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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Trevena Inc | NASDAQ:TRVN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.0374 | 9.06% | 0.45 | 0.4378 | 0.45 | 0.4497 | 0.41 | 0.4281 | 132,333 | 23:38:12 |
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 or to secure additional funding in the future;
|
•
|
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.
|
|
September 30, 2017
|
|
December 31, 2016
|
||||
|
(unaudited)
|
|
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
18,068
|
|
|
$
|
24,266
|
|
Marketable securities
|
58,505
|
|
|
86,335
|
|
||
Prepaid expenses and other current assets
|
2,111
|
|
|
1,788
|
|
||
Total current assets
|
78,684
|
|
|
112,389
|
|
||
Property and equipment, net
|
4,132
|
|
|
1,059
|
|
||
Restricted cash
|
1,413
|
|
|
1,193
|
|
||
Intangible asset, net
|
12
|
|
|
13
|
|
||
Total assets
|
$
|
84,241
|
|
|
$
|
114,654
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,783
|
|
|
$
|
8,749
|
|
Accrued expenses and other current liabilities
|
3,868
|
|
|
8,208
|
|
||
Current portion of loans payable, net
|
10,283
|
|
|
5,039
|
|
||
Deferred rent
|
58
|
|
|
52
|
|
||
Total current liabilities
|
15,992
|
|
|
22,048
|
|
||
Loans payable, net
|
17,783
|
|
|
13,270
|
|
||
Capital leases, net of current portion
|
34
|
|
|
18
|
|
||
Deferred rent, net of current portion
|
2,675
|
|
|
187
|
|
||
Warrant liability
|
22
|
|
|
75
|
|
||
Other long term liabilities
|
925
|
|
|
475
|
|
||
Total liabilities
|
37,431
|
|
|
36,073
|
|
||
Commitments and contingencies (Note 6)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Common stock—$0.001 par value; 100,000,000 shares authorized, 61,688,322 and 55,768,414 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively
|
62
|
|
|
56
|
|
||
Preferred stock—$0.001 par value; 5,000,000 shares authorized, none issued or outstanding at September 30, 2017 and December 31, 2016
|
—
|
|
|
—
|
|
||
Additional paid-in capital
|
389,539
|
|
|
364,148
|
|
||
Accumulated deficit
|
(342,770
|
)
|
|
(285,625
|
)
|
||
Accumulated other comprehensive income (loss)
|
(21
|
)
|
|
2
|
|
||
Total stockholders’ equity
|
46,810
|
|
|
78,581
|
|
||
Total liabilities and stockholders’ equity
|
$
|
84,241
|
|
|
$
|
114,654
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Collaboration revenue
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,750
|
|
Total revenue
|
—
|
|
|
—
|
|
|
—
|
|
|
3,750
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
General and administrative
|
5,232
|
|
|
4,078
|
|
|
14,496
|
|
|
11,693
|
|
||||
Research and development
|
10,181
|
|
|
25,549
|
|
|
41,776
|
|
|
58,505
|
|
||||
Total operating expenses
|
15,413
|
|
|
29,627
|
|
|
56,272
|
|
|
70,198
|
|
||||
Loss from operations
|
(15,413
|
)
|
|
(29,627
|
)
|
|
(56,272
|
)
|
|
(66,448
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Change in fair value of warrant liability
|
(2
|
)
|
|
(7
|
)
|
|
53
|
|
|
63
|
|
||||
Net (loss) gain on asset disposals
|
—
|
|
|
(9
|
)
|
|
1
|
|
|
(9
|
)
|
||||
Miscellaneous income
|
—
|
|
|
—
|
|
|
628
|
|
|
222
|
|
||||
Interest income
|
167
|
|
|
178
|
|
|
505
|
|
|
585
|
|
||||
Interest expense
|
(732
|
)
|
|
(434
|
)
|
|
(2,041
|
)
|
|
(1,307
|
)
|
||||
Loss on foreign currency exchange
|
(19
|
)
|
|
—
|
|
|
(19
|
)
|
|
—
|
|
||||
Total other expense
|
(586
|
)
|
|
(272
|
)
|
|
(873
|
)
|
|
(446
|
)
|
||||
Net loss attributable to common stockholders
|
$
|
(15,999
|
)
|
|
$
|
(29,899
|
)
|
|
$
|
(57,145
|
)
|
|
$
|
(66,894
|
)
|
|
|
|
|
|
|
|
|
||||||||
Other comprehensive (loss) income, net:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on marketable securities
|
36
|
|
|
(19
|
)
|
|
(23
|
)
|
|
262
|
|
||||
Other comprehensive (loss) income
|
36
|
|
|
(19
|
)
|
|
(23
|
)
|
|
262
|
|
||||
Comprehensive loss
|
$
|
(15,963
|
)
|
|
$
|
(29,918
|
)
|
|
$
|
(57,168
|
)
|
|
$
|
(66,632
|
)
|
|
|
|
|
|
|
|
|
||||||||
Per share information:
|
|
|
|
|
|
|
|
||||||||
Net loss per share of common stock, basic and diluted
|
$
|
(0.27
|
)
|
|
$
|
(0.57
|
)
|
|
$
|
(0.98
|
)
|
|
$
|
(1.29
|
)
|
Weighted average common shares outstanding, basic and diluted
|
60,113,327
|
|
|
52,205,156
|
|
|
58,475,079
|
|
|
51,911,107
|
|
|
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
|
—
|
|
|
—
|
|
|
5,344
|
|
|
—
|
|
|
—
|
|
|
5,344
|
|
|||||
Exercise of stock options
|
283,995
|
|
|
—
|
|
|
355
|
|
|
—
|
|
|
—
|
|
|
355
|
|
|||||
Net issuance of common stock warrant
|
—
|
|
|
—
|
|
|
501
|
|
|
—
|
|
|
—
|
|
|
501
|
|
|||||
Issuance of common stock, net of issuance costs
|
5,635,913
|
|
|
6
|
|
|
19,191
|
|
|
—
|
|
|
—
|
|
|
19,197
|
|
|||||
Unrealized loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(23
|
)
|
|
(23
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(57,145
|
)
|
|
—
|
|
|
(57,145
|
)
|
|||||
Balance, September 30, 2017
|
61,688,322
|
|
|
$
|
62
|
|
|
$
|
389,539
|
|
|
$
|
(342,770
|
)
|
|
$
|
(21
|
)
|
|
$
|
46,810
|
|
|
Nine Months Ended
September 30, |
||||||
|
2017
|
|
2016
|
||||
Operating activities:
|
|
|
|
||||
Net loss
|
$
|
(57,145
|
)
|
|
$
|
(66,894
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
345
|
|
|
180
|
|
||
Stock-based compensation
|
5,344
|
|
|
4,258
|
|
||
Noncash interest expense on loans
|
786
|
|
|
404
|
|
||
Loss on disposal of assets
|
—
|
|
|
10
|
|
||
Revaluation of warrant liability
|
(53
|
)
|
|
(63
|
)
|
||
Amortization of bond premiums on marketable securities
|
415
|
|
|
1,120
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid expenses and other assets
|
(324
|
)
|
|
248
|
|
||
Accounts payable, accrued expenses and other liabilities
|
(8,816
|
)
|
|
621
|
|
||
Deferred revenue
|
—
|
|
|
(3,750
|
)
|
||
Net cash used in operating activities
|
(59,448
|
)
|
|
(63,866
|
)
|
||
Investing activities:
|
|
|
|
||||
Purchases of property and equipment
|
(3,391
|
)
|
|
(229
|
)
|
||
Maturities of marketable securities
|
72,123
|
|
|
84,264
|
|
||
Purchases of marketable securities
|
(44,730
|
)
|
|
(53,643
|
)
|
||
Net cash provided by investing activities
|
24,002
|
|
|
30,392
|
|
||
Financing activities:
|
|
|
|
||||
Proceeds from exercise of common stock options
|
355
|
|
|
139
|
|
||
Proceeds from issuance of common stock, net
|
19,197
|
|
|
11,793
|
|
||
Capital lease payments
|
(5
|
)
|
|
(3
|
)
|
||
Proceeds from loans payable, net
|
9,921
|
|
|
—
|
|
||
Net cash provided by financing activities
|
29,468
|
|
|
11,929
|
|
||
Net decrease in cash and cash equivalents
|
(5,978
|
)
|
|
(21,545
|
)
|
||
Cash, cash equivalents and restricted cash—beginning of period
|
25,459
|
|
|
46,886
|
|
||
Cash, cash equivalents and restricted cash—end of period
|
$
|
19,481
|
|
|
$
|
25,341
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Cash paid for interest
|
$
|
1,253
|
|
|
$
|
903
|
|
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.
|
|
September 30, 2017
|
||||||||||||||||||||||||||
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Loss
|
|
Fair Value
|
|
Cash and Cash Equivalents
|
|
Restricted Cash
|
|
Marketable Securities
|
||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||||||||
Cash
|
$
|
7,471
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,471
|
|
|
$
|
6,058
|
|
|
$
|
1,413
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 1 (1):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
12,010
|
|
|
—
|
|
|
—
|
|
|
12,010
|
|
|
12,010
|
|
|
—
|
|
|
—
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 2 (2):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
U.S. government agency securities
|
58,526
|
|
|
—
|
|
|
(21
|
)
|
|
58,505
|
|
|
—
|
|
|
—
|
|
|
58,505
|
|
|||||||
Total
|
$
|
78,007
|
|
|
$
|
—
|
|
|
$
|
(21
|
)
|
|
$
|
77,986
|
|
|
$
|
18,068
|
|
|
$
|
1,413
|
|
|
$
|
58,505
|
|
|
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
|
(53
|
)
|
|
Balance as of September 30, 2017
|
$
|
22
|
|
|
September 30, 2017
|
|
December 31, 2016
|
||||
Estimated remaining term
|
4.6 years
|
|
|
5.3 years
|
|
||
Risk-free interest rate
|
1.6
|
%
|
|
2.0
|
%
|
||
Volatility
|
77.9
|
%
|
|
77.2
|
%
|
||
Dividend yield
|
0
|
%
|
|
0
|
%
|
||
Fair value of underlying instrument*
|
$
|
2.55
|
|
|
$
|
5.88
|
|
|
September 30, 2017
|
|
December 31, 2016
|
||||
|
|
||||||
Gross proceeds
|
$
|
28,500
|
|
|
$
|
18,500
|
|
Debt discount and debt issuance costs
|
(434
|
)
|
|
(191
|
)
|
||
Carrying value
|
28,066
|
|
|
18,309
|
|
||
Current portion of loans payable, net
|
10,283
|
|
|
5,039
|
|
||
Loans payable, net
|
$
|
17,783
|
|
|
$
|
13,270
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Research and development
|
$
|
533
|
|
|
$
|
635
|
|
|
$
|
1,974
|
|
|
$
|
1,763
|
|
General and administrative
|
1,124
|
|
|
910
|
|
|
3,370
|
|
|
2,495
|
|
||||
Total stock-based compensation
|
$
|
1,657
|
|
|
$
|
1,545
|
|
|
$
|
5,344
|
|
|
$
|
4,258
|
|
|
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
|
4,187,344
|
|
|
3.96
|
|
|
|
|
Exercised
|
(283,995
|
)
|
|
1.25
|
|
|
|
|
Forfeited/Cancelled
|
(839,250
|
)
|
|
6.75
|
|
|
|
|
Balance, September 30, 2017
|
9,434,677
|
|
|
$
|
5.24
|
|
|
7.94
|
Vested or expected to vest at September 30, 2017
|
9,434,677
|
|
|
$
|
5.24
|
|
|
7.94
|
Exercisable at September 30, 2017
|
3,535,664
|
|
|
$
|
5.18
|
|
|
6.03
|
|
Nine Months Ended
September 30, |
||||
|
|||||
|
2017
|
|
2016
|
||
Expected term of options (in years)
|
6.2
|
|
|
6.2
|
|
Risk-free interest rate
|
2.0
|
%
|
|
1.5
|
%
|
Expected volatility
|
75.6
|
%
|
|
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
|
(3,966,844
|
)
|
|
(220,500
|
)
|
Forfeited/Cancelled
|
839,250
|
|
|
—
|
|
Available at September 30, 2017
|
204,473
|
|
|
279,500
|
|
Stock options outstanding
|
9,434,677
|
|
Shares available for future grant under 2013 Plan
|
204,473
|
|
Shares available for future grant under Inducement Plan
|
279,500
|
|
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
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Basic and diluted net loss per common share calculation:
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(15,999
|
)
|
|
$
|
(29,899
|
)
|
|
$
|
(57,145
|
)
|
|
$
|
(66,894
|
)
|
Net loss attributable to common stockholders
|
$
|
(15,999
|
)
|
|
$
|
(29,899
|
)
|
|
$
|
(57,145
|
)
|
|
$
|
(66,894
|
)
|
Weighted average common shares outstanding
|
60,113,327
|
|
|
52,205,156
|
|
|
58,475,079
|
|
|
51,911,107
|
|
||||
Net loss per share of common stock - basic and diluted
|
$
|
(0.27
|
)
|
|
$
|
(0.57
|
)
|
|
$
|
(0.98
|
)
|
|
$
|
(1.29
|
)
|
Balance, December 31, 2016
|
$
|
2
|
|
Net unrealized loss on marketable securities
|
(23
|
)
|
|
Balance, September 30, 2017
|
$
|
(21
|
)
|
•
|
OLINVO
TM
(oliceridine injection):
We are developing OLINVO, a G protein based ligand of the μ opioid receptor, 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 l 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, 768 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 the second quarter of 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. We also held a successful pre-NDA meeting with FDA regarding the clinical and non-clinical data package of the planned NDA in the second quarter of 2017. On November 2, 2017, we announced that the NDA for OLINVO has been submitted.
|
•
|
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; we expect to complete dosing by the end of the first quarter of 2018.
|
|
Three Months Ended
September 30, |
|
|
|
Nine Months Ended
September 30, |
|
|
||||||||||||||||
|
|
|
|
|
|
||||||||||||||||||
|
2017
|
|
2016
|
|
Change
|
|
2017
|
|
2016
|
|
Change
|
||||||||||||
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Collaboration revenue
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,750
|
|
|
$
|
(3,750
|
)
|
Total revenue
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,750
|
|
|
(3,750
|
)
|
||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
General and administrative
|
5,232
|
|
|
4,078
|
|
|
1,154
|
|
|
14,496
|
|
|
11,693
|
|
|
2,803
|
|
||||||
Research and development
|
10,181
|
|
|
25,549
|
|
|
(15,368
|
)
|
|
41,776
|
|
|
58,505
|
|
|
(16,729
|
)
|
||||||
Total operating expenses
|
15,413
|
|
|
29,627
|
|
|
(14,214
|
)
|
|
56,272
|
|
|
70,198
|
|
|
(13,926
|
)
|
||||||
Loss from operations
|
(15,413
|
)
|
|
(29,627
|
)
|
|
14,214
|
|
|
(56,272
|
)
|
|
(66,448
|
)
|
|
10,176
|
|
||||||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Change in fair value of warrant liability
|
(2
|
)
|
|
(7
|
)
|
|
5
|
|
|
53
|
|
|
63
|
|
|
(10
|
)
|
||||||
Net (loss) gain on asset disposals
|
—
|
|
|
(9
|
)
|
|
9
|
|
|
1
|
|
|
(9
|
)
|
|
10
|
|
||||||
Miscellaneous income
|
—
|
|
|
—
|
|
|
—
|
|
|
628
|
|
|
222
|
|
|
406
|
|
||||||
Interest income
|
167
|
|
|
178
|
|
|
(11
|
)
|
|
505
|
|
|
585
|
|
|
(80
|
)
|
||||||
Interest expense
|
(732
|
)
|
|
(434
|
)
|
|
(298
|
)
|
|
(2,041
|
)
|
|
(1,307
|
)
|
|
(734
|
)
|
||||||
Loss on foreign currency exhange
|
(19
|
)
|
|
—
|
|
|
(19
|
)
|
|
(19
|
)
|
|
—
|
|
|
(19
|
)
|
||||||
Total other expense
|
(586
|
)
|
|
(272
|
)
|
|
(314
|
)
|
|
(873
|
)
|
|
(446
|
)
|
|
(427
|
)
|
||||||
Net loss attributable to common stockholders
|
$
|
(15,999
|
)
|
|
$
|
(29,899
|
)
|
|
$
|
13,900
|
|
|
$
|
(57,145
|
)
|
|
$
|
(66,894
|
)
|
|
$
|
9,749
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
||||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Personnel-related costs
|
$
|
3,273
|
|
|
$
|
3,136
|
|
|
$
|
10,448
|
|
|
$
|
9,294
|
|
OLINVO
|
4,733
|
|
|
20,014
|
|
|
25,159
|
|
|
37,145
|
|
||||
TRV027
|
26
|
|
|
775
|
|
|
138
|
|
|
6,122
|
|
||||
TRV250
|
750
|
|
|
364
|
|
|
2,091
|
|
|
2,622
|
|
||||
Other research and development
|
1,399
|
|
|
1,260
|
|
|
3,940
|
|
|
3,322
|
|
||||
|
$
|
10,181
|
|
|
$
|
25,549
|
|
|
$
|
41,776
|
|
|
$
|
58,505
|
|
|
Nine Months Ended
September 30, |
||||||
|
|||||||
|
2017
|
|
2016
|
||||
Net cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(59,448
|
)
|
|
$
|
(63,866
|
)
|
Investing activities
|
24,002
|
|
|
30,392
|
|
||
Financing activities
|
29,468
|
|
|
11,929
|
|
||
Net decrease in cash, cash equivalents and restricted cash
|
$
|
(5,978
|
)
|
|
$
|
(21,545
|
)
|
•
|
the timing and results of the FDA's review 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)
|
$
|
12,809
|
|
|
$
|
947
|
|
|
$
|
2,704
|
|
|
$
|
2,302
|
|
|
$
|
6,856
|
|
Loans payable
|
$
|
28,500
|
|
|
$
|
10,556
|
|
|
$
|
17,944
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
41,309
|
|
|
$
|
11,503
|
|
|
$
|
20,648
|
|
|
$
|
2,302
|
|
|
$
|
6,856
|
|
|
|
|
|
|
|
|
|
|
|
•
|
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.
|
•
|
significantly delay, scale back, or discontinue our operations, development programs, and/or any future commercialization efforts;
|
•
|
relinquish, or license on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves;
|
•
|
seek collaborators for one or more of our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or
|
•
|
cease operations altogether.
|
•
|
the costs, timing and outcome of regulatory review of the OLINVO NDA or any future product candidates, both in the United States and in territories outside the United States;
|
•
|
our ability to enter into collaborative agreements for the development and commercialization of our product candidates, including OLINVO;
|
•
|
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 scope, progress, results and costs of preclinical development, laboratory testing, and clinical trials for our other product candidates, including TRV250; the expenses needed to attract and retain skilled personnel;
|
•
|
the number and development requirements of other product candidates that we pursue;
|
•
|
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 any intellectual property-related claims, both in the United States and in territories outside the United States.
|
Exhibit
Number
|
|
Description
|
|
|
|
31.1
|
|
|
|
|
|
31.2
|
|
|
|
|
|
32.1*
|
|
|
|
|
|
32.2*
|
|
|
|
|
|
101
|
|
The following financial information from this Quarterly Report on Form 10-Q for the nine months ended September 30, 2017, formatted in XBRL (eXtensible Business Reporting Language): (i) Balance Sheets as of September 30, 2017 and December 31, 2016, (ii) Statements of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2017 and 2016, (iii) Statement of Stockholders’ Equity for the period from January 1, 2017 to September 30, 2017, (iv) Statements of Cash Flows for the nine months ended September 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)
|
1 Year Trevena Chart |
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