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): October 23, 2014
ARDELYX, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36485 | 26-1303944 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
34175 Ardenwood Blvd.
Fremont, CA 94555
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (510) 745-1700
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:
| ¨ | 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)) |
| Item 7.01 | Regulation FD Disclosure. |
On October 23, 2014, Ardelyx, Inc. announced that it, together with its development partner, AstraZeneca, will present tenapanor-related preclinical and clinical results during Kidney Week 2014, the annual meeting of the American Society of Nephrology scheduled to be held from November 11, 2014 to November 16, 2014. A copy of the press release is attached hereto as Exhibit 99.1, which is being furnished herewith under this Item 7.01.
The information furnished under this Item 7.01 shall not be considered “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any future filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, unless the Company expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit No. |
Description | |
| 99.1 | Press release of Ardelyx, Inc. | |
SIGNATURES
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 hereunto duly authorized.
| Date: October 23, 2014 | ARDELYX, INC. | |||||
| By: | /s/ Mark Kaufmann | |||||
| Mark Kaufmann | ||||||
| Chief Financial Officer | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press release of Ardelyx, Inc. | |
Exhibit 99.1
|
34175 Ardenwood Blvd Fremont, CA 94555 (510) 745-1700 – Tele (510) 745-0493 – Fax www.ardelyx.com |
Ardelyx’s Tenapanor Selected for Oral and Poster Presentations at the American
Society of Nephrology’s Kidney Week 2014
Fremont, CA, October 23, 2014 – Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal and metabolic diseases, today announced that Ardelyx, together with its development partner, AstraZeneca (NYSE:AZN, LON:AZN), will present tenapanor-related preclinical and clinical results during Kidney Week 2014, the annual meeting of the American Society of Nephrology (ASN). Abstracts of the presentations were published today on the ASN website.
ASN Kidney Week, the world’s largest nephrology meeting, will take place November 11 - 16, 2014 in Philadelphia, PA. Oral and poster presentations related to tenapanor are listed below.
Tenapanor-Related Oral Abstract Presentations:
November 14, 2014, 5:30 p.m. ET
Title: Tenapanor Inhibits Phosphorous Absorption, and Protects Against Vascular Calcification in Nephrectomized Rats (abstract # 425; FR-OR111)
Presenter: Dominique Charmot, Ph.D., Ardelyx Chief Scientific Officer
Session Title: Mineral Disease: Ca/Mg/PO4
Location: Room 119-B
November 14, 2014, 5:42 p.m. ET
Title: Tenapanor, a Minimally Absorbed NHE3 Inhibitor, Reduces Dietary Phosphorus Absorption in Healthy Volunteers (abstract #4829; FR-OR112)
Presenter: David Rosenbaum, Ph.D., Ardelyx Vice President Drug Development
Session Title: Mineral Disease: Ca/Mg/PO4
Location: Room 119-B
Tenapanor-Related Poster Presentations:
November 14, 2014, 10:00 a.m.-12:00 p.m. ET; Location: Exhibit Hall A
Title: Reduction of Sodium and Phosphorus Absorption Provided by Tenapanor is Not Affected by Co-Administration of Sevelamer in Healthy Volunteers (abstract # 903; Poster Board #FR-PO966)
Authors: Susanne Johansson, David Rosenbaum, Maria Leonsson-Zachrisson, Mikael Knutsson, Dennis Ruff
Title: Tenapanor, a Minimally Absorbed Small-Molecule Inhibitor of NHE3, Reduces Absorption of Sodium and Phosphorus in Healthy Japanese Volunteers (abstract # 2498; Poster Board #FR-PO965)
Authors: Susanne Johansson, David Rosenbaum, Mikael Knutsson, Maria Leonsson-Zachrisson
A full list of Ardelyx sessions is available on the ASN website here: http://www.asn-online.org/abstracts
For more information about ASN visit: http://www.asn-online.org/
About Tenapanor
Tenapanor (also known as RDX5791 and AZD1722) is a minimally-systemic small molecule inhibitor of NHE3, a transporter of sodium in the gastrointestinal tract. Orally administered tenapanor has been shown in clinical trials to reduce the intestinal absorption of both dietary sodium and phosphorus. Ardelyx licensed tenapanor to AstraZeneca in October 2012. A total of 12 clinical trials of tenapanor have been completed or are ongoing, including over 830 subjects who have been administered tenapanor to date. Ardelyx and AstraZeneca are evaluating tenapanor in three indications:
| • | ESRD patients on hemodialysis to treat hyperphosphatemia: Phase 2b randomized, double-blind, placebo-controlled clinical trial in 150 ESRD patients to evaluate the effects of tenapanor on serum phosphorus. Enrollment is ongoing and the results of this clinical trial are expected in the first half of 2015. |
| • | Stage 3 CKD patients with type 2 diabetes mellitus, the presence of the protein albumin in the urine, or albuminuria, and high blood pressure, Phase 2a randomized, double-blind, placebo-controlled clinical trial in 140 patients to evaluate the effects of tenapanor on kidney function and fluid overload. Enrollment is ongoing and the results of this clinical trial are expected in the second half of 2015 |
| • | IBS-C patients: Phase 2b randomized, double-blind, placebo-controlled clinical trial in 371 patients to evaluate the effect of tenapanor on the frequency of bowel movements versus placebo. Results were announced October 1, 2014. At the 50 mg dose given twice daily, the study met its primary efficacy endpoint of an increase in the complete spontaneous bowel movement (CSBM) responder rate. Most secondary endpoints, including abdominal pain and other abdominal and IBS-C symptoms, demonstrated clinically meaningful improvements. Tenapanor was well-tolerated. |
Page 2 of 3 Pages
About Ardelyx, Inc.
Ardelyx is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative, non-systemic, small molecule therapeutics that work exclusively in the gastrointestinal tract to treat cardio-renal, gastrointestinal and metabolic diseases. The Company has developed a proprietary drug discovery and design platform enabling it, in a rapid and cost-efficient manner, to discover and design novel drug candidates. Utilizing this platform, Ardelyx has discovered and designed tenapanor.
Ardelyx formed a collaboration with AstraZeneca in October 2012 to develop and commercialize tenapanor. In addition to tenapanor, the Company has discovered small molecule NaP2b inhibitors for the treatment of hyperphosphatemia in ESRD, a program licensed to Sanofi, and independently is advancing several additional research programs focused in cardio-renal, gastrointestinal and metabolic diseases. Ardelyx is located in Fremont, California. For more information, please visit Ardelyx’s website at www.ardelyx.com.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including statements regarding the availability and timing of data from ongoing tenapanor clinical trials, and the potential of our drug discovery and design platform. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of tenapanor, or Ardelyx’s future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical development process, Ardelyx’s reliance upon AstraZeneca for the development of tenapanor, and AstraZeneca’s right under the license agreement to choose which indication or indications for which tenapanor will be developed. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx’s business in general, please refer to Ardelyx’s second quarter report filed on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2014.
Investor and Media Contact:
Mark Kaufmann
Chief Financial Officer
mkaufmann@ardelyx.com
510-745-1751
For investors:
Kimberly Minarovich
Burns McClellan on behalf of Ardelyx
kminarovich@burnsmc.com
212-213-0006
SOURCE Ardelyx, Inc.
Page 3 of 3 Pages