SPPI Spectrum Pharmaceuticals Inc.

1.69
-0.07  -4%
Previous Close 1.76
Open 1.74
52 Week Low 1.67
52 Week High 5.24
Market Cap $277,086,216
Shares 163,956,341
Float 133,706,397
Enterprise Value $156,419,160
Volume 4,123,728
Av. Daily Volume 2,820,834
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Upcoming Catalysts

Drug Stage Catalyst Date
Poziotinib (ZENITH20)
Non-small cell lung cancer (NSCLC) with exon 20 insertion mutation in EGFR or HER2
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
ROLONTIS (eflapegrastim)
Chemotherapy-Induced Neutropenia.
CRL
CRL
CRL announced August 6, 2021.
FUSILEV (levoleucovorin)
Colorectal cancer
Approved
Approved
CRL received October 9, 2009. Approved April 29, 2011.
BELEODAQ (belinostat)
Peripheral T-Cell Lymphoma cancer
Approved
Approved
Approved July 7, 2014.
EVOMELA (melphalan) for Injection
Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
Approved
Approved
CRL October 23 2015. Approved March 15 2016.
ZEVALIN
Non-Hodgkin’s lymphoma
CRL
CRL
CRL received July 5, 2009.

Latest News

  1. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that management will participate in the 2021 Jefferies London Healthcare Conference. A virtual fireside chat will be available to conference attendees, on-demand beginning on Thursday, November 18, 2021, at 3 a.m. ET / 8 a.m. GMT.

    The webcast of the fireside chat will also be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations at the same time.

    About Spectrum Pharmaceuticals, Inc.

    Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that management will participate in the 2021 Jefferies London Healthcare Conference. A virtual fireside chat will be available to conference attendees, on-demand beginning on Thursday, November 18, 2021, at 3 a.m. ET / 8 a.m. GMT.

    The webcast of the fireside chat will also be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations at the same time.

    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.

    Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum's business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our dependence on third parties for clinical trials, manufacturing, distribution and quality control 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.

    SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate. 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

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  2. Poziotinib NDA is on track for submission in 2021 under a Fast Track designation

    Positive front line poziotinib data presented at ESMO Congress 2021 from Cohort 4 of the ZENITH20 clinical trial

    Preclinical data presented at 2021 AACR-NCI-EORTC (Triple) conference demonstrated the synergistic impact of poziotinib when combined with KRAS inhibitors in KRASG12C mutant specific cell line

    ROLONTIS® (eflapegrastim) CRL manufacturing deficiencies expected to be remediated by the end of the year

    Management to host webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT

    Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced financial results for the three-month…

    Poziotinib NDA is on track for submission in 2021 under a Fast Track designation

    Positive front line poziotinib data presented at ESMO Congress 2021 from Cohort 4 of the ZENITH20 clinical trial

    Preclinical data presented at 2021 AACR-NCI-EORTC (Triple) conference demonstrated the synergistic impact of poziotinib when combined with KRAS inhibitors in KRASG12C mutant specific cell line

    ROLONTIS® (eflapegrastim) CRL manufacturing deficiencies expected to be remediated by the end of the year

    Management to host webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT

    Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced financial results for the three-month period ended September 30, 2021 and provided a corporate update.

    "The submission of the poziotinib NDA this quarter remains our top corporate priority. The front line data presented at ESMO and the preclinical combination data with KRAS inhibitors at the Triple meeting has the potential to significantly expand the poziotinib opportunity," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Following a productive Type A meeting with the FDA on ROLONTIS, we anticipate the remediation efforts at Hanmi to be completed by the end of the year and would expect to resubmit our BLA for ROLONTIS shortly thereafter."

    Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

    • Submission of the NDA, based on the positive results of Cohort 2 in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations is on track for this year under a Fast Track designation. There is currently no treatment specifically approved for this indication.
    • Encouraging results from Cohort 4 of the ZENITH20 clinical trial were presented at the European Society of Medical (ESMO) Congress 2021. The primary endpoint of objective rate of response (ORR) was 44% (95% CI:29.5-58.8%) in the first 48 treated patients including one complete response. 88% of patients showed tumor reduction with a disease control rate of 75%. Median duration of response was 5.4 months (range 2.8-19.1+). Median progression free survival was 5.6 months (range 0-20.2+). The most common treatment related Grade ≥ 3 adverse effects (AEs) were rash, stomatitis, diarrhea, and paronychia. In addition, only one patient experienced Grade ≥ 3 pneumonitis. Poziotinib demonstrated clinically meaningful anti-tumor activity in newly diagnosed NSCLC patients with HER2 exon 20 mutations with 16mg QD dosing. The safety profile was manageable and similar to those observed in previous studies and other second-generation tyrosine kinase inhibitors.
    • Preclinical data showed the synergistic impact of poziotinib when combined with KRAS inhibitors in KRASG12C mutant specific cell lines. Jacqulyne Robichaux, Ph.D., Assistant Professor, University of Texas, MD Anderson Cancer Center presented a poster titled "Pan-ErbB inhibition enhances activity of KRASG12C inhibitors in preclinical models of KRASG12C mutant cancers" at the Virtual International Conference on Molecular Targets and Cancer Therapeutics hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI), and the European Organization for Research and Treatment of Cancer (EORTC). The preclinical data showed that inhibition of EGFR, HER2, HER3, and HER4 signaling was synergistic when combined with KRASG12C inhibitors. These results highlight the importance of a pan inhibitor of the Erb family of proteins.

    ROLONTIS (eflapegrastim), a novel long-acting G-CSF

    • The company held a Type A meeting with the U.S. Food and Drug Administration (FDA) to better understand the issues identified in the Complete Response Letter (CRL). At that meeting, the company learned that the deficiencies at the fill finish site have been adequately addressed. Remediation of deficiencies at the drug substance facility are well under way and expected to be completed by the end of the year. The FDA confirmed that the reinspection of the drug substance facility would be in-person.

    Three-Month Period Ended September 30, 2021 (All numbers are from Continuing Operations and are approximate)

    GAAP Results

    Spectrum recorded a net loss of $33.1 million, or $0.21 loss per basic and diluted share, in the three-month period ended September 30, 2021, compared to a net loss of $48.5 million, or $0.37 loss per basic and diluted share, in the comparable period in 2020. Total research and development expenses were $20.9 million in the quarter, as compared to $24.5 million in the same period in 2020. Selling, general and administrative expenses were $12.2 million in the quarter, compared to $15.1 million in the same period in 2020.

    The company ended the quarter with cash, cash equivalents, and marketable securities of $133.6 million.

    Non-GAAP Results

    Spectrum recorded a non-GAAP net loss of $25.8 million, or $0.16 loss per basic and diluted share, in the three-month period ended September 30, 2021, compared to a non-GAAP net loss of $35.2 million, or $0.27 loss per basic and diluted share, in the comparable period in 2020. Non-GAAP research and development expenses were $16.7 million, as compared to $23.3 million in the same period of 2020. Non-GAAP selling, general and administrative expenses were $9.2 million, as compared to $12.3 million in the same period in 2020.

    Conference Call

    Wednesday, November 10, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic: (877) 837-3910

    International: (973) 796-5077

    Conference ID#: 6579214

    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 November 10, 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 the ZENITH20 Clinical Trial

    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 significance of the results from Cohort 4 of the ZENITH20 clinical trial, the synergistic impact of poziotinib when combined with KRAS inhibitors, the timing and outcome of the remediation efforts at the Hanmi Pharmaceutical, Inc. manufacturing facility and the company's resubmission of its BLA for ROLONTIS, 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 possibility that the different methodologies, assumptions and applications the company utilizes to assess particular safety or efficacy parameters may yield different statistical results, and even if the company believes the data collected from the clinical trials of its product candidates, including poziotinib, are positive, these data may not be sufficient to support approval by the FDA; the possibility that success in early clinical trials, especially if based on a small patient sample, might not result in success in later clinical trials, and other unforeseen events during clinical trials which could cause delays or other adverse consequences; other uncertainties inherent in new product development; 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 company's ability to remediate the deficiencies cited in the CRL for ROLONTIS in a timely manner, if at all; 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, 2020, 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.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share amounts)

    (Unaudited)

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

    2021

     

    2020

     

    2021

     

    2020

    Revenues

    $

     

     

    $

     

     

    $

     

     

    $

     

    Operating costs and expenses:

     

     

     

     

     

     

     

    Selling, general and administrative

    12,243

     

     

    15,116

     

     

    41,515

     

     

    44,654

     

    Research and development

    20,850

     

     

    24,453

     

     

    69,335

     

     

    62,192

     

    Total operating costs and expenses

    33,093

     

     

    39,569

     

     

    110,850

     

     

    106,846

     

    Loss from continuing operations before other income (expense) and income taxes

    (33,093

    )

     

    (39,569

    )

     

    (110,850

    )

     

    (106,846

    )

    Other income (expense):

     

     

     

     

     

     

     

    Interest income, net

    11

     

     

    188

     

     

    121

     

     

    1,217

     

    Other income (expense), net

    9

     

     

    (9,131

    )

     

    (7,948

    )

     

    (15,720

    )

    Total other income (expense)

    20

     

     

    (8,943

    )

     

    (7,827

    )

     

    (14,503

    )

    Loss from continuing operations before income taxes

    (33,073

    )

     

    (48,512

    )

     

    (118,677

    )

     

    (121,349

    )

    Provision for income taxes from continuing operations

     

     

    (6

    )

     

    (9

    )

     

    (15

    )

    Loss from continuing operations

    $

    (33,073

    )

     

    $

    (48,518

    )

     

    $

    (118,686

    )

     

    $

    (121,364

    )

    Income (loss) from discontinued operations, net of income taxes

    (11

    )

     

    66

     

     

    (227

    )

     

    255

     

    Net loss

    $

    (33,084

    )

     

    $

    (48,452

    )

     

    $

    (118,913

    )

     

    $

    (121,109

    )

     

     

     

     

     

     

     

     

    Basic and diluted loss per share:

     

     

     

     

     

     

     

    Loss from continuing operations

    $

    (0.21

    )

     

    $

    (0.37

    )

     

    $

    (0.77

    )

     

    $

    (1.02

    )

    Income (loss) from discontinued operations

    $

    (0.00

    )

     

    $

    0.00

     

     

    $

    (0.00

    )

     

    $

    0.00

     

    Net loss per share, basic and diluted

    $

    (0.21

    )

     

    $

    (0.37

    )

     

    $

    (0.78

    )

     

    $

    (1.02

    )

    Weighted average shares outstanding, basic and diluted

    159,261,818

     

     

    131,455,727

     

     

    153,341,854

     

     

    118,664,914

     

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and par value amounts)

    (Unaudited)

     

     

    September 30,

    2021

     

    December 31,

    2020

    ASSETS

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    107,435

     

     

    $

    46,009

     

    Marketable securities

    26,160

     

     

    134,016

     

    Accounts receivable, net

     

     

    67

     

    Other receivables

    3,863

     

     

    2,394

     

    Prepaid expenses and other current assets

    2,540

     

     

    4,161

     

    Total current assets

    139,998

     

     

    186,647

     

    Property and equipment, net

    507

     

     

    3,577

     

    Facility and equipment under lease

    2,881

     

     

    2,247

     

    Other assets

    4,415

     

     

    4,327

     

    Total assets

    $

    147,801

     

     

    $

    196,798

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and other accrued liabilities

    $

    48,982

     

     

    $

    43,771

     

    Accrued payroll and benefits

    8,290

     

     

    9,375

     

    Total current liabilities

    57,272

     

     

    53,146

     

    Other long-term liabilities

    11,065

     

     

    9,409

     

    Total liabilities

    68,337

     

     

    62,555

     

    Commitments and contingencies

     

     

     

    Stockholders' equity:

     

     

     

    Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding

     

     

     

    Common stock, $0.001 par value; 300,000,000 shares authorized; 163,957,900 and 146,083,110 issued and outstanding at September 30, 2021 and December 31, 2020, respectively

    164

     

     

    146

     

    Additional paid-in capital

    1,086,989

     

     

    1,021,221

     

    Accumulated other comprehensive loss

    (3,481

    )

     

    (1,829

    )

    Accumulated deficit

    (1,004,208

    )

     

    (885,295

    )

    Total stockholders' equity

    79,464

     

     

    134,243

     

    Total liabilities and stockholders' equity

    $

    147,801

     

     

    $

    196,798

     

    Non-GAAP Financial Measures (from Continuing Operations)

    In this press release, Spectrum reports certain historical results that have not been prepared in accordance with generally accepted accounting principles (GAAP), including non-GAAP selling, general and administrative expenses, non-GAAP research and development expenses, non-GAAP net loss and non-GAAP net loss per share. Non-GAAP financial measures are reconciled to the most directly comparable GAAP financial measures in the tables of this press release and the accompanying footnotes. The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with GAAP. The non-GAAP financial measures presented exclude the items summarized in the below table.

    Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results and that these items are not indicative of the company's on-going core operating performance. Management uses non-GAAP net loss in its evaluation of the company's core after-tax results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Management believes that these non-GAAP financial measures are useful to investors in providing greater transparency to the information used by management in its operational decision-making. Management believes that the use of these non-GAAP financial measures also facilitates a comparison of the company's underlying operating performance with that of other companies in its industry, which use similar non-GAAP measures to supplement their GAAP results.

    The non-GAAP financial measures presented herein have certain limitations in that they do not reflect all of the costs associated with the operations of the company's business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, other companies, including other companies in our industry, may calculate non-GAAP financial measures differently than we do, limiting their usefulness as a comparative tool. Investors and potential investors are encouraged to review the reconciliation of our non-GAAP financial measures contained within this news release with our GAAP financial results.

    SPECTRUM PHARMACEUTICALS, INC.

    Reconciliation of Non-GAAP Adjustments for Condensed Consolidated Statements of Operations

    (In thousands, except share and per share amounts)

    (Unaudited)

       

     

     

     

    CONTINUING OPERATIONS

    ONLY

    Three Months Ended

    September 30,

     

    CONTINUING OPERATIONS

    ONLY

    Nine Months Ended

    September 30,

     

     

     

    2021

     

    2020

     

    2021

     

    2020

    (1

    )

     

    GAAP selling, general and administrative

    $

    12,243

     

     

    $

    15,116

     

     

    $

    41,515

     

     

    $

    44,654

     

     

     

    Non-GAAP adjustments to SG&A:

     

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (2,927

    )

     

    (3,018

    )

     

    (8,730

    )

     

    (9,773

    )

     

     

    Depreciation expense

    (72

    )

     

    144

     

     

    (206

    )

     

    (74

    )

     

     

    Lease expense

    (33

    )

     

    23

     

     

    16

     

     

    47

     

     

     

    Non-GAAP selling, general and administrative

    $

    9,211

     

     

    $

    12,265

     

     

    $

    32,595

     

     

    $

    34,854

     

    (2

    )

     

    GAAP research and development

    $

    20,850

     

     

    $

    24,453

     

     

    $

    69,335

     

     

    $

    62,192

     

     

     

    Non-GAAP adjustments to R&D:

     

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (1,187

    )

     

    (1,090

    )

     

    (3,956

    )

     

    (3,598

    )

     

     

    Depreciation expense

    (2

    )

     

    (33

    )

     

    (6

    )

     

    (98

    )

     

     

    Loss on disposal of manufacturing equipment

    (2,912

    )

     

     

     

    (2,912

    )

     

     

     

     

    Non-GAAP research and development

    $

    16,749

     

     

    $

    23,330

     

     

    $

    62,461

     

     

    $

    58,496

     

    (3

    )

     

    GAAP net loss from continuing operations

    $

    (33,073

    )

     

    $

    (48,518

    )

     

    $

    (118,686

    )

     

    $

    (121,364

    )

     

     

    Non-GAAP adjustments to net loss from continuing operations:

     

     

     

     

     

     

     

     

     

    Adjustments to SG&A and R&D, as noted above

    7,133

     

     

    3,974

     

     

    15,794

     

     

    13,496

     

     

     

    Adjustments to other income (expense)

    94

     

     

    9,317

     

     

    8,663

     

     

    15,899

     

     

     

    Adjustments to provision for income taxes

     

     

    6

     

     

    9

     

     

    15

     

     

     

    Non-GAAP net loss from continuing operations

    $

    (25,846

    )

     

    $

    (35,221

    )

     

    $

    (94,220

    )

     

    $

    (91,954

    )

    (4)  

    GAAP net loss from continuing operations - per basic and diluted share

    $

    (0.21

    )

     

    $

    (0.37

    )

     

    $

    (0.77

    )

     

    $

    (1.02

    )

     

     

    Non-GAAP net loss from continuing operations - per basic and diluted share

    $

    (0.16

    )

     

    $

    (0.27

    )

     

    $

    (0.61

    )

     

    $

    (0.77

    )

     

     

    Weighted average shares outstanding, basic and diluted

    159,261,818

     

     

    131,455,727

     

     

    153,341,854

     

     

    118,664,914

     

    (1) Non-GAAP selling, general and administrative expenses (from continuing operations): These amounts reflect adjustments to reverse allocated operating expenses for certain non-cash items including stock-based compensation, depreciation and lease expense. We believe the resulting non-GAAP SG&A value is reflective of the period-over-period success of our administrative expense control and more indicative of our normalized SG&A expense trends.

    (2) Non-GAAP research and development expenses (from continuing operations): These amounts reflect adjustments to reverse allocated operating expenses for certain non-cash items including stock-based compensation, depreciation expense and loss on disposal of manufacturing equipment. We believe the resulting non-GAAP R&D value is more indicative of our normalized R&D expense trends.

    (3) Non-GAAP net loss (from continuing operations): These amounts reflect all non-GAAP adjustments described in (1) through (2) above, plus other non-cash and/or non-recurring items, including: (i) adjustments to reverse the impact of income taxes; (ii) reversal of foreign exchange gains and losses (non-cash); (iii) reversal of the mark-to-market adjustment (non-cash) on our equity securities holdings; and (iv) reversal of realized gain recorded on the sales of our equity holdings.

    (4) Non-GAAP net loss per share (from continuing operations): These amounts reflect all non-GAAP adjustments in (1) through (3) above to present our overall non-GAAP financial results for each period on a per-share basis.

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  3. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced it will host a conference call to discuss the third quarter 2021 financial results and provide a corporate update on Wednesday, November 10, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Wednesday, November 10, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
     

    Domestic: (877) 837-3910, Conference ID# 6579214

     

    International: (973) 796-5077, Conference ID# 6579214

    The conference call will also be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations and will be archived there shortly after the live event…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced it will host a conference call to discuss the third quarter 2021 financial results and provide a corporate update on Wednesday, November 10, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Wednesday, November 10, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
     

    Domestic: (877) 837-3910, Conference ID# 6579214

     

    International: (973) 796-5077, Conference ID# 6579214

    The conference call will also be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations and will be archived there shortly after the live event.

    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.

    Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum's business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our dependence on third parties for clinical trials, manufacturing, distribution and quality control 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.

    SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate. 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

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  4. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced the presentation of preclinical data demonstrating the synergistic impact of poziotinib when combined with KRAS inhibitors in KRASG12C mutant specific cell lines. Jacqulyne Robichaux, Ph.D., Assistant Professor, University of Texas, MD Anderson Cancer Center is presenting a poster titled "Pan-ErbB inhibition enhances activity of KRASG12C inhibitors in preclinical models of KRASG12C mutant cancers" at the Virtual International Conference on Molecular Targets and Cancer Therapeutics being held October 7-10. The conference is hosted by the American Association for Cancer Research (AACR), the National Cancer Institute…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced the presentation of preclinical data demonstrating the synergistic impact of poziotinib when combined with KRAS inhibitors in KRASG12C mutant specific cell lines. Jacqulyne Robichaux, Ph.D., Assistant Professor, University of Texas, MD Anderson Cancer Center is presenting a poster titled "Pan-ErbB inhibition enhances activity of KRASG12C inhibitors in preclinical models of KRASG12C mutant cancers" at the Virtual International Conference on Molecular Targets and Cancer Therapeutics being held October 7-10. The conference is hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI), and the European Organization for Research and Treatment of Cancer (EORTC).

    The preclinical data demonstrated that inhibition of EGFR, HER2, HER3, and HER4 signaling by the pan-ErbB inhibitor poziotinib was synergistic when combined with KRASG12C inhibitors. These results highlight the importance of HER3 and HER4 signaling, in addition to EGFR and HER2, after KRASG12C inhibition.

    "We are encouraged by these promising data developed by Dr. John Heymach and the research team at MD Anderson," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "The in vitro findings presented by Dr. Robichaux illustrate well the importance of pan-HER inhibition blocking the over expression of HER receptors induced by KRAS inhibitors. Poziotinib is a potent clinical stage pan-HER inhibitor and may be optimally suited for this rational combination. These exciting findings warrant further evaluation in the clinic given the large number of patients with NSCLC and other solid tumors with KRASG12C mutations who could possibly benefit from such a combination."

    The poster presentation will be available for viewing by registered participants during the conference via the meeting website beginning at 9 a.m. ET on October 7, 2021. It will also be available on the Spectrum Pharmaceuticals website at: https://investor.sppirx.com/index.php/events-and-presentations.

    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.

    Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum's business and its future, including certain company milestones, the timing and results of FDA decisions, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include, but are not limited to, the possibility that success in preclinical studies, might not translate into success in clinical trials, the possibility that the combination synergies observed in preclinical studies may yield different results when tested in clinical studies, the possibility that poziotinib's potency in combination with KRAS inhibitors may cause unforeseen issues when tested in a clinical setting, and other unforeseen events during clinical trials which could cause delays or other adverse consequences; other uncertainties inherent in new product development; the possibility that Spectrum's new and existing drug candidates, including poziotinib, may not ultimately prove to be safe or effective; the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs; the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail; our dependence on third parties for clinical trials, manufacturing, distribution and quality control; and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission (SEC). 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, 2020, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Spectrum.

    SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate. 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

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  5. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that management will participate in the 2021 Cantor Virtual Global Healthcare Conference. A fireside chat is scheduled for Wednesday, September 29, 2021, at 1:20 p.m. ET.

    A live webcast of the fireside chat will be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations with a replay available shortly after the event.

    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…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that management will participate in the 2021 Cantor Virtual Global Healthcare Conference. A fireside chat is scheduled for Wednesday, September 29, 2021, at 1:20 p.m. ET.

    A live webcast of the fireside chat will be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations with a replay available shortly after the event.

    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.

    Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum's business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our dependence on third parties for clinical trials, manufacturing, distribution and quality control 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.

    SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate. 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

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