– Non-dilutive capital extends cash trail to further support launch of IBSRELA® (tenapanor)
WALTHAM, Mass., February 24, 2022 /PRNewswire/ — Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize first-in-class, innovative medicines that address significant unmet medical needs, today announced have entered into a debt financing agreement with investment affiliates managed by SLR Capital Partners (“SLR”).
“We are pleased to enter into this agreement with SLR for non-dilutive capital ahead of an important catalyst for the company this year, namely the launch and commercialization of IBSRELA for the treatment of irritable bowel syndrome with constipation in adults” , said justin renz, Chief Financial Officer of Ardelyx. “This financing further strengthens our balance sheet and extends our cash runway providing operational flexibility to further support the launch of IBSRELA.”
“SLR is delighted to be a long-term partner with Ardelyx as they launch and commercialize IBSRELA,” said Anthony Storin, Head of Life Science Finance at SLR. “We are delighted to partner with Ardelyx during this important period of transition to a commercial company, and this significant capital commitment represents this belief and our commitment to financing life science companies at all stages of development.
The loan agreement provides for a senior secured term loan facility with a maturity date of March 1, 2027 and an interest-only period up to March 2024. Under the loan agreement, $27.5 million was drawn at closing and will be used by the company to repay in full the 2018 term loan agreement with Solar Capital Ltd. and Western Alliance, under which the interest only period had expired. Ardelyx can also borrow an additional amount $22.5 million under new facility with SLR on or before July 25, 2023; provided that the company has received approval from the United States Food and Drug Administration (“FDA”) for its New Drug Application (“NDA”) for tenapanor for the control of serum phosphorus in adult patients with chronic renal failure (CKD) on dialysis on or before December 31, 2022, and that the company has achieved certain product revenue milestones. The term loan has an interest rate of 7.95% plus 30-day LIBOR. Additional information regarding the transaction may be found in the company’s filing with the Securities and Exchange Commission (“SEC”) at February 24, 2022and in its future current and periodic reports to be filed with the SEC.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
IBSRELA is contraindicated in patients under 6 years of age; in nonclinical studies in young juvenile rats, administration of tenapanor caused deaths presumed to be due to dehydration. Avoid the use of IBSRELA in patients aged 6 years to less than 12 years. The safety and efficacy of IBSRELA have not been established in patients under 18 years of age.
IBSRELA is contraindicated in patients under 6 years of age due to the risk of severe dehydration.
IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
WARNINGS AND PRECAUTIONS
Risk of severe dehydration in pediatric patients
IBSRELA is contraindicated in patients under 6 years of age. The safety and efficacy of IBSRELA in patients under 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent less than 2 years), decreased body weight and death occurred, presumably due to dehydration, after oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent of 2 years to less than 12 years).
Avoid the use of IBSRELA in patients aged 6 years to less than 12 years. Although there are no data in older juvenile rats, considering deaths in younger rats and lack of clinical data on safety and efficacy in pediatric patients, avoid use of IBSRELA in patients aged 6 to less than 12 years.
Diarrhea was the most common adverse effect in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of patients treated with IBSRELA. In case of severe diarrhoea, suspend administration and rehydrate the patient.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in patients treated with IBSRELA (incidence ≥2% and greater than placebo) were: diarrhea (16% versus 4% for placebo), abdominal distension (3% versus
IBSRELA (tenapanor) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
Please see full Prescribing Informationincluding boxed warning, for additional hazard information.
About Ardelyx, Inc.
Ardelyx was founded with the mission to discover, develop and commercialize first-in-class, innovative medicines that address significant unmet medical needs. Ardelyx has received approval for IBSRELA (tenapanor) with launch plans in the second quarter of 2022. Ardelyx is developing XPHOZAH (tenapanor), a new product candidate to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, which has three successful phase 3 trials. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of hyperkalemia, or hyperkalemia, a problem in some patients with kidney and/or heart disease and has an early stage program in metabolic acidosis, severe electrolyte disturbance in patients with CKD. Ardelyx has entered into agreements with Kyowa Kirin in JapanFosun Pharma at China and Knight Therapeutics at Canada for the development and commercialization of tenapanor in their respective territories.
About SLR Capital Partners
SLR Capital Partners, LLC (“SLR Capital Partners”) is an SEC-registered investment adviser that invests primarily directly in leveraged middle-market U.S. companies in the form of cash flow and guaranteed investments of Tier 1 asset-based. SLR Capital Partners manages over $8 billion of investable capital, including as investment advisor to two publicly traded business development companies, SLR Investment Corp. , diagnostics, health informatics and health services, both private and public venture-backed, and from pre-revenue clinical to early commercial stage. For more information, please visit:
To the extent that the statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting management’s current beliefs and expectations made pursuant to safe harbor law. Private Securities Reform Act of 1995, including statements of Ardelyx plans to launch IBSRELA in Q2 2022; and Ardelyx’s expectations regarding the impact that the execution of a new loan and guarantee agreement with SLR will have on Ardelyx’s cash position. These forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx’s future results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, the uncertainties associated with the commercialization of drugs. Ardelyx assumes no obligation to update or revise any forward-looking statements. For a more detailed 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 related to Ardelyx’s business generally, please refer to Ardelyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2021and its future current and periodic reports to be filed with the Securities and Exchange Commission.
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