Eflapegrastim BLA under FDA review; PDUFA date
September 9, 2022
FDA completes re-inspection of drug substance
manufacturing facility for eflapegrastim
Poziotinib NDA under FDA review with ODAC
meeting on September 22, 2022
Management to host webcast and conference call
today at 8:30 a.m. ET / 5:30 a.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 June 30, 2022 and provided a corporate update.
“The completion of the FDA re-inspection of the drug substance
facility for eflapegrastim is a critical step in the regulatory
review process. With this hurdle behind us, we have turned our
focus to our potential approval and commercialization,” said Tom
Riga, President and Chief Executive Officer of Spectrum
Pharmaceuticals. “Additionally, our team is engaged in extensive
preparations ahead of poziotinib’s ODAC review in September, and we
look forward to moving a step closer to bringing this therapy to
patients.”
Pipeline Updates
Eflapegrastim, a novel long-acting G-CSF
- The Biologics License Application (BLA) for eflapegrastim is
under active review at the U.S. Food and Drug Administration (FDA)
with a Prescription Drug User Fee Act (PDUFA) date of September 9,
2022. The pre-approval inspection of the drug substance
manufacturing facility has been completed by the FDA. The company
anticipates an FDA decision by the PDUFA date and is actively
preparing for the potential commercial launch.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon 20
mutations
- The New Drug Application (NDA) for poziotinib is under active
review at the FDA with Fast Track designation and a PDUFA date of
November 24, 2022. The NDA is based on the positive results of
Cohort 2 from the ZENITH20 clinical trial in patients with
previously treated locally advanced or metastatic non-small cell
lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations.
There is currently no FDA approved therapy for patients with NSCLC
harboring HER2 exon 20 insertion mutations.
- An abstract showing a high level of activity for poziotinib in
patients with a G778_P780dup mutation, the second most prevalent
mutation in HER2 exon 20 NSCLC, has been accepted for presentation
at ESMO 2022 being held September 9-13 in Paris. The data comes
from Cohorts 2 and 4 of the ZENITH20 clinical trial.
- A study for poziotinib is in progress 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 is
progression free survival.
- The 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 poziotinib ODAC review is
scheduled for September 22, 2022 at 9 a.m. ET. 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 non-binding
recommendations to the FDA. The final decision regarding the
approval of the product is made solely by the FDA.
- The company presented data on the predictive ability of
circulating tumor DNA (ctDNA) in poziotinib treated patients with
NSCLC harboring HER2 exon 20 insertion mutations at the 2022
American Society of Clinical Oncology (ASCO) Annual Meeting in
June. 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.
Three-Month Period Ended June 30, 2022
(All numbers are from Continuing Operations)
Spectrum recorded a net loss of $29.0 million, or a $0.17 loss
per basic and diluted share, in the three-month period ended June
30, 2022, compared to a net loss of $49.9 million, or a $0.32 loss
per basic and diluted share, in the comparable period in 2021.
Total research and development expenses were $16.0 million in the
quarter, as compared to $29.1 million in the same period in 2021.
Selling, general and administrative expenses were $9.4 million in
the quarter, compared to $15.0 million in the same period in
2021.
Cash Position and Guidance
The company’s cash, cash equivalents and marketable securities
balance was approximately $68 million at June 30, 2022, which
provides for a cash runway into 2023.
Conference Call
Thursday, August 11, 2022 @ 8:30 a.m. Eastern/5:30 a.m.
Pacific
To access the live call by phone, please go to this link
(registration link), and you will be provided with dial in details.
To avoid delays, participants are encouraged to dial into the
conference call fifteen minutes ahead of the scheduled start
time.
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 August 11,
2022 at 8:30 a.m. Eastern/5:30 a.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.
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 eflapegrastim, if FDA
approval is received, the success and timing of the company’s
commercialization efforts, 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 HER2 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
(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, 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
June 30,
Six Months Ended
June 30,
2022
2021
2022
2021
Operating costs and expenses:
Selling, general and administrative
$
9,385
$
14,957
$
19,255
$
29,272
Research and development
16,007
29,114
20,200
48,485
Total operating costs and expenses
25,392
44,071
39,455
77,757
Loss from continuing operations before
other income (expense) and income taxes
(25,392
)
(44,071
)
(39,455
)
(77,757
)
Other income (expense):
Interest income, net
117
26
128
110
Other expense, net
(3,757
)
(5,876
)
(5,091
)
(7,957
)
Total other expense
(3,640
)
(5,850
)
(4,963
)
(7,847
)
Loss from continuing operations before
income taxes
(29,032
)
(49,921
)
(44,418
)
(85,604
)
Provision for income taxes from continuing
operations
(13
)
(16
)
(29
)
(9
)
Loss from continuing operations
(29,045
)
(49,937
)
(44,447
)
(85,613
)
Loss from discontinued operations, net of
income taxes
(3
)
(195
)
(43
)
(216
)
Net loss
$
(29,048
)
$
(50,132
)
$
(44,490
)
$
(85,829
)
Basic and diluted loss per share:
Loss from continuing operations
$
(0.17
)
$
(0.32
)
$
(0.26
)
$
(0.57
)
Loss from discontinued operations
$
(0.00
)
$
(0.00
)
$
(0.00
)
$
(0.00
)
Net loss per share, basic and diluted
$
(0.17
)
$
(0.32
)
$
(0.26
)
$
(0.57
)
Weighted average shares outstanding, basic
and diluted
175,566,757
155,243,402
172,558,831
150,334,548
SPECTRUM PHARMACEUTICALS,
INC.
Condensed Consolidated Balance
Sheets
(In thousands, except share and
par value amounts)
(Unaudited)
June 30,
2022
December 31,
2021
ASSETS
Current assets:
Cash and cash equivalents
$
25,512
$
88,539
Marketable securities
42,447
12,108
Other receivables
608
1,028
Prepaid expenses and other current
assets
5,012
2,277
Total current assets
73,579
103,952
Property and equipment, net
347
455
Facility and equipment under lease
1,703
2,505
Other assets
3,800
4,636
Total assets
$
79,429
$
111,548
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable and other accrued
liabilities
$
33,123
$
41,258
Accrued payroll and benefits
7,918
11,971
Total current liabilities
41,041
53,229
Other long-term liabilities
4,946
10,766
Total liabilities
45,987
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; 184,870,273 and 164,502,013 issued
and outstanding at June 30, 2022 and December 31, 2021,
respectively
185
165
Additional paid-in capital
1,124,625
1,094,353
Accumulated other comprehensive loss
(2,955
)
(3,042
)
Accumulated deficit
(1,088,413
)
(1,043,923
)
Total stockholders’ equity
33,442
47,553
Total liabilities and stockholders’
equity
$
79,429
$
111,548
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220811005222/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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