Trevena, Inc. (NASDAQ: TRVN) 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, oliceridine injection, for the management of moderate-to-severe acute pain.
Trevena was founded to translate Nobel Prize-winning research into a new generation of groundbreaking medicines. Its novel approach to drug discovery has established it as pioneers in acute care medicine.
ON August 2, 2018, the company announced financial results for the quarter ended June 30, 2018 and provided an update on its pipeline of differentiated new chemical entities, including its lead asset, oliceridine, currently under review by the U.S. Food and Drug Administration (FDA) for potential approval this year.
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“The second quarter saw important progress towards Trevena’s long-term success,” said Maxine Gowen, Ph.D., President, and Chief Executive Officer. “We remain confident that the oliceridine NDA remains on track for an FDA decision by the November 2, 2018 PDUFA date. In addition, the second quarter saw us secure two important ex-US licensing transactions for oliceridine, strengthen our leadership team with important medical and commercial hires, and continue a smooth transition to Carrie Bourdow’s assumption of the CEO role.”
More recently, on 11th October the company announced the outcome of the meeting of the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to review and discuss oliceridine. At the meeting, the Advisory Committee voted eight against, and 7 in favor of, the approval of oliceridine for the management of moderate to severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted.
Notwithstanding this adverse outcome, the management strongly believes that the totality of the evidence presented and discussed supports the utility of oliceridine as a new analgesic option for the management of moderate to severe acute pain for patients in hospitals or other controlled clinical settings. Trevena is working closely with the FDA as they complete their review of the NDA for oliceridine.
Near-term Catalyst: Trevena’s New Drug Application (NDA) submission for oliceridine was accepted for review by the FDA on January 2, 2018, with a Prescription Drug User Fee Act (PDUFA) target date for completion of review by the FDA of November 2, 2018.
Pipeline:
Financial profile is marked by comfortable liquidity: So far liquidity and financial position are concerned, TRVN had $63.5 million as of June 30, 2018. The Company expects this amount, together with interest thereon and proceeds from oliceridine ex-U.S. licensing activities, to be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months. Furthermore, this would also ensure that the company does not suffer any unforeseen liquidity related contingencies over the near to medium term.
TRVN stock has started showing enormous strength and strong momentum in the recent past. The momentum is likely to continue as the company approaches PDUFA target date next month. Moreover, the company presently has a low market cap, with sufficient liquidity, efficient/promising product pipeline in a very high growth industry. Driven by factors as mentioned earlier, traders and investors seem to be pricing TRVN positively.
Analyst views and brokerage actions:
Per www.marketbeat.com, their average twelve-month price target is $6.8333, suggesting that the stock has a possible upside of 538.63%. The high price target for TRVN is $15.00, and the low-price target for TRVN is $1.00. There are currently two hold ratings, and 4 buy ratings for the stock, resulting in a consensus rating of “Buy.”
Below are the excerpts of recent ratings by brokerage house:
Source – www.marketbeat.com
About the Company: Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of new and innovative treatment options for patients in pain. The Company has discovered three novel and differentiated drug candidates using its proprietary platform, including intravenous (IV) oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the treatment of an acute migraine, and TRV734 for pain and/or management of opioid dependence. In its preclinical programs, Trevena is evaluating a set of novel S1P modulators that may offer a new, non-narcotic approach to managing chronic pain.
About Oliceridine: Oliceridine is a G-protein biased mu-opioid receptor (MOR) ligand in development for the management of moderate to severe acute pain in hospitals or other controlled clinical settings and where intravenous (IV) therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company has requested that oliceridine be classified as a Schedule II controlled substance.
The pipeline, its present stage, and upcoming milestone:
Other recent announcements/achievements:
- Licensed oliceridine for development and commercialization in South Korea and China.
- Successful completion of Phase 1 study of TRV250 for acute migraine.
- National Institute on Drug Abuse studying TRV734 as a potentially differentiated therapy for maintenance treatment of opioid dependence.
- Continued advancement of preclinical non-narcotic analgesic program.
- Carrie Bourdow selected as next CEO.
- Strengthened leadership team.
Litigation/ Complaint, filed in the United States District Court – As per public sources, there are class action lawsuits initiated/filed against the company and certain of its officers alleging violations of the federal securities laws. However, there is no recent press release/response from the management about the same.
Quarterly Financial Results (in, thousands):
Net Loss: For the second quarter of 2018, Trevena reported a net loss attributable to common stockholders of $9.3 million, or $0.13 per share, compared with a net loss attributable to common stockholders for the second quarter of 2017 of $20.4 million, or $0.35 per share.
R&D Expenses: Research and development expenses were $5.1 million in the second quarter of 2018 compared to $15.5 million for the same period in 2017; general and administrative expenses were $5.9 million, compared to $4.4 million for the second quarter of 2017.
Liquidity: Cash, cash equivalents, and marketable securities were $63.5 million as of June 30, 2018. The Company expects this amount, together with interest thereon and proceeds from oliceridine ex-U.S. licensing activities, to be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months from today’s date.
Key risk factors and potential stock drivers:
- Biotech space in itself is a high-risk sector due to uncertainties associated with the novel drug development. Successful completion of the upcoming milestones would lead future direction for the company. Any adversities might adversely impact the overall investor sentiments.
- The FDA decision for oliceridine is crucial for TRVN, as the company needs to establish a steady stream of revenue to maintain its financial flexibility and fund its ongoing studies.
- TRVN has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.
- Notwithstanding the expected improvement in the business and financial risk profile of the company, TRVN is still a loss-making entity. Therefore, the company’s ability to achieve successful commercialization will continue to remain a long-term stock sensitivity factor.
Stock Performance:
Comments:
- On Wednesday, Oct 17th, 2018, TRVN was at $.91, with a volume of 3.9 million shares exchanging hands. Market capitalization is $81.408 million. The current RSI is 35.95
- In the past 52 weeks, shares of TRVN have traded as low as $0.76 and as high as $3.58
- At $1.07, shares of TRVN are trading below its 50-day moving average (MA) at $1.74 and below its 200-day moving average (MA) at $1.72
- The present support and resistance levels for the stock are at $0.74 & $1.26 respectively.
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