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 | ||
September 30, 2016 | December 31, 2015 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 22,569,107 | $ | 67,493,047 | |||
Short-term investments | 24,376,904 | — | |||||
Accounts receivable | 85,152 | 98,736 | |||||
Prepaid expenses and other assets | 946,388 | 789,285 | |||||
Total current assets | 47,977,551 | 68,381,068 | |||||
Property and equipment, net | 4,654,876 | 2,690,579 | |||||
Other assets | 371,243 | 374,004 | |||||
Total Assets | $ | 53,003,670 | $ | 71,445,651 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 925,173 | $ | 1,040,868 | |||
Accrued expenses | 4,558,809 | 1,903,797 | |||||
Deferred rent | 279,710 | 30,614 | |||||
Current portion of long-term debt | 801,024 | 5,225,818 | |||||
Total current liabilities | 6,564,716 | 8,201,097 | |||||
Long-term debt, less current portion | 15,595,400 | 11,246,188 | |||||
Derivative financial instruments - warrants | 2,622,243 | 3,297,077 | |||||
Deferred rent, net of current portion | 1,446,912 | — | |||||
Total Liabilities | 26,229,271 | 22,744,362 | |||||
Commitments and contingencies (Note 9) | |||||||
Stockholders’ equity | |||||||
Preferred stock, $0.001 par value, 20,000,000 shares authorized; 60,600 shares outstanding at September 30, 2016 and December 31, 2015; designated as Series A Convertible Preferred Stock with liquidation preference of $606,000 at September 30, 2016 and December 31, 2015 | 60 | 60 | |||||
Common stock, $0.0001 par value, 150,000,000 shares authorized; 30,599,140 and 29,737,601 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 3,060 | 2,974 | |||||
Additional paid-in capital | 166,337,512 | 157,585,498 | |||||
Accumulated other comprehensive loss | (4,742 | ) | — | ||||
Accumulated deficit | (139,561,491 | ) | (108,887,243 | ) | |||
Total stockholders’ equity | 26,774,399 | 48,701,289 | |||||
Total liabilities and stockholders’ equity | $ | 53,003,670 | $ | 71,445,651 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Revenues: | |||||||||||||||
Royalties | $ | 47,236 | $ | 51,301 | $ | 207,869 | $ | 222,931 | |||||||
Diagnostic services | 37,978 | 6,026 | 69,558 | 10,712 | |||||||||||
Clinical research services | 3,900 | — | 35,573 | — | |||||||||||
Total revenues | 89,114 | 57,327 | 313,000 | 233,643 | |||||||||||
Costs and expenses: | |||||||||||||||
Cost of revenues | 424,559 | 173,537 | 1,143,293 | 429,992 | |||||||||||
Research and development | 3,937,398 | 2,546,533 | 11,221,876 | 7,428,349 | |||||||||||
Selling and marketing | 2,940,862 | 1,798,263 | 9,127,450 | 4,508,766 | |||||||||||
General and administrative | 2,710,782 | 1,948,546 | 9,183,761 | 5,756,047 | |||||||||||
Total operating expenses | 10,013,601 | 6,466,879 | 30,676,380 | 18,123,154 | |||||||||||
Loss from operations | (9,924,487 | ) | (6,409,552 | ) | (30,363,380 | ) | (17,889,511 | ) | |||||||
Net interest expense | (354,993 | ) | (335,359 | ) | (967,522 | ) | (1,100,080 | ) | |||||||
Gain (loss) from change in fair value of derivative financial instruments — warrants | 88,208 | 4,017,212 | 674,834 | (1,105,270 | ) | ||||||||||
Other income (loss), net | — | (8,130 | ) | — | 4,617 | ||||||||||
Net loss | (10,191,272 | ) | (2,735,829 | ) | (30,656,068 | ) | (20,090,244 | ) | |||||||
Preferred stock dividend | (6,060 | ) | (6,060 | ) | (18,180 | ) | (18,180 | ) | |||||||
Net loss attributable to common stockholders | $ | (10,197,332 | ) | $ | (2,741,889 | ) | $ | (30,674,248 | ) | $ | (20,108,424 | ) | |||
Net loss per common share — basic | $ | (0.34 | ) | $ | (0.10 | ) | $ | (1.02 | ) | $ | (0.80 | ) | |||
Net loss per common share — diluted | $ | (0.34 | ) | $ | (0.23 | ) | $ | (1.04 | ) | $ | (0.96 | ) | |||
Weighted average shares outstanding — basic | 30,339,774 | 28,560,211 | 30,018,841 | 25,014,966 | |||||||||||
Weighted average shares outstanding — diluted | 30,339,774 | 29,128,235 | 30,136,572 | 25,204,307 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Net loss | $ | (10,191,272 | ) | $ | (2,735,829 | ) | $ | (30,656,068 | ) | $ | (20,090,244 | ) | |||
Other comprehensive loss: | |||||||||||||||
Foreign currency translation loss | (81 | ) | — | (1,877 | ) | — | |||||||||
Unrealized loss on securities available-for-sale | (7,997 | ) | — | (2,865 | ) | — | |||||||||
Total other comprehensive loss | (8,078 | ) | — | (4,742 | ) | — | |||||||||
Total comprehensive loss | (10,199,350 | ) | (2,735,829 | ) | (30,660,810 | ) | (20,090,244 | ) | |||||||
Preferred stock dividend | (6,060 | ) | (6,060 | ) | (18,180 | ) | (18,180 | ) | |||||||
Comprehensive loss attributable to common stockholders | $ | (10,205,410 | ) | $ | (2,741,889 | ) | $ | (30,678,990 | ) | $ | (20,108,424 | ) |
Nine Months Ended September 30, | |||||||
2016 | 2015 | ||||||
Operating activities | |||||||
Net loss | $ | (30,656,068 | ) | $ | (20,090,244 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Net gain on disposal of fixed assets | — | 4,562 | |||||
Depreciation and amortization | 693,485 | 250,600 | |||||
Stock based compensation expense | 5,942,392 | 2,758,847 | |||||
Accretion of final fee premium | 266,423 | 253,028 | |||||
Amortization of discount on debt | 105,710 | 59,665 | |||||
Amortization of premiums on short-term investments | 61,719 | — | |||||
Deferred rent | (133,378 | ) | — | ||||
Interest income accrued on short-term investments | 10,122 | — | |||||
Change in fair value of derivative financial instruments - warrants | (674,834 | ) | 1,105,270 | ||||
Changes in operating assets and liabilities: | |||||||
Decrease (increase) in other assets | 2,761 | (10,273 | ) | ||||
Decrease (increase) in accounts receivable | 13,584 | (231,672 | ) | ||||
Increase in prepaid expenses | (157,051 | ) | (26,238 | ) | |||
Increase in accounts payable and accrued expenses | 2,490,137 | 616,366 | |||||
Net cash used in operating activities | (22,034,998 | ) | (15,310,089 | ) | |||
Investing activities: | |||||||
Capital expenditures, net | (797,781 | ) | (1,256,988 | ) | |||
Net purchases of short-term investments | (24,451,611 | ) | — | ||||
Net cash used in investing activities | (25,249,392 | ) | (1,256,988 | ) | |||
Financing activities: | |||||||
Proceeds from sales of common stock, net of expenses | 2,293,857 | 61,215,398 | |||||
Proceeds from exercise of options | 366,966 | 818,251 | |||||
Proceeds from exercise of warrants | — | 1,389,427 | |||||
Borrowings under equipment line of credit | 792,251 | — | |||||
Borrowings under long-term debt, net of costs | 7,805,086 | — | |||||
Repayments of long-term debt | (8,896,166 | ) | — | ||||
Net cash provided by financing activities | 2,361,994 | 63,423,076 | |||||
Effect of exchange rate changes on cash and cash equivalents | (1,544 | ) | — | ||||
Net change in cash and equivalents | (44,923,940 | ) | 46,855,999 | ||||
Cash and cash equivalents—Beginning of period | 67,493,047 | 27,293,798 | |||||
Cash and cash equivalents—End of period | $ | 22,569,107 | $ | 74,149,797 | |||
Supplementary disclosure of cash flow activity: | |||||||
Cash paid for taxes | $ | 4,560 | $ | 800 | |||
Cash paid for interest | $ | 806,228 | $ | 795,375 | |||
Supplemental disclosure of non-cash investing and financing activities: | |||||||
Preferred stock dividends accrued | $ | 18,180 | $ | 18,180 | |||
Warrants issued in connection with Amendment to the Loan and Security Agreement | $ | 148,885 | $ | — | |||
Reclassification of derivative financial instruments - warrants to additional paid in capital | $ | — | $ | 435,365 | |||
Leasehold improvements paid for by lessor | $ | 1,860,000 | $ | — |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Numerator: Net loss attributable to common shareholders | $ | (10,197,332 | ) | $ | (2,741,889 | ) | $ | (30,674,248 | ) | $ | (20,108,424 | ) | |||
Adjustment for (gain) loss from change in fair value of derivative financial instruments - warrants | — | (4,017,212 | ) | (533,750 | ) | (4,017,212 | ) | ||||||||
Net loss used for diluted loss per share | $ | (10,197,332 | ) | $ | (6,759,101 | ) | $ | (31,207,998 | ) | $ | (24,125,636 | ) | |||
Denominator for basic and diluted net loss per share: | |||||||||||||||
Weighted average shares used to compute basic loss per share | 30,339,774 | 28,560,211 | 30,018,841 | 25,014,966 | |||||||||||
Adjustments to reflect assumed exercise of warrants | — | 568,024 | 117,731 | 189,341 | |||||||||||
Weighted average shares used to compute diluted net loss per share | 30,339,774 | 29,128,235 | 30,136,572 | 25,204,307 | |||||||||||
Net loss per share attributable to common stockholders: | |||||||||||||||
Basic | $ | (0.34 | ) | $ | (0.10 | ) | $ | (1.02 | ) | $ | (0.80 | ) | |||
Diluted | $ | (0.34 | ) | $ | (0.23 | ) | $ | (1.04 | ) | $ | (0.96 | ) |
September 30, | |||||
2016 | 2015 | ||||
Options to purchase Common Stock | 6,051,186 | 6,514,130 | |||
Warrants to purchase Common Stock | 4,546,939 | 4,565,947 | |||
Restricted Stock Units | 392,000 | — | |||
Series A Convertible Preferred Stock | 63,125 | 63,125 | |||
11,053,250 | 11,143,202 |
Fair Value Measurements at September 30, 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) | $ | 19,841,032 | $ | — | $ | — | $ | 19,841,032 | |||||||
Corporate debt securities (2) | — | 15,887,439 | — | 15,887,439 | |||||||||||
Commercial paper (2) | — | 8,489,465 | — | 8,489,465 | |||||||||||
Total Assets | $ | 19,841,032 | $ | 24,376,904 | $ | — | $ | 44,217,936 | |||||||
Liabilities: | |||||||||||||||
Derivative financial instruments - warrants | $ | — | $ | — | $ | 2,622,243 | $ | 2,622,243 | |||||||
Total Liabilities | $ | — | $ | — | $ | 2,622,243 | $ | 2,622,243 |
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 financial instruments - 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 September 30, 2016 | |||||||||
Derivative financial instruments - warrants | $ | 3,297,077 | $ | (674,834 | ) | $ | 2,622,243 |
Unrealized | |||||||||||||||||
Maturity in Years | Cost | Gains | Losses | Fair Value | |||||||||||||
Corporate debt securities | Less than 1 year | $ | 15,890,304 | $ | 2,162 | $ | (5,027 | ) | $ | 15,887,439 | |||||||
Commercial paper | Less than 1 year | 8,489,465 | — | — | 8,489,465 | ||||||||||||
Total Investment | $ | 24,379,769 | $ | 2,162 | $ | (5,027 | ) | $ | 24,376,904 |
As of September 30, 2016 | As of December 31, 2015 | ||||||
Furniture and office equipment | $ | 1,727,321 | $ | 1,483,227 | |||
Leasehold improvements | 1,994,514 | 39,401 | |||||
Laboratory equipment | 2,472,444 | 2,022,733 | |||||
6,194,279 | 3,545,361 | ||||||
Less—accumulated depreciation and amortization | (1,539,403 | ) | (854,782 | ) | |||
Property and equipment, net | $ | 4,654,876 | $ | 2,690,579 |
2016 | $ | 104,351 | |
2017 | 626,104 | ||
2018 | 626,104 | ||
2019 | 521,753 | ||
Total principal | 1,878,312 | ||
Plus final fee premium accretion | 23,972 | ||
Total long-term obligations | $ | 1,902,284 |
2016 | $ | — | |
2017 | 2,000,000 | ||
2018 | 6,000,000 | ||
2019 | 6,000,000 | ||
2020 | 1,000,000 | ||
Total principal | 15,000,000 | ||
Less discount | (582,435 | ) | |
Plus final fee premium accretion | 76,575 | ||
Total long-term obligations | $ | 14,494,140 |
Nine Months Ended September 30, | |||||
2016 | 2015 | ||||
Estimated fair value of Trovagene common stock | 4.49-4.65 | 5.69-10.15 | |||
Expected warrant term | 2.3-2.8 years | 3.3-3.8 years | |||
Risk-free interest rate | 0.71-0.87% | 0.89-1.01% | |||
Expected volatility | 82-90% | 75-77% | |||
Dividend yield | 0 | % | 0 | % |
Date | Description | Number of Warrants | Derivative Instrument Liability | ||||||
December 31, 2015 | Balance of derivative financial instruments - warrants liability | 967,295 | $ | 3,297,077 | |||||
Change in fair value of derivative financial instruments - warrants during the period recognized as a gain in the condensed consolidated statements of operations | — | (674,834 | ) | ||||||
September 30, 2016 | Balance of derivative financial instruments - warrants liability | 967,295 | $ | 2,622,243 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Included in research and development expense | $ | 872,792 | $ | 342,122 | $ | 1,862,069 | $ | 1,054,443 | |||||||
Included in cost of revenue | 42,639 | 7,518 | 99,164 | 22,468 | |||||||||||
Included in selling and marketing expense | 476,865 | 225,892 | 1,493,744 | 480,006 | |||||||||||
Included in general and administrative expense | 437,075 | 348,127 | 2,487,415 | 1,201,929 | |||||||||||
Total stock-based compensation expense | $ | 1,829,371 | $ | 923,659 | $ | 5,942,392 | $ | 2,758,846 |
Nine Months Ended September 30, | |||||
2016 | 2015 | ||||
Risk-free interest rate | 1.48 | % | 1.77 | % | |
Dividend yield | 0 | % | 0 | % | |
Expected volatility | 103 | % | 76 | % | |
Expected term | 5.5 years | 6.1 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 | 3,234,750 | 5.02 | ||||||||
Exercised | (1,335,271 | ) | 3.81 | |||||||
Canceled / Forfeited | (2,690,146 | ) | 5.44 | |||||||
Expired | (106,777 | ) | 11.14 | |||||||
Balance outstanding, September 30, 2016 | 6,051,186 | 5.49 | 1,724,990 | |||||||
Exercisable at September 30, 2016 | 2,287,028 | 5.13 | 1,325,134 |
Number of Shares | Weighted Average Grant Date Fair Value Per Share | |||||
Non-vested restricted stock units outstanding, December 31, 2015 | — | $ | — | |||
Granted | 402,000 | 4.06 | ||||
Forfeited | (10,000 | ) | 3.99 | |||
Non-vested restricted stock units outstanding, September 30, 2016 | 392,000 | 4.06 |
Total Warrants | Weighted Average Exercise Price Per Share | Weighted Average Remaining Contractual Term | ||||||
Balance outstanding, December 31, 2015 | 5,533,242 | $ | 3.86 | 2.50 | ||||
Granted | 30,992 | 4.84 | ||||||
Expired | (50,000 | ) | 8.00 | |||||
Balance outstanding, September 30, 2016 | 5,514,234 | 3.82 | 1.85 |
• | Entered into preferred provider agreements with Blue Cross Blue Shield Illinois, 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 168 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. |
• | 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. |
• | Presented clinical study results for our Trovera™ ctDNA tests at the 2016 ASCO Annual Meeting. Results demonstrated highly sensitive detection of EGFR T790M mutations and validated urine ctDNA testing as an alternative to tissue and plasma. |
• | Entered into a clinical collaboration with the University of Michigan for monitoring and early detection of pancreatic cancer utilizing the TroveraTM KRAS ctDNA liquid biopsy test. |
• | Entered into a clinical collaboration with the USC Norris Comprehensive Cancer Center to standardize the use of TroveraTM ctDNA liquid biopsy test in patient care. |
• | Published study results in the Journal of Thoracic Oncology that demonstrate the clinical and analytical validity of the Trovera™ urine and blood-based liquid biopsy tests to assess EGFR T790M mutational status. The data shows that the Trovera™ test successfully identifies EGFR mutations, and has high concordance with tumor tissue. |
• | Presented clinical study results for our Trovera™ tests at the 3rd Annual Precision Medicine Congress. The presentation highlighted Trovera'sTM clinical utility in identifying driver mutations as well as the potential benefits of liquid biopsies, including: patient response to therapy, progression monitoring, and early detection. |
• | Entered into a partnership with the Pancreatic Cancer Action Network (PanCAN) to be the liquid biopsy provider for Precision Promise--the first large-scale precision medicine trial designed to transform care and treatment for patients with pancreatic cancer. |
• | Published study results in Experimental Hematology & Oncology that illustrates the clinical utility of using Trovera™ urine liquid biopsy to confirm the presence of EGFR T790M mutational status in a patient with late-stage non-small cell lung cancer. The study concluded that ctDNA analysis should be considered a valuable diagnostic tool in treatment decision-making. |
• | Invited to present four abstracts at the International Association for the Study of Lung Cancer's (IASLC) 17th World Conference on Lung Cancer. The presentation will focus on the clinical utility of Trovera™ in detection and monitoring of the EGFR T790M resistance mutation in non-small cell lung cancer. The presentation will also include first health outcomes and a total cost of care analysis, demonstrating that a urine-testing strategy shows improved cost-savings and patients' experiences compared to a tissue-testing strategy. |
• | Invited to present at the 31st International Papillomavirus Conference. Two abstracts will be presented. The first demonstrates clinical performance of urine and cervical samples in a Chinese screening population. These results support the utility of urine testing for cervical cancer screening among this population. The second abstract describes the analytical performance of the Trovagene HPV-UR urine test. |
Three Months Ended September 30, | |||||||||||
2016 | 2015 | Increase (Decrease) | |||||||||
Royalties | $ | 47,236 | $ | 51,301 | $ | (4,065 | ) | ||||
Diagnostic services | 37,978 | 6,026 | 31,952 | ||||||||
Clinical research services | $ | 3,900 | $ | — | 3,900 | ||||||
Total revenues | $ | 89,114 | $ | 57,327 | $ | 31,787 |
Three Months Ended September 30, | |||||||||||
2016 | 2015 | Increase (Decrease) | |||||||||
Salaries and staff costs | $ | 1,407,529 | $ | 1,037,831 | $ | 369,698 | |||||
Stock-based compensation | 872,792 | 342,122 | 530,670 | ||||||||
Outside services, consultants and lab supplies | 1,215,889 | 901,662 | 314,227 | ||||||||
Facilities | 372,891 | 193,926 | 178,965 | ||||||||
Travel and scientific conferences | 51,203 | 52,684 | (1,481 | ) | |||||||
Other | 17,094 | 18,308 | (1,214 | ) | |||||||
Total research and development | $ | 3,937,398 | $ | 2,546,533 | $ | 1,390,865 |
Three Months Ended September 30, | |||||||||||
2016 | 2015 | Increase (Decrease) | |||||||||
Salaries and staff costs | $ | 1,427,254 | $ | 681,421 | $ | 745,833 | |||||
Stock-based compensation | 476,865 | 225,892 | 250,973 | ||||||||
Outside services and consultants | 441,699 | 218,582 | 223,117 | ||||||||
Facilities | 112,573 | 70,665 | 41,908 | ||||||||
Trade shows, conferences and marketing | 243,692 | 432,123 | (188,431 | ) | |||||||
Travel | 212,375 | 157,163 | 55,212 | ||||||||
Other | 26,404 | 12,417 | 13,987 | ||||||||
Total sales and marketing | $ | 2,940,862 | $ | 1,798,263 | $ | 1,142,599 |
Three Months Ended September 30, | |||||||||||
2016 | 2015 | Increase (Decrease) | |||||||||
Personnel and outside services costs | $ | 1,136,266 | $ | 879,722 | $ | 256,544 | |||||
Board of Directors’ fees | 122,187 | 108,612 | 13,575 | ||||||||
Stock-based compensation | 437,075 | 348,127 | 88,948 | ||||||||
Legal and accounting fees | 695,061 | 286,312 | 408,749 | ||||||||
Facilities and insurance | 149,921 | 152,714 | (2,793 | ) | |||||||
Travel | 47,769 | 97,106 | (49,337 | ) | |||||||
Fees, licenses, taxes and other | 122,503 | 75,953 | 46,550 | ||||||||
Total general and administrative | $ | 2,710,782 | $ | 1,948,546 | $ | 762,236 |
Three Months Ended September 30, | |||||||||||
2016 | 2015 | Increase | |||||||||
Net loss attributable to common shareholders | $ | (10,197,332 | ) | $ | (2,741,889 | ) | $ | 7,455,443 | |||
Net loss per common share — basic | $ | (0.34 | ) | $ | (0.10 | ) | $ | 0.24 | |||
Net loss per common share — diluted | $ | (0.34 | ) | $ | (0.23 | ) | $ | 0.11 | |||
Weighted average shares outstanding — basic | 30,339,774 | 28,560,211 | 1,779,563 | ||||||||
Weighted average shares outstanding — diluted | 30,339,774 | 29,128,235 | 1,211,539 |
Nine Months Ended September 30, | |||||||||||
2016 | 2015 | Increase (Decrease) | |||||||||
Royalties | $ | 207,869 | $ | 222,931 | $ | (15,062 | ) | ||||
Diagnostic services | 69,558 | 10,712 | 58,846 | ||||||||
Clinical research services | 35,573 | — | 35,573 | ||||||||
Total revenues | $ | 313,000 | $ | 233,643 | $ | 79,357 |
Nine Months Ended September 30, | |||||||||||
2016 | 2015 | Increase | |||||||||
Salaries and staff costs | $ | 4,263,595 | $ | 2,679,951 | $ | 1,583,644 | |||||
Stock-based compensation | 1,862,069 | 1,054,443 | 807,626 | ||||||||
Outside services, consultants and lab supplies | 3,837,485 | 2,955,738 | 881,747 | ||||||||
Facilities | 1,042,682 | 552,259 | 490,423 | ||||||||
Travel and scientific conferences | 157,445 | 148,766 | 8,679 | ||||||||
Other | 58,600 | 37,192 | 21,408 | ||||||||
Total research and development | $ | 11,221,876 | $ | 7,428,349 | $ | 3,793,527 |
Nine Months Ended September 30, | |||||||||||
2016 | 2015 | Increase | |||||||||
Salaries and staff costs | $ | 4,266,029 | $ | 1,758,789 | $ | 2,507,240 | |||||
Stock-based compensation | 1,493,744 | 480,006 | 1,013,738 | ||||||||
Outside services and consultants | 1,117,368 | 654,512 | 462,856 | ||||||||
Facilities | 362,339 | 210,153 | 152,186 | ||||||||
Trade shows, conferences and marketing | 1,082,883 | 1,005,859 | 77,024 | ||||||||
Travel | 716,473 | 330,399 | 386,074 | ||||||||
Other | 88,614 | 69,048 | 19,566 | ||||||||
Total sales and marketing | $ | 9,127,450 | $ | 4,508,766 | $ | 4,618,684 |
Nine Months Ended September 30, | |||||||||||
2016 | 2015 | Increase (Decrease) | |||||||||
Personnel and outside services costs | $ | 3,279,860 | $ | 2,582,108 | $ | 697,752 | |||||
Board of Directors’ fees | 345,240 | 339,823 | 5,417 | ||||||||
Stock-based compensation | 2,487,415 | 1,201,929 | 1,285,486 | ||||||||
Legal and accounting fees | 2,077,585 | 855,101 | 1,222,484 | ||||||||
Facilities and insurance | 551,382 | 366,109 | 185,273 | ||||||||
Travel | 151,355 | 206,741 | (55,386 | ) | |||||||
Fees, licenses, taxes and other | 290,924 | 204,236 | 86,688 | ||||||||
Total general and administrative | $ | 9,183,761 | $ | 5,756,047 | $ | 3,427,714 |
Nine Months Ended September 30, | |||||||||||
2016 | 2015 | Increase | |||||||||
Net loss attributable to common shareholders | $ | (30,674,248 | ) | $ | (20,108,424 | ) | $ | 10,565,824 | |||
Net loss per common share — basic | $ | (1.02 | ) | $ | (0.80 | ) | $ | 0.22 | |||
Net loss per common share — diluted | $ | (1.04 | ) | $ | (0.96 | ) | $ | 0.08 | |||
Weighted average shares outstanding — basic | 30,018,841 | 25,014,966 | 5,003,875 | ||||||||
Weighted average shares outstanding — diluted | 30,136,572 | 25,204,307 | 4,932,265 |
Exhibit Number | Description of Exhibit | |
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 September 30, 2016 filed on November 9, 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. | ||
November 9, 2016 | By: | /s/ William Welch |
William Welch | ||
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) |
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. |
November 9, 2016 | /s/ William J. Welch |
William J. Welch | |
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) |
November 9, 2016 | /s/ William J. Welch |
William J. Welch | |
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) |
Document and Entity Information - shares |
9 Months Ended | |
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Sep. 30, 2016 |
Oct. 31, 2016 |
|
Document and Entity Information | ||
Entity Registrant Name | Trovagene, Inc. | |
Entity Central Index Key | 0001213037 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 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 | 30,615,406 | |
Document Fiscal Year Focus | 2016 | |
Document Fiscal Period Focus | Q3 |
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) |
Sep. 30, 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 | 30,599,140 | 29,737,601 |
Common stock, shares outstanding | 30,599,140 | 29,737,601 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Income Statement [Abstract] | ||||
Royalties | $ 47,236 | $ 51,301 | $ 207,869 | $ 222,931 |
Diagnostic services | 37,978 | 6,026 | 69,558 | 10,712 |
Clinical research services | 3,900 | 0 | 35,573 | 0 |
Total revenues | 89,114 | 57,327 | 313,000 | 233,643 |
Costs and expenses: | ||||
Cost of revenues | 424,559 | 173,537 | 1,143,293 | 429,992 |
Research and development | 3,937,398 | 2,546,533 | 11,221,876 | 7,428,349 |
Selling and marketing | 2,940,862 | 1,798,263 | 9,127,450 | 4,508,766 |
General and administrative | 2,710,782 | 1,948,546 | 9,183,761 | 5,756,047 |
Total operating expenses | 10,013,601 | 6,466,879 | 30,676,380 | 18,123,154 |
Loss from operations | (9,924,487) | (6,409,552) | (30,363,380) | (17,889,511) |
Net interest expense | (354,993) | (335,359) | (967,522) | (1,100,080) |
Gain (loss) from change in fair value of derivative financial instruments — warrants | 88,208 | 4,017,212 | 674,834 | (1,105,270) |
Other income (loss), net | 0 | (8,130) | 0 | 4,617 |
Net loss | (10,191,272) | (2,735,829) | (30,656,068) | (20,090,244) |
Preferred stock dividend | (6,060) | (6,060) | (18,180) | (18,180) |
Net loss attributable to common stockholders | $ (10,197,332) | $ (2,741,889) | $ (30,674,248) | $ (20,108,424) |
Net loss per common share - basic (in USD per share) | $ (0.34) | $ (0.10) | $ (1.02) | $ (0.80) |
Net loss per common share - diluted (in USD per share) | $ (0.34) | $ (0.23) | $ (1.04) | $ (0.96) |
Weighted average shares outstanding — basic | 30,339,774 | 28,560,211 | 30,018,841 | 25,014,966 |
Weighted average shares outstanding — diluted | 30,339,774 | 29,128,235 | 30,136,572 | 25,204,307 |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) Statement - USD ($) |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (10,191,272) | $ (2,735,829) | $ (30,656,068) | $ (20,090,244) |
Other Comprehensive Income (Loss), Net of Tax [Abstract] | ||||
Foreign currency translation loss | (81) | 0 | (1,877) | 0 |
Unrealized loss on securities available-for-sale | (7,997) | 0 | (2,865) | 0 |
Total other comprehensive loss | (8,078) | 0 | (4,742) | 0 |
Total comprehensive loss | (10,199,350) | (2,735,829) | (30,660,810) | (20,090,244) |
Preferred stock dividend | 6,060 | 6,060 | 18,180 | 18,180 |
Comprehensive loss attributable to common stockholders | $ (10,205,410) | $ (2,741,889) | $ (30,678,990) | $ (20,108,424) |
Organization and Basis of Presentation |
9 Months Ended |
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Sep. 30, 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 diagnostics company headquartered in San Diego, California. The Company’s primary focus is to leverage its cell-free DNA molecular diagnostic technology in cancer and other diseases. Trovagene's goal is to broadly commercialize its molecular diagnostic technology via direct sales as well as external license agreements and/or collaborations to democratize cancer care by establishing the best access for patient care. The Company’s proprietary Precision Cancer Monitoring® (“PCM”) platform measures circulating tumor DNA (“ctDNA”) in urine and blood, enabling personalized patient care. The Company’s PCM platform as well as urine and blood based tests, also known as liquid biopsies, have the potential to dramatically improve cancer care and usher in an era of precision oncology. Trovagene’s tests are available to clinicians for the assessment of known driver mutations in lung, pancreatic, colorectal, neuroendocrine cancers, melanoma and histiocytic disorders. The Company’s noninvasive technology provides for clinically actionable information through the detection of cancer mutations and the monitoring of changes in tumor dynamics before, during, and after treatment. Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements of Trovagene, which include its wholly owned subsidiary, Trovagene, Srl, 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. Liquidity Trovagene’s condensed consolidated financial statements as of September 30, 2016 have been prepared under the assumption that Trovagene will continue as a going concern. The Company’s ability to continue as a going concern is dependent upon its ability to obtain additional equity or debt financing, attain further operating efficiencies and, ultimately, to generate additional revenue. Based on current plans, the Company will be required to raise additional capital in the next twelve months to complete the development and commercialization of current product candidates and to continue to fund operations at its current projected cash expenditure levels. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company’s ability to conduct its business. If the Company is unable to raise additional capital when required or on acceptable terms, it may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more of its product candidates. The Company may also be required to: •Seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and •Relinquish licenses or otherwise dispose of rights to technologies, product candidates or products that the Company would otherwise seek to develop or commercialize themselves, on unfavorable terms. The Company has approximately $44.4 million of cash, cash equivalents and short-term investments at October 31, 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 condensed consolidated statements of operations under the caption “Gain (loss) from change in fair value of derivative financial instruments - warrants.” 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 September 30, 2016, and December 31, 2015, the fair value of these warrants was $2,622,243 and $3,297,077, respectively, and are recorded as a liability under the caption "Derivative financial instruments - warrants" 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 August 2016, the FASB issued Accounting Standards Update 2016-15, Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), which includes amendments that clarify how certain cash receipts and cash payments are presented in the statement of cash flows. ASU 2016-15 also provides guidance clarifying when an entity should separate cash receipts and cash payments and classify them into more than one class of cash flows. The new amendments and guidance are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted provided that all amendments are adopted in the same period. The Company is currently evaluating the impact of adoption of ASU 2016-15 on its consolidated statements of cash flows. 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 statement. |
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 September 30, 2016 and December 31, 2015:
(1) Included as a component of cash and cash equivalents on the accompanying condensed consolidated balance sheets. (2) Included in short-term investments 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 nine months ended September 30, 2016:
The unrealized gain on the derivative financial instruments - warrants is recorded as a change in fair value of derivative financial instruments - warrants in the Company’s condensed consolidated statements 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. |
Investments |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments | Investments Investments consist of corporate debt securities and commercial paper. The Company classifies debt securities as available-for-sale, as the sale of such securities may be required prior to maturity to execute management strategies. Investments classified as available-for-sale are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. A decline in the market value of any available-for-sale security below cost that is determined to be other than temporary will result in an impairment charge to earnings and a new cost basis for the security is established. No such impairment charges were recorded for any period presented. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method and included in interest income. Interest income is recognized when earned. Realized gains and losses on investments in securities will be included in other income (loss) within the condensed consolidated statements of operations. There were no realized gains and losses for the nine months ended September 30, 2016. The following table sets forth the composition of securities available-for-sale as of September 30, 2016.
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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 September 30, 2016, the Company was in compliance with all covenants. As of September 30, 2016, $1,878,312 has been borrowed under the Equipment Line of Credit. As of September 30, 2016, amounts due under the Equipment Line of Credit included $573,929 in current liabilities and $1,328,355 in long-term liabilities, which includes $23,972 of final fee premium accretion. The Company recorded $80,176 in interest expense related to the Equipment Line of Credit during the nine months ended September 30, 2016. Future principal payments of long-term debt at September 30, 2016 are as follows: Year Ended December 31,
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. 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. On July 20, 2016, the Company signed the 5th Amendment to Loan and Security Agreement (“Amendment”) to refinance its existing term loan. Under the Amendment, interest is equal to 3.75% plus the Wall Street Journal Prime Rate, subject to a floor of 7.25%. The Company is required to make interest only payments on the outstanding amount of the loan on a monthly basis through September 1, 2017, after which equal monthly payments of principal and interest are due until the loan maturity date of February 1, 2020. In addition, the lenders received a warrant to purchase an aggregate 30,992 shares of the Company’s common stock at an exercise price of $4.84 per share exercisable for ten years from the date of issuance. The fair value of the warrants, totaling $148,885, was recorded as debt discount and additional paid-in capital as the warrants were equity classified. As of September 30, 2016, warrants to purchase 73,727 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 Amendment, either in the event of repayment of the loan at maturity or upon any prepayment, the Company is obligated to pay the final fee of $1,125,000. 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, and is required to maintain its primary operating, deposit and securities accounts with the lender. In addition, 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 September 30, 2016. As of September 30, 2016, amounts due under the Agreement include $227,095 in current liabilities, which include $272,905 of current portion of debt discount, and $14,267,045 in long-term liabilities, which include $76,575 of final fee premium accretion. The Company recorded $1,113,943 in interest expense related to the Agreement during the nine months ended September 30, 2016. Future principal payments of long-term debt at September 30, 2016 are as follows: Year Ended December 31,
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Derivative Financial Instruments - Warrants |
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Derivative Instruments and Hedging Activities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 condensed consolidated statements of operations. The Company estimates the fair value of these warrants using the Black-Scholes option pricing model. The range of assumptions used to determine the fair value of the warrants valued using the Black-Scholes option pricing model during the periods indicated was:
Expected volatility is based on historical volatility. 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 - warrants 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 Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity | Stockholders’ Equity Common Stock During the nine months ended September 30, 2016, the Company issued a total of 861,539 shares of Common Stock. The Company received gross proceeds of approximately $2.4 million from the sale of 421,810 shares of its common stock at a weighted average price of $5.61 under the agreement with Cantor Fitzgerald & Co. (“Agent”). In addition, 98,396 shares were issued upon exercise of options for a weighted average price of $3.73, and 341,333 shares were issued upon net exercise of 1,236,875 options at a weighted average exercise price of $3.81. Stock Options Stock-based compensation expense related to Trovagene equity awards have been recognized in operating results as follow:
The unrecognized compensation cost related to non-vested stock options outstanding at September 30, 2016 and 2015, net of expected forfeitures, was $10,416,565 and $10,308,131, 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 September 30, 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:
During the nine months ended September 30, 2016, the Company had issued 996,000 options to its executive officers and non-employee directors that were over the authorized number of shares available in the Trovagene 2014 Equity Incentive Plan (2014 EIP) and were subject to shareholder approval. As per ASC Topic 815-40, the options were accounted for as liabilities and recorded at fair value with the changes in fair value being recorded in the Company’s condensed consolidated statements of operations. Stockholder approval was obtained on May 17, 2016 to increase the number of authorized shares in the 2014 EIP from 5,000,000 to 7,500,000. Accordingly, the options were remeasured as of the date of stockholder approval with the change recorded in stock based compensation expense and the $217,333 liability was reclassified to additional paid in capital. As of September 30, 2016 there were 2,346,478 shares available for issuance under the 2014 EIP. Restricted Stock Units Under guidance provided by ASC Topic 718 “Compensation—Stock Compensation” for share-based payments, the fair value of our restricted stock units is based on the grant date fair value of our common stock. All restricted stock units were granted with no purchase price. Vesting of the restricted stock units is generally subject to service conditions, while vesting of certain units are based on attainment of specific performance objectives. The weighted-average grant date fair value of the restricted stock units was $4.06 per share during the nine months ended September 30, 2016. There were no restricted stock units granted during the year ended December 31, 2015. A summary of the restricted stock unit activity is presented below:
None of the restricted stock units vested during the nine months ended September 30, 2016. At September 30, 2016, total unrecognized compensation cost related to non-vested restricted stock units was $537,134, which is expected to be recognized over a weighted-average period of three months. 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 |
9 Months Ended |
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Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Executive and Consulting Agreements The Company has longer-term contractual commitments with various consultants and employees. Certain employment agreements provide for severance payments. Lease Agreements The Company previously leased approximately 22,600 square feet of office and laboratory space at a monthly rental rate of approximately $60,000. On April 4, 2016, the Company entered into an amendment to the lease agreement which expanded the square footage of its office space to approximately 26,100 square feet at a revised monthly rental rate of approximately $68,000. Under the amendment, the lessor provided the Company with a $1,860,000 tenant improvement allowance which the Company recorded as a deferred rent obligation. The Company will amortize the deferred rent on a straight-line basis over the life of the lease. The new lease will expire on December 31, 2021. The Company also leases certain lab and office space in Torino, Italy, 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 $0.8 million for the nine months ended September 30, 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. The Company has entered into a collaborative research program under which it will work to design and validate custom enrichment panels--as specified by the Company. The research partner will be reimbursed for a portion of incurred costs, plus a fixed fee for target services performed. The research agreement includes an outline for a provisional commercial agreement that provides the Company with an exclusive license to use the research partner's technology in exchange for two milestone payments. The commercial agreement has not been finalized as of September 30, 2016. Public Offering and Controlled Equity Offering On May 27, 2016 the Company filed a Form S-3 Registration Statement to offer and sell in one or more offerings, any combination of common stock, preferred stock, debt securities, warrants, or units having an aggregate initial offering price not exceeding $250,000,000. The preferred stock, debt securities, warrants, and units may be convertible or exercisable or exchangeable for common stock or preferred stock or other Trovagene securities. This form was declared effective on June 13, 2016. The Company had an agreement with Cantor Fitzgerald & Co. (“Agent”) on January 25, 2013 to issue and sell up to $30,000,000 of shares of common stock through the Agent. As payment for its services, the Agent is entitled to a 3% commission on gross proceeds. Gross proceeds of $2.4 million have been raised since the date of effectiveness of the Form S-3 on June 13, 2016. Database Usage In March 2016 the Company entered into an agreement with an outside vendor to develop an online database for test requisition and test results. Under the agreement, the Company is obligated to pay a fixed development fee, and a usage fee each time an external user completes and submits a test order form to the database. To date, the Company has paid the fixed development fee, but has incurred no costs in connection with the usage fees. 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 |
9 Months Ended |
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Sep. 30, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions In March 2016, the Company engaged Rutan & Tucker, LLP, a law firm to represent Trovagene, Inc. with respect to various lawsuits. One of the partners from Rutan & Tucker, LLP, is the son of the Company’s Chairman of the Board. The fees for legal services are based on the hourly rates of the individuals performing the legal services. As of September 30, 2016, the Company has incurred approximately $376,000 of legal expenses for services performed by Rutan & Tucker, LLP. 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 $743,000 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 September 30, 2016, the Company has incurred and recorded approximately $555,000 of research and development expenses related to the agreement. No royalty expense has been incurred as of September 30, 2016. |
Summary of Significant Accounting Policies (Policies) |
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Sep. 30, 2016 | |
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 condensed consolidated statements of operations under the caption “Gain (loss) from change in fair value of derivative financial instruments - warrants.” 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 September 30, 2016, and December 31, 2015, |
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 August 2016, the FASB issued Accounting Standards Update 2016-15, Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), which includes amendments that clarify how certain cash receipts and cash payments are presented in the statement of cash flows. ASU 2016-15 also provides guidance clarifying when an entity should separate cash receipts and cash payments and classify them into more than one class of cash flows. The new amendments and guidance are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted provided that all amendments are adopted in the same period. The Company is currently evaluating the impact of adoption of ASU 2016-15 on its consolidated statements of cash flows. 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 statement. |
Investment | Investments consist of corporate debt securities and commercial paper. The Company classifies debt securities as available-for-sale, as the sale of such securities may be required prior to maturity to execute management strategies. Investments classified as available-for-sale are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. A decline in the market value of any available-for-sale security below cost that is determined to be other than temporary will result in an impairment charge to earnings and a new cost basis for the security is established. No such impairment charges were recorded for any period presented. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method and included in interest income. Interest income is recognized when earned. Realized gains and losses on investments in securities will be included in other income (loss) within the condensed consolidated statements of operations. |
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 September 30, 2016 and December 31, 2015:
(1) Included as a component of cash and cash equivalents on the accompanying condensed consolidated balance sheets. (2) Included in short-term investments 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 nine months ended September 30, 2016:
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Investments (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Available-for-sale Securities | The following table sets forth the composition of securities available-for-sale as of September 30, 2016.
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Property and Equipment (Tables) |
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Future Principal Payments of Long-Term Debt | Future principal payments of long-term debt at September 30, 2016 are as follows: Year Ended December 31,
Future principal payments of long-term debt at September 30, 2016 are as follows: Year Ended December 31,
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Derivative Financial Instruments - Warrants (Tables) - Black Scholes Option Pricing Method |
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Derivative financial instruments | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Assumptions Used to Determine the Fair Value of the Warrants | The range of assumptions used to determine the fair value of the warrants valued using the Black-Scholes option pricing model during the periods indicated was:
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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 - warrants 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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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock-Based Compensation Expense | Stock-based compensation expense related to Trovagene equity awards 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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Schedule of Share-based Compensation, Restricted Stock and Restricted Stock Units Activity | Under guidance provided by ASC Topic 718 “Compensation—Stock Compensation” for share-based payments, the fair value of our restricted stock units is based on the grant date fair value of our common stock. All restricted stock units were granted with no purchase price. Vesting of the restricted stock units is generally subject to service conditions, while vesting of certain units are based on attainment of specific performance objectives. The weighted-average grant date fair value of the restricted stock units was $4.06 per share during the nine months ended September 30, 2016. There were no restricted stock units granted during the year ended December 31, 2015. A summary of the restricted stock unit activity is presented below:
None of the restricted stock units vested during the nine months ended September 30, 2016. At September 30, 2016, total unrecognized compensation cost related to non-vested restricted stock units was $537,134, which is expected to be recognized over a weighted-average period of three months. |
Organization and Basis of Presentation - Liquidity (Details) $ in Millions |
Oct. 31, 2016
USD ($)
|
---|---|
Subsequent Event | |
Investment [Line Items] | |
Cash, cash equivalents, and short-term investments | $ 44.4 |
Summary of Significant Accounting Policies - Warrants (Details) - USD ($) |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Derivative financial instruments | ||
Derivative financial instruments - warrants | $ 2,622,243 | $ 3,297,077 |
Warrants | Black Scholes Option Pricing Method | ||
Derivative financial instruments | ||
Derivative financial instruments - warrants | $ 2,622,243 | $ 3,297,077 |
Summary of Significant Accounting Policies - Antidilutive Securities (Details) - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 11,053,250 | 11,143,202 |
Stock Option | ||
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 6,051,186 | 6,514,130 |
Warrants | ||
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 4,546,939 | 4,565,947 |
Restricted Stock Units (RSUs) | ||
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 392,000 | 0 |
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 - Changes in Fair Value of Level 3 Liabilities (Details) - Warrants |
9 Months Ended |
---|---|
Sep. 30, 2016
USD ($)
| |
Reconciliation of the beginning and ending balances | |
Balance at December 31, 2015 | $ 3,297,077 |
Unrealized Gain | (674,834) |
Balance at September 30, 2016 | $ 2,622,243 |
Investments (Details) |
Sep. 30, 2016
USD ($)
|
---|---|
Investments, Debt and Equity Securities [Abstract] | |
Corporate debt securities, cost | $ 15,890,304 |
Corporate debt securities gross unrealized gains | 2,162 |
Corporate debt securities, unrealized loss | (5,027) |
Corporate debt securities, fair value | 15,887,439 |
Commercial paper, cost | 8,489,465 |
Available-for-sale securities, amortized cost | 24,379,769 |
Available-for-sale securities, fair value | $ 24,376,904 |
Property and Equipment (Details) - USD ($) |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | $ 6,194,279 | $ 3,545,361 |
Less—accumulated depreciation and amortization | (1,539,403) | (854,782) |
Property and equipment, net | 4,654,876 | 2,690,579 |
Furniture and office equipment | ||
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | 1,727,321 | 1,483,227 |
Leasehold improvements | ||
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | 1,994,514 | 39,401 |
Laboratory equipment | ||
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | $ 2,472,444 | $ 2,022,733 |
Debt - Equipment Line of Credit (Details) - USD ($) |
1 Months Ended | 9 Months Ended |
---|---|---|
Nov. 30, 2015 |
Sep. 30, 2016 |
|
Line of Credit Facility [Line Items] | ||
Line of credit balance | $ 1,878,312 | |
Line of credit included in current liabilities | 573,929 | |
Line of credit in long-term liabilities | 1,328,355 | |
Line of Credit [Member] | ||
Line of Credit Facility [Line Items] | ||
Line of credit borrowing capacity (up to) | $ 2,000,000 | |
Principal and interest payments after advances, period | 36 months | |
Final payment of total amounts borrowed, percentage | 7.00% | |
Accrued final payment | 23,972 | |
Interest expenses recorded | $ 80,176 | |
Prime Rate [Member] | Line of Credit [Member] | ||
Line of Credit Facility [Line Items] | ||
Interest above base rate | 1.25% |
Debt - Future Payments on Line of Credit (Details) - Line of Credit [Member] |
Sep. 30, 2016
USD ($)
|
---|---|
Debt Instrument [Line Items] | |
2016 | $ 104,351 |
2017 | 626,104 |
2018 | 626,104 |
2019 | 521,753 |
Total principal | 1,878,312 |
Plus final fee premium accretion | 23,972 |
Total long-term obligations | $ 1,902,284 |
Stockholders' Equity - Restricted Stock (Details) - Restricted Stock Units (RSUs) |
9 Months Ended |
---|---|
Sep. 30, 2016
USD ($)
$ / shares
shares
| |
Number of Shares | |
Non-vested at beginning of period (in shares) | shares | 0 |
Granted (in shares) | shares | 402,000 |
Forfeited (in shares) | shares | (10,000) |
Non-vested at end of period (in shares) | shares | 392,000 |
Weighted Average Grant Date Fair Value Per Share | |
Nonvested, weighted average grant date fair value at beginning of period (in USD per share) | $ / shares | $ 0.00 |
Granted, weighted average grant date fair value (in USD per share) | $ / shares | 4.06 |
Forfeited (in USD per share) | $ / shares | 3.99 |
Nonvested, weighted average grant date fair value at end of period (in USD per share) | $ / shares | $ 4.06 |
Share-based compensation cost not yet recognized | $ | $ 537,134 |
Weighted-average remaining vesting period for recognition | 3 months |
Stockholders' Equity - Warrants (Details) - $ / shares |
9 Months Ended | 12 Months Ended |
---|---|---|
Sep. 30, 2016 |
Dec. 31, 2014 |
|
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) | 5,514,234 | |
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 | |
Term | ||
Weighted Average Remaining Contractual Term | 1 year 10 months 6 days | 2 years 6 months |
Class of Warrant or Right Number Granted | 30,992 | |
Class of Warrant or Right Weighted Average Exercise Price of Warrants or Rights Granted | $ 4.84 |
Commitments and Contingencies (Details) |
1 Months Ended | 9 Months Ended | |
---|---|---|---|
Apr. 04, 2016
USD ($)
ft²
|
Nov. 30, 2015
USD ($)
ft²
|
Sep. 30, 2016
USD ($)
ft²
|
|
Commitments and Contingencies Disclosure [Abstract] | |||
Area under lease (in square feet) | ft² | 2,300 | 22,600 | |
Monthly rental rate | $ | $ 68,000 | $ 3,100 | $ 60,000 |
Deferred rent obligation | $ | $ 1,860,000 | ||
Lease term | 3 years | ||
Area of land after expansion | ft² | 26,100 |
Commitments and Contingencies - Research and Development Agreements (Details) $ in Millions |
9 Months Ended |
---|---|
Sep. 30, 2016
USD ($)
| |
Research and Development Arrangement | Research and Development Expense | |
Other Commitments [Line Items] | |
Revenue and license fee expense | $ 0.8 |
Commitments and Contingencies - Public Offering and Controlled Equity Offering and Database Usage (Details) - USD ($) |
4 Months Ended | 7 Months Ended | ||
---|---|---|---|---|
Jan. 25, 2013 |
Sep. 30, 2016 |
Sep. 30, 2016 |
May 27, 2016 |
|
Other Commitments [Line Items] | ||||
Proceeds from public offering | $ 2,400,000 | |||
Costs in connection with usage fees | $ 0 | |||
Public Offering And Controlled Equity Offering | Maximum [Member] | ||||
Other Commitments [Line Items] | ||||
Aggregate initial offering price | $ 250,000,000 | |||
Selling Agents [Member] | Public Offering And Controlled Equity Offering | ||||
Other Commitments [Line Items] | ||||
Commission on gross proceeds | 3.00% | |||
Selling Agents [Member] | Public Offering And Controlled Equity Offering | Maximum [Member] | ||||
Other Commitments [Line Items] | ||||
Aggregate initial offering price | $ 30,000,000 |
Related Party Transactions (Details) |
9 Months Ended |
---|---|
Sep. 30, 2016
USD ($)
| |
Affiliated Entity | |
Related Party Transaction [Line Items] | |
Legal Fees | $ 376,000 |
Scientific Advisory Board Member | |
Related Party Transaction [Line Items] | |
Commitment to pay for services performed, related party | 743,000 |
Research and development expense with related party | 555,000 |
Royalty expense | $ 0 |
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