Cascadian Therapeutics Reports Third Quarter 2017 Financial Results
09 November 2017 - 8:01AM
Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today reported financial results for the
third quarter ended September 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 for the treatment of HER2 overexpressing cancers.
Scott Myers, President and CEO of Cascadian Therapeutics,
stated, “We had a productive third quarter. Tucatinib was granted
orphan drug designation for a second indication, HER2+ colorectal
cancer and enrollment began for an investigator-sponsored study of
tucatinib in combination with trastuzumab in HER2 amplified
metastatic colorectal cancer. Results from a pooled analysis of
tucatinib combination studies were presented at ESMO that provide
further support for the development of tucatinib in HER2+
metastatic breast cancer with brain metastases. Finally, enrollment
of the HER2CLIMB pivotal trial continues to be robust, and we
expect to end the year within our cash guidance.”
Mr. Myers added, “We look forward to sharing new follow up data
from our tucatinib Phase 1b studies at the San Antonio Breast
Cancer Symposium in early December.” Third Quarter and
Recent Highlights
- Tucatinib was granted orphan drug designation by the U.S. Food
and Drug Administration (FDA) for the treatment of HER2+ colorectal
cancer. This is the second orphan designation for tucatinib, which
also has orphan designation in breast cancer with brain
metastases.
- Began enrollment in an investigator-initiated Phase 2 study of
tucatinib in combination with trastuzumab for patients with HER2
amplified metastatic colorectal cancer. The study, known as
MOUNTAINEER, is described on www.clinicaltrials.gov
(NCT03043313).
- Presented at the European Society for Medical Oncology 2017
Congress in September results from a pooled analysis of Phase 1b
combination studies supporting the potential utility of tucatinib
for patients with HER2+ metastatic breast cancer with brain
metastases, including untreated or progressive brain metastases
after radiation therapy. Additional analyses of long-term patients
in tucatinib studies will be presented at the 40th San Antonio
Breast Cancer Symposium 2017 in early December. In addition,
results of non-clinical studies were presented that support the
MOUNTAINEER study, demonstrating tucatinib is active as a single
agent in models of HER2+ colorectal cancer, as well as in other
gastrointestinal cancers.
- Continued enrollment of HER2CLIMB pivotal trial, which is on
track and enrolling in North America, Western Europe and
Australia.
- Received positive regulatory feedback from the European
Medicines Agency’s (EMA) Scientific Advice Working Group and Health
Canada, validating the potential for the ongoing HER2CLIMB pivotal
clinical trial and nonclinical programs to be sufficient for
tucatinib registration, if data are supportive.
- Management is pursuing partnering opportunities for CASC-578, a
Chk1 kinase inhibitor, and CASC-674, a TIGIT antibody program, and
is closing internal laboratory operations to focus resources on
tucatinib registration-enabling critical path activities.
Third Quarter Financial Results
- Cash, cash equivalents and investments totaled $113.0
million as of September 30, 2017, compared to $62.8
million at December 31, 2016. The increase was primarily due
to net proceeds of $88.0 million from the Company’s January 2017
financing, less cash used in operations of $37.2 million.
- Net loss attributable to common stockholders for the three
months ended September 30, 2017 was $14.1 million, or $0.28 per
share, compared with a net loss attributable to common stockholders
of $11.8 million, or $0.52 per share, for the comparable period in
2016. The $2.3 million increase in net loss attributable to common
stockholders for the quarter was primarily due to an increase in
research and development expenses of $3.6 million primarily due to
greater activity related to the development of the Company’s
product candidates, offset by a non-cash deemed dividend of $1.0
million related to the beneficial conversion feature on convertible
preferred stock for the three months ended September 30, 2016.
- Net loss attributable to common stockholders for the nine
months ended September 30, 2017 was $41.2 million, or $0.87 per
share, compared to a net loss attributable to common stockholders
of $49.8 million, or $2.74 per share, for the same period in 2016.
The $8.6 million decrease in net loss attributable to common
stockholders for the nine months ended September 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, each of which was 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 $4.6 million primarily due
to compensation-related expenses in connection with management
changes in the first quarter of 2016 and lower non-cash expenses of
$1.6 million 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 $11.0 million due to greater activity related to the
development of the Company’s product candidates.
2017 Financial Outlook
Cascadian 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 hereof 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 third quarter financial
results and provide an update on business activities today at 4:30
p.m. ET / 1:30 p.m. PT. 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 Therapeutics
Cascadian 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+ breast cancer with and without brain metastases,
who have previously been treated with 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 Information
Additional information relating to Cascadian Therapeutics can be
found on EDGAR at www.sec.gov and on SEDAR at
www.sedar.com.
Investor and Media Contact:Monique
GreerCascadian Therapeutics206-801-2107mgreer@cascadianrx.com
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CASCADIAN THERAPEUTICS, INC.Condensed
Consolidated Statements of Operations(In thousands except share and
per share amounts)(Unaudited) |
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Three months ended
September 30, |
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Nine months ended
September 30, |
|
2017 |
|
2016 |
|
|
2017 |
|
2016 |
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
10,910 |
|
|
$ |
7,281 |
|
|
$ |
31,011 |
|
|
$ |
19,998 |
|
General
and administrative |
|
3,448 |
|
|
|
3,511 |
|
|
|
9,930 |
|
|
|
14,509 |
|
Intangible asset impairment |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
19,738 |
|
Total
operating expenses |
|
14,358 |
|
|
|
10,792 |
|
|
|
40,941 |
|
|
|
54,245 |
|
Loss from
operations |
|
(14,358 |
) |
|
|
(10,792 |
) |
|
|
(40,941 |
) |
|
|
(54,245 |
) |
Other
income |
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|
|
|
|
|
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|
|
|
|
Investment and other income, net |
|
297 |
|
|
|
19 |
|
|
|
769 |
|
|
|
144 |
|
Total
other income, net |
|
297 |
|
|
|
19 |
|
|
|
769 |
|
|
|
144 |
|
Net loss before
income taxes |
$ |
(14,061 |
) |
|
$ |
(10,773 |
) |
|
$ |
(40,172 |
) |
|
$ |
(54,101 |
) |
Income tax benefit |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,908 |
) |
Net
loss |
|
(14,061 |
) |
|
|
(10,773 |
) |
|
|
(40,172 |
) |
|
|
(47,193 |
) |
Deemed dividend
related to beneficial conversion feature on convertible preferred
stock |
|
— |
|
|
|
(989 |
) |
|
|
(982 |
) |
|
|
(2,588 |
) |
Net loss
attributable to common stockholders |
|
(14,061 |
) |
|
|
(11,762 |
) |
|
|
(41,154 |
) |
|
|
(49,781 |
) |
Net loss per
share – basic and diluted |
$ |
(0.28 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.87 |
) |
|
$ |
(2.74 |
) |
Shares used to
compute basic and diluted net loss per share |
|
50,404,201 |
|
|
|
22,551,740 |
|
|
|
47,089,996 |
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18,159,603 |
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CASCADIAN THERAPEUTICS,
INC.Consolidated Balance Sheet Data(In thousands except
share amounts)(Unaudited) |
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As of |
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September 30, 2017 |
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December 31, 2016 |
Cash, cash
equivalents and investments |
|
$ |
112,979 |
|
$ |
62,805 |
Total
assets |
|
$ |
133,387 |
|
$ |
83,265 |
Long term
liabilities |
|
$ |
38 |
|
$ |
135 |
Stockholders’ equity |
|
$ |
124,616 |
|
$ |
74,357 |
Common
shares outstanding |
|
|
50,560,320 |
|
|
22,562,640 |
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