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Item 1. Business

2025-03-31 compared with 2024-03-28 · 1022 added, 871 removed, 635 unchanged (75% of the section changed)

We are a biotechnology company dedicated to developing treatments for

certain medical conditions.

Currently, two of our programs are focused on kidney disease, an area we believe we have the potential to

offer medical benefit.

As we grow the company and build our team, we intend to focus on identifying medical conditions within and outside

of kidney disease.

Our current development programs are focused on two novel therapies:

Oxylanthanum Carbonate, for treatment of hyperphosphatemia

in patients with chronic kidney disease on dialysis, and UNI 494, for treatment of acute kidney injury (AKI).

Oxylanthanum Carbonate and

UNI 494 were initially developed by and licensed to us from Spectrum Pharmaceuticals (“Spectrum”) and Sphaera Pharma, respectively.

Spectrum conducted a Phase 1 clinical trial with Oxylanthanum Carbonate in 2012, prior to the grant of our license in 2018.

Sphaera conceived

and performed initial characterization of various potential pro-drug linkers, including the initial patent application, and performed

some initial physiochemical characterization and preliminary animal pharmacokinetic studies.

As discussed herein, after completing IND

enabling preclinical studies, we have conducted a Phase I clinical study in healthy volunteers with UNI 494 in 2023.

We are a clinical-stage biotechnology company

focused on identifying, developing, and commercializing innovative therapies to address significant unmet medical needs, with an initial

focus on kidney disease.

Founded in 2016, Unicycive was established to create a streamlined and efficient drug development platform capable

of accelerating the advancement of promising therapies from discovery to commercialization.

Currently, our two programs are focused on

kidney disease, an area we believe we have the potential to offer medical benefit.

Our initial focus is on developing drugs and getting

them approved in the U.S., and then to partner with global biopharmaceutical companies in the rest of the world.

As we grow the company

and build our team, we intend to focus on identifying medical conditions within and outside of kidney disease.

Our business model is to

license technologies and drugs in order to pursue development, regulatory approval, and commercialization of those products in global

Many biotechnology companies utilize similar strategies of in-licensing and then developing and commercializing drugs.

however, that our management team’s broad network, expertise in the biopharmaceutical industry, and successful track record gives

us an advantage in identifying and bringing these assets into our company.

Our current development programs are focused on

two novel therapies:

Oxylanthanum Carbonate, a next-generation phosphate binder for the treatment of hyperphosphatemia in chronic kidney

disease patients on dialysis, and UNI-494, a novel drug candidate in development for the treatment of acute kidney injury.

Carbonate and UNI-494 were initially developed by and licensed to us from Spectrum Pharmaceuticals (“Spectrum”) and Sphaera

Pharma, respectively.

Spectrum conducted a Phase 1 clinical trial with Oxylanthanum Carbonate in 2012, prior to the grant of our license

Sphaera conceived and performed initial characterization of various potential pro-drug linkers, including the initial patent

As discussed herein, after completing IND enabling preclinical studies, we have completed a Phase I clinical study in healthy

volunteers with UNI-494 in 2024.

Chronic kidney disease (CKD) is the gradual loss of kidney (renal)

function that can get worse over time leading to lasting damage and possibly Stage 5 or end-stage renal disease (ESRD).

Our initial focus

is on developing drugs and getting them approved in the U.S., and then to partner with global biopharmaceutical companies in the rest

of the world.

According to the United States Renal Data System (USRDS) 2022 Annual Data Report, 30 million (14%) of adults in the United

States are estimated to have CKD and, of these, approximately 13 million patients have advanced CKD (stage 3-5).

Approximately 550,000

patients (ESRD) are on dialysis and of those, approximately 450,000 patients (~80%) take phosphate binders to control hyperphosphatemia

hyperphosphatemia (too much phosphorus in their blood).

The number of patients with ESRD in the U.S.

is increasing steadily and is projected

to reach between 971,000 and 1,259,000 patients in 2030.

AKI is a sudden episode of kidney failure or

kidney damage (within the first 90 days of injury).

CKD affects nearly

36 million Americans;

approximately 550,000 of them have end stage renal disease and require dialysis.

Hyperphosphatemia is common in

people with CKD and has been directly linked to increased morbidity and mortality for people on dialysis.

For an estimated 75% of people

on dialysis, hyperphosphatemia remains uncontrolled due to challenges with the six currently available phosphate binders,

namely insufficient potency, pill burden and unpalatable formulations.

To address this significant and growing challenge, Unicycive is

developing Oxylanthanum Carbonate, which leverages proprietary nanoparticle technology to address the shortcomings of current therapies

by delivering higher potency that enables fewer and smaller pills — all in a formulation that is more acceptable for patients because

it is swallowed, not chewed.

With OLC, if approved, people on dialysis and their physicians may have a better option to control hyperphosphatemia.

AKI is a sudden episode of kidney failure or kidney

damage (within the first 90 days of injury).

After 90 days, the patient is considered to have progressed into CKD.

more than 2 million U.S.

AKI affects more than

2 million U.S.

patients and costs the healthcare system in excess of $9 billion per year.

More than 300,000 patients per year

die due to AKI that has many causes.

business model is to license technologies and drugs in order to pursue development, regulatory approval, and commercialization of those

products in global markets.

Many biotechnology companies utilize similar strategies of in-licensing and then developing and commercializing

We believe, however, that our management team’s broad network, expertise in the biopharmaceutical industry, and successful

track record gives us an advantage in identifying and bringing these assets into our company.

proprietary pipeline is comprised of our two product candidates – Oxylanthanum Carbonate and UNI 494 – which are described

Figure 1 Unicycive Product Pipeline

Carbonate Purchase Agreement

September 20, 2018, we entered into an Assignment and Asset Purchase Agreement (the “Spectrum Agreement”) with Spectrum Pharmaceuticals,

(“Spectrum”), pursuant to which we purchased certain assets from Spectrum, including Spectrum’s right, title,

interest in and intellectual property related to Oxylanthanum Carbonate RZB 012, also known as RENALAN™ (“Renalan”)

and RZB 014, also known as SPI 014 (“SPI” and together with Renalan, the “Compounds”).

Pursuant to the Spectrum

Agreement, in consideration for the Compounds, we issued 313,663 shares of common stock to Spectrum.

Additionally,

the Spectrum Agreement provides that until the earlier of (i) 36 months from the first date on which our stock trades on a public market,

or (ii) the date upon which we attain a public market capitalization of $50,000,000 or greater, we are required to issue additional shares

of our common stock as may be needed to ensure Spectrum maintains a 4% ownership of our issued and outstanding common stock on a fully-diluted

Fully-diluted shares of common stock for purposes of the Spectrum Agreement assumes conversion of any security convertible into

or exchangeable or exercisable for common stock or any combination thereof, including any common stock reserved for issuance under a

stock option plan, restricted stock plan, or other equity incentive plan approved by the Board of Directors of the Company immediately

following the issuance of additional shares of our common stock (but prior to the issuance of any additional shares of common stock to

We are also required to pay Spectrum 40% of all of our sublicense income for any sublicense granted to certain sublicensees

during the first 12 months after the Closing Date (as that term is defined in the Spectrum Agreement) and 20% of all other sublicense

Our payment obligations to Spectrum will expire on the twentieth (20 th ) anniversary of the Closing Date of the Spectrum

More than 300,000 patients per year in the U.S.

die due to AKI.

Currently there are no FDA approved medicines to treat DGF and/or AKI.

Treatment options for AKI include continuous renal

replacement therapy, renal transplant, and dialysis.

In most cases the damage to the kidney is irreversible, and the patient needs to

have a renal transplant or be on dialysis for life.

Therefore, there is a high unmet medical need.

If approved, UNI-494 has the potential

to be a first-in-class drug for the treatment of AKI.

We operate with a sense of urgency to bring new

treatments to patients faster, leveraging our team’s expertise, operational efficiency, and strategic focus on high-value opportunities

within the renal space.

Through this approach, we aim to deliver innovative therapies that provide meaningful clinical and economic benefits

for patients, providers, and healthcare systems.

Our proprietary

pipeline is comprised of our two product candidates – Oxylanthanum Carbonate and UNI-494 – which are described below in Figure

Unicycive Therapeutics’ Pipeline

Carbonate (lanthanum dioxycarbonate) is an investigational next-generation lanthanum-based phosphate binding agent being developed

for the treatment of hyperphosphatemia in CKD patients on dialysis.

Oxylanthanum Carbonate is a phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis

and is intended to be administered as a tablet that will be swallowed whole at mealtimes.

CKD patients typically have co-morbidities,

which often require them to be on strict pill schedules.

Current phosphate binder products involve patients needing to take a

large number of pills daily, some of which are large and/or must be chewed, often resulting in poor adherence to the prescribed drug therapy.

By virtue of its novel nanoparticle technology,

OLC leverages the high phosphate binding potency of lanthanum in a palatable dose form that has the potential to substantially reduce

the pill burden volume for patients.

In this regard, we believe that the combined effect of smaller pill size, lower number of pills,

and improved palatability with Oxylanthanum Carbonate will compete favorably with currently available phosphate binders and may lead

to improved patient compliance/adherence and more effective disease management.

is seeking the U.S.

Food and Drug Administration (FDA) approval of OLC via the 505(b)(2) regulatory pathway.

The Company has submitted

a New Drug Application (NDA) and has an assigned Prescription Drug User Fee Act (PDUFA) date of June 28, 2025.

Hyperphosphatemia

kidney disease (CKD) is the gradual loss of kidney function that can get worse over time leading to lasting damage.

The stages of chronic

kidney disease are shown below in Table 1.

Table 1 Chronic Kidney Disease Stages

adapted from The Renal Association (https://renal.org/information-resources/the-uk-eckd-guide/ckd-stages/)

kidney disease (CKD) is the gradual loss of kidney (renal) function that can get worse over time leading to lasting damage and possibly

Stage 5 or end-stage renal disease (ESRD).

The stages of chronic kidney disease are shown below in Figure 2 .

estimated glomerular filtration rate (a measure of kidney function)

Complications of CKD include electrolyte imbalances, fluid build-up,

anemia, bone disease, and heart disease.

Hyperphosphatemia is an electrolyte disorder in which elevated phosphorus levels in the blood

lead to cardiovascular complications and vascular calcification (hardening).

According to Kidney Disease Improving Global Outcomes (KDIGO)

guidelines, hyperphosphatemia is defined as an abnormally high serum phosphorus concentration >4.5 mg/dL.

In healthy people, normal

serum phosphorus levels are maintained s by absorbing from food and excreting (removing from the body) it in the urine and feces.

with CKD, not enough phosphate is excreted, leading to elevated levels of phosphorus in the blood.

In CKD, hyperphosphatemia is caused

by a chronic dysregulation of serum phosphorus levels as a result of progressive kidney damage.

According to a 2009 paper authored by

Covic, hyperphosphatemia is associated with increased risk of cardiovascular disease, metabolic bone disease, and deaths from all-causes

(all-cause mortality) mortality.

According to a study completed by Palmer in 2011, it is estimated that all-cause mortality is increased

by 18% for every 1 mg/dL increase in serum phosphorus concentration.

Hyperphosphatemia is also a major cause of morbidity in CKD

patients, which increases the economic and clinical burden on patients and the health system and results in Medicare expenditures of $70

billion in the U.S.

According to the 2023 United States Renal Data System (USRDS) Annual

Report, it is estimated that 14% of U.S.

adults (approximately 31 million people) have CKD.

Most patients with Stage 5 CKD (ESRD) either

undergo kidney transplants or go on dialysis.

The 2023 USRDS annual report indicates that there were 541,326 prevalent dialysis patients

in 2021 (the latest reported year).

https://www.kidney.org/kidney-topics/stages-chronic-kidney-disease-ckd

Stages of Chronic Kidney Disease

to the United States Renal Data System (USRDS) 2022 Annual Data Report, 30 million (14%) of adults in the United States are estimated

to have CKD and, of these, approximately 13 million patients have advanced CKD (stage 3-5).

Complications of CKD include electrolyte

imbalances, fluid build-up, anemia, bone disease, and heart disease.

Most patients with Stage 5 CKD (ESRD) either undergo kidney transplantations

or go on dialysis.

The 2023 USRDS annual report indicates that there were 541,326 prevalent dialysis patients in 2021 (the latest reported

year), and of those, approximately 450,000 patients (~80%) take phosphate binders to control hyperphosphatemia.

The prevalent U.S.

dialysis population has grown at an average yearly rate of 3.5% over the past decade.

Furthermore, in a paper published by McCullough in 2019, the number of patients in the U.S.

with ESRD is increasing steadily and is projected

to reach between 971,000 and 1,259,000 in 2030.

In 2020-21, the number of prevalent dialysis patients declined due to an increased death

rate of dialysis patients as a consequence of COVID-19.

population has grown at an average yearly rate of 3.5% over the past decade.

The number of patients with ESRD in the U.S.

is increasing

steadily and is projected to reach between 971,000 and 1,259,000 patients in 2030.

Hyperphosphatemia

is a bone and mineral metabolism disorder in which elevated phosphorus levels in the blood lead to cardiovascular complications and vascular calcification

According to Kidney Disease Improving Global Outcomes (KDIGO) guidelines, hyperphosphatemia is defined as an abnormally

high serum phosphorus concentration >4.5 mg/dL.

In CKD, hyperphosphatemia is caused by a chronic dysregulation of serum phosphorus

levels as a result of progressive kidney damage.

In healthy people, normal serum phosphorus levels are maintained in the body by the

absorption from food and subsequent excretion from the body via urine and feces.

In people with CKD, not enough phosphate is excreted,

leading to elevated levels of phosphorus in the blood.

to a 2009 paper authored by Covic, hyperphosphatemia is associated with increased risk of cardiovascular disease, metabolic bone disease,

and deaths from all-causes (all-cause mortality).

According to a study completed by Palmer in 2011, it is estimated that all-cause mortality

is increased by 18% for every 1 mg/dL increase in serum phosphorus concentration.

Hyperphosphatemia is also a major cause of morbidity

in CKD patients, which increases the economic and clinical burden on patients and the health system and results in Medicare expenditures

of $70 billion in the U.S.

Treatment of Hyperphosphatemia

The treatment goal for patients with hyperphosphatemia is focused on

controlling the level of phosphate in the body.

treatment goal for patients with hyperphosphatemia is focused on controlling the level of phosphate in the body.

KDIGO guidelines recommend

three main strategies for managing hyperphosphatemia:

dietary intake restrictions, use of phosphate binders, and dialysis, as shown in

Figure 3 below.

KDIGO Guidelines Recommend Three Main Strategies for Managing Hyperphosphatemia

intake restrictions, use of phosphate binders, and dialysis, as shown in Figure 2 below.

Figure 2 KDIGO Guidelines Recommend Three

Main Strategies

While KDIGO guidelines do not recommend one phosphate binder over another,

they do recommend restricting the dose of calcium-based binders and avoiding long-term us of aluminum-containing binders..

that physicians prescribe their medication of choice, usually based on clinical and patient factors.

Utilization of calcium-based binders

is discouraged by the most recent KDOQI/KDIGO guidelines due to mounting clinical evidence that excess calcium load from calcium-based

phosphate binder is associated with hypercalcemia and cardiovascular calcification which has been associated with an increased risk of

morbidity (disease) and mortality (death).

KDIGO guidelines do not recommend one phosphate binder over another, they do recommend restricting the dose of calcium-based binders

and avoiding long-term use of aluminum-containing binders.

This means that physicians prescribe their medication of choice, usually

based on clinical factors and patient preferences.

Utilization of calcium-based binders is discouraged by the most recent KDOQI/KDIGO

guidelines due to mounting clinical evidence that excess calcium load from calcium-based phosphate binder is associated with

hypercalcemia and cardiovascular calcification which has been associated with an increased risk of morbidity (disease) and mortality

to data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) in 2021, 82% of U.S.

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Medical Need in the Management of Hyperphosphatemia

The brief descriptions of the mechanism of action and what we believe

to be the advantages and disadvantages of various phosphate binders are shown below in Table 2 .

brief descriptions of the mechanism of action and what we believe to be the advantages and disadvantages of various phosphate binders

are shown below in Figure 4 .

Phosphate Binder Mechanisms of Action,

Adapted from Covic and Rastogi, 2013.

Despite the commercial availability of the six phosphate binders in

the table above, 75% of U.S.

dialysis patients fail to achieve the serum phosphorus target levels established by the KDIGO guidelines.

Moreover, serum phosphorus outcomes are trending downward—underscoring the need for new and effective treatment options.

Figure 3 Serum Phosphorus Target Achievement from 2012 to

Despite the commercial availability of the six phosphate binders in the table above, 75% of U.S.

dialysis patients

fail to achieve the serum phosphorus target levels established by the KDIGO guidelines.

Moreover, the

percentage of patients achieving these serum phosphorus guidelines is trending downward — underscoring the need for new and effective

treatment options ( Figure 5 ).

The Kidney Disease Outcomes Quality Initiative

Serum Phosphorus Target Achievement from 2012 to 2021

2005, Unruh, ML published a paper that showed poor adherence to treatment is common in patients with ESRD and has been associated with

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for better medication compliance.

virtue of its novel nanoparticle technology, OLC leverages the high phosphate binding potency of lanthanum in a palatable dose form that

has the potential to substantially reduce the pill burden volume for patients.

In this regard, we believe that the combined effect of

smaller pill size, lower number of pills, and improved palatability with Oxylanthanum Carbonate compared with currently available phosphate

binders may lead to improved patient compliance/adherence and more effective disease management.

of Oxylanthanum Carbonate

Carbonate (lanthanum dioxycarbonate) is an investigational phosphate binding agent utilizing proprietary nanoparticle technology for

the treatment of hyperphosphatemia in CKD patients on dialysis.

Carbonate Mechanism of Action

Oxylanthanum Carbonate binds to phosphates and forms an insoluble lanthanum

phosphate complex which is then excreted via the feces.

This results in reduced absorption of phosphate leading to a reduction of serum

phosphorus levels.

In rat studies, Oxylanthanum Carbonate exhibited comparable reduction

in the urine phosphorus excretion following administration of a lower dose of drug product (0.40g) vs a higher dose (0.57g) of Fosrenol®

(lanthanum carbonate tetrahydrate) which is a currently approved lanthanum-based phosphate binder.

While differing in the mass of drug

product, each dose contained comparable amounts of the active moiety (elemental lanthanum).

In the same study, at equivalent doses, Oxylanthanum

Carbonate was superior to Sevelamer (the most commonly used phosphate binder) in reducing urine phosphorus excretion (see Fig 3).

Figure 4 Urine Phosphate Levels in Rats Following Comparable

Dosing of Oxylanthanum Carbonate, Fosrenol, or Sevelamer

In animal toxicology studies with oxylanthanum carbonate no unexpected

toxicity was found and systemic absorption of lanthanum was extremely low, which is consistent with similar studies conducted with Fosrenol.

The chemical design of Oxylanthanum Carbonate was designed to allow

for a smaller tablet size and require fewer pills compared with currently available phosphate binder alternatives, specifically with a

dosing regimen of only one tablet per meal.

The Oxylanthanum Carbonate tablet is designed to disintegrate rapidly in the stomach after

swallowing and does not need to be chewed.

Carbonate binds to phosphates and forms an insoluble lanthanum phosphate complex which is then excreted via the feces.

This results in

reduced absorption of phosphate leading to a reduction of serum phosphorus levels.

rat studies, Oxylanthanum Carbonate exhibited comparable reduction in the urine phosphorus excretion following administration of a lower

dose of drug product (0.40g) vs a higher dose (0.57g) of Fosrenol® (lanthanum carbonate tetrahydrate) which is a currently approved

lanthanum-based phosphate binder.

While differing in the mass of drug product, each dose contained comparable amounts of the active moiety

(elemental lanthanum).

In the same study, at equivalent doses, Oxylanthanum Carbonate was superior to Sevelamer (the most commonly used

phosphate binder) in reducing urine phosphorus excretion (see Figure 6 below).

Urine Phosphate Levels in Rats Following Comparable Dosing of Oxylanthanum Carbonate, Fosrenol, or Sevelamer

animal toxicology studies with Oxylanthanum Carbonate no unexpected toxicity was found and systemic absorption of lanthanum was extremely

low, which is consistent with similar studies conducted with Fosrenol.

chemical structure of Oxylanthanum Carbonate was designed to allow for a smaller tablet size and require fewer pills compared with currently

available phosphate binder alternatives, specifically with a dosing regimen of only one tablet per meal.

The Oxylanthanum Carbonate tablet

is designed to disintegrate rapidly in the stomach after swallowing and does not need to be chewed.

Trial Experience

First-in-Human Phase 1 Study

is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway.

The NDA submission package is based on data from three clinical

a first in human Phase I study in healthy volunteers, a Bioequivalence (BE) study in healthy volunteers, and a pivotal Phase

2 tolerability study of OLC in CKD patients on dialysis, as well as multiple preclinical studies, and the chemistry, manufacturing and

controls (CMC) data.

Phase 2 Study

conducted a Phase 2, open-label, single-arm, multicenter trial in adult patients receiving maintenance hemodialysis with hyperphosphatemia.

The primary objective was to evaluate the tolerability of OLC at clinically effective doses with a goal serum phosphate concentration

(sP) ≤5.5 mg/dL.

The trial included washout, titration, and maintenance periods.

Eligible patients had sP ≥4.0 and ≤7.5 mg/dL

for at least 8 weeks prior to screening while receiving thrice weekly hemodialysis and a stable phosphate binder regimen.

Patients started

titration when sP was >5.5 mg/dL and entered maintenance once sP was ≤5.5 mg/dL.

The starting dose of OLC during titration was

1500 mg/day (500 mg thrice daily).

the study, 106 patients were enrolled, of which 86 patients entered titration and were followed as the Safety Population.

78 entered the maintenance period.

Of the 78 patients that entered maintenance, 7 patients did not have phosphate control, leaving an

Evaluable Population of 71 patients, exceeding the planned enrollment number of 60.

Of the 86 patients, the trial enrolled 47 males and

39 females with a mean age of 62.

Renvela® was the most prescribed phosphate binder for patients entering the study.

Endpoint - Tolerability:

T he objective of the OLC-201 trial was to evaluate the tolerability of clinically effective doses of OLC

in CKD patients on dialysis.

A clinically effective dose was established when a patient achieved a serum phosphate level ≤5.5 mg/dL.

Tolerability was assessed based on the incidence of treatment-related AEs leading to discontinuation from the study in the maintenance

In the OLC-201 trial, there was only 1 discontinuation due to a treatment-related AE in the Evaluable Population, a rate of 1.4%.

In the Safety Population of 86 patients there were only 3 treatment-related discontinuations, a rate of 3.5%.

In total, 5 patients discontinued

due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.

Endpoint - Safety:

The secondary endpoint assessing safety was reported as the treatment-related AEs occurring in ≥5% of patients.

The safety analysis covered all 86 patients in the Safety Population.

Consistent with the AEs observed with other phosphate binders,

the AEs were gastrointestinal related with diarrhea and vomiting being the most common at 9% and 6% respectively.

There were no treatment-related

serious adverse events (SAEs).

Six patients experienced SAEs but those were deemed not related to OLC treatment.

Most treatment-related

AEs were mild to moderate in severity with only 2 AEs reported as severe.

OLC Pivotal Phase 2 Trial Treatment-Related Adverse Events

Phosphate Control:

While the UNI-OLC-201 study was not designed to evaluate efficacy, the trial enrolled patients on stable doses

of approved hyperphosphatemia medications.

At baseline 59% of patients had phosphate levels ≤5.5 mg/dL, the level recommended by KDOQI

After washout from the prior phosphate binders, 90% of patients were able to achieve phosphate levels ≤5.5ng/dL at the

end of titration with OLC.

This includes the last serum phosphate levels from all patients including those that discontinued during titration:

77/86 (90%) ( Figure 8 ).

In addition, 69% of the 71 Evaluable Patients achieved a target serum phosphate level of ≤5.5 mg/dL

at OLC doses of 1500 mg/day or lower.

90% Of Patients Were Able to Achieve Phosphate Levels ≤5.5ng/dL with OLC.

69% of the 71 Evaluable Patients Achieved a Target Serum Phosphate Level of ≤5.5 mg/dL at OLC Doses of 1500 mg/Day or Lower

First-in-Human

Phase 1 Study

September 2012 a Phase 1 single-center clinical trial evaluating Oxylanthanum Carbonate in 32 healthy volunteers was completed in the

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(p=0.3676) but was significant at 3000 (p=0.0004), 4500 (p<0.0001), and 6000 (p=0.0001) mg/day, as shown in the figure below.

The mean reduction in urine phosphorus excretion was significant (p<0.001)

at all four doses of Oxylanthanum Carbonate ( Figure 4 ).

Figure 5 Daily Urine Phosphate Reduction in Healthy

mean reduction in urine phosphorus excretion was significant (p<0.001) at all four doses of Oxylanthanum Carbonate ( Figure 10 ).

Daily Urine Phosphate Reduction in Healthy Volunteers

Carbonate Bioequivalence Study in Healthy Volunteers

We conducted a randomized, open label, two-way crossover bioequivalence

BE study to establish the bioequivalence of the phosphate binding capacity of Oxylanthanum Carbonate and Fosrenol.

The primary objective

of the study was to demonstrate PD equivalence of orally administered Oxylanthanum Carbonate 1000 mg three-times daily (TID) to orally

administered Fosrenol 1000 mg TID in healthy subjects, and the secondary objective was to compare the safety and tolerability of UNI-014

versus Fosrenol in healthy subjects.

The study design, including the dose, primary endpoint and the sample size was reviewed by the Agency

prior to the initiation of the study.

The primary outcome measure was least squares (LS) mean change in urinary phosphorous excretion

(in mg/day) from baseline to the evaluation period.

The evaluation period was defined as the approximately 72-hour urine collection period

starting on Day 1 and ending on Day 4.

Baseline was defined as the approximately 48-hour urine collection period starting on Day -2 and

ending on Day 1.

PD equivalence was to be claimed if the 90% confidence interval (CI) of the primary PD variable for Oxylanthanum Carbonate

was completely contained within the reference interval, which was defined as ±20% of the LS mean of the primary PD variable for

lanthanum carbonate.

The LS mean change from Baseline for Oxylanthanum Carbonate (-320.4 mg/day) was similar to the LS mean change from

Baseline for Fosrenol (-324.0 mg/day).

The 90% CI for the LS mean was (-45.88, 53.16), which is well within the acceptance range

of (-64.80, 64,80) ( Table 3 ).

It was concluded that UNI-014 was bioequivalent to Fosrenol.

Primary outcome data is presented in

the table below.

conducted a randomized, open label, two-way crossover bioequivalence BE study to establish the bioequivalence of the phosphate binding

capacity of Oxylanthanum Carbonate and Fosrenol.

The primary objective of the study was to demonstrate PD equivalence of orally administered

Oxylanthanum Carbonate 1000 mg three-times daily (TID) to orally administered Fosrenol 1000 mg TID in healthy subjects, and the secondary

objective was to compare the safety and tolerability of Oxylanthanum Carbonate versus Fosrenol in healthy subjects.

The study design,

including the dose, primary endpoint and the sample size was reviewed by the Agency prior to the initiation of the study.

outcome measure was least squares (LS) mean change in urinary phosphorous excretion (in mg/day) from baseline to the evaluation period.

The evaluation period was defined as the approximately 72-hour urine collection period starting on Day 1 and ending on Day 4.

was defined as the approximately 48-hour urine collection period starting on Day -2 and ending on Day 1.

PD equivalence was to be claimed

if the 90% confidence interval (CI) of the primary PD variable for Oxylanthanum Carbonate was completely contained within the reference

interval, which was defined as ±20% of the LS mean of the primary PD variable for lanthanum carbonate.

The LS mean change from

Baseline for Oxylanthanum Carbonate (-320.4 mg/day) was similar to the LS mean change from Baseline for Fosrenol (-324.0 mg/day).

The 90% CI for the LS mean was (-37.83, 45.12), which is well within the acceptance range of (-64.80, 64,80).

It was concluded that Oxylanthanum

Carbonate was bioequivalent to Fosrenol.

Primary outcome data is presented in the table below ( Figure 11 ).

Summary of Mean Change in Urinary Phosphorus Excretion (mg/day)

Phosphorus Excretion

Evaluation Period

Change from Baseline

LS Mean Change

90% Confidence Interval for the LS mean (Test-Reference)

(-45.88, 53.16)

Acceptance Range

(-64.80, 64.799)

Unicycive is seeking approval for Oxylanthanum

Carbonate from the U.S.

is seeking approval for Oxylanthanum Carbonate from the U.S.

Food and Drug Administration (FDA) through the 505(b)(2) regulatory pathway.

The 505(b)(2) pathway allows for

full approval of a drug using data from an approved drug with the same active moiety.

The approved drug is called the Reference Listed

The 505(b)(2) pathway allows for full approval of a drug using data from an approved drug with the same active moiety.

The approved drug

is called the Reference Listed Drug (RLD).

The RLD for the Oxylanthanum Carbonate submission is Fosrenol (lanthanum carbonate).

The FDA recommended conducting a BE study

in healthy volunteers and a 6-month toxicity study in mice with both Oxylanthanum Carbonate and Fosrenol to be able to rely on the efficacy

and safety of Fosrenol.

We completed both studies and submitted the data for the FDA’s review during the pre-NDA (New Drug Application)

meeting request.

A summary of the human BE study is provided above.

After reviewing the data, the Agency recommend that we conduct a tolerability

recommended conducting a BE study in healthy volunteers and a 6-month toxicity study in mice with both Oxylanthanum Carbonate and Fosrenol

to be able to rely on the efficacy and safety of Fosrenol.

We completed both studies and submitted the data for the FDA’s review

during the pre-NDA (New Drug Application) meeting request.

After reviewing the data, the Agency recommended that we conduct a tolerability

study of Oxylanthanum Carbonate in chronic kidney disease patients on dialysis before filing the NDA.

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on the study design, sample size, and endpoints of the proposed pivotal clinical study during a Type-C meeting in September 2023.

study was initiated in December 2023 and the topline data is expected at the end of Q2, 2024.

We plan to submit the NDA soon after the

completion of the clinical study.

study was initiated in December 2023 and reported positive results in June 2024.

Unicycive announced the OLC NDA submission in September

2024 and received a PDUFA date of June 28, 2025.

In March 2025, FDA conducted a general surveillance inspection

of Shilpa Medicare Ltd, where the company received one procedural observation in form 483.

Commercial Opportunity for Oxylanthanum Carbonate

Oxylanthanum Carbonate is a phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis

and is intended to be administered as a tablet that will be swallowed whole at mealtimes.

CKD patients typically have co-morbidities,

which often require them to be on strict pill schedules.

Current phosphate binder products such as Renvela ® ,

Calcium Acetate, Auryxia ® , Velphoro ® , and Fosrenol ® involve patients needing to take large

numbers and/or large sized pills each day which in some cases must be chewed and which often results in poor adherence to the prescribed

drug therapy ( Figure 12 ).

By virtue of its novel nanoparticle technology, Oxylanthanum Carbonate leverages the high phosphate binding

potency of lanthanum in a palatable dose form that has the potential to substantially reduce the pill burden volume for patients.

regard, we believe that the combined effect of smaller pill size, lower number of pills, and improved palatability with Oxylanthanum Carbonate

compared with currently available phosphate binders may lead to improved patient compliance/adherence and more effective disease management.

Recommended Daily Starting Dose for Phosphate Binders

A New Hyperphosphatemia Market Player

Tenapanor is a new oral treatment for hyperphosphatemia that utilizes a novel mechanism of action that inhibits

paracellular transport of phosphorus into the bloodstream.We believe that due to its novel mechanism of action, Xphozah represents an

important new addition to the nephrologist’s hyperphosphatemia treatment armamentarium.

One of the key features of Xphozah’s

value proposition as an add-on therapy is its low pill burden.

Given its substantially lower pill burden than other phosphate lowering

therapy options, we believe that OLC may be the most logical phosphate binder to combine with tenapanor making these two new medicines

complimentary rather than competitive as the combination would leverage two distinct mechanisms of action to control phosphorus with a

much lower total pill burden than the current standard of care.

Strategy for Oxylanthanum Carbonate

The worldwide market for hyperphosphatemia agents is estimated at ~$2.5 billion and is growing at a 5.3% CAGR

(Fortune Business Insights, Hyperphosphatemia Treatment Market,

According to a study conducted by Syneos Health for the Company, the U.S.

market makes up over $1 billion of that total.

We own commercial rights to Oxylanthanum Carbonate globally and in some territories have licensed out commercial rights.

market, we are preparing to launch Oxylanthanum Carbonate on our own by building out a specialty commercial operation to address the highly

concentrated nephrology prescription market.

Executive management of the company has considerable product launch experience in the nephrology

space with specific working knowledge of the hyperphosphatemia market.

While there are ~10,000 prescribers of phosphate binders, ~2,500

prescribers are responsible for over half of the ~2.5 million prescriptions written annually.

We believe that we can efficiently create

demand for Oxylanthanum Carbonate within the most productive segments of the market with a relatively small salesforce, while addressing

the broader segments of prescribers through non-personal and digital promotion tactics.

alternative or complementary commercial strategy would be to out-license and/or co-promote Oxylanthanum Carbonate with and

established biopharmaceutical company that has an existing commercial infrastructure in the renal disease space and/or enter into

distribution agreement(s) with dialysis organizations for the commercialization of Oxylanthanum Carbonate.

Access and Reimbursement Environment

Historically, under the End-Stage Renal Disease

(ESRD) Prospective Payment System (PPS), referred to commonly as “the bundle”, dialysis-related drugs have been included

in the bundled payment system, with certain exceptions.

Oral-only drugs, including phosphate lowering therapies (PLTs) like OLC, had

been exempted from inclusion in the ESRD PPS until January 1, 2025.

Beginning in 2025, the Centers for Medicare & Medicaid Services

(CMS) has included these oral-only renal dialysis drugs into the PPS.

Because PLT payments were not previously included in the bundle,

CMS has added these drugs through the Transitional Drug Add-on Payment Adjustment (TDAPA).

The TDAPA is designed to provide separate

reimbursement for eligible new dialysis drugs for a period of two or more years, based on the drug’s Average Sales Price (ASP).

This adjustment is paid as an add-on to the base PPS rate for each dialysis treatment to facilitate the adoption of innovative therapies

in the dialysis space.

Upon FDA approval, we believe our product, OLC,

will be included in the ESRD PPS bundle and be eligible for TDAPA.

We will be required to submit a TDAPA application for OLC, a process

that has historically taken from 3-6 months from time of submission to approval.

If TDAPA designation is granted, OLC will become eligible

for separate TDAPA payment based on its average sales price (ASP), subject to quarterly updates by CMS.

The payment rate will be at 100%

of OLC’s ASP for 2 years and at 65% of ASP for an additional 3 years under the post-TDAPA extension.

After the end of the TDAPA

period for OLC, no further separate payments will be made and dialysis organizations will absorb the cost of OLC into the established

ESRD PPS bundled payment.

We believe that the timing of these reimbursement

changes coincides favorably with our anticipated launch timing of OLC and may provide for a more rapid launch uptake and for additional

market access and pricing advantages.

A key factor affecting initial launch uptake of OLC is the expanded access to our product to Medicare

beneficiaries which make up over two-thirds of patients on dialysis.

Under prior Part D reimbursement, Medicare patients often faced prior

authorization and high co-pays for branded drugs which tended to restrict access to these drugs.

In the new bundled reimbursement environment

with TDAPA, Medicare patients no longer face Part D program restrictions and are expected to enjoy greater access to phosphate lowering

We also see a pricing benefit to OLC under TDAPA.

In the past reimbursement environment, manufacturers often paid significant rebates to Part D plans for formulary access.

Current branded

PLTs have diluted their ASP as a result of these rebate agreements and under the Inflation Reduction Act (IRA) are limited in their ability

to raise prices above the rate of inflation.

Due to the expected launch timing of OLC, we expect to enjoy a net price advantage over

other branded competitors in the market.

Most dialysis clinics operate within dialysis

organization networks, the largest of which are Fresenius, DaVita, and U.S.

Renal Care, which together account for over 85% of US dialysis

Treatment within these dialysis organizations is usually driven by medical protocols that dialysis organizations (DOs) implement

across their entire network of clinics.

Upon approval of OLC, we intend to enter into mutually beneficial commercial supply contracts

with DOs to ensure access to OLC for appropriate patients by gaining favorable placement on treatment protocols and formularies.

There is no guarantee that CMS will ultimately designate OLC as eligible

for TDAPA, and should such eligibility be denied, it could substantially impact the commercialization and revenue potential of OLC.

if TDAPA is granted, downward pricing pressure in the post-TDAPA period could materially reduce our revenue from the drug and adversely

affect our profitability, financial results, and future prospects.

Transitional Drug Add-on Payment Adjustment

The Transitional Drug Add-on Payment Adjustment

(TDAPA) is part of the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), providing additional payments for certain new

renal dialysis drugs and biological products.

Implemented by the Centers for Medicare & Medicaid Services (CMS), TDAPA helps integrate

innovative treatments into ESRD care by offering financial support to dialysis facilities during the adoption phase.

This support enables

facilities to utilize new treatments that may otherwise face adoption barriers, such as high initial costs and the need for adjustments

to new therapies.

The program also helps bridge the gap between product launch and integration into the ESRD PPS, fostering the introduction

of novel treatments and innovation in ESRD care.

for the TDAPA under the ESRD PPS must be submitted through the electronic application intake system, Medicare Electronic Application

Request Information SystemTM (MEARIS).

Under CMS regulations (42 C.F.R.

§ 413.234(a)), to be eligible for a TDAPA, the product must

be a “new renal dialysis drug or biological product,” meaning it:

an injectable, intravenous, oral or other form or route of administration drug or biological

product that is used to treat or manage a condition(s) associated with ESRD.

approved by the Food and Drug Administration (FDA) on or after January 1, 2020, under section

505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service

commercially available.

an HCPCS application submitted in accordance with the official Level II HCPCS coding procedures.

been designated by CMS as a renal dialysis service under § 413.171.

codes (Healthcare Common Procedure Coding System) are a set of standardized codes used to identify medical procedures, services, supplies,

and equipment for billing and documentation purposes in healthcare settings.

HCPCS codes are primarily used by healthcare providers,

Medicare, Medicaid, and private insurers for billing, claims processing, and reimbursement.

These codes ensure that healthcare providers

are reimbursed accurately and consistently for services and products provided to patients.

company typically applies for a HCPCS (Healthcare Common Procedure Coding System) code when they introduce a new product, service, or

procedure that needs to be standardized for billing and reimbursement purposes.

The review cycle for HCPCS codes generally occurs quarterly,

with specific deadlines for submission.

applicants are required to provide a Healthcare Common Procedure Coding System (HCPCS) Application Confirmation Number when applying

for the TDAPA, the TDAPA application should be submitted after the application for a HCPCS code.

The TDAPA and HCPCS application submissions

will be reviewed simultaneously on a quarterly basis, by following the CMS Level II HCPCS application deadlines for drugs and biological

The TDAPA submissions received after the Level II HCPCS quarterly submission deadline will be reviewed in the following quarter.

aims for an effective date for applying the TDAPA for a particular product that is one quarter after the effective date of the HCPCS

code for the product, or approximately 6 months after the quarterly submission deadline, however, a longer evaluation period may be necessary

due to a number of factors.

Payment Process

is based on 100 percent of average sales price (ASP).

If ASP is not available, then the TDAPA is based on 100 percent of wholesale acquisition

If WAC is unavailable, then the payment is based on the drug manufacturer’s invoice.

TDAPA is paid for 2 years.

The TDAPA payment period begins on the effective date of the CMS Change Request (CR).

During the time a new

renal dialysis drug or biological product is eligible for the TDAPA, it is not an eligible ESRD outlier service as defined under 42 C.F.R.

§ 413.237(a)(1) and therefore is ineligible for outlier payment.

Add-On Payment Adjustment

of the TDAPA payment period, the new renal dialysis drug or biological product is paid the post-TDAPA add-on payment adjustment and no

changes to the base rate are made.

New drugs or biological products are eligible for the post-TDAPA add-on adjustment for 3 years.

calculates the adjustment annually based on the most recent 12 months of claims data.

For products without a full year of data, the adjustment

amount will be published in a Change Request (CR) once 12 months of data are available (89 FR 89135–98136).

The adjustment is based

on the total expenditure for the drug divided by total ESRD PPS expenditures, reduced by a case-mix standardization factor and a 65%

risk-sharing factor, then inflated by the market basket price proxy for pharmaceuticals.

All Part B drug manufacturers report Average

Sales Price (ASP) data for relevant products on the ASP Reporting website.

If CMS doesn’t receive the latest ASP data, the adjustment

won’t be applied for the drug in the upcoming or future years.

The adjustment may vary quarterly, depending on the number of drugs

and biological products included in the calculation.

The adjustment paid on a claim is adjusted by patient-level case-mix factors.

TDAPA Approvals:

2024, CMS approved a TDAPA application for Akebia’s VAFSEO® (vadadustat) under the ESRD PPS.

The TDAPA payment period is January

1, 2025, through December 31, 2026.

January 1, 2025, the following oral-only phosphate binders are approved for the TDAPA under the ESRD PPS:

sevelamer carbonate, sevelamer

hydrochloride, sucroferric oxyhydroxide, lanthanum carbonate, ferric citrate, and calcium acetate.

Phosphate binders are not considered

included in the ESRD PPS base rate, and they will be paid for using the TDAPA under the ESRD PPS for at least 2 years.

At the end of

the TDAPA payment period, CMS will go through rulemaking to modify the base rate, if appropriate, to account for these drugs in the ESRD

PPS bundled payment.

Implementation instructions are included in the TDAPA Administrative Issuances section above.

TDAPA Approvals:

CorMedix’s DEFENCATH® (taurolidine and heparin) approved for TDAPA from July

1, 2024, to June 30, 2026.

GlaxoSmithKline’s Jesduvroq™ (daprodustat) approved for TDAPA from October

1, 2023, to September 30, 2025.

Vifor Pharma and Cara Therapeutics’ Korsuva™ (difelikefalin) approved for

TDAPA, with payment from April 1, 2022, to March 31, 2024.

Oral cinacalcet and injectable etelcalcetide were the first drugs approved for TDAPA under

the ESRD PPS, with payment from January 1, 2018, to December 31, 2020.

Manufacturing

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commercial sale quantities and serve patient needs.

regards to manufacturing, testing and potential commercial supply of Oxylanthanum Carbonate, we have entered into an agreement with Shilpa

Medicare Ltd based in India.

According to the terms of the agreement, following Oxylanthanum Carbonate approval by the FDA, Unicycive

will pay the vendor $2 million in the first calendar year when the net revenue reaches $10 million from sales of Oxylanthanum Carbonate

and commercial supply of the product by the vendor (First Payment).

Thereafter, we will pay $2 million per year for four consecutive

years, after the first year’s payment, for the total payments of $10 million, provided all commercial supplies are continued to

be manufactured and supplied by the vendor.

Unicycive is not obligated to make any payments to the vendor until FDA approval of the product

is obtained and commercial revenue is generated.

Strategy for Oxylanthanum Carbonate

worldwide market for hyperphosphatemia agents is estimated at ~$2.5 billion and is growing at a 5.3% CAGR (Fortune Business Insights,

Hyperphosphatemia Treatment Market, 2021-2028 ).

According to a study conducted by Syneos Health for the Company, the U.S.

makes up over $1 billion of that total.

We own commercial rights to Oxylanthanum Carbonate globally.

market, we are preparing

to launch Oxylanthanum Carbonate on our own by building out a specialty commercial operation to address the highly concentrated nephrology

prescription market.

Executive management of the company has considerable product launch experience in the nephrology space with specific

working knowledge of the hyperphosphatemia market.

While there are ~10,000 prescribers of phosphate binders, ~2,500 prescribers are responsible

for over half of the ~2.5 million prescriptions written annually.

We believe that we can efficiently create demand for Oxylanthanum Carbonate

within the most productive segments of the market with a relatively small salesforce, while addressing the broader segments of prescribers

through non-personal and digital promotion tactics.

alternative commercial strategy would be to out-license and/or co-promote Oxylanthanum Carbonate with and established biopharmaceutical

company that has an existing commercial infrastructure in the renal disease space and/or enter into distribution agreement(s) with dialysis

organizations for the commercialization of Oxylanthanum Carbonate.

With regards to manufacturing, testing and potential

commercial supply of oxylanthanum carbonate, on October 31, 2020, the Company entered into an agreement with Shilpa Medicare Ltd (“Shilpa”)

based in India.

Pursuant to the Agreement, Shilpa provides certain development, manufacturing, supply and other CMC-related services related

to the development and commercialization of oxylanthanum carbonate (“OLC”).

In June 2024, we entered into the First Amendment

to Manufacturing and Supply Agreement with Shilpa (the “Amendment”) in anticipation of an increased manufacturing demand for

Pursuant to the Amendment, we agreed to make a binding purchase order for tablets of OLC and Shilpa has agreed to deliver such order

by September 30, 2025.

In addition, we agreed to order additional tablets for delivery between December 31, 2025, and September 30, 2026.

Further, we agreed to make certain milestone payments and to provide certain funding to Shilpa for a new manufacturing line.

term of the Agreement shall continue until the eighth (8th) anniversary of the date of receipt by us of FDA approval of our NDA of OLC

(the “Initial Term”).

Following the Initial Term, the Agreement shall continue in effect for consecutive periods of four (4)

years each unless earlier terminated pursuant to the terms of the Agreement.

Collaboration

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tiered royalties upon achievement of prespecified regulatory and commercial achievements.

In February of 2023, we entered into an exclusive license agreement

with Lotus Pharmaceutical for the development and commercialization of Oxylanthanum Carbonate in the Republic of Korea.

Under the terms

of the agreement, Lotus will be responsible for development, registration filing and approval of Oxylanthanum Carbonate in the Republic

In addition, Lotus will have sole responsibility for the importation of the drug product from Unicycive and for the costs of

commercialization of Oxylanthanum Carbonate in the Republic of Korea.

We received an upfront payment of $750,000 and may receive up to

$3.7 million in milestone payments and tiered royalties upon achievement of prespecified regulatory and commercial achievements.

February of 2023, we entered into an exclusive license agreement with Lotus Pharmaceutical for the development and commercialization

of Oxylanthanum Carbonate in the Republic of Korea.

Under the terms of the agreement, Lotus will be responsible for development, registration

filing and approval of Oxylanthanum Carbonate in the Republic of Korea.

In addition, Lotus will have sole responsibility for the importation

of the drug product from Unicycive and for the costs of commercialization of Oxylanthanum Carbonate in the Republic of Korea.

an upfront payment of $750,000 and may receive up to $3.7 million in milestone payments and tiered royalties upon achievement of prespecified

regulatory and commercial achievements.

will continue to seek licensing partners for Oxylanthanum Carbonate in other territories outside the U.S.

1 unchanged sentence

South America, and the Middle East.)

opportunity for Oxylanthanum Carbonate

Carbonate is a phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis and is intended to be administered

as a tablet that will be swallowed whole at mealtimes.

CKD patients typically have co-morbidities, which often require them to be on

strict pill schedules.

Current phosphate binder products such as Renvela ® , Calcium Acetate, Auryxia ® , Velphoro ® ,

and Fosrenol ® involve patients needing to take large numbers and/or large sized, chewable pills each day, which often

results in poor adherence to the prescribed drug therapy (Figure 4 below).

By virtue of its novel nanoparticle technology, Oxylanthanum

Carbonate leverages the high phosphate binding potency of lanthanum in a palatable dose form that has the potential to substantially

reduce the pill burden volume for patients.

In this regard, we believe that the combined effect of smaller pill size, lower number of

pills, and improved palatability with Oxylanthanum Carbonate compared with currently available phosphate binders is likely to lead to

improved patient compliance/adherence and more effective disease management.

Figure 6 Phosphate Binders

A New Hyperphosphatemia Market Player

is a new oral treatment for hyperphosphatemia that utilizes a novel mechanism of action that inhibits paracellular transport of phosphorus

into the bloodstream.

Ardelyx filed an NDA for tenapanor with the FDA in June of 2020 which received a Complete Response Letter (“CRL”)

from the FDA’s Division of Cardiology and Nephrology in July of 2021, According to the CRL, the Division characterized the treatment

effect of tenapanor as “small and of unclear clinical significance.” Ardelyx appealed FDA’s decision and resubmitted

their application and was granted approval in October of 2023.

The labelled indication for Xphozah (tenapanor) is “…as add-on

therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.”

The limited indication as add-on therapy is presumably due to the drug’s relatively modest treatment effect when used as monotherapy

in clinical trials (intent-to-treat (ITT) analysis of treatment effect of 0.70 mg/dL on serum phosphorus levels).

Additionally, the product

label lists diarrhea as the most common adverse event occurring in 43-53% of patients.

believe that due to its novel mechanism of action, Xphozah represents an important new addition to the nephrologist’s hyperphosphatemia

treatment armamentarium.

We believe that the relative competitive profile of Oxylanthanum Carbonate (OLC) has several advantages over

1) Based on our demonstration of pharmacodynamic equivalence of OLC to the reference-listed drug, Fosrenol, our label for OLC

is expected to describe its treatment effect as a change of 1.91 mg/dL in serum phosphorus levels in an ITT analysis of patients treated

with OLC as monotherapy.

This represents more than a 2.7 times greater treatment effect compared to Xphozah.

2) The labelled indication

for OLC is expected to be identical to that of Fosrenol which will support its use as monotherapy and will be not limited to add-on therapy,

3) The demonstrated adverse event profile of lanthanum-based phosphate binders (subject to validation of OLC’s GI tolerability

profile currently being evaluated in a clinical trial) will compare favorably to high rate of reported GI adverse events of Xphozah.

of the key features of Xphozah’s value proposition as an add-on therapy is its low pill burden.

Given its substantially lower pill

burden than other phosphate binder options, we believe that OLC may be the most logical phosphate binder to combine with tenapanor making

these two new medicines more complimentary than competitive as the combination would leverage two distinct mechanisms of action to control

phosphorus with a much lower total pill burden than the current standard of care.

Access and Reimbursement Environment

current federal regulation, phosphate lowering drugs (PLTs), which are currently provided to patients by Medicare Part D insurers, are

scheduled to be included into the dialysis bundle in 2025 and will be paid for separately by CMS through a Transitional Drug Add-On Payment

Adjustment (TDAPA) program for a minimum of 2 years.

In the 2023 ESRD PPS Final Rule, CMS stated, “We have seen that incorporating

Medicare Part D drugs into the ESRD PPS has had a significant positive effect of expanding access to such drugs for beneficiaries who

do not have Medicare Part D coverage.” (federalregister.gov/d/2022-13449).

We believe that the timing of this change coincides

favorably with our anticipated launch timing of Oxylanthanum Carbonate (OLC) and could provide for a more rapid launch uptake and competitive

pricing advantages.

A key factor affecting initial launch uptake of OLC is the expanded access to our product to Medicare beneficiaries

which make up over two-thirds of patients on dialysis.

Currently under Part D, patients often face high co-pays for branded drugs which

tends to restrict access to these drugs.

Under the current TDAPA rules, CMS reimburses dialysis organizations for 100% of the average

selling cost (ASP) of all phosphate lowering drugs—eliminating the access restrictions patients face from Part D plans.

also see a pricing benefit to OLC under TDAPA.

In the current reimbursement environment, manufacturers often pay significant rebates

to Part D plans for formulary access.

Current branded PLTs have diluted their ASP as a result of these rebate agreements and under the

Inflation Reduction Act (IRA) are limited in their ability to raise prices above the rate of inflation.

Due to the expected launch timing

of OLC, we expect to enjoy a pricing advantage over other branded competitors in the market.