Trovagene, Inc. (Form: 10-Q, Received: 05/12/2014 16:06:23)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

(Mark One)

x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2014

o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

COMMISSION FILE NUMBER 000-54556

TROVAGENE, INC.

(Exact Name of small business issuer as specified in its charter)

Delaware		27-2004382
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)

11055 Flintkote Avenue, Suite A, San Diego, California 92121

(Address of principal executive offices) (Zip Code)

Issuer’s telephone Number: (858) 952-7570

Indicate by check mark whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer o		Accelerated filer x

Non-accelerated filer o		Smaller reporting company ¨
(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of May 9, 2014 the issuer had 18,902,991 shares of Common Stock issued and outstanding.

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TROVAGENE, INC.

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		Page
PART I	FINANCIAL INFORMATION

Item 1:	Financial Statements

	Condensed Consolidated Balance Sheets as of March 31, 2014 (unaudited) and December 31, 2013	3

	Condensed Consolidated Statements of Operations (unaudited) for the three months ended March 31, 2014 and 2013 and for the period from August 4, 1999 (inception) through March 31, 2014	4

	Condensed Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2014 and 2013 and for the period from August 4, 1999 (inception) through March 31, 2014	5

	Notes to Condensed Consolidated Financial Statements (unaudited)	6

Item 2:	Management’s Discussion and Analysis of Financial Condition and Results of Operations	12

Item 3:	Quantitative and Qualitative Disclosures About Market Risk	16

Item 4:	Controls and Procedures	16

PART II	OTHER INFORMATION

Item 1:	Legal Proceedings	17

Item 1A:	Risk Factors	17

Item 2:	Unregistered Sales of Equity Securities and Use of Proceeds	17

Item 3:	Default Upon Senior Securities	17

Item 4:	Mine Safety Disclosures	17

Item 5:	Other Information	17

Item 6:	Exhibits	17

SIGNATURES

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TROVAGENE, INC.

(A Development Stage Company)

CONDENSED CONSOLIDATED BALANCE SHEETS

	March 31,			December 31,
	2014			2013
	(Unaudited)

Assets
Current assets:
Cash and cash equivalents	$	22,871,122		$	25,836,937
Accounts receivable	129,303			78,994
Prepaid expenses and other assets	262,188			152,789
Total current assets	23,262,613			26,068,720
Property and equipment, net	859,645			750,565
Other assets	336,450			336,450
Total assets	$	24,458,708		$	27,155,735

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	427,424		$	286,608
Accrued expenses	1,403,848			1,524,092
Current portion of long-term debt	200,792			198,166
Total current liabilities	2,032,064			2,008,866
Long-term debt, less current portion	274,852			322,998
Derivative financial instruments	4,399,025			4,431,871
Total liabilities	6,705,941			6,763,735

Commitments and contingencies (Note 9)
Stockholders’ equity

Preferred stock, $0.001 par value, 20,000,000 shares authorized; 60,600 shares outstanding at March 31, 2014 and December 31, 2013; designated as Series A Convertible Preferred Stock with liquidation preference of $606,000 at March 31, 2014 and December 31, 2013	60			60

Common stock, $0.0001 par value, 150,000,000 shares authorized; 18,902,782 shares issued and outstanding at March 31, 2014 and December 31, 2013	1,890			1,890

Additional paid-in capital	87,993,233			87,433,460
Deficit accumulated during the development stage	(70,242,416		)	(67,043,410		)
Total stockholders’ equity	17,752,767			20,392,000
Total liabilities and stockholders’equity	$	24,458,708		$	27,155,735

See accompanying notes to the unaudited financial statements.

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TROVAGENE, INC.
(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	Three Months Ended March 31,						Period from August 4, 1999 (Inception) through
	2014			2013			March 31, 2014

Royalty income	$	110,953		$	119,123		$	1,295,673
Milestone fees	—			—			150,000
License fees	—			—			1,383,175
Total revenues	110,953			119,123			2,828,848
Costs and expenses:
Research and development	1,442,521			802,245			22,839,561
Purchased in-process research and development — related party	—			—			2,666,869
Selling and marketing	569,590			360,459			2,606,284
General and administrative	1,358,480			1,346,258			32,244,100
Total operating expenses	3,370,591			2,508,962			60,356,814
Loss from operations	(3,259,638		)	(2,389,839		)	(57,527,966		)

Interest income	2,391			—			272,937
Interest expense	(9,496		)	—			(1,351,873		)
Gain on disposal of equipment	44,101			—			25,160
Amortization of deferred debt costs and original issue discount	—			—			(2,346,330		)
Change in fair value of derivative instruments-warrants	32,846			1,279,143			(6,546,067		)
Gain on extinguishment of debt	—			—			623,383
Liquidated damages and other forbearance agreement settlement costs	—			—			(1,758,111		)
Net loss	(3,189,796		)	(1,110,696		)	(68,608,867		)

Preferred stock dividend	(9,210		)	(5,885		)	(385,208		)
Cumulative effect of early adopting ASC Topic 815-40	—			—			(455,385		)
Series A Convertible Preferred stock conversion rate change accreted as a dividend	—			—			(792,956		)
Net loss attributable to common stockholders	$	(3,199,006	)	$	(1,116,581	)	$	(70,242,416	)

Net loss per common share-basic and diluted	$	(0.17	)	$	(0.07	)

Weighted average shares outstanding - basic and diluted	18,902,782			15,510,340

See accompanying notes to the unaudited financial statements.

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TROVAGENE, INC.

(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	Three Months Ended March 31,						Period from August 4, 1999 (Inception) through
	2014			2013			March 31, 2014
Operating activities
Net loss	$	(3,189,796	)	$	(1,110,696	)	$	(68,608,867	)
Adjustments to reconcile net loss to net cash used in operating activities:
Net gain on disposal of fixed assets	(44,101		)	—			(25,160		)
Depreciation and amortization	53,528			17,779			447,689
Stock based compensation expense	559,773			341,475			14,551,602
Founders compensation contributed to equity	—			—			1,655,031
Donated services contributed to equity	—			—			829,381
Settlement of consulting services in stock	—			—			478,890
Amortization of deferred debt costs and original issue discount	—			—			2,346,330
Liquidated damages and other forbearance agreement settlement costs paid in stock	—			—			1,758,111
Interest expense on convertible debentures paid in stock	—			—			757,198
Change in fair value of financial instruments	(32,846		)	(1,279,143		)	6,546,067
Gain on extinguishment of debt	—			—			(623,383		)
Purchased in process research and development expense-related party	—			—			2,666,869
Stock issued in connection with payment of deferred salary	—			—			28,346
Stock issued in connection with settlement of legal fees	—			—			100,000
Stock and warrant issued in connection with consulting services	—			198,791			651,180
Changes in operating assets and liabilities:
Increase in other assets	—			(156,694		)	(44,250		)
(Increase) decrease in accounts receivable	(50,309		)	110,317			(129,304		)
Increase in prepaid expenses	(109,399		)	(67,043		)	(262,188		)
Increase in accounts payable and accrued expenses	14,479			316,554			1,748,788
Net cash used in operating activities	(2,798,671		)	(1,628,660		)	(35,127,670		)

Investing activities:
Assets acquired in Etherogen, Inc. merger	—			—			(104,700		)
Capital expenditures, net	(118,507		)	(93,351		)	(1,282,174		)
Net cash used in investing activities	(118,507		)	(93,351		)	(1,386,874		)

Financing activities:
Proceeds from sale of 6% convertible debenture	—			—			2,335,050
Debt issuance costs	—			—			(297,104		)
Proceeds from sale of common stock, net of expenses	—			—			51,585,195
Proceeds from exercise of warrants	—			66,505			3,599,831
Proceeds from exercise of options	—			—			38,849
Proceeds from a non-exclusive selling agent’s agreement	—			—			142,187
Net borrowings (repayments) under equipment line of credit	(48,637		)	—			467,327
Costs associated with recapitalization	—			—			(362,849		)
Proceeds from sale of preferred stock	—			—			2,771,000
Payment of finders’ fee on preferred stock	—			—			(277,102		)
Redemption of common stock	—			—			(500,000		)
Payment of preferred stock dividends	—			—			(116,718		)
Net cash (used in) provided by financing activities	(48,637		)	66,505			59,385,666
Net change in cash and equivalent	(2,965,815		)	(1,655,506		)	22,871,122
Cash and cash equivalents—Beginning of period	25,836,937			10,819,781			—
Cash and cash equivalents—End of period	$	22,871,122		$	9,164,275		$	22,871,122
Supplementary disclosure of cash flow activity:
Cash paid for taxes	$	2,400		$	7,650		$	10,050

Cash paid for interest	$	6,601		$	—		$	16,060

Supplemental disclosure of non-cash investing and financing activities:
Issuance of 41,750 shares of common stock for prior year Board of Directors’ fees in lieu of cash payment	$	—		$	—		$	125,250
Conversion of $2,335,050 of 6% debentures	$	—		$	—		$	1,130,164
Issuance of 125,000 shares of common stock pursuant to Asset Purchase Agreement with MultiGen Diagnostics, Inc.	$	—		$			$	187,500
Issuance of 2,043,797 shares of common stock pursuant to Agreement and Plan of Merger with Etherogen, Inc.	$	—		$	—		$	2,771,389
Reclassification of derivative financial instruments to additional paid in capital	$	—		$	—		$	(8,735,334	)
Correction of error in derivative financial instruments	$	—		$	—		$	(274,967	)
Series A Preferred beneficial conversion feature accreted as a dividend	$	—		$	—		$	792,956
Issuance of common stock from net exercise of warrants	$	—		$	—		$	—
Preferred stock dividends accrued	$	9,210		$	5,885		$	230,250
Interest paid in common stock	$	—		$	—		$	1,325,372

See accompanying notes to the unaudited financial statements.

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TROVAGENE, INC.

(A Development Stage Company)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Business Overview, Basis of Presentation and Liquidity

Business Overview

Trovagene, Inc. (“Trovagene” or the “Company”) is focused on developing and commercializing its precision cancer monitoring technology,which can inform oncologists and guide treatment decisions by determining a patient’s mutational status and tracking therapeutic response and resistance over time.

The Company is in the process of expanding the body of clinical evidence supporting its urine-based cell-free DNA mutation tracking system through collaborations with major cancer treatment centers and integrated healthcare networks. This year, Trovagene expects that the benefits of its precision cancer monitoring technology will become more apparent in terms of its clinical utility and impact on patient outcomes. The Company’s intellectual property estate protecting its technology includes methods of extracting, purifying, preparing, and detecting cell-free DNA and RNA mutations in urine.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of Trovagene, which include its wholly owned subsidiaries Xenomics, Inc., a California corporation, Xenomics Europa Ltd, (an inactive subsidiary formed in the United Kingdom and liquidated) and Etherogen, Inc. 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. Certain items in the comparable prior period’s financial statements have been reclassified to conform to the current period’s presentation. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements as of December 31, 2013 and 2012 and for each of the three years ended December 31, 2013 and from inception (August 4, 1999) to December 31, 2013 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 17, 2014. The accompanying condensed consolidated financial statements have been prepared by the Company without audit. In the opinion of management, all adjustments (which include only normal recurring adjustments) necessary to present fairly the financial position, results of operations, and cash flows at March 31, 2014, and for all periods presented herein, have been made. The results of operations for the periods ended March 31, 2014 and 2013 are not necessarily indicative of the operating results for the full year.

Reverse Stock Split

On May 24, 2012, the Board of Directors approved a 1-for-6 reverse stock split of the Company’s issued and outstanding common stock effective on May 29, 2012. All the relevant information relating to number of shares and per share information contained in these condensed consolidated financial statements has been retrospectively adjusted to reflect the reverse stock split for all periods presented.

Liquidity

Trovagene’s condensed consolidated financial statements as of March 31, 2014 have been prepared under the assumption that Trovagene will continue as a going concern. The Company’s ability to continue as a going concern is dependent upon its ability to obtain additional equity or debt financing, attain further operating efficiencies and, ultimately, to generate additional revenue. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company will be required to raise additional capital within the next twelve months to complete the development and commercialization of current product candidates and to continue to fund operations at its current projected cash expenditure levels.

Cash used in operating activities was $2,798,671 and $1,628,660, for the three months ended March 31, 2014 and 2013, respectively. During the three months ended March 31, 2014 and 2013, the Company incurred a net loss of $3,189,796 and $1,110,696, respectively.

To date, Trovagene’s sources of cash have been primarily related to financing activities, including the sale of debt and equity securities, debt borrowings and proceeds from exercise of warrants and options. During the three months ended March 31, 2014 cash used by financing activities was $48,637 and resulted from debt repayments, while in the same period of the prior year, $66,505 was provided by the exercise of warrants. The Company cannot be certain that additional funding will be available on acceptable terms, or

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at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company’s ability to conduct its business.

If the Company is unable to raise additional capital when required or on acceptable terms, it may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more of its product candidates. The Company may also be required to:

· Seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and

· Relinquish licenses or otherwise dispose of rights to technologies, product candidates or products that the Company would otherwise seek to develop or commercialize themselves, on unfavorable terms.

The Company has approximately $21.9 million of cash and cash equivalents at April 30, 2014.

2. 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 and diluted 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. In a period where there is a net loss position, diluted weighted-average shares are the same as basic weighted-average shares. Shares used in calculating basic and diluted net loss per common share for the three months ended March 31 exclude as antidilutive the following share equivalents:

	March 31,
	2014	2013
Options to purchase Common Stock	4,423,638	3,962,710
Warrants to purchase Common stock	6,233,483	7,009,824
Series A Convertible Preferred Stock	63,125	81,354
	10,720,246	11,053,888

3. Accounting for Share-Based Payments

Stock Options

ASC Topic 718 “Compensation—Stock Compensation” requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award. ASC Topic 718 did not change the way Trovagene accounts for non-employee stock-based compensation. Trovagene accounts for shares of common stock, stock options and warrants issued to non-employees based on the fair value of the stock, stock option or warrant, if that value is more reliably measurable than the fair value of the consideration or services received. The Company accounts for stock options issued and vesting to non-employees in accordance with ASC Topic 505-50 “ Equity-Based Payment to Non-Employees” whereas the value of the stock compensation is based upon the measurement date as determined at either: a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Accordingly the fair value of these options is being “marked to market” quarterly until the measurement date is determined.

Stock-based compensation expense related to Trovagene options have been recognized in operating results as follow:

	Three Months Ended March 31,
	2014		2013
Included in research and development expense	$	189,635	$	122,317
Included in selling and marketing expense	22,680		21,717
Included in general and administrative expense	347,458		197,441
Total stock-based compensation expense	$	559,773	$	341,475

The unrecognized compensation cost related to non-vested stock options outstanding at March 31, 2014 and 2013, net of expected forfeitures, was $3,695,076 and $3,504,395, respectively, to be recognized over a weighted-average remaining vesting period of approximately three and four years, respectively. The remaining contractual term of outstanding options as of March 31, 2014 was approximately 6.5 years.

The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following assumptions during the following periods indicated.

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	Three Months Ended March 31,
	2014		2013
Risk-free interest rate	1.5-1.6	%	0.82-0.89	%
Dividend yield	0	%	0	%
Expected volatility	83	%	97	%
Expected term (in years)	5.0 yrs.		5.0 yrs.

A summary of stock option activity and of changes in stock options outstanding under the the Trovagene Stock Option Plan is presented below:

	Number of Options		Weighted Average Exercise Price Per Share		Intrinsic Value
Balance outstanding, December 31, 2013	4,287,545		$	5.18
Granted	167,870		6.13
Forfeited	(31,777	)	6.16
Balance outstanding, March 31, 2014	4,423,638		$	5.20	$	5,860,704
Exercisable at March 31, 2014	2,520,235		$	5.52	$	3,617,109

Warrants

As of March 31, 2014 and December 31, 2013, the Company had 6,233,483 warrants outstanding at a weighted average exercise price of $3.87. The remaining contractual term of outstanding warrants as of March 31, 2014 was approximately 4 years.

4. Stockholders’ Equity

Common Stock

On January 25, 2013, the Company filed a Form S-3 Registration Statement to offer and sell in one or more offerings, any combination of common stock, preferred stock, warrants, or units having an aggregate initial offering price not exceeding $150,000,000. The preferred stock, warrants, and units may be convertible or exercisable or exchangeable for common stock or preferred stock or other Trovagene securities. This form was declared effective on February 4, 2013. In addition, in connection with the Form S-3, 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 them. As payment for its services, the Agent is entitled to a 3% commission on gross proceeds. There were no sales of common stock during the quarter ended March 31, 2014.

5. Asset Purchase Agreement

On February 1, 2012, the Company entered into an asset purchase agreement with MultiGen Diagnostics, Inc. The Company determined that the acquired asset did not meet the definition of a business, as defined in ASC 805 , Business Combinations and was accounted for under ASC 350, Intangibles- Goodwill and Other . In connection with the acquisition, the Company issued 125,000 shares of restricted common stock to MultiGen. In addition, up to an additional $3.7 million may be paid in a combination of common stock and cash to MultiGen upon the achievement of specific sales and earnings targets. In addition, in connection with the acquisition, the Company entered into a Reagent Supply Agreement dated as of February 1, 2012 pursuant to which MultiGen will supply and deliver reagents to be used in connection with a Clinical Laboratory Improvement Amendment (CLIA) laboratory. The total purchase consideration was determined to be $187,500 which was paid in the Company’s common stock and allocated to an indefinite lived intangible asset related to the CLIA license.

Under ASC Topic 805, Business Combinations, the Company was required to assess the fair value of the assets acquired and the contingent consideration at the date of acquisition. Therefore, the Company assessed the fair value of the assets purchased and concluded that the purchase price would be allocated entirely to one intangible asset, a CLIA license. The contingent consideration of the $3.7 million milestone was determined to have no fair value by applying a weighted average probability on the achievement of the milestones developed during the valuation process. The Company assesses the fair value of the contingent consideration at each quarter and makes adjustments as necessary until the milestone dates have expired. As of March 31, 2014, no adjustments to the fair value of the contingent consideration have been necessary, and therefore the fair value of the contingent consideration remains unchanged.

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6. Derivative Financial Instruments - Warrants

Effective January 1, 2009, the Company adopted provisions of ASC Topic 815-40, “Derivatives and Hedging: Contracts in Entity’s Own Equity” (“ASC Topic 815-40”). ASC Topic 815-40 clarifies the determination of whether an instrument issued by an entity (or an embedded feature in the instrument) is indexed to an entity’s own stock, which would qualify as a scope exception under ASC Topic 815-10.

Based upon the Company’s analysis of the criteria contained in ASC Topic 815-40, Trovagene has determined that the warrants issued in connection with certain of its debentures must be recorded as derivative liabilities. Accordingly the warrants are also being re-measured at each balance sheet date based on estimated fair value, and any resultant changes in fair value is being recorded in the Company’s condensed consolidated statement of operations.

The Company estimates the fair value of the warrants issued in connection with certain of its debentures using the Black-Scholes model in order to determine the associated derivative instrument liability and change in fair value described above. The range of assumptions used to determine the fair value of the warrants at the end of each three month period, March 31, 2014 and 2013 were as follows:

	Three Months Ended March 31,
	2014		2013
Estimated fair value of Trovagene common stock	$	5.73	$	6.26
Expected warrant term	4.76 years		0.82 – 5.76 years
Risk-free interest rate	1.73%		0.11-1.01%
Expected volatility	83%		97%
Dividend yield	0%		0%

The following table sets forth the components of changes in the Company’s derivative financial instruments liability balance, valued using the Black-Scholes option pricing method, for the periods indicated:

Date	Description	Warrants	Derivative Instrument Liability

December 31, 2013	Balance of derivative financial instruments liability	1,013,961	$	4,431,871

	Change in fair value of warrants during the quarter recognized as a gain in the condensed consolidated statement of operations	—	(32,846		)

March 31, 2014	Balance of derivative financial instruments liability	1,013,961	$	4,399,025

7. Fair Value Measurements

Fair value of financial instruments

The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of March 31, 2014 and December 31, 2013:

	Fair Value Measurements at
	March 31, 2014
	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)	$	22,580,276	$	—	$	—	$	22,580,276
Total Assets	$	22,580,276	$	—	$	—	$	22,580,276
Liabilities:
Derivative liabilities related to warrants	—		$	—	$	4,399,025	$	4,399,025
Total Liabilities	$	—	$	—	$	4,399,025	$	4,399,025

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	Fair Value Measurements at
	December 31, 2013
	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)	$	25,703,330	$	—	$	—	$	25,703,330
Total Assets	$	25,703,330	$	—	$	—	$	25,703,330
Liabilities:
Derivative liabilities related to warrants	—		$	—	$	4,431,871	$	4,431,871
Total Liabilities	$	—	$	—	$	4,431,871	$	4,431,871

(1)Included as a component of cash and cash equivalents on the accompanying condensed consolidated balance sheets.

The following table sets forth a summary of changes in the fair value of the Company’s Level 3 liabilities for the three months ended March 31, 2014:

Description	Balance at December 31, 2013		Unrealized Gain			Balance at March 31, 2014
Derivative liabilities related to Warrants	$	4,431,871	$	(32,846	)	$	4,399,025

The unrealized gain on the derivative liabilities is recorded as a change in fair value of derivative liabilities in the Company’s condensed consolidated statement of operations. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC Topic 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3.

8. Debt

Equipment Line of Credit

In June 2013, the Company entered into a Loan and Security Agreement with Silicon Valley Bank that provides for cash borrowings for equipment of up to $1.0 million, secured by the equipment financed. As of March 31, 2014, $515,964 has been borrowed under the agreement. As of March 31, 2014, amounts due under the agreement include $200,792 in current liabilities and $274,852 in long-term liabilities, which includes $8,317 of accrued interest.

Under the terms of the agreement, interest is the greater of 5% or 4.6% above the U.S. Treasury Note as of the date of each borrowing. The weighted average interest rate of the borrowings is 5.28% as of March 31, 2014. Interest only payments were due on borrowings through December 31, 2013, with both interest and principal payments commencing in January 2014. Any equipment advances after December 31, 2013 are subject to principal and interest payments immediately over a 30 month period following the advance. The Company has an obligation to make a final payment equal to 7% of total amounts borrowed at the loan maturity date and the final payment is being accrued over the term of the loans using the effective-interest method.

At March 31, 2014, Trovagene was in compliance with all covenants under the Loan Agreement. The Company is subject to certain nonfinancial covenants and a material adverse change clause.

The Company recorded approximately $9,500 in interest expense related to the Loan and Security Agreement during the three months ended March 31, 2014.

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9. Commitments and Contingencies

Executive and Consulting Agreements

The Company has contracted with various consultants and third parties, including the Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”). The executive agreements with the CEO and CFO provide for severance payments.

Lease Agreement

The Company leases approximately 8,300 square feet of office space at a monthly rental rate of approximately $18,300 to $20,000 during the remaining term of the lease, through December 2017.

Research and Development Agreements

During 2012, the Company entered into research agreements with University of Texas MD Anderson Cancer Center (“MDACC”) to provide samples and evaluate methods used by the Company in identification of pancreatic cancer mutations, as well as to measure the degree of concordance between results of cell-free DNA mutations analysis from urine samples and tumor tissue. During 2013, the agreements were amended to increase the scope of the agreements. Under these agreements, the Company has committed to pay approximately $266,000 for the services performed by MDACC. As of March 31, 2014, the Company has incurred and recorded approximately $216,000 of research and development expenses related to these agreements.

In April 2013, the Company entered into a research and development agreement with PerkinElmer Health Sciences, Inc. (“PerkinElmer”) pursuant to which the Company will design an assay, based on the Company’s urine-based cell-free molecular diagnostic technology, to determine the risk for developing hepatocellular carcinoma. In addition, the Company has granted PerkinElmer an exclusive option (the “HCC Option”) to obtain an exclusive royalty-bearing license to use the Company’s technology within the hepatocellular carcinoma field (the “HCC Field”) as well as other fields. Together with PerkinElmer we will jointly validate the assay and evaluate the potential of combining our urine-based cell-free molecular diagnostic technology with PerkinElmer’s technology for automation of nucleic acid isolation. PerkinElmer will pay us milestone payments. The Company recognizes milestone payments received from PerkinElmer as a reduction in research and development costs as the services are performed. Amounts received in advance of services performed are recorded as accrued liabilities until the services for which the payment has been received have been performed. As of March 31, 2014, the Company has received milestone payments related to this agreement of approximately $90,000 and incurred and recorded approximately $90,000 of research and development costs. A notice of termination was received in March 2014 terminating the agreement. No further commitments exist from either party.

In June 2013, the Company entered into a research agreement with Illumina, Inc. (“Illumina”) pursuant to which the parties will work together to evaluate the potential for integrating the Company’s transrenal technology for isolating, extracting and genetic analysis of nucleic acids from urine with Illumina’s genetic analysis sequencing technology (the “Research Plan”). The parties have agreed that all results and reagents from the research plan will be shared between the parties. The agreement will terminate upon the earlier of 30 days after completion of the research plan or the one year anniversary of the agreement unless extended by mutual written agreement.

In August 2013, the Company entered into a clinical trial agreement with the University of Southern California (“USC”), pursuant to which USC will provide the principal investigator and conduct the clinical trial related to the genetic characterization of metastatic colorectal cancers. Under the agreement, the Company may pay USC approximately $232,000 for services provided. Through March 31, 2014 the Company has incurred and recorded approximately $1,300 of research and development expense related to this agreement.

In December 2013, the Company entered into a clinical trial agreement with US Oncology Research LLC (“USOR”), pursuant to which USOR will provide the principal investigator and conduct the clinical trial related to the examining the utility of transrenal quantitative KRAS testing in disease monitoring in patients with metastatic pancreatic cancer. Under the agreement, the Company may pay USOR approximately $270,000 for services provided. As of March 31, 2014 the Company has incurred and recorded approximately $30,000 of research and development expense related to this agreement.

10. Subsequent Events

On May 8, 2014, we entered into a Patent Assignment and License Agreement, effective as of April 23, 2014, with GenSignia IP Ltd., a United Kingdom company, pursuant to which the Company assigned all of its miRNA patents, including methods of using miRNA for detection of in vivo cell death and detecting cell-free miRNA in urine and blood. Concurrent with the assignment, GenSignia granted to the Company an exclusive, world-wide, royalty-free, fully paid, perpetual license under the transferred patents in the urine field. Pursuant to the agreement, GenSignia will pay the Company a low single digit royalty on net sales and will pay an aggregate $6.5 million in milestone payments upon the achievement of up to $150 million in net sales. GenSignia shall be responsible for the preparation, filing and maintenance of all patents under the agreement. Antonius Schuh, the Company’s CEO and a director, is a director of GenSignia. Dr. Schuh did not participate in any negotiations with respect to the agreement and recused himself from any director vote in connection with the agreement.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions.

In addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2013, filed on March 17, 2014. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for us to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

You should not rely upon forward looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward looking statements will be achieved or occur. Although we believe that the expectations reflected in the forward looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

The following discussion and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present assessment of our management.

Overview

We are focused on developing and commercializing our precision cancer monitoring technology, which can inform oncologists; and guide treatment decisions by determining a patient’s mutational status and tracking therapeutic response and resistance over time.

We are expanding the body of clinical evidence supporting our urine-based cell-free DNA mutation tracking system through collaborations with major cancer treatment centers and integrated healthcare networks. We expect that the benefits of our precision cancer monitoring technology will become more apparent in terms of its clinical utility and impact on patient outcomes. Our intellectual property estate protecting our technology includes methods of extracting, purifying, preparing, and detecting cell-free DNA and RNA mutations in urine.

From August 4, 1999 (inception) through March 31, 2014, we have sustained a cumulative total deficit of $70,242,416. From inception through March 31, 2014, we have generated minimal revenues and expect to incur additional losses to perform further research and development activities. During 2014, we have advanced our business with the following activities:

· We introdued our non-invasive cancer monitoring platform with the release of our first multiplexed oncogene mutation assay using next generation sequencing. This allows us to leverage the scalability of our proprietary platform and next generation sequencing to introduce a full line of multiplexed urine-based oncogene mutation assays.

· We entered into a strategic partnership with Catholic Health Initiatives Center for Translational Research to clinically evaluate non-invasive genomic diagnostics to improve cancer care. The partnership seeks to establish clinical and health economic benefits for potential adoption in cancer management strategies.

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· Our clinical study results were presented at the American Association for Cancer Research (AACR) Annual Meeting to demonstrate the ability of our molecular diagnostic platform to detect and monitor BRAF V600E mutations in cancer patients. The results were presented by Filip Janku, M.D., Ph.D., of The University of Texas MD Anderson Cancer Center on April 8, 2014.

Our product development and commercialization efforts are in their early stages, and we cannot make estimates of the costs or the time our development efforts will take to complete, or the timing and amount of revenues related to the sale of our tests and revenues related to our license agreements. The risk of completion of any program is high because of the many uncertainties involved in bringing new diagnostic products to market including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols and/or CLIA requirements, the extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources.

Off-Balance Sheet Arrangements

We had no off-balance sheet arrangements as of March 31, 2014.

Critical Accounting Policies

Financial Reporting Release No. 60 requires all companies to include a discussion of critical accounting policies or methods used in the preparation of financial statements. Our accounting policies are described in ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS of our Annual Report on Form 10-K as of and for the year ended December 31, 2013, filed with the SEC on March 17, 2014. There have been no changes to our critical accounting policies since December 31, 2013.

RECENT ACCOUNTING PRONOUNCEMENTS

There are no recent accounting pronouncements affecting the Company.

RESULTS OF OPERATIONS

Three Months Ended March 31, 2014 and 2013

Revenues

Our total revenues were $110,953 and $119,123 for the three months ended March 31, 2014 and 2013, respectively, and consisted of royalty income. Royalty income decreased by $8,170 in the three months ended March 31, 2014, primarily due to timing of royalty payments received. There was no milestone, license fee or diagnostic revenue in the three months ended March 31, 2014 and 2013.

We expect our royalty income to fluctuate as the royalties are based on the portion of our partners’ revenues as well as the timing of when payments are received. Milestone and license fee revenue is difficult to predict and can vary significantly from period to period. In addition, we expect to have revenues from our diagnostics tests in future periods, but as the revenue recognition will be based on cash receipts, the timing of these revenues is also uncertain.

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Research and Development Expenses

Research and development expenses consisted of the following:

	Three Months Ended March 31,
	2014		2013		Increase
Salaries and staff costs	$	543,791	$	304,312	$	239,479
Stock-based compensation	189,635		122,317		67,318
Outside services, consultants and lab supplies	551,250		268,642		282,608
Facilities	130,742		91,762		38,980
Travel and scientific conferences	25,804		15,212		10,592
Other	1,299		—		1,299
Total research and development	$	1,442,521	$	802,245	$	640,276

Research and development expenses increased by $640,726 to $1,442,521 for the three months ended March 31, 2014 from $802,245 for the same period in 2013. Substantially all of the increase resulted from the expansion of our research and development efforts to support the clinical collaborations we have entered into related to validating our tests to detect certain types of cancer in urine samples. As a result of these collaborations, we increased the average number of our internal research and development personnel from seven to thirteen, and purchased additional laboratory equipment, lab supplies and clinical samples. We expect research and development expenses to increase as we enter into additional collaborations.

Selling and Marketing Expenses

Selling and marketing expenses consisted of the following:

	Three Months Ended March 31,
	2014		2013		Increase/(Decrease)
Salaries and staff costs	$	318,518	$	185,970	$	132,548
Stock-based compensation	22,680		21,717		963
Outside services and consultants	106,007		70,645		35,362
Facilities	28,068		22,253		5,815
Trade shows, conferences and marketing	65,198		12,582		52,616
Travel	28,877		20,327		8,550
Other	242		26,965		(26,723		)
Total sales and marketing	$	569,590	$	360,459	$	209,131

Selling and marketing expenses increased by $209,131 to $569,590 for the three months ended March 31, 2014 from $360,459 for the same period in 2013. We have increased our sales and marketing headcount and costs as we expand our efforts to inform the major cancer centers in the United States of our current and future product offerings. We expect these costs to increase as we continue to market and sell our tests.

General and Administrative Expenses

General and administrative expenses consisted of the following:

	Three Months Ended March 31,
	2014		2013		Increase/(Decrease)
Salaries and staff costs	$	175,727	$	117,448	$	58,279
Board of Directors’ fees	65,374		63,855		1,519
Stock-based compensation	347,458		396,233		(48,775		)
Outside services and consultants	353,922		309,044		44,878
Legal and accounting fees	203,854		335,731		(131,877		)
Facilities and insurance	59,233		53,121		6,112
Travel	59,264		40,410		18,854
Fees, licenses, taxes and other	93,648		30,416		63,232
Total general and administrative	$	1,358,480	$	1,346,258	$	12,222

General and administrative expenses increased by $12,222 to $1,358,480 for the three months ended March 31, 2014, from $1,346,258 for the same period in 2013. Continued patent filing and maintenance as well as the costs associated with being a publicly traded company, such as additional costs for insurance, NASDAQ fees and Sarbanes-Oxley compliance have added to our general and

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administrative expenses in comparison to the same period of the prior year. We expect our general and administrative costs to increase as a result of our accelerated filer status and as we raise more capital.

Change in Fair Value of Derivative Instruments - Warrants

We have issued securities that are accounted for as derivative liabilities. As of March 31, 2014, the derivative liabilities related to securities issued were revalued to $4,399,025, resulting in a net decrease in value of $32,846 from December 31, 2013, based primarily upon the change in our stock price from $5.74 at December 31, 2013 to $5.73 at March 31, 2014 and the changes in the expected term and risk free interest rates for the expected term. The decrease in value was recorded as non-operating gain for the three months ended March 31, 2014.

Net Loss

Net loss and per share amounts were as follows:

	Three Months Ended March 31,
	2014			2013			Increase
Net loss attributable to common shareholders	$	(3,199,006	)	$	(1,116,581	)	$	2,082,425

Net loss per common share: basic and diluted	$	(0.17	)	$	(0.07	)	$	0.10
Weighted average shares: basic and diluted	18,902,782			15,510,340			3,392,442

The $2,082,425 increase in net loss attributable to common shareholders and $0.10 increase in net loss per share in 2014 compared to 2013 reflected a slight decrease in revenues, an increase in operating expenses, and a decrease in the gain from the change in fair value in derivative liabilities. Net loss per share in 2014 was also impacted by the sale and issuance of approximately 3.4 million shares of common stock resulting from the sales of stock during the third quarter of 2013, and exercise of stock options and warrants from April 1, 2013 through December 31, 2013.

LIQUIDITY AND CAPITAL RESOURCES

As of March 31, 2014, we had $22,871,122 in cash and cash equivalents. Net cash used in operating activities for the three months ended March 31, 2014 was $2,798,671, compared to $1,628,660 for the three months ended March 31, 2013. Our use of cash was primarily a result of the net loss of $3,189,796 for the three months ended March 31, 2014, adjusted for non-cash items related to stock-based compensation of $559,773, depreciation and amortization of $53,528 and the gain from the change in fair value of derivatives of $32,846. The changes in our operating assets and liabilities consisted of higher accounts payable and accrued expenses, prepaid expenses and other assets, and an increase in accounts receivable. At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.

Investing activities consisted of net purchases for capital equipment that used $118,507 in cash during the three months ended March 31, 2014, compared to $93,351 for the same period in 2013.

Net cash used by financing activities was $48,637 during the three months ended March 31, 2014, compared to net cash provided by financing activities of $66,505 in 2013. Financing activites during the three months ended March 31, 2014 related to net repayments under an equipment line of credit, while financing activities during the same period of the prior year were from proceeds received upon the exercise of warrants.

As of March 31, 2014, and December 31, 2013, we had working capital of $21,230,549 and $24,059,854, respectively. As of April 30, 2014, our working capital was $20,303,849.

Our working capital requirements will depend upon numerous factors including but not limited to the nature, cost and timing of our research and development programs and ramp up of our sales and marketing function. We will be required to raise additional capital within the next twelve months to complete the development and commercialization of current product candidates, to fund the existing working capital deficit and to continue to fund operations at our current cash expenditure levels. To date, our sources of cash have been primarily limited to the sale of equity securities and debentures. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct business. If we are unable to raise additional capital when required or on acceptable terms, we may have to (i) significantly delay, scale back or discontinue the development and/or commercialization of one or more of product candidates; (ii) seek collaborators for

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product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to technologies, product candidates or products that we would otherwise seek to develop or commercialize ourselves on unfavorable terms.

Public Offering and Controlled Equity Offering

On January 25, 2013 we filed a Form S-3 Registration Statement to offer and sell in one or more offerings, any combination of common stock, preferred stock, warrants, or units having an aggregate initial offering price not exceeding $150,000,000. The preferred stock, warrants, and units may be convertible or exercisable or exchangeable for common stock or preferred stock or other securities. This form was declared effective on February 4, 2013. In addition, in connection with the Form S-3, we 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 them. As payment for their services, the Agent is entitled to a 3% commission on gross proceeds.

CONTRACTUAL OBLIGATIONS

For a discussion of our contractual obligations see (i) our Financial Statements and Notes to Consolidated Financial Statements Note 9. Commitments and Contingencies , and (ii) Item 7 Management Discussion and Analysis of Financial Condition and Results of Operations — Contractual Obligations and Commitments , included in our Annual Report on Form 10-K as of December 31, 2013.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Interest Rate Risk

Our cash and cash equivalent primary consists of deposits, and money market deposits managed by commercial banks. The goals of our investment policy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk.

Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of interest rates, particularly because our investments are in short-term money marketable funds. Due to the short-term duration of our investment portfolio and the relatively low risk profile of our investments, a sudden change in interest rates would not have a material effect on the fair market value of our portfolio, nor our operating results or cash flows.

We do not believe our cash and cash equivalents have significant risk of default or illiquidity, however, we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits. Given the current instability of financial institutions, we cannot provide assurance that we will not experience losses on these deposits.

Foreign Currency Risk

We have no operations outside the U.S. and do not hold any foreign currency denominated financial instruments.

Effects of Inflation

We do not believe that inflation and changing prices during the three months ended March 31, 2014 had a significant impact on our results of operations.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), of the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”). Based on that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective as of March 31, 2014 to provide reasonable assurance that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

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Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting during the quarter ended March 31, 2014 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

We are not a party to any pending legal proceeding, nor is our property the subject of a pending legal proceeding, that is not in the ordinary course of business or otherwise material to the financial condition of our business. None of our directors, officers or affiliates is involved in a proceeding adverse to our business or has a material interest adverse to our business.

ITEM 1A. RISK FACTORS

There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2013.

ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds

Not applicable.

ITEM 3. Default Upon Senior Securities

Not applicable.

ITEM 4. Mine Safety Disclosures

Not applicable.

ITEM 5. Other Information

On May 8, 2014, we entered into a Patent Assignment and License Agreement, effective as of April 23, 2014, with GenSignia IP Ltd. (“GenSignia”), a United Kingdom company, pursuant to which we assigned all of our miRNA patents, including methods of using miRNA for detection of in vivo cell death and detecting cell-free miRNA in urine and blood. Concurrent with the assignment, GenSignia granted to us an exclusive, world-wide, royalty-free, fully paid, perpetual license under the transferred patents in the urine field. Pursuant to the agreement, GenSignia will pay us a low single digit royalty on net sales and will pay an aggregate $6.5 million in milestone payments upon the achievement of up to $150 million in net sales. GenSignia shall be responsiblefor the preparation, filing and maintenance of all patents under the agreement. Antonius Schuh, our CEO and a director, is a director of GenSignia. Dr. Schuh did not participate in any negotiations with respect to the agreement and recused himself from any director vote in connection with the agreement.

ITEM 6. EXHIBITS

Exhibit Number		Description of Exhibit

10.1*		Patent Assignment and License Agreement between Trovagene, Inc. and Gensignia IP Ltd. effective as of April 23, 2014.

31.1		Certification of Chief Executive Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act.

31.2		Certification of Principal Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.

32.1		Certification of Chief Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2		Certification of Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101		Financial statements from the quarterly report on Form 10-Q of the Company for the quarter ended March 31, 2014 filed on May 12, 2014, formatted in Extensible Business Reporting Language (XBRL): (i) the Condensed Consolidated Statements of Operations, (ii) the Condensed Consolidated Balance Sheets, (iii) the Condensed Consolidated Statements of Cash Flows and (iv) the Notes to the Condensed Consolidated Financial Statements tagged as blocks of text.

*Portions of this exhibit were omitted and filed separately with the U.S. Securities and Exchange Commission pursuant to a request for confidential treatment.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	TROVAGENE, INC.

May 12, 2014	By:	/s/ Antonius Schuh
		Antonius Schuh
		Chief Executive Officer


	TROVAGENE, INC.

May 12, 2014	By:	/s/ Stephen Zaniboni
		Stephen Zaniboni
		Chief Financial Officer

Exhibit 10.1

CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.

PATENT ASSIGNMENT AND LICENSE AGREEMENT

This Patent Assignment and License Agreement (hereinafter the “ Agreement ”), effective as of April 23, 2014 (the “ Effective Date ”), is entered by and between:

TROVAGENE, INC. , a California company with offices located at 11055 Flintkote Avenue, San Diego California, 92121 ( hereinafter referred to as “ Trovagene ”);

and

GENSIGNIA IP LTD., a UK company with offices located at 18 South Street, Mayfair, London, W1K 1DG, United Kingdom (hereinafter referred to as “ GenSignia ”);

RECITALS

A. WHEREAS Trovagene owns or has exclusive rights in or to certain patents and patent applications related to certain diagnostic tests;

B. WHEREAS GenSignia desires to obtain an assignment of Trovagene’s rights in such patents and patent applications; and

C. WHEREAS, subject to the terms and conditions set forth in this Agreement, Trovagene is willing to assign its rights in such patents and patent applications to GenSignia subject to receiving a perpetual, exclusive, irrevocable license in the Field (as defined below).

NOW, THEREFORE , in consideration of the foregoing premises and mutual agreements, covenants and conditions herein contained all the Parties hereto hereby agree as follows:

Article 1 Definitions

For purposes of this Agreement, the following terms shall have the meanings set forth below:

1.1 “ Affiliate ” shall mean with respect to any corporation, partnership or other business entity a Person or any other Person controlling, controlled by or under common control with such Person. For purposes of this definition, “control” (including with correlative meaning, the terms “controlled by” and “under common control with”) shall mean, directly or indirectly, the ownership of fifty percent (50%) or more of the voting securities or other voting interests of such Person, or the ability or power to direct or cause the direction of management policies of such Person or otherwise direct the affairs of such Person.

1.2 “ Bundled Product ” shall mean a Product for which Net Sales is calculated that is sold or otherwise transferred or delivered with one or more other products or services in circumstances where the price of such Product is either not shown separately on the invoice or is shown as nil (free of charge).

1.3 “ Bundled Product Adjustment ” means the following:

CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.

(a) In the event of a Bundled Product, then Net Sales for such Bundled Product shall be calculated, on a country-by-country basis, by multiplying actual Net Sales of such Bundled Product by the fraction A/(A+B), where A is the average gross invoiced sales amount of the Product if sold separately in finished form, and B is the average gross invoiced sales amount of all other products or services in finished form in such country.

(b) If, on a country-by-country basis, the Products are sold separately in finished form in such country but the other products or services in the Bundled Product are not sold separately in finished form in such country, Net Sales shall be calculated by multiplying actual Net Sales of such Bundled Product by the fraction C/(C+D), where C is the average gross invoiced sales amount of the Products in finished form in such country, and D is the difference between the average gross invoice sales amount of the Bundled Product and the average sales price of the Products in finished form in such country.

(c) If, on a country-by-country basis, the other products or services in the Bundled Product are sold separately in finished form in such country but the Products are not sold separately in finished form in such country, Net Sales shall be calculated by multiplying actual Net Sales of such Bundled Product by the fraction 1 minus C/(C+D), where C is the average gross invoiced sales amount of the other products or services in finished form in such country, and D is the difference between the average gross invoiced sales amount of the Bundled Product and the average gross invoiced sales amount of the other products or services in finished form in such country.

(d) If, on a country-by-country basis, neither the Products nor the other products or services of the Bundled Product are sold separately in finished form in such country, Net Sales of the Bundled Product shall be determined by the Parties in good faith based on the relative fair market value for the Products and products or services, as applicable.

1.4 “ Confidential Information ” means any and all information, data, results, inventions, trade secrets, techniques, material, or compositions of matter of any type or kind, including without limitation all know-how and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, personnel, financial, legal and commercial information or data, whether communicated in writing, orally or by any other method, that a Party treats or identifies as confidential and, in each case, is disclosed by one Party to the other Party with respect to such disclosing Party’s rights or obligations under this Agreement.

1.5 “ Distributors ” shall mean any Third Party appointed by GenSignia or any of its Affiliates to distribute, market and sell Products of GenSignia or any of its Affiliates that: (i) is not required to make royalty or other similar payment to GenSignia or any of its Affiliates with respect to any Transferred Patent whose claims cover the Product; and (ii) has no right to market such Product under its own trademark or trade name.

1.6 “ End User ” shall mean the ultimate user or practicer of a Product.

CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.

1.7 “ Field ” shall mean use, practice or other exploitation in urine for any and all indications, including for the performance of diagnostic tests in urine.

1.8 “ Licensee ” shall mean any individual or entity to whom GenSignia or any of its Affiliates grants a license to research, develop, make, have made, use, sell, offer to sell, have sold, import or otherwise practice or exploit Products covered by Transferred Patent Rights in the Territory.

1.9 “ License Income ” shall mean all up-front fees, license signing fees, milestone payments, success fees, royalties and other consideration received by GenSignia or its Affiliates from Licensees on account of the use or sale of Products or grant of a license under the Transferred Patents; provided, however that License Income will not include: (a) amounts paid by such licensee as reimbursement for research and development costs incurred under such license with respect to Products in the event GenSignia collaborates on research and/or development with such a licensee; (b) bona fide loans with market terms; (c) fair market value reimbursement for clinical trial costs and expenses; (d) equity investment in GenSignia at the market value for such equity; (e) amounts paid at fair market value for supplies of Products or other tangible materials, or that are otherwise paid in reimbursement of costs or expenditures, whether incurred before or after the date of the relevant license agreement; (f) upfront fees and milestone payments payable solely for products other than the Products, and (g) withholding taxes or other amounts actually witheld from the amounts received, paid to a governmental authority and not reimbursed by Licensee or any Third Party. License Income shall also not include amounts received in connection with a merger, consolidation or sale of all or substantially all of the business or assets of GenSignia to which this Agreement relates.

1.10 “ Net Sales ” shall mean, with respect to each Product, the total amount invoiced by GenSignia and its Affiliates and Distributors for sales of Products to Third Parties (other than Distributors in the Territory, except as set forth below), less the following deductions with respect to such sale, to the extent applicable to the Products, and to the extent actually allowed and/or taken: (i) trade, cash and quantity credits, discounts, credits, and refunds, (ii) allowances or credits for returns or rejected Product; (iii) prepaid freight and insurance; (iv) sales taxes and other governmental charges (including value added and similar taxes, but solely to the extent not otherwise creditable or reimbursed and excluding any income tax) actually paid by GenSignia or its Affiliates in connection with the sale; and (v) customary rebates (including, for this purpose, discounts provided by means of chargebacks or rebates) actually granted to managed health care organizations, federal, state, or local governments (or their agencies) (including without limitation Medicaid rebates), all to the extent in accordance with GAAP as consistently applied across all Products.

For the avoidance of any doubt, (i) sales between GenSignia and its Affiliates, or (ii) from GenSignia or any of its Affiliates to any of its or their Distributors or Licensees shall be excluded from the computation of Net Sales, except in connection with sales where such Affiliates, Distributors or Licensees are End Users.

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Such amounts shall be determined from books and records maintained in accordance with the law under which GenSignia is organized.

1.11 “ Party ” or “ Parties ” shall mean either Trovagene or GenSignia or both, as applicable.

1.12 “ Pending Patent Claim ” means a claim in a pending patent application within the Transferred Patents that has not been abandoned, expired or held finally rejected by a decision of a court or governmental authority of competent jurisdiction over such claim, and which rejection is not appealable or has not been appealed within the time allowed for appeal.

1.13 “ Person ” shall mean a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company, any governmental authority or any other entity or organization.

1.14 “ Products ” shall mean (i) any process which is covered, in whole or in part, by any Pending Patent Claim or any Valid Claim of any Transferred Patent; and (ii) any any product, the manufacture, use or sale of which is covered, in whole or in part, by any Pending Patent Claim or any Valid Claim of any Transferred Patent.

1.15 “Reserved Indication” shall mean the performance of diagnostic tests for lung cancer in the Field.

1.16 “ Royalty Term ” means, with respect to a Product, for each country in the Territory, the period of time commencing on the first commercial sale of such Product in any country and ending upon the expiration of the last Valid Patent Claim.

1.17 “ Territory ” means all of the countries in the world, and their territories and possessions, where there is a Valid Patent Claim or Pending Patent Claim in effect.

1.18 “ Third Party ” or “ Third Parties ” shall mean any individual, entity or entities other than GenSignia, Trovagene, and their respective Affiliates.

1.19 “ Transferred Patents ” shall mean:

(i) all patents and patent applications listed in Exhibit A attached hereto, and any patents issuing on such patent applications;

(ii) any divisional, continuations, continuations-in-part, refiling, and extensions of any of the foregoing patents and patent applications;

(iii) all substitutions, reissues, renewals, re-examinations, patents of addition, and inventors’ certificates thereof, patent term extensions, supplementary protection certificates and exclusivity extensions of the foregoing patents; and

(iv) any foreign counterparts with respect to any of the foregoing.

1.20 “ Valid Patent Claim ” means a claim of an issued and unexpired Transferred Patent or a Pending Patent Claim, which, in either case, has not been revoked or held unenforceable or invalid, or held finally rejected, by a decision of a court or other governmental agency of competent jurisdiction over such claim, and which is not appealable or has not been appealed within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue,

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re-examination or disclaimer, otherwise, and which has not been abandoned or expired.

Article 2 Assignment and Grant of License

2.1 Assignment. Trovagene, concurrent with the execution of this Agreement, shall assign all right, title and interest in the Transferred Patents to GenSignia by executing the patent assignment document attached hereto as Exhibit B .

2.2 License to Trovagene. Upon the terms and subject to the conditions of this Agreement, subject to execution of the assignment in Section 2.1 above, GenSignia hereby grants to Trovagene an exclusive (even as to GenSignia), royalty-free, fully paid up, perpetual, irrevocable license under the Transferred Patents to research, develop, make, have made, use, sell, offer to sell, have sold, import and export, and otherwise practice and exploit Products in the Field in the Territory. Such license is freely transferable and sublicensable, in whole or in part, and including through multiple tiers.

2.3 No Implied License. No right or license under any know-how, or other intellectual property other than the Transferred Patents is granted to GenSignia or shall be granted by implication or estoppel.

2.4 Right of First Refusal .

(a) Trovagene hereby grants to GenSignia an exclusive right of first refusal to negotiate a license under the Transferred Patents in the Reserved Indication, on the terms and subject to the conditions set forth in this Section 2.4. Such right would be triggered by either:

i. Trovagene’s written notification to GenSignia that Trovagene or its Affiliates intends to grant a Third Party a license or similar right to commercialize Products in the Reserved Indication in the Territory; or

ii. GenSignia providing written notice to Trovagene of GenSignia’s interest in pursuing a license to the Transferred Patents in the Reserved Indication.

(b) Upon receipt of such written notice, GenSignia shall have forty-five (45) days to negotiate a license under the Transferred Patents in the Reserved Indication with Trovagene on commercially reasonable terms. Unless otherwise agreed by the Parties in writing prior to the expiration of such forty-five (45) day period, Trovagene shall thereafter be free to enter into any agreement or other arrangement with any Third Party for a license or similar right to commercialize a Product in the Reserved Indication with no further obligation to GenSignia.

(c) The foregoing right of first refusal shall not be triggered by, and nothing herein shall restrict Trovagene from developing Products on its own or in collaboration with any Third Parties or from commercializing Products in the Reserved

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Indication itself, through its Affiliates and Distributors (without the grant of a commercialization license), or through a Third Party.

Article 3 Payments

3.1 In consideration of all the rights granted to GenSignia herein, GenSignia shall pay the following amounts to Trovagene in accordance with written instructions provided by Trovagene to GenSignia, and, all such amounts shall be non-refundable:

(a) Up-Front Payment: a single one-time payment of $* USD upon execution of this Agreement.

(b) Milestone Payments: (i) a single one-time payment of $* USD upon the achievement of $* Net Sales in a calendar year, (ii) a single one-time payment of $* USD upon the achievement of $* Net Sales in a calendar year; and (iii) a single one-time payment of $* USD upon the achievement of $* Net Sales in a calendar year, each payable within thirty (30) days following achievement of such Net Sales milestone;

(c) Royalties: Commencing upon first commercial sale of a Product in the Territory and continuing thereafter throughout the Royalty Term, GenSignia shall pay to Trovagene a royalty equal to * per cent (*%) of Net Sales of such Product in the Territory. Royalty payments shall be made within thirty (30) days after the end of each calendar quarter for which royalties are due, and shall be payable on a country-by-country, product-by-product basis. Upon expiration of the Royalty Term for a Product in a country, GenSignia may thereafter continue to sell such Product in such country on a royalty-free basis. Notwithstanding the foregoing, in the event that during the Royalty Term, the only remaining Valid Claims with respect to a Product in a particular country are Pending Patent Claims that have been pending for more than seven (7) years, the obligation to pay royalties with respect to Net Sales occuring after such date shall be waived until the date such Pending Patent Claims issue, from which point forward all royalties for sales shall recommence and be due and payable and paid within thirty (30) days after the date GenSignia is first notified of the issuance of such Pending Patent Claims; and

(d) Licensing: in the event that GenSignia derives any License Income during the Royalty Term, GenSignia shall pay * percent (*%) of all such License Income to Trovagene. Such licensing payments shall be made within thirty (30) days after the end of each calendar quarter in which such payments are due.

* Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portion.

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Article 4 Publicity, Use of Names.

4.1 General. Either Party shall be free to disclose, without the other Party’s prior written consent, the existence of this Agreement, the identity of the other Party and those terms of the Agreement which the parties have mutually agreed in writing may be publicly disclosed.

4.2 No Implied License. Except as set forth in Section 4.1, or as expressly permitted by this Agreement, neither Party shall use the name, trademark, trade name or logo of the other Party or its employees, in any publicity, news release or disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party.

Article 5 Representations and Warranties

5.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as follows:

(a) Corporate Existence and Power . It is a corporation duly organized, validly existing and in good standing under the laws of the state in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the right to grant the licenses granted hereunder.

(b) Authority and Binding Agreement . As of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder; and (iii) the Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms.

(c) No Conflict . It has not entered, and will not enter, into any agreement with any Third Party which is in conflict with the rights granted to the other Party under this Agreement, and has not taken and will not take any action that would in any way prevent it from granting the rights granted to the other Party under this Agreement, or that would otherwise materially conflict with or adversely affect the rights granted to the other Party under this Agreement.

5.2 Trovagene Representations and Warranties. Trovagene represents and warrants to GenSignia that as of the Effective Date, it owns the entire right, title and interest under the Transferred Patents necessary to execute the assignment in this Agreement.

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5.3 No Other Representations or Warranties. The express representations and warranties stated in this Article 5 are in place of all other representations and warranties, express, implied, or statutory, including without limitation, warranties of merchantability, fitness for a particular purpose, non-infringement or non-misappropriation of Third Party intellectual property rights, title, custom or trade.

Article 6 Confidentiality

6.1 Nondisclosure Obligation . All Confidential Information shall be maintained in confidence by the receiving Party and shall not be disclosed to any Third Party or used for any purpose except to exercise its rights and perform its obligations under this Agreement without the prior written consent of the disclosing Party, except to the extent that the receiving Party can demonstrate by competent written evidence that such Confidential Information: (i) is known by the receiving Party at the time of its receipt and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s business records, and receiving Party does not have a duty to maintain its confidentiality; (ii) is publicly available other than as a result of any breach of this Agreement by the receiving Party (from and after the date that such information becomes publicly known); (iii) is subsequently rightfully disclosed to the receiving Party on a non-confidential basis by a Third Party who does not have a duty to preserve its confidentiality; or (iv) is independently discovered or developed by the receiving Party without the use of Confidential Information provided by the disclosing Party, as documented by the receiving Party’s records.

6.2 Return of Confidential Information . Upon the request of the other Party or within thirty (30) days after any expiration or termination of this Agreement, each Party shall destroy (and certify to the other Party such destruction) or return (as requested by the other Party) all Confidential Information provided by the other Party except as otherwise set forth in this Agreement, and except that each Party may retain a single copy of the Confidential Information in its confidential legal files for the sole purpose of ascertaining its ongoing rights and responsibilities regarding the Confidential Information.

6.3 Permitted Disclosure . Each Party may disclose Confidential Information provided by the other Party to the extent such disclosure is reasonably necessary in the following instances:

(a) disclosure to governmental or other regulatory agencies in order to obtain patents, or to gain or maintain approval to conduct clinical trials, validation studies or to market Products (in each case to the extent permitted by this Agreement), but such disclosure may be only to the extent reasonably necessary to obtain patents or authorizations;

(b) complying with applicable court orders or governmental regulations, including without limitation rules or regulations of the Securities and Exchange Commission, or by rules of the National Association of Securities Dealers, any securities exchange or NASDAQ; provided, however, that the receiving Party shall

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first have given notice to the other Party hereto in order to allow such Party the opportunity to seek confidential treatment of the Confidential Information; and

(c) disclosure to consultants, agents or other Third Parties solely to the extent required to accomplish the purposes of this Agreement or in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents for the purposes of such financing, in each case on the condition that such Third Parties are bound by confidentiality and non-use obligations at least equivalent in scope to those contained in this Agreement and subject to the protection of privilege with respect to the Common Interest Materials (as defined below).

6.4 Written Agreements . Each Party shall have in effect or obtain written agreements from each of its employees, consultants and contractors who have access to Confidential Information, which agreements shall obligate such persons to obligations of confidentiality and non-use at least as protective of the Confidential Information of the other Party as the provisions set forth herein. Each Party will notify the other Party promptly upon discovery of any unauthorized use or disclosure of the Confidential Information of the other Party.

6.5 Joint and Common Interest. To facilitate their performance in connection with this Agreement (including without limitation the preparation, prosecution (including any interferences, reissue proceedings and reexaminations) and maintenance of the Transferred Patents), the parties may share certain information that is protected by the attorney-client privilege, the attorney work product doctrine, and/or other applicable privileges and immunities, including (but not limited to) information regarding their respective analyses of patents and the potential exploitation thereof (collectively, the “ Common Interest Materials ”). The parties acknowledge and agree that they have a joint and common legal and commercial interest in sharing the Common Interest Materials in connection with this Agreement. In furtherance of this Agreement, the parties agree that such sharing and exchange of Common Interest Materials will be subject to the attorney-client privilege, the work product privilege, legal advice privilege and the so-called “Common Interest Doctrine” to the maximum extent possible. This Agreement memorializes the understanding of the parties that their exchange of the Common Interest Materials is not intended to, and is not understood to, void, waive or compromise in any respect any applicable privilege, protection, immunity, or other legal protection applicable to such information prior to this Agreement and prior to the mutual exchange of information contemplated hereby.

6.6 Required Disclosure . If a Party is required by judicial or administrative process to disclose Confidential Information that is subject to the non-disclosure provisions of Section 6.1, such Party shall promptly provide reasonable advance written notice to the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Each Party shall provide reasonable cooperation to the other Party in any such process. Confidential Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article 6, and the Party disclosing Confidential Information pursuant to law or court order shall take

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all reasonable steps necessary, including without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.

6.7 Assertion of Common Interest Doctrine . If any other person or entity requests or demands, by subpoena or otherwise, any document or other communication received by a party or its counsel pursuant to this Agreement, the requested party will (1) promptly notify the other party, and (2) assert all applicable privileges, including (without limitation) the Common Interest Doctrine, unless attorney-client privilege and all other privileges have previously been waived in writing by the other party. The requested party further agrees to take all steps reasonable and necessary (including, without limitation, making all appropriate objections and motions) to permit the assertion of all applicable rights and privileges with respect to said Common Interest Materials, and shall cooperate fully in any judicial proceeding relating to the disclosure of the Common Interest Materials.

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Article 7 Intellectual Property

7.1 Prosecution and Transferred Patent Status.

(a) GenSignia shall be responsible for the preparation, filing, prosecution and maintenance of the Transferred Patents, including all payment obligations in all the countries in the Territory where such Transferred Patents have been granted and to defend such Transferred Patents from Third Party challenges. Trovagene shall have the right to participate in the preparation, filing, prosecution (including any interferences, reissue proceedings and reexaminations) and maintenance of the Transferred Patents at Trovagene’s expense. GenSignia shall reasonably cooperate with Trovagene in the preparation, prosecution and maintenance of the Transferred Patents and upon request by Trovagene, GenSignia shall provide Trovagene with an update of the filing, prosecution and maintenance status for each Transferred Patent. GenSignia shall not take or fail to take any action with respect to the preparation, prosecution and maintenance of the Transferred Patents that may adversely affect Trovagene without Trovagene’s prior written consent, such consent not to be unreasonably withheld.

(b) GenSignia shall not intentionally fail to file or intentionally abandon in any country any of the Transferred Patents without Trovagene first being given a reasonable and timely opportunity to assume full responsibility for the filing and continued prosecution and maintenance of such Transferred Patents. In the event that GenSignia decides not to file or prosecute, maintain or defend any Transferred Patent in a country, GenSignia shall provide reasonable notice to Trovagene of such decision and such notice shall be at least sixty (60) days prior to any pending lapse or abandonment thereof. Thereupon, the ownership of such Transferred Patent in that country shall automatically revert to Trovagene. GenSigna shall cooperate, at Trovagene’s cost, to execute any documents or take any other actions necessary to effect the ownership of such Transferred Patent in Trovagene, and transfer or cause to be transferred to Trovagene the complete prosecution file for such Transferred Patent(s) with respect to such country, including all correspondence and filings with patent granting authorities in such country with respect to such patent(s) and GenSignia shall have no further rights in such Transferred Patent or pursuant to this Agreement with respect to such Transferred Patent.

(c) In the event that Trovagene or GenSignia becomes aware that a Transferred Patent is challenged in any action or proceeding, such Party shall notify the other Party promptly and shall provide the other Party with available evidence of such suspected infringement or challenge, and following such notification, the Parties shall confer.

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7.2 Infringement by Third Parties .

(a) Each Party shall promptly notify the other in writing of any suspected or alleged infringement by Third Parties of any Transferred Patent and provide any information available to that Party relating to such suspected or alleged infringement.

(b) GenSignia shall have the first right, but not the obligation, to initiate and prosecute any legal action or defense with respect to any infringement of Transferred Patents by Third Parties relating to the infringement activities outside the Field but not in or affecting the Field, at its own expense and, if necessary, to name Trovagene as a co-party. GenSignia shall pay all attorneys’ fees and costs associated with such action; provided, however , that Trovagene may separately represent itself in such prosecution or defense by counsel of its own choice (at Trovagene’s own expense), in which case Trovagene shall cooperate fully with GenSignia.

(c) Trovagene shall have the first right, but not the obligation, to initiate and prosecute any legal action or defense with respect to any infringement of Transferred Patents by Third Parties relating to the infringement activities in or affecting the Field, at its own expense and, if necessary, to name GenSignia as a co-party. Trovagene shall pay all attorneys’ fees and costs associated with such action; provided, however , that GenSignia may separately represent itself in such prosecution or defense by counsel of its own choice (at GenSignia’s own expense), in which case GenSignia shall cooperate fully with Trovagene.

(d) If, within ninety (90) days of receiving the notice provided for in Section 7.2(b), or thirty (30) days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, if the Party with the first right to initiate legal action (the “ Initiating Party ”) fails to take such action, or if the Initiating Party informs the other Party that it elects not to exercise such first right, the other Party (or its designee) thereafter shall have the right either to initiate and prosecute such action, or to control the defense of such declaratory judgment action, and the other Party shall pay all attorneys’ fees and costs associated with such action; provided, however, that the Initiating Party may separately represent itself in such prosecution or defense by counsel of its own choice (at the Initiating Party’s own expense ), in which case the Initiating Party shall cooperate fully with the other Party.

(e) For any action to terminate any infringement of Transferred Patents, if either Party is unable to initiate or prosecute such action solely in its own name, the other Party shall join such action voluntarily and shall execute all documents necessary to initiate litigation to prosecute and maintain such action. In connection with any such action, GenSignia and Trovagene shall cooperate fully and will provide each other with any information or assistance that either reasonably requests. Each Party shall keep the other informed of developments in any such action or proceeding, including, to the extent permissible by law, the consultation on and approval of any offer related thereto.

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(f) Any recovery obtained by either or both GenSignia and Trovagene in connection with or as a result of any action contemplated by this Section 7.2, whether by settlement or otherwise, shall be first applied toward each Party’s costs and expenses incurred in respect of such action. If the action was solely initiated by one of the Parties, any recovery amount remaining shall be awarded to the Party that initiated such action, provided, however that any such amounts received by GenSignia shall be subject to payment of Royalties pursuant to Section 3.1(b). If the action was jointly initiated by the Parties, any recovery amount remaining shall be allocated to each of the Parties in proportion to their respective Net Sales, provided, however that any such amounts received by GenSignia shall be subject to payment of Royalties pursuant to Section 3.1(b).

(g) No settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of a Transferred Patent may be entered into by GenSignia without the prior written consent of Trovagene. No settlement of any such action or proceeding which restricts the scope or adversely affects the enforceability, of a Transferred Patent outside of the Field may be entered into by Trovagene without the prior written consent of GenSignia.

Article 8 Indemnification

8.1 Indemnification by Trovagene . Trovagene shall indemnify, defend and hold GenSignia and its officers, directors, shareholders, agents and employees harmless against any and all claims, liability, damage, loss, cost or expense, including reasonable attorney’s fees, (collectively, “ Losses ”) arising or resulting from any Third Party claim made or suit brought against GenSignia or such persons to the extent any such Losses arise out of (i) any breach by Trovagene of any of its representations or warranties in this Agreement; (ii) Trovagene’s gross negligence or willful misconduct; or (iii) the development, manufacture, use, importation, promotion, marketing, commercialization, distribution and/or sale of Product(s) by Trovagene, or its Affiliates, Distributors, or its sublicensees; provided, however, that Trovagene shall not be required to indemnify GenSignia to the extent it is determined that the Losses resulted from the gross negligence or willful misconduct of GenSignia or to the extent GenSignia would be required to indemnify Trovagene under Section 8.2 below.

8.2 Indemnification by GenSignia . GenSignia shall indemnify, defend and hold Trovagene, its Affiliates and sublicensees, and its and their officers, directors, shareholders, agents and employees harmless against any and all Losses arising or resulting from any Third Party claim made or suit brought against Trovagene, its Affiliates or sublicensees or such other persons to the extent any such Losses arise out of (i) any breach by GenSignia of any of its representations or warranties in this Agreement; (ii) GenSignia’s gross negligence or willful misconduct; (iii) the development, manufacture, use, importation, promotion, marketing, commercialization, distribution and/or sale of Product(s) by GenSignia, or its Affiliates, Distributors or licensees provided, however, that GenSignia shall not be required to indemnify Trovagene to the extent it is determined that the Losses resulted

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from the gross negligence or willful misconduct of Trovagene or to the extent Trovagene would be required to indemnify GenSignia under Section 8.1.

8.3 Limitation Of Liability. Neither Party shall be liable to the other Party for incidental, consequential or special damages, including but not limited to lost profits, whether in contract, tort or otherwise, arising from or relating to any breach of or activities under this Agreement, regardless of any notice of the possibility of such damages. Nothing in this Section 8.3 is intended to limit or restrict the indemnification rights or obligations of any Party under this Agreement, nor to relieve a Party from its obligations with respect to any special, indirect, incidental, or consequential damages awarded to a Third Party in circumstances in which such Party is obligated to indemnify the other Party hereunder.

Article 9 Term and Termination

9.1 Term . This Agreement shall commence on the Effective Date and, unless terminated earlier pursuant to Section 9.2, shall be in full force and effect until the expiration of all Valid Patent Claims.

9.2 Termination for Material Breach. If a Party materially breaches this Agreement, the other Party may terminate this Agreement effective sixty (60) days after providing written notice to the breaching Party, if within that time the breaching Party fails to cure its material breach and the non-breaching Party does not withdraw its termination notice.

9.3 Effects of Termination. If a Party terminates this Agreement under Section 9.2, all terms and provisions shall terminate as of the effective date of termination, except as otherwise expressly provided in Section 9.4. In addition, in the event this Agreement is terminated by Trovagene for an uncured GenSignia material breach, (a) ownership of all of the Transferred Patents shall automatically revert to Trovagene; (b) GenSigna shall cooperate to execute any documents or take any other actions necessary to effect the ownership of such Transferred Patents in Trovagene; and (c) GenSignia shall pay any amounts due pursuant to Article 3 with respect to activities prior to the date of termination. All rights and licenses granted to Trovagene hereunder shall survive the expiration or termination of this Agreement for any reason.

9.4 Accrued Rights and Obligations; Survival. Termination of this Agreement by a Party pursuant to Section 9.2 shall not be a Party’s sole remedy for a material breach of this Agreement, but shall be in addition to any other rights or remedies of a Party under this Agreement or available at law or in equity. Termination or expiration of this Agreement shall not affect any accrued rights or surviving obligations of the Parties. The provisions of Articles 6, 8 and 10 and Sections 2.2, 9.3 and 9.4 shall survive the expiration or termination of this Agreement for any reason whatsoever.

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Article 10 Miscellaneous

10.1 Assignment . GenSignia may not assign or otherwise transfer the Transferred Patents or any of its rights or obligations under this Agreement to any Third Party without the prior express written consent of Trovagene, which consent shall not be unreasonably withheld, provided, however, that Trovagene may without Trovagene’s prior consent assign or otherwise transfer this Agreement and the Transferred Patents to a third party that acquires all or substantially all of the assets of GenSignia to which this Agreement relates (whether by asset sale, merger, change of control, operation of law or otherwise), provided that (a) such third party has financial resources and experience in connection with the sales of diagnostics that are at least comparable to that of GenSignia; (b) such third party expressly agrees in writing to assume the obligations of GenSignia hereunder. Trovagene may assign or otherwise transfer (by asset sale, merger, change of control, operation of law or otherwise) its rights or obligations hereunder to any Third Party without consent. In the event either Party transfers its rights hereunder to a third party such Party shall provide prompt written notice to the other Party of such transfer, no later than thirty (30) days after the date thereof. This Agreement shall be binding upon, and inure to the benefit of, the successors and permitted assigns of the Parties. Any purported assignment or other transfer not in compliance with this Section 10.1 will be void.

10.2 Governing Law . This Agreement shall be governed and construed in accordance with the laws of the State of California, except for any of its choice of law rules that would require the application of the laws of another jurisdiction.

10.3 Payment Disputes/Arbitration.

(a) In the event of any dispute, controversy or claim relating to the calculation or payment of Royalties or Licensee Income under this Agreement (a “ Dispute ”), the Parties shall first try to resolve such Dispute amicably. In this regard, either Party may send a notice of Dispute to the other, and each Party shall appoint, within ten (10) business days from receipt of such notice of Dispute, a senior executive officer of such Party, who will to attempt to negotiate a resolution to such Dispute. If these representatives fail to resolve the matter within thirty (30) days from their appointment, or if a Party fails to appoint a representative within the ten (10) business day period set forth above, such Dispute shall immediately be referred to the Chief Executive Officer (or such other officer as the Chief Executive Officer may designate) of each Party who will meet and discuss as necessary in order to try to resolve the dispute amicably within the next thirty (30) days. Should the Parties fail to reach a resolution under this Section 10.3 in the allotted time, at the option of either Party exercisable by written notice of such Party’s desire to arbitration, such unresolved Dispute shall be submitted to and determined finally and exclusively by expedited arbitration in accordance with this Section 10.3.

(b) All Disputes subject to resolution pursuant to this Section 10.3 shall be governed exclusively and finally by expedited arbitration with the American Arbitration Association (“ AAA ”) in such location as mutually agreed and will be initiated and conducted in accordance with the Commercial Arbitration Rules of the AAA, as

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such rules are in effect on the date such arbitration is initiated by the Parties, except to the extent that such rules are inconsistent with the provisions of this Agreement and further provided that such expedited arbitration shall be concluded within sixty (60) days of the initiation of arbitration. The arbitration shall be conducted by one arbitrator mutually selected by the Parties with significant experience in the pharmaceutical or biotechnology industry and with respect to the subject matter of the Dispute at issue. If the Parties are unable to agree on an arbitrator within ten (10) business days, an arbitrator having the foregoing qualifications shall be designated by the AAA.

(c) The Federal Arbitration Act, 9 U.S.C. §§ 1 and 16, and not state law, shall govern whether or not any Dispute that is subject to this Section 10.3 can be arbitrated. The arbitrator shall allow such discovery as is appropriate to the purposes of arbitration in accomplishing a fair, speedy and cost-effective resolution of the Dispute. The arbitrator shall reference the Federal Rules of Civil Procedure then in effect in setting the scope and timing of discovery. The Federal Rules of Evidence shall apply in toto . The arbitrator may enter a default decision against any Party who fails to participate in the arbitration proceedings.

(d) The only monetary damages the arbitrator shall have the ability to award are compensatory damages.

(e) Any award by the arbitrator shall be accompanied by a written opinion setting forth the findings of fact and conclusions of law relied upon in reaching the decision. The award rendered by the arbitrator shall be final, binding and nonappealable, and judgment upon such award may be entered by any court of competent jurisdiction. The Parties agree that the existence, conduct and content of any arbitration shall be kept confidential and no Party shall disclose to any Person any information about such arbitration, except as may be required by law or by any governmental authority or for financial reporting purposes in each Party’s financial statements.

(f) Each Party shall pay the fees of its own attorneys, expenses of witnesses and all other expenses and costs in connection with the presentation of such Party’s case (collectively, “ Attorneys’ Fees ”). The remaining costs of the arbitration, including fees of the arbitrator, costs of records or transcripts and administrative fees (collectively, “ Arbitration Costs ”) shall be borne equally by the Parties. Notwithstanding the foregoing, the arbitrator may modify the allocation of Arbitration Costs and award Attorneys’ Fees in those cases where fairness dictates a different allocation of Arbitration Costs between the Parties and an award of Attorneys’ Fees to the prevailing Party as determined by the arbitrator.

10.4 Jurisdiction and Venue . In connection with any dispute arising hereunder, each of the Parties hereby consents to the non-exclusive jurisdiction and venue of the U.S. federal courts located within the state of California and of the California state courts. Each Party hereby irrevocably waives any right that it may have to assert that any such court lacks jurisdiction or that such forum is not convenient.

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10.5 Compliance with Laws. Each Party shall carry out its activities pursuant to this Agreement in compliance with all applicable supranational, national, state, provincial and other local laws, rules, regulations and guidelines.

10.6 Notice. All notices, payments or other communications required under this Agreement are deemed fully given when written, addressed and sent as follows:

All notices to GenSignia are mailed or e-mailed to:

Name:		Gabriele Cerrone
Address:		18 South Street, Mayfair, London, UK
E-mail:		Gabriele@gensignialtd.com
Phone:

With a copy to:

Name:		Ivor Elrifi
Address:		Cooley LLP, 1114 Ave of the Americas, New York, NY 10036
E-mail:		ielrifi@cooley.com
Phone:		212 479 6840

All notices to Trovagene are mailed or e-mailed to:

Name:		Michael Terry
Address:		11055 Flintkote Avenue, Suite B
		San Diego, CA 92121
E-mail:		MTerry@trovagene.com
Phone:		858.952.7641

With a copy to:

Name:		Susan Hendrickson
Address:		Arnold & Porter, 555 Twelfth Street, Washington, DC 20004
E-mail:		Susan.Hendrickson@APORTER.com
Phone:		202 942 6751

10.7 Waiver . The failure on the part of a Party to exercise or enforce any rights conferred upon it hereunder shall not be deemed to be a waiver of any such rights nor operate to bar the exercise or enforcement thereof at any time or times hereafter

10.8 Bankruptcy. All rights and licenses granted under or pursuant to this Agreement are, and shall be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code and any similar law or regulation in any other country, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that all intellectual property rights licensed hereunder are part of the “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code subject to the protections afforded the non-terminating Party under Section 365(n) of the Bankruptcy Code, and any similar law or regulation in any other country.

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10.9 Severability . The provisions of this Agreement are severable. If any item or provision of this Agreement shall to any extent be invalid or unenforceable, the remainder of this Agreement shall not be affected thereby, and each term and provision of this Agreement shall be valid and shall be enforced to the fullest extent permitted by law. The Parties will use diligent good faith efforts to revise this Agreement as and to the extent reasonably necessary to effectuate their original intent and purpose under this Agreement.

10.10 Force Majeure . The performance by either Party of its respective obligations under this Agreement shall be excused during the period of time that such performance is delayed or prevented in whole or in part by acts of God, fire, floods, storms, explosions, epidemics, war, act or threat of terrorist activity, emergency, civil disorder, strikes, lockouts or other labor difficulties or shortages, or the like (each such event, an “ Event of Force Majeure ”), provided that the Party whose performance is affected by an Event of Force Majeure immediately notifies the other Party of the occurrence of such event and uses and continues to use commercially reasonable efforts to overcome the same and to resume performance hereunder.

10.11 Entire Agreement; Modification . This Agreement, including any exhibits expressly named and referenced herein, constitutes the entire agreement and understanding of the Parties and supersedes any prior agreements or understandings relating to the subject matter hereof. Any modification of this Agreement shall be effective only to the extent it is reduced to writing and signed by a duly authorized representative of each Party hereto.

10.12 Headings . The captions to the several Articles and Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof.

10.13 Independent Contractors . It is expressly agreed that GenSignia and Trovagene shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither GenSignia nor Trovagene shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

10.14 Cumulative Remedies . No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

10.15 Counterparts . This Agreement may be executed in one or more counterparts, each of which shall be an original and all of which shall constitute together the same document.

10.16 Exhibits. All Exhibits, schedules and other attachments to this Agreement, and amendments thereto, are by this reference incorporated herein and made a part of this Agreement.

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The persons executing this Agreement represent and warrant that they have the full power and authority to cause their respective entities to enter into this Agreement.

IN WITNESS WHEREOF the Parties have executed this Agreement as of the Effective Date by their duly authorized representatives.

TROVAGENE, INC.			GENSIGNIA IP LTD


By:	/s/ Michael Terry		By:	/s/ Gabriele Cerrone
	Name:	Michael Terry		Name:	Gabriele Cerrone
	Title:	Executive Vice President,		Title:	Chairman
		Commercial Operations

Exhibit 31.1

CERTIFICATION

I, Antonius Schuh, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Trovagene, Inc. (the “Registrant”);

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.

5) The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions);

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

May 12, 2014	/s/ANTONIUS SCHUH
	Antonius Schuh
	Chief Executive Officer

Exhibit 31.2

CERTIFICATION

I, Stephen Zaniboni, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Trovagene, Inc. (the “Registrant”);

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


May 12, 2014	/s/ STEPHEN ZANIBONI
	Stephen Zaniboni
	Chief Financial Officer

Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Trovagene, Inc. (the “Company”) on Form 10-Q for the three months ended March 31, 2014 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Antonius Schuh, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

May 12, 2014	/s/ ANTONIUS SCHUH
	Antonius Schuh
	Chief Executive Officer

Exhibit 32.2

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Trovagene, Inc. (the “Company”) on Form 10-Q for the three months ended March 31, 2014 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Stephen Zaniboni, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

May 12, 2014	/s/ STEPHEN ZANIBONI
	Stephen Zaniboni
	Chief Financial Officer