Cascadian Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results
March 09 2017 - 4:01PM
Cascadian Therapeutics, Inc. (NASDAQ:CASC) today reported financial
results for the fourth quarter and full year ended December 31,
2016.
“In 2016, we focused our efforts on the development of tucatinib
for late-stage HER2-positive metastatic breast cancer for patients
with and without brain metastases and amended our ongoing HER2CLIMB
study by increasing the sample size so that, if successful, the
trial could serve as a single pivotal trial to support
registration,” said Scott Myers, President and CEO of Cascadian
Therapeutics. “For 2017, we have prioritized our resources on
expanding HER2CLIMB globally and exploring the potential utility of
tucatinib in additional HER2-positive expressing cancers. With a
global development plan underway, clarity on a U.S. regulatory
pathway and a solid financial position, we have set the foundation
to execute our strategy.”
Fourth Quarter and Recent Highlights
Tucatinib – targeted HER2 inhibitor
- In December 2016, researchers presented updated data from the
Company’s ongoing Phase 1b Triplet combination study (tucatinib
with capecitabine and trastuzumab) at the 2016 San Antonio Breast
Cancer Symposium. This Triplet combination continued to be well
tolerated and showed an updated median progression-free survival of
7.8 months, an overall response rate of 61 percent and a median
duration of response of 10 months. Patients treated with the
Triplet combination previously received a median of 3 HER2-targeted
agents, such as trastuzumab, pertuzumab, lapatinib and T-DM1.
- In December 2016, the Company announced that, following a
meeting with the U.S. Food and Drug Administration (FDA) and
discussions with the Company’s external Steering Committee, the
Company amended the HER2CLIMB trial of tucatinib by increasing the
sample size so that, if successful, the trial could serve as a
single pivotal study to support a new drug application.
- In October 2016, the Company announced presentation of data
from the ongoing Phase 1b Triplet combination study (tucatinib with
capecitabine and trastuzumab) at the European Society for Medical
Oncology 2016 Congress that showed clinical activity in
HER2-positive metastatic lesions to the skin.
CASC-578 – a novel Chk1 cell cycle inhibitor
- In December 2016, the Company completed a non-human
pharmacology study to evaluate the impact of CASC-578 on multiple
cardiovascular endpoints. The results indicate CASC-578 has an
acceptable profile at the doses tested and warrants further study
of the drug in both single agent and combination settings.
Corporate
- In January 2017, the Company strengthened its balance sheet
through an underwritten public offering, resulting in net proceeds
of approximately $88 million.
Fourth Quarter and Full Year 2016 Financial
Results
- Cash, cash equivalents and investments totaled $62.8
million as of December 31, 2016, compared to $56.4
million at December 31, 2015, an increase of $6.4 million, or
11.3 percent. The increase was primarily due to the result of net
proceeds of $43.3 million from the Company’s June 2016 financing
offset by cash used to fund operations of $36.9 million.
- Net loss attributable to common stockholders for the three
months ended December 31, 2016 was $10.5 million, or $0.47 per
share, compared to a net loss attributable to common stockholders
of $9.1 million, or $0.58 per share, for the same period in 2015.
The $1.4 million increase in net loss attributable to common
stockholders for the quarter was primarily due to an increase in
research and development expense associated with the development of
the Company’s product candidates and an increase in general and
administrative expense, which included expenses related to
headcount and the Company’s adoption of the Retention Plan in early
January 2016.
- Net loss attributable to common stockholders for the year ended
December 31, 2016 was $60.3 million, or $3.13 per share, compared
to a net loss attributable to common stockholders of $32.6 million,
or $2.02 per share, for the same period in 2015. The increase in
net loss attributable to common stockholders for the year ended
December 31, 2016 was primarily due to the intangible asset
impairment charge of $19.7 million, which was the result of the
mutual termination of the STC.UNM agreement. In addition, the
increases in research and development expenses of $4.0 million, due
to greater activity related to the development of the Company’s
product candidates, and increases in general and administrative
expenses of $8.3 million, primarily related to the retirement and
separation of the former chief executive officer and other
headcount-related expenses, contributed to the year-over-year
increase in net loss. The Company also recognized a non-cash $2.6
million deemed dividend due to the beneficial conversion feature on
the Series D convertible preferred stock. The increase in the net
loss attributable to common stockholders was partially offset by a
$6.9 million tax benefit during the year ended December 31,
2016.
2017 Financial Outlook
Cascadian Therapeutics believes the following 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.
Cascadian Therapeutics expects operating expenses in 2017 to be
slightly higher than in 2016, which included a one-time expense
associated with the intangible asset impairment. The 2017 increase
is due to an increase in activities related to the ongoing
HER2CLIMB pivotal trial. Cash used in operations is expected to be
approximately $50.0 million to $54.0 million.
About Cascadian Therapeutics
Cascadian Therapeutics is a clinical-stage biopharmaceutical
company dedicated to developing innovative product candidates for
the treatment of cancer. The lead product candidate, tucatinib, is
an 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 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.clinicaltrials.gov (Identifier: NCT02614794) or
www.HER2CLIMB.com. 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, timing of
additional data, potential benefits of its product candidates, 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, 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 are encouraged to review
the documents filed with the securities regulators in the United
States on EDGAR and in Canada on SEDAR. Except as required by law,
Cascadian Therapeutics does not undertake any obligation to
publicly update its forward-looking statements based on events or
circumstances after the date hereof.
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. |
Consolidated Statements of Operations |
(In thousands except share and per share amounts) |
(Unaudited) |
|
|
Three months ended
December 31, |
Year ended December 31, |
|
|
2016 |
2015 |
2016 |
|
|
2015 |
|
|
|
Operating
Expenses |
|
|
|
|
Research and
development |
$ |
7,469 |
|
$ |
6,887 |
|
$ |
27,467 |
|
$ |
23,468 |
|
General and
administrative |
|
3,121 |
|
|
2,264 |
|
|
17,630 |
|
|
9,321 |
|
Intangible asset
impairment |
|
— |
|
|
— |
|
|
19,738 |
|
|
— |
|
Total operating
expenses |
|
10,590 |
|
|
9,151 |
|
|
64,835 |
|
|
32,789 |
|
Loss from
operations |
|
(10,590 |
) |
|
(9,151 |
) |
|
(64,835 |
) |
|
(32,789 |
) |
Other income
(expense) |
|
|
|
|
Investment and other
income (expense), net |
|
78 |
|
|
20 |
|
|
222 |
|
|
80 |
|
Change in fair value of
warrant liability |
|
— |
|
|
— |
|
|
— |
|
|
128 |
|
Total other income
(expense), net |
|
78 |
|
|
20 |
|
|
222 |
|
|
208 |
|
Net loss before
income taxes |
$ |
(10,512 |
) |
$ |
(9,131 |
) |
$ |
(64,613 |
) |
$ |
(32,581 |
) |
Income tax (benefit)
provision |
|
— |
|
|
— |
|
|
(6,908 |
) |
|
— |
|
Net
loss |
|
(10,512 |
) |
|
(9,131 |
) |
|
(57,705 |
) |
|
(32,581 |
) |
Deemed dividend
related to beneficial conversion feature on Series D convertible
preferred stock |
|
— |
|
|
— |
|
|
(2,588 |
) |
|
— |
|
Net loss
attributable to common stockholders |
|
(10,512 |
) |
|
(9,131 |
) |
|
(60,293 |
) |
|
(32,581 |
) |
Net loss per
share – basic and diluted |
$ |
(0.47 |
) |
$ |
(0.58 |
) |
$ |
(3.13 |
) |
$ |
(2.02 |
) |
Shares used to
compute basic and diluted net loss per share |
|
22,553,642 |
|
|
15,822,410 |
|
|
19,264,121 |
|
|
16,102,860 |
|
|
CASCADIAN THERAPEUTICS, INC. |
Consolidated Balance Sheet Data |
(In thousands except share amounts) |
(Unaudited) |
|
|
|
|
As of |
|
|
|
|
|
December 31, 2016 |
|
December 31, 2015 |
|
|
Cash, cash
equivalents and investments |
|
$ |
62,805 |
|
$ |
56,360 |
|
|
Total
assets |
|
$ |
83,265 |
|
$ |
96,574 |
|
|
Long term
liabilities |
|
$ |
135 |
|
$ |
8,044 |
|
|
Stockholders’ equity |
|
$ |
74,357 |
|
$ |
83,735 |
|
|
Common
shares outstanding |
|
|
22,562,640 |
|
|
15,826,985 |
|
Investor and Media Contact:
Monique Greer
Cascadian Therapeutics
206-801-2107
mgreer@cascadianrx.com
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