Table of Contents

 
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 June 30, 2019
 
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 001-35558
 
TROVAGENE, INC.
(Exact Name of registrant as specified in its charter)
Delaware
 
27-2004382
(State or other jurisdiction of incorporation or organization)
 
(I.R.S. Employer Identification No.)
 
 
 
11055 Flintkote Avenue, San Diego, California
 
92121
(Address of principal executive offices)
 
(Zip Code)
 
 
 
(858) 952-7570
(Registrant’s telephone number, including area code)
Title of each class:
 
Trading Symbol(s)
 
Name of each exchange on which registered:
Common Stock
 
TROV
 
Nasdaq Capital Market
 
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, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer  o
 
Accelerated filer o  
 
Non-accelerated filer x

 
Smaller reporting company  x
 
Emerging growth company o
  
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

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 July 31, 2019 , the issuer had 5,445,764 shares of Common Stock issued and outstanding.
 

Table of Contents

TROVAGENE, INC.
 
Table of Contents
 
 
 
Page
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


2
Table of Contents

PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

TROVAGENE, INC. 
CONDENSED BALANCE SHEETS
(Unaudited)
 
 
June 30, 2019
 
December 31, 2018
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
10,791,270

 
$
11,453,133

Accounts receivable and unbilled receivable
122,281

 
167,755

Prepaid expenses
906,466

 
1,144,377

Total current assets
11,820,017

 
12,765,265

Property and equipment, net
252,053

 
1,304,433

Operating lease right-of-use assets
1,660,631

 
—

Other assets
135,262

 
102,798

Total Assets
$
13,867,963

 
$
14,172,496

 
 
 
 
Liabilities and Stockholders’ Equity
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
525,690

 
$
664,840

Accrued expenses
2,352,265

 
1,813,842

Operating lease liabilities
816,102

 
—

Deferred rent, current portion
—

 
486,636

Total current liabilities
3,694,057

 
2,965,318

Derivative financial instruments—warrants
18,287

 
32,315

Operating lease liabilities, net of current portion
1,307,384

 
—

Deferred rent, net of current portion
—

 
1,090,671

Total Liabilities
5,019,728

 
4,088,304

 
 
 
 
Commitments and contingencies (Note 8)


 


 
 
 
 
Stockholders’ equity
 
 
 
Preferred stock, $0.001 par value, 20,000,000 shares authorized; 277,100 designated as Series A Convertible Preferred Stock; 60,600 shares outstanding at June 30, 2019 and December 31, 2018 with liquidation preference of $606,000 at June 30, 2019 and December 31, 2018; 200,000 designated as Series C Convertible Preferred Stock; 0 shares outstanding at June 30, 2019 and December 31, 2018
60

 
60

Common stock, $0.0001 par value, 150,000,000 shares authorized; 5,441,390 and 3,831,880 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively
7,997

 
7,742

Additional paid-in capital
210,706,090

 
202,267,605

Service receivables
(1,364,234
)
 
—

Accumulated deficit
(200,501,678
)
 
(192,191,215
)
Total stockholders’ equity
8,848,235

 
10,084,192

Total liabilities and stockholders’ equity
$
13,867,963

 
$
14,172,496

 
See accompanying notes to the unaudited condensed financial statements.

3
Table of Contents

TROVAGENE, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Royalties
$
36,852

 
$
52,423

 
$
98,873

 
$
101,478

Services and other
101,433

 
59,390

 
201,370

 
110,471

Total revenues
138,285

 
111,813

 
300,243

 
211,949

Costs and expenses:
 
 
 
 
 
 
 
Cost of revenues
—

 
204,436

 
—

 
570,780

Research and development
2,830,340

 
1,952,767

 
5,478,939

 
3,836,605

Selling, general and administrative
1,527,904

 
2,150,871

 
3,003,026

 
4,655,848

Restructuring charges
—

 
243,335

 
—

 
243,335

Total operating expenses
4,358,244

 
4,551,409

 
8,481,965

 
9,306,568

 
 
 
 
 
 
 
 
Loss from operations
(4,219,959
)
 
(4,439,596
)
 
(8,181,722
)
 
(9,094,619
)
 
 
 
 
 
 
 
 
Interest income
69,761

 
36,202

 
134,504

 
57,973

Interest expense
—

 
(925
)
 
—

 
(25,161
)
Gain from change in fair value of derivative financial instruments—warrants
23,789

 
711,229

 
14,028

 
581,540

Gain on extinguishment of debt
—

 
17,974

 
—

 
17,974

Other income (expense), net
1,106

 
(71,839
)
 
3,116

 
(70,839
)
Net loss
(4,125,303
)
 
(3,746,955
)
 
(8,030,074
)
 
(8,533,132
)
 
 
 
 
 
 
 
 
Preferred stock dividend payable on Series A Convertible Preferred Stock
(6,060
)
 
(6,060
)
 
(12,120
)
 
(12,120
)
Deemed dividend recognized on beneficial conversion features of Series B Convertible Preferred Stock issuance
—

 
(2,769,533
)
 
—

 
(2,769,533
)
Deemed dividend recognized on beneficial conversion features of Series C Convertible Preferred Stock issuance
—

 
—

 
(268,269
)
 
—

 
 
 
 
 
 
 
 
Net loss attributable to common stockholders
$
(4,131,363
)
 
$
(6,522,548
)
 
$
(8,310,463
)
 
$
(11,314,785
)
 
 
 
 
 
 
 
 
Net loss per common share — basic
$
(0.79
)
 
$
(5.27
)
 
$
(1.78
)
 
$
(11.27
)
Net loss per common share — diluted
$
(0.79
)
 
$
(5.27
)
 
$
(1.78
)
 
$
(11.27
)
 
 
 
 
 
 
 
 
Weighted-average shares outstanding — basic
5,241,924

 
1,237,244

 
4,667,434

 
1,004,391

Weighted-average shares outstanding — diluted
5,241,924

 
1,237,244

 
4,667,434

 
1,004,391

 
See accompanying notes to the unaudited condensed financial statements.


4
Table of Contents


TROVAGENE, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)

 
Preferred Stock
Shares
 
Preferred Stock
Amount
 
Common Stock
Shares
 
Common Stock
Amount
 
Additional
Paid-In Capital
 
Service Receivable
 
Accumulated Deficit
 
Total
Stockholders’ Equity
Balance, January 1, 2019
60,600

 
$
60

 
3,831,879

 
$
7,742

 
$
202,267,605

 
$
—

 
$
(192,191,215
)
 
$
10,084,192

Stock-based compensation
—

 
—

 
—

 
—

 
200,067

 
—

 
—

 
200,067

Issuance of common stock, preferred stock and warrants for clinical trial funding commitment, net of expenses and discount of $40,000 and $235,640, respectively
200,000

 
200

 
183,334

 
110

 
1,634,690

 
(1,675,000
)
 
—

 
(40,000
)
Deemed dividend recognized on beneficial conversion features of Series C Convertible Preferred Stock issuance
—

 
—

 
—

 
—

 
268,269

 
—

 
(268,269
)
 
—

Issuance of common stock upon exercise of warrants
—

 
—

 
497,313

 
50

 
3,282,216

 
—

 
—

 
3,282,266

Issuance of common stock upon vesting of restricted stock units
—

 
—

 
6,362

 
4

 
(4
)
 
—

 
—

 
—

Preferred stock dividend payable on Series A Convertible Preferred Stock
—

 
—

 
—

 
—

 
—

 
—

 
(6,060
)
 
(6,060
)
Issuance of common stock for share rounding as a result of reverse stock split
—

 
—

 
6,466

 
—

 
—

 
—

 
—

 
—

Release of clinical trial funding commitment
—

 
—

 
—

 
—

 
—

 
70,487

 
—

 
70,487

Net loss
—

 
—

 
—

 
—

 
—

 
—

 
(3,904,771
)
 
(3,904,771
)
Balance, March 31, 2019
260,600

 
260

 
4,525,354

 
7,906

 
207,652,843

 
(1,604,513
)
 
(196,370,315
)
 
9,686,181

Stock-based compensation
—

 
—

 
—

 
—

 
148,834

 
—

 
—

 
148,834

Sale of common stock and warrants, net of expenses
—

 
—

 
421,917

 
42

 
2,902,698

 
—

 
—

 
2,902,740

Issuance of common stock upon exercise of warrants
—

 
—

 
156,353

 
16

 
1,548

 
—

 
—

 
1,564

Issuance of common stock upon vesting of restricted stock units
—

 
—

 
4,433

 
—

 
—

 
—

 
—

 
—

Issuance of common stock upon conversion of Series C Convertible Preferred Stock
(200,000
)
 
(200
)
 
333,333

 
33

 
167

 
—

 
—

 
—

Preferred stock dividend payable on Series A Convertible Preferred Stock
—

 
—

 
—

 
—

 
—

 
—

 
(6,060
)
 
(6,060
)
Release of clinical trial funding commitment
—

 
—

 
—

 
—

 
—

 
240,279

 
—

 
240,279

Net loss
—

 
—

 
—

 
—

 
—

 

 
(4,125,303
)
 
(4,125,303
)
Balance, June 30, 2019
60,600

 
$
60

 
5,441,390

 
$
7,997

 
$
210,706,090

 
$
(1,364,234
)
 
$
(200,501,678
)
 
$
8,848,235



5
Table of Contents

 
Preferred Stock
Shares
 
Preferred Stock
Amount
 
Common Stock
Shares
 
Common Stock
Amount
 
Additional
Paid-In Capital
 
Accumulated Deficit
 
Total
Stockholders’ Equity
Balance, January 1, 2018
60,600

 
$
60

 
733,217

 
$
5,279

 
$
179,546,954

 
$
(173,046,186
)
 
$
6,506,107

Stock-based compensation
—

 
—

 
—

 
—

 
1,406,131

 
—

 
1,406,131

Issuance of common stock upon exercise of warrants
—

 
—

 
71,347

 
514

 
1,448,653

 
—

 
1,449,167

Issuance of common stock upon vesting of restricted stock units
—

 
—

 
12,567

 
90

 
(90
)
 
—

 
—

Preferred stock dividend payable on Series A Convertible Preferred Stock
—

 
—

 
—

 
—

 
—

 
(6,060
)
 
(6,060
)
Cumulative adjustment upon adoption of ASC 606
—

 
—

 
—

 
—

 
—

 
109,922

 
109,922

Net loss
—

 
—

 
—

 
—

 
—

 
(4,786,177
)
 
(4,786,177
)
Balance, March 31, 2018
60,600

 
60

 
817,131

 
5,883

 
182,401,648

 
(177,728,501
)
 
4,679,090

Stock-based compensation
—

 
—

 
—

 
—

 
221,300

 
—

 
221,300

Sale of common stock and warrants, net of expenses
—

 
—

 
1,523,333

 
914

 
11,778,611

 
—

 
11,779,525

Sale of Series B Convertible Preferred Stock, net of expenses
8,860

 
9

 
—

 
—

 
4,386,753

 
—

 
4,386,762

Deemed dividend recognized on beneficial conversion features of Series B Convertible Preferred Stock issuance
—

 
—

 
—

 
—

 
2,769,533

 
(2,769,533
)
 
—

Issuance of common stock upon exercise of warrants
—

 
—

 
7,570

 
55

 
163,445

 
—

 
163,500

Issuance of common stock upon conversion of Series B Convertible Preferred Stock
(3,210
)
 
(3
)
 
535,000

 
321

 
(318
)
 
—

 
—

Preferred stock dividend payable on Series A Convertible Preferred Stock
—

 
—

 
—

 
—

 
—

 
(6,060
)
 
(6,060
)
Issuance of common stock for share rounding as a result of reverse stock split
—

 
—

 
1,134

 
—

 
—

 
—

 
—

Net loss
—

 
—

 
—

 
—

 
—

 
(3,746,955
)
 
(3,746,955
)
Balance, June 30, 2018
66,250

 
$
66

 
2,884,168

 
$
7,173

 
$
201,720,972

 
$
(184,251,049
)
 
$
17,477,162


See accompanying notes to the unaudited condensed financial statements.

6
Table of Contents

TROVAGENE, INC. 
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
 
 
Six Months Ended June 30,
 
2019
 
2018
Operating activities
 
 
 
Net loss
$
(8,030,074
)
 
$
(8,533,132
)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
 
Loss on disposal of assets
—

 
198,099

Impairment loss
—

 
187,500

Depreciation and amortization
87,219

 
483,495

Stock-based compensation expense
348,901

 
1,627,431

Gain on extinguishment of debt
—

 
(17,974
)
Deferred rent
—

 
(163,847
)
Change in fair value of derivative financial instruments—warrants
(14,028
)
 
(581,540
)
Release of clinical trial funding commitment
310,766

 
—

Changes in operating assets and liabilities:
 
 
 
Other assets
(32,464
)
 
(199,743
)
Accounts receivable and unbilled receivable
45,474

 
62,935

Prepaid expenses
163,950

 
191,321

Operating lease right-of-use assets
309,713

 
—

Accounts payable and accrued expenses
387,046

 
638,701

Operating lease liabilities
(379,662
)
 
—

Net cash used in operating activities
(6,803,159
)
 
(6,106,754
)
 
 
 
 
Investing activities:
 
 
 
Capital expenditures
(5,274
)
 
(5,100
)
Purchases of short-term investments
—

 
(31,500
)
Net cash used in investing activities
(5,274
)
 
(36,600
)
 
 
 
 
Financing activities:
 
 
 
Proceeds from sales of common stock and warrants, net of expenses of $97,260 and $1,336,123, respectively
2,902,740

 
11,779,525

Proceeds from sales of Series B Convertible Preferred Stock, net of expenses of $497,617
—

 
4,386,762

Costs related to the clinical trial funding commitment
(40,000
)
 
—

Proceeds from exercise of warrants
3,283,830

 
1,612,667

Payment upon debt extinguishment
—

 
(175,381
)
Repayments of equipment line of credit
—

 
(1,200,033
)
Net cash provided by financing activities
6,146,570

 
16,403,540

Net change in cash and cash equivalents
(661,863
)
 
10,260,186

Cash and cash equivalents—Beginning of period
11,453,133

 
8,225,764

Cash and cash equivalents—End of period
$
10,791,270

 
$
18,485,950

 
 
 
 
Supplementary disclosure of cash flow activity:
 
 
 
Cash paid for taxes
$
800

 
$
800

Cash paid for interest
$
—

 
$
22,482

Supplemental disclosure of non-cash investing and financing activities:
 
 
 
Preferred stock dividend payable on Series A Convertible Preferred Stock
$
12,120

 
$
12,120


7
Table of Contents

Deemed dividend recognized for beneficial conversion features of Series B Convertible Preferred Stock issuance
$
—

 
$
2,769,533

Deemed dividend recognized for beneficial conversion features of Series C Convertible Preferred Stock issuance
$
268,269

 
$
—

Common stock, Series C Convertible Preferred Stock and warrants issued in connection with clinical trial funding commitment, net of discount of $235,640
$
1,675,000

 
$
—

Common stock issued upon conversion of Series B Convertible Preferred Stock
$
—

 
$
321

Common stock issued upon conversion of Series C Convertible Preferred Stock
$
33

 
$
—

 
See accompanying notes to the unaudited condensed financial statements.

8
Table of Contents

TROVAGENE, INC.  
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
 
1. Organization and Basis of Presentation
 
Business Organization and Overview
 
Trovagene, Inc. (“Trovagene” or the “Company”) headquartered in San Diego, California, is a clinical-stage, oncology therapeutics company, taking a Precision Cancer Medicine TM (PCM) approach to develop drugs that target mitosis (cell division) to treat various types of cancer, including leukemias, lymphomas and solid tumors.

Trovagene’s intellectual property and proprietary technology enables the Company to analyze circulating tumor DNA (“ctDNA”) and clinically actionable markers. Unique to the Company’s clinical development plan, and a key component of its precision cancer medicine approach, is the integration of predictive clinical biomarkers to identify patients most likely to respond to treatment.
 
Basis of Presentation
 
The accompanying unaudited interim condensed financial statements of Trovagene have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and the results of its operations and cash flows for the periods presented. The unaudited condensed balance sheet at December 31, 2018 has been derived from the audited financial statements at that date but does not include all of the information and disclosures required by GAAP for annual financial statements. The operating results presented in these unaudited interim condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2018 included in the Company’s annual report on Form 10-K filed with the SEC on March 6, 2019.

The Company made a reverse split of its common stock, $0.0001 par value, at a ratio of 1 for 6 , effective February 19, 2019. All share and per share information in the unaudited condensed financial statements and the accompanying notes have been retroactively adjusted to reflect the reverse stock split for all periods presented.

Liquidity
 
Trovagene’s condensed financial statements as of June 30, 2019 have been prepared under the assumption that Trovagene will continue as a going concern, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning the Company’s ability to continue as a going concern.
 
The Company has incurred net losses since its inception and has negative operating cash flows. Considering the Company’s current cash resources, and service receivable related to the clinical trial funding commitment, management projects the Company’s existing resources will be sufficient to fund the Company’s planned operations into the first quarter of 2020 . Based on its current business plan and assumptions, the Company expects to continue to incur significant losses and require significant additional capital to further advance its clinical trial programs and support its other operations. The Company has based its cash sufficiency estimates on its current business plan and its assumptions that may prove to be wrong. The Company could utilize its available capital resources sooner than it currently expects, and it could need additional funding to sustain its operations even sooner than currently anticipated. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. For the foreseeable future, the Company’s ability to continue its operations is dependent upon its ability to obtain additional capital.


9

The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. 
 
If the Company is unable to raise additional capital when required or on acceptable terms, it may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more of its product candidates, all of which would have a material adverse impact on the Company’s operations. The Company may also be required to:
 
•
Seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and

•
Relinquish licenses or otherwise dispose of rights to technologies, product candidates or products that the Company would otherwise seek to develop or commercialize themselves, on unfavorable terms.
 
The Company is evaluating the following options to raise additional capital, increase revenue, as well as reduce costs, in an effort to strengthen its liquidity position:

•
Raising capital through public and private equity offerings;

•
Introducing operation and business development initiatives to bring in new revenue streams;

•
Reducing operating costs by identifying internal synergies; and

•
Engaging in strategic partnerships.

As of June 30, 2019 , the Company has received approximately $3.3 million upon exercise of 497,313 warrants in connection with the June 2018 underwritten public offering. The Company has also received approximately $2.9 million from proceeds from the sale of common stock and warrants, net of expenses. The Company continually assesses its spending plans to effectively and efficiently address its liquidity needs.

2. Summary of Significant Accounting Policies
 
During the six months ended June 30, 2019 , there have been no changes to the Company’s significant accounting policies as described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2018 , except as described below.

Leases

The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current operating lease liabilities and non-current operating lease liabilities in the Company’s balance sheets.
ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As its leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The operating lease ROU asset also includes any lease payments made less lease incentives received. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. Our facilities lease agreements contain lease and non-lease components, such as common area maintenance. We have elected to account for these lease and non-lease components of these agreements as a single lease component.

Leases with an initial term of 12 months or less are not recorded on the Company's balance sheets. These short term leases are expensed on a straight line basis over the lease term.
 
Net Loss Per Share
 
Basic and diluted net loss per share is presented in conformity with ASC Topic 260, Earnings per Share , for all periods presented. In accordance with this guidance, basic net loss per common share was determined by dividing net loss applicable to

10

common stockholders by the weighted-average common shares outstanding during the period. Preferred dividends are included in income available to common stockholders in the computation of basic and diluted earnings per share. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common share equivalents outstanding for the period. Common share equivalents are only included when their effect is dilutive.
 
The following table sets forth the computation of basic and diluted earnings per share:
 
 
Three Months
Ended June 30,
 
Six Months
Ended June 30,
 
2019
 
2018
 
2019
 
2018
Numerator: Net loss attributable to common shareholders
$
(4,131,363
)
 
$
(6,522,548
)
 
$
(8,310,463
)
 
$
(11,314,785
)
Net loss used for diluted loss per share
$
(4,131,363
)
 
$
(6,522,548
)
 
$
(8,310,463
)
 
$
(11,314,785
)
Denominator for basic and diluted net loss per share:
 
 
 
 
 
 
 
Weighted-average shares used to compute basic loss per share
5,241,924

 
1,237,244

 
4,667,434

 
1,004,391

Weighted-average shares used to compute diluted net loss per share
5,241,924

 
1,237,244

 
4,667,434

 
1,004,391

Net loss per share attributable to common stockholders:
 
 
 
 
 
 
 
Basic
$
(0.79
)
 
$
(5.27
)
 
$
(1.78
)
 
$
(11.27
)
Diluted
$
(0.79
)
 
$
(5.27
)
 
$
(1.78
)
 
$
(11.27
)

The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their effect was anti-dilutive:
 
 
June 30,
 
2019
 
2018
Options to purchase Common Stock
1,033,274

 
90,167

Warrants to purchase Common Stock
4,404,185

 
3,698,256

Restricted Stock Units
14,187

 
2,067

Series A Convertible Preferred Stock
877

 
877

Series B Convertible Preferred Stock
—

 
941,667

 
5,452,523

 
4,733,034


Recently Adopted Accounting Pronouncement

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASU 2016-02”). ASU 2016-02 changes accounting for leases and requires lessees to recognize the assets and liabilities arising from most leases, including those classified as operating leases under previous accounting guidance, on the balance sheet and requires disclosure of key information about leasing arrangements to increase transparency and comparability among organizations. In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842 , which provides narrow amendments to clarify how to apply certain aspects of the new lease standard. In July 2018, ASU 2018-11, Leases: Targeted Improvements , was issued to provide relief to companies from restating comparative periods. Pursuant to this ASU, in the period of adoption the Company will not restate comparative periods presented in its financial statements.

The Company adopted ASU 2016-02 in the first quarter of 2019 utilizing the modified retrospective transition method through a cumulative-effect adjustment at the beginning of the first quarter of 2019 and did not restate comparative periods.  The Company has elected the package of practical expedients, which allows the Company not to reassess (1) whether any expired or existing contracts as of the adoption date are or contain a lease, (2) lease classification for any expired or existing leases as of the adoption date and (3) initial direct costs for any existing leases as of the adoption date. The Company did not elect to apply the hindsight practical expedient when determining lease term and assessing impairment of right-of-use assets. The adoption of ASU 2016-02 on January 1, 2019 resulted in the recognition of right-of-use assets of approximately $1,970,000 and lease liabilities for operating leases of approximately $2,503,000 . There was no cumulative effect adjustment to

11

accumulated deficit as a result of the adoption and there was not a material impact to the Company’s consolidated statement of operations. Refer to Note 5 to the condensed financial statements for further details.

Recent Accounting Pronouncement Not Yet Adopted
 
In August 2018, the FASB issued ASU No. 2018-13, Changes to the Disclosure Requirements for Fair Value Measurement . This ASU eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. The standard is effective for all entities for financial statements issued for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on the Company’s financial statements.

3. Fair Value Measurements
 
The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of June 30, 2019 and December 31, 2018 :
 
 
Fair Value Measurements at
June 30, 2019
 
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)
$
10,742,715

 
$
—

 
$
—

 
$
10,742,715

Total Assets
$
10,742,715

 
$
—

 
$
—

 
$
10,742,715

Liabilities:
 
 
 
 
 
 
 
Derivative financial instruments — warrants
$
—

 
$
—

 
$
18,287

 
$
18,287

Total Liabilities
$
—

 
$
—

 
$
18,287

 
$
18,287

 
Fair Value Measurements at
December 31, 2018
 
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)
$
11,392,093

 
$
—

 
$
—

 
$
11,392,093

Total Assets
$
11,392,093

 
$
—

 
$
—

 
$
11,392,093

Liabilities:
 
 
 
 
 
 
 
Derivative financial instruments — warrants
$
—

 
$
—

 
$
32,315

 
$
32,315

Total Liabilities
$
—

 
$
—

 
$
32,315

 
$
32,315

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

The following table sets forth a summary of changes in the fair value of the Company’s Level 3 liabilities for the six months ended June 30, 2019 :
 
Description
 
Balance at
December 31, 2018
 
Realized (gains) or losses
 
Balance at
June 30, 2019
Derivative financial instruments — warrants
 
$
32,315

 
$
(14,028
)
 
$
18,287

 
The change in the fair value of the “derivative financial instruments—warrants” is recorded as a gain or loss in the Company’s 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 and ASC Topic 480-10. At each reporting period, all assets and liabilities for

12

which the fair value measurement is based on significant unobservable inputs or instruments that trade infrequently and therefore have little or no price transparency are classified as Level 3.

4. Property and Equipment
 
Property and equipment consist of the following:
 
 
As of June 30,
2019
 
As of December 31,
2018
Furniture and office equipment
$
775,030

 
$
775,030

Leasehold improvements
102,230

 
1,962,230

Laboratory equipment
682,508

 
677,234

 
1,559,768

 
3,414,494

Less—accumulated depreciation and amortization
(1,307,715
)
 
(2,110,061
)
Property and equipment, net
$
252,053

 
$
1,304,433

 
5. Leases

 As a lessee, the Company’s current leases include its master facility lease and immaterial equipment leases, all of which are considered operating leases.

The Company (as a sublessor) also subleases portions of its facility to third parties under three separate subleases. All of these subleases have been determined to be operating leases and are accounted for separately from the head lease.

Master Facility Lease

The Company leases a building in San Diego under an operating lease that expires on December 31, 2021. The lease currently requires fixed monthly rent payments of approximately $76,000 , with 3% annual escalation. The lease also contains one five -year renewal option with minimum monthly rent equal to the then-current fair market value, subject to a 3% annual increase. As the Company is not reasonably certain to exercise this option, it has not been included in the calculation of the lease liability or right-of-use asset related to this lease.

Facility Subleases

As a result of corporate restructurings in previous years, the Company vacated a portion of its facility and has subleased the space to third parties under three separate sublease agreements, including one that expires October 31, 2019 and two that expire December 31, 2021. Under the new standard, ROU assets and lease liabilities are not required to be established on the Company’s balance sheet for such operating subleases. The Company recorded a cease-use loss liability and expense in 2018 pursuant to ASC 420, Exit or Disposal Cost Obligations , representing the total expected shortfall in sublease income for two of the subleases as compared to its required payments for those spaces under the remainder of the master lease term. This liability was being amortized over the remaining lease term until the adoption of ASC 842, whereupon the remaining cease-use loss liability of approximately $487,000 was eliminated and treated as a reduction to the beginning ROU asset value for the master lease as of January 1, 2019. Income will continue to be recognized on a straight-line basis over the term of the sublease and will be reported on a gross basis as other revenue in the Company’s condensed statement of operations since the Company is not relieved of its primary obligation under the head lease.

The components of lease expense were as follows:

 
 
Three months ended June 30, 2019
 
Six Months Ended June 30, 2019
Operating lease cost
 
$
192,985

 
$
387,447

Operating sublease income
 
(99,938
)
 
(199,875
)
Net operating lease cost
 
$
93,047

 
$
187,572



13

Supplemental balance sheet information related to leases was as follows:

 
 
June 30, 2019
Operating lease ROU assets
 
$
1,660,631

 
 
 
Current operating lease liabilities
 
$
816,102

Non-current operating lease liabilities
 
1,307,384

Total operating lease liabilities
 
$
2,123,486

 
 
 
Weighted-average remaining lease term–operating leases
 
2.5 years

Weighted-average discount rate–operating leases
 
6.5
%

Supplemental cash flow and other information related to leases was as follows:
 
 
Three months ended June 30, 2019
 
Six Months Ended June 30, 2019
Cash paid for amounts included in the measurement of lease liabilities:
 
 
 
 
Operating cash flows from operating leases
 
$
229,574

 
$
455,938

 
 
 
 
 
ROU assets obtained in exchange for lease obligations:
 
 
 
 
Operating leases
 
$
—

 
$
2,503,148


Total remaining annual commitments under non-cancelable lease agreements for each of the years ended December 31 are as follows:

Year Ending December 31,
 
 Operating Leases
 
 Sublease Income
 
 Net Operating Leases
2019 (excluding the six months ended June 30, 2019)
 
$
384,533

 
$
(181,779
)
 
$
202,754

2020
 
941,670

 
(291,173
)
 
650,497

2021
 
968,165

 
(291,173
)
 
676,992

2022
 
5,868

 
—

 
5,868

2023
 
3,423

 
—

 
3,423

Total future minimum lease payments
 
2,303,659

 
$
(764,125
)
 
$
1,539,534

Less imputed interest
 
(180,173
)
 
 
 
 
Total
 
$
2,123,486

 
 
 
 

Total annual commitments under non-cancelable lease agreements as of December 31, 2018 under the previous lease accounting guidance are as follows:
 
 
Operating Leases
 
Sublease Income
 
Net Operating Leases
2019
$
914,540

 
$
(333,124
)
 
$
581,416

2020
941,670

 
—

 
941,670

2021
968,165

 
—

 
968,165

2022
5,868

 
—

 
5,868

2023
3,423

 
—

 
3,423

Total
$
2,833,666

 
$
(333,124
)
 
$
2,500,542



14

6. Derivative Financial Instruments — Warrants
 
Based upon the Company’s analysis of the criteria contained in ASC Topic 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”) or ASC Topic 480-10, Distinguishing Liabilities from Equity (“ASC 480-10”), Trovagene determined that certain warrants issued in connection with the execution of certain equity financings must be recorded as derivative liabilities. In accordance with ASC 815-40 and ASC 480-10, the warrants are also being re-measured at each balance sheet date based on estimated fair value, and any resultant change in fair value is being recorded in the Company’s condensed statements of operations. The Company estimates the fair value of these warrants using the Black-Scholes option pricing model.
 
The range of assumptions used to determine the fair value of the warrants valued using the Black-Scholes option pricing model during the periods indicated were:
 
 
Six Months Ended June 30,
 
2019
 
2018
Estimated fair value of Trovagene common stock
2.50-3.75

 
4.62-25.20

Expected warrant term
3.6-4.1 years

 
0.5-5.1 years

Risk-free interest rate
1.72-2.49%

 
1.76-2.71%

Expected volatility
102-106%

 
91-131%

Dividend yield
0
%
 
0
%

Expected volatility is based on historical volatility of Trovagene’s common stock. The warrants have a transferability provision and based on guidance provided in Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment (“SAB No. 107”) , for instruments issued with such a provision, Trovagene used the remaining contractual term as the expected term of the warrants. The risk-free rate is based on the U.S. Treasury security rates consistent with the expected remaining term of the warrants at each balance sheet date.
 
The following table sets forth the components of changes in the Company’s derivative financial instruments — warrants liability balance, valued using the Black-Scholes option pricing method, for the periods indicated.
 
Date
 
Description
 
Number of Warrants
 
Derivative
Instrument
Liability
December 31, 2018
 
Balance of derivative financial instruments — warrants liability
 
64,496

 
$
32,315

 
 
Change in fair value of derivative financial instruments — warrants during the period recognized as a gain in the condensed statements of operations
 
—

 
(14,028
)
June 30, 2019
 
Balance of derivative financial instruments — warrants liability
 
64,496

 
$
18,287

 
7. Stockholders’ Equity
 
Common Stock
 
During the six months ended June 30, 2019 , the Company issued a total of 1,609,511 shares of Common Stock. The Company issued 183,334 shares of its common stock, 150,000 warrants, and 200,000 shares of Series C Convertible Preferred Stock through a private placement in January 2019 to PoC Capital, LLC (“PoC”) in exchange for funding Company’s clinical trials in the aggregate amount of $1.675 million . The Company also received gross proceeds of $3.0 million from the sale of 421,917 shares of its common stock, 840,181 warrants, and 418,264 pre-funded warrants through registered direct offerings and private placements in April and May 2019. 497,313 shares were issued upon exercise of warrants for a weighted-average price of $6.60 . 10,795 shares were issued upon vesting of restricted stock units (“RSUs”). 333,333 shares were issued upon conversion of Series C Convertible Preferred Stock. In addition, 6,466 shares were issued for share rounding as a result of the reverse stock split.
 

15

Stock Options
 
Stock-based compensation expense related to Trovagene equity awards have been recognized in operating results as follows:
 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2019
 
2018
 
2019
 
2018
Included in cost of revenue
$
—

 
$
(9,143
)
 
$
—

 
$
30,488

Included in research and development expense
$
86,058

 
$
111,812

 
$
196,139

 
$
507,521

Included in selling, general and administrative expense
62,776

 
118,631

 
152,763

 
1,089,422

Total stock-based compensation expense
$
148,834

 
$
221,300

 
$
348,902

 
$
1,627,431

 
The unrecognized compensation cost related to non-vested stock options outstanding at June 30, 2019 and 2018 , net of expected forfeitures, was $1,735,973 and $650,165 , respectively, which is expected to be recognized over a weighted-average remaining vesting period of 2.5 and 1.4 years , respectively. The weighted-average remaining contractual term of outstanding options as of June 30, 2019 was approximately 9.7 years . The total fair value of stock options vested during the six months ended June 30, 2019 and 2018 were $279,760 and $1,246,260 , respectively.

The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following weighted-average assumptions during the following periods indicated:
 
 
Six Months Ended June 30,
 
2019
 
2018
Risk-free interest rate
1.8
%
 
2.43
%
Dividend yield
0
%
 
0
%
Expected volatility
95
%
 
90
%
Expected term
5.9 years

 
5.2 years


A summary of stock option activity and changes in stock options outstanding is presented below:
 
 
Total Options
 
Weighted-Average
Exercise Price
Per Share
 
Intrinsic
Value
Balance outstanding, December 31, 2018
83,345

 
$
146.09

 
$
—

Granted
961,313

 
$
2.50

 
 

Canceled / Forfeited
(11,384
)
 
$
70.82

 
 

Balance outstanding, June 30, 2019
1,033,274

 
$
13.34

 
$
19,059

Exercisable at June 30, 2019
74,486

 
$
149.43

 
$
—

 
On June 6, 2019, the number of authorized shares in the Trovagene 2014 Equity Incentive Plan (“2014 EIP”) was increased from 243,056 to 1,243,056 . As of June 30, 2019 , there were 161,500 shares available for issuance under the 2014 EIP.

Restricted Stock Units

The weighted-average grant date fair value of the RSUs was $4.04 per share during the six months ended June 30, 2019 . There were no RSUs granted during the six months ended June 30, 2018 .


16

A summary of the RSU activity is presented below:
 
Number of Shares
 
Weighted-Average
Grant Date Fair Value
Per Share
 
Intrinsic Value
Non-vested RSUs outstanding, December 31, 2018
30,132

 
$
14.36

 
$
95,005

Granted
167

 
$
4.04

 
 
Vested
(10,795
)
 
$
13.67

 
$
41,233

Forfeited
(5,317
)
 
$
13.04

 
 
Non-vested RSUs outstanding, June 30, 2019
14,187

 
$
15.25

 
$
35,468


At June 30, 2019 , total unrecognized compensation cost related to non-vested RSUs was $122,189 , which is expected to be recognized over a weighted-average period of 1.3 years . The total fair value of vested RSUs during the six months ended June 30, 2019 and 2018 were $147,516 and $1,071,069 , respectively.

Warrants
 
A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications is presented below:
 
 
Total Warrants
 
Weighted-Average
Exercise Price
Per Share
 
Weighted-Average
Remaining Contractual
Term
Balance outstanding, December 31, 2018
3,649,341

 
$
8.91

 
4.4
Granted
1,408,510

 
$
3.50

 
 
Exercised
(653,666
)
 
$
5.96

 
 
Balance outstanding, June 30, 2019
4,404,185

 
$
7.62

 
4.3

Series C Convertible Preferred Stock

On January 25, 2019, the Company entered into a Master Services Agreement and a Stock and Warrant Subscription Agreement with PoC, whereby PoC agreed to finance $1.675 million in clinical studies, including the development costs associated with Phase 1b/2 trial of onvansertib in combination with FOLFIRI and Avastin ® in patients with metastatic Colorectal Cancer (“mCRC”) harboring KRAS mutation in exchange for (i) 183,334 shares of common stock, (ii) warrants to purchase an aggregate of 150,000 shares of common stock, with an exercise price of $3.762 per share, expiring on January 25, 2024, and (iii) 200,000 shares of Series C Convertible Preferred Stock, each share of which was convertible into 1.67 shares of common stock.

The Company evaluated the awards issued under this transaction and determined they should be classified as equity. These equity awards were fully vested and nonforfeitable. Since the equity awards were for clinical study services yet to be provided, the Company recognized $1.675 million service receivables as contra equity. The Company releases the service receivables as clinical study services are performed. The conversion feature of the Series C Convertible Preferred Stock at the time of issuance was determined to be beneficial on the commitment date. Because the Series C Convertible Preferred Stock was perpetual with no stated maturity date, and the conversions could occur any time from inception, the Company immediately recorded a non-cash deemed dividend of $0.3 million related to the beneficial conversion feature arising from the issuance of Series C Convertible Preferred Stock. This non-cash deemed dividend increased the Company’s net loss attributable to common stockholders and net loss per share.

The holders of Series C Convertible Preferred Stock were granted the right to vote, on an as-converted to common stock basis (limited to 93.41% of the then as-if converted common stock) all matters submitted to a vote of holders of the Company’s common stockholders. In the event of liquidation, dissolution or winding-up, holders of Series C Convertible Preferred Stock were entitled to receive the same amount that a holder of the Company’s common stock would receive if the Series C Convertible Preferred Stock were fully converted into shares of the Company’s common stock at the conversion price which amounts shall be paid  pari passu  with all holders of common stock.

In April of 2019, all 200,000 shares of Series C Convertible Preferred Stock were converted into 333,333 shares of the Company's common stock. As of June 30, 2019 , there were no shares of Series C Convertible Preferred Stock outstanding.

17


8. Commitments and Contingencies
 
Executive and Consulting Agreements
 
The Company has longer-term contractual commitments with various consultants and employees. Certain employment agreements provide for severance payments.
 
Research and Development and Clinical Trial Agreements

In March 2017, the Company entered into a license agreement with Nerviano Medical Sciences S.r.l. (“Nerviano”) which granted the Company development and commercialization rights to NMS-1286937, which Trovagene refers to as onvansertib. Onvansertib is an oral, investigative drug and a highly-selective adenosine triphosphate competitive inhibitor of the serine/threonine PLK1. The Company plans to develop onvansertib in patients with leukemias/lymphomas and solid tumor cancers. Upon execution of the agreement, the Company paid $2.0 million in license fees which were expensed to research and development costs. Under the agreement, the Company is committed to purchase $1.0 million for services provided by Nerviano, such as service for manufacturing drug product, no later than June 30, 2019. As of June 30, 2019 , services in excess of $1.0 million have been ordered in full satisfaction of this obligation. Terms of the agreement also provide for the Company to pay royalties based on certain development and sales milestones.
 
The Company is a party to various agreements under which it licenses technology on an exclusive basis in the field of human diagnostics and oncology therapeutics. License fees are generally calculated as a percentage of product revenues, with rates that vary by agreement. To date, payments have not been material.

Litigation
 
Trovagene does not believe that it has legal liabilities that are probable or reasonably possible that require either accrual or disclosure. From time to time, the Company may become involved in various lawsuits and legal proceedings that arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in matters may arise from time to time that may harm the Company’s business. As of the date of this report, management believes that there are no claims against the Company, which it believes will result in a material adverse effect on the Company’s business or financial condition.

9. Related Party Transactions

In November 2018, the Company entered into a Material Transfer Agreement (“MTA”) with Leucadia Life Sciences (“Leucadia”) pursuant to which Leucadia will develop a PCR-based assay for onvansertib for AML. In May 2019, the MTA was amended and increased to $1,070,000 to account for additional deliverables in development of the PCR-based assay. The Company’s CEO, Dr. Thomas Adams, is a principal stockholder of Leucadia. In addition, in connection with the MTA, the Company entered into a consulting agreement with Tommy Adams, VP of Operations of Leucadia, who is the son of Dr. Adams. During the six months ended June 30, 2019 , the Company incurred and recorded approximately $503,000 of research and development expenses for services performed by Leucadia and Tommy Adams.

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.
 

18
Table of Contents

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, 2018 , filed on March 6, 2019. 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 a clinical-stage, oncology therapeutics company, taking a Precision Cancer Medicine TM (PCM) approach to develop drugs that target mitosis (cell division) to treat various types of cancer, including leukemias, lymphomas and solid tumors. By integrating a biomarker strategy into our development programs, we will be able to identify patients more likely to respond to treatment.

On March 15, 2017, we announced that we licensed onvansertib, a PLK1 inhibitor, from Nerviano, pursuant to a license agreement with Nerviano dated March 13, 2017. This exclusive, world-wide license agreement includes 3 issued patents for onvansertib which cover composition of matter, salt forms of onvansertib and combination of onvansertib with other drugs. Onvansertib was developed to have high selectivity to PLK1 (at low nanomolar IC 50 levels), to have ideal pharmacokinetics, including oral bioavailability and administration and a drug half-life of approximately 24 hours, allowing for flexible dosing and scheduling, and is well tolerated and safe with only mild- to moderate side effects reported to-date. A Phase 1 safety study of onvansertib has been successfully completed in patients with advanced metastatic solid tumors and published in 2017 in Investigational New Drugs. We currently have three active clinical trials: a Phase 2 open-label clinical trial of onvansertib in combination with abiraterone acetate (Zytiga ® ) and prednisone in patients with metastatic Castration-Resistant Prostate Cancer (“mCRPC”), being conducted at Beth Israel Deaconess Medical Center ("BIDMC"), Dana-Farber Cancer Institute ("DFCI"), and Massachusetts General Hospital ("MGH"); a Phase 1b/2 open-label clinical trial of onvansertib in combination with FOLFIRI and Avastin ® in patients with mCRC with a KRAS mutation, being conducted at USC Norris Comprehensive Cancer Center and The Mayo Clinic; and a Phase 1b/2 open-label clinical trial of onvansertib in combination with standard-of-care chemotherapy in patients with AML, being conducted at eight sites across the U.S..

Onvansertib is a first-in-class, third-generation, oral and highly-selective PLK1 inhibitor with demonstrated antitumor activity in different preclinical models. Polo-like kinase family consists of 5 members (PLK1-PLK5) and they are involved in multiple functions in cell division, including the regulation of centrosome maturation, checkpoint recovery, spindle assembly, cytokinesis, apoptosis and many others. PLK1 is essential for the maintenance of genomic stability during cell division. The over-expression of PLK1 can lead to immature cell division followed by aneuploidy and cell death, a hallmark of cancer. PLK1 is over-expressed in a wide variety of leukemias/lymphomas and solid tumor cancers, including acute myeloid leukemia, non-Hodgkin lymphoma, prostate, lung, breast, ovarian, colorectal and adrenocortical carcinoma. In addition, several studies have shown that over-expression of PLK1 is associated with poor prognosis. Blocking the expression of PLK1 by kinase inhibitors, such as onvansertib, can effectively inhibit growth of, and induce, tumor cell death.

Studies have shown that inhibition of polo-like-kinases can lead to tumor cell death, including a Phase 2 study in Acute Myeloid Leukemia (“AML”) where response rates with a prior PLK inhibitor of up to 31% were observed when used in conjunction with a standard therapy for AML (low-dose cytarabine (“LDAC”)) versus a 13.3% response rate with LDAC alone. We believe the more selective nature of onvansertib to PLK1, its 24-hour half-life and oral bioavailability, as well as its demonstrated safety and tolerability, with only mild- to moderate side effects reported, may prove useful in addressing clinical therapeutic needs across a variety of cancers.


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Onvansertib has been tested in-vivo in different xenograft and transgenic models suggesting tumor growth inhibition or tumor regression when used in combination with other therapies. Onvansertib has been tested for antiproliferative activity on a panel of 148 tumor cell lines and appeared highly active with an IC 50 (a measure concentration for 50% target inhibition) below 100 nM in 75 cell lines and IC 50 values below 1 uM in 133 out of 148 cell lines. Onvansertib also appears active in cells expressing multi-drug resistant (“MDR”) transporter proteins and we believe its apparent ability to overcome the MDR transporter resistance mechanism in cancer cells could prove useful in broader drug combination applications.

In in-vitro and in-vivo preclinical studies, synergy (interaction of discrete drugs such that the total effect is greater than the sum of the individual effects) has been demonstrated with onvansertib when used in combination with numerous different chemotherapies, including cisplatin, cytarabine, doxorubicin, gemcitabine and paclitaxel, as well as targeted therapeutics, such as abiraterone acetate (Zytiga ® ), histone deacetylase (“HDAC”) inhibitors, such as belinostat (Beleodaq ® ), quizartinib (AC220), a development stage FLT3 inhibitor, and bortezomib (Velcade ® ). These therapies are used clinically for the treatment of leukemias, lymphomas and solid tumor cancers, including AML, Non-Hodgkin Lymphoma (“NHL”), mCRPC, mCRC, and Triple Negative Breast Cancer (“TNBC”).

We continue to focus on advancing our three active clinical trials with onvansertib in 2019. We have achieved a number of key milestones during the first half of 2019 and anticipate achieving the following milestones throughout 2019:

Phase 1b/2 Trial of Onvansertib in Combination with Either Low-Dose Cytarabine or Decitabine for the Treatment of Acute Myeloid Leukemia

•
Complete Phase 1b dose escalation cohorts and identify the recommended Phase 2 dose (“RP2D”) for the Phase 2 continuation trial (dependent upon the number of dose escalation cohorts required to reach the maximum tolerated dose or RP2D of onvansertib).
•
Provide top line safety and efficacy data on the combination of onvansertib + LDAC and the combination of onvansertib + decitabine in patients treated through the end of 2019.
•
Present data from the AML trial at key oncology conferences, including the American Society of Hematology (“ASH”) annual meeting.
•
Initiate the Phase 2 segment of the AML trial, which will enroll approximately 32 patients, for continued evaluation of safety and efficacy of onvansertib in combination with either LDAC or decitabine (once the RP2D has been determined in Phase 1b).

Phase 2 Trial of Onvansertib in Combination with Abiraterone Acetate (Zytiga ® ) and Prednisone for the Treatment of Metastatic Castration-Resistant Prostate Cancer

•
Completed enrollment and evaluation of the 3 safety lead-in patients in the second arm (2-week dosing schedule) with onvansertib at 24 mg/m 2 in combination with abiraterone acetate (Zytiga ® ) and prednisone.
•
Provide top line preliminary safety and efficacy data of onvansertib in combination with abiraterone acetate (Zytiga ® ) and prednisone in patients treated.
•
Present data from the mCRPC trial at key oncology conferences throughout 2019 and first quarter of 2020.

Phase 1b/2 Trial of Onvansertib in Combination with FOLFIRI and Bevacizumab (Avastin ® ) for Second-Line Treatment of Metastatic Colorectal Cancer with a KRAS Mutation

•
Complete enrollment of the initial dose level cohort of onvansertib 12 mg/m 2 .
•
Provide top line safety and preliminary efficacy data on the combination of onvnasertib + FOLFIRI + Avastin ® in patients treated through the end of 2019.
During 2019, we have advanced our business with the following activities:

•
Announced ESMO Accepts Trovagene AML Clinical Trial Abstract for Oral Presentation
On July 22, 2019, Trovagene announced the acceptance of three abstracts for presentation at the upcoming European Society for Medical Oncology (ESMO) conference in Barcelona on September 27 to October 1, 2019. The abstract accepted for an oral presentation (Abstract #2411), "Polo-like Kinase Inhibitor, Onvansertib, in Combination with Low-Dose Cytarabine or Decitabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia in Phase 1b," will be presented by Amer Zeidan, MBBS, MHS, Yale University, and will feature safety and preliminary efficacy data, including patients who achieved a complete response, as well as biomarker data and correlation with treatment response.

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•
Announced initiation of enrollment for Phase 1b/2 trial in KRAS-mutated metastatic Colorectal Cancer trial at leading cancer centers

On July 9, 2019, we announced the initiation of patient enrollment of our Phase 1b/2 study of onvansertib in combination with FOLFIRI and Avastin ® (bevacizumab) for second-line treatment of patients with metastatic Colorectal Cancer (mCRC) with a KRAS mutation.

•
Announced research collaboration with Nektar Therapeutics to evaluate the efficacy of the combination of onvansertib and ONZEALD TM in models of colorectal cancer.

On May 23, 2019, we announced we entered into a research collaboration agreement with Nektar Therapeutics to explore the combination of our PLK1 inhibitor, onvansertib, and Nektar’s topoisomerase I inhibitor, ONZEALD, for the treatment of mCRC. Under the collaboration, the two companies will evaluate the antitumor activity and tolerability of the combination of onvansertib and ONZEALD in two (HT29 - BRAF mutant and HCT-116 - KRAS mutant) preclinical tumor models of colorectal cancer.

•
Announced Data Demonstrating Significant Synergy of Onvansertib in Combination with Venetoclax in Cell Model of Venetoclax-Resistant AML.

On April 23, 2019, we announced preclinical data that evaluated the effect of combining onvansertib with venetoclax in an AML cell model known to be resistant to venetoclax (Venclexta ®  - AbbVie). This combination demonstrated synergy (the combined effect of the two drugs is greater than the sum of their individual effects) with a significant decrease in tumor cell viability. This data provides support for clinical evaluation of onvansertib in combination with venetoclax in patients with difficult-to-treat relapsed/refractory AML, for which there are limited treatment options and the prognosis is poor.

•
Announced Equity Investments of $3.0 Million at Premium to Market Price from Institutional Investor, Lincoln Park Capital
On April 5 and May 13, 2019, respectively, Trovagene announced that it has entered into definitive purchase agreements with Lincoln Park Capital Fund, LLC ("Lincoln Park") an existing institutional investor, in which Lincoln Park agreed to purchase in a registered direct offering shares of common stock and pre-funded warrants at a premium to the closing sale price on April 5 and May 10, 2019, respectively, on the Nasdaq Capital Market. In a concurrent private placement, Lincoln Park agreed to purchase warrants to purchase shares of common stock.

•
Announced Update to Phase 1b/2 Trial Data Presented at AACR - Additional Patients Achieve Complete Response at Two Highest Dose Levels of Onvansertib.
    
On April 5, 2019, we announced an update to our Phase 1b/2 trial data presented at AACR on April 1, showing additional patients having achieved complete response at the two highest dose levels of onvansertib. A complete response (2 CR’s and 1 CRi) was achieved in 3 of 6 (50%) of evaluable patients at the highest doses (27mg/m 2 and 40 mg/m 2 ) of onvansertib in combination with standard-of-care decitabine. Approximately a 90% clinical benefit rate has been demonstrated (CR + PR + SD). No dose-limiting toxicities have been observed to-date.

•
Announced Early Data from Phase 2 Trial Indicates Activity of Onvansertib in Prostate Cancer Patients Showing Initial Resistance to Anti-Androgen Therapy.

On April 2, 2019, we announced early data from our ongoing Phase 2 study evaluating onvansertib in combination with Zytiga ® in patients with mCRPC. Early prostate specific antigen (“PSA”) response was observed when onvansertib is added to abiraterone (Zytiga ® ) in 2 of 6 patients to-date; the first patient achieved the primary efficacy endpoint of disease stabilization. The PSA trajectory in the patient achieving the primary efficacy endpoint indicates alteration of the natural history of early signs of resistance to Zytiga ® . Patients with observed responses to-date harbor the highly aggressive androgen receptor variant (AR-V7) which is known to be resistant to treatment with Zytiga ® .

•
Announced Phase 1b/2 Dose Escalation Trial of Onvansertib in Relapsed/Refractory AML Demonstrates Safety, Tolerability and relative Durability with Complete Responses at Highest Dose Levels.


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On April 1, 2019, we announced the presentation of new data from our ongoing Phase 1b/2 study evaluating onvansertib in combination with standard-of-care chemotherapy in AML. The greatest anti-leukemic activity has been observed in the onvansertib + decitabine arm, with complete response in 2 (1 CR and 1 CRi) of 4 (50%) evaluable patients from the two highest dose levels. There have been no dose-limiting toxicities observed to-date and two-thirds of patients have completed ≥2 cycles of treatment, with 2 patients currently on treatment for more than 11 and 5 months, respectively. There has been a significant association observed between biomarker-positive patients and response to onvansertib treatment.

•
Announced Presentation Update on Phase 2 Study of Onvansertib in Combination with Zytiga ® in Patients with mCRPC at ASCO-GU.

On February 14, 2019, we announced an update on our Phase 2 study of onvansertib in combination with Zytiga ® in patients with mCRPC was presented at the Genitourinary Cancers Symposium. The data presented confirmed the safety and tolerability of the combination and the expansion of the trial to include an alternate dosing schedule to maximize observed clinical activity.

•
Entered Agreement with PoC Capital, LLC to Fund Clinical Development of Onvansertib in mCRC.

On January 29, 2019, we announced an agreement with PoC Capital, LLC, to fund clinical development of onvansertib in a Phase1b/2 clinical trial in patients with mCRC. We submitted an Investigational New Drug application and protocol to the U.S. Food and Drug Administration (“FDA”) on December 19, 2018, and received a “study may proceed” notification from the FDA on January 16, 2019. The trial will be conducted at two prestigious cancer centers in the U.S.; USC Norris Comprehensive Cancer Center and The Mayo Clinic.

•
Announced New Patent Issued for Combination of Onvansertib with Anti-Androgen Drugs to Treat Non-Metastatic and Metastatic Prostate Cancer.

On January 23, 2019, we announced the issuance of a new patent (10,155,006), entitled Combination Therapies and Methods of Use Thereof for Treating Cancer, by the U.S. Patent and Trademark Office (“USPTO”). This patent broadens previously issued patent (9,566,280), by expanding the use of onvansertib to encompass combination therapies with any anti-androgen and androgen antagonist drug, such as Zytiga ® , Xtandi ® and Erleada ® for the treatment of metastatic and non-metastatic castrate-resistant prostate cancer.

Our accumulated deficit through June 30, 2019 is $200,501,678 . To date, we have generated minimal revenues and expect to incur additional losses to perform further research and development activities. 

Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drugs. The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, 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 June 30, 2019 .
 
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, 2018 , filed with the SEC on March 6, 2019. There have been no changes to our critical accounting policies other than adoption of ASC 842 since December 31, 2018 .


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RESULTS OF OPERATIONS
 
Three Months Ended June 30, 2019 and 2018
 
Revenues
 
Our total revenues were $138,285 and $111,813 for the three months ended June 30, 2019 and 2018 , respectively. The components of our revenues were as follows:
 
 
Three Months Ended June 30,
 
2019
 
2018
 
Increase (Decrease)
Royalties
$
36,852

 
$
52,423

 
$
(15,571
)
Services and other
101,433

 
59,390

 
42,043

Total revenues
$
138,285

 
$
111,813

 
$
26,472

 
The decrease in royalty income related primarily to a reduction to the accrual rate. The increase in service and other revenue for the three months ended June 30, 2019 as compared to the prior period is primarily resulting from the sublease income recognized as revenue upon adoption of ASC 842 in 2019, offset by decrease in service revenue as a result of the disposition of our CLIA laboratory. We expect our royalties to fluctuate as the royalties are sales-based or usage-based royalties on our intellectual property license. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
 
Cost of Revenues
 
Our total cost of revenues was $0 for the three months ended June 30, 2019 , compared to $204,436 in the same period of 2018 . Cost of revenues mainly relates to the costs of our diagnostic service revenues. The decrease in cost of revenues for the three months ended June 30, 2019 compared to the same period of last year is mainly due to the disposition of our CLIA laboratory. We do not expect any cost of revenue for 2019 based on our current business model.
 
Research and Development Expenses
 
Research and development expenses consisted of the following:
 
 
Three Months Ended June 30,
 
2019
 
2018
 
Increase (Decrease)
Salaries and staff costs
$
380,050

 
$
513,331

 
$
(133,281
)
Stock-based compensation
86,058

 
111,812

 
(25,754
)
Clinical trials, outside services, and lab supplies
2,134,974

 
1,115,009

 
1,019,965

Facilities and other
229,258

 
212,615

 
16,643

Total research and development
$
2,830,340

 
$
1,952,767

 
$
877,573

 
Research and development expenses increase d by $877,573 to $2,830,340 for the three months ended June 30, 2019 from $1,952,767 for the same period in 2018 . The overall increase in research and development expenses was primarily due to the increased clinical trials and outside service costs for clinical studies related to the development of our lead drug candidate, onvansertib. We expect an increase in research and development costs as we advance the development of onvansertib.


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Table of Contents

Selling, General and Administrative Expenses
 
Selling, general and administrative expenses consisted of the following:
 
 
Three Months Ended June 30,
 
2019
 
2018
 
Increase (Decrease)
Salaries and staff costs
$
458,361

 
$
1,109,476

 
$
(651,115
)
Stock-based compensation
62,776

 
118,631

 
(55,855
)
Outside services and professional fees
576,214

 
523,192

 
53,022

Facilities and other
430,553

 
399,572

 
30,981

Total selling, general and administrative
$
1,527,904


$
2,150,871


$
(622,967
)
 
Selling, general and administrative expenses decrease d by $622,967 to $1,527,904 for the three months ended June 30, 2019 from $2,150,871 for the same period in 2018 . The significant components of the decrease were primarily due to the decrease in salaries and staff costs and stock-based compensation. The decreased salaries and staff cost for the three months ended June 30, 2019 as compared to the same period of 2018, was due to decreased headcount in 2019, and a one-time executive severance expense occurring in the second quarter of 2018.

Interest Income and Expense
 
Interest income was $69,761 for the three months ended June 30, 2019 as compared to $36,202 for the same period of 2018 . The increase of interest income is primarily due to a higher money market fund balance and higher interest rate. Interest expense was $0 for the three months ended June 30, 2019 as compared to $925 for the same period of 2018 . The decrease of interest expense is resulting from pay-off of our Equipment Line of Credit.

Change in Fair Value of Derivative Financial Instruments — Warrants
 
We have issued warrants that are accounted for as derivative liabilities. As of June 30, 2019 , the derivative financial instruments — warrants liabilities were revalued to $18,287 , resulting in a decrease in value of $23,789 from March 31, 2019 , based primarily upon the fluctuation in our stock price as well as the changes in the expected term, volatility, and risk-free interest rates for the expected term. The decrease in value upon remeasurement at June 30, 2019 was recorded as a gain from the change in fair value of derivative financial instruments — warrants in the condensed statement of operations.

Net Loss
 
Net loss and per share amounts were as follows:

 
Three Months Ended June 30,
 
2019
 
2018
 
Increase (Decrease)
Net loss attributable to common shareholders
$
(4,131,363
)
 
$
(6,522,548
)
 
$
(2,391,185
)
Net loss per common share — basic
$
(0.79
)
 
$
(5.27
)
 
$
(4.48
)
Net loss per common share — diluted
$
(0.79
)
 
$
(5.27
)
 
$
(4.48
)
 
 
 
 
 
 
Weighted average shares outstanding — basic
5,241,924

 
1,237,244

 
4,004,680

Weighted average shares outstanding — diluted
5,241,924

 
1,237,244

 
4,004,680

 
The $2,391,185 decrease in net loss attributable to common shareholders was primarily the result of a decrease in Series B deemed dividend expense of $2.8 million, and a decrease in operating expenses of $0.2 million , offset by a $0.7 million decrease in gain from change in fair value of derivative financial instruments-warrants for the three months ended June 30, 2019 compared to the same period in the prior year. The $4.48 decrease in basic net loss per share was impacted by the decrease in operating expense and the increase in basic weighted average shares outstanding resulting primarily from the sales of approximately 2.1 million shares of common stock through public and direct offerings, the issuance of approximately 1.5 million shares of common stock upon conversion of Series B Convertible Preferred Stock, issuance of approximately 0.7 million shares of common stock upon exercise of warrants, and 0.3 million shares of common stock upon conversion of Series C Convertible Preferred Stock.

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Six Months Ended June 30, 2019 and 2018

Revenues
 
Our total revenues were $300,243 and $211,949 for the six months ended June 30, 2019 and 2018 , respectively. The components of our revenues were as follows:
 
 
Six Months Ended June 30,
 
2019
 
2018
 
Increase (Decrease)
Royalties
$
98,873

 
$
101,478

 
$
(2,605
)
Services and other
201,370

 
110,471

 
90,899

Total revenues
$
300,243

 
$
211,949

 
$
88,294

 
The increase in service and other revenue for the six months ended June 30, 2019 as compared to the prior period is primarily resulting from the sublease income recognized as revenue upon adoption of ASC 842 in 2019, offset by decrease in service revenue as a result of the disposition of our CLIA laboratory. We expect our royalties to fluctuate as the royalties are sales-based or usage-based royalties on our intellectual property license. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
 
Cost of Revenues
 
Our total cost of revenues was $0 for the six months ended June 30, 2019 , compared to $570,780 in the same period of 2018 . Cost of revenues mainly relates to the costs of our diagnostic service revenues. The decrease in cost of revenues for the six months ended June 30, 2019 compared to the same period of last year is mainly due to the disposition of our CLIA laboratory. We do not expect any cost of revenue for 2019 based on our current business model.
 
Research and Development Expenses
 
Research and development expenses consisted of the following:
 
 
Six Months Ended June 30,
 
2019
 
2018
 
Increase (Decrease)
Salaries and staff costs
$
783,939

 
$
915,399

 
$
(131,460
)
Stock-based compensation
196,139

 
507,521

 
(311,382
)
Clinical trials, outside services, and lab supplies
4,062,903

 
1,964,997

 
2,097,906

Facilities and other
435,958

 
448,688

 
(12,730
)
Total research and development
$
5,478,939

 
$
3,836,605

 
$
1,642,334

 
Research and development expenses increase d by $1,642,334 to $5,478,939 for the six months ended June 30, 2019 from $3,836,605 for the same period in 2018 . The overall increase in research and development expenses was primarily due to the increased clinical trials and outside service costs for clinical studies related to the development of our lead drug candidate, onvansertib. We expect an increase in research and development costs as we advance the development of onvansertib.


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Table of Contents

Selling, General and Administrative Expenses
 
Selling, general and administrative expenses consisted of the following:
 
 
Six Months Ended June 30,
 
2019
 
2018
 
Increase (Decrease)
Salaries and staff costs
$
981,158

 
$
1,799,646

 
$
(818,488
)
Stock-based compensation
152,763

 
1,089,422

 
(936,659
)
Outside services and professional fees
1,034,045

 
1,005,602

 
28,443

Facilities and other
835,060

 
761,178

 
73,882

Total selling, general and administrative
$
3,003,026

 
$
4,655,848


$
(1,652,822
)
 
Selling, general and administrative expenses decrease d by $1,652,822 to $3,003,026 for the six months ended June 30, 2019 from $4,655,848 for the same period in 2018 . The significant components of the decrease were primarily due to the decrease in salaries and staff costs and stock-based compensation. The decreased salaries and staff cost for the six months ended June 30, 2019 as compared to the same period of 2018, was due to decreased headcount in 2019, and a one-time executive severance expense occurring in the second quarter of 2018. The decreased stock-based compensation related to a one time-employee stock option grants in lieu of cash bonuses occurring in January 2018, these options were immediately expensed. Our selling, general and administrative costs may increase in future periods in order to support fundraising activities and general business activities as we continue to develop and introduce new product offerings.

Interest Income and Expense
 
Interest income was $134,504 for the six months ended June 30, 2019 as compared to $57,973 for the same period of 2018 . The increase of interest income is primarily due to a higher money market fund balance and higher interest rate. Interest expense was $0 for the six months ended June 30, 2019 as compared to $25,161 for the same period of 2018 . The decrease of interest expense is resulting from pay-off of our Equipment Line of Credit.

Change in Fair Value of Derivative Financial Instruments — Warrants
 
We have issued warrants that are accounted for as derivative liabilities. As of June 30, 2019 , the derivative financial instruments — warrants liabilities were revalued to $18,287 , resulting in a decrease in value of $14,028 from December 31, 2018 , based primarily upon the fluctuation in our stock price as well as the changes in the expected term, volatility, and risk-free interest rates for the expected term. The decrease in value upon remeasurement at June 30, 2019 was recorded as a gain from the change in fair value of derivative financial instruments — warrants in the condensed statement of operations.

Net Loss
 
Net loss and per share amounts were as follows:

 
Six Months Ended June 30,
 
2019
 
2018
 
Increase (Decrease)
Net loss attributable to common shareholders
$
(8,310,463
)
 
$
(11,314,785
)
 
$
(3,004,322
)
Net loss per common share — basic
$
(1.78
)
 
$
(11.27
)
 
$
(9.49
)
Net loss per common share — diluted
$
(1.78
)
 
$
(11.27
)
 
$
(9.49
)
 
 
 
 
 
 
Weighted average shares outstanding — basic
4,667,434

 
1,004,391

 
3,663,043

Weighted average shares outstanding — diluted
4,667,434

 
1,004,391

 
3,663,043

 
The $3,004,322 decrease in net loss attributable to common shareholders was primarily the result of a decrease in Series B deemed dividend expense of $2.8 million, and a decrease in operating expenses of $0.8 million , offset by a decrease in gain from change in fair value of derivative financial instruments-warrants for the six months ended June 30, 2019 compared to the same period in the prior year. The $9.49 decrease in basic net loss per share was impacted by the decrease in operating expense and the increase in basic weighted average shares outstanding resulting primarily from the sales of approximately 2.1 million shares of common stock through public and direct offerings, the issuance of approximately 1.5 million shares of

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common stock upon conversion of Series B Convertible Preferred Stock, issuance of approximately 0.7 million shares of common stock upon exercise of warrants, and 0.3 million shares of common stock upon conversion of Series C Convertible Preferred Stock.

LIQUIDITY AND CAPITAL RESOURCES
 
As of June 30, 2019 , we had $10,791,270 in cash and cash equivalents. Net cash used in operating activities for the six months ended June 30, 2019 was $6,803,159 , compared to $6,106,754 for the six months ended June 30, 2018 . Our use of cash was primarily a result of the net loss of $8,030,074 for the six months ended June 30, 2019 , adjusted for non-cash items related to stock-based compensation of $348,901 , depreciation and amortization of $87,219 , release of clinical trial funding commitment of $310,766 , and the loss from the change in fair value of derivative financial instruments — warrants of $14,028 . The changes in our operating assets and liabilities consisted of higher accounts payable and accrued expenses, a decrease in accounts receivable and unbilled receivable, prepaid expenses, operating lease ROU assets, and other asset, and a decrease in operating lease liabilities. At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.
 
Net cash used in investing activities was $5,274 during the six months ended June 30, 2019 , compared to $36,600 for the same period in 2018 , both of which were for capital expenditures.
 
Net cash provided in financing activities was $6,146,570 during the six months ended June 30, 2019 , compared to $16,403,540 for the same period in 2018 . Net cash provided in financing activities during the six months ended June 30, 2019  was primarily from $3.3 million of proceeds from the exercise of warrants and $2.9 million from the sale of common stock and warrants, net of expenses. Net cash provided in financing activities during the six months ended June 30, 2018 was primarily from $11.8 million of proceeds from the sale of common stock and warrants, net of expenses, and $1.6 million from the proceeds from the exercise of warrants, offset by $1.2 million of repayments of equipment line of credit.
 
As of June 30, 2019 , and December 31, 2018 , we had working capital of $8,125,960 and $9,799,947 , respectively. 
 
Based on our current business plan and assumptions, we expect to continue to incur significant losses and require significant additional capital to further advance our clinical trial programs and support our other operations. Considering our current cash resources, we believe our existing resources will be sufficient to fund our planned operations into the first quarter of 2020 . In addition, we have based our cash sufficiency estimates on our current business plan and assumptions that may prove to be wrong. We could utilize our available capital resources sooner than we currently expect, and we could need additional funding to sustain our operations even sooner than currently anticipated. These circumstances raise substantial doubt about our ability to continue as a going concern.

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. To date, our sources of cash have been primarily limited to the sale of equity securities. 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. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more product candidates, all of which may have a material adverse impact on our operations. We may also be required to (i) 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; or (ii) 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. We are evaluating all options to raise additional capital, increase revenue, as well as reduce costs, in an effort to strengthen our liquidity position, which may include the following: (1) Raising capital through public and private equity offerings; (2) Introducing operation and business development initiatives to bring in new revenue streams; (3) Reducing operating costs by identifying internal synergies; or (4) Engaging in strategic partnerships. We continually assess our spending plans to effectively and efficiently address our liquidity needs.

CONTRACTUAL OBLIGATIONS
 
For a discussion of our contractual obligations see (i) our Financial Statements and Notes to Financial Statements Note 10. 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, 2018 .


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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Interest Rate Risk
 
Our cash and cash equivalents primarily consists of deposits and money market deposits managed by commercial banks as of June 30, 2019 . The goals of our investment policy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments.

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 as of June 30, 2019 . 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 issues; 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 stability of financial institutions, we believe that we will not experience losses on these deposits.

Foreign Currency Risk
 
We face the foreign currency risk as a result of entering into transactions denominated in currencies other than U.S. dollars. Changes in foreign currency exchange rates can create foreign exchange gains or losses to us. We did not incur significant foreign currency gains or losses for the six months ended June 30, 2019 .
 
Effects of Inflation
 
We do not believe that inflation and changing prices during the six months ended June 30, 2019 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 principal executive officer (CEO) and principal financial officer (VP, Finance), of the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of June 30, 2019 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.

Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives as specified above. Management does not expect, however, that our disclosure controls and procedures will prevent or detect all errors and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected.
 
Changes in Internal Control over Financial Reporting
 
There was no change in our internal control over financial reporting during the three months ended June 30, 2019 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II.  OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS
 
None.

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, 2018 .

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None .

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS
 
Exhibit
Number
 
Description of Exhibit
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
101.INS
 
XBRL Instance Document
 
 
 
101.SCH
 
XBRL Taxonomy Extension Schema
 
 
 
101.CAL
 
XBRL Taxonomy Extension Calculation Linkbase
 
 
 
101.LAB
 
XBRL Taxonomy Extension Labels Linkbase
 
 
 
101.PRE
 
XBRL Taxonomy Extension Presentation Linkbase
 
 
 
101.DEF
 
XBRL Taxonomy Extension Definition Linkbase


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Table of Contents

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.
 
 
 
August 8, 2019
By:
/s/ Thomas Adams
 
 
Thomas Adams
 
 
Chief Executive Officer
 
 
 
 
TROVAGENE, INC.
 
 
 
August 8, 2019
By:
/s/ Brigitte Lindsay
 
 
Brigitte Lindsay
 
 
VP, Finance


30


Exhibit 31.1
 
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
 
I, Thomas Adams, 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 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 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; and

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.
 
August 8, 2019
/s/ Thomas Adams
 
Thomas Adams
 
Chief Executive Officer





Exhibit 31.2
 
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
 
I, Brigitte Lindsay, 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 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 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; and

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.
 
August 8, 2019
/s/ Brigitte Lindsay
 
Brigitte Lindsay
 
VP, Finance





Exhibit 32.1
 
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
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 June 30, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Thomas Adams, 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.
 
August 8, 2019
/s/ Thomas Adams
 
Thomas Adams
 
Chief Executive Officer





Exhibit 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
 
In connection with the Quarterly Report of Trovagene, Inc. (the “Company”) on Form 10-Q for the three months ended June 30, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Brigitte Lindsay, VP, Finance 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.
 
August 8, 2019
/s/ Brigitte Lindsay
 
Brigitte Lindsay
 
VP, Finance