Spectrum Pharmaceuticals Reports First Quarter 2021 Financial Results and Corporate Update
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today financial results for the three-month period ended March 31, 2021 and provided a corporate update.
“Our top priority is submission of the NDA to the FDA for poziotinib based on the positive data from Cohort 2 of the ZENITH20 clinical trial,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “The additional data on twice daily dosing presented at AACR has the potential to significantly expand the value of poziotinib. We also look forward to the FDA’s pre-approval inspection of the ROLONTIS manufacturing facility which has been scheduled for later this month.”
Pipeline Updates
Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations
- Spectrum is actively working on its new drug application (NDA) for the use of poziotinib in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations. Submission of the NDA, based on the positive results of Cohort 2 from the ZENITH20 clinical trial, is planned for later this year.
-
New data was presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting 2021 from ZENITH20 Cohort 5 which demonstrated improved efficacy and tolerability for twice daily (BID) dosing. In the 38 patients, with EGFR or HER2 exon 20 insertion mutations, who received 16mg per day and randomized either to poziotinib 16mg once daily (QD) or 8mg BID in Cohort 5, improved responses were observed in the BID arm with
31.6% of patients reaching a partial response, and Grade 3 or higher related adverse events were reduced by approximately60% . Additionally, the BID dosing allowed for an improved rate of dose reductions and interruptions relative to the QD dose. - Faster enrollment is expected in Cohort 5 which is now dosing exclusively at 8mg BID.
- Enrollment of first-line patients with NSCLC HER2 exon 20 mutations is continuing for Cohort 4 of the ZENITH20 clinical trial. Poziotinib is being administered at a dose of 8mg BID in first line treatment.
- A poster titled “CNS activity of poziotinib in NSCLC with exon 20 insertion mutations” based on data from Cohorts 1-3 has been accepted for presentation at ASCO.
ROLONTIS (eflapegrastim), a novel long-acting G-CSF
- The FDA’s pre-approval inspection of the ROLONTIS manufacturing facility has been scheduled for later this month and pre-commercial preparation activities are underway.
Three-Month Period Ended March 31, 2021 (All numbers are from Continuing Operations and are approximate)
GAAP Results
Spectrum recorded a net loss of
The company ended the quarter with cash, cash equivalents, and marketable securities of
Non-GAAP Results
Spectrum recorded a non-GAAP net loss of
Conference Call
Thursday, May 13, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID# 1373243
International: (973) 796-5077, Conference ID# 1373243
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 https://investor.sppirx.com/events-and-presentations on May 13, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals please visit www.sppirx.com.
About ZENITH20
The ZENITH20 study consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2) have completed enrollment of previously treated NSCLC patients with exon 20 mutations. Cohorts 3 (EGFR) and 4 (HER2) are currently enrolling first-line NSCLC patients with exon 20 mutations. Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate (ORR). Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains.
Notice Regarding Forward-looking statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to Spectrum’s business and its future, including the likelihood and timing of the FDA approval of poziotinib, the timing of an NDA submission for poziotinib based on the positive results of Cohort 2 from the ZENITH20 clinical trial, the potential for an increase in the value of poziotinib using BID dosing, the speed of enrollment in Cohort 5, the timing of the FDA’s pre-approval inspection of the ROLONTIS manufacturing facility, whether the final safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial will continue to demonstrate similar results to the preliminary data, the future potential of Spectrum’s existing drug pipeline, the progression of the poziotinib and ROLONTIS development programs and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Spectrum and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. Risks that could cause actual results to differ include, but are not limited to, the uncertainties inherent in new product development, including clinical trial results and additional analysis of existing preclinical and clinical data, the possibility that Spectrum's new and existing drug candidates, including poziotinib, may not ultimately prove to be safe or effective, the possibility that Spectrum's new and existing drug candidates, if approved, may not be more effective, safer, or more cost-efficient than competing drugs, the possibility that the FDA postpones its pre-approval inspection of the ROLONTIS manufacturing facility past May 2021 and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Spectrum in general, see the risk disclosures in the Annual Report on Form 10-K of Spectrum for the year ended December 31, 2021, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Spectrum.
SPECTRUM PHARMACEUTICALS, INC.® and ROLONTIS® are registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals’ logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.
© 2021 Spectrum Pharmaceuticals, Inc. All Rights Reserved
SPECTRUM PHARMACEUTICALS, INC. |
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Condensed Consolidated Statements of Operations |
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(In thousands, except share and per share amounts) |
||||||||
(Unaudited) |
||||||||
|
Three Months Ended
|
|||||||
|
2021 |
|
2020 |
|||||
Revenues |
$ |
— |
|
|
$ |
— |
|
|
Operating costs and expenses: |
|
|
|
|||||
Selling, general and administrative |
14,315 |
|
|
14,794 |
|
|||
Research and development |
19,371 |
|
|
15,993 |
|
|||
Total operating costs and expenses |
33,686 |
|
|
30,787 |
|
|||
Loss from continuing operations before other income (expense) and income taxes |
(33,686 |
) |
|
(30,787 |
) |
|||
Other income (expense): |
|
|
|
|||||
Interest income, net |
84 |
|
|
704 |
|
|||
Other expense, net |
(2,081 |
) |
|
(10,534 |
) |
|||
Total other expense |
(1,997 |
) |
|
(9,830 |
) |
|||
Loss from continuing operations before income taxes |
(35,683 |
) |
|
(40,617 |
) |
|||
Benefit for income taxes from continuing operations |
7 |
|
|
— |
|
|||
Loss from continuing operations |
$ |
(35,676 |
) |
|
$ |
(40,617 |
) |
|
(Loss) income from discontinued operations, net of income taxes |
(21 |
) |
|
45 |
|
|||
Net loss |
$ |
(35,697 |
) |
|
$ |
(40,572 |
) |
|
|
|
|
|
|||||
Basic and diluted loss per share: |
|
|
|
|||||
Loss from continuing operations |
$ |
(0.25 |
) |
|
$ |
(0.36 |
) |
|
(Loss) income from discontinued operations |
$ |
0.00 |
|
|
$ |
0.00 |
|
|
Net loss per share, basic and diluted |
$ |
(0.25 |
) |
|
$ |
(0.36 |
) |
|
Weighted average shares outstanding, basic and diluted |
145,371,657 |
|
|
111,780,571 |
|
|||
SPECTRUM PHARMACEUTICALS, INC. |
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Condensed Consolidated Balance Sheets |
||||||||
(In thousands, except share and par value amounts) |
||||||||
(Unaudited) |
||||||||
|
March 31,
|
|
December 31,
|
|||||
ASSETS |
|
|
|
|||||
Current assets: |
|
|
|
|||||
Cash and cash equivalents |
$ |
69,521 |
|
|
$ |
46,009 |
|
|
Marketable securities |
93,336 |
|
|
134,016 |
|
|||
Accounts receivable, net |
64 |
|
|
67 |
|
|||
Other receivables |
2,795 |
|
|
2,394 |
|
|||
Prepaid expenses and other current assets |
3,491 |
|
|
4,161 |
Spectrum Pharmaceuticals, Inc.
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SPPI Stock DataAbout SPPIspectrum's core mission is to bring pharmaceutical products to patients for unmet medical needs. to this mission, we bring our years of drug development expertise, coupled with the insight of working in many different oncology indications. spectrum and its subsidiaries have six marketed oncology/hematology products, three for different types of non-hodgkins lymphoma, one for advanced metastatic colorectal cancer, one for a certain type of acute lymphoblastic leukemia (all) and one for multiple myeloma. there are two products in late-stage development, as well as a broad and diversified portfolio of proprietary drugs in various stages of development, all with a focus on oncology and hematology.
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