- Enrollment in LEADERSHIP 301 with
Rosiptor in IC/BPS Passes 50% -
Aquinox Pharmaceuticals, Inc. (“Aquinox”) (NASDAQ:AQXP), a
clinical-stage pharmaceutical company discovering and developing
targeted therapeutics in disease areas of inflammation and
immuno-oncology, today provided a corporate update and reported
financial results for the second quarter ending June 30, 2017.
“With more than one hundred trial sites initiated, enrollment in
LEADERSHIP 301 is now on pace with expectations and we anticipate
reporting top-line data in the third quarter of 2018,” said David
Main, President & CEO of Aquinox. “After a thorough examination
of numerous potential disease states, we also are pleased to
announce the expansion of our rosiptor (AQX-1125) clinical
development program with the planned initiation of a Phase 2
clinical trial in Chronic Prostatitis/Chronic Pelvic Pain Syndrome
(CP/CPPS) and expect patient enrollment to commence in the first
quarter of 2018.”
Recent Business
Highlights
Progress in Leadership 301. As of August 7,
2017, 195 patients have been enrolled in Aquinox’s LEADERSHIP 301
Phase 3 clinical trial with rosiptor (AQX-1125) in Interstitial
Cystitis/Bladder Pain Syndrome (IC/BPS) across 108 trial sites.
With 154 women enrolled to date, we have surpassed 50% of our
female enrollment target. Based on the number of active sites and
current enrollment rates, Aquinox anticipates reporting top-line
data from the LEADERSHIP 301 trial in the third quarter of 2018.
Aquinox will announce once enrollment is complete in the LEADERSHIP
301 trial.
Initiation of Phase 2 Trial with Rosiptor in
CP/CPPS. Aquinox is today announcing its plans to initiate
a proof-of-concept Phase 2 trial with rosiptor (AQX-1125) in
patients with CP/CPPS. CP/CPPS is characterized by pelvic pain,
unrelated to urinary bladder filling or emptying, and lower urinary
tract symptoms present for at least three months without evidence
of urinary tract infection.
USAN Assigns Generic Name
“Rosiptor”
to AQX-1125. On April 26, 2017, the United States
Adopted Name Council (USAN) adopted the generic name “rosiptor”
(pronounced “roe sip’ tor”) for AQX-1125. This name was published
by USAN on July 7, 2017. Aquinox will adopt the reference of
rosiptor for appropriate use going forward while phasing out
reference to AQX-1125.
Summary of Financial
Results
Cash Position. Cash, cash equivalents,
short-term and long-term investments totaled $131.3 million as of
June 30, 2017, compared to $153.1 million as of December 31, 2016.
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, short-term and long-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 beyond top-line data from the LEADERSHIP
301 trial and into 2019.
R&D Expenses. Research and development
expenses for the second quarter of 2017 increased to $10.5 million
from $9.2 million in the second quarter of 2016. This increase was
primarily driven by increased clinical activities as Aquinox
continued its LEADERSHIP 301 clinical trial with rosiptor
(AQX-1125) in IC/BPS.
G&A Expenses. General and administrative
expenses for the second quarter of 2017 increased to $3.5 million
from $1.8 million in the second quarter of 2016. This increase was
primarily driven by higher personnel related costs and
pre-commercial and market assessment activities.
Net Loss. Net loss for the second quarter of
2017 was $13.8 million compared to a net loss of $10.9 million in
the second quarter of 2016. This increase was primarily driven by
increased operating expenditures as Aquinox continued its
LEADERSHIP 301 clinical trial of rosiptor (AQX-1125) in IC/BPS.
Aquinox will host a conference call and live audio webcast
on Tuesday, August 8,
2017 at 8:30AM (ET)/ 5:30AM
(PT).
Conference Call and Webcast Details: Date: Tuesday, August
8, 2017 Time: 8:30 AM (ET) / 5:30 AM (PT) Toll-free:
(866) 357-7878 International: (315) 625-3088 Audience
Passcode 5911876 Conference ID: 59711876 Webcast
URL: http://edge.media-server.com/m/p/mqa4bkna
The live webcast may be accessed through the "Events &
Presentations" page in the "Investor Relations" section of the
company's website at www.aqxpharma.com. The archived webcast
will also be available on Aquinox's website approximately two
hours after the event and will be available for replay for at least
30 days after the event.
About Rosiptor (AQX-1125)
Rosiptor, Aquinox's lead drug candidate, is a small molecule
activator of SHIP1, which is a regulating component of the PI3K
cellular signaling pathway. By increasing SHIP1 activity, rosiptor
accelerates a natural mechanism that has evolved to maintain
homeostasis of the immune system and reduce immune cell activation
and migration to sites of inflammation. Rosiptor has demonstrated
preliminary safety and favorable drug properties for once daily
oral administration in multiple preclinical studies and eight
completed clinical trials.
About Interstitial Cystitis/Bladder Pain Syndrome
(IC/BPS)
IC/BPS is a chronic inflammatory bladder disease characterized
by pelvic pain and increased urinary frequency and/or urgency. For
many sufferers, these symptoms are severe and adversely affect all
major aspects of their lives, including overall physical and
emotional health, employment, social and intimate relationships,
and leisure activities. While the cause of the disease remains
largely unknown, erosion of the bladder lining is thought to be a
significant contributor. IC/BPS is estimated to affect millions of
people in the United States and around the world. Most
IC/BPS patients continue to suffer this debilitating condition,
despite treatment with existing therapies. Most current therapies
and those in development are focused solely on symptomatic relief
of IC/BPS. Aquinox believes new and innovative therapies that
target the underlying disease to reduce the chronic pain and
urinary symptoms are needed.
About the LEADERSHIP
301 Trial
The LEADERSHIP 301 trial, which commenced enrollment in
September 2016, is a three-arm, multicenter, randomized,
double-blind, placebo-controlled Phase 3 clinical trial
investigating the ability of 200 mg and 100 mg oral, once daily
rosiptor (AQX-1125) to reduce bladder pain in patients with IC/BPS.
The primary endpoint of the LEADERSHIP 301 trial is the difference
in the change from baseline in the maximum daily bladder pain score
based on an 11-point numeric rating scale (NRS) at twelve weeks
recorded by electronic diary. Additional endpoints include urinary
symptoms, including frequency and nighttime awakenings to void, as
well as measures of quality of life. The LEADERSHIP 301 trial also
has an additional 52-week extension period, affording all
participating patients the opportunity for treatment with rosiptor.
An anticipated minimum of 300 female patients, up to a maximum of
600 patients including males, are currently being enrolled at
clinical research centers in the United States, Canada and Europe.
Top-line data from the LEADERSHIP 301 trial is anticipated in third
quarter of 2018.
About Chronic Prostatitis/Chronic Pelvic Pain Syndrome
(CP/CPPS)
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a
chronic pain disorder characterized by the presence of
noninfectious pelvic pain, unrelated to urinary bladder filling or
emptying, lasting longer than 3 months. CP/CPPS is a complex
condition of uncertain etiology affecting men of all ages, which
can significantly impair the quality of life and the social
functioning of patients. In the US, the number of patients
diagnosed with and receiving treatment for CP/CPPS is similar to
that of IC/BPS - at approximately 1 million. There are no FDA
approved products for the treatment of CP/CPPS and effective
management of this condition is challenging and often inadequate,
supporting the need for new and effective therapies to treat
CP/CPPS.
About Aquinox
Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a late clinical-stage
pharmaceutical company discovering and developing targeted
therapeutics in disease areas of inflammation and immuno-oncology.
Our primary focus is anti-inflammatory product candidates
targeting SH2-containing inositol-5'-phosphatase 1, or SHIP1,
which is a key regulator of an important cellular signaling pathway
in immune cells, known as the PI3K pathway. Aquinox's lead drug
candidate, rosiptor (AQX-1125), is a small molecule activator of
SHIP1 suitable for oral, once daily dosing. In September
2016, we began enrolling patients in a Phase 3 clinical trial of
rosiptor in our lead indication, Interstitial Cystitis/Bladder Pain
Syndrome (IC/BPS). Other indications are under consideration
for future investigation. Aquinox has a broad intellectual property
portfolio and pipeline of preclinical drug candidates that activate
SHIP1. 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 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: our ability to enroll patients
in our clinical trials at the pace that we project; 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 June 30, 2017 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.
Investor Contact Info:
Brendan PayneAssociate Director, Investor
Relations Aquinox Pharmaceuticals,
Inc.604.901.3019ir@aqxpharma.com
Gitanjali Ogawa Vice President The Trout
Group646-378-2949Gogawa@troutgroup.com
AQUINOX PHARMACEUTICALS,
INC. |
Condensed consolidated balance
sheets |
(Unaudited) |
In thousands of U.S. dollars) |
|
|
|
|
|
JUNE 30, 2017 |
|
DECEMBER 31,
2016 |
|
|
|
|
Assets |
|
|
|
Cash,
cash equivalents, short-term and long-term investments |
$ |
131,277 |
|
$ |
153,105 |
Other
current assets |
|
915 |
|
|
426 |
Other
long-term assets |
|
1,092 |
|
|
849 |
Total assets |
$ |
133,284 |
|
$ |
154,380 |
|
|
|
|
Liabilities |
|
|
|
Current
liabilities |
$ |
8,128 |
|
$ |
9,519 |
Non-current liabilities |
|
548 |
|
|
197 |
Total liabilities |
|
8,676 |
|
|
9,716 |
Stockholders’
equity |
|
124,608 |
|
|
144,664 |
Total liabilities and
stockholders' equity |
$ |
133,284 |
|
$ |
154,380 |
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, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
Operating
expenses |
|
|
|
|
|
|
|
Research
and development |
$ |
10,475 |
|
|
$ |
9,235 |
|
|
$ |
16,252 |
|
|
$ |
14,116 |
|
General
and administrative |
|
3,520 |
|
|
|
1,830 |
|
|
|
6,265 |
|
|
|
3,783 |
|
Total operating
expenses |
|
13,995 |
|
|
|
11,065 |
|
|
|
22,517 |
|
|
|
17,899 |
|
Other income, net |
|
229 |
|
|
|
164 |
|
|
|
435 |
|
|
|
287 |
|
Net
loss |
$ |
(13,766 |
) |
|
$ |
(10,901 |
) |
|
$ |
(22,082 |
) |
|
$ |
(17,612 |
) |
Net loss per common
stock - basic and diluted |
$ |
(0.59 |
) |
|
$ |
(0.63 |
) |
|
$ |
(0.94 |
) |
|
$ |
(1.02 |
) |
Basic and diluted
weighted average number of common stock outstanding |
|
23,444,150 |
|
|
|
17,212,007 |
|
|
|
23,433,708 |
|
|
|
17,211,997 |
|
|
|
|
|
|
|
|
|
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