Aquinox Pharmaceuticals, Inc. ("Aquinox") (NASDAQ:AQXP), a
pharmaceutical company discovering and developing novel drug
candidates to treat inflammation, inflammatory pain, and blood
cancers, today provided a corporate update and reported financial
results for the second quarter ending June 30, 2018.
“At the end of last quarter, we announced that
the Phase 3 clinical trial of our lead drug candidate, rosiptor, in
interstitial cystitis/bladder pain syndrome (IC/BPS) failed to meet
its primary endpoint. As a result, we’ve halted all development
activities for rosiptor and significantly reduced the size of our
organization,” said David Main, President & CEO of Aquinox. “We
are currently evaluating our internal pipeline for further
development, as well as considering other strategic
alternatives.”
Recent Business Updates
LEADERSHIP 301 Topline Data
Analysis. On June 27, 2018 Aquinox announced that the
LEADERSHIP 301 clinical trial of rosiptor in IC/BPS did not achieve
a statistically significant reduction in the mean change from
Baseline at Week 12 in maximum daily bladder pain score compared to
placebo (P=0.41) in female subjects, which was the primary
endpoint. Rosiptor was generally well tolerated with the rate of
adverse events during the 12-week treatment period similar to that
of placebo and prior trials. Based on these results, all further
development activities with rosiptor have been halted, including
the extension period of the trial. LEADERSHIP 301 enrolled 433
participants, including 341 female subjects who were randomized to
receive rosiptor 100 mg or 200 mg, or placebo.
Phase 2 Proof-of-Concept Trial with
Rosiptor in CP/CPPS. Following the June 27, 2018
announcement that the LEADERSHIP 301 clinical trial failed to meet
its primary endpoint and that all further development activities
with rosiptor are halted, the ProShip Phase 2 clinical trial in
CP/CPPS has also been discontinued.
Company Restructuring and Future
Plans. On July 9, 2018 the Company announced a
restructuring plan to reduce operating costs and better align the
Company’s workforce with the needs of its business following the
announcement that its Phase 3 LEADERSHIP 301 clinical trial failed
to meet its primary endpoint. Under this plan, the Company reduced
its workforce by 30 employees (approximately 53%) and closed its
office in San Bruno, California.
Astellas Licensing Agreement.
On May 9, 2018 Aquinox announced that Aquinox and Astellas Pharma
Inc. had entered into an exclusive license agreement for Japan and
certain other countries in the Asia-Pacific region for Astellas to
develop and commercialize rosiptor. In connection with entry into
the Agreement, Aquinox received a payment of $25 million.
Summary of Financial
Results
Cash Position. Cash, cash
equivalents and short-term investments totaled $102.1
million as of June 30, 2018, compared to $108.1
million as of December 31, 2017. The decrease was
primarily the result of the remaining expenditures related to the
LEADERSHIP 301 clinical trial in IC/BPS, and its termination, and
the initiation and subsequent termination of the ProShip clinical
trial in CP/CPPS, off-set by the $25 million payment from Astellas
in relation to the exclusive licensing agreement. Aquinox expects
its cash, cash equivalents, and short-term investments to be
sufficient to support the development of internal programs. Based
upon current internal infrastructure and pipeline initiatives,
Aquinox expects that its cash-on-hand will carry it beyond
2019.
R&D Expenses. Research and
development expenses for the second quarter of 2018 increased to
$18.0 million from $10.5 million in the second quarter of 2017.
This increase was primarily driven by increased clinical activities
as Aquinox continued its LEADERSHIP 301 clinical trial with
rosiptor in IC/BPS and initiated the ProShip clinical trial in
CP/CPPS. Aquinox expects research and development expenses to
decrease for the second half of 2018 following the termination of
all further development of rosiptor.
G&A Expenses. General and
administrative expenses for the second quarter of 2018 increased to
$4.3 million from $3.5 million in the second quarter of 2017. This
increase was primarily driven by higher personnel related costs,
professional fees, and pre-commercial and market assessment
activities. Subsequent to its restructuring, Aquinox expects
G&A expenses to decrease for the second half of 2018.
Net Loss. Net income for the
second quarter of 2018 was $2.9 million compared to a net loss of
$13.8 million in the second quarter of 2017. The net income for the
second quarter of 2018 was the result of the upfront payment from
the Astellas licensing agreement partly offset by increased
operating expenditures as Aquinox continued its LEADERSHIP 301
clinical trial of rosiptor in IC/BPS and initiated the ProShip
clinical trial in CP/CPPS.
The Company will not be holding a conference
call to review the financial results. The Company will advise at a
later date if it will be re-implementing regular financial
conference calls.
About Aquinox Pharmaceuticals,
Inc.Aquinox Pharmaceuticals, Inc. is a pharmaceutical
company developing novel therapeutics for conditions marked by
inflammation, inflammatory pain, and blood cancers. For more
information, please visit www.aqxpharma.com.
Cautionary Note on Forward-Looking
Statements Certain of the statements made in this press
release are forward looking, including those relating to evaluation
of our pipeline and strategic options. These statements are subject
to risks and uncertainties that could cause actual results and
events to differ materially from those anticipated, including, but
not limited to, risks and uncertainties related to: clinical drug
development is a lengthy and expensive process with an uncertain
outcome; our ability to identify or acquire additional clinical
candidates, our ability to obtain and maintain regulatory
approval for any future product candidates and the potential
safety, efficacy or clinical utility of or any future product
candidates. Actual results or developments may differ materially
from those projected or implied in these forward-looking
statements. More information about the risks and uncertainties
faced by Aquinox is contained in the company’s Annual Report on
Form 10-K for the year ended December 31, 2017, and subsequent
reports, filed with the Securities and Exchange Commission.
Aquinox disclaims any intention or obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact Info:
Kamran Alam Vice President, Finance & CFO
Aquinox Pharmaceuticals, Inc. 604.629.9223
ir@aqxpharma.com
AQUINOX PHARMACEUTICALS,
INC.
Condensed consolidated
balance sheets(Unaudited)(In thousands of U.S.
dollars)
|
JUNE 30, 2018 |
|
DECEMBER 31,
2017 |
|
|
|
|
Assets |
|
|
|
Cash,
cash equivalents and short-term investments |
$ |
102,137 |
|
$ |
108,085 |
Other
current assets |
|
1,104 |
|
|
740 |
Other
long-term assets |
|
1,185 |
|
|
1,504 |
Total assets |
$ |
104,426 |
|
$ |
110,329 |
|
|
|
|
Liabilities |
|
|
|
Current
liabilities |
$ |
13,348 |
|
$ |
10,956 |
Non-current liabilities |
|
401 |
|
|
486 |
Total liabilities |
|
13,749 |
|
|
11,442 |
Stockholders’
equity |
|
90,677 |
|
|
98,887 |
Total liabilities and
stockholders' equity |
$ |
104,426 |
|
$ |
110,329 |
AQUINOX PHARMACEUTICALS,
INC.
Condensed consolidated statements of
operations(Unaudited) (In thousands
of U.S. dollars, except per share and share amounts)
|
THREE MONTHS ENDEDJUNE
30, |
|
SIX MONTHS ENDEDJUNE
30, |
|
|
|
2018 |
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
Revenue |
$ |
25,000 |
|
$ |
- |
|
|
$ |
25,000 |
|
|
$ |
- |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
Research
and development |
|
17,996 |
|
|
10,475 |
|
|
|
28,504 |
|
|
|
16,252 |
|
|
General
and administrative |
|
4,314 |
|
|
3,520 |
|
|
|
8,623 |
|
|
|
6,265 |
|
|
Total operating
expenses |
|
22,310 |
|
|
13,995 |
|
|
|
37,127 |
|
|
|
22,517 |
|
|
Income (loss) from
operations |
|
2,690 |
|
|
(13,995 |
) |
|
|
(12,127 |
) |
|
|
(22,517 |
) |
|
Other income, net |
|
228 |
|
|
229 |
|
|
|
422 |
|
|
|
435 |
|
|
Net income
(loss) |
$ |
2,918 |
|
$ |
(13,766 |
) |
|
$ |
(11,705 |
) |
|
$ |
(22,082 |
) |
|
Earnings (net loss) per
common stock |
|
|
|
|
|
|
|
|
Basic |
$ |
0.12 |
|
$ |
(0.59 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.94 |
) |
|
Diluted |
$ |
0.12 |
|
$ |
(0.59 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.94 |
) |
|
Weighted average number
of common stock outstanding |
|
|
|
|
|
|
|
|
Basic |
|
23,521,719 |
|
|
23,444,150 |
|
|
|
23,501,351 |
|
|
|
23,433,708 |
|
|
Diluted |
|
23,846,256 |
|
|
23,444,150 |
|
|
|
23,501,351 |
|
|
|
23,433,708 |
|
|
|
|
|
|
|
|
|
|
|
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