1. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented a data update on the safety and tolerability of twice daily (BID) administered poziotinib in NSCLC patients with EGFR or HER2 exon 20 insertion mutations. These preliminary data, from Cohort 5 of the ZENITH20 clinical trial, continue to show improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also demonstrate improved anti-tumor activity with 8mg BID dosing. The presentation is part of the AACR Virtual Meeting 2021 taking place April 10-15, 2021.

    "The 8mg BID dosing arm…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented a data update on the safety and tolerability of twice daily (BID) administered poziotinib in NSCLC patients with EGFR or HER2 exon 20 insertion mutations. These preliminary data, from Cohort 5 of the ZENITH20 clinical trial, continue to show improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also demonstrate improved anti-tumor activity with 8mg BID dosing. The presentation is part of the AACR Virtual Meeting 2021 taking place April 10-15, 2021.

    "The 8mg BID dosing arm is showing the best performance we have seen across the various dosing arms for a mixed population of EGFR and HER2 exon 20 insertion mutations in NSCLC patients. There is clearly an improved therapeutic effect and a lower adverse event rate which is highly encouraging," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "We are currently expanding the 8mg BID dataset and look forward to evaluating this dose in additional NSCLC patients and other solid tumors."

    A copy of the AACR presentation titled "Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2 exon 20 mutations" is available on Spectrum's website at https://investor.sppirx.com/events-and-presentations.

    ZENITH20 Trial Design and Preliminary Safety and Efficacy Data for Cohort 5

    Cohort 5 of the ZENITH20 trial includes previously treated NSCLC patients with EGFR or HER2 exon 20 insertion mutations. This cohort is investigating the efficacy of poziotinib with various dosing levels including BID administration. For the 38 patients randomized to poziotinib 16mg QD or 8mg BID in Cohort 5, improved responses were reported in the BID arm with 31.6% of patients (6/19) reaching a partial response. For the 38 patients randomized to poziotinib 12mg QD or 6mg BID, these dosing levels were not as active as 8mg BID but showed improved tolerance with BID dosing relative to QD dosing.

    Improved tolerability was also observed for the typical TKI related adverse events, with a clinically meaningful reduction in Grade 3 or higher adverse events for the 8mg BID dose relative to 16mg QD. In addition, there were fewer dose interruptions and dose reductions for the BID arms relative to the same QD dose. Cohort 5 is now enrolling exclusively in the 8mg BID arm and data collection is ongoing.

    About Poziotinib

    Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.

    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.

    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 significance of the preliminary dosing data for poziotinib, including the ability to achieve an improved therapeutic effect and a lowered adverse event rate with BID dosing; the demonstration of improved anti-tumor activity; the reduction in dose interruptions and dose reductions; poziotinib's potential to significantly advance the treatment of NSCLC patients with EGFR or HER2 exon 20 insertion mutations; the timing and results of the company's planned NDA submission; the overall progression of the poziotinib development program; the company's ability to advance and fund the development and commercialization of its late-stage pipeline assets and such assets' ability to serve areas of unmet need; the future potential of the company's existing drug pipeline and its ability to transform the company in the near future; 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, 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; and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission (the "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-K, 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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  2. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation on safety and tolerability of twice daily administered poziotinib in patients with EGFR or HER2 exon 20 mutations. The company will also present a poster on the evaluation of same-day dosing of ROLONTIS® (eflapegrastim) in neutropenic rats and patients with early-stage breast cancer. These poster presentations will be available at the American Association for Cancer Research (AACR) Virtual Annual Meeting, taking place from April 10-15, 2021. Details of the presentations are as follows:

    Title: Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation on safety and tolerability of twice daily administered poziotinib in patients with EGFR or HER2 exon 20 mutations. The company will also present a poster on the evaluation of same-day dosing of ROLONTIS® (eflapegrastim) in neutropenic rats and patients with early-stage breast cancer. These poster presentations will be available at the American Association for Cancer Research (AACR) Virtual Annual Meeting, taking place from April 10-15, 2021. Details of the presentations are as follows:

    Title: Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2 exon 20 mutations

    Speaker: Xiuning Le, M.D., Ph.D.

    Session: PO.CT02 - Phase 2 Clinical Trials

    Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET

    Presentation Number: CT169

    Title: Same-day administration of Eflapegrastim with chemotherapy enhances neutropenic recovery in neutropenic rats and in early-stage breast cancer patients

    Speaker: John A. Barrett

    Session: PO.CT01 - Phase 1 Clinical Trials

    Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET

    Presentation Number: CT116

    The poster presentations will be available for viewing by registered participants during the conference via the AACR website on April 10, 2021.

    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.® and ROLONTIS® are registered trademarks 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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  3. Poziotinib receives Fast Track Designation from FDA

    Preliminary safety and efficacy data for poziotinib twice daily dosing (BID) demonstrates improved anti-tumor activity and reduced toxicity relative to once daily dosing

    FDA has scheduled the pre-approval inspection at the ROLONTIS® (eflapegrastim) manufacturing facility for May 2021

    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, announced today financial results for the three-month period and full year ended December 31, 2020.

    "The Fast Track designation for poziotinib is a significant achievement towards an expedited review…

    Poziotinib receives Fast Track Designation from FDA

    Preliminary safety and efficacy data for poziotinib twice daily dosing (BID) demonstrates improved anti-tumor activity and reduced toxicity relative to once daily dosing

    FDA has scheduled the pre-approval inspection at the ROLONTIS® (eflapegrastim) manufacturing facility for May 2021

    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, announced today financial results for the three-month period and full year ended December 31, 2020.

    "The Fast Track designation for poziotinib is a significant achievement towards an expedited review," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "In addition, we are delighted that the FDA has scheduled the pre-approval inspection at the ROLONTIS manufacturing facility for May 2021. The company has made tremendous progress advancing our development programs and conducting our clinical trials, despite the challenges of the global pandemic. I am proud of our employees who demonstrated resiliency and creativity during these unprecedented times."

    Pipeline Updates

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

    • Poziotinib received Fast Track designation from the FDA for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 insertion mutations. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions and fill unmet medical needs.
    • Spectrum is preparing a new drug application (NDA) for poziotinib in the treatment of patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations after a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2020. Submission of the NDA based on the positive results of Cohort 2 from the ZENITH20 clinical trial is planned for later this year.
    • Preliminary safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial demonstrated improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also demonstrated improved anti-tumor activity with 8mg BID dosing. These results were presented at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 in early March. Spectrum will be presenting further data on BID dosing at the upcoming AACR Annual Meeting 2021.

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

    • The FDA's pre-approval inspection of the ROLONTIS manufacturing facility has been scheduled for May 2021. In October 2020, the FDA deferred its action on the Biologics License Application (BLA) for ROLONTIS due to an inability to inspect the drug substance manufacturing facility, citing travel restrictions related to the COVID-19 pandemic.

    IGN002, interferon/CD20 monoclonal antibody fusion protein

    • Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 has two sites open for enrollment in a Phase 1 study for treating relapsed or refractory non-Hodgkin's lymphoma patients, including diffuse large B-cell lymphoma.

    Three-Month Period Ended December 31, 2020 (All numbers are from Continuing Operations)

    GAAP Results

    Spectrum recorded net loss of $49.9 million, or $0.36 per basic and diluted share, in the three-month period ended December 31, 2020, compared to net loss of $40.2 million, or $0.36 per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $47.2 million in the quarter, as compared to $23.3 million in the same period in 2019. Selling, general and administrative expenses were $15.7 million in the quarter, compared to $15.1 million in the same period in 2019.

    Non-GAAP Results

    Spectrum recorded non-GAAP net loss of $28.9 million, or $0.20 per basic and diluted share, in the three-month period ended December 31, 2020, compared to non-GAAP net loss of $33.4 million, or $0.30 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $17.1 million, as compared to $22.4 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $12.3 million, as compared to $11.6 million in the same period in 2019.

    Twelve-Month Period Ended December 31, 2020 (All numbers are from Continuing Operations)

    GAAP Results

    Spectrum recorded net loss of $171.3 million, or $1.38 per basic and diluted share, in the twelve-month period ended December 31, 2020, compared to net loss of $135.4 million, or $1.22 per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $109.4 million for the year, as compared to $79.3 million in the same period in 2019. Selling, general and administrative expenses were $60.4 million for the year, compared to $61.4 million in the same period in 2019.

    Non-GAAP Results

    Spectrum recorded non-GAAP net loss of $120.9 million, or $0.97 per basic and diluted share, in the twelve-month period ended December 31, 2020, compared to non-GAAP net loss of $111.9 million, or $1.01 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $75.6 million, as compared to $72.0 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $47.2 million, as compared to $45.5 million in the same period in 2019.

    Cash Position and Guidance

    Spectrum reported cash, cash equivalents, and marketable securities of approximately $180.0 million as of December 31, 2020, compared to $224 million at December 31, 2019.

    Conference Call

    Tuesday, March 30, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic:

    (877) 837-3910, Conference ID# 3577235

    International:

    (973) 796-5077, Conference ID# 3577235

    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: http://investor.sppirx.com/events-and-presentations on March 30, 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. Cohort 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, given its Fast Track designation and the significance of such designation, the timing of an NDA submission for poziotinib based on the positive results of Cohort 2 from the ZENITH20 clinical trial, 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 content of the company's presentation at the AACR Annual Meeting 2021, the company's ability to advance development of its late-stage pipeline assets, the ability of such assets to meet currently unaddressed medical needs, the future potential of Spectrum's existing drug pipeline, the progression of the poziotinib, ROLONTIS and Anti-CD20-IFNα 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, 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 per share amounts)

    (Unaudited)

     

    Three Months Ended

    December 31,

     

    Twelve Months Ended

    December 31,

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues

    $

     

     

    $

     

     

    $

     

     

    $

     

    Operating costs and expenses:

     

     

     

     

     

     

     

    Selling, general and administrative

    15,703

     

     

    15,065

     

     

    60,357

     

     

    61,373

     

    Research and development

    47,185

     

     

    23,290

     

     

    109,377

     

     

    79,325

     

    Total operating costs and expenses

    62,888

     

     

    38,355

     

     

    169,734

     

     

    140,698

     

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

    (62,888)

     

     

    (38,355)

     

     

    (169,734)

     

     

    (140,698)

     

    Other income (expense):

     

     

     

     

     

     

     

    Interest income (expense), net

    125

     

     

    920

     

     

    1,342

     

     

    4,996

     

    Other (expense) income, net

    12,780

     

     

    (3,345)

     

     

    (2,940)

     

     

    (8,892)

     

    Total other (expense) income

    12,905

     

     

    (2,425)

     

     

    (1,598)

     

     

    (3,896)

     

    Loss from continuing operations before income taxes

    (49,983)

     

     

    (40,780)

     

     

    (171,332)

     

     

    (144,594)

     

    Benefit for income taxes from continuing operations

    75

     

     

    579

     

     

    60

     

     

    9,208

     

    Loss from continuing operations

    $

    (49,908)

     

     

    $

    (40,201)

     

     

    $

    (171,272)

     

     

    $

    (135,386)

     

    Income from discontinued operations, net of income taxes

    10,149

     

     

    1,150

     

     

    10,404

     

     

    22,697

     

    Net loss

    $

    (39,759)

     

     

    $

    (39,051)

     

     

    $

    (160,868)

     

     

    $

    (112,689)

     

     

     

     

     

     

     

     

     

    Basic and diluted loss per share:

     

     

     

     

     

     

     

    Loss per common share from continuing operations

    $

    (0.36)

     

     

    $

    (0.36)

     

     

    $

    (1.38)

     

     

    $

    (1.22)

     

    Income per common share from discontinued operations

    $

    0.07

     

     

    $

    0.01

     

     

    $

    0.08

     

     

    $

    0.21

     

    Net loss per common share, basic and diluted

    $

    (0.29)

     

     

    $

    (0.35)

     

     

    $

    (1.29)

     

     

    $

    (1.02)

     

     

     

     

     

     

     

     

     

    Weighted average shares outstanding, basic and diluted

    141,432,302

     

    111,355,254

     

    124,386,545

     

    110,585,768

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, expect per share and par value amounts)

     

    December 31,

     

    2020

     

    2019

    ASSETS

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    46,009

     

     

    $

    64,418

     

    Marketable securities

    134,016

     

     

    159,455

     

    Accounts receivable, net

    67

     

     

    441

     

    Other receivables

    2,394

     

     

    9,558

     

    Prepaid expenses and other current assets

    4,161

     

     

    10,148

     

    Total current assets

    186,647

     

     

    244,020

     

    Property and equipment, net

    3,577

     

     

    11,607

     

    Facility and equipment under lease

    2,247

     

     

    3,806

     

    Other assets

    4,327

     

     

    4,000

     

    Total assets

    $

    196,798

     

     

    $

    263,433

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and other accrued liabilities

    $

    43,771

     

     

    $

    54,284

     

    Accrued payroll and benefits

    9,375

     

     

    7,686

     

    Total current liabilities

    53,146

     

     

    61,970

     

    Other long-term liabilities

    9,409

     

     

    11,070

     

    Total liabilities

    62,555

     

     

    73,040

     

    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; 146,083,110 and 113,299,612 issued and outstanding at December 31, 2020 and 2019, respectively

    146

     

     

    113

     

    Additional paid-in capital

    1,021,221

     

     

    918,205

     

    Accumulated other comprehensive loss

    (1,829)

     

     

    (3,498)

     

    Accumulated deficit

    (885,295)

     

     

    (724,427)

     

    Total stockholders' equity

    134,243

     

     

    190,393

     

    Total liabilities and stockholders' equity

    $

    196,798

     

     

    $

    263,433

     

    Non-GAAP Financial Measures

    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 from continuing operations and non-GAAP net loss per share from continuing operations. 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 from continuing operations in its evaluation of the company's core 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, expect per share amounts)

     

     

    CONTINUING OPERATIONS ONLY

     

    CONTINUING OPERATIONS ONLY

     

     

    Three Months Ended

    December 31,

     

    Twelve Months Ended

    December 31,

     

     

    2020

     

    2019

     

    2020

     

    2019

    (1)

    GAAP selling, general and administrative

    $

    15,703

     

     

    $

    15,065

     

     

    $

    60,357

     

     

    $

    61,373

     

     

    Non-GAAP adjustments to SG&A:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (3,354)

     

     

    (3,393)

     

     

    (13,127)

     

     

    (13,822)

     

     

    Depreciation expense

    (55)

     

     

    (96)

     

     

    (130)

     

     

    (276)

     

     

    Lease expense

    23

     

     

    (25)

     

     

    69

     

     

    (282)

     

     

    Severance expense

     

     

     

     

     

     

    (1,515)

     

     

    Non-GAAP selling, general and administrative

    $

    12,317

     

     

    $

    11,551

     

     

    $

    47,169

     

     

    $

    45,478

     

    (2)

    GAAP research and development

    $

    47,185

     

     

    $

    23,290

     

     

    $

    109,377

     

     

    $

    79,325

     

     

    Non-GAAP adjustments to R&D:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (1,094)

     

     

    (882)

     

     

    (4,692)

     

     

    (4,254)

     

     

    Depreciation expense

    (33)

     

     

    (36)

     

     

    (131)

     

     

    (81)

     

     

    Impairment of second source manufacturer

    (28,197)

     

     

     

     

    (28,197)

     

     

     

     

    Other R&D milestone payments

    (750)

     

     

     

     

    (750)

     

     

    (2,751)

     

     

    Severance expense

     

     

     

     

     

     

    (260)

     

     

    Non-GAAP research and development

    $

    17,111

     

     

    $

    22,372

     

     

    $

    75,607

     

     

    $

    71,979

     

    (3)

    GAAP net loss from continuing operations

    $

    (49,908)

     

     

    $

    (40,201)

     

     

    $

    (171,272)

     

     

    $

    (135,386)

     

     

    Non-GAAP adjustments to net loss from continuing operations:

     

     

     

     

     

     

     

     

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

    33,460

     

     

    4,432

     

     

    46,958

     

     

    23,241

     

     

    Adjustments to other (income) expense

    (12,379)

     

     

    2,969

     

     

    3,521

     

     

    9,418

     

     

    Adjustments to benefit for income taxes

    (75)

     

     

    (579)

     

     

    (60)

     

     

    (9,208)

     

     

    Non-GAAP net loss from continuing operations

    $

    (28,902)

     

     

    $

    (33,379)

     

     

    $

    (120,853)

     

     

    $

    (111,935)

     

    (4)

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

    $

    (0.35)

     

     

    $

    (0.36)

     

     

    $

    (1.38)

     

     

    $

    (1.22)

     

     

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

    $

    (0.20)

     

     

    $

    (0.30)

     

     

    $

    (0.97)

     

     

    $

    (1.01)

     

     

    Weighted average shares outstanding, basic and diluted

     

    141,432,302

     

    111,355,254

     

    124,386,545

     

    110,585,768

    (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), as well as the reversal of non-recurring severance expenses. 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 and depreciation), as well as non-recurring severance expenses, other R&D milestone achievement payments, and impairment of second source manufacturer that we record to this expense caption. We believe this 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) and (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 from continuing operations - per basic and diluted share: 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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  4. 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 fourth quarter and full year 2020 financial results and provide a corporate update on Tuesday, March 30, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Tuesday, March 30, 20201 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
    Domestic: (877) 837-3910, Conference ID# 3577235
    International: (973) 796-5077, Conference ID# 3577235

    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 (NASDAQ:SPPI) a biopharmaceutical company focused on novel and targeted oncology therapies, today announced it will host a conference call to discuss the fourth quarter and full year 2020 financial results and provide a corporate update on Tuesday, March 30, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Tuesday, March 30, 20201 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic: (877) 837-3910, Conference ID# 3577235

    International: (973) 796-5077, Conference ID# 3577235

    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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  5. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the pre-approval inspection at the ROLONTIS® (eflapegrastim) manufacturing site in May 2021. In October 2020, the company received notification from the agency that it would defer its decision on the BLA because an inspection of the Hanmi Bioplant in South Korea could not be conducted during the review cycle due to restrictions on travel related to the COVID-19 pandemic.

    "I am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May," said Joe Turgeon, President and CEO…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the pre-approval inspection at the ROLONTIS® (eflapegrastim) manufacturing site in May 2021. In October 2020, the company received notification from the agency that it would defer its decision on the BLA because an inspection of the Hanmi Bioplant in South Korea could not be conducted during the review cycle due to restrictions on travel related to the COVID-19 pandemic.

    "I am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We believe the pre-approval inspection marks the final step in the ROLONTIS review process."

    About ROLONTIS

    ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.

    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.

    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 timing and outcome of the FDA's inspection of the Hanmi Bioplant in South Korea, the FDA's ability to complete the inspection, the overall likelihood of success and timing of the company's BLA for ROLONTIS, the future potential of Spectrum's existing drug pipeline, including ROLONTIS, and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, understandings, 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, 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; and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission (the "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, 2019, and in subsequent reports on Forms 10-K, 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 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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  6. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations. Spectrum plans to submit a new drug application (NDA) for poziotinib later this year.

    "There are currently no approved therapies to treat patients with HER2 exon 20 mutations and we are pleased that the FDA has granted Fast Track designation for poziotinib," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Momentum is building to unlock the potential of poziotinib."

    "We are actively…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations. Spectrum plans to submit a new drug application (NDA) for poziotinib later this year.

    "There are currently no approved therapies to treat patients with HER2 exon 20 mutations and we are pleased that the FDA has granted Fast Track designation for poziotinib," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Momentum is building to unlock the potential of poziotinib."

    "We are actively preparing the NDA and delighted with this Fast Track designation," stated Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "In addition, last week we presented at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 that twice daily dosing (BID) suggests improved anti-tumor activity and reduced toxicity relative to once daily dosing. We are optimistic about this BID strategy and we will provide a data update at AACR in April."

    About Fast Track Designation

    Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions and fill unmet medical needs, with the intention of getting important new drugs to patients earlier. Specifically, Fast Track designation facilitates meetings with the FDA to discuss aspects of development to support licensure and provides the opportunity to submit sections of a NDA on a rolling basis as data become available. When Fast Track designation is requested later in development, available clinical data should demonstrate the potential to address an unmet medical need. Additionally, another potential benefit of Fast Track designation is priority review, which reduces the standard 10 months NDA review to six months.

    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.

    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 significance of the granting of Fast Track designation for poziotinib; the potential for poziotinib to significantly advance the treatment of NSCLC patients with HER2 exon 20 insertion mutations; the timing and results of the company's planned NDA submission; the significance of the preliminary dosing data for poziotinib, including the ability to achieve improved anti-tumor activity and reduced toxicity with BID dosing; the overall progression of the poziotinib development program; the company's ability to advance and fund the development and commercialization of poziotinib; 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, 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; and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission (the "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, 2019, and in subsequent reports on Forms 10-K, 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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  7. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented results from Cohort 3 and initial twice daily (BID) dosing safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial. These preliminary data demonstrate improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also suggest improved anti-tumor activity with 8mg BID dosing. The presentation is part of the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 being held March 1-2, 2021.

    "As predicted by…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented results from Cohort 3 and initial twice daily (BID) dosing safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial. These preliminary data demonstrate improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also suggest improved anti-tumor activity with 8mg BID dosing. The presentation is part of the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 being held March 1-2, 2021.

    "As predicted by the pharmacokinetic modeling, the 8mg BID arm is showing an improved therapeutic effect and a lowered adverse event rate in this early data," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "The data build on the positive results we have reported for Cohort 2 which will be the basis for our NDA submission later this year. We look forward to reporting additional data at AACR in April."

    A copy of the ESMO presentation titled "Safety, tolerability and preliminary efficacy of poziotinib with twice daily strategy in EGFR/HER2 Exon 20 mutant non-small cell lung cancer" is available on Spectrum's website at https://investor.sppirx.com/events-and-presentations.

    ZENITH20 Trial Design and Preliminary Safety and Efficacy Data for Cohort 5

    Cohort 5 of the ZENITH20 trial includes previously treated NSCLC patients with EGFR or HER2 exon 20 insertion mutations. This cohort is investigating the efficacy of poziotinib with a BID dosing strategy. For the first 20 patients randomized to poziotinib 16 mg QD or 8 mg BID in Cohort 5, a trend towards improved responses was reported in the BID arm with 30% of patients reaching a partial response and two patients still too early to evaluate.

    Preliminary Data on Best Overall Response

     

     

    Cohort 1

    Cohort 5a

    Cohort 5d

     

    16mg QD

    16mg QD

    8mg BID

     

    N=10 (%)

    N=10 (%)

    N=10 (%)

    PR - Partial Response

    2 (20)

    2 (20)

    3 (30)

    SD - Stable Disease

    5 (50)

    4 (40)

    2 (20)

    PD - Progressive Disease

    2 (20)

    0

    1 (10)

    NE - Not Evaluable (withdrawn)

    1 (10)

    4 (40)

    2 (20)

    NA - Too Early to Assess

    0

    0

    2 (20)

    Improved tolerability was also observed, with a greater than 30% reduction in Grade 3 or higher adverse events for the BID arms relative to QD. In addition, there were 23% fewer dose interruptions for 8mg BID vs 16mg QD and 43% fewer dose interruptions for 6mg BID vs 12mg QD.

    BID Dosing Exposure and Safety

    Preliminary Data (study enrolling)

     

     

    16mg QD

    8mg BID

    12mg QD

    6mg BID

    Enrolled

    22

    16

    23

    16

    Drug Interruption, n (%)

    18 (82)

    10 (63)

    20 (87)

    8 (50)

    Dose Reduction

    13 (59)

    8 (50)

    13 (57)

    6 (38)

    Treatment Related AE ≥ Grade 3

    10 (45)

    5 (31)

    9 (39)

    3 (19)

    While preliminary, these data support the hypothesis that BID dosing could improve the therapeutic effect for patients receiving poziotinib and result in better outcomes. Cohort 5 is continuing to enroll patients and a presentation of additional results is expected later this year at a medical conference.

    About Poziotinib

    Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.

    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.

    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 significance of the preliminary dosing data for poziotinib, including the ability to achieve an improved therapeutic effect and a lowered adverse event rate with BID dosing; the company's plans to present additional study results at a medical conference later in the year; poziotinib's potential to significantly advance the treatment of NSCLC patients with EGFR or HER2 exon 20 insertion mutations; the timing and results of the company's planned NDA submission; the overall progression of the poziotinib development program; the company's ability to advance and fund the development and commercialization of its late-stage pipeline assets and such assets' ability to serve areas of unmet need; the future potential of the company's existing drug pipeline and its ability to transform the company in the near future; 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, 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; and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission (the "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, 2019, and in subsequent reports on Forms 10-K, 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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  8. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation on interim safety evaluation of same-day dosing of ROLONTIS® (eflapegrastim) in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide. This presentation will take place as part of the 38th Annual Miami Breast Cancer Conference® taking place virtually March 4-7, 2021. Details of the presentation are as follows:

    Title: Interim safety evaluation of same-day dosing of eflapegrastim in patients with early-stage breast cancer (ESBC) receiving docetaxel and cyclophosphamide (TC)
    Speaker: Lee S. Schwartzberg. M.D., FACP
    Session: Poster Presentation
    Date and Time: March…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation on interim safety evaluation of same-day dosing of ROLONTIS® (eflapegrastim) in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide. This presentation will take place as part of the 38th Annual Miami Breast Cancer Conference® taking place virtually March 4-7, 2021. Details of the presentation are as follows:

    Title: Interim safety evaluation of same-day dosing of eflapegrastim in patients with early-stage breast cancer (ESBC) receiving docetaxel and cyclophosphamide (TC)

    Speaker: Lee S. Schwartzberg. M.D., FACP

    Session: Poster Presentation

    Date and Time: March 4, 2021, 6:00pm EST

    Access to the presentations is available to members of Physicians Education Resource (PER®) and can be found here: https://www.gotoper.com/conferences/mbcc/meetings/38th-annual-miami-breast-cancer-conference.

    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.® and ROLONTIS® are registered trademarks 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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  9. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced two presentations, one oral and one eposter, at the upcoming European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021. The oral presentation will provide some initial safety and efficacy data for poziotinib from the twice daily dosing cohort. The meeting takes place on March 1 – 2, 2021. Details of the presentations are as follows:

    Title: IGN002 (antiCD20-IFNα2b) intravenously administered tumor targeted delivery of IFNα2b and its effects in non-Hodgkin lymphoma
    Speaker: Sribalaji Lakshmikanthan, Ph.D.
    Session: Immunotherapy (ID 361)
    Date and Time:
    March 1, 2021…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced two presentations, one oral and one eposter, at the upcoming European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021. The oral presentation will provide some initial safety and efficacy data for poziotinib from the twice daily dosing cohort. The meeting takes place on March 1 – 2, 2021. Details of the presentations are as follows:

    Title: IGN002 (antiCD20-IFNα2b) intravenously administered tumor targeted delivery of IFNα2b and its effects in non-Hodgkin lymphoma

    Speaker: Sribalaji Lakshmikanthan, Ph.D.

    Session: Immunotherapy (ID 361)

    Date and Time:
    March 1, 2021, 9:41 a.m. CET / 3:41 a.m. ET

    Presentation Number:
    #20P (poster)

    Title: Safety, tolerability and preliminary efficacy of poziotinib with twice daily strategy in EGFR/HER2 Exon 20 mutant non-small cell lung cancer

    Speaker: Adrian Sacher, M.D.

    Session: Mini Oral Session (ID 17) Channel 1

    Date and Time: March 2, 2021, 17:25 CET / 11:25 a.m. ET

    Presentation Number: 36MO (mini-oral)

    Access to the presentations is available to members of ESMO and can be found here: https://cslide.ctimeetingtech.com/tat2021/signin?back=%2Ftat2021%2Fattendee%2Fconfcal%2Fsession%2Fcalendar&module=attendee#signin

    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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  10. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will participate in a fireside chat at the Guggenheim Healthcare Talks 2021 Oncology Day. The fireside chat is scheduled for Thursday, February 11, 2021, at 4 p.m. EST.

    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…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will participate in a fireside chat at the Guggenheim Healthcare Talks 2021 Oncology Day. The fireside chat is scheduled for Thursday, February 11, 2021, at 4 p.m. EST.

    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

    View Full Article Hide Full Article
  11. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. In addition, Spectrum also announced an oral presentation on the structural classification of atypical EGFR mutations and their patterns of drug sensitivity. These presentations will take place as part of the IASLC 2020 World Conference on Lung Cancer (#WCLC20) hosted by the International Association for the Study of Lung Cancer (IASLC) taking place virtually January 28-31, 2021. Details of the presentations are as follows:

    Title: Updated efficacy, safety, and dosing management…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. In addition, Spectrum also announced an oral presentation on the structural classification of atypical EGFR mutations and their patterns of drug sensitivity. These presentations will take place as part of the IASLC 2020 World Conference on Lung Cancer (#WCLC20) hosted by the International Association for the Study of Lung Cancer (IASLC) taking place virtually January 28-31, 2021. Details of the presentations are as follows:

    Title: Updated efficacy, safety, and dosing management of poziotinib in previously treated EGFR and HER2 exon 20 NSCLC patients

    Speaker: Robin Cornelissen, Ph.D., M.D.

    Session: Expanding Targetable Genetic Alterations in NSCLC Mini Oral Session

    Date and Time: January 31, 2021, 14:20 SGT (January 30, 2021 10:20 p.m. PT)

    Presentation Number: MA11.04

    Title: Structural classification of atypical EGFR mutations identifies four major subgroups with distinct patterns of drug sensitivity

    Speaker: Jacqulyne P. Robichaux. Ph.D.

    Session: Tumor Biology: Focus on EGFR Mutation, DNA Repair and Tumor Microenvironment Mini Oral Session

    Date and Time: January 31, 2021, 17:20 SGT (January 31, 2021 1:20 a.m. PT)

    Presentation Number: MA13.07

    Access to the presentations is available to members of IASLC and can be found here: https://wclc2020.iaslc.org/registration/.

    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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  12. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will provide an overview of the company's business strategy and development-stage programs at three upcoming virtual investor conferences:

    • H.C. Wainwright BioConnect Conference, a fireside chat will be available on-demand through the conference portal and on the Spectrum corporate website beginning Monday, January 11th at 6 a.m. ET.
    • ICR Conference 2021, presentation, live webcast, Thursday, January 14th at 1:45 p.m. ET.
    • B. Riley Oncology Investor Conference, fireside chat, live webcast, Thursday, January 21st at 1 p.m. ET.

    These events will be available from the Investor Relations section…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will provide an overview of the company's business strategy and development-stage programs at three upcoming virtual investor conferences:

    • H.C. Wainwright BioConnect Conference, a fireside chat will be available on-demand through the conference portal and on the Spectrum corporate website beginning Monday, January 11th at 6 a.m. ET.
    • ICR Conference 2021, presentation, live webcast, Thursday, January 14th at 1:45 p.m. ET.
    • B. Riley Oncology Investor Conference, fireside chat, live webcast, Thursday, January 21st at 1 p.m. ET.

    These events will be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations. An archived webcast will be available shortly after the ICR and B. Riley live events from the same website location.

    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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  13. FDA agrees to the submission of an NDA for poziotinib for non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 insertion mutations, NDA submission planned for 2021

    Cohort 3 of the ZENITH20 clinical trial, which enrolled first-line NSCLC patients with EGFR exon 20 insertion mutations at 16mg once daily, did not meet its primary endpoint

    Preliminary data from 8 mg twice daily dosing demonstrates meaningful improvement in tolerability

    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 that the U.S. Food and Drug Administration (FDA) has agreed…

    FDA agrees to the submission of an NDA for poziotinib for non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 insertion mutations, NDA submission planned for 2021

    Cohort 3 of the ZENITH20 clinical trial, which enrolled first-line NSCLC patients with EGFR exon 20 insertion mutations at 16mg once daily, did not meet its primary endpoint

    Preliminary data from 8 mg twice daily dosing demonstrates meaningful improvement in tolerability

    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 that the U.S. Food and Drug Administration (FDA) has agreed to the submission of an NDA based on data from Cohort 2 of its Phase 2 clinical trial, ZENITH20, which evaluated previously treated patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations. The company also reported that its pre-specified primary endpoint in its Phase 2 clinical trial evaluating poziotinib in first-line NSCLC patients with EGFR exon 20 insertion mutations was not met in Cohort 3. Spectrum additionally reported that preliminary data from patients receiving 8 mg of poziotinib twice daily demonstrated meaningful improvement in tolerability as measured by adverse events and dosing interruptions.

    "The agreement with the FDA to proceed with the submission of a new drug application is a significant milestone for the poziotinib program," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The improved tolerability from the BID dosing could have a meaningful impact on the overall safety and efficacy profile of poziotinib in an area of high unmet medical need."

    The company had a successful pre-NDA meeting with the FDA which resulted in an agreement to submit an NDA for poziotinib. During the meeting, Spectrum confirmed with the FDA that Cohort 2 data could serve as the basis of an NDA submission. The company will continue to work with the FDA as it prepares the application for submission in 2021. Cohort 2 enrolled 90 patients who received an oral once daily dose of 16 mg of poziotinib. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% Confidence Interval (CI), 18.9%-38.2%). The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17%. The median duration of response was 5.1 months and the median progression free survival was 5.5 months. In this cohort, 87% of patients had drug interruptions with 11 patients (12%) permanently discontinuing due to adverse events. 13 patients (14%) had treatment-related serious adverse events.

    "We are pleased that the FDA meeting confirmed that Cohort 2 data can serve as the basis of a NDA submission and our team is diligently working on preparing our file for submission in 2021," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "While Cohort 3 did not meet its pre-specified ORR endpoint, we are seeing evidence of clinical activity with a disease control rate (DCR) of 86% and progression free survival data of 7.2 months." Dr. Lebel added, "The preliminary data from Cohort 5 with 8 mg twice daily dosing is supporting our hypothesis that this new dosing paradigm improves tolerability substantially, with Grade 3 adverse events reduced by about a third. We believe that improved tolerability and reduced drug dosing interruptions are key to patients staying on the drug longer and could potentially enhance anti-tumor effectiveness across the various EGFR and HER2 cohorts. These early findings, if confirmed, could benefit the entire poziotinib program."

    Cohort 3 of the ZENITH20 clinical trial enrolled a total of 79 patients who received an oral once daily dose of 16 mg of poziotinib. The median time of follow up of all patients was 9.2 months with 12 ongoing patients still on treatment. The intent-to-treat analysis showed that 22 patients had a partial response (by RECIST) and 68 patients had stable disease for an 86.1% DCR. 91% of patients experienced tumor reduction with a median reduction of 25.5%. The confirmed ORR was 27.8% (95% CI 18.4-39.1%). Based on the pre-specified statistical hypothesis for the primary endpoint, the observed lower bound of 18.4% did not meet the pre-specified lower bound of >20%. The median duration of response was 6.5 months and the median progression free survival was 7.2 months. The safety profile was similar with the type of adverse events observed with other second-generation EGFR tyrosine kinase inhibitors. Grade 3 treatment related rash was 33% and diarrhea was 23%. 94% of patients had drug interruptions with 6 patients (8%) permanently discontinuing due to adverse events.

    Preliminary data from Cohort 5 for patients with exon 20 insertion mutations receiving 8 mg twice daily dosing shows improved tolerability versus patients who received the 16 mg once daily dose. The data from this cohort includes patients with both EGFR and HER2 mutations. In Cycle 1, the incidence of Grade 3 or higher treatment related adverse events (rash, diarrhea and stomatitis) decreased by 32% for patients receiving the 8 mg twice daily dose. In addition, dose interruptions were reduced by 38% for the 8 mg twice daily dose versus the 16 mg once daily dose. No new types of adverse events were observed with the twice daily dosing regimen.

    Conference Call and Webcast

    The company's management will host a webcast and conference call today, December 22, 2020, at 4:30 p.m. ET / 1:30 p.m. PT. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 5036836. A live webcast of the call will be available from the Investor Relations section of the company's website at https://investor.sppirx.com/events-and-presentations and will be archived there shortly after the live event.

    About Poziotinib

    Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.

    About ZENITH20

    The ZENITH20 trial is comprised of 7 independent cohorts. Cohorts 1 - 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5 - 7 are exploratory. In December 2019, the company reported that the primary endpoint for Cohort 1 (EGFR) was not met but clinical activity was seen. Based on the results of Cohort 1, the company has amended the protocol for ZENITH20 to explore additional twice-daily dosing regimens as well as lower single daily dosage. In September 2020, the company reported that Cohort 2 met its primary endpoint. Cohorts 4 - 7 are still enrolling patients.

    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.

    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 the company's business and its future, including the significance of Cohort 3's reported results; the significance of the preliminary data from Cohort 5, including, but not limited to, whether the new dosing paradigm will continue to improve tolerability, lead to patients staying on the drug longer and enhance anti-tumor effectiveness and the impact of such data on the entire poziotinib program; the timing and outcome of filing an NDA with Cohort 2 data with the FDA; the overall determination of a path forward for poziotinib; poziotinib's potential to significantly advance the treatment of NSCLC patients with EGFR or HER2 exon 20 insertion mutations; the timing and result of future FDA approvals; the overall progression of the poziotinib development program; the company's ability to advance development of its late-stage pipeline assets and such assets' ability to serve areas of unmet need; the potential of the company's existing drug pipeline to transform the company in the near future; 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 the company 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 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; the company's existing and new drug candidates, including poziotinib, may not prove safe or effective; the possibility that the company's existing and new applications to the FDA and other regulatory agencies, including the NDA with Cohort 2 data it plans to submit in 2021, may not receive approval in a timely manner or at all; the possibility that the company's existing and new drug candidates, including poziotinib, if approved, may not be more effective, safer or more cost efficient than competing drugs; the possibility that the company's efforts to acquire or in-license and develop additional drug candidates may fail; the company's 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 the company in general, see the risk disclosures in the company's Annual Report on Form 10-K for the year ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by the company.

    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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  14. NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ:BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the appointment of Dr. Jeffrey Vacirca to its Board of Directors to help guide the company as it seeks commercial approval following announcement of positive Phase 3 data from the PROTECTIVE-2 study of plinabulin in combination with pegfilgrastim for protection against chemotherapy-induced neutropenia.

    "We are delighted to welcome Dr. Vacirca as a member of our Board of Directors, especially given his impressive leadership within the oncology community," said Dr. Lan Huang, Founder and Chief Executive Officer of BeyondSpring…

    NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ:BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the appointment of Dr. Jeffrey Vacirca to its Board of Directors to help guide the company as it seeks commercial approval following announcement of positive Phase 3 data from the PROTECTIVE-2 study of plinabulin in combination with pegfilgrastim for protection against chemotherapy-induced neutropenia.

    "We are delighted to welcome Dr. Vacirca as a member of our Board of Directors, especially given his impressive leadership within the oncology community," said Dr. Lan Huang, Founder and Chief Executive Officer of BeyondSpring. "In addition to his many years as an accomplished oncology clinician, Dr. Vacirca also has extensive experience as a key business leader in the oncology market, including as CEO of a large community oncology practice, New York Cancer & Blood Specialists. His demonstrated success in being able to collaborate with different groups of stakeholders in the oncology market is unique and very notable. Dr. Vacirca's deep engagement within the oncology community will be of much benefit to BeyondSpring."

    Jeffrey Vacirca, MD, FACP is a board-certified hematologist and oncologist and serves as CEO and Chairman of the Board of New York Cancer & Blood Specialists. Dr. Vacirca is the immediate past president of the Community Oncology Alliance (COA) and is Medical Director for International Oncology Network (ION) at AmerisourceBergen and for Oncology Network Development at Mt. Sinai Health Network. Dr. Vacirca serves on the board of directors of OneOncology, the American Red Cross of Greater New York, New York Cancer Foundation, and is chairman of the board of directors of New York Cancer Foundation. He is also co-founder & former Vice Chairman of Odonate Therapeutics (NASDAQ:ODT), and Director & Chair of the Compensation Committee of Spectrum Pharmaceuticals (NASDAQ:SPPI).

    Dr. Vacirca added, "Joining the BeyondSpring Board will provide me the opportunity to participate in improving the standard of care for cancer patients by making plinabulin, in combination with pegfilgrastim, available to prevent chemotherapy-induced neutropenia and help ensure that patients are more likely to complete their planned chemotherapy regimen to achieve the optimal clinical outcome. I am also excited about the ongoing Phase 3 trial with plinabulin in NSCLC that will potentially demonstrate the anti-tumor effects of the product and could open up treatment options for other solid tumors."

    About BeyondSpring 

    BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSpring's lead asset, plinabulin, a first-in-class agent as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and Phase 3 clinical programs in the prevention of CIN. The U.S. FDA granted Breakthrough Therapy designation to plinabulin for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to plinabulin, including three immuno-oncology assets and a drug discovery platform utilizing the protein degradation pathway, which is being developed in a subsidiary company, Seed Therapeutics, Inc. The Company has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.

    Cautionary Note Regarding Forward-Looking Statements

    This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring's most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

    Media Contacts

    Investor Contact:

    Ashley R. Robinson

    LifeSci Advisors, LLC

    +1 617-430-7577

    Media Contact:

    Darren Opland, Ph.D.

    LifeSci Communications

    +1 646-627-8387



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  15. Spectrum Pharmaceuticals (NASDAQ:SPPI) a biopharmaceutical company focused on novel and targeted oncology therapies, today announced the appointment of Nora Brennan to its Board of Directors. Ms. Brennan fills a vacancy left by Ms. Elizabeth Czerepak, who retired from the Board effective December 10, 2020.

    "We are delighted to have Ms. Brennan join Spectrum's Board of Directors as the company continues to focus its development efforts on novel treatments for patients with cancer," said William Ashton, Chairman of the Board, Spectrum Pharmaceuticals. "Her leadership and experience in the pharmaceutical and medical technology sectors make her an ideal contributor to our future growth. We would also like to thank Ms. Czerepak for her dedicated…

    Spectrum Pharmaceuticals (NASDAQ:SPPI) a biopharmaceutical company focused on novel and targeted oncology therapies, today announced the appointment of Nora Brennan to its Board of Directors. Ms. Brennan fills a vacancy left by Ms. Elizabeth Czerepak, who retired from the Board effective December 10, 2020.

    "We are delighted to have Ms. Brennan join Spectrum's Board of Directors as the company continues to focus its development efforts on novel treatments for patients with cancer," said William Ashton, Chairman of the Board, Spectrum Pharmaceuticals. "Her leadership and experience in the pharmaceutical and medical technology sectors make her an ideal contributor to our future growth. We would also like to thank Ms. Czerepak for her dedicated service and numerous contributions to the Board, and we wish her well in all of her future endeavors."

    Nora Brennan is an experienced life sciences executive and currently serves as Chief Financial Officer of TELA Bio, Inc., a commercial stage medical device company. Ms. Brennan has extensive financial experience of more than 20 years, and she has held leadership roles across the healthcare and banking industries for both private and public global companies. Prior to joining TELA, Ms. Brennan served as Chief Financial Officer at Xeris Pharmaceuticals, Inc., a specialty pharmaceutical company, where she led the finance function and execution of corporate strategy, including its initial public offering. Previously, she was employed at Integra Lifesciences Corporation, a global medical device company, where she held various senior leadership roles, including Senior Vice President, Investor Relations and Corporate Treasurer. Prior to joining Integra, Ms. Brennan worked at Citigroup and JP Morgan in various finance and investment banking roles. Ms. Brennan holds a Master of Business Administration degree from the University of Chicago Booth School of Business and a Bachelor of Arts from the University of Illinois.

    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.

    Notice Regarding Forward-Looking Statements

    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 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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  16. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that three posters highlighting its drug development pipeline would be presented at the upcoming San Antonio Breast Cancer Conference (SABCS) to be held December 8 – 11, 2020.

    "We are pleased to have two scientific communications at SABCS on ROLONTIS® (eflapegrastim) and the results of our Phase 2 study for Poziotinib in HER2+ metastatic breast cancer who have failed multiple lines of HER2 directed therapy," said Francois Lebel, M.D., Chief Medical Officer at Spectrum Pharmaceuticals. "We look forward to sharing these data with the medical and scientific community."

    The three posters are listed below.

    Poster

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that three posters highlighting its drug development pipeline would be presented at the upcoming San Antonio Breast Cancer Conference (SABCS) to be held December 8 – 11, 2020.

    "We are pleased to have two scientific communications at SABCS on ROLONTIS® (eflapegrastim) and the results of our Phase 2 study for Poziotinib in HER2+ metastatic breast cancer who have failed multiple lines of HER2 directed therapy," said Francois Lebel, M.D., Chief Medical Officer at Spectrum Pharmaceuticals. "We look forward to sharing these data with the medical and scientific community."

    The three posters are listed below.

    Poster Title: A Phase 2 study of poziotinib in patients with HER2-positive metastatic breast cancer previously treated with HER2 therapies

    Authors: Adam Brufsky, M.D., Ph.D., et al.

    Poster Number: PD1-07 (Spotlight Poster Discussion)

    Poster Category: Breast Cancer treatment

    Poster Section: Spotlight Poster Discussion 1

    Poster Presentation Date/Time: December 9, 2020 4:00 PM – 5:15 PM CT

    Poster Title: Pooled efficacy analysis from two Phase 3 studies in patients receiving eflapegrastim, a novel, long-acting granulocyte-colony stimulating factor, following TC for early stage breast cancer

    Authors: Lee S. Schwartzberg, M.D., et al.

    Poster Number: PS9-59

    Poster Category: Psychosocial, Quality of Life and Educational Aspects

    Poster Section: Poster Session 9

    Poster Presentation Date/Time: Wednesday, December 9, 2020: 8:00 AM CT.

    Poster Title: Open-label, Phase 1 study to evaluate duration of severe neutropenia after the same-day, varying dosing time schedules of eflapegrastim administration in patients with breast cancer receiving docetaxel and cyclophosphamide (NCT04187898)

    Authors: Lee S. Schwartzberg, M.D., et al.

    Poster Number: OT-06-01

    Poster Category: Chemotherapy - Targeting Neutropenia

    Poster Section: Ongoing Trial posters

    Poster Presentation Date/Time: Wednesday, December 9, 2020: 8:00 AM CT

    Copies of the posters will be available on the Spectrum Pharmaceuticals website following presentation at the meeting. ROLONTIS is an investigational drug not approved by the U.S. Food and Drug Administration (FDA) and the BLA is currently under review by the agency for the treatment of chemotherapy-induced neutropenia.

    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.® and ROLONTIS® are registered trademarks 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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  17. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will present an overview of the company's business strategy and development-stage programs at two upcoming virtual investor conferences:

    • Stifel Virtual Healthcare Conference, Monday, November 16th, 2020 at 2:40 p.m. ET.
    • Jefferies London Healthcare Conference, Wednesday, November 18th, 2020 at 2:20 p.m. ET.

    A live webcast of the presentations 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 each event.

    About Spectrum Pharmaceuticals, Inc.

    Spectrum Pharmaceuticals is…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will present an overview of the company's business strategy and development-stage programs at two upcoming virtual investor conferences:

    • Stifel Virtual Healthcare Conference, Monday, November 16th, 2020 at 2:40 p.m. ET.
    • Jefferies London Healthcare Conference, Wednesday, November 18th, 2020 at 2:20 p.m. ET.

    A live webcast of the presentations 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 each 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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  18. FDA deferred action on the BLA for ROLONTIS® (eflapegrastim) due to inability to conduct inspection of the manufacturing facility citing COVID-19 related travel restrictions

    Pre-NDA meeting with FDA is scheduled for poziotinib in NSCLC HER2 exon-20 insertion mutations in previously treated patients

    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, announced today financial results for the three-month period ended September 30, 2020.

    "The third quarter was marked by significant progress in our drug development programs and a strengthened financial position," said Joe Turgeon, President…

    FDA deferred action on the BLA for ROLONTIS® (eflapegrastim) due to inability to conduct inspection of the manufacturing facility citing COVID-19 related travel restrictions

    Pre-NDA meeting with FDA is scheduled for poziotinib in NSCLC HER2 exon-20 insertion mutations in previously treated patients

    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, announced today financial results for the three-month period ended September 30, 2020.

    "The third quarter was marked by significant progress in our drug development programs and a strengthened financial position," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "Our team is preparing for the upcoming pre-NDA meeting with the FDA for poziotinib and actively working to obtain an approval for ROLONTIS as soon as possible."

    Pipeline Updates

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

    • Spectrum has a pre-NDA meeting with the FDA to review the positive results from Cohort 2 and the path forward for poziotinib registration for the treatment of patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations.
    • Spectrum presented the results from Cohort 2 at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 in September. This marked the first presentation to the medical and scientific community of the positive results from this registrational cohort from the ZENITH20 clinical trial.
    • Spectrum expects to provide poziotinib update, including dosing strategy and topline results from Cohort 3 of the ZENITH20 trial in first-line EGFR NSCLC patients, by year-end 2020.

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

    • The FDA deferred its action on the BLA for ROLONTIS, due to an inability to inspect the Hanmi Bioplant in South Korea citing travel restrictions related to the COVID-19 pandemic.
    • Spectrum has confirmed with the FDA that the deferral is not a Complete Response Letter (CRL). The company is actively working to find a way to expedite the plant inspection.

    Three-Month Period Ended September 30, 2020 (All numbers are from Continuing Operations and are approximate)

    GAAP Results

    Spectrum recorded a net loss of $48.5 million, or $0.37 loss per basic and diluted share, in the three-month period ended September 30, 2020, compared to a net loss of $26.6 million, or $0.24 loss per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $24.5 million in the quarter, as compared to $17.2 million in the same period in 2019. Selling, general and administrative expenses were $15.1 million in the quarter, compared to $13.1 million in the same period in 2019.

    The company ended the quarter with cash, cash equivalents, and marketable securities of $198.3 million.

    Non-GAAP Results

    Spectrum recorded a non-GAAP net loss of $35.2 million, or $0.27 loss per basic and diluted share, in the three-month period ended September 30, 2020, compared to a non-GAAP net loss of $24.5 million, or $0.22 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $23.3 million, as compared to $16.1 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $12.3 million, as compared to $9.9 million in the same period in 2019.

    Conference Call and Webcast

    Spectrum's management will host a webcast and conference call today, November 4, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 1281757. A live webcast of the call will 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.

    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. Cohort 3 (EGFR) has completed enrollment and Cohort 4 (HER2) is 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 significance of Cohort 2's reported results; the outcome of the upcoming pre-NDA meeting with the FDA regarding poziotinib and the FDA's determination of a path forward for poziotinib; poziotinib's potential to significantly advance the treatment of NSCLC patients with HER2 exon 20 insertion mutations; the timing and results of future FDA decisions, including the timing of the FDA's inspection of the Hanmi Bioplant in South Korea and its action on the ROLONTIS BLA; the timing of the poziotinib update, including dosing strategy and topline results from Cohort 3; the overall progression of the poziotinib and ROLONTIS development programs; the company's ability to advance and fund the development and commercialization of its late-stage pipeline assets and such assets' ability to serve areas of unmet need; the future potential of the company's existing drug pipeline and its ability to transform the company in the near future; 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 ongoing effects of the COVID-19 pandemic, including the duration of travel restrictions related thereto; 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, including ROLONTIS and 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; 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, 2019, 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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Statements of Operations

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    Nine Months Ended

    September 30,

     

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    $

     

     

     

    $

     

     

     

    $

     

     

    Operating costs and expenses:

     

     

     

     

     

     

     

    Selling, general and administrative

    15,116

     

     

     

    13,126

     

     

     

    44,654

     

     

     

    46,308

     

     

    Research and development

    24,453

     

     

     

    17,167

     

     

     

    62,192

     

     

     

    56,035

     

     

    Total operating costs and expenses

    39,569

     

     

     

    30,293

     

     

     

    106,846

     

     

     

    102,343

     

     

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

    (39,569

    )

     

     

    (30,293

    )

     

     

    (106,846

    )

     

     

    (102,343

    )

     

    Other income (expense):

     

     

     

     

     

     

     

    Interest income, net

    188

     

     

     

    1,521

     

     

     

    1,217

     

     

     

    4,076

     

     

    Other income (expense), net

    (9,131

    )

     

     

    2,015

     

     

     

    (15,720

    )

     

     

    (5,547

    )

     

    Total other income (expense)

    (8,943

    )

     

     

    3,536

     

     

     

    (14,503

    )

     

     

    (1,471

    )

     

    Loss from continuing operations before income taxes

    (48,512

    )

     

     

    (26,757

    )

     

     

    (121,349

    )

     

     

    (103,814

    )

     

    (Provision) benefit for income taxes from continuing operations

    (6

    )

     

     

    200

     

     

     

    (15

    )

     

     

    8,628

     

     

    Loss from continuing operations

    $

    (48,518

    )

     

     

    $

    (26,557

    )

     

     

    $

    (121,364

    )

     

     

    $

    (95,186

    )

     

    Income from discontinued operations, net of income taxes

    66

     

     

     

    572

     

     

     

    255

     

     

     

    21,547

     

     

    Net loss

    $

    (48,452

    )

     

     

    $

    (25,985

    )

     

     

    $

    (121,109

    )

     

     

    $

    (73,639

    )

     

     

     

     

     

     

     

     

     

    Basic and diluted loss per share:

     

     

     

     

     

     

     

    Loss from continuing operations

    $

    (0.37

    )

     

     

    $

    (0.24

    )

     

     

    $

    (1.02

    )

     

     

    $

    (0.86

    )

     

    Income from discontinued operations

    $

    0.00

     

     

     

    $

    0.01

     

     

     

    $

    0.00

     

     

     

    $

    0.20

     

     

    Net loss per share, basic and diluted

    $

    (0.37

    )

     

     

    $

    (0.23

    )

     

     

    $

    (1.02

    )

     

     

    $

    (0.67

    )

     

    Weighted average shares outstanding, basic and diluted

    131,455,727

     

     

     

    111,178,880

     

     

     

    118,664,914

     

     

     

    110,291,090

     

     

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, expect per share and par value amounts)

    (Unaudited)

     

     

    September 30,

    2020

     

    December 31,

    2019

    ASSETS

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    77,132

     

     

     

    $

    64,418

     

     

    Marketable securities

    121,179

     

     

     

    159,455

     

     

    Accounts receivable, net of allowance for credit losses of $43 and $43, respectively

    453

     

     

     

    441

     

     

    Other receivables

    3,186

     

     

     

    9,558

     

     

    Prepaid expenses and other current assets

    10,876

     

     

     

    10,148

     

     

    Total current assets

    212,826

     

     

     

    244,020

     

     

    Property and equipment, net

    18,456

     

     

     

    11,607

     

     

    Facility and equipment under lease

    2,662

     

     

     

    3,806

     

     

    Other assets

    3,994

     

     

     

    4,000

     

     

    Total assets

    $

    237,938

     

     

     

    $

    263,433

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and other accrued liabilities

    $

    52,985

     

     

     

    $

    54,284

     

     

    Accrued payroll and benefits

    8,113

     

     

     

    7,686

     

     

    Total current liabilities

    61,098

     

     

     

    61,970

     

     

    Other long-term liabilities

    8,480

     

     

     

    11,070

     

     

    Total liabilities

    69,578

     

     

     

    73,040

     

     

    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; 145,931,172 and 113,299,612 issued and outstanding at September 30, 2020 and December 31, 2019, respectively

    146

     

     

     

    113

     

     

    Additional paid-in capital

    1,016,474

     

     

     

    918,205

     

     

    Accumulated other comprehensive loss

    (2,724

    )

     

     

    (3,498

    )

     

    Accumulated deficit

    (845,536

    )

     

     

    (724,427

    )

     

    Total stockholders' equity

    168,360

     

     

     

    190,393

     

     

    Total liabilities and stockholders' equity

    $

    237,938

     

     

     

    $

    263,433

     

     

    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 income (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, expect per share amounts)

     

     

     

    CONTINUING OPERATIONS ONLY

    Three Months Ended

    September 30,

     

    CONTINUING OPERATIONS ONLY

    Nine Months Ended

    September 30,

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    (1)

    GAAP selling, general and administrative

    $

    15,116

     

     

     

    $

    13,126

     

     

     

    $

    44,654

     

     

     

    $

    46,308

     

     

     

    Non-GAAP adjustments to SG&A:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (3,018

    )

     

     

    (3,155

    )

     

     

    (9,773

    )

     

     

    (10,254

    )

     

     

    Depreciation expense

    144

     

     

     

    (58

    )

     

     

    (74

    )

     

     

    (180

    )

     

     

    Lease expense

    23

     

     

     

     

     

     

    47

     

     

     

    (129

    )

     

     

    Severance expense

     

     

     

     

     

     

     

     

     

    (1,515

    )

     

     

    Non-GAAP selling, general and administrative

    $

    12,265

     

     

     

    $

    9,913

     

     

     

    $

    34,854

     

     

     

    $

    34,230

     

     

    (2)

    GAAP research and development

    $

    24,453

     

     

     

    $

    17,167

     

     

     

    $

    62,192

     

     

     

    $

    56,035

     

     

     

    Non-GAAP adjustments to R&D:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (1,090

    )

     

     

    (1,030

    )

     

     

    (3,598

    )

     

     

    (3,190

    )

     

     

    Depreciation expense

    (33

    )

     

     

    (30

    )

     

     

    (98

    )

     

     

    (45

    )

     

     

    Severance expense

     

     

     

     

     

     

     

     

     

    (260

    )

     

     

    R&D milestones and in-license upfront fees

     

     

     

     

     

     

     

     

     

    (2,751

    )

     

     

    Non-GAAP research and development

    $

    23,330

     

     

     

    $

    16,107

     

     

     

    $

    58,496

     

     

     

    $

    49,789

     

     

    (3)

    GAAP net loss from continuing operations

    $

    (48,518

    )

     

     

    $

    (26,557

    )

     

     

    $

    (121,364

    )

     

     

    $

    (95,186

    )

     

     

    Non-GAAP adjustments to net loss from continuing operations:

     

     

     

     

     

     

     

     

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

    3,974

     

     

     

    4,273

     

     

     

    13,496

     

     

     

    18,324

     

     

     

    Adjustments to other (income) expense

    9,317

     

     

     

    (1,979

    )

     

     

    15,899

     

     

     

    6,449

     

     

     

    Adjustments to provision (benefit) for income taxes

    6

     

     

     

    (200

    )

     

     

    15

     

     

     

    (8,628

    )

     

     

    Non-GAAP net loss from continuing operations

    $

    (35,221

    )

     

     

    $

    (24,463

    )

     

     

    $

    (91,954

    )

     

     

    $

    (79,041

    )

     

    (4)

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

    $

    (0.37

    )

     

     

    $

    (0.24

    )

     

     

    $

    (1.02

    )

     

     

    $

    (0.86

    )

     

     

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

    $

    (0.27

    )

     

     

    $

    (0.22

    )

     

     

    $

    (0.77

    )

     

     

    $

    (0.72

    )

     

     

    Weighted average shares outstanding, basic and diluted

    131,455,727

     

     

     

    111,178,880

     

     

     

    118,664,914

     

     

     

    110,291,090

     

     

    (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), as well as the reversal of non-recurring severance expenses. 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 and depreciation), as well as the reversal of non-recurring severance expenses and R&D milestone achievements and in-license upfront fees that we record to this expense caption. We believe this 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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  19. 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 2020 financial results and provide a corporate update on Wednesday, November 4, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Wednesday, November 4, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic:

    (877) 837-3910, Conference ID# 1281757

    International:

    (973) 796-5077, Conference ID# 1281757

    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 2020 financial results and provide a corporate update on Wednesday, November 4, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Wednesday, November 4, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic:

    (877) 837-3910, Conference ID# 1281757

    International:

    (973) 796-5077, Conference ID# 1281757

    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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  20. Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel restrictions

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that an inspection of the Hanmi Bioplant in South Korea is required before the FDA can approve the company's Biologics License Application (BLA) for ROLONTIS. The FDA was unable to conduct an inspection during the current review cycle due to restrictions on travel related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until an inspection can be completed. The company will continue to work actively with the FDA to define an approach for scheduling…

    Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel restrictions

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that an inspection of the Hanmi Bioplant in South Korea is required before the FDA can approve the company's Biologics License Application (BLA) for ROLONTIS. The FDA was unable to conduct an inspection during the current review cycle due to restrictions on travel related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until an inspection can be completed. The company will continue to work actively with the FDA to define an approach for scheduling the required inspection. Spectrum has confirmed with the FDA that this is not a Complete Response Letter.

    "We are actively working with the FDA to find a way to expedite the plant inspection," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible."

    About ROLONTIS

    ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.

    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.

    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. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by our use of words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "seek," "look forward," "believe," "committed," "investigational," "pipeline," "launch," and similar terms, or by express or implied discussions relating to Spectrum's business and its future, including the timing and outcome of the FDA's inspection of the Hanmi Bioplant in South Korea, the FDA's ability to complete the inspection using alternative means, the overall likelihood of success and timing of the company's BLA for ROLONTIS, the future potential of Spectrum's existing drug pipeline, including ROLONTIS, 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 Spectrum's existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or 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.

    SPECTRUM PHARMACEUTICALS, INC.® and ROLONTIS® are registered trademarks 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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  21. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented additional results from its pivotal Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2). The on-demand mini oral session is part of the European Society for Medical Oncology (ESMO) Virtual Congress 2020 Science Weekend being held September 19 – 21, 2020.

    "This is the first presentation to the medical and scientific community of the positive results from our registrational Cohort 2 from the ZENITH20 clinical trial," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented additional results from its pivotal Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2). The on-demand mini oral session is part of the European Society for Medical Oncology (ESMO) Virtual Congress 2020 Science Weekend being held September 19 – 21, 2020.

    "This is the first presentation to the medical and scientific community of the positive results from our registrational Cohort 2 from the ZENITH20 clinical trial," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "There is no approved treatment for NSCLC patients with HER2 exon 20 insertion mutations, and we look forward to sharing this data with the FDA and discussing the path forward for poziotinib registration."

    The presentation titled "ZENITH20, a multinational, multi-cohort Phase 2 study of poziotinib in NSCLC patients with EGFR or HER2 Exon 20 mutations" is available to members of ESMO and can be accessed on the meeting website here: https://cslide.ctimeetingtech.com/esmo2020/attendee/confcal_1/session/list?q=poziotinib&r=st%7E12. A copy of the slides can also be found at: https://investor.sppirx.com/index.php/events-and-presentations.

    ZENITH20 Trial Design and Results for Cohort 2

    Cohort 2 of the ZENITH20 trial enrolled 90 patients who received an oral once daily dose of 16 mg of poziotinib. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% CI, 18.9%-38.2%). The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17%. The disease control rate (DCR) was 70% while tumor reduction occurred in 67 patients (74%), with median tumor reduction of 22%. The evaluable patient analysis (n=74) demonstrated a confirmed ORR of 35.1% (95% CI, 24.4% – 47.1%) with a disease control rate of 82.4%.

    The median duration of response was 5.1 months (range 1 to >12.3), with a median follow up of 8.3 months and the median progression free survival was 5.5 months (range 0 to >13.1). 13 patients (14%) had treatment-related serious adverse events and 11 patients (12%) permanently discontinued due to adverse events. Grade 3 treatment related rash was observed in 27 patients (30%) with diarrhea in 23 patients (26%). Stomatitis/mucosal inflammation Grades 3 and 4 occurred in 21 patients (23%). Dose interruptions were reported in 78 patients (87%), and dose reductions in 70 patients (78%), which was similar to the rates in Cohort 1.

    Cohort 2 was designed to be a registrational study. Based on these results, Spectrum has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss the data and its plans for a New Drug Application (NDA) submission.

    The ZENITH20 trial is comprised of 7 independent cohorts. Cohorts 1 - 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5 - 7 are exploratory. In December 2019, the company reported that the primary endpoint for Cohort 1 (EGFR) was not met but clinical activity was seen. Based on the results of Cohort 1, the company has amended the protocol for ZENITH20 to explore additional twice-daily dosing regimens as well as lower single daily dosage. This amendment did not impact Cohorts 2 and 3 as these cohorts were fully enrolled. Top line results from Cohort 3 are expected by the end of the year.

    About Poziotinib

    Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.

    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.

    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 the company's business and its future, including the significance of Cohort 2's reported results; the timing and outcome of a potential meeting with the FDA regarding poziotinib and the FDA's determination of a path forward for poziotinib; poziotinib's potential to significantly advance the treatment of NSCLC patients with HER2 exon 20 insertion mutations; the timing and result of future FDA approvals; the timing of the results of Cohort 3; the overall progression of the poziotinib development program; the company's ability to advance development of its late-stage pipeline assets and such assets' ability to serve areas of unmet need; the future potential of the company's existing drug pipeline; 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 the company 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 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; the company's existing and new drug candidates, including poziotinib, may not prove safe or effective; the possibility that the company's 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 the company's existing and new drug candidates, including poziotinib, if approved, may not be more effective, safer or more cost efficient than competing drugs; the possibility that the company's efforts to acquire or in-license and develop additional drug candidates may fail; the company's 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. 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 the company in general, see the risk disclosures in the company's Annual Report on Form 10-K for the year ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by the company.

    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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  22. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a presentation of the results for Cohort 2 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations. In addition, a poster presentation of results from a single site expanded access program will also be presented for poziotinib in the treatment of patients with advanced NSCLC with EGFR or HER2 exon 20 insertion mutations. These presentations will take place as part of the European Society for Medical Oncology (ESMO) Virtual Congress 2020 Science Weekend to be held September 19 – 21, 2020. Details of…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a presentation of the results for Cohort 2 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations. In addition, a poster presentation of results from a single site expanded access program will also be presented for poziotinib in the treatment of patients with advanced NSCLC with EGFR or HER2 exon 20 insertion mutations. These presentations will take place as part of the European Society for Medical Oncology (ESMO) Virtual Congress 2020 Science Weekend to be held September 19 – 21, 2020. Details of the presentations are as follows:

    Title: ZENITH20, a multinational, multi-cohort Phase 2 study of poziotinib in NSCLC patients with EGFR or HER2 Exon 20 insertion mutations

    Speaker: Mark A. Socinski, M.D.

    Session: On-Demand Mini Oral Session

    Date and Time: September 18, 2020, 09:00 hours CEST, pre-release of mini oral sessions

    Presentation Number: LBA60

    Abstract Title: Poziotinib in advanced NSCLC with EGFR or HER2 exon 20 mutations; initial results from a single site expanded assess program

    Speaker: Arsela Prelaj, M.D.

    Session: On-Demand E-Poster Display

    Date and Time: September 17, 2020, 09:00 hours CEST, pre-release of e-posters on demand

    Presentation Number: 1388P

    Access to the presentations is available to members of ESMO and can be found here: esmo.org/meetings/esmo-virtual-congress-2020/registration.

    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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  23. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will present an overview of the company's business strategy and development-stage programs at two upcoming virtual investor conferences:

    • Rodman & Renshaw 22nd Annual Global Investment Conference, Sponsored by H.C. Wainwright, Monday, September 14, 2020 at 2:00 p.m. ET.
    • Cantor Virtual Global Healthcare Conference, Thursday, September 17, 2020 at 10:40 a.m. ET.

    A live webcast of the presentations 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 each event.

    About Spectrum

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will present an overview of the company's business strategy and development-stage programs at two upcoming virtual investor conferences:

    • Rodman & Renshaw 22nd Annual Global Investment Conference, Sponsored by H.C. Wainwright, Monday, September 14, 2020 at 2:00 p.m. ET.
    • Cantor Virtual Global Healthcare Conference, Thursday, September 17, 2020 at 10:40 a.m. ET.

    A live webcast of the presentations 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 each 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.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  24. Recently announced positive topline results in HER2 exon 20 insertion mutations from Cohort 2 of the poziotinib ZENITH20 trial

    Company is in process of requesting a pre-NDA meeting with the FDA seeking an indication for second-line NSCLC patients with HER2 exon 20 insertion mutations

    BLA for ROLONTIS® (eflapegrastim) under active FDA review - PDUFA date of October 24, 2020

    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, announced today financial results for the three-month period ended June 30, 2020.

    "The recently announced positive results from Cohort 2 are a meaningful development…

    Recently announced positive topline results in HER2 exon 20 insertion mutations from Cohort 2 of the poziotinib ZENITH20 trial

    Company is in process of requesting a pre-NDA meeting with the FDA seeking an indication for second-line NSCLC patients with HER2 exon 20 insertion mutations

    BLA for ROLONTIS® (eflapegrastim) under active FDA review - PDUFA date of October 24, 2020

    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, announced today financial results for the three-month period ended June 30, 2020.

    "The recently announced positive results from Cohort 2 are a meaningful development for patients with NSCLC HER2 exon 20 insertion mutations for which there is no approved therapy," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "We are in the process of requesting a pre-NDA meeting with the FDA and look forward to reviewing this data with the agency. In addition, the BLA for ROLONTIS is under active FDA review with a PDUFA date of October 24, 2020. We are in a strong capital position to fund our ongoing development and commercialization of our late stage assets."

    Pipeline Updates

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

    • Poziotinib met the pre-specified primary endpoint for Cohort 2 in the ZENITH20 Phase 2 clinical trial evaluating previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations. Cohort 2 of the ZENITH20 clinical trial enrolled a total of 90 patients who received an oral, once daily dose of 16 mg/day of poziotinib. All responses were read independently and confirmed by a central imaging laboratory using RECIST criteria. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% Confidence Interval (CI) 18.9%-38.2%). Based on the pre-specified statistical hypothesis for the primary endpoint, the observed lower bound of 18.9% exceeded the pre-specified lower bound of 17% in this heavily pre-treated population.
    • The median duration of response was 5.1 (range 1 to >12.3) months, with a median follow up of 8.3 months. The disease control rate (DCR) was 70% and the median progression free survival was 5.5 months.
    • Spectrum plans to present additional results from Cohort 2 at a medical meeting later in the year.
    • The company is in the process of requesting a pre-NDA meeting with the FDA based on the positive results from Cohort 2 to seek an indication for the treatment of patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations.
    • Cohort 3 of the ZENITH20 trial in first-line EGFR NSCLC patients is fully enrolled and topline results are expected by year-end 2020.

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

    • FDA is actively reviewing the BLA for ROLONTIS for the treatment of chemotherapy-induced neutropenia. The PDUFA target action date for the ROLONTIS BLA is October 24, 2020.

    Three-Month Period Ended June 30, 2020 (All numbers are from Continuing Operations and are approximate)

    GAAP Results

    Spectrum recorded a net loss of $32.2 million, or $0.29 loss per basic and diluted share, in the three-month period ended June 30, 2020, compared to a net loss of $28.8 million, or $0.26 loss per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $21.7 million in the quarter, as compared to $17.0 million in the same period in 2019. Selling, general and administrative expenses were $14.7 million in the quarter, compared to $17.2 million in the same period in 2019.

    The company ended the quarter with cash, cash equivalents, and marketable securities of $156.5 million. The quarter-end cash balance does not include aggregate net proceeds of $82.1 million, after deducting underwriting discounts and commissions, from our recent underwritten public offering and sales under our at-the-market sales agreement.

    Non-GAAP Results

    Spectrum recorded a non-GAAP net loss of $31.8 million, or $0.28 per basic and diluted share, in the three-month period ended June 30, 2020, compared to a non-GAAP net loss of $25.2 million, or $0.23 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $20.6 million, as compared to $13.2 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $11.8 million, as compared to $13.7 million in the same period in 2019.

    Conference Call and Webcast

    Spectrum's management will host a webcast and conference call today, August 10, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 4093736. A live webcast of the call will 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.

    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. Cohort 3 (EGFR) has completed enrollment and Cohort 4 (HER2) is 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 significance of Cohort 2's reported results; the availability, timing and outcome of a potential pre-NDA meeting with the FDA regarding poziotinib and the FDA's determination of a path forward for poziotinib; poziotinib's potential to significantly advance the treatment of NSCLC patients with HER2 exon 20 insertion mutations; the timing and results of future FDA decisions, including with respect to the ROLONTIS BLA; the timing of the topline results of Cohort 3; the overall progression of the poziotinib and ROLONTIS development programs; the company's plans to present additional study results from Cohort 2 at a medical meeting later in the year; the company's ability to advance and fund the development and commercialization of its late-stage pipeline assets and such assets' ability to serve areas of unmet need; the future potential of the company's existing drug pipeline and its ability to transform the company in the near future; 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, including ROLONTIS and 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; 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, 2019, 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.

    © 2020 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

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenues

    $

     

     

     

    $

     

     

     

    $

     

     

     

    $

     

     

    Operating costs and expenses:

     

     

     

     

     

     

     

    Selling, general and administrative

    14,744

     

     

     

    17,230

     

     

     

    29,538

     

     

     

    33,182

     

     

    Research and development

    21,746

     

     

     

    16,982

     

     

     

    37,739

     

     

     

    38,868

     

     

    Total operating costs and expenses

    36,490

     

     

     

    34,212

     

     

     

    67,277

     

     

     

    72,050

     

     

    Loss from continuing operations before other expense and income taxes

    (36,490

    )

     

     

    (34,212

    )

     

     

    (67,277

    )

     

     

    (72,050

    )

     

    Other income (expense):

     

     

     

     

     

     

     

    Interest income, net

    325

     

     

     

    1,495

     

     

     

    1,029

     

     

     

    2,556

     

     

    Other income (expense), net

    3,945

     

     

     

    3,722

     

     

     

    (6,589

    )

     

     

    (7,563

    )

     

    Total other income (expense)

    4,270

     

     

     

    5,217

     

     

     

    (5,560

    )

     

     

    (5,007

    )

     

    Loss from continuing operations before income taxes

    (32,220

    )

     

     

    (28,995

    )

     

     

    (72,837

    )

     

     

    (77,057

    )

     

    (Provision) benefit for income taxes from continuing operations

    (9

    )

     

     

    212

     

     

     

    (9

    )

     

     

    8,428

     

     

    Loss from continuing operations

    $

    (32,229

    )

     

     

    $

    (28,783

    )

     

     

    $

    (72,846

    )

     

     

    $

    (68,629

    )

     

    Income from discontinued operations, net of income taxes

    144

     

     

     

    388

     

     

     

    189

     

     

     

    20,975

     

     

    Net loss

    $

    (32,085

    )

     

     

    $

    (28,395

    )

     

     

    $

    (72,657

    )

     

     

    $

    (47,654

    )

     

     

     

     

     

     

     

     

     

    Basic and diluted loss per share:

     

     

     

     

     

     

     

    Loss per common share from continuing operations

    $

    (0.29

    )

     

     

    $

    (0.26

    )

     

     

    $

    (0.65

    )

     

     

    $

    (0.63

    )

     

    Income per common share from discontinued operations

    $

    0.00

     

     

     

    $

    0.00

     

     

     

    $

    0.00

     

     

     

    $

    0.19

     

     

    Net loss per common share, basic and diluted

    $

    (0.28

    )

     

     

    $

    (0.26

    )

     

     

    $

    (0.65

    )

     

     

    $

    (0.43

    )

     

    Weighted average shares outstanding, basic and diluted

    112,615,744

     

     

     

    110,345,135

     

     

     

    112,199,229

     

     

     

    109,744,405

     

     

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, expect per share and par value amounts)

    (Unaudited)

     

     

    June 30,

    2020

     

    December 31,

    2019

    ASSETS

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    85,126

     

     

     

    $

    64,418

     

     

    Marketable securities

    71,390

     

     

     

    159,455

     

     

    Accounts receivable, net of allowance for credit losses of $43 and $43, respectively

    441

     

     

     

    441

     

     

    Other receivables

    6,294

     

     

     

    9,558

     

     

    Prepaid expenses and other current assets

    11,789

     

     

     

    10,148

     

     

    Total current assets

    175,040

     

     

     

    244,020

     

     

    Property and equipment, net

    12,547

     

     

     

    11,607

     

     

    Facility and equipment under lease

    3,068

     

     

     

    3,806

     

     

    Other assets

    3,598

     

     

     

    4,000

     

     

    Total assets

    $

    194,253

     

     

     

    $

    263,433

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and other accrued liabilities

    $

    49,684

     

     

     

    $

    54,284

     

     

    Accrued payroll and benefits

    5,874

     

     

     

    7,686

     

     

    Total current liabilities

    55,558

     

     

     

    61,970

     

     

    Other long-term liabilities

    8,098

     

     

     

    11,070

     

     

    Total liabilities

    63,656

     

     

     

    73,040

     

     

    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; 117,823,973 and 113,299,612 issued and outstanding at June 30, 2020 and December 31, 2019, respectively

    118

     

     

     

    113

     

     

    Additional paid-in capital

    930,817

     

     

     

    918,205

     

     

    Accumulated other comprehensive loss

    (3,254

    )

     

     

    (3,498

    )

     

    Accumulated deficit

    (797,084

    )

     

     

    (724,427

    )

     

    Total stockholders' equity

    130,597

     

     

     

    190,393

     

     

    Total liabilities and stockholders' equity

    $

    194,253

     

     

     

    $

    263,433

     

     

    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 income (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, expect per share amounts)

     

     

     

    CONTINUING OPERATIONS ONLY

    Three Months Ended

    June 30,

     

    CONTINUING OPERATIONS ONLY

    Six Months Ended

    June 30,

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    (1)

    GAAP selling, general and administrative

    $

    14,744

     

     

     

    $

    17,230

     

     

     

    $

    29,538

     

     

     

    $

    33,182

     

     

     

    Non-GAAP adjustments to SG&A:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (2,877

    )

     

     

    (3,555

    )

     

     

    (6,755

    )

     

     

    (7,030

    )

     

     

    Depreciation expense

    (112

    )

     

     

    (56

    )

     

     

    (218

    )

     

     

    (122

    )

     

     

    Lease expense

    5

     

     

     

     

     

     

    14

     

     

     

    (129

    )

     

     

    Severance expense

     

     

     

    126

     

     

     

     

     

     

    (1,515

    )

     

     

    Non-GAAP selling, general and administrative

    $

    11,760

     

     

     

    $

    13,745

     

     

     

    $

    22,579

     

     

     

    $

    24,386

     

     

    (2)

    GAAP research and development

    $

    21,746

     

     

     

    $

    16,982

     

     

     

    $

    37,739

     

     

     

    $

    38,868

     

     

     

    Non-GAAP adjustments to R&D:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (1,110

    )

     

     

    (1,344

    )

     

     

    (2,508

    )

     

     

    (2,227

    )

     

     

    Depreciation expense

    (31

    )

     

     

    (13

    )

     

     

    (65

    )

     

     

    (15

    )

     

     

    Severance expense

     

     

     

    286

     

     

     

     

     

     

    (260

    )

     

     

    R&D milestones and in-license upfront fees

     

     

     

    (2,751

    )

     

     

     

     

     

    (2,751

    )

     

     

    Non-GAAP research and development

    $

    20,605

     

     

     

    $

    13,160

     

     

     

    $

    35,166

     

     

     

    $

    33,615

     

     

    (3)

    GAAP net loss from continuing operations

    $

    (32,229

    )

     

     

    $

    (28,783

    )

     

     

    $

    (72,846

    )

     

     

    $

    (68,629

    )

     

     

    Non-GAAP adjustments to net loss from continuing operations:

     

     

     

     

     

     

     

     

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

    4,125

     

     

     

    7,307

     

     

     

    9,532

     

     

     

    14,049

     

     

     

    Adjustments to other expense

    (3,667

    )

     

     

    (3,477

    )

     

     

    6,582

     

     

     

    8,428

     

     

     

    Adjustments to provision (benefit) for income taxes

    9

     

     

     

    (212

    )

     

     

    9

     

     

     

    (8,428

    )

     

     

    Non-GAAP net loss from continuing operations

    $

    (31,762

    )

     

     

    $

    (25,165

    )

     

     

    $

    (56,723

    )

     

     

    $

    (54,580

    )

     

    (4)

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

    $

    (0.29

    )

     

     

    $

    (0.26

    )

     

     

    $

    (0.65

    )

     

     

    $

    (0.63

    )

     

     

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

    $

    (0.28

    )

     

     

    $

    (0.23

    )

     

     

    $

    (0.51

    )

     

     

    $

    (0.50

    )

     

     

    Weighted average shares outstanding, basic and diluted

    112,615,744

     

     

     

    110,345,135

     

     

     

    112,199,229

     

     

     

    109,744,405

     

     

    (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), as well as the reversal of non-recurring severance expenses. 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 and depreciation), as well as the reversal of non-recurring severance expenses and R&D milestone achievements and in-license upfront fees that we record to this expense caption. We believe this 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 o