Trevena Q1 2024 Results and Business Update

Trevena, Inc., a biopharmaceutical company listed on Nasdaq under the ticker TRVN, disclosed its financial performance for the first quarter ending March 31, 2024, along with recent operational updates. The company focuses on developing and commercializing novel therapies for central nervous system (CNS) disorders.

Carrie Bourdow, President and CEO of Trevena, highlighted the ongoing progress in the development of TRV045, a novel S1P receptor modulator. TRV045, which is being developed for chronic pain and epilepsy, has shown promising results in various studies, demonstrating a favorable safety profile and the potential to meet the demand for non-opioid pain therapies and new epilepsy treatments. The company expects data from an ongoing clinical pharmacokinetics (PK) study and other toxicology studies to be available in the second half of 2024.

During the first quarter, TRV045 continued to show positive outcomes in two proof-of-concept studies, supporting further investigation into its effectiveness for neuropathic pain and epilepsy. The drug maintained its favorable tolerability profile across three completed Phase 1 studies, and this trend persists in the ongoing PK study. The NIH-supported Epilepsy Therapy Screening Program (ETSP) is also examining TRV045 in additional epilepsy models, with results anticipated by mid-2024.

Trevena is conducting a strategic review of OLINVYK, its FDA-approved opioid analgesic for managing acute pain. The review is exploring various options, including potential sale, licensing, or discontinuation of U.S. commercial sales. The company has not committed to any specific timeline or outcome for this review.

In terms of financial performance, Trevena reported a net loss of $7.7 million, or $0.36 per share, for the first quarter of 2024, slightly lower than the $7.8 million, or $0.81 per share, net loss from the first quarter of 2023. The company's cash and cash equivalents totaled $23.6 million as of March 31, 2024. The Nasdaq Hearings Panel has granted Trevena an extension until August 28, 2024, to regain compliance with Nasdaq's continued listing requirements. The company is exploring various strategies to meet these requirements but acknowledges that there is no guarantee of success.

Trevena has made significant efforts to streamline operations, resulting in cost reductions of $3.5-$4.0 million annually, including a 35% reduction in workforce since the end of 2023. These measures are part of the company's broader strategy to optimize resource allocation and focus on its key development programs.

The company's product portfolio includes TRV045, which is currently in development for diabetic neuropathic pain and epilepsy. Trevena is also working on TRV250 for acute migraine treatment and TRV734 for maintenance treatment of opioid use disorder. These investigational drugs are based on Nobel Prize-winning research.

TRV045, a selective sphingosine-1-phosphate (S1P) receptor modulator, is being explored as a potential treatment for acute and chronic neuropathic pain due to diabetic peripheral neuropathy and epilepsy. The drug has shown effectiveness in reversing thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models. Importantly, TRV045 did not cause lymphopenia or affect blood pressure, heart rate, or respiratory function at therapeutic doses in these studies. However, TRV045 is still an investigational product and has not received FDA approval.

Meanwhile, OLINVYK, a new chemical entity approved by the FDA in August 2020, is an opioid analgesic indicated for adults with acute pain that requires intravenous opioid treatment when alternatives are inadequate. The drug, which contains oliceridine, a Schedule II controlled substance, is available in various dosages for patient-controlled analgesia (PCA). There are specific limitations and safety precautions associated with its use, including risks of addiction, respiratory depression, and potential interactions with other CNS depressants.

Trevena continues to explore strategic alternatives for OLINVYK while advancing its pipeline of innovative CNS therapies. The company remains committed to addressing unmet medical needs through the development of novel treatments.