CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, has reported its financial results for the first quarter ended March 31, 2021, and provided an overview of its recent operational highlights.
“In the first quarter, we made significant progress across our business. We continued to expand awareness of OLINVYK with key customers and announced an exciting outcomes study to further enhance the value proposition,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. “In parallel, we advanced our pipeline with major new studies for TRV027 in COVID-19 patients, in collaboration with two of the most prominent platform trial networks in the world, and we selected diabetic neuropathic pain as the initial indication for TRV045.”
First Quarter 2021 and Recent Corporate Highlights:
OLINVYK (oliceridine) injection Milestones
- Established a solid foundation for launch. The Company deployed a virtual field team at the end of February. Over 60 accounts are in various stages of OLINVYK review and 10 accounts have already added OLINVYK to formulary. Despite the impact of COVID-19, the Company is encouraged by the early progress and reaffirms its year-end goal of 100 formulary approvals.
- Announced clinical outcomes study examining potential respiratory, GI, and cognitive benefits. The Company announced that it has initiated an open-label, multi-site, differentiation study to further characterize the impact of OLINVYK on respiratory, gastrointestinal (GI), and cognitive function outcomes in the postoperative setting. The study, which will enroll approximately 200 adults undergoing major surgery, will be led by clinical outcomes research experts from Cleveland Clinic. Respiratory safety will be assessed by continuous monitoring. Additional outcomes will include GI tolerability as measured by GI complete response, and cognitive function as measured by standardized somnolence, sedation, and delirium assessment scales. The Company expects patient enrollment to begin in Q3 2021.
- Published compelling health economic models. In April 2021, the Company presented two health economic models for OLINVYK at the AMCP 2021 Annual Meeting. Both models demonstrate substantial overall total cost of care savings for hospitals when using OLINVYK compared to IV morphine in postoperative care. They were developed using adverse event (AE) incidence rates from the OLINVYK Phase 3 program and a conservative, low-end estimate of AE costs based on government and published literature sources.
- Advanced TRV027 in two large COVID-19 trials led by NIH / VUMC and REMAP-CAP, with TRV027 studied in up to 600 patients. The Company announced that TRV027, its novel AT1 receptor selective agonist, has been selected for an NIH-funded, multi-arm, multi-site trial in COVID-19 patients, with Vanderbilt University Medical Center (VUMC) as the lead coordinating site. TRV027 will be administered in up to 300 patients. The trial is part of the NIH’s ACTIV public-private partnership, an initiative that seeks to prioritize and expedite the development of promising COVID-19 treatments and vaccines.
In April 2021, the Company announced that TRV027 had been selected for an international, multi-arm, multi-site Phase 2/3 trial in COVID-19 patients. TRV027 will be administered in conjunction with an ACE inhibitor in 200-300 patients. The trial is being conducted and funded as part of REMAP-CAP, a global clinical trial network led by experts in pandemic response and financially supported by an array of governments and research organizations worldwide.
- Announced diabetic neuropathic pain as lead indication for TRV045, with IND on track for 1H 2021. The Company announced it will be filing the IND for TRV045, its novel S1P receptor modulator, with a lead indication of diabetic neuropathic pain (DNP). DNP is a painful condition with significant need for new treatment options, due to poor efficacy and tolerability of current available therapies. TRV045 offers a non-opioid based approach, and its novel pharmacologic class may offer unique advantages in the treatment of DNP and other CNS indications. The NIH, with whom the Company has an ongoing collaboration for this program, is also continuing its evaluation of TRV045 for epilepsy.
Financial Results for First Quarter 2021
For the first quarter of 2021, the Company reported a net loss attributable to common stockholders of $9.8 million, or $0.06 per share, compared to $5.7 million, or $0.06 per share, for the first quarter of 2020. This increase is primarily related to increases in commercialization activities for OLINVYK.
Cash and cash equivalents were $97.7 million as of March 31, 2021, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements through the fourth quarter of 2022.
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