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S SPECTRUM® PHARMACEUTICALS Redefining Cancer Care Spectrum Pharmaceuticals Reports Third Quarter 2021 Financial Results and Corporate Update November 10 , 2021 Poziotinib NDA is on track for submission in 2021 under a Fast Track designation Positive front line poziotinib data presented at ESMO Congress 2021 from Cohort 4 of the ZENITH20 clinical trial Preclinical data presented at 2021 AACR - NCI - EORTC ( Triple ) conference demonstrated the synergistic impact of poziotinib when combined with KRAS inhibitors in KRASG12C mutant specific cell line ROLONTIS® ( eflapegrastim ) CRL manufacturing deficiencies expected to be remediated by the end of the year Management to host webcast and conference call today at 4:30 p.m. ET / 1 : 30 p.m. PT HENDERSON , Nev .-- ( BUSINESS WIRE ) -- Nov . 10 , 2021-- Spectrum Pharmaceuticals , Inc. ( NasdaqGS : SPPI ) , a biopharmaceutical company focused on novel and targeted oncology therapies , today announced financial results for the three - month period ended September 30 , 2021 and provided a corporate update . " The submission of the poziotinib NDA this quarter remains our top corporate priority . The front line data presented at ESMO and the preclinical combination data with KRAS inhibitors at the Triple meeting has the potential to significantly expand the poziotinib opportunity , " said Joe Turgeon , President and CEO of Spectrum Pharmaceuticals . " Following a productive Type A meeting with the FDA on ROLONTIS , we anticipate the remediation efforts at Hanmi to be completed by the end of the year and would expect to resubmit our BLA for ROLONTIS shortly thereafter . " Poziotinib , an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations • Submission of the NDA , based on the positive results of Cohort 2 in patients with previously treated locally advanced or metastatic non - small cell lung cancer ( NSCLC ) with HER2 exon 20 insertion mutations is on track for this year under a Fast Track designation . There is currently no treatment specifically approved for this indication . ● Encouraging results from Cohort 4 of the ZENITH20 clinical trial were presented at the European Society of Medical ( ESMO ) Congress 2021. The primary endpoint of objective rate of response ( ORR ) was 44 % ( 95 % CI : 29.5-58.8 % ) in the first 48 treated patients including one complete response . 88 % of patients showed tumor reduction with a disease control rate of 75 % . Median duration of response was 5.4 months ( range 2.8-19.1 + ) . Median progression free survival was 5.6 months ( range 0-20.2 + ) . The most common treatment related Grade ≥ 3 adverse effects ( AES ) were rash , stomatitis , diarrhea , and paronychia . In addition , only one patient experienced Grade ≥ 3 pneumonitis . Poziotinib demonstrated clinically meaningful anti - tumor activity in newly diagnosed NSCLC patients with HER2 exon 20 mutations with 16mg QD dosing . The safety profile was manageable and similar to those observed in previous studies and other second - generation tyrosine kinase inhibitors . • Preclinical data showed the synergistic impact of poziotinib when combined with KRAS inhibitors in KRASG12C mutant specific cell lines . Jacqulyne Robichaux , Ph.D. , Assistant Professor , University of Texas , MD Anderson Cancer Center presented a poster titled " Pan - ErbB inhibition enhances activity of KRAS G12C inhibitors in preclinical models of KRASG12C mutant cancers " at the Virtual International Conference on Molecular Targets and Cancer Therapeutics hosted by the American Association for Cancer Research ( AACR ) , the National Cancer Institute ( NCI ) , and the European Organization for Research and Treatment of Cancer ( EORTC ) . The preclinical data showed that inhibition of EGFR , HER2 , HER3 , and HER4 signaling was synergistic when combined with KRASG12C inhibitors . These results highlight the importance of a pan inhibitor of the Erb family of proteins . ROLONTIS ( eflapegrastim ) , a novel long - acting G - CSF • The company held a Type A meeting with the U.S. Food and Drug Administration ( FDA ) to better understand the issues identified in the Complete Response Letter ( CRL ) . At that meeting , the company learned that the deficiencies at the fill finish site have been adequately addressed . Remediation of deficiencies at the drug substance facility are well under way and expected to be completed by the end of the year . The FDA confirmed that the reinspection of the drug substance facility would be in - person . Three - Month Period Ended September 30 , 2021 ( All numbers are from Continuing Operations and are approximate ) GAAP Results Spectrum recorded a net loss of $ 33.1 million , or $ 0.21 loss per basic and diluted share , in the three - month period ended September 30 , 2021 ,