On March 17, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that financial results for the three-month period and full year ended December 31, 2021 (Press release, Spectrum Pharmaceuticals, MAR 17, 2022, View Source [SID1234610285]).

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"We have made significant progress against our core business objectives including the acceptance of the poziotinib NDA and resubmission of the eflapegrastim BLA to the FDA. We have also recently released positive data in front-line NSCLC patients harboring HER2 exon 20 insertion mutations," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Additionally, we have strengthened our strategic corporate partnerships, restructured our operations, and are focused on advancing our mission."

Pipeline Updates

Eflapegrastim, a novel long-acting G-CSF

The company has resubmitted the Biologics License Application (BLA) with an expected six-month review for eflapegrastim following remediation of manufacturing deficiencies. The FDA has indicated that a reinspection of the drug substance manufacturing facility in South Korea will be required.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon20 mutations

The New Drug Application (NDA) was accepted for review by the FDA under a 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 Prescription Drug User Fee Act (PDUFA) date of November 24, 2022. There is no FDA approved therapy for patients with NSCLC harboring HER2 exon 20 insertion mutations.
Data from Cohort 4 of the ZENITH20 study in patients with treatment-naïve NSCLC harboring HER2 exon 20 insertion mutations were recently delivered in an oral presentation 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% (95% CI:30%-54%), 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 AEs were reduced with BID dosing.
Preclinical data showing synergy of poziotinib combined with KRAS inhibitors in KRASG12C mutant specific cell lines, was presented in a poster titled "Pan-ErbB inhibition enhances activity of KRASG12C inhibitors in preclinical models of KRASG12C mutant cancers" at the AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (AACR-NCI-EORTC) (Free AACR-NCI-EORTC Whitepaper). The data showed that inhibition of EGFR, HER2, HER3, and HER4 (Pan ErbB) signaling was synergistic when combined with KRASG12C inhibitors.
Corporate Updates

As of December 31, 2021, Tom Riga, who had been serving as Chief Commercial and Chief Operating Officer became President and Chief Executive Officer of Spectrum Pharmaceuticals and joined the Board of Directors. On February 23, 2022, Kurt Gustafson, Chief Financial Officer, provided notice of his resignation to pursue other professional opportunities. His last day at the company is March 18, 2022. The company has initiated a selection process to name a new chief financial officer.
Hanmi Pharmaceutical completed a $20 million strategic equity investment in Spectrum in January 2022, which included revisions to the licensing agreement for eflapegrastim and poziotinib.
Juhyun Lim was appointed to the company’s Board of Directors. 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. She also serves as Director, Healthcare Investment at Hanmi Ventures.
Strategic restructuring with a ~30% staff reduction and ~20-25% reduction in operating cash burn was announced in January 2022 to focus the company’s development activities on late-stage assets, poziotinib and eflapegrastim. Further development activity for its early-stage pipeline have been deprioritized.
Three-Month Period Ended December 31, 2021 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $39.8 million, or $0.26 per basic and diluted share, in the three-month period ended December 31, 2021, compared to net loss of $49.9 million, or $0.36 per basic and diluted share, in the comparable period in 2020. Total research and development expenses were $18.0 million in the quarter, as compared to $47.2 million in the same period in 2020. Selling, general and administrative expenses were $18.9 million in the quarter, compared to $15.7 million in the same period in 2020.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $26.4 million, or $0.17 per basic and diluted share, in the three-month period ended December 31, 2021, compared to non-GAAP net loss of $28.9 million, or $0.20 per basic and diluted share, in the comparable period in 2020. Non-GAAP research and development expenses were $16.7 million, as compared to $17.1 million in the same period of 2020. Non-GAAP selling, general and administrative expenses were $10.2 million, as compared to $12.3 million in the same period in 2020.

Twelve-Month Period Ended December 31, 2021 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $158.4 million, or $1.02 per basic and diluted share, in the twelve-month period ended December 31, 2021, compared to net loss of $171.3 million, or $1.38 per basic and diluted share, in the comparable period in 2020. Total research and development expenses were $87.3 million for the year, as compared to $109.4 million in the same period in 2020. Selling, general and administrative expenses were $60.4 million for the year, compared to $60.4 million in the same period in 2020.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $120.7 million, or $0.78 per basic and diluted share, in the twelve-month period ended December 31, 2021, compared to non-GAAP net loss of $120.9 million, or $0.97 per basic and diluted share, in the comparable period in 2020. Non-GAAP research and development expenses were $79.2 million, as compared to $75.6 million in the same period of 2020. Non-GAAP selling, general and administrative expenses were $42.8 million, as compared to $47.2 million in the same period in 2020.

Cash Position and Guidance

Spectrum reported cash, cash equivalents, and marketable securities of approximately $100.6 million as of December 31, 2021, compared to $180 million at December 31, 2020. In January, the company received a $20 million strategic equity investment from Hanmi. The additional cash, combined with the restructuring, is expected to extend the company’s cash runway into 2023.

Conference Call

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 March 17, 2022 at 4:30 p.m. Eastern/1:30 p.m. Pacific.