Spectrum Therapeutics Inc. (NASDAQ:SPPI) has announced its financial results for the third quarter ended September 30, 2020.
FDA to review poziotinib NDA
Joe Turgeon the company’s CEO and President, stated that in Q3 Spectrum Therapeutics made significant progress in its drug development programs and also strengthened its financial position. The Spectrum Therapeutics team is currently preparing for its upcoming poziotinib pre-NDA meeting with the FDA. Poziotinib is an irreversible tyrosine kinase inhibitor that targets HER2 and EGFR mutations. Turgeon added that the company is working on getting approval for ROLONTIS as quickly as possible.
The company will review the encouraging results from cohort two poziotinib study with the FDA in a pre-NDA meeting. They will also discuss the registration pathway for poziotinib for treating patients that had previously received treatment for metastatic or locally advanced non-small cell lung cancer with HER2 exon 20 insertion mutations. In September, Spectrum Therapeutics presented results from Cohort 2 at this year’s Virtual European Society for Medical Oncology (ESMO) Congress. Interestingly this was the first presentation to the scientific and medical community of positive data from the registration cohort in the ZENITH20 clinical trial. The company is planning to offer updates on poziotinib that include top-line results and dosing strategy from Cohort 3 of the ZENITH20 study in first-line EGFR non-small cell lung cancer patients by the end of this year.
FDA defers ROLONTIS BLA action
During the quarter the FDA postponed its action on ROLONTIS BLA because of the inability to conduct inspections at the Hanmi Bioplant in South Koreas due to travel restrictions related to the pandemic. The company has confirmed that the deferral of action by the agency is not a Complete Response Letter, and it is working to establish ways of expediting the inspection of the plant.
In the third quarter, the company posted a net loss of $48.5 million or $0.37 per share compared to a net loss of $26.6 million or $0.24 per share a year ago. Spectrum ended the quarter with $198.3 million in cash and equivalents.