On November 7, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period ended September 30, 2019 (Press release, Spectrum Pharmaceuticals, NOV 7, 2019, View Source [SID1234550611]).

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"Spectrum has an expanding pipeline, significant near-term milestones, solid capitalization and a highly focused team," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "In December, we look forward to results from Cohort 1 of our ZENITH20 study investigating poziotinib in lung cancer patients with hard-to-treat mutations. We recently submitted our BLA for ROLONTIS to the FDA, a key milestone, as we continue to execute on our strategic priorities."

Pipeline Updates

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Topline results from the EGFR previously treated non-small cell lung cancer cohort (Cohort 1) in the ZENITH20 trial are expected in December. These data could potentially support a New Drug Application (NDA) filing with the FDA.
The HER2 previously-treated non-small cell lung cancer cohort (Cohort 2) of the ZENITH20 trial is fully accrued and is expected to have topline results by mid-year 2020. This cohort also has the potential to support an NDA filing with the FDA in the future.
A basket study has been initiated to investigate poziotinib in patients with EGFR or HER2 mutation-positive malignant solid tumors in an investigator-led study, with the first patient enrolled at The University of Texas MD Anderson Cancer Center.
In September, new preclinical data from The University of Texas MD Anderson Cancer Center, was presented during the IASLC 2019 World Conference on Lung Cancer in Barcelona, Spain. These scientific data support the recently announced expansion of the ZENITH20 trial.
ROLONTIS (eflapegrastim), a novel long-acting GCSF

Spectrum submitted the ROLONTIS BLA to the FDA on October 24, 2019.
In October, Spectrum presented a poster at the ASCO (Free ASCO Whitepaper) Supportive Care in Oncology Symposium in San Francisco, CA, highlighting integrated efficacy data from the Phase 3 ROLONTIS clinical trials, ADVANCE and RECOVER which studied more than 600 patients combined and met all primary and secondary endpoints.
Integrated safety data from the ROLONTIS studies will be presented at the San Antonio Breast Cancer Symposium meeting in December.
Three-Month Period Ended September 30, 2019 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a loss of $26.6 million, or $0.24 loss per basic and diluted share, in the three-month period ended September 30, 2019, compared to net loss of $69.2 million, or $0.66 loss per basic and diluted share, in the comparable period in 2018. Total research and development expenses were $17.2 million in the quarter, as compared to $15.3 million in the same period in 2018. Selling, general and administrative expenses were $13.1 million in the quarter, compared to $13.1 million in the same period in 2018.

The company ended the quarter with cash, cash equivalents, restricted cash, and marketable securities of $252 million.

Non-GAAP Results

Spectrum recorded a non-GAAP loss of $24.5 million, or a non-GAAP loss of $0.22 per basic and diluted share, in the three-month period ended September 30, 2019, compared to a non-GAAP loss of $25.3 million, or a non-GAAP loss of $0.24 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $16.1 million, as compared to $14.7 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $9.9 million, as compared to $11.1 million in the same period in 2018.

Conference Call:

Thursday, November 7, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 1469173
International: (973) 796-5077, Conference ID# 1469173

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 November 7, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.