![]() ![]() The $4.0 million decrease is primarily due to lower costs associated with employee compensation, benefits, and other headcount related expenses related to the reduction of workforce announced in January, as well as decreases in stock-based compensation. Selling, General and Administrative expenses were $8.3 million during the quarter, compared to $12.2 million in the same period in 2021. The $7.5 million decrease is primarily attributable to completed program spend associated with ROLVEDON, as well as a decrease in personnel-related expenses of $3.0 million related to the strategic restructuring that began in January 2022. Total research and development expenses were $13.3 million during the quarter, compared to $20.9 million in the same period in 2021. Three-Month Period Ended Septem(All numbers are from Continuing Operations) “While we are disappointed by the ODAC vote on poziotinib, we are awaiting the final response from the FDA and will continue to act in the best interest of the Company, our shareholders, and the patients who need our medicines.” Importantly, we have been preparing for this milestone and have the financial runway to support ROLVEDON in the marketplace,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. ![]() We are proud that the product became commercially available in October and are excited to be competing in an estimated $2 billion market opportunity. “The approval of ROLVEDON marks a significant accomplishment for Spectrum and our partner Hanmi Pharmaceutical. The PDUFA date for poziotinib is scheduled for November 24, 2022. Food and Drug Administration’s (“FDA”) Oncologic Drugs Advisory Committee (“ODAC”) reviewed poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer (“NSCLC”) harboring HER2 exon 20 insertion mutations and voted 9-4 that the current benefits of poziotinib do not outweigh its risks. Launched ROLVEDON™ (eflapegrastim-xnst) injection for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia into an estimated approximately $2 billion market.Ĭlosed on debt financing with SLR Capital Partners, LLC (SLR) for a term loan facility of up to $65 million, of which $30 million was funded at closing.Īs of September 30, 2022, the Company had $100.3 million of cash, cash equivalents, and marketable securities available to optimize the ROLVEDON commercial launch and extends the Company’s cash runway through 2024. Third Quarter 2022 and Recent Business Update (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today financial results for the three-month period ended Septemand provided a corporate update. Management to host webcast and conference call today at 4:30 p.m. Cash runway expected to extend through 2024. ROLVEDON™ (eflapegrastim-xnst) injection is now commercially available. ![]()
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