Item 5. Other Information
ITEM 5. OTHER INFORMATION
Trading Plans
During the three months ended September 30, 2025, no director or Section 16 officer adopted or terminated any Rule 10b5-1 plans or non-Rule 10b5-1 trading arrangements.
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ITEM 6. EXHIBITS
Exhibit
Number Incorporated by Reference Filed
Herewith
Exhibit Description Form Date Number
3.1 Amended and Restated Certificate of Incorporation.
8-K 06/24/2024 3.1
3.2 Certificate of Amendment to Amended and Restated Certificate of Incorporation.
8-K 06/20/2023 3.1
3.3 Second Amended and Restated Bylaws.
8-K 08/04/2025 3.1
10.1#
Transition and Separation Agreement, dated August 1, 2025, by and between Ardelyx, Inc. and Justin Renz.
X
10.2#
Offer Letter, dated September 23, 2025, by and between Ardelyx, Inc. and Sue Hohenleitner.
X
10.3#
Offer Letter, dated June 29, 2025, by and between Ardelyx, Inc. and John Bishop.
X
10.4#
Offer Letter, dated May 29, 2025, by and between Ardelyx, Inc. and Edward Conner.
X
31.1 Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
31.2 Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1* Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
101 The following financial statements, formatted in Inline Extensible Business Reporting Language (XBRL): (i) Condensed Balance Sheets as of September 30, 2025 and December 31, 2024, (ii) Condensed Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2025 and 2024, (iii) Condensed Statements of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2025 and 2024, (iv) Condensed Statements of Cash Flows for the nine months ended September 30, 2025 and 2024, and (v) Notes to Unaudited Condensed Financial Statements.
X
104 Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. X
_______________________________
# Indicates management contract or compensatory plan.
*The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q, is deemed furnished and not filed with the SEC and is not to be incorporated by reference into any filing of Ardelyx, Inc. under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Ardelyx, Inc.
Date: October 30, 2025 By: /s/ Joseph Reilly
Joseph Reilly
Senior Vice President and Chief Accounting Officer
(Principal Accounting Officer)
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SUMMARY OF ABBREVIATED TERMS
Throughout this Quarterly Report on Form 10-Q, we have used terms which are defined below:
340B Program Public Health Service’s 340B Drug Pricing Program GTN gross-to-net
AAKP American Association of Kidney Patients HCR HealthCare Royalty Partners IV, L.P.
ACA Affordable Care Act HCR Agreement Royalty and Sales Milestone Interest Acquisition Agreement
AI Technologies
Artificial intelligence, machine learning and certain automated decision-making technologies
HHS Department of Health and Human Services
AMP average manufacturer price HIPAA Health Insurance Portability and Accountability Act of 1996, as amended, and regulations promulgated thereunder
ANDA abbreviated New Drug Application HRSA Health Resources and Services Administration
2024 Form 10-K
Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 20, 2025
IBS-C irritable bowel syndrome with constipation
API active pharmaceutical ingredient IND Investigational New Drug
AstraZeneca AstraZeneca AB IRA Inflation Reduction Act of 2022
ASU Accounting Standards Update IRB institutional review board
CCPA
California Consumer Privacy Act, as amended by the California Privacy Rights Act
Jefferies Jefferies, LLC
cGMP
current Good Manufacturing Practice
Kyowa Kirin
Kyowa Kirin Co., Ltd.
CKD chronic kidney disease Knight
Knight Therapeutics, Inc.
CME Chicago Mercantile Exchange MDRP Medicaid Drug Rebate Program
CMO contract manufacturing organization METiS METiS Therapeutics, Inc.
CMS Centers for Medicare & Medicaid Services MHLW Ministry of Health, Labour and Welfare
CRO contract research organization
MIPPA Medicare Improvements for Patients and
Providers Act
CODM
Chief Operating Decision Maker
OLC Oxylanthanum Carbonate
Customers
collectively, major wholesalers, specialty pharmacies and GPOs (IBSRELA) and specialty wholesaler (XPHOZAH)
NCE new chemical entity
DPF
EU-US Data Privacy Framework NDA New Drug Application
EEA European Economic Area NH3 sodium hydrogen exchange 3
ESPP Employee Stock Purchase Plan NMPA National Medical Products Administration
ESRD End-Stage Renal Disease NOL net operating loss
ESRD PPS End-Stage Renal Disease Prospective Payment System NMQF National Minority Quality Forum
EU Patent Package European Patent Package Non-FAMP Non-Federal Average Manufacturer Price
Exchange Act
the Securities Exchange Act of 1934, as amended
R&D research and development
FASB Financial Accounting Standards Board REMS Risk Evaluation and Mitigation Strategy
FDA Food and Drug Administration RSU restricted stock units
FFDCA Federal Food, Drug, and Cosmetic Act SLR SLR Investment Corp.
Fosun Pharma Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. SEC Securities and Exchange Commission
FSS Federal Supply Schedule SOFR
Secured Overnight Financing Rate
FTC
Federal Trade Commission
TDAPA Transitional Drug Add-on Payment Adjustment
GAAP
generally accepted accounting principles
UPC European Unified Patent Court
GCP Good Clinical Practice U.S. United States
GDPR European Union General Data Protection Regulation USPTO U.S. Patent and Trademark Office
GLP Good Laboratory Practice VA Department of Veterans Affairs
GPO group purchasing organization
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