SPECTRUM PHARMACEUTICALS, INC.

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Spectrum Pharmaceuticals : Management's Discussion and Analysis of Financial Condition and Results of Operations

08/12/2021 | 04:21pm EDT
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended (the
"Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as
amended (the "Exchange Act"), in reliance upon the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Forward-looking statements
include, without limitation, statements regarding our future product development
and commercialization activities and costs, the revenue potential (licensing,
royalty and sales) of our products and product candidates, the impact of the
novel coronavirus ("COVID-19") global pandemic on our business, the success,
safety and efficacy of our drug products, revenues and revenue assumptions,
clinical studies, including designs and implementation, development and
commercialization timelines, product acquisitions, accounting principles,
litigation expenses, liquidity and capital resources and trends, and other
statements containing forward-looking words, such as, "believes," "may,"
"could," "would," "will," "expects," "intends," "estimates," "anticipates,"
"plans," "seeks," "continues," or the negative thereof or variation thereon or
similar terminology (although not all forward-looking statements contain these
words). Such forward-looking statements are based on the reasonable beliefs of
our management as well as assumptions made by and information currently
available to our management. All forward-looking statements included in this
Form 10-Q speak only as of the date of this Form 10-Q and readers should not put
undue reliance on these forward-looking statements. Forward-looking statements
are inherently subject to risks and uncertainties, some of which cannot be
predicted or quantified; therefore, our actual results may differ materially
from those described in any forward-looking statements. Factors that might cause
such a difference include, but are not limited to, those discussed in our
periodic reports filed with the U.S. Securities and Exchange Commission (the
"SEC"), including our Annual Report on Form 10-K for the fiscal year ended
December 31, 2020, as well as those discussed elsewhere in this Quarterly Report
on Form 10-Q, and the following factors, among others:
•our ability to successfully develop, obtain regulatory approval, and market our
products;
•the approval, or timing of approval, of our products or new indications for our
products by the U.S. Food and Drug Administration (the "FDA") and other
international regulatory agencies;
•the overall impact of COVID-19 on our business, including, without limitation,
delays caused by COVID-19 related travel restrictions;
•actions by the FDA and other regulatory agencies, including international
agencies;
•the timing and/or results of pending or future clinical trials, and our
reliance on contract research organizations;
•our ability to maintain sufficient cash resources to fund our business
operations;
•our history of net losses;
•our ability to enter into strategic alliances with partners for manufacturing,
development and commercialization;
•our competitors' progress with their drug development programs, which could
adversely impact the perceived or actual value of our in-development drugs;
•the ability of our manufacturing partners to satisfy regulatory requirements
and to meet our product demands and timelines;
•our ability to identify and acquire new product candidates and to successfully
integrate those product candidates into our operations;
•our ability to protect our intellectual property rights;
•the impact of legislative or regulatory reform on the pricing for
pharmaceutical products;
•the impact of any litigation to which we are, or may become a party, including,
without limitation, the patent infringement claims made against us by Bioverativ
Therapeutics, Inc.;
•our ability, and that of our suppliers, development partners, and manufacturing
partners, to comply with laws, regulations and standards that govern or affect
the pharmaceutical and biotechnology industries; and
•our ability to maintain the services of our key executives and other personnel.
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All subsequent written and oral forward-looking statements attributable to us or
by persons acting on our behalf are expressly qualified in their entirety by
these cautionary statements. We expressly disclaim any intent or obligation to
update information contained in any forward-looking statement after the date
thereof to conform such information to actual results or to changes in our
opinions or expectations.
Impact of COVID-19 Pandemic
On March 11, 2020, COVID-19 was declared a pandemic by the World Health
Organization. Concerns related to the spread of COVID-19 have created global
business disruptions as well as disruptions in our operations. The ongoing
COVID-19 pandemic has adversely impacted economic activity and conditions
worldwide, including workforces, liquidity, capital markets, consumer behavior,
supply chains, and macroeconomic conditions.
On October 26, 2020, we announced that the FDA had deferred action on our
Biologics License Application ("BLA") for ROLONTIS due to the inability to
conduct an inspection of the Hanmi Pharmaceutical Co. Ltd. ("Hanmi") third-party
manufacturing facility in South Korea as a result of COVID-19 related travel
restrictions. In early June 2021, the FDA conducted the pre-approval inspection
of the Hanmi manufacturing facility. In August 2021, we received a Complete
Response Letter from the FDA regarding our BLA, citing deficiencies related to
manufacturing and indicating that a reinspection will be necessary. We are
seeking further clarification from the FDA and plan to meet with the agency as
soon as possible.

The extent to which the COVID-19 pandemic may continue to impact our results of
operations, including the long-term nature of the impacts, depends on numerous
evolving factors, which are highly uncertain and difficult to predict, including
the adoption rate of the COVID-19 vaccines, the emergence and spread of variants
(including the Delta variant, a rapidly spreading strain of coronavirus), the
scope and the timing to further contain the virus or treat its impact, and to
what extent normal economic and operating conditions can resume, among
others.For more information related to the impact of COVID-19 on our business,
refer to the risk factors included in our Annual Report on Form 10-K for the
year ended December 31, 2020, as filed with the SEC on March 31, 2021.
Company Overview
Spectrum Pharmaceuticals, Inc. ("Spectrum", the "Company", "we", "our", or "us")
is a biopharmaceutical company, with a primary strategy comprised of acquiring,
developing, and commercializing novel and targeted oncology therapies. Our
in-house development organization includes clinical development, regulatory,
quality and data management. We continue to build out our commercial and
marketing capabilities to prepare for the launch of ROLONTIS.
We have three drugs in development:
•ROLONTIS, a novel long-acting granulocyte colony-stimulating factor ("G-CSF")
for chemotherapy-induced neutropenia, which is under review by the FDA. On
October 26, 2020, the Company announced that the FDA had deferred action on the
BLA for ROLONTIS due to the inability to conduct an inspection of the Hanmi
third-party manufacturing facility in South Korea as a result of travel
restrictions associated with the novel coronavirus ("COVID-19") global pandemic.
In early June 2021, the FDA conducted the pre-approval inspection of the Hanmi
manufacturing facility. In August 2021, we received a Complete Response Letter
from the FDA regarding our BLA, citing deficiencies related to manufacturing and
indicating that a reinspection will be necessary. We are seeking further
clarification from the FDA and plan to meet with the agency as soon as possible;
•Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation
for non-small cell lung cancer ("NSCLC") tumors with various mutations. A New
Drug Application ("NDA") based on data from Cohort 2 of ZENITH20, which
evaluated previously treated patients with NSCLC with HER2 exon 20 insertion
mutation is expected to be filed with the FDA in 2021; and

•Anti-CD20-IFN?, an antibody-interferon fusion molecule directed against CD20
that is in Phase 1 development for treating relapsed or refractory non-Hodgkin's
lymphoma patients.
Our business strategy is the development of our late-stage assets through
commercialization and the sourcing of additional assets that are synergistic
with our existing portfolio (through purchase acquisitions, in-licensing
transactions, or co-development and marketing arrangements).
Recent Highlights of Our Business, Product Development Initiatives, and
Regulatory Approvals
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During the six months ended June 30, 2021, we continued our strategic shift in
our business following the completion of the sale of our legacy Commercial
Product Portfolio in March 2019. We also continued to make meaningful progress
in the advancement of our product pipeline, as summarized below:
ROLONTIS, a novel long-acting G-CSF:
We submitted our updated BLA for ROLONTIS to the FDA on October 24, 2019, which
was accepted for review by the FDA on December 20, 2019. Our BLA is supported by
data from two similarly 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. On October 26, 2020, we announced that the FDA PDUFA target action
date set for October 24, 2020 was deferred pending inspection of the Hanmi
manufacturing facility in Korea due to COVID-19 related travel restrictions. In
early June 2021, the FDA conducted the pre-approval inspection of the Hanmi
manufacturing facility. In August 2021, we received a Complete Response Letter
from the FDA regarding our BLA, citing deficiencies related to manufacturing and
indicating that a reinspection will be necessary. We are seeking further
clarification from the FDA and plan to meet with the agency as soon as possible.
A company sponsored clinical trial has been initiated to evaluate the
administration of ROLONTIS on the same day as chemotherapy. This Phase 1
clinical trial is a randomized, open label, actively controlled study to
evaluate the same-day dosing of eflapegrastim on duration of neutropenia when
administered at varying intervals following docetaxel and cyclophosphamide (TC)
chemotherapy in patients with early-stage breast cancer. On March 4, 2021, at
the virtual 38th Annual Miami Breast Cancer Conference®, the company presented
positive early data showing rapid absolute neutrophil count (ANC) recovery in
the first three patients dosed in the 30-minute arm of the same-day dosing. This
arm met the prespecified interim safety evaluation criteria and therefore
supports the expansion of this arm to 15 patients. The study design included an
interim safety evaluation that was conducted once the first three patients in
each arm (30 minutes, 3 hours, or 5 hours) completed Cycle 1. Based on this
review, the 30-minute arm will expand to a total of 15 patients, while the 3-
and 5-hour dosing arms have been discontinued. In the 30-minute dosing arm, ANC
recovery was more rapid compared to the 3- and 5-hour arms. The overall safety
profile for the 30-minute arm was similar to what has been seen previously in
large randomized studies with GCSF given 24 hours after chemotherapy.
Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2
mutations:
In October 2017, we announced the start of our pivotal ZENITH20 Phase 2 global
clinical trial with active sites in the U.S., Canada and Europe. The ZENITH20
trial consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2)
include previously treated NSCLC patients with exon 20 mutations. Cohort 3
(EGFR) and 4 (HER2) include 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 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. Cohorts 1-3 have completed enrollment while Cohorts 4-7 continue to
enroll patients.

On December 26, 2019, we announced that the pre-specified primary endpoint was
not met in Cohort 1 of the ZENITH20 trial evaluating poziotinib in previously
treated NSCLC patients with EGFR exon 20 insertion mutations. Cohort 1 enrolled
a total of 115 patients who received 16 mg/day of poziotinib. The
intent-to-treat analysis showed that 17 patients had a response (by RECIST) and
62 patients had stable disease for a 68.7% DCR. The confirmed ORR was 14.8% (95%
CI 8.9%-22.6%). The median duration of response was 7.4 months and the
progression free survival was 4.2 months. The safety profile was in-line with
other second-generation EGFR tyrosine kinase inhibitors.

On July 27, 2020, we announced that we met the pre-specified primary endpoint
for Cohort 2 in the ZENITH20 trial evaluating previously treated NSCLC patients
with HER2 exon 20 insertion mutations. Cohort 2 enrolled a total of 90 patients
who received an oral, once daily dose of 16 mg of poziotinib. All the patients
had failed at least one line of prior systemic therapy with 60 patients (67%)
having failed two or more prior therapies, including chemotherapy and
immunotherapy. All responses were read independently and confirmed by a central
imaging laboratory using RECIST criteria. The intent-to-treat analysis
demonstrated a confirmed ORR of 27.8% (95% CI of 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 safety profile was in-line with the type of
adverse events seen with other second-generation EGFR tyrosine kinase
inhibitors. These results were presented at the ESMO Virtual Congress 2020
Science Weekend held in September 2020.

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In March 2021, we announced that the FDA granted Fast Track designation for
poziotinib based on data from Cohort 2 of ZENITH20, which evaluated previously
treated patients with NSCLC with HER2 exon 20 insertion mutations. In December
2020, we reported that its pre-specified primary endpoint in Cohort 3 evaluating
poziotinib in first-line NSCLC patients with EGFR exon 20 insertion mutations
was not met. We 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.

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.

In April 2021, new data was presented at the American Association for Cancer
Research (AACR) Virtual Annual Meeting 2021 from ZENITH20 Cohort 5 which
demonstrated improved efficacy and tolerability for twice daily dosing. In the
38 patients, comprised of EGFR or HER2 exon 20 insertion mutations, who received
16 mg per day and randomized either to poziotinib 16 mg once daily or 8 mg twice
daily in Cohort 5, improved responses were observed in the twice daily arm with
31.6% of patients reaching a partial response, while Grade 3 or higher adverse
events were reduced by approximately 60%. Additionally, the twice daily dosing
allowed for an improved rate of dose reductions and interruptions relative to
the once daily dose.

Anti-CD20-IFN?:

In April 2019, we executed a license agreement with ImmunGene for an
antibody-interferon fusion molecule directed against CD20 (Anti-CD20-IFN?) that
is in Phase 1 development for treating relapsed or refractory NHL, This
technology is designed to selectively target NHL with therapeutic doses of IFNa,
while minimizing systemic toxicity. Under the terms of this agreement, we
received the exclusive worldwide rights to commercialize this drug for any
indication, and are financially responsible for the clinical and regulatory
development programs.
Components of Operating Results
See Item 7. Components of Operating Results of our Annual Report on Form 10-K
for the year ended December 31, 2020, for a discussion of the nature of our
revenue and operating expense line items within our accompanying Condensed
Consolidated Statements of Operations.
Critical Accounting Policies and Estimates
See Item 7. Management's Discussion and Analysis of Financial Condition and
Results of Operations - Critical Accounting Policies and Estimates of our Annual
Report on Form 10-K for the year ended December 31, 2020, for a discussion of
significant estimates and assumptions made by our management as part of the
preparation of our accompanying Condensed Consolidated Financial Statements.
These critical accounting policies and estimates arise in conjunction with the
following accounts in the preparation of this Form 10-Q:
•Revenue recognition;
•Property and equipment, net;
•Stock-based compensation; and
•Research and development costs.

Results of Operations

Comparison of the Three and Six Months Ended June 30, 2021 and 2020

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                                                      Three Months Ended                                                                 Six Months Ended
                                                           June 30,                                  Change                                  June 30,                                  Change
                                                    2021               2020                   $                     %                 2021               2020                   $                     %
                                                        (in thousands)                  (in thousands)                                   ($ in thousands)                 (in thousands)

Operating costs and expenses:


Selling, general and administrative             $  14,957          $  14,744          $           213                1.4  %       $  29,272          $  29,538          $          (266)             (0.9) %
Research and development                           29,114             21,746                    7,368               33.9  %          48,485             37,739                   10,746              28.5  %

Total operating costs and expenses                 44,071             36,490                    7,581               20.8  %          77,757             67,277                   10,480              15.6  %
Loss from continuing operations before
other income (expense) and income taxes           (44,071)           (36,490)                  (7,581)              20.8  %         (77,757)           (67,277)                 (10,480)             15.6  %
Interest income, net                                   26                325                     (299)             (92.0) %             110              1,029                     (919)            (89.3) %
Other income (expense), net                        (5,876)             3,945                   (9,821)            (248.9) %          (7,957)            (6,589)                  (1,368)             20.8  %
Total other income (expense)                       (5,850)             4,270                  (10,120)            (237.0) %          (7,847)            (5,560)                  (2,287)             41.1  %
Loss from continuing operations before
income taxes                                      (49,921)           (32,220)                 (17,701)              54.9  %         (85,604)           (72,837)                 (12,767)             17.5  %
Provision for income taxes from
continuing operations                                 (16)                (9)                      (7)              77.8  %              (9)                (9)                       -                 -  %
Loss from continuing operations                   (49,937)           (32,229)                 (17,708)              54.9  %         (85,613)           (72,846)                 (12,767)             17.5  %
Income (loss) from discontinued
operations, net of income taxes                      (195)               144                     (339)            (235.4) %            (216)               189                     (405)           (214.3) %
Net loss                                        $ (50,132)         $ (32,085)         $       (18,047)              56.2  %       $ (85,829)         $ (72,657)         $       (13,172)             18.1  %


Quarterly Discussion
Selling, General and Administrative. Selling, general and administrative
expenses remained consistent compared to the prior period.
Research and Development. Research and development expenses increased by $7.4
million in the current period, primarily due to (i) increased program activities
of $6.2 million for poziotinib, (ii) $0.8 million for ROLONTIS and (iii) $1.3
million of increased personnel-related expenses. These increases were partially
offset by $0.9 million of decreased spend related to our early stage compounds.
Total Other Income (Expense). Total other income (expense) increased by $10.1
million primarily due to $11 million of decrease in the market value of our
equity holdings compared to the prior year period, partially offset by $0.8
million of realized gains recorded from the sale of our equity holdings.
Year to Date Discussion
Selling, General and Administrative. Selling, general and administrative
expenses remained consistent compared to the prior period.
Research and Development. Research and development expenses increased by $10.7
million in the current period, primarily due to (i) increased program activities
of $6.8 million for poziotinib, (ii) $1.7 million for ROLONTIS, and (iii) $3.1
million of increased personnel-related expenses. These increases were partially
offset by $0.8 million of decreased spend related to our early stage compounds.
Total Other Expense. Total other expense increased by $2.3 million primarily due
to $5.8 million of decrease in the market value of our equity holdings compared
to the prior year period and $1 million of lower interest income from our
investments. These increases to other expense were partially offset by (i) $3.5
million of realized gains from the sale of our equity holdings, (ii) $0.4
million of gains from our life insurance policies, and (iii) $0.5 million of
lower currency exchange losses.
Liquidity and Capital Resources
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We believe that our $158.8 million in aggregate cash, cash equivalents and
marketable securities as of June 30, 2021, are sufficient to fund our current
and planned operations for at least the next twelve months. We may however,
require additional liquidity as we continue to execute our business strategy,
and in connection with opportunistic acquisitions or licensing arrangements. We
anticipate that to the extent that we require additional liquidity, it will be
funded through additional equity or debt financings, or out-licensing
arrangements. However, we cannot provide assurance that we will be able to
obtain this additional liquidity on terms favorable to us or our current
stockholders, if at all. Additionally, our liquidity and our ability to fund our
capital requirements are also dependent on our future financial performance
which is subject to various market and economic factors that are beyond our
control.
Net Cash Used In Operating Activities
Net cash used in operating activities was $64.1 million for the six months ended
June 30, 2021, as compared to $60.4 million in the prior year period. This
increase in net cash used in operating activities was primarily related to
increased research and development program spend.
Net Cash Provided by Investing Activities
Net cash provided by investing activities was $79.6 million for the six months
ended June 30, 2021, as compared to $77.8 million during the prior year period.
The cash provided by investing activities for the first six months of 2021
primarily relates to $92.0 million of proceeds from maturities of our
investments and $4.1 million of proceeds received from the sale of our equity
holdings. This cash received was partially offset by $16.4 million of purchased
investments and $0.1 million of purchased property and equipment.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $53.1 million for the six months
ended June 30, 2021, as compared to $3.4 million during the prior year period.
Our cash provided by financing activities for the first six months of 2021
primarily relates to $52.6 million of proceeds from shares of common stock sold
pursuant to an at-the-market sales agreement and $0.5 million of proceeds from
employee stock purchases under our employee stock purchase plan.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements during the periods presented,
nor do we currently have any, as defined under SEC rules.
Item 3.  Quantitative and Qualitative Disclosures About Market Risk
Not applicable.
Item 4.  Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our chief executive officer and chief
financial officer, evaluated the effectiveness of our disclosure controls and
procedures as of June 30, 2021. The term "disclosure controls and procedures,"
as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means
controls and other procedures of a company that are designed to ensure that
information required to be disclosed by a company in the reports that it files
or submits under the Exchange Act is recorded, processed, summarized and
reported, within the time periods specified in the SEC's rules and forms. These
include controls and procedures that are designed to ensure that information
required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the company's
management, including its principal executive and principal financial officers,
as appropriate, to allow timely decisions regarding required disclosure.
Based on the evaluation of our disclosure controls and procedures as of June 30,
2021, our chief executive officer and chief financial officer concluded that, as
of that date, our disclosure controls and procedures were effective.
Changes in Internal Controls Over Financial Reporting
There has been no change in our internal controls over financial reporting (as
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the
second fiscal quarter of 2021 that has materially affected, or is reasonably
likely to
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materially affect, our internal controls over financial reporting. We have not
experienced any material impact to our internal controls over financial
reporting despite the fact that most of our employees are working remotely due
to the COVID-19 pandemic. We are continually monitoring and assessing the
COVID-19 situation on our internal controls to minimize the impact on their
design and operating effectiveness.
Limitations on Ensuring the Effectiveness of Internal Controls
An internal control system, no matter how well conceived and operated, cannot
provide more than reasonable assurance that its objectives are completely met
due to inherent limitations. Accordingly, no evaluation can provide absolute
assurance that all internal control issues within a company have been detected.
As part of our ongoing activities, we continuously seek to improve the
efficiency and effectiveness of our business operations and accompanying
internal controls.

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