On May 12, 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 March 31, 2022 and provided a corporate update (Press release, Spectrum Pharmaceuticals, MAY 12, 2022, View Source [SID1234614358]).
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"We anticipate FDA approvals later this year for poziotinib and eflapegrastim. In the first quarter, we initiated a confirmatory study and presented additional positive scientific data for poziotinib. The resubmitted BLA for eflapegrastim was also accepted for review by the FDA," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We are proud of the progress we’ve made toward our core business objectives and we remain dedicated to making a meaningful difference in the lives of cancer patients."
Pipeline Updates
Eflapegrastim, a novel long-acting G-CSF
The U.S. Food and Drug Administration (FDA) has accepted Spectrum’s resubmitted Biologics License Application (BLA) for eflapegrastim with a Prescription Drug User Fee Act (PDUFA) date of September 9, 2022. The company is working with its partner, Hanmi Pharmaceutical, to support the FDA regulatory review process.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon20 mutations
The New Drug Application (NDA) for poziotinib is under active review at the FDA with Fast Track designation. The NDA is based on the positive results of Cohort 2 in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The agency has set a PDUFA date of November 24, 2022. There is currently no FDA approved therapy for patients with NSCLC harboring HER2 exon 20 insertion mutations.
A study for poziotinib has been initiated 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 will be Progression Free Survival.
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 fall ODAC meeting is being held September 22-23, 2022. 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 appropriate recommendations to the FDA. As usual, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
Data from Cohort 4 of the ZENITH20 study in patients with treatment-naïve NSCLC harboring HER2 exon 20 insertion mutations were presented in an oral session at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2022. The results showed a confirmed objective response rate (ORR) of 41%, as evaluated centrally by an independent image review committee using RECIST 1.1 criteria. The evaluable patient population showed an ORR of 50%. The study met its primary endpoint as the observed lower bound of 30% exceeded the pre-specified lower bound of 20%. The safety profile was consistent with the tyrosine kinase inhibitor (TKI) class. Notably, on-target adverse events (AEs) were meaningfully reduced with BID dosing.
The company presented a poster on the predictive ability of circulating tumor DNA (ctDNA) in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. 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. Additional data from this study will be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting in early June.
Corporate Updates
Nora E. Brennan was named Chief Financial Officer effective May 25, 2022. Ms. Brennan has served on Spectrum’s Board of Directors since December 2020 and as Chair of the Audit Committee. She will relinquish her board duties to assume her new senior leadership role. Most recently, Ms. Brennan served as Chief Financial Officer of Fore Biotherapeutics, a developer of cancer therapies driven by functional genomics. Prior to Fore, she served as Chief Financial Officer at TELA Bio, Inc. and as Senior Vice President of Treasury and Investor Relations at Integra Life Sciences Holdings Corporation.
Hanmi Pharmaceutical completed a $20 million strategic equity investment in Spectrum in January 2022, which included revisions to the licensing and supply agreements for eflapegrastim and poziotinib.
Two new members of the Board of Directors have been named. In March, Juhyun Lim was appointed to the Board. Ms. Lim currently serves as President, Global Strategy and Planning at Hanmi Science and Hanmi Pharmaceutical, where she leads the execution of corporate strategy and investment. In May, Spectrum named Brittany Bradrick to the Board and she will succeed Ms. Brennan as Chair of the Audit Committee. Ms. Bradrick currently serves as Chief Financial Officer of Neurelis, Inc. Ms. Bradrick is a seasoned executive with 25 years of experience in the life sciences sector including in the areas of mergers and acquisitions, investment banking, finance, strategy and corporate development.
A strategic restructuring with a ~30% staff reduction and ~20-25% reduction in operating cash burn was initiated in January 2022 to focus the company’s development activities on its late-stage assets, poziotinib and eflapegrastim. Development activities for the early-stage pipeline has been deprioritized.
Three-Month Period Ended March 31, 2022 (All numbers are from Continuing Operations and are approximate)
GAAP Results
Spectrum recorded a net loss of $15.4 million, or a $0.09 loss per basic and diluted share, in the three-month period ended March 31, 2022, compared to a net loss of $35.7 million, or a $0.25 loss per basic and diluted share, in the comparable period in 2021. Total research and development expenses were $4.2 million in the quarter, as compared to $19.4 million in the same period in 2021. Selling, general and administrative expenses were $9.9 million in the quarter, compared to $14.3 million in the same period in 2021.
Non-GAAP Results
Spectrum recorded a non-GAAP net loss of $9.6 million, or a $0.06 non-GAAP loss per basic and diluted share, in the three-month period ended March 31, 2022, compared to a non-GAAP net loss of $29.4 million, or a $0.20 non-GAAP loss per basic and diluted share, in the comparable period in 2021. Non-GAAP research and development expenses were $2.1 million, as compared to $18.0 million in the same period of 2021. Non-GAAP selling, general and administrative expenses were $7.5 million, as compared to $11.5 million in the same period in 2021.
Cash Position and Guidance
In January, the company received a $20 million strategic equity investment from Hanmi Pharmaceutical. Together with this strategic investment, Spectrum ended the quarter with cash, cash equivalents, and marketable securities of approximately $89.2 million. The additional cash, combined with the restructuring, is expected to extend the company’s cash runway into 2023.
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 12, 2022 at 4:30 p.m. Eastern/1:30 p.m. Pacific.