Unicycive Therapeutics : June 2024 Corporate Presentation

NASDAQ: UNCY

Novel Treatments for Kidney Disease

Company Presentation

June 2024

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 for clinical trials and 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.

The company obtained the industry, market and competitive position data used throughout this presentation from its own internal estimates and research, as well as from industry and general publications, and research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, the company's internal research and our industry experience, and are based on assumptions made by the company based on such data and its knowledge of the industry and market, which the company believes to be reasonable. In addition, while the company believes the industry, market and competitive position data included in this presentation is reliable and based on reasonable assumptions, the company has not independently verified any third- party information, and all such data involve risks and uncertainties and are subject to change based on various factors.

This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

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The Opportunity

• Lead program's pivotal trial readout expected in Q2 '24 with New Drug Application (NDA) filing expected mid-year 2024
• Near-termcommercial opportunity in a multibillion-dollar, unsatisfied market with potential to improve treatment paradigm
• Potential best-in-class product with de-risked path to approval and strong IP protection
• Seasoned management team with a winning track record in the market for their 1st product
• Anticipated favorable Medicare reimbursement offering unrestricted product access with unnegotiated pricing through a special TDAPA (transitional drug add-on payment adjustment) program
• Second pipeline program in clinical development for AKI with Orphan Drug Designation granted by the FDA

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Focused on Developing New Treatment Options for Renal Diseases

PROGRAM INDICATION PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA

OLC	Hyperphosphatemia	505(b)(2)
		Healthy volunteer BE study	Pivotal clinical study
		Completed	Ongoing

UNI-494 Acute Kidney Injury (AKI)

Phase 1 (in UK)

Ongoing

UNI-494 Chronic Kidney Disease (CKD)

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Kidney Disease Is a Major Public Health Concern

>500,000

Source: Chronic Kidney Disease Initiative, www.cdc.gov

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Expected Catalysts in 2024 and Beyond

OLC for Hyperphosphatemia

• Successful bioequivalence study in healthy volunteers
• FDA alignment on regulatory path
• Completed enrollment in pivotal clinical trial
• Oral and Poster presentations at NKF & ERA (Q2 '24)

• Pivotal trial readout (Q2 '24)
• NDA Filing (mid-year '24)
• Buildout of commercial infrastructure
• FDA Approval (mid-year '25 )
• TDAPA Designation (6 months post approval)

UNI-494 for Acute Kidney Injury

• Initiated Phase 1 clinical trial
• Orphan Drug Designation granted for the prevention of Delayed Graft Function in kidney transplant patients
• Oral and poster presentations at AKI and CRRT (Q1 '24)
• Oral presentations at ERA (Q2 '24)

• Phase 1 study completion (2024)
• Advance to Phase 2 POC Study (2024/2025)

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Broad Support from Prominent Healthcare Investors

• Recent $50 Million private placement funds planned operations into 2026
• Additional $100 Million in committed capital in 3 tranches of warrants to support commercialization

Tranche & Amount	Trigger	Exercise Price	Conversion into Equivalent
Common Stock
Tranche A: $25 MM	FDA Approval	$0.54	47.9 million
Tranche B: $25 MM	TDAPA Designation	$0.59	43.5 million
Tranche C : $50MM	Four quarters of OLC Sales	$0.74	69.6 million
Cumulative Warrants (All Tranches)			161 million

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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

Oxylanthanum Carbonate (OLC) Product Profile

Overview

• Potential best-in-class product being developed under FDA's 505(b)(2) regulatory pathway for the treatment of hyperphosphatemia
• If approved, OLC is expected to share substantially the same product label and prescribing information as the reference-listed drug Fosrenol (lanthanum carbonate)
• OLC tablet advantage: (1) smaller in size and(2) are swallowed whole with water and not chewed

Proprietary Nanoparticle Technology

• UNICYCIVE has harnessed the phosphate binding potency of lanthanum to reduce the number and size of pills that patients must take to control hyperphosphatemia

• Enhanced surface area

•	Lower molecular weight	§	Enables smaller pills
•	Immediate release tablets	§	Pills are swallowed (not chewed)

Strong Global Intellectual Property

• A family of patents (including composition of matter) were filed in 2011 for the U.S with exclusivity until 2031
• Corresponding patents granted in Canada, Europe, Japan, China, Australia, and other countries with 2031 expiry

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