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

Our business model is to

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

Our business model is

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

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

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

Our current development programs are focused on

two novel therapies:

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

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

Our current development programs are focused

on two novel therapies:

oxylanthanum carbonate, a next-generation phosphate binder for the treatment of hyperphosphatemia in chronic

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

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

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volunteers with UNI-494 in 2024.

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

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

CKD affects nearly

36 million Americans;

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).

CKD affects nearly 36 million Americans;

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

Hyperphosphatemia is common in

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

For an estimated 75% of people

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

namely insufficient potency, pill burden and unpalatable formulations.

To address this significant and growing challenge, Unicycive is

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

Hyperphosphatemia

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

For an estimated

75% of people in the U.S.

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

binders, namely insufficient potency, pill burden and unpalatable formulations.

To address this significant and growing challenge, Unicycive

is developing oxylanthanum carbonate, which leverages proprietary nanoparticle technology to address the shortcomings of current therapies

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

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

AKI is a sudden episode of kidney failure or kidney

damage (within the first 90 days of injury).

AKI is a sudden episode of kidney failure or

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

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

AKI affects more than

2 million U.S.

more than 2 million U.S.

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

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

More than 300,000 patients per year

die due to AKI.

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

Treatment options for AKI include continuous renal

replacement therapy, renal transplant, and dialysis.

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

have a renal transplant or be on dialysis for life.

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.

If approved, UNI-494

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

We operate with a sense of urgency to bring new

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for patients, providers, and healthcare systems.

Our proprietary

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

Our proprietary pipeline is comprised of our two product candidates

– oxylanthanum carbonate and UNI-494 – which are described below in Figure 1 :

Unicycive Therapeutics’ Pipeline

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

for the treatment of hyperphosphatemia in CKD patients on dialysis.

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

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

CKD patients typically have co-morbidities,

which often require them to be on strict pill schedules.

Current phosphate binder products involve patients needing to take a

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

Oxylanthanum Carbonate

Oxylanthanum carbonate (lanthanum dioxycarbonate)

is an investigational next-generation lanthanum-based phosphate binding agent being developed for the treatment of hyperphosphatemia

in CKD patients on dialysis.

Oxylanthanum carbonate is a phosphate binder

for the treatment of hyperphosphatemia in patients with CKD on dialysis and is intended to be administered as a tablet that will be swallowed

whole at mealtimes.

CKD patients typically have co-morbidities, which often require them to be on strict pill schedules.

Current phosphate

binder products involve patients needing to take a large number of pills daily, some of which are large and/or must be chewed, often

resulting in poor adherence to the prescribed drug therapy.

By virtue of its novel nanoparticle technology,

4 unchanged sentences

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

is seeking the U.S.

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

The Company has submitted

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

We are seeking the U.S.

Food and Drug Administration

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

In September 2024, we submitted a New Drug Application (NDA) for

OLC to the FDA.

In November 2024 we announced the FDA had accepted its NDA and set a Prescription Drug User Fee Act (PDUFA) target

action date of June 28, 2025.

In June 2025, the FDA issued us a Complete Response Letter (CRL) notifying us that a third-party

manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP

No other concerns have been identified to us, including pre-clinical, clinical, or safety data submitted as part

In October 2025, we held a Type A meeting with the FDA to discuss the resolution of the single deficiency identified

in the CRL related to the compliance status of a third-party manufacturing vendor.

Following receipt of the official meeting minutes

from the Type A meeting and engaging in discussions with its third-party manufacturing vendor, we resubmitted its NDA to the FDA

in December 2025.

In January 2026, the FDA accepted the resubmission of the NDA for OLC, deeming the resubmission to be a Class II complete

response which has a six-month review period from the date of resubmission, and set a PDUFA) target action date of June 29, 2026.

Disease Overview:

Hyperphosphatemia

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).

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).

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

estimated glomerular filtration rate (a measure of kidney function)

eGFR = estimated glomerular filtration rate (a measure of kidney

Image Source:

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

Stages of Chronic Kidney Disease

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

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

Complications of CKD include electrolyte

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

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

or go on dialysis.

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

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

Stages of Chronic Kidney

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).

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

disease, and heart disease.

Most patients with Stage 5 CKD (ESRD) either undergo kidney transplantations or go on dialysis.

USRDS annual report indicates that there were 541,326 prevalent dialysis patients in 2021 (the latest reported year), and of those, approximately

450,000 patients (~80%) take phosphate binders to control hyperphosphatemia.

The prevalent U.S.

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

dialysis population has grown at an average

yearly rate of 3.5% over the past decade.

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

is increasing

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

Hyperphosphatemia

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

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

high serum phosphorus concentration >4.5 mg/dL.

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

levels as a result of progressive kidney damage.

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

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

In people with CKD, not enough phosphate is excreted,

leading to elevated levels of phosphorus in the blood.

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

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

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

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

Hyperphosphatemia is also a major cause of morbidity

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

of $70 billion in the U.S.

Treatment of Hyperphosphatemia

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

KDIGO guidelines recommend

three main strategies for managing hyperphosphatemia:

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

Figure 3 below.

is increasing steadily and is projected to reach

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

Hyperphosphatemia is a bone and mineral metabolism

disorder in which elevated phosphorus levels in the blood lead to cardiovascular complications and vascular calcification (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 CKD, hyperphosphatemia is caused by a chronic dysregulation of serum phosphorus levels as a result of

progressive kidney damage.

In healthy people, normal serum phosphorus levels are maintained in the body by the absorption from food and

subsequent excretion from the body via urine and feces.

In people with CKD, not enough phosphate is excreted, leading to elevated levels

of phosphorus in the blood.

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

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.

Current 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:

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

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

This means that physicians prescribe their medication of choice, usually

based on clinical factors and patient preferences.

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

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

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

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

dialysis patients were prescribed phosphate

binders, which equates to approximately 450,000 patients.

Medical Need in the Management of Hyperphosphatemia

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

are shown below in Figure 4 .

Phosphate Binder Mechanisms of Action,

Adapted from Covic and Rastogi, 2013.

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

dialysis patients

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

Moreover, the

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

treatment options ( Figure 5 ).

dietary intake restrictions, use of phosphate binders, and dialysis, as shown in Figure 3 below.

KDIGO Guidelines Recommend Three

Main Strategies for Managing Hyperphosphatemia

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 use of aluminum-containing

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

Utilization of calcium-based binders is discouraged by the most recent KDOQI/KDIGO guidelines due to mounting clinical evidence that

excess calcium load from calcium-based phosphate binder is associated with hypercalcemia and cardiovascular calcification which has been

associated with an increased risk of morbidity (disease) and mortality (death).

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 brief descriptions of the mechanism of action

and what we believe to be the advantages and disadvantages of various phosphate binders are shown below in Figure 4 .

Phosphate Binder Mechanisms

of Action, Adapted from Covic and Rastogi, 2013.

Despite the commercial availability of the six

phosphate binders in the table above, 75% of U.S.

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

the KDIGO guidelines.

Moreover, the percentage of patients achieving these serum phosphorus guidelines is trending downward — underscoring

the need for new and effective treatment options ( Figure 5 ).

The Kidney Disease Outcomes Quality Initiative

Serum Phosphorus Target Achievement from 2012 to 2021

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

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.

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

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

In this regard, we believe that the combined effect of

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

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

of Oxylanthanum Carbonate

Carbonate Mechanism of Action

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

This results in

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

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

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

lanthanum-based phosphate binder.

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

(elemental lanthanum).

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

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

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

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

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

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

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

The Oxylanthanum Carbonate tablet

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

Trial Experience

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

The NDA submission package is based on data from three clinical

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

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

controls (CMC) data.

Phase 2 Study

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

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

(sP) ≤5.5 mg/dL.

The trial included washout, titration, and maintenance periods.

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

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

Patients started

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

The starting dose of OLC during titration was

1500 mg/day (500 mg thrice daily).

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

78 entered the maintenance period.

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

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

Of the 86 patients, the trial enrolled 47 males and

39 females with a mean age of 62.

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

Endpoint - Tolerability:

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

in CKD patients on dialysis.

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

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

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

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

In total, 5 patients discontinued

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

Endpoint - Safety:

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

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

Consistent with the AEs observed with other phosphate binders,

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

There were no treatment-related

serious adverse events (SAEs).

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.

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

showed that patients took a mean of 11 ± 4 medications with a median daily pill intake of 19 as shown by Chiu, YW in

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.

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.

By virtue of its novel nanoparticle technology,

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

the pill burden volume for patients.

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

and improved palatability with oxylanthanum carbonate compared with currently available phosphate binders may lead to improved patient

compliance/adherence and more effective disease management.

Development of Oxylanthanum Carbonate

Oxylanthanum 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 Figure 6 below).

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 structure of oxylanthanum carbonate

was designed to allow for a smaller tablet size and require fewer pills compared with currently available phosphate binder alternatives,

specifically with a dosing regimen of only one tablet per meal.

The oxylanthanum carbonate tablet is designed to disintegrate rapidly

in the stomach after swallowing and does not need to be chewed.

Clinical Trial Experience

Unicycive is seeking FDA approval of OLC via

the 505(b)(2) regulatory pathway.

The NDA submission package is based on data from three clinical studies:

a first in human Phase I study

in healthy volunteers, a Bioequivalence (BE) study in healthy volunteers, and a pivotal Phase 2 tolerability study of OLC in CKD patients

on dialysis, as well as multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data.

Pivotal Phase 2 Study

We conducted a Phase 2, open-label, single-arm,

multicenter trial in adult patients receiving maintenance hemodialysis with hyperphosphatemia.

The primary objective was to evaluate

the tolerability of OLC at clinically effective doses with a goal serum phosphate concentration (sP) ≤5.5 mg/dL.

The trial included

washout, titration, and maintenance periods.

Eligible patients had sP ≥4.0 and ≤7.5 mg/dL for at least 8 weeks prior to screening

while receiving thrice weekly hemodialysis and a stable phosphate binder regimen.

Patients started titration when sP was >5.5 mg/dL

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

The starting dose of OLC during titration was 1500 mg/day (500 mg thrice daily).

In the study, 106 patients were enrolled, of

which 86 patients entered titration and were followed as the Safety Population.

Of the 86, 78 entered the maintenance period.

78 patients that entered maintenance, 7 patients did not have phosphate control, leaving an Evaluable Population of 71 patients, exceeding

the planned enrollment number of 60.

Of the 86 patients, the trial enrolled 47 males and 39 females with a mean age of 62.

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

Primary Endpoint - Tolerability:

T he objective

of the OLC-201 trial was to evaluate the tolerability of clinically effective doses of OLC in CKD patients on dialysis.

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

Tolerability was assessed based on the

incidence of treatment-related AEs leading to discontinuation from the study in the maintenance period.

In the OLC-201 trial, there was

only 1 discontinuation due to a treatment-related AE in the Evaluable Population, a rate of 1.4%.

In the Safety Population of 86 patients

there were only 3 treatment-related discontinuations, a rate of 3.5%.

In total, 5 patients discontinued due to AEs in the Safety Population,

3 were related to OLC and 2 were deemed unrelated to OLC.

Secondary Endpoint - Safety:

The secondary

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

The safety analysis covered all

86 patients in the Safety Population.

Consistent with the AEs observed with other phosphate binders, the AEs were gastrointestinal related

with diarrhea and vomiting being the most common at 9% and 6% respectively.

There were no treatment-related serious adverse events (SAEs).

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

Most treatment-related

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

OLC Pivotal Phase 2 Trial Treatment-Related Adverse Events

Phosphate Control:

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

of approved hyperphosphatemia medications.

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

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

end of titration with OLC.

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

Most treatment-related AEs were mild to moderate in

severity with only 2 AEs reported as severe.

OLC Pivotal Phase 2 Trial Treatment-Related

Adverse Events

Serum Phosphate Control:

While the UNI-OLC-201

study was not designed to evaluate efficacy, the trial enrolled patients on stable doses of approved hyperphosphatemia medications.

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

After washout from the prior

phosphate binders, 90% of patients were able to achieve phosphate levels ≤5.5ng/dL at the end of titration with OLC.

This includes

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

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

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

at OLC doses of 1500 mg/day or lower.

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

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

First-in-Human

Phase 1 Study

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

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.

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

In addition, 69% of the 71 Evaluable Patients achieved a target serum phosphate level of ≤5.5 mg/dL at OLC doses of 1500 mg/day or

90% Of Patients Were Able to Achieve

Phosphate Levels ≤5.5ng/dL with OLC.

69% of the 71 Evaluable Patients

Achieved a Target Serum Phosphate Level of ≤5.5 mg/dL at OLC Doses of 1500 mg/Day or Lower

First-in-Human Phase 1 Study

In 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 10 ).

Daily Urine Phosphate Reduction in Healthy Volunteers

Carbonate Bioequivalence Study in Healthy Volunteers

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

capacity of Oxylanthanum Carbonate and Fosrenol.

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

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

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

The study design,

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

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

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

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

PD equivalence was to be claimed

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

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

The LS mean change from

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

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

It was concluded that Oxylanthanum

Carbonate was bioequivalent to Fosrenol.

Oxylanthanum 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 oxylanthanum carbonate versus Fosrenol in healthy subjects.

The study design, including the dose, primary

endpoint and the sample size was reviewed by the Agency prior to the initiation of the study.

The primary outcome measure was least squares

(LS) mean change in urinary phosphorous excretion (in mg/day) from baseline to the evaluation period.

The evaluation period was defined

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

Baseline was defined as the approximately

48-hour urine collection period starting on Day -2 and ending on Day 1.

PD equivalence was to be claimed if the 90% confidence interval

(CI) of the primary PD variable for oxylanthanum carbonate was completely contained within the reference interval, which was defined

as ±20% of the LS mean of the primary PD variable for lanthanum carbonate.

The LS mean change from Baseline for oxylanthanum carbonate

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

The 90% CI for the LS mean was (-37.83,

45.12), which is well within the acceptance range of (-64.80, 64,80).

It was concluded that oxylanthanum carbonate was bioequivalent

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

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

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

Summary of Mean Change in

Urinary Phosphorus Excretion (mg/day)

Regulatory Guidance

We are 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.

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

1 unchanged sentence

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

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

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

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

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

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

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

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 reported positive results in June 2024.

Unicycive announced the OLC NDA submission in September

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

In March 2025, FDA conducted a general surveillance inspection

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

Commercial Opportunity for Oxylanthanum Carbonate

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

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

CKD patients typically have co-morbidities,

which often require them to be on strict pill schedules.

Current phosphate binder products such as Renvela ® ,

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

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

drug therapy ( Figure 12 ).

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

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

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

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

Recommended Daily Starting Dose for Phosphate Binders

A New Hyperphosphatemia Market Player

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

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

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

One of the key features of Xphozah’s

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

Given its substantially lower pill burden than other phosphate lowering

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

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

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

Strategy for Oxylanthanum Carbonate

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

(Fortune Business Insights, Hyperphosphatemia Treatment Market,

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

market makes up over $1 billion of that total.

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

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

concentrated nephrology prescription market.

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

space with specific working knowledge of the hyperphosphatemia market.

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

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

We believe that we can efficiently create

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

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

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

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

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

Access and Reimbursement Environment

Historically, under the End-Stage Renal Disease

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

in the bundled payment system, with certain exceptions.

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

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

Beginning in 2025, the Centers for Medicare & Medicaid Services

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

Because PLT payments were not previously included in the bundle,

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

The TDAPA is designed to provide separate

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

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

in the dialysis space.

Upon FDA approval, we believe our product, OLC,

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

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

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

If TDAPA designation is granted, OLC will become eligible

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

The payment rate will be at 100%

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

After the end of the TDAPA

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

ESRD PPS bundled payment.

We believe that the timing of these reimbursement

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

market access and pricing advantages.

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

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

Under prior Part D reimbursement, Medicare patients often faced prior

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

In the new bundled reimbursement environment

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

We also see a pricing benefit to OLC under TDAPA.

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

Current branded

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

to raise prices above the rate of inflation.

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

other branded competitors in the market.

Most dialysis clinics operate within dialysis

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

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

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

across their entire network of clinics.

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

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

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

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

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

affect our profitability, financial results, and future prospects.

Transitional Drug Add-on Payment Adjustment

The Transitional Drug Add-on Payment Adjustment

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

renal dialysis drugs and biological products.

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

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

This support enables

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

to new therapies.

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

of novel treatments and innovation in ESRD care.

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

Request Information SystemTM (MEARIS).

Under CMS regulations (42 C.F.R.

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

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

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

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

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

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

commercially available.

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

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

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

and equipment for billing and documentation purposes in healthcare settings.

HCPCS codes are primarily used by healthcare providers,

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

These codes ensure that healthcare providers

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

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

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

The review cycle for HCPCS codes generally occurs quarterly,

with specific deadlines for submission.

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

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

The TDAPA and HCPCS application submissions

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

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

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

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

due to a number of factors.

Payment Process

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

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

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

TDAPA is paid for 2 years.

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

During the time a new

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

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

Add-On Payment Adjustment

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

changes to the base rate are made.

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

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

For products without a full year of data, the adjustment

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

The adjustment is based

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

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

All Part B drug manufacturers report Average

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

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

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

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

and biological products included in the calculation.

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

TDAPA Approvals:

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

The TDAPA payment period is January

1, 2025, through December 31, 2026.

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

sevelamer carbonate, sevelamer

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

Phosphate binders are not considered

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

At the end of

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

PPS bundled payment.

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

TDAPA Approvals:

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

1, 2024, to June 30, 2026.

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

1, 2023, to September 30, 2025.

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

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

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

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

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.

After reviewing the data, the Agency recommended that

we conduct a tolerability study of oxylanthanum carbonate in chronic kidney disease patients on dialysis before filing the NDA.

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.

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

We announced the

OLC NDA submission in September 2024 and received a PDUFA date of June 28, 2025.

In June 2025 the FDA issued us a Complete Response

Letter (CRL) notifying us that a third-party manufacturing vendor of its main contract development and manufacturing organization

(CDMO) was cited for deficiencies following a cGMP inspection.

No other concerns have been identified to the Company, including

pre-clinical, clinical, or safety data submitted as part of the NDA.

In October 2025 we held a Type A meeting with the

FDA to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party

manufacturing vendor.

Following receipt of the official meeting minutes from the Type A meeting and engaging in discussions with its

third-party manufacturing vendor, we resubmitted its NDA to the FDA in December 2025.

In January 2026, the FDA accepted the

resubmission of the NDA for OLC, deeming the resubmission to be a Class II complete response which has a six-month review period

from the date of resubmission, and set a PDUFA) target action date of June 29, 2026.

Commercial Opportunity for Oxylanthanum

Unicycive Therapeutics is a biopharmaceutical company dedicated to

developing and commercializing innovative therapies for patients with kidney disease.

Our lead product candidate, oxylanthanum carbonate

(OLC), is a next-generation, orally administered, non-calcium-based phosphate binder being developed for the treatment of hyperphosphatemia

in patients with chronic kidney disease (CKD) on dialysis.

We are transitioning from a clinical-stage organization to a commercial-stage

company in anticipation of the potential U.S.

approval and launch of OLC.

Our strategy is to establish OLC as a differentiated therapy

within the hyperphosphatemia treatment paradigm while building a focused nephrology franchise supported by disciplined commercial execution

and capital-efficient infrastructure.

Our commercial organization is led by executives with significant

expertise in nephrology and dialysis markets.

Members of our leadership team have extensive experience launching and managing renal franchises,

including navigating the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), contracting with dialysis organizations,

and executing within highly concentrated provider environments.

Our objective is to combine a differentiated clinical profile, a concentrated

go-to-market model, and a strategically aligned reimbursement approach to support meaningful adoption of OLC.

Commercial Strategy:

Oxylanthanum Carbonate

Market Opportunity and Unmet Need

Hyperphosphatemia is a near-universal complication

among the approximately 550,000 dialysis patients in the United States.

Elevated serum phosphorus levels are associated with secondary

hyperparathyroidism, renal bone disease, vascular calcification, and increased cardiovascular morbidity and mortality.

Effective phosphate

management is therefore a foundational component of dialysis care.

Approximately 80% of dialysis patients are prescribed

phosphate-lowering therapies (PLTs), representing a total addressable U.S.

market of more than 440,000 patients.

The global market for

hyperphosphatemia therapies is estimated to be approximately $2.5 billion annually, with the U.S.

market accounting for more than $1

Despite multiple available therapeutic options,

significant unmet need persists:

Standard-of-care binders often require patients to ingest up to 10–12 tablets

Dialysis patients are commonly prescribed numerous additional medications to manage

anemia, mineral bone disorder, and cardiovascular comorbidities, resulting in substantial

cumulative pill burden and treatment fatigue.

● Tolerability

and Administration Challenges :

Existing binders are frequently associated with gastrointestinal

(GI) side effects.

Certain lanthanum and iron-based therapies (Velphoro – sucroferric

oxyhydroxide and Fosrenol – lanthanum carbonate) require chewable administration of

large, chalky tablets, which may impact palatability and persistence with long-term therapy.

Phosphorus Control :

A substantial proportion of U.S.

dialysis patients fail to consistently

achieve recommended phosphorus targets.

Non-adherence and dose reductions due to tolerability

are commonly cited contributors with 44-75% of U.S.

dialysis patients failing to achieve

target phosphorus levels established by published clinical practice guidelines.

Because dialysis patients require chronic, lifelong

phosphate management, therapies that improve ease of administration and reduce pill burden may have important clinical and economic implications.

Our Solution:

Oxylanthanum Carbonate (OLC)

OLC is designed to address limitations of current phosphate binders

through a proprietary formulation intended to combine potency with reduced medication volume.

We believe OLC offers the following potential advantages:

Potency-to-Volume Ratio :

Designed to achieve phosphorus control with a lower daily pill

burden compared to commonly prescribed binders.

● Swallowable

Unlike currently marketed iron and lanthanum-based therapies that require chewable

administration, OLC tablets are designed to be swallowed whole.

● Calcium-Free

Composition :

Avoids calcium exposure associated with certain legacy therapies.

Positioning :

May be used as monotherapy or, where clinically appropriate, in combination

regimens for patients requiring additional control.

By directly addressing pill burden and administration

challenges, OLC is intended to improve patient experience and potentially support adherence within this chronic treatment population.

Commercial Readiness and Organizational Development

Leadership and Talent

We have recruited a commercial leadership team

with deep nephrology experience, including prior hyperphosphatemia launches and dialysis organization contracting expertise.

commercial team includes Marketing, Market Access, Medical Affairs, Professional Relations, and Commercial Operations functions.

These teams maintain established relationships

with key opinion leaders (KOLs), high-volume prescribers, and dialysis organization decision-makers.

Market Development Activities

During OLC pre-launch market development, our teams have:

● Conducted advisory boards with nephrology key opinion leaders

(KOLs) and primary market research

● Participated in major nephrology conferences

● Published and presented OLC-related clinical data

● Engaged with dialysis organizations regarding clinical and economic

considerations

Commercial Operations Infrastructure

Throughout 2025 and early 2026, we have significantly

accelerated our commercial readiness activities to support the pending U.S.

approval and launch of OLC.

We have evolved from a development-led

organization into a launch-ready commercial enterprise by establishing the relevant infrastructure and systems to support our commercial

● Advanced CRM systems

● Data analytics platforms for physician segmentation

● Compliance frameworks and internal controls

● Medical information and pharmacovigilance systems

● Scalable supply chain and logistics infrastructure

Targeted Sales and Account Management

Our market analysis indicates that the U.S.

nephrology market is highly

concentrated.

While there are more than 10,000 total prescribers of phosphate lowering therapies (PLTs), our data shows that the approximately

2,100 highest prescribers are responsible for half of the prescriptions written for PLTs annually.

● Specialty Sales Force :

We intend to address this

concentrated market through a lean, highly technical specialty sales force that will target

the most productive segments of PLT market.

● Digital & Non-Personal Promotion:

We are leveraging

AI technology to reach the broader prescriber base efficiently, through an omnichannel digital

strategy to extend our OLC promotion and medical education campaigns.

● Strategic Dialysis Partnerships:

Given the consolidated

nature of the U.S.

dialysis market, we are prioritizing engagement with large Dialysis Organizations

(LDOs) and mid-sized dialysis organization to ensure OLC is integrated into clinical protocols

and institutional formularies .

Dialysis Market Concentration

dialysis market is highly consolidated.

A limited number

of dialysis organizations treat the substantial majority of the approximately 550,000 U.S.

dialysis patients.

Dialysis Organization

Cumulative % of U.S.

Fresenius Kidney Care

Renal Care (including Satellite-administered network)

Dialysis Clinic, Inc.

Innovative Renal Care

The source is:

The National Forum of ESRD Networks.

Quarterly National

ESRD Census www.esrdnetworks.org

Collectively, these organizations influence treatment decisions for

approximately 85% of U.S.

dialysis patients through centralized medical leadership, formulary governance, group purchasing organizations,

and aligned specialty pharmacy networks.

Because oral-only phosphate binders are reimbursed within the ESRD

PPS bundled payment for Medicare beneficiaries, dialysis organizations play a meaningful role in therapy adoption decisions.

contracting, formulary positioning, and clinical protocol integration within a limited number of dialysis organizations may therefore

provide access to a substantial majority of bundled Medicare dialysis patients.

This concentrated structure enables a focused and capital-efficient

commercial strategy centered on high-volume prescribers and key dialysis accounts.

Distribution and Logistics

We have established a streamlined and capital-efficient distribution

model designed to support broad and reliable access to OLC shortly following FDA approval.

● Channel Strategy:

We are entering into agreements with

a limited number of national specialty distributors and wholesalers.

These partners will

manage the physical distribution of OLC to the pharmacies designated by prescribers and dialysis

organizations, including LDO-owned specialty pharmacies and independent providers.

● Third-Party Logistics (3PL):

We have engaged a third-party

logistics provider to manage our inventory, warehousing, and order-to-cash processes.

allows us to scale our commercial footprint rapidly upon FDA approval without the capital-intensive

requirement of building a proprietary physical distribution network.

Market Access and Reimbursement Strategy

Phosphate Lowering Therapies (PLTs) Payer

Phosphate-lowering therapies are reimbursed through two primary pathways:

● Bundled Medicare (~65% of patients):

Includes Medicare

Fee-for-Service and Medicare Advantage beneficiaries treated under the ESRD PPS bundled payment.

● Unbundled / Traditional Payers (~35% of patients):

commercial insurance, managed Medicaid, and state Medicaid programs where therapies are reimbursed

under the pharmacy benefit.

Supporting OLC Market Access for Non-Medicare

We intend to establish UniSource™, a comprehensive reimbursement

support program designed to facilitate access for patients covered under commercial and Medicaid plans.

UniSource™ will provide

the following high-touch, friction-minimizing reimbursement support to providers and patients:

● Benefit investigations

● Prior authorization and appeals support

● Co-pay assistance programs for eligible commercially insured

● Patient assistance programs for uninsured or underinsured patients

Navigating the Bundled Medicare Reimbursement

Over two thirds of our target patient population

is covered by Medicare.

Effective January 1, 2025, CMS transitioned oral-only phosphate binders into the ESRD PPS bundled payment.

promote innovation within the bundle, CMS provides the Transitional Drug Add-on Payment Adjustment (TDAPA).

If OLC receives FDA approval,

we intend to apply for TDAPA.

If granted, TDAPA would provide separate reimbursement

for OLC at 100% of Average Sales Price (ASP), for a two-year period.

Following the initial 2-year TDAPA period, CMS

has established a transitional risk-sharing adjustment under which dialysis organizations may receive an additional payment equal to

65% of incremental costs above the bundled rate during a defined transition period of 3 years.

The TDAPA period applicable to certain existing

phosphate binders is expected to conclude at the end of 2026, after which CMS is expected to incorporate related expenditures into a

rebased ESRD PPS bundled rate.

If OLC receives approval and is granted TDAPA with an anticipated first-half 2027 launch, OLC may be the

only phosphate binder eligible for separate reimbursement during its TDAPA period.

In such a scenario, dialysis organizations could receive

both rebased bundle payments reflecting prior phosphate binder utilization and separate reimbursement for OLC during its separate TDAPA

We believe this dynamic may create a favorable economic framework for rapid evaluation and adoption of OLC.

Congressional legislation currently under consideration,

the Kidney Care Access Protection Act (KCAPA), proposes potential enhancements to TDAPA duration (from 2 to 3 years) and post-TDAPA payments

(from 3 years to perpetuity) which may substantially expand the revenue potential for OLC.

We cannot predict whether such legislation

will be enacted.

The market for hyperphosphatemia treatments is

highly competitive and characterized by a well-established standard of care.

Our potential competitors include biopharmaceutical innovators

and generic companies that market calcium-based binders, non-calcium-based binders, and novel phosphate absorption inhibitors.

Current Landscape and Limitations of Standard

Existing therapies are often limited by significant

patient hurdles, primarily high pill burden and poor gastrointestinal (GI) tolerability.

Standard-of-care binders, such as sevelamer

carbonate, often require patients to ingest up to 10–12 large tablets daily.

This “pill fatigue” contributes to low adherence,

with studies suggesting a significant portion of dialysis patients fail to achieve target phosphorus levels.

Primary Competitors

Leading Products

OLC Competitive Advantage

Non-Calcium Binders

Renvela ® /Renagel ® (sevelamer), Fosrenol ®

(lanthanum carbonate)

OLC offers a significantly lower pill burden and avoids

the need for chewable administration.

Iron-Based Binders

Velphoro ® , Auryxia ®

OLC avoids potential iron-overload concerns and offers

a more favorable volume-per-dose profile.

Absorption Inhibitors

Xphozah ® (tenapanor)

While tenapanor offers a novel mechanism, OLC remains

a potent binder that can be used as monotherapy or potentially in combination with tenapanor.

Calcium Binders

PhosLo ® (calcium acetate)

OLC is calcium-free, avoiding the risk of vascular

calcification associated with long-term calcium-based therapy.

Primary competitors of OLC

Our Competitive Advantage:

Oxylanthanum Carbonate

We believe OLC is positioned to disrupt the current

treatment paradigm through its proprietary formulation, which offers:

Potency-to-Volume Ratio:

OLC is designed to provide high phosphate-binding capacity with

a significantly lower daily medication volume compared to sevelamer and other metallic binders.

Patient Experience:

Unlike many existing binders that must be chewed (e.g., lanthanum carbonate/Fosrenol),

OLC tablets are designed to be swallowed whole, addressing a common patient aversion to the

chalky taste and dental issues associated with chewable tablets.

for Patient Adherence:

By reducing the total number of pills required to achieve target levels,

OLC directly addresses the primary driver of non-adherence in the dialysis population.

Global Strategy and Strategic Partnerships

We retain full global commercial rights to OLC,

except in certain territories where we have established strategic licensing partnerships.

In Greater China, we have licensed rights to

Lee’s Pharmaceutical Holdings Limited, which is responsible for regulatory approval and commercialization within the territory.

In select Asian markets, we have entered into a licensing agreement with Lotus Pharmaceutical Co., Ltd., which is responsible for regulatory

filings, commercialization, and distribution within its designated regions.

Under these agreements, we are eligible to receive milestone

payments and tiered royalties on net sales.

These partnerships allow us to leverage established

regional infrastructure while preserving capital and maintaining strategic focus on the U.S.

While our primary near-term focus is a self-directed

launch of OLC, we continue to evaluate complementary strategies, including potential co-promotion or distribution partnerships,

where such arrangements may enhance market penetration and long-term franchise value.

Strategic Vision

We view OLC as the foundation of a focused nephrology

By leveraging our dialysis relationships, reimbursement expertise, and commercial infrastructure, we aim to establish a durable

presence in the renal therapeutic landscape and evaluate additional complementary opportunities over time

Manufacturing

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.

With regards to manufacturing, testing and potential

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

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

based in India.

2 unchanged sentences

In June 2024, we entered into the First Amendment

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

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

by September 30, 2025.

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

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

order by September 30, 2025.

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

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

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

(the “Initial Term”).

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

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

Collaboration

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.

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

of Oxylanthanum Carbonate in the Republic of Korea.

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

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

In addition, Lotus will have sole responsibility for the importation

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

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

regulatory and commercial achievements.

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

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

South America, and the Middle East.)

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

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

NDA of OLC (the “Initial Term”).

Following the Initial Term, the Agreement shall continue in effect for consecutive periods

of four (4) years each unless earlier terminated pursuant to the terms of the Agreement.

Oxylanthanum Carbonate Purchase Agreement

On September 20, 2018, we entered into an Assignment

and Asset Purchase Agreement (the “Spectrum 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 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 basis.

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 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 Spectrum Agreement) and 20% of all other sublicense income.

Our payment obligations

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

Disease Overview:

Acute Kidney Injury (AKI)

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 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 refers to the acute kidney injury that occurs in the first week

after kidney transplantation, which necessitates dialysis intervention.

Ischemia/reperfusion injury (IRI) is known to be a major risk

factor for the AKI that results in DGF.

Patients who experience DGF have an increased risk of mortality that’s 59% higher than

those without DGF.

Patients 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.

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 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).

Delayed Graft Function (DGF)

Our initial target indication for UNI-494 is

delayed graft function.

DGF refers to the acute kidney injury that occurs in the first week after kidney transplantation, which necessitates

dialysis intervention.

Ischemia/reperfusion injury (IRI) is known to be a major risk factor for the AKI that results in DGF.

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

Patients 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

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

The 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.

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.

This 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 organs.

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

Currently there are no FDA approved medicines

to treat DGF and/or AKI.

Treatment options for AKI include continuous renal replacement therapy, renal transplant, and dialysis.

cases the damage to the kidney is irreversible, and the patient needs to have a renal transplant or be on dialysis for life.

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.

A Novel Prodrug of Nicorandil

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

It is not currently

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 Figure 13 below:

Nicorandil, marketed in such products as Ikorel

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

It is not currently 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 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.

Although nicorandil is known to be safe, gastrointestinal ulceration is a rare but severe

side effect and it is dose-dependent.

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.

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.

for Development

of UNI-494 in Animal Models:

We conducted pre-clinical pharmacology studies to evaluate 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.

The study evaluated the in vivo efficacy of intravenous UNI-494 in the unilateral renal ischemia-reperfusion

rat model of acute kidney injury, which is a well-established model of DGF.

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 below in Figure 14 :

Effect of UNI-494 on Ischemia-Reperfusion Injury in Rats

UNI-494 prevented serum and urinary markers of AKI at 5 mg/kg, and proximal tubular injury scores improved in a dose-dependent manner.

The study concluded that UNI-494 is a potential candidate for prevention of DGF and other AKI clinical conditions.

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.

The proposed mechanism of action

of UNI-494 is shown in Figure 13 below:

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.

Ischemic 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.

Rationale for Development

Efficacy of UNI-494 in Animal Models:

We conducted pre-clinical pharmacology studies to evaluate 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).

The study evaluated the in vivo efficacy of intravenous UNI-494 in the unilateral renal ischemia-reperfusion rat

model of acute kidney injury, which is a well-established model of DGF.

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 below in Figure 14 :

Effect of UNI-494 on Ischemia-Reperfusion Injury in

Importantly, UNI-494 prevented serum and urinary markers of AKI at

5 mg/kg, and proximal tubular injury scores improved in a dose-dependent manner.

The study concluded that UNI-494 is a potential candidate

for prevention of DGF and other AKI clinical conditions.

UNI-494 Clinical Development Status

We have completed a Phase

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

We have completed a Phase I study in healthy

volunteers to evaluate the safety and tolerability of UNI-494.

Phase I Study in Healthy Volunteers

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Dosing in both arms was completed in a stepwise fashion.

The objective of the study was to assess the safety, tolerability

and pharmacokinetics of UNI-494.

The objective of the study was to assess the safety,

tolerability and pharmacokinetics of UNI-494.

Single Ascending Dose:

3 unchanged sentences

in healthy participants as a single dose ranging from 10 mg to 160 mg.

There were no serious adverse events (SAEs) or adverse events (AEs)

leading to withdrawal.

There were no serious adverse events (SAEs) or adverse events

(AEs) leading to withdrawal.

Headache was the most common adverse event reported.

4 unchanged sentences

study enrolled 19 participants in two cohorts with 15 participants dosed with UNI-494 and 4 dosed with placebo.

In Cohort One (n=9), participants

were dosed with 40 mg two times a day (BID) for 5 days with UNI-494 or matching placebo.

In Cohort Two (n=10), participants were dosed

with 80 mg BID for 5 days.

In Cohort One (n=9),

participants were dosed with 40 mg two times a day (BID) for 5 days with UNI-494 or matching placebo.

In Cohort Two (n=10), participants

were dosed with 80 mg BID for 5 days.

There were no serious adverse events (SAEs) in Part 2 of the study, and UNI-494 was safe and well-tolerated

8 unchanged sentences

The absorption of UNI-494 was fast, and UNI-494 was rapidly metabolized to release nicorandil and the linker as expected.

Following the

completion of Phase I study in healthy volunteers, we requested a meeting with the FDA to discuss our proposed clinical study in

patients undergoing kidney transplantation.

This study is designed to evaluate the safety and tolerability of UNI-494 in patients

undergoing kidney transplantation and to get proof of concept data on the efficacy of UNI-494 to prevent DGF.

In a written response,

the FDA recommended additional studies before a clinical study is initiated in patients undergoing kidney transplantation.

Based on the feedback from the FDA, and our current focus on commercializing and launching our lead drug, OLC, the company decided to

deprioritize further development of UNI-494 for the time being.

Following the completion of Phase I study in

healthy volunteers, we requested a meeting with the FDA to discuss our proposed clinical study in patients undergoing kidney transplantation.

This study is designed to evaluate the safety and tolerability of UNI-494 in patients undergoing kidney transplantation and to get proof

of concept data on the efficacy of UNI-494 to prevent DGF.

In a written response, the FDA recommended additional studies before a clinical

study is initiated in patients undergoing kidney transplantation.

Based on the feedback from the FDA, and our current focus on commercializing

and launching our lead drug, OLC, the company decided to deprioritize further development of UNI-494 for the time being.

Regulatory Strategy for UNI-494

2 unchanged sentences

the FDA granted orphan drug designation to UNI-494 for prevention of DGF in patients undergoing solid organ transplantation.

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.

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.

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.

The FDA issued a guidance to industry in 2019

4 unchanged sentences

a clear path for development of drugs for prevention of DGF.

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.

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.

FDA review of UNI-494.

While 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 FDA.

While 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 FDA.

Market Potential

8 unchanged sentences

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

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.

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.

AKI is a heterogeneous

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.

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.

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 nephropathy.

Sphaera License Agreement

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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 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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We face significant competition from organizations that are pursuing products

that would compete with the product candidates we are developing and the same or similar products that target the same conditions we intend

Due to our limited resources, we may not be able to compete successfully against these organizations, which include many large,

well-financed and experienced pharmaceutical and biotechnology companies, as well as academic and research institutions and government

that would compete with the product candidates we are developing and the same or similar products that target the same conditions we

intend to treat.

Due to our limited resources, we may not be able to compete successfully against these organizations, which include

many large, well-financed and experienced pharmaceutical and biotechnology companies, as well as academic and research institutions and

government agencies.

Intellectual Property

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continuing technological innovation, confidentiality agreements, and invention assignment agreements to develop and maintain our proprietary

The confidentiality agreements are designed to protect our proprietary information and the invention assignment agreements are

designed to grant us ownership of technologies that are developed for us by our employees, consultants, or other third parties.

to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical

and electronic security of our information technology systems.

While we have confidence in our agreements and security measures, either

may be breached, and we may not have adequate remedies.

In addition, our trade secrets may otherwise become known or independently discovered

by competitors.

The confidentiality agreements are designed to protect our proprietary information and the invention assignment agreements

are designed to grant us ownership of technologies that are developed for us by our employees, consultants, or other third parties.

seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and

physical and electronic security of our information technology systems.

While we have confidence in our agreements and security measures,

either may be breached, and we may not have adequate remedies.

In addition, our trade secrets may otherwise become known or independently

discovered by competitors.

With respect to both licensed and company-owned

intellectual property, we cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect

to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents that may be granted

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

intellectual property, we cannot be sure that patents will be granted with respect to any of our pending patent applications or with

respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents that

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

Patent Portfolio

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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.

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.

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countries have statutory expiration dates in 2032.

In some cases, granted United States patents claiming

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

We anticipate patent exclusivity until May

2036 with the patent term extension available for the ’240 patent.

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.

In some cases, granted United States patents

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

We anticipate patent exclusivity

until May 2036 with the patent term extension available for the ’240 patent.

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

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.

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

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that is exclusively licensed to us from Sphaera Pharma Pte Ltd.

In addition, we have two granted U.S.

In addition, we have four granted U.S.

patents that we own.

The first granted

patent is directed to methods of making UNI-494, and it is expected to expire in 2032.

The second granted U.S.

patent is directed

to methods of using UNI-494, and to other compositions of matter and their uses and is expected to expire in 2040.

The other granted U.S.

directed to methods of using UNI-494, and to other compositions of matter and are expected to expire in 2040.

Patent Number

Projected Expiration

Substituted methylformyl reagents and method of using same to modify physicochemical and/or pharmacokinetic properties of compounds

Substituted methylformyl reagents and method of using same to modify

physicochemical and/or pharmacokinetic properties of compounds

July 11, 2032

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March 16, 2040

Nicorandil derivatives

March 16, 2040

Nicorandil derivatives

March 16, 2040

Government Regulations

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 approval

and possible civil and criminal sanctions.

Regulations, enforcement positions, statutes and legal interpretations applicable to the pharmaceutical

industry are constantly evolving and are not always clear.

Significant changes in regulations, enforcement positions, statutes and legal

interpretations could have a material adverse effect on our financial condition and results of our operations.

Additionally, future healthcare legislation

or other legislative proposals at the federal and state levels could bring about major changes in the affected health care systems, including

statutory restrictions on the means that can be employed by brand and generic pharmaceutical companies to settle Paragraph IV patent litigations.

We cannot predict the outcome of such initiatives, but such initiatives, if passed, could result in significant costs to us in terms of

costs of compliance and penalties associated with failure to comply.

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.

Regulations, enforcement positions, statutes and legal interpretations applicable

to the pharmaceutical industry are constantly evolving and are not always clear.

Significant changes in regulations, enforcement positions,

statutes and legal interpretations could have a material adverse effect on our financial condition and results of our operations.

Additionally, future healthcare legislation or

other legislative proposals at the federal and state levels could bring about major changes in the affected health care systems, including

statutory restrictions on the means that can be employed by brand and generic pharmaceutical companies to settle Paragraph IV patent

We cannot predict the outcome of such initiatives, but such initiatives, if passed, could result in significant costs to

us in terms of costs of compliance and penalties associated with failure to comply.

Pharmaceutical Regulation in the United States

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under the Food, Drug and Cosmetic Act (FDCA) and its implementing regulations.

The process of obtaining regulatory approvals and the subsequent

compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and

financial resources.

The process of obtaining regulatory approvals and the

subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial

time and financial resources.

Failure to comply with the applicable U.S.

requirements at any time during the product development process, approval

process or after approval may subject an applicant to administrative or judicial sanctions.

These sanctions could include the FDA’s

refusal to approve pending applications, withdrawal of an approval, a clinical hold, Warning or Untitled Letters, product recalls, product

seizures, total or partial suspension of production or distribution of product(s), injunctions, fines, refusals of government contracts,

restitution, disgorgement or civil or criminal penalties.

Any agency or judicial enforcement action could have a material adverse effect

requirements at any time during the product development process,

approval process or after approval may subject an applicant to administrative or judicial sanctions.

These sanctions could include the

FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, Warning or Untitled Letters, product

recalls, product seizures, total or partial suspension of production or distribution of product(s), injunctions, fines, refusals of government

contracts, restitution, disgorgement or civil or criminal penalties.

Any agency or judicial enforcement action could have a material

adverse effect on us.

FDA approval is required before any new unapproved

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in the United States.

The process required by the FDA before a new 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;

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

Performance of adequate and well-controlled human clinical trials in accordance with the FDA good clinical practice (GCP) requirements and other clinical trial-related regulations to establish the 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.

The process required by the FDA before a new

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;

● Approval by an

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

● Performance of

adequate and well-controlled human clinical trials in accordance with the FDA good clinical

practice (GCP) requirements and other clinical trial-related regulations to establish the

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.

Preclinical Studies

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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 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.

Progress reports detailing the results of the

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and Phase 3 trials may not be completed successfully within any specified period, or at all.

Furthermore, the FDA or the sponsor may suspend

or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if it is not being conducted in

accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.

Furthermore, the FDA or the sponsor may

suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed

to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if it is not

being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.

Marketing Approval

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relating to the product’s pharmacology, chemistry, manufacture and controls.

Under federal law, the submission of most NDAs is subject

to a substantial application user fee, and the manufacturer or sponsor of an approved NDA is also subject to annual program fees.

FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s

Under federal law, the submission of most NDAs is

subject to a substantial application user fee, and the manufacturer or sponsor of an approved NDA is also subject to annual program fees.

The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s

threshold determination that it is sufficiently complete to permit its substantive review.

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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,

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.

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

The FDA endeavors to review most

applications subject to Standard Review within ten to twelve months whereas its goal is to complete most Priority Review applications

The FDA endeavors to review

most applications subject to Standard Review within ten to twelve months whereas its goal is to complete most Priority Review applications

within six to eight months, depending on whether the drug is a new molecular entity.

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and to seek advice as to whether the application should be approved and under what conditions.

Before approving an NDA, the FDA will typically

inspect one or more clinical sites to assure compliance with GCP requirements.

Additionally, the FDA will inspect the facility or the

facilities at which the drug is manufactured.

The FDA will not approve the NDA unless it determines that the manufacturing process and

facilities are in compliance with cGMP requirements and are adequate to assure consistent production of the product within required specifications,

and the NDA contains data that provide substantial evidence that the drug is safe and effective for the labeled indication.

Before approving an NDA, the FDA will

typically inspect one or more clinical sites to assure compliance with GCP requirements.

Additionally, the FDA will inspect the facility

or the facilities at which the drug is manufactured.

The FDA will not approve the NDA unless it determines that the manufacturing process

and facilities are in compliance with cGMP requirements and are adequate to assure consistent production of the product within required

specifications, and the NDA contains data that provide substantial evidence that the drug is safe and effective for the labeled indication.

After the FDA evaluates the NDA and the manufacturing

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Further changes to some of the conditions established

in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and

FDA approval of a new NDA or NDA supplement before the change can be implemented, which may require us to develop additional data or conduct

additional preclinical studies and clinical trials.

An NDA supplement for a new indication typically requires clinical data similar to

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

in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission

and FDA approval of a new NDA or NDA supplement before the change can be implemented, which may require us to develop additional data

or conduct additional preclinical studies and clinical trials.

An NDA supplement for a new indication typically requires clinical data

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.

Disclosure of Clinical Trial Information

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products, including drugs, are required to register and disclose certain clinical trial information on www.clinical trials.gov.

related to the product, subject population, phase of investigation, study sites and investigators, and other aspects of the clinical trial

is then made public as part of the registration.

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

their completion.

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

related to the product, subject population, phase of investigation, study sites and investigators, and other aspects of the clinical

trial is then made public as part of the registration.

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

after their completion.

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

has been approved.

Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.

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compliance with cGMPs.

Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with

regulatory standards, if it encounters problems following initial marketing or if previously unrecognized problems are subsequently discovered.

The FDA may also impose a REMS requirement on a drug already on the market if the FDA determines, based on new safety information, that

a REMS is necessary to ensure that the drug’s benefits outweigh its risks.

In addition, regulatory authorities may take other enforcement

action, including, among other things, Warning or Untitled Letters, the seizure of products, injunctions, consent decrees placing significant

restrictions on or suspending manufacturing operations, refusal to approve pending applications or supplements to approved applications,

civil penalties and criminal prosecution.

Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply

with regulatory standards, if it encounters problems following initial marketing or if previously unrecognized problems are subsequently

The FDA may also impose a REMS requirement on a drug already on the market if the FDA determines, based on new safety information,

that a REMS is necessary to ensure that the drug’s benefits outweigh its risks.

In addition, regulatory authorities may take other

enforcement action, including, among other things, Warning or Untitled Letters, the seizure of products, injunctions, consent decrees

placing significant restrictions on or suspending manufacturing operations, refusal to approve pending applications or supplements to

approved applications, civil penalties and criminal prosecution.

The Hatch-Waxman Amendments

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listed drugs.

An ANDA is a comprehensive submission that contains, among other things, data and information pertaining to the active pharmaceutical

ingredient (API), drug product formulation, specifications, and stability of the generic drug, as well as analytical methods, manufacturing

process validation data and quality control procedures.

Premarket applications for generic drugs are termed abbreviated because they generally

do not include clinical data to demonstrate safety and effectiveness.

However, a generic manufacturer is typically required to conduct

bioequivalence studies of its test product against the listed drug.

The bioequivalence studies for orally administered, systemically available

drug products assess the rate and extent to which the API is absorbed into the bloodstream from the drug product and becomes available

at the site of action.

Bioequivalence is established when there is an absence of a significant difference in the rate and extent for absorption

of the generic product and the reference listed drug.

For some drugs, other means of demonstrating bioequivalence may be required by the

FDA, especially where rate or extent of absorption are difficult or impossible to measure.

The FDA will approve the generic product as

suitable for an ANDA application if it finds that the generic product does not raise new questions of safety and effectiveness as compared

to the reference listed drug.

A product is not eligible for ANDA approval if the FDA determines that it is not bioequivalent to the reference

listed drug, if it is intended for a different use, or if it is not subject to, and requires, an approved Suitability Petition.

An ANDA is a comprehensive submission that contains, among other things, data and information pertaining to the active

pharmaceutical ingredient (API), drug product formulation, specifications, and stability of the generic drug, as well as analytical methods,

manufacturing process validation data and quality control procedures.

Premarket applications for generic drugs are termed abbreviated

because they generally do not include clinical data to demonstrate safety and effectiveness.

However, a generic manufacturer is typically

required to conduct bioequivalence studies of its test product against the listed drug.

The bioequivalence studies for orally administered,

systemically available drug products assess the rate and extent to which the API is absorbed into the bloodstream from the drug product

and becomes available at the site of action.

Bioequivalence is established when there is an absence of a significant difference in the

rate and extent for absorption of the generic product and the reference listed drug.

For some drugs, other means of demonstrating bioequivalence

may be required by the FDA, especially where rate or extent of absorption are difficult or impossible to measure.

The FDA will approve

the generic product as suitable for an ANDA application if it finds that the generic product does not raise new questions of safety and

effectiveness as compared to the reference listed drug.

A product is not eligible for ANDA approval if the FDA determines that it is

not bioequivalent to the reference listed drug, if it is intended for a different use, or if it is not subject to, and requires, an approved

Suitability Petition.

Orange Book Listing

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product will expire prior to the marketing of the generic product, in which case the ANDA will not be finally approved by the FDA until

the expiration of such patent or (iv) that any patent listed as covering the branded drug is invalid or will not be infringed by the manufacture,

sale or use of the generic product for which the ANDA is submitted.

A notice of the Paragraph IV certification must be provided to each

owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA or 505(b)(2) application

The applicant may also elect to submit a “section viii” statement certifying that its proposed label does not contain

(or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent.

the expiration of such patent or (iv) that any patent listed as covering the branded drug is invalid or will not be infringed by the

manufacture, sale or use of the generic product for which the ANDA is submitted.

A notice of the Paragraph IV certification must be provided

to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA or 505(b)(2)

application refers.

The applicant may also elect to submit a “section viii” statement certifying that its proposed label

does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent.

If the reference NDA holder and patent owners

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In addition to patent exclusivity, the holder

of the NDA for the listed drug may be entitled to a period of non-patent exclusivity, during which the FDA cannot approve an ANDA or 505(b)(2)

application that relies on the listed drug.

of the NDA for the listed drug may be entitled to a period of non-patent exclusivity, during which the FDA cannot approve an ANDA or

505(b)(2) application that relies on the listed drug.

For example, for listed drugs that were considered

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case the applicant may submit its application four years following the original product approval.

A drug, including one approved under Section 505(b)(2),

may obtain a three-year period of exclusivity for a particular condition of approval, or change to a marketed product, such as a new formulation

for a previously approved product, if one or more new clinical studies (other than bioavailability or bioequivalence studies) was essential

to the approval of the application and was conducted/sponsored by the applicant.

In addition, drugs approved for diseases for which the

patient population is sufficiently small, or orphan indications, may be entitled to a seven-year data exclusivity period.

A drug, including one approved under Section

505(b)(2), may obtain a three-year period of exclusivity for a particular condition of approval, or change to a marketed product, such

as a new formulation for a previously approved product, if one or more new clinical studies (other than bioavailability or bioequivalence

studies) was essential to the approval of the application and was conducted/sponsored by the applicant.

In addition, drugs approved for

diseases for which the patient population is sufficiently small, or orphan indications, may be entitled to a seven-year data exclusivity

Pharmaceutical Coverage, Pricing and Reimbursement

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status of products approved by the FDA and other government authorities.

Thus, even if a product candidate is approved, sales of the product

will depend, in part, on the extent to which third-party payors, including government health programs in the United States such as Medicare

and Medicaid, commercial health insurers and managed care organizations, provide coverage, and establish adequate reimbursement levels

for, the product.

The process for determining whether a payor will provide coverage for a product may be separate from the process for

setting the price or reimbursement rate that the payor will pay for the product once coverage is approved.

Third-party payors are increasingly

challenging the prices charged, examining the medical necessity, and reviewing the cost-effectiveness of medical products and services

and imposing controls to manage costs.

Third-party payors may limit coverage to specific products on an approved list, also known as a

formulary, which might not include all of the approved products for a particular indication.

In addition, third-party payors may impose

prior authorization or step edit requirements requiring patients to have tried other therapies prior to our products for coverage.

may also decline to include our products or product candidates on their formulary, which means that unless healthcare providers seek a

medical exception for coverage, the payors will not pay for the product.

In order to secure coverage and reimbursement for any product

that might be approved for sale, a company may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical

necessity and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparable marketing approvals.

Thus, even if a product candidate is approved, sales of the

product will depend, in part, on the extent to which third-party payors, including government health programs in the United States such

as Medicare and Medicaid, commercial health insurers and managed care organizations, provide coverage, and establish adequate reimbursement

levels for, the product.

The process for determining whether a payor will provide coverage for a product may be separate from the process

for setting the price or reimbursement rate that the payor will pay for the product once coverage is approved.

Third-party payors are

increasingly challenging the prices charged, examining the medical necessity, and reviewing the cost-effectiveness of medical products

and services and imposing controls to manage costs.

Third-party payors may limit coverage to specific products on an approved list, also

known as a formulary, which might not include all of the approved products for a particular indication.

In addition, third-party payors

may impose prior authorization or step edit requirements requiring patients to have tried other therapies prior to our products for coverage.

Payors may also decline to include our products or product candidates on their formulary, which means that unless healthcare providers

seek a medical exception for coverage, the payors will not pay for the product.

In order to secure coverage and reimbursement for any

product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic studies in order to demonstrate the

medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparable marketing

Nonetheless, product candidates may not be considered medically necessary or cost effective.

A decision by a third-party payor not to

cover a product candidate could reduce physician utilization once the product is approved and have a material adverse effect on sales,

results of operations and financial condition.

Additionally, a payor’s decision to provide coverage for a product does not imply

that an adequate reimbursement rate will be approved.

A decision by a third-party payor

not to cover a product candidate could reduce physician utilization once the product is approved and have a material adverse effect on

sales, results of operations and financial condition.

Additionally, a payor’s decision to provide coverage for a product does not

imply that an adequate reimbursement rate will be approved.

Further, one payor’s determination to provide coverage for a drug product

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can differ significantly from payor to payor.

Dialysis-related drugs are included in the ESRD

bundled prospective payment system (PPS) for renal dialysis services furnished to Medicare beneficiaries and are grouped into functional

categories such as bone and mineral metabolism, except that oral-only drugs are exempted from inclusion until 2025.

In a final ESRD PPS

rule published in October 2022, CMS confirmed that it intends to end the oral-only exclusion of hyperphosphatemia drugs from the ESRD

PPS on January 1, 2025.

At this time a TDAPA (transitional drug add-on payment adjustment) will provide separate payment for hyperphosphatemia

drugs for “no less than 2 years” based on the drug’s Average Sales Price, or ASP, that will be in addition to the base

The incremental cost associated with the addition of this class of drugs into the bundle will be assessed in the final year of the

TDAPA and the base rate will be adjusted accordingly, and no further separate payment will be provided.

Although there are several details

that need further clarification, including precise timing related to receiving codes to allow for reimbursement under TDAPA, which are

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

a priority of federal, state and foreign governments and the prices of drugs have been a focus in this effort.

Governments have shown

significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements

Dialysis-related drugs are included in the

ESRD bundled prospective payment system (PPS) for renal dialysis services furnished to Medicare beneficiaries and are grouped into functional

categories such as bone and mineral metabolism.

Oral-only drugs were paid for outside of the bundle until their inclusion on January 1,

Currently, CMS pays for phosphate binders through TDAPA (transitional drug add-on payment adjustment) which provides separate payment

for hyperphosphatemia drugs for “no less than 2 years” based on the drug’s Average Sales Price, or ASP, that is paid

in addition to the base rate.

The incremental cost associated with the addition of this class of drugs into the bundle will be assessed

in the final year of the TDAPA and the base rate will be adjusted accordingly, and no further separate payment will be provided.

that oxylanthanum carbonate, if approved by FDA will be eligible for its own TDAPA for a period of 2 years, followed by an additional

3 years reduced payment of 65% of prior 12 months of OLC utilization.

The containment of healthcare costs also has

become a priority of federal, state and foreign governments and the prices of drugs have been a focus in this effort.

Governments have

shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements

for substitution of generic products.

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Coverage policies and third-party reimbursement rates may change at any time.

Even if favorable coverage and reimbursement status

is attained for one or more products for which a company or its collaborators receive marketing approval, less favorable coverage policies

and reimbursement rates may be implemented in the future.

Outside the United States, ensuring adequate coverage and payment for a product

also involves challenges.

Even if favorable coverage and reimbursement

status is attained for one or more products for which a company or its collaborators receive marketing approval, less favorable coverage

policies and reimbursement rates may be implemented in the future.

Outside the United States, ensuring adequate coverage and payment

for a product also involves challenges.

Pricing of prescription pharmaceuticals is subject to governmental control in many countries.

Pricing negotiations

with governmental authorities can extend well beyond the receipt of regulatory marketing approval for a product and may require a clinical

trial that compares the cost effectiveness of a product to other available therapies.

The conduct of such a clinical trial could be expensive

and result in delays in commercialization.

In the European Union, pricing and reimbursement schemes vary widely from country to country.

Pricing negotiations with governmental authorities can extend well beyond the receipt of regulatory marketing approval for a product

and may require a clinical trial that compares the cost effectiveness of a product to other available therapies.

The conduct of such

a clinical trial could be expensive and result in delays in commercialization.

In the European Union, pricing and reimbursement schemes

vary widely from country to country.

Some countries provide that products may be marketed only after a reimbursement price has been agreed.

Some countries may require the

completion of additional studies that compare the cost-effectiveness of a particular drug candidate to currently available therapies or

so-called health technology assessments, in order to obtain reimbursement or pricing approval.

For example, the European Union provides

options for its member states to restrict the range of products for which their national health insurance systems provide reimbursement

and to control the prices of medicinal products for human use.

EU member states may approve a specific 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.

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.

The downward pressure on health care costs in general, particularly prescription

drugs, has become intense.

As a result, increasingly high barriers are being erected to the entry of new products.

Political, economic,

and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has

been obtained.

Reference pricing used by various EU member states, and parallel trade, i.e., arbitrage between low-priced and high-priced

member states, can further reduce prices.

There can be no assurance that any country that has price controls or reimbursement limitations

for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any products, if approved in those countries.

Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug candidate to

currently available therapies or so-called health technology assessments, in order to obtain reimbursement or pricing approval.

the European Union provides options for its member states to restrict the range of products for which their national health insurance

systems provide reimbursement and to control the prices of medicinal products for human use.

EU member states may approve a specific

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.

The downward pressure on health care

costs in general, particularly prescription drugs, has become intense.

As a result, increasingly high barriers are being erected to the

entry of new products.

Political, economic, and regulatory developments may further complicate pricing negotiations, and pricing negotiations

may continue after reimbursement has been obtained.

Reference pricing used by various EU member states, and parallel trade, i.e., arbitrage

between low-priced and high-priced member states, can further reduce prices.

There can be no assurance that any country that has price

controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any

products, if approved in those countries.

Dialysis Organizations Protocols

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formulary status within dialysis organizations may affect what products are prescribed within that specific organization.

Therefore, if

a product is not on a formulary, the prescribers within that organization may be less likely to prescribe that product or may have a difficult

time prescribing that product, resulting in less sales.

Further, one dialysis organization’s determination to add a product to their

formulary does not assure that other dialysis organizations will also add the product to theirs.

There is always a risk a dialysis organization

will not contract with a drug manufacturer for a specific product, resulting in that product not being on that organization’s formulary.

Additionally, dialysis organizations typically assess a product’s efficacy before adding it to their formulary.

Their process for

assessing a product may differ among organizations and the timing of such assessment could delay adding such treatment to formulary, further

affecting product sales.

if a product is not on a formulary, the prescribers within that organization may be less likely to prescribe that product or may have

a difficult time prescribing that product, resulting in less sales.

Further, one dialysis organization’s determination to add a

product to their formulary does not assure that other dialysis organizations will also add the product to theirs.

There is always a risk

a dialysis organization will not contract with a drug manufacturer for a specific product, resulting in that product not being on that

organization’s formulary.

Additionally, dialysis organizations typically assess a product’s efficacy before adding it to

their formulary.

Their process for assessing a product may differ among organizations and the timing of such assessment could delay adding

such treatment to formulary, further affecting product sales.

Our ability to generate product revenue and achieve

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

obtaining 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 or acquired;

obtaining and maintaining market acceptance of Oxylanthanum Carbonate, UNI-494, and any other product candidate, including those that may be in-licensed or acquired;

the 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;

the 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 and maintaining supply and manufacturing relationships with third parties that can provide adequate supplies of products that are compliant with good manufacturing practices, or GMPs, 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;

current and future restrictions or limitations on our approved or future indications and patient populations or other adverse regulatory actions or in the event that the FDA requires Risk Evaluation and Mitigation Strategies, or REMS, or risk management plans that use restrictive risk minimization strategies;

the effectiveness of our sales, marketing, manufacturing and distribution strategies and operations;

competing effectively with any products for the same or similar indications as our products;

maintaining, protecting and expanding our portfolio of intellectual property rights, including patents and trade secrets;

the impact of the COVID-19 pandemic on the above factors, including the disproportionate impact of the COVID-19 pandemic on CKD patients, the adverse impact on the phosphate binder market in which we compete, and the limitation of our sales professionals to meet in person with healthcare professionals as the result of travel restrictions or limitations on access for non-patients.

● obtaining 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 or acquired;

● obtaining and

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

including those that may be in-licensed or acquired;

● the 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;

● the 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 and

maintaining supply and manufacturing relationships with third parties that can provide adequate

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

● current and future

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

or other adverse regulatory actions or in the event that the FDA requires Risk Evaluation

and Mitigation Strategies, or REMS, or risk management plans that use restrictive risk minimization

● the effectiveness

of our sales, marketing, manufacturing and distribution strategies and operations;

● competing effectively

with any products for the same or similar indications as our products;

● maintaining, protecting

and expanding our portfolio of intellectual property rights, including patents and trade

● the impact of

the COVID-19 pandemic on the above factors, including the disproportionate impact of the

COVID-19 pandemic on CKD patients, the adverse impact on the phosphate binder market in which

we compete, and the limitation of our sales professionals to meet in person with healthcare

professionals as the result of travel restrictions or limitations on access for non-patients.

Risks Related to Commercialization

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of factors, including:

the availability of adequate coverage and reimbursement by and the availability of discounts, rebates, and price concessions from third party payors, pharmacy benefit managers, or PBMs, and governmental authorities;

the safety and efficacy of the product, as demonstrated in clinical trials and in the post-marketing setting;

the prevalence and complications of the disease treated by the product;

the clinical indications for which the product is approved and the product label approved by regulatory authorities, including any warnings or limitations that may be required on the label as a consequence of potential safety risks associated with the product;

the countries in which marketing approvals are obtained;

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

the success of our physician and patient communications and education programs;

acceptance by physicians and patients of the product as a safe and effective treatment and the willingness of the target patient population to try new therapies and of physicians to prescribe new therapies;

the cost, safety and efficacy of the product in relation to alternative treatments;

the timing of receipt of marketing approvals and product launch relative to competing products and potential generic entrants;

relative convenience and ease of administration;

the frequency and severity of adverse side effects;

favorable or adverse publicity about our products or favorable or adverse publicity about competing products;

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

● the availability

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

price concessions from third party payors, pharmacy benefit managers, or PBMs, and governmental

● the safety and

efficacy of the product, as demonstrated in clinical trials and in the post-marketing setting;

● the prevalence

and complications of the disease treated by the product;

● the clinical indications

for which the product is approved and the product label approved by regulatory authorities,

including any warnings or limitations that may be required on the label as a consequence

of potential safety risks associated with the product;

● the countries

in which marketing approvals are obtained;

● the claims we

and our collaborators are able to make regarding the safety and efficacy of the product;

● the success of

our physician and patient communications and education programs;

● acceptance by

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

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

● the cost, safety

and efficacy of the product in relation to alternative treatments;

● the timing of

receipt of marketing approvals and product launch relative to competing products and potential

generic entrants;

● relative convenience

and ease of administration;

● the frequency

and severity of adverse side effects;

● favorable or adverse

publicity about our products or favorable or adverse publicity about competing products;

● the effectiveness

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

In order to market oxylanthanum carbonate and

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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:

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

potential lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines, and

costs and expenses associated with maintaining our own sales and marketing organization.

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:

● potential inability

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

● potential lack

of complementary products to be offered by sales personnel, which may put us at a competitive

disadvantage relative to companies with more extensive product lines, and

● costs and expenses

associated with maintaining our own sales and marketing organization.

If we are unable to build our own sales and marketing

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

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.

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

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

a covered benefit under the health plan;

safe, effective, and medically necessary;

appropriate for the specific patient;

● a covered benefit

under the health plan;

● safe, effective,

and medically necessary;

● appropriate for

the specific patient;

● cost effective.

Obtaining coverage and reimbursement approval

for a product from a governmental authority, PBM or a third-party payor is a time consuming and costly process that could require us to

provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payor.

In the United States, there

are multiple governmental authorities, PBMs and third-party payors with varying coverage and reimbursement levels for pharmaceutical products,

and the timing of commencement of reimbursement by a governmental payor can be dependent on the assignment of codes via the Healthcare

Common Procedural Coding System, which codes are assigned on a quarterly basis.

Within Medicare, for oral drugs dispensed by pharmacies

and also administered in facilities, coverage and reimbursement may vary depending on the setting.

CMS, local Medicare administrative

contractors, Medicare Part D plans and/or PBMs operating on behalf of Medicare Part D plans, may have some responsibility for determining

the medical necessity of such drugs, and therefore coverage, for different patients.

Different reimbursement methodologies may apply,

and CMS may have some discretion in interpreting their application in certain settings.

Additionally, we may be required to enter into

contracts with third party payors and/or PBMs offering rebates or discounts on our products in order to obtain favorable formulary status

and we may not be able to agree upon commercially reasonable terms with such third party payors or PBMs, or provide data sufficient to

obtain favorable coverage and reimbursement for many reasons, including that we may be at a competitive disadvantage relative to companies

for a product from a governmental authority, PBM or a third-party payor is a time consuming and costly process that could require us

to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payor.

In the United States,

there are multiple governmental authorities, PBMs and third-party payors with varying coverage and reimbursement levels for pharmaceutical

products, and the timing of commencement of reimbursement by a governmental payor can be dependent on the assignment of codes via the

Healthcare Common Procedural Coding System, which codes are assigned on a quarterly basis.

Within Medicare, for oral drugs dispensed

by pharmacies and also administered in facilities, coverage and reimbursement may vary depending on the setting.

CMS, local Medicare

administrative contractors, Medicare Part D plans and/or PBMs operating on behalf of Medicare Part D plans, may have some responsibility

for determining the medical necessity of such drugs, and therefore coverage, for different patients.

Different reimbursement methodologies

may apply, and CMS may have some discretion in interpreting their application in certain settings.

Additionally, we may be required to

enter into contracts with third party payors and/or PBMs offering rebates or discounts on our products in order to obtain favorable formulary

status and we may not be able to agree upon commercially reasonable terms with such third party payors or PBMs, or provide data sufficient

to obtain favorable coverage and reimbursement for many reasons, including that we may be at a competitive disadvantage relative to companies

with more extensive product lines.

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

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 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.

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,

which may result in others discovering, developing or commercializing products before, or more successfully than, we do.

The development and commercialization of new drugs

is highly competitive and subject to rapid and significant technological change.

The development and commercialization of new

drugs is highly competitive and subject to rapid and significant technological change.

Our future success depends on our ability to demonstrate

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(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.

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 Carbonate.

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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other changes to the healthcare system of the United States.

It is uncertain what other legislative proposals may be adopted or what actions

federal, state, or private payors may take in response to any healthcare reform proposals or legislation.

We cannot predict the effect

such reforms may have on our business, and no assurance can be given that any such reforms will not have a material adverse effect.

It is uncertain what other legislative proposals may be adopted or what

actions federal, state, or private payors may take in response to any healthcare reform proposals or legislation.

We cannot predict the

effect such reforms may have on our business, and no assurance can be given that any such reforms will not have a material adverse effect.

By way of example, in March 2010, the Affordable

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The law includes measures that (i) significantly increase Medicaid rebates through both

the expansion of the program and significant increases in rebates, (ii) substantially expand the Public Health System (340B) program to

allow other entities to purchase prescription drugs at substantial discounts, (iii) extend the Medicaid rebate rate to a significant portion

of Managed Medicaid enrollees, (iv) assess a rebate on Medicaid Part D spending in the coverage gap for branded and authorized generic

prescription drugs, and (v) levy a significant excise tax on the industry to fund the healthcare reform.

the expansion of the program and significant increases in rebates, (ii) substantially expand the Public Health System (340B) program

to allow other entities to purchase prescription drugs at substantial discounts, (iii) extend the Medicaid rebate rate to a significant

portion of Managed Medicaid enrollees, (iv) assess a rebate on Medicaid Part D spending in the coverage gap for branded and authorized

generic prescription drugs, and (v) levy a significant excise tax on the industry to fund the healthcare reform.

In addition to the changes brought about by the

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that Congress or the Biden Administration intend to provide for such authorizations.

The Biden administration has also undertaken other

actions – and may continue to do so – signaling a change in policy from the prior Trump administration.

Such activities include

Executive Order 13992, revoking several Trump administration orders that had certain deregulatory effects, and a letter to the United

Nations retracting the United States’ intent to withdraw from the World Health Organization.

Other actions by the Biden administration

and/or legislation passed by the new Congress could further impact the pharmaceutical and broader healthcare industries in ways that are

difficult to predict but that could also materially impact our operations.

We cannot predict what other healthcare reforms will ultimately

be implemented at the federal or state level or the effect of any future legislation, executive action or regulation and, accordingly,

face uncertainties that might result from additional reforms.

The Biden administration has also undertaken

other actions – and may continue to do so – signaling a change in policy from the prior Trump administration.

Such activities

include Executive Order 13992, revoking several Trump administration orders that had certain deregulatory effects, and a letter to the

United Nations retracting the United States’ intent to withdraw from the World Health Organization.

The One Big Beautiful Bill Act, which was signed

into law in July 2025, includes provisions that will impact the U.S.

healthcare system in various ways, including by cuts to Medicaid

and introducing new participant work and eligibility requirements for Medicaid coverage, which are expected to significantly change the

administration and applicability of Medicaid coverage.

In November 2025, CMS announced a voluntary initiative called the GENEROUS Model

(GENErating cost Reductions for U.S.

Medicaid Model) to introduce the option of most-favored-nation pricing to the Medicaid program, whereby

a drug manufacturer may voluntarily offer supplemental rebates to participating state Medicaid programs for a manufacturer’s covered

outpatient drugs.

Government agreements with pharmaceutical companies and other measures that use most-favored-nation pricing targets

for prescription drugs, including the use of international pricing reference to set drug prices in the U.S., or that increase generic

and biosimilar drug entry sooner than expected, can have a material adverse effect on our industry, ability to set adequate pricing for

new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future.

We cannot predict the full

impact of the executive orders focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other

measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the U.S.

The impact of ongoing and future judicial challenges, as well as future legislative, executive, and administrative actions and any future

healthcare measures and agency rules implemented by the current administration, including the Department of Government Efficiency, on

our company and the pharmaceutical industry as a whole is unclear.

The implementation of cost containment measures or other healthcare

reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.

At the state level, individual

states are increasingly aggressive in passing legislation and implementing regulations designed to control prescription drug pricing,

including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure

and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

states are considering or have recently enacted state drug price transparency and reporting laws that could substantially increase our

compliance burdens and expose us to greater liability under such state laws.

We expect that additional state and federal healthcare reform

measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare

products and services, which could result in reduced demand for our products or product candidates or additional pricing pressures.

Other actions by the Trump administration and/or legislation passed

by the new Congress could further impact the pharmaceutical and broader healthcare industries in ways that are difficult to predict but

that could also materially impact our operations.

We cannot predict what other healthcare reforms will ultimately be implemented at the

federal or state level or the effect of any future legislation, executive action or regulation and, accordingly, face uncertainties that

might result from additional reforms.

At the state level, legislatures have increasingly

passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement

constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases,

designed to encourage importation from other countries and bulk purchasing.

constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some

cases, designed to encourage importation from other countries and bulk purchasing.

Healthcare Regulations

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on the one hand and prescribers, purchasers and formulary managers on the other.

Although there are several statutory exceptions and regulatory

safe harbors protecting certain common activities from prosecution, the exceptions and safe harbors are drawn narrowly, and practices

that involve remuneration intended to induce prescribing, purchasing, or recommending may be subject to scrutiny if they do not qualify

for an exception or safe harbor.

In addition, a person or entity does not need to have actual knowledge of the statute or specific intent

to violate it to have committed a violation.

Moreover, the government may assert that a claim including items or services resulting from

a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

The penalties

for violating the federal Anti-Kickback Statute include administrative civil money penalties, imprisonment for up to five years, fines

of up to $25,000 per violation and possible exclusion from federal healthcare programs such as Medicare and Medicaid.

Although there are several statutory exceptions and

regulatory safe harbors protecting certain common activities from prosecution, the exceptions and safe harbors are drawn narrowly, and

practices that involve remuneration intended to induce prescribing, purchasing, or recommending may be subject to scrutiny if they do

not qualify for an exception or safe harbor.

In addition, a person or entity does not need to have actual knowledge of the statute or

specific intent to violate it to have committed a violation.

Moreover, the government may assert that a claim including items or services

resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims

The penalties for violating the federal Anti-Kickback Statute include administrative civil money penalties, imprisonment for up

to five years, fines of up to $25,000 per violation and possible exclusion from federal healthcare programs such as Medicare and Medicaid.

The federal civil and criminal false claims laws,

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investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any

materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Like the federal Anti-Kickback Statute, the ACA amended the intent standard for certain healthcare fraud statutes under HIPAA such that

a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed

materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or

Like the federal Anti-Kickback Statute, the ACA amended the intent standard for certain healthcare fraud statutes under HIPAA

such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have

committed a violation.

Analogous state and foreign laws and regulations,

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Sunshine laws, including the Federal Open Payments

law enacted as part of the ACA, require pharmaceutical manufacturers to disclose payments and other transfers of value to physicians and

certain other health care providers or professionals, and in the case of some state sunshine laws, restrict or prohibit certain such payments.

Pharmaceutical manufacturers are required to submit reports to the government by the 90 th day of each calendar year.

to submit the required information may result in civil monetary penalties of up to an aggregate of $100,000 per year, adjusted for inflation

(or up to an aggregate of $1 million per year, adjusted for inflation for “knowing failures”) for all payments, transfers

of value or ownership or investment interests not reported in an annual submission, and may result in liability under other federal laws

or regulations.

Certain states and foreign governments require the tracking and reporting of gifts, compensation and other remuneration

to physicians.

law enacted as part of the ACA, require pharmaceutical manufacturers to disclose payments and other transfers of value to physicians

and certain other health care providers or professionals, and in the case of some state sunshine laws, restrict or prohibit certain such

Pharmaceutical manufacturers are required to submit reports to the government by the 90 th day of each calendar

Failure to submit the required information may result in civil monetary penalties of up to an aggregate of $100,000 per year, adjusted

for inflation (or up to an aggregate of $1 million per year, adjusted for inflation for “knowing failures”) for all payments,

transfers of value or ownership or investment interests not reported in an annual submission, and may result in liability under other

federal laws or regulations.

Certain states and foreign governments require the tracking and reporting of gifts, compensation and other

remuneration to physicians.

Privacy laws, such as the privacy regulations

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Specifically, HIPAA, as amended by HITECH, and their respective implementing

regulations, including the final omnibus rule published on January 25, 2013, imposes specified requirements relating to the privacy, security,

and transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s privacy and security

standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities that

create, receive, maintain, or transmit protected health information in connection with providing a service for or on behalf of a covered

HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly

other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce

the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.

In addition, state laws

govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways,

thus complicating compliance efforts.

regulations, including the final omnibus rule published on January 25, 2013, imposes specified requirements relating to the privacy,

security, and transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s privacy and

security standards directly applicable to “business associates,” defined as independent contractors or agents of covered

entities that create, receive, maintain, or transmit protected health information in connection with providing a service for or on behalf

of a covered entity.

HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates

and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal

courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.

addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other

in significant ways, thus complicating compliance efforts.

The FDA regulates the sale and marketing of prescription

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In the event that a government authority challenges

or finds ambiguity with regard to our report of payments, such authority may impose civil and criminal sanctions, which could have a material

adverse effect on our business.

or finds ambiguity with regard to our report of payments, such authority may impose civil and criminal sanctions, which could have a

material adverse effect on our business.

From time to time we conduct routine reviews of our government pricing calculations.

These reviews may

have an impact on government price reporting and rebate calculations used to comply with various government regulations regarding reporting

and payment obligations.

These reviews

may have an impact on government price reporting and rebate calculations used to comply with various government regulations regarding

reporting and payment obligations.

Many governments and third-party payors reimburse

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to comply with these laws, there is uncertainty about future changes in legislation and government enforcement of these laws.

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

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

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stringent federal, state and local environmental laws and regulations concerning, among other things, the generation, handling, storage,

transportation, treatment and disposal of toxic and hazardous substances, the discharge of pollutants into the air and water and the cleanup

of contamination.

We are required to maintain and comply with environmental permits and controls for some of our operations, and these

permits are subject to modification, renewal and revocation by the issuing authorities.

Our environmental capital expenditures and costs

for environmental compliance may increase in the future as a result of changes in environmental laws and regulations or increased manufacturing

activities at any of our facilities.

We could incur significant costs or liabilities as a result of any failure to comply with environmental

laws, including fines, penalties, third-party claims and the costs of undertaking a clean-up at a current or former site or at a site

to which our wastes were transported.

In addition, we have grown in part by acquisition, and our diligence may not have identified environmental

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

transportation, treatment and disposal of toxic and hazardous substances, the discharge of pollutants into the air and water and the

cleanup of contamination.

We are required to maintain and comply with environmental permits and controls for some of our operations,

and these permits are subject to modification, renewal and revocation by the issuing authorities.

Our environmental capital expenditures

and costs for environmental compliance may increase in the future as a result of changes in environmental laws and regulations or increased

manufacturing activities at any of our facilities.

We could incur significant costs or liabilities as a result of any failure to comply

with environmental laws, including fines, penalties, third-party claims and the costs of undertaking a clean-up at a current or former

site or at a site to which our wastes were transported.

In addition, we have grown in part by acquisition, and our diligence may not

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, 2026, we had 21 full-time employees

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on August 18, 2016.

Our principal executive offices are located at 4300 El Camino Real, Suite 210, Los Altos, CA 94022 and our telephone

Our principal executive offices are located at 1975 W El Camino Real, Ste 204, Mountain View, CA 94040, and our telephone

number is (650) 351-4495.

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is included in this document as an inactive textual reference only.

We make our filings with the SEC, including our Annual Report on Form

10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports, available free of charge on our

website as soon as reasonably practicable after we file such reports with, or furnish such reports to, the SEC.

The public may read and

copy the materials we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549.

may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.

Additionally, the SEC maintains

an internet site that contains reports, proxy and information statements and other information.

The address of the SEC’s website

is www.sec.gov .

We make our filings with the SEC, including our Annual Report on

Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports, available free of charge

on our website as soon as reasonably practicable after we file such reports with, or furnish such reports to, the SEC.

The public may

read and copy the materials we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549.

The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.

Additionally, the

SEC maintains an internet site that contains reports, proxy and information statements and other information.

The address of the SEC’s

website is www.sec.gov .

The information contained in the SEC’s website is not intended to be a part of this filing.

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