SEATTLE, Aug. 2, 2018 /PRNewswire/ -- CTI BioPharma
Corp. (NASDAQ:CTIC) today reported financial results for the second
quarter and six months ended June 30,
2018.
In July 2018, CTI BioPharma
announced the continuation without modification of the PAC203 Phase
2 study following a planned interim review by an Independent Data
Monitoring Committee. The Company also announced a pacritinib
program update following a Type B meeting with the U.S. Food and
Drug Administration (FDA) and announced a plan to conduct a new,
randomized, Phase 3 study of pacritinib in patients with
myelofibrosis. The Company has recently received the Day 180 List
of Outstanding Issues from the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) regarding
the marketing authorization application (MAA) for pacritinib.
Following the recently reported results from the PIX306 study, the
Company is conducting a review of the clinical study data to assess
the next steps for the PIXUVRI® program.
Upcoming Milestones
- In the third quarter of 2018, a second interim analysis of the
PAC203 study of pacritinib in patients with myelofibrosis will be
conducted by an Independent Data Monitoring Committee. PAC203 is
expected to complete enrollment in the fourth quarter of 2018. Full
top-line data from the study is expected in the second quarter of
2019.
- The Company has been granted a two month extension for
submitting the responses to the Day 180 List of Outstanding Issues.
The extension will allow CTI to submit clinical data from PAC203
for review by the EMA. Given this extension, the CHMP opinion on
the MAA is now expected in the fourth quarter of 2018.
"We believe we have now re-established a collaborative
relationship with the FDA and have received greater clarity on the
development path for pacritinib in the U.S.," commented
Adam R. Craig, M.D., Ph.D.,
President and Chief Executive Officer of CTI BioPharma. "We plan to
request a meeting with the FDA following the second interim
analysis of PAC203 data with a meeting expected in the fourth
quarter of 2018. The purpose of the meeting will be to
discuss the interim data and to review the design of a
registrational Phase 3 trial. We expect that this trial will begin
in 2019, once the optimal dose of pacritinib has been confirmed
using all pharmacokinetic, efficacy and safety data from the PAC203
study."
"In Europe, we continue to make progress with our marketing
authorization application (MAA) and have now received the Day 180
List of Outstanding Issues report. The EMA has expressed interest
in the emerging data from the PAC203 study, so the two month
extension granted by CHMP will allow us to submit additional PAC203
data for review as part of our Day 180 responses."
Second Quarter Financial Results
Total revenues for the second quarter and six months ended
June 30, 2018 were $0.6 million and $11.1
million, respectively, compared to $22.2 million and $23.0
million for the respective periods in 2017. The decrease in
total revenues for the second quarter in 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 as well as the receipt of a
payment from Teva Pharmaceutical Industries Ltd. related
to the achievement of a sales milestone for TRISENOX® (arsenic
trioxide) in 2017. The decrease in total revenues for the six
months ended June 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 $14.0
million and $18.3 million for
the second quarter and six months ended June
30, 2018, respectively, compared to GAAP operating income of
$5.3 million and GAAP operating loss
of $14.0 million for the respective
periods in 2017. Non-GAAP operating loss, which excludes non-cash
share-based compensation expense, for the second quarter and six
months ended June 30, 2018 was
$13.0 million and $16.0 million, respectively, compared to non-GAAP
operating income of $6.4 million and
non-GAAP operating loss of $11.1
million for the respective periods in 2017. Non-cash
share-based compensation expense for the second quarter and six
months ended June 30, 2018, was
$1.0 million and $2.4 million, respectively, compared to $1.1
million and $2.9 million for the
respective periods in 2017. Operating loss in the second quarter of
2018 as compared to an operating income for 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 six months ended
June 30, 2018, 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. 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 for the second quarter of 2018 was $11.3 million, or $(0.20) per share, compared to a net income of
$1.0 million, or $0.03 per share, for the same period in 2017. Net
loss for six months ended June 30,
2018, was $15.4 million, or
$(0.29) per share, compared to a net
loss of $18.8 million, or
($0.63) per share, for the same
period in 2017.
As of June 30, 2018, cash, cash
equivalents and short-term investments totaled $92.8 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 second 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 3255708. The telephone replay will be available until
August 9, 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 second quarter and six months ended June 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 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 , 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. 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 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:
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
June
30,
|
|
Six Months
Ended
June
30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
|
—
|
|
|
$
|
211
|
|
|
$
|
—
|
|
|
$
|
837
|
|
License and contract
revenue
|
613
|
|
|
22,014
|
|
|
11,090
|
|
|
22,142
|
|
Total
revenues
|
613
|
|
|
22,225
|
|
|
11,090
|
|
|
22,979
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of product
sold
|
588
|
|
|
78
|
|
|
678
|
|
|
211
|
|
Research and
development
|
9,124
|
|
|
8,914
|
|
|
18,809
|
|
|
18,167
|
|
Selling, general and
administrative
|
4,865
|
|
|
7,962
|
|
|
10,274
|
|
|
18,650
|
|
Other operating
expense (income)
|
37
|
|
|
—
|
|
|
(334)
|
|
|
—
|
|
Total operating costs
and expenses, net
|
14,614
|
|
|
16,954
|
|
|
29,427
|
|
|
37,028
|
|
(Loss) income from
operations
|
(14,001)
|
|
|
5,271
|
|
|
(18,337)
|
|
|
(14,049)
|
|
Non-operating
(expense) income:
|
|
|
|
|
|
|
|
Interest
expense
|
(297)
|
|
|
(488)
|
|
|
(585)
|
|
|
(1,022)
|
|
Amortization of debt
discount and issuance costs
|
(130)
|
|
|
(37)
|
|
|
(264)
|
|
|
(75)
|
|
Foreign exchange
(loss) gain
|
(1,575)
|
|
|
657
|
|
|
(852)
|
|
|
614
|
|
Other non-operating
income (expense)
|
4,659
|
|
|
(30)
|
|
|
4,659
|
|
|
(30)
|
|
Total non-operating
(expense) income, net
|
2,657
|
|
|
102
|
|
|
2,958
|
|
|
(513)
|
|
Net (loss) income
before noncontrolling interest
|
(11,344)
|
|
|
5,373
|
|
|
(15,379)
|
|
|
(14,562)
|
|
Noncontrolling
interest
|
8
|
|
|
25
|
|
|
22
|
|
|
132
|
|
Net (loss)
income
|
(11,336)
|
|
|
5,398
|
|
|
(15,357)
|
|
|
(14,430)
|
|
Deemed dividends on
preferred stock
|
—
|
|
|
(4,350)
|
|
|
(80)
|
|
|
(4,350)
|
|
Net (loss) income
attributable to common stockholders
|
$
|
(11,336)
|
|
|
$
|
1,048
|
|
|
$
|
(15,437)
|
|
|
$
|
(18,780)
|
|
Net (loss) income per
common share:
|
|
|
|
|
|
|
|
Basic
|
$
|
(0.20)
|
|
|
$
|
0.03
|
|
|
$
|
(0.29)
|
|
|
$
|
(0.63)
|
|
Diluted
|
$
|
(0.20)
|
|
|
$
|
0.03
|
|
|
$
|
(0.29)
|
|
|
$
|
(0.63)
|
|
Shares used in
calculation of (loss) income per common share:
|
|
|
|
|
|
|
|
Basic
|
57,941
|
|
|
31,725
|
|
|
54,148
|
|
|
29,895
|
|
Diluted
|
57,941
|
|
|
31,901
|
|
|
54,148
|
|
|
29,895
|
|
Balance Sheet Data
(unaudited):
|
|
(amounts in
thousands)
|
|
|
June 30,
|
|
December
31,
|
|
|
2018
|
|
2017
|
Cash, cash
equivalents and restricted cash
|
|
$
|
65,374
|
|
|
$
|
43,218
|
|
Short-term
investments
|
|
27,450
|
|
|
—
|
|
Working
capital
|
|
72,818
|
|
|
27,666
|
|
Total
assets
|
|
102,586
|
|
|
54,886
|
|
Current portion of
long-term debt
|
|
2,590
|
|
|
444
|
|
Long-term debt, less
current portion
|
|
11,673
|
|
|
13,575
|
|
Total stockholders'
equity
|
|
63,648
|
|
|
16,090
|
|
Non-GAAP
Reconciliations
(In thousands)
(unaudited)
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended June
30,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
As reported - (loss)
income from operations (GAAP)
|
$
|
(14,001)
|
|
|
$
|
5,271
|
|
|
$
|
(18,337)
|
|
|
$
|
(14,049)
|
|
|
As reported -
share-based compensation expense (GAAP)
|
1,040
|
|
|
1,149
|
|
|
2,376
|
|
|
2,948
|
|
|
As adjusted - loss
from operations (Non-GAAP)
|
$
|
(12,961)
|
|
|
$
|
6,420
|
|
|
$
|
(15,961)
|
|
|
$
|
(11,101)
|
|
|
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SOURCE CTI BioPharma Corp.