|
x
|
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
|
27-2004382
|
(State or other jurisdiction of 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
|
Large accelerated filer o
|
|
Accelerated filer o
|
|
Non-accelerated filer x
|
|
Smaller reporting company x
|
|
Emerging growth company o
|
|
|
|
Page
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2019
|
|
December 31, 2018
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
9,032,206
|
|
|
$
|
11,453,133
|
|
Accounts receivable and unbilled receivable
|
152,038
|
|
|
167,755
|
|
||
Prepaid expenses
|
792,540
|
|
|
1,144,377
|
|
||
Total current assets
|
9,976,784
|
|
|
12,765,265
|
|
||
Property and equipment, net
|
271,401
|
|
|
1,304,433
|
|
||
Operating lease right-of-use assets
|
1,503,335
|
|
|
—
|
|
||
Other assets
|
170,943
|
|
|
102,798
|
|
||
Total Assets
|
$
|
11,922,463
|
|
|
$
|
14,172,496
|
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
492,367
|
|
|
$
|
664,840
|
|
Accrued expenses
|
2,842,153
|
|
|
1,813,842
|
|
||
Operating lease liabilities
|
836,294
|
|
|
—
|
|
||
Deferred rent, current portion
|
—
|
|
|
486,636
|
|
||
Total current liabilities
|
4,170,814
|
|
|
2,965,318
|
|
||
Derivative financial instruments—warrants
|
4,956
|
|
|
32,315
|
|
||
Operating lease liabilities, net of current portion
|
1,090,713
|
|
|
—
|
|
||
Deferred rent, net of current portion
|
—
|
|
|
1,090,671
|
|
||
Total Liabilities
|
5,266,483
|
|
|
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 September 30, 2019 and December 31, 2018 with liquidation preference of $606,000 at September 30, 2019 and December 31, 2018; 200,000 designated as Series C Convertible Preferred Stock; 0 shares outstanding at September 30, 2019 and December 31, 2018
|
60
|
|
|
60
|
|
||
Common stock, $0.0001 par value, 150,000,000 shares authorized; 6,436,505 and 3,831,880 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively
|
8,096
|
|
|
7,742
|
|
||
Additional paid-in capital
|
212,463,077
|
|
|
202,267,605
|
|
||
Service receivables
|
(1,165,966
|
)
|
|
—
|
|
||
Accumulated deficit
|
(204,649,287
|
)
|
|
(192,191,215
|
)
|
||
Total stockholders’ equity
|
6,655,980
|
|
|
10,084,192
|
|
||
Total liabilities and stockholders’ equity
|
$
|
11,922,463
|
|
|
$
|
14,172,496
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Royalties
|
$
|
51,687
|
|
|
$
|
72,568
|
|
|
$
|
150,560
|
|
|
$
|
174,046
|
|
Services and other
|
—
|
|
|
15,793
|
|
|
1,495
|
|
|
126,264
|
|
||||
Total revenues
|
51,687
|
|
|
88,361
|
|
|
152,055
|
|
|
300,310
|
|
||||
Costs and expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of revenues
|
—
|
|
|
26,677
|
|
|
—
|
|
|
597,457
|
|
||||
Research and development
|
2,818,824
|
|
|
1,830,441
|
|
|
8,297,763
|
|
|
5,667,046
|
|
||||
Selling, general and administrative
|
1,440,339
|
|
|
1,665,200
|
|
|
4,243,490
|
|
|
6,321,048
|
|
||||
Restructuring charges
|
—
|
|
|
421,351
|
|
|
—
|
|
|
664,686
|
|
||||
Total operating expenses
|
4,259,163
|
|
|
3,943,669
|
|
|
12,541,253
|
|
|
13,250,237
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Loss from operations
|
(4,207,476
|
)
|
|
(3,855,308
|
)
|
|
(12,389,198
|
)
|
|
(12,949,927
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Interest income
|
53,700
|
|
|
85,938
|
|
|
188,204
|
|
|
143,911
|
|
||||
Interest expense
|
—
|
|
|
(16
|
)
|
|
—
|
|
|
(25,177
|
)
|
||||
Gain (loss) from change in fair value of derivative financial instruments—warrants
|
13,330
|
|
|
(2,500
|
)
|
|
27,359
|
|
|
579,040
|
|
||||
Gain on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
17,974
|
|
||||
Other income (expense), net
|
(1,103
|
)
|
|
2,318
|
|
|
2,012
|
|
|
(68,521
|
)
|
||||
Net loss
|
(4,141,549
|
)
|
|
(3,769,568
|
)
|
|
(12,171,623
|
)
|
|
(12,302,700
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Preferred stock dividend payable on Series A Convertible Preferred Stock
|
(6,060
|
)
|
|
(6,060
|
)
|
|
(18,180
|
)
|
|
(18,180
|
)
|
||||
Deemed dividend recognized on beneficial conversion features of Series B Convertible Preferred Stock issuance
|
—
|
|
|
—
|
|
|
—
|
|
|
(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
|
$
|
(4,147,609
|
)
|
|
$
|
(3,775,628
|
)
|
|
$
|
(12,458,072
|
)
|
|
$
|
(15,090,413
|
)
|
|
|
|
|
|
|
|
|
||||||||
Net loss per common share — basic
|
$
|
(0.71
|
)
|
|
$
|
(1.10
|
)
|
|
$
|
(2.46
|
)
|
|
$
|
(8.27
|
)
|
Net loss per common share — diluted
|
$
|
(0.71
|
)
|
|
$
|
(1.10
|
)
|
|
$
|
(2.46
|
)
|
|
$
|
(8.27
|
)
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares outstanding — basic
|
5,822,818
|
|
|
3,437,100
|
|
|
5,056,794
|
|
|
1,824,208
|
|
||||
Weighted-average shares outstanding — diluted
|
5,822,818
|
|
|
3,437,100
|
|
|
5,056,794
|
|
|
1,824,208
|
|
|
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
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
266,325
|
|
|
—
|
|
|
—
|
|
|
266,325
|
|
||||||
Sale of common stock and warrants, net of expenses
|
—
|
|
|
—
|
|
|
271,744
|
|
|
27
|
|
|
1,483,554
|
|
|
—
|
|
|
—
|
|
|
1,483,581
|
|
|
Preferred Stock
Shares |
|
Preferred Stock
Amount |
|
Common Stock
Shares |
|
Common Stock
Amount |
|
Additional
Paid-In Capital |
|
Service Receivable
|
|
Accumulated Deficit
|
|
Total
Stockholders’ Equity |
||||||||||||||
Issuance of common stock upon exercise of warrants
|
—
|
|
|
—
|
|
|
717,969
|
|
|
72
|
|
|
7,108
|
|
|
—
|
|
|
—
|
|
|
7,180
|
|
||||||
Issuance of common stock upon vesting of restricted stock units
|
—
|
|
|
—
|
|
|
5,402
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Preferred stock dividend payable on Series A Convertible Preferred Stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,060
|
)
|
|
(6,060
|
)
|
||||||
Release of clinical trial funding commitment
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
198,268
|
|
|
—
|
|
|
198,268
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,141,549
|
)
|
|
(4,141,549
|
)
|
||||||
Balance, September 30, 2019
|
60,600
|
|
|
$
|
60
|
|
|
6,436,505
|
|
|
$
|
8,096
|
|
|
$
|
212,463,077
|
|
|
$
|
(1,165,966
|
)
|
|
$
|
(204,649,287
|
)
|
|
$
|
6,655,980
|
|
|
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
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
278,221
|
|
|
—
|
|
|
278,221
|
|
|||||
Preferred stock dividend
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,060
|
)
|
|
(6,060
|
)
|
|||||
Issuance of common stock upon conversion of Series B Convertible Preferred Stock
|
(5,650
|
)
|
|
(6
|
)
|
|
941,667
|
|
|
565
|
|
|
(559
|
)
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock upon vesting of restricted stock units
|
—
|
|
|
—
|
|
|
362
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock for share rounding as a result of reverse stock split
|
—
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,769,568
|
)
|
|
(3,769,568
|
)
|
|||||
Balance, September 30, 2018
|
60,600
|
|
|
$
|
60
|
|
|
3,826,199
|
|
|
$
|
7,738
|
|
|
$
|
201,998,634
|
|
|
$
|
(188,026,677
|
)
|
|
$
|
13,979,755
|
|
|
Nine Months Ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(12,171,623
|
)
|
|
$
|
(12,302,700
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Loss on disposal of assets
|
—
|
|
|
197,490
|
|
||
Impairment loss
|
—
|
|
|
187,500
|
|
||
Depreciation and amortization
|
130,219
|
|
|
701,774
|
|
||
Stock-based compensation expense
|
615,226
|
|
|
1,905,652
|
|
||
Gain on extinguishment of debt
|
—
|
|
|
(17,974
|
)
|
||
Deferred rent
|
—
|
|
|
(266,556
|
)
|
||
Change in fair value of derivative financial instruments—warrants
|
(27,359
|
)
|
|
(579,040
|
)
|
||
Release of clinical trial funding commitment
|
509,034
|
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Other assets
|
(68,145
|
)
|
|
(170,602
|
)
|
||
Accounts receivable and unbilled receivable
|
15,717
|
|
|
58,440
|
|
||
Prepaid expenses
|
277,876
|
|
|
316,746
|
|
||
Operating lease right-of-use assets
|
467,009
|
|
|
—
|
|
||
Accounts payable and accrued expenses
|
837,551
|
|
|
383,037
|
|
||
Operating lease liabilities
|
(576,141
|
)
|
|
—
|
|
||
Net cash used in operating activities
|
(9,990,636
|
)
|
|
(9,586,233
|
)
|
||
|
|
|
|
||||
Investing activities:
|
|
|
|
||||
Proceeds from disposals of capital equipment
|
—
|
|
|
27,942
|
|
||
Capital expenditures
|
(67,622
|
)
|
|
(5,100
|
)
|
||
Purchases of short-term investments
|
—
|
|
|
(31,500
|
)
|
||
Sales of short-term investments
|
—
|
|
|
31,500
|
|
||
Net cash used in investing activities
|
(67,622
|
)
|
|
22,842
|
|
||
|
|
|
|
||||
Financing activities:
|
|
|
|
||||
Proceeds from sales of common stock and warrants, net of expenses of $113,678 and $1,336,123, respectively
|
4,386,321
|
|
|
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
|
3,291,010
|
|
|
1,612,667
|
|
||
Payment upon debt extinguishment
|
—
|
|
|
(175,381
|
)
|
||
Repayments of equipment line of credit
|
—
|
|
|
(1,200,033
|
)
|
||
Net cash provided by financing activities
|
7,637,331
|
|
|
16,403,540
|
|
||
Net change in cash and cash equivalents
|
(2,420,927
|
)
|
|
6,840,149
|
|
||
Cash and cash equivalents—Beginning of period
|
11,453,133
|
|
|
8,225,764
|
|
||
Cash and cash equivalents—End of period
|
$
|
9,032,206
|
|
|
$
|
15,065,913
|
|
|
|
|
|
||||
Supplementary disclosure of cash flow activity:
|
|
|
|
||||
Cash paid for taxes
|
$
|
800
|
|
|
$
|
800
|
|
Cash paid for interest
|
$
|
—
|
|
|
$
|
22,482
|
|
|
Nine Months Ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
||||
Preferred stock dividend payable on Series A Convertible Preferred Stock
|
$
|
18,180
|
|
|
$
|
18,180
|
|
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
|
$
|
—
|
|
|
$
|
886
|
|
Common stock issued upon conversion of Series C Convertible Preferred Stock
|
$
|
33
|
|
|
$
|
—
|
|
•
|
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.
|
•
|
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.
|
|
Three Months
Ended September 30, |
|
Nine Months
Ended September 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Numerator: Net loss attributable to common shareholders
|
$
|
(4,147,609
|
)
|
|
$
|
(3,775,628
|
)
|
|
$
|
(12,458,072
|
)
|
|
$
|
(15,090,413
|
)
|
Net loss used for diluted loss per share
|
$
|
(4,147,609
|
)
|
|
$
|
(3,775,628
|
)
|
|
$
|
(12,458,072
|
)
|
|
$
|
(15,090,413
|
)
|
Denominator for basic and diluted net loss per share:
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares used to compute basic loss per share
|
5,822,818
|
|
|
3,437,100
|
|
|
5,056,794
|
|
|
1,824,208
|
|
||||
Weighted-average shares used to compute diluted net loss per share
|
5,822,818
|
|
|
3,437,100
|
|
|
5,056,794
|
|
|
1,824,208
|
|
||||
Net loss per share attributable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.71
|
)
|
|
$
|
(1.10
|
)
|
|
$
|
(2.46
|
)
|
|
$
|
(8.27
|
)
|
Diluted
|
$
|
(0.71
|
)
|
|
$
|
(1.10
|
)
|
|
$
|
(2.46
|
)
|
|
$
|
(8.27
|
)
|
|
September 30,
|
||||
|
2019
|
|
2018
|
||
Options to purchase Common Stock
|
1,016,426
|
|
|
83,375
|
|
Warrants to purchase Common Stock
|
4,870,076
|
|
|
3,698,256
|
|
Restricted Stock Units
|
14,161
|
|
|
35,812
|
|
Series A Convertible Preferred Stock
|
877
|
|
|
877
|
|
|
5,901,540
|
|
|
3,818,320
|
|
|
Fair Value Measurements at
September 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)
|
$
|
8,965,312
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8,965,312
|
|
Total Assets
|
$
|
8,965,312
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8,965,312
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Derivative financial instruments—warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,956
|
|
|
$
|
4,956
|
|
Total Liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,956
|
|
|
$
|
4,956
|
|
|
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
|
|
|
Description
|
|
Balance at
December 31, 2018 |
|
Realized (gains) or losses
|
|
Balance at
September 30, 2019 |
||||||
Derivative financial instruments—warrants
|
|
$
|
32,315
|
|
|
$
|
(27,359
|
)
|
|
$
|
4,956
|
|
|
As of September 30,
2019 |
|
As of December 31,
2018 |
||||
Furniture and office equipment
|
$
|
775,030
|
|
|
$
|
775,030
|
|
Leasehold improvements
|
102,230
|
|
|
1,962,230
|
|
||
Laboratory equipment
|
744,856
|
|
|
677,234
|
|
||
|
1,622,116
|
|
|
3,414,494
|
|
||
Less—accumulated depreciation and amortization
|
(1,350,715
|
)
|
|
(2,110,061
|
)
|
||
Property and equipment, net
|
$
|
271,401
|
|
|
$
|
1,304,433
|
|
|
|
Three months ended September 30, 2019
|
|
Nine Months Ended September 30, 2019
|
||||
Operating lease cost
|
|
$
|
191,472
|
|
|
$
|
578,919
|
|
Operating sublease income
|
|
(99,937
|
)
|
|
(299,812
|
)
|
||
Net operating lease cost
|
|
$
|
91,535
|
|
|
$
|
279,107
|
|
|
|
September 30, 2019
|
||
Operating lease ROU assets
|
|
$
|
1,503,335
|
|
|
|
|
||
Current operating lease liabilities
|
|
$
|
836,294
|
|
Non-current operating lease liabilities
|
|
1,090,713
|
|
|
Total operating lease liabilities
|
|
$
|
1,927,007
|
|
|
|
|
||
Weighted-average remaining lease term–operating leases
|
|
2.3 years
|
|
|
Weighted-average discount rate–operating leases
|
|
6.5
|
%
|
|
|
Three months ended September 30, 2019
|
|
Nine Months Ended September 30, 2019
|
||||
Cash paid for amounts included in the measurement of lease liabilities:
|
|
|
|
|
||||
Operating cash flows from operating leases
|
|
$
|
229,927
|
|
|
$
|
685,865
|
|
|
|
|
|
|
||||
ROU assets obtained in exchange for lease obligations:
|
|
|
|
|
||||
Operating leases
|
|
$
|
—
|
|
|
$
|
2,503,148
|
|
Year Ending December 31,
|
|
Operating Leases
|
|
Sublease Income
|
|
Net Operating Leases
|
||||||
2019 (excluding the nine months ended September 30, 2019)
|
|
$
|
154,606
|
|
|
$
|
(81,841
|
)
|
|
$
|
72,765
|
|
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
|
|
2,073,732
|
|
|
$
|
(664,187
|
)
|
|
$
|
1,409,545
|
|
|
Less imputed interest
|
|
(146,725
|
)
|
|
|
|
|
|||||
Total
|
|
$
|
1,927,007
|
|
|
|
|
|
|
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
|
|
|
Nine Months Ended September 30,
|
||||
|
2019
|
|
2018
|
||
Estimated fair value of Trovagene common stock
|
1.51-3.75
|
|
|
4.62-25.20
|
|
Expected warrant term
|
3.3-4.1 years
|
|
|
0.3-5.1 years
|
|
Risk-free interest rate
|
1.56-2.49%
|
|
|
1.76-2.92%
|
|
Expected volatility
|
102-106%
|
|
|
47-131%
|
|
Dividend yield
|
0
|
%
|
|
0
|
%
|
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
|
|
—
|
|
|
(27,359
|
)
|
|
September 30, 2019
|
|
Balance of derivative financial instruments—warrants liability
|
|
64,496
|
|
|
$
|
4,956
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Included in cost of revenue
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
30,488
|
|
Included in research and development expense
|
104,152
|
|
|
130,300
|
|
|
300,291
|
|
|
637,821
|
|
||||
Included in selling, general and administrative expense
|
162,172
|
|
|
147,921
|
|
|
314,935
|
|
|
1,237,343
|
|
||||
Total stock-based compensation expense
|
$
|
266,324
|
|
|
$
|
278,221
|
|
|
$
|
615,226
|
|
|
$
|
1,905,652
|
|
|
Total Options
|
|
Weighted-Average
Exercise Price
Per Share
|
|
Intrinsic
Value
|
|||||
Balance outstanding, December 31, 2018
|
83,345
|
|
|
$
|
146.09
|
|
|
$
|
—
|
|
Granted
|
971,313
|
|
|
$
|
2.49
|
|
|
|
|
|
Canceled / Forfeited
|
(36,148
|
)
|
|
$
|
26.55
|
|
|
|
|
|
Expired
|
(2,084
|
)
|
|
$
|
216.00
|
|
|
|
|
|
Balance outstanding, September 30, 2019
|
1,016,426
|
|
|
$
|
12.98
|
|
|
$
|
—
|
|
Exercisable at September 30, 2019
|
72,224
|
|
|
$
|
147.79
|
|
|
$
|
—
|
|
|
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
|
6,167
|
|
|
$
|
1.71
|
|
|
|
||
Vested
|
(16,197
|
)
|
|
$
|
10.47
|
|
|
$
|
53,947
|
|
Forfeited
|
(5,941
|
)
|
|
$
|
13.82
|
|
|
|
||
Non-vested RSUs outstanding, September 30, 2019
|
14,161
|
|
|
$
|
13.52
|
|
|
$
|
21,383
|
|
|
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
|
2,592,370
|
|
|
$
|
2.81
|
|
|
|
Exercised
|
(1,371,635
|
)
|
|
$
|
4.15
|
|
|
|
Balance outstanding, September 30, 2019
|
4,870,076
|
|
|
$
|
7.00
|
|
|
4.2
|
•
|
Completed enrollment and evaluation of the 6 safety lead-in patients in the second arm (2-week dosing schedule) with onvansertib at 24 mg/m2 in combination with abiraterone acetate (Zytiga®) and prednisone.
|
•
|
Provide safety and preliminary efficacy data of onvansertib in combination with abiraterone acetate (Zytiga®) and prednisone in patients treated through the end of 2019.
|
•
|
Present data from the mCRPC trial at key oncology conferences throughout 2019, including the Asia-Pacific Prostate Cancer Conference ("APPC"), and first quarter of 2020 including ASCO-GU.
|
•
|
Completed enrollment and evaluation of the initial dose level cohort of onvansertib 12 mg/m2 and opened the second dose level (onvansertib 15 mg/m2) cohort to enrollment.
|
•
|
Provide safety and preliminary efficacy data on the combination of onvansertib + FOLFIRI + Avastin® in patients treated through the end of 2019.
|
•
|
Completed Phase 1b dose escalation safety segment of trial, identified the recommended Phase 2 dose (“RP2D”) of onvansertib at 60mg/m2.
|
•
|
Initiated 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 decitabine.
|
•
|
Provide safety and preliminary efficacy data on the combination of onvansertib in combination with decitabine in patients treated through the end of 2019.
|
•
|
Present data from the AML trial at key oncology conferences, including the European Society for Medical Oncology ("ESMO") and the American Society of Hematology (“ASH”) annual meetings.
|
•
|
Announced positive response to treatment in Phase 1b/2 trial of onvansertib in patients with KRAS-mutated metastatic colorectal cancer.
|
•
|
Announced data presented at ESMO providing rationale for a clinical trial of onvansertib in subset of patients with Highly-Aggressive Triple Negative Breast Cancer (TNBC).
|
•
|
Announced presentation of a poster at ESMO of Phase 1b/2 trial of onvansertib in patients with KRAS-mutated mCRC.
|
•
|
Announced Oral Presentation of Positive Data from Trovagene Phase 1b/2 Study of Onvansertib at ESMO Conference.
|
•
|
Announced Successful Completion of the AML Phase 1b Trial and Initiation of the Phase 2 Continuation Trial.
|
•
|
Announced the Presentation of Positive Clinical Data from Ongoing Phase 2 Study of Onvansertib in mCRPC at the Asia-Pacific Prostate Cancer Conference.
|
•
|
Announced research collaboration with Nektar Therapeutics to evaluate the efficacy of the combination of onvansertib and ONZEALDTM in models of colorectal cancer.
|
•
|
Announced Data Demonstrating Significant Synergy of Onvansertib in Combination with Venetoclax in Cell Model of Venetoclax-Resistant AML.
|
•
|
Announced New Patent Issued for Combination of Onvansertib with Anti-Androgen Drugs to Treat Non-Metastatic and Metastatic Prostate Cancer.
|
|
Three Months Ended September 30,
|
||||||||||
|
2019
|
|
2018
|
|
Increase (Decrease)
|
||||||
Royalties
|
$
|
51,687
|
|
|
$
|
72,568
|
|
|
$
|
(20,881
|
)
|
Services and other
|
—
|
|
|
15,793
|
|
|
(15,793
|
)
|
|||
Total revenues
|
$
|
51,687
|
|
|
$
|
88,361
|
|
|
$
|
(36,674
|
)
|
|
Three Months Ended September 30,
|
||||||||||
|
2019
|
|
2018
|
|
Increase (Decrease)
|
||||||
Salaries and staff costs
|
$
|
399,962
|
|
|
$
|
354,643
|
|
|
$
|
45,319
|
|
Stock-based compensation
|
104,153
|
|
|
130,300
|
|
|
(26,147
|
)
|
|||
Clinical trials, outside services, and lab supplies
|
2,052,224
|
|
|
1,023,201
|
|
|
1,029,023
|
|
|||
Facilities and other
|
262,485
|
|
|
322,297
|
|
|
(59,812
|
)
|
|||
Total research and development
|
$
|
2,818,824
|
|
|
$
|
1,830,441
|
|
|
$
|
988,383
|
|
|
Three Months Ended September 30,
|
||||||||||
|
2019
|
|
2018
|
|
Increase (Decrease)
|
||||||
Salaries and staff costs
|
$
|
468,821
|
|
|
$
|
535,582
|
|
|
$
|
(66,761
|
)
|
Stock-based compensation
|
162,172
|
|
|
147,921
|
|
|
14,251
|
|
|||
Outside services and professional fees
|
507,074
|
|
|
494,208
|
|
|
12,866
|
|
|||
Facilities and other
|
302,272
|
|
|
487,489
|
|
|
(185,217
|
)
|
|||
Total selling, general and administrative
|
$
|
1,440,339
|
|
|
$
|
1,665,200
|
|
|
$
|
(224,861
|
)
|
|
Three Months Ended September 30,
|
||||||||||
|
2019
|
|
2018
|
|
Increase (Decrease)
|
||||||
Net loss attributable to common shareholders
|
$
|
(4,147,609
|
)
|
|
$
|
(3,775,628
|
)
|
|
$
|
371,981
|
|
Net loss per common share — basic
|
$
|
(0.71
|
)
|
|
$
|
(1.10
|
)
|
|
$
|
(0.39
|
)
|
Net loss per common share — diluted
|
$
|
(0.71
|
)
|
|
$
|
(1.10
|
)
|
|
$
|
(0.39
|
)
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding — basic
|
5,822,818
|
|
|
3,437,100
|
|
|
2,385,718
|
|
|||
Weighted average shares outstanding — diluted
|
5,822,818
|
|
|
3,437,100
|
|
|
2,385,718
|
|
|
Nine Months Ended September 30,
|
||||||||||
|
2019
|
|
2018
|
|
Increase (Decrease)
|
||||||
Royalties
|
$
|
150,560
|
|
|
$
|
174,046
|
|
|
$
|
(23,486
|
)
|
Services and other
|
1,495
|
|
|
126,264
|
|
|
(124,769
|
)
|
|||
Total revenues
|
$
|
152,055
|
|
|
$
|
300,310
|
|
|
$
|
(148,255
|
)
|
|
Nine Months Ended September 30,
|
||||||||||
|
2019
|
|
2018
|
|
Increase (Decrease)
|
||||||
Salaries and staff costs
|
$
|
1,183,901
|
|
|
$
|
1,270,042
|
|
|
$
|
(86,141
|
)
|
Stock-based compensation
|
300,291
|
|
|
637,821
|
|
|
(337,530
|
)
|
|||
Clinical trials, outside services, and lab supplies
|
6,115,127
|
|
|
2,988,198
|
|
|
3,126,929
|
|
|||
Facilities and other
|
698,444
|
|
|
770,985
|
|
|
(72,541
|
)
|
|||
Total research and development
|
$
|
8,297,763
|
|
|
$
|
5,667,046
|
|
|
$
|
2,630,717
|
|
|
Nine Months Ended September 30,
|
||||||||||
|
2019
|
|
2018
|
|
Increase (Decrease)
|
||||||
Salaries and staff costs
|
$
|
1,449,979
|
|
|
$
|
2,335,228
|
|
|
$
|
(885,249
|
)
|
Stock-based compensation
|
314,935
|
|
|
1,237,343
|
|
|
(922,408
|
)
|
|||
Outside services and professional fees
|
1,541,120
|
|
|
1,499,810
|
|
|
41,310
|
|
|||
Facilities and other
|
937,456
|
|
|
1,248,667
|
|
|
(311,211
|
)
|
|||
Total selling, general and administrative
|
$
|
4,243,490
|
|
|
$
|
6,321,048
|
|
|
$
|
(2,077,558
|
)
|
|
Nine Months Ended September 30,
|
||||||||||
|
2019
|
|
2018
|
|
Increase (Decrease)
|
||||||
Net loss attributable to common shareholders
|
$
|
(12,458,072
|
)
|
|
$
|
(15,090,413
|
)
|
|
$
|
(2,632,341
|
)
|
Net loss per common share — basic
|
$
|
(2.46
|
)
|
|
$
|
(8.27
|
)
|
|
$
|
(5.81
|
)
|
Net loss per common share — diluted
|
$
|
(2.46
|
)
|
|
$
|
(8.27
|
)
|
|
$
|
(5.81
|
)
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding — basic
|
5,056,794
|
|
|
1,824,208
|
|
|
3,232,586
|
|
|||
Weighted average shares outstanding — diluted
|
5,056,794
|
|
|
1,824,208
|
|
|
3,232,586
|
|
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
|
|
TROVAGENE, INC.
|
|
|
|
|
November 7, 2019
|
By:
|
/s/ Thomas Adams
|
|
|
Thomas Adams
|
|
|
Chief Executive Officer
|
|
|
|
|
TROVAGENE, INC.
|
|
|
|
|
November 7, 2019
|
By:
|
/s/ Brigitte Lindsay
|
|
|
Brigitte Lindsay
|
|
|
VP, Finance
|
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.
|
November 7, 2019
|
/s/ Thomas Adams
|
|
Thomas Adams
|
|
Chief Executive Officer
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Trovagene, Inc. (the “Registrant”);
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this 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.
|
November 7, 2019
|
/s/ Brigitte Lindsay
|
|
Brigitte Lindsay
|
|
VP, Finance
|
November 7, 2019
|
/s/ Thomas Adams
|
|
Thomas Adams
|
|
Chief Executive Officer
|
November 7, 2019
|
/s/ Brigitte Lindsay
|
|
Brigitte Lindsay
|
|
VP, Finance
|