CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company, reported its financial results for the first quarter ended March 31, 2023, and provided an overview of its recent operational highlights.
“This is an important year for Trevena as we expect topline data from two TRV045 proof-of-concept studies, one to support potential use in epilepsy and the other in chronic pain, and new OLINVYK respiratory data from the VOLITION study with Cleveland Clinic,” said Carrie Bourdow, President and CEO of Trevena. “We were also pleased that Jiangsu Nhwa recently received approval of OLINVYK in China which will allow patients there to have access to this innovative therapeutic option”.
First Quarter 2023 and Recent Corporate Highlights
- OLINVYK receives Chinese regulatory approval; milestone and expected near-term commercialization provides up to $18 million of non-dilutive funding for Trevena. Jiangsu Nhwa Pharmaceutical (Nhwa) recently announced regulatory approval of OLINVYK from the National Medical Products Administration (NMPA) of China. Based on this approval, the Company is eligible to receive a $3 million milestone payment from Nhwa (the Nhwa Milestone) and upon first commercial sale by Nhwa, which Nhwa expects in 3Q 2023, the Company may receive an additional $15 million non-dilutive funding tranche through its ex-US royalty-based financing with R-Bridge Healthcare Fund (the R-Bridge Financing).
- TRV045 topline data expected in 3Q for two proof-of-concept studies, one supporting continued development for potential use in epilepsy and the other in chronic pain. TRV045 is a novel S1P modulator selective for the S1P receptor subtype 1. The TRV045 Target Engagement Study and the Transcranial Magnetic Stimulation Study are each enrolling subjects, with enrollment completion expected by mid-2023. The studies will help inform the Company’s future development path for TRV045, which has shown promising anti-inflammatory data in nonclinical models suggesting a potential disease-modifying role in CNS disorders. Subjects are being enrolled at study sites outside of the United States. The studies are not being conducted under the Investigational New Drug Application (IND) for TRV045.
- Recent Electronic Medical Records (EMR) data from the ARTEMIS study provides additional clinical support for the use of OLINVYK. The Company recently announced OLINVYK initial topline EMR data and has incorporated these data in its medical information resources. The data includes the statistically significant 1.6-day (~27%) reduction in average hospital length of stay vs matched patients treated with other IV opioids in ARTEMIS patients at Wake Forest Baptist Health. There was no statistically significant difference in the average duration of time in the PACU in this study. While an EMR analysis does not provide definitive data regarding group differences, as seen in a prospectively randomized study, the Company believes the EMR data bring a unique perspective to understanding how drugs may perform in the real world.
- Respiratory data from real-world VOLITION study anticipated mid-2023. In March 2023, the Company reported initial top-line data from the VOLITION study, a 203 patient, real-world, open-label, multi-site study led by clinical outcomes research experts from Cleveland Clinic and Wake Forest Baptist Medical Center. The data from the study demonstrated over 50% GI complete response rate (defined as a patient who did not vomit and did not require the use of antiemetics throughout the post-operative period) and less than 4% incidence of symptoms suggestive of delirium in patients treated with OLINVYK. The Company expects to report respiratory data from this study, assessed by continuous respiratory monitoring, in mid-2023. Additional health utilization data and cost analyses are also expected in mid-2023.
Financial Results for First Quarter 2023
For the first quarter of 2023, the Company reported a net loss attributable to common stockholders of $7.8 million, or $0.81 per share, compared to $16.4 million, or $2.48 per share in the first quarter of 2022.
Cash, cash equivalents and marketable securities were $27.4 million as of March 31, 2023, which the Company believes will be sufficient to fund the Company’s operations through year-end 2023. Together with the expected $3 million Nhwa Milestone payment and $15 million available under the R-Bridge Financing upon Nhwa’s first commercial sale of OLINVYK in China, the Company believes this will be sufficient to fund operations to mid-2024.
For more information, visit www.Trevena.com.
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