Cascadian Therapeutics Reports Second Quarter 2016 Financial Results and Provides Corporate Update
August 08 2016 - 4:02PM
Reported positive interim results from Phase 1b
“Triplet” study investigating ONT-380 in combination with
trastuzumab and capecitabine
Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today provided a corporate update and
reported financial results for the quarter ended June 30, 2016.
“During the second quarter, we continued to accelerate the
clinical development of our lead product candidate ONT-380, a
promising small molecule for the treatment of advanced, metastatic
HER2+ breast cancer,” said Scott Myers, President and CEO of
Cascadian Therapeutics. “Early clinical results with ONT-380 when
combined with T-DM1 or capecitabine have suggested a favorable
safety and tolerability profile, systemic activity in advanced
disease and the potential to improve outcomes in patients with and
without brain metastases. We’re looking forward to reporting new
data from the ongoing Phase 1b Triplet study expected later this
year. In addition, we were granted Fast Track designation from the
FDA for ONT-380 in HER2+ metastatic breast cancer.”
“Our continued progress and the refocusing of resources on
development of ONT-380 and our Chk1 inhibitor, supported by a
recent financing in June, leave us well-positioned to deliver on
our business and clinical development plans,” said Mr. Myers.
SECOND QUARTER AND RECENT HIGHLIGHTS
Clinical Development
- Presented positive results from the Phase 1b “Triplet”
study of ONT-380 in combination with trastuzumab and capecitabine
at the Company’s R&D Day in June. The study is
evaluating ONT-380 in patients with locally advanced or metastatic
breast cancer with and without brain metastases who have previously
received treatment with multiple HER2 agents, including T-DM1.
Topline results showed a progression free survival (PFS) of 6.3
months and an overall response rate (ORR) of 58%. A majority of
adverse events were Grade 1, with most patients being able to
continue on the full dose of ONT-380. Additionally, Grade 3
diarrhea was infrequent, without the need for a prophylactic
anti-diarrheal medicine. These data suggest ONT-380’s promising
systemic activity, favorable safety profile and activity against
brain metastases as well as support the ongoing Phase 2 trial in
this combination, known as HER2CLIMB, which the Company initiated
in February 2016. The Company expects to present more mature data
from the Triplet study before the end of the year.
- Presented updated safety and activity data from the
Phase 1b combination trial of ONT-380 with T-DM1 at the American
Society of Clinical Oncology annual meeting in June. This
study includes patients with advanced disease who were previously
treated with trastuzumab and a taxane. Results showed a PFS of 8.2
months, with an ORR of 47%. Many of the patients with brain
metastases in the study had long-term control of both brain
metastases and systemic disease. PFS in the 30 patients with brain
metastases was similar to patients without brain metastases, and
there were no patients without brain metastases at baseline who
developed new clinically apparent brain metastases while on the
study.
- Phase 2 ONT-380 combination trial, HER2CLIMB, continues
to enroll patients with late-stage HER2+ metastatic breast
cancer. This randomized, double-blind, placebo-controlled
Phase 2 study is evaluating ONT-380 versus placebo in combination
with capecitabine and trastuzumab in late stage HER2+ breast cancer
patients, with and without brain metastases, who have previously
been treated with a taxane, trastuzumab, pertuzumab and T-DM1. The
Phase 2 trial is expected to enroll approximately 180 patients at
sites in the U.S., Canada and select countries in Western Europe.
Building on encouraging Phase 1b Triplet results, the primary and
secondary endpoint objectives are designed to measure ONT-380's
contribution to treating systemic disease in patients with and
without brain metastases. For more information, visit
www.clinicaltrials.gov: NCT02614794.
- Received Fast Track Designation for ONT-380 from FDA
for the treatment of advanced HER2+ metastatic breast
cancer. The Company continues to evaluate additional
opportunities for ONT-380 and establish the most efficient
regulatory and commercialization path forward.
- Developing novel Chk1 cell cycle inhibitors with plans
to move the program forward through IND-enabling studies in
2017. Topline preclinical results presented at
the American Association for Cancer Research (AACR)
Annual Meeting 2016 showed that select Cascadian Chk1 inhibitors
display cellular potency against Chk1, are active against a diverse
range of cancer cell lines, and demonstrate synergistic activity in
combination with certain chemotherapeutic drugs.
Corporate Update
- Raised gross proceeds of $46 million in a
concurrent, but separate, underwritten public offering and a
registered direct offering to support ongoing program
development.
- Completed corporate name change to Cascadian
Therapeutics from Oncothyreon, reflecting the shift in the
Company's focus from therapeutic vaccines to advancing targeted
treatments for cancer.
- Prioritized the Company’s pipeline to focus on ONT-380
and the Chk1 cell cycle inhibitor program and ceased
development of the protocell research program.
SECOND QUARTER 2016 FINANCIAL HIGHLIGHTS
- Cash, cash equivalents and investments totaled $80.9 million as
of June 30, 2016, compared to $56.4 million at December 31, 2015,
an increase of $24.5 million, or 43.4%. The increase was the result
of net proceeds of $43.2 million from the Company’s June 2016
financing offset by cash used to fund operations of $18.7
million.
- Net loss attributable to common stockholders for the three
months ended June 30, 2016 was $25.1 million, or $0.26 per basic
and diluted share, compared with a net loss attributable to common
stockholders of $10.9 million, or $0.11 per basic and diluted
share, for the comparable period in 2015. The increase in net loss
attributable to common stockholders for the quarter was primarily
due to the intangible asset impairment charge of $19.7 million
during the three months ended June 30, 2016, which was the result
of the mutual termination of the STC.UNM agreement and the
Company’s intent to no longer develop, license or commercialize the
protocell technology. In addition, the increase in net loss
attributable to common stockholders was due to increases in general
and administrative expenses of $1.7 million primarily due to higher
professional fees associated with legal and regulatory compliance
and expenses related to the Company’s Retention Payment Plan, and
increases in research and development expenses of $0.7 million
primarily due to greater activity related to the development of the
Company’s product candidates. The Company also recognized a
non-cash $1.6 million deemed dividend as a result of 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 that resulted from
the reversal of the deferred tax liability that was associated with
the impaired intangible asset during the three months ended June
30, 2016 and lower non-cash expense from the change in the fair
value of the Company’s warrant liability, which was zero for the
three months ended June 30, 2016 compared to $2.6 million for
the three months ended June 30, 2015. The change in the fair
value of warrant liability was due to the expiration of September
2010 warrants, which expired in October 2015.
- Net loss attributable to common stockholders for the six month
ended June 30, 2016 was $38.0 million, or $0.40 per basic and
diluted share, compared with a net loss attributable to common
stockholders of $18.8 million, or $0.19 per basic and diluted
share, for the comparable period in 2015. The increase in net loss
attributable to common stockholders for the six months ended June
30, 2016 was primarily due to the intangible asset impairment
charge of $19.7 million during the six months ended June 30, 2016,
increases in research and development expenses of $1.2 million
primarily due to greater activity related to the development of the
Company’s product candidates, and increases in general and
administrative expenses of $6.0 million primarily related to the
retirement and separation agreement that Cascadian entered into
with its former Chief Executive Officer in January 2016, higher
professional fees associated with legal and regulatory compliance
and expenses related to the Company’s Retention Payment Plan. The
Company also recognized a non-cash $1.6 million deemed dividend as
a result of 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 six months ended June 30, 2016 and
lower non-cash expense from the change in the fair value of the
Company’s warrant liability, which was zero for the six months
ended June 30, 2016 compared to $2.5 million for the six
months ended June 30, 2015. The change in the fair value of
warrant liability was due to the expiration of the September 2010
warrants, which expired in October 2015.
Financial GuidanceCascadian Therapeutics
believes the following financial guidance to be correct as of the
date provided. Cascadian Therapeutics is providing this
guidance as a convenience to investors and assumes no obligation to
update it.
Cascadian Therapeutics currently expects cash used in operations
in 2016 to be approximately $38.0 million to $40.0 million.
With cash, cash equivalents and investments of $80.9 million as of
June 30, 2016, Cascadian Therapeutics estimates that its cash,
cash-equivalents and investments will be sufficient to fund
operations for at least the next 12 months.
About Cascadian TherapeuticsCascadian
Therapeutics is a clinical-stage biopharmaceutical company
dedicated to developing innovative product candidates for the
treatment of cancer. Our lead product candidate, ONT-380, is an
orally active and selective small molecule HER2 inhibitor, which
has been studied in approximately 200 patients to date. Preliminary
results from two ongoing Phase 1b studies of ONT-380 in combination
showed promising systemic activity, a favorable safety profile and
encouraging activity against brain metastases. Cascadian
Therapeutics is also conducting a randomized, double-blind,
placebo-controlled Phase 2 study called HER2CLIMB. The study is
evaluating ONT-380 versus placebo in combination with capecitabine
and trastuzumab in late stage HER2+ breast cancer patients, with
and without brain metastases, who have previously been treated with
a taxane, trastuzumab, pertuzumab and T-DM1. This study is
expected to enroll 180 patients with and without brain metastases
across approximately 100 clinical sites in the U.S., Canada, and
Western Europe. The Company is also developing a cell cycle
inhibitor, Chk1, and plans to move the program forward through
IND-enabling studies in 2017. For more information, visit
www.cascadianrx.com.
Forward-Looking StatementsIn 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 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. |
Condensed Consolidated Statements of Operations |
(In thousands except share and per share amounts) |
(Unaudited) |
|
|
Three months endedJune 30, |
|
|
Six months endedJune 30, |
|
|
2016 |
|
2015 |
|
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
6,380 |
|
$ |
5,701 |
|
|
$ |
12,717 |
|
$ |
11,459 |
|
General and administrative |
|
4,365 |
|
|
2,636 |
|
|
|
10,998 |
|
|
4,957 |
|
Intangible asset impairment |
|
19,738 |
|
|
— |
|
|
|
19,738 |
|
|
— |
|
Total operating expenses |
|
30,483 |
|
|
8,337 |
|
|
|
43,453 |
|
|
16,416 |
|
Loss from operations |
|
(30,483 |
) |
|
(8,337 |
) |
|
|
(43,453 |
) |
|
(16,416 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment and other income
(expense), net |
|
42 |
|
|
19 |
|
|
|
125 |
|
|
35 |
|
Change in fair value of warrant
liability |
|
— |
|
|
(2,578 |
) |
|
|
— |
|
|
(2,450 |
) |
Total other income (expense),
net |
|
42 |
|
|
(2,559 |
) |
|
|
125 |
|
|
(2,415 |
) |
Net loss before
income taxes |
$ |
(30,441 |
) |
$ |
(10,896 |
) |
|
$ |
(43,328 |
) |
$ |
(18,831 |
) |
Income tax (benefit)
provision |
|
(6,908 |
) |
|
— |
|
|
|
(6,908 |
) |
|
— |
|
Net
loss |
|
(23,533 |
) |
|
(10,896 |
) |
|
|
(36,420 |
) |
|
(18,831 |
) |
Deemed dividend
related to beneficial conversion feature on Series D convertible
preferred stock |
|
(1,599 |
) |
|
— |
|
|
|
(1,599 |
) |
|
— |
|
Net loss
attributable to common stockholders |
|
(25,132 |
) |
|
(10,896 |
) |
|
|
(38,019 |
) |
|
(18,831 |
) |
Net loss per share
– basic and diluted |
$ |
(0.26 |
) |
$ |
(0.11 |
) |
|
$ |
(0.40 |
) |
$ |
(0.19 |
) |
Shares used to
compute basic and diluted net loss per share |
|
96,310,963 |
|
|
98,364,146 |
|
|
|
95,636,411 |
|
|
98,337,816 |
|
|
|
|
|
|
CASCADIAN THERAPEUTICS,
INC. |
Consolidated Balance Sheet Data |
(In thousands except share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
As of |
|
|
June 30,
2016 |
|
December 31, 2015 |
Cash, cash equivalents
and investments |
|
$ |
80,879 |
|
|
$ |
56,360 |
|
Total assets |
|
$ |
100,828 |
|
|
$ |
96,574 |
|
Long term
liabilities |
|
$ |
262 |
|
|
$ |
8,044 |
|
Stockholders’
equity |
|
$ |
94,306 |
|
|
$ |
83,735 |
|
Common shares
outstanding |
|
|
135,310,441 |
|
|
|
94,961,859 |
|
|
|
|
|
|
|
|
|
|
Source: Cascadian Therapeutics
Investor Contact:
Julie Rathbun
Rathbun Communications
206-769-9219
ir@cascadianrx.com
Tricia Truehart
The Trout Group
646-378-2953
ttruehart@troutgroup.com
Media Contact:
Amy Bonanno
BMC Communications
646-513-3117
abonanno@bmccommunications.com
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