UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 12, 2018
Aquinox Pharmaceuticals, Inc.
(Exact name of Registrant as specified in its charter)
Delaware | 001-36327 | 98-0542593 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
450 - 887 Great Northern Way,
Vancouver, B.C.
Canada, V5T 4T5
(Address of principal executive offices, including zip code)
Registrants telephone number, including area code: (604) 629-9223
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company | ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02 Results of Operations and Financial Condition
On March 12, 2018, Aquinox Pharmaceuticals, Inc. (the Company) issued a press release announcing financial results for the year ended December 31, 2017. The full text of the press release announcing such results is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this current report on Form 8-K and the press release attached as Exhibit 99.1 hereto is being furnished, but shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (Exchange Act), and is not incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Number |
Description | |
99.1 | Press Release of Aquinox Pharmaceuticals, Inc. dated March 12, 2018 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Aquinox Pharmaceuticals, Inc. | ||
By: | /s/ Kamran Alam | |
Name: | Kamran Alam | |
Title: | Chief Financial Officer |
Date: March 12, 2018
Exhibit 99.1
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For Immediate Release |
Aquinox Pharmaceuticals Announces Year End 2017 Financial Results
VANCOUVER, British Columbia, March 12, 2018 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 year ending December 31, 2017.
We are excited to have completed enrollment in our LEADERSHIP 301 clinical trial of rosiptor in interstitial cystitis/bladder pain syndrome (IC/BPS), with the hope of showing that rosiptor demonstrates efficacy and tolerability in these patients, said David Main, President & CEO of Aquinox. We recognize that there is a great need for new treatment options in IC/BPS. We remain on track and anticipate releasing topline data in the third quarter of 2018.
Recent Business Highlights & Upcoming Milestones
LEADERSHIP 301 Enrollment. On February 15, 2018, Aquinox completed enrollment in its LEADERSHIP 301 clinical trial of rosiptor (AQX-1125) in IC/BPS, with a total of 433 enrolled subjects, including 341 females and 92 males. Previously, on February 9, 2018, Aquinox announced that it had met its enrollment threshold of 300 females enrolled in LEADERSHIP 301.
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 subjects with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in the second quarter of 2018. This 12-week, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of once-daily rosiptor in approximately 100 male subjects with CP/CPPS. Study sites will be located in the US and Canada. 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.
FDA BRUDAC Advisory Committee Meeting on IC/BPS. On December 7, 2018 the U.S. Food and Drug Administration (FDA) division of Bone, Reproductive, and Urologic Drugs (BRUDAC) held an Advisory Committee meeting specific to the topic of IC/BPS. At the meeting, the panel voted 15 to 0 that patients with interstitial cystitis and patients with bladder pain syndrome should be combined in clinical trials. This is aligned with the current American Urological Association (AUA) guideline and Aquinoxs position that IC/BPS is a single symptom complex defined by bladder pain and urinary symptoms. Minutes from the meeting have since been published and are available online at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM594730.pdf
Analyst and Investor Event. Aquinox hosted an analyst and investor event on February 9, 2018 in New York City, including a presentation from Dr. Philip Hanno, MD, MPH, clinical professor of urology at the Stanford University School of Medicine and co-chair of the Medical Advisory Board of the Interstitial Cystitis Association (ICA). Dr. Hanno shared his expert perspective on the current diagnosis and treatment landscape for patients with IC/BPS, and the need for effective treatment options for this patient population. Members of Aquinox management, Dr. Barbara Troupin and Ms. Abigail Jenkins, provided an update on Aquinoxs clinical program in IC/BPS with rosiptor and the prospective commercial opportunity, respectively.
Summary of Financial Results
Cash Position. Cash, cash equivalents, short-term and long-term investments totaled $108.1 million as of December 31, 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, 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 beyond topline data from the LEADERSHIP 301 trial and at least to mid-2019.
R&D Expenses. Research and development expenses for the year ended December 31, 2017 increased to $36.3 million from $28.4 million for the year ended December 31, 2016. 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 year ended December 31, 2017 increased to $14.9 million from $9.3 million for the year ended December 31, 2016. This increase was primarily driven by higher personnel related costs, professional fees, and pre-commercial and market assessment activities.
Net Loss. Net loss for the year ended December 31, 2017 was $50.2 million compared to a net loss of $37.0 million for the year ended December 31, 2016. This increase was primarily driven by increased operating expenditures as Aquinox continued its LEADERSHIP 301 clinical trial of rosiptor in IC/BPS.
Aquinox will host a conference call and live audio webcast on Monday, March 12, 2018 at 4.30 PM (ET)/ 1.30 PM (PT).
Conference Call and Webcast Details:
Date: Monday, March 12, 2018
Time: 4.30 PM (ET) / 1.30 PM (PT)
Toll-free: (866) 357-7878
International: (315) 625-3088
Audience Passcode 4665267
Webcast URL: https://edge.media-server.com/m6/p/9vvkbdes
The live webcast may be accessed through the Events & Presentations page in the Investor Relations section of the companys website at www.aqxpharma.com. The archived webcast will also be available on Aquinoxs website approximately two hours after the event and will be available for replay for at least 30 days after the event.
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 the LEADERSHIP 301 Trial
The LEADERSHIP 301 trial is a three-arm, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial assessing the effect of once-daily rosiptor (AQX-1125) 100 mg and 200 mg on bladder pain and urinary symptoms in female and male subjects with IC/BPS. The primary endpoint of the LEADERSHIP 301 trial is the change from baseline at week 12 in maximum daily bladder pain based on an 11-point numeric rating scale (NRS) compared to placebo in female subjects, recorded by electronic diary. Additional endpoints include urinary symptoms as well as an evaluation of overall improvement with therapy. The LEADERSHIP 301 trial has a 52-week extension period, affording all participating subjects the opportunity for treatment with rosiptor. Subjects have been enrolled at clinical research centers in the United States, Canada, and Europe. Top-line data are anticipated in the third quarter of 2018.
About Rosiptor
Rosiptor (AQX-1125), Aquinoxs 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. Aquinoxs 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: 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 companys Annual Report on Form 10-K for the year ended December 31, 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.
Contact Info:
Brendan Payne
Associate Director, Investor Relations
Aquinox Pharmaceuticals, Inc.
604.901.3019
ir@aqxpharma.com
Bill Kadel
Vice President
Solebury Trout
646.378.2934
bkadel@troutgroup.com
AQUINOX PHARMACEUTICALS, INC.
Condensed consolidated balance sheets
(In thousands of U.S. dollars)
DECEMBER 31, 2017 |
DECEMBER 31, 2016 | |||||||
Assets |
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Cash, cash equivalents, short-term and long-term investments |
$ 108,085 | $ 153,105 | ||||||
Other current assets |
740 | 426 | ||||||
Other long-term assets |
1,504 | 849 | ||||||
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Total assets |
$ 110,329 | $ 154,380 | ||||||
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Liabilities |
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Current liabilities |
$ 10,956 | $ 9,519 | ||||||
Non-current liabilities |
486 | 197 | ||||||
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Total liabilities |
$ 11,442 | $ 9,716 | ||||||
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Stockholders equity |
98,887 | 144,664 | ||||||
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Total liabilities and stockholders equity |
$ 110,329 | $ 154,380 | ||||||
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AQUINOX PHARMACEUTICALS, INC.
Condensed consolidated statements of operations
(In thousands of U.S. dollars, except per share and share amounts)
YEARS ENDED DECEMBER 31,
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2017 | 2016 | 2015 | ||||||||||
Operating expenses |
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Research and development |
$ 36,267 | $ 28,382 | $ 15,799 | |||||||||
General and administrative |
14,852 | 9,263 | 5,541 | |||||||||
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Total operating expenses |
51,119 | 37,645 | 21,340 | |||||||||
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Other income (expenses) |
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Interest expense |
(4 | ) | (1 | ) | - | |||||||
Other income (expenses) |
940 | 644 | (520 | ) | ||||||||
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936 | 643 | (520 | ) | |||||||||
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Net loss |
$ (50,183 | ) | $ (37,002 | ) | $ (21,860 | ) | ||||||
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Net loss per common stock - basic and diluted |
$ (2.14 | ) | $ (1.96 | ) | $ (1.73 | ) | ||||||
Basic and diluted weighted average number of common stock outstanding |
23,450,315 | 18,893,515 | 12,637,839 |