Unicycive Therapeutics, Inc. · NASDAQ:UNCY
Unicycive Therapeutics — Investor Presentation (October 2026)
33 slides from Unicycive Therapeutics's investor presentation, October 2026
Slide 1: Novel Treatments for Kidney Disease
NOVEL TREATMENTS FOR KIDNEY DISEASE Corporate Presentation October 2026
Slide 2: Forward Looking Statements
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 statement
Slide 3: Key Investment Highlights
Key Investment Highlights Corporate Overview OLC Opportunity OLC Launch Readiness o Diversified portfolio focused on o Hyperphosphatemia represents >$1B o Reimbursement landscape expands kidney disease US market opportunity OLC market opportunity o Potential best-in-class product profile • Lead asse
Slide 4: OLC NDA Resubmission Update
OLC NDA Resubmission Update OLC NDA resubmitted in September 2026 with CMC data from a new third-party drug product manufacturing vendor Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission If the original thi
Slide 5: Unicycive is Focused on Developing New Treatment Options for Kidney Diseases
Unicycive is Focused on Developing New Treatment Options for Kidney Diseases PIPELINE PROGRAM INDICATION PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVAL 505(b)(2) OLC Hyperphosphatemia OLC NDA Resubmitted September 2026 UNI-494 Acute Kidney Injury (AKI) UNI-494 Chronic Kidney Disease (CKD) 5
Slide 6: Oxylanthanum Carbonate (OLC)
LEAD PROGRAM 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 substanti
Slide 7: Hyperphosphatemia is a Large and Growing Market Opportunity
Hyperphosphatemia is a Large and Growing Market Opportunity 8 out of 10 US Dialysis Patients Receive WORLDWIDE SALES Phosphate Binders for Hyperphosphatemia 0.05 0.22 0.12 US EU/UK China 0.29 1.12 Japan LATAM 0.23 Canada ROW 0.43 >550,000 US dialysis patients in 2020 (3% growth rate) $2.5 Billion in
Slide 8: Uncontrolled Hyperphosphatemia is Strongly Associated with Increased Death and Hospitalization
Uncontrolled Hyperphosphatemia is Strongly Associated with Increased Death and Hospitalization DEATH HOSPITALIZATION Relative Risk of Hospitalization 2.25 1.50 ↑ >100% Relative Risk of Death 2.00 1.40 ↑ 38% All-Cause ↑ 29% 1.30 ↑ 28% 1.75 ↑ 67% Cardiovascular 1.20 1.50 ↑ 43% ↑ 15% ↑ 10% ↑ 25% 1.10 R
Slide 9: The Unmet Need in Hyperphosphatemia
The Unmet Need in Hyperphosphatemia Serum Phosphorus (3-month Average) <4.5 mg/dl 4.5-5.5 mg/dl >5.5 mg/dl Despite the 100% availability of 6 90% Fail to achieve US KDOQI guideline target FDA-approved 80% (<5.5 mg/dl) 70% 44% phosphate 60% binders, a large 50% Fail to achieve international KDIGO gui
Slide 10: Addressing the Problem of Excessive Pill Burden
Addressing the Problem of Excessive Pill Burden Distribution of Dialysis Patient Daily Pill Burden Daily pill burden for maintenance dialysis patients is among the highest across various chronic disease states including Contribution from phosphate binders HIV/AIDS, diabetes mellitus, and congestive
Slide 11: Oxylanthanum Carbonate (OLC) Product Profile
Oxylanthanum Carbonate (OLC) Product Profile Overview Proprietary Nanoparticle Technology Potential best-in-class product being developed under FDA’s UNICYCIVE has harnessed the phosphate binding potency of 505(b)(2) regulatory pathway for the treatment of lanthanum to reduce the number and size of
Slide 12: Recommended Daily Starting Dose for Phosphate Binders
Recommended Daily Starting Dose for Phosphate Binders Renvela® Oxylanthanum Carbonate (OLC)* Phoslo® MOST PRESCRIBED sevelamer carbonate 800 mg 500 mg calcium acetate 667 mg 2 tablets 3 times per day, swallowed 1 tablet 3 times per day, swallowed 2 tablets 3 times per day, swallowed Volume: 6.5 cm3
Slide 13: OLC Clinical Data
NASDAQ: UNCY OLC Clinical Data
Slide 14: Pivotal Study Demonstrated Safety & Tolerability of OLC
Pivotal Study Demonstrated Safety & Tolerability of OLC Study objective to evaluate the safety & tolerability of clinically effective doses (serum phosphate ≤5.5 mg/dL) of OLC in CKD patients on dialysis Treatment-Related Adverse Events in ≥5% Patients Safety • No treatment-related Serious Adverse E
Slide 15: Adverse Event Profiles of Phosphate Lowering Therapies from FDA-Approved Product Labels
Adverse Event (AE) Profiles of Phosphate Lowering Therapies from FDA-Approved Product Labels Fosrenol Renvela Phoslo Velphoro Auryxia Xphozah Lanthanum carbonate Sevelamer carbonate Calcium acetate Sucroferric oxyhydroxide Ferric citrate tenapanor Nausea 11% Vomiting 22% Hypercalcemia 13-16% Diarrhe
Slide 16: OLC Pivotal Study - Serum Phosphate Control
OLC Pivotal Study - Serum Phosphate Control 100 91% Percent of Patients 80 59% 60 41% 40 20 9% 0 Screening Baseline End of Titration Baseline – Serum phosphate levels at screening before washout 78 patients entered maintenance of which 71 patients achieved P control; 71/78=91% Source: Block GA, Cher
Slide 17: OLC Pivotal Study - Phosphate Control and Effective Dose in Evaluable Population
OLC Pivotal Study - Phosphate Control and Effective Dose in Evaluable Population (n=71) 69% Of the 71 evaluable patients, 60 54% 69% achieved a target serum phosphate level of Percent Of Patients ≤5.5 mg/dL at an OLC dose of ≤1500 mg/day or less 40 OLC oxylanthanum carbonate 1,500 mg 17% 20 14% 9% 6
Slide 18: Patients Preferred OLC Over Their Prior Phosphate Binder Therapy
Patients Preferred OLC Over Their Prior Phosphate Binder Therapy in Pivotal Clinical Trial*† 79% of patients preferred OLC over 98% of patients said OLC was easy to 89% of patients were satisfied with their current medication take vs 55% with current medication OLC vs 49% with current medication Pre
Slide 19: OLC Commercial Strategy
NASDAQ: UNCY OLC Commercial Strategy
Slide 20: Hyperphosphatemia is a Large and Growing Market Opportunity in the U.S.
Hyperphosphatemia is a Large and Growing Market Opportunity in the U.S. o Nearly 450K dialysis patients in the US require phosphate management >550,000 US dialysis patients therapies, representing a market opportunity of over $1 billion o 75% of the patients that take these drugs do not achieve phos
Slide 21: OLC: Innovative Dose Formulation May Offer an Attractive New Treatment Option for Patients
OLC: Innovative Dose Formulation May Offer an Attractive New Treatment Option for Patients Nanoparticle technology One swallowed pill taken at each Lower pill burden may harnesses high phosphate meal may offer patients a facilitate treatment binding capacity of lanthanum, substantial reduction in da
Slide 22: Optimize patient access across all reimbursement settings
Unicycive’s goal is to optimize patient access across all reimbursement settings Medicare Non-Medicare Reimbursement Reimbursement 64% of patients 36% of patients Contract with dialysis Provide dedicated access and organizations to gain access to reimbursement support treatment protocols for Medicar
Slide 23: Payer Mix and TDAPA Pathway Support OLC Commercial Launch
Payer Mix and TDAPA Pathway Support OLC Commercial Launch Branded PLT’s Payer Mix1 o Plan to apply for separate Medicare Separate TDAPA payment Fee For Service reimbursement through CMS TDAPA 32% to DOs @ 100% of ASP CHNGE (Part B) program BUNDLED o TDAPA was established to ensure access to innovati
Slide 24: Medicare Reimbursement Dynamics Benefit OLC Launch
Medicare Reimbursement Dynamics Benefit OLC Launch OLC is expected to be only phosphate-lowering therapy with TDAPA designation PRE-TDAPA Period TDAPA 2-year PERIOD POST-TDAPA 3-year PERIOD After POST TDAPA Period WAC Price 100% ASP 65% ASP Drive broad awareness, trial, and Rapid adoption of OLC dri
Slide 25: Concentrated Prescriber Universe Can Be Addressed with Small, Targeted Salesforce
Concentrated Prescriber Universe Can Be Addressed with Small, Targeted Salesforce Half of all Rx’s (deciles 6-10) written by only 2,100 readily-targeted prescribers Deciles Prescribers 10 159 2023 Phosphate Lowering 9 304 Therapies TRx’s 8 425 ~2.2 M (220K/Decile) 7 543 6 684 5 882 4 1,187 3 1,919 2
Slide 26: Oxylanthanum Carbonate (OLC) IP Status
Oxylanthanum Carbonate (OLC) IP Status Strong Global Intellectual Property 01 02 03 A family of patents (incl. Corresponding patents granted Potential patent term composition of matter) were in Canada, Europe, Japan, extension through 2035 filed in 2011 for the U.S with China, Australia, and other e
Slide 27: Anticipated Future Catalysts in 2026 and Beyond
Anticipated Future Catalysts in 2026 and Beyond OLC Approval & Launch UNI-494 for Acute Kidney Injury ✓ Resubmit OLC NDA ✓ Orphan Drug Designation granted for the prevention of Delayed Graft Function in kidney transplant patients ❑ Receive new PDUFA date ❑ Execute on market-shaping and commercial re
Slide 28: Corporate Overview
secee THERAPEUTICS INC Corporate Overview
Slide 29: Seasoned Management Team With Winning Track Record in Hyperphosphatemia Market
Seasoned Management Team With Winning Track Record in Hyperphosphatemia Market Management Shalabh Gupta, MD John Townsend, CPA Doug Jermasek, MBA Pramod Gupta, PhD Guru Reddy, PhD Chief Executive Officer Chief Financial Officer EVP, Corporate Strategy EVP, Pharmaceutical & VP, Preclinical R&D NYU Me
Slide 30: Unicycive Directors & Advisors
Unicycive Directors & Advisors Board of Directors Sara Kenkare-Mitra, PhD Sandeep “Steve” Laumas, MD Meredith S. Manning, MBA Shalabh Gupta, MD Soleno Therapeutics, NYU Medical Center, Genentech, UBS, President & Head of R&D Alector Goldman Sachs, North Sound Capital PharmaEssentia, resTORbio Rodman
Slide 31: Financial Overview
Financial Overview Cash and Share Counts Supported by Prominent Healthcare Investors Unaudited Cash, $61.4 million Cash Equivalents, and (as of June 30, 2026) Short-term Investments $152.4 million Market Cap (as of August 12, 2026) Shares of Common 27.9 million Stock Outstanding common shares 31
Slide 32: Investor Relations
Investor Relations T: (650) 900-5470 | ir@unicycive.com
Slide 33: Potential Commercial Funding
Potential Commercial Funding Additional $102 Million in committed capital in three tranches of warrants to support commercialization Tranche & Amount Trigger Exercise Price Conversion into Equivalent Common Stock Tranche A: $24.3 MM FDA Approval 5.40 4.51 million Tranche B: $25.7 MM TDAPA Designatio
Unicycive Therapeutics — Investor Presentation (October 2026) on 6ix