CHESTERBROOK, Pa., May 11, 2022 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the first quarter ended March 31, 2022 and provided an overview of its recent operational highlights.
“In the first quarter, we began to see hospitals opening up post the pandemic as evidenced by accelerated field execution of the OLINVYK strategy and an increase in educational programs and training,” said Carrie Bourdow, President and CEO of Trevena. “We also remained focused on advancing the clinical studies for OLINVYK and TRV045, our novel S1P receptor modulator and we strengthened our balance sheet following receipt of the initial $15 million tranche of our ex-US royalty-based financing.”
First Quarter 2022 and Recent Corporate Highlights
OLINVYK (oliceridine) injection Milestones
- Continued progress on launch execution. Initiated launch acceleration and refocus of field sales organization in mid-February which led to 2,500 customer calls in the first quarter concentrated in critical care areas such as burn, colorectal and anesthesiology. 90% of customer interactions have been executed in an impactful face-to-face forum versus virtual engagements, and awareness is increasing via a presence at national congresses.
- Announced results from respiratory physiology study in elderly/overweight subjects. The Company announced topline results from its double blinded, crossover study evaluating OLINVYK injection versus IV morphine for the management of acute pain in elderly/overweight subjects. The study was completed in collaboration with Dr. Albert Dahan and his research team at Leiden University Medical Center (LUMC). The data showed that OLINVYK had a significantly reduced impact on respiratory function compared to IV morphine among elderly/overweight subjects. The data replicated the results from a previously reported study in younger subjects. Dr. Dahan and his team are expected to report these results to the wider scientific community and submit for publication later this year. As with all opioids, serious, life-threatening, or fatal respiratory depression may occur in patients treated with OLINVYK as indicated in the boxed warning.
- Top-line data from OLINVYK post-approval clinical outcomes studies expected later this year. The Company expects to report topline data by mid-2022 from a study designed to assess the potential changes in cognitive function in subjects treated with OLINVYK compared to IV morphine. The study is being conducted in collaboration with the Netherlands-based Center for Human Drug Research. In addition, the Company expects to report topline data in the second half of 2022 from the VOLITION study, which is assessing the potential impact of OLINVYK on respiratory, gastrointestinal (GI), and cognitive function outcomes in the postoperative setting. The study is being led by clinical outcomes research experts from the Cleveland Clinic and the Wake Forest Baptist Health Medical Center.
- Closed $40M ex-US royalty-based financing agreement with R-Bridge Healthcare Fund in March 2022 and received first $15 million tranche in April 2022. The Company announced it received the $15 million upfront tranche from its financing agreement with R-Bridge Healthcare Fund. The transaction is mainly focused on OLINVYK royalties expected from Trevena’s partner in China, Jiangsu Nhwa Pharmaceutical. Trevena will receive an additional $15 million upon first commercial sale of OLINVYK in China as well as a $10 million tranche based on a financing or commercial milestone. If approved by year-end 2023, repayment will be limited to Chinese royalties from Nhwa, plus a 4% royalty (capped at $10 million) on OLINVYK US net sales. Trevena retains all milestones from its partnership with Nhwa, including a potential $3 million milestone on Chinese approval.
Pipeline Updates
- Advanced Phase 1 study of TRV045, our novel S1P receptor modulator, for diabetic neuropathic pain. TRV045 is a novel, selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy with potential application to other rare or orphan seizure disorders. S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy and, in nonclinical studies, produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses.
- Announced TRV027 enrollment in COVID-19 patients ceased as part of ACTIV-4 Host Tissue platform study. The Company announced that it received notice that enrollment for TRV027 as part of the ACTIV-4 Host Tissue platform study has been halted. Based upon data at the interim analysis, the Data and Safety Monitoring Board (DSMB) unfortunately recommended that certain trials in the ACTIV-4 Platform, including the TRV027 vs placebo trial, should cease enrollment. The 90-day follow up of participants in the TRV207 trial will proceed as planned. Details about the trial results and conclusions will be disseminated once all data have been fully analyzed.
Financial Results for First Quarter 2022
For the first quarter of 2022, the Company reported a net loss attributable to common stockholders of $16.4 million, or $0.10 per share, compared to $9.8 million, or $0.06 per share, for the first quarter of 2021.
Cash and cash equivalents were $48.7 million as of March 31, 2022, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements into 2023. This cash balance does not include proceeds from the receipt in April of the first $15 million tranche from the royalty-based financing agreement with an affiliate of R Bridge Healthcare Fund.
In addition, the Company announced its Annual General Meeting will be held on June 9th, 2022. In the definitive proxy statements, the Company is requesting approval for additional authorized shares. The proposal would result in no immediate dilution for stockholders. The increase in authorized shares is intended to provide flexibility to execute on the Company’s business development opportunities, achieve the $10M tranche from our R-Bridge financing, and advance the Company’s products and pipeline.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
About OLINVYK® (oliceridine) injection
OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
