Arno Therapeutics, Inc. (OTCQB: ARNI), a clinical stage
biopharmaceutical company focused on the development of therapeutics for
cancer and other life threatening diseases, today announced financial
results for the quarter ended September 30, 2016 and provided an update
on recent clinical developments for its lead compound, onapristone.
Q3 2016 and Recent Highlights:
"We are making good progress with the enrollment into CRPC study. The
data review committee has reviewed the data from the ongoing study and
agreed to continue with enrollment at the higher onapristone dose levels
of onapristone plus abiraterone acetate Phase II cohort and the US
investigative sites are open and recruiting patients," said Alex
Zukiwski, MD, Chief Executive Officer of Arno Therapeutics.
Third Quarter 2016 Financial Results
For the three months ended September 30, 2016, Arno reported net loss of
$3.8 million, or $0.09 per share, which includes non-cash expense of
$2.0 million related to the increase in derivative liability of common
stock warrants, and $1.0 million of non-cash stock based compensation
expense. Adjusting for these non-cash items, which resulted in an
expense of $3.0 million, the Company reported a net loss of
approximately $0.8 million, or $0.02 per share, on a non-GAAP basis.
Adjusted third quarter 2015 net loss was approximately $1.9 million, or
$0.10 per share, on a non-GAAP basis, which includes the same non-cash
adjustments as third quarter 2016. On a GAAP basis, third quarter 2015
net loss was $0.7 million, or $0.03 per share.
The primary factors for the $1.1 million year-over-year improvement in
adjusted (non-GAAP) net loss in the third quarter of 2016 compared to
the third quarter of 2015 were reduced spending of $0.4 million on
onapristone's clinical trials and non-clinical research activities,
lower compensation expense of $0.1 million and receipt of final proceeds
of $0.4 million from the sale of AR-67 preclinical and clinical data
For the nine months ended September 30, 2016, Arno reported net loss of
$9.7 million, or $0.23 per share, which includes non-cash expense of
$1.8 million related to the increase in derivative liability of common
stock warrants, and $2.9 million of non-cash stock based compensation
expense. Adjusting for these non-cash items, which resulted in an
expense of $4.7 million, the Company reported a net loss of
approximately $5.0 million, or $0.12 per share, on a non-GAAP basis.
This compares to an adjusted non-GAAP net loss for the first nine months
of 2015 of approximately $7.8 million, or $0.38 per share, when
considering the same non-cash adjustments as for the first nine months
of 2016. On a GAAP basis, the first nine months of 2015 net loss was
$7.5 million, or $0.37 per share.
The primary factors for the $2.8 million year-over-year improvement in
adjusted (non-GAAP) net loss in the first nine months of 2016 compared
to the first nine months of 2016 were reduced spending of $1.2 million
on onapristone's non-clinical research activities, lower compensation
expense of $0.8 million and total gross proceeds of $0.5 million from
the sale of AR-67 preclinical and clinical data package.
Cash and cash equivalents as of September 30, 2016 totaled $2.1 million,
compared to $0.1 million as of December 31, 2015. In combination with
the capital raised by the Company in August 2016, the current level of
cash resources is expected to fund the Company's planned operating
activities into January 2017.
Arno believes it prepared its consolidated financial statements in
conformity with accounting principles generally accepted in the United
States of America (GAAP) and pursuant to accounting requirements of the
Securities and Exchange Commission. In an effort to provide investors
with additional information regarding Arno's results and to provide a
meaningful period-over-period comparison of Arno's financial
performance, the Company sometimes uses non-GAAP financial measures as
defined by the Securities and Exchange Commission. The differences
between the GAAP and non-GAAP financial measures are reconciled in
schedule below. In presenting comparable results, the Company discloses
non-GAAP financial measures when it believes such measures will be
useful to investors in evaluating Arno's underlying business
performance. Management uses the non-GAAP financial measures to evaluate
Arno's financial performance against internal budgets and targets. In
addition, management internally reviews Arno's results excluding the
impact of certain items, as it believes that these non-GAAP financial
measures are useful for evaluating Arno's core operating results and
facilitating comparison across reporting periods. Importantly, Arno
believes non-GAAP financial measures should be considered in addition
to, and not in lieu of, GAAP financial measures. Arno's non-GAAP
financial measures may be different from non-GAAP financial measures
used by other companies.
Onapristone has the potential to be the first approved anti-progestin
for oncology indications and provide chemotherapy-sparing treatment to
cancer patients who express a specific biomarker, as detected by a
companion diagnostic under development. Onapristone is an oral,
anti-progestin hormone blocker that has been shown in previous clinical
trials to have anti-tumor activity in patients with breast cancer.
Onapristone appears to have a unique ability to block the activation of
the progesterone receptor, which is believed to be a mechanism that may
inhibit the growth of breast, endometrial and other tumors. The
activated form of the progesterone receptor (APR) has the potential to
function as a biomarker of anti-progestin activity.
About Arno Therapeutics
Arno Therapeutics is a clinical stage biopharmaceutical company
developing innovative products for the treatment of cancer and other
life threatening diseases. Arno has exclusive worldwide rights to
develop and market three innovative anti-cancer product candidates.
These compounds are in clinical or preclinical development. For more
information about the company, please visit www.arnothera.com.
This press release contains forward-looking statements that involve
substantial risks and uncertainties. These statements are often, but not
always, made through the use of words or phrases such as "anticipates,"
"expects," "plans," "believes," "intends," and similar words or phrases.
These forward-looking statements include, without limitation, statements
regarding the potential of onapristone as a treatment of CRPC,
statements regarding the timing, progress and anticipated results of the
clinical development of onapristone, statements regarding the expected
proceeds from the Company's August 2016 private placement, statements
regarding Arno's available cash resources, as well as Arno's strategy,
future operations, outlook, milestones, future financial position,
future financial results, plans and objectives. Arno may not actually
achieve these plans, intentions or expectations and Arno cautions
investors not to place undue reliance on our forward-looking statements.
Actual results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking statements
we make. Various important factors could cause actual results or events
to differ materially from the forward-looking statements that we make.
Such factors include, among others, risks that we will not obtain the
capital necessary to fund our operations in a timely manner, if ever, or
on acceptable terms, that if we are unable to obtain additional capital,
we may be required to cease our ongoing clinical development activities,
that the results of clinical trials will not support our claims or
beliefs concerning the effectiveness of onapristone or any of our other
product candidates, that we will be able to successfully develop a
diagnostic to identify APR tumors, regulatory risks, and our reliance on
third party researchers and other collaborators. Additional risks are
described in the Company's Annual Report on Form 10-K for the year
ended December 31, 2015 and in its Quarterly Report on Form 10-Q for the
quarter ended September 30, 2016. Arno is providing this information as
of the date of this press release and does not undertake any obligation
to update any forward-looking statements as a result of new information,
future events or otherwise.
Arno Therapeutics, Inc.
Condensed Statements of Operations
(Amounts in thousands, except per share data)
Balance Sheet Data
(Amounts in thousands)
Reconciliation Between Reported (GAAP) and Adjusted Net Loss
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