On August 9, 2019 Ardelyx, Inc. (NASDAQ: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, reported business highlights and financial results for the second quarter ended June 30, 2019 (Press release, Ardelyx, AUG 9, 2019, View Source [SID1234538570]).
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"We are excited for a catalyst-rich second half of 2019 with planned completion of the final stages of development for tenapanor before we seek approval for its use in treating hyperphosphatemia in end-stage renal disease patients on dialysis," said Mike Raab, president and chief executive officer of Ardelyx. "There continues to be a high unmet need for novel hyperphosphatemia treatments to help ESRD patients achieve phosphorus goals. If positive, the results from our ongoing second Phase 3 clinical trial, PHREEDOM, investigating tenapanor as monotherapy, will allow us to file our NDA next year. If approved, tenapanor will provide patients and health care providers with a novel, first-in-class and much more patient-friendly approach to managing phosphorus levels in dialysis patients. We look forward to announcing results for PHREEDOM in the fourth quarter of this year, and announcing results for AMPLIFY, our ongoing Phase 3 clinical trial evaluating tenapanor’s use in combination with phosphate binders in the third quarter of this year."
Remaining Expected 2019 Milestones
Results from the PHREEDOM clinical trial, the company’s second Phase 3 clinical trial evaluating tenapanor as a monotherapy treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis, are currently expected to be announced in the fourth quarter of 2019.
Results from the AMPLIFY clinical trial, the company’s Phase 3 clinical trial evaluating tenapanor’s efficacy in combination with phosphate binders, are currently expected to be announced in the third quarter of 2019.
The company’s New Drug Application for U.S. marketing authorization of tenapanor for patients with IBS-C has a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019.
Second Quarter 2019 Financial Results
Cash Position: As of June 30, 2019, Ardelyx had total capital resources including cash, cash equivalents and short-term investments of $123.9 million compared to total capital resources including cash, cash equivalents and short-term investments of $168.1 million as of December 31, 2018.
R&D Expenses: Research and development expenses were $19.4 million for the three months ended June 30, 2019, an increase of $3.4 million, or 21 percent, compared to $16.0 million for the three months ended June 30, 2018. The increase included a $7.5 million increase in expense primarily related to the Company’s manufacturing of tenapanor, the continued clinical development of tenapanor for the treatment of hyperphosphatemia in ESRD patients on dialysis and the Company’s hyperkalemia program, RDX013, partially offset by an out-of-period adjustment that reduced clinical trial expenses by $4.1 million related to the tenapanor clinical trials.
G&A Expenses: General and administrative expenses were $5.4 million for the three months ended June 30, 2019, a decrease of $0.7 million, or 12 percent, compared to $6.1 million for the three months ended June 30, 2018. The decrease was primarily related to a decrease in professional services and a reduction in stock-based compensation costs partially offset by an increase in headcount and related personnel costs.
Net Loss: Net loss for the three months ended June 30, 2019 was $25.5 million, or $0.41 per share, compared to a net loss of $22.3 million, or $0.42 per share, for the three months ended June 30, 2018.