x | QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 27-2004382 | |
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification No.) |
Large accelerated filer o | Accelerated filer x | |
Non-accelerated filer o | Smaller reporting company o | |
(Do not check if a smaller reporting company) |
Page | ||
3/31/2016 | 12/31/2015 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 59,989,329 | $ | 67,493,047 | |||
Accounts receivable | 61,935 | 98,736 | |||||
Prepaid expenses and other assets | 840,724 | 789,285 | |||||
Total current assets | 60,891,988 | 68,381,068 | |||||
Property and equipment, net | 4,745,781 | 2,690,579 | |||||
Other assets | 371,243 | 374,004 | |||||
Total Assets | $ | 66,009,012 | $ | 71,445,651 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,297,306 | $ | 1,040,868 | |||
Accrued expenses | 2,974,493 | 1,934,411 | |||||
Current portion of long-term debt | 5,850,051 | 5,225,818 | |||||
Total current liabilities | 10,121,850 | 8,201,097 | |||||
Long-term debt, less current portion | 10,373,081 | 11,246,188 | |||||
Derivative financial instruments | 2,763,327 | 3,297,077 | |||||
Other liabilities | 1,591,306 | — | |||||
Total Liabilities | 24,849,564 | 22,744,362 | |||||
Commitments and contingencies (Note 8) | |||||||
Stockholders’ equity | |||||||
Preferred stock, $0.001 par value, 20,000,000 shares authorized; 60,600 shares outstanding at March 31, 2016 and December 31, 2015; designated as Series A Convertible Preferred Stock with liquidation preference of $606,000 at March 31, 2016 and December 31, 2015 | 60 | 60 | |||||
Common stock, $0.0001 par value, 150,000,000 shares authorized; 29,782,601 and 29,737,601 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively | 2,979 | 2,974 | |||||
Additional paid-in capital | 160,312,881 | 157,585,498 | |||||
Accumulated other comprehensive loss | (651 | ) | — | ||||
Accumulated deficit | (119,155,821 | ) | (108,887,243 | ) | |||
Total stockholders’ equity | 41,159,448 | 48,701,289 | |||||
Total liabilities and stockholders’ equity | $ | 66,009,012 | $ | 71,445,651 |
Three Months Ended March 31, | |||||||
2016 | 2015 | ||||||
Royalty income | $ | 112,868 | $ | 124,804 | |||
Diagnostic service revenue | 7,618 | 2,166 | |||||
Total revenues | 120,486 | 126,970 | |||||
Costs and expenses: | |||||||
Cost of revenue | 309,271 | 176,425 | |||||
Research and development | 3,208,064 | 2,197,659 | |||||
Selling and marketing | 3,057,552 | 794,653 | |||||
General and administrative | 4,004,247 | 1,805,985 | |||||
Total operating expenses | 10,579,134 | 4,974,722 | |||||
Loss from operations | (10,458,648 | ) | (4,847,752 | ) | |||
Net interest expense | (337,620 | ) | (383,469 | ) | |||
Gain (loss) from change in fair value of derivative instruments — warrants | 533,750 | (1,946,728 | ) | ||||
Other income, net | — | 3,568 | |||||
Net loss | (10,262,518 | ) | (7,174,381 | ) | |||
Preferred stock dividend | (6,060 | ) | (6,060 | ) | |||
Net loss attributable to common stockholders | $ | (10,268,578 | ) | $ | (7,180,441 | ) | |
Net loss per common share — basic | $ | (0.35 | ) | $ | (0.33 | ) | |
Net loss per common share — diluted | $ | (0.36 | ) | $ | (0.33 | ) | |
Weighted average shares outstanding — basic | 29,755,184 | 21,817,710 | |||||
Weighted average shares outstanding — diluted | 30,108,377 | 21,817,710 |
Three Months Ended March 31, | |||||||
2016 | 2015 | ||||||
Net loss | $ | (10,262,518 | ) | $ | (7,174,381 | ) | |
Other comprehensive loss: | |||||||
Foreign currency translation loss | (651 | ) | — | ||||
Total other comprehensive loss | (651 | ) | — | ||||
Total comprehensive loss | (10,263,169 | ) | (7,174,381 | ) | |||
Preferred stock dividend | (6,060 | ) | (6,060 | ) | |||
Comprehensive loss attributable to common stockholders | $ | (10,269,229 | ) | $ | (7,180,441 | ) |
Three Months Ended March 31, | |||||||
2016 | 2015 | ||||||
Operating activities | |||||||
Net loss | $ | (10,262,518 | ) | $ | (7,174,381 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Net gain on disposal of fixed assets | — | (3,568 | ) | ||||
Depreciation and amortization | 156,821 | 68,519 | |||||
Stock based compensation expense | 2,811,108 | 711,741 | |||||
Amortization of debt costs | 93,062 | 124,713 | |||||
Accretion of discount on debt | 27,631 | 28,486 | |||||
Change in fair value of derivative instruments - warrants | (533,750 | ) | 1,946,728 | ||||
Changes in operating assets and liabilities: | |||||||
Decrease in other assets | 2,761 | — | |||||
Decrease (increase) in accounts receivable | 36,801 | (2,697 | ) | ||||
Increase in prepaid expenses | (51,272 | ) | (48,781 | ) | |||
Increase (decrease) in accounts payable and accrued expenses | 1,072,343 | (383,642 | ) | ||||
Decrease in other liabilities | (268,694 | ) | — | ||||
Net cash used in operating activities | (6,915,707 | ) | (4,732,882 | ) | |||
Investing activities: | |||||||
Capital expenditures, net | (352,023 | ) | (247,097 | ) | |||
Net cash used in investing activities | (352,023 | ) | (247,097 | ) | |||
Financing activities: | |||||||
Proceeds from sales of common stock, net of expenses | — | 21,445,785 | |||||
Proceeds from exercise of options | 133,613 | 236,038 | |||||
Borrowing under equipment line of credit | 550,297 | — | |||||
Repayments of long-term debt | (919,864 | ) | — | ||||
Net cash (used in) provided by financing activities | (235,954 | ) | 21,681,823 | ||||
Effect of exchange rate changes on cash and cash equivalents | (34 | ) | — | ||||
Net change in cash and equivalents | (7,503,718 | ) | 16,701,844 | ||||
Cash and cash equivalents—Beginning of period | 67,493,047 | 27,293,798 | |||||
Cash and cash equivalents—End of period | $ | 59,989,329 | $ | 43,995,642 | |||
Supplementary disclosure of cash flow activity: | |||||||
Cash paid for taxes | $ | — | $ | 800 | |||
Cash paid for interest | $ | 276,214 | $ | 265,125 | |||
Supplemental disclosure of non-cash investing and financing activities: | |||||||
Preferred stock dividends accrued | $ | 6,060 | $ | 6,060 | |||
Leasehold improvements paid for by lessor | $ | 1,860,000 | $ | — |
Three Months Ended March 31, | |||||||
2016 | 2015 | ||||||
Numerator: Net loss attributable to common shareholders | $ | (10,268,578 | ) | $ | (7,180,441 | ) | |
Adjustment for change in fair value of derivative instruments - warrants | (533,750 | ) | — | ||||
Net loss used for diluted loss per share | $ | (10,802,328 | ) | $ | (7,180,441 | ) | |
Denominator for basic and diluted net loss per share: | |||||||
Weighted average shares used to compute basic loss per share | 29,755,184 | 21,817,710 | |||||
Adjustments to reflect assumed exercise of warrants | 353,193 | — | |||||
Weighted average shares used to compute diluted net loss per share | 30,108,377 | 21,817,710 | |||||
Net loss per share attributable to common stockholders: | |||||||
Basic | $ | (0.35 | ) | $ | (0.33 | ) | |
Diluted | $ | (0.36 | ) | $ | (0.33 | ) |
March 31, | |||||
2016 | 2015 | ||||
Options to purchase Common Stock | 8,117,024 | 5,875,138 | |||
Warrants to purchase Common Stock | 4,515,947 | 5,993,952 | |||
Series A Convertible Preferred Stock | 63,125 | 63,125 | |||
12,696,096 | 11,932,215 |
Fair Value Measurements at March 31, 2016 | |||||||||||||||
Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Total | ||||||||||||
Assets: | |||||||||||||||
Money market fund (1) | $ | 59,070,272 | $ | — | $ | 59,070,272 | |||||||||
Total Assets | $ | 59,070,272 | $ | — | $ | — | $ | 59,070,272 | |||||||
Liabilities: | |||||||||||||||
Derivative liabilities related to warrants | $ | — | $ | — | $ | 2,763,327 | $ | 2,763,327 | |||||||
Total Liabilities | $ | — | $ | — | $ | 2,763,327 | $ | 2,763,327 |
Fair Value Measurements at December 31, 2015 | |||||||||||||||
Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Total | ||||||||||||
Assets: | |||||||||||||||
Money market fund (1) | $ | 65,016,222 | $ | — | $ | — | $ | 65,016,222 | |||||||
Total Assets | $ | 65,016,222 | $ | — | $ | — | $ | 65,016,222 | |||||||
Liabilities: | |||||||||||||||
Derivative liabilities related to warrants | $ | — | $ | — | $ | 3,297,077 | $ | 3,297,077 | |||||||
Total Liabilities | $ | — | $ | — | $ | 3,297,077 | $ | 3,297,077 |
Description | Balance at December 31, 2015 | Unrealized gain | Balance at March 31, 2016 | |||||||||
Derivative liabilities related to Warrants | $ | 3,297,077 | $ | (533,750 | ) | $ | 2,763,327 |
As of March 31, 2016 | As of December 31, 2015 | ||||||
Furniture and office equipment | $ | 1,509,546 | $ | 1,483,227 | |||
Leasehold Improvements | 1,952,180 | 39,401 | |||||
Laboratory equipment | 2,294,203 | 2,022,733 | |||||
5,755,929 | 3,545,361 | ||||||
Less—accumulated depreciation and amortization | (1,010,148 | ) | (854,782 | ) | |||
Property and equipment, net | $ | 4,745,781 | $ | 2,690,579 |
2016 | $ | 181,818 | |
2017 | 545,453 | ||
2018 | 545,453 | ||
2019 | 363,635 | ||
Total principal | 1,636,359 | ||
Plus final fee premium accretion | 7,719 | ||
Total long-term obligations | $ | 1,644,078 |
2016 | $ | 5,752,026 | |
2017 | 6,172,134 | ||
2018 | 2,155,976 | ||
Total principal | 14,080,136 | ||
Less discount | (124,264 | ) | |
Plus final fee premium accretion | 623,182 | ||
Total long-term obligations | $ | 14,579,054 |
Three Months Ended March 31, | |||||
2016 | 2015 | ||||
Estimated fair value of Trovagene common stock | 4.65 | 6.81 | |||
Expected warrant term | 2.75 years | 3.75 years | |||
Risk-free interest rate | 0.87 | % | 0.89 | % | |
Expected volatility | 81.8 | % | 75.4 | % | |
Dividend yield | 0 | % | 0 | % |
Date | Description | Warrants | Derivative Instrument Liability | ||||||
December 31, 2015 | Balance of derivative financial instruments liability | 967,297 | $ | 3,297,077 | |||||
Change in fair value of warrants during the period recognized as a gain in the condensed consolidated statement of operations | — | (533,750 | ) | ||||||
March 31, 2016 | Balance of derivative financial instruments liability | 967,297 | $ | 2,763,327 |
Three Months Ended March 31, | |||||||
2016 | 2015 | ||||||
Included in research and development expense | $ | 398,741 | $ | 289,197 | |||
Included in cost of revenue | 18,297 | 26,706 | |||||
Included in selling and marketing expense | 578,721 | 80,488 | |||||
Included in general and administrative expense | 1,815,349 | 315,350 | |||||
Total stock-based compensation expense | $ | 2,811,108 | $ | 711,741 |
Three Months Ended March 31, | |||||
2016 | 2015 | ||||
Risk-free interest rate | 1.48 | % | 1.77 | % | |
Dividend yield | 0 | % | 0 | % | |
Expected volatility | 82 | % | 75 | % | |
Expected term | 5.2 years | 6.2 years |
Total Options | Weighted Average Exercise Price Per Share | Intrinsic Value | ||||||||
Balance outstanding, December 31, 2015 | 6,948,630 | $ | 5.45 | $ | 5,903,466 | |||||
Granted | 2,091,950 | 5.14 | ||||||||
Exercised | (45,000 | ) | 2.97 | |||||||
Canceled / Forfeited | (809,279 | ) | 5.36 | |||||||
Expired | (69,277 | ) | 11.01 | |||||||
Balance outstanding, March 31, 2016 | 8,117,024 | 5.35 | 3,346,992 | |||||||
Exercisable at March 31, 2016 | 3,533,611 | 4.59 | 2,638,307 |
Total Warrants | Weighted Average Exercise Price Per Share | Weighted Average Remaining Contractual Term | ||||||
Balance outstanding, December 31, 2015 | 5,533,242 | $ | 3.86 | 2.5 | ||||
Exercised | (50,000 | ) | 8.00 | |||||
Balance outstanding, March 31, 2016 | 5,483,242 | 3.82 | 2.3 |
• | Entered into preferred provider agreements with Stratose, Inc., Multiplan, Inc., Three Rivers Provider Network, Fortified Provider Network, FedMed, Inc., American’s Choice Provider Network, and Galaxy Health Network. These combined agreements represent in-network coverage for approximately 160 million covered lives. |
• | Presented clinical study results at the 2016 American Association for Cancer Research (“AACR”) Annual Meeting that demonstrated ctDNA assay performance for detection and monitoring KRAS mutations in urine from patients with advanced cancers. |
• | We appointed William J. Welch, as our Chief Executive Officer, after announcing the departure of Matthew Posard, Chief Commercial Officer and the termination of Antonius Schuh and Stephen Zaniboni as our previous CEO and CFO, respectively. |
Three Months Ended March 31, | |||||||||||
2016 | 2015 | Increase (Decrease) | |||||||||
Royalty income | $ | 112,868 | $ | 124,804 | $ | (11,936 | ) | ||||
Diagnostic service revenue | 7,618 | 2,166 | 5,452 | ||||||||
Total revenues | $ | 120,486 | $ | 126,970 | $ | (6,484 | ) |
Three Months Ended March 31, | |||||||||||
2016 | 2015 | Increase | |||||||||
Salaries and staff costs | $ | 1,302,260 | $ | 799,942 | $ | 502,318 | |||||
Stock-based compensation | 398,741 | 289,197 | 109,544 | ||||||||
Outside services, consultants and lab supplies | 1,181,379 | 921,016 | 260,363 | ||||||||
Facilities | 261,237 | 148,353 | 112,884 | ||||||||
Travel and scientific conferences | 42,410 | 38,238 | 4,172 | ||||||||
Other | 22,037 | 913 | 21,124 | ||||||||
Total research and development | $ | 3,208,064 | $ | 2,197,659 | $ | 1,010,405 |
Three Months Ended March 31, | |||||||||||
2016 | 2015 | Increase/(Decrease) | |||||||||
Salaries and staff costs | $ | 1,408,576 | $ | 300,131 | $ | 1,108,445 | |||||
Stock-based compensation | 578,721 | 80,488 | 498,233 | ||||||||
Outside services and consultants | 356,958 | 150,680 | 206,278 | ||||||||
Facilities | 118,261 | 58,981 | 59,280 | ||||||||
Trade shows, conferences and marketing | 342,173 | 132,511 | 209,662 | ||||||||
Travel | 219,633 | 33,855 | 185,778 | ||||||||
Other | 33,230 | 38,007 | (4,777 | ) | |||||||
Total sales and marketing | $ | 3,057,552 | $ | 794,653 | $ | 2,262,899 |
Three Months Ended March 31, | |||||||||||
2016 | 2015 | Increase/(Decrease) | |||||||||
Personnel and outside services costs | $ | 1,028,651 | $ | 836,222 | $ | 192,429 | |||||
Board of Directors’ fees | 101,995 | 116,007 | (14,012 | ) | |||||||
Stock-based compensation | 1,815,349 | 315,350 | 1,499,999 | ||||||||
Legal and accounting fees | 769,797 | 306,564 | 463,233 | ||||||||
Facilities and insurance | 135,922 | 114,241 | 21,681 | ||||||||
Travel | 76,145 | 85,452 | (9,307 | ) | |||||||
Fees, licenses, taxes and other | 76,388 | 32,149 | 44,239 | ||||||||
Total general and administrative | $ | 4,004,247 | $ | 1,805,985 | $ | 2,198,262 |
Three Months Ended March 31, | |||||||||||
2016 | 2015 | Increase | |||||||||
Net loss attributable to common shareholders | $ | (10,268,578 | ) | $ | (7,180,441 | ) | $ | 3,088,137 | |||
Net loss per common share — basic | $ | (0.35 | ) | $ | (0.33 | ) | $ | 0.02 | |||
Net loss per common share — diluted | $ | (0.36 | ) | $ | (0.33 | ) | $ | 0.03 | |||
Weighted average shares outstanding — basic | 29,755,184 | 21,817,710 | 7,937,474 | ||||||||
Weighted average shares outstanding — diluted | 30,108,377 | 21,817,710 | 8,290,667 |
Exhibit Number | Description of Exhibit | |
10.33+ | Employment Agreement, dated as of February 18, 2016, by and between Trovagene, Inc. and Mark Erlander. | |
10.34+ | Employment Agreement, dated as of February 18, 2016, by and between Trovagene, Inc. and Matthew Posard. | |
10.35+ | Form of Employment Agreement by and between Trovagene, Inc. and William J. Welch. | |
10.36+ | Form of Indemnification Agreement, dated as of May 6, 2016, by and between Trovagene, Inc. and William J. Welch. | |
31.1 | Certification of Principal Executive Officer and Principal Financial Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act. | |
32.1 | Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
101 | Financial statements from the quarterly report on Form 10-Q of the Company for the quarter ended March 31, 2016 filed on May 10, 2016, formatted in Extensible Business Reporting Language (XBRL): (i) the Condensed Consolidated Statements of Operations, (ii) the Condensed Consolidated Balance Sheets, (iii) the Condensed Consolidated Statements of Cash Flows and (iv) the Notes to the Condensed Consolidated Financial Statements tagged as blocks of text. |
TROVAGENE, INC. | |||
Date: | May 10, 2016 | By: | /s/ William J. Welch |
William J. Welch | |||
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) |
COMPANY: | Trovagene, Inc. | ||
By: | /s/ Antonius Schuh | ||
Name: | Antonius Schuh | ||
Title: | Chief Executive Officer | ||
EXECUTIVE: | /s/ Mark Erlander | ||
Mark Erlander |
COMPANY: | Trovagene, Inc. | ||
By: | /s/ Antonius Schuh | ||
Name: | Antonius Schuh | ||
Title: | Chief Executive Officer | ||
EXECUTIVE: | /s/ Matthew Posard | ||
Matthew Posard |
COMPANY: | Trovagene, Inc. | ||
By: | |||
Name: | Thomas H. Adams | ||
Title: | Chairman | ||
EXECUTIVE: | |||
William J. Welch |
TROVAGENE, INC. | |||
By: | /s/ Thomas Adams | ||
Title: | Chairman | ||
INDEMNITEE | |||
/s/ William J. Welch | |||
Address: | |||
PO BOX 9778 | |||
Rancho Santa Fe, CA 92091 | |||
1. | I have reviewed this quarterly report on Form 10-Q of Trovagene, Inc. (the “Registrant”); |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; |
4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; |
b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions); |
a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
May 10, 2016 | /s/ William J. Welch |
William J. Welch | |
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) |
May 10, 2016 | /s/ William J. Welch |
William J. Welch | |
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) |
Document and Entity Information - shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2016 |
Apr. 29, 2016 |
|
Document and Entity Information | ||
Entity Registrant Name | Trovagene, Inc. | |
Entity Central Index Key | 0001213037 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 29,861,820 | |
Document Fiscal Year Focus | 2016 | |
Document Fiscal Period Focus | Q1 |
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) |
Mar. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares outstanding | 60,600 | 60,600 |
Series A Convertible Preferred Stock, liquidation preference (in dollars) | $ 606,000 | $ 606,000 |
Common stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 29,782,601 | 29,737,601 |
Common stock, shares outstanding | 29,782,601 | 29,737,601 |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS Statement - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
|
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (10,262,518) | $ (7,174,381) |
Other Comprehensive Income (Loss), Net of Tax [Abstract] | ||
Other Comprehensive Income (Loss), Foreign Currency Transaction and Translation Gain (Loss) Arising During Period, Net of Tax | (651) | 0 |
Other Comprehensive Income (Loss), Net of Tax | (651) | 0 |
Total comprehensive income (loss), net of tax | (10,263,169) | (7,174,381) |
Preferred Stock Dividends, Income Statement Impact | 6,060 | 6,060 |
Comprehensive Income (Loss), Net of Tax, Attributable to Parent | $ (10,269,229) | $ (7,180,441) |
Organization and Basis of Presentation |
3 Months Ended |
---|---|
Mar. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | Organization and Basis of Presentation Business Organization and Overview Trovagene, Inc. (“Trovagene” or the “Company”) is a molecular diagnostic company that focuses on the development and commercialization of a proprietary urine-based cell-free molecular diagnostic technology for use in disease detection and monitoring across a variety of medical disciplines. Trovagene’s primary internal focus is to leverage its novel urine-based molecular diagnostic platform to facilitate improvements in the field of oncology, while the Company’s external focus includes entering into collaborations to develop the Company’s technology in areas such as infectious disease, transplant medicine, and prenatal genetics. The Company’s goal is to improve treatment outcomes for cancer patients using its proprietary technology to detect and quantitatively monitor cell-free DNA in urine. Circulating tumor DNA (“ctDNA”) is a subtype of cell-free DNA, and represents the mutant cell-free DNA that we use to detect and monitor cancer. Basis of Presentation The accompanying consolidated financial statements of Trovagene, which include its wholly owned subsidiary, Trovagene, Srl, a subsidiary formed in Italy, have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). All intercompany balances and transactions have been eliminated. The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with GAAP and the rules and regulations of the Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed consolidated financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited interim condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2015 included in the Company’s annual report on Form 10-K filed with the SEC on March 10, 2016. |
Summary of Significant Accounting Policies |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with GAAP 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 revenues and expenses during the reporting period. Actual results could differ from those estimates. Revenue Recognition Revenue is recognized when persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collection is reasonably assured. Milestone, Royalty and License Revenues The Company licenses and sublicenses its patent rights to healthcare companies, medical laboratories and biotechnology partners. These agreements may involve multiple elements such as license fees, royalties and milestone payments. Revenue is recognized when the criteria described above have been met as well as the following: •Up-front nonrefundable license fees pursuant to agreements under which the Company has no continuing performance obligations are recognized as revenues on the effective date of the agreement and when collection is reasonably assured. •Minimum royalties are recognized as earned, and royalties in excess of minimum amounts are recognized upon receipt of payment when collection is assured. •Milestone payments are recognized when both the milestone is achieved and the related payment is received. Diagnostic Service Revenues Revenue for clinical laboratory tests may come from several sources, including commercial third-party payors, such as insurance companies and health maintenance organizations, government payors, such as Medicare and Medicaid in the United States, patient self-pay and, in some cases, from hospitals or referring laboratories who, in turn, might bill third-party payors for testing. The Company is recognizing diagnostic service revenue on the cash collection basis until such time as it is able to properly estimate collections on third party reimbursements. Derivative Financial Instruments—Warrants The Company has issued common stock warrants in connection with the execution of certain equity financings. Such warrants are classified as derivative liabilities under the provisions of Financial Accounting Standards Board (“FASB”) ASC 815 Derivatives and Hedging (“ASC 815”) and are recorded at their fair market value as of each reporting period. Such warrants do not meet the exemption that a contract should not be considered a derivative instrument if it is (1) indexed to its own stock and (2) classified in stockholders’ equity. Changes in fair value of derivative liabilities are recorded in the consolidated statement of operations under the caption “Change in fair value of derivative instruments.” The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the volatility of Trovagene’s common share price, the fair value of the underlying common shares, the remaining life of the warrant, and the risk-free interest rates at each period end. The Company thus uses model-derived valuations where inputs are observable in active markets to determine the fair value and accordingly classifies such warrants in Level 3 per ASC 820, Fair Value Measurements. At March 31, 2016, and December 31, 2015, the fair value of these warrants was $2,763,327 and $3,297,077, respectively, and were included in the derivative financial instruments liability on the balance sheet. Net Loss Per Share Basic and diluted net loss per share is presented in conformity with ASC Topic 260, Earnings per Share, for all periods presented. In accordance with this guidance, basic net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. Preferred dividends are included in income available to common stockholders in the computation of basic and diluted earnings per share. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common share equivalents outstanding for the period. Common share equivalents are only included when their effect is dilutive. The following table sets forth the computation of basic and diluted earnings per share:
The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their effect was anti-dilutive:
Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, Leases. The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact the adoption of the new standard will have on its consolidated financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern, which impacts the accounting guidance related to the evaluation of an entity’s ability to continue as a going concern. The amendment establishes management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern in connection with preparing financial statements for each annual and interim reporting period. The amendment also gives guidance to determine whether to disclose information about relevant conditions and events when there is substantial doubt about an entity’s ability to continue as a going concern. The amended guidance is effective prospectively for fiscal years beginning after December 15, 2016. The new guidance is not expected to have a material impact on the Company’s financial position, results of operations or cash flows. In May 2014, the FASB issued ASU 2014-9, Revenue from Contracts with Customers (“ASU 2014-9”). ASU 2014-9 provides companies with a single model for accounting for revenue arising from contracts with customers and supersedes current revenue recognition guidance, including industry-specific revenue guidance. The core principle of the model is to recognize revenue when control of the goods or services transfers to the customer, as opposed to recognizing revenue when the risks and rewards transfer to the customer under the existing revenue guidance. The guidance permits companies to either apply the requirements retrospectively to all prior periods presented, or apply the requirements in the year of adoption, through a cumulative adjustment. In August 2015, the FASB issued ASU 2015-14, Deferral of the Effective Date, which defers the required adoption date of ASU 2014-09 by one year. As a result of the deferred effective date, ASU 2014-09 will be effective for the Company in its first quarter of fiscal year 2018. Early adoption is permitted but not before the original effective date of the first quarter of fiscal year 2017. The Company is in the process of evaluating the transition method that will be elected and the impact of adoption of ASU 2014-09 on its consolidated financial statements. |
Fair Value Measurements |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | Fair Value Measurements The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of March 31, 2016 and December 31, 2015:
(1) Included as a component of cash and cash equivalents on the accompanying condensed consolidated balance sheets. The following table sets forth a summary of changes in the fair value of the Company’s Level 3 liabilities for the three months ended March 31, 2016:
The unrealized loss on the derivative liabilities is recorded as a change in fair value of derivative liabilities in the Company’s condensed consolidated statement of operations. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC Topic 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3. |
Property and Equipment |
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment | Property and Equipment Property and equipment consist of the following:
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Debt |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt | Debt Equipment Line of Credit In November 2015, the Company entered into a Loan and Security Agreement (“Equipment Line of Credit”) with Silicon Valley Bank that provided for cash borrowings for equipment (“Equipment Advances”) of up to $2.0 million, secured by the equipment financed. Under the terms of the agreement, interest is equal to 1.25% above the Prime Rate. Interest only payments are due on borrowings through November 30, 2016, with both interest and principal payments commencing in December 2016. Any equipment advances after November 30, 2016 are subject to principal and interest payments immediately over a 36-month period following the advance. All unpaid principal and interest on each Equipment Advance will be due on November 1, 2019. The Company has an obligation to make a final payment equal to 7% of total amounts borrowed at the loan maturity date. The Company is also subject to certain affirmative and negative covenants under the Equipment Line of Credit. As of March 31, 2016, the Company was in compliance with all covenants. As of March 31, 2016, $1,636,359 has been borrowed under the Equipment Line of Credit. As of March 31, 2016, amounts due under the Equipment Line of Credit included $181,818 in current liabilities and $1,462,260 in long-term liabilities, which includes $7,719 of accrued final payment. The Company recorded $21,179 in interest expense related to the Equipment Line of Credit during the year ended March 31, 2016. Future payments of long-term debt at March 31, 2016 are as follows:
Loan and Security Agreement In June 2014, the Company entered into a $15,000,000 loan and security agreement (“Agreement”) under which the lenders provided the Company a term loan, which was funded at closing. The interest rate is 7.07% per annum. Under the Agreement, the Company made interest only payments on the outstanding amount of the loan on a monthly basis through February 2016, after which equal monthly payments of principal and interest are due until the loan maturity date of July 1, 2018. The loan is secured by a security interest in all of the Company’s assets except intellectual property, which is subject to a negative pledge. In connection with the loan, the lenders received a warrant to purchase an aggregate 85,470 shares of the Company’s common stock at an exercise price of $3.51 per share exercisable for ten years from the date of issuance. The original value of the warrants, totaling $235,857, was recorded as debt discount and additional paid-in capital as the warrants were equity classified. As of March 31, 2016, a warrant to purchase 42,735 shares of common stock remains outstanding. At the Company’s option, it may prepay all of the outstanding principal balance, subject to certain pre-payment fees ranging from 1% to 3% of the prepayment amount. In the event of a final payment of the loans under the loan agreement, either in the event of repayment of the loan at maturity or upon any prepayment, the Company is obligated to pay the amortized portion of the final fee of $1,050,000. The Company is also subject to certain affirmative and negative covenants under the Agreement, including limitations on its ability to: undergo certain change of control events; convey, sell, lease, license, transfer or otherwise dispose of any equipment financed by loans under the loan agreement; create, incur, assume, guarantee or be liable with respect to indebtedness, subject to certain exceptions; grant liens on any equipment financed under the loan agreement; and make or permit any payment on specified subordinated debt. In addition, under the Agreement, subject to certain exceptions, the Company is required to maintain with the lender its primary operating, other deposit and securities accounts. Furthermore, under the amendment to the Agreement, the Company is required to be in compliance with healthcare laws and regulations and terms and conditions of healthcare permits. The Company was in compliance with all covenants as of March 31, 2016. As of March 31, 2016, amounts due under the Agreement include $5,752,026 in current liabilities and $8,827,028 in long-term liabilities, which include $623,182 of accrued final payment. The Company recorded $345,162 in interest expense related to the Agreement during the three months ended March 31, 2016. Future payments of long-term debt at March 31, 2016 are as follows:
Debt Agreement In February 2016, the Company signed a term sheet to refinance its existing term loan in June 2014. Under the term sheet, interest would be equal to 3.75% plus the Wall Street Journal Prime Rate, subject to a floor of 7.25%. Interest only payments would be for 12 months, followed by equal monthly payments of principal and interest over the following 30 months. The Company would also have an obligation to make a final payment equal to 7.50% of total funded amounts at the loan maturity date. In addition, the lenders would receive a warrant to purchase such number of shares of the Company’s common stock as is equal to 1% of the funded amount divided by an average closing price of the Company’s common stock. As of March 31, 2016, the refinancing documents have not been fully executed. |
Derivative Financial Instruments - Warrants |
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Derivative Financial Instruments - Warrants | Derivative Financial Instruments — Warrants Based upon the Company’s analysis of the criteria contained in ASC Topic 815-40, Contracts in Entity’s Own Equity, Trovagene determined that certain warrants issued in connection with the execution of certain equity financings must be recorded as derivative liabilities. In accordance with ASC Topic 815-40, the warrants are also being re-measured at each balance sheet date based on estimated fair value, and any resultant change in fair value is being recorded in the Company’s statement of operations. The Company estimates the fair value of these warrants using the Black-Scholes option pricing model. The assumptions used to determine the Black-Scholes fair value of the warrants during the periods indicated were:
Expected volatility is based on the volatility of a peer group of companies with attributes similar to Trovagene. The warrants have a transferability provision and based on guidance provided in SAB 107 for instruments issued with such a provision, Trovagene used the full contractual term as the expected term of the warrants. The risk free rate is based on the U.S. Treasury security rates consistent with the expected remaining term of the warrants at each balance sheet date. The following table sets forth the components of changes in the Company’s derivative financial instruments liability balance, valued using the Black-Scholes option pricing method, for the periods indicated.
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Stockholders' Equity |
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Stockholders' Equity | Stockholders’ Equity Common Stock During the three months ended March 31, 2016, the Company issued a total of 45,000 shares of Common Stock, all of which were issued upon exercise of options for a weighted average price of $2.97. Stock Options Stock-based compensation expense related to Trovagene options have been recognized in operating results as follow:
The unrecognized compensation cost related to non-vested stock options outstanding at March 31, 2016 and 2015, net of expected forfeitures, was $12,118,815 and $7,715,890, respectively, both to be recognized over a weighted-average remaining vesting period of approximately three years. The weighted average remaining contractual term of outstanding options as of March 31, 2016 was approximately eight years. The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following weighted average assumptions during the following periods indicated:
A summary of stock option activity and changes in stock options outstanding is presented below:
As of March 31, 2016, the Company had issued 996,000 options to its executive officers and non-employee directors that are over the authorized number of options in the Plan and are subject to shareholder approval. As per ASC Topic 815-40, the options have been accounted for as liabilities and recorded at fair value with the changes in fair value being recorded in the Company’s statement of operations. Once shareholder approval is obtained to increase the number of authorized shares, the liability will then be reversed into additional paid in capital. The Company has recorded a $217,333 liability for this amount in accrued expenses. The Trovagene Inc. 2014 Equity Incentive Plan (the “2014 EIP”) authorizing up to 2,500,000 shares of common stock for issuance under the Plan was approved by the Board of Directors in June 2014 and approved by the Shareholders at the September 17, 2014 Annual Shareholders’ Meeting. An additional 2,500,000 shares of common stock for issuance was authorized by the Board of Directors in March 2015 and approved by the Shareholders at the June 10, 2015 Annual Shareholders’ Meeting. As of March 31, 2016, excluding the options to purchase an aggregate of 996,000 shares granted to our executive officers and non-employee directors that are subject to stockholder approval, there were 887,911 shares available for issuance under the 2014 EIP. The Company will hold the Annual Shareholders' Meeting on May 17, 2016 to consider and act upon a proposal to approve an amendment to the 2014 EIP to increase the number of shares issuable to 7,500,000 shares from 5,000,000 shares. Warrants A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications is presented below:
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Commitments and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Employment and Consulting Agreements The Company has longer-term contractual commitments with various consultants and employees. Certain employment agreements provide for severance payments. Lease Agreement The Company currently leases approximately 22,600 square feet of office and laboratory space at a monthly rental rate of approximately $60,000. The lease will expire on December 31, 2021. The Company also leases certain office building in Torino, Italy, consisting of approximately 2,300 square feet at a monthly rental rate of approximately $3,100. The lease is for a period of three years and expires December 31, 2018. Research and Development Agreements The Company has entered into a variety of collaboration and specimen transfer agreements relating to its development efforts. Included in research and development expense, the Company has recorded approximately $317,000 for the three months ended March 31, 2016 relating to services provided by the collaborators in connection with these agreements. The Company is a party to various agreements under which it licenses technology on an exclusive basis in the field of human diagnostics. License fees are generally calculated as a percentage of product revenues, with rates that vary by agreement. To date, payments have not been material. Other Matters The Company may be subject to litigation or administrative proceedings related to our business, such as claims related to employment practices, commercial disputes, or patent infringement. Responding to litigation or administrative proceedings, regardless of whether they have merit, can be expensive and disruptive to normal business operations. We are not able to predict the timing or outcome of these matters. |
Related Party Transactions |
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Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions In September 2015, the Company entered into a research agreement with University of Turin (“University”) to collaborate on a program of research to develop, optimize and test molecular profiling tools for plasma and urine ctDNA in cancer. Dr. Alberto Bardelli, the Principal Investigator of the University who oversees this research program is also a member of the Scientific Advisory Board of the Company. Under the agreement, the Company has committed to pay up to $529,000 for the services performed by the University. In addition, the Company may pay royalties to the University on revenue generated by the Company from the commercialization of any tools developed during the collaboration. As of March 31, 2016, the Company has incurred and recorded approximately $146,000 of research and development expenses related to the agreement. No royalty expense has been incurred as of March 31, 2016. |
Subsequent events (Notes) |
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Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events Employment Agreement In May 2016, the Company entered into an employment agreement with Mr. William J. Welch in which he agreed to serve as the Chief Executive Officer. The term of the agreement is effective as of May 6, 2016. Mr. Welch’s base compensation is $475,000 per year. Mr. Welch is eligible to receive an annual bonus of up to 50% of his base compensation based on meeting certain performance objectives and bonus criteria. Upon entering the agreement, Mr. Welch was granted an option to purchase 750,000 shares of Common Stock. The options have an exercise price of $4.73 per share and will vest over four years. If employment is terminated by the Company without cause or by Mr. Welch for good reason, Mr. Welch is entitled to receive a severance payment equal to base compensation for 24 months and the potential bonus and any benefits Mr. Welch would be eligible for during that 24 month period. If the employment is terminated as a result of a change of control, in addition to the severance payment described above, all unvested equity awards would immediately vest and become fully exercisable. Lease Agreement On April 4, 2016, the Company entered into an amendment to the lease agreement to add approximately 3,500 square feet of office space at a monthly rental rate of approximately $8,300. The amended lease will expire on December 31, 2021 and is expected to commence at the end of 2016. |
Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP 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 revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Revenue Recognition | Revenue Recognition Revenue is recognized when persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collection is reasonably assured. Milestone, Royalty and License Revenues The Company licenses and sublicenses its patent rights to healthcare companies, medical laboratories and biotechnology partners. These agreements may involve multiple elements such as license fees, royalties and milestone payments. Revenue is recognized when the criteria described above have been met as well as the following: •Up-front nonrefundable license fees pursuant to agreements under which the Company has no continuing performance obligations are recognized as revenues on the effective date of the agreement and when collection is reasonably assured. •Minimum royalties are recognized as earned, and royalties in excess of minimum amounts are recognized upon receipt of payment when collection is assured. •Milestone payments are recognized when both the milestone is achieved and the related payment is received. Diagnostic Service Revenues Revenue for clinical laboratory tests may come from several sources, including commercial third-party payors, such as insurance companies and health maintenance organizations, government payors, such as Medicare and Medicaid in the United States, patient self-pay and, in some cases, from hospitals or referring laboratories who, in turn, might bill third-party payors for testing. The Company is recognizing diagnostic service revenue on the cash collection basis until such time as it is able to properly estimate collections on third party reimbursements. |
Derivative Financial Instruments-Warrants | Derivative Financial Instruments—Warrants The Company has issued common stock warrants in connection with the execution of certain equity financings. Such warrants are classified as derivative liabilities under the provisions of Financial Accounting Standards Board (“FASB”) ASC 815 Derivatives and Hedging (“ASC 815”) and are recorded at their fair market value as of each reporting period. Such warrants do not meet the exemption that a contract should not be considered a derivative instrument if it is (1) indexed to its own stock and (2) classified in stockholders’ equity. Changes in fair value of derivative liabilities are recorded in the consolidated statement of operations under the caption “Change in fair value of derivative instruments.” The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the volatility of Trovagene’s common share price, the fair value of the underlying common shares, the remaining life of the warrant, and the risk-free interest rates at each period end. The Company thus uses model-derived valuations where inputs are observable in active markets to determine the fair value and accordingly classifies such warrants in Level 3 per ASC 820, Fair Value Measurements. |
Net Loss Per Share | Net Loss Per Share Basic and diluted net loss per share is presented in conformity with ASC Topic 260, Earnings per Share, for all periods presented. In accordance with this guidance, basic net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. Preferred dividends are included in income available to common stockholders in the computation of basic and diluted earnings per share. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common share equivalents outstanding for the period. Common share equivalents are only included when their effect is dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, Leases. The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact the adoption of the new standard will have on its consolidated financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern, which impacts the accounting guidance related to the evaluation of an entity’s ability to continue as a going concern. The amendment establishes management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern in connection with preparing financial statements for each annual and interim reporting period. The amendment also gives guidance to determine whether to disclose information about relevant conditions and events when there is substantial doubt about an entity’s ability to continue as a going concern. The amended guidance is effective prospectively for fiscal years beginning after December 15, 2016. The new guidance is not expected to have a material impact on the Company’s financial position, results of operations or cash flows. In May 2014, the FASB issued ASU 2014-9, Revenue from Contracts with Customers (“ASU 2014-9”). ASU 2014-9 provides companies with a single model for accounting for revenue arising from contracts with customers and supersedes current revenue recognition guidance, including industry-specific revenue guidance. The core principle of the model is to recognize revenue when control of the goods or services transfers to the customer, as opposed to recognizing revenue when the risks and rewards transfer to the customer under the existing revenue guidance. The guidance permits companies to either apply the requirements retrospectively to all prior periods presented, or apply the requirements in the year of adoption, through a cumulative adjustment. In August 2015, the FASB issued ASU 2015-14, Deferral of the Effective Date, which defers the required adoption date of ASU 2014-09 by one year. As a result of the deferred effective date, ASU 2014-09 will be effective for the Company in its first quarter of fiscal year 2018. Early adoption is permitted but not before the original effective date of the first quarter of fiscal year 2017. The Company is in the process of evaluating the transition method that will be elected and the impact of adoption of ASU 2014-09 on its consolidated financial statements. |
Summary of Significant Accounting Policies (Tables) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Computation of Basic and Diluted Earnings per Share | The following table sets forth the computation of basic and diluted earnings per share:
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Schedule of Antidilutive Securities Excluded from the Calculation of Diluted Net Loss per Share | The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their effect was anti-dilutive:
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Fair Value Measurements (Tables) |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of the Company’s Assets and Liabilities that are Measured and Recognized at Fair Value on a Recurring Basis Classified Under the Appropriate Level of the Fair Value Hierarchy | The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of March 31, 2016 and December 31, 2015:
(1) Included as a component of cash and cash equivalents on the accompanying condensed consolidated balance sheets. |
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Schedule of Changes in the Fair Value of the Company’s Level 3 Liabilities | The following table sets forth a summary of changes in the fair value of the Company’s Level 3 liabilities for the three months ended March 31, 2016:
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Property and Equipment (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Components of Property and Equipment | Property and equipment consist of the following:
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Debt (Tables) |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||
Schedule of Maturities of Long-term Debt |
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Schedule of Future Minimum Principal Payments Under Loan and Security Agreement | Future payments of long-term debt at March 31, 2016 are as follows:
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Derivative Financial Instruments - Warrants (Tables) - Black Scholes Option Pricing Method |
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Derivative financial instruments | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Assumptions Used to Determine the Fair Value of the Warrants | The assumptions used to determine the Black-Scholes fair value of the warrants during the periods indicated were:
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Schedule of Components of Changes in the Company’s Derivative Financial Instruments Liability Balance | The following table sets forth the components of changes in the Company’s derivative financial instruments liability balance, valued using the Black-Scholes option pricing method, for the periods indicated.
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Stockholders' Equity (Tables) |
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Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock-Based Compensation Expense | Stock-based compensation expense related to Trovagene options have been recognized in operating results as follow:
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Schedule of Assumptions to Estimate Fair Value of Stock Option Awards | The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following weighted average assumptions during the following periods indicated:
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Summary of Stock Option Activity and of Changes in Stock Options Outstanding | A summary of stock option activity and changes in stock options outstanding is presented below:
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Summary of Warrant Activity and Changes in Warrants Outstanding | A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications is presented below:
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Summary of Significant Accounting Policies (Details) - USD ($) |
Mar. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Derivative financial instruments | ||
Derivative liabilities related to warrants | $ 2,763,327 | $ 3,297,077 |
Warrants | Black Scholes Option Pricing Method | ||
Derivative financial instruments | ||
Derivative liabilities related to warrants | $ 2,763,327 | $ 3,297,077 |
Summary of Significant Accounting Policies (Details 2) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
|
Numerator: | ||
Numerator: Net loss attributable to common shareholders | $ (10,268,578) | $ (7,180,441) |
Adjustment for change in fair value of derivative instruments - warrants | (533,750) | 0 |
Net loss used for diluted loss per share | $ (10,802,328) | $ (7,180,441) |
Denominator for basic and diluted net loss per share: | ||
Weighted average shares used to compute basic loss per share | 29,755,184 | 21,817,710 |
Adjustments to reflect assumed exercise of warrants | 353,193 | 0 |
Weighted average shares used to compute diluted net loss per share | 30,108,377 | 21,817,710 |
Net loss per share attributable to common stockholders: | ||
Net loss per common share - basic (in USD per share) | $ (0.35) | $ (0.33) |
Net loss per common share - diluted (in USD per share) | $ (0.36) | $ (0.33) |
Summary of Significant Accounting Policies (Details 3) - shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
|
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 12,696,096 | 11,932,215 |
Stock options | ||
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 8,117,024 | 5,875,138 |
Warrants | ||
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 4,515,947 | 5,993,952 |
Series A Convertible Preferred Stock | ||
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 63,125 | 63,125 |
Fair Value Measurements (Details) - USD ($) |
Mar. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Liabilities: | ||
Derivative liabilities related to warrants | $ 2,763,327 | $ 3,297,077 |
Recurring basis | ||
Assets: | ||
Money market fund | 59,070,272 | 65,016,222 |
Total Assets | 59,070,272 | 65,016,222 |
Liabilities: | ||
Derivative liabilities related to warrants | 2,763,327 | 3,297,077 |
Total Liabilities | 2,763,327 | 3,297,077 |
Recurring basis | Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1) | ||
Assets: | ||
Money market fund | 59,070,272 | 65,016,222 |
Total Assets | 59,070,272 | 65,016,222 |
Recurring basis | Significant Unobservable Inputs (Level 3) | ||
Liabilities: | ||
Derivative liabilities related to warrants | 2,763,327 | 3,297,077 |
Total Liabilities | $ 2,763,327 | $ 3,297,077 |
Fair Value Measurements (Details 2) - Warrants |
3 Months Ended |
---|---|
Mar. 31, 2016
USD ($)
| |
Reconciliation of the beginning and ending balances | |
Balance at December 31, 2015 | $ 3,297,077 |
Unrealized gain | (533,750) |
Balance at March 31, 2016 | $ 2,763,327 |
Property and Equipment (Details) - USD ($) |
Mar. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | $ 5,755,929 | $ 3,545,361 |
Less—accumulated depreciation and amortization | (1,010,148) | (854,782) |
Property and equipment, net | 4,745,781 | 2,690,579 |
Furniture and office equipment | ||
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | 1,509,546 | 1,483,227 |
Leasehold Improvements | ||
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | 1,952,180 | 39,401 |
Laboratory equipment | ||
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | $ 2,294,203 | $ 2,022,733 |
Stockholders' Equity (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
|
Proceeds from sales of common stock, net of expenses | $ 0 | $ 21,445,785 |
Exercised warrants (in shares) | 50,000 | |
Common Stock | ||
Shares of common stock issued | 45,000 | |
Common Stock | Option exercise price, weighted average of $3.31 per share | ||
Exercise price of stock options exercised (in USD per share) | $ 2.97 |
Stockholders' Equity (Details 2) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
|
Stock-based compensation expense | ||
Total stock based compensation expense | $ 2,811,108 | $ 711,741 |
Research and Development Expense | ||
Stock-based compensation expense | ||
Total stock based compensation expense | 398,741 | 289,197 |
Cost of Revenue | ||
Stock-based compensation expense | ||
Total stock based compensation expense | 18,297 | 26,706 |
Selling and Marketing Expense | ||
Stock-based compensation expense | ||
Total stock based compensation expense | 578,721 | 80,488 |
General and Administrative Expense | ||
Stock-based compensation expense | ||
Total stock based compensation expense | $ 1,815,349 | $ 315,350 |
Stockholders' Equity (Details 4) - $ / shares |
3 Months Ended | 12 Months Ended |
---|---|---|
Mar. 31, 2016 |
Dec. 31, 2015 |
|
Number of Warrants | ||
Balance of warrants outstanding at the beginning of the period (in shares) | 5,533,242 | |
Exercised (in shares) | (50,000) | |
Balance of warrants outstanding at the end of the period (in shares) | 5,483,242 | 5,533,242 |
Weighted Average Exercise Price Per Share | ||
Weighted average exercise price of warrants at the beginning of the period (in USD per share) | $ 3.86 | |
Exercised (in USD per share) | 8.00 | |
Weighted average exercise price of warrants at the end of the period (in USD per share) | $ 3.82 | $ 3.86 |
Term | ||
Weighted Average Remaining Contractual Term | 2 years 3 months 18 days | 2 years 6 months |
Commitments and Contingencies (Details) |
1 Months Ended | 3 Months Ended | |
---|---|---|---|
Jun. 11, 2015
USD ($)
ft²
|
Nov. 30, 2015
USD ($)
ft²
|
Mar. 31, 2016
USD ($)
|
|
Lease Agreements | |||
Area of Land | ft² | 22,600 | 2,300 | |
Operating Lease Monthly Rent | $ 60,000 | $ 3,100 | |
Lessee Leasing Arrangements, Operating Leases, Term of Contract | 3 years | ||
Research and Development Agreements | Research and Development Expense | |||
Lease Agreements | |||
Revenue and license fee expense | $ 317,000 |
Related Party Transactions (Details) - Scientific Advisory Board Member |
3 Months Ended |
---|---|
Mar. 31, 2016
USD ($)
| |
Related Party Transaction [Line Items] | |
Commitment to pay for services performed, related party | $ 529,000 |
Research and development expense with related party | 146,000 |
Royalty expense | $ 0 |
Subsequent events Lease agreement (Details) |
1 Months Ended | ||
---|---|---|---|
Apr. 04, 2016
USD ($)
ft²
|
Jun. 11, 2015
USD ($)
ft²
|
Nov. 30, 2015
USD ($)
ft²
|
|
Subsequent Event [Line Items] | |||
Area of Land | ft² | 22,600 | 2,300 | |
Operating Lease Monthly Rent | $ | $ 60,000 | $ 3,100 | |
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Area of Land | ft² | 3,500 | ||
Operating Lease Monthly Rent | $ | $ 8,300 |
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