– New ATHENA data show OLINVO effectiveness with promising safety/tolerability in key target procedures –
– Positive interim data for Phase 1 study of investigational migraine treatment TRV250 leads to study expansion –
CHESTERBROOK, PA, November 7, 2017 – Trevena, Inc. (NASDAQ: TRVN) today announced financial results for the quarter ended September 30, 2017, and announced positive new data from both its OLINVO™ (oliceridine injection) and TRV250 programs.
“The recent submission of the OLINVO NDA capped a transformative period for our Company,” said Maxine Gowen, Ph.D., chief executive officer. “We are now focused on preparing for the approval and commercialization of OLINVO, while continuing to advance our development pipeline following our recent strategic decision to halt our discovery research efforts. To this end, new results continue to highlight the potential value of OLINVO for patients in a real world setting who require IV opioids but are at risk of opioid-related adverse events. Positive interim Phase 1 data for TRV250 bode well for future clinical development of this exciting potential migraine therapy.”
- The most common procedures were orthopedic, colorectal, gynecologic, and general surgeries. Patients at elevated risk of opioid-related adverse events were well represented; more than 30% of patients were 65 years or older, and more than 50% of patients were obese, with body mass index (BMI) >30 kg/m2.
- Only 2% of patients discontinued for adverse events, and 4% of patients discontinued for lack of efficacy. The most common adverse events were nausea, constipation, and vomiting, with prevalence lower than in the APOLLO studies. Adverse event rates associated with OLINVO administered by patient controlled analgesia (PCA) and as-needed bolus dosing were similar, supporting potential use of OLINVO in both administration paradigms.
- Peer-reviewed publication of full Phase 2b results, by Singla et al: Dovepress Article (PDF)
- Prevalence and costs of opioid-related adverse events presented at PainWeek and the American Society of Anesthesiologist annual meetings
- Unmet needs and potential new options in acute pain management, by Gan et al: Dovepress Article (PDF)
- Structural basis for the novel OLINVO mechanism of action, by Kappor et al: NCBI Article (PDF)
- In the doses studied to date, TRV250 demonstrated dose-proportional exposure after s.c. administration. TRV250 was well tolerated at all doses tested. Because no dose-limiting adverse events were identified in the initial cohorts of healthy subjects, the company has expanded the study to evaluate higher doses to support future Phase 2 planning.
- Preliminary data from oral administration of TRV250 to healthy volunteers suggest TRV250 has adequate oral bioavailability to support further clinical development.
For the third quarter of 2017, Trevena reported a net loss attributable to common stockholders of $16.0 million, or $0.27 per share, compared with a net loss attributable to common stockholders for the third quarter of 2016 of $29.9 million, or $0.57 per share. Research and development expenses were $10.2 million in the third quarter of 2017 compared to $25.5 million for the same period in 2016; general and administrative expenses were $5.2 million, compared to $4.1 million for the third quarter of 2016.Cash, cash equivalents, and marketable securities were $76.6 million as of September 30, 2017, which the Company expects to be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months from today’s date.
For additional details, please see the Company’s Form 10-Q, which will be filed with the SEC today.
Conference Call and Webcast
Date: November 7, 2017
Time: 8:00 a.m. EST
Telephone Access: (855) 465-0180
International: (484) 756-4313
Conference ID: 9796968
Trevena, Inc. is a biopharmaceutical company focused on providing better, safer therapies to patients in pain. The Company has leveraged breakthrough science to discover and develop its investigational product OLINVO™ (oliceridine injection) for the management of moderate-to-severe acute pain. OLINVO has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration and was designed to provide healthcare providers an innovative new option for patients who would otherwise require conventional intravenous opioids. The Company has an early stage pipeline of new chemical entities targeting novel mechanisms of action, including for acute migraine, neuropathic pain, and other indications.
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 or any future trials, including whether the positive interim data from the Phase 1 study of TRV250 bode well for the future clinical development of this therapy; the uncertainties inherent in conducting clinical trials; interpretations of regulatory interactions and expectations for regulatory submissions and approvals; 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, including whether the ATHENA data highlights the potential value of OLINVO for patients who require IV opioids but are at risk of opioid-related adverse events; 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.
Jonathan Violin, Ph.D.
Vice president, corporate strategy & investor relations
|Condensed Statements of Operations|
|(Unaudited, in thousands except share and per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|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)||(586||)||(272||)||(873||)||(446||)|
|Per share information:|
|Net loss per share of common stock, basic and diluted||($0.27||)||($0.57||)||($0.98||)||($1.29||)|
|Weighted average shares outstanding, basic and diluted||60,113,327||52,205,156||58,475,079||51,911,017|
|Condensed Balance Sheets|
|(Unaudited, in thousands)|
|September 30, 2017||December 31, 2016|
|Cash and cash equivalents||$||18,068||$||24,266|
|Prepaid expenses and other current assets||2,111||1,788|
|Total current assets||78,684||112,389|
|Property and equipment, net||4,132||1,059|
|Intangible asset, net||12||13|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||3,868||8,208|
|Current portion of loans payable, net||10,283||5,039|
|Total current liabilities||15,992||22,048|
|Loans payable, net||17,783||13,270|
|Capital leases, net of current portion||34||18|
|Deferred rent, net of current portion||2,675||187|
|Other long term liabilities||925||475|
|Additional paid-in capital||389,539||364,148|
|Accumulated other comprehensive income (loss)||(21||)||2|
|Total stockholders’ equity||46,810||78,581|
|Total liabilities and stockholders’ equity||$||84,241||$||114,654|
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