Form: 8-K

Current report filing

November 3, 2016

Exhibit 99.1

 

 

Trevena Reports Third Quarter 2016 Financial Results and Provides Corporate Update

 

- Oliceridine Phase 3 pivotal efficacy trials progressing on schedule for top-line data in 1Q17 -

 

KING OF PRUSSIA, PA. Trevena, Inc. (NASDAQ: TRVN) today announced financial results for the quarter ended September 30, 2016 and provided an update regarding its ongoing clinical programs.

 

“This quarter saw important progress for our company, with continued execution of our Phase 3 program for oliceridine.  We had extensive engagement with the medical community to discuss the challenges of acute pain management in the hospital and how oliceridine may provide an important treatment option to patients and physicians,” said Maxine Gowen, Ph.D., chief executive officer. “We look forward to sharing top-line data from both Phase 3 APOLLO pivotal efficacy studies in the first quarter of 2017, and filing an NDA in the second half of next year.”

 

Third Quarter and Recent Highlights

 

·                  APOLLO-1 and APOLLO-2 Phase 3 efficacy trials of oliceridine remain on track for first quarter 2017 top-line data release. The APOLLO-1 trial includes patients suffering moderate to severe pain after undergoing bunionectomy, while the APOLLO-2 trial includes patients suffering moderate to severe pain after undergoing abdominoplasty; both are 375-patient, multicenter, randomized, double-blind, placebo- and active-controlled studies. Patients are randomized to receive placebo, morphine, or one of three oliceridine regimens, all dosed as needed via patient-controlled analgesia (PCA) device for the management of their post-operative pain, with approximately 75 patients per study arm. The primary objective of both trials is to evaluate the analgesic efficacy of oliceridine versus placebo.  Secondary endpoints compare the efficacy, safety, and tolerability of oliceridine to morphine.

 

·                  Patient enrollment remains on track in the ATHENA multi-procedure safety study of oliceridine to support NDA filing in 2H 2017.  This trial complements the APOLLO studies and aims to evaluate the safety and tolerability of oliceridine in patients with moderate to severe acute pain caused by a broad range of medical conditions or surgeries. Patients are treated on an as-needed basis via IV bolus, PCA administration, or both, as determined by the investigator.

 

·                  Continued engagement at pain medicine conferences. The company gave or sponsored presentations at numerous medical conferences, including meetings of the American Society for Pain Management Nursing, American College of Surgeons, and American Society of Anesthesiologists (ASA). Two abstracts were selected for oral podium presentations at the ASA meeting.

 

·                  Hosted an investor webcast featuring presentations on acute pain management by leading clinicians.  In October, the company webcast a symposium in which leading clinicians provided their perspectives on the unmet needs associated with current injectable analgesics and how

 



 

oliceridine may fit into the current treatment landscape for acute moderate to severe pain. A webcast replay is available at http://investors.trevena.com/events.cfm.

 

·                  TRV250 program on track for IND submission this year.  TRV250 is a potential first-in-class medicine in preclinical development for the treatment of episodic migraine. It was designed to use a novel non-narcotic approach to treating migraine by selectively targeting the delta receptor.  There are no approved drugs selectively targeting this receptor.  The company continues to expect to submit an investigational new drug application for TRV250 to the FDA by the end of 2016.

 

Financial Results

 

Net loss attributable to common stockholders for the quarter ended September 30, 2016 was $29.9 million, or $0.57 per share, compared to $10.6 million, or $0.24 per share for the quarter ended September 30, 2015. General and administrative expenses were $4.1 million in the third quarter of 2016, compared to $2.8 million for the third quarter of 2015.  Research and development expenses were $25.5 million in the third quarter of 2016 compared to $9.7 million for the same period in 2015, with the increase primarily due to expenses associated with the oliceridine Phase 3 program. The Company expects that research and development expenses will be higher in the fourth quarter of 2016 than in the third quarter before decreasing in 2017 as ongoing Phase 3 trials are completed.

 

Cash, cash equivalents, and marketable securities totaled $119.6 million as of September 30, 2016, which Trevena continues to expect will be sufficient to fund its operations into 2018.

 

About Trevena

 

Trevena, Inc. is a biopharmaceutical company developing innovative therapies based on breakthrough science to benefit patients and healthcare providers confronting serious medical needs. The company has discovered four novel and differentiated drug candidates including oliceridine (TRV130), an FDA-designated Breakthrough Therapy currently in Phase 3 development for intravenous management of moderate-to-severe acute pain.  Trevena has also discovered TRV250, in preclinical development for the treatment of migraine, as well as TRV734 for pain and TRV027 for acute heart failure. The Company also has an early stage portfolio of drug discovery programs.

 

Cautionary Note on Forward Looking Statements

 

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,”

 



 

“suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials, including the expected timing of the release of top-line data from the APOLLO studies and the timing of the NDA filing for oliceridine; the uncertainties inherent in conducting clinical trials, including whether the Phase 3 studies will support the approval of oliceridine and any potential differentiation of oliceridine from conventional opioids; whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials will be indicative of the results of future trials; expectations for regulatory approvals, including for oliceridine; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company’s intellectual property; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

 

Investor contact:

 

Trevena, Inc.

Jonathan Violin, Ph.D.

Sr. Director, Investor Relations

(610) 354-8840 x231

jviolin@trevenainc.com

 

Media Contact:

 

Trevena, Inc.

Public Relations

PR@trevena.com

 


 


 

TREVENA, INC.

Condensed Statements of Operations

(Unaudited)

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

—

 

$

1,875,000

 

$

3,750,000

 

$

4,375,000

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

General and administrative

 

4,078,349

 

2,780,115

 

11,692,781

 

8,977,000

 

Research and development

 

25,548,532

 

9,650,138

 

58,504,964

 

30,524,601

 

Total operating expenses

 

29,626,881

 

12,430,253

 

70,197,745

 

39,501,601

 

Loss from operations

 

(29,626,881

)

(10,555,253

)

(66,447,745

)

(35,126,601

)

Other income (expense)

 

(271,775

)

(60,230

)

(446,208

)

62,622

 

Net loss

 

$

(29,898,656

)

$

(10,615,483

)

$

(66,893,953

)

$

(35,063,979

)

 

 

 

 

 

 

 

 

 

 

Per share information:

 

 

 

 

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(0.57

)

$

(0.24

)

$

(1.29

)

$

(0.85

)

Weighted average shares outstanding, basic and diluted

 

52,205,156

 

44,214,428

 

51,911,107

 

41,443,362

 

 



 

TREVENA, INC.

Condensed Balance Sheets

 

 

 

30-Sep-16

 

December 31, 2015

 

 

 

(Unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

25,228,034

 

$

46,773,566

 

Marketable securities

 

94,386,006

 

125,864,447

 

Prepaid expenses and other current assets

 

1,644,792

 

1,892,217

 

Total current assets

 

121,258,832

 

174,530,230

 

Property and equipment, net

 

745,292

 

696,280

 

Intangible asset, net

 

13,438

 

14,844

 

Restricted cash

 

112,620

 

112,620

 

Total assets

 

$

122,130,182

 

$

175,353,974

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

6,903,250

 

$

6,749,625

 

Accrued expenses and other current liabilities

 

3,530,702

 

3,029,782

 

Current portion of loans payable, net

 

4,635,046

 

—

 

Deferred revenue

 

—

 

3,750,000

 

Deferred rent

 

50,175

 

43,907

 

Total current liabilities

 

15,119,173

 

13,573,314

 

Loans payable, net

 

13,644,787

 

18,185,898

 

Capital leases, net of current portion

 

12,022

 

7,942

 

Deferred rent, net of current portion

 

200,666

 

238,917

 

Warrant liability

 

90,561

 

153,238

 

Other long term liabilities

 

373,488

 

63,200

 

Total liabilities

 

29,440,697

 

32,222,509

 

 

 

 

 

 

 

Common stock

 

52,243

 

50,802

 

Additional paid-in capital

 

341,973,243

 

325,784,484

 

Accumulated deficit

 

(249,391,918

)

(182,497,965

)

Accumulated other comprehensive income (loss)

 

55,917

 

(205,856

)

Total stockholders’ equity

 

92,689,485

 

143,131,465

 

Total liabilities and stockholders’ equity

 

$

122,130,182

 

$

175,353,974