On August 11, 2022 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, 2022 and provided a corporate update (Press release, Spectrum Pharmaceuticals, AUG 11, 2022, View Source [SID1234618092]).

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"The completion of the FDA re-inspection of the drug substance facility for eflapegrastim is a critical step in the regulatory review process. With this hurdle behind us, we have turned our focus to our potential approval and commercialization," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Additionally, our team is engaged in extensive preparations ahead of poziotinib’s ODAC review in September, and we look forward to moving a step closer to bringing this therapy to patients."

Pipeline Updates

Eflapegrastim, a novel long-acting G-CSF

The Biologics License Application (BLA) for eflapegrastim is under active review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of September 9, 2022. The pre-approval inspection of the drug substance manufacturing facility has been completed by the FDA. The company anticipates an FDA decision by the PDUFA date and is actively preparing for the potential commercial launch.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon 20 mutations

The New Drug Application (NDA) for poziotinib is under active review at the FDA with Fast Track designation and a PDUFA date of November 24, 2022. The NDA is based on the positive results of Cohort 2 from the ZENITH20 clinical trial in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. There is currently no FDA approved therapy for patients with NSCLC harboring HER2 exon 20 insertion mutations.
An abstract showing a high level of activity for poziotinib in patients with a G778_P780dup mutation, the second most prevalent mutation in HER2 exon 20 NSCLC, has been accepted for presentation at ESMO (Free ESMO Whitepaper) 2022 being held September 9-13 in Paris. The data comes from Cohorts 2 and 4 of the ZENITH20 clinical trial.
A study for poziotinib is in progress to confirm the clinical benefit seen in Cohort 2, as required for an accelerated approval. The trial, Study SPI-POZ-301 (PINNACLE), is designed to enroll 268 patients with previously treated NSCLC harboring HER2 exon 20 mutations. Patients are being randomized 2-to-1 into one of two treatment arms using 8mg of poziotinib orally administered BID (twice daily) versus 75mg/m2 of docetaxel administered intravenously every three weeks. The primary endpoint is progression free survival.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) is scheduled to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations. The poziotinib ODAC review is scheduled for September 22, 2022 at 9 a.m. ET. ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes non-binding recommendations to the FDA. The final decision regarding the approval of the product is made solely by the FDA.
The company presented data on the predictive ability of circulating tumor DNA (ctDNA) in poziotinib treated patients with NSCLC harboring HER2 exon 20 insertion mutations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June. Preliminary results suggest that decreases in plasma ctDNA during poziotinib therapy correlate with clinical response in patients with advanced NSCLC with HER2 exon 20 insertion mutations.
Three-Month Period Ended June 30, 2022 (All numbers are from Continuing Operations)

Spectrum recorded a net loss of $29.0 million, or a $0.17 loss per basic and diluted share, in the three-month period ended June 30, 2022, compared to a net loss of $49.9 million, or a $0.32 loss per basic and diluted share, in the comparable period in 2021. Total research and development expenses were $16.0 million in the quarter, as compared to $29.1 million in the same period in 2021. Selling, general and administrative expenses were $9.4 million in the quarter, compared to $15.0 million in the same period in 2021.

Cash Position and Guidance

The company’s cash, cash equivalents and marketable securities balance was approximately $68 million at June 30, 2022, which provides for a cash runway into 2023.

Conference Call

Thursday, August 11, 2022 @ 8:30 a.m. Eastern/5:30 a.m. Pacific

To access the live call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, participants are encouraged to dial into the conference call fifteen minutes ahead of the scheduled start time.

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 11, 2022 at 8:30 a.m. Eastern/5:30 a.m. Pacific.