SEATTLE, March 13, 2019 /PRNewswire/ -- CTI BioPharma
Corp. (Nasdaq: CTIC) today reported financial results for the
fourth quarter and full year ended December
31, 2018.
"The Company is focused on advancing its development
program of pacritinib for the treatment for myelofibrosis patients
with severe thrombocytopenia in the
United States and Europe in
2019," commented Adam R. Craig,
M.D., Ph.D., President and Chief Executive Officer of CTI
BioPharma. "Following the previously-announced completion of full
enrollment in the U.S. Phase 2 PAC203 study of pacritinib in
myelofibrosis patients with severe thrombocytopenia, the Company
expects to meet with the U.S. Food and Drug Administration and
report the determination of an optimal dose of pacritinib in
mid-2019, with a Phase 3 registration study targeted to commence
enrollment shortly thereafter. The Company further expects to
report topline efficacy and safety data from the Phase 2 study by
the end of 2019."
Expected 2019 Milestones
- Determination of the optimal dose of pacritinib – mid-2019
- Commence enrollment in Phase 3 study of pacritinib in
myelofibrosis patients with severe thrombocytopenia (platelet count
of less than 50,000 per microliter) – 3Q 2019
- Reporting of top-line efficacy and safety data from PAC203 at a
major medical meeting by the end of 2019
Fourth Quarter Financial Results
Total revenues for the three months and year ended December 31, 2018 were $14.1 million and $26.3
million, respectively, compared to $0.5 million and $25.1
million for the respective periods in 2017. The increase in
total revenues for the fourth quarter in 2018 compared to the same
period in 2017 is primarily due to the recognition of license and
contract revenue in 2018 related to the achievement of a regulatory
milestone under the license and collaboration agreement for
PIXUVRI® with Servier as well as the attainment of a worldwide
net sales milestone of TRISENOX under the agreement with Teva
Pharmaceutical Industries Ltd.
GAAP operating income was $0.2
million for the fourth quarter of 2018 and GAAP operating
loss was $32.9 million for the year
ended December 31, 2018, compared to
GAAP operating loss of $13.7 million
and $39.5 million for the respective
periods in 2017. Operating income in the fourth quarter of 2018 as
compared to operating loss in the same period in 2017 resulted
primarily from the increase in license and contract revenue as
mentioned above. Operating loss for the year ended December 31, 2018 as compared to 2017 resulted
primarily from the decrease in selling, general and administrative
expenses.
Net income attributable to common stockholders for the fourth
quarter of 2018 was $0.8 million, or
$0.01 for basic and diluted earnings
per share, compared to net loss attributable to common stockholders
of $14.3 million, or $(0.33) per share, for the same period in 2017.
Net loss attributable to common stockholders for the twelve months
ended December 31, 2018, was
$29.4 million, or $(0.52) per share, compared to a net loss of
$45.0 million, or $(1.24) per share, for the same period in
2017.
As of December 31, 2018, cash,
cash equivalents and short-term investments totaled $67.0 million, compared to $43.2 million as of December 31, 2017.
About CTI BioPharma Corp.
CTI BioPharma Corp. is a biopharmaceutical company focused on
the acquisition, development and commercialization of novel
targeted therapies covering a spectrum of blood-related cancers
that offer a unique benefit to patients and healthcare providers.
The CTI BioPharma lead product candidate, pacritinib, is being
developed for the treatment of patients with myelofibrosis. CTI
BioPharma is headquartered in Seattle,
Washington.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include statements regarding our expectations regarding,
the timing of and results from clinical trials and pre-clinical
development activities related to pacritinib, the potential
efficacy, safety profile, future development plans, addressable
market, regulatory success and commercial potential of pacritinib,
the anticipated timing of regulatory submissions and interactions,
the efficacy of, and potential changes to, our clinical trial
designs and anticipated enrollment, our ability to successfully
develop and achieve milestones in the development of pacritinib,
and the anticipated benefits of pacritinib and the anticipated cost
savings from the December 2018
workforce reduction. These forward-looking statements are based on
current assumptions that involve risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from those expressed or implied by such
forward-looking statements. These risks and uncertainties, many of
which are beyond our control, include, but are not limited to:
clinical trials may not demonstrate safety and efficacy of any of
our or our collaborators' product candidates; our assumptions
regarding our planned expenditures and sufficiency of our cash to
fund operations may be incorrect; cost savings from the
December 2018 workforce reduction may
be less than anticipated; our efforts to advance our pipeline may
not be successful; any of our or our collaborators' product
candidates may fail in development, may not receive required
regulatory approvals, or may be delayed to a point where they are
not commercially viable; we may not achieve additional milestones
in our proprietary or partnered programs; the impact of
competition; the impact of expanded product development and
clinical activities on operating expenses; adverse conditions in
the general domestic and global economic markets; as well as the
other risks identified in our filings with the Securities and
Exchange Commission. These forward-looking statements speak only as
of the date hereof and we assume no obligation to update these
forward-looking statements, and readers are cautioned not to place
undue reliance on such forward-looking statements.
"CTI BioPharma" and the CTI BioPharma logo are registered
trademarks or trademarks of CTI BioPharma Corp. in various
jurisdictions. All other trademarks belong to their respective
owner.
CTI BioPharma Investor Contacts:
Maeve Conneighton/Maghan Meyers
+212-600-1902
cti@argotpartners.com
CTI BioPharma
Corp.
Condensed
Consolidated Statements of Operations
(In thousands, except
per share amounts)
(unaudited)
|
|
|
Three Months
Ended
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
853
|
|
License and contract
revenue
|
14,108
|
|
|
462
|
|
|
26,290
|
|
|
24,293
|
|
Total
revenues
|
14,108
|
|
|
462
|
|
|
26,290
|
|
|
25,146
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of product
sold
|
87
|
|
|
84
|
|
|
879
|
|
|
364
|
|
Research and
development
|
7,928
|
|
|
7,098
|
|
|
36,467
|
|
|
32,866
|
|
Selling, general and
administrative
|
5,225
|
|
|
6,983
|
|
|
21,183
|
|
|
31,435
|
|
Restructuring
expenses
|
660
|
|
|
—
|
|
|
660
|
|
|
—
|
|
Total operating
costs and expenses
|
13,900
|
|
|
14,165
|
|
|
59,189
|
|
|
64,665
|
|
Income (loss) from
operations
|
208
|
|
|
(13,703)
|
|
|
(32,899)
|
|
|
(39,519)
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
419
|
|
|
—
|
|
|
1,219
|
|
|
—
|
|
Interest
expense
|
(316)
|
|
|
(393)
|
|
|
(1,209)
|
|
|
(1,872)
|
|
Amortization of debt
discount and issuance costs
|
(131)
|
|
|
(50)
|
|
|
(525)
|
|
|
(163)
|
|
Foreign exchange gain
(loss)
|
665
|
|
|
42
|
|
|
(233)
|
|
|
817
|
|
Other non-operating
(expense) income
|
—
|
|
|
(166)
|
|
|
4,295
|
|
|
(94)
|
|
Total
non-operating income (expense), net
|
637
|
|
|
(567)
|
|
|
3,547
|
|
|
(1,312)
|
|
Net income (loss)
before noncontrolling interest
|
845
|
|
|
(14,270)
|
|
|
(29,352)
|
|
|
(40,831)
|
|
Noncontrolling
interest
|
1
|
|
|
4
|
|
|
32
|
|
|
161
|
|
Net income
(loss)
|
846
|
|
|
(14,266)
|
|
|
(29,320)
|
|
|
(40,670)
|
|
Deemed dividends on
preferred stock
|
—
|
|
|
—
|
|
|
(80)
|
|
|
(4,350)
|
|
Net income (loss)
attributable to common stockholders
|
$
|
846
|
|
|
$
|
(14,266)
|
|
|
$
|
(29,400)
|
|
|
$
|
(45,020)
|
|
Net income (loss) per
common share:
|
|
|
|
|
|
|
|
Basic
|
$
|
0.01
|
|
|
$
|
(0.33)
|
|
|
$
|
(0.52)
|
|
|
$
|
(1.24)
|
|
Diluted
|
$
|
0.01
|
|
|
$
|
(0.33)
|
|
|
$
|
(0.52)
|
|
|
$
|
(1.24)
|
|
Shares used in
calculation of income (loss) per common share:
|
|
|
|
|
|
|
|
Basic
|
57,969
|
|
|
42,899
|
|
|
56,073
|
|
|
36,445
|
|
Diluted
|
57,970
|
|
|
42,899
|
|
|
56,073
|
|
|
36,445
|
|
Balance Sheet Data
(unaudited):
|
|
(amounts in
thousands)
|
|
|
December
31,
|
|
December
31,
|
|
|
2018
|
|
2017
|
Cash, cash
equivalents and restricted cash
|
|
$
|
36,439
|
|
|
$
|
43,218
|
|
Short-term
investments
|
|
30,599
|
|
|
—
|
|
Working
capital
|
|
59,437
|
|
|
27,666
|
|
Total
assets
|
|
89,832
|
|
|
54,886
|
|
Current portion of
long-term debt
|
|
4,812
|
|
|
444
|
|
Long-term debt, less
current portion
|
|
9,267
|
|
|
13,575
|
|
Total stockholders'
equity
|
|
52,939
|
|
|
16,090
|
|
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SOURCE CTI BioPharma Corp.