Business Overview and History

Trevena, Inc. (TRVN) is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders. The company has faced a range of challenges in recent years, but it continues to pursue innovative solutions to address unmet medical needs in the CNS space.

Trevena was founded in 2007 with a focus on developing and commercializing novel therapeutics for CNS disorders. In late 2017, the company submitted a new drug application (NDA) for its lead product candidate, OLINVYK (oliceridine) injection, to the United States Food and Drug Administration (FDA). After a period of review, the FDA approved the NDA for OLINVYK in August 2020, marking a major milestone for the company.

OLINVYK is an opioid agonist designed to provide pain relief with a differentiated safety and tolerability profile compared to conventional IV opioids. It is indicated for use in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Trevena initiated the commercial launch of OLINVYK in the first quarter of 2021. However, the company has faced significant challenges in commercializing the product, particularly in the hospital environment, which has proven to be difficult for driving meaningful sales.

In addition to OLINVYK, Trevena has been developing a pipeline of other product candidates. This includes TRV045, a novel sphingosine-1-phosphate (S1P) receptor modulator being evaluated for the treatment of chronic pain, epilepsy, and seizure disorders, as well as TRV734 for the treatment of moderate-to-severe acute and chronic pain and opioid use disorders. While the company has made progress in advancing these pipeline candidates, it has also faced setbacks and delays along the way.

Financial Overview

Trevena's financial performance has been impacted by the challenges in commercializing OLINVYK. For the nine months ended September 30, 2024, the company reported total revenue of $628,000, which included $13,000 in product revenue and $615,000 in license and royalty revenue. The company's net loss for the same period was $17.51 million, or $20.54 per share.

For the three months ended September 30, 2024, Trevena recorded negative $21,000 in product revenue due to a returns reserve adjustment of $26,000. This compares to $1,000 in product revenue for the same period in 2023. License and royalty revenue for Q3 2024 was $304,000, up from $179,000 in Q3 2023, primarily due to royalties earned on OLINVYK sales by Trevena's licensee, Jiangsu Nhwa Pharmaceutical Co. Ltd., in China.

The company's total revenue for Q3 2024 was $283,000, with a quarterly net loss of $4.94 million. This represents an improvement from the net loss of $7.9 million in Q3 2023.

Cost of goods sold for the three and nine months ended September 30, 2024 decreased slightly compared to the same periods in 2023, due to a reduction in indirect overhead costs. Selling, general and administrative expenses decreased by $0.7 million, or 15%, for Q3 2024 and by $2.5 million, or 16%, for the nine months ended September 30, 2024 compared to the prior year periods, primarily due to a reduction in full-time employees and marketing activities.

Research and development expenses decreased by $2.4 million, or 56%, for Q3 2024 and by $3.2 million, or 26%, for the nine months ended September 30, 2024 compared to the same periods in 2023. The decreases were driven by lower spend on the company's TRV045 program, which had studies completed in 2023, as well as lower personnel costs.

Liquidity

As of September 30, 2024, Trevena had $13.46 million in cash and cash equivalents, $282,000 in restricted cash, and $32.87 million in loans payable, net. The company's current ratio and quick ratio both stand at 2.42. The company's management has concluded that its existing balance of cash and cash equivalents is not sufficient to fund its operating expenses and capital expenditure requirements for one year after the date of the most recent filing, and has therefore expressed substantial doubt about the company's ability to continue as a going concern.

Challenges and Pivots

Trevena has faced several challenges in recent years, including the difficulties in commercializing OLINVYK and the company's ongoing financial constraints. In October 2024, the company received notice that the Nasdaq Hearings Panel had determined to delist its common stock from the Nasdaq Stock Market due to the company's failure to comply with the minimum stockholders' equity requirement.

In response to these challenges, Trevena has taken several actions, including substantially eliminating commercial support for OLINVYK and exploring strategic alternatives for the product. These alternatives may include a sale, license, divestiture or discontinuation of U.S. commercial sales of OLINVYK or a sale, merger or wind down of the company. While OLINVYK remains available for purchase by customers, the company has significantly reduced its marketing efforts to preserve capital.

Trevena has also focused on advancing its pipeline, particularly the development of TRV045 for chronic pain, epilepsy, and seizure disorders. The company recently announced positive data from two clinical proof-of-concept studies for TRV045, demonstrating statistically significant analgesic effect in a neuropathic pain model and evidence of central nervous system activity.

Trevena has also undergone leadership changes, with the termination of employment of its President and Chief Executive Officer, Executive Vice President and Chief Operating Officer, and Senior Vice President and Chief Medical Officer in October 2024. The company's Board of Directors has also seen significant changes, with the resignation of four directors in November 2024.

Outlook and Catalysts

Despite the challenges Trevena has faced, the company's pipeline, particularly TRV045, continues to hold promise. The positive data from the proof-of-concept studies for TRV045 suggest that the product candidate may offer a new, non-opioid approach to managing chronic pain and addressing seizure disorders.

However, the company's financial situation remains a significant concern, and its ability to continue operations is uncertain. Trevena will need to secure additional funding or pursue a strategic transaction to support the continued development of its pipeline and maintain operations.

Investors should closely monitor Trevena's progress in exploring strategic alternatives for OLINVYK, as well as the advancement of TRV045 through clinical trials. The company's ability to navigate the current challenges and successfully develop and commercialize its pipeline will be critical to its long-term success.

Conclusion

Trevena has faced a series of challenges in recent years, from the difficulties in commercializing OLINVYK to its ongoing financial constraints. However, the company's pipeline, particularly TRV045, continues to hold promise, and Trevena is exploring strategic alternatives to address its current situation.

Investors in Trevena will need to closely monitor the company's progress as it navigates these challenges and pursues innovative solutions in the CNS space. While the path forward may not be straightforward, Trevena's commitment to developing novel therapies for patients with CNS disorders remains a key focus for the company.