Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
|
|
26-1469215
(I.R.S. Employer
Identification No.)
|
955 Chesterbrook Boulevard, Suite 200
Chesterbrook, PA
(Address of Principal Executive Offices)
|
|
19087
(Zip Code)
|
|
Page
|
|
|
|
|
|
|
|
|
||
|
||
|
||
|
||
|
||
|
|
|
|
|
|
•
|
our plans to develop and potentially commercialize our product candidates;
|
•
|
our ability to fund future operating expenses and capital expenditures with our current cash resources;
|
•
|
our planned clinical trials and preclinical studies for our product candidates;
|
•
|
the timing and likelihood of obtaining and maintaining regulatory approvals for our product candidates;
|
•
|
the extent of clinical trials potentially required by the FDA for our product candidates;
|
•
|
the clinical utility and market acceptance of our product candidates, particularly in light of existing and future competition;
|
•
|
our commercialization, marketing and manufacturing capabilities and strategy;
|
•
|
our intellectual property position; and
|
•
|
our ability to identify additional product candidates with significant commercial potential that are consistent with our commercial objectives.
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
|
(unaudited)
|
|
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
14,037
|
|
|
$
|
24,266
|
|
Marketable securities
|
70,163
|
|
|
86,335
|
|
||
Prepaid expenses and other current assets
|
3,462
|
|
|
1,788
|
|
||
Total current assets
|
87,662
|
|
|
112,389
|
|
||
Property and equipment, net
|
2,921
|
|
|
1,059
|
|
||
Restricted cash
|
1,413
|
|
|
1,193
|
|
||
Intangible asset, net
|
12
|
|
|
13
|
|
||
Total assets
|
$
|
92,008
|
|
|
$
|
114,654
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
2,290
|
|
|
$
|
8,749
|
|
Accrued expenses and other current liabilities
|
2,822
|
|
|
8,208
|
|
||
Current portion of loans payable, net
|
7,093
|
|
|
5,039
|
|
||
Deferred rent
|
56
|
|
|
52
|
|
||
Total current liabilities
|
12,261
|
|
|
22,048
|
|
||
Loans payable, net
|
20,895
|
|
|
13,270
|
|
||
Capital leases, net of current portion
|
15
|
|
|
18
|
|
||
Deferred rent, net of current portion
|
2,465
|
|
|
187
|
|
||
Warrant liability
|
19
|
|
|
75
|
|
||
Other long term liabilities
|
747
|
|
|
475
|
|
||
Total liabilities
|
36,402
|
|
|
36,073
|
|
||
Commitments and contingencies (Note 6)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Common stock—$0.001 par value; 100,000,000 shares authorized, 59,456,364 and 55,768,414 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively
|
59
|
|
|
56
|
|
||
Preferred stock—$0.001 par value; 5,000,000 shares authorized, none issued or outstanding at June 30, 2017 and December 31, 2016
|
—
|
|
|
—
|
|
||
Additional paid-in capital
|
382,375
|
|
|
364,148
|
|
||
Accumulated deficit
|
(326,771
|
)
|
|
(285,625
|
)
|
||
Accumulated other comprehensive income (loss)
|
(57
|
)
|
|
2
|
|
||
Total stockholders’ equity
|
55,606
|
|
|
78,581
|
|
||
Total liabilities and stockholders’ equity
|
$
|
92,008
|
|
|
$
|
114,654
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Collaboration revenue
|
—
|
|
|
$
|
1,875
|
|
|
$
|
—
|
|
|
$
|
3,750
|
|
|
Total revenue
|
—
|
|
|
1,875
|
|
|
—
|
|
|
3,750
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
General and administrative
|
4,385
|
|
|
3,697
|
|
|
9,264
|
|
|
7,615
|
|
||||
Research and development
|
15,499
|
|
|
17,203
|
|
|
31,595
|
|
|
32,956
|
|
||||
Total operating expenses
|
19,884
|
|
|
20,900
|
|
|
40,859
|
|
|
40,571
|
|
||||
Loss from operations
|
(19,884
|
)
|
|
(19,025
|
)
|
|
(40,859
|
)
|
|
(36,821
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Change in fair value of warrant liability
|
19
|
|
|
28
|
|
|
56
|
|
|
70
|
|
||||
Net (loss) gain on asset disposals
|
1
|
|
|
—
|
|
|
1
|
|
|
—
|
|
||||
Miscellaneous income
|
—
|
|
|
—
|
|
|
628
|
|
|
222
|
|
||||
Interest income
|
163
|
|
|
214
|
|
|
337
|
|
|
407
|
|
||||
Interest expense
|
(731
|
)
|
|
(433
|
)
|
|
(1,309
|
)
|
|
(873
|
)
|
||||
Total other expense
|
(548
|
)
|
|
(191
|
)
|
|
(287
|
)
|
|
(174
|
)
|
||||
Net loss attributable to common stockholders
|
$
|
(20,432
|
)
|
|
$
|
(19,216
|
)
|
|
$
|
(41,146
|
)
|
|
$
|
(36,995
|
)
|
|
|
|
|
|
|
|
|
||||||||
Other comprehensive (loss) income, net:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on marketable securities
|
(8
|
)
|
|
45
|
|
|
(59
|
)
|
|
281
|
|
||||
Other comprehensive (loss) income
|
(8
|
)
|
|
45
|
|
|
(59
|
)
|
|
281
|
|
||||
Comprehensive loss
|
$
|
(20,440
|
)
|
|
$
|
(19,171
|
)
|
|
$
|
(41,205
|
)
|
|
$
|
(36,714
|
)
|
|
|
|
|
|
|
|
|
||||||||
Per share information:
|
|
|
|
|
|
|
|
||||||||
Net loss per share of common stock, basic and diluted
|
$
|
(0.35
|
)
|
|
$
|
(0.37
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(0.71
|
)
|
Weighted average common shares outstanding, basic and diluted
|
58,381,868
|
|
|
52,174,569
|
|
|
57,642,379
|
|
|
51,762,467
|
|
|
Stockholders' Equity
|
|||||||||||||||||||||
|
Common Stock
|
|
|
|
|
|
|
|
|
|||||||||||||
|
|
|
$0.001 Par Value
|
|
Additional Paid-in Capital
|
|
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Total Stockholders' Equity
|
|||||||||||
|
Number of Shares
|
|
|
|
Accumulated Deficit
|
|
|
|||||||||||||||
|
|
|
|
|
|
|||||||||||||||||
Balance, January 1, 2017
|
55,768,414
|
|
|
$
|
56
|
|
|
$
|
364,148
|
|
|
$
|
(285,625
|
)
|
|
$
|
2
|
|
|
$
|
78,581
|
|
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
3,687
|
|
|
—
|
|
|
—
|
|
|
3,687
|
|
|||||
Exercise of stock options
|
283,995
|
|
|
—
|
|
|
355
|
|
|
—
|
|
|
—
|
|
|
355
|
|
|||||
Net issuance of common stock warrant
|
—
|
|
|
—
|
|
|
501
|
|
|
—
|
|
|
—
|
|
|
501
|
|
|||||
Issuance of common stock, net of issuance costs
|
3,403,955
|
|
|
3
|
|
|
13,684
|
|
|
—
|
|
|
—
|
|
|
13,687
|
|
|||||
Unrealized loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(59
|
)
|
|
(59
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(41,146
|
)
|
|
—
|
|
|
(41,146
|
)
|
|||||
Balance, June 30, 2017
|
59,456,364
|
|
|
$
|
59
|
|
|
$
|
382,375
|
|
|
$
|
(326,771
|
)
|
|
$
|
(57
|
)
|
|
$
|
55,606
|
|
|
Six Months Ended
June 30, |
||||||
|
2017
|
|
2016
|
||||
Operating activities:
|
|
|
|
||||
Net loss
|
$
|
(41,146
|
)
|
|
$
|
(36,995
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
158
|
|
|
119
|
|
||
Stock-based compensation
|
3,687
|
|
|
2,713
|
|
||
Noncash interest expense on loans
|
530
|
|
|
271
|
|
||
Revaluation of warrant liability
|
(56
|
)
|
|
(70
|
)
|
||
Amortization of bond premiums on marketable securities
|
316
|
|
|
804
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid expenses and other assets
|
(1,674
|
)
|
|
(1,238
|
)
|
||
Accounts payable, accrued expenses and other liabilities
|
(9,563
|
)
|
|
(1,090
|
)
|
||
Deferred revenue
|
—
|
|
|
(3,750
|
)
|
||
Net cash used in operating activities
|
(47,748
|
)
|
|
(39,236
|
)
|
||
Investing activities:
|
|
|
|
||||
Purchases of property and equipment
|
(2,019
|
)
|
|
(220
|
)
|
||
Maturities of marketable securities
|
48,443
|
|
|
55,014
|
|
||
Purchases of marketable securities
|
(32,646
|
)
|
|
(37,380
|
)
|
||
Net cash provided by investing activities
|
13,778
|
|
|
17,414
|
|
||
Financing activities:
|
|
|
|
||||
Proceeds from exercise of common stock options
|
355
|
|
|
61
|
|
||
Proceeds from issuance of common stock, net
|
13,687
|
|
|
11,792
|
|
||
Capital lease payments
|
(3
|
)
|
|
(2
|
)
|
||
Proceeds from loans payable, net
|
9,921
|
|
|
—
|
|
||
Net cash provided by financing activities
|
23,960
|
|
|
11,851
|
|
||
Net decrease in cash and cash equivalents
|
(10,010
|
)
|
|
(9,971
|
)
|
||
Cash, cash equivalents and restricted cash—beginning of period
|
25,459
|
|
|
46,886
|
|
||
Cash, cash equivalents and restricted cash—end of period
|
$
|
15,449
|
|
|
$
|
36,915
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Cash paid for interest
|
$
|
778
|
|
|
$
|
602
|
|
Capital lease additions
|
$
|
—
|
|
|
9
|
|
|
Fair value of common stock warrants issued
|
$
|
184
|
|
|
—
|
|
•
|
Level 1-Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.
|
•
|
Level 2-Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly.
|
•
|
Level 3-Valuations based on inputs that are unobservable and significant to the overall fair value measurement.
|
|
June 30, 2017
|
||||||||||||||||||||||||||
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Loss
|
|
Fair Value
|
|
Cash and Cash Equivalents
|
|
Restricted Cash
|
|
Marketable Securities
|
||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||||||
Cash
|
$
|
5,283
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,283
|
|
|
$
|
3,870
|
|
|
$
|
1,413
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 1 (1):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
10,167
|
|
|
—
|
|
|
—
|
|
|
10,167
|
|
|
10,167
|
|
|
—
|
|
|
—
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 2 (2):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
U.S. government agency securities
|
70,222
|
|
|
—
|
|
|
(59
|
)
|
|
70,163
|
|
|
—
|
|
|
—
|
|
|
70,163
|
|
|||||||
Total
|
$
|
85,672
|
|
|
$
|
—
|
|
|
$
|
(59
|
)
|
|
$
|
85,613
|
|
|
$
|
14,037
|
|
|
$
|
1,413
|
|
|
$
|
70,163
|
|
|
December 31, 2016
|
||||||||||||||||||||||||||
|
Adjusted
Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
|
|
Cash and Cash Equivalent
|
|
Restricted Cash
|
|
Marketable Securities
|
||||||||||||||
|
|
|
|
Fair Value
|
|
|
|
||||||||||||||||||||
Cash
|
$
|
13,756
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
13,756
|
|
|
$
|
12,563
|
|
|
$
|
1,193
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 1 (1):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Money market funds
|
10,043
|
|
|
—
|
|
|
—
|
|
|
10,043
|
|
|
10,043
|
|
|
—
|
|
|
—
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 2 (2):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Cash and cash equivalents
|
1,660
|
|
|
—
|
|
|
—
|
|
|
1,660
|
|
|
1,660
|
|
|
—
|
|
|
—
|
|
|||||||
U.S. government agency securities
|
86,333
|
|
|
19
|
|
|
(17
|
)
|
|
86,335
|
|
|
—
|
|
|
—
|
|
|
86,335
|
|
|||||||
Subtotal
|
87,993
|
|
|
19
|
|
|
(17
|
)
|
|
87,995
|
|
|
1,660
|
|
|
—
|
|
|
86,335
|
|
|||||||
Total
|
$
|
111,792
|
|
|
$
|
19
|
|
|
$
|
(17
|
)
|
|
$
|
111,794
|
|
|
$
|
24,266
|
|
|
$
|
1,193
|
|
|
$
|
86,335
|
|
|
Warrant Liability
|
||
Balance as of December 31, 2016
|
$
|
75
|
|
Amounts acquired or issued
|
—
|
|
|
Changes in estimated fair value
|
(56
|
)
|
|
Balance as of June 30, 2017
|
$
|
19
|
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
Estimated remaining term
|
4.9 years
|
|
|
5.3 years
|
|
||
Risk-free interest rate
|
1.8
|
%
|
|
2.0
|
%
|
||
Volatility
|
77.6
|
%
|
|
77.2
|
%
|
||
Dividend yield
|
0
|
%
|
|
0
|
%
|
||
Fair value of underlying instrument*
|
$
|
2.30
|
|
|
$
|
5.88
|
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
|
|
||||||
Gross proceeds
|
$
|
28,500
|
|
|
$
|
18,500
|
|
Debt discount and debt issuance costs
|
(512
|
)
|
|
(191
|
)
|
||
Carrying value
|
27,988
|
|
|
18,309
|
|
||
Current portion of loans payable, net
|
7,093
|
|
|
5,039
|
|
||
Loans payable, net
|
$
|
20,895
|
|
|
$
|
13,270
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Research and development
|
$
|
735
|
|
|
$
|
623
|
|
|
$
|
1,441
|
|
|
$
|
1,129
|
|
General and administrative
|
1,158
|
|
|
887
|
|
|
2,246
|
|
|
1,584
|
|
||||
Total stock-based compensation
|
$
|
1,893
|
|
|
$
|
1,510
|
|
|
$
|
3,687
|
|
|
$
|
2,713
|
|
|
Options Outstanding
|
|||||||
|
Number of
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Term (in
years)
|
|||
Balance, December 31, 2016
|
6,370,578
|
|
|
$
|
6.10
|
|
|
7.6
|
Granted
|
2,826,844
|
|
|
4.72
|
|
|
|
|
Exercised
|
(283,995
|
)
|
|
1.25
|
|
|
|
|
Forfeited/Cancelled
|
(393,275
|
)
|
|
6.80
|
|
|
|
|
Balance, June 30, 2017
|
8,520,152
|
|
|
$
|
5.78
|
|
|
8.02
|
Vested or expected to vest at June 30, 2017
|
8,520,152
|
|
|
$
|
5.78
|
|
|
8.02
|
Exercisable at June 30, 2017
|
3,514,623
|
|
|
$
|
5.19
|
|
|
6.58
|
|
Six Months Ended
June 30, |
||||
|
|||||
|
2017
|
|
2016
|
||
Expected term of options (in years)
|
6.2
|
|
|
6.2
|
|
Risk-free interest rate
|
2.1
|
%
|
|
1.5
|
%
|
Expected volatility
|
75.7
|
%
|
|
67.9
|
%
|
Dividend yield
|
0
|
%
|
|
0
|
%
|
|
2013 Plan
|
|
Inducement Plan
|
||
Available at December 31, 2016
|
1,101,331
|
|
|
—
|
|
Authorized
|
2,230,736
|
|
|
500,000
|
|
Granted
|
(2,726,844
|
)
|
|
(100,000
|
)
|
Forfeited/Cancelled
|
393,275
|
|
|
—
|
|
Available at June 30, 2017
|
998,498
|
|
|
400,000
|
|
Stock options outstanding
|
8,520,152
|
|
Shares available for future grant under 2013 Plan
|
998,498
|
|
Shares available for future grant under Inducement Plan
|
400,000
|
|
Employee stock purchase plan
|
225,806
|
|
Warrants outstanding
|
123,091
|
|
Total shares of common stock reserved for future issuance
|
10,267,547
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Basic and diluted net loss per common share calculation:
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(20,432
|
)
|
|
$
|
(19,216
|
)
|
|
$
|
(41,146
|
)
|
|
$
|
(36,995
|
)
|
Net loss attributable to common stockholders
|
$
|
(20,432
|
)
|
|
$
|
(19,216
|
)
|
|
$
|
(41,146
|
)
|
|
$
|
(36,995
|
)
|
Weighted average common shares outstanding
|
58,381,868
|
|
|
52,174,569
|
|
|
57,642,379
|
|
|
51,762,467
|
|
||||
Net loss per share of common stock - basic and diluted
|
$
|
(0.35
|
)
|
|
$
|
(0.37
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(0.71
|
)
|
Balance, December 31, 2016
|
$
|
2
|
|
Net unrealized loss on marketable securities
|
(59
|
)
|
|
Balance, June 30, 2017
|
$
|
(57
|
)
|
•
|
OLINVO
TM
(oliceridine injection):
We are developing OLINVO, a μ-receptor
G protein pathway selective modulator, or μ-GPS, for the management of moderate-to-severe acute pain where intravenous, or IV, administration is preferred. On February 21, 2017, we announced positive top-line results from our Phase 3 APOLLO-1 and APOLLO-2 pivotal efficacy studies of OLINVO in moderate-to-severe acute pain following bunionectomy and abdominoplasty, respectively. In both studies, all dose regimens achieved their primary endpoint of statistically greater analgesic efficacy than placebo, as measured by responder rate. On July 20, 2017, we announced that we have completed enrollment in the Phase 3 open-label ATHENA safety study to support the planned new drug application, or NDA, for OLINVO. In the study, 772 patients were administered OLINVO to manage pain associated with a wide range of procedures and diagnoses. We have retained all worldwide development and commercialization rights to OLINVO. If OLINVO receives regulatory approval, we plan to commercialize it in the United States either on our own or with a commercial partner for use in acute care settings such as hospitals and ambulatory surgery centers; outside the United States, we plan to commercialize OLINVO with a commercial partner. In early April 2017, we held a successful Type B meeting with the United States Food and Drug Administration, or FDA, regarding the Chemistry, Manufacturing and Controls data package of our new drug application, or NDA, submission for OLINVO. In the second quarter of
2017
, we held another successful pre-NDA meeting with FDA regarding the clinical and non-clinical data package of the planned NDA. The Company currently expects to submit the NDA in September or October of
2017
.
|
•
|
TRV250:
We are developing TRV250, a G protein biased ligand targeting the δ-receptor, as a compound with a potential first-in-class, non-narcotic
mechanism for the treatment of migraine. TRV250 also may have utility in a range of other central nervous system, or CNS, indications. Because TRV250 selectively targets the δ-receptor, we believe it will not have the addiction liability of conventional opioids or other μ-opioid related adverse effects like those seen with morphine or oxycodone. In the second quarter of
2017
, we began a Phase I study of TRV250 in the United Kingdom in healthy volunteers; results from this study are expected in the second half of 2017.
|
|
Three Months Ended
June 30, |
|
|
|
Six Months Ended
June 30, |
|
|
||||||||||||||||
|
|
|
|
|
|
||||||||||||||||||
|
2017
|
|
2016
|
|
Change
|
|
2017
|
|
2016
|
|
Change
|
||||||||||||
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Collaboration revenue
|
$
|
—
|
|
|
$
|
1,875
|
|
|
$
|
(1,875
|
)
|
|
$
|
—
|
|
|
$
|
3,750
|
|
|
$
|
(3,750
|
)
|
Total revenue
|
—
|
|
|
1,875
|
|
|
(1,875
|
)
|
|
—
|
|
|
3,750
|
|
|
(3,750
|
)
|
||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
General and administrative
|
4,385
|
|
|
3,697
|
|
|
688
|
|
|
9,264
|
|
|
7,615
|
|
|
1,649
|
|
||||||
Research and development
|
15,499
|
|
|
17,203
|
|
|
(1,704
|
)
|
|
31,595
|
|
|
32,956
|
|
|
(1,361
|
)
|
||||||
Total operating expenses
|
19,884
|
|
|
20,900
|
|
|
(1,016
|
)
|
|
40,859
|
|
|
40,571
|
|
|
288
|
|
||||||
Loss from operations
|
(19,884
|
)
|
|
(19,025
|
)
|
|
(859
|
)
|
|
(40,859
|
)
|
|
(36,821
|
)
|
|
(4,038
|
)
|
||||||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Change in fair value of warrant liability
|
21
|
|
|
28
|
|
|
(7
|
)
|
|
56
|
|
|
70
|
|
|
(14
|
)
|
||||||
Net (loss) gain on asset disposals
|
1
|
|
|
—
|
|
|
1
|
|
|
1
|
|
|
—
|
|
|
1
|
|
||||||
Miscellaneous income
|
—
|
|
|
—
|
|
|
—
|
|
|
628
|
|
|
221
|
|
|
407
|
|
||||||
Interest income
|
163
|
|
|
214
|
|
|
(51
|
)
|
|
337
|
|
|
407
|
|
|
(70
|
)
|
||||||
Interest expense
|
(733
|
)
|
|
(433
|
)
|
|
(300
|
)
|
|
(1,309
|
)
|
|
(872
|
)
|
|
(437
|
)
|
||||||
Total other expense
|
(548
|
)
|
|
(191
|
)
|
|
(357
|
)
|
|
(287
|
)
|
|
(174
|
)
|
|
(113
|
)
|
||||||
Net loss attributable to common stockholders
|
$
|
(20,432
|
)
|
|
$
|
(19,216
|
)
|
|
$
|
(1,216
|
)
|
|
$
|
(41,146
|
)
|
|
$
|
(36,995
|
)
|
|
$
|
(4,151
|
)
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
||||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Personnel-related costs
|
$
|
3,478
|
|
|
$
|
3,112
|
|
|
$
|
7,174
|
|
|
$
|
6,158
|
|
OLINVO
|
9,670
|
|
|
10,085
|
|
|
20,426
|
|
|
17,130
|
|
||||
TRV027
|
20
|
|
|
1,895
|
|
|
113
|
|
|
5,348
|
|
||||
TRV250
|
898
|
|
|
954
|
|
|
1,341
|
|
|
2,258
|
|
||||
Other research and development
|
1,433
|
|
|
1,157
|
|
|
2,541
|
|
|
2,062
|
|
||||
|
$
|
15,499
|
|
|
$
|
17,203
|
|
|
$
|
31,595
|
|
|
$
|
32,956
|
|
|
Six Months Ended
June 30, |
||||||
|
|||||||
|
2017
|
|
2016
|
||||
Net cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(47,748
|
)
|
|
$
|
(39,236
|
)
|
Investing activities
|
13,778
|
|
|
17,414
|
|
||
Financing activities
|
23,960
|
|
|
11,851
|
|
||
Net decrease in cash, cash equivalents and restricted cash
|
$
|
(10,010
|
)
|
|
$
|
(9,971
|
)
|
•
|
the progress, timing and results of the NDA submission for OLINVO and related regulatory activities;
|
•
|
our ability to enter into collaborative agreements for the development and/or commercialization of our product candidates, including for OLINVO;
|
•
|
the number and development requirements of any other product candidates that we may pursue;
|
•
|
the scope, progress, results and costs of researching and developing our product candidates or any future product candidates, both in the United States and in territories outside the United States;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates or any future product candidates, both in the United States and in territories outside the United States;
|
•
|
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;
|
•
|
any product liability or other lawsuits related to our products;
|
•
|
the expenses needed to attract and retain skilled personnel;
|
•
|
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; and
|
•
|
the costs involved in preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending our intellectual property-related claims, both in the United States and in territories outside the United States.
|
|
Payments Due By Period
|
||||||||||||||||||
|
Total
|
|
Less than
1 Year
|
|
1 - 3 years
|
|
3 - 5 years
|
|
More than
5 years
|
||||||||||
|
|
|
|
|
|||||||||||||||
Operating lease obligations(1)
|
$
|
12,889
|
|
|
$
|
945
|
|
|
$
|
2,416
|
|
|
$
|
2,378
|
|
|
$
|
7,150
|
|
Loans payable
|
$
|
28,500
|
|
|
$
|
7,389
|
|
|
$
|
21,111
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
41,389
|
|
|
$
|
8,334
|
|
|
$
|
23,527
|
|
|
$
|
2,378
|
|
|
$
|
7,150
|
|
|
|
|
|
|
|
|
|
|
|
•
|
regulatory authorities may require additional warnings on the label or even withdraw approvals of such product;
|
•
|
we may be required to create a medication guide outlining the risks of such side effects for distribution to patients, if one is not required in connection with regulatory approval;
|
•
|
we could be sued and held liable for harm caused to patients; and
|
•
|
our reputation may suffer.
|
Exhibit
Number
|
|
Description
|
|
|
|
10.1
|
|
First amendment dated June 12, 2017 to Agreement of Lease between Chesterbrook Partners, LP and Trevena, Inc. for 955 Chesterbrook Blvd., Suite 200, Chesterbrook, PA as of December 9, 2016.
|
|
|
|
31.1
|
|
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
|
|
|
|
31.2
|
|
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
|
|
|
|
32.1*
|
|
Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.2*
|
|
Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
101
|
|
The following financial information from this Quarterly Report on Form 10-Q for the six months ended June 30, 2017, formatted in XBRL (eXtensible Business Reporting Language): (i) Balance Sheets as of June 30, 2017 and December 31, 2016, (ii) Statements of Operations and Comprehensive Income (Loss) for the three and six months ended June 30, 2017 and 2016, (iii) Statement of Stockholders’ Equity for the period from January 1, 2017 to June 30, 2017, (iv) Statements of Cash Flows for the six months ended June 30, 2017 and 2016 and (v) Notes to Unaudited Financial Statements, tagged as blocks of text.
|
|
TREVENA, INC.
|
|
|
|
|
|
By:
|
/s/ ROBERTO CUCA
|
|
|
Roberto Cuca
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
Expansion Premises Lease Months
|
Rate/RSF (8,231)
|
Annualized Fixed Rent
|
Monthly Installment
|
** Months 1 – 9 *
|
$26.50
|
$218,121.50
|
$18,176.79
|
Months 10 – 21*
|
$27.00
|
$222,237.00
|
$18,519.75
|
Months 22 – 33
|
$27.50
|
$226,352.50
|
$18,862.71
|
Months 34 – 45
|
$28.00
|
$230,468.00
|
$19,205.67
|
Months 46 – 57
|
$28.50
|
$234,583.50
|
$19,548.63
|
Months 58 – 69
|
$29.00
|
$238,699.00
|
$19,891.58
|
Months 70 – 81
|
$29.50
|
$242,814.50
|
$20,234.54
|
Months 82 – 93
|
$30.00
|
$246,930.00
|
$20,577.50
|
Months 94 – 105
|
$30.50
|
$251,045.50
|
$20,920.46
|
Months 106 – 117
|
$31.00
|
$255,161.00
|
$21,263.42
|
Months 118 – 127
|
$31.50
|
$259,276.50
|
$21,606.38
|
Date of Reduction
|
Amount of Letter of Credit After Reduction
|
First Day of the Thirty-Seventh (37th)
Full Month of the Term |
$900,000
|
First Day of the Sixty-First (61st)
Full Month of the Term |
$540,000
|
First Day of the Eighty-Fifth (85th)
Full Month of the Term |
$340,000
|
CHESTERBROOK PARTNERS, LP,
|
TREVENA, INC.,
|
a Delaware limited partnership
|
a Delaware corporation
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Trevena, Inc.;
|
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.
|
|
|
|
/s/ MAXINE GOWEN
|
|
Maxine Gowen
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Trevena, Inc.;
|
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;
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4.
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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:
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a.
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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;
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b.
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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;
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c.
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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
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d.
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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
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5.
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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):
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a.
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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
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b.
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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.
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/s/ ROBERTO CUCA
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Roberto Cuca
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Senior Vice President and Chief Financial Officer (Principal
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Financial Officer)
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1)
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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2)
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The information contained in the Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Report and results of operations of the Company for the period covered by the Report.
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Date:
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August 3, 2017
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/s/ MAXINE GOWEN
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Maxine Gowen
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President and Chief Executive Officer
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(Principal Executive Officer)
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Dated:
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August 3, 2017
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/s/ ROBERTO CUCA
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Roberto Cuca
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Chief Financial Officer and Treasurer
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(Principal Financial Officer)
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