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Mar 31, 2020
Trevena Q1 2020 Earnings Report
Trevena reported financial results for the first quarter ended March 31, 2020.
Key Takeaways
Trevena reported a net loss of $5.7 million for the first quarter of 2020. The company's cash and cash equivalents were $28.1 million at the end of the quarter, expected to fund operations into the first quarter of 2021. The FDA's review of the oliceridine NDA resubmission is ongoing with a decision expected by August 7.
FDA review of oliceridine NDA is ongoing with a PDUFA date of August 7, 2020.
IND filing for novel S1P modulator (TRV045) is expected in 1H 2021.
Ongoing collaboration with NIH to evaluate TRV045 for epilepsy and pain.
Net loss attributable to common stockholders was $5.7 million, or $0.06 per share.
Trevena
Trevena
Forward Guidance
Trevena expects to receive a decision from the FDA regarding the oliceridine NDA resubmission by August 7. The company believes its cash and cash equivalents are sufficient to fund operating expenses and capital expenditure requirements into the first quarter of 2021.
Positive Outlook
- FDA accepted the NDA resubmission for oliceridine.
- FDA engagement in the review process is viewed positively.
- NIH is investigating TRV045 as a potential non-addictive treatment for various acute and chronic pain conditions.
- Cash and cash equivalents are expected to fund operations into the first quarter of 2021.
Challenges Ahead
- Increase in net loss primarily due to higher research and development expenses.
- Uncertainties inherent in conducting clinical trials.
- Uncertainties related to the ongoing COVID-19 pandemic.
- Dependence on FDA approval of oliceridine.