On August 8, 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 June 30, 2019 (Press release, Spectrum Pharmaceuticals, AUG 8, 2019, View Source [SID1234538457]).

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"We’ve made significant progress on our pipeline in the last few months," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Most notably, we completed enrollment in our first two poziotinib cohorts in the ZENITH20 study and expect to see results from cohort 1 in the fourth quarter. Based on strong science, we’ve expanded the poziotinib development program to include additional areas of high unmet medical need in lung cancer. We also had a productive meeting with the FDA and expect to submit the ROLONTIS BLA in the fourth quarter."

Pipeline Overview:

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

The cornerstone poziotinb ZENITH20 trial currently consists of seven cohorts of patients with non-small cell lung cancer (NSCLC).
Cohorts Fully Enrolled
Cohort 1: Previously treated patients with EGFR exon 20 insertion mutation; topline results expected in the fourth quarter 2019
Cohort 2: Previously treated patients with HER2 exon 20 insertion mutation; topline results expected in mid-2020
Cohorts Currently Enrolling
Cohort 3: Treatment naïve patients with EGFR exon 20 insertion mutation
Cohort 4: Treatment naïve patients with HER2 exon 20 insertion mutation
Cohort 5: Previously treated or treatment naïve patients with EGFR or HER2 exon 20 insertion mutation
Cohort 6: Previously treated first-line osimertinib patients with acquired EGFR mutations
Cohort 7: Previously treated patients with atypical EGFR or HER2 mutation
Spectrum expects to initiate a basket study in H2 2019.
ROLONTIS (eflapegrastim), a novel long-acting GCSF:

Integrated data from both Phase 3 ROLONTIS clinical trials with 643 patients were presented in a poster session at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 annual meeting.
The analysis found that integrated efficacy and safety data from the two identically designed Phase 3 trials – ADVANCE and RECOVER – were consistent with results from the individual trials, demonstrating that ROLONTIS was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of treatment.
Spectrum met with the FDA and expects to submit the ROLONTIS BLA in the fourth quarter of 2019.
Business Development

In May 2019, Spectrum completed an asset purchase and license agreement with ImmunGene, Inc., a privately held biotechnology company.
The deal includes an exclusive license for the intellectual property related to the FIT antibody-interferon fusion technology drug delivery platform and two innovative early-stage drug candidates derived from the platform.
Originally developed by scientists at UCLA, the FIT platform fuses interferon with a monoclonal antibody providing a mechanism for targeting many different tumor antigens and has the potential for broad application in oncology.
Three-Month Period Ended June 30, 2019 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a loss of $28.8 million, or a loss of $0.26 per basic and diluted share, in the three-month period ended June 30, 2019, compared to income of $14.9 million, or $0.15 income per basic share and $0.14 per diluted share, in the comparable period in 2018. Total research and development expenses were $17.0 million in the quarter, as compared to $16.6 million in the same period in 2018. Selling, general and administrative expenses were $17.2 million in the quarter, compared to $16.4 million in the same period in 2018.

The company ended the quarter with cash, cash equivalents, restricted cash, and marketable securities of $282 million.

Non-GAAP Results

Spectrum recorded a non-GAAP loss of $25.2 million, or a non-GAAP loss of $0.23 per basic and diluted share, in the three-month period ended June 30, 2019, compared to a non-GAAP loss of $28.8 million, or a non-GAAP loss of $0.28 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $13.2 million, as compared to $15.4 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $13.7 million, as compared to $13.8 million in the same period in 2018.

Conference Call:

Thursday, August 8, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 5378656
International: (973) 796-5077, Conference ID# 5378656

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 August 8, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.