Le Lézard
Classified in: Health, Business
Subjects: ERN, TRI

Ardelyx Reports Third Quarter 2017 Operating Results and Clinical Progress


FREMONT, Calif., Nov. 7, 2017 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), today provided an update on its clinical programs and reported financial results for the third quarter ended September 30, 2017.

Ardelyx logo (PRNewsFoto/Ardelyx)

"2017 has been a landmark year for Ardelyx, with three statistically significant Phase 3 trial readouts for tenapanor ? two for IBS-C and one for hyperphosphatemia," said Mike Raab, chief executive officer of Ardelyx. "For IBS-C patients, tenapanor could offer a completely new mechanism of action with a demonstrated best-in-class response rate, as seen in our T3MPO-2 study. For patients with hyperphosphatemia, tenapanor could be the first-ever non-binder treatment, potentially relieving the significant pill burden associated with binders. In order to maximize its therapeutic opportunity across both indications, we plan to leverage collaborations as part of our strategy of efficiently bringing tenapanor to patients as quickly as possible. As we head into 2018, we are closer to realizing the significant potential that minimally systemic, non-absorbed medicines could have for patients, which is the vision on which Ardelyx was founded."

Clinical Program Updates

Tenapanor for IBS-C

Tenapanor for Hyperphosphatemia

RDX7675 for Hyperkalemia

Third Quarter 2017 Financial Results

About Ardelyx, Inc.
Ardelyx is focused on enhancing the way patients with cardiorenal and gastrointestinal (GI) diseases are treated by using the gut as the gateway to delivering medicines that matter. The company has established unique cardiorenal and GI business portfolios aimed at bringing new, effective medicines with distinct safety and dosing advantages to underserved patients. Ardelyx's cardiorenal portfolio includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis and the Phase 3 development of RDX7675 for the treatment of people with hyperkalemia. The company's GI portfolio includes the Phase 3 development of tenapanor for the treatment of people with irritable bowel syndrome with constipation (IBS-C), and RDX8940, the company's TGR5 agonist. For more information, please visit http://www.ardelyx.com/ and connect with us on Twitter @Ardelyx.

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 the potential for Ardelyx's product candidates in treating the diseases and conditions for which they are being developed; Ardelyx's future development plans for tenapanor and RDX7675 and the expected timing thereof; Ardelyx's ability to establish collaborations in the future; and Ardelyx's expectations regarding the filing of an NDA with the FDA seeking marketing authorization for tenapanor for the treatment of IBS-C. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of Ardelyx's product candidates 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 research and the clinical development process, including the regulatory approval process. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2017, and its future current and periodic reports to be filed with the Securities and Exchange Commission.


 

Ardelyx, Inc.

Condensed Consolidated Balance Sheets

 (In thousands)




September 30,
2017


December 31,
2016



(Unaudited)


(1)

Assets





Cash and cash equivalents


$        59,454


$          74,598

Short-term investments


69,834


126,225

Property and equipment, net


8,622


8,991

Prepaid and other assets


5,195


3,317

Total Assets


$      143,105


$        213,131






Liabilities and stockholders' equity





Accounts payable and other current liabilities


$        15,727


$          19,201

Long-term liabilities


741


779

Stockholders' equity


126,637


193,151

Total liabilities and stockholders' equity


$      143,105


$        213,131






(1)

Derived from the audited consolidated financial statements included on Form 10-K for the year ended December 31, 2016.

 

Ardelyx, Inc.

Condensed Consolidated Statements of Operations

 (In thousands, except share and per share amounts)



Three Months Ended September 30,

Nine Months Ended September 30,


2017


2016


2017


2016


(Unaudited)


(Unaudited)


(Unaudited)


(Unaudited)

Operating expenses:








Research and development

$             15,365


$        24,863


$         58,325


$          67,951

General and administrative

5,860


4,337


17,752


13,469

Total operating expenses

21,225


29,200


76,077


81,420

Loss from operations

(21,225)


(29,200)


(76,077)


(81,420)

Other income

501


169


1,624


307

Provision for income taxes

?


?


?


?

Net loss

$          (20,724)


$      (29,031)


$      (74,453)


$      (81,113)

Net loss per common share, basic & diluted

$              (0.44)


$          (0.65)


$          (1.57)


$          (2.15)

Shares used in computing net loss per share, basic and diluted

47,464,310


44,935,126


47,404,039


37,706,045










 

SOURCE Ardelyx


These press releases may also interest you

at 06:30
The "Sample Preparation Market by Product (Workstation, Instrument {Pipette, Washer, Centrifuge, Grinder}, Consumable {Kits, Filters, Plates}) Technique (Solid Phase Extraction, Purification) Application (Drug Discovery, Diagnostic) - Global Forecast...

at 06:15
The "Global Immune Health Supplements Market - Outlook & Forecast 2023-2028" report has been added to  ResearchAndMarkets.com's offering. The global immune health supplements market was valued at $20.80 billion in 2022 and is expected to reach...

at 06:08
ConTemporary Locums, a physician-focused medical staffing company, is ushering in a new era with a bold rebrand: Era Locums. This brand evolution marks a commitment to continued innovation and a deeper connection with the company's physician and...

at 06:05
AIS Healthcare, a leading provider of targeted drug delivery (TDD) and infusion care solutions, is proud to recognize March 25-31 as National Physicians Week. This week and throughout the year, we celebrate the dedication of physicians who selflessly...

at 06:00
The "Liquid Biopsy Markets by Cancer, Usage, Biomarker, Place, & Product With Price and Volume Outlook. Including Executive and Consultant Guides and Customized Forecasting and Analysis 2023-2027" report has been added to  ResearchAndMarkets.com's...

at 05:45
The "Global Proteomic Biomarker Analytics Market Forecasts by Application, Technology, Product, and Place, with Executive & Consultant Guides; Including Customized Forecasting and Analysis" report has been added to  ResearchAndMarkets.com's offering....



News published on and distributed by: