Resubmitted eflapegrastim BLA accepted for
review by the FDA, PDUFA date September 9, 2022
Poziotinib NDA under review by FDA with PDUFA
date of November 24, 2022 and will be discussed at ODAC meeting in
September
Positive poziotinib results in treatment naïve
patients with NSCLC harboring HER2 exon 20 insertion mutations
Management to host webcast and conference call
today at 4:30 p.m. ET / 1:30 p.m. PT
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a
biopharmaceutical company focused on novel and targeted oncology
therapies, announced today financial results for the three-month
period ended March 31, 2022 and provided a corporate update.
“We anticipate FDA approvals later this year for poziotinib and
eflapegrastim. In the first quarter, we initiated a confirmatory
study and presented additional positive scientific data for
poziotinib. The resubmitted BLA for eflapegrastim was also accepted
for review by the FDA,” said Tom Riga, President and Chief
Executive Officer of Spectrum Pharmaceuticals. “We are proud of the
progress we’ve made toward our core business objectives and we
remain dedicated to making a meaningful difference in the lives of
cancer patients.”
Pipeline Updates
Eflapegrastim, a novel long-acting G-CSF
- The U.S. Food and Drug Administration (FDA) has accepted
Spectrum’s resubmitted Biologics License Application (BLA) for
eflapegrastim with a Prescription Drug User Fee Act (PDUFA) date of
September 9, 2022. The company is working with its partner, Hanmi
Pharmaceutical, to support the FDA regulatory review process.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon20
mutations
- The New Drug Application (NDA) for poziotinib is under active
review at the FDA with Fast Track designation. The NDA is based on
the positive results of Cohort 2 in patients with previously
treated locally advanced or metastatic non-small cell lung cancer
(NSCLC) harboring HER2 exon 20 insertion mutations. The agency has
set a PDUFA date of November 24, 2022. There is currently no FDA
approved therapy for patients with NSCLC harboring HER2 exon 20
insertion mutations.
- A study for poziotinib has been initiated to confirm the
clinical benefit seen in Cohort 2, as required for an accelerated
approval. The trial, Study SPI-POZ-301 (PINNACLE), is designed to
enroll 268 patients with previously treated NSCLC harboring HER2
exon 20 mutations. Patients are being randomized 2-to-1 into one of
two treatment arms using 8mg of poziotinib orally administered BID
(twice daily) versus 75mg/m2 of docetaxel administered
intravenously every three weeks. The primary endpoint will be
Progression Free Survival.
- FDA’s Oncologic Drugs Advisory Committee (ODAC) is scheduled to
review poziotinib for the treatment of patients with previously
treated locally advanced or metastatic NSCLC harboring HER2 exon 20
insertion mutations. The fall ODAC meeting is being held September
22-23, 2022. ODAC is an independent panel of experts that evaluates
data concerning the efficacy and safety of marketed and
investigational products for use in the treatment of cancer and
makes appropriate recommendations to the FDA. As usual, the final
decision regarding the approval of the product is made by the FDA
solely, and the recommendations by the panel are non-binding.
- Data from Cohort 4 of the ZENITH20 study in patients with
treatment-naïve NSCLC harboring HER2 exon 20 insertion mutations
were presented in an oral session at the European Society for
Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress
2022. The results showed a confirmed objective response rate (ORR)
of 41%, as evaluated centrally by an independent image review
committee using RECIST 1.1 criteria. The evaluable patient
population showed an ORR of 50%. The study met its primary endpoint
as the observed lower bound of 30% exceeded the pre-specified lower
bound of 20%. The safety profile was consistent with the tyrosine
kinase inhibitor (TKI) class. Notably, on-target adverse events
(AEs) were meaningfully reduced with BID dosing.
- The company presented a poster on the predictive ability of
circulating tumor DNA (ctDNA) in poziotinib-treated patients with
NSCLC harboring HER2 exon 20 insertion mutations at the American
Association for Cancer Research (AACR) Annual Meeting. Preliminary
results suggest that decreases in plasma ctDNA during poziotinib
therapy correlate with clinical response in patients with advanced
NSCLC with HER2 exon 20 insertion mutations. Additional data from
this study will be presented at the 2022 ASCO Annual Meeting in
early June.
Corporate Updates
- Nora E. Brennan was named Chief Financial Officer effective May
25, 2022. Ms. Brennan has served on Spectrum’s Board of Directors
since December 2020 and as Chair of the Audit Committee. She will
relinquish her board duties to assume her new senior leadership
role. Most recently, Ms. Brennan served as Chief Financial Officer
of Fore Biotherapeutics, a developer of cancer therapies driven by
functional genomics. Prior to Fore, she served as Chief Financial
Officer at TELA Bio, Inc. and as Senior Vice President of Treasury
and Investor Relations at Integra Life Sciences Holdings
Corporation.
- Hanmi Pharmaceutical completed a $20 million strategic equity
investment in Spectrum in January 2022, which included revisions to
the licensing and supply agreements for eflapegrastim and
poziotinib.
- Two new members of the Board of Directors have been named. In
March, Juhyun Lim was appointed to the Board. Ms. Lim currently
serves as President, Global Strategy and Planning at Hanmi Science
and Hanmi Pharmaceutical, where she leads the execution of
corporate strategy and investment. In May, Spectrum named Brittany
Bradrick to the Board and she will succeed Ms. Brennan as Chair of
the Audit Committee. Ms. Bradrick currently serves as Chief
Financial Officer of Neurelis, Inc. Ms. Bradrick is a seasoned
executive with 25 years of experience in the life sciences sector
including in the areas of mergers and acquisitions, investment
banking, finance, strategy and corporate development.
- A strategic restructuring with a ~30% staff reduction and
~20-25% reduction in operating cash burn was initiated in January
2022 to focus the company's development activities on its
late-stage assets, poziotinib and eflapegrastim. Development
activities for the early-stage pipeline has been
deprioritized.
Three-Month Period Ended March 31, 2022
(All numbers are from Continuing Operations and are
approximate)
GAAP Results
Spectrum recorded a net loss of $15.4 million, or a $0.09 loss
per basic and diluted share, in the three-month period ended March
31, 2022, compared to a net loss of $35.7 million, or a $0.25 loss
per basic and diluted share, in the comparable period in 2021.
Total research and development expenses were $4.2 million in the
quarter, as compared to $19.4 million in the same period in 2021.
Selling, general and administrative expenses were $9.9 million in
the quarter, compared to $14.3 million in the same period in
2021.
Non-GAAP Results
Spectrum recorded a non-GAAP net loss of $9.6 million, or a
$0.06 non-GAAP loss per basic and diluted share, in the three-month
period ended March 31, 2022, compared to a non-GAAP net loss of
$29.4 million, or a $0.20 non-GAAP loss per basic and diluted
share, in the comparable period in 2021. Non-GAAP research and
development expenses were $2.1 million, as compared to $18.0
million in the same period of 2021. Non-GAAP selling, general and
administrative expenses were $7.5 million, as compared to $11.5
million in the same period in 2021.
Cash Position and Guidance
In January, the company received a $20 million strategic equity
investment from Hanmi Pharmaceutical. Together with this strategic
investment, Spectrum ended the quarter with cash, cash equivalents,
and marketable securities of approximately $89.2 million. The
additional cash, combined with the restructuring, is expected to
extend the company’s cash runway into 2023.
Conference Call
Thursday, May 12, 2022 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
Domestic:
(877) 837-3910, Conference ID# 2863606
International:
(973) 796-5077, Conference ID# 2863606
This conference call will also be webcast. Listeners may access
the webcast, which will be available on the investor relations page
of Spectrum Pharmaceuticals' website:
https://investor.sppirx.com/events-and-presentations on May 12,
2022 at 4:30 p.m. Eastern/1:30 p.m. Pacific.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused
on acquiring, developing, and commercializing novel and targeted
oncology therapies. Spectrum has a strong track record of
successfully executing across the biopharmaceutical business model,
from in-licensing and acquiring differentiated drugs, clinically
developing novel assets, successfully gaining regulatory approvals
and commercializing in a competitive healthcare marketplace.
Spectrum has a late-stage pipeline with novel assets that serve
areas of unmet need. This pipeline has the potential to transform
the company in the near future. For additional information on
Spectrum Pharmaceuticals please visit www.sppirx.com.
About the ZENITH20 Clinical Trial
The ZENITH20 study consists of seven cohorts of NSCLC patients.
Cohorts 1 (EGFR) and 2 (HER2) in previously treated NSCLC patients
with exon 20 mutations. Cohort 3 (EGFR) in first-line patients and
Cohort 4 (HER2) in first-line NSCLC patients with exon 20 mutations
have completed enrollment. 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 and eflapegrastin, the
results of the confirmatory study for poziotinib, the results of
the ODAC’s review of poziotinib and related recommendation to the
FDA, the speed of enrollment in the company’s remaining ZENITH20
Cohorts, whether additional data for poziotinib-treated patients
with NSCLC harboring HER20 exon 20 insertion mutations will
continue to demonstrate similar results to the preliminary data
suggesting the predictive ability of circulating tumor DNA (ctDNA),
the future potential of Spectrum’s existing drug pipeline, the
results of the company’s strategic restructuring, the length of the
company’s cash runway 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 and other risks
that are described in further detail in the company's reports filed
with the Securities and Exchange Commission. The company does not
plan to update any such forward-looking statements and expressly
disclaims any duty to update the information contained in this
press release except as required by law. For a further discussion
of risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to the business of Spectrum in general, see
the risk disclosures in the Annual Report on Form 10-K of Spectrum
for the year ended December 31, 2021, and in subsequent reports on
Forms 10-Q and 8-K and other filings made with the SEC by
Spectrum.
SPECTRUM PHARMACEUTICALS, INC.® 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.
© 2022 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
March 31,
2022
2021
Operating costs and expenses:
Selling, general and administrative
$
9,870
$
14,315
Research and development
4,193
19,371
Total operating costs and expenses
14,063
33,686
Loss from continuing operations before
other income (expense) and income taxes
(14,063
)
(33,686
)
Other income (expense):
Interest income, net
11
84
Other expense, net
(1,334
)
(2,081
)
Total other expense
(1,323
)
(1,997
)
Loss from continuing operations before
income taxes
(15,386
)
(35,683
)
Benefit for income taxes from continuing
operations
(16
)
7
Loss from continuing operations
$
(15,402
)
$
(35,676
)
Loss from discontinued operations, net of
income taxes
(40
)
(21
)
Net loss
$
(15,442
)
$
(35,697
)
Basic and diluted loss per share:
Loss from continuing operations
$
(0.09
)
$
(0.25
)
Loss from discontinued operations
$
0.00
$
0.00
Net loss per share, basic and diluted
$
(0.09
)
$
(0.25
)
Weighted average shares outstanding, basic
and diluted
169,735,019
145,371,657
SPECTRUM PHARMACEUTICALS,
INC.
Condensed Consolidated Balance
Sheets
(In thousands, except share and
par value amounts)
(Unaudited)
March 31, 2022
December 31,
2021
ASSETS
Current assets:
Cash and cash equivalents
$
78,679
$
88,539
Marketable securities
10,535
12,108
Other receivables
639
1,028
Prepaid expenses and other current
assets
3,328
2,277
Total current assets
93,181
103,952
Property and equipment, net
418
455
Facility and equipment under lease
2,107
2,505
Other assets
4,348
4,636
Total assets
$
100,054
$
111,548
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable and other accrued
liabilities
$
32,575
$
41,258
Accrued payroll and benefits
6,633
11,971
Total current liabilities
39,208
53,229
Other long-term liabilities
5,590
10,766
Total liabilities
44,798
63,995
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; 178,827,485 and 164,502,013 issued
and outstanding at March 31, 2022 and December 31, 2021,
respectively
179
165
Additional paid-in capital
1,117,350
1,094,353
Accumulated other comprehensive loss
(2,908
)
(3,042
)
Accumulated deficit
(1,059,365
)
(1,043,923
)
Total stockholders’ equity
55,256
47,553
Total liabilities and stockholders’
equity
$
100,054
$
111,548
Non-GAAP Financial Measures (from Continuing
Operations)
In this press release, Spectrum reports certain historical
results that have not been prepared in accordance with generally
accepted accounting principles (GAAP), including non-GAAP selling,
general and administrative expenses, non-GAAP research and
development expenses, non-GAAP net loss and non-GAAP net loss per
share. Non-GAAP financial measures are reconciled to the most
directly comparable GAAP financial measures in the tables of this
press release and the accompanying footnotes. The non-GAAP
financial measures contained herein are a supplement to the
corresponding financial measures prepared in accordance with GAAP.
The non-GAAP financial measures presented exclude the items
summarized in the below table.
Management believes that adjustments for these items assist
investors in making comparisons of period-to-period operating
results and that these items are not indicative of the company's
on-going core operating performance. Management uses non-GAAP net
loss in its evaluation of the company's core after-tax results of
operations and trends between fiscal periods and believes that
these measures are important components of its internal performance
measurement process. Management believes that these non-GAAP
financial measures are useful to investors in providing greater
transparency to the information used by management in its
operational decision-making. Management believes that the use of
these non-GAAP financial measures also facilitates a comparison of
the company’s underlying operating performance with that of other
companies in its industry, which use similar non-GAAP measures to
supplement their GAAP results.
The non-GAAP financial measures presented herein have certain
limitations in that they do not reflect all of the costs associated
with the operations of the company's business as determined in
accordance with GAAP. Therefore, investors should consider non-GAAP
financial measures in addition to, and not as a substitute for, or
as superior to, measures of financial performance prepared in
accordance with GAAP. In addition, other companies, including other
companies in our industry, may calculate non-GAAP financial
measures differently than we do, limiting their usefulness as a
comparative tool. Investors and potential investors are encouraged
to review the reconciliation of our non-GAAP financial measures
contained within this news release with our GAAP financial
results.
SPECTRUM PHARMACEUTICALS,
INC.
Reconciliation of Non-GAAP
Adjustments for Condensed Consolidated Statements of
Operations
(In thousands, except share and
per share amounts)
CONTINUING OPERATIONS
ONLY
Three Months Ended
March 31,
2022
2021
(1
)
GAAP selling, general and
administrative
$
9,870
$
14,315
Non-GAAP adjustments to SG&A:
Stock-based compensation expense
(1,905
)
(2,799
)
Depreciation expense
(71
)
(63
)
Lease expense
39
23
Severance expense
(408
)
—
Non-GAAP selling, general and
administrative
$
7,525
$
11,476
(2
)
GAAP research and development
$
4,193
$
19,371
Non-GAAP adjustments to R&D:
Stock-based compensation expense
(1,090
)
(1,414
)
Depreciation expense
(2
)
(2
)
Severance expense
(1,040
)
—
Non-GAAP research and
development
$
2,061
$
17,955
(3
)
GAAP net loss from continuing
operations
$
(15,402
)
$
(35,676
)
Non-GAAP adjustments to net loss from
continuing operations:
Adjustments to SG&A and R&D, as
noted above
4,477
4,255
Adjustments to other expense
1,329
2,072
Adjustments to benefit for income
taxes
16
(7
)
Non-GAAP net loss from continuing
operations
$
(9,580
)
$
(29,356
)
(4
)
GAAP net loss from continuing
operations - per basic and diluted share
$
(0.09
)
$
(0.25
)
Non-GAAP net loss from continuing
operations - per basic and diluted share
$
(0.06
)
$
(0.20
)
Weighted average shares outstanding, basic
and diluted
169,735,019
145,371,657
(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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220512005915/en/
Robert Uhl Managing Director, Westwicke ICR 858.356.5932
robert.uhl@westwicke.com
Tom Riga Chief Executive Officer 949.788.6700
InvestorRelations@sppirx.com
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