Aquinox Pharmaceuticals, Inc. ("Aquinox") (NASDAQ:AQXP), a
clinical-stage 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 first quarter ending March 31, 2018.
"The first quarter was important as we surpassed recruitment
targets and completed enrollment of the LEADERSHIP 301 Phase 3
clinical trial in subjects with interstitial cystitis/bladder pain
syndrome (IC/BPS),” said David Main, President & CEO of
Aquinox. “IC/BPS remains an area of high unmet medical need with
few effective treatments available. We remain on track for sharing
the topline results of this trial in Q3.”
Business Highlights
LEADERSHIP 301 Topline Data Analysis. Aquinox
completed enrollment of its LEADERSHIP 301 Phase 3 clinical trial
of rosiptor in IC/BPS in February 2018. Topline data are on track
for announcement in Q3 2018. LEADERSHIP 301 is a three-arm,
multicenter, randomized, double-blind, placebo-controlled Phase 3
clinical trial assessing the effect of once-daily rosiptor 100 mg
and rosiptor 200 mg on bladder pain and urinary symptoms when
compared with placebo in female and male subjects with IC/BPS.
Planned Initiation of Phase 2 Trial with Rosiptor in
CP/CPPS. Aquinox is on track to initiate a Phase 2
proof-of-concept clinical trial with rosiptor in male subjects with
Chronic Prostatitis Syndrome/Chronic Pelvic Pain Syndrome (CP/CPPS)
in Q2 2018. This 12-week, randomized, double-blind,
placebo-controlled clinical trial will evaluate the efficacy and
safety of once-daily rosiptor 200 mg versus placebo in
approximately 100 male subjects with CP/CPPS at study sites in the
US and Canada.
AACR Poster Presentation. Aquinox, in
collaboration with researchers from the University of Southampton
in the United Kingdom, presented the poster “Development of pelorol
analogues to activate the SHIP1 lipid phosphatase; a novel paradigm
to suppress B-cell receptor signaling in human B-cell cancers” last
month at the annual meeting of the American Association for Cancer
Research, in Chicago, Illinois.
Executive Change. Ms Abigail Jenkins, Chief
Commercial Officer, will resign her position on May 11, 2018 for
family reasons. Abbey has been instrumental in our commercial
planning for rosiptor and will be missed. The Company intends to
initiate a search for a replacement Chief Commercial Officer.
Summary of Financial Results
Cash Position. Cash, cash equivalents, and
short-term investments totaled $92.7 million as
of March 31, 2018, compared to $108.1 million as
of December 31, 2017. The decrease was primarily the result of
the ongoing expenditures related to our LEADERSHIP 301 clinical
trial in IC/BPS. Aquinox expects its cash, cash equivalents, and
short-term investments to be sufficient for additional clinical
development, manufacturing, preclinical, and pre-commercial and
market assessment activities. Aquinox continues to expect that its
cash-on-hand will carry it at least to mid-2019.
R&D Expenses. Research and development
expenses for the first quarter of 2018 increased to $10.5 million
from $5.8 million in the first 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.
G&A Expenses. General and administrative
expenses for the first quarter of 2018 increased to $4.3 million
from $2.7 million for the first quarter of 2017. This increase was
primarily driven by higher personnel related costs, and
pre-commercial and market assessment activities.
Net Loss. Net loss for the first quarter of
2018 was $14.6 million compared to a net loss of $8.3 million in
the first quarter of 2017. This increase was primarily driven by
increased operating expenditures as Aquinox continued its
LEADERSHIP 301 clinical trial of rosiptor in IC/BPS.
About Interstitial Cystitis/Bladder Pain
Syndrome
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a
debilitating condition marked by chronic bladder pain and urinary
symptoms. Patients may experience recurring pain, pressure, and/or
discomfort perceived to be related to the urinary bladder as well
as urinary frequency, urgency, and/or nocturia. The pain often
worsens upon bladder filling and may be relieved upon bladder
emptying. Many patients living with IC/BPS report that it takes a
physical, emotional, and psychological toll, greatly impacting
employment and social and intimate relationships. There are
currently few FDA approved and/or effective treatment options for
IC/BPS. Only about 1M of the 5.5M adults in the United States with
symptoms of IC/BPS have been diagnosed or are receiving
treatment.
About Chronic Prostatitis/Chronic Pelvic Pain Syndrome
(CP/CPPS)
CP/CPPS is a urological condition characterized by chronic
pelvic pain and voiding symptoms without evidence of urinary tract
infection. Symptoms may include pelvic pain, urinary symptoms, and
sexual dysfunction. Estimates suggest up to 5M males in the United
States have symptoms of CP/CPPS yet only about 1M of these patients
are diagnosed and treated. There are currently no FDA approved
and/or effective treatment options for CP/CPPS, and few treatments
in development.
About Rosiptor
Rosiptor (AQX-1125), Aquinox's lead drug candidate, is a
first-in-class, once-daily, oral treatment being studied for its
effects on inflammation and inflammatory pain. Rosiptor has a novel
mechanism of action, activating SHIP1 (SH2-containing
inositol-5'-phosphatase 1), an enzyme that serves to down-regulate
inflammation through its role in the PI3K signaling pathway.
Rosiptor has been generally well tolerated in multiple completed
clinical studies, with more than 395 subjects dosed.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical
company developing novel therapeutics for chronic urological
conditions marked by inflammation and pain. Aquinox's lead drug
candidate, rosiptor (AQX-1125), is in Phase 3 development for the
treatment of patients with interstitial cystitis/bladder pain
syndrome (IC/BPS), a condition for which there are currently few
FDA approved and/or effective treatment options. Aquinox is focused
on leveraging its library of novel compounds that activate SHIP1 to
develop therapeutics for application in 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, such as those, among others, relating to: development of
rosiptor (AQX-1125), LEADERSHIP 301, availability of top-line data,
initiation of additional clinical trials and expected sufficiency
of cash-on-hand. 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; as an
organization, we have never conducted a pivotal clinical trial
before; the size and growth of the potential markets for rosiptor
(AQX-1125) or any future product candidates and our ability to
serve those markets; our ability to obtain and maintain regulatory
approval of rosiptor (AQX-1125) or any future product candidates;
reaching agreement on design of pivotal trials with regulatory
authorities and our expectations regarding the potential safety,
efficacy or clinical utility of rosiptor 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 Quarterly Report on
Form 10-Q for the quarter ended March 31, 2018, and subsequent
filings, 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:
Brendan
Payne Associate Director, Investor Relations Aquinox
Pharmaceuticals, Inc. 604.901.3019
ir@aqxpharma.com |
Bill
Kadel Vice PresidentSolebury Trout
646.378.2934bkadel@troutgroup.com
|
AQUINOX PHARMACEUTICALS,
INC.
Condensed consolidated
balance sheets(Unaudited)(In thousands of U.S.
dollars)
|
MARCH 31, 2018 |
|
DECEMBER 31,
2017 |
|
|
|
|
Assets |
|
|
|
Cash,
cash equivalents and short-term investments |
$ |
92,660 |
|
$ |
108,085 |
Other
current assets |
|
1,563 |
|
|
740 |
Other
long-term assets |
|
1,400 |
|
|
1,504 |
Total assets |
$ |
95,623 |
|
$ |
110,329 |
|
|
|
|
Liabilities |
|
|
|
Current
liabilities |
$ |
9,355 |
|
$ |
10,956 |
Non-current liabilities |
|
443 |
|
|
486 |
Total liabilities |
|
9,798 |
|
|
11,442 |
Stockholders’
equity |
|
85,825 |
|
|
98,887 |
Total liabilities and
stockholders' equity |
$ |
95,623 |
|
$ |
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 ENDEDMARCH
31, |
|
|
2018 |
|
|
|
2017 |
|
Operating
expenses |
|
|
|
Research
and development |
$ |
10,508 |
|
|
$ |
5,777 |
|
General
and administrative |
|
4,309 |
|
|
|
2,745 |
|
Total operating
expenses |
|
14,817 |
|
|
|
8,522 |
|
Other income, net |
|
194 |
|
|
|
206 |
|
Net
loss |
$ |
(14,623 |
) |
|
$ |
(8,316 |
) |
Net loss per common
stock - basic and diluted |
$ |
(0.62 |
) |
|
$ |
(0.36 |
) |
|
|
|
|
Basic and diluted
weighted average number of common stock outstanding |
|
23,480,757 |
|
|
|
23,423,150 |
|
|
|
|
|
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