Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Jul. 31, 2017 | |
Document and Entity Information | ||
Entity Registrant Name | Trovagene, Inc. | |
Entity Central Index Key | 1,213,037 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 37,269,581 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q2 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 7,783,891 | $ 13,915,094 |
Short-term investments | 0 | 23,978,022 |
Accounts receivable | 157,445 | 100,460 |
Prepaid expenses and other assets | 713,913 | 956,616 |
Total current assets | 8,655,249 | 38,950,192 |
Property and equipment, net | 3,321,532 | 3,826,915 |
Other assets | 583,973 | 1,173,304 |
Total Assets | 12,560,754 | 43,950,411 |
Current liabilities: | ||
Accounts payable | 602,738 | 1,130,536 |
Accrued expenses | 4,929,631 | 4,021,365 |
Deferred rent | 285,246 | 285,246 |
Current portion of long-term debt (in default) | 1,644,567 | 2,360,109 |
Total current liabilities | 7,462,182 | 7,797,256 |
Long-term debt, less current portion | 0 | 14,176,359 |
Derivative financial instruments—warrants | 350,862 | 834,940 |
Deferred rent, net of current portion | 1,236,941 | 1,373,717 |
Total Liabilities | 9,049,985 | 24,182,272 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity | ||
Preferred stock, $0.001 par value, 20,000,000 shares authorized; 60,600 shares outstanding at June 30, 2017 and December 31, 2016; designated as Series A Convertible Preferred Stock with liquidation preference of $606,000 at June 30, 2017 and December 31, 2016 | 60 | 60 |
Common stock, $0.0001 par value, 150,000,000 shares authorized; 31,076,872 and 30,696,791 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 3,108 | 3,070 |
Additional paid-in capital | 169,693,921 | 167,890,984 |
Accumulated other comprehensive loss | (13,650) | (10,773) |
Accumulated deficit | (166,172,670) | (148,115,202) |
Total stockholders’ equity | 3,510,769 | 19,768,139 |
Total liabilities and stockholders’ equity | $ 12,560,754 | $ 43,950,411 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
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 | 31,076,872 | 30,696,791 |
Common stock, shares outstanding | 31,076,872 | 30,696,791 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Income Statement [Abstract] | ||||
Royalties | $ 44,810 | $ 47,765 | $ 110,636 | $ 160,633 |
Diagnostic services | 55,501 | 23,962 | 84,363 | 31,580 |
Clinical research services | 1,700 | 31,673 | 2,050 | 31,673 |
Total revenues | 102,011 | 103,400 | 197,049 | 223,886 |
Costs and expenses: | ||||
Cost of revenues | 338,203 | 409,463 | 954,629 | 718,734 |
Research and development | 981,715 | 4,076,414 | 5,261,545 | 7,284,478 |
Selling and marketing | 615,019 | 3,129,036 | 2,023,004 | 6,186,588 |
General and administrative | 4,059,133 | 2,468,732 | 6,255,772 | 6,472,979 |
Restructuring Charges | (3,806) | 0 | 1,715,998 | 0 |
Total operating expenses | 5,990,264 | 10,083,645 | 16,210,948 | 20,662,779 |
Loss from operations | (5,888,253) | (9,980,245) | (16,013,899) | (20,438,893) |
Net interest expense | (431,871) | (274,909) | (861,268) | (612,529) |
Gain (loss) from change in fair value of derivative financial instruments—warrants | (71,428) | 52,876 | 484,078 | 586,626 |
Gain (Loss) on Extinguishment of Debt | (1,655,825) | 0 | (1,655,825) | 0 |
Other income, net | 1,566 | 0 | 1,566 | 0 |
Net loss | (8,045,811) | (10,202,278) | (18,045,348) | (20,464,796) |
Preferred stock dividend | (6,060) | (6,060) | (12,120) | (12,120) |
Net loss attributable to common stockholders | $ (8,051,871) | $ (10,208,338) | $ (18,057,468) | $ (20,476,916) |
Net loss per common share - basic (in USD per share) | $ (0.26) | $ (0.34) | $ (0.58) | $ (0.69) |
Net loss per common share - diluted (in USD per share) | $ (0.26) | $ (0.34) | $ (0.58) | $ (0.70) |
Weighted-average shares outstanding — basic | 30,991,740 | 29,958,037 | 30,976,462 | 29,856,611 |
Weighted-average shares outstanding — diluted | 30,991,740 | 29,958,037 | 30,976,462 | 30,033,207 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) Statement - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (8,045,811) | $ (10,202,278) | $ (18,045,348) | $ (20,464,796) |
Other Comprehensive Income (Loss), Net of Tax [Abstract] | ||||
Foreign currency translation loss | (9,543) | (1,145) | (11,942) | (1,796) |
Unrealized gain or reversal of previous losses on securities available-for-sale | 9,519 | 5,132 | 9,065 | 5,132 |
Total other comprehensive income (loss) | (24) | 3,987 | (2,877) | 3,336 |
Total comprehensive loss | (8,045,835) | (10,198,291) | (18,048,225) | (20,461,460) |
Preferred stock dividend | 6,060 | 6,060 | 12,120 | 12,120 |
Comprehensive loss attributable to common stockholders | $ (8,051,895) | $ (10,204,351) | $ (18,060,345) | $ (20,473,580) |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Operating activities | ||
Net loss | $ (18,045,348) | $ (20,464,796) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Loss on disposal of assets | 28,097 | 0 |
Impairment loss | 485,000 | 0 |
Depreciation and amortization | 645,962 | 489,708 |
Stock based compensation expense | 1,696,184 | 4,113,021 |
Loss on extinguishment of debt | 1,655,825 | 0 |
Accretion of final fee premium | 293,614 | 181,318 |
Amortization of discount on debt | 113,780 | 52,641 |
Net realized loss on short-term investments | 6,400 | 0 |
Amortization of premiums on short-term investments | 9,230 | 27,481 |
Deferred rent | (136,776) | (66,689) |
Interest income accrued on short-term investments | (90,330) | (75,300) |
Change in fair value of derivative financial instruments—warrants | (484,078) | (586,626) |
Changes in operating assets and liabilities: | ||
Decrease in other assets | 0 | 2,761 |
Increase in accounts receivable | (56,985) | (59,801) |
Decrease (increase) in prepaid expenses | 243,571 | (88,678) |
Increase in accounts payable and accrued expenses | 280,520 | 1,481,532 |
Net cash used in operating activities | (13,355,334) | (14,993,428) |
Investing activities: | ||
Capital expenditures, net | (20,738) | (670,867) |
Proceeds from Sale and Maturity of Available-for-sale Securities | 16,431,837 | 0 |
Payments for (Proceeds from) Short-term Investments | (8,804,604) | (27,951,611) |
Proceeds from Sale of Available-for-sale Securities | 16,434,553 | 0 |
Net cash provided by (used in) investing activities | 24,041,048 | (28,622,478) |
Financing activities: | ||
Proceeds from sales of common stock, net of expenses | 106,791 | 0 |
Proceeds from exercise of options | 0 | 232,144 |
Borrowings under equipment line of credit | 0 | 792,251 |
Payment upon debt extinguishment | (1,613,067) | 0 |
Repayments of long-term debt | (15,000,000) | (2,320,083) |
Repayments of equipment line of credit | (313,052) | 0 |
Net cash used in financing activities | (16,819,328) | (1,295,688) |
Effect of exchange rate changes on cash and cash equivalents | 2,411 | (2,473) |
Net change in cash and equivalents | (6,131,203) | (44,914,067) |
Cash and cash equivalents—Beginning of period | 13,915,094 | |
Cash and cash equivalents—End of period | 7,783,891 | 22,578,980 |
Supplementary disclosure of cash flow activity: | ||
Cash paid for taxes | 800 | 4,560 |
Cash paid for interest | 629,952 | 536,727 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Preferred stock dividends accrued | 12,120 | 12,120 |
Leasehold improvements paid for by lessor | $ 0 | $ 1,860,000 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2017 | |
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 precision medicine biotechnology company headquartered in San Diego, California. The Company’s primary focus is to develop oncology therapeutics for improved cancer care, incorporating its proprietary Precision Cancer Monitoring® (“PCM”) diagnostic technology in tumor genomics. The Company’s PCM technology enables detection and quantitation of oncogene mutations in various solid tumor and hematological malignancies to identify clinically actionable markers for predicting patient response to cancer therapeutics. Trovagene’s lead product candidate, PCM-075, was licensed from Nerviano Medical Sciences S.r.l. (“Nerviano”), a leading European oncology research and discovery organization, and is being developed for the treatment of patients with acute myeloid leukemia (“AML”). PCM-075 is an oral and highly-selective polo-like kinase 1 (“PLK1”) inhibitor. Trovagene is uniquely positioned to leverage its expertise in tumor genomics to optimize the clinical development process. Trovagene plans to complement the development of PCM-075 with correlative AML biomarker analysis to identify and measure patient response to therapy. Trovagene offers its PCM technology at its Clinical Laboratory Improvement Amendments (“CLIA”)-certified/College of American Pathologists (“CAP”)-accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. 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, 2016 included in the Company’s annual report on Form 10-K filed with the SEC on March 15, 2017. Liquidity Trovagene’s condensed consolidated financial statements as of June 30, 2017 have been prepared under the assumption that Trovagene will continue as a going concern, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning the Company’s ability to continue as a going concern. However, the Company has incurred net losses since its inception and has negative operating cash flows. Based on its current business plan and assumptions, the Company expects to continue to incur significant losses and require significant additional capital to further advance its clinical trial programs and support its other operations. Considering the Company’s current cash resources, including the net proceeds received from the offering of its equity securities in July 2017, management believes the Company’s existing resources will be sufficient to fund the Company’s planned operations until the first quarter of 2018. In addition, the Company has based its cash sufficiency estimates on its current business plan and its assumptions that may prove to be wrong. The Company could utilize its available capital resources sooner than it currently expects, and it could need additional funding to sustain its operations even sooner than currently anticipated. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. For the foreseeable future, the Company’s ability to continue its operations is dependent upon its ability to obtain additional capital. 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, all of which may have a material adverse impact on the Company’s operations. 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 is evaluating the following options to raise additional capital, increase revenue, as well as reduce costs, in an effort to strengthen its liquidity position: • Raising capital through public and private equity offerings; • Adding capital through short-term and long-term borrowings; • Introducing operation and business development initiatives to bring in new revenue streams by leveraging capabilities within our CLIA lab, as well as monetizing our proprietary NextCollect™ DNA collection and preservation cup; • Reducing operating costs by identifying internal synergies; • Engaging in strategic partnerships; and • Taking actions to reduce or delay capital expenditures. The Company continually assesses any spending plans, including a review of its discretionary spending in connection with certain strategic contracts, to effectively and efficiently address its liquidity needs. NASDAQ Notice On May 30, 2017, the Company received a written notice from the NASDAQ Stock Market LLC (“NASDAQ”) that it was not in compliance with NASDAQ Listing Rule 5550(a)(2) for continued listing on the NASDAQ Capital Market, as the minimum bid price of the Company’s common stock had been below $1.00 per share for 30 consecutive business days. In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until November 27, 2017, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180 calendar day period. On July 10, 2017, NASDAQ notified the Company that it had regained compliance with the applicable minimum bid price rule. Accordingly, the matter related to the notice it received in May 2017 was closed. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2017 | |
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. Short-Term Investments Short-term investments consisted of corporate debt securities, U.S. treasury securities, and commercial paper. The Company classified its short-term investments 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 consolidated accumulated other comprehensive income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities were 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 were 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 was recognized when earned. Realized gains and losses on investments in securities were included in other income (loss) within the consolidated statements of operations. As of June 30, 2017 , all of the short-term investments have been sold to satisfy the Company’s outstanding obligations under the Loan and Security Agreement dated as of June 30, 2014 upon demanding repayment by the lenders. As a result, the Company recognized $6,400 net realized losses for the six months ended June 30, 2017 . 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 are earned based on the licensee’s use. The Company is unable to predict licensee’s sales and thus revenue is recognized upon receipt of notification from licensee and payment when collection is assured. Notification is generally one quarter in arrears. • 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. Clinical Research Services Revenue Revenue from clinical research services consists of revenue from the sale of urine and blood collection supplies and tests performed under agreements with our clinical research and business development partners. Revenue was recognized when supplies and/or test results were delivered. Cost of Revenue Cost of revenue represents the cost of materials, personnel costs and costs associated with processing specimens including pathological review, quality control analyses, and delivery charges necessary to render an individualized test result. Costs associated with performing tests are recorded as the tests are processed. However, the revenue on diagnostic services is recognized on a cash collection basis resulting in costs incurred before the collection of related revenue. Derivative Financial Instruments—Warrants The Company has issued common stock warrants in connection with the execution of certain equity financings. Such warrants are classified as derivative liabilities under the provisions of Financial Accounting Standards Board (“FASB”) ASC 815 Derivatives and Hedging (“ASC 815”) and are recorded at their fair market value as of each reporting period. Such warrants do not meet the exemption that a contract should not be considered a derivative instrument if it is (1) indexed to its own stock and (2) classified in stockholders’ equity. Changes in fair value of derivative liabilities are recorded in the consolidated statement of operations under the caption “Change in fair value of derivative instruments.” The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the volatility of Trovagene’s common stock price, 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 FASB ASC Topic 820, Fair Value Measurements (“ASC 820”). At June 30, 2017 , and December 31, 2016 , the fair value of these warrants was $350,862 and $834,940 , respectively, and was recorded as a liability under the caption “derivative financial instruments — warrants” on the consolidated balance sheets. 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: Three Months Six Months 2017 2016 2017 2016 Numerator: Net loss attributable to common shareholders $ (8,051,871 ) $ (10,208,338 ) $ (18,057,468 ) $ (20,476,916 ) Adjustment for (gain) loss from change in fair value of derivative financial instruments — warrants — — — (533,750 ) Net loss used for diluted loss per share $ (8,051,871 ) $ (10,208,338 ) $ (18,057,468 ) $ (21,010,666 ) Denominator for basic and diluted net loss per share: Weighted-average shares used to compute basic loss per share 30,991,740 29,958,037 30,976,462 29,856,611 Adjustments to reflect assumed exercise of warrants — — — 176,596 Weighted-average shares used to compute diluted net loss per share 30,991,740 29,958,037 30,976,462 30,033,207 Net loss per share attributable to common stockholders: Basic $ (0.26 ) $ (0.34 ) $ (0.58 ) $ (0.69 ) Diluted $ (0.26 ) $ (0.34 ) $ (0.58 ) $ (0.70 ) 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: June 30, 2017 2016 Options to purchase Common Stock 3,589,147 6,137,495 Warrants to purchase Common Stock 4,328,877 4,515,947 Restricted Stock Units 1,452,289 396,500 Series A Convertible Preferred Stock 63,125 63,125 9,433,438 11,113,067 License Fees The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. Restructuring Restructuring costs are included in loss from operations in the condensed consolidated statements of operations. The Company has accounted for these costs in accordance with ASC Topic 420, Exit or Disposal Cost Obligations . One-time termination benefits are recorded at the time they are communicated to the affected employees. In March 2017, the Company announced a restructuring plan which is expected to be completed in the last quarter of 2017. See Note 10 to the condensed consolidated financial statements for further information. Recent Accounting Pronouncements In August 2016, the FASB issued Accounting Standards Update (“ASU”) 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 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 most leases. 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 new standard will impact the Company’s accounting for its office leases and the Company is currently evaluating the impact of the new standard on its consolidated financial statements. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”). The new standard is based on the principal that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Since its initial release, FASB has issued several amendments to the standard, which include clarification of accounting guidance related to identification of performance obligations, intellectual property licenses, and principal versus agent considerations. ASU 2014-09 and all subsequent amendments (collectively, the “new standards”) will be effective for the Company beginning in the first quarter of fiscal year 2018 and may be applied using either the full retrospective method, in which case the standard would be applied to each prior reporting period presented, or the modified retrospective method, in which case the cumulative effect of applying the standard would be recognized at the date of initial application. To date, the Company has derived its revenues from a limited number of royalty, license and diagnostic service agreements. The consideration the Company is eligible to receive under these agreements includes upfront payments, milestone payments and royalties. Each of its collaboration agreements has unique terms that will need to be evaluated separately under the new standards. The Company has started its preliminary assessment of its active license and collaboration agreements. The new standards differ from the current accounting standard in many respects, such as in the accounting for variable consideration, including milestone payments. For example, the Company currently recognizes milestone revenue using the milestone method specified in ASC 605-28, which generally results in recognition of milestone revenue in the period that the milestone event is achieved. However, under the new accounting standards, it is possible to start to recognize milestone revenue before the milestone is achieved if management determines with a high degree of certainty that amounts recorded as revenues will not have to be reversed when the uncertainty associated with the variable consideration is subsequently resolved. In addition, the current accounting standards include a presumption that revenue from upfront non-refundable fees are recognized ratably over the performance period, unless another attribution method is determined to more closely approximate the delivery of the goods or services to the customer. The new accounting standards will require entities to determine an appropriate attribution method using either output or input methods and do not include a presumption that entities would default to ratable attribution approach. The Company is continuing to assess the impact these items will have on its financial statements. The Company has completed its initial assessment of the new standards, including a detailed review of the Company’s contract portfolio and revenue streams, particularly around royalty revenues, to identify potential differences in accounting as a result of the new standards. The Company expects to adopt the new standards using the modified retrospective method with an adjustment, if any, to beginning retained earnings for the cumulative effect of the change. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2017 | |
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 June 30, 2017 and December 31, 2016 : Fair Value Measurements at 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) $ 6,496,826 $ — $ — $ 6,496,826 Total Assets $ 6,496,826 $ — $ — $ 6,496,826 Liabilities: Derivative financial instruments — warrants $ — $ — $ 350,862 $ 350,862 Total Liabilities $ — $ — $ 350,862 $ 350,862 Fair Value Measurements at 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) $ 12,095,620 $ — $ — $ 12,095,620 Corporate debt securities (2) — 14,160,686 — 14,160,686 Commercial paper (3) — 2,393,948 — 2,393,948 U.S. treasury securities (2) — 8,621,892 — 8,621,892 Total Assets $ 12,095,620 $ 25,176,526 $ — $ 37,272,146 Liabilities: Derivative financial instruments — warrants $ — $ — $ 834,940 $ 834,940 Total Liabilities $ — $ — $ 834,940 $ 834,940 (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. (3) $0 and $1,198,504 of commercial paper was included as a component of cash and cash equivalents at June 30, 2017 and December 31, 2016 , respectively, and the remaining amount was included in short-term investments on the accompanying 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 six months ended June 30, 2017 : Description Balance at Unrealized Gain Balance at Derivative financial instruments — warrants $ 834,940 $ (484,078 ) $ 350,862 The unrealized gains or losses on the derivative financial instruments—warrants are recorded as a change in fair value of derivative financial instruments—warrants in the Company’s consolidated statement of operations. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC Topic 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments that trade infrequently and therefore have little or no price transparency are classified as Level 3. |
Investments
Investments | 6 Months Ended |
Jun. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Short-Term Investments As of June 30, 2017 , all short-term investments have been sold to satisfy the Company’s outstanding obligations under the Loan and Security Agreement dated as of June 30, 2014 upon demanding repayment by the lenders. The following table sets forth the composition of short-term investments as of December 31, 2016 . December 31, 2016 Unrealized Maturity in Years Cost Gains Losses Fair Value Corporate debt securities Less than 1 year $ 14,165,915 $ 44 $ (5,273 ) $ 14,160,686 Commercial paper Less than 1 year 1,195,444 — — 1,195,444 U.S. treasury securities Less than 1 year 8,625,728 330 (4,166 ) 8,621,892 Total Investment $ 23,987,087 $ 374 $ (9,439 ) $ 23,978,022 |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment consist of the following: As of June 30, As of December 31, Furniture and office equipment $ 1,077,785 $ 1,144,741 Leasehold improvements 1,994,514 1,994,514 Laboratory equipment 2,515,530 2,449,645 5,587,829 5,588,900 Less—accumulated depreciation and amortization (2,266,297 ) (1,761,985 ) Property and equipment, net $ 3,321,532 $ 3,826,915 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2017 | |
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 (“SVB”) 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. At June 30, 2017 , the interest rate was 5.50% . Interest only payments are due on borrowings through November 30, 2016, with both interest and principal payments commencing in December 2016. 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. On June 20, 2017, the Company received a Notice of Event of Default (“Default Letter”) from SVB which stated that Events of Default had occurred and SVB will decide in its sole discretion whether or not to exercise rights and remedies. Pursuant to the Default Letter, the Company has classified the entire balance of $1,644,567 as a current liability as of June 30, 2017 and also started recording accrued interest at a default rate. The Company recorded $171,959 in interest expense related to the Equipment Line of Credit during the six months ended June 30, 2017 . The Company is currently working with lender for resolution. 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. On July 20, 2016, the Company signed the 5th Amendment to Loan and Security Agreement 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. On June 1, 2017, the Company received a Notice of Event of Default from the lenders which stated that Events of Default had occurred and all of the obligation under the Agreement were immediately due and payable. On June 6, 2017, the lenders took the total pay-off amount of $16,668,583 for the principal, interest, final payment, and other amounts out of the Company’s bank accounts which satisfied all of the Company’s outstanding obligations under the Agreement. Accordingly, the Agreement was terminated in June 2017. Upon termination of the Agreement, the prepayment fee of $450,000 , unamortized debt discount of $400,562 and unamortized final fee of $738,196 were recorded as loss on debt extinguishment. The Company recorded total interest expense of $ 801,173 related to the Agreement during the six months ended June 30, 2017 . |
Derivative Financial Instrument
Derivative Financial Instruments - Warrants | 6 Months Ended |
Jun. 30, 2017 | |
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 (“ASC 815-40”), 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: Six Months Ended June 30, 2017 2016 Estimated fair value of Trovagene common stock 1.15-1.26 4.53-4.65 Expected warrant term 1.5-1.8 years 2.5-2.8 years Risk-free interest rate 1.27-1.38% 0.71-0.87% Expected volatility 98-109% 82-89% Dividend yield 0 % 0 % Expected volatility is based on historical volatility of Trovagene’s common stock. The warrants have a transferability provision and based on guidance provided in Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment (“SAB No. 107”) , for instruments issued with such a provision, Trovagene used the remaining 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. Date Description Number of Warrants Derivative Instrument Liability December 31, 2016 Balance of derivative financial instruments — warrants liability 967,295 $ 834,940 Change in fair value of derivative financial instruments — warrants during the period recognized as a gain in the condensed consolidated statements of operations — (484,078 ) June 30, 2017 Balance of derivative financial instruments — warrants liability 967,295 $ 350,862 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2017 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Common Stock During the six months ended June 30, 2017 , the Company issued a total of 380,081 shares of Common Stock. The Company received gross proceeds of approximately $0.1 million from the sale of 102,081 shares of its common stock at a weighted average price of $1.08 under the agreement with Cantor Fitzgerald & Co. (“Agent”). In addition, 278,000 shares were issued upon vesting of restricted stock units (“RSU”). Stock Options Stock-based compensation expense related to Trovagene equity awards have been recognized in operating results as follow: Three Months Ended Six Months Ended 2017 2016 2017 2016 Included in research and development expense $ 206,463 $ 590,536 $ 578,663 $ 989,277 Included in cost of revenue 15,209 38,228 41,365 56,525 Included in selling and marketing expense 127,351 438,158 431,883 1,016,879 Included in general and administrative expense 472,718 234,991 769,495 2,050,340 Benefit from restructuring (46,356 ) — (125,222 ) — Total stock-based compensation expense $ 775,385 $ 1,301,913 $ 1,696,184 $ 4,113,021 The unrecognized compensation cost related to non-vested stock options outstanding at June 30, 2017 and 2016 , net of expected forfeitures, was $3,456,979 and $11,419,948 , respectively, which is expected to be recognized over a weighted-average remaining vesting period of 2.5 and 3.1 years , respectively. The weighted-average remaining contractual term of outstanding options as of June 30, 2017 was approximately 6.9 years . The total fair value of stock options vested during the six months ended June 30, 2017 and 2016 was $2,796,924 and $4,181,755 , respectively. 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: Six Months Ended 2017 (1) 2016 Risk-free interest rate — % 1.5 % Dividend yield 0 % 0 % Expected volatility — % 102 % Expected term 0.0 years 5.5 years (1) No options granted during the six months ended June 30, 2017. A summary of stock option activity and changes in stock options outstanding is presented below: Total Options Weighted-Average Exercise Price Per Share Intrinsic Value Balance outstanding, December 31, 2016 5,528,628 $ 5.49 $ — Canceled / Forfeited (1,922,024 ) $ 6.40 Expired (17,457 ) $ 4.74 Balance outstanding, June 30, 2017 3,589,147 $ 5.01 $ — Exercisable at June 30, 2017 2,329,718 $ 4.96 $ — On June 13, 2017, the number of authorized shares in the Trovagene 2014 Equity Incentive Plan (“2014 EIP”) was increased from 7,500,000 to 9,500,000 . As of June 30, 2017 there were 5,018,758 shares available for issuance under the 2014 EIP. Restricted Stock Units The weighted-average grant date fair value of the RSU was $1.59 and $4.06 per share during the six months ended June 30, 2017 and 2016 , respectively. A summary of the RSU activity is presented below: Number of Shares Weighted-Average Grant Date Fair Value Per Share Intrinsic Value Non-vested RSU outstanding, December 31, 2016 272,000 $ 3.99 $ 571,200 Granted 2,249,242 $ 1.59 Vested (278,000 ) $ 3.95 $ 580,180 Forfeited (790,953 ) $ 1.81 Non-vested RSU outstanding, June 30, 2017 1,452,289 $ 1.46 $ 1,829,884 At June 30, 2017 , total unrecognized compensation cost related to non-vested RSU was $1,310,838 , which is expected to be recognized over a weighted-average period of 2.5 years . The total fair value of vested RSU during the six months ended June 30, 2017 was $1,097,880 . Warrants A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications is presented below: Total Warrants Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term Balance outstanding, December 31, 2016 5,505,901 $ 3.83 1.6 Expired (1,177,024 ) $ 5.32 Balance outstanding, June 30, 2017 4,328,877 $ 3.42 1.4 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2017 | |
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 leases approximately 26,100 square feet of office and laboratory space at a monthly rental rate of approximately $68,000 . The 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 through the end of September 2017. Research and Development Agreements In March 2017, the Company entered into a license agreement with Nerviano which granted the Company development and commercialization rights to NMS-1286937, which Trovagene refers to as PCM-075. PCM-075 is an oral, investigative drug and a highly-selective adenosine triphosphate competitive inhibitor of the serine/threonine PLK 1. The Company plans to develop PCM-075 initially in patients with AML. Upon execution of the agreement, the Company paid $2.0 million in license fees which were expensed to research and development costs during the six months ended June 30, 2017 . The Company is committed to pay $1.0 million for future services provided by Nerviano, such as the costs to manufacture drug product, no later than June 30, 2019. Terms of the agreement also provide for the Company to pay royalties based on certain development and sales milestones. 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 $88,000 for the six months ended June 30, 2017 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. Litigation Trovagene does not believe that the Company has legal liabilities that are probable or reasonably possible that require either accrual or disclosure, except for the following: On March 28, 2016 the Company filed a complaint in the Superior Court of the State of California for the County of San Diego against the Company’s former CEO and CFO, for, among other things, breach of fiduciary duty for failing to present a lucrative corporate opportunity to the Company concerning promising new therapeutics in the field of precision medicine and instead taking that opportunity for their own personal benefit (the “Complaint”). The Complaint asks that these two former executives be required to turn over their interests in these new therapeutics to the Company. The former CEO and CFO filed a cross complaint in the Superior Court of the State of California for the County of San Diego against the Company on May 23, 2016 for, among other things, breach of contract (the “Cross Complaint”, and together with the Complaint, collectively, the “Litigation”). On July 28, 2017, the parties settled the Litigation. The settlement involved mutual releases by all parties involved. The net cost to Trovagene in connection with the settlement is approximately $2.1 million , which has been accrued within the condensed consolidated balance sheet as of June 30, 2017. Of that amount, $975,000 was the net amount paid directly to the former CEO and CFO. From time to time, the Company may become involved in various lawsuits and legal proceedings that arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in matters may arise from time to time that may harm the Company’s business. Public Offering and Controlled Equity Offering On March 15, 2017, the Company filed a Form 424B5 to amend and supplement the information in the Company’s registration statement and prospectus, dated June 13, 2016, to offer and sell additional shares of the Company’s common stock having an aggregate offering price up to $20,698,357 . The Company entered into 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 commission on gross proceeds of up to 3% . Gross proceeds of approximately $110,000 have been raised in 2017. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2017 | |
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. During the six months ended June 30, 2017 and 2016 , the Company has incurred approximately $541,000 and $222,000 of legal expenses, net of insurance reimbursements, for services performed by Rutan & Tucker, LLP, respectively. |
Restructuring Charges (Notes)
Restructuring Charges (Notes) | 6 Months Ended |
Jun. 30, 2017 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Activities Disclosure [Text Block] | Restructuring Charges On March 15, 2017, in connection with the addition of precision medicine therapeutics to its business, the Company announced a restructuring plan (the “Restructuring”) which included a reduction in force. The Restructuring is expected to be completed in the last quarter of 2017. The Company estimates that it will incur approximately $2.0 million in charges related to this Restructuring. During the six months ended June 30, 2017 , the Company incurred approximately $1.7 million in restructuring charges which included approximately $1.2 million of personnel termination costs and an approximately $0.5 million charge related to impairment of capitalized license fees. As of June 30, 2017 , approximately $0.8 million of these restructuring costs were included in accrued liabilities in the condensed consolidated balance sheet. |
Subsequent Events Subsequent Ev
Subsequent Events Subsequent Events (Notes) | 6 Months Ended |
Jun. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | Subsequent Events Removal of NASDAQ Notice On July 10, 2017, the Company received notice from NASDAQ indicating that the Company has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) for continued listing on The NASDAQ Capital Market. Accordingly, the Company is in compliance with all applicable listing standards and its common stock will continue to be listed on The NASDAQ Capital Market and NASDAQ considers the matter closed. Registered Direct Offering On July 19, 2017, the Company closed a registered direct offering of 6,191,500 shares of its common stock. In a concurrent private placement, the Company also issued warrants to purchase up to 4,643,626 shares of its common stock. The warrants will be exercisable six months following the date of issuance, will expire on the fifth anniversary of the initial exercise date and have an exercise price of $1.41 per share. The combined purchase price for one registered share of common stock and one unregistered warrant to purchase 0.75 of an unregistered share of common stock is $1.15 . The net proceeds to the Company were approximately $6.5 million . |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
License Fees | License Fees The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. |
Costs Associated with Exit or Disposal Activities or Restructurings, Policy | Restructuring Restructuring costs are included in loss from operations in the condensed consolidated statements of operations. The Company has accounted for these costs in accordance with ASC Topic 420, Exit or Disposal Cost Obligations . One-time termination benefits are recorded at the time they are communicated to the affected employees. In March 2017, the Company announced a restructuring plan which is expected to be completed in the last quarter of 2017. See Note 10 to the condensed consolidated financial statements for further information. |
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 are earned based on the licensee’s use. The Company is unable to predict licensee’s sales and thus revenue is recognized upon receipt of notification from licensee and payment when collection is assured. Notification is generally one quarter in arrears. • 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. Clinical Research Services Revenue Revenue from clinical research services consists of revenue from the sale of urine and blood collection supplies and tests performed under agreements with our clinical research and business development partners. Revenue was recognized when supplies and/or test results were delivered. |
Cost of Sales, Policy | Cost of Revenue Cost of revenue represents the cost of materials, personnel costs and costs associated with processing specimens including pathological review, quality control analyses, and delivery charges necessary to render an individualized test result. Costs associated with performing tests are recorded as the tests are processed. However, the revenue on diagnostic services is recognized on a cash collection basis resulting in costs incurred before the collection of related revenue. |
Derivative Financial Instruments-Warrants | Derivative Financial Instruments—Warrants The Company has issued common stock warrants in connection with the execution of certain equity financings. Such warrants are classified as derivative liabilities under the provisions of Financial Accounting Standards Board (“FASB”) ASC 815 Derivatives and Hedging (“ASC 815”) and are recorded at their fair market value as of each reporting period. Such warrants do not meet the exemption that a contract should not be considered a derivative instrument if it is (1) indexed to its own stock and (2) classified in stockholders’ equity. Changes in fair value of derivative liabilities are recorded in the consolidated statement of operations under the caption “Change in fair value of derivative instruments.” The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the volatility of Trovagene’s common stock price, 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 FASB ASC Topic 820, Fair Value Measurements (“ASC 820”). At June 30, 2017 , and December 31, 2016 , |
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 (“ASU”) 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 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 most leases. 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 new standard will impact the Company’s accounting for its office leases and the Company is currently evaluating the impact of the new standard on its consolidated financial statements. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”). The new standard is based on the principal that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Since its initial release, FASB has issued several amendments to the standard, which include clarification of accounting guidance related to identification of performance obligations, intellectual property licenses, and principal versus agent considerations. ASU 2014-09 and all subsequent amendments (collectively, the “new standards”) will be effective for the Company beginning in the first quarter of fiscal year 2018 and may be applied using either the full retrospective method, in which case the standard would be applied to each prior reporting period presented, or the modified retrospective method, in which case the cumulative effect of applying the standard would be recognized at the date of initial application. To date, the Company has derived its revenues from a limited number of royalty, license and diagnostic service agreements. The consideration the Company is eligible to receive under these agreements includes upfront payments, milestone payments and royalties. Each of its collaboration agreements has unique terms that will need to be evaluated separately under the new standards. The Company has started its preliminary assessment of its active license and collaboration agreements. The new standards differ from the current accounting standard in many respects, such as in the accounting for variable consideration, including milestone payments. For example, the Company currently recognizes milestone revenue using the milestone method specified in ASC 605-28, which generally results in recognition of milestone revenue in the period that the milestone event is achieved. However, under the new accounting standards, it is possible to start to recognize milestone revenue before the milestone is achieved if management determines with a high degree of certainty that amounts recorded as revenues will not have to be reversed when the uncertainty associated with the variable consideration is subsequently resolved. In addition, the current accounting standards include a presumption that revenue from upfront non-refundable fees are recognized ratably over the performance period, unless another attribution method is determined to more closely approximate the delivery of the goods or services to the customer. The new accounting standards will require entities to determine an appropriate attribution method using either output or input methods and do not include a presumption that entities would default to ratable attribution approach. The Company is continuing to assess the impact these items will have on its financial statements. The Company has completed its initial assessment of the new standards, including a detailed review of the Company’s contract portfolio and revenue streams, particularly around royalty revenues, to identify potential differences in accounting as a result of the new standards. The Company expects to adopt the new standards using the modified retrospective method with an adjustment, if any, to beginning retained earnings for the cumulative effect of the change. |
Investment | Short-Term Investments Short-term investments consisted of corporate debt securities, U.S. treasury securities, and commercial paper. The Company classified its short-term investments 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 consolidated accumulated other comprehensive income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities were 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 were 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 was recognized when earned. Realized gains and losses on investments in securities were included in other income (loss) within the consolidated statements of operations. |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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: Three Months Six Months 2017 2016 2017 2016 Numerator: Net loss attributable to common shareholders $ (8,051,871 ) $ (10,208,338 ) $ (18,057,468 ) $ (20,476,916 ) Adjustment for (gain) loss from change in fair value of derivative financial instruments — warrants — — — (533,750 ) Net loss used for diluted loss per share $ (8,051,871 ) $ (10,208,338 ) $ (18,057,468 ) $ (21,010,666 ) Denominator for basic and diluted net loss per share: Weighted-average shares used to compute basic loss per share 30,991,740 29,958,037 30,976,462 29,856,611 Adjustments to reflect assumed exercise of warrants — — — 176,596 Weighted-average shares used to compute diluted net loss per share 30,991,740 29,958,037 30,976,462 30,033,207 Net loss per share attributable to common stockholders: Basic $ (0.26 ) $ (0.34 ) $ (0.58 ) $ (0.69 ) Diluted $ (0.26 ) $ (0.34 ) $ (0.58 ) $ (0.70 ) |
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: June 30, 2017 2016 Options to purchase Common Stock 3,589,147 6,137,495 Warrants to purchase Common Stock 4,328,877 4,515,947 Restricted Stock Units 1,452,289 396,500 Series A Convertible Preferred Stock 63,125 63,125 9,433,438 11,113,067 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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 June 30, 2017 and December 31, 2016 : Fair Value Measurements at 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) $ 6,496,826 $ — $ — $ 6,496,826 Total Assets $ 6,496,826 $ — $ — $ 6,496,826 Liabilities: Derivative financial instruments — warrants $ — $ — $ 350,862 $ 350,862 Total Liabilities $ — $ — $ 350,862 $ 350,862 Fair Value Measurements at 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) $ 12,095,620 $ — $ — $ 12,095,620 Corporate debt securities (2) — 14,160,686 — 14,160,686 Commercial paper (3) — 2,393,948 — 2,393,948 U.S. treasury securities (2) — 8,621,892 — 8,621,892 Total Assets $ 12,095,620 $ 25,176,526 $ — $ 37,272,146 Liabilities: Derivative financial instruments — warrants $ — $ — $ 834,940 $ 834,940 Total Liabilities $ — $ — $ 834,940 $ 834,940 (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. (3) $0 and $1,198,504 of commercial paper was included as a component of cash and cash equivalents at June 30, 2017 and December 31, 2016 , respectively, and the remaining amount was included in short-term investments on the accompanying consolidated balance sheets. |
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 six months ended June 30, 2017 : Description Balance at Unrealized Gain Balance at Derivative financial instruments — warrants $ 834,940 $ (484,078 ) $ 350,862 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-sale Securities | The following table sets forth the composition of short-term investments as of December 31, 2016 . December 31, 2016 Unrealized Maturity in Years Cost Gains Losses Fair Value Corporate debt securities Less than 1 year $ 14,165,915 $ 44 $ (5,273 ) $ 14,160,686 Commercial paper Less than 1 year 1,195,444 — — 1,195,444 U.S. treasury securities Less than 1 year 8,625,728 330 (4,166 ) 8,621,892 Total Investment $ 23,987,087 $ 374 $ (9,439 ) $ 23,978,022 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Components of Property and Equipment | Property and equipment consist of the following: As of June 30, As of December 31, Furniture and office equipment $ 1,077,785 $ 1,144,741 Leasehold improvements 1,994,514 1,994,514 Laboratory equipment 2,515,530 2,449,645 5,587,829 5,588,900 Less—accumulated depreciation and amortization (2,266,297 ) (1,761,985 ) Property and equipment, net $ 3,321,532 $ 3,826,915 |
Derivative Financial Instrume24
Derivative Financial Instruments - Warrants (Tables) - Black Scholes Option Pricing Method | 6 Months Ended |
Jun. 30, 2017 | |
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: Six Months Ended June 30, 2017 2016 Estimated fair value of Trovagene common stock 1.15-1.26 4.53-4.65 Expected warrant term 1.5-1.8 years 2.5-2.8 years Risk-free interest rate 1.27-1.38% 0.71-0.87% Expected volatility 98-109% 82-89% Dividend yield 0 % 0 % |
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. Date Description Number of Warrants Derivative Instrument Liability December 31, 2016 Balance of derivative financial instruments — warrants liability 967,295 $ 834,940 Change in fair value of derivative financial instruments — warrants during the period recognized as a gain in the condensed consolidated statements of operations — (484,078 ) June 30, 2017 Balance of derivative financial instruments — warrants liability 967,295 $ 350,862 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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: Three Months Ended Six Months Ended 2017 2016 2017 2016 Included in research and development expense $ 206,463 $ 590,536 $ 578,663 $ 989,277 Included in cost of revenue 15,209 38,228 41,365 56,525 Included in selling and marketing expense 127,351 438,158 431,883 1,016,879 Included in general and administrative expense 472,718 234,991 769,495 2,050,340 Benefit from restructuring (46,356 ) — (125,222 ) — Total stock-based compensation expense $ 775,385 $ 1,301,913 $ 1,696,184 $ 4,113,021 |
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: Six Months Ended 2017 (1) 2016 Risk-free interest rate — % 1.5 % Dividend yield 0 % 0 % Expected volatility — % 102 % Expected term 0.0 years 5.5 years (1) No options granted during the six months ended June 30, 2017. |
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: Total Options Weighted-Average Exercise Price Per Share Intrinsic Value Balance outstanding, December 31, 2016 5,528,628 $ 5.49 $ — Canceled / Forfeited (1,922,024 ) $ 6.40 Expired (17,457 ) $ 4.74 Balance outstanding, June 30, 2017 3,589,147 $ 5.01 $ — Exercisable at June 30, 2017 2,329,718 $ 4.96 $ — |
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: Total Warrants Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term Balance outstanding, December 31, 2016 5,505,901 $ 3.83 1.6 Expired (1,177,024 ) $ 5.32 Balance outstanding, June 30, 2017 4,328,877 $ 3.42 1.4 |
Schedule of Share-based Compensation, Restricted Stock and Restricted Stock Units Activity | The weighted-average grant date fair value of the RSU was $1.59 and $4.06 per share during the six months ended June 30, 2017 and 2016 , respectively. A summary of the RSU activity is presented below: Number of Shares Weighted-Average Grant Date Fair Value Per Share Intrinsic Value Non-vested RSU outstanding, December 31, 2016 272,000 $ 3.99 $ 571,200 Granted 2,249,242 $ 1.59 Vested (278,000 ) $ 3.95 $ 580,180 Forfeited (790,953 ) $ 1.81 Non-vested RSU outstanding, June 30, 2017 1,452,289 $ 1.46 $ 1,829,884 At June 30, 2017 , total unrecognized compensation cost related to non-vested RSU was $1,310,838 , which is expected to be recognized over a weighted-average period of 2.5 years . |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Warrants (Details) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Derivative financial instruments | ||
Derivative financial instruments—warrants | $ 350,862 | $ 834,940 |
Warrants [Member] | Black Scholes Option Pricing Method | ||
Derivative financial instruments | ||
Derivative financial instruments—warrants | $ 350,862 | $ 834,940 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Net Loss Per Share (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Numerator: | ||||
Numerator: Net loss attributable to common shareholders | $ (8,051,871) | $ (10,208,338) | $ (18,057,468) | $ (20,476,916) |
Adjustment for (gain) loss from change in fair value of derivative financial instruments—warrants | 0 | 0 | 0 | (533,750) |
Net loss used for diluted loss per share | $ (8,051,871) | $ (10,208,338) | $ (18,057,468) | $ (21,010,666) |
Denominator for basic and diluted net loss per share: | ||||
Weighted-average shares used to compute basic loss per share | 30,991,740 | 29,958,037 | 30,976,462 | 29,856,611 |
Adjustments to reflect assumed exercise of warrants | 0 | 0 | 0 | 176,596 |
Weighted-average shares used to compute diluted net loss per share | 30,991,740 | 29,958,037 | 30,976,462 | 30,033,207 |
Net loss per share attributable to common stockholders: | ||||
Net loss per common share - basic (in USD per share) | $ (0.26) | $ (0.34) | $ (0.58) | $ (0.69) |
Net loss per common share - diluted (in USD per share) | $ (0.26) | $ (0.34) | $ (0.58) | $ (0.70) |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Antidilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 9,433,438 | 11,113,067 |
Stock Option | ||
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 3,589,147 | 6,137,495 |
Warrants [Member] | ||
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 4,328,877 | 4,515,947 |
Restricted Stock Units (RSUs) | ||
Net Loss Per Share | ||
Antidilutive securities excluded from the calculation of basic and diluted loss per share (in shares) | 1,452,289 | 396,500 |
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 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Short-Term Investments (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Accounting Policies [Abstract] | ||
Net realized loss on short-term investments | $ 6,400 | $ 0 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Assets and Liabilities (Details) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Liabilities: | ||
Derivative financial instruments—warrants | $ 350,862 | $ 834,940 |
Recurring basis | Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1) | ||
Assets: | ||
Money market fund | 6,496,826 | 12,095,620 |
Total Assets | 6,496,826 | 12,095,620 |
Liabilities: | ||
Derivative financial instruments—warrants | 0 | 0 |
Total Liabilities | 0 | 0 |
Recurring basis | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Money market fund | 0 | 0 |
Total Assets | 0 | 25,176,526 |
Liabilities: | ||
Derivative financial instruments—warrants | 0 | 0 |
Total Liabilities | 0 | 0 |
Recurring basis | Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Money market fund | 0 | 0 |
Total Assets | 0 | 0 |
Liabilities: | ||
Total Liabilities | 350,862 | 834,940 |
Corporate Debt Securities [Member] | Recurring basis | ||
Assets: | ||
Available-for-sale Securities | 14,160,686 | |
Corporate Debt Securities [Member] | Recurring basis | Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1) | ||
Assets: | ||
Available-for-sale Securities | 0 | |
Corporate Debt Securities [Member] | Recurring basis | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Available-for-sale Securities | 14,160,686 | |
Corporate Debt Securities [Member] | Recurring basis | Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Available-for-sale Securities | 0 | |
Commercial Paper | Recurring basis | ||
Assets: | ||
Available-for-sale Securities | 2,393,948 | |
Commercial Paper | Recurring basis | Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1) | ||
Assets: | ||
Available-for-sale Securities | 0 | |
Commercial Paper | Recurring basis | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Available-for-sale Securities | 2,393,948 | |
Commercial Paper | Recurring basis | Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Available-for-sale Securities | 0 | |
US Treasury Securities [Member] | Recurring basis | ||
Assets: | ||
Available-for-sale Securities | 8,621,892 | |
US Treasury Securities [Member] | Recurring basis | Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1) | ||
Assets: | ||
Available-for-sale Securities | 0 | |
US Treasury Securities [Member] | Recurring basis | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Available-for-sale Securities | 8,621,892 | |
US Treasury Securities [Member] | Recurring basis | Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Available-for-sale Securities | 0 | |
Warrants [Member] | Black Scholes Option Pricing Method | ||
Liabilities: | ||
Derivative financial instruments—warrants | 350,862 | 834,940 |
Estimate of Fair Value Measurement [Member] | ||
Assets: | ||
Available-for-sale Securities | 23,978,022 | |
Estimate of Fair Value Measurement [Member] | Recurring basis | ||
Assets: | ||
Money market fund | 6,496,826 | 12,095,620 |
Total Assets | 6,496,826 | 37,272,146 |
Liabilities: | ||
Derivative financial instruments—warrants | 350,862 | 834,940 |
Total Liabilities | 350,862 | 834,940 |
Estimate of Fair Value Measurement [Member] | Corporate Debt Securities [Member] | ||
Assets: | ||
Available-for-sale Securities | 14,160,686 | |
Estimate of Fair Value Measurement [Member] | Commercial Paper | ||
Assets: | ||
Available-for-sale Securities | 1,195,444 | |
Estimate of Fair Value Measurement [Member] | US Treasury Securities [Member] | ||
Assets: | ||
Available-for-sale Securities | 8,621,892 | |
Cash and Cash Equivalents [Member] | Commercial Paper | Recurring basis | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Available-for-sale Securities | $ 0 | $ 1,198,504 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Fair Value of Level 3 Liabilities (Details) - Warrants [Member] | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Reconciliation of the beginning and ending balances | |
Balance at December 31, 2016 | $ 834,940 |
Unrealized Gain | (484,078) |
Balance at June 30, 2017 | $ 350,862 |
Investments (Details)
Investments (Details) | Dec. 31, 2016USD ($) |
Schedule of Available-for-sale Securities [Line Items] | |
Available-for-sale securities, amortized cost | $ 23,987,087 |
Available-for-sale Debt Securities, Accumulated Gross Unrealized Gain, before Tax | 374 |
Corporate debt securities, unrealized loss | (9,439) |
US Treasury Securities [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Available-for-sale Securities, Accumulated Gross Unrealized Gain, before Tax | 330 |
Available-for-sale Securities, Accumulated Gross Unrealized Loss, before Tax | (4,166) |
Corporate debt securities, cost | 8,625,728 |
Commercial Paper | |
Schedule of Available-for-sale Securities [Line Items] | |
Available-for-sale Securities, Accumulated Gross Unrealized Gain, before Tax | 0 |
Available-for-sale Securities, Accumulated Gross Unrealized Loss, before Tax | 0 |
Corporate debt securities, cost | 1,195,444 |
Corporate Debt Securities [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Available-for-sale Securities, Accumulated Gross Unrealized Gain, before Tax | 44 |
Available-for-sale Securities, Accumulated Gross Unrealized Loss, before Tax | (5,273) |
Corporate debt securities, cost | 14,165,915 |
Estimate of Fair Value Measurement [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Available-for-sale Securities | 23,978,022 |
Estimate of Fair Value Measurement [Member] | US Treasury Securities [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Available-for-sale Securities | 8,621,892 |
Estimate of Fair Value Measurement [Member] | Commercial Paper | |
Schedule of Available-for-sale Securities [Line Items] | |
Available-for-sale Securities | 1,195,444 |
Estimate of Fair Value Measurement [Member] | Corporate Debt Securities [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Available-for-sale Securities | $ 14,160,686 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | $ 5,587,829 | $ 5,588,900 |
Less—accumulated depreciation and amortization | (2,266,297) | (1,761,985) |
Property and equipment, net | 3,321,532 | 3,826,915 |
Furniture and office equipment | ||
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | 1,077,785 | 1,144,741 |
Leasehold improvements | ||
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | 1,994,514 | 1,994,514 |
Laboratory equipment | ||
Property, equipment and depreciation and amortization | ||
Property and equipment, gross | $ 2,515,530 | $ 2,449,645 |
Debt - Equipment Line of Credit
Debt - Equipment Line of Credit (Details) - Line of Credit [Member] - USD ($) | 1 Months Ended | 6 Months Ended |
Nov. 30, 2015 | Jun. 30, 2017 | |
Line of Credit Facility [Line Items] | ||
Line of credit borrowing capacity (up to) | $ 2,000,000 | |
Interest rate at end of period | 5.50% | |
Final payment of total amounts borrowed, percentage | 7.00% | |
Line of credit balance | $ 1,644,567 | |
Interest expenses recorded | $ 171,959 | |
Prime Rate [Member] | ||
Line of Credit Facility [Line Items] | ||
Interest above base rate | 1.25% |
- Loan and Security Agreement (
- Loan and Security Agreement (Details) - USD ($) | Jun. 06, 2017 | Jul. 20, 2016 | Jun. 30, 2017 | Nov. 30, 2015 | Jun. 30, 2017 | Jun. 30, 2014 |
Line of Credit [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Interest expenses recorded | $ 171,959 | |||||
Line of Credit [Member] | Prime Rate [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Interest above base rate | 1.25% | |||||
Secured Debt [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Face value of term loan | $ 15,000,000 | |||||
Payment for debt extinguishment | $ 16,668,583 | |||||
Prepayment fee | $ 450,000 | |||||
Debt discount | 400,562 | 400,562 | ||||
Unamortized portion of final fee upon repayment | $ 738,196 | |||||
Interest expenses recorded | $ 801,173 | |||||
Secured Debt [Member] | Line of Credit [Member] | Minimum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument stated rate | 7.25% | |||||
Secured Debt [Member] | Line of Credit [Member] | Prime Rate [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Interest above base rate | 3.75% |
Derivative Financial Instrume36
Derivative Financial Instruments - Warrants (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Changes in the Company's derivative financial instruments liability balance | ||||
Balance of warrants outstanding at the beginning of the period (in shares) | 5,505,901 | |||
Balance of warrants outstanding at the end of the period (in shares) | 4,328,877 | 4,328,877 | ||
Balance of derivative financial instruments liability at the beginning of the period | $ 834,940 | |||
Change in fair value of warrants during the period recognized as a gain in the condensed consolidated statement of operations | $ 71,428 | $ (52,876) | (484,078) | $ (586,626) |
Balance of derivative financial instruments liability at the end of the period | $ 350,862 | $ 350,862 | ||
Warrants [Member] | Black Scholes Option Pricing Method | ||||
Range of assumptions used to determine the fair value of warrants | ||||
Dividend yield (as a percent) | 0.00% | 0.00% | ||
Changes in the Company's derivative financial instruments liability balance | ||||
Balance of warrants outstanding at the beginning of the period (in shares) | 967,295 | |||
Balance of warrants outstanding at the end of the period (in shares) | 967,295 | 967,295 | ||
Balance of derivative financial instruments liability at the beginning of the period | $ 834,940 | |||
Balance of derivative financial instruments liability at the end of the period | $ 350,862 | $ 350,862 | ||
Warrants [Member] | Black Scholes Option Pricing Method | Minimum [Member] | ||||
Range of assumptions used to determine the fair value of warrants | ||||
Estimated fair value of Trovagene common stock (in dollars per share) | $ 1.15 | $ 4.53 | ||
Expected warrant term | 1 year 6 months | 2 years 6 months | ||
Risk-free interest rate | 1.27% | 0.71% | ||
Expected volatility (as a percent) | 98.00% | 82.00% | ||
Warrants [Member] | Black Scholes Option Pricing Method | Maximum [Member] | ||||
Range of assumptions used to determine the fair value of warrants | ||||
Estimated fair value of Trovagene common stock (in dollars per share) | $ 1.26 | $ 4.65 | ||
Expected warrant term | 1 year 9 months 18 days | 2 years 9 months 18 days | ||
Risk-free interest rate | 1.38% | 0.87% | ||
Expected volatility (as a percent) | 109.00% | 89.00% |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Class of Stock [Line Items] | ||
Proceeds from sales of common stock, net of expenses | $ 106,791 | $ 0 |
Stock Issued During Period Restricted Stock Units | 278,000 | |
Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Shares of common stock issued | 380,081 | |
Cantor Fitzgerald And Co [Member] | Public Offering And Controlled Equity Offering | Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Shares of common stock issued | 102,081 | |
Common stock, price per share (in dollars per share) | $ 1.08 | |
Proceeds from sales of common stock, net of expenses | $ 100,000 |
Stockholders' Equity - Stock-ba
Stockholders' Equity - Stock-based Compensation Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Stock-based compensation expense | ||||
Total stock based compensation expense | $ 775,385 | $ 1,301,913 | $ 1,696,184 | $ 4,113,021 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | 2,796,924 | 4,181,755 | ||
Research and Development Expense | ||||
Stock-based compensation expense | ||||
Total stock based compensation expense | 206,463 | 590,536 | 578,663 | 989,277 |
Cost of Revenue | ||||
Stock-based compensation expense | ||||
Total stock based compensation expense | 15,209 | 38,228 | 41,365 | 56,525 |
Selling and Marketing Expense | ||||
Stock-based compensation expense | ||||
Total stock based compensation expense | 127,351 | 438,158 | 431,883 | 1,016,879 |
General and Administrative Expense | ||||
Stock-based compensation expense | ||||
Total stock based compensation expense | 472,718 | 234,991 | 769,495 | 2,050,340 |
Restructuring Charges [Member] | ||||
Stock-based compensation expense | ||||
Total stock based compensation expense | (46,356) | 0 | (125,222) | 0 |
Stock Option | ||||
Stock-based compensation expense | ||||
Unrecognized compensation cost | $ 3,456,979 | $ 11,419,948 | $ 3,456,979 | $ 11,419,948 |
Weighted-average remaining vesting period for recognition | 2 years 6 months 4 days | 3 years 1 month 24 days | ||
Options outstanding, weighted average contractual life | 6 years 10 months 14 days |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Option Activity (Details) - USD ($) | 6 Months Ended | ||||
Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | May 17, 2016 | Jun. 10, 2015 | |
Stock Option | |||||
Weighted-average assumptions | |||||
Risk-free interest rate | 0.00% | 1.50% | |||
Dividend yield (as a percent) | 0.00% | 0.00% | |||
Expected volatility (as a percent) | 0.00% | 102.00% | |||
Expected term | 0 years | 5 years 6 months | |||
Unrecognized compensation cost | |||||
Unrecognized compensation cost | $ 3,456,979 | $ 11,419,948 | |||
Weighted-average remaining vesting period for recognition | 2 years 6 months 4 days | 3 years 1 month 24 days | |||
Options outstanding, weighted average contractual life | 6 years 10 months 14 days | ||||
Number of Options | |||||
Balance outstanding at the beginning of the period (in shares) | 5,528,628 | ||||
Granted (in shares) | 0 | ||||
Cancelled / Forfeited (in shares) | (1,922,024) | ||||
Expired (in shares) | (17,457) | ||||
Balance outstanding at the end of the period (in shares) | 3,589,147 | ||||
Vested and exercisable at the end of the period (in shares) | 2,329,718 | ||||
Weighted Average Exercise Price Per Share | |||||
Balance outstanding at the beginning of the period (in USD per share) | $ 5.49 | ||||
Canceled / Forfeited (in USD per share) | 6.40 | ||||
Expired (in USD per share) | 4.74 | ||||
Balance outstanding at the end of the period (in USD per share) | 5.01 | ||||
Vested and exercisable at the end of the period (in USD per share) | $ 4.96 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures | |||||
Options outstanding, intrinsic value | $ 0 | $ 0 | |||
Vested and exercisable at the end of the period, intrinsic value | $ 0 | ||||
2014 EIP | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures | |||||
Authorized shares under the plan | 9,500,000 | 7,500,000 | |||
Number of remaining shares available for issuance | 5,018,758 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock (Details) - USD ($) | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Weighted-Average Grant Date Fair Value Per Share | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Aggregate Intrinsic Value, Vested | $ 580,180 | ||
Restricted Stock Units (RSUs) | |||
Number of Shares | |||
Non-vested at beginning of period (in shares) | 272,000 | ||
Granted (in shares) | 2,249,242 | ||
Vested (in shares) | (278,000) | ||
Forfeited (in shares) | (790,953) | ||
Non-vested at end of period (in shares) | 1,452,289 | ||
Weighted-Average Grant Date Fair Value Per Share | |||
Nonvested, weighted average grant date fair value at end of period (in USD per share) | $ 3.99 | ||
Granted, weighted average grant date fair value (in USD per share) | 1.59 | $ 4.06 | |
Vested, weighted average grant date fair value (in USD per share) | 3.95 | ||
Forfeited (in USD per share) | 1.81 | ||
Nonvested, weighted average grant date fair value at end of period (in USD per share) | $ 1.46 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Aggregate Intrinsic Value, Nonvested | $ 1,829,884 | $ 571,200 | |
Share-based compensation cost not yet recognized | $ 1,310,838 | ||
Weighted-average remaining vesting period for recognition | 2 years 5 months 16 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period, Fair Value | $ 1,097,880 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2017 | Dec. 31, 2016 | |
Number of Warrants | ||
Balance of warrants outstanding at the beginning of the period (in shares) | 5,505,901 | |
Exercised (in shares) | (1,177,024) | |
Balance of warrants outstanding at the end of the period (in shares) | 4,328,877 | 5,505,901 |
Weighted Average Exercise Price Per Share | ||
Weighted average exercise price of warrants at the beginning of the period (in USD per share) | $ 3.83 | |
Exercised (in USD per share) | 5.32 | |
Weighted average exercise price of warrants at the end of the period (in USD per share) | $ 3.42 | $ 3.83 |
Term | ||
Weighted-Average Remaining Contractual Term | 1 year 5 months 3 days | 1 year 7 months 6 days |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 1 Months Ended | 6 Months Ended |
Nov. 30, 2015USD ($)ft² | Jun. 30, 2017USD ($)ft² | |
Commitments and Contingencies Disclosure [Abstract] | ||
Area under lease (in square feet) | ft² | 2,300 | 26,100 |
Monthly rental rate | $ | $ 3,100 | $ 68,000 |
Commitments and Contingencies -
Commitments and Contingencies - Research and Development Agreements (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Research and Development Arrangement | Research and Development Expense | |
Other Commitments [Line Items] | |
Revenue and license fee expense | $ 0.1 |
Norviano [Member] | |
Other Commitments [Line Items] | |
Other Commitment | 1 |
Norviano [Member] | Licensing Agreements [Member] | |
Other Commitments [Line Items] | |
Research and Development Expense | $ 2 |
Commitments and Contingencies L
Commitments and Contingencies Litigation (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Loss Contingencies [Line Items] | |
Accrued net cost for litigation | $ 2,100 |
Former CEO and CFO [Member] | |
Loss Contingencies [Line Items] | |
Net amount paid | $ 975 |
Commitments and Contingencies45
Commitments and Contingencies - Public Offering and Controlled Equity Offering and Database Usage (Details) - USD ($) | Jan. 25, 2013 | Jun. 30, 2017 | Mar. 15, 2017 |
Other Commitments [Line Items] | |||
Proceeds from public offering | $ 100,000 | ||
Public Offering And Controlled Equity Offering | Selling Agents [Member] | |||
Other Commitments [Line Items] | |||
Commission on gross proceeds | 3.00% | ||
Public Offering And Controlled Equity Offering | Maximum [Member] | |||
Other Commitments [Line Items] | |||
Aggregate initial offering price | $ 20,698,357 | ||
Public Offering And Controlled Equity Offering | Maximum [Member] | Selling Agents [Member] | |||
Other Commitments [Line Items] | |||
Aggregate initial offering price | $ 30,000,000 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Affiliated Entity | ||
Related Party Transaction [Line Items] | ||
Legal Fees | $ 541,000 | $ 222,000 |
Restructuring Charges (Details)
Restructuring Charges (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring Reserve | $ 800,000 | $ 800,000 | ||
Restructuring and Related Cost, Expected Cost | 2,000,000 | 2,000,000 | ||
Restructuring Charges | $ (3,806) | $ 0 | 1,715,998 | $ 0 |
Employee Severance [Member] | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring Charges | 1,200,000 | |||
Impaired Long-Lived Assets [Member] | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring Charges | $ 500,000 |
Subsequent Events (Details)
Subsequent Events (Details) | Jul. 19, 2017USD ($)anniversary$ / sharesshares | Jun. 30, 2017USD ($)shares | Jun. 30, 2016USD ($) |
Subsequent Event [Line Items] | |||
Proceeds from sales of common stock, net of expenses | $ | $ 106,791 | $ 0 | |
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Exercisable term of warrant | 6 months | ||
Expiration term of warrants, number of anniversaries | anniversary | 5 | ||
Exercise price of warrants (in USD per share) | $ / shares | $ 1.41 | ||
Shares called by each warrant (in shares) | 0.75 | ||
Common stock, price per share (in dollars per share) | $ / shares | $ 1.15 | ||
Proceeds from sales of common stock, net of expenses | $ | $ 6,500,000 | ||
Common Stock [Member] | |||
Subsequent Event [Line Items] | |||
Shares of common stock issued | 380,081 | ||
Registered Direct Offering [Member] | Common Stock [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Shares of common stock issued | 6,191,500 | ||
Private Placement [Member] | Warrants [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Warrants granted (in shares) | 4,643,626 |