Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) reported topline results from Cohort 2. It provides meaningful data for the company to develop drugs for patients suffering from NSCLC HER2 exon 20 IM (insertion mutations). CEO of Spectrum, Joe Turgeon said the company is seeking a pre-NDA (New Drug Application) meeting with the US FDA to review the results.
BLA is under review by FDA
Spectrum said its BLA ROLONTIS is being reviewed by the US FDA. The date for Prescription Drug User Fee Act (PDUFA) is October 24, 2020. Joe said the company is sufficient cash for the commercialization efforts of its late-stage drug candidates and ongoing development activities.
Spectrum achieved a pre-specified primary endpoint for Poziotinib in Cohort 2 in Phase 2 clinical study. The company is investigating the drug to treat NSCLC (non-small cell lung cancer) in people suffering from HER2 exon 20 IM. Spectrum enrolled 90 patients for the ZENITH 20 clinical study. It orally administered 16 mg of poziotinib daily in all the 90 patients. A central imaging laboratory analyzed all the responses independently using RECIST criteria and ORR is 27.8%.
Spectrum will request FDA in its Pre-NDA meeting to allow the treatment of people, who are previously treated for metastatic NSCLC, using Poziotinib. The company enrolled patients for the Cohort 3 ZENITH clinical study and expects to release topline data by the end of this year.
Spectrum posted a net loss of $32.2 million in Q2 2020. Its expenses on R&D increased marginally to $21.7 million in Q2 2020 from $17 million in Q2 2019. SG&A expenses declined to $14.7 million in Q2 2020 from $17.2 million in Q2 2019. Its marketable securities, cash equivalents, and cash balance as of June 30, 2020, is $156.5 million. The underwriters of Spectrum’s previous public offering have fully exercised their options.
They purchased additional 3.25 million shares of Spectrum at $3 per each share. The company netted $9.2 million from this exercise on August 3, 2020. Overall, the company received net proceeds of $70.3 million by offering total shares of 24.916 million to the underwriters. Spectrum appointed Cantor Fitzgerald & Co. and Jefferies as BRM (book-running managers) for this offering.