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Item 1. Business

2024-03-28 compared with 2023-03-31 · 732 added, 705 removed, 774 unchanged (65% 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.

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:

Renazorb™, for treatment of

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

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

respectively.

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

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

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some initial physiochemical characterization and preliminary animal pharmacokinetic studies.

As discussed herein, during 2021 and 2022

we have conducted preclinical studies with UNI 494.

Chronic kidney disease (CKD) is the gradual loss

of kidney function that can get worse over time leading to lasting damage.

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 with end-stage renal disease (ESRD)

are on dialysis and of those, approximately 450,000 take phosphate binders to control hyperphosphatemia.

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 in 2030.

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.

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

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

AKI kills more than 300,000 patients

per year in the U.S.

and is caused by multiple etiologies.

Our 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 drugs.

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.

Our proprietary pipeline is comprised of our two product candidates

– Renazorb and UNI 494 – which are described below.

UNI-014 (Renazorb)

Renazorb Purchase Agreement

On September 20, 2018, we entered into an Assignment

and Asset Purchase Agreement (the “Renazorb Purchase Agreement”) with Spectrum Pharmaceuticals, Inc.

(“Spectrum”),

pursuant to which we purchased certain assets from Spectrum, including Spectrum’s right, title, interest in and intellectual property

related to Renazorb 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 Renazorb Purchase Agreement, in consideration for the Compounds,

we issued 313,663 shares of common stock to Spectrum.

Additionally, the Renazorb Purchase 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 basis.

Fully-diluted

shares of common stock for purposes of the Renazorb Purchase 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 Spectrum).

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 Renazorb Purchase Agreement) and 20% of all other sublicense income.

obligations to Spectrum will expire on the twentieth (20 th ) anniversary of the Closing Date of the Renazorb Purchase Agreement.

Disease overview:

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

Hyperphosphatemia

Chronic 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

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/)

eGFR = 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 untreated 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 healthy people,

phosphorus levels are maintained as phosphate is absorbed from food and excreted in the urine and feces.

In people 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 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.

According to the 2022 United States Renal Data

System (USRDS), it is estimated that 14% of U.S.

= 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 either

undergo kidney transplant or go on dialysis.

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

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The prevalent U.S.

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

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, the number of prevalent dialysis patients declined due to an

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

Current treatment of hyperphosphatemia

The treatment goal for patients with hyperphosphatemia

is focused on controlling the level of phosphate in the body.

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.

treatment of hyperphosphatemia

The 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:

diet restrictions, phosphate binders, and dialysis, as shown in figure 1 below.

KDIGO guidelines recommend 3 main strategies.

While KDIGO guidelines support the treatment

of hyperphosphatemia with phosphate binders in patients with CKD, with the exception of calcium-based binders, they do not recommend

one agent over another.

This means 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 and mortality.

According to data from the Dialysis Outcomes

and Practice Patterns Study (DOPPS) in 2021, 82% of U.S.

dialysis patients were prescribed phosphate binders, which equates to approximately

450,000 patients.

Unmet Medical Need in the Management of Hyperphosphatemia

The mechanism of action and what we believe to

be the advantages and disadvantages of various phosphate binders are shown below.

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).

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

dialysis patients were prescribed phosphate

binders, which equates to approximately 450,000 patients.

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 .

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 established by the KDIGO

Moreover, serum phosphorus outcomes are trending downward—underscoring the need for newer, more effective treatment

In 2005, Unruh, ML published a paper that showed

poor adherence to treatment is common in patients with ESRD and has been associated with an increased risk of mortality.

poor adherence to phosphate binder therapy has been associated with failure to adequately control serum phosphorus concentrations as

shown in a publication by Arenas, MD and others in 2010.

Results from a study of 233 patients on maintenance dialysis from three different

dialysis units in the U.S.

showed that patients took a mean of 11 ± 4 medications with a median daily pill intake of 19 as shown

by Chiu, YW in 2009.

Phosphate binders accounted for nearly 50% of the total pill burden, with a median daily pill count of nine.

38% of patients in this study reported that they were adherent to their prescribed phosphate binder therapy and adherence decreased significantly

with increased pill count.

Potential strategies to improve adherence to

phosphate binders in patients with ESRD include:

(i) a reduction in pill size and number, (ii) improvement of palatability, and (iii)

a reduction in associated adverse effects as published in a study by Covic and Rastogi in 2013.

Therefore, we believe there is a current need

for better phosphate binders with high phosphate binding capacity, enabling a reduced pill burden for better medication compliance.

Development of Renazorb

Renazorb (lanthanum dioxycarbonate) is an investigational

phosphate binding agent utilizing proprietary nanoparticle technology for the treatment of hyperphosphatemia in CKD patients on dialysis.

Renazorb Mechanism of Action

Renazorb binds to phosphates and forms an insoluble

lanthanum phosphate complex which is then excreted via the feces.

This results in reduction of serum phosphorus levels.

In rat studies, Renazorb 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).

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, Renazorb was superior to sevelamer (the most commonly

used phosphate binder) in reducing urine phosphorus excretion (see Fig 2).

Urine phosphate levels in rats following comparable dosing

of Renazorb, Fosrenol, or Sevelamer

In animal toxicology studies no unexpected toxicity

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

The chemical design of Renazorb allows for smaller

tablet size and fewer pills compared with currently available phosphate binder alternatives, specifically with a dosing regimen of only

one tablet per meal.

The Renazorb tablet is designed to disintegrate in the stomach after swallowing and disperse the product in a short

period of time at a pH ≥3.0.

Clinical Trial Experience

In September 2012 a Phase 1 single-center clinical

trial evaluating Renazorb in 32 healthy volunteers was completed in the United States.

Four sequential dose cohorts of 8 subjects each

(6 actives and 2 placebos) received Renazorb at 1500, 3000, 4500, or 6000 mg/day, taken orally in 3 divided doses within 15 minutes after

meals, for five consecutive days.

The primary endpoint of the study was the evaluation of safety, and the secondary endpoint was the

phosphate binding capacity of Renazorb as judged by the level of phosphorus in feces and urine.

We believe the study indicated

that Renazorb was minimally absorbed to the systemic circulation and was well-tolerated at doses up to 6000 mg/day.

Renazorb significantly

reduced urine phosphate excretion and significantly increased fecal phosphate excretion at doses at and above 3000 mg/day.

mean overall change in phosphorus from baseline in both urine and feces, across all treatment groups, showed a dose-response trend that

was statistically significant (p<0.0001 and p=0.0004, respectively).

The mean reduction in urine phosphorus excretion was not significant

at 1500 mg/day (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

Daily urine phosphate reduction

Regulatory Strategy for Renazorb

Feedback from the FDA

We received additional guidance on the regulatory

pathway for Renazorb from the U.S.

Food and Drug Administration (FDA) following a Type C meeting in March 2022, in which the FDA confirmed

that a single clinical bioequivalence study in healthy volunteers, together with the previously agreed-upon 6-month mouse toxicology

study can support the New Drug Application (NDA) filing of Renazorb through a 505(b)(2) pathway.

We reached an agreement with the FDA on the clinical

study design including the doses of Renazorb and Fosrenol, sample size and the primary endpoints of the bioequivalence study.

confirmed that no additional clinical studies would be required for the NDA application.

BE Study Description

We conducted a randomized, open label, two-way

crossover BE study to establish pharmacodynamic (PD) bioequivalence between Renazorb and Fosrenol.

The primary objective of the study

was to demonstrate PD equivalence of orally administered Renazorb 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

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

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

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

an increased risk of mortality.

In addition, poor adherence to phosphate binder therapy has been associated with failure to adequately

control serum phosphorus concentrations as shown in a publication by Arenas, MD and others in 2010.

Results from a study of 233 patients

on maintenance dialysis from three different dialysis units in the U.S.

showed that patients took a mean of 11 ± 4 medications

with a median daily pill intake of 19 as shown by Chiu, YW in 2009.

Phosphate binders accounted for nearly 50% of the total pill burden,

with a median daily pill count of nine.

Only 38% of patients in this study reported that they were adherent to their prescribed phosphate

binder therapy and adherence decreased significantly with increased pill count.

strategies to improve adherence to phosphate binders in patients with ESRD include:

(i) a reduction in pill size and number, (ii) improvement

of palatability, and (iii) a reduction in associated adverse effects as published in a study by Covic and Rastogi in 2013.

we believe there is a current need for better phosphate binders with high phosphate binding capacity, enabling a reduced pill burden

for better medication compliance.

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.

Trial Experience

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

United States.

Four sequential dose cohorts of 8 subjects each (6 actives and 2 placebos) received Oxylanthanum Carbonate at 1500, 3000,

4500, or 6000 mg/day, taken orally in 3 divided doses within 15 minutes after meals, for five consecutive days.

The primary endpoint

of the study was the evaluation of safety, and the secondary endpoint was the phosphate binding capacity of Oxylanthanum Carbonate as

judged by the level of phosphorus in feces and urine.

We believe the study indicated that Oxylanthanum Carbonate was minimally

absorbed to the systemic circulation and was well-tolerated at doses up to 6000 mg/day.

Oxylanthanum Carbonate significantly reduced

urine phosphate excretion and significantly increased fecal phosphate excretion at doses at and above 3000 mg/day.

The mean overall

change in phosphorus from baseline in both urine and feces, across all treatment groups, showed a dose-response trend that was statistically

significant (p<0.0001 and p=0.0004, respectively).

The mean reduction in urine phosphorus excretion was not significant at 1500 mg/day

(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

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.

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

equivalence was to be claimed if the 90% confidence interval (CI) of the primary PD variable for UNI-014 was completely contained within

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

change from Baseline for UNI-014 (-320.4 mg/day) was similar to the LS mean change from Baseline for Fosrenol (-324.0 mg/day).

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.

Table 3 Summary of Mean

Change in Urinary Phosphorus Excretion (mg/day)

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.

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

Phosphorus Excretion

Evaluation Period

5 unchanged sentences

(-64.80, 64.799)

Unicycive 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 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

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

We gained alignment with the FDA

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.

Manufacturing

We do not own or operate manufacturing facilities

for the production of clinical or commercial quantities of our product candidates.

We currently have no plans to build our own clinical

or commercial scale manufacturing capabilities.

If and when any of our product candidates are approved, we plan to obtain manufacturing

capacity through contract manufacturing organizations (CMOs) to meet projected needs for commercial sale quantities and serve patient

With regards to manufacturing, testing and potential

commercial supply of Renazorb, we have entered into an agreement with Shilpa Medicare Ltd based in India.

According to the terms of the

agreement, following Renazorb 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 Renazorb 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.

Commercial Strategy for Renazorb

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, 2021-2028 ).

do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates.

currently have no plans to build our own clinical or commercial scale manufacturing capabilities.

If and when any of our product candidates

are approved, we plan to obtain manufacturing capacity through contract manufacturing organizations (CMOs) to meet projected needs for

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.

market makes up over $1 billion of that total.

We own commercial

rights to Renazorb globally.

market, we intend to maintain optionality by pursuing 3 potential go-to-market models in parallel.

We believe that this is the best strategy to maximize both the clinical value of the Renazorb asset for patients and the economic value

of the asset to our investors.

Launch Renazorb in the U.S.

market ourselves 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.

that we can efficiently create demand for Renazorb 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.

Out-license and/or co-promote Renazorb

with an established biopharma company that has an existing commercial infrastructure in the

renal disease space.

Out-license rights or enter into distribution agreement(s) with dialysis organization(s) for the

commercialization of Renazorb.

Collaboration Partners

In July of 2022, we entered into an agreement

granting exclusive rights to develop, market and commercialize Renazorb (lanthanum dioxycarbonate) to Lee’s Pharmaceutical (HK)

in Mainland China, Hong Kong, and certain other Asian markets.

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.

Collaboration

July of 2022, we entered into an agreement granting exclusive rights to develop, market and commercialize Oxylanthanum Carbonate (lanthanum

dioxycarbonate) to Lee’s Pharmaceutical (HK) in Mainland China, Hong Kong, and certain other Asian markets.

Under the terms of

the agreement, Lee’s Pharm will be responsible for development, registration filing and approval for Oxylanthanum Carbonate in

the licensed territories.

In addition, Lee’s Pharm will have sole responsibility for the importation of the drug product from Unicycive

and for the costs of commercialization of Oxylanthanum Carbonate in the licensed territories.

We received an upfront payment of $1.0

million upon signature and may receive up to $1.0 million in milestone payments upon product launch in China and will be eligible for

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, Lee’s Pharm will be responsible for development, registration filing and approval for Renazorb in the licensed

In addition, Lee’s Pharm will have sole responsibility for the importation of the drug product from Unicycive and

for the costs of commercialization of Renazorb in the licensed territories.

We received an upfront payment of $1.0 million upon signature

and may receive up to $1.0 million in milestone payments upon product launch in China and will be eligible for 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 Renazorb in the Republic of Korea.

terms of the agreement, Lotus will be responsible for development, registration filing and approval of Renazorb 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 Renazorb in the Republic of Korea.

We received an upfront payment of $750,000 and may receive up to $4.45 million in milestone payments

and tiered royalties upon achievement of prespecified regulatory and commercial achievements.

We will continue to seek licensing partners for

Renazorb in other territories outside the U.S.

(i.e., Europe, Japan, Canada, South America, and the Middle East.)

opportunity for Renazorb

Renazorb 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

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, Renazorb 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 Renazorb compared with currently

available phosphate binders is likely to lead to improved patient compliance/adherence and more effective disease management.

Average daily dose of phosphate binder

therapies from www.dailymed.nlm.nih.gov.

Product images are proportionally sized.

Tenapanor (Ardelyx):

A Potential 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.

Ardelyx filed an NDA

for tenapanor with the FDA in June of 2020.

In July of 2021, Ardelyx received a Complete Response Letter (“CRL”) from the

FDA’s Division of Cardiology and Nephrology.

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 ultimately was granted an Advisory

Committee meeting in November of 2022, where committee members voted in favor of approving tenapanor (9 to 4 in favor of approving tenapanor

as monotherapy and 10 to 2 in favor of its approval in combination with phosphate binders).

Ardelyx is in discussions with FDA about

the nature of a potential approval of tenapanor and expects that approval in the second half of 2023.

While we can’t predict the outcome of these

negotiations, we believe that given the modest treatment effect of tenapanor that, regardless of the scope of the indication, the clinical

utilization of tenapanor will be predominantly in combination with phosphate binders.

In FDA Advisory Committee briefing documents, the

efficacy of tenapanor in lowering serum phosphorus levels in dialysis patients in an intent-to-treat (ITT) analysis was 0.70mg/dL.

comparison, in the same document FDA summarized the efficacy of lanthanum carbonate as resulting in a reduction in serum phosphorus of

2.0mg/dL in a comparable ITT analysis of clinical data.

Based on this FDA commentary, we would expect Renazorb to be substantially more

effective than tenapanor when used as monotherapy.

Similar to Renazorb, one of the key features of tenapanor’s value proposition

is its low pill burden.

For this reason, we believe that Renazorb may be the most logical phosphate binder to combine with tenapanor

making the two potential new medicines more complimentary than competitive as it would leverage two distinct mechanisms of action to

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

Changing Access and Reimbursement Environment

According to the most recent ESRD PPS “Final

Rule” published for 2023, drugs for the treatment of hyperphosphatemia for Medicare beneficiaries, which are currently provided

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 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 with our anticipated launch timing of Renazorb and could provide for a more rapid launch uptake and competitive

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.

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

(i.e., Europe, Japan, Canada,

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.

Disease overview:

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.

acute kidney injury (AKI)

Acute kidney injury (AKI) is defined as a sudden

loss of kidney function that is diagnosed by increased serum creatinine levels and decreased urine output and is limited to a duration

of 7 days, whereas chronic kidney disease (CKD) is a defined as persistent decrease in kidney function beyond 90 days.

Thus, AKI and

CKD can form a continuum whereby initial kidney injury can lead to persistent renal injury, eventually leading to CKD.

Acute kidney injury (AKI) is estimated to occur

in approximately 20–200 per million population in the community, 7–18% of patients in hospital, and approximately 50% of

patients admitted to the intensive care unit (ICU).

Importantly, AKI is associated with morbidity and mortality;

AKI affects 13 million

people worldwide, and an estimated 2 million people die of AKI every year, whereas AKI survivors are at increased risk of developing

chronic kidney disease (CKD) and end-stage renal disease (ESRD) — conditions that carry a high economic, societal and personal

burden (Chawla et al., Nature Reviews-Nephrology, 2017).

Current treatment of acute kidney injury

Currently there are no FDA approved medicines

to treat 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.

Role of Mitochondria in kidney diseases

The kidney has one of the highest mitochondrial

densities in the body.

Both acute and chronic kidney disease is associated with mitochondrial loss and impaired repair mechanisms, which

subsequently result in increased oxidative damage, cellular injury and cell death.

AKI and CKD not only form a continuum but are a bidirectional

process, wherein maladaptive repair of AKI leads to CKD and patients with underlying CKD conditions are predisposed to the development

Mitochondrial dysfunction plays a crucial role in both AKI and CKD, as shown in the diagram below.

Since mitochondrial dysfunction

is an important factor in the pathogenesis of AKI and CKD, mitochondria have emerged as a therapeutic target for treatment of these diseases.

Adapted from Bhatia et al, Kidney Research

and Practice 2020 39(3):244-258.

Background on nicorandil

Nicorandil, marketed in such products as Ikorel

and Dancor, is indicated for the treatment of chronic stable angina pectoris.

It is currently not approved in the United States

but has been approved for use in Australia, the United Kingdom and most of Europe, and in India, Japan, South Korea, and Taiwan.

is a dual-action mitochondrial potassium (mitochondrial K ATP ) channel activator and nitrate-like vasodilator.

Activation of

mitochondrial K ATP channel leads to restoration of mitochondrial function and cytoprotection.

Nicorandil has extensive safety

and efficacy data from multiple clinical trials, including a 5,000-patient randomized controlled trial (IONA Study, Lancet 2002) and

there is a consensus in the literature that the activation of mitochondrial K ATP channel is the biological basis for

the observed cardio-protection and reno-protection in multiple clinical trials.

Nicorandil efficacy in acute kidney injury

Nicorandil has been reported to have a potential

protective effect in the kidneys in preclinical studies (Shiraishi 2014, Tamura 2012, Tanabe 2012).

In animal studies, nicorandil has

demonstrated efficacy in multiple standard models of kidney disease such as ischemic reperfusion injury, 5/6 nephrectomy models of chronic

kidney disease, diabetic nephropathy and hypertensive models (see Table 4).

Notably, these effects occur in a blood pressure-independent

manner, indicating that these beneficial effects are not simply a result of decreasing pressure-mediated kidney damage, but a direct

beneficial effect on the kidney.

A brief summary from these preclinical studies is provided in the Table below.

Efficacy of nicorandil in standard

models of kidney disease

More importantly, several randomized clinical

studies have indicated improved renal outcomes with nicorandil in patients with chronic kidney disease, poor renal function, and those

undergoing coronary angiography/percutaneous coronary intervention (CAG/PCI).

A brief summary from a couple of randomized clinical trials

in contrast induced nephropathy (AKI) is described in the table below.

Efficacy of nicorandil in clinical

trials in Acute Kidney Injury

In 2020, to bring together the growing evidence

of the effectiveness of nicorandil for the prevention of Contrast Induced Nephropathy (CIN).

Pranata published the results of a systematic

literature review and meta-analysis of clinical studies investigating the use of nicorandil in patients undergoing CAG or PCI.

the seven trials (sample size N=1,532), nicorandil was shown to decrease the incidence of CIN by 69% (OR:

of other factors in the respective studies.

In addition, a subgroup analysis showed that nicorandil also provided protection against

CIN in patients with renal dysfunction (OR:

95% CI 0.22, 0.61), which was defined as an eGFR £ 60 mL/min/1.73 m 2 .

When analyzed by the mode of administration, oral nicorandil was shown to have greater efficacy compared with nicorandil infusions (OR:

0.29 vs 0.40).

Overall, Pranata et al.

concluded that nicorandil was associated with a lower risk of CIN in patients undergoing

CAG/PCI with a moderate level of certainty (Pranata et al 2020).

Limitations of Nicorandil

Despite these promising results, development

of nicorandil for use in acute kidney injury has not been successfully pursued to date.

Nicorandil possesses at least two features that

may limit its use in this clinical setting.

First, nicorandil has a short half-life in humans of approximately 1 hour, which results

in the need to dose nicorandil multiple times per day to achieve sustained blood levels.

Second, nicorandil has been associated with

rare but serious ulcerations in the gastrointestinal tract.

The chance of this rare, but potentially severe, side effect increases with

higher doses and long-term use of this drug and heals after drug withdrawal.

A recent population-based study of this drug’s association

with GI ulceration or perforation has been reported (Lee et al., Scientific Reports, 2015).

This study, based on more than 600,000 randomly

selected patients, found a 43% increase in the risk of GI ulceration and a 60% increase in the risk of GI perforation.

This effect appears

dose-dependent and limits the maximum labeled dose of nicorandil in Europe.

a Pro-drug of Nicorandil

UNI-494 was rationally designed to be absorbed

into the systemic circulation, and once absorbed, to release nicorandil into the bloodstream.

By avoiding direct exposure to the gastrointestinal

tract of nicorandil, it is believed that UNI-494 may be able to minimize or avoid the gastrointestinal side effects of nicorandil.

based on the rate of conversion of UNI-494 to nicorandil in the systemic circulation, UNI-494 may offer greater and/or more prolonged

exposure to nicorandil for the treatment of patients with acute kidney injury.

Our technology for UNI-494 is licensed from Sphaera Pharmaceutical

Private Limited, a Singapore-based company (“Sphaera”), with offices in India and the U.S.

We have the global, exclusive

license to UNI-494.

Sphaera conceived of 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.

We conducted preclinical studies in rats and

dogs demonstrating systemic exposure to nicorandil following oral dosing of UNI-494.

In dogs, oral dosing of UNI-494 produced up to four

times greater systemic exposure to nicorandil compared with literature data on equimolar doses of nicorandil itself.

Mechanism of Action of UNI-494

UNI-494 is a novel proprietary drug that selectively

binds to the SUR2B subunit of the mitochondrial K ATP channel and activates it to restore mitochondrial function and reduce

oxidative stress.

UNI-494 is cleaved by esterase enzymes to form nicorandil, the active metabolite .

kidney injury (AKI) is defined as a sudden loss of kidney function that is diagnosed by increased serum creatinine levels and decreased

urine output and is limited to a duration of 7 days, whereas chronic kidney disease (CKD) is a defined as persistent decrease in kidney

function beyond 90 days.

Thus, AKI and CKD can form a continuum whereby initial kidney injury can lead to persistent renal injury, eventually

leading to CKD.

kidney injury (AKI) is estimated to occur in approximately 20–200 per million population in the community, 7–18% of patients

in hospital, and approximately 50% of patients admitted to the intensive care unit (ICU).

Importantly, AKI is associated with morbidity

and mortality;

AKI affects 13 million people worldwide, and an estimated 2 million people die of AKI every year, whereas AKI survivors

are at increased risk of developing chronic kidney disease (CKD) and end-stage renal disease (ESRD) — conditions that carry a high

economic, societal, and personal burden (Chawla et al., Nature Reviews-Nephrology, 2017).

Graft Function (DGF)

initial target indication for UNI-494 is delayed graft function (DGF).

DGF is a form of acute kidney injury (AKI) caused by the ischemia

reperfusion injury (IRI) phenomenon in kidney transplantation surgery.

DGF is a serious complication of kidney transplantation with no

approved therapies.

Patients who experience DGF have an increased risk of mortality that’s 59% higher than those without DGF.

with DGF are also more than 2 times more likely to be readmitted to the hospital within 30-days post-transplantation and are at 41% increased

risk of long-term graft loss.

Given the average cost of a kidney transplant of nearly $500,000, the economic implications of graft failure

due to DGF are staggering.

potential commercial opportunity for UNI-494 in DGF is substantial.

In the US, 46,630 kidney transplants were performed in 2023.

number would undoubtedly be higher were more donor organs available.

Currently, there are over 80,000 Americans on the waitlist for a

donor kidney.

15% of transplanted kidneys come from living donors meaning that the remaining 85% of donor organs come from deceased donors.

While the incidence of DGF is relatively small (1.6 -3.6%) for living donor organs, the risk is considerably higher for deceased donor

The rate of DGF is 20 - 30.4% for DBD (donor brain death) organs and 45 – 55.1% for DCD (donor circulatory death) organs.

Due to the shortage of donor kidneys and the size of the kidney transplant waitlist, the incidence of DGF is expected to increase as

lower quality organs are transplanted.

treatment of delayed graft function and acute kidney injury

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.

of Mitochondria in kidney diseases

Mitochondria are where most of the energy in a cell is produced.

kidney has one of the highest mitochondrial densities in the body.

Both acute and chronic kidney disease is associated with mitochondrial

loss and impaired repair mechanisms, which subsequently result in increased oxidative damage, cellular injury and cell death.

CKD not only form a continuum but are a bidirectional process, wherein maladaptive repair of AKI leads to CKD and patients with underlying

CKD conditions are predisposed to the development of AKI.

Mitochondrial dysfunction plays a crucial role in both AKI and CKD, as shown

in the diagram below.

Since mitochondrial dysfunction is an important factor in the pathogenesis of AKI and CKD, mitochondria have emerged

as a therapeutic target for treatment of these diseases.

Figure 7 Mitochondrial Damage from Acute Kidney Injury and

Chronic Kidney Disease

from Bhatia et al, Kidney Research and Practice 2020 39(3):244-258.

a Novel Pro-drug of Nicorandil

marketed in such products as Ikorel and Dancor, is indicated for the treatment of chronic stable angina pectoris.

It is currently not

approved in the United States but has been approved for use in Australia, the United Kingdom and most of Europe, and in India, Japan,

South Korea, and Taiwan.

Nicorandil is a dual-action mitochondrial potassium (mitochondrial K ATP ) channel activator and nitrate-like

Activation of mitochondrial K ATP channel leads to restoration of mitochondrial function and cytoprotection.

has extensive safety and efficacy data from multiple clinical trials, including a 5,000-patient randomized controlled trial (IONA Study,

Lancet 2002) and there is a consensus in the literature that the activation of mitochondrial K ATP channel is the biological

basis for the observed cardio-protection and reno-protection in multiple clinical trials.

Although nicorandil is known to be safe, gastrointestinal

ulceration is a rare but severe side effect and it is dose-dependent.

was rationally designed to be absorbed into the systemic circulation, and once absorbed, to release nicorandil into the bloodstream.

By avoiding direct exposure to the gastrointestinal tract of nicorandil, it is believed that UNI-494 may be able to minimize or avoid

the gastrointestinal side effects of nicorandil.

Also, based on the rate of conversion of UNI-494 to nicorandil in the systemic circulation,

UNI-494 may offer greater and/or more prolonged exposure to nicorandil for the treatment of patients with acute kidney injury.

Our technology

for UNI-494 is licensed from Sphaera Pharmaceutical Private Limited, a Singapore-based company (“Sphaera”), with offices

in India and the U.S.

We have the global, exclusive license to UNI-494.

Sphaera conceived of 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.

of Action of UNI-494

is a novel proprietary drug that selectively binds to the SUR2B subunit of the mitochondrial K ATP channel and activates

it to restore mitochondrial function and reduce oxidative stress.

UNI-494 is cleaved by esterase enzymes to form nicorandil, the active

The proposed mechanism of action of UNI-494 is shown in the diagram below:

Clinical trials for UNI-494 in AKI

It is challenging to conduct clinical trials

in AKI trials due to the multiple etiologies of AKI.

We believe that UNI-494 should be evaluated in clinical trials focusing on a few

select etiologies in which UNI-494 has a very strong mechanistic rationale based on nicorandil clinical experience in terms of protection

of kidney function and secondary benefits.

Based on our understanding of the mechanism of

action of the drug, we are in discussions with key opinion leaders (KOLs) to identify the AKI subsets where UNI-494 can be most active

and subsets of AKI patients who are most likely to benefit from UNI-494.

We are planning to conduct preclinical studies in animal models

to further explore the efficacy and development path in the AKI indication.

We have also identified patient populations where we would

not likely evaluate UNI-494 in clinical trials, including patients with prior history of gastrointestinal ulcerations.

This will become

exclusion criteria in future clinical trials for UNI-494.

UNI-494 Development Status

We have completed all

non-clinical safety assessment studies required for regulatory filing and submitted a Clinical Trial Application (CTA) to the Medicines

and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 1 study in healthy volunteers in the United Kingdom in December

The MHRA has completed review of our CTA and issued a notice of acceptance for UNI-494 first-in-human Phase 1 study in healthy

We also plan to file a corresponding Investigational New Drug (IND) application with the FDA in 2024 for a Phase 2 proof-of-concept

trial in acute kidney injury (AKI) patients.

Regulatory Strategy for UNI-494

Nicorandil is already approved in Europe and

Asia for the treatment of heart disease.

We believe there is a possibility these historical Nicorandil data, along with preclinical and

clinical data with UNI-494 itself, can be utilized for streamlined U.S.

Figure 8 Mechanism of Action of UNI-494

Ischemia/reperfusion

injury (IRI) is one of the main reasons for causing acute kidney injury (AKI) that results in DGF during kidney transplantation.

preconditioning, that works by activating K ATP channels in mitochondria, is a natural endogenous mechanism which protects

cells from IRI in the heart, kidney, liver, and other organs.

UNI-494 is a pharmacological approach that emulates and enhances this natural

phenomenon of ischemic preconditioning.

of UNI-494 in Animal Models:

We recently conducted pre-clinical pharmacology studies to evaluate the efficacy of UNI-494 in animal

The ischemia reperfusion injury (IRI) model of DGF in rats was used to study the efficacy of UNI-494 in preventive mode on kidney

injury with a special focus on kidney functional markers (serum creatinine [sCr], blood urea nitrogen [BUN], and urinary albumin/creatinine

ratio [ACR]), tubular injury markers (urinary neutrophil gelatinase-associated lipocalin [NGAL] and proximal tubular damage (proximal

tubular injury scores via histology.

UNI-494 was administered 30 minutes prior to the induction of ischemia, IR induced significant increases

of sCr, BUN, ACR, NGAL, β2-MG, and proximal tubular injury damage scores in the vehicle treated DGF group when compared to No DGF

sham group (p<0.0001 – as per one-way ANOVA multiple comparison test).

Following treatment with UNI-494, there was a statistically

significant reduction of biomarkers and improvement in tubular injury as shown in the figure below.

Figure 9 Effect of UNI-494 on Ischemia-Reperfusion Injury in

Clinical Development Status

have completed non-clinical safety assessment studies required for regulatory filing and submitted a Clinical Trial Application (CTA)

to the Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 1 study in healthy volunteers in the United

The MHRA has completed review of our CTA and issued a notice of acceptance for UNI-494 first-in-human Phase 1 study in

healthy volunteers.

We initiated the Phase I study in healthy volunteers to evaluate the safety and tolerability of UNI-494.

to complete the study during the 2H of 2024.

trials for UNI-494 in Acute Kidney Injury

I study in Healthy volunteers:

This is a single-center, double-blind, placebo-controlled, randomized single ascending dose (SAD)

(Part 1) and multiple ascending dose (MAD) (Part 2) study in healthy male and female subjects of non-childbearing potential.

enroll up to approximately 40 subjects in 5 cohorts of 8 subjects each (randomized to a ratio of 6 active and 2 placebo per cohort).

There will be an interim decision meeting after each cohort/period, to review the safety, tolerability, and PK data in order to decide

the dose level for the subsequent cohort.

Part 2 will enroll approximately 20 subjects in 2 cohorts of 10 subjects each, randomized to

a ratio of 8 active treatment to 2 placebo who will be dosed for 5 days.

The dose level for the Part 2 Cohort 1 will be selected based

on the safety, tolerability and PK data from Part 1.

study is actively enrolling subjects in the UK.

We have completed Part 1 of the study.

Part 2 of the study is in progress and we expect

to complete this study in 2H of 2024.

of Concept Phase 2 Study in DGF

are in discussions with our Key Opinion Leaders (KOLs) regarding target patient population, study design including dose, duration of

treatment, and sample size for the proof of principle Phase 2 study to prevent DGF in kidney transplantation patients.

Based on the mechanism

of action of UNI-494, our goal is to identify the target kidney transplant patient population who are most likely to benefit from UNI-494.

We have also identified patient populations where we would not likely evaluate UNI-494 in clinical trials, including patients with prior

history of gastrointestinal ulcerations.

This will become exclusion criteria in future clinical trials for UNI-494.

plan to file an Investigational New Drug (IND) application with the FDA to initiate a Phase 2 proof-of-concept trial for the prevention

of Delayed Graft Function in Kidney Transplantation in Q4, 2024.

Strategy for UNI-494

Drug Designation:

In February 2024, the FDA granted orphan drug designation to UNI-494 for prevention of DGF in patients undergoing solid

organ transplantation.

The FDA, through its Office of Orphan Products Development (OOPD), grants orphan drug designation to drugs that

have the potential to offer a safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 patients

in the United States.

Orphan drug designation provides certain benefits to the drug developer that include the following:

1) tax credits

for qualified clinical trials, 2) exemption of user fees and 3) potential for seven years of market exclusivity after approval.

FDA issued a guidance to industry in 2019 for development of drugs for prevention of DGF in kidney transplantation.

This guidance outlines

the study design, patient population, randomization, stratification, dose selection and primary endpoints required for registration of

drugs in DGF.

This guidance provides a clear path for development of drugs for prevention of DGF.

is already approved in Europe and Asia for the treatment of heart disease.

We believe there is a possibility these historical Nicorandil

data, along with preclinical and clinical data with UNI-494 itself, can be utilized for streamlined U.S.

FDA review of UNI-494.

While pre-clinical requirements to start

a clinical program for an IND would be similar for UNI-494 as for NCE (New Chemical Entity).

We believe that the vast clinical data set

from Nicorandil will potentially help us to expedite the clinical development program with the FDA.

Market Potential

According to a 2017 article by Silver and Chertow,

the current cost of care for AKI in the U.S.

is estimated to be between $5.4 billion to $24 billion per year.

In England, inpatient costs

related to AKI are estimated to make up 1% of the total National Health Service budget.

With no effective treatment for AKI, it is not

possible to definitively state a market figure.

However, with the high cost and burden of caring for AKI patients, we believe a conservative

market estimate is approximately $3 billion in the U.S.

The lack of effective therapeutic interventions for AKI means that UNI-494

has the potential to be the first drug approved for the treatment of AKI.

the pre-clinical requirements to start a clinical program for an IND would be similar for UNI-494 as for NCE (New Chemical Entity), we

believe that the vast clinical data set from Nicorandil will potentially help us to expedite the clinical development program with the

Delayed Graft Function (DGF):

A UNI-494 per patient treatment cost of $25,000 for the ~40,000 deceased donor kidney transplants per

year values the DGF market at $1 billion.

This estimate of the DGF market potential is only intended to be illustrative.

The commercial

potential of UNI-494 will be determined by the portion of the market ultimately addressable by UNI-494 and its actual launch price.

the economic consequences of kidney graft failure, a clinically effective UNI-494 could reasonably command a significantly higher market

Acute Kidney Injury (AKI):

According to a 2017 article by Silver and Chertow, the current cost of care for AKI in the U.S.

to be between $5.4 billion to $24 billion per year.

In England, inpatient costs related to AKI are estimated to make up 1% of the total

National Health Service budget.

With no effective treatment for AKI, it is not possible to definitively state a market figure.

with the high cost and burden of caring for AKI patients, we believe a conservative market estimate is approximately $3 billion in the

The lack of effective therapeutic interventions for AKI means that UNI-494 has the potential to be the first drug approved

for the treatment of AKI.

AKI is a heterogeneous disease.

We plan to target a more homogeneous

AKI population for UNI-494 by focusing on kidney injury caused by complications from heart failure, surgeries, drugs, and contrast induced

Sphaera License Agreement

On October 1, 2017, we entered into an exclusive

license agreement (the “Sphaera License Agreement”) with Sphaera Pharma Pte.

Ltd., a Singaporean pharmaceutical corporation

Pursuant to the Sphaera License Agreement, we acquired an exclusive royalty-bearing worldwide license to develop,

make, have made, use, practice, research, distribute, lease, sell, offer for sale, license, import or otherwise dispose of certain rights

owned or controlled by Sphaera and/or any of its affiliates, related to UNI-494 (the “UNI-494 Rights”).

We also acquired

a non-exclusive license to certain know-how and technology related to the UNI-494 Rights.

Sphaera conceived of and performed initial

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

characterization and preliminary animal pharmacokinetic studies.

We plan to target a more homogeneous AKI population for UNI-494 by focusing

on kidney injury caused by complications from heart failure, surgeries, drugs, and contrast induced nephropathy.

License Agreement

October 1, 2017, we entered into an exclusive license agreement (the “Sphaera License Agreement”) with Sphaera Pharma Pte.

Ltd., a Singaporean pharmaceutical corporation (“Sphaera”).

Pursuant to the Sphaera License Agreement, we acquired an exclusive

royalty-bearing worldwide license to develop, make, have made, use, practice, research, distribute, lease, sell, offer for sale, license,

import or otherwise dispose of certain rights owned or controlled by Sphaera and/or any of its affiliates, related to UNI-494 (the “UNI-494

We also acquired a non-exclusive license to certain know-how and technology related to the UNI-494 Rights.

Sphaera conceived

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

some initial physicochemical characterization and preliminary animal pharmacokinetic studies.

Under the terms of the Sphaera License Agreement,

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may be granted to us in the future will be commercially useful in protecting our commercial products and methods of using and manufacturing

Renazorb Patent Portfolio

Our Renazorb patent portfolio includes one family

of granted United States patents, with related applications pending, and an additional family of granted foreign patents, with related

applications also pending.

Granted and pending claims offer various forms of protection for Renazorb including claims to compositions

of matter, pharmaceutical compositions, specific forms (such as polymorphs of lanthanum dioxycarbonate), methods of making the composition

of matter, and methods for treating elevated levels of phosphate in the blood using Renazorb.

These United States patents and applications,

and their foreign equivalents, are described in more detail below.

Oxylanthanum Carbonate Patent Portfolio

Our Oxylanthanum Carbonate patent portfolio includes

one family of granted United States patents, with related applications pending, and an additional family of granted foreign patents,

with related applications also pending.

Granted and pending claims offer various forms of protection for Oxylanthanum Carbonate including

claims to compositions of matter, pharmaceutical compositions, specific forms (such as polymorphs of lanthanum dioxycarbonate),

methods of making the composition of matter, and methods for treating elevated levels of phosphate in the blood using Oxylanthanum Carbonate.

These United States patents and applications, and their foreign equivalents, are described in more detail below.

Both the U.S.

patent family and the foreign patent

family containing claims to Renazorb and related compounds were filed in 2011.

Exclusive of patent term extension, the U.S.

from this family containing claims covering Renazorb has a statutory expiration date in 2031.

Corresponding patents granted in Canada,

Europe (validated in multiple European Patent Convention member states), Japan, China, Australia, and other countries have statutory

expiration dates in 2031.

family containing claims to Oxylanthanum Carbonate and related compounds were filed in 2011.

Exclusive of patent term extension,

patents from this family containing claims covering Oxylanthanum Carbonate has a statutory expiration date in 2031.

Corresponding

patents granted in Canada, Europe (validated in multiple European Patent Convention member states), Japan, China, Australia, and other

countries have statutory expiration dates in 2031.

In some cases, granted United States patents

claiming Renazorb have a longer statutory term than the corresponding foreign patents.

This results from the USPTO’s practice of

granting patent term adjustments for prosecution delays originating at the USPTO.

Such adjustments are generally not available under

foreign patent laws.

If Renazorb is approved for marketing in the United States, under the Hatch-Waxman Act we may be eligible for up

to five years patent term extension for a granted United States patent containing claims covering Renazorb.

Similar term extensions may

be available in Europe, Japan, Australia, and certain other foreign jurisdictions.

The amount of any such term extension, and the identity

of the patent to which it would apply, are dependent upon several factors including the duration of the development program and the date

of marketing approval.

claiming Oxylanthanum Carbonate have a longer statutory term than the corresponding foreign patents.

This results from the USPTO’s

practice of granting patent term adjustments for prosecution delays originating at the USPTO.

Such adjustments are generally not available

under foreign patent laws.

If Oxylanthanum Carbonate is approved for marketing in the United States, under the Hatch-Waxman Act we may

be eligible for up to five years patent term extension for a granted United States patent containing claims covering Oxylanthanum Carbonate.

Similar term extensions may be available in Europe, Japan, Australia, and certain other foreign jurisdictions.

The amount of any such

term extension, and the identity of the patent to which it would apply, are dependent upon several factors including the duration of

the development program and the date of marketing approval.

The most relevant granted United States patents

with claims covering Renazob are listed below, along with their projected expiration dates exclusive of any patent term extension.

Lanthanum carbonate hydroxide, lanthanum oxycarbonate and

methods of their manufacture and use

Lanthanum carbonate hydroxide, lanthanum oxycarbonate and methods of

their manufacture and use

with claims covering Oxylanthanum Carbonate are listed below, along with their projected expiration dates exclusive of any patent term

carbonate hydroxide, lanthanum oxycarbonate and methods of their manufacture and use

We believe that we have a strong global intellectual

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Government authorities in the United States at

the federal, state and local level, including the FDA, the FTC and the DEA, extensively regulate, among other things, the research, development,

testing, manufacturing, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising, distribution,

marketing and export and import of products such as those we plan to develop and market.

For both the products under development and

to be marketed, failure to comply with applicable regulatory requirements can, among other things, result in suspension of regulatory

the federal, state, and local level, including the FDA, the FTC and the DEA, extensively regulate, among other things, the research,

development, testing, manufacturing, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising,

distribution, marketing and export and import of products such as those we plan to develop and market.

For both the products under development

and to be marketed, failure to comply with applicable regulatory requirements can, among other things, result in suspension of regulatory

approval and possible civil and criminal sanctions.

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drug may be marketed in the United States generally involves:

Completion of preclinical laboratory and animal testing and formulation

studies in compliance with the FDA’s current good laboratory practice (GLP) regulations;

Submission to the FDA of an IND for human clinical testing, which must

become effective before human clinical trials may begin in the United States;

of preclinical laboratory and animal testing and formulation studies in compliance with the

FDA’s current good laboratory practice (GLP) regulations;

to the FDA of an IND for human clinical testing, which must become effective before human

clinical trials may begin in the United States;

by an institutional review board (IRB) at each clinical site before each trial may be initiated;

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safety and efficacy of the proposed drug product for each intended use;

Satisfactory completion of a pre-approval inspection by FDA of the

facility or facilities at which the product is manufactured to assess compliance with the FDA’s cGMP regulations and to assure

that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

Submission to the FDA of an NDA;

Satisfactory completion of a potential review by an FDA advisory committee,

if applicable;

FDA review and approval of the NDA.

● Satisfactory

completion of a pre-approval inspection by FDA of the facility or facilities at which the

product is manufactured to assess compliance with the FDA’s cGMP regulations and to

assure that the facilities, methods and controls are adequate to preserve the drug’s

identity, strength, quality and purity;

to the FDA of an NDA;

● Satisfactory

completion of a potential review by an FDA advisory committee, if applicable;

review and approval of the NDA.

Preclinical Studies

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Clinical Trials

Clinical trials involve the administration of

the investigational new drug to human subjects under the supervision of qualified investigators in accordance with GCP requirements,

which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical

Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be

used in monitoring safety, and the effectiveness criteria to be evaluated.

A protocol for each clinical trial and any subsequent protocol

amendments must be submitted to the FDA as part of the IND.

In addition, an IRB at each institution participating in the clinical trial

must review and approve the plan for any clinical trial before it is initiated at that institution.

Information about certain clinical

trials must be submitted within specific timeframes to the NIH for public dissemination on their www.clinicaltrials.gov website.

Once the IND has been approved by the FDA, the company may begin conducting

clinical trials.

Clinical trials involve the administration of the investigational new drug to human subjects under the supervision of

qualified investigators in accordance with GCP requirements, which include the requirement that all research subjects provide their informed

consent in writing for their participation in any clinical trial.

Clinical trials are conducted under protocols detailing, among other

things, the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated.

protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND.

an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it is initiated

at that institution.

Information about certain clinical trials must be submitted within specific timeframes to the NIH for public dissemination

on their www.clinicaltrials.gov website.

Human clinical trials are typically conducted

in three sequential phases, which may be distinct, or overlap or be combined:

The drug is initially introduced into healthy human subjects

or patients with the target disease or condition, and tested for safety, dosage tolerance, absorption, metabolism, distribution,

excretion and, if possible, to gain an early indication of its effectiveness.

The drug is administered to a limited patient population to

identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases

and to determine dosage tolerance.

The drug is administered to an expanded patient population,

generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically

evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to

provide adequate information for the labeling of the product.

The drug is initially introduced into healthy human subjects or patients with the target

disease or condition, and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain

an early indication of its effectiveness.

The drug is administered to a limited patient population to identify possible adverse

effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage

The drug is administered to an expanded patient population, generally at geographically

dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and

safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information

for the labeling of the product.

Progress reports detailing the results of the

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rather than accept an NDA for filing.

In some events, the NDA may be required to be resubmitted with the additional information and it

may be subject to payment of additional user fees.

The resubmitted application is also subject to review before the FDA accepts it for

In some events, the NDA may be required to be resubmitted with additional information and it may

be subject to payment of additional user fees.

The resubmitted application is also subject to review before the FDA accepts it for filing.

Once the submission is accepted for filing, the FDA begins an in-depth substantive review.

Under the Prescription Drug User Fee

Act, as amended, the FDA has agreed to certain performance goals for itself for the review of NDAs through a two-tiered classification

system, Standard Review and Priority Review.

Priority Review designation is given to drugs that are intended to treat a serious condition

and, if approved, would provide a significant improvement in safety or effectiveness over existing therapies.

Under the Prescription Drug User Fee Act,

as amended, the FDA has agreed to certain performance goals for itself for the review of NDAs through a two-tiered classification system,

Standard Review and Priority Review.

Priority Review designation is given to drugs that are intended to treat a serious condition and,

if approved, would provide a significant improvement in safety or effectiveness over existing therapies.

The FDA endeavors to review

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An NDA supplement for a new indication typically requires clinical data

similar to that in the original application, and the FDA uses the similar procedures in reviewing NDA supplements as it does in reviewing

similar to that in the original application, and the FDA uses similar procedures in reviewing NDA supplements as it does in reviewing

the original NDAs.

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Sponsors are also obligated to discuss certain results of their clinical trials

after its completion.

after their completion.

Disclosure of the results of these trials can be delayed until the new product or new indication being studied

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which are typically assigned on a quarterly basis, the rule provides some support for our assumption that all hyperphosphatemia drugs,

including Renazorb, will be included in the ESRD PPS bundle and will be eligible for separate payment initially under TDAPA.

including Oxylanthanum Carbonate, will be included in the ESRD PPS bundle and will be eligible for separate payment initially under TDAPA.

The containment of healthcare costs also has

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EU member states may approve a specific

price for a product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the product

on the market.

Other member states allow companies to fix their own prices for products but monitor and control prescription volumes

and issue guidance to physicians to limit prescriptions.

Recently, many countries in the European Union have increased the amount of

discounts required on pharmaceuticals and these efforts could continue as countries attempt to manage healthcare expenditures, especially

price for a product or they may instead adopt a system of direct or indirect controls on the profitability of the company placing the

product on the market.

Other member states allow companies to fix their own prices for products but monitor and control prescription

volumes and issue guidance to physicians to limit prescriptions.

Recently, many countries in the European Union have increased the amount

of discounts required on pharmaceuticals and these efforts could continue as countries attempt to manage healthcare expenditures, especially

in light of the severe fiscal and debt crises experienced by many countries in the European Union.

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Our ability to generate product revenue and achieve

profitability depends on the overall success of Renazorb , UNI-494, and any current or future product candidates, including those that

may be in-licensed or acquired, which depends on several factors, including:

profitability depends on the overall success of Oxylanthanum Carbonate, UNI-494, and any current or future product candidates, including

those that may be in-licensed or acquired, which depends on several factors, including:

adequate or favorable pricing and reimbursement from private and governmental payors for

UNI-494, and any other product or product candidate, including those that may be in-licensed

and maintaining market acceptance of Renazorb, UNI-494, and any other product candidate,

including those that may be in-licensed or acquired;

size of any market in which Renazorb, UNI-494, and any other product or product candidate,

including those that may be in-licensed or acquired, receives approval and obtaining adequate

market share in those markets;

timing and scope of marketing approvals for Renazorb, UNI-494, and any other product candidate,

if approved, including those that may be in-licensed or acquired;

or perceived advantages or disadvantages of our products or product candidates as compared

to alternative treatments, including their respective safety, tolerability and efficacy profiles,

the potential convenience and ease of administration and cost;

● maintaining

an acceptable safety and tolerability profile of our approved products, including the frequency

and severity of any side effects;

willingness of the target patient population to try new therapies and of physicians to prescribe

these therapies, based, in part, on their perception of our clinical trial data and/or the

actual or perceived safety, tolerability and efficacy profile;

and maintaining market acceptance of Oxylanthanum Carbonate, UNI-494, and any other product

candidate, including those that may be in-licensed or acquired;

size of any market in which Oxylanthanum Carbonate, UNI-494, and any other product or product

candidate, including those that may be in-licensed or acquired, receives approval and obtaining

adequate market share in those markets;

timing and scope of marketing approvals for Oxylanthanum Carbonate, UNI-494, and any other

product candidate, if approved, including those that may be in-licensed or acquired;

actual or perceived advantages

or disadvantages of our products or product candidates as compared to alternative treatments, including their respective safety,

tolerability and efficacy profiles, the potential convenience and ease of administration and cost;

maintaining an acceptable

safety and tolerability profile of our approved products, including the frequency and severity of any side effects;

the willingness of the

target patient population to try new therapies and of physicians to prescribe these therapies, based, in part, on their perception

of our clinical trial data and/or the actual or perceived safety, tolerability and efficacy profile;

● establishing

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adequate supplies of products that are compliant with good manufacturing practices, or GMPs,

to support the clinical development and the market demand for Renazorb, UNI-494, and any

other product and product candidate, including those that may be in-licensed or acquired;

to support the clinical development and the market demand for Oxylanthanum Carbonate, UNI-494,

and any other product and product candidate, including those that may be in-licensed or acquired;

and future restrictions or limitations on our approved or future indications and patient

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Our business is substantially dependent on the

commercial success of Renazorb, if approved.

If we are unable to successfully commercialize Auryxia, our results or operations and financial

condition will be materially harmed.

Our ability to generate revenue depends on our ability to execute on our commercialization plans,

and the size of the market for, and the level of market acceptance of, Renazorb and any other product or product candidate, including

those that may be in-licensed or acquired.

If the size of any market for which a product or product candidate is approved decreases or

is smaller than we anticipate, our revenue and results of operations could be materially adversely affected.

Market acceptance is also

critical to our ability to generate significant product revenue.

Any product may achieve only limited market acceptance or none at all.

If Renazorb, or any of our product candidates that is approved, is not accepted by the market to the extent that we expect or market

acceptance decreases, we may not be able to generate significant product revenue and our business would be materially harmed.

acceptance of Renazorb or any other approved product depends on a number of factors, including:

commercial success of Oxylanthanum Carbonate, if approved.

If we are unable to successfully commercialize Oxylanthanum Carbonate, our

results or operations and financial condition will be materially harmed.

Our ability to generate revenue depends on our ability to execute

on our commercialization plans, and the size of the market for, and the level of market acceptance of, Oxylanthanum Carbonate and any

other product or product candidate, including those that may be in-licensed or acquired.

If the size of any market for which a product

or product candidate is approved decreases or is smaller than we anticipate, our revenue and results of operations could be materially

adversely affected.

Market acceptance is also critical to our ability to generate significant product revenue.

Any product may achieve

only limited market acceptance or none at all.

If Oxylanthanum Carbonate, or any of our product candidates that is approved, is not accepted

by the market to the extent that we expect or market acceptance decreases, we may not be able to generate significant product revenue

and our business would be materially harmed.

Market acceptance of Oxylanthanum Carbonate or any other approved product depends on a number

of factors, including:

availability of adequate coverage and reimbursement by and the availability of discounts,

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claims we and our collaborators are able to make regarding the safety and efficacy of the

success of our physician and patient communications and education programs;

the success of our physician

and patient communications and education programs;

by physicians and patients of the product as a safe and effective treatment and the willingness

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effectiveness of our and our collaborators’ sales, marketing, and distribution efforts.

In order to market Renazorb and any other approved

product, we intend to invest in sales and marketing, which will require substantial effort and significant management and financial resources.

Additionally, training a sales force to successfully sell and market a new commercial product is expensive and time-consuming and could

delay any commercial launch of such product candidate.

We may underestimate the size of the sales force required for a successful product

launch and we may need to expand our sales force earlier and at a higher cost than we anticipated.

We will devote significant effort,

in particular, to recruiting individuals with experience in the sales and marketing of pharmaceutical products.

Competition for personnel

with these skills is significant and retaining qualified personnel with experience in our industry is difficult.

As a result, we may

not be able to retain our existing employees or hire new employees quickly enough to meet our needs.

At the same time, we may face high

turnover, requiring us to expend time and resources to source, train and integrate new employees.

There are risks involved with building

our own sales and marketing capabilities, including the following:

In order to market Oxylanthanum Carbonate and

any other approved product, we intend to invest in sales and marketing, which will require substantial effort and significant management

and financial resources.

Additionally, training a sales force to successfully sell and market a new commercial product is expensive and

time-consuming and could delay any commercial launch of such product candidate.

We may underestimate the size of the sales force required

for a successful product launch and we may need to expand our sales force earlier and at a higher cost than we anticipated.

We will devote

significant effort, in particular, to recruiting individuals with experience in the sales and marketing of pharmaceutical products.

for personnel with these skills is significant and retaining qualified personnel with experience in our industry is difficult.

we may not be able to retain our existing employees or hire new employees quickly enough to meet our needs.

At the same time, we may

face high turnover, requiring us to expend time and resources to source, train and integrate new employees.

There are risks involved

with building our own sales and marketing capabilities, including the following:

inability to recruit, train and retain adequate numbers of effective sales and marketing

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If we are unable to build our own sales and marketing

capabilities, we will not be successful in commercializing Renazorb, UNI-494, and any other product candidate that may be approved.

if we are unable to maintain our arrangements with third parties with respect to sales and marketing, if we are unsuccessful in entering

into additional arrangements with third parties to sell and market our products or we are unable to do so on terms that are favorable

to us, or if such third parties are unable to carry out their obligations under such arrangements, it will be difficult to successfully

commercialize our product and product candidates, including Renazorb, if approved.

capabilities, we will not be successful in commercializing Oxylanthanum Carbonate, UNI-494, and any other product candidate that may

Furthermore, if we are unable to maintain our arrangements with third parties with respect to sales and marketing, if we

are unsuccessful in entering into additional arrangements with third parties to sell and market our products or we are unable to do so

on terms that are favorable to us, or if such third parties are unable to carry out their obligations under such arrangements, it will

be difficult to successfully commercialize our product and product candidates, including Oxylanthanum Carbonate, if approved.

Our, or our partners’, failure to obtain

or maintain adequate coverage, pricing and reimbursement for Renazorb, if approved, or any other future approved products, could have

a material adverse effect on our or our collaboration partners’ ability to sell such approved products profitably and otherwise

have a material adverse impact on our business.

or maintain adequate coverage, pricing and reimbursement for Oxylanthanum Carbonate, if approved, or any other future approved products,

could have a material adverse effect on our or our collaboration partners’ ability to sell such approved products profitably and

otherwise have a material adverse impact on our business.

Market acceptance and sales of any approved products,

including Renazorb and UNI-494, depends significantly on the availability of adequate coverage and reimbursement from third party payors

and may be affected by existing and future healthcare reform measures.

Governmental authorities, third party payors, and PBMs decide

which drugs they will cover, as well as establish formularies or implement other mechanisms to manage utilization of products and determine

reimbursement levels.

We cannot be sure that coverage or adequate reimbursement will be available for Renazorb, UNI-494, or any of our

potential future products.

Even if we obtain coverage for an approved product, third party payors may not establish adequate reimbursement

amounts, which may reduce the demand for our product and prompt us to have to reduce pricing for the product.

If reimbursement is not

available or is limited, we may not be able to commercialize certain of our products.

Coverage and reimbursement by a governmental authority,

third-party payor or PBM may depend upon a number of factors, including the determination that use of a product is:

including Oxylanthanum Carbonate and UNI-494, depends significantly on the availability of adequate coverage and reimbursement from third

party payors and may be affected by existing and future healthcare reform measures.

Governmental authorities, third party payors, and

PBMs decide which drugs they will cover, as well as establish formularies or implement other mechanisms to manage utilization of products

and determine reimbursement levels.

We cannot be sure that coverage or adequate reimbursement will be available for Oxylanthanum Carbonate,

UNI-494, or any of our potential future products.

Even if we obtain coverage for an approved product, third party payors may not establish

adequate reimbursement amounts, which may reduce the demand for our product and prompt us to reduce pricing for the product.

If reimbursement

is not available or is limited, we may not be able to commercialize certain of our products.

Coverage and reimbursement by a governmental

authority, third-party payor or PBM may depend upon a number of factors, including the determination that use of a product is:

covered benefit under the health plan;

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for the specific patient;

cost effective.

Obtaining coverage and reimbursement approval

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with more extensive product lines.

We currently believe it is likely that Renazorb, if approved, will be reimbursed using the Transitional

Drug Add-on Payment Adjustment, or TDAPA, followed by inclusion in the bundled reimbursement model for Medicare beneficiaries.

that obtain dialysis through commercial insurance during the 30-month coordination period or through Medicaid prior to Medicare becoming

primary payer after 90 days, patients may access Renazorb through contracts we negotiate with third party payors for reimbursement of

Renazorb, which would be subject to the risks and uncertainties described above.

Additionally, applying for and obtaining reimbursement

under the TDAPA may take an undetermined amount of time following approval, which will affect adoption, uptake and product revenue for

Renazorb during that time, and if there are updates to the TDAPA rule that decrease the basis for reimbursement or eligibility criteria

during the transition period or if the TDAPA is eliminated, then our profitability may be adversely affected.

Further, if Renazorb is

approved in the United States and included in the fixed reimbursement model for a bundle of dialysis services, or the bundle, we would

be required to enter into contracts to supply Renazorb to specific dialysis providers, instead of through distributors.

We currently believe it is likely that Oxylanthanum Carbonate, if approved, will be reimbursed using

the Transitional Drug Add-on Payment Adjustment, or TDAPA, followed by inclusion in the bundled reimbursement model for Medicare beneficiaries.

For those that obtain dialysis through commercial insurance during the 30-month coordination period or through Medicaid prior to Medicare

becoming primary payer after 90 days, patients may access Oxylanthanum Carbonate through contracts we negotiate with third party payors

for reimbursement of Oxylanthanum Carbonate, which would be subject to the risks and uncertainties described above.

Additionally, applying

for and obtaining reimbursement under the TDAPA may take an undetermined amount of time following approval, which will affect adoption,

uptake, and product revenue for Oxylanthanum Carbonate during that time, and if there are updates to the TDAPA rule that decrease the

basis for reimbursement or eligibility criteria during the transition period or if the TDAPA is eliminated, then our profitability may

be adversely affected.

Further, if Oxylanthanum Carbonate is approved in the United States and included in the fixed reimbursement model

for a bundle of dialysis services, or the bundle, we would be required to enter into contracts to supply Oxylanthanum Carbonate to specific

dialysis providers, instead of through distributors.

The dialysis market is unique and is dominated

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resulting in that product not being on that organization’s formulary.

If any dialysis organization does not add Renzorb, to the

formulary, our business may be materially harmed.

In addition, we may be unable to sell Renazorb to dialysis providers on a profitable

basis if CMS significantly reduces the level of reimbursement for dialysis services and providers choose to use alternative therapies

or look to re-negotiate their contracts with us.

Adequate coverage and reimbursement of our products by government and private insurance

plans are central to patient and provider acceptance of any products for which we receive marketing approval.

Further, in many countries

outside the United States, a drug must be approved for reimbursement before it can be marketed or sold in that country.

In some cases,

the prices that we intend to charge for our products are also subject to approval.

Approval by the EMA or another regulatory authority

does not ensure approval by reimbursement authorities in that jurisdiction, and approval by one reimbursement authority outside the United

States does not ensure approval by any other reimbursement authorities.

However, the failure to obtain reimbursement in one jurisdiction

may negatively impact our ability to obtain reimbursement in another jurisdiction.

We may not be able to obtain such reimbursement approvals

on a timely basis, if at all, and favorable pricing in certain countries depends on a number of factors, some of which are outside of

In addition, if Renazorb is approved outside of the United States, we plan to rely on a partner to obtain approval by reimbursement

authorities outside the United States.

If we are unsuccessful or delayed in entering into an agreement with a new partner, the launch

of Renazorb following approval outside the United States may be delayed, which could have an adverse effect on our results of operations.

If any dialysis organization does not add Oxylanthanum Carbonate,

to the formulary, our business may be materially harmed.

In addition, we may be unable to sell Oxylanthanum Carbonate to dialysis providers

on a profitable basis if CMS significantly reduces the level of reimbursement for dialysis services and providers choose to use alternative

therapies or look to re-negotiate their contracts with us.

Adequate coverage and reimbursement of our products by government and private

insurance plans are central to patient and provider acceptance of any products for which we receive marketing approval.

Further, in many

countries outside the United States, a drug must be approved for reimbursement before it can be marketed or sold in that country.

some cases, the prices that we intend to charge for our products are also subject to approval.

Approval by the EMA or another regulatory

authority does not ensure approval by reimbursement authorities in that jurisdiction, and approval by one reimbursement authority outside

the United States does not ensure approval by any other reimbursement authorities.

However, the failure to obtain reimbursement in one

jurisdiction may negatively impact our ability to obtain reimbursement in another jurisdiction.

We may not be able to obtain such reimbursement

approvals on a timely basis, if at all, and favorable pricing in certain countries depends on a number of factors, some of which are

outside of our control.

In addition, if Oxylanthanum Carbonate is approved outside of the United States, we plan to rely on a partner

to obtain approval by reimbursement authorities outside the United States.

If we are unsuccessful or delayed in entering into an agreement

with a new partner, the launch of Oxylanthanum Carbonate following approval outside the United States may be delayed, which could have

an adverse effect on our results of operations.

We expect to face substantial competition,

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Our future success depends on our ability to demonstrate

and maintain a competitive advantage with respect to the development and commercialization of Renazorb, and any other product or product

candidate, including those that may be in-licensed or acquired.

Renazorb will compete in the hyperphosphatemia market in the United States

with other FDA-approved phosphate binders such as Renagel® (sevelamer hydrochloride) and Renvela® (sevelamer carbonate), both

marketed by Sanofi, PhosLo® and Phoslyra® (calcium acetate), marketed by Fresenius Medical Care North America, Fosrenol®

(lanthanum carbonate), marketed by Shire Pharmaceuticals Group plc, Velphoro® (sucroferric oxyhydroxide), marketed by Fresenius Medical

Care North America, and Auryxia (ferric citrate), marketed by Akebia Therapeutics, as well as over-the-counter calcium carbonate products

such as TUMS® and metal-based options such as aluminum, lanthanum and magnesium.

Most of the phosphate binders listed above are now

also available in generic forms.

In addition, other agents are in development, including OPKO Health Inc.’s Alpharen™ Tablets

(fermagate tablets) and Ardelyx, Inc.’s tenapanor (which is approved in the United States for the treatment of adults with irritable

bowel syndrome with constipation, and for which the FDA granted an appeal in the fourth quarter of 2022 that will allow Ardelyx to resubmit

a new drug application in 2023 with respect to the control of serum phosphorus in adult patients with CKD on dialysis), that may impact

the market for Renazorb.

and maintain a competitive advantage with respect to the development and commercialization of Oxylanthanum Carbonate, and any other product

or product candidate, including those that may be in-licensed or acquired.

Oxylanthanum Carbonate will compete in the hyperphosphatemia

market in the United States with other FDA-approved phosphate binders such as Renagel® (sevelamer hydrochloride) and Renvela®

(sevelamer carbonate), both marketed by Sanofi, PhosLo® and Phoslyra® (calcium acetate), marketed by Fresenius Medical Care North

America, Fosrenol® (lanthanum carbonate), marketed by Shire Pharmaceuticals Group plc, Velphoro® (sucroferric oxyhydroxide),

marketed by Fresenius Medical Care North America, and Auryxia (ferric citrate), marketed by Akebia Therapeutics, Xphozah® (tenapanor),

marketed by Ardelyx, as well as over-the-counter calcium carbonate products such as TUMS® and metal-based options such as aluminum,

lanthanum and magnesium.

Most of the phosphate binders listed above are now also available in generic forms.

In addition, other agents

are in development, including OPKO Health Inc.’s Alpharen™ Tablets (fermagate tablets) that may impact the market for Oxylanthanum

Smaller and other early-stage companies may also prove to be significant

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to comply could result in fines or penalties, as well as loss of business that could have a material adverse effect on our financial

Federal Regulation of Patent Litigation Settlements

and Authorized Generic Arrangements

Federal Regulation of Patent Litigation Settlements and Authorized

Generic Arrangements

As part of the Medicare Prescription Drug Improvement

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have identified environmental impacts from historical operations at sites we have acquired in the past or may acquire in the future.

As of March 30, 2023, we had 12 full-time employees

and no part-time employees.

As of March 28, 2024, we had 14 full-time employees and no part-time

We are not a party to any collective bargaining agreements.

We believe that we maintain good relations with

our employees.

We believe that we maintain good relations with our employees.

Our Corporate History

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business