What changed in this filing

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Item 1A. Risk Factors

2024-03-28 compared with 2023-03-31 · 467 added, 345 removed, 1242 unchanged (40% of the section changed)

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Need for Capital

We have generated no revenue to date and

our future profitability is uncertain.

We have generated no product revenue to

date and our future profitability is uncertain.

We were incorporated in August 2016 and have

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Our likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered

in connection with development and expansion of a new business enterprise.

Since inception, we have incurred losses and expect to continue

to operate at a net loss for at least the next several years as we continue our research and development efforts, conduct clinical trials

and develop manufacturing, sales, marketing and distribution capabilities.

Our net loss for the years ended December 31, 2021 and 2022

was $10.0 million and $18.1 million, and our accumulated deficit as of December 31, 2022 was $34.0 million.

There can be no assurance

that the product candidates currently under development or that may be under development by us in the future will be approved for sale

in connection with the development and expansion of a new business enterprise.

Since inception, we have incurred losses and expect to

continue to operate at a net loss for at least the next several years as we continue our research and development efforts, conduct clinical

trials and develop manufacturing, sales, marketing and distribution capabilities.

Our net loss for the years ended December 31, 2022

and 2023 was $18.1 million and $30.5 million, and our accumulated deficit as of December 31, 2023 was $64.5 million.

There can be no

assurance that the product candidates currently under development or that may be under development by us in the future will be approved

for sale in the U.S.

or elsewhere.

Furthermore, there can be no assurance that if such products are approved they will be successfully commercialized,

and the extent of our future losses and the timing of our profitability are highly uncertain.

If we are unable to achieve profitability,

we may be unable to continue our operations.

Furthermore, there can be no assurance that if such products are approved, they will be successfully

commercialized, and the extent of our future losses and the timing of our profitability are highly uncertain.

If we are unable to achieve

profitability, we may be unable to continue our operations.

If we fail to obtain the capital necessary

to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment.

We will need to continue to seek capital from

time to time to continue development of our product candidates.

As of December 31, 2021 and 2022, we had cash of $16.6 million and $0.5

million, respectively.

On March 3, 2023, the Company signed a securities purchase agreement with certain healthcare-focused institutional

investors that will provide up to $130 million in gross proceeds to Unicycive through a private placement that included initial upfront

funding of $30 million.

We expect our existing cash as of December 31, 2022 plus the funding received in March 2023 will enable us to

fund our operating expenses and capital expenditure requirements for at least 12 months from the date of this Form 10-K.

that we will need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization

We will need to continue to seek capital from time to time to continue

development of our product candidates.

As of December 31, 2022 and 2023, we had cash of $0.5 million and $9.7 million, respectively.

March 3, 2023, the Company signed a securities purchase agreement with certain healthcare-focused institutional investors that will provide

up to $130 million in gross proceeds to Unicycive through a private placement that included initial upfront funding of $30 million.

expect our existing cash as of December 31, 2023 plus the $50 million funding received in March 2024 will enable us to fund our operating

expenses and capital expenditure requirements for at least 12 months from the date of filing of this Form 10-K.

We believe that we

will need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization

of our current product candidates and future product candidates.

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of stockholder rights, preferences, and privileges, and decrease in market price of our common stock as a result of our private placement

in March 2023 financing efforts.

On March 3, 2023, we signed a securities

purchase agreement with certain healthcare-focused institutional investors pursuant to which we issued and sold 30,190 shares of

financing efforts in March 2023 and March 2024.

On March 3, 2023, we signed a securities purchase

agreement with certain healthcare-focused institutional investors pursuant to which we issued and sold 30,190 shares of Series A-1 Preferred

Such Series A-1 Preferred Stock and the securities issuable upon conversion of the Series A-1 Preferred Stock are potentially dilutive

instruments and the conversion of these securities upon Stockholder Approval resulted in dilution to our existing stockholders:

Stockholder Approval, the Series A-1 Preferred Stock was converted into 19,516,205 shares of common stock as well as 43,649 shares of

Series A-2 Preferred Stock.

Such Series A-1 Preferred Stock and the securities issuable upon conversion of the Series A-1 Preferred

Stock are potentially dilutive instruments and the conversion of these securities upon Stockholder Approval will result in dilution

to our existing stockholders:

As of March 30, 2023, subject to Stockholder Approval, the Series A-1 Preferred Stock will be

convertible into approximately 61,612,000 shares of common stock.

In addition, on March 13, 2024, we entered into a securities purchase agreement with certain accredited investors,

pursuant to which we agreed to issue and sell, in a private placement, 50,000 shares of our Series B Convertible Preferred Stock, par

value $0.001 per share, at a purchase price of $1,000 per share with an initial conversion price of $1.00 per share, subject to adjustment,

for an aggregate purchase price of $50 million.

As a result, these stockholders, acting together, may have the ability to control the

outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation or

sale of all or substantially all of our assets.

In addition, these stockholders, acting together, may have the ability to control

the management and affairs of our company.

Additionally, such shares of Series A-1 Preferred Stock contain certain preferences and

privileges not applicable to the shares of common stock, which are described further in the Certificate of Designation filed hereto

as Exhibit 3.4.

outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation or sale

of all or substantially all of our assets.

In addition, these stockholders, acting together, may have the ability to control the management

and affairs of our company.

Our cash could be adversely impacted if

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conditions in the financial or credit markets.

For example, on March 10, 2023, Silicon Valley Bank was closed by the California Department

of Financial Protection and Innovation and taken into receivership by the FDIC.

At that time, substantially all of our cash and cash

equivalents were held in accounts with Silicon Valley Bank and we could not access such accounts.

While we were afforded full access

to our accounts on March 13, 2023 as a result of action taken by the U.S.

Department of the Treasury, the Federal Reserve and the FDIC

under the systemic risk exception, there is no guarantee that the system risk exception will be relied upon to provide access to uninsured

deposits and other assets in the future in the event of the closure of a financial institution, or that such access would be afforded

in a timely fashion.

Any loss of our cash or cash equivalents or any delay in our access thereto could, among other risks, adversely

impact our ability to pay our operating expenses, result in breaches of our contractual obligations, or result in violations of federal

or state wage and hour laws if we are unable to pay our employees on a timely basis.

Any loss of our cash or cash equivalents or any delay in our access thereto could, among

other risks, adversely impact our ability to pay our operating expenses, result in breaches of our contractual obligations, or result

in violations of federal or state wage and hour laws if we are unable to pay our employees on a timely basis.

Risks Related to Our Business

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marketing approval for many reasons, including among others:

The FDA may decide that additional CMC, nonclinical and clinical studies

would be needed for the approval of Renazorb;

the FDA may disagree with the design, implementation, or interpretation

of data of our CMC, preclinical, or clinical studies;

the FDA could determine that we cannot rely on specific regulatory

approval pathway, e.g., Section 505(b)(2), for our current or future product candidates;

the FDA may determine that we have identified the wrong reference listed

drug or drugs or that approval of our regulatory application for any of our product candidates is blocked by patent or non-patent

exclusivity of the reference listed drug or drugs.

The FDA may decide that

additional CMC, nonclinical and clinical studies would be needed for the approval of Oxylanthanum Carbonate;

the FDA may disagree with

the design, implementation, or interpretation of data of our CMC, preclinical, or clinical studies;

the FDA could determine

that we cannot rely on specific regulatory approval pathway, e.g., Section 505(b)(2), for our current or future product candidates;

the FDA may determine that

we have identified the wrong reference listed drug or drugs or that approval of our regulatory application for any of our product

candidates is blocked by patent or non-patent exclusivity of the reference listed drug or drugs.

In addition, the process of seeking regulatory

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or future product candidates will prove safe or effective in humans or will receive regulatory approval.

Before obtaining

marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to

demonstrate the safety and efficacy of the product candidates in humans.

Clinical testing is expensive, time-consuming and uncertain

as to outcome.

Before obtaining marketing

approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate

the safety and efficacy of the product candidates in humans.

Clinical testing is expensive, time-consuming and uncertain as to outcome.

We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all.

of one or more clinical studies can occur at any stage of testing.

Events that may prevent successful or timely completion of clinical

development include:

delays in reaching, or failing to reach, a consensus with regulatory

agencies on study design;

delays in reaching, or failing to reach, agreement on acceptable terms

with a sufficient number of prospective contract research organizations (“CROs”) and clinical study sites, the terms

of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

delays in recruiting a sufficient number of suitable patients to participate

in our clinical studies;

imposition of a clinical hold by regulatory agencies, after an inspection

of our clinical study operations or study sites;

failure by our CROs, other third parties or us to adhere to clinical

study, regulatory or legal requirements;

failure to perform in accordance with the FDA’s good clinical

practices (“GCPs”) or applicable regulatory guidelines in other countries;

delays in the testing, validation, manufacturing and delivery of sufficient

quantities of our product candidates to the clinical sites;

delays in having patients complete participation in a study or return

for post-treatment follow-up;

clinical study sites or patients dropping out of a study;

delay or failure to address any patient safety concerns that arise

during the course of a trial;

unanticipated costs or increases in costs of clinical trials of our

product candidates;

occurrence of serious adverse events associated with the product candidates

that are viewed to outweigh its potential benefits;

changes in regulatory requirements and guidance that require amending

or submitting new clinical protocols.

A failure of one or more

clinical studies can occur at any stage of testing.

Events that may prevent successful or timely completion of clinical development include:

in reaching, or failing to reach, a consensus with regulatory agencies on study design;

in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations

(“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly

among different CROs and trial sites;

in recruiting a sufficient number of suitable patients to participate in our clinical studies;

of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites;

by our CROs, other third parties or us to adhere to clinical study, regulatory or legal requirements;

to perform in accordance with the FDA’s good clinical practices (“GCPs”) or applicable regulatory guidelines in other

in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;

in having patients complete participation in a study or return for post-treatment follow-up;

study sites or patients dropping out of a study;

or failure to address any patient safety concerns that arise during the course of a trial;

● unanticipated

costs or increases in costs of clinical trials of our product candidates;

of serious adverse events associated with the product candidates that are viewed to outweigh its potential benefits;

in regulatory requirements and guidance that require amending or submitting new clinical protocols.

We could also encounter delays if a clinical

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adverse events associated with our product candidates, we may:

be delayed in obtaining marketing approval for our product candidates,

if approved at all;

obtain approval for indications or patient populations that are not

as broad as intended or desired;

obtain approval with labeling that includes significant use or distribution

restrictions or safety warnings;

be required to change the way the product is administered;

be required to perform additional clinical studies to support approval

or be subject to additional post-marketing testing requirements;

have regulatory authorities withdraw their approval of a product or

impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy;

experience damage to our reputation.

delayed in obtaining marketing approval for our product candidates, if approved at all;

approval for indications or patient populations that are not as broad as intended or desired;

approval with labeling that includes significant use or distribution restrictions or safety warnings;

required to change the way the product is administered;

required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk

evaluation and mitigation strategy;

damage to our reputation.

Additionally, our product candidates could potentially

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commercial sale, will depend on a number of factors, including:

the efficacy and potential advantages compared to alternative therapies;

the size of the markets in the countries in which approvals are obtained;

terms, limitations or warnings contained in any labeling approved by

the FDA or other regulatory authority;

our ability to offer any approved products for sale at competitive

convenience and ease of administration compared to alternative treatments;

the willingness of the target patient population to try new therapies

or dosing regimens;

the willingness of physicians to prescribe these therapies;

the strength of marketing and distribution support;

the success of competing products and the marketing efforts of our

sufficient third-party payor coverage and adequate reimbursement;

the prevalence and severity of any side effects.

efficacy and potential advantages compared to alternative therapies;

size of the markets in the countries in which approvals are obtained;

limitations, or warnings contained in any labeling approved by the FDA or other regulatory authority;

ability to offer any approved products for sale at competitive prices;

● convenience

and ease of administration compared to alternative treatments;

willingness of the target patient population to try new therapies or dosing regimens;

willingness of physicians to prescribe these therapies;

strength of marketing and distribution support;

success of competing products and the marketing efforts of our competitors;

third-party payor coverage and adequate reimbursement;

prevalence and severity of any side effects.

Even if we are able to commercialize our

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may result in, among other things:

restrictions on such products, manufacturers or manufacturing processes

or facilities;

restrictions on the labeling, marketing, distribution or use of a product;

requirements to conduct post-approval clinical trials, other studies

or other post-approval commitments;

warning or untitled letters;

withdrawal or recall of the products from the market;

refusal to approve pending applications or supplements to approved

applications that we submit;

fines, restitution or disgorgement of profits or revenue;

suspension or withdrawal of marketing approvals;

refusal to permit the import or export of our products;

product seizure;

injunctions or the imposition of civil or criminal penalties.

● restrictions

on such products, manufacturers or manufacturing processes or facilities;

● restrictions

on the labeling, marketing, distribution or use of a product;

● requirements

to conduct post-approval clinical trials, other studies or other post-approval commitments;

or untitled letters;

or recall of the products from the market;

to approve pending applications or supplements to approved applications that we submit;

restitution or disgorgement of profits or revenue;

or withdrawal of marketing approvals;

to permit the import or export of our products;

● injunctions

or the imposition of civil or criminal penalties.

We may expend our limited resources to

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sole development and commercialization rights to such product candidate or opportunity.

We may be adversely affected by the ongoing

coronavirus pandemic.

We may be adversely affected by the coronavirus-type

The outbreak of the novel coronavirus (“COVID-19”)

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have a material impact on our operations, and we will continue to monitor the situation closely.

Our reliance on third parties heightens

the risks faced by our business.

Our reliance on

third parties heightens the risks faced by our business.

We rely on suppliers, vendors and partners for

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including failing to meet deadlines for the completion of such trials, research or testing.

We expect to rely on third parties, such as CROs,

contract manufacturers of clinical supplies, clinical data management organizations, medical institutions and clinical investigators,

to conduct our clinical trials and to conduct some aspects of our research and pre-clinical testing.

These third parties may terminate

their engagements with us at any time.

If these third parties do not successfully carry out their duties, meet expected deadlines or

conduct our studies in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed

in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully

commercialize our product candidates.

Furthermore, these third parties may also have relationships with other entities, some of which

may be our competitors.

If we are required to enter into alternative arrangements, it could delay our product development activities.

We expect to rely on third parties, such as CROs (contract research

organizations), CMOs (contract manufacturers) of clinical supplies, clinical data management organizations, medical institutions and clinical

investigators, to conduct our clinical trials and to conduct some aspects of our research and pre-clinical testing.

These third parties

may terminate their engagements with us at any time.

If these third parties do not successfully carry out their duties, meet expected

deadlines or conduct our studies in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or

may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts

to, successfully commercialize our product candidates.

Furthermore, these third parties may also have relationships with other entities,

some of which may be our competitors.

If we are required to enter into alternative arrangements, it could delay our product development

Our reliance on third parties for research and

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with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

reliance on the third party for regulatory compliance and quality assurance;

the possible breach of the manufacturing agreement by the third party,

including the inability to supply sufficient quantities or to meet quality standards or timelines;

the possible termination or nonrenewal of the agreement by the third

party at a time that is costly or inconvenient for us.

on the third party for regulatory compliance and quality assurance;

possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet

quality standards or timelines;

possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.

Third-party manufacturers may not be able to

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Our anticipated future dependence upon others

for the manufacture of our current and future product candidates or products may adversely affect our future profit margins and our ability

to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

for the manufacture and supply of our current and future product candidates or products may adversely affect our future profit margins

and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

Furthermore, we expect to rely on third parties

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and future product candidates, and in turn prevent us from generating revenues:

unwillingness on the part of a partner to pay us milestone payments

or royalties we believe are due to us under a collaboration;

uncertainty regarding ownership of intellectual property rights arising

from our collaborative activities, which could prevent us from entering into additional collaborations;

unwillingness by the partner to cooperate in the development or manufacture

of the product, including providing us with product data or materials;

unwillingness on the part of a partner to keep us informed regarding

the progress of its development and commercialization activities or to permit public disclosure of the results of those activities;

initiating of litigation or alternative dispute resolution options

by either party to resolve the dispute;

attempts by either party to terminate the agreement.

unwillingness on the part

of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;

uncertainty regarding ownership

of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;

unwillingness by the partner

to cooperate in the development or manufacture of the product, including providing us with product data or materials;

unwillingness on the part

of a partner to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure

of the results of those activities;

initiating of litigation

or alternative dispute resolution options by either party to resolve the dispute;

attempts by either party

to terminate the agreement.

Our products will face significant competition,

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services and product lines, (ii) make greater investments in research and development and (iii) carry on larger research and development

Our competitors also have greater development capabilities than we do and have substantially greater experience in undertaking

pre-clinical and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products.

initiatives than us.

Our competitors also have greater development capabilities than we do and have substantially greater experience

in undertaking pre-clinical and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical

They also have greater name recognition and better access to customers than us.

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Regardless of merit or eventual outcome, liability claims may result in:

decreased demand for any product candidates or products that we may

termination of clinical trial sites or entire clinical trial programs;

injury to our reputation and significant negative media attention;

withdrawal of clinical trial participants;

significant costs to defend the related litigation;

substantial monetary awards to trial subjects or patients;

decreased demand for any

product candidates or products that we may develop;

termination of clinical

trial sites or entire clinical trial programs;

injury to our reputation

and significant negative media attention;

withdrawal of clinical

trial participants;

significant costs to defend

the related litigation;

substantial monetary awards

to trial subjects or patients;

loss of revenue;

diversion of management and scientific resources from our business

the inability to commercialize any products that we may develop.

diversion of management

and scientific resources from our business operations;

the inability to commercialize

any products that we may develop.

Prior to engaging in future clinical trials,

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of management, including:

managing our clinical trials effectively;

identifying, recruiting, maintaining, motivating and integrating additional

managing our internal development efforts effectively while complying

with our contractual obligations to licensors, licensees, contractors and other third parties;

improving our managerial, development, operational, information technology,

and finance systems;

managing our clinical trials

identifying, recruiting,

maintaining, motivating and integrating additional employees;

managing our internal development

efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;

improving our managerial,

development, operational, information technology, and finance systems;

expanding our facilities.

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or keep our competitive advantage.

others may be able to make compounds that are similar to our product

candidates, but that are not covered by the claims of our licensed patents;

any patents that we obtain from licensing or otherwise may not provide

us with any competitive advantages;

any granted patents that we rely upon may be held invalid or unenforceable

as a result of legal challenges by third parties;

the patents of others may have an adverse effect on our business.

others may be able to make

compounds that are similar to our product candidates, but that are not covered by the claims of our licensed patents;

any patents that we obtain

from licensing or otherwise may not provide us with any competitive advantages;

any granted patents that

we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties;

the patents of others may

have an adverse effect on our business.

If we fail to comply with our obligations

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with respect to licensed products and may need to satisfy specified milestone and royalty payment obligations.

If we fail to comply

with any obligations under our agreements with any of these licensors, we may be subject to termination of the license agreement in whole

If we fail to comply with

any obligations under our agreements with any of these licensors, we may be subject to termination of the license agreement in whole

increased financial obligations to our licensors or loss of exclusivity in a particular field or territory, in which case

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property subject to a license agreement, including:

the scope of rights granted under the license agreement and other interpretation-related issues;

the extent to which our technology and processes infringe on intellectual

property of the licensor that is not subject to the licensing agreement;

our diligence obligations under the license agreement and what activities

satisfy those obligations;

if a third-party expresses interest in an area under a license

that we are not pursuing, under the terms of certain of our license agreements, we may be required to sublicense rights in that area

to a third party, and that sublicense could harm our business;

the ownership of inventions and know-how resulting from the joint

creation or use of intellectual property by our licensors and us.

the scope of rights granted

under the license agreement and other interpretation-related issues;

the extent to which our

technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

our diligence obligations

under the license agreement and what activities satisfy those obligations;

if a third-party expresses

interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements, we may be required

to sublicense rights in that area to a third party, and that sublicense could harm our business;

the ownership of inventions

and know-how resulting from the joint creation or use of intellectual property by our licensors and us.

If disputes over intellectual property that we

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these claims.

If we fail in defending any such claims, in addition to paying monetary damages, we could lose valuable intellectual property

If we fail to defend any such claims, in addition to paying monetary damages, we could lose valuable intellectual property

rights or personnel, which could adversely impact our business.

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property rights in this type of litigation, we may be subject to:

paying monetary damages related to the legal expenses of the third

facing additional competition that may have a significant adverse effect

on our product pricing, market share, business operations, financial condition, and the commercial viability of our product;

restructuring our company or delaying or terminating select business

opportunities, including, but not limited to, research and development, clinical trial, and commercialization activities, due to

a potential deterioration of our financial condition or market competitiveness.

paying monetary damages

related to the legal expenses of the third party;

facing additional competition

that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the

commercial viability of our product;

restructuring our company

or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial,

and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

A third party may also challenge the validity,

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The laws include:

the federal healthcare program anti-kickback law, which prohibits,

among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral

of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under

federal healthcare programs such as the Medicare and Medicaid programs;

federal false claims laws which prohibit, among other things, individuals

or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party

payers that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;

HIPAA which prohibits executing a scheme to defraud any healthcare

benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to

the privacy, security and transmission of individually identifiable health information;

the FDCA which among other things, strictly regulates drug manufacturing

and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the

distribution of drug samples;

state law equivalents of each of the above federal laws, such as anti-kickback

and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and

state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other

in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.

the federal healthcare

program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly

or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or

service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

federal false claims laws

which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment

from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us which

provide coding and billing information to customers;

HIPAA which prohibits executing

a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes

certain requirements relating to the privacy, security and transmission of individually identifiable health information;

the FDCA which among other

things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and

regulates the distribution of drug samples;

state law equivalents of

each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any

third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain

circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating

compliance efforts.

If our operations are found to be in violation

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applicable federal and state privacy, security and fraud laws may prove costly.

Our, or our partners', failure to obtain

or maintain adequate coverage, pricing and reimbursement for Oxylanthanum Carbonate (OLC), 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 OLC, if approved, 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 OLC, if approved, or any of our

potential future products.

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

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

If reimbursement is not

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

Coverage and reimbursement by a governmental

authority, third-party payor or PBMs 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;

● 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 U.S., 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.

In the current reimbursement environment, oral

phosphate lowering therapies like OLC are covered by Medicare under Part D for the treatment of p atients

with hyperphosphatemia .

In January 2011, CMS implemented the ESRD PPS, a prospective payment system for dialysis treatment.

the ESRD PPS, CMS generally makes a single bundled payment to the dialysis facility for each dialysis treatment that covers all items

and services routinely required for dialysis treatments furnished to Medicare beneficiaries in Medicare-certified ESRD facilities or at

The inclusion of oral medications without injectable or intravenous equivalents such as OLC in the bundled payment was initially

delayed by CMS until January 1, 2014, and through several subsequent legislative actions has been delayed until January 1, 2025.

the potential approval timeline for OLC in mid-2025, our drug would be launched into this bundled setting.

Absent further legislation or regulation on this

matter, beginning in January 2025, oral ESRD-related drugs without injectable or intravenous equivalents, including phosphate lowering

medications, will be included in the ESRD bundle and separate Medicare payment for these drugs will no longer be available, as is the

case today under Medicare Part D.

ESRD facilities may nonetheless receive a TDAPA for new renal dialysis drugs and biological products

that meet certain criteria for a minimum of two years.

The TDAPA will provide separate payment based on the drug’s Average Sales

Price, or ASP , that will be in addition to the base rate in order to facilitate the adoption of innovative therapies.

be no assurances that CMS will not again delay the inclusion of these oral ESRD-related drugs in the bundled payment.

Moreover, in the

post-TDAPA period, CMS currently expects to increase the single bundled payment base rate paid to the dialysis facility for each dialysis

treatment to reflect that oral only phosphate lowering drugs will be reimbursed as part of the single bundled payment for Medicare patients.

There can be no assurances that any increase in the single bundled payment base rate will be sufficient to adequately reimburse the dialysis

facilities for OLC at a price that is profitable for us.

Medicaid reimbursement of drugs varies by state.

Private third-party payor reimbursement policies also vary and may or may not be consistent with Medicare reimbursement methodologies.

Manufacturers of outpatient prescription drugs may be required to provide discounts or rebates under government healthcare programs or

to certain third-party payors in order to obtain coverage of such products.

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.

In addition, third party payors, PBMs and other entities that purchase our products may impose restrictions

on our ability to raise prices for our products over time without incurring additional costs.

We currently believe it is likely that OLC, 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, but reimbursement under TDAPA it is subject to review and approval by CMS.

For those that

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

payor after 90 days, patients may access OLC through contracts we negotiate with third party payors for reimbursement of OLC, which would

be subject to the risks and uncertainties described above.

Additionally, applying for and obtaining reimbursement under the TDAPA is expected

to take six months following filing acceptance, which will affect adoption, uptake and product revenue for OLC 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 OLC is approved in the U.S., we expect

it to be included in the fixed reimbursement model for a bundle of dialysis services, or the bundle, which may require us to enter into

contracts to supply OLC to specific dialysis providers, instead of through distributors, which we believe could be challenging.

market is unique and is dominated by two providers:

DaVita and Fresenius Medical Care, which account for a vast majority of the dialysis

population in the U.S.

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 OLC, if approved, to the formulary, our business may

be materially harmed.

In addition, we may be unable to sell OLC, if

approved, 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.

Our profitability may also be affected

if our costs of production increase faster than increases in reimbursement levels.

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

Existing competitive products may enter into sole source agreements with dialysis providers that impact the ability for new

product innovations and new competitors may face price pressure based on existing contracts with dialysis providers.

Further, in many countries outside the U.S., 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 U.S.

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.

In addition, we plan to rely on a partner to obtain approval by reimbursement authorities

outside the U.S.

Our partners 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 partners' control.

Healthcare Reform in the United States.

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Among the provisions of the ACA of greatest importance to the pharmaceutical and biotechnology industry are the

an annual, nondeductible fee on any entity that manufactures or imports

certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain

government healthcare programs;

implementation of the federal physician payment transparency requirements,

sometimes referred to as the “Physician Payments Sunshine Act”;

a licensure framework for follow-on biologic products;

a new Patient-Centered Outcomes Research Institute to oversee, identify

priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

establishment of a Center for Medicare Innovation at the Centers for

Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending,

potentially including prescription drug spending;

an increase in the statutory minimum rebates a manufacturer must pay

under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively

and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price;

a new methodology by which rebates owed by manufacturers under the

Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled,

infused, instilled, implanted or injected;

extension of manufacturers’ Medicaid rebate liability to covered

drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

expansion of eligibility criteria for Medicaid programs by, among other

things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for

individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid

rebate liability;

a new Medicare Part D coverage gap discount program, in which manufacturers

must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries

during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part

expansion of the entities eligible for discounts under the Public Health

an annual, nondeductible

fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities

according to their market share in certain government healthcare programs;

implementation of the federal

physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;

a licensure framework for follow-on biologic

a new Patient-Centered

Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with

funding for such research;

establishment of a Center

for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery

models to lower Medicare and Medicaid spending, potentially including prescription drug spending;

an increase in the statutory

minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price

for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer

a new methodology by which

rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our

product candidates, that are inhaled, infused, instilled, implanted or injected;

extension of manufacturers’

Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

expansion of eligibility

criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by

adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially

increasing manufacturers’ Medicaid rebate liability;

a new Medicare Part D coverage

gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable

brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs

to be covered under Medicare Part D;

expansion of the entities

eligible for discounts under the Public Health program.

Some of the provisions of the ACA have yet to

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risks mentioned in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K, are:

sale of our common stock by our stockholders, executives, and directors;

volatility and limitations in trading volumes of our shares of common

our ability to obtain financings to conduct and complete research and

development activities including, but not limited to, our clinical trials, and other business activities;

possible delays in the expected recognition of revenue due to lengthy

and sometimes unpredictable sales timelines;

the timing and success of introductions of new products by us or our

competitors or any other change in the competitive dynamics of our industry, including consolidation among competitors, customers

or strategic partners;

network outages or security breaches;

our ability to secure resources and the necessary personnel to conduct

clinical trials on our desired schedule;

commencement, enrollment or results of our clinical trials for our

product candidates or any future clinical trials we may conduct;

changes in the development status of our product candidates;

any delays or adverse developments or perceived adverse developments

with respect to the FDA’s review of our planned pre-clinical and clinical trials;

any delay in our submission for studies or product approvals or adverse

regulatory decisions, including failure to receive regulatory approval for our product candidates;

unanticipated safety concerns related to the use of our product candidates;

failures to meet external expectations or management guidance;

changes in our capital structure or dividend policy, future issuances

of securities, sales of large blocks of common stock by our stockholders;

sale of our common stock

by our stockholders, executives, and directors;

volatility and limitations

in trading volumes of our shares of common stock;

our ability to obtain financings

to conduct and complete research and development activities including, but not limited to, our clinical trials, and other business

possible delays in the

expected recognition of revenue due to lengthy and sometimes unpredictable sales timelines;

the timing and success

of introductions of new products by us or our competitors or any other change in the competitive dynamics of our industry, including

consolidation among competitors, customers or strategic partners;

network outages or security

our ability to secure resources

and the necessary personnel to conduct clinical trials on our desired schedule;

commencement, enrollment

or results of our clinical trials for our product candidates or any future clinical trials we may conduct;

changes in the development

status of our product candidates;

any delays or adverse developments

or perceived adverse developments with respect to the FDA’s review of our planned pre-clinical and clinical trials;

any delay in our submission

for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory approval for our product

unanticipated safety concerns

related to the use of our product candidates;

failures to meet external

expectations or management guidance;

changes in our capital

structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders;

our cash position;

announcements and events surrounding financing efforts, including debt

and equity securities;

our inability to enter into new markets or develop new products;

announcements and events

surrounding financing efforts, including debt and equity securities;

our inability to enter

into new markets or develop new products;

reputational issues;

competition from existing technologies and products or new technologies

and products that may emerge;

announcements of acquisitions, partnerships, collaborations, joint

ventures, new products, capital commitments, or other events by us or our competitors;

changes in general economic, political and market conditions in or

any of the regions in which we conduct our business;

changes in industry conditions or perceptions;

changes in valuations of similar companies or groups of companies;

analyst research reports, recommendation and changes in recommendations,

price targets, and withdrawals of coverage;

departures and additions of key personnel;

disputes and litigations related to intellectual property, proprietary

rights, and contractual obligations;

changes in applicable laws, rules, regulations, or accounting practices

and other dynamics;

other events or factors, many of which may be out of our control.

competition from existing

technologies and products or new technologies and products that may emerge;

announcements of acquisitions,

partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

changes in general economic,

political and market conditions in or any of the regions in which we conduct our business;

changes in industry conditions

or perceptions;

changes in valuations of

similar companies or groups of companies;

analyst research reports,

recommendation and changes in recommendations, price targets, and withdrawals of coverage;

departures and additions

of key personnel;

disputes and litigations

related to intellectual property, proprietary rights, and contractual obligations;

changes in applicable laws,

rules, regulations, or accounting practices and other dynamics;

other events or factors,

many of which may be out of our control.

In addition, if the market for stocks in our

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to defend and a distraction to management.

do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares, except we

have agreed to pay cash dividends in the event Renazorb is approved by the FDA and commercial sales is commenced.

anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring

or paying any cash dividends for the foreseeable future, except that i n March 2023,we agreed with certain investors to modify our

dividend policy to state that we intend to pay dividends to all stockholders on a quarterly basis in an amount of which the aggregate

of all quarterly dividends shall equal at least seventy-five percent (75%) of our annual net cash flow from operations following the approval

of Renazorb by the FDA if obtained, and the commencement of commercial sales.

We do not intend to pay cash dividends

on our shares of common stock so any returns will be limited to the value of our shares, except we have agreed to pay cash dividends

in the event Oxylanthanum Carbonate is approved by the FDA and commercial sales is commenced.

We currently anticipate that we will retain future

earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for

the foreseeable future, except that in March 2023,we agreed with certain investors to modify our dividend policy to state that we intend

to pay dividends to all stockholders on a quarterly basis in an amount of which the aggregate of all quarterly dividends shall equal

at least seventy-five percent (75%) of our annual net cash flow from operations following the approval of Oxylanthanum Carbonate by the

FDA if obtained, and the commencement of commercial sales.

Market and economic conditions may negatively

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Nasdaq Capital Market if we fail to comply with continued listing standards.

If we fail to meet any of the continued listing standards of The Nasdaq

Capital Market, our common stock could be delisted from The Nasdaq Capital Market.

These continued listing standards include specifically

enumerated criteria, such as:

$1.00 minimum closing bid price;

● stockholders’

equity of $2.5 million;

shares of publicly-held common stock with a market value of at least $1 million;

If we fail to meet any of the continued listing

standards of The Nasdaq Capital Market, our common stock could be delisted from The Nasdaq Capital Market.

These continued listing standards

include specifically enumerated criteria, such as:

a $1.00 minimum closing

stockholders’ equity

of $2.5 million;

500,000 shares of publicly-held

common stock with a market value of at least $1 million;

300 round-lot stockholders;

with Nasdaq’s corporate governance requirements, as well as additional or more stringent criteria that may be applied in the exercise

of Nasdaq’s discretionary authority.

On August 8, 2022, we

received a written notice (the “Notice”) from the Nasdaq Stock Market LLC (“Nasdaq”) notifying us that were not

in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Rule”), as the minimum bid price of the Company’s common stock

has been below $1.00 per share for 30 consecutive business days.

On February 1, 2023, Nasdaq notified us that we had not regained compliance

with the Rule and were not eligible for a second 180 day period since we did not comply with the minimum $5,000,000 stockholders’

equity initial listing requirement for The Nasdaq Capital Market.

We had requested a hearing

before the Nasdaq Hearings Panel and on February 28, 2023, Nasdaq granted to us an exception until July 24, 2023 to regain compliance

with the Rule.

On March 28, 2023, we

received notice from Nasdaq that we had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq

Capital Market.

compliance with Nasdaq’s

corporate governance requirements, as well as additional or more stringent criteria that may be applied in the exercise of Nasdaq’s

discretionary authority.

On September 19, 2023,

we received written notification (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market LLC

(“Nasdaq”) indicating that, for the last thirty consecutive business days, the market value of our Common Stock, had closed

below the minimum $35 million requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2) (the

“Minimum Market Value Requirement”).

In addition, on September

19, 2023, we received a Notice from Nasdaq indicating that the bid price for the Common Stock, for the last 30 consecutive business

days for the last thirty consecutive business days, had closed below the minimum $1.00 per share and, as a result, we were not in

compliance with the $1.00 minimum bid price requirement (the “Minimum Bid Price Requirement”) for the continued listing on

the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2).

On February 21, 2024,

we received a letter from Nasdaq that we had regained compliance with the Minimum Market Value Requirement and the Minimum Bid Price

Requirement and the matters are now closed.

If we fail to comply

16 unchanged sentences

concentration of ownership might harm the market price of our common stock by:

delaying, deferring or preventing a change in corporate control;

impeding a merger, consolidation, takeover or other business combination

involving us;

discouraging a potential acquirer from making a tender offer or otherwise

attempting to obtain control of us.

delaying, deferring, or

preventing a change in corporate control;

impeding a merger, consolidation,

takeover or other business combination involving us;

discouraging a potential

acquirer from making a tender offer or otherwise attempting to obtain control of us.

We are an “emerging growth company”

55 unchanged sentences

and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law, as applicable, among other things:

provide the board of directors with the ability to alter the bylaws

without stockholder approval;

place limitations on the removal of directors;

establish advance notice requirements for nominations for election

to the board of directors or for proposing matters that can be acted upon at stockholder meetings;

provide that vacancies on the board of directors may be filled by a

majority of directors in office, although less than a quorum.

provide the board of directors

with the ability to alter the bylaws without stockholder approval;

place limitations on the

removal of directors;

establish advance notice

requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder

provide that vacancies

on the board of directors may be filled by a majority of directors in office, although less than a quorum.

Financial reporting obligations of being

81 unchanged sentences

condition or divert financial and management resources from our core business.

STAFF COMMENTS

Our principal address is 4300 El Camino Real,

Suite 210, Los Altos, CA 94022.

We believe our facilities are adequate to meet our current needs, although we may seek to negotiate new

leases or evaluate additional or alternate space for our operations.

We believe appropriate alternative space would be readily available

on commercially reasonable terms.

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

What changed 10-K

Item 1A. Risk Factors