SEATTLE, Nov. 1, 2018 /PRNewswire/ -- CTI BioPharma
Corp. (NASDAQ:CTIC) today reported financial results for the third
quarter and nine months ended September 30,
2018.
In October 2018, CTI BioPharma
announced the continuation of the PAC203 Phase 2 study without
modification, following a planned second interim review by an
Independent Data Monitoring Committee (IDMC). The IDMC did not
identify significant drug- or dose-related safety concerns and
specifically did not identify any concerns around hemorrhagic or
cardiac toxicity. A complete dataset from the full enrollment of
150 patients (including efficacy, safety, pharmacokinetic and
pharmacodynamic data) will now be used to determine the optimal
dose of pacritinib for further clinical development. The PAC203
study is expected to complete enrollment by the end of 2018, with
the next planned interim safety review to be conducted in the first
quarter of 2019. Top-line data from the study are expected in the
second quarter of 2019. The Company has scheduled a Type C meeting
with the U.S. Food and Drug Administration (FDA) to take place
before the end of the year to discuss the design of a new
registrational Phase 3 study of pacritinib in myelofibrosis
patients with severe thrombocytopenia (platelet counts of less than
50,000 per microliter). Following the identification of the optimal
dose from the PAC203 study, the Company expects to begin Phase 3
patient recruitment mid-year in 2019.
In the third quarter of 2018, the Company submitted
comprehensive responses to the Day 180 List of Outstanding Issues
from the European Medicines Agency (EMA) regarding the marketing
authorization application (MAA) for pacritinib. These responses
include new data from the PAC203 trial. The Company expects an
opinion from the EMA Committee for Medicinal Products for Human Use
(CHMP) on the MAA for pacritinib by the end of 2018.
"We continue to progress with pacritinib development and look
forward to our meeting with the FDA to discuss the design of a
registrational Phase 3 trial expected to address the needs of
myelofibrosis patients with severe thrombocytopenia," commented
Adam R. Craig, M.D., Ph.D.,
President and Chief Executive Officer of CTI BioPharma. "Regarding
PAC203, we expect to determine the optimal dose of pacritinib in
the first half of 2019 and initiate patient recruitment for the
Phase 3 trial in mid-2019, adapting the PAC203 study from a Phase 2
to a Phase 3."
Third Quarter Financial Results
Total revenues for the
third quarter and nine months ended September 30, 2018, were $0.7 million and $11.8
million, respectively, compared to $1.7 million and $24.7
million for the respective periods in 2017. The decrease in
total revenues for the third quarter in 2018 compared to the same
period in 2017 is primarily due to the recognition of license and
contract revenue in 2017 related to the achievement of a regulatory
milestone under the license and collaboration agreement for
PIXUVRI® with Servier. The decrease in total
revenues for the nine months ended September
30, 2018 compared to the same period in 2017 is primarily
due to license and contract revenue that included the recognition
of payments received from the expansion of the license and
collaboration agreement for PIXUVRI® with Servier in
2017.
GAAP operating loss was $14.8
million and $33.1 million for
the third quarter and nine months ended September 30, 2018, respectively, compared to
GAAP operating loss of $11.8 million
and $25.8 million for the respective
periods in 2017. Non-GAAP operating loss, which excludes non-cash
share-based compensation expense, for the third quarter and nine
months ended September 30, 2018, was
$12.2 million and $28.2 million, respectively, compared to non-GAAP
operating loss of $10.4 million and
$21.5 million for the respective
periods in 2017. Non-cash share-based compensation expense for the
third quarter and nine months ended September 30, 2018, was $2.5 million and $4.9
million, respectively, compared to $1.4
million and $4.3 million for the
respective periods in 2017. Operating loss in the third quarter of
2018 as compared to the same period in 2017 resulted primarily from
the decrease in license and contract revenue as mentioned above and
a decrease in selling, general and administrative expenses.
Operating loss for the nine months ended September 30, 2018, as compared to the same
period in 2017 resulted primarily from the decrease in license and
contract revenue as mentioned above and an increase in research and
development expenses. For information on CTI BioPharma's use of
non-GAAP operating loss and a reconciliation of such measure to
GAAP operating loss, see the section below titled "Non-GAAP
Financial Measures."
Net loss attributable to common stockholders for the third
quarter of 2018 was $14.8 million, or
$(0.26) per share, compared to
$12.0 million, or $(0.28) per share, for the same period in 2017.
Net loss attributable to common stockholders for the nine months
ended September 30, 2018, was
$30.2 million, or $(0.55) per share, compared to a net loss of
$30.8 million, or $(0.90) per share, for the same period in
2017.
As of September 30, 2018, cash,
cash equivalents and short-term investments totaled $80.9 million, compared to $43.2 million as of December 31, 2017.
Conference Call Information
CTI BioPharma management
will host a conference call to review its third quarter 2018
financial results and provide an update on business activities. The
event will be held today at 1:30 p.m.
PT / 4:30 p.m. ET.
Participants can access the call at 877-260-1479 (domestic) or +1
334-323-0522 (international). To access the live audio webcast or
the subsequent archived recording, visit www.ctibiopharma.com.
Webcast and telephone replays of the conference call will be
available approximately two hours after completion of the call.
Callers can access the replay by dialing 1-888-203-1112 (domestic)
or +1 719-457-0820 (international). The access code for the replay
is 4559931. The telephone replay will be available until
November 8, 2018.
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.
Non-GAAP Financial Measures
CTI BioPharma has provided
in this press release the historical non-GAAP financial measure of
operating loss, excluding non-cash share-based compensation
expense, for the third quarter and nine months ended September 30, 2018 and 2017. Due to varying
available valuation methodologies, subjective assumptions and the
different GAAP accounting treatment of different award types that
companies can use under ASC Topic 718, CTI BioPharma's management
believes that providing a non-GAAP financial measure that excludes
non-cash share-based compensation expense can enhance management's
and investors' comparison of CTI BioPharma's operating results over
different periods of time as compared to the operating results of
other companies.
CTI BioPharma's use of a non-GAAP financial measure has
limitations and should not be considered in isolation from, or as a
substitute for, financial information prepared in accordance with
GAAP. One limitation is that CTI BioPharma's reported non-GAAP
operating loss in 2018 results in the exclusion of a recurring
expense, since CTI BioPharma expects that share-based compensation
will continue to be a significant recurring expense in CTI
BioPharma's business. A second limitation is that CTI BioPharma's
methodology for calculating non-GAAP operating loss, which only
excludes the component of share-based compensation, may differ from
the methodology CTI BioPharma's peer companies utilize to the
extent they report non-GAAP operating income or similarly titled
measures. Accordingly, CTI BioPharma's non-GAAP operating loss may
not necessarily be comparable to similarly titled measures of other
companies. Investors are urged to review the reconciliation of
these non-GAAP measures to their most directly comparable GAAP
financial measures. A reconciliation of CTI BioPharma's non-GAAP
financial measures to the most directly comparable GAAP measures
has been provided in the financial statement tables included below
in this press release.
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 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
our interactions with regulators, the efficacy of, and potential
changes to, our clinical trial designs and anticipated enrollment,
including timing thereof, our ability to successfully develop and
achieve milestones in the development of pacritinib, and the
anticipated benefits of pacritinib. 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; our efforts to advance the development of pacritinib 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 Contacts:
Julia Balanova (investors)
+1 646 378 2936
jbalanova@troutgroup.com
Rich Allan (media)
+1 646-378-2958
rallan@troutgroup.com
CTI BioPharma
Corp.
|
Condensed
Consolidated Statements of Operations
|
(In thousands, except
per share amounts)
|
(unaudited)
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
853
|
|
License and contract
revenue
|
723
|
|
|
1,705
|
|
|
11,813
|
|
|
23,831
|
|
Total
revenues
|
723
|
|
|
1,705
|
|
|
11,813
|
|
|
24,684
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of product
sold
|
114
|
|
|
69
|
|
|
792
|
|
|
280
|
|
Research and
development
|
9,730
|
|
|
7,601
|
|
|
28,539
|
|
|
25,768
|
|
Selling, general and
administrative
|
5,649
|
|
|
5,802
|
|
|
15,923
|
|
|
24,452
|
|
Other operating
income
|
—
|
|
|
—
|
|
|
(334)
|
|
|
—
|
|
Total operating costs
and expenses, net
|
15,493
|
|
|
13,472
|
|
|
44,920
|
|
|
50,500
|
|
Loss from
operations
|
(14,770)
|
|
|
(11,767)
|
|
|
(33,107)
|
|
|
(25,816)
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
436
|
|
|
—
|
|
|
800
|
|
|
—
|
|
Interest
expense
|
(308)
|
|
|
(457)
|
|
|
(893)
|
|
|
(1,479)
|
|
Amortization of debt
discount and issuance costs
|
(130)
|
|
|
(38)
|
|
|
(394)
|
|
|
(113)
|
|
Foreign exchange
(loss) gain
|
(46)
|
|
|
161
|
|
|
(898)
|
|
|
775
|
|
Other non-operating
income
|
—
|
|
|
102
|
|
|
4,295
|
|
|
72
|
|
Total non-operating
(expense) income, net
|
(48)
|
|
|
(232)
|
|
|
2,910
|
|
|
(745)
|
|
Net loss before
noncontrolling interest
|
(14,818)
|
|
|
(11,999)
|
|
|
(30,197)
|
|
|
(26,561)
|
|
Noncontrolling
interest
|
9
|
|
|
25
|
|
|
31
|
|
|
157
|
|
Net loss
|
(14,809)
|
|
|
(11,974)
|
|
|
(30,166)
|
|
|
(26,404)
|
|
Deemed dividends on
preferred stock
|
—
|
|
|
—
|
|
|
(80)
|
|
|
(4,350)
|
|
Net loss attributable
to common stockholders
|
$
|
(14,809)
|
|
|
$
|
(11,974)
|
|
|
$
|
(30,246)
|
|
|
$
|
(30,754)
|
|
Basic and diluted net
loss per common share
|
$
|
(0.26)
|
|
|
$
|
(0.28)
|
|
|
$
|
(0.55)
|
|
|
$
|
(0.90)
|
|
Shares used in
calculation of basic and diluted net loss per common
share
|
57,964
|
|
|
42,878
|
|
|
55,434
|
|
|
34,270
|
|
Balance Sheet Data
(unaudited):
|
|
(amounts in
thousands)
|
|
|
September
30,
|
|
December
31,
|
|
|
2018
|
|
2017
|
Cash, cash
equivalents and restricted cash
|
|
$
|
52,911
|
|
|
$
|
43,218
|
|
Short-term
investments
|
|
28,005
|
|
|
—
|
|
Working
capital
|
|
59,303
|
|
|
27,666
|
|
Total
assets
|
|
89,629
|
|
|
54,886
|
|
Current portion of
long-term debt
|
|
3,923
|
|
|
444
|
|
Long-term debt, less
current portion
|
|
10,470
|
|
|
13,575
|
|
Total stockholders'
equity
|
|
51,362
|
|
|
16,090
|
|
Non-GAAP
Reconciliations
|
(In
thousands)
|
(unaudited)
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
As reported - loss
from operations (GAAP)
|
$
|
(14,770)
|
|
|
$
|
(11,767)
|
|
|
$
|
(33,107)
|
|
|
$
|
(25,816)
|
|
As reported -
share-based compensation expense (GAAP)
|
2,528
|
|
|
1,355
|
|
|
4,904
|
|
|
4,303
|
|
As adjusted - loss
from operations (Non-GAAP)
|
$
|
(12,242)
|
|
|
$
|
(10,412)
|
|
|
$
|
(28,203)
|
|
|
$
|
(21,513)
|
|
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SOURCE CTI BioPharma Corp.