Unicycive Therapeutics, Inc.

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Its lead investigational treatment is oxylanthanum carbonate*, a phosphate-binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. UNI-494 is being developed for conditions related to acute kidney injury (AKI) and has been granted Orphan Drug Designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.

Pipeline

Source: Company Documents

Cash Position

As of September 30, 2025, Unicycive had $42.7 million in cash and cash equivalents, providing runway into 2027.

*Oxylanthanum Carbonate (OLC) is an unapproved investigational drug being developed under the FDA’s 505(b)(2) regulatory pathway.

Oxylanthanum Carbonate (OLC)

Treating end-stage renal disease (ESRD) requires effective phosphate control, since elevated phosphorus levels can contribute to cardiovascular complications and other serious outcomes. Current phosphate binders often involve a burdensome number of large pills. Oxylanthanum carbonate* is being developed as a patient-friendly alternative that may significantly reduce pill burden for dialysis patients.

OLC is an investigational phosphate-binding agent formulated with proprietary nanoparticle technology. This technology increases the surface area of active drug, allowing more medication to be delivered in smaller tablets that can be swallowed whole. The goal is to make phosphate control easier for patients while maintaining therapeutic effectiveness.

In a clinical study of healthy volunteers, OLC was minimally absorbed, safe, and well tolerated at doses up to 6000 mg/day. The study also showed reductions in urinary phosphate excretion and increases in fecal phosphate excretion at doses at and above 3000 mg/day, supporting OLC’s potential to help manage hyperphosphatemia.

OLC Advantages

• Potency: Shares the high phosphate binding capacity of lanthanum

• Pill Burden: Smaller and fewer pills than current options

• Palatability: Swallowed whole with water—not chewed

Unicycive's proprietary nanoparticle technology enables these benefits through enhanced surface area, lower molecular weight, and immediate-release tablet formulation.

Regulatory Status

• OLC is being developed under the FDA’s 505(b)(2) regulatory pathway.

• The bioequivalence study comparing urinary phosphorus changes with Fosrenol was completed in Q4 2022.

• Unicycive submitted the NDA in August 2024, and the application was accepted by the FDA.

• The FDA issued a Complete Response Letter citing a single deficiency related to a third-party manufacturing vendor. A Type A meeting was held with FDA in late 2025 to discuss resolution.

• Unicycive resubmitted the NDA in late December 2025 following continued progress by the manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness.

• A new PDUFA date is expected in 1H 2026.

Key Features of OLC

• Enhanced surface area due to nanoparticle formulation

• Lower molecular weight

• Immediate-release tablets

• Smaller pills that are swallowed whole

• Potential for reduced pill burden

Intellectual Property

Unicycive holds issued U.S. and international patents protecting OLC, along with pending applications across major global markets.

*Oxylanthanum carbonate (OLC) is an unapproved investigational drug being developed under the FDA’s 505(b)(2) regulatory pathway.

UNI-494

Mitochondria play an important role in maintaining kidney cell health, particularly during periods of stress or injury. In acute kidney injury (AKI), mitochondrial dysfunction can impair energy production and contribute to the loss of kidney function. UNI-494 is being developed to help protect mitochondrial function and address AKI’s significant unmet medical need. There are currently no FDA-approved medicines to treat AKI, and severe cases can lead to long-term dialysis or kidney transplant.

UNI-494 is a novel investigational compound and a prodrug of nicorandil with improved properties and extended patent life. It is designed to support mitochondrial stability and help maintain cellular energy balance in the kidney. While AKI is the initial focus, Unicycive may explore potential follow-on development in chronic kidney disease (CKD).

Clinical and Regulatory Status

Unicycive has advanced UNI-494 through preclinical studies, manufactured clinical supplies, and received MHRA clearance in the United Kingdom to initiate a Phase 1 healthy volunteer study. UNI-494 completed a Phase 1 dose-ranging safety study in healthy volunteers in 2023. The FDA has granted Orphan Drug Designation for the prevention of Delayed Graft Function in kidney transplant patients, and the USPTO has granted a Method of Use patent.

Milestones Achieved

• Orphan Drug Designation granted for prevention of Delayed Graft Function in kidney transplant patients
• Method of Use patent granted by USPTO
• Phase 1 dose-ranging safety study in healthy volunteers completed

This communication is neither an offer to sell nor a solicitation of an offer to buy, nor a recommendation of any securities of the company mentioned herein.

Unicycive Therapeutics Inc (the “Company”) and its counsel have reviewed the content of this page as well as the accompanying presentation (“Company Presentation”) displayed on this page. To the best of its knowledge, the Company does not believe this content to be misleading or inaccurate in any material respect, nor does it believe there are any material omissions with respect to such content. The Company does not believe the contents of the page or the Company Presentation to contain any non-public material information.

Information and opinions presented in the Company Presentation are provided by the Company, and b2i Digital makes no representation as to their accuracy or completeness. The information contained on this page is not intended to constitute any form of advice, and the information provided is not intended to provide a sufficient basis on which to make an investment decision. It is not investment research, nor does it constitute a research recommendation, as it does not constitute substantive research or analysis. This information is not to be relied upon in substitution for the exercise of independent judgment. 

Information, opinions and estimates contained on this page or in the Company Presentation reflect judgments by the Company as of the original date of publication by the Company and are subject to change without notice. Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied is made regarding future performance.

A complete description of the risks and uncertainties relating to the Company and its securities can be found in the company's filings with the U.S. Securities and Exchange Commission available for free at www.sec.gov.

Information on this page may relate to penny stocks, which may also be referred to as low-priced stocks. Penny stocks are low-priced shares typically issued by small companies. Penny stocks involve greater than normal risk, they may be less liquid than other stocks (i.e., more difficult to sell), and there may be less reliable information available regarding such stocks. Investors in penny stocks should be prepared for the possibility that they may lose their entire investment.

B2i Digital or its related entities may own securities of the Company. Specifically, the CEO of B2i Digital owns 22,000 shares of unrestricted UNCY stock as of August 14, 2024.

To comply with Rule 17(b) of the Securities Act of 1933, as amended, B2i Digital must provide full disclosure of all compensation received for investor awareness services provided by the Company.

The Company is a client of B2i Digital. The Company agreed to pay B2i Digital no greater than $100,000 in cash for 12 months of digital marketing consulting and investor awareness services.