NASDAQ: UNCY

Novel Treatments for Kidney Disease

Company Presentation

October 2023

Forward Looking Statements

This presentation contains certain "forward-looking" statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical or present facts, are forward-looking statements, including statements regarding our future financial condition, future revenues, projected costs, prospects, business strategy, and plans and objectives of management for future operations, including our plans to submit for regulatory filings. In some cases, you can identify forward-looking statements by terminology such as "believe," "will," "may," "might," "estimate," "continue," "anticipate," "intend," "target," "project," "model," "should," "would," "plan," "expect," "predict," "could," "seek," "goal," "potential," or the negative of these terms or other similar terms or expressions that concern our expectations, strategy, plans, or intentions. These statements are based on our intentions, beliefs, projections, outlook, analyses, or current expectations using currently available information, and are not guarantees of future performance, and involve certain risks and uncertainties. Although we believe that the expectations reflected in these forward- looking statements are reasonable, we cannot assure you that our expectations will prove to be correct. Therefore, actual outcomes and results could materially differ from what is expressed, implied, or forecasted in these statements. Any differences could be caused by a number of factors including but not limited to: our expectations regarding the timing, costs, conduct, and outcome of our clinical trials, including statements regarding the timing of the initiation and availability of data from such trials; the timing and likelihood of regulatory filings and approvals for our product candidates; whether regulatory authorities determine that additional trials or data are necessary in order to obtain approval; our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates; our plans to research, develop, and commercialize our product candidates; the commercialization of our product candidates, if approved; the rate and degree of market acceptance of our product candidates; our expectations regarding the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the potential market opportunities for commercializing our product candidates; the success of competing therapies that are or may become available; our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; the ability to license additional intellectual property relating to our product candidates and to comply with our existing license agreements; our ability to maintain and establish relationships with third parties, such as contract research organizations, suppliers, and distributors; our ability to maintain and establish collaborators with development, regulatory, and commercialization expertise; our ability to attract and retain key scientific or management personnel; our ability to grow our organization and increase the size of our facilities to meet our anticipated growth; the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; our expectations related to the use of our available cash; our ability to develop, acquire, and advance product candidates into, and successfully complete, clinical trials; the initiation, timing, progress, and results of future preclinical studies and developments and projections relating to our competitors and our industry.

Additional factors that could cause actual results to differ materially from our expectations can be found in our Securities and Exchange Commission filings. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the effects of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. All forward-looking statements included in this presentation are expressly qualified in their entirety by these cautionary statements. The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any

forward-looking statements, whether as a result of new information, future events, or otherwise.

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Investment Highlights

Addressing unmet patient needs and large markets within kidney disease

  • Hyperphosphatemic Chronic Kidney Disease (CKD) patients live with extreme treatment burden
  • Acute Kidney Injury (AKI) patients live without any approved medication

Unique product candidates with proven mechanisms of action

  • Oxylanthanum Carbonate (OLC) is an investigational phosphate binder candidate for the treatment of hyperphosphatemia in patients with CKD on dialysis
  • UNI-494is a novel mitochondrial-targeted treatment for AKI and CKD entered first-in-human Phase 1 trial in 2023

Our first product, OLC, is already blazing a positive pathway

  • Multiple meetings with FDA provide clear guidance to file NDA under expedited 505(b)(2) pathway
  • Positive bioequivalence study completed in healthy volunteers
  • Aligning with FDA on next steps; program update expected in the Fall 2023

Strong balance sheet to support OLC filing, launch and commercialization

  • Up to $130 million in long-term funding from top healthcare focused institutional investors with exercise of warrants based on achievement of defined milestones

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Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Chronic Kidney Disease (CKD) Patients on Dialysis

Oxylanthanum carbonate (OLC) is an unapproved investigational new drug being developed under FDA's 505(b)(2) regulatory pathway. If approved, OLC will share substantially the same product label and prescribing information as the reference-listed drug (RLD) Fosrenol (lanthanum carbonate) with the exception that OLC tablets are smaller in size and swallowed whole with water and not chewed

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Disclaimer

Unicycive Therapeutics Inc. published this content on 04 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 October 2023 17:55:13 UTC.