On May 13, 2021 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that financial results for the three-month period ended March 31, 2021 and provided a corporate update (Press release, Spectrum Pharmaceuticals, MAY 13, 2021, View Source [SID1234579909]).
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"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 Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The additional data on twice daily dosing presented at AACR (Free AACR Whitepaper) 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) (Free AACR Whitepaper) 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 (Free ASCO Whitepaper).
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
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website View Source on May 13, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.