Delaware | 47-3116175 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
184 Liberty Corner Road, Suite 302 Warren, New Jersey (Address of principal executive offices) | 07059 (Zip Code) |
Large accelerated filer | o | Accelerated filer | o | |||
Non-accelerated filer | o | (Do not check if a smaller reporting company) | Smaller reporting company | ý | ||
Emerging growth company | ý |
Page No. | ||
PART I. FINANCIAL INFORMATION | ||
Item 1. | Financial Statements | |
Condensed Consolidated Balance Sheets as of September 30, 2017 and December 31, 2016 (Unaudited) | ||
Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2017 and 2016 (Unaudited) | ||
Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2017 and 2016 (Unaudited) | ||
Condensed Consolidated Statement of Changes in Stockholders’ Equity for the nine months ended September 30, 2017 (Unaudited) | ||
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2017 and 2016 (Unaudited) | ||
Notes to Condensed Consolidated Financial Statements (Unaudited) | ||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | |
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | |
Item 4. | Controls and Procedures | |
PART II. OTHER INFORMATION | ||
Item 1. | Legal Proceedings | |
Item 1A. | Risk Factors | |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | |
Item 3. | Defaults Upon Senior Securities | |
Item 4. | Mine Safety Disclosures | |
Item 5. | Other Information | |
Item 6. | Exhibits | |
Signatures |
• | 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; |
• | our ability to obtain adequate financing to meet our future operational and capital needs; |
• | 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; |
• | our ability to comply with government laws and regulations; |
• | our commercialization, marketing and manufacturing capabilities and strategy; |
• | our estimates regarding the potential market opportunity for our product candidates; |
• | the timing of or our ability to enter into partnerships to market and commercialize our product candidates; |
• | the rate and degree of market acceptance of any product candidate for which we receive marketing approval; |
• | our intellectual property position; |
• | our estimates regarding expenses, future revenues, capital requirements and needs for additional funding; |
• | the success of competing treatments; |
• | our competitive position; and |
• | our expectations regarding the time during which we will be an “emerging growth company” under the Jumpstart Our Business Startups Act of 2012. |
As of | As of | |||||||
September 30, 2017 | December 31, 2016 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 32,283 | $ | 14,453 | ||||
Restricted cash | — | 150 | ||||||
Marketable securities | 3,178 | 5,571 | ||||||
Prepaid expenses and other current assets | 3,934 | 6,331 | ||||||
Total current assets | 39,395 | 26,505 | ||||||
Restricted cash, non-current | 300 | 307 | ||||||
Other non-current assets | 59 | 1,491 | ||||||
Property and equipment, net | 1,116 | 1,399 | ||||||
Total assets | $ | 40,870 | $ | 29,702 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,755 | $ | 2,807 | ||||
Accrued research and development | 1,873 | 2,573 | ||||||
Accrued expenses | 1,784 | 1,115 | ||||||
Total current liabilities | 6,412 | 6,495 | ||||||
Common stock warrant liability | 18,784 | 5,215 | ||||||
Total liabilities | 25,196 | 11,710 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Common stock, $0.01 par value per share; 125,000,000 shares authorized, 54,960,068 and 31,702,624 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | 550 | 317 | ||||||
Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at September 30, 2017 and December 31, 2016 | — | — | ||||||
Additional paid-in capital | 170,275 | 142,167 | ||||||
Accumulated other comprehensive income (loss) | — | — | ||||||
Accumulated deficit | (155,151 | ) | (124,492 | ) | ||||
Total stockholders’ equity | 15,674 | 17,992 | ||||||
Total liabilities and stockholders’ equity | $ | 40,870 | $ | 29,702 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 4,438 | $ | 2,472 | $ | 12,464 | $ | 11,539 | |||||||||
General and administrative | 1,746 | 1,745 | 4,826 | 4,926 | |||||||||||||
Total operating expenses | 6,184 | 4,217 | 17,290 | 16,465 | |||||||||||||
Loss from operations | (6,184 | ) | (4,217 | ) | (17,290 | ) | (16,465 | ) | |||||||||
Change in fair value of common stock warrant liability | (1,435 | ) | — | (13,455 | ) | — | |||||||||||
Interest and other income, net | 33 | 22 | 86 | 74 | |||||||||||||
Pre-tax loss | (7,586 | ) | (4,195 | ) | (30,659 | ) | (16,391 | ) | |||||||||
Income tax benefit (expense) | — | — | — | — | |||||||||||||
Net loss | $ | (7,586 | ) | $ | (4,195 | ) | $ | (30,659 | ) | $ | (16,391 | ) | |||||
Weighted average shares outstanding: | |||||||||||||||||
Basic and diluted | 34,989,831 | 13,854,188 | 33,505,444 | 13,335,358 | |||||||||||||
Net loss per share: | |||||||||||||||||
Basic and diluted | $ | (0.22 | ) | $ | (0.30 | ) | $ | (0.92 | ) | $ | (1.23 | ) |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||
Net loss | $ | (7,586 | ) | $ | (4,195 | ) | $ | (30,659 | ) | $ | (16,391 | ) | |||||
Other comprehensive income | |||||||||||||||||
Unrealized (losses) gains on available-for-sale marketable securities | — | (3 | ) | — | 18 | ||||||||||||
Total other comprehensive (loss) income | — | (3 | ) | — | 18 | ||||||||||||
Comprehensive loss | $ | (7,586 | ) | $ | (4,198 | ) | $ | (30,659 | ) | $ | (16,373 | ) |
Common Stock | Additional | Accumulated Other Comprehensive | Accumulated | Total Stockholders’ | |||||||||||||||||||
Shares | Amount | Paid in Capital | Income (Loss) | Deficit | Equity | ||||||||||||||||||
December 31, 2016 | 31,702,624 | $ | 317 | $ | 142,167 | $ | — | $ | (124,492 | ) | $ | 17,992 | |||||||||||
Net loss | — | — | — | — | (30,659 | ) | (30,659 | ) | |||||||||||||||
Other comprehensive income | — | — | — | — | — | — | |||||||||||||||||
Sale of common stock and warrants in PIPE Offering, net of offering expenses of $677 | 19,449,834 | 195 | 22,565 | — | — | 22,760 | |||||||||||||||||
Sale of common stock in Direct Offering, net of offering expenses of $187 | 2,000,000 | 20 | 1,675 | — | — | 1,695 | |||||||||||||||||
Warrant exercises | 934,300 | 9 | 1,743 | — | — | 1,752 | |||||||||||||||||
Stock-based compensation | 873,310 | 9 | 2,125 | — | — | 2,134 | |||||||||||||||||
September 30, 2017 | 54,960,068 | $ | 550 | $ | 170,275 | $ | — | $ | (155,151 | ) | $ | 15,674 |
Nine Months Ended September 30, | ||||||||
2017 | 2016 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (30,659 | ) | $ | (16,391 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Change in fair value of common stock warrant liability | 13,455 | — | ||||||
Stock based compensation | 2,134 | 2,148 | ||||||
Depreciation | 283 | 301 | ||||||
Issuance costs attributable to common stock warrant liability | 111 | — | ||||||
Accretion and amortization of discounts and premiums on marketable securities, net | — | 29 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other current assets | 2,397 | (980 | ) | |||||
Restricted cash held as security deposit | 157 | — | ||||||
Other non-current assets | 1,432 | 3,397 | ||||||
Accounts payable, accrued research and development, and accrued expenses | (552 | ) | (3,298 | ) | ||||
Net cash used in operating activities | (11,242 | ) | (14,794 | ) | ||||
Cash flows from investing activities: | ||||||||
Capital expenditures | — | (22 | ) | |||||
Purchase of marketable securities | (2,982 | ) | — | |||||
Proceeds from sale of marketable securities | 5,375 | 10,566 | ||||||
Net cash provided by investing activities | 2,393 | 10,544 | ||||||
Cash flows from financing activities: | ||||||||
Proceeds from sale of Units in PIPE Offering | 23,437 | — | ||||||
Proceeds from sale of Units in Direct Offering, net of commissions and offering expenses | 2,730 | — | ||||||
Proceeds received from exercise of warrants | 747 | — | ||||||
Proceeds from sale of common stock in ATM Offering, net of commissions and offering expenses | — | 2,048 | ||||||
Tax withholding payments for stock compensation | — | (128 | ) | |||||
Payment of offering expenses related to the 2016 secondary offering | (235 | ) | — | |||||
Net cash provided by financing activities | 26,679 | 1,920 | ||||||
Net change in cash and cash equivalents | 17,830 | (2,330 | ) | |||||
Cash and cash equivalents at beginning of period | 14,453 | 6,260 | ||||||
Cash and cash equivalents at end of period | $ | 32,283 | $ | 3,930 | ||||
Non-cash financing activities: | ||||||||
Conversion of warrant liability to common stock upon exercise of warrants | $ | 1,005 | $ | — | ||||
Unpaid expenses related to offerings | $ | 720 | $ | 35 | ||||
Non-cash investing activities: | ||||||||
Change in unrealized holding gains on marketable securities, net | $ | — | $ | 18 |
• | 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. |
September 30, 2017 | December 31, 2016 | ||||
Prepaid expenses and other current assets | 3,163 | 5,842 | |||
Other non-current assets | — | 1,406 | |||
3,163 | 7,248 |
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||
Certificates of deposit | 1,677 | — | — | 1,677 | |||||||
Agency bonds | 1,501 | — | — | 1,501 | |||||||
Total | 3,178 | — | — | 3,178 |
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||
Certificates of deposit | 3,619 | — | — | 3,619 | |||||||
Corporate bonds | 1,952 | — | — | 1,952 | |||||||
Total | 5,571 | — | — | 5,571 |
September 30, 2017 | December 31, 2016 | ||||
Due within one year | 3,178 | 5,571 | |||
Due after one year | — | — | |||
3,178 | 5,571 |
Equity Classified | Liability Classified | |||||||||
Warrants | Warrants | Estimated Fair Value | ||||||||
Beginning balance | — | 17,142,858 | $ | 5,215 | ||||||
Exercises | — | (934,300 | ) | (1,005 | ) | |||||
Additions | 19,449,834 | 1,060,000 | 1,119 | |||||||
Change in fair value of common stock warrant liability recognized in consolidated statement of operations | — | — | 13,455 | |||||||
Ending balance | 19,449,834 | 17,268,558 | $ | 18,784 |
• | 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 | $ | — | $ | 3,178 | $ | — | $ | 3,178 | ||||||||
Common stock warrant liability | — | — | 18,784 | 18,784 |
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Marketable securities | $ | — | $ | 5,571 | $ | — | $ | 5,571 | ||||||||
Common stock warrant liabilities | — | — | 5,215 | 5,215 |
September 30, 2017 | December 31, 2016 | ||||
Valuation assumptions: | |||||
Risk-free interest rate | 1.79 | % | 1.91 | % | |
Expected volatility | 95.80 | % | 83.73 | % | |
Expected term (in years) | 4.2 | 4.9 | |||
Dividend yield | — | % | — | % |
September 30, 2017 | |||
Opening balance (a) | $ | 110 | |
Cash payments | (110 | ) | |
Ending balance | $ | — |
Nine Months Ended September 30, 2017 | Nine Months Ended September 30, 2016 | ||||
Valuation assumptions: | |||||
Risk-free rate | 1.98 | % | 1.34 | % | |
Expected volatility | 90.98 | % | 81.80 | % | |
Expected term (years) | 6.0 | 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, 2016 | 3,189,881 | $ | 0.49 | - | 13.28 | $ | 3.08 | 9.4 | |||||||
Granted | 80,800 | 1.12 | - | 1.38 | 1.12 | ||||||||||
Forfeited | (20,900 | ) | 0.49 | - | 12.00 | 1.58 | |||||||||
Options outstanding as of September 30, 2017 | 3,249,781 | $ | 0.49 | - | 13.28 | $ | 3.04 | 8.7 | |||||||
Options vested and exercisable as of September 30, 2017 | 540,908 | $ | 1.40 | - | 13.28 | $ | 11.19 | 7.0 |
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, 2016 | 155,846 | $ | 2.05 | $ | 0.3 | 0.0 | |||||||
Granted | 873,310 | 1.45 | 1.3 | ||||||||||
Vested | (374,981 | ) | (1.70 | ) | (0.6 | ) | |||||||
Restricted stock outstanding as of September 30, 2017 | 654,175 | $ | 1.45 | $ | 0.9 | 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, 2016 | 87,369 | $ | 7.77 | - | 17.92 | $ | 9.14 | 4.3 | |||||||
Forfeited | (10,530 | ) | 7.77 | - | 14.91 | 8.88 | |||||||||
Options outstanding as of September 30, 2017 | 76,839 | $ | 7.77 | - | 17.92 | $ | 9.17 | 4.0 | |||||||
Options vested and exercisable as of September 30, 2017 | 76,839 | $ | 7.77 | - | 17.92 | $ | 9.17 | 4.0 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||
Research and development | $ | 188 | $ | 203 | $ | 661 | $ | 656 | |||||||||
General and administrative | 568 | 576 | 1,473 | 1,492 | |||||||||||||
Total expense | $ | 756 | $ | 779 | $ | 2,134 | $ | 2,148 |
• | 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 September 30, | |||||||||||||||
(Dollar amounts in thousands) | 2017 | 2016 | $ Change | % Change | |||||||||||
Research and development expenses: | |||||||||||||||
PAH | $ | 1,705 | $ | 475 | $ | 1,230 | 259 | % | |||||||
BCM | 7 | 16 | (9 | ) | (56 | )% | |||||||||
PH-COPD and PH-ILD | 48 | 11 | 37 | 336 | % | ||||||||||
Drug and delivery system costs | 1,174 | 381 | 793 | 208 | % | ||||||||||
Clinical programs | 2,934 | 883 | 2,051 | 232 | % | ||||||||||
Research and development infrastructure | 1,232 | 1,106 | 126 | 11 | % | ||||||||||
INOpulse engineering | 272 | 483 | (211 | ) | (44 | )% | |||||||||
Total research and development expenses | 4,438 | 2,472 | 1,966 | 80 | % | ||||||||||
General and administrative expenses | 1,746 | 1,745 | 1 | — | % | ||||||||||
Total operating expenses | 6,184 | 4,217 | 1,967 | 47 | % | ||||||||||
Loss from operations | (6,184 | ) | (4,217 | ) | (1,967 | ) | 47 | % | |||||||
Change in fair value of common stock warrant liability | (1,435 | ) | — | (1,435 | ) | n.a. | |||||||||
Interest and other income, net | 33 | 22 | 11 | 50 | % | ||||||||||
Net loss | $ | (7,586 | ) | $ | (4,195 | ) | $ | (3,391 | ) | 81 | % |
Nine Months Ended September 30, | |||||||||||||||
(Dollar amounts in thousands) | 2017 | 2016 | $ Change | % Change | |||||||||||
Research and development expenses: | |||||||||||||||
PAH | $ | 4,333 | $ | 4,647 | $ | (314 | ) | (7 | )% | ||||||
BCM | 46 | 371 | (325 | ) | (88 | )% | |||||||||
PH-COPD and PH-ILD | 85 | 65 | 20 | 31 | % | ||||||||||
Drug and delivery system costs | 3,423 | 1,620 | 1,803 | 111 | % | ||||||||||
Clinical programs | 7,887 | 6,703 | 1,184 | 18 | % | ||||||||||
Research and development infrastructure | 3,766 | 3,346 | 420 | 13 | % | ||||||||||
INOpulse engineering | 811 | 1,490 | (679 | ) | (46 | )% | |||||||||
Total research and development expenses | 12,464 | 11,539 | 925 | 8 | % | ||||||||||
General and administrative expenses | 4,826 | 4,926 | (100 | ) | (2 | )% | |||||||||
Total operating expenses | 17,290 | 16,465 | 825 | 5 | % | ||||||||||
Loss from operations | (17,290 | ) | (16,465 | ) | (825 | ) | 5 | % | |||||||
Change in fair value of common stock warrant liability | (13,455 | ) | — | (13,455 | ) | n.a. | |||||||||
Interest and other income, net | 86 | 74 | 12 | 16 | % | ||||||||||
Net loss | $ | (30,659 | ) | $ | (16,391 | ) | $ | (14,268 | ) | 87 | % |
• | 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. |
Nine Months Ended September 30, | ||||||||
(Dollar amounts in thousands) | 2017 | 2016 | ||||||
Operating activities | $ | (11,242 | ) | $ | (14,794 | ) | ||
Investing activities | 2,393 | 10,544 | ||||||
Financing activities | 26,679 | 1,920 | ||||||
Net change in cash and cash equivalents | $ | 17,830 | $ | (2,330 | ) |
BELLEROPHON THERAPEUTICS, INC. | ||
Date: 11/7/2017 | By: | /s/ Fabian Tenenbaum |
Fabian Tenenbaum | ||
Chief Executive Officer (Principal Executive Officer) | ||
Date: 11/7/2017 | By: | /s/ Megan Schoeps |
Megan Schoeps | ||
Controller (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: 11/7/2017 | By: | /s/ Fabian Tenenbaum |
Fabian Tenenbaum | ||
Chief Executive Officer | ||
(Principal Executive Officer) |
Date: 11/7/2017 | By: | /s/ Megan Schoeps |
Megan Schoeps | ||
Controller | ||
(Principal Financial Officer) |
Date: 11/7/2017 | By: | /s/ Fabian Tenenbaum |
Fabian Tenenbaum Chief Executive Officer (Principal Executive Officer) |
Date: 11/7/2017 | By: | /s/ Megan Schoeps |
Megan Schoeps Controller (Principal Financial Officer) |
Document and Entity Information - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2017 |
Nov. 01, 2017 |
|
Document and Entity Information | ||
Entity Registrant Name | Bellerophon Therapeutics, Inc. | |
Entity Central Index Key | 0001600132 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 55,179,788 | |
Document Fiscal Year Focus | 2017 | |
Document Fiscal Period Focus | Q3 |
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Sep. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 |
Common stock, shares issued (in shares) | 54,960,068 | 31,702,624 |
Common stock, shares outstanding (in shares) | 31,702,624 | |
Preferred tock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
Operating expenses: | ||||
Research and development | $ 4,438 | $ 2,472 | $ 12,464 | $ 11,539 |
General and administrative | 1,746 | 1,745 | 4,826 | 4,926 |
Total operating expenses | 6,184 | 4,217 | 17,290 | 16,465 |
Loss from operations | (6,184) | (4,217) | (17,290) | (16,465) |
Fair Value Adjustment of Warrants | (1,435) | 0 | (13,455) | 0 |
Interest and other income | 33 | 22 | 86 | 74 |
Pre-tax loss | (7,586) | (4,195) | (30,659) | (16,391) |
Income tax benefit (expense) | 0 | 0 | 0 | 0 |
Net loss | $ (7,586) | $ (4,195) | $ (30,659) | $ (16,391) |
Weighted average shares outstanding: | ||||
Basic and diluted (in shares) | 34,989,831 | 13,854,188 | 33,505,444 | 13,335,358 |
Net loss per share: | ||||
Basic and diluted (in dollars per share) | $ (0.22) | $ (0.30) | $ (0.92) | $ (1.23) |
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (7,586) | $ (4,195) | $ (30,659) | $ (16,391) |
Other comprehensive income | ||||
Unrealized gains on available-for-sale marketable securities | 0 | (3) | 0 | 18 |
Total other comprehensive income, net of tax | 0 | (3) | 0 | 18 |
Comprehensive loss | $ (7,586) | $ (4,198) | $ (30,659) | $ (16,373) |
Condensed Consolidated Statements of Changes in Stockholders'/Members Equity - 9 months ended Sep. 30, 2017 - USD ($) $ in Thousands |
Total |
Common Stock |
Additional Paid in Capital |
Accumulated Other Comprehensive Income (Loss) |
Accumulated Deficit |
PIPE Offering [Member] |
PIPE Offering [Member]
Common Stock
|
PIPE Offering [Member]
Additional Paid in Capital
|
Direct Offering [Member] |
Direct Offering [Member]
Common Stock
|
Direct Offering [Member]
Additional Paid in Capital
|
Warrant [Member] |
Warrant [Member]
Common Stock
|
Warrant [Member]
Additional Paid in Capital
|
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Balance at beginning of period at Dec. 31, 2016 | $ 17,992 | $ 317 | $ 142,167 | $ 0 | $ (124,492) | |||||||||
Balance at beginning of period (in shares) at Dec. 31, 2016 | 31,702,624 | 31,702,624 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Net loss | $ (30,659) | |||||||||||||
Other comprehensive income | 0 | |||||||||||||
Stock Issued During Period, Shares, New Issues | 19,449,834 | 2,000,000 | 934,300 | |||||||||||
Stock Issued During Period, Value, New Issues | $ 22,760 | $ 195 | $ 22,565 | $ 1,695 | $ 20 | $ 1,675 | $ 1,752 | $ 9 | $ 1,743 | |||||
Stock Issued During Period, Value, New Issues | $ 677 | $ 187 | ||||||||||||
Stock-based compensation | $ 9 | 2,125 | ||||||||||||
Stock-based compensation (in shares) | 873,310 | |||||||||||||
Balance at end of period at Sep. 30, 2017 | $ 15,674 | $ 550 | $ 170,275 | $ 0 | $ (155,151) | |||||||||
Balance at end of period (in shares) at Sep. 30, 2017 | 54,960,068 |
Organization and Nature of the Business |
9 Months Ended | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||
Organization and Nature of the Business | Organization and Nature of the Business Bellerophon Therapeutics, Inc., or the Company, is a clinical-stage therapeutics company focused on developing innovative products at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The focus of the Company’s clinical program is the continued development of its nitric oxide therapy for patients with pulmonary hypertension, or PH, using its proprietary delivery system, INOpulse, with pulmonary arterial hypertension, or PAH, representing the lead indication. The Company has three wholly-owned subsidiaries: Bellerophon BCM LLC, a Delaware limited liability company; Bellerophon Pulse Technologies LLC, a Delaware limited liability company; and Bellerophon Services, Inc., a Delaware corporation. The Company’s business is subject to significant risks and uncertainties, including but not limited to:
|
Liquidity |
9 Months Ended | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||
Liquidity | |||||||||||||||||||||||||||||||||||||
Liquidity | (3) Liquidity In the course of its development activities, the Company has sustained operating losses and expects such losses to continue over the next several years. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it continues the development and clinical trials of, and seeks regulatory approval for, its product candidates. The Company's primary uses of capital are, and it expects will continue to be, compensation and related expenses, third-party clinical research and development services, contract manufacturing services, laboratory and related supplies, clinical costs, legal and other regulatory expenses and general overhead costs. The Company had cash and cash equivalents of $32.3 million and marketable securities of $3.2 million as of September 30, 2017. The Company's existing cash and cash equivalents and marketable securities as of September 30, 2017 will be used primarily to fund the first of two INOpulse for PAH Phase 3 trials, a portion of the second of two INOpulse for PAH Phase 3 trials, and a Phase 2b trial of INOpulse for PH-ILD. In addition, as of September 30, 2017, the Company had $3.2 million prepayments of research and development expenses related to its amended drug supply agreement with Ikaria, Inc. (a subsidiary of Mallinckrodt plc), or Ikaria and the clinical research organization it has partnered with for the first of the two Phase 3 clinical trials for INOpulse for PAH. The corresponding prepayments balance as of December 31, 2016 was $7.2 million. These prepayment amounts are presented on the respective consolidated balance sheets as follows (in thousands):
On May 5, 2016, the Company filed a shelf registration statement with the SEC on Form S-3, which as amended became effective on May 23, 2016. The shelf registration will allow the Company to issue, from time to time at prices and on terms to be determined prior to the time of any such offering, up to $30.0 million of any combination of the Company’s common stock, preferred stock, debt securities, warrants, rights, purchase contracts or units, either individually or in units. As of September 30, 2017, the Company had sold 1,025,793 shares of its common stock for gross and net proceeds of $2.2 million and $2.1 million, respectively, under the Company’s effective shelf registration statement on Form S-3 and the related prospectus supplement dated May 27, 2016 and filed with the SEC on May 27, 2016. On October 25, 2016, the Company filed a registration statement on Form S-1 with the SEC, which as amended became effective on November 22, 2016. On November 29, 2016, the Company completed the sale of 17,142,858 Class A Units consisting of an aggregate of 17,142,858 shares of its common stock and warrants exercisable for up to 17,142,858 shares of its common stock at a price of $0.70 per Unit, or the Secondary Offering, resulting in net proceeds of $10.9 million, after deducting placement fees of $0.8 million and offering costs of $0.3 million. Each warrant has an exercise price per full share of common stock equal to $0.80, is immediately exercisable and expires five years from the date on which such warrant becomes exercisable. The warrants require cash settlement by the Company under certain situations. During the nine months ended September 30, 2017, the Company received proceeds of $0.7 million for the exercise of 934,300 warrants. Refer to Note 5 - Common Stock Warrant Liability for further details on the warrants. On May 9, 2017, the Company entered into a Securities Purchase Agreement, or the Purchase Agreement, with a single institutional investor, or the investor, for the sale of 2,000,000 shares of its common stock at a purchase price of $1.50 per share and warrants to purchase up to an aggregate of 1,000,000 shares of its common stock, or the Direct Offering. The warrants will be initially exercisable commencing six months from the issuance date at an exercise price equal to $1.50 per full share of common stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date. In addition, the Company issued the placement agent of the Direct Offering, warrants to purchase up to 60,000 shares. The placement agent warrants have substantially the same terms as the warrants issued to the investor, except that the placement agent warrants have an exercise price equal to $1.875 and will be exercisable for five years from the date of the closing of this offering. The closing of the sales of these securities under the Purchase Agreement occurred on May 15, 2017. The aggregate gross and net proceeds for the Direct Offering were $3.0 million and $2.7 million, respectively. On September 26, 2017, the Company entered into a Securities Purchase Agreement, or the PIPE Purchase Agreement, pursuant to which the Company sold an aggregate of 19,449,834 shares of its common stock at a purchase price of $1.205 per share and warrants to purchase up to an aggregate of 19,449,834 shares of its common stock, or the PIPE Offering. The warrants will be initially exercisable commencing six months from the issuance date at an exercise price equal to $1.2420 per full share of common stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date. The closing of the sales of these securities under the PIPE Purchase Agreement occurred on September 29, 2017. The aggregate gross and net proceeds for the PIPE Offering were $23.4 million and $22.8 million, respectively. In connection with the PIPE Offering, the Company entered into a Registration Rights Agreement, pursuant to which the Company timely filed a registration statement on Form S-3 declared effective by the SEC on November 6, 2017 and is obligated to maintain the registration until all registrable securities may be sold pursuant to Rule 144 under the Securities Act, without restriction as to volume. The Registration Rights Agreement provides for cash penalties of up to 3% of the gross proceeds of the PIPE Offering for the Company’s failure to satisfy specified filing and effectiveness time periods. As of September 30, 2017, no liability had been recorded under the Registration Rights Agreement. The Company evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year beyond the filing of this Quarterly Report on Form 10-Q. Based on such evaluation, management believes that, following the closing of the PIPE Offering in September 2017, substantial doubt about the Company’s ability to continue as a going concern has been alleviated and the Company's existing cash and cash equivalents and marketable securities as of September 30, 2017 will be sufficient to satisfy the Company's operating cash needs for at least one year after the filing of this Quarterly Report on Form 10-Q. In addition, the Company expects to have proceeds that become available upon the sale of the Company's state net operating losses, or NOLs, and R&D tax credits under the State of New Jersey's Technology Business Tax Certificate Transfer Program. The Company’s estimates and assumptions may prove to be wrong, and the Company may exhaust its capital resources sooner than expected. The process of testing product candidates in clinical trials is costly, and the timing of progress in clinical trials is uncertain. Because the Company’s product candidates are in clinical development and the outcome of these efforts is uncertain, the Company may not be able to accurately estimate the actual amounts that will be necessary to successfully complete the development and commercialization, if approved, of its product candidates or whether, or when, the Company may achieve profitability. Until such time, if ever, as the Company can generate substantial product revenues, its expects to finance its cash needs through a combination of equity and debt offerings, existing working capital and funding from potential future collaboration arrangements. To the extent that the Company raises additional capital through the future sale of equity or debt, the ownership interest of its existing stockholders will be diluted, and the terms of such securities may include liquidation or other preferences or rights such as anti-dilution rights that adversely affect the rights of the Company's existing stockholders. If the Company raises additional funds through strategic partnerships in the future, it may have to relinquish valuable rights to its technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to it. If the Company is unable to raise additional funds through equity or debt financings when needed, it may be required to delay, limit, reduce or terminate its product development or future commercialization efforts or grant rights to develop and market product candidates that it would otherwise prefer to develop and market itself. In addition, the timing of when existing and new capital resources are used and received may not align with the period of time evaluated by management for going concern purposes such that management may be required to conclude that substantial doubt about the Company’s ability to continue as a going concern in accordance with relevant accounting guidance may exist in future periods. |
Marketable Securities |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Marketable Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Marketable Securities | Marketable Securities The Company considers all of its investments to be available-for-sale. Marketable securities as of September 30, 2017 consist of the following (in thousands):
Marketable securities as of December 31, 2016, consist of the following (in thousands):
Maturities of marketable securities classified as available-for-sale were as follows at September 30, 2017 and December 31, 2016 (in thousands):
|
Income Taxes |
9 Months Ended |
---|---|
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (9) Income Taxes The effective tax rate for each of the three and nine months ended September 30, 2017 and 2016 was 0.0%. For the three and nine months ended September 30, 2017 and 2016, the effective rate was lower than the federal statutory rates primarily due to the losses incurred and the full valuation allowance on deferred tax assets. The Company’s estimated tax rate for 2017 excluding any benefits from any sales of net operating losses or research and development, or R&D, tax credits is expected to be zero because the Company expects to generate additional losses and currently has a full valuation allowance. The deferred tax assets balance before valuation allowance as of September 30, 2017 was approximately $60.0 million. The valuation allowance is required until the Company has sufficient positive evidence of taxable income necessary to support realization of its deferred tax assets. In addition, the Company may be subject to certain limitations in its annual utilization of NOL carry forwards to off-set future taxable income (and of tax credit carry forwards to off-set future tax expense) pursuant to Section 382 of the Internal Revenue Code, which could result in tax attributes expiring unused. The Company did not have material uncertain tax positions as of September 30, 2017. As of September 30, 2017, there were no material uncertain tax positions. There are no tax positions for which a material change in any unrecognized tax benefit liability is reasonably possible in the next 12 months. |
Stock-Based Compensation |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | (8) Stock-Based Compensation Bellerophon 2015 and 2014 Equity Incentive Plans During 2015, the Company adopted the 2015 Equity Incentive Plan, or the 2015 Plan, which provides for the grant of options, restricted stock and other forms of equity compensation. On May 4, 2017, the Company’s stockholders approved an amendment to the 2015 Plan to increase the aggregate number of shares available for the grant of awards to 5,000,000 and to increase the maximum number of shares available under the annual increase to 3,000,000 shares. As of September 30, 2017, there was approximately $2.3 million of total unrecognized compensation expense related to unvested stock awards. This expense is expected to be recognized over a weighted-average period of 1.6 years. No tax benefit was recognized during the three and nine months ended September 30, 2017 and 2016 related to stock-based compensation expense since the Company incurred operating losses and has established a full valuation allowance to offset all the potential tax benefits associated with its deferred tax assets. Options The weighted average grant-date fair values of options issued during the nine months ended September 30, 2017 and 2016 were $0.84 and $1.52, respectively. The following are the weighted average assumptions used in estimating the fair values of options issued during the nine months ended September 30, 2017 and 2016.
A summary of option activity under the 2015 and 2014 Plans for the nine months ended September 30, 2017 is presented below:
The intrinsic value of options outstanding, vested and exercisable as of September 30, 2017 was zero. Restricted Stock All restricted stock awards granted under the 2015 Plan during the nine months ended September 30, 2017 were in relation to 2016 incentives for employees or director compensation and vest in full less than one year from the grant date. A summary of restricted stock activity under the 2015 Plan for the nine months ended September 30, 2017 is presented below:
Ikaria Equity Incentive Plans prior to February 12, 2014 Options A summary of option activity under Ikaria incentive plans assumed in 2014 for the nine months ended September 30, 2017, is presented below:
The intrinsic value of options outstanding, vested and exercisable as of September 30, 2017 was zero. Stock-Based Compensation Expense, Net of Estimated Forfeitures The following table summarizes the stock-based compensation expense by the unaudited condensed consolidated statement of operations line items for the nine months ended September 30, 2017 and 2016 (in thousands):
|
Commitments and Contingencies |
9 Months Ended |
---|---|
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (11) Commitments and Contingencies Legal Proceedings The Company periodically becomes subject to legal proceedings and claims arising in connection with its business. The ultimate legal and financial liability of the Company in respect to all proceedings, claims and lawsuits, pending or threatened, cannot be estimated with any certainty. As of this report, the Company is not aware of any proceeding, claim or litigation, pending or threatened, that could, individually or in the aggregate, have a material adverse effect on the Company’s business, operating results, financial condition and/or liquidity. |
Net Loss Per Share |
9 Months Ended |
---|---|
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share/Unit | (10) Net Loss Per Share The Company reported a net loss for the three and nine months ended September 30, 2017 and 2016, therefore diluted net loss per share is the same as the basic net loss per share. As of September 30, 2017, the Company had 3,326,620 options to purchase shares, 654,175 restricted shares and warrants to purchase 36,718,392 shares outstanding that have been excluded from the computation of diluted weighted average shares outstanding, because such securities had an anti-dilutive impact due to the loss reported. |
Fair Value Measurements - USD ($) $ in Thousands |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 |
Dec. 31, 2016 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrant, Fair Value Disclosure | $ 18,784 | $ 5,215 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | (6) Fair Value Measurements Assets and liabilities recorded at fair value on the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows:
The following table summarizes fair value measurements by level at September 30, 2017 for assets and liabilities measured at fair value on a recurring basis (in thousands):
The following table summarizes fair value measurements by level at December 31, 2016 for assets and liabilities measured at fair value on a recurring basis (in thousands):
The Company uses a Black-Scholes-Merton option pricing model to value its liability classified common stock warrants. The significant unobservable inputs used in calculating the fair value of common stock warrants represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. For volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of common stock warrants due to its limited history as a public company. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected term of the common stock warrant. Any significant changes in the inputs may result in significantly higher or lower fair value measurements. The following are the weighted average assumptions used in estimating the fair value of warrants issued as of September 30, 2017 and December 31, 2016:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Derivative Liability, Current | $ 5,215 |
Restructuring Charges |
9 Months Ended | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||
Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||
Restructuring Charges | (7) Restructuring Charges On July 27, 2015, the Company announced that its PRESERVATION I clinical trial for its BCM product candidate did not meet its primary or secondary endpoints. Following these results, on September 11, 2015, the Board of Directors of the Company approved a staff reduction plan in order to reduce operating expenses and conserve cash resources, or the Restructuring. The following table summarizes changes to the related accrued restructuring costs for the nine months ended September 30, 2017 (in thousands):
(a) Included in Accrued expenses. |
Summary of Significant Accounting Policies (Policies) |
9 Months Ended |
---|---|
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies (a) Basis of Presentation The accompanying unaudited condensed consolidated financial statements were prepared following the requirements of the Securities and Exchange Commission, or the SEC, for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by accounting principles generally accepted in the United States of America, or U.S. GAAP, can be condensed or omitted. The Company operates in one reportable segment and solely within the United States. Accordingly, no segment or geographic information has been presented. The Company is responsible for the unaudited condensed consolidated financial statements. The condensed consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s financial position, results of operations, comprehensive loss and its cash flows for the periods presented. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements for the year ended December 31, 2016, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. The results of operations for the three and nine months ended September 30, 2017 for the Company are not necessarily indicative of the results expected for the full year. The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of costs and expenses during the reporting period, including accrued expenses, accrued research and development expenses, stock-based compensation, common stock warrant liabilities and income taxes. Actual results could differ from those estimates. (b) Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity date of three months or less to be cash equivalents. All investments with maturities of greater than three months from date of purchase are classified as available-for-sale marketable securities. (c) Stock-Based Compensation The Company accounts for its stock-based compensation in accordance with applicable accounting guidance which establishes accounting for share-based awards, including stock options and restricted stock, exchanged for services and requires companies to expense the estimated fair value of these awards over the requisite service period. The Company recognizes stock-based compensation expense in operations based on the fair value of the award on the date of the grant net of estimated forfeitures. The resulting compensation expense is recognized on a straight-line basis over the requisite service period or sooner if the awards immediately vest. The Company determines the fair value of stock options issued using a Black-Scholes-Merton option pricing model. Certain assumptions used in the model include expected volatility, dividend yield, risk-free interest rate, and expected term. For restricted stock, the fair value is the closing market price per share on the grant date. See Note 8 - Stock-Based Compensation for a description of these assumptions. (d) Common Stock Warrants and Warrant Liability The Company accounts for common stock warrants issued as freestanding instruments in accordance with applicable accounting guidance as either liabilities or as equity instruments depending on the specific terms of the warrant agreement. The Company classifies warrant liabilities on the consolidated balance sheet based on their terms as long-term liabilities, which are revalued at each balance sheet date subsequent to the initial issuance. Changes in the fair value of the warrants are reflected in the consolidated statement of operations as “Change in fair value of common stock warrant liability.” The Company uses the Black-Scholes-Merton pricing model to value the related warrant liabilities. Certain assumptions used in the model include expected volatility, dividend yield, risk-free interest rate, and expected term. See Note 6 - Fair Value Measurements for a description of these assumptions. (e) Income Taxes The Company uses the asset and liability approach to account for income taxes as required by applicable accounting guidance which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Valuation allowances are provided when necessary to reduce deferred tax assets to the amount expected to be realized, on a more likely than not basis. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. (f) Marketable Securities The Company’s marketable securities consist of federally insured certificates of deposit classified as available-for-sale that are recorded at amortized cost, which approximates fair value, and corporate or agency bonds classified as available-for-sale that are recorded at fair value. Unrealized gains and losses are reported as accumulated other comprehensive income (loss), except for losses from impairments which are determined to be other-than-temporary. Realized gains and losses, and declines in value judged to be other-than-temporary on available-for-sale securities are included in the determination of net loss and are included in interest income, at which time the average cost basis of these securities are adjusted to fair value. Fair values are based on quoted market prices at the reporting date. Interest on available-for-sale securities are included in interest income. (g) Research and Development Expense Research and development costs are expensed as incurred. These expenses include the costs of the Company’s proprietary research and development efforts, as well as costs incurred in connection with certain licensing arrangements. Upfront and milestone payments made to third parties in connection with research and development collaborations are expensed as incurred up to the point of regulatory approval. Payments made to third parties upon or subsequent to regulatory approval are capitalized and amortized over the remaining useful life of the related product. The Company also expenses the cost of purchased technology and equipment in the period of purchase if it believes that the technology or equipment has not demonstrated technological feasibility and it does not have an alternative future use. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and are recognized as research and development expense as the related goods are delivered or the related services are performed. (h) Reclassification Certain prior year balances have been reclassified to conform to the current period presentation. (i) Recently Issued Accounting Pronouncements Adopted In March 2016, the Financial Accounting Standards Board, or FASB issued ASU 2016-09, "Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting" which provides for simplification of several aspects related to the accounting for share-based payment transactions. The provisions of ASU 2016-09 that are currently applicable to the Company are as follows: (a) forfeitures and (b) classification of employee taxes paid on the statement of cash flows when an employer withholds shares for tax-withholding purposes. This standard is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The Company adopted ASU 2016-09 during the quarter ended March 31, 2017. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements. The Company will continue to use its current method of estimated forfeitures each period rather than accounting for forfeitures as they occur. ASU 2016-09 requires the presentation of cash paid by an employer when directly withholding shares for tax-withholding purposes as a financing activity in the cash flow statement. The Company’s historical accounting treatment is consistent with such guidance. Not Yet Adopted In January 2016, the FASB issued ASU 2016-01, "Financial Instruments - Overall - Recognition and Measurement of Financial Assets and Financial Liabilities," which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. This standard will be effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company is assessing ASU 2016-01’s impact and will adopt it when effective. In February 2016, the FASB issued ASU 2016-02, "Leases," which is intended to improve financial reporting about leasing transactions. This standard requires a lessee to record on the balance sheet the assets and liabilities for the rights and obligations created by lease terms of more than 12 months. This standard will be effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company is assessing ASU 2016-02’s impact and will adopt it when effective. In August 2016, the FASB issued ASU 2016-15, “Statement of Cash Flows: Clarification of Certain Cash Receipts and Cash Payments”, which eliminates the diversity in practice related to the classification of certain cash receipts and payments in the statement of cash flows, by adding or clarifying guidance on eight specific cash flow issues. ASU 2016-15 is effective for annual and interim reporting periods beginning after December 15, 2017 and early adoption is permitted. ASU 2016-15 provides for retrospective application for all periods presented. The Company is assessing ASU 2016-15’s impact and will adopt it when effective. In November 2016, the FASB issued ASU 2016-18 "Statement of Cash Flows: Restricted Cash", which eliminates the diversity in practice related to the inclusion of restricted cash in the statement of cash flows by requiring that a statement of cash flows include the change during the period in restricted cash when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for annual and interim reporting periods beginning after December 15, 2017 and early adoption is permitted. ASU 2016-18 provides for retrospective application for all periods presented. The Company is assessing ASU 2016-18’s impact and will adopt it when effective. In May 2017, the FASB issued ASU 2017-09, "Stock Compensation - Scope of Modification Accounting", guidance that clarifies that all changes to share-based payment awards are not necessarily accounted for as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award changes as a result of the change in terms or conditions. The amendments in this guidance should be applied prospectively in annual periods beginning after December 15, 2017, including interim periods within those periods. This guidance will apply to any future modifications. The Company will adopt ASU 2017-09 when effective. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements were prepared following the requirements of the Securities and Exchange Commission, or the SEC, for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by accounting principles generally accepted in the United States of America, or U.S. GAAP, can be condensed or omitted. The Company operates in one reportable segment and solely within the United States. Accordingly, no segment or geographic information has been presented. The Company is responsible for the unaudited condensed consolidated financial statements. The condensed consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s financial position, results of operations, comprehensive loss and its cash flows for the periods presented. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements for the year ended December 31, 2016, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. The results of operations for the three and nine months ended September 30, 2017 for the Company are not necessarily indicative of the results expected for the full year. The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of costs and expenses during the reporting period, including accrued expenses, accrued research and development expenses, stock-based compensation, common stock warrant liabilities and income taxes. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity date of three months or less to be cash equivalents. All investments with maturities of greater than three months from date of purchase are classified as available-for-sale marketable securities. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for its stock-based compensation in accordance with applicable accounting guidance which establishes accounting for share-based awards, including stock options and restricted stock, exchanged for services and requires companies to expense the estimated fair value of these awards over the requisite service period. The Company recognizes stock-based compensation expense in operations based on the fair value of the award on the date of the grant net of estimated forfeitures. The resulting compensation expense is recognized on a straight-line basis over the requisite service period or sooner if the awards immediately vest. The Company determines the fair value of stock options issued using a Black-Scholes-Merton option pricing model. Certain assumptions used in the model include expected volatility, dividend yield, risk-free interest rate, and expected term. For restricted stock, the fair value is the closing market price per share on the grant date. See Note 8 - Stock-Based Compensation for a description of these assumptions. |
Common Stock Warrant Liability [Policy Text Block] | (d) Common Stock Warrants and Warrant Liability The Company accounts for common stock warrants issued as freestanding instruments in accordance with applicable accounting guidance as either liabilities or as equity instruments depending on the specific terms of the warrant agreement. The Company classifies warrant liabilities on the consolidated balance sheet based on their terms as long-term liabilities, which are revalued at each balance sheet date subsequent to the initial issuance. Changes in the fair value of the warrants are reflected in the consolidated statement of operations as “Change in fair value of common stock warrant liability.” The Company uses the Black-Scholes-Merton pricing model to value the related warrant liabilities. Certain assumptions used in the model include expected volatility, dividend yield, risk-free interest rate, and expected term. See Note 6 - Fair Value Measurements for a description of these assumptions. |
Deferred Transaction Costs | Income Taxes The Company uses the asset and liability approach to account for income taxes as required by applicable accounting guidance which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Valuation allowances are provided when necessary to reduce deferred tax assets to the amount expected to be realized, on a more likely than not basis. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. |
Marketable Securities | Marketable Securities The Company’s marketable securities consist of federally insured certificates of deposit classified as available-for-sale that are recorded at amortized cost, which approximates fair value, and corporate or agency bonds classified as available-for-sale that are recorded at fair value. Unrealized gains and losses are reported as accumulated other comprehensive income (loss), except for losses from impairments which are determined to be other-than-temporary. Realized gains and losses, and declines in value judged to be other-than-temporary on available-for-sale securities are included in the determination of net loss and are included in interest income, at which time the average cost basis of these securities are adjusted to fair value. Fair values are based on quoted market prices at the reporting date. Interest on available-for-sale securities are included in interest income. |
Research and Development Expense | Research and Development Expense Research and development costs are expensed as incurred. These expenses include the costs of the Company’s proprietary research and development efforts, as well as costs incurred in connection with certain licensing arrangements. Upfront and milestone payments made to third parties in connection with research and development collaborations are expensed as incurred up to the point of regulatory approval. Payments made to third parties upon or subsequent to regulatory approval are capitalized and amortized over the remaining useful life of the related product. The Company also expenses the cost of purchased technology and equipment in the period of purchase if it believes that the technology or equipment has not demonstrated technological feasibility and it does not have an alternative future use. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and are recognized as research and development expense as the related goods are delivered or the related services are performed. |
Reclassifications [Text Block] | (h) Reclassification Certain prior year balances have been reclassified to conform to the current period presentation. |
New Accounting Pronouncements | (i) Recently Issued Accounting Pronouncements Adopted In March 2016, the Financial Accounting Standards Board, or FASB issued ASU 2016-09, "Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting" which provides for simplification of several aspects related to the accounting for share-based payment transactions. The provisions of ASU 2016-09 that are currently applicable to the Company are as follows: (a) forfeitures and (b) classification of employee taxes paid on the statement of cash flows when an employer withholds shares for tax-withholding purposes. This standard is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The Company adopted ASU 2016-09 during the quarter ended March 31, 2017. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements. The Company will continue to use its current method of estimated forfeitures each period rather than accounting for forfeitures as they occur. ASU 2016-09 requires the presentation of cash paid by an employer when directly withholding shares for tax-withholding purposes as a financing activity in the cash flow statement. The Company’s historical accounting treatment is consistent with such guidance. Not Yet Adopted In January 2016, the FASB issued ASU 2016-01, "Financial Instruments - Overall - Recognition and Measurement of Financial Assets and Financial Liabilities," which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. This standard will be effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company is assessing ASU 2016-01’s impact and will adopt it when effective. In February 2016, the FASB issued ASU 2016-02, "Leases," which is intended to improve financial reporting about leasing transactions. This standard requires a lessee to record on the balance sheet the assets and liabilities for the rights and obligations created by lease terms of more than 12 months. This standard will be effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company is assessing ASU 2016-02’s impact and will adopt it when effective. In August 2016, the FASB issued ASU 2016-15, “Statement of Cash Flows: Clarification of Certain Cash Receipts and Cash Payments”, which eliminates the diversity in practice related to the classification of certain cash receipts and payments in the statement of cash flows, by adding or clarifying guidance on eight specific cash flow issues. ASU 2016-15 is effective for annual and interim reporting periods beginning after December 15, 2017 and early adoption is permitted. ASU 2016-15 provides for retrospective application for all periods presented. The Company is assessing ASU 2016-15’s impact and will adopt it when effective. In November 2016, the FASB issued ASU 2016-18 "Statement of Cash Flows: Restricted Cash", which eliminates the diversity in practice related to the inclusion of restricted cash in the statement of cash flows by requiring that a statement of cash flows include the change during the period in restricted cash when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for annual and interim reporting periods beginning after December 15, 2017 and early adoption is permitted. ASU 2016-18 provides for retrospective application for all periods presented. The Company is assessing ASU 2016-18’s impact and will adopt it when effective. In May 2017, the FASB issued ASU 2017-09, "Stock Compensation - Scope of Modification Accounting", guidance that clarifies that all changes to share-based payment awards are not necessarily accounted for as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award changes as a result of the change in terms or conditions. The amendments in this guidance should be applied prospectively in annual periods beginning after December 15, 2017, including interim periods within those periods. This guidance will apply to any future modifications. The Company will adopt ASU 2017-09 when effective. |
Number of Reportable Segments | 1 |
Marketable Securities (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Marketable Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Available-for-sale Securities Reconciliation | The Company considers all of its investments to be available-for-sale. Marketable securities as of September 30, 2017 consist of the following (in thousands):
Marketable securities as of December 31, 2016, consist of the following (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Available-for-sale Securities | Maturities of marketable securities classified as available-for-sale were as follows at September 30, 2017 and December 31, 2016 (in thousands):
|
Stock-Based Compensation (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assumptions used in estimating the fair value of options issued | The following are the weighted average assumptions used in estimating the fair values of options issued during the nine months ended September 30, 2017 and 2016.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of option activity | The following table summarizes the stock-based compensation expense by the unaudited condensed consolidated statement of operations line items for the nine months ended September 30, 2017 and 2016 (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of restricted stock activity | A summary of restricted stock activity under the 2015 Plan for the nine months ended September 30, 2017 is presented below:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of stock-based compensation expense by the condensed consolidated statement of operations line item | A summary of option activity under Ikaria incentive plans assumed in 2014 for the nine months ended September 30, 2017, is presented below:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Bellerophon 2015 And 2014 Equity Incentive Plan | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of option activity | A summary of option activity under the 2015 and 2014 Plans for the nine months ended September 30, 2017 is presented below:
|
Fair Value Measurements (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of fair value measurements by level | The following table summarizes fair value measurements by level at September 30, 2017 for assets and liabilities measured at fair value on a recurring basis (in thousands):
The following table summarizes fair value measurements by level at December 31, 2016 for assets and liabilities measured at fair value on a recurring basis (in thousands):
|
Restructuring Charges (Tables) |
9 Months Ended | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||
Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||
Summary of restructuring activities | The following table summarizes changes to the related accrued restructuring costs for the nine months ended September 30, 2017 (in thousands):
(a) Included in Accrued expenses. |
Organization and Nature of the Business (Details) - USD ($) $ / shares in Units, $ in Thousands |
9 Months Ended | 11 Months Ended | |||||
---|---|---|---|---|---|---|---|
Sep. 29, 2017 |
May 15, 2017 |
May 09, 2017 |
Nov. 29, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
Apr. 26, 2017 |
|
Organization and Nature of the Business [Line Items] | |||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | Mar. 29, 2018 | Nov. 15, 2017 | |||||
Completed sale (in shares) | 2,000,000 | 17,142,858 | |||||
Price to the public (in dollars per share) | $ 1.205 | $ 1.50 | $ 0.70 | ||||
Underwriting Discounts And Commissions | $ 800 | ||||||
Offering costs deducted | $ 300 | ||||||
Warrants Issued | 19,449,834 | 1,000,000 | 17,142,858 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.242 | $ 1.50 | $ 0.80 | ||||
WarrantsExpiration | 5 years | 5 years | 5 years | ||||
Proceeds from Issuance of Common Stock | $ 3,000 | $ 0 | $ 2,048 | $ 2,200 | |||
Proceeds from Issuance of Common Stock, Net | $ 2,700 | $ 2,100 |
Marketable Securities (Details) - USD ($) $ in Thousands |
Sep. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale Securities, Amortized Cost Basis | $ 3,178 | $ 5,571 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 3,178 | 5,571 |
Certificates of deposit | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale Securities, Amortized Cost Basis | 1,677 | 3,619 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 1,677 | $ 3,619 |
Marketable Securities Schedule of Available-for-sale Securities Reconciliation (Details) - USD ($) $ in Thousands |
Sep. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 3,178 | $ 5,571 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 3,178 | 5,571 |
Certificates of deposit | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,677 | 3,619 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 1,677 | 3,619 |
Agency bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,501 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 1,501 | |
Corporate Bond Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,952 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 1,952 |
Marketable Securities Schedule of Investments in Debt and Marketable Equity Securities (Details) - USD ($) $ in Thousands |
Sep. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Marketable Securities [Abstract] | ||
Due within one year | $ 3,178 | $ 5,571 |
Due after one year | 0 | 0 |
Total | $ 3,178 | $ 5,571 |
Income Taxes (Details) - USD ($) |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
Dec. 31, 2017 |
|
Valuation Allowance [Line Items] | |||||
Deferred Tax Assets, Gross | $ 60,000,000 | $ 60,000,000 | |||
Effective tax rate (as a percent) | 0.00% | 0.00% | 0.00% | ||
Expected change to unrecognized tax benefit liability in next twelve months | $ 0 | $ 0 | |||
Scenario, Actual [Member] | |||||
Valuation Allowance [Line Items] | |||||
Effective tax rate (as a percent) | 0.00% | ||||
Scenario, Forecast [Member] | |||||
Valuation Allowance [Line Items] | |||||
Effective tax rate (as a percent) | 0.00% |
Stock-Based Compensation (Summary of Fair Value of Options Issued) (Details) - Bellerophon Equity Incentive Plans - $ / shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average grant-date fair value of options issued | $ 0.84 | $ 1.52 |
Risk-free rate (as a percent) | 1.98% | 1.34% |
Expected volatility (as a percent) | 90.98% | 81.80% |
Expected term (years) | 5 years 11 months 30 days | 6 years 1 month 6 days |
Dividend yield (as a percent) | 0.00% | 0.00% |
Stock-Based Compensation (Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs) (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
Stock-based compensation expense by condensed consolidated statement of operations and comprehensive loss line item | ||||
Allocated Share-based Compensation Expense | $ 756 | $ 779 | $ 2,134 | $ 2,148 |
Charged to research and development expense | ||||
Stock-based compensation expense by condensed consolidated statement of operations and comprehensive loss line item | ||||
Allocated Share-based Compensation Expense | 188 | 203 | 661 | 656 |
Charged to general and administrative expense | ||||
Stock-based compensation expense by condensed consolidated statement of operations and comprehensive loss line item | ||||
Allocated Share-based Compensation Expense | $ 568 | $ 576 | $ 1,473 | $ 1,492 |
Related-Party Transactions (Details) - USD ($) $ in Thousands |
Sep. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Related Party Transaction [Line Items] | ||
Prepaid Research and Development, Current | $ 3,163 | $ 5,842 |
Net Loss Per Share (Details) |
9 Months Ended |
---|---|
Sep. 30, 2017
shares
| |
Options to purchase units outstanding | |
Net Loss Per Share | |
Antidilutive securities excluded from computation of weighted average units outstanding | 3,326,620 |
Restricted stock outstanding | |
Net Loss Per Share | |
Antidilutive securities excluded from computation of weighted average units outstanding | 654,175 |
Warrant [Member] | |
Net Loss Per Share | |
Antidilutive securities excluded from computation of weighted average units outstanding | 36,718,392 |
Restructuring Charges (Details) $ in Thousands |
3 Months Ended | 9 Months Ended |
---|---|---|
Dec. 31, 2015
person
|
Sep. 30, 2017
USD ($)
|
|
Restructuring Reserve [Roll Forward] | ||
Restructuring reserve, beginning balance | $ 110 | |
Cash payments | (110) | |
Restructuring reserve, ending balance | $ 0 | |
Employee Severance | ||
Restructuring and Related Cost, Positions Eliminated [Abstract] | ||
Number of positions to be eliminated | person | 20 |