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S SPECTRUM PHARMACEUTICALS Redefining Cancer Care Spectrum Pharmaceuticals Reports First Quarter 2021 Financial Results and Corporate Update May 13 , 2021 Poziotinib NDA on track for 2021 submission New poziotinib twice daily dosing ( BID ) data presented at AACR demonstrated improved anti - tumor activity and better tolerance FDA pre - approval inspection at the ROLONTIS® manufacturing facility scheduled for May 2021 Management to host webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT HENDERSON , Nev .-- ( BUSINESS WIRE ) --May 13 , 2021-- Spectrum Pharmaceuticals , Inc. ( NasdaqGS : SPPI ) , a biopharmaceutical company focused on novel and targeted oncology therapies , announced today financial results for the three - month period ended March 31 , 2021 and provided a corporate update . " Our top priority is submission of the NDA to the FDA for poziotinib based on the positive data from Cohort 2 of the ZENITH20 clinical trial , " said J oe Turgeon , President and CEO of Spectrum Pharmaceuticals . " The additional data on twice daily dosing presented at AACR has the potential to significantly expand the value of poziotinib . We also look forward to the FDA's pre - approval inspection of the ROLONTIS manufacturing facility which has been scheduled for later this month . " Pipeline Updates Poziotinib , an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations • Spectrum is actively working on its new drug application ( NDA ) for the use of poziotinib in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations . Submission of the NDA , based on the positive results of Cohort 2 from the ZENITH20 clinical trial , is planned for later this year . • New data was presented at the American Association for Cancer Research ( AACR ) Virtual Annual Meeting 2021 from ZENITH20 Cohort 5 which demonstrated improved efficacy and tolerability for twice daily ( BID ) dosing . In the 38 patients , with EGFR or HER2 exon 20 insertion mutations , who received 16mg per day and randomized either to poziotinib 16mg once daily ( QD ) or 8mg BID in Cohort 5 , improved responses were observed in the BID arm with 31.6 % of patients reaching a partial response , and Grade 3 or higher related adverse events were reduced by approximately 60 % . Additionally , the BID dosing allowed for an improved rate of dose reductions and interruptions relative to the QD dose . • Faster enrollment is expected in Cohort 5 which is now dosing exclusively at 8mg BID . • Enrollment of first - line patients with NSCLC HER2 exon 20 mutations is continuing for Cohort 4 of the ZENITH20 clinical trial . Poziotinib is being administered at a dose of 8mg BID in first line treatment . • A poster titled " CNS activity of poziotinib in NSCLC with exon 20 insertion mutations " based on data from Cohorts 1-3 has been accepted for presentation at ASCO . ROLONTIS ( eflapegrastim ) , a novel long - acting G - CSF • The FDA's pre - approval inspection of the ROLONTIS manufacturing facility has been scheduled for later this month and pre - commercial preparation activities are underway . Three - Month Period Ended March 31 , 2021 ( All numbers are from Continuing Operations and are approximate ) GAAP Results Spectrum recorded a net loss of $ 35.7 million , or $ 0.25 loss per basic and diluted share , in the three - month period ended March 31 , 2021 , compared to a net loss of $ 40.6 million , or $ 0.36 loss per basic and diluted share , in the comparable period in 2020. Total research and development expenses were $ 19.4 million in the quarter , as compared to $ 16.0 million in the same period in 2020. Selling , general and administrative expenses were $ 14.3 million in the quarter , compared to $ 14.8 million in the same period in 2020 . The company ended the quarter with cash , cash equivalents , and marketable securities of $ 162.9 million . Non - GAAP Results Spectrum recorded a non - GAAP net loss of $ 29.4 million , or $ 0.20 loss per basic and diluted share , in the three - month period ended March 31 , 2021 , compared to a non - GAAP net loss of $ 25.0 million , or $ 0.22 loss per basic and diluted share , in the comparable period in 2020. Non - GAAP research and development expenses were $ 18.0 million , as compared to $ 14.6 million in the same period of 2020. Non - GAAP selling , general and administrative expenses were $ 11.5 million , as compared to $ 10.8 million in the same period in 2020 . Conference Call