Cascadian Therapeutics Reports Second Quarter 2017 Financial Results
August 08 2017 - 4:01PM
First Patients Randomized in Western
Europe and Australia in Ongoing Global HER2CLIMB Registrational
Trial of Tucatinib Conference Call Scheduled for
Today at 4:30 p.m. ET
Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today reported financial results for the
second quarter ended June 30, 2017, and provided an update on
tucatinib, an investigational oral, small molecule kinase inhibitor
that is highly selective for HER2 and the Company’s lead product in
development.
“During the second quarter, we were pleased to
receive confirmation from the European Medicines Agency (EMA) that
HER2CLIMB, if positive, could serve as a single registrational
trial for submission to the European regulators for potential
marketing approval, and that tucatinib was granted orphan drug
designation by the U.S. Food and Drug Administration (FDA) for the
treatment of breast cancer patients with brain metastases,” said
Scott Myers, President and CEO of Cascadian Therapeutics. “We are
now enrolling patients in HER2CLIMB on three continents. We are
pleased with site activations and patient enrollment, which are
currently ahead of our projections in North America.”
Second Quarter and Recent Highlights
- In July 2017, the Company announced that it received
confirmation from the EMA that positive results from its ongoing
pivotal trial of tucatinib, known as HER2CLIMB, could serve as a
single registrational trial for submission of a Marketing
Authorization Application to the EMA and potential marketing
approval. The Company had received similar confirmation from the
FDA in 2016.
- In June 2017, the Company announced that tucatinib was granted
orphan drug designation by the FDA for the treatment of breast
cancer patients with brain metastases.
Second Quarter Financial Results
- Cash, cash equivalents and investments totaled $125.4
million as of June 30, 2017, compared to $62.8
million at December 31, 2016. The increase was primarily due
to the result of net proceeds of $88.0 million from the Company’s
January 2017 financing, less cash used in operations of $24.8
million.
- Net loss attributable to common stockholders for the three
months ended June 30, 2017 was $14.7 million, or $0.30 per share,
compared with a net loss attributable to common stockholders of
$25.1 million, or $1.57 per share, for the comparable period in
2016. The $10.4 million decrease in net loss attributable to common
stockholders for the quarter was primarily due to the non-cash
intangible asset impairment charge of $19.7 million offset by a
$6.9 million tax benefit related to the reversal of the deferred
tax liability. Both amounts were recorded in connection with the
termination of the STC.UNM license agreement in 2016. The
decrease was offset by an increase in research and development
expenses of $5.1 million primarily due to greater activity related
to the development of the Company’s product candidates.
- Net loss attributable to common stockholders for the six months
ended June 30, 2017 was $27.1 million, or $0.60 per share, compared
to a net loss attributable to common stockholders of $38.0 million,
or $2.39 per share, for the same period in 2016. The $10.9 million
decrease in net loss attributable to common stockholders for the
six months ended June 30, 2017 was primarily due to the non-cash
intangible asset impairment charge of $19.7 million offset by a
$6.9 million tax benefit related to the reversal of the deferred
tax liability. Both of these amounts were recorded in connection
with the termination of the STC.UNM license agreement in 2016.
In addition, the decrease was due to lower general and
administrative expenses of $4.5 million primarily due to
compensation-related expenses in connection with management changes
in the first quarter of 2016 and lower non-cash expense from the
deemed dividend related to the beneficial conversion feature on
convertible preferred stock. The decrease in net loss attributable
to common stockholders were partially offset by increases in
research and development expenses of $7.4 million due to greater
activity related to the development of the Company’s product
candidates.
2017 Financial OutlookCascadian Therapeutics
expects operating expenses in 2017 to be slightly higher than in
2016, primarily due to an increase in activities related to the
ongoing worldwide HER2CLIMB pivotal trial. Cash used in operations
for 2017 is expected to be approximately $50.0 million to $54.0
million. Cascadian Therapeutics believes the above financial
guidance to be correct as of the date provided and is providing the
guidance as a convenience to investors and assumes no obligation to
update it. Conference Call Information Cascadian
Therapeutics management will host a conference call and live audio
webcast to review its second quarter financial results and provide
an update on business activities today at 1:30 p.m. PT / 4:30 p.m.
ET. Participants can access the call at +1 (877) 280-7291
(domestic) or +1 (707) 287-9361 (international). To access the live
audio webcast or the subsequent archived recording, visit the
Events & Presentations page of the News & Events section of
the Cascadian Therapeutics’ website at www.cascadianrx.com.
About Cascadian TherapeuticsCascadian Therapeutics
is a clinical-stage biopharmaceutical company dedicated to
developing innovative product candidates for the treatment of
cancer. Its lead product candidate, tucatinib, is an
investigational oral, selective small molecule HER2 inhibitor.
Cascadian Therapeutics is conducting a randomized, double-blind
controlled pivotal clinical trial called HER2CLIMB, which is
comparing tucatinib vs. placebo, each in combination with
capecitabine and trastuzumab, in patients with locally advanced or
metastatic HER2-positive breast cancer with and without brain
metastases, who have previously been treated with a taxane,
trastuzumab, pertuzumab and T-DM1. Additional details on
HER2CLIMB can be found at www.HER2CLIMB.com or
www.clinicaltrials.gov. For more information, please
visit www.cascadianrx.com.Forward-Looking
Statements In order to provide Cascadian Therapeutics'
investors with an understanding of its current results and future
prospects, this release contains statements that are
forward-looking. Any statements contained in this press release
that are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "will," "intends," "potential,"
"possible" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements
include Cascadian Therapeutics' expectations regarding clinical
development activities, HER2CLIMB enrollment, timing of additional
data, potential benefits of its product candidates, timing of
submission of marketing applications, potential regulatory
approvals, and its use and adequacy of cash reserves and future
financial results.
Forward-looking statements involve risks and uncertainties
related to Cascadian Therapeutics' business and the general
economic environment, many of which are beyond its control. These
risks, uncertainties and other factors could cause Cascadian
Therapeutics' actual results to differ materially from those
projected in forward-looking statements, including the risks
associated with the costs and expenses of developing its product
candidates, the adequacy of financing and cash, cash equivalents
and investments, changes in general accounting policies, general
economic factors, achievement of the results it anticipates from
its preclinical development and clinical trials of its product
candidates, the receipt of regulatory approvals, and its ability to
adequately obtain and protect its intellectual property rights.
Although Cascadian Therapeutics believes that the forward-looking
statements contained herein are reasonable as of the date hereof,
it can give no assurance that its expectations are correct. All
forward-looking statements are expressly qualified in their
entirety by this cautionary statement. For a detailed description
of Cascadian Therapeutics' risks and uncertainties, you should
review the documents filed by Cascadian Therapeutics with the
securities regulators in the United States on EDGAR and in Canada
on SEDAR. Cascadian Therapeutics does not undertake any obligation
to publicly update its forward-looking statements based on events
or circumstances after the date hereof, except to the extent
required by law.Additional InformationAdditional
information relating to Cascadian Therapeutics can be found on
EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
|
CASCADIAN THERAPEUTICS, 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, |
|
|
2017 |
2016 |
2017 |
2016 |
Operating expenses |
|
|
|
|
|
Research
and development |
|
$ |
11,514 |
|
$ |
6,380 |
|
$ |
20,101 |
|
$ |
12,717 |
|
General
and administrative |
|
|
3,507 |
|
|
4,365 |
|
|
6,482 |
|
|
10,998 |
|
Intangible asset impairment |
|
|
— |
|
|
19,738 |
|
|
— |
|
|
19,738 |
|
Total operating expenses |
|
|
15,021 |
|
|
30,483 |
|
|
26,583 |
|
|
43,453 |
|
Loss from operations |
|
|
(15,021 |
) |
|
(30,483 |
) |
|
(26,583 |
) |
|
(43,453 |
) |
Other income (expense) |
|
|
|
|
|
Investment and other income (expense), net |
|
|
312 |
|
|
42 |
|
|
472 |
|
|
125 |
|
Total other income (expense), net |
|
|
312 |
|
|
42 |
|
|
472 |
|
|
125 |
|
Net loss before income taxes |
|
$ |
(14,709 |
) |
$ |
(30,441 |
) |
$ |
(26,111 |
) |
$ |
(43,328 |
) |
Income
tax (benefit) provision |
|
|
— |
|
|
(6,908 |
) |
|
— |
|
|
(6,908 |
) |
Net loss |
|
|
(14,709 |
) |
|
(23,533 |
) |
|
(26,111 |
) |
|
(36,420 |
) |
Deemed dividend related to beneficial conversion feature on
convertible preferred stock |
|
|
— |
|
|
(1,599 |
) |
|
(982 |
) |
|
(1,599 |
) |
Net loss attributable to common stockholders |
|
|
(14,709 |
) |
|
(25,132 |
) |
|
(27,093 |
) |
|
(38,019 |
) |
Net loss per share – basic and diluted |
|
$ |
(0.30 |
) |
$ |
(1.57 |
) |
$ |
(0.60 |
) |
$ |
(2.39 |
) |
Shares used to compute basic and diluted net loss per
share |
|
|
49,244,348 |
|
|
16,051,836 |
|
|
45,405,430 |
|
|
15,939,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASCADIAN THERAPEUTICS, INC. |
Consolidated Balance Sheet Data |
(In thousands except share amounts) |
(Unaudited) |
|
|
|
|
As of |
|
|
|
|
|
|
June 30, 2017 |
|
December 31, 2016 |
|
|
|
Cash, cash
equivalents and investments |
|
$ |
125,415 |
|
$ |
62,805 |
|
|
|
Total
assets |
|
$ |
145,512 |
|
$ |
83,265 |
|
|
|
Long term
liabilities |
|
$ |
70 |
|
$ |
135 |
|
|
|
Stockholders’ equity |
|
$ |
137,908 |
|
$ |
74,357 |
|
|
|
Common
shares outstanding |
|
|
49,303,172 |
|
|
22,562,640 |
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Contact:
Monique Greer
Cascadian Therapeutics
206-801-2107
mgreer@cascadianrx.com
Cascadian Therapeutics, Inc. (NASDAQ:CASC)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cascadian Therapeutics, Inc. (NASDAQ:CASC)
Historical Stock Chart
From Apr 2023 to Apr 2024