Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ:APTO)
(TSX:APS), a clinical-stage company developing highly
differentiated therapeutics that target the underlying mechanisms
of cancer, today announced financial results for the three months
ended March 31, 2017 and reported on corporate developments. Unless
specified otherwise, all amounts are in Canadian dollars.
The net loss for the quarter ended March 31,
2017 was $4.4 million ($0.25 per share) compared with $5.1 million
($0.42 per share) in the quarter ended March 31, 2016. Total cash
and cash equivalents and investments as of March 31, 2017 were
$12.0 million (or $9.0 million US dollars) which, based on
information currently available, provides the Company with
sufficient resources to fund research and development and
operations into Q2 2018.
“We, along with some of the nation’s leading
hematology researchers, continue to generate compelling data on
CG’806, an oral first-in-class pan-FLT3/BTK inhibitor that we plan
to develop for patients with FLT3-driven acute myeloid leukemia and
certain B-cell malignancies,” said William G. Rice, Ph.D.,
Chairman, President and Chief Executive Officer. “Preclinical data
presented at AACR this past week demonstrated the ability of CG’806
to potently inhibit all mutant forms of FLT3 tested and to
completely eradicate tumors in AML xenograft models in the absence
of toxicities. Though early, we believe these data begin to
position CG’806 as a best-in-class pan-FLT3 inhibitor for the
treatment of AML. In addition, CG’806 is a potent non-covalent
inhibitor of the wild type and C481S mutant forms of BTK, and we
plan to develop CG806 in parallel for patients with B cell
malignancies resistant and intolerant to covalent BTK inhibitors.
We are working towards advancing this molecule into clinical trials
within a year.”
Corporate Highlights
- In January 2017, Aptose announced the prioritization of its
resources toward the development of CG’806, an oral preclinical
compound being developed for patients with FLT3-driven acute
myeloid leukemia (AML) and certain BTK-driven B-cell
malignancies.
- CG’806 was the subject of two poster presentations at the 2017
AACR Hematologic Malignancies meeting held in Boston this past week
(May 6-9). ° The first poster included data from studies
conducted at The University of Texas MD Anderson Cancer Center, in
which CG’806 demonstrated superior potency relative to competitive
agents, against hematologic malignancy cell lines driven by various
WT or mutant forms of FLT3. In addition, once daily oral dosing of
CG’806 in a murine model achieved sustained micromolar plasma
concentration over a 24 hour period, and was accompanied by
complete elimination of AML FLT3-ITD tumors in the absence of
toxicity. ° The second poster included highlighted studies
conducted at Oregon Health & Science University (OHSU) and
through a collaboration with the Beat AML Initiative, in which
CG’806 demonstrated the ability to potently kill primary malignant
cells in samples from patients with various hematologic
malignancies including AML, CLL and others.
- Separately, Aptose has begun formal studies on APTO-253, a
phase 1 stage compound for AML, in an effort to define the root
cause of recent manufacturing setbacks related to the intravenous
formulation, and to restore the molecule to a state supporting
clinical development and potential partnering. APTO-253, which
effectively inhibits expression of the c-Myc oncogene, is a
potential treatment for AML.
Financial Results
Our net loss for the three months ended March
31, 2017 was $4.4 million ($0.25 per share) compared with $5.1
million ($0.42 per share) during the three months ended March 31,
2016.
The decrease in the net loss during the three
months ended March 31, 2017 compared with the three months ended
March 31, 2016 is primarily related to savings from cancelling the
LALS/Moffitt collaboration, lower stock-based compensation, and
offset by development activities related to the CG’806 development
program which started in the second half of 2016.
We utilized cash of $3.5 million in our
operating activities in the three months ended March 31, 2017
compared with $4.5 million in the three months ended March 31,
2016. The decrease in cash used in operating activities in the
current period is due mostly to increased accounts payable and
accrual balances during the three months ended March 31, 2017.
Research and
DevelopmentResearch and development expenses totaled $2.3
million in the three months ended March 31, 2017 compared with $2.3
million in the three months ended March 31, 2016. Research and
development costs consist of the following:
|
|
Three months ended |
(in thousands) |
|
March 31,2017 |
|
March 31,2016 |
|
|
|
|
|
Program costs – APTO-253 |
|
S 1,102 |
|
$ |
1,040 |
Program costs – CG’806 |
|
|
540 |
|
|
- |
Program costs – LALS/Moffitt |
|
|
- |
|
|
485 |
Salaries |
|
|
566 |
|
|
722 |
Stock-based compensation |
|
|
68 |
|
|
56 |
Depreciation of equipment |
|
|
19 |
|
|
12 |
|
|
$ |
2,295 |
|
$ |
2,315 |
|
|
|
|
|
|
|
Expenditures for the three months ended March 31, 2017 were
comparable to the expenses incurred in the three months ended March
31, 2016. Higher program costs associated with the Company’s
CG’806 program were offset by lower costs associated related to the
cancellation of the LALS/Moffitt collaboration. Lower salaries
expense was primarily related to severance payments made in the
three months ended March 31, 2016 due to a reduction in Research
& Development FTE.
General and
AdministrativeGeneral and administrative expenses totaled
$2.1 million in the three months ended March 31, 2017, compared to
$2.6 million in the three months ended March 31, 2016. General and
administrative costs consist of the following:
|
|
Three months ended |
(in thousands) |
|
March 31,2017 |
|
March 31,2016 |
|
|
|
|
|
General and
administrative excluding salaries |
|
$ |
942 |
|
$ |
1,133 |
Salaries |
|
|
1,135 |
|
|
975 |
Stock-based compensation |
|
|
13 |
|
|
479 |
Depreciation of equipment |
|
|
11 |
|
|
21 |
|
|
$ |
2,101 |
|
$ |
2,608 |
|
|
|
|
|
|
|
General and administrative expenses excluding
salaries, decreased in the three months ended March 31, 2017,
compared with the three months ended March 31, 2016, mostly the
result of lower travel, consulting and rent costs in the current
year related to cost containment initiatives taken in the prior
fiscal year. Salary charges in the three months ended March 31,
2017, increased slightly in comparison with the three months ended
March 31, 2016, due to severance payments made in the current
period that will result in savings in the following fiscal
quarters.
Stock-based compensation decreased in the three
months ended March 31, 2017, compared with the three months ended
March 31, 2016, due to large forfeitures in the current period and
also due to grants in prior periods having a greater fair value
than the grants issued in the three months ended March 31, 2017,
and therefore contributing to higher stock-based compensation in
the prior year period.
Finance Expense
|
|
Three months ended |
|
|
March 31,2017 |
|
March 31,2016 |
Foreign exchange loss |
|
- |
|
|
196 |
|
|
$ |
- |
|
$ |
196 |
|
|
|
|
|
|
|
Foreign exchange loss in the three months ended
March 31, 2016, is the result of a decrease in the value of US
dollar denominated cash and cash equivalents balances during the
period due to an appreciation of the Canadian dollar compared to
the US dollar. During this period the Company’s functional currency
was the Canadian dollar.
Finance Income
|
|
Three months ended |
|
|
March 31,2017 |
|
March 31, 2016 |
Interest income |
|
$ |
11 |
|
$ |
47 |
Foreign exchange gain |
|
|
30 |
|
- |
|
|
$ |
41 |
|
$ |
47 |
|
|
|
|
|
|
|
Interest income represents interest earned on
our cash and cash equivalent and investment balances. Foreign
exchange gains in the three months ended March 31, 2017, are the
result of an appreciation of the Canadian dollar compared to the US
dollar. During this period the Company’s functional currency was
the US dollar.
Effective January 1, 2017, the Company changed
its functional currency to US dollars given the prevalence of US
dollar denominated activities over time. The Company’s historic
source of financing, with the exception of the recent at-the-market
equity facility, has been in Canadian dollars and the Company still
has a majority of its shareholders in Canada. For this reason
the Company has chosen to keep the presentation currency as
Canadian.
|
|
|
|
Aptose
Biosciences Inc. |
|
|
|
Condensed Consolidated Interim Statements of Loss and
Comprehensive Loss |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
Three |
|
Three |
|
|
months ended |
|
months ended |
|
(amounts in 000's of
Canadian Dollars except for per common share data) |
March 31, 2017 |
|
March 31, 2016 |
|
REVENUE |
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
EXPENSES |
|
|
|
|
|
|
|
|
Research and
development |
|
2,295 |
|
|
|
2,315 |
|
|
General
and administrative |
|
2,101 |
|
|
|
2,608 |
|
|
Operating
expenses |
|
4,396 |
|
|
|
4,923 |
|
|
Finance
expense |
|
- |
|
|
|
196 |
|
|
Finance
income |
|
(41 |
) |
|
|
(47 |
) |
|
Net financing income |
|
(41 |
) |
|
|
149 |
|
|
Net loss for the period |
|
4,355 |
|
|
|
5,072 |
|
|
|
|
|
|
Other comprehensive loss |
|
|
|
Items
that may subsequently be reclassified to earnings: |
|
|
|
Foreign currency translation loss |
|
123 |
|
|
|
- |
|
|
Comprehensive loss for the period |
|
4,478 |
|
|
|
5,072 |
|
|
|
|
|
|
Basic and diluted loss per common share |
$ |
0.25 |
|
|
$ |
0.42 |
|
|
|
|
|
|
|
|
|
|
|
The press release, the financial statements and the management’s
discussion and analysis for the quarter ended March 31, 2017 will
be available on SEDAR at www.sedar.com and EDGAR at
www.sec.gov/edgar.shtml
Conference Call and
Webcast
Aptose will host a conference call to discuss
results for the three months ended March 31, 2017 today, Thursday
May 11, 2017 at 5:00 p.m. EDT. Participants can access the
conference call by dialing (844) 882-7834 (North American toll free
number) and (574) 990-9707 (International) and using passcode
13003413. The conference call can also be accessed
at http://edge.media-server.com/m/p/bfhzuofp and will
also be available through a link on the Investor Relations section
of Aptose’s website at ir.aptose.com. Please log onto the
webcast at least 10 minutes prior to the start of the call to
ensure time for any software downloads that may be required.
An archived version of the webcast along with a transcript will be
available on the Company’s website for 30 days. An
audio replay of the webcast will be available approximately two
hours after the conclusion of the call for 7 days by dialing (855)
859-2056, using the passcode 13003413.
Note
The information contained in this news release
is unaudited.
About Aptose
Aptose Biosciences is a clinical-stage
biotechnology company committed to developing personalized
therapies addressing unmet medical needs in oncology. Aptose is
advancing new therapeutics focused on novel cellular targets on the
leading edge of cancer. The Company's small molecule cancer
therapeutics pipeline includes products designed to provide single
agent efficacy and to enhance the efficacy of other anti-cancer
therapies and regimens without overlapping toxicities. For further
information, please visit www.aptose.com.
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of Canadian and U.S. securities laws,
including, but not limited to, statements relating to the expected
cash runway of the Company, the clinical potential and favorable
properties of CG’806, the clinical trials for CG’806, the clinical
development and potential partnering of APTO-253, the focus of
resources on CG’806, and statements relating to the Company’s
plans, objectives, expectations and intentions and other statements
including words such as “continue”, “expect”, “intend”, “will”,
“should”, “would”, “may”, and other similar expressions. Such
statements reflect our current views with respect to future events
and are subject to risks and uncertainties and are necessarily
based upon a number of estimates and assumptions that, while
considered reasonable by us are inherently subject to significant
business, economic, competitive, political and social uncertainties
and contingencies. Many factors could cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements described in this press
release. Such factors could include, among others: our ability to
obtain the capital required for research and operations; the
inherent risks in early stage drug development including
demonstrating efficacy; development time/cost and the regulatory
approval process; the progress of our clinical trials; our ability
to find and enter into agreements with potential partners; our
ability to attract and retain key personnel; changing market and
economic conditions; inability of new manufacturers to produce
acceptable batches of GMP in sufficient quantities; unexpected
manufacturing defects; and other risks detailed from time-to-time
in our ongoing quarterly filings, annual information forms, annual
reports and annual filings with Canadian securities regulators and
the United States Securities and Exchange Commission.
Should one or more of these risks or
uncertainties materialize, or should the assumptions set out in the
section entitled "Risk Factors" in our filings with Canadian
securities regulators and the United States Securities and Exchange
Commission underlying those forward-looking statements prove
incorrect, actual results may vary materially from those described
herein. These forward-looking statements are made as of the date of
this press release and we do not intend, and do not assume any
obligation, to update these forward-looking statements, except as
required by law. We cannot assure you that such statements will
prove to be accurate as actual results and future events could
differ materially from those anticipated in such statements.
Investors are cautioned that forward-looking statements are not
guarantees of future performance and accordingly investors are
cautioned not to put undue reliance on forward-looking statements
due to the inherent uncertainty therein.
For further information, please contact:
Aptose Biosciences
Greg Chow, CFO
647-479-9828
gchow@aptose.com
SMP Communications
Susan Pietropaolo
201-923-2049
susan@smpcommunications.com
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