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 third quarter ending September 30, 2016.
“In September we commenced enrollment in the LEADERSHIP 301
Phase 3 clinical trial with AQX-1125 in interstitial
cystitis/bladder pain syndrome (IC/BPS) and we are continuing to
add sites and jurisdictions to the trial as planned,” said David
Main, President & CEO of Aquinox. “Our objective remains to
release top-line data from this first Phase 3 trial in the fourth
quarter of 2017 and we will provide an enrollment update when we
release year-end 2016 financial results in early 2017. Our recent
financing, together with cash on-hand, positions us well to advance
AQX-1125 and broaden our clinical and research activities.”
The LEADERSHIP 301 Phase 3 trial is anticipated to enroll a
minimum of 300 female patients, up to a maximum of 600 patients
including males, at clinical research centers in Canada, the United
States and Europe. LEADERSHIP 301 will be conducted as 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 AQX-1125 to reduce bladder pain in patients with IC/BPS.
The primary endpoint of the LEADERSHIP 301 trial is to measure 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. The trial will also
include an open-label extension of up to 40 weeks affording all
participating patients the opportunity for treatment with AQX-1125.
Secondary endpoints will include urinary symptoms, including
frequency and nighttime awakenings, as well as measures of quality
of life. For more information on the LEADERSHIP 301 trial, please
visit www.clinicaltrials.gov.
Business
Highlights
Appointment of New Chief Medical Officer. On
October 3, 2016, Aquinox announced the appointment of Dr. Barbara
Troupin, M.D. as Chief Medical Officer and Vice President, Clinical
Development. From Aquinox’s offices in San Bruno, California, Dr.
Troupin will lead overall clinical and medical affairs strategies
for Aquinox's ongoing programs as well as future development
and potential commercialization plans. Dr. Troupin brings extensive
clinical leadership experience from previous roles with Apricus
Bioscience, Inc. and VIVUS, Inc. Dr. Troupin received her Doctorate
in Medicine in 1995 from the University of Pennsylvania School of
Medicine where she also completed her Master's in Business
Administration, with an emphasis in health care management, from
the Wharton School of Business.
Closing of $75.4 Million Public
Offering. On September 23, 2016, Aquinox
completed an underwritten public offering of 6,152,500 shares of
its common stock, including 802,500 shares sold pursuant to the
underwriters' full exercise of their option to purchase additional
shares, at a price to the public of $12.25 per share. The gross
proceeds from the offering (inclusive of the option exercise),
before underwriting discounts and commissions and offering costs,
were $75.4 million. Aquinox intends to use the net proceeds from
this offering to fund additional clinical development of AQX-1125
and to fund pre-commercial and market assessment activities,
research and development costs to advance its pipeline of
preclinical product candidates and for working capital and other
general corporate purposes. Leerink Partners, Canaccord Genuity and
Guggenheim Securities acted as joint book-running managers for the
offering. Needham & Company acted as lead manager.
Summary of Financial
Results
Cash Position. Cash, cash equivalents,
short-term and long-term investments totaled $162.6 million as of
September 30, 2016, compared to $112.9 million as of December 31,
2015. The increase was primarily the result of the public offering
of common stock in September 2016 partly offset by 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 to complete the LEADERSHIP
301 trial as well as additional clinical development,
manufacturing, preclinical, and pre-commercial and market
assessment activities.
R&D Expenses. Research and development
expenses for the third quarter of 2016 increased to $6.1 million
from $3.7 million in the third quarter of 2015. This increase was
primarily driven by increased clinical activities related to the
initiation of our LEADERSHIP 301 clinical trial.
G&A Expenses. General and administrative
expenses for the third quarter of 2016 increased to $2.1 million
from $1.2 million in the third quarter of 2015. This increase was
primarily driven by higher personnel related costs and the
establishment of an office in San Bruno, CA.
Net Loss. Net loss for the third quarter of
2016 was $8.1 million compared to a net loss of $5.0 million for
the third quarter of 2015. This increase was primarily driven by
increased operating expenditures related to the initiation of our
LEADERSHIP 301 clinical trial.
About Interstitial Cystitis/Bladder Pain Syndrome
(IC/BPS)
IC/BPS is a chronic inflammatory bladder disease characterized
by pelvic pain and increased urinary urgency and/or frequency. 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 in order to reduce the chronic pain and urinary
symptoms are
needed.
About AQX-1125
AQX-1125, 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, AQX-1125
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. AQX-1125 has demonstrated
preliminary safety and favorable drug properties for once daily
oral administration in multiple preclinical studies and seven
completed clinical trials.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical
company discovering and developing targeted therapeutics in disease
areas of inflammation and immuno-oncology. Aquinox’s lead drug
candidate, AQX-1125, is a small molecule activator of SHIP1
suitable for oral, once daily dosing. With a successful Phase 2
clinical trial completed in 2015, Aquinox initiated a Phase 3 trial
(LEADERSHIP 301) with AQX-1125 for treatment of IC/BPS in September
of 2016. 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 the planning for,
and timing of, our ongoing and planned clinical trials in IC/BPS;
potential commercialization of, and market opportunities for,
AQX-1125; and our projected cash position. 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 AQX-1125 or any future product candidates and our ability to
serve those markets; our ability to obtain and maintain regulatory
approval of 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 AQX-1125 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
third quarter ended September 30, 2016 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
PayneSenior Manager, 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) |
|
|
|
SEPTEMBER 30,
2016 |
|
DECEMBER 31,
2015 |
|
|
|
|
|
Assets |
|
|
|
|
Cash, cash equivalents, short-term
and long-term investments |
|
$ |
162,602 |
|
|
$ |
112,940 |
|
Other current assets |
|
|
676 |
|
|
|
314 |
|
Other long-term assets |
|
|
791 |
|
|
|
89 |
|
Total assets |
|
$ |
164,069 |
|
|
$ |
113,343 |
|
|
|
|
|
|
Liabilities |
|
|
|
|
Current liabilities |
|
$ |
8,564 |
|
|
$ |
4,792 |
|
Non-current
liabilities |
|
|
142 |
|
|
|
131 |
|
Total liabilities |
|
$ |
8,706 |
|
|
$ |
4,923 |
|
Stockholders’
equity |
|
|
155,363 |
|
|
|
108,420 |
|
Total liabilities and
stockholders' equity |
|
$ |
164,069 |
|
|
$ |
113,343 |
|
AQUINOX PHARMACEUTICALS, INC. |
|
Condensed consolidated statements of
operations |
(Unaudited) |
(In thousands of U.S. dollars, except per share and share
amounts) |
|
|
|
|
THREE MONTHS ENDEDSEPTEMBER
30, |
|
NINE MONTHS ENDEDSEPTEMBER
30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,134 |
|
|
$ |
3,687 |
|
|
$ |
20,250 |
|
|
$ |
11,873 |
|
|
General and administrative |
|
|
2,149 |
|
|
|
1,230 |
|
|
|
5,932 |
|
|
|
3,874 |
|
|
Total operating
expenses |
|
|
8,283 |
|
|
|
4,917 |
|
|
|
26,182 |
|
|
|
15,747 |
|
|
Other income
(expenses) |
|
|
137 |
|
|
|
(118 |
) |
|
|
424 |
|
|
|
(450 |
) |
|
Net loss before income
taxes |
|
|
(8,146 |
) |
|
|
(5,035 |
) |
|
|
(25,758 |
) |
|
|
(16,197 |
) |
|
Net
loss |
|
$ |
(8,146 |
) |
|
$ |
(5,035 |
) |
|
$ |
(25,758 |
) |
|
$ |
(16,197 |
) |
|
Net loss per common stock - basic and
diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.48 |
) |
|
$ |
(1.46 |
) |
|
Basic and diluted
weighted average number of common stock outstanding |
|
|
17,690,362 |
|
|
|
11,841,147 |
|
|
|
17,372,616 |
|
|
|
11,096,369 |
|
|
|
|
|
|
|
|
|
|
|
|
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