Decisions by regulatory authorities regarding whether and when to approve the Company’s regulatory applications as well as their decisions regarding labeling and other matters which could affect the commercial potential of the Company’s products or product candidates.
|
•
|
The risk that the Company will fail to obtain adequate financing to meet its future operational and capital needs.
|
•
|
The risk that the Company will be unable to obtain additional funds on a timely basis and hence there will be substantial doubt about its ability to continue as a going concern.
|
•
|
The risk that key personnel will leave the Company and/or that the Company will be unable to recruit and retain senior level officers to manage its business.
|
|
March 31, 2018
|
|
December 31, 2017
|
||||||||||
|
Amortized Cost
|
Gross Unrealized Losses
|
Fair Value
|
|
Amortized Cost
|
Gross Unrealized Losses
|
Fair Value
|
||||||
US Government bonds
|
2,999
|
|
(5
|
)
|
2,994
|
|
|
3,000
|
|
(4
|
)
|
2,996
|
|
Total
|
2,999
|
|
(5
|
)
|
2,994
|
|
|
3,000
|
|
(4
|
)
|
2,996
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||||
|
Amortized Cost
|
Fair Value
|
|
Amortized Cost
|
Fair Value
|
||||
Due within one year
|
2,999
|
|
2,994
|
|
|
3,000
|
|
2,996
|
|
Total
|
2,999
|
|
2,994
|
|
|
3,000
|
|
2,996
|
|
|
|
Equity Classified
|
|
Liability Classified
|
||||||
|
|
Warrants
|
|
Warrants
|
|
Estimated Fair Value
|
||||
Warrants outstanding as of December 31, 2017
|
|
19,449,834
|
|
|
15,041,004
|
|
|
$
|
32,325
|
|
Change in fair value of common stock warrant liability recognized in consolidated statement of operations
|
|
—
|
|
|
—
|
|
|
(7,050
|
)
|
|
Warrants outstanding as of March 31, 2018
|
|
19,449,834
|
|
|
15,041,004
|
|
|
$
|
25,275
|
|
|
|
Liability Classified
|
|||||
|
|
Warrants
|
|
Estimated Fair Value
|
|||
Warrants outstanding as of December 31, 2016
|
|
17,142,858
|
|
|
$
|
5,215
|
|
Exercises
|
|
(648,586
|
)
|
|
(702
|
)
|
|
Additions
|
|
—
|
|
|
—
|
|
|
Change in fair value of common stock warrant liability recognized in consolidated statement of operations
|
|
—
|
|
|
14,387
|
|
|
Warrants outstanding as of March 31, 2017
|
|
16,494,272
|
|
|
$
|
18,900
|
|
•
|
Level 1 — Values are based on unadjusted quoted prices for identical assets or liabilities in an active market which the company has the ability to access at the measurement date.
|
•
|
Level 2 — Values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments with similar attributes in active markets.
|
•
|
Level 3 — Values are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions a market participant would use in pricing the asset.
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Marketable securities
|
|
$
|
—
|
|
|
$
|
2,994
|
|
|
$
|
—
|
|
|
$
|
2,994
|
|
Common stock warrant liability
|
|
—
|
|
|
—
|
|
|
25,275
|
|
|
25,275
|
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Marketable securities
|
|
$
|
—
|
|
|
$
|
2,996
|
|
|
$
|
—
|
|
|
$
|
2,996
|
|
Common stock warrant liabilities
|
|
—
|
|
|
—
|
|
|
32,325
|
|
|
32,325
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||
Valuation assumptions:
|
|
|
|
||
Risk-free interest rate
|
2.44
|
%
|
|
2.08
|
%
|
Expected volatility
|
98.97
|
%
|
|
96.24
|
%
|
Expected term (in years)
|
3.7
|
|
|
4.0
|
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
Three Months Ended March 31, 2018
|
|
Valuation assumptions:
|
|
|
Risk-free rate
|
2.43
|
%
|
Expected volatility
|
90.82
|
%
|
Expected term (years)
|
6.1
|
|
Dividend yield
|
—
|
|
|
Bellerophon 2015 and 2014 Equity Incentive Plans
|
||||||||||||||
|
Options
|
|
Range of
Exercise
Price
|
|
Weighted
Average
Price
|
|
Weighted Average
Remaining
Contractual
Life (in years)
|
||||||||
Options outstanding as of December 31, 2017
|
3,269,883
|
|
|
$
|
0.49
|
|
-
|
13.28
|
|
|
$
|
3.04
|
|
|
8.4
|
Granted
|
1,202,000
|
|
|
2.03
|
|
-
|
2.20
|
|
|
2.05
|
|
|
|
||
Forfeited
|
(5,225
|
)
|
|
0.49
|
|
-
|
4.12
|
|
|
1.57
|
|
|
|
||
Options outstanding as of March 31, 2018
|
4,466,658
|
|
|
$
|
0.49
|
|
-
|
13.28
|
|
|
$
|
2.77
|
|
|
8.6
|
Options vested and exercisable as of March 31, 2018
|
1,189,355
|
|
|
$
|
0.49
|
|
-
|
13.28
|
|
|
$
|
5.79
|
|
|
7.6
|
|
|
Bellerophon 2015 Equity Incentive Plan
|
|||||||||||
|
|
Shares
|
|
Weighted
Average
Fair Value
|
|
Aggregate
Grant Date
Fair Value
(in millions)
|
|
Weighted Average
Remaining
Contractual
Life (in years)
|
|||||
Restricted stock outstanding as of December 31, 2017
|
|
328,530
|
|
|
$
|
1.42
|
|
|
$
|
0.5
|
|
|
0.2
|
Granted
|
|
180,543
|
|
|
2.03
|
|
|
0.4
|
|
|
|
||
Vested
|
|
(208,337
|
)
|
|
(1.38
|
)
|
|
(0.3
|
)
|
|
|
||
Restricted stock outstanding as of March 31, 2018
|
|
300,736
|
|
|
$
|
1.81
|
|
|
$
|
0.6
|
|
|
0.2
|
|
|
Ikaria Equity Incentive Plans
|
|||||||||||||||
|
|
Options
|
|
Range of
Exercise
Price
|
|
Weighted
Average
Price
|
|
Weighted Average
Remaining
Contractual
Life (in years)
|
|||||||||
Options outstanding as of December 31, 2017
|
|
72,209
|
|
|
$
|
7.77
|
|
-
|
17.92
|
|
|
$
|
9.21
|
|
|
4.0
|
|
Forfeited
|
|
—
|
|
|
—
|
|
-
|
—
|
|
|
—
|
|
|
—
|
|
||
Options outstanding as of March 31, 2018
|
|
72,209
|
|
|
$
|
7.77
|
|
-
|
17.92
|
|
|
$
|
9.21
|
|
|
3.8
|
|
Options vested and exercisable as of March 31, 2018
|
|
72,209
|
|
|
$
|
7.77
|
|
-
|
17.92
|
|
|
$
|
9.21
|
|
|
3.8
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Research and development
|
|
$
|
198
|
|
|
$
|
291
|
|
General and administrative
|
|
518
|
|
|
438
|
|
||
Total expense
|
|
$
|
716
|
|
|
$
|
729
|
|
|
Three months ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Net income (loss)
|
$
|
4,096
|
|
|
$
|
(19,143
|
)
|
Weighted-average shares:
|
|
|
|
||||
Basic
|
57,059,686
|
|
|
31,934,253
|
|
||
Effect of dilutive securities:
|
|
|
|
||||
Warrants
|
15,041,004
|
|
|
—
|
|
||
Diluted
|
72,100,690
|
|
|
31,934,253
|
|
||
Net income (loss) per share:
|
|
|
|
||||
Basic
|
$
|
0.07
|
|
|
$
|
(0.60
|
)
|
Diluted
|
$
|
(0.04
|
)
|
|
$
|
(0.60
|
)
|
•
|
expenses incurred under agreements with contract research organizations, investigative sites that conduct our clinical trials and consultants that conduct a portion of our pre-clinical studies;
|
•
|
lab supplies, reagents, active pharmaceutical ingredients and other direct and indirect costs in support of our pre-clinical and clinical activities;
|
|
|
Three Months Ended
March 31, |
|
|
|
|
|||||||||
(Dollar amounts in thousands)
|
|
2018
|
|
2017
|
|
$ Change
|
|
% Change
|
|||||||
Research and development expenses:
|
|
|
|
|
|
|
|
|
|||||||
PAH
|
|
$
|
2,257
|
|
|
$
|
1,168
|
|
|
$
|
1,089
|
|
|
93
|
%
|
BCM
|
|
6
|
|
|
26
|
|
|
(20
|
)
|
|
(77
|
)%
|
|||
PH-ILD and PH-COPD
|
|
501
|
|
|
29
|
|
|
472
|
|
|
1,628
|
%
|
|||
Drug and delivery system costs
|
|
1,800
|
|
|
473
|
|
|
1,327
|
|
|
281
|
%
|
|||
Clinical programs
|
|
4,564
|
|
|
1,696
|
|
|
2,868
|
|
|
169
|
%
|
|||
Research and development infrastructure
|
|
1,493
|
|
|
1,355
|
|
|
138
|
|
|
10
|
%
|
|||
INOpulse engineering
|
|
323
|
|
|
286
|
|
|
37
|
|
|
13
|
%
|
|||
Total research and development expenses
|
|
6,380
|
|
|
3,337
|
|
|
3,043
|
|
|
91
|
%
|
|||
General and administrative expenses
|
|
2,112
|
|
|
1,446
|
|
|
666
|
|
|
46
|
%
|
|||
Total operating expenses
|
|
8,492
|
|
|
4,783
|
|
|
3,709
|
|
|
78
|
%
|
|||
Loss from operations
|
|
(8,492
|
)
|
|
(4,783
|
)
|
|
(3,709
|
)
|
|
78
|
%
|
|||
Change in fair value of common stock warrant liability
|
|
7,050
|
|
|
(14,387
|
)
|
|
21,437
|
|
|
(149
|
)%
|
|||
Interest and other income, net
|
|
99
|
|
|
27
|
|
|
72
|
|
|
267
|
%
|
|||
Pre-tax loss
|
|
(1,343
|
)
|
|
(19,143
|
)
|
|
17,800
|
|
|
(93
|
)%
|
|||
Income tax benefit
|
|
$
|
5,439
|
|
|
$
|
—
|
|
|
5,439
|
|
|
n.a.
|
|
|
Net income (loss)
|
|
$
|
4,096
|
|
|
$
|
(19,143
|
)
|
|
$
|
23,239
|
|
|
(121
|
)%
|
•
|
progress and cost of our clinical trials and other research and development activities;
|
•
|
our ability to manufacture sufficient supply of our product candidates and the costs thereof;
|
•
|
the cost and timing of seeking regulatory approvals;
|
•
|
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution for any of our product candidates for which we receive marketing approval;
|
•
|
the number and development requirements of any other product candidates we pursue;
|
•
|
our ability to enter into collaborative agreements and achieve milestones under those agreements;
|
•
|
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
|
•
|
the cost of filing, prosecuting, defending and enforcing patent applications, claims, patents and other intellectual property rights; and
|
•
|
the extent to which we acquire or in-license other products and technologies.
|
|
|
Three Months Ended
March 31, |
||||||
(Dollar amounts in thousands)
|
|
2018
|
|
2017
|
||||
Operating activities
|
|
$
|
(444
|
)
|
|
$
|
(3,657
|
)
|
Investing activities
|
|
—
|
|
|
2,458
|
|
||
Financing activities
|
|
(28
|
)
|
|
285
|
|
||
Net change in cash, cash equivalents and restricted cash
|
|
$
|
(472
|
)
|
|
$
|
(914
|
)
|
|
BELLEROPHON THERAPEUTICS, INC.
|
|
|
|
|
Date: May 10, 2018
|
By:
|
/s/ Fabian Tenenbaum
|
|
|
Fabian Tenenbaum
|
|
|
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
Date: May 10, 2018
|
By:
|
/s/ Assaf Korner
|
|
|
Assaf Korner
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
Exhibit
Number
|
|
Description
|
|
||
|
||
|
||
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
|
Date: 5/10/2018
|
By:
|
/s/ Fabian Tenenbaum
|
|
|
Fabian Tenenbaum
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
Date: 5/10/2018
|
By:
|
/s/ Assaf Korner
|
|
|
Assaf Korner
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
Date: 5/10/2018
|
By:
|
/s/ Fabian Tenenbaum
|
|
|
Fabian Tenenbaum
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
Date: 5/10/2018
|
By:
|
/s/ Assaf Korner
|
|
|
Assaf Korner
Chief Financial Officer
(Principal Financial Officer)
|