NASDAQ: UNCY

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 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
it is swallowed, not chewed. With OLC, if approved, people on dialysis and their physicians may have a better option to control hyperphosphatemia.

AKI is a sudden episode of kidney failure or
kidney damage (within the first 90 days of injury). After 90 days, the patient is considered to have progressed into CKD. AKI affects
more than 2 million U.S. patients and costs the healthcare system in excess of $9 billion per year. More than 300,000 patients per year
in the U.S. die due to AKI. Currently there are no FDA approved medicines to treat DGF and/or AKI. Treatment options for AKI include
continuous renal replacement therapy, renal transplant, and dialysis. In most cases the damage to the kidney is irreversible, and the
patient needs to have a renal transplant or be on dialysis for life. Therefore, there is a high unmet medical need. If approved, UNI-494
has the potential to be a first-in-class drug for the treatment of AKI.

We operate with a sense of urgency to bring new
treatments to patients faster, leveraging our team’s expertise, operational efficiency, and strategic focus on high-value opportunities
within the renal space. Through this approach, we aim to deliver innovative therapies that provide meaningful clinical and economic benefits
for patients, providers, and healthcare systems.

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Pipeline

Our proprietary pipeline is comprised of our two product candidates
– oxylanthanum carbonate and UNI-494 – which are described below in Figure 1:

Figure 1: Unicycive Therapeutics’ Pipeline

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,
OLC leverages the high phosphate binding potency of lanthanum in a palatable dose form that has the potential to substantially reduce
the pill burden volume for patients. In this regard, we believe that the combined effect of smaller pill size, lower number of pills,
and improved palatability with Oxylanthanum carbonate will compete favorably with currently available phosphate binders and may lead
to improved patient compliance/adherence and more effective disease management.

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
inspection. No other concerns have been identified to us, 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.

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Disease Overview: Hyperphosphatemia

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.

eGFR = estimated glomerular filtration rate (a measure of kidney
function)

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

Figure 2: Stages of Chronic Kidney
Disease

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. The 2023
USRDS annual report indicates that there were 541,326 prevalent dialysis patients in 2021 (the latest reported year), and of those, approximately
450,000 patients (~80%) take phosphate binders to control hyperphosphatemia. The prevalent U.S. dialysis population has grown at an average
yearly rate of 3.5% over the past decade. 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 (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
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.

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

Figure 3: 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
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 (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.

Figure 4: Phosphate Binder Mechanisms
of Action, Adapted from Covic and Rastogi, 2013.

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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).

KDOQI: The Kidney Disease Outcomes Quality Initiative

Figure 5: Serum Phosphorus Target Achievement from 2012 to 2021

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
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.

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.

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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).

Figure 6: 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).

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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. 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.

Primary Endpoint - Tolerability: The 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 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. (Figure 7)

Figure 7: 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. At
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. (Figure 9)

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Figure 8: 90% Of Patients Were Able to Achieve
Phosphate Levels ≤5.5ng/dL with OLC.

Figure 9: 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).

Figure 10: Daily Urine Phosphate Reduction in Healthy Volunteers

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

Figure 11: 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. The approved drug
is called the Reference Listed Drug (RLD). The RLD for the oxylanthanum carbonate submission is Fosrenol (lanthanum carbonate). The
FDA recommended conducting a BE study in healthy volunteers and a 6-month toxicity study in mice with both oxylanthanum carbonate
and Fosrenol to be able to rely on the efficacy and safety of Fosrenol. We completed both studies and submitted the data for the
FDA’s review during the pre-NDA (New Drug Application) meeting request. 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. 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.

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U.S. Commercial Opportunity for Oxylanthanum
Carbonate

Overview

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
(OLC)

U.S. 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
billion.

Despite multiple available therapeutic options,
significant unmet need persists:

●Pill
Burden: Standard-of-care binders often require patients to ingest up to 10–12 tablets
daily. 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.

●Suboptimal
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.

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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:

●High
Potency-to-Volume Ratio: Designed to achieve phosphorus control with a lower daily pill
burden compared to commonly prescribed binders.

●Swallowable
Tablet: 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.

●Flexible
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. Our embedded
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

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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
teams.

●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

The U.S. 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

Approx. U.S. Patients

Cumulative % of U.S. Dialysis

Population

DaVita Inc.

~200,800

~37%

Fresenius Kidney Care

~190,000

~71%

U.S. Renal Care (including Satellite-administered network)

~37,000

~78%

Dialysis Clinic, Inc. (DCI)

~15,000

~81%

Innovative Renal Care

~16,000

~85%

The source is: The National Forum of ESRD Networks. Quarterly National
ESRD Census www.esrdnetworks.org

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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. Successful
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. This
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
Mix

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): Includes
commercial insurance, managed Medicaid, and state Medicaid programs where therapies are reimbursed
under the pharmacy benefit.

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Supporting OLC Market Access for Non-Medicare
Patients

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
patients

●Patient assistance programs for uninsured or underinsured patients

Navigating the Bundled Medicare Reimbursement
Environment

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. To
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
period. 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.

Competition

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
of Care

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.

-14-

Primary Competitors

Category

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.

Figure 12: Primary competitors of OLC

Our Competitive Advantage: Oxylanthanum Carbonate
(OLC)

We believe OLC is positioned to disrupt the current
treatment paradigm through its proprietary formulation, which offers:

●Superior
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.

●Improved
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.

●Optimized
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.

-15-

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. market.

While our primary near-term focus is a self-directed
U.S. 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
franchise. 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

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
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”)
based in India. Pursuant to the Agreement, Shilpa provides certain development, manufacturing, supply and other CMC-related services related
to the development and commercialization of oxylanthanum carbonate (“OLC”).

In June 2024, we entered into the First Amendment
to Manufacturing and Supply Agreement with Shilpa (the “Amendment”) in anticipation of an increased manufacturing demand
for OLC. Pursuant to the Amendment, we agreed to make a binding purchase order for tablets of OLC and Shilpa has agreed to deliver such
order by September 30, 2025. In addition, we agreed to order additional tablets for delivery between December 31, 2025, and September
30, 2026. Further, we agreed to make certain milestone payments and to provide certain funding to Shilpa for a new manufacturing line.
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.

-16-

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

UNI-494

Disease Overview: Acute Kidney Injury (AKI)

Acute kidney injury (AKI) is defined as a sudden
loss of kidney function that is diagnosed by increased serum creatinine levels and decreased urine output and is limited to a duration
of 7 days, whereas chronic kidney disease (CKD) is 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).

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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. 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.

The potential commercial opportunity for UNI-494
in DGF is substantial. In the US, 46,630 kidney transplants were performed in 2023. 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. 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.

UNI-494: A Novel Prodrug of Nicorandil

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 KATP) channel activator and nitrate-like vasodilator. Activation of mitochondrial
KATP 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 KATP 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. 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.

-18-

Mechanism of Action of UNI-494

UNI-494 is a novel proprietary drug that selectively
binds to the SUR2B subunit of the mitochondrial KATP 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:

Figure 13: 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 KATP 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.

-19-

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:

Figure 14: Effect of UNI-494 on Ischemia-Reperfusion Injury in
Rats

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.

Phase I Study in Healthy Volunteers

The Phase 1 study was a single center, double-blind,
placebo-controlled, randomized single ascending dose (Part 1) and multiple ascending dose (Part 2) study in healthy volunteers conducted
in the United Kingdom. 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.

Single Ascending Dose: Part 1 of the study
enrolled 40 participants in 5 cohorts with 30 participants dosed with UNI-494 and 10 participants dosed with placebo. UNI-494 was well-tolerated
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. Headache was the most common adverse event reported. Most of the adverse events were mild, and all participants
dosed with UNI-494 completed the study.

Multiple Ascending Dose: Part 2 of the
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. There were no serious adverse events (SAEs) in Part 2 of the study, and UNI-494 was safe and well-tolerated
at the 40 mg BID dose for 5 days. Most common adverse events reported included headache, nausea, and vomiting. In Cohort One, the majority
of the adverse events reported were mild and all but one participant completed the study. In Cohort Two, UNI-494 was not well-tolerated
with 4 participants withdrawing from the study due to adverse events.

Pharmacokinetics of UNI-494 were also evaluated
in the study. 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.

-20-

Regulatory Strategy for UNI-494

Orphan Drug Designation: In February 2024,
the FDA granted orphan drug designation to UNI-494 for prevention of DGF in patients undergoing solid organ transplantation. The FDA,
through its Office of Orphan Products Development (OOPD), grants orphan drug designation to drugs that have the potential to offer a
safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 patients in the United States.
Orphan drug designation provides certain benefits to the drug developer that include the following: 1) tax credits for qualified clinical
trials, 2) exemption of user fees and 3) potential for seven years of market exclusivity after approval.

The FDA issued a guidance to industry in 2019
for development of drugs for prevention of DGF in kidney transplantation. This guidance outlines the study design, patient population,
randomization, stratification, dose selection and primary endpoints required for registration of drugs in DGF. This guidance provides
a clear path for development of drugs for prevention of DGF.

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.

Market Potential

In Delayed Graft Function (DGF): A UNI-494
per patient treatment cost of $25,000 for the ~40,000 deceased donor kidney transplants per year values the DGF market at $1 billion.
This estimate of the DGF market potential is only intended to be illustrative. The commercial potential of UNI-494 will be determined
by the portion of the market ultimately addressable by UNI-494 and its actual launch price. Given the economic consequences of kidney
graft failure, a clinically effective UNI-494 could reasonably command a significantly higher market price.

In Acute Kidney Injury (AKI): According
to a 2017 article by Silver and Chertow, the current cost of care for AKI in the U.S. is estimated to be between $5.4 billion to $24
billion per year. In England, inpatient costs related to AKI are estimated to make up 1% of the total National Health Service budget.
With no effective treatment for AKI, it is not possible to definitively state a market figure. However, with the high cost and burden
of caring for AKI patients, we believe a conservative market estimate is approximately $3 billion in the U.S. alone. The lack of effective
therapeutic interventions for AKI means that UNI-494 has the potential to be the first drug approved for the treatment of AKI. AKI is
a heterogeneous disease. We plan to target a more homogeneous AKI population for UNI-494 by focusing on kidney injury caused by complications
from heart failure, surgeries, drugs, and contrast induced nephropathy.

Sphaera License Agreement

On October 1, 2017, we entered into an exclusive
license agreement (the “Sphaera License Agreement”) with Sphaera Pharma Pte. Ltd., a Singaporean pharmaceutical corporation
(“Sphaera”). Pursuant to the Sphaera License Agreement, we acquired an exclusive royalty-bearing global license to develop,
make, have made, use, practice, research, distribute, lease, sell, offer for sale, license, import or otherwise dispose of certain rights
owned or controlled by Sphaera and/or any of its affiliates, related to UNI-494 (the “UNI-494 Rights”). We also acquired
a non-exclusive license to certain know-how and technology related to the UNI-494 Rights. Sphaera conceived of and performed initial
characterization of various potential pro-drug linkers, including the initial patent application, and performed some initial physicochemical
characterization and preliminary animal pharmacokinetic studies.

-21-

Under the terms of the Sphaera License Agreement,
we are obligated to pay to Sphaera, on a quarterly basis, a running royalty of 2% of our net sales (including our affiliates) in connection
with the global sales of UNI-494; provided, however, that if we are required to make royalty payments to one or more third parties whose
patent rights would be infringed by the exercise of the UNI-494 Rights, we may reduce such running royalty due to Sphaera by the amount
of such third-party royalty rate.

We are also required to pay to Sphaera certain
milestone payments, including, upon our initiation of a second clinical trial; $50,000 at the time the first patient in such trial is
dosed; an additional $50,000 within 30 days of completion of such trial; and at the time the FDA accepts an NDA for UNI494, $1.65 million.
In addition, we are responsible for the prosecution of patent rights, and any related costs and expenses for patent prosecution and maintenance.

We also have the right, but not the obligation,
to defend the UNI-494 rights during the term of the Sphaera License Agreement; provided, however, that if we determine not to prosecute
or maintain such rights in any country, we must provide ninety (90) days written notice to Sphaera. We may terminate the Sphaera License
Agreement at any time by providing thirty (30) days’ written notice to Sphaera. Additionally, in the event that either we or Sphaera
breach any of our respective material obligations, the non-breaching party may, in its sole discretion, have the right to terminate the
Sphaera License Agreement, provided that it give the breaching party written notice specifying the nature of the breach and amounts of
running royalty payments due, if any. In such an occurrence, the termination notice is effective ninety (90) days from receipt of the
notice if the breaching party has failed to cure the breach.

Competition

We operate in a highly competitive and regulated
industry that is subject to rapid and frequent changes. 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 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

Our commercial success depends in part on our
ability to obtain and maintain proprietary protection for our product candidates, as well as novel discoveries, product development technologies,
and know-how.

Our commercial success also depends in part on
our ability to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights.
Our policy is to develop and maintain protection of our proprietary position by, among other methods, filing or in-licensing U.S. and
foreign patents and applications related to our technology, inventions, and improvements that are important to the development and implementation
of our business.

We also rely on trademarks, trade secrets, know-how,
continuing technological innovation, confidentiality agreements, and invention assignment agreements to develop and maintain our proprietary
position. 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. We
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.

-22-

Patent Portfolio

Oxylanthanum Carbonate

Our oxylanthanum carbonate patent portfolio includes
one family of granted United States patents, with related applications pending, and an additional family of granted foreign patents,
with related applications also pending. Granted and pending claims offer various forms of protection for oxylanthanum carbonate including
claims to compositions of matter, pharmaceutical compositions, specific forms (such as polymorphs of lanthanum dioxycarbonate),
methods of making the composition of matter, and methods for treating elevated levels of phosphate in the blood using oxylanthanum carbonate.
These United States patents and applications, and their foreign equivalents, are described in more detail below.

Both the U.S. patent family and the foreign patent
family containing claims to oxylanthanum carbonate and related compounds were filed in 2011. Exclusive of patent term extension,
the U.S. patents from this family containing claims covering oxylanthanum carbonate has a statutory expiration date in 2032. Corresponding
patents granted in Canada, Europe (validated in multiple European Patent Convention member states), Japan, China, Australia, and other
countries have statutory expiration dates in 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.

The most relevant granted United States patents
with claims covering oxylanthanum carbonate are listed below, along with their projected expiration dates exclusive of any patent term
extension.

Patent
Number

Title

Projected
Expiration

8,961,917

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

October 26, 2032

10,350,240

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

November 12, 2032

11,406,663

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

May 12, 2031

UNI 494

We believe that we have a strong global intellectual
property position, substantial know-how and trade secrets relating to UNI-494. As of October 28, 2020, we have one granted U.S. patent
that is exclusively licensed to us from Sphaera Pharma Pte Ltd. In addition, we have four granted U.S. patents that we own. The first
granted U.S. patent is directed to methods of making UNI-494, and it is expected to expire in 2032. The other granted U.S. patents are
directed to methods of using UNI-494, and to other compositions of matter and are expected to expire in 2040.

Patent Number

Title

Projected Expiration

9,359,376

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

July 11, 2032

12,036,211

Nicorandil derivatives

March 16, 2040

12,377,082

Nicorandil derivatives

March 16, 2040

12,396,989

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.

-23-

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.

Pharmaceutical Regulation in the United States

In the United States, the FDA regulates drugs
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. 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 on us.

FDA approval is required before any new unapproved
drug or dosage form, including a new use of a previously approved drug or a generic version of a previously approved drug, can be marketed
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; and

●FDA review and
approval of the NDA.

Preclinical Studies

When developing a branded product and bringing
it to market, the first step in proceeding to clinical studies is preclinical testing. Preclinical tests are intended to provide a laboratory
or animal study evaluation of the product to determine its chemistry, formulation, and stability. Toxicology studies are also performed
to assess the potential safety of the product. The conduct of the preclinical tests must comply with federal regulations and requirements,
including GLPs. The results of these studies are submitted to the FDA as part of an IND application along with other information, including
product chemistry, manufacturing and controls and a proposed clinical trial protocol. Long-term preclinical tests, such as animal tests
of reproductive toxicity and carcinogenicity, may continue concurrently with the IND application.

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Clinical Trials

Once the IND has been approved by the FDA, the
company may begin conducting clinical trials. Clinical trials involve the administration of the investigational new drug to human subjects
under the supervision of qualified investigators in accordance with GCP requirements, which include the requirement that all research
subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under
protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness
criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part
of the IND. In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical
trial before it is initiated at that institution. Information about certain clinical trials must be submitted within specific timeframes
to the NIH for public dissemination on their www.clinicaltrials.gov website.

Human clinical trials are typically conducted
in three sequential phases, which may be distinct, or overlap or be combined:

●Phase 1:
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.

●Phase 2:
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.

●Phase 3:
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
clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. Phase 1, Phase 2,
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 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

After completion of the required clinical testing,
an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the United
States. The NDA must include, among other things, the results of all preclinical, clinical and other testing and a compilation of data
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.
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. The FDA may request additional information
rather than accept an NDA for filing. In some events, the NDA may be required to be resubmitted with additional information and it may
be subject to payment of additional user fees. The resubmitted application is also subject to review before the FDA accepts it for filing.
Once the submission is accepted for filing, the FDA begins an in-depth substantive review. Under the Prescription Drug User Fee Act,
as amended, the FDA has agreed to certain performance goals for itself for the review of NDAs through a two-tiered classification system,
Standard Review and Priority Review. Priority Review designation is given to drugs that are intended to treat a serious condition and,
if approved, would provide a significant improvement in safety or effectiveness over existing therapies. 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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The FDA may refer applications for certain drug
products which present difficult questions related to its safety or efficacy to an advisory committee for review, evaluation, and recommendation,
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.

After the FDA evaluates the NDA and the manufacturing
facilities, it issues either an approval letter or a complete response letter to indicate that the review cycle for an application is
complete and that the application is not ready for approval. A complete response letter generally outlines the deficiencies in the submission
and may require substantial additional testing, or information, in order for the FDA to reconsider the application. Even with submission
of this additional information, the FDA may ultimately decide that an application does not satisfy the regulatory criteria for approval.
If, or when, the deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an
approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

As a condition of NDA approval, the FDA may require
a risk evaluation and mitigation strategy (REMS) to help ensure that the benefits of the drug outweigh the potential risks. If the FDA
determines a REMS is necessary during review of the application, the drug sponsor must agree to the REMS plan at the time of approval.
A REMS may be required to include various elements, such as a medication guide or patient package insert, a communication plan to educate
healthcare providers of the drug’s risks, limitations on who may prescribe or dispense the drug, or other elements to assure safe
use, such as special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring
and the use of patient registries. In addition, the REMS must include a timetable to periodically assess the strategy. The requirement
for a REMS can materially affect the potential market and profitability of a drug.

Sometimes, product approval may require substantial
post-approval testing and surveillance to monitor the drug’s safety or efficacy, and the FDA has the authority to prevent or limit
further marketing of a product based on the results of these post-marketing programs. Once granted, product approvals may be withdrawn
if compliance with regulatory standards is not maintained or certain problems are identified following initial marketing. Drugs may be
marketed only for the approved indications and in accordance with the provisions of the approved labeling, and, even if the FDA approves
a product, it may limit the approved indications for use for the product or impose other conditions, including labeling or distribution
restrictions or other risk-management mechanisms.

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 NDAs.

Disclosure of Clinical Trial Information

Sponsors of certain clinical trials of FDA-regulated
products, including drugs, are required to register and disclose certain clinical trial information on www.clinical trials.gov. Information
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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Post-Approval Requirements

Once an NDA is approved, a product will be subject
to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to drug listing and registration,
recordkeeping, periodic reporting, product sampling and distribution, adverse event reporting, and advertising, marketing and promotion,
including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational
activities and promotional activities involving the Internet. Drugs may be marketed only for the approved indications and in a manner
consistent with the provisions of the approved labeling. While physicians may choose to prescribe a drug for off-label uses, manufacturers
may only promote it for the approved indications and in accordance with the provisions of the approved labeling. The FDA and other agencies
actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly
promoted off-label uses may be subject to significant liability. There also are extensive DEA regulations applicable to controlled substances.

Adverse event reporting and submission of periodic
reports is also required following FDA approval of an NDA. Additionally, the FDA may require post-marketing testing, known as Phase 4
testing, REMS, and/or surveillance to monitor the effects of an approved product. Alternatively, the FDA may place conditions on an approval
that could restrict the distribution or use of the product. In addition, quality-control, drug manufacture, packaging and labeling procedures
must continue to comply with cGMPs after its approval. Drug manufacturers and certain of their subcontractors are required to register
their establishments and list their marketed products with the FDA and certain state agencies. Registration with the FDA subjects entities
to periodic unannounced inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with cGMPs.
Accordingly, manufacturers must continue to expend time, money, and effort in the areas of production and quality-control to maintain
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.

The Hatch-Waxman Amendments

505(b)(2) NDAs

The FDA is also authorized to approve an alternative
type of NDA under Section 505(b)(2) of the FDCA. Section 505(b)(2) permits the filing of an NDA where at least some of the information
required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of
reference from the data owner. The applicant may rely upon the FDA’s findings of safety and efficacy for an approved product that
acts as the “listed drug.” The FDA may also require 505(b)(2) applicants to perform additional studies or measurements to
support the change from the listed drug. The FDA may then approve the new product candidate for all, or some, of the conditions of use
for which the branded reference drug has been approved, or for a new condition of use sought by the 505(b)(2) applicant.

Abbreviated New Drug Applications

The Hatch-Waxman amendments to the FDCA established
a statutory procedure for submission and FDA review and approval of abbreviated new drug applications (ANDAs) for generic versions of
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.

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Orange Book Listing

In seeking approval for a drug through an NDA,
including a 505(b)(2) NDA, applicants are required to list with the FDA certain patents whose claims cover the applicant’s product.
Upon approval of an NDA, each of the patents listed in the application for the drug is then published in the Orange Book. Any applicant
who files an ANDA seeking approval of a generic equivalent version of a drug listed in the Orange Book or a 505(b)(2) NDA referencing
a drug listed in the Orange Book must certify to the FDA (i) that there is no patent listed with the FDA as covering the relevant branded
product, (ii) that any patent listed as covering the branded product has expired, (iii) that the patent listed as covering the branded
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 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
assert a patent challenge directed to one of the Orange Book listed patents within 45 days of the receipt of the Paragraph IV certification
notice, the FDA is prohibited from approving the application until the earlier of 30 months from the receipt of the Paragraph IV certification,
expiration of the patent, settlement of the lawsuit or a decision in the infringement case that is favorable to the applicant. The ANDA
or 505(b)(2) application also will not be approved until any applicable non-patent exclusivity listed in the Orange Book for the branded
reference drug has expired as described in further detail below.

Non-Patent Exclusivity

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.

For example, for listed drugs that were considered
new chemical entities at the time of approval, an ANDA or 505(b)(2) application referencing that drug may not be filed with the FDA until
the expiration of five years after approval of that drug, unless the submission is accompanied by a Paragraph IV certification, in which
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.

Pharmaceutical Coverage, Pricing and Reimbursement

In the United States and markets in other countries,
patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party
payors to reimburse all or part of the associated healthcare costs. Significant uncertainty exists as to the coverage and reimbursement
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.
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
approvals. 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. Further, one payor’s determination to provide coverage for a drug product
does not assure that other payors will also provide coverage and reimbursement for the product, and the level of coverage and reimbursement
can differ significantly from payor to payor.

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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,
2025. 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. We believe
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. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies
in jurisdictions with existing controls and measures, could further limit a company’s revenue generated from the sale of any approved
products. 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. 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. 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. 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.

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Dialysis Organizations Protocols

Dialysis organizations have their own formularies
that list primary or preferred therapeutic options based on contracting status with drug manufacturers. While a prescriber may make their
own independent decision to prescribe what they determine most appropriate for a given patient, any non-formulary therapeutic options
are only available through an exception process based on clinical need. Similar to how payor coverage may affect the sales of a product,
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.

Our ability to generate product revenue and achieve
profitability depends on the overall success of oxylanthanum carbonate, UNI-494, and any current or future product candidates, including
those that may be in-licensed or acquired, which depends on several factors, including:

●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;

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●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; and

●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

Our business is substantially dependent on the
commercial success of oxylanthanum carbonate, if approved. If we are unable to successfully commercialize oxylanthanum carbonate, our
results or operations and financial condition will be materially harmed. Our ability to generate revenue depends on our ability to execute
on our commercialization plans, and the size of the market for, and the level of market acceptance of, oxylanthanum carbonate and any
other product or product candidate, including those that may be in-licensed or acquired. If the size of any market for which a product
or product candidate is approved decreases or is smaller than we anticipate, our revenue and results of operations could be materially
adversely affected. Market acceptance is also critical to our ability to generate significant product revenue. Any product may achieve
only limited market acceptance or none at all. If oxylanthanum carbonate, or any of our product candidates that is approved, is not accepted
by the market to the extent that we expect or market acceptance decreases, we may not be able to generate significant product revenue
and our business would be materially harmed. Market acceptance of oxylanthanum carbonate or any other approved product depends on a number
of factors, including:

●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;

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●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;
and

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

In order to market oxylanthanum carbonate and
any other approved product, we intend to invest in sales and marketing, which will require substantial effort and significant management
and financial resources. Additionally, training a sales force to successfully sell and market a new commercial product is expensive and
time-consuming and could delay any commercial launch of such product candidate. We may underestimate the size of the sales force required
for a successful product launch and we may need to expand our sales force earlier and at a higher cost than we anticipated. We will devote
significant effort, in particular, to recruiting individuals with experience in the sales and marketing of pharmaceutical products. Competition
for personnel with these skills is significant and retaining qualified personnel with experience in our industry is difficult. As a result,
we may not be able to retain our existing employees or hire new employees quickly enough to meet our needs. At the same time, we may
face high turnover, requiring us to expend time and resources to source, train and integrate new employees. There are risks involved
with building our own sales and marketing capabilities, including the following:

●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.

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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 approved. Furthermore, if we are unable to maintain our arrangements with third parties with respect to sales and marketing, if we
are unsuccessful in entering into additional arrangements with third parties to sell and market our products or we are unable to do so
on terms that are favorable to us, or if such third parties are unable to carry out their obligations under such arrangements, it will
be difficult to successfully commercialize our product and product candidates, including oxylanthanum carbonate, if approved.

Our, or our partners’, failure to obtain
or maintain adequate coverage, pricing and reimbursement for oxylanthanum carbonate, if approved, or any other future approved products,
could have a material adverse effect on our or our collaboration partners’ ability to sell such approved products profitably and
otherwise have a material adverse impact on our business.

Market acceptance and sales of any approved products,
including oxylanthanum carbonate and UNI-494, depends significantly on the availability of adequate coverage and reimbursement from third
party payors and may be affected by existing and future healthcare reform measures. Governmental authorities, third party payors, and
PBMs decide which drugs they will cover, as well as establish formularies or implement other mechanisms to manage utilization of products
and determine reimbursement levels. We cannot be sure that coverage or adequate reimbursement will be available for oxylanthanum carbonate,
UNI-494, or any of our potential future products. Even if we obtain coverage for an approved product, third party payors may not establish
adequate reimbursement amounts, which may reduce the demand for our product and prompt us to reduce pricing for the product. If reimbursement
is not available or is limited, we may not be able to commercialize certain of our products. Coverage and reimbursement by a governmental
authority, third-party payor or PBM may depend upon a number of factors, including the determination that use of a product is:

●a covered benefit
under the health plan;

●safe, effective,
and medically necessary;

●appropriate for
the specific patient; and

●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
with more extensive product lines. We currently believe it is likely that oxylanthanum carbonate, if approved, will be reimbursed using
the Transitional Drug Add-on Payment Adjustment, or TDAPA, followed by inclusion in the bundled reimbursement model for Medicare beneficiaries.
For those that obtain dialysis through commercial insurance during the 30-month coordination period or through Medicaid prior to Medicare
becoming primary payer after 90 days, patients may access oxylanthanum carbonate through contracts we negotiate with third party payors
for reimbursement of oxylanthanum carbonate, which would be subject to the risks and uncertainties described above. Additionally, applying
for and obtaining reimbursement under the TDAPA may take an undetermined amount of time following approval, which will affect adoption,
uptake, and product revenue for oxylanthanum carbonate during that time, and if there are updates to the TDAPA rule that decrease the
basis for reimbursement or eligibility criteria during the transition period or if the TDAPA is eliminated, then our profitability may
be adversely affected. Further, if oxylanthanum carbonate is approved in the United States and included in the fixed reimbursement model
for a bundle of dialysis services, or the bundle, we would be required to enter into contracts to supply oxylanthanum carbonate to specific
dialysis providers, instead of through distributors.

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The dialysis market is unique and is dominated
by two providers: DaVita and Fresenius, which account for a vast majority of the dialysis population in the United States. Similar to
how payor coverage may affect the sales of a product, 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. If any dialysis organization does not add oxylanthanum carbonate,
to the formulary, our business may be materially harmed. In addition, we may be unable to sell oxylanthanum carbonate to dialysis providers
on a profitable basis if CMS significantly reduces the level of reimbursement for dialysis services and providers choose to use alternative
therapies or look to re-negotiate their contracts with us. Adequate coverage and reimbursement of our products by government and private
insurance plans are central to patient and provider acceptance of any products for which we receive marketing approval. Further, in many
countries outside the United States, a drug must be approved for reimbursement before it can be marketed or sold in that country. In
some cases, the prices that we intend to charge for our products are also subject to approval. Approval by the EMA or another regulatory
authority does not ensure approval by reimbursement authorities in that jurisdiction, and approval by one reimbursement authority outside
the United States does not ensure approval by any other reimbursement authorities. However, the failure to obtain reimbursement in one
jurisdiction may negatively impact our ability to obtain reimbursement in another jurisdiction. We may not be able to obtain such reimbursement
approvals on a timely basis, if at all, and favorable pricing in certain countries depends on a number of factors, some of which are
outside of 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. Our future success depends on our ability to demonstrate
and maintain a competitive advantage with respect to the development and commercialization of oxylanthanum carbonate, and any other product
or product candidate, including those that may be in-licensed or acquired. oxylanthanum carbonate will compete in the hyperphosphatemia
market in the United States with other FDA-approved phosphate binders such as Renagel® (sevelamer hydrochloride) and Renvela®
(sevelamer carbonate), both marketed by Sanofi, PhosLo® and Phoslyra® (calcium acetate), marketed by Fresenius Medical Care North
America, Fosrenol® (lanthanum carbonate), marketed by Shire Pharmaceuticals Group plc, Velphoro® (sucroferric oxyhydroxide),
marketed by Fresenius Medical Care North America, and Auryxia (ferric citrate), marketed by Akebia Therapeutics, Xphozah® (tenapanor),
marketed by Ardelyx, as well as over-the-counter calcium carbonate products such as TUMS® and metal-based options such as aluminum,
lanthanum and magnesium. Most of the phosphate binders listed above are now also available in generic forms. In addition, other agents
are in development, including OPKO Health Inc.’s Alpharen™ Tablets (fermagate tablets) that may impact the market for oxylanthanum
carbonate.

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

As a result of all of these factors, our competitors
may succeed in obtaining patent protection and/or marketing approval, or discovering, developing and commercializing competitive products,
before, or more effectively than, we do. If we are not able to compete effectively against potential competitors, our business will not
grow and our financial condition and operations will suffer.

Healthcare Reform

In the United States, there have been a number
of federal and state proposals during the last several years regarding the pricing of pharmaceutical products, government control and
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.

By way of example, in March 2010, the Affordable
Care Act (the “ACA”), was signed into law, which, among other things, includes changes to the coverage and payment for drug
products under government health care programs. 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.

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In addition to the changes brought about by the
ACA, other legislative changes have been proposed and adopted, including aggregate reductions of Medicare payments to providers of 2%
per fiscal year and reduced payments to several types of Medicare providers. Moreover, there has recently been heightened governmental
scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries
and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review
the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drug
products. Any proposed measures will require authorization through additional legislation to become effective. There can be no assurance
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.

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. A number of
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.

Healthcare Regulations

Pharmaceutical companies are subject to various
federal and state laws that are intended to combat health care fraud and abuse and that govern certain of our business practices, especially
our interactions with third-party payors, healthcare providers, patients, customers and potential customers through sales and marketing
or research and development activities. These include anti-kickback laws, false claims laws, sunshine laws, privacy laws and FDA regulation
of advertising and promotion of pharmaceutical products.

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Anti-kickback laws, including the federal Anti-Kickback
Statute, make it a criminal offense knowingly and willfully to offer, pay, solicit, or receive any remuneration to induce or reward referral
of an individual for, or the purchase, order or recommendation of, any good or service reimbursable by, a federal health care program
(including our products). The federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers
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.

The federal civil and criminal false claims laws,
including the civil False Claims Act, prohibit knowingly presenting, or causing to be presented, claims for payment to the federal government
(including Medicare and Medicaid) that are false or fraudulent (and, under the Federal False Claims Act, a claim is deemed false or fraudulent
if it is made pursuant to an illegal kickback). Manufacturers can be held liable under these laws if they are deemed to “cause”
the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting
a product off-label. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual
in the name of the government. Violations of the False Claims Act can result in significant monetary penalties, including fines ranging
from $13,508 to $27,018 for each false claim, and treble damages. The federal government is using the False Claims Act, and the accompanying
threat of significant liability, in its investigation and prosecution of pharmaceutical companies throughout the country, for example,
in connection with the promotion of products for unapproved uses and other improper sales and marketing practices. The government has
obtained multi-million and multi-billion-dollar settlements under the False Claims Act in addition to individual criminal convictions
under applicable criminal statutes. In addition, companies have been forced to implement extensive corrective action plans and have often
become subject to consent decrees or corporate integrity agreements, severely restricting the manner in which they conduct their business.
Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial
resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.

The Federal Civil Monetary Penalties Law prohibits,
among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should
know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.
Noncompliance can result in civil money penalties ranging from $10,000 to $50,000 per violation and exclusion from the federal healthcare
programs.

Federal criminal statutes prohibit, among other
actions, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private
third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal
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 a violation.

Analogous state and foreign laws and regulations,
including state anti-kickback and false claims laws, may apply to products and services reimbursed by non-governmental third-party payors,
including commercial payors. Additionally, there are state laws that require pharmaceutical companies to comply with the pharmaceutical
industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or that otherwise
restrict payments that may be made to healthcare providers as well as state and foreign laws that require drug manufacturers to report
marketing expenditures or pricing information and register sales representatives.

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 90th day of each calendar
year. 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.

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Privacy laws, such as the privacy regulations
implemented under HIPAA, restrict covered entities from using or disclosing protected health information. Covered entities commonly include
physicians, hospitals and health insurers from which we may seek to acquire data to aid in our research, development, sales and marketing
activities. Although pharmaceutical manufacturers are not covered entities under HIPAA, our ability to acquire or use protected health
information from covered entities may be affected by privacy laws. 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 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. 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.

The FDA regulates the sale and marketing of prescription
drug products and, among other things, prohibits pharmaceutical manufacturers from making false or misleading statements and from promoting
products for unapproved uses. There has been an increase in government enforcement efforts at both the federal and state level. Numerous
cases have been brought against pharmaceutical manufacturers under the Federal False Claims Act, alleging, among other things, that certain
sales or marketing-related practices violate the Anti-Kickback Statute or the FDA’s regulations, and many of these cases have resulted
in settlement agreements under which the companies were required to change certain practices, pay substantial fines and operate under
the supervision of a federally appointed monitor for a period of years. Due to the breadth of these laws and their implementing regulations
and the absence of guidance in some cases, it is possible that our practices might be challenged by government authorities. Violations
of fraud and abuse laws may be punishable by civil and criminal sanctions including fines, civil monetary penalties, as well as the possibility
of exclusion of our products from payment by federal health care programs.

Government Price Reporting

Government regulations regarding reporting and
payment obligations are complex, and we are continually evaluating the methods we use to calculate and report the amounts owed with respect
to Medicaid and other government pricing programs. Our calculations are subject to review and challenge by various government agencies
and authorities, and it is possible that any such review could result either in material changes to the method used for calculating the
amounts owed to such agency or the amounts themselves. Because the process for making these calculations, and our judgments supporting
these calculations, involve subjective decisions, these calculations are subject to audit. 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. 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.

Many governments and third-party payors reimburse
the purchase of certain prescription drugs based on a drug’s average wholesale price (AWP). In the past several years, state and
federal government agencies have conducted ongoing investigations of manufacturers’ reporting practices with respect to AWP, which
they have suggested have led to excessive payments by state and federal government agencies for prescription drugs. We and numerous other
pharmaceutical companies have been named as defendants in various state and federal court actions alleging improper or fraudulent practices
related to the reporting of AWP.

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Drug Pedigree Laws

State and federal governments have proposed or
passed various drug pedigree laws which can require the tracking of all transactions involving prescription drugs from the manufacturer
to the pharmacy (or other dispensing) level. Companies are required to maintain records documenting the chain of custody of prescription
drug products beginning with the purchase of such products from the manufacturer. Compliance with these pedigree laws requires implementation
of extensive tracking systems as well as heightened documentation and coordination with customers and manufacturers. While we fully intend
to comply with these laws, there is uncertainty about future changes in legislation and government enforcement of these laws. Failure
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.

Federal Regulation of Patent Litigation Settlements and Authorized
Generic Arrangements

As part of the Medicare Prescription Drug Improvement
and Modernization Act of 2003, companies are required to file with the U.S. Federal Trade Commission (“FTC”) and the U.S.
Department of Justice (the “DOJ”) certain types of agreements entered into between brand and generic pharmaceutical companies
related to the settlement of patent litigation or manufacture, marketing and sale of generic versions of branded drugs. This requirement
could affect the manner in which generic drug manufacturers resolve intellectual property litigation and other disputes with brand pharmaceutical
companies and could result generally in an increase in private-party litigation against pharmaceutical companies or additional investigations
or proceedings by the FTC or other governmental authorities.

Other

The U.S. federal government, various states and
localities have laws regulating the manufacture and distribution of pharmaceuticals, as well as regulations dealing with the substitution
of generic drugs for branded drugs. Our operations are also subject to regulation, licensing requirements and inspection by the states
and localities in which our operations are located or in which we conduct business.

Certain of our activities are also subject to
FTC enforcement actions. The FTC also enforces a variety of antitrust and consumer protection laws designed to ensure that the nation’s
markets function competitively, are vigorous, efficient and free of undue restrictions. Federal, state, local and foreign laws of general
applicability, such as laws regulating working conditions, also govern us.

In addition, we are subject to numerous and increasingly
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.

Employees

As of March 30, 2026, we had 21 full-time employees
and one part-time employee. We are not a party to any collective bargaining agreements. We believe that we maintain good relations with
our employees.

Our Corporate History

We were incorporated as a Delaware corporation
on August 18, 2016. 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.

Available Information

Our website address is http://www.unicycive.com.
The contents of, or information accessible through, our website are not part of this Annual Report on Form 10-K, and our website address
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.
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.

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