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 ground-breaking medicines. Its novel approach to drug discovery has established it as pioneers in acute care medicine.
Recent developments/milestone: Company announced initial path forward /clarity on oliceridine NDA.
On 19th Jan, the company announced the receipt of the official Type A meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the oliceridine New Drug Application (NDA).
FDA also has agreed that the Company can conduct a study in healthy volunteers to collect the requested QT interval data and that the study should include placebo- and positive-control arms. The Company intends to submit a detailed protocol and analysis plan to FDA shortly and, following receipt of FDA feedback, anticipates initiating this study in the first half of this year. The Company is not required to provide any additional efficacy data to resubmit the oliceridine NDA.
To address other items in the CRL, FDA has indicated that the Company should include supporting nonclinical data related to the characterization of the 9662 metabolite and the remaining product validation reports when the oliceridine NDA is resubmitted.
“We are encouraged by the productive discussion with FDA, which we believe has provided a path to resubmit the oliceridine NDA,” said Carrie L. Bourdow, President and Chief Executive Officer. “We remain committed to our mission of ensuring access to safe and effective treatment options for hospital patients who require an IV opioid to manage their moderate to severe acute pain.”
Near term Catalysts: The company discussed the minutes of Type A meetings and its plan in its conference call and webcast on January 28, 2019.
- The company is now aiming to finalise a study protocol and analysis plan and submit it to FDA for feedback.
- The company plans to commence study in the first half of 2019
- After the company receives FDA feedback, it will begin enrolment and will update the investors about the projected study timelines and cost. It said the company expects a relatively short and cost-effective study
The management strongly believes in 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 and has laid out a detailed plan to capitalize this opportunity and gain approval for Oliceridine:
- The company continues to prioritize and reduce expenses, including, reduction in workforce by about one-third.
- In addition, the company is actively working with external clinical experts in the area of cardiac electrophysiology and with seasoned regulator consultant who has experience working on NDAs and complete response letters, with companies as well as with the agency.
- Third, Trevena will pause spending on its early pipeline until it finalizes the path forward and has a better understanding of the investment needed for oliceridine.
- The Company also announced that it expects cash, cash equivalents, and marketable securities as of December 31, 2018, to be approximately $61.5 million, which the Company anticipates will be sufficient to fund operating expenses and capital expenditure requirements into the second quarter of 2020. In March 2019, the Company expects to announce full financial results for the fourth quarter and full year ended December 31, 2018.
As a result of this most recent announcement, TRVN stock has started showing enormous strength and strong momentum. 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 $6.35, suggesting that the stock has a possible upside of 433.61%. The high price target for TRVN is $15.00, and the low-price target for TRVN is $0.75. There are currently three hold ratings, and 3 buy ratings for the stock, resulting in a consensus rating of “Buy.”
Per Yahoo, 7 out of 8 ratings, recommends buying including two strong buy ratings.
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 three novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the treatment of acute migraine, and TRV734 for pain and/or management of opioid dependence. In its preclinical programs, Trevena is evaluating a set of novel S1P receptor modulators that may offer a new, non-opioid 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 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:
Industry Potential: Significant unmet need in a large addressable market
Quarterly Financial Results (in, thousands):
- Net Loss: For the third quarter of 2018, Trevena reported a net loss attributable to common stockholders of $4.5 million, or $0.06 per share, compared with a net loss attributable to common stockholders for the third quarter of 2017 of $16.0 million, or $0.27 per share. Research and development expenses were $3.4 million in the third quarter of 2018 compared to $10.2 million for the same period in 2017; general and administrative expenses were $3.9 million, compared to $5.2 million for the third quarter of 2017.
- Liquidity and Financial Flexibility: Cash, cash equivalents, and marketable securities were $70.0 million as of September 30, 2018. The Company expects this amount, together with interest thereon, to be sufficient to fund operating expenses and capital expenditure requirements into the second quarter of 2020.
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/approval 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.
- On Tuesday, Jan 29th, 2019, TRVN was at $1.25, with a robust volume of 19.9 million shares exchanging hands. Market capitalization is $96.57 million. The current RSI is 84.60
- In the past 52 weeks, shares of TRVN have traded as low as $0.38 and as high as $3.58
- At $1.25, shares of TRVN are trading above its 50-day moving average (MA) at $0.59 and below its 200-day moving average (MA) at $1.34
- The present support and resistance levels for the stock are at $0.48 & $1.56 respectively.
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