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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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, 2016 and December 31, 2015 (Unaudited)
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Condensed Consolidated Statements of Operations for the three months ended March 31, 2016 and 2015 (Unaudited)
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Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2016 and 2015 (Unaudited)
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Condensed Consolidated Statement of Changes in Stockholders’ Equity for three months ended March 31, 2016 (Unaudited)
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Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2016 and 2015 (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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As of
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As of
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||||
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March 31, 2016
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December 31, 2015
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||||
Assets
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Current assets:
|
|
|
|
|
|
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||
Cash and cash equivalents
|
|
$
|
1,270
|
|
|
$
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6,260
|
|
Marketable securities
|
|
16,088
|
|
|
17,807
|
|
||
Prepaid expenses and other current assets
|
|
5,727
|
|
|
5,385
|
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||
Total current assets
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23,085
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29,452
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||
Restricted cash, non-current
|
|
457
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457
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||
Other non-current assets
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5,985
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6,701
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||
Property and equipment, net
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1,695
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1,799
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||
Total assets
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$
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31,222
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$
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38,409
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Liabilities and Stockholders’ Equity
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|
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Current liabilities:
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|
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Accounts payable
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$
|
641
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$
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1,613
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Accrued research and development
|
|
3,487
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|
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2,825
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||
Accrued expenses
|
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3,036
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|
|
3,487
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Due to Ikaria, Inc.
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|
159
|
|
|
148
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||
Total current liabilities
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7,323
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|
|
8,073
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Total liabilities
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7,323
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8,073
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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, 13,475,196 and 13,130,800 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively
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135
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|
|
131
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|
||
Preferred stock, $0.01 par value per share; 5,000,000 share authorized, zero shares issued and outstanding at March 31, 2016 and December 31, 2015
|
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—
|
|
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—
|
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||
Additional paid-in capital
|
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131,499
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|
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130,902
|
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Accumulated other comprehensive income (loss)
|
|
2
|
|
|
(19
|
)
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||
Accumulated deficit
|
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(107,737
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)
|
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(100,678
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)
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Total stockholders’ equity
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23,899
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30,336
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Total liabilities and stockholders’ equity
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$
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31,222
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$
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38,409
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|
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Three Months Ended March 31,
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||||||
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2016
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2015
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||||
Operating expenses:
|
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|
|
|
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||
Research and development
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$
|
5,113
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|
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$
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9,520
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General and administrative
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1,976
|
|
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4,573
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Total operating expenses
|
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7,089
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14,093
|
|
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||
Other operating income
|
|
—
|
|
|
1,166
|
|
|
||
Loss from operations
|
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(7,089
|
)
|
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(12,927
|
)
|
|
||
Interest income
|
|
30
|
|
|
19
|
|
|
||
Pre-tax loss
|
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(7,059
|
)
|
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(12,908
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)
|
|
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Income tax benefit (expense)
|
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—
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|
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—
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|
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Net loss
|
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$
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(7,059
|
)
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|
$
|
(12,908
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)
|
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Weighted average shares outstanding:
|
|
|
|
|
|
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||
Basic and diluted
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13,053,007
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10,152,487
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||
Net loss per share:
|
|
|
|
|
|
|
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||
Basic and diluted
|
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$
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(0.54
|
)
|
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$
|
(1.27
|
)
|
|
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Three Months Ended March 31,
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||||||
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2016
|
|
2015
|
|
||||
Net loss
|
|
$
|
(7,059
|
)
|
|
$
|
(12,908
|
)
|
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Other comprehensive income
|
|
|
|
|
|
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|
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Unrealized gains on available-for-sale marketable securities
|
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21
|
|
|
—
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|
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||
Total other comprehensive income
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21
|
|
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—
|
|
|
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Comprehensive loss
|
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$
|
(7,038
|
)
|
|
$
|
(12,908
|
)
|
|
|
|
Common Stock
|
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Additional
|
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Accumulated
Other
Comprehensive
|
|
Accumulated
|
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Total
Stockholders’
|
|||||||||||||
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Shares
|
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Amount
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Paid in Capital
|
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Income (Loss)
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Deficit
|
|
Equity
|
|||||||||||
December 31, 2015
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|
13,130,800
|
|
|
$
|
131
|
|
|
$
|
130,902
|
|
|
$
|
(19
|
)
|
|
$
|
(100,678
|
)
|
|
$
|
30,336
|
|
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,059
|
)
|
|
(7,059
|
)
|
|||||
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
21
|
|
|
—
|
|
|
21
|
|
|||||
Stock-based compensation
|
|
344,396
|
|
|
4
|
|
|
597
|
|
|
—
|
|
|
—
|
|
|
601
|
|
|||||
March 31, 2016
|
|
13,475,196
|
|
|
$
|
135
|
|
|
$
|
131,499
|
|
|
$
|
2
|
|
|
$
|
(107,737
|
)
|
|
$
|
23,899
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||
Net loss
|
|
$
|
(7,059
|
)
|
|
$
|
(12,908
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
||
Depreciation
|
|
104
|
|
|
92
|
|
||
Stock based compensation
|
|
601
|
|
|
444
|
|
||
Accretion and amortization of discounts and premiums on marketable securities, net
|
|
15
|
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
||
Receivables due from Ikaria, Inc.
|
|
—
|
|
|
(167
|
)
|
||
Prepaid expenses and other current assets
|
|
(342
|
)
|
|
(372
|
)
|
||
Restricted cash held for Ikaria, Inc.
|
|
—
|
|
|
2,315
|
|
||
Other non-current assets
|
|
716
|
|
|
—
|
|
||
Accounts payable, accrued research and development, and accrued expenses
|
|
(739
|
)
|
|
1,397
|
|
||
Amounts due to Ikaria, Inc.
|
|
11
|
|
|
408
|
|
||
Net cash used in operating activities
|
|
(6,693
|
)
|
|
(8,791
|
)
|
||
Cash flows from investing activities:
|
|
|
|
|
|
|
||
Capital expenditures
|
|
(22
|
)
|
|
—
|
|
||
Purchase of marketable securities
|
|
—
|
|
|
—
|
|
||
Proceeds from sale of marketable securities
|
|
1,725
|
|
|
—
|
|
||
Net cash provided by investing activities
|
|
1,703
|
|
|
—
|
|
||
Cash flows from financing activities:
|
|
|
|
|
|
|
||
Proceeds from sale of membership units
|
|
—
|
|
|
1
|
|
||
Cash proceeds from issuance of common stock from initial public offering, net of issuance costs
|
|
—
|
|
|
54,910
|
|
||
Net cash provided by financing activities
|
|
—
|
|
|
54,911
|
|
||
|
|
|
|
|
||||
Net change in cash and cash equivalents
|
|
(4,990
|
)
|
|
46,120
|
|
||
Cash and cash equivalents at beginning of period
|
|
6,260
|
|
|
16,815
|
|
||
Cash and cash equivalents at end of period
|
|
$
|
1,270
|
|
|
$
|
62,935
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
||
Non-cash financing activities:
|
|
|
|
|
|
|
||
Unpaid IPO transaction costs
|
|
$
|
—
|
|
|
$
|
1,083
|
|
Non-cash investing activities:
|
|
|
|
|
|
|
||
Change in unrealized holding gains on marketable securities, net
|
|
$
|
21
|
|
|
$
|
—
|
|
•
|
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 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.
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Fair Value
|
||||
Certificates of deposit
|
8,912
|
|
|
—
|
|
|
—
|
|
|
8,912
|
|
Corporate bonds
|
4,425
|
|
|
3
|
|
|
—
|
|
|
4,428
|
|
Agency bonds
|
2,749
|
|
|
—
|
|
|
(1
|
)
|
|
2,748
|
|
Total
|
16,086
|
|
|
3
|
|
|
(1
|
)
|
|
16,088
|
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Fair Value
|
||||
Certificates of deposit
|
10,140
|
|
|
—
|
|
|
—
|
|
|
10,140
|
|
Corporate bonds
|
4,938
|
|
|
—
|
|
|
(11
|
)
|
|
4,927
|
|
Agency bonds
|
2,748
|
|
|
—
|
|
|
(8
|
)
|
|
2,740
|
|
Total
|
17,826
|
|
|
—
|
|
|
(19
|
)
|
|
17,807
|
|
|
March 31, 2016
|
|
December 31, 2015
|
||
Due within one year
|
11,471
|
|
|
10,230
|
|
Due after one year through two years
|
4,617
|
|
|
7,577
|
|
|
16,088
|
|
|
17,807
|
|
|
|
Three Months Ended March 31, 2016
|
|
Three Months Ended March 31, 2015
|
||
Valuation assumptions:
|
|
|
|
|
|
|
Risk-free rate
|
|
1.38
|
%
|
|
1.71
|
%
|
Expected volatility
|
|
81.58
|
%
|
|
80.81
|
%
|
Expected term (years)
|
|
6.2
|
|
|
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, 2015
|
|
705,180
|
|
|
$
|
4.12
|
|
-
|
13.28
|
|
|
$
|
12.08
|
|
|
8.7
|
Granted
|
|
155,000
|
|
|
2.21
|
|
-
|
2.30
|
|
|
2.29
|
|
|
|
||
Exercised
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|||
Forfeited
|
|
(20,504
|
)
|
|
10.22
|
|
-
|
13.28
|
|
|
11.52
|
|
|
|
||
Options outstanding as of March 31, 2016
|
|
839,676
|
|
|
$
|
2.21
|
|
-
|
13.28
|
|
|
$
|
10.29
|
|
|
8.7
|
Options vested and exercisable as of March 31, 2016
|
|
240,204
|
|
|
$
|
10.22
|
|
-
|
13.28
|
|
|
$
|
12.76
|
|
|
8.4
|
|
|
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, 2015
|
|
77,793
|
|
|
$
|
3.99
|
|
|
$
|
0.3
|
|
|
0.7
|
Granted
|
|
364,025
|
|
|
2.55
|
|
|
0.9
|
|
|
|
||
Forfeited
|
|
(19,629
|
)
|
|
3.59
|
|
|
—
|
|
|
|
||
Restricted stock outstanding as of March 31, 2016
|
|
422,189
|
|
|
$
|
2.77
|
|
|
$
|
1.2
|
|
|
0.6
|
|
|
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, 2015
|
|
113,709
|
|
|
$
|
0.26
|
|
-
|
17.92
|
|
$
|
8.93
|
|
|
5.2
|
Exercised
|
|
—
|
|
|
|
|
|
|
|
||||||
Forfeited
|
|
(7,222
|
)
|
|
0.26
|
-
|
8.65
|
|
4.65
|
|
|
|
|||
Options outstanding as of March 31, 2016
|
|
106,487
|
|
|
$
|
7.77
|
|
-
|
17.92
|
|
$
|
9.22
|
|
|
5.0
|
Options vested and exercisable as of March 31, 2016
|
|
106,487
|
|
|
$
|
7.77
|
|
-
|
17.92
|
|
$
|
9.22
|
|
|
5.0
|
|
|
Three Months Ended March 31,
|
|
||||||
(in thousands)
|
|
2016
|
|
2015
|
|
||||
Research and development
|
|
$
|
216
|
|
|
$
|
165
|
|
|
General and administrative
|
|
385
|
|
|
279
|
|
|
||
Total expense
|
|
$
|
601
|
|
|
$
|
444
|
|
|
|
|
Three Months Ended March, 31
|
|
||
(in millions)
|
|
2015
|
|
||
Expense in connection with the TSA
|
|
$
|
2.3
|
|
|
Other operating income in connection with the 2015 Services Agreement
|
|
(1.2
|
)
|
|
|
Expense in connection with the 2015 Services Agreement
|
|
0.1
|
|
|
|
|
|
|
|
(Dollar amounts in thousands)
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||
Marketable securities
|
|
—
|
|
|
$
|
16,088
|
|
|
—
|
|
|
$
|
16,088
|
|
(Dollar amounts in thousands)
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||
Marketable securities
|
|
—
|
|
|
$
|
17,807
|
|
|
—
|
|
|
$
|
17,807
|
|
|
Amounts
|
||
|
(in thousands)
|
||
Accrual balance at December 31, 2015
|
$
|
969
|
|
Cash payments
|
(160
|
)
|
|
Accrual balance at March 31, 2016 (a)
|
$
|
809
|
|
|
|
Three Months Ended March 31,
|
|
|
|
|
|||||||||
(Dollar amounts in thousands)
|
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
Research and development expenses:
|
|
|
|
|
|
|
|
|
|||||||
BCM
|
|
$
|
320
|
|
|
$
|
2,834
|
|
|
$
|
(2,514
|
)
|
|
(89
|
)%
|
PAH
|
|
3,029
|
|
|
2,930
|
|
|
99
|
|
|
3
|
%
|
|||
PH-COPD and PH-IPF
|
|
14
|
|
|
30
|
|
|
(16
|
)
|
|
(53
|
)%
|
|||
Clinical programs
|
|
3,363
|
|
|
5,794
|
|
|
(2,431
|
)
|
|
(42
|
)%
|
|||
Research and development infrastructure
|
|
1,018
|
|
|
2,507
|
|
|
(1,489
|
)
|
|
(59
|
)%
|
|||
INOpulse engineering
|
|
732
|
|
|
1,219
|
|
|
(487
|
)
|
|
(40
|
)%
|
|||
Total research and development expenses
|
|
5,113
|
|
|
9,520
|
|
|
(4,407
|
)
|
|
(46
|
)%
|
|||
General and administrative expenses
|
|
1,976
|
|
|
4,573
|
|
|
(2,597
|
)
|
|
(57
|
)%
|
|||
Total operating expenses
|
|
7,089
|
|
|
14,093
|
|
|
(7,004
|
)
|
|
(50
|
)%
|
|||
Other operating income
|
|
—
|
|
|
(1,166
|
)
|
|
1,166
|
|
|
(100
|
)%
|
|||
Loss from operations
|
|
(7,089
|
)
|
|
(12,927
|
)
|
|
5,838
|
|
|
(45
|
)%
|
|||
Interest income
|
|
(30
|
)
|
|
(19
|
)
|
|
(11
|
)
|
|
58
|
%
|
|||
Net loss
|
|
$
|
(7,059
|
)
|
|
$
|
(12,908
|
)
|
|
$
|
5,849
|
|
|
(45
|
)%
|
•
|
the timing, progress and results of our ongoing and planned clinical trials of INOpulse for PAH, PH-COPD and PH-IPF;
|
•
|
our ability to manufacture sufficient supply of our product candidates and the costs thereof;
|
•
|
discussions with regulatory agencies regarding the design and conduct of our clinical trials and the costs, timing and outcome of regulatory review of our product candidates;
|
•
|
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 costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and
|
•
|
the extent to which we acquire or in-license other products and technologies.
|
|
|
Three Months Ended March 31,
|
||||||
(Dollar amounts in thousands)
|
|
2016
|
|
2015
|
||||
Operating activities
|
|
$
|
(6,693
|
)
|
|
$
|
(8,791
|
)
|
Investing activities
|
|
1,703
|
|
|
—
|
|
||
Financing activities
|
|
—
|
|
|
54,911
|
|
||
Net change in cash and cash equivalents
|
|
$
|
(4,990
|
)
|
|
$
|
46,120
|
|
|
BELLEROPHON THERAPEUTICS, INC.
|
|
|
|
|
Date: May 10, 2016
|
By:
|
/s/ Jonathan M. Peacock
|
|
|
Jonathan M. Peacock
|
|
|
Chairman, President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
Date: May 10, 2016
|
By:
|
/s/ Fabian Tenenbaum
|
|
|
Fabian Tenenbaum
|
|
|
Chief Financial Officer and Chief Business Officer (Principal Financial and Accounting Officer)
|
Exhibit
Number
|
|
Description
|
|
10.1
+
|
|
|
Retention Letter by and between the Registrant and Parag Shah dated September 21, 2015
|
31.1
|
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended
|
31.2
|
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended
|
32
|
|
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
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
|
Acknowledged by:
|
/s/ Parag Shah
|
|
21-Sept-2015
|
|
Employee Signature
|
|
Date
|
Date: May 10, 2016
|
By:
|
/s/ Jonathan M. Peacock
|
|
|
Jonathan M. Peacock
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
Date: May 10, 2016
|
By:
|
/s/ Fabian Tenenbaum
|
|
|
Fabian Tenenbaum
|
|
|
Chief Financial Officer and Chief Business Officer
|
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
Date: May 10, 2016
|
By:
|
/s/ Jonathan M. Peacock
|
|
|
Jonathan M. Peacock
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
Date: May 10, 2016
|
By:
|
/s/ Fabian Tenenbaum
|
|
|
Fabian Tenenbaum
Chief Financial Officer and Chief Business Officer
(Principal Financial Officer)
|