ARDX Ardelyx Inc.

1.6
-0.04  -2%
Previous Close 1.64
Open 1.62
52 Week Low 1.51
52 Week High 9.23
Market Cap $157,934,701
Shares 98,709,188
Float 83,827,402
Enterprise Value $46,365,987
Volume 11,077,208
Av. Daily Volume 9,895,806
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Drug Pipeline

Drug Stage Notes
Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis
CRL
CRL
FDA issued CRL on July 29 2021.
RDX013
Hyperkalemia
Phase 2
Phase 2
Phase 2 trial planned for 2021.
Tenapanor - AMPLIFY
Hyperphosphatemia - adjunctive therapy to phosphate binders
Phase 3
Phase 3
Phase 3 trial met primary endpoint.
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
Approved
Approved
FDA approval announced September 12, 2019.
Tenapanor (T3MPO-1)
Constipation-predominant irritable bowel syndrome (IBS-C)
Phase 3
Phase 3
Phase 3 data released May 12, 2017. Primary endpoint met - however, competitive concerns raised.

Latest News

  1. FREMONT, Calif. and WALTHAM, Mass., July 29, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

    According to the CRL, while the FDA agrees that "the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis," they characterize the magnitude of the treatment effect as "small and of unclear clinical significance." Additionally, the FDA noted that for the application to be approved, Ardelyx needs "to conduct an additional adequate and well-controlled trial demonstrating a clinically relevant treatment effect on serum phosphorus or an effect on the clinical outcome thought to be caused by hyperphosphatemia in CKD patients on dialysis." There were no safety, clinical pharmacology/biopharmaceutics, CMC or non-clinical issues identified in the CRL.

    The FDA indicated it is willing to meet with Ardelyx to discuss options for obtaining approval. To that end, the company intends to request a Type A meeting as soon as possible to discuss the CRL and determine potential paths forward for the approval of tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis.

    "We are saddened by this communication from the FDA and what it means for the patients and the physicians who treat them," said Mike Raab, president and chief executive officer of Ardelyx. "We continue to believe tenapanor represents an important, first-in-class treatment option for patients with elevated phosphorus. We do not agree with the FDA's subjective assessment on the clinical relevance of the treatment effect of tenapanor in our studies which met all clinical endpoints agreed upon by the FDA. In our view, the serum phosphorus lowering data generated with tenapanor in all of our clinical studies is meaningful and clinically significant. We will work with the agency to address the issues raised and, to the extent possible, find an expeditious path forward."

    Arnold Silva, M.D., Ph.D., director of Clinical Research at Boise Kidney and Hypertension Institute, added, "Lowering serum phosphorus is a priority for me in managing my patients on dialysis, and is an established standard of care driven by the peer-reviewed globally accepted KDIGO clinical practice guidelines. Years of research have demonstrated the negative consequences associated with even slight elevations in serum phosphorus. Despite our best efforts with currently available therapies, managing phosphorus remains a significant challenge. We need new tools. I've closely followed the extensive clinical development of tenapanor, not only as an interested nephrologist, but also as a clinical investigator. I've seen the clinical benefits of tenapanor first-hand in my patients and I'm stunned that the FDA is not granting approval of this novel mechanism drug, despite extensive clinical data demonstrating its safety and efficacy."

    "Neither peritoneal nor hemodialysis provides adequate control of serum phosphorus, obligating the use of medications," said Glenn Chertow, M.D., M.P.H., division chief of nephrology and professor of medicine at Stanford University. "Unfortunately, phosphate binders – individually or in combination – rarely yield consistent control of serum phosphorus concentrations, and persistent hyperphosphatemia leads to dystrophic calcification, accelerated arteriosclerotic vascular disease, fractures, and other complications that profoundly affect patients' lives. The effect of tenapanor on serum phosphorus observed in the Phase 3 trials is clinically meaningful. Tenapanor would enable a substantially larger fraction of patients to reach target serum phosphorus concentrations and would yield significant clinical benefit to this vulnerable population."

    The NDA for tenapanor for the control of serum phosphorus is supported by a comprehensive development program involving more than 1,000 patients and included three Phase 3 clinical trials, all of which met their primary and key secondary endpoints.  

    At the end of the second quarter ended June 30, 2021, Ardelyx had $171.8 million in cash and cash equivalents (unaudited).

    Conference Call Details

    The company will host a conference call today, July 29, 2021, at 5:00 PM ET to discuss today's announcement. To participate in the conference call, please call (855) 296-9612 (toll-free) or (920) 663-6277 (toll) and reference call ID number 6823689. A webcast of the call can also be accessed by visiting the Investor page of the company's website www.ardelyx.com and will be available on the website for 30 days following the call.

    About Ardelyx, Inc.

    Ardelyx is focused on discovering, developing and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is developing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.

    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 Ardelyx's expectation with regard to its interactions and communications with the FDA and its plans and expectations as to the possibility of a pathway to approval of tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease patients on dialysis. Such forward-looking statements involve substantial risks and uncertainties that could cause 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, whether the company will be able to address the deficiencies identified by the FDA, whether additional trials will be necessary and if so, the scope of those trials. 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 May 6, 2021, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

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  2. FREMONT, Calif. and WALTHAM, Mass., July 19, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that it received a letter from the U.S. Food and Drug Administration (the "FDA") on July 13, 2021, stating that, as part of its ongoing review of the company's New Drug Application ("NDA") for the control of serum phosphorus in adult patients with chronic kidney disease ("CKD") on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter stated that…

    FREMONT, Calif. and WALTHAM, Mass., July 19, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that it received a letter from the U.S. Food and Drug Administration (the "FDA") on July 13, 2021, stating that, as part of its ongoing review of the company's New Drug Application ("NDA") for the control of serum phosphorus in adult patients with chronic kidney disease ("CKD") on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter stated that the notification does not reflect a final decision on the information under review. The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied.    

    While the FDA has not provided specific details regarding the deficiencies, the FDA noted that a key issue is the size of the treatment effect and its clinical relevance. 

    "This is an extremely disheartening and disappointing communication from the FDA, particularly following the weeks of label discussions that occurred in early April, the fact that our NDA submission included three pivotal trials across 1,000 patients, all which met their primary and key secondary endpoints, as well as the additional data analyses we submitted in late April in response to the FDA's requests," said Mike Raab, president and chief executive officer of Ardelyx. "We plan to work with the FDA to learn more about the identified deficiencies and will seek to resolve them as quickly as possible."      

    About Ardelyx, Inc.

    Ardelyx is focused on discovering, developing, and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company submitted an NDA to the FDA in June 2020. In April 2021, the FDA extended the PDUFA date to July 29, 2021, following the submission of additional analyses determined to be a major amendment. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD.  In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.

    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 company's expectations with regard to its interactions and communications with the FDA and its plans and expectations as to the path forward for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease patients on dialysis. Such forward-looking statements involve substantial risks and uncertainties that could cause 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, whether the company will be able to address the deficiencies identified by the FDA and obtain regulatory approval for tenapanor. 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 May 6, 2021, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

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  3. FREMONT, Calif. and WALTHAM, June 7, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced two presentations highlighting new tenapanor data at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress 2021, taking place June 5-8, 2021.

    Interim data from the company's ongoing OPTIMIZE study shows that tenapanor can play a central role across the hyperphosphatemia treatment paradigm in adult patients with chronic kidney disease on dialysis, enabling greater achievement of phosphorus targets in binder-treated patients with phosphorus >5.5 and control of serum phosphorus in binder-naïve patients.

    In a separate presentation, the company reported that patients who were on tenapanor had a smaller percentage of deaths and hospitalizations than those on the phosphate binder, sevelamer, in the long-term Phase 3 PHREEDOM study. 

    "Our OPTIMIZE study was designed to evaluate multiple methods for integrating the novel blocking mechanism of tenapanor into the hyperphosphatemia treatment paradigm with the goal of increasing the proportion of patients able to achieve target phosphorus levels," said David Rosenbaum, Ph.D. chief development officer. "We are extremely pleased with the interim results demonstrating that tenapanor use resulted in approximately 50% of previously uncontrolled patients achieving target phosphorus levels when either switched to tenapanor monotherapy or with the addition of tenapanor with a concurrent reduction in binder dose. The interim results also demonstrated that two-thirds of binder-naïve patients who started on tenapanor monotherapy were able to achieve and/or maintain target phosphorus levels."

    Dr. Steven Fishbane, Chief of Nephrology, Northwell Health and Professor of Medicine, Zucker School of Medicine, commented "I am excited by these results that demonstrate both binder-treated and binder-naïve patients may be better able to achieve target phosphorus levels by applying a blocking mechanism approach as an integral component to hyperphosphatemia management, reflecting the important role of tenapanor across a broad range of patients and treatment regimen scenarios."

    Ardelyx Presentations at ERA-EDTA

    Abstract Title: A Randomized, Open-Label Study to Evaluate Potential Real-World Use of Tenapanor as the Core Therapy in the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis (OPTIMIZE)

    Authors: Steven Fishbane, David P. Rosenbaum, Yang Yang, Stuart Sprague, Robert I Lynn, Geoff Block, Arnold Silva, Daniel Weiner, George Fadda, Pablo Pergola

    Session Title: Late Breaking Clinical Trials

    Format: Mini Oral Presentation (available June 5th, 8:00AM CET)

    OPTIMIZE Oral Presentation

    As of the interim analysis, 232 patients had been randomized in the OPTIMIZE study to Cohort 1 (straight switch to tenapanor from binder, n=116) or Cohort 2 (start tenapanor and reduce binder dose by 50%, n=116) and 27 binder naïve individuals had been enrolled into Cohort 3 and started on tenapanor. Among participants that had completed 8 weeks of treatment, 47.7% in Cohort 1, 47.8% in Cohort 2 achieved, and 66.7% in Cohort 3 achieved and/or maintained recommended serum phosphorus (s-P) levels ≤ 5.5 mg/dL at week 8. Furthermore, subgroup analyses on randomized participants in Cohort 1 and Cohort 2 demonstrated that 53.3% of participants with a baseline s-P > 5.5 and ≤ 6.5 mg/dL, 51.7% of participants with a baseline s-P > 6.5 and ≤ 7.5, and 38.7% of participants with a baseline s-P > 7.5 mg/dL achieved an s-P ≤ 5.5 mg/dL at week 8. Diarrhea, the most common adverse event in this study, was reported with an incidence rate of 29.3% in Cohort 1, 36.2% in Cohort 2, and 14.8% in Cohort 3. Five participants (1.9%), none from Cohort 3, experienced diarrhea that led to study drug discontinuation. 

    Abstract Title: Long-Term Safety of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis

    Authors: Daniel Weiner, Robert I Lynn, Steven Fishbane, Yang Yang, David P. Rosenbaum,

    Session Title: Bones & Outcomes in CKD

    Format: Oral Presentation (June 7th, 12:00-12:15PM CET)

    PHREEDOM Oral Presentation

    The 52-week PHREEDOM study consisted of a 26-week, open-label, randomized treatment period with a 12-week placebo-controlled randomized withdrawal period, followed by a 14-week open label safety extension period.

    Maintenance dialysis patients with serum phosphorus ≥ 6.0 mg/dL and a 1.5 mg/dL increase in serum phosphorus following phosphate binder washout were randomized 3:1 to receive tenapanor 30 mg twice daily or sevelamer carbonate, dosed per package insert. Sevelamer was used as a safety control for comparisons of serious adverse events/hospitalizations.  Comparing patients who only received tenapanor versus those who only received sevelamer, the data demonstrated a lower overall incidence of death (3.1% versus 3.6%) as well as serious adverse events leading to hospitalization (22.5% versus 35.8%) and a shorter mean duration of hospitalization (11.5 days versus 13.5 days) in patients treated with tenapanor (n=293) compared to sevelamer (n=137), respectively.

    About OPTIMIZE

    OPTIMIZE is a randomized, open label study, which will include approximately 330 patients with chronic kidney disease (CKD) on dialysis with hyperphosphatemia. The study is designed to evaluate different methods of initiating tenapanor therapy across the hyperphosphatemia treatment paradigm to optimize phosphorus management in both binder-naïve and binder-treated patients.  The objective is to evaluate the ability of tenapanor, with its novel blocking mechanism, administered as core therapy for the treatment of hyperphosphatemia in adult patients with CKD on dialysis, alone or in combination with phosphate binders, to achieve target serum phosphorus (s-P) levels ≤5.5 mg/dL. Patients with s-P >5.5 and ≤10.0 mg/dL during stable phosphate binder treatment are being randomized into in a 1:1 ratio to two different treatment cohorts: Cohort 1, a straight switch approach is used where current phosphate binder treatment is discontinued and patients are switched to tenapanor 30 mg twice daily (BID) or Cohort 2 (50% binder reduction), where current phosphate binder dose is reduced by at least 50% and tenapanor therapy is initiated at 30 mg BID.  After week 2, investigators can adjust phosphate binder dose to achieve a s-P level of ≤5.5 mg/dL with tenapanor as the core therapy and binders as adjunctive. A third cohort comprised of phosphate binder naïve patients with s-P >4.5 and ≤10.0 mg/dL (Cohort 3) were enrolled and initiated tenapanor 30 mg BID.

    About PHREEDOM

    PHREEDOM is a one-year Phase 3 study with a 26-week open-label treatment period, a 12-week double-blind, placebo-controlled randomized withdrawal period, and a 14-week open-label safety extension period. The study randomized a total of 564 patients with CKD on dialysis who had a serum phosphorus level between 6.0 mg/dL and 10.0 mg/dL and had an increase in serum phosphorus of at least 1.5 mg/dL after an up to 3-week phosphate binder wash-out period. Patients were randomized 3:1 to either the tenapanor arm (n=423, n=408 intent to treat) or the active safety control arm (sevelamer n=141). Patients randomized to the active safety control arm were treated with sevelamer for 52 weeks. Patients in the tenapanor arm received tenapanor twice daily at a starting dose of 30 mg with dose adjustments allowed based on serum phosphorus level and gastrointestinal tolerability. At the end of the 26-week treatment period, patients in the tenapanor arm were randomized 1:1 to enter the randomized withdrawal period and either remain on the tenapanor dose they were taking or receive placebo. After the randomized withdrawal period, patients continued on the study for an additional three months as part of the long-term safety extension. Patients in the active safety control arm received sevelamer at an initial dose based on its package insert with dose changes allowed at the discretion of the principal investigator for up to one year.

    The primary efficacy endpoint of the study was the difference in change in serum phosphorus between the pooled tenapanor-treated patients and placebo-treated patients in the efficacy analysis set from the end of the 26-week treatment period to the endpoint visit of the 12-week randomized withdrawal period. The efficacy analysis set (n=131) included patients who completed the 26-week treatment period and achieved a 1.2 mg/dL decrease in serum phosphorus in the same period.

    About Hyperphosphatemia

    Hyperphosphatemia is a serious condition resulting in an abnormally elevated level of phosphorus in the blood that is estimated to affect the vast majority of the 550,000 patients in the United States with CKD on dialysis. The kidney is the organ responsible for regulating phosphorus levels, but when kidney function is significantly impaired, phosphorus is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on dialysis with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL).

    About Ardelyx, Inc.

    Ardelyx is focused on discovering, developing, and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company's NDA is currently under review by the FDA, with a PDUFA date of July 29, 2021. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.

    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 potential for CKD patients on dialysis to achieve target phosphorus levels with the use of tenapanor alone or in combination with phosphate binders. Such forward-looking statements involve substantial risks and uncertainties that could cause 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 associated with the clinical development and 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 May 6, 2021, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

     

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  4. FREMONT, Calif. and WALTHAM, Mass., May 25, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that Mike Raab, president and chief executive officer of Ardelyx, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 3:30 p.m. ET.  

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 60 days following the conference.

    About Ardelyx, Inc.

    Ardelyx is focused on discovering, developing and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company's NDA is currently under review by the FDA. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2020. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.

     

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  5. FREMONT, Calif. and WALTHAM, Mass., May 6, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today reported business highlights and financial results for the first quarter ended March 31, 2021.

    "We continue to prepare for the potential approval and launch of tenapanor following the recent extension of our PDUFA date to July 29, 2021," said Mike Raab, president and chief executive officer of Ardelyx. "We remain confident in the comprehensive data included in our New Drug Application and believe tenapanor represents an attractive alternative to currently available therapies to control serum phosphorus in CKD patients on dialysis. To that end, we are committed to working with the FDA through the completion of its review of our NDA and look forward to the possibility of making a significant impact in the lives of patients."

    Recent Business and Pipeline Updates

    • Prescription Drug User Fee Act (PDUFA) date for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis was extended by three months to July 29, 2021.
    • Received a $5 million milestone payment in April 2021 from the company's collaboration partner, Kyowa Kirin Co., Ltd. (KKC) following KKC's initiation of four Phase 3 clinical studies of tenapanor for hyperphosphatemia patients on dialysis in Japan.
    • Appointed industry veteran, Muna Bhanji, R.Ph., to the company's board of directors.
    • Presented two posters: 1) the mechanistic understanding of phosphate absorption and 2) continuing education needs of clinicians managing hyperphosphatemia, at the National Kidney Foundation 2021 Spring Clinical Meeting.
    • Presented poster titled: A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination with Sevelamer to Achieve Normal Serum Phosphorus in Patients with CKD on Dialysis (NORMALIZE) at the ISN World Congress of Nephrology 2021.

    First Quarter 2021 Financial Results

    • Cash Position: As of March 31, 2021, Ardelyx had total cash, cash equivalents and short-term investments of $178.2 million, as compared to total cash, cash equivalents and short-term investments of $188.6 million as of December 31, 2021.
    • Revenue: The company generated $6.6 million in revenue, which primarily represents a $5.0 million milestone from KKC following its initiation of four Phase 3 clinical studies of tenapanor for hyperphosphatemia patients on dialysis in Japan.
    • R&D Expenses: Research and development expenses were $20.5 million for the three months ended March 31, 2021, an increase of $4.6 million, or 29 percent, compared to $15.8 million for the three months ended March 31, 2020. The increase was due primarily to clinical study costs from the advancement of the company's OPTIMIZE study which were partially offset by lower costs for the PHREEDOM clinical study, as well as higher employee-related expenses for the research and development workforce.
    • G&A Expenses: General and administrative expenses were $17.1 million for the three months ended March 31, 2021, an increase of $10.0 million, or 140 percent, compared to $7.1 million for the three months ended March 31, 2020. The increase in general and administrative expenses was primarily due to an increase in costs associated with building and staffing the company's commercial infrastructure as it prepares for the anticipated U.S. launch of tenapanor for the control of serum phosphorus in CKD patients on dialysis.
    • Net Loss: Net loss for the quarter ended March 31, 2021 was $33.2 million, as compared to $22.4 million for the quarter ended March 31, 2020.

    About Ardelyx, Inc.

    Ardelyx is focused on discovering, developing and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company's NDA is currently under review by the FDA. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2020. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.

    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 potential for tenapanor to be approved for marketing by the FDA for the control of serum phosphorus in chronic kidney disease patients on dialysis. Such forward-looking statements involve substantial risks and uncertainties that could cause 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 associated with 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 May 6, 2021, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

     

     

    Ardelyx, Inc.

    Condensed Balance Sheets

    (In thousands)

     



    March 31, 2021



    December 31, 2020



    (Unaudited)



    (1)

    Assets







    Cash and cash equivalents

    $

    84,070



    $

    91,032

    Investments

    94,142



    97,566

    Accounts receivable

    5,783



    Property and equipment, net

    2,292



    1,936

    Right-of-use assets

    1,667



    2,274

    Prepaid and other assets

    22,339



    8,754

    Total assets

    $

    210,293



    $

    201,562









    Liabilities and stockholders' equity







    Accounts payable

    $

    5,378



    $

    5,626

    Accrued compensation and benefits

    4,348



    5,672

    Current portion of operating lease liability

    1,412



    2,117

    Loan payable, current portion

    16,667



    4,167

    Deferred revenue

    5,670



    4,177

    Accrued expenses and other liabilities

    11,262



    6,657

    Operating lease liability, net of current portion

    397



    413

    Loan payable, net of current portion

    34,348



    46,621

    Stockholders' equity

    130,811



    126,112

    Total liabilities and stockholders' equity

    $

    210,293



    $

    201,562

















    (1) Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2020.



     

     

    Ardelyx, Inc.

    Condensed Statements of Operations

    (Unaudited)

    (In thousands, except share and per share amounts)

     



    Three Months Ended March 31,



    2021



    2020

    Revenues:







    Collaborative development revenue

    $

    1,454



    $

    1,175

    Product supply revenue

    126



    38

    Licensing revenue

    5,002



    Total revenues

    6,582



    1,213

    Operating expenses:







    Cost of revenue

    1,000



    Research and development

    20,456



    15,844

    General and administrative

    17,131



    7,138

    Total operating expenses

    38,587



    22,982

    Loss from operations

    (32,005)





    (21,769)



    Interest expense

    (1,100)





    (1,357)



    Other income (expense), net

    (49)



    753

    Loss before provision for income taxes

    (33,154)





    (22,373)

    Provision for income taxes

    $

    1





    $



    Net loss

    $

    (33,155)





    $

    (22,373)



    Net loss per common share, basic and diluted

    $

    (0.34)



    $

    (0.25)

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

    97,179,241



    88,880,658

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ardelyx-reports-first-quarter-2021-financial-results-and-recent-business-highlights-301285361.html

    SOURCE Ardelyx

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