Aquinox Pharmaceuticals Announces First Quarter 2018 Financial Results
"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
LEADERSHIP 301 Topline Data Analysis. Aquinox completed enrollment of its LEADERSHIP 301 Phase 3 clinical trial of rosiptor in IC/BPS in
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
AACR Poster Presentation. Aquinox, in collaboration with researchers from the
Executive Change. Ms
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
G&A Expenses. General and administrative expenses for the first quarter of 2018 increased to
Net Loss. Net loss for the first quarter of 2018 was
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
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
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.
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
Condensed consolidatedbalance sheets
Condensed consolidated statements of operations
Source: Aquinox Pharmaceuticals, Inc.