On May 7, 2020 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, financial results for the three-month period ended March 31, 2020 (Press release, Spectrum Pharmaceuticals, MAY 7, 2020, View Source [SID1234557259]).
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"The progress in our development pipeline speaks to the investigator interest and the commitment of our team during these unprecedented times," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "The PDUFA date for ROLONTIS remains October 24, 2020 and our updated poziotinib strategy is well under way. We continue to drive the business forward and remain focused on achieving our milestones this year."
Pipeline Updates
ROLONTIS (eflapegrastim), a novel long-acting G-CSF
FDA is actively reviewing the BLA for ROLONTIS for the treatment of chemotherapy-induced neutropenia. The PDUFA target action date for the ROLONTIS BLA is October 24, 2020.
Company-sponsored study evaluating the administration of ROLONTIS on the same day as chemotherapy, dosed its first patient. The trial will evaluate the duration of severe neutropenia when administered at three different time points on the same day following standard chemotherapy in patients with early stage breast cancer.
Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations
Spectrum presented additional results for Cohort 1 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations at a plenary session of the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting on April 27, 2020. The podium presentation included additional safety and efficacy data. Although the results for Cohort 1 did not meet the primary endpoint, as previously announced, poziotinib demonstrated a 68.7% disease control rate.
Spectrum provided an update on its ZENITH20 trial evaluating poziotinib in NSCLC patients with EGFR and HER2 exon 20 insertion mutations. The protocol has been amended to explore additional dosing regimens and the earlier use of corticosteroids in an effort to increase drug compliance.
Cohort 2 of the ZENITH20 trial enrolling previously treated HER2 NSCLC patients is fully accrued as previously announced and is expected to have topline results released in mid-2020. Cohort 3 of the ZENITH20 trial enrolling first-line EGFR NSCLC patients is now fully enrolled and is expected to have topline results in the second half of 2020. Either cohort has the potential to support a future NDA submission.
Three-Month Period Ended March 31, 2020 (All numbers are from Continuing Operations and are approximate)
GAAP Results
Spectrum recorded a net loss of $40.6 million, or $0.36 loss per basic and diluted share, in the three-month period ended March 31, 2020, compared to net loss of $39.8 million, or $0.36 loss per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $16.0 million in the quarter, as compared to $21.9 million in the same period in 2019. Selling, general and administrative expenses were $14.8 million in the quarter, compared to $16.0 million in the same period in 2019.
The company ended the quarter with cash, cash equivalents, and marketable securities of $177.8 million.
Non-GAAP Results
Spectrum recorded a non-GAAP net loss of $25.0 million, or $0.22 per basic and diluted share, in the three-month period ended March 31, 2020, compared to a non-GAAP net loss of $29.2 million, or $0.27 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $14.6 million, as compared to $20.4 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $10.8 million, as compared to $10.7 million in the same period in 2019.
Conference Call and Webcast
Spectrum’s management will host a webcast and conference call today, May 7, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 8470139. A live webcast of the call will be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.