Trevena Releases Q2 2024 Results and Business Update

Trevena, Inc., a biopharmaceutical firm known for its focus on developing innovative treatments for central nervous system (CNS) disorders, has released its financial results for the second quarter ending June 30, 2024. The company also shared updates on its recent operational progress, notably advancements in the development of TRV045, a promising drug candidate for the treatment of neuropathic pain and epilepsy.

Throughout the second quarter, Trevena made significant strides in the development of TRV045. Preclinical data suggest that TRV045 has a potential long-term analgesic effect without evidence of receptor desensitization, which is a critical factor in pain management. Additionally, the drug candidate demonstrated a significant, dose-dependent increase in seizure thresholds, providing protection against seizures in preclinical models. These findings bolster the therapeutic potential and unique mechanism of action of TRV045, positioning it as a strong candidate for addressing the need for non-opioid therapies for neuropathic pain and epilepsy.

Financially, Trevena has successfully completed a $12 million financing round. This includes a non-dilutive $2 million tranche and a significant $10 million reduction in existing liabilities related to ex-US royalty financing. Specifically, the company received a $2 million payment from R-Bridge Healthcare Fund and may receive up to an additional $8 million based on achieving certain US commercial milestones for OLINVYK, another product in their portfolio. The outstanding liability associated with the Royalty Financing was reduced by $10 million through an amendment to their agreement.

Trevena also continues to review strategic alternatives for OLINVYK, a product designed for the management of acute pain requiring intravenous opioid analgesics. Potential strategic moves under consideration include sale, licensing, divestiture, or discontinuation of US commercial sales. However, there is no guarantee of the outcome or completion of any specific transaction.

For the second quarter of 2024, Trevena reported a net loss attributable to common stockholders of $4.9 million, equating to $0.23 per share. This is a decrease from the net loss of $8.0 million, or $0.69 per share, reported in the same period of the previous year. As of June 30, 2024, Trevena's cash and cash equivalents stood at $16.4 million, not accounting for the $2 million received from R-Bridge in July 2024.

Trevena's pipeline and focus on CNS disorders are built on Nobel Prize-winning research, featuring three key investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for acute migraine treatment, and TRV734 for maintenance treatment of opioid use disorder. The company is dedicated to developing and commercializing novel medicines that address significant unmet medical needs within CNS disorders.

TRV045, a selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator, is under development as a treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. In collaboration with the National Institutes of Health, Trevena is also exploring its potential for treating epilepsy. TRV045 has shown efficacy in reversing thermal hyperalgesia in preclinical models, with no associated lymphopenia or significant changes in cardiovascular or respiratory functions at therapeutic doses.

OLINVYK, another key product of Trevena, is an FDA-approved opioid for managing acute pain in adults when alternative treatments are inadequate. It comes in various dosages suitable for patient-controlled analgesia, though it carries significant risks associated with opioid addiction, misuse, and respiratory depression.

In summary, Trevena continues to advance its innovative treatment pipeline, supported by ongoing financial and strategic initiatives. The progress of TRV045 and the realignment of financial obligations position the company to address significant medical needs in the CNS disorder space, while maintaining a commitment to exploring strategic options for OLINVYK.