What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2025-03-31 compared with 2024-03-28 · 970 added, 791 removed, 606 unchanged (74% of the section changed)

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Report of Independent Registered Public Accounting Firm (PCAOB ID # 606 ) F-2

Report of Independent Registered Public Accounting Firm (PCAOB ID #199) F-3

Balance Sheets as of December 31, 2023 and 2024 F-3

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Opinion on the Financial Statements

We have audited the accompanying balance

sheet of Unicycive Therapeutics, Inc.

(the “Company”) as of December 31, 2023, and the related statements of operations, stockholders’

deficit, and cash flows for the year ended, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December

31, 2023, and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally

accepted in the United States of America.

Basis for Opinion

These financial statements are the responsibility

of the Company’s management.

Our responsibility is to express an opinion on the Company’s financial statements based on our

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)

and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable

rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance

with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether

the financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were

we engaged to perform, an audit of its internal control over financial reporting.

As part of our audit, we are required to obtain an understanding

of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s

internal control over financial reporting.

Accordingly, we express no such opinion.

Our audit included performing procedures

to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that

respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial

Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as

evaluating the overall presentation of the financial statements.

We believe that our audit provide a reasonable basis for our opinion.

/s/ Grassi & Co., CPAs, P.C .

We have served as the Company’s

auditors since 2023.

Jericho, New York

March 28, 2024

of Independent Registered Public Accounting Firm

To the Board of Directors

and Stockholders of Unicycive Therapeutics,

Opinion on the Financial Statements

We have audited the accompanying balance sheet of Unicycive Therapeutics,

(the “Company”) as of December 31, 2022, and the related statement of operations, stockholders’ (deficit) equity,

and cash flows for the year ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December

31, 2022, and the results of its operations and its cash flows for the year ended December 31, 2022, in conformity with accounting principles

We have audited the accompanying balance sheet

of Unicycive Therapeutics, Inc.

(the “Company”) as of December 31, 2024 and 2023, and the related statements of operations,

stockholders’ deficit, and cash flows for the year ended, and the related notes (collectively referred to as the “financial

statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company

as of December 31, 2024, and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles

generally accepted in the United States of America.

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the overall presentation of the financial statements.

We believe that our audit provides a reasonable basis for our opinion.

We served as the Company's auditor from 2019 to

/s/ Mayer Hoffman McCann P.C.

San Diego, California

We believe that our audit provide a reasonable basis for our opinion.

Critical Audit Matters

Critical audit matters are matters arising from

the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and

that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,

subjective, or complex judgments.

We determined that there were no critical audit matters.

/s/ Grassi & Co., CPAs, P.C .

GRASSI & CO., CPAs, P.C.

We have served as the Company’s

auditors since 2023.

Jericho, New York

March 31, 2024

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Property, plant and equipment, net

Liabilities and stockholders’ deficit

Liabilities and stockholders’( deficit) equity

Current liabilities:

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Commitments and contingencies (Note 8)

Stockholders’ deficit:

Series A-2 preferred stock, $ 0.001 par value per share – zero and 43,649 shares authorized at December 31, 2022 and December 31, 2023, respectively;

Stockholders’ (deficit) equity:

Series A-2 Prime preferred stock, $ 0.001 par value per share – 43,649 Series A-2 shares authorized at December 31, 2023 and 21,388.01 Series A-2 Prime shares authorized at December 31, 2024;

43,649 Series A-2 shares outstanding at December 31, 2023 and 6,150.21 Series A-2 Prime shares outstanding at December 31, 2024

Series B-2 preferred stock, $ 0.001 par value per share – zero and 7,882 shares authorized at December 31, 2023 and December 31, 2024, respectively;

zero and 3,000 shares outstanding at December 31, 2023 and December 31, 2024, respectively

Preferred stock:

$ 0.001 par value per share— 10,000,000 and 9,926,161

shares authorized at December 31, 2022 and December 31, 2023, respectively;

zero shares issued and outstanding at December 31, 2022 and

December 31, 2023

Common stock, $ 0.001 par value per share – 200,000,000 shares

authorized at December 31, 2022 and December 31, 2023;

15,231,655 shares issued and outstanding at December 31, 2022 and 34,756,049 issued

and outstanding at December 31, 2023

$ 0.001 par value per share— 9,926,161 and 9,846,891 shares authorized at December 31, 2023 and December 31, 2024, respectively;

zero shares issued and outstanding at December 31, 2023 and December 31, 2024

Common stock, $ 0.001 par value per share – 200,000,000 and 400,000,000 shares authorized at December 31, 2023 and 2024, respectively;

34,756,049 shares issued and outstanding at December 31, 2023 and 113,842,364 issued and outstanding at December 31, 2024

Additional paid-in capital

Accumulated deficit

Total stockholders’ deficit

Total liabilities and stockholders’ deficit

Total stockholders’(deficit) equity

Total liabilities and stockholders’ (deficit) equity

See accompanying notes to the financial statements

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Deemed dividend to Series A-1 preferred stockholders

Dividends on Series B-1 Preferred Stock

Net loss attributable to common stockholders

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(in thousands, except share amounts)

Series A-2 Prime

Preferred Stock

Stockholders’

Balance at December 31, 2021

Issuance of common stock for cash, net of issuance costs

Issuance of common stock

Issuance of common stock for vested restricted stock units

Issuance of common stock for exercise of options

Stock-based compensation expense

Balance at December 31, 2022

Issuance of Series A-1 preferred stock, net of issuance costs and allocated fair value of warrant liability

Deemed dividends on Series A-1 preferred stock

Issuance of Series A-2 preferred stock and common stock upon conversion of Series A-1 preferred stock

Issuance of common stock for exercise of options

Stock-based compensation expense

December 31, 2022

Issuance of Series A-1 preferred

stock, net of issuance costs and allocated fair value of warrant liability

Deemed dividends on Series

A-1 preferred stock

Issuance of Series A-2 preferred

stock and common stock upon conversion of Series A-1 preferred stock

Issuance of common stock for

exercise of options

compensation expense

Balance at December 31,

Issuance of Series B-1 preferred

stock , net of issuance costs

Dividends on Series B-1 preferred

Exchange of Series A-2 preferred

stock for Series A-2 Prime preferred stock

Conversion of Series A-2 Prime

preferred stock into common stock

Issuance of Series B-2 preferred

stock and common stock upon conversion of Series B-1 preferred stock

Conversion of Series B-2 preferred

stock into common stock

Issuance of common stock for

cash, net of issuance costs

Issuance of common stock for

exercise of options

compensation expense

at December 30, 2024

$ ( 101,270 )

See accompanying notes to the financial statements

Unicycive Therapeutics,

Unicycive Therapeutics, Inc.

Statements of Cash Flows

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Payments on financed insurance policies

Issuance of common stock for cash, net of issuance costs

Gross Proceeds from Secondary Offerings

Deferred Cost of at the market offering

Proceeds from issuance of Series A-1 preferred stock and warrants

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Issuance of Series A-2 preferred stock and common stock upon conversion of Series A-1 preferred stock

Issuance of Series B-2 preferred stock and common stock upon conversion of Series B-1 preferred stock

Accrued dividends on preferred stock

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drug candidate, Renazorb RZB 012 and its trademark, RENALAN, and various patents from Spectrum Pharmaceuticals, Inc.

Renazorb (“Oxylanthanum Carbonate”) is being developed for the treatment of hyperphosphatemia in patients with

Chronic Kidney Disease (“CKD”).

The Company continues to evaluate the licensing of additional technologies

and drugs, targeting orphan diseases and other renal, liver, and other metabolic diseases affecting fibrosis and inflammation.

Renazorb (“Oxylanthanum Carbonate”) is being developed for the treatment of hyperphosphatemia in patients with Chronic

Kidney Disease (“CKD”).

The Company continues to evaluate the licensing

of additional technologies and drugs, targeting orphan diseases and other renal, liver, and other metabolic diseases affecting fibrosis

and inflammation.

The Company is subject to risks and uncertainties

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revenue as well as product sales.

The Company has generated approximately $ 0.7 million in licensing revenue during the year ended December

The Company has incurred operating losses and

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a private placement and that included initial upfront funding of $ 28.0 million in net proceeds.

On March 13, 2024, the Company entered into a securities purchase agreement

with certain healthcare-focused institutional investors to provide $ 50 million in gross proceeds through a private placement.

to the securities purchase agreement, the Company issued institutional purchasers $ 50 million in shares of Series B Convertible Preferred

On March 13, 2024, the Company entered into a

securities purchase agreement with certain healthcare-focused institutional investors to provide $ 50.0 million in gross proceeds through

a private placement.

Pursuant to the securities purchase agreement, the Company issued institutional purchasers $ 50.0 million in shares

of Series B Convertible Preferred Stock.

The Company received $ 46.2 million in net proceeds (net of issuance costs).

On November 13, 2024, the Company entered into

a Sales Agreement, with Guggenheim Securities, LLC pursuant to which, the Company may offer and sell shares of our common stock having

an aggregate offering price of up to $ 50.0 million, subject to certain limitations and in accordance with the terms of the Sales Agreement,

from time to time through or to Guggenheim Securities, acting as sales agent or principal.

From November 13, 2024 through December 31,

2024 the Company sold 977,407 shares of common stock at an average price of $ 0.72 per share resulting in aggregate gross proceeds of approximately

$ 0.7 million, for which it paid Guggenheim approximately $ 21,000 in commissions, resulting in net proceeds to the Company of approximately

$ 0.7 million.

The Company expects to continue incurring losses

in the future and will be required to raise additional capital in the future to complete its planned clinical trials, pursue product

development initiatives and penetrate markets for the sale of its products.

Management believes that the Company will continue to have

access to capital resources through possible equity offerings, debt financing, corporate collaborations, or other means.

no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis or at

If the Company is unable to secure additional capital, it may be required to curtail any clinical trials and development of new

or existing products and take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations

and meet its obligations.

Based on the Company’s currently anticipated level of expenditures, and after receiving the proceeds

from the private placement in March 2024, the Company believes that it has sufficient resources such that there is not substantial doubt

about the ability to continue operations for at least one year after the date that these financial statements are available to be issued.

in the future and will be required to raise additional capital in the future to complete its planned clinical trials, pursue product development

initiatives and penetrate markets for the sale of its products.

Management believes that the Company will continue to have access to capital

resources through possible equity offerings, debt financing, corporate collaborations, or other means.

There can be no assurance that

the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis or at all.

If the Company

is unable to secure additional capital, it may be required to curtail any clinical trials and development of new or existing products

and take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its

Based on the Company’s currently anticipated level of expenditures, and after receiving the proceeds from the private

placement in March 2024 and at-the-market public offering in November 2024, the Company believes that it has sufficient resources such

that there is not substantial doubt about the ability to continue operations for at least one year after the date that these financial

statements are available to be issued.

Summary of Significant Accounting Policies

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could have a material effect on future results of operations and financial position.

Significant items subject to such estimates and

assumptions include stock-based compensation and valuation of warrant liabilities.

Significant items subject to such estimates and assumptions

include stock-based compensation and valuation of warrant liabilities.

Actual results may materially differ from those estimates.

Revenue Recognition

The Company recognizes revenue in accordance

with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”).

The Company applies the five-step model in ASC 606 and recognizes revenue from product sales or services rendered when control of the

promised goods or services are transferred to a counterparty in an amount that reflects the consideration to which the Company expects

to be entitled in exchange for those goods and services.

The Company recognizes revenue in accordance with

Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”).

applies the five-step model in ASC 606 and recognizes revenue from product sales or services rendered when control of the promised goods

or services are transferred to a counterparty in an amount that reflects the consideration to which the Company expects to be entitled

in exchange for those goods and services.

To achieve this core principle, the Company applies the following five steps:

identify the contract with the client, identify the performance obligations in the contract, determine the transaction price, allocate

the transaction price to performance obligations in the contract and recognize revenues when or as the Company satisfies a performance

identify the contract

with the client, identify the performance obligations in the contract, determine the transaction price, allocate the transaction price

to performance obligations in the contract and recognize revenues when or as the Company satisfies a performance obligation.

Warrant Liability

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Segment Information

The Company operates and manages its business

as one reportable operating segment.

The Company’s Chief Executive Officer, who is the chief operating decision maker, reviews

financial information on an aggregate basis for the purposes of allocating resources and evaluating financial performance.

The Company reports its segment information to

reflect the manner in which the CODM reviews and assesses performance.

The Company’s Chief Executive Officer has the responsibility

as the CODM to review and assess the performance of the Company as a whole.

The primary financial measures used by the CODM

to evaluate performance and allocate resources are net income (loss) and operating income (loss).

The CODM uses net income (loss) and

operating income (loss) to evaluate the performance of the Company’s ongoing operations and as part of the Company’s internal

planning and forecasting processes.

Information on net income (loss) and operating income (loss) is disclosed in the Statements of Operations.

Segment expenses and other segment items are provided to the CODM on the same basis as disclosed in the Statements of Operations.

The CODM does not evaluate performance or allocate

resources based on segment assets, and therefore such information is not presented in the notes to the financial statements.

Risks and Uncertainties

The Company operates in a dynamic and highly

competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s

future financial position, results of operations, or cash flows:

The Company operates in a dynamic and highly competitive

industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial

position, results of operations, or cash flows:

ability to obtain future financing;

advances and trends in new technologies

and industry standards;

advances and trends in new technologies and industry

results of clinical trials;

regulatory approval and market acceptance of the Company’s products;

of sales channels;

development of sales

certain strategic relationships;

litigation or claims against the Company related to intellectual property, product,

regulatory, or other matters;

litigation or claims against the Company related to intellectual property, product, regulatory,

or other matters;

and the Company’s ability to attract and retain employees necessary to support its growth.

The Company’s general business strategy

may be adversely affected by any such economic downturns (including the current downturn related to the COVID-19 pandemic), volatile

business environments and continued unstable or unpredictable economic and market conditions.

may be adversely affected by any such economic downturns, volatile business environments and continued unstable or unpredictable economic

and market conditions.

Any product candidates developed by the Company

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the Company’s current product candidates or any future product candidates will receive the necessary approvals.

If the Company

is denied approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the

If the Company is

denied approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the Company.

The Company has expended and will continue to

expend substantial funds to complete the research, development and clinical testing of its product candidates.

The Company also will

be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and

distribution of products that receive regulatory approval.

The Company also will be

required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution

of products that receive regulatory approval.

The Company will require additional funds to commercialize its products.

Company is unable to entirely fund these efforts with its current financial resources.

If adequate funds are unavailable on a timely

basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more

of its research or development programs, which would materially and adversely affect its business, financial condition and operations.

The Company is

unable to entirely fund these efforts with its current financial resources.

If adequate funds are unavailable on a timely basis from operations

or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development

programs, which would materially and adversely affect its business, financial condition and operations.

The Company is dependent upon the services of

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cost less accumulated depreciation.

Additions, improvements, and major renewals or replacements that substantially extend the useful

life of an asset are capitalized.

Additions, improvements, and major renewals or replacements that substantially extend the useful life

of an asset are capitalized.

repairs and maintenance expenditures are expensed as incurred.

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fair value at that time.

On December 31, 2023, management determined there were no impairments of the Company’s property and equipment.

As of December 31, 2024, management determined there were no impairments of the Company’s property and

The Company determines whether a contract is,

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hierarchy contains the following levels:

Level 1 — defined

as observable inputs based on unadjusted quoted prices for identical instruments in active markets;

Level 2 — defined

as inputs other than Level 1 that are either directly or indirectly observable in the marketplace for identical or similar instruments

in markets that are not active;

Level 3 — defined

as unobservable inputs in which little or no market data exists where valuations are derived from techniques in which one or more

significant inputs are unobservable.

● Level 1 — defined as observable inputs based on unadjusted

quoted prices for identical instruments in active markets;

● Level 2 — defined as inputs other than Level 1 that

are either directly or indirectly observable in the marketplace for identical or similar instruments in markets that are not active;

● Level 3 — defined as unobservable inputs in which little

or no market data exists where valuations are derived from techniques in which one or more significant inputs are unobservable.

The fair value of the warrant liability associated

with the Company’s March 2023 private placement transaction, further described in Note 11, was determined as of March 3, 2023,

and March 31, 2023, by using a Monte Carlo simulation technique (“MCS”) to value the embedded derivatives associated with

the warrants.

with the Company’s March 2023 private placement transaction, further described in Note 12, was determined as of March 3, 2023, and

March 31, 2023, by using a Monte Carlo simulation technique (“MCS”) to value the embedded derivatives associated with the

The MCS methodology calculates the theoretical value of a warrant liability based on certain parameters, including:

the threshold of exercising the warrants, (ii) the price of the underlying security, (iii) the time to expiration, or expected term,

(iv) the expected volatility of the underlying security, (v) the risk-free rate, (vi) the number of paths, and (vii) estimated probability

threshold of exercising the warrants, (ii) the price of the underlying security, (iii) the time to expiration, or expected term, (iv)

the expected volatility of the underlying security, (v) the risk-free rate, (vi) the number of paths, and (vii) estimated probability

assumptions surrounding shareholder approval as well as the achievement by the Company of technical milestones associated with regulatory

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and the potential variability in the warrant exercise prices.

On June 26, 2023, the Company held its annual shareholder meeting, and

as a result, shareholder approval for the issuance of common shares upon the conversion of the Series A-1 Preferred Stock was obtained,

the warrants were issued, and the exercise price for the warrants became fixed.

Therefore, as of December 31, 2023, the fair value of

the warrant liability was determined using a Black Scholes model with parameters including (i) the exercise price of the warrants, (ii)

the price of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying

security, (v) the risk-free rate, and (vi) estimated probability assumptions surrounding the achievement by the Company of technical

milestones associated with regulatory and commercial progress.

On June 26, 2023, the Company held its annual shareholder meeting, and as

a result, shareholder approval for the issuance of common shares upon the conversion of the Series A-1 Preferred Stock was obtained, the

warrants were issued, and the exercise price for the warrants became fixed.

Therefore, as of December 31, 2023, the fair value of the

warrant liability was determined using a Black Scholes model with parameters including (i) the exercise price of the warrants, (ii) the

price of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying security,

(v) the risk-free rate, and (vi) estimated probability assumptions surrounding the achievement by the Company of technical milestones

associated with regulatory and commercial progress.

These valuation techniques involve management’s

estimates and judgment based on unobservable inputs and are classified in Level 3.

The fair value estimates may not be indicative of

the amounts that would be realized in a market exchange.

Additionally, there may be inherent uncertainties or changes in the underlying

assumptions used, which could significantly affect the current or future fair value estimates.

Generally, a significant increase (decrease)

in the probabilities of shareholder approval and the achievement of technical milestones would have resulted in a significantly higher

(lower) fair value measurement;

however, changes in other inputs such as expected term and price of the underlying common stock will

have a directionally opposite impact on fair value measurement.

The fair value estimates may not be indicative of the

amounts that would be realized in a market exchange.

Additionally, there may be inherent uncertainties or changes in the underlying assumptions

used, which could significantly affect the current or future fair value estimates.

Generally, a significant increase (decrease) in the

probabilities of shareholder approval and the achievement of technical milestones would have resulted in a significantly higher (lower)

fair value measurement;

however, changes in other inputs such as expected term and price of the underlying common stock will have a directionally

opposite impact on fair value measurement.

The following table summarizes the fair value

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Total liabilities at fair value

The following table summarizes the changes in fair value of the warrant

liability classified in Level 3.

Gains and losses reported in this table include changes in fair value that are attributable to unobservable

inputs (in thousands).

The following table summarizes the changes in

fair value of the warrant liability classified in Level 3.

Gains and losses reported in this table include changes in fair value that

are attributable to unobservable inputs (in thousands).

Fair value, January 1, 2023

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Fair value, December 31, 2023

The expense relating to the change in fair value

of the warrant liability of $ 10.3 million for the year ended December 31, 2023, is included in other income (expense) in the statements

of operations.

ASC 820, Fair Value Measurement and Disclosures

requires all entities to disclose the fair value of financial instruments, both assets and liabilities, for which it is practicable to

estimate fair value.

As of December 31, 2022 and 2023, the recorded values of cash and cash equivalents, accounts payable, and accrued

liabilities approximated fair value due to the short-term nature of the instruments.

Cash and cash equivalents, accounts payable, and

accrued liabilities are Level 1 financial instruments.

Fair value, January 1, 2024

Change in fair value of warrants

Fair value, December 31, 2024

Expense relating to the change in fair value of

the warrant liability of $ 10.3 million and $ 5.8 million, for the years ended December 31, 2023 and 2024, respectively, are included in

other income (expense) in the statements of operations.

ASC 820, Fair Value Measurement requires all entities

to disclose the fair value of financial instruments, both assets and liabilities, for which it is practicable to estimate fair value.

As of December 31, 2023 and 2024, the recorded values of cash and cash equivalents, accounts payable, and accrued liabilities approximated

fair value due to the short-term nature of the instruments.

Cash and cash equivalents, accounts payable, and accrued liabilities are Level

1 financial instruments.

Concentration of Credit Risk

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the Company to concentration of credit risk consist of cash and cash equivalents.

All of the Company’s cash was deposited in one

account at a financial institution during 2022.

Beginning in 2023, the Company’s cash and cash equivalents are distributed across

multiple financial institutions.

Cash balances may at times exceed federally insured limits.

Cash and cash equivalents could be adversely

impacted, including the loss of uninsured deposits and other uninsured financial assets, if one or more of the financial institutions

in which the Company holds its cash or cash equivalents fails or is subject to other adverse conditions in the financial or credit markets.

The cash and cash equivalents the Company uses to satisfy

working capital and operating expense needs are held in accounts at various financial institutions.

Cash balances may at times exceed

federally insured limits.

Cash and cash equivalents could be adversely impacted, including the loss of uninsured deposits and other uninsured

financial assets, if one or more of the financial institutions in which the Company holds its cash or cash equivalents fails or is subject

to other adverse conditions in the financial or credit markets.

No such losses have been incurred through December 31, 2024.

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Additional costs included in general and administrative expenses consist of professional fees for legal (including patent costs),

audit and other consulting services, stock-based compensation, and other general corporate overhead expenses as well as costs from a

service agreement with a related party (See Note 7).

audit and other consulting services, stock-based compensation, and other general corporate overhead expenses as well as costs from a service

agreement with a related party (See Note 7).

The Company expenses all costs as incurred in

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The Company estimates the fair value of stock options using the Black-Scholes option-pricing model.

The Black-Scholes

model requires the input of subjective assumptions, including expected common stock volatility, expected dividend yield, expected term,

risk-free interest rate, and the estimated fair value (prior to the Company’s initial public offering) or the public market closing

price of the Company’s underlying common stock on the date of grant.

The Black-Scholes model

requires the input of subjective assumptions, including expected common stock volatility, expected dividend yield, expected term, risk-free

interest rate, and the estimated fair value (prior to the Company’s initial public offering) or the public market closing price

of the Company’s underlying common stock on the date of grant.

The Company accounts for corporate income taxes

in accordance with GAAP as stipulated in ASC, Topic 740, Income Taxes, (“ASC 740”).

This standard entails the use of the

asset and liability method of computing the provision for income tax expense.

Current tax expense results from corporate tax payable

at the Federal and California jurisdictions for the Company, which relates to the current accounting period.

Deferred tax expense results

primarily from temporary differences between financial statement and tax return reporting, which result in additional tax payable in

future periods.

Deferred tax assets and liabilities are determined based on the differences between the financial statement basis and

tax basis of assets and liabilities using enacted tax rates and law.

Net future tax benefits are subject to a valuation allowance when

management expects that it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized.

This standard entails the use of the asset

and liability method of computing the provision for income tax expense.

Current tax expense results from corporate tax payable at the

Federal and California jurisdictions for the Company, which relates to the current accounting period.

Deferred tax expense results primarily

from temporary differences between financial statement and tax return reporting, which result in additional tax payable in future periods.

Deferred tax assets and liabilities are determined based on the differences between the financial statement basis and tax basis of assets

and liabilities using enacted tax rates and law.

Net future tax benefits are subject to a valuation allowance when management expects

that it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized.

Current and non-current tax assets and liabilities

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interest or penalties related to income tax matters in income tax expense.

The Tax Cuts and Jobs Act of 2017 eliminated

the option to immediately deduct research and development expenditures in the year incurred under Section 174, which became effective

January 1, 2022.

We are monitoring legislation for any further changes to Section 174 and the impact, if any, on the financial statements

The Tax Cuts and Jobs Act of 2017 eliminated the

option to immediately deduct research and development expenditures in the year incurred under Section 174, which became effective January

We are monitoring legislation for any further changes to Section 174 and the impact, if any, on the financial statements in 2025.

Comprehensive Loss

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in conformity with the two-class method required for participating securities.

Basic and diluted net loss for common stock

and for preferred stock is computed by dividing the sum of distributed earnings and undistributed earnings for each class of stock by

the weighted average number of shares outstanding for each class of stock for the period.

Basic and diluted net loss for common stock and

for preferred stock is computed by dividing the sum of distributed earnings and undistributed earnings for each class of stock by the

weighted average number of shares outstanding for each class of stock for the period.

Diluted net loss per share includes potentially

dilutive securities outstanding for the period.

As the Company has reported a net loss for all periods presented, a diluted net loss

per common share is the same as basic net loss per common share for those periods.

As the Company has reported a net loss for all periods presented, a diluted net loss per

common share is the same as basic net loss per common share for those periods.

Recent Accounting Pronouncements

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not expected to have a material impact on the Company’s financial position or results of operations upon adoption.

The Company adopted Accounting Standards Update

2016-13, Financial Instruments – Credit Losses (“ASC 326”), as of October 1, 2023.

standard adds to U.S.

GAAP an impairment model, known as the current expected credit loss (“CECL”) model, that is based on

expected losses rather than incurred losses.

Under the new guidance, an entity recognizes as an allowance its estimate of expected credit

losses, which is intended to result in the timelier recognition of losses.

Under the CECL model, entities estimate credit losses over

the entire contractual term from the date of initial recognition of the financial instrument.

As the Company does not currently have

any trade receivables, there was no cumulative effect adjustment, and the adoption of this standard did not have a material impact on

the Company’s financial statements.

In November 2023, the Financial Accounting Standards

Board (“FASB”) issued Accounting Standard Update (“ASU”) No.

2023-07, Segment Reporting (Topic280):

to Reportable Segment Disclosures, which requires an enhanced disclosure of significant segment expenses on an annual and interim basis.

This guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after

December 15, 2024.

Early adoption is permitted.

Upon adoption, the guidance should be applied retrospectively to all prior periods presented

in the financial statements.

We have adopted this guidance and do not expect it to have a material impact on our financial statements.

Income Taxes Disclosures – In December

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Company is currently evaluating the impact of this guidance on its consolidated financial statements.

In August 2020, the FASB issued ASU 2020-06,

Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies the accounting for convertible

ASU 2020-06 eliminates certain models that require separate accounting for embedded conversion features.

Additionally, among

other changes, the guidance eliminates certain of the conditions for equity classification for contracts in an entity’s own equity.

The guidance also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share

calculation and include the effect of share settlement for instruments that may be settled in cash or shares, except for certain liability-classified

share-based payment awards.

This guidance is effective for the Company beginning in the first quarter of 2022 and must be applied using

either a modified or full retrospective approach.

Early adoption is permitted, but no earlier than annual periods beginning after December

The Company adopted the standard on January 1, 2022 using a modified retrospective approach, and the adoption did not result

in any adjustments on the Company’s financial statements.

Accounting pronouncements pending adoption

On November 4, 2024, the FASB issued ASU No.

Expense Disaggregation Disclosures (“ASU 2024-03”).

ASU 2024-03 amends 220, Comprehensive Income to expand income statement

expense disclosures and require disclosure in the notes to the financial statements of specified information about certain costs and expenses.

ASU 2024-03 is required to be adopted for fiscal years commencing after December 15, 2026, with early adoption permitted.

is currently evaluating the impact of adopting the standard on the Consolidated Financial Statements.

Significant Agreements

With regards to manufacturing, testing and potential

commercial supply of Oxylanthanum Carbonate, the Company has entered into an agreement with Shilpa Medicare Ltd based in India.

to the terms of the agreement Unicycive will pay the vendor $ 2 million in the first calendar year when the net revenue reaches $ 10 million

from sales of Oxylanthanum Carbonate following its approval by the FDA and commercial supply of the product by the vendor.

the Company will pay $ 2 million per year for four consecutive years , after the first year’s payment, for total payments of $ 10

million, provided all commercial supplies are continued to be manufactured and supplied by the vendor.

Unicycive is not obligated to

make any payments to the vendor until FDA approval of the product is obtained and commercial revenue is generated.

In October 2017, the Company entered into an

exclusive license agreement with Sphaera, a stockholder, for the rights to further develop the drug candidate, UNI 494, for commercialization.

No payments were made upon execution of the agreement but payments for $ 50,000 will be due commencing with the initiation by the Company

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, the Company 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, the Company has 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, the Company has agreed to order additional tablets for delivery between December

31, 2025, and September 30, 2026.

Further, the Company has 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 the Company of FDA approval of its 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.

In October 2017, the Company entered into an exclusive

license agreement with Sphaera, a stockholder, for the rights to further develop the drug candidate, UNI 494, for commercialization.

payments were made upon execution of the agreement but payments for $ 50,000 will be due commencing with the initiation by the Company

of a second clinical trial and $ 50,000 on completion of such trial.

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Assignment and Asset Purchase Agreement with Spectrum Pharmaceuticals, Inc.

(“Spectrum Agreement”) pursuant to which the

Company purchased certain assets from Spectrum, including Spectrum’s right, title, interest in and intellectual property related

to Renazorb RZB 012, also known as RENALAN™ (“Renalan”) and RZB 014, also known as SPI 014 (“SPI” and together

with Renalan, the “Compounds”), to further develop and commercialize Oxylanthanum Carbonate and related compounds.

consideration for the Spectrum Agreement, the Company issued 313,663 shares of common stock to Spectrum valued at approximately $ 4,000

which represented four percent of the Company on a fully-diluted basis at the date of the execution of the Spectrum Agreement.

Agreement has an anti-dilution provision, which provides that Spectrum maintain its ownership interest in the Company at 4 % of the Company’s

shares on a fully-diluted basis.

Fully-diluted shares of common stock for purposes of the Oxylanthanum Carbonate Purchase Agreement assumes

conversion of any security convertible into or exchangeable or exercisable for common stock or any combination thereof, including any

common stock reserved for issuance under a stock option plan, restricted stock plan, or other equity incentive plan approved by the Board

of Directors of the Company immediately following the issuance of additional shares of the Company’s common stock (but prior to

the issuance of any additional shares of common stock to Spectrum).

Spectrum’s ownership shall not be subject to dilution until

the earlier of thirty-six months from the first date the Company’s stock trades on a public market, or the date upon which the

Company attains a public market capitalization of at least $ 50 million.

On July 13, 2021, the Company’s initial public offering

resulted in a public market capitalization of at least $ 50 million, and as a result the Company was required to issue 438,374 anti-dilution

shares of common stock.

This issuance represented the final anti-dilution calculation required under the Spectrum Agreement, and no further

anti-dilution shares will be issued.

The Company calculated the fair value of the shares and recognized $ 2.2 million to research and

development expenses as cost to issue those shares during the third quarter of 2021.

In the event an NDA filing for Oxylanthanum Carbonate

is accepted by the FDA, the Company will be required to pay $ 0.2 million to Altair Nanomaterials, Inc., (“Altair”) in accordance

with the Spectrum Agreement.

In addition, in the event FDA approval for Oxylanthanum Carbonate is received, the Company will be required

to pay $ 4.5 million to Altair.

The Company is also required to pay Spectrum 40 % of all the Company’s 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.

The Company’s payment obligations to Spectrum will expire on the twentieth (20 th )

anniversary of the Closing Date of the Spectrum Agreement.

In August 2022, the Company received an upfront payment of approximately $ 1.0

million resulting from a sublicense development agreement with Lee’s Pharmaceutical (HK) Limited.

The payment represents sublicense

income as described in the Spectrum Agreement, and 20 % of the amount received has been accrued as an R&D expense in the accompanying

statements of operations for the year ended December 31, 2022.

In February 2023, the Company received an upfront payment of approximately

$ 0.7 million resulting from a sublicense development agreement with Lotus International Pte Ltd.

The payment represents sublicense income

as described in the Spectrum Agreement, and 20 % of the amount received has been accrued as an R&D expense in the accompanying statements

of operations for the year ended December 31, 2023.

(“Spectrum Agreement”) pursuant to which the Company

purchased certain assets from Spectrum, including Spectrum’s right, title, interest in and intellectual property related to Renazorb

RZB 012, also known as RENALAN™ (“Renalan”) and RZB 014, also known as SPI 014 (“SPI” and together with

Renalan, the “Compounds”), to further develop and commercialize oxylanthanum carbonate and related compounds.

In partial consideration

for the Spectrum Agreement, the Company issued 313,663 shares of common stock to Spectrum valued at approximately $ 4,000 which represented

four percent of the Company on a fully-diluted basis at the date of the execution of the Spectrum Agreement.

The Spectrum Agreement has

an anti-dilution provision, which provides that Spectrum maintain its ownership interest in the Company at 4 % of the Company’s shares

on a fully-diluted basis.

Fully-diluted shares of common stock for purposes of the oxylanthanum carbonate Purchase Agreement assumes conversion

of any security convertible into or exchangeable or exercisable for common stock or any combination thereof, including any common stock

reserved for issuance under a stock option plan, restricted stock plan, or other equity incentive plan approved by the Board of Directors

of the Company immediately following the issuance of additional shares of the Company’s common stock (but prior to the issuance

of any additional shares of common stock to Spectrum).

Spectrum’s ownership shall not be subject to dilution until the earlier of

thirty-six months from the first date the Company’s stock trades on a public market, or the date upon which the Company attains

a public market capitalization of at least $ 50 million.

On July 13, 2021, the Company’s initial public offering resulted in a public

market capitalization of at least $ 50 million, and as a result the Company was required to issue 438,374 anti-dilution shares of common

This issuance represented the final anti-dilution calculation required under the Spectrum Agreement, and no further anti-dilution

shares will be issued.

The Company calculated the fair value of the shares and recognized $ 2.2 million to research and development expenses

as cost to issue those shares during the third quarter of 2021.

In the event an NDA filing for oxylanthanum carbonate is accepted by the

FDA, the Company will be required to pay $ 0.2 million to Altair Nanomaterials, Inc., (“Altair”) in accordance with the Spectrum

In addition, in the event FDA approval for oxylanthanum carbonate is received, the Company will be required to pay $ 4.5 million

The Company is also required to pay Spectrum 40 % of all the Company’s 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.

The Company’s payment obligations to Spectrum will expire on the twentieth (20th) anniversary of the

Closing Date of the Spectrum Agreement.

In August 2022, the Company received an upfront payment of approximately $ 1.0 million resulting

from a sublicense development agreement with Lee’s Pharmaceutical (HK) Limited.

In February 2023, the Company received an upfront

payment of approximately $ 0.7 million resulting from a sublicense development agreement with Lotus International Pte Ltd.

represents sublicense income as described in the Spectrum Agreement, and 20 % of the amount received has been accrued as a research and

development expense in the accompanying statements of operations for the year ended December 31, 2024.

On July 19, 2021, the Company entered into an

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and bioanalytical services, was approximately $ 2.3 million.

Approximately $ 0.2 million has been recorded as accounts payable or accrued

expense in the accompanying balance sheet as of December 31, 2022, and the research was completed during 2023.

On January 6, 2022, the Company entered into

a Master Services Agreement with Quotient Sciences Limited (“Quotient”), a UK based company that provides drug development

and analysis services, for the purpose of performing clinical research in support of UNI-494.

The initial budget for the study is

approximately $ 3.7 million, and subsequent revisions reduced the overall budget to $ 3.3 million.

Related payments totaling approximately

$ 2.5 million have been paid to Quotient as of December 31, 2023.

Approximately $ 2.0 million of related expense has been recorded, and

approximately $ 1.0 million and $ 0.6 million has been recorded in prepaid expenses and other current assets in the accompanying balance

sheets as of December 31, 2022 and 2023, respectively.

Approximately $ 2.0 million has been paid to Syneos and the research was completed

On January 6, 2022, the Company entered into a

Master Services Agreement with Quotient Sciences Limited (“Quotient”), a UK based company that provides drug development and

analysis services, for the purpose of performing clinical research in support of UNI-494.

The initial budget for the study is approximately

$ 3.7 million, and subsequent revisions reduced the overall budget to $ 2.9 million.

Related payments totaling approximately $ 2.8 million

have been paid to Quotient as of December 31, 2024.

Approximately $ 2.8 million of related expense has been recorded, and approximately

$ 0.6 million has been recorded in prepaid expenses and other current assets in the accompanying balance sheets as of December 31, 2023

and there is no prepaid balance in 2024.

On February 9, 2022, the Company entered into

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revised the remaining services budget to approximately $ 0.1 million, and the research was completed as of March 31, 2023.

On June 29, 2022, the Company entered into an agreement with Inotiv,

an Indiana based company that provides preclinical trial and related services, for the purpose of performing research in support of Oxylanthanum

The budget for the services is approximately $ 1.3 million.

On April 10, 2023, the Company entered into an agreement with Inotiv

that provides preclinical trial and related services, for the purpose of performing research in support of UNI-494.

The budget for these

services is approximately $ 1.4 million.

Approximately $ 2.2 million has been paid to Inotiv as of December 31, 2023, and approximately

$ 0.4 million and $ 0.3 million has been recorded in prepaid expenses and other current assets in the accompanying balance sheets as of

December 31, 2022 and 2023, respectively.

On July 14, 2022, the Company entered into a

license agreement with Lee’s Pharmaceutical (HK) Limited (see Note 4).

Under the terms of the agreement, Lee’s Pharmaceutical

will be responsible for development, registration filing and approval for Oxylanthanum Carbonate in China, Hong Kong, and certain other

Asian markets.

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

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

The Company has received an upfront

payment of $ 1.0 million, expects to receive up to $ 1.0 million in milestone payments upon product launch in China and will be eligible

for tiered royalties of between 7 % and 10 % upon achievement of prespecified regulatory and commercial achievements.

On June 29, 2022, the Company entered into an

agreement with Inotiv, an Indiana based company that provides preclinical trial and related services, for the purpose of performing research

in support of Oxylanthanum Carbonate.

On April 10, 2023, the Company entered into an

agreement with Inotiv that provides preclinical trial and related services, for the purpose of performing research in support of UNI-494.

The budget for these services is approximately $ 2.9 million.

Approximately $ 2.9 million has been paid to Inotiv as of December 31, 2024,

and approximately $ 0.3 million has been recorded in prepaid expenses and other current assets in the accompanying balance sheet as of

December 31, 2023 and there is no prepaid balance in 2024.

On July 14, 2022, the Company entered into a license

agreement with Lee’s Pharmaceutical (HK) Limited (see Note 4).

Under the terms of the agreement, Lee’s Pharmaceutical will

be responsible for development, registration filing and approval for Oxylanthanum Carbonate in China, Hong Kong, and certain other Asian

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

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

The Company has received an upfront payment

of $ 1.0 million, expects to receive up to $ 1.0 million in milestone payments upon product launch in China and will be eligible for tiered

royalties of between 7 % and 10 % upon achievement of prespecified regulatory and commercial achievements.

On July 27, 2022, the Company entered into an

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in support of Oxylanthanum Carbonate.

The budget for the services is approximately $ 2.7 million, approximately $ 2.7 million has been

paid to Celerion as of December 31, 2023, and the research was completed during 2023.

The budget for the services is approximately $ 2.7 million, approximately $ 2.7 million has been paid

to Celerion as of December 31, 2023, and the research was completed during 2023.

On February 1, 2023, the Company entered into

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million in future milestone payments and will be eligible for tiered royalties upon achievement of specified commercial achievements.

On June 29, 2023 and October 26, 2023, the Company entered into services

agreements with Shilpa Medicare Ltd related to NDA filing support for Oxylanthanum Carbonate.

The agreements provide for total payments

of up to $ 3.7 million, and the Company has made $ 3.0 million in payments pursuant to the agreements as of December 31, 2023.

On June 29, 2023 and October 26, 2023, the Company

entered into services agreements with Shilpa Medicare Ltd related to NDA filing support for Oxylanthanum Carbonate.

The agreements provide

for total payments of up to $ 6.5 million, and the Company has made $ 6.5 million in payments pursuant to the agreements as of December

Licensing Revenues

On July 14, 2022, the Company entered into a

license agreement (the “Lee’s Agreement”) with Lee’s Pharmaceutical (HK) Limited (“Lee’s”).

Under the terms of the agreement, Lee’s Pharmaceutical will be responsible for development, registration filing and approval for

Oxylanthanum Carbonate in China, Hong Kong, and certain other Asian markets.

In addition, Lee’s will have sole responsibility for

the importation of the drug product from the Company and for the costs of commercialization of Oxylanthanum Carbonate in the licensed

Both parties agreed to enter into a separate manufacturing and supply agreement whereby Unicycive will supply Lee’s

with Oxylanthanum Carbonate product.

The Company has received an upfront payment of approximately $ 1.0 million, expects to receive up

to $ 1.0 million in milestone payments upon product launch in China and will be eligible for tiered royalties of between 7 % and 10 % upon

achievement of prespecified regulatory and commercial achievements.

On July 14, 2022, the Company entered into a license

agreement (the “Lee’s Agreement”) with Lee’s Pharmaceutical (HK) Limited (“Lee’s”).

terms of the agreement, Lee’s Pharmaceutical will be responsible for development, registration filing and approval for Oxylanthanum

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

In addition, Lee’s will have sole responsibility for the importation

of the drug product from the Company and for the costs of commercialization of Oxylanthanum Carbonate in the licensed territories.

parties agreed to enter into a separate manufacturing and supply agreement whereby Unicycive will supply Lee’s with Oxylanthanum

Carbonate product.

The Company has received an upfront payment of approximately $ 1.0 million, expects to receive up to $ 1.0 million in

milestone payments upon product launch in China and will be eligible for tiered royalties between 7 % and 10 % upon achievement of prespecified

regulatory and commercial achievements.

The Company has evaluated the Lee’s Agreement

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the IP license.

ASC 606 indicates that constrained variable consideration should be

included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue

recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.

ASC 606 indicates that constrained variable consideration

should be included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative

revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.

Variable consideration

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date until the uncertainties are resolved.

For the sales-based royalty payments, guidance requires an entity to

recognize revenue for a sales-based royalty promised in exchange for a license of intellectual property only when the later of 1) the

subsequent sale or usage occurs, or 2) the performance obligation to which some or all the sales-based or usage-based royalty has been

allocated has been satisfied or partially satisfied.

The Company has concluded that the future sales-based royalties should be excluded

from the transaction price as of December 31, 2022 and December 31, 2023.

The Company will reassess this conclusion at each reporting

For the sales-based royalty payments, guidance

requires an entity to recognize revenue for a sales-based royalty promised in exchange for a license of intellectual property only when

the later of 1) the subsequent sale or usage occurs, or 2) the performance obligation to which some or all the sales-based or usage-based

royalty has been allocated has been satisfied or partially satisfied.

The Company has concluded that the future sales-based royalties

should be excluded from the transaction price as of December 31, 2023, and December 31, 2024.

The Company will reassess this conclusion

at each reporting date.

The Company has concluded that at contract inception

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the functionality of the IP is not expected to substantially change during the license period based on Unicycive’s activities.

The revenue should therefore be recognized at a point in time.

This intellectual property was transferred to Lee’s in July 2022,

and the Company has recognized $ 1.0 million in the accompanying statements of operations as licensing revenue for the year ended December

revenue should therefore be recognized at a point in time.

This intellectual property was transferred to Lee’s in July 2022, and

the Company has recognized $ 1.0 million in the accompanying statements of operations as licensing revenue for the year ended December

On February 1, 2023, the Company entered into

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biotech companies.

The license portion of the contract as well as the future potential transactions under a manufacturing and supply

agreement both represent a vendor-customer relationship.

The license portion of the contract as well as the future potential transactions under a manufacturing and supply agreement

both represent a vendor-customer relationship.

The Company does not believe that its promise

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combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.

The combination of the license grant and development services is distinct as Lotus plans to use the product of this bundled unit for

developing its regulatory applications.

The Company concluded that the Lotus agreement contains one performance obligation, the bundle

of the license grant and development services.

The combination of the license grant and development services is distinct as Lotus plans to use the product of this bundled unit for developing

its regulatory applications.

The Company concluded that the Lotus agreement contains one performance obligation, the bundle of the license

grant and development services.

ASC 606 indicates that constrained variable consideration

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revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.

considerations consisting of milestone payments and sales-based royalties may be received based on the completion of certain clinical,

regulatory, and commercial activities.

The Company has concluded that the future milestone payments should be excluded from the transaction

price due to the uncertainty of achievement as of December 31, 2023.

The Company will reassess this conclusion at each reporting date

until the uncertainties are resolved.

Variable considerations

consisting of milestone payments and sales-based royalties may be received based on the completion of certain clinical, regulatory, and

commercial activities.

The Company has concluded that the future milestone payments should be excluded from the transaction price due

to the uncertainty of achievement as of December 31, 2024.

The Company will reassess this conclusion at each reporting date until the

uncertainties are resolved.

For the sales-based royalty payments, guidance

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The Company has concluded that at contract inception

the total transaction price is $ 675,000 amount of the upfront payment.

the total transaction price is $ 675,000 in the amount of the upfront payment.

ASC 606 generally requires an entity to allocate the transaction

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The $ 675,000 initial transaction price will therefore be entirely allocated to this obligation.

The Company has concluded that the license of the Oxylanthanum Carbonate

IP is functional IP.

However, since it is not distinct, revenue must be recognized based on the combination of the functional IP and the

related development services.

Lotus will not simultaneously receive and consume the benefits of the Oxylanthanum Carbonate IP or development

Since the performance of the development services creates an asset that will also be used by the Company and can be licensed

to other customers outside of the Territory, the Company is considered to control the asset as it is created, and it does create an asset

with an alternative use.

Therefore, the Company concluded that control is not deemed to be transferred over time and is instead transferred

at a point in time.

The intellectual property was transferred to Lotus in February 2023, and the development services were determined

to be immaterial to the contract.

The Company has recognized $ 0.7 million in the accompanying statements of operations as licensing revenue

for the year ended December 31, 2023.

The Company has concluded that the license of

the Oxylanthanum Carbonate IP is functional IP.

However, since it is not distinct, revenue must be recognized based on the combination

of the functional IP and the related development services.

Lotus will not simultaneously receive and consume the benefits of the Oxylanthanum

Carbonate IP or development services.

Since the performance of the development services creates an asset that will also be used by the

Company and can be licensed to other customers outside of the Territory, the Company is considered to control the asset as it is created,

and it does create an asset with an alternative use.

Therefore, the Company concluded that control is not deemed to be transferred over

time and is instead transferred at a point in time.

The intellectual property was transferred to Lotus in February 2023, and the development

services were determined to be immaterial to the contract.

The Company has recognized $ 0.7 million in the accompanying statements of operations

as licensing revenue for the year ended December 31, 2023.

We may earn additional licensing revenue in the

future if we negotiate business development arrangements with third parties.

Balance Sheet Components

Prepaid expenses and other current assets as

of December 31, 2022 and 2023 consisted of the following (in thousands):

Prepaid expenses and other current assets as of

December 31, 2023, and 2024 consisted of the following (in thousands):

Prepaid directors’ and officers’ liability insurance premiums

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Leasehold improvements

Lab Equipment

Furniture and fixtures

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lease is for three years with an option to extend the lease for three additional years .

On June 28, 2024, the Company further expanded

its leased space through a lease amendment by an additional 2,581 square feet commencing July 15, 2024.

The term of the amended lease

unifies with the current expiration of the lease.

The lease amendment represents a modification

of the original lease, and the Company evaluated the new agreement under ASC 842, Leases .

The Company classified the lease as

an operating lease and, on March 15, 2023, determined that the present value of the lease was approximately $ 1.0 million using an estimated

The Company classified the lease as an

operating lease and, on July 15, 2024, determined that the present value of the lease was approximately $ 1.0 million using an estimated

incremental borrowing rate of 10 %.

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December 31, 2024.

During the year ended December 31, 2023, the

Company made cash payments on the lease of approximately $ 331,000 towards the lease liabilities.

As of December 31, 2023, the total lease

liability was $ 0.8 million.

Rent expense for the lease for the years ended December 31, 2022 and 2023 was approximately $ 173,000 and

$ 354,000 , respectively.

During the years ended December 31, 2023, and

2024 the Company made cash payments on the lease of approximately $ 331,000 and $ 474,000 respectively towards the lease liabilities.

of December 31, 2024, the total lease liability was $ 0.7 million.

Rent expense for the lease for the years ended December 31, 2023, and

2024 was approximately $ 354,000 and $ 484,000 , respectively.

Maturities of the Company’s lease liabilities

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Year ending December 31, 2026

Total lease payments

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The Company repaid amounts owed to the stockholder of $ 210,000 plus accrued interest during March 2023.

Common Stock Purchase Agreement and Service

Agreement with Globavir

On July 1, 2017, as amended on April 6, 2020,

the Company entered into a Service Agreement with Globavir Biosciences, Inc.

(“Globavir”), a related party (the “Service

Globavir provided administrative and consulting services and shared office space and other costs in connection with

the Company’s drug development programs.

The initial amended term of the Service Agreement expired on December 31, 2020, and the

agreement automatically renewed for successive one-month periods after the initial termination date.

Pursuant to the Service Agreement,

the Company paid Globavir $ 50,000 per month through December 31, 2019, and $ 10,000 per month commencing on January 1, 2020.

fourth quarter of 2021, after initially determining that future services under the Service Agreement were no longer required, the Company

wrote off the $ 28,000 remaining prepaid balance due from Globavir as of December 31, 2021.

During the year ended December 31, 2022, after

determining that although a shared office space is no longer utilized, consulting services continued to be provided, the Company amended

the Service Agreement to reflect the consulting services at a reduced service fee of $ 6,000 per month and a termination date of June

The Company has not entered into any additional agreements with Globavir during the year ended December 31, 2023.

Commitments and Contingencies

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that arise in the ordinary course of business.

Such matters are inherently uncertain, and there can be no guarantee that the outcome

of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse

effect upon the Company’s financial statements.

Such matters are inherently uncertain, and there can be no guarantee that the outcome of

any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse effect

upon the Company’s financial statements.

The Company currently has no pending claims or legal proceedings.

In December 2022, the Company signed an advisory

services agreement with Maxim Group LLC (“Maxim”) pursuant to which the Company will pay Maxim $ 100,000 upon the closing

of a private placement of the Company’s equity or equity-linked securities.

Maxim provided advisory services with respect to a

private placement securities purchase agreement with certain healthcare-focused institutional investors, which closed in March of 2023.

The Company paid the $ 100,000 advisory fee in March 2023.

services agreement with Maxim Group LLC (“Maxim”) pursuant to which the Company will pay Maxim $ 100,000 upon the closing of

a private placement of the Company’s equity or equity-linked securities.

Maxim provided advisory services with respect to a private

placement securities purchase agreement with certain healthcare-focused institutional investors, which closed in March of 2023.

paid the $ 100,000 advisory fee in March 2023.

Indemnifications

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The Company believes that the likelihood of conditions

arising that would trigger these indemnities is remote and, historically, the Company had not made any significant payment under such

arising that would trigger these indemnities is remote and, historically, the Company has not made any significant payment under such

indemnification provisions.

2 unchanged sentences

may record charges in the future as a result of these indemnification obligations.

Additionally, the Company has agreed to indemnify

its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company’s

request in such a capacity.

The indemnification period covers all pertinent events and occurrences during the director’s or officer’s

Additionally, the Company has agreed to indemnify its directors and

officers for certain events or occurrences while the director or officer is, or was serving, at the Company’s request in such a

The indemnification period covers all pertinent events and occurrences during the director’s or officer’s service.

Employee Benefit Plan

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Authorized Common Stock

The Company is authorized to issue up to 200,000,000

shares of common stock at par value of $ 0.001 per share.

Issuance of Common Stock and Warrants from

Initial Public Offering

During July 2021, as a result of its initial

public offering, the Company issued 5,000,000 shares of common stock and 4,000,000 warrants to investors in exchange for cash at $ 5.00

per unit, consisting of $ 4.99 per share of common stock and $ .0125 per four fifths of a warrant.

The warrants have a 5 -year term and

an exercise price of $ 6.00 per warrant.

The underwriters exercised their option to purchase an additional 600,000 warrants, and the Company

received $ 7,500 in proceeds.

As a result of the initial public offering, the

Company’s outstanding convertible notes and unpaid accrued interest were converted into 736,773 shares of common stock.

Additionally,

convertible noteholders were granted a total of 184,193 common stock warrants with a 5 -year term and with an exercise price of $ 6.00

The warrants from the initial public offering

are equity classified.

The Company is authorized to issue up to 400,000,000 shares of common

stock at par value of $ 0.001 per share.

Issuance of Common Stock and Warrants from Initial Public Offering

During July 2021, as a result of its initial public offering, the Company

issued 5,000,000 shares of common stock and 4,000,000 warrants to investors in exchange for cash at $ 5.00 per unit, consisting of $ 4.99

per share of common stock and $ .0125 per four fifths of a warrant.

The warrants have a 5 -year term and an exercise price of $ 6.00 per

The underwriters exercised their option to purchase an additional 600,000 warrants, and the Company received $ 7,500 in proceeds.

As a result of the initial public offering, the Company’s outstanding

convertible notes and unpaid accrued interest were converted into 736,773 shares of common stock.

Additionally, convertible noteholders

were granted a total of 184,193 common stock warrants with a 5 -year term and with an exercise price of $ 6.00 per warrant.

The warrants from the initial public offering are equity classified.

The following table summarizes activity for the Company’s IPO warrants for the year ended December 31, 2024:

(in thousands)

Number of Average

Shares Weighted- Remaining Aggregate

Underlying Average Contractual Intrinsic

Outstanding Exercise Term Value

Warrants Price (in Years) (in thousands)

Outstanding, December 31, 2023 4,784,193 6.00 2.54 -

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Outstanding, December 31, 2024 4,784,193 6.00 1.54 -

Issuance of Common Stock Upon Conversion of

Series A-1 Preferred Stock

On June 26, 2023, the Company held its annual

shareholder meeting and, as a result, shareholder approval for the issuance of common shares upon the conversion of the Series A-1 Preferred

Stock was obtained (see Notes 10 and 11).

On July 11, 2023, pursuant to the Certificate of Designation of Preferences, Rights and Limitations

of the Series A Convertible Voting Preferred Stock (the “Certificate of Designation”), the Company issued a total of 19,516,205

shares of common stock and 43,649 Series A-2 Preferred Stock in settlement of the auto-conversion of the Series A-1 Preferred Stock.

Issuance of Common Stock Upon Conversion of Series A and Series

B Preferred Stock

On June 26, 2023, the Company held its annual shareholder meeting and,

as a result, shareholder approval for the issuance of common shares upon the conversion of the Series A-1 Preferred Stock was obtained

(see Note 10).

On July 11, 2023, pursuant to the Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible

Voting Preferred Stock (the “Certificate of Designation”), the Company issued a total of 19,516,205 shares of common stock

and 43,649 Series A-2 Preferred Stock in settlement of the auto-conversion of the Series A-1 Preferred Stock.

On March 26, 2024, the Company issued 2,850,000 shares of common stock

upon conversion of 1,396.50 shares of Series A-2 Prime Preferred Stock.

On June 20, 2024, we held our annual stockholder meeting, and as a

result, stockholder approval for the conversion of the Series B-1 Convertible Preferred Stock was obtained (see Note 11).

On July 5, 2024,

pursuant to the Certificate of Designation of Preferences, Rights and Limitations of the Series B Convertible Preferred Stock, the Company

issued 42,118,000 shares of common stock and 7,882 shares of Series B-2 preferred stock in settlement of the automatic conversion of the

Series B-1 Convertible Preferred Stock.

On June 25, 2024, the Company issued 5,956,000 shares of common stock

upon conversion of 2,918.44 shares of the Company’s Series A-2 Prime Preferred Stock.

On July 23, 2024, the Company issued 3,550,000 shares of common stock

upon conversion of 1,739.50 shares of the Company’s Series A-2 Prime Preferred Stock.

On July 25, 2024, the Company issued 3,756,000 shares of common stock

upon conversion of 1,840.44 shares of the Company’s Series A-2 Prime Preferred Stock.

On July 29, 2024, the Company issued 1,359,000 shares of common stock

upon conversion of 665.91 shares of the Company’s Series A-2 Prime Preferred Stock.

On August 14, 2024, the Company issued 3,502,000 shares of common stock

upon conversion of 1,715.98 shares of the Company’s Series A-2 Prime Preferred Stock.

On October 9, 2024, the Company issued 5,500,000 shares of common stock

upon conversion of 2,695 shares of the Company’s Series A-2 Prime Preferred Stock.

On October 31, 2024, the Company issued 438,000 shares of common stock

upon conversion of 438 shares of the Company’s Series B-2 Preferred Stock.

On December 11, 2024, the Company issued 7,863,327 shares of common

stock upon conversion of 3,853.03 shares of the Company’s Series A-2 Prime Preferred Stock.

On December 18, 2024, the Company issued 1,441,000 shares of common

stock upon conversion of 1,441 shares of the Company’s Series B-2 Preferred Stock.

On December 19, 2024, the Company issued 3,003,000 shares of common

stock upon conversion of 3,003 shares of the Company’s Series B-2 Preferred Stock.

Voting Rights of Common Stock

Each holder of shares of common stock shall be

entitled to one vote for each share thereof held.

Each holder of shares of common stock shall be entitled to one vote

for each share thereof held.

Issuance of Series A Preferred Stock

As of December 31, 2022, the Company had 10,000,000

shares of preferred stock authorized, par value of $ 0.001 per share, and no shares of preferred stock were issued or outstanding.

On March 3, 2023, the Company issued and sold,

in a private placement, 30,190 shares of Series A-1 Preferred Stock for an aggregate net proceeds of $ 28.0 million (the “Preferred

Stock Offering”), net of placement agent fees and offering expenses of $ 2.2 million.

The Company intends to use the net proceeds

from the Preferred Stock Offering to support the Company’s New Drug Application (NDA) submission for approval of Oxylanthanum Carbonate

for the treatment of hyperphosphatemia and, if approved, for the commercial launch of Oxylanthanum Carbonate in the U.S.

Pursuant to the Certificate of Designation, as

of March 3, 2023, each share of Series A-1 Preferred Stock was, subject to approval of the Company’s stockholders, convertible

into a unit (“Unit”) consisting of:

(i) shares of common stock of the Company and, if applicable, shares of Series A-2 Preferred

Stock, in lieu of common stock, (ii) a tranche A warrant to acquire approximately 46,675,940 shares (excluding deemed dividends) of Series

A-3 Preferred Stock (the “Tranche A Warrant”), (iii) a tranche B warrant to acquire approximately 42,432,672 shares (excluding

deemed dividends) of Series A-4 Preferred Stock (the “Tranche B Warrant”), and (iv) a tranche C warrant to acquire approximately

67,892,276 shares (excluding deemed dividends) of Series A-5 Preferred Stock (the “Tranche C Warrant”, together with the

Tranche A Warrant and the Tranche B Warrant, the “Warrants”).

The Tranche A Warrant, for an aggregate exercise price of approximately

$25 million, is exercisable until 21 days following the Company’s announcement of receipt of FDA approval for Oxylanthanum Carbonate,

the Tranche B Warrant, for an aggregate exercise price of approximately $25 million, is exercisable until 21 days following the Company’s

announcement of receipt of Transitional Drug Add-On Payment Adjustment (“TDAPA”) approval for Oxylanthanum Carbonate, and

the Tranche C Warrant for an aggregate exercise price of approximately $50 million is exercisable until 21 days following four quarters

of commercial sales of Oxylanthanum Carbonate following receipt of TDAPA approval.

The Company has designated 30,190 shares of Series

A-1 Preferred Stock, 1,800,000 shares of Series A-2 Preferred Stock, 1,800,000 shares of Series A-3 Preferred Stock, 1,800,000 shares

of Series A-4 Preferred Stock, and 3,600,000 shares of Series A-5 Preferred Stock, together the “Series A Preferred Stock”.

The Series A Preferred Stock has a par value of $ 0.001 per share.

The Certificate of Designation states that, to the extent that the

conversion of the Series A-1 preferred stock as well as the exercise of the Warrants into Series A-2, Series A-3, Series A-4, and Series

A-5 preferred stock results in a beneficial ownership interest in excess of the maximum percentage of common stock upon conversion, the

holders will receive the as converted equivalent for the remaining shares in preferred stock.

The Company determined that the holders could

detach the Warrants from the Series A-1 Preferred Stock, because the stock will automatically convert into shares of common stock, and

the holders will be able to sell those shares while retaining the Warrants.

Accordingly, the Warrants are considered freestanding from

the Series A-1 Preferred Stock.

The Company noted that at contract inception, the Warrants were contingently issuable upon the occurrence

of a specified event (shareholder approval).

In connection with the Series A-1 Preferred Stock

issuance, the Company recognized liabilities for the associated Warrants, which had an aggregate fair value of $ 2.8 million at the time

Offering costs of $ 0.2 million were allocated to the Warrants and expensed during March 2023.

The fair value of the Warrants

was accounted for as a reduction to the net proceeds of the Preferred Stock Offering, which resulted in an initial carrying value of

$ 25.4 million for the Series A-1 Preferred Stock (net of $ 2.0 million of placement agent fees and offering costs allocated to the Series

A-1 Preferred Stock).

On March 3, 2023, the Company issued and sold, in a private placement,

30,190 shares of Series A-1 Preferred Stock for an aggregate net proceeds of $ 28.0 million (the “Preferred Stock Offering”),

net of placement agent fees and offering expenses of $ 2.2 million.

The Company intends to use the net proceeds from the Preferred Stock

Offering to support the Company’s New Drug Application (NDA) submission for approval of Oxylanthanum Carbonate for the treatment

of hyperphosphatemia and, if approved, for the commercial launch of Oxylanthanum Carbonate in the U.S.

Pursuant to the Certificate of Designation, as of March 3, 2023, each

share of Series A-1 Preferred Stock was, subject to approval of the Company’s stockholders, convertible into a unit (“Unit”)

consisting of:

(i) shares of common stock of the Company and, if applicable, shares of Series A-2 Preferred Stock, in lieu of common stock,

(ii) a tranche A warrant to acquire approximately 46,675,940 shares (excluding deemed dividends) of Series A-3 Preferred Stock (the “Tranche

A Warrant”), (iii) a tranche B warrant to acquire approximately 42,432,672 shares (excluding deemed dividends) of Series A-4 Preferred

Stock (the “Tranche B Warrant”), and (iv) a tranche C warrant to acquire approximately 67,892,276 shares (excluding deemed

dividends) of Series A-5 Preferred Stock (the “Tranche C Warrant”, together with the Tranche A Warrant and the Tranche B Warrant,

the “Warrants”).

The Tranche A Warrant, for an aggregate exercise price of approximately $ 25 million, is exercisable until

21 days following the Company’s announcement of receipt of FDA approval for Oxylanthanum Carbonate, the Tranche B Warrant, for an

aggregate exercise price of approximately $ 25 million, is exercisable until 21 days following the Company’s announcement of receipt

of Transitional Drug Add-On Payment Adjustment (“TDAPA”) approval for Oxylanthanum Carbonate, and the Tranche C Warrant for

an aggregate exercise price of approximately $ 50 million is exercisable until 21 days following four quarters of commercial sales of Oxylanthanum

Carbonate following receipt of TDAPA approval.

The Company has designated 30,190 shares of Series A-1 Preferred Stock,

1,800,000 shares of Series A-2 Preferred Stock, 1,800,000 shares of Series A-3 Preferred Stock, 1,800,000 shares of Series A-4 Preferred

Stock, and 3,600,000 shares of Series A-5 Preferred Stock, together the “Series A Preferred Stock”.

The Series A Preferred

Stock has a par value of $ 0.001 per share.

The Certificate of Designation states that, to the extent that the conversion of the Series

A-1 preferred stock as well as the exercise of the Warrants into Series A-2, Series A-3, Series A-4, and Series A-5 preferred stock results

in a beneficial ownership interest in excess of the maximum percentage of common stock upon conversion, the holders will receive the as

converted equivalent for the remaining shares in preferred stock.

The Company determined that the Warrants are freestanding from the

Series A-1 Preferred Stock, because the stock will automatically convert into shares of common stock, and the holders will be able to

sell those shares while retaining the Warrants.

The Company noted that at contract inception, the Warrants were contingently issuable

upon the occurrence of a specified event (shareholder approval).

In connection with the Series A-1 Preferred Stock issuance, the Company

recognized liabilities for the associated Warrants, which had an aggregate fair value of $ 2.8 million at the time of issuance.

costs of $ 0.2 million were allocated to the Warrants and expensed during March 2023.

The fair value of the Warrants was accounted for

as a reduction to the net proceeds of the Preferred Stock Offering, which resulted in an initial carrying value of $ 25.4 million for the

Series A-1 Preferred Stock (net of $ 2.0 million of placement agent fees and offering costs allocated to the Series A-1 Preferred Stock).

Refer to Note 11 for disclosures related to the Warrants.

On June 26, 2023, the Company held its annual

shareholder meeting and, as a result, shareholder approval for the conversion of the Series A-1 Preferred Stock was obtained.

11, 2023, pursuant to the Certificate of Designation, the Company issued 19,516,205 shares of common stock (see Note 9) and 43,649 shares

of Series A-2 Preferred Stock in partial settlement of the auto-conversion of the Series A-1 preferred shares.

As of December 31, 2023,

there were zero shares of Series A-1 preferred stock issued and outstanding and there were 43,649 shares of Series A-2 Preferred Stock

issued and outstanding.

The Series A-1 Preferred Stock have the following

Prior to the receiving stockholder

approval, dividends will accrue, on all issued and outstanding shares of Series A-1 Preferred Stock, prior to and in preference to all

other shares of capital stock of the Company, at an annual rate of eight percent ( 8 %) compounded annually on the original per share price

(plus any such accreted compounded amounts);

provided that such annual dividend rate shall increase to fourteen percent ( 14 %) if stockholder

approval is not obtained at the first meeting of stockholders following the date of the Preferred Stock offering.

If such dividends are

not declared and paid in cash, the dividend amounts will be added to the aggregate liquidation preference then outstanding of the Series

A-1 Preferred Stock.

As of December 31, 2023, the Company recorded $ 0.9 million, or $ 28.71 per share, of deemed dividends on the Series

A-1 Preferred Stock.

Holders of the Series A-1 Preferred Stock

On June 26, 2023, the Company held its annual shareholder meeting and,

as a result, shareholder approval for the conversion of the Series A-1 Preferred Stock was obtained.

On July 11, 2023, pursuant to the

Certificate of Designation, the Company issued 19,516,205 shares of common stock (see Note 9) and 43,649 shares of Series A-2 Preferred

Stock in partial settlement of the auto-conversion of the Series A-1 preferred shares.

As of December 31, 2023, there were zero shares

of Series A-1 preferred stock issued and outstanding and there were 43,649 shares of Series A-2 Preferred Stock issued and outstanding.

The Series A-2, A-3, A-4, and A-5 Preferred Stock have the following

While shares of Series A Preferred Stock are issued and

outstanding, holders of Series A Preferred Stock shall be entitled to receive, and the Corporation shall pay, dividends on shares of Series

A Preferred Stock equal (on an as-if-converted-to-Common-Stock basis) and in the same form as dividends (other than dividends in the form

of Common Stock) actually paid on shares of the Common Stock when, as and if such dividends are paid on shares of the Common Stock.

Holders of the Series A-2, A-3, A-4, and A-5 Preferred Stock

are entitled to vote together with the common stock on an as-if-converted-to-common-stock basis as determined by dividing the liquidation

preference with respect to such shares of Series A Preferred Stock by the conversion price.

Holders of common stock are entitled to one

vote for each share of common stock held on all matters submitted to a vote of stockholders.

Accordingly, holders of Series A Preferred

Stock will be entitled to one vote for each whole share of Common Stock into which their Series A Preferred Stock is then-convertible

on all matters submitted to a vote of stockholders.

Board of Directors Designation Rights:

of Series A-1 Preferred Stock have the right to appoint one member to the Board of Directors.

In March 2023, Dr.

Gaurav Aggarwal was

appointed to the Company’s Board of Directors.

On the tenth trading day following the announcement

of the stockholder approval, each share of Series A-1 Preferred Stock shall automatically convert into a unit consisting of:

number of shares of common stock equal to the quotient of (A) the liquidation preference with respect to such share of Series A-1 Preferred

Stock, divided by (B) the conversion price, provided that, to the extent the share conversion would cause such Holder’s beneficial

ownership to exceed 9.99%, such holder shall receive shares of Series A-2 Preferred Stock in lieu of common stock, on a one-for-one basis,

with respect to the number of shares of common stock that exceed 9.99% ownership, (2) a Tranche A Warrant, (3) a Tranche B Warrant, and

(4) a Tranche C Warrant.

preference with respect to such shares of Preferred Stock by the conversion price.

Holders of common stock are entitled to one vote for

each share of common stock held on all matters submitted to a vote of stockholders.

Accordingly, holders of Series A Preferred Stock will

be entitled to one vote for each whole share of Common Stock into which their Series A Preferred Stock is then-convertible on all matters

submitted to a vote of stockholders.

At the option of the holder thereof, each share of Series A-2 Preferred

Stock, Series A-3 Preferred Stock, Series A-4 Preferred Stock, or Series A-5 Preferred Stock shall be convertible into one share of common

Exchange Agreement – Issuance of Series A-2 Prime Preferred

On March 13, 2024, the Company entered into an exchange agreement (the

“Exchange Agreement”) with certain accredited investors (the “Investors”), pursuant to which the Investors surrendered

all shares of Series A-2 Preferred Stock held by them in exchange for an aggregate of 21,388.01 shares of new preferred stock to beknown

as “Series A-2 Prime Preferred” (the “Exchanged Preferred”) having rights set forth the Amended and Restated Certificate

of Designation of Preferences, Rights and Limitations of the Series A Convertible Voting Preferred Stock (the “Amended Series A

Certificate of Designation”).

Concurrent with execution of the Exchange Agreement, but prior to filing

of the Amended Series A Certificate of Designation with the Delaware Secretary of State, the Company filed Certificates of Elimination

for each of its Series A-1 Preferred Stock, Series A-2 Preferred Stock, Series A-3 Preferred Stock, Series A-4Preferred Stock and Series

A-5 Preferred Stock (collectively, the “Certificates of Elimination”) with the Delaware Secretary of State.

Concurrent with the execution of the Exchange

Agreement, the Company and each Investor have amended and restated the following warrants:

(i) tranche A warrants to acquire an aggregate

of 47,852,430 shares of Series A-3 Convertible Preferred Stock of the Company convertible into 47,852,430 shares of common stock that

were issued on July 11 2023 (the “Original Tranche A Warrants”) have been amended and restated to acquire an aggregate of

25,840.3122 shares of Series A-3 Convertible Preferred Stock (as amended, the “Amended Tranche A Warrants”) convertible into

47,852,430 shares of common stock;

(ii) tranche B warrants to acquire an aggregate of 43,502,206 shares of Series A-4 Convertible Preferred

Stock of the Company convertible into 43,502,206 shares of common stock that were issued on July 11, 2023 (the “Original Tranche

B Warrants”) have been amended and restated to acquire an aggregate of 25,666.30154 shares of Series A-4 Convertible Preferred Stock

(as amended, the “Amended Tranche B Warrants”) convertible into 43,502,206 shares of common stock and (iii) tranche C warrants

to acquire an aggregate of 69,603,531 shares of Series A-5 Convertible Preferred Stock of the Company convertible into 69,603,531 shares

of common stock that were issued on July 11, 2023 (the “Original Tranche C Warrants”, and together with the Original Tranche

A Warrants and Tranche B Warrants, the “Original Warrants”) have been amended and restated to acquire 51,506.61294 shares

of Series A-5 Convertible Preferred Stock (as amended, the “Amended Tranche C Warrants,” together with the Amended Tranche

A Warrants and the Amended Tranche B Warrants, the “Amended Warrants”) convertible into 69,603,351 shares of common stock.

The Amended Warrants have the same terms and conditions as the original warrants except that such Amended Warrants:

(i) reduced the amount

of shares of Series A-3 Convertible Preferred Stock, Series A-4 Convertible Preferred Stock and Series A-5 Convertible Preferred Stock

into which such Amended Warrants are convertible as described above;

(ii) allow for the issuance of fractional shares of Series A-3 Preferred

Stock, Series A-4 Preferred Stock and Series A-5 Preferred Stock, as applicable upon exercise of such Amended Warrants and (ii) revised

the exercise price to be $ 1,000 per share of Series A-3 Preferred Stock, Series A-4 Preferred Stock and Series A-5 Preferred Stock, as

applicable in such Amended Warrants.

The aggregate exercise price, the amount of shares of Common Stock upon conversion of the Series

A-3 Preferred Stock, the Series A-4 Preferred Stock and the Series A-5 Preferred Stock and exercise period in the Amended Warrants did

not change from the Original Warrants.

Subject to the terms and limitations contained in the Amended Series

A Certificate of Designation, each share of Series A-2 Prime Convertible Preferred Stock, Series A-3 Convertible Preferred Stock, Series

A-4 Convertible Preferred Stock or Series A-5 Convertible Preferred Stock are convertible into a number shares of Common Stock obtained

by dividing the Original Per Share Price ($ 1,000 ) of each such share of Series A-2 Prime Convertible Preferred Stock, Series A-3Convertible

Preferred Stock, Series A-4 Convertible Preferred Stock or Series A-5 Convertible Preferred Stock by the applicable conversion price of

$ 0.49 , $ 0.54 ,$ 0.59 and $ 0.74 of each such share of Series A-2 Prime Convertible Preferred Stock, Series A-3 Convertible Preferred Stock,

Series A-4 Convertible Preferred Stock or Series A-5 Convertible Preferred Stock, respectively.

Pursuant to the terms of the Exchange Agreement, effective March 13,

2024, the Company filed the Amended Certificate of Designation with the Delaware Secretary of State designating, 21,400 shares as Series

A-2 Prime Preferred Stock, 25,900 shares as Series A-3 Convertible Preferred Stock, 25,700 shares as SeriesA-4 Convertible Preferred Stock,

and 51,600 shares as Series A-5 Convertible Preferred Stock (all such series of preferred stock referred to herein collectively as “Series

A Preferred Stock”), each with a stated value of $ 1,000 per share (the “Original Per Share Price”).

The Amended Certificate

of Designation sets forth the rights, preferences and limitations of the shares of Series A Preferred Stock.

Terms not otherwise defined

in this item shall have the meanings given in the Amended Certificate of Designation.

The Amended Certificate of Designation was filed

with an effective date of March 14, 2024 and the Series A-2 Prime, A-3, A-4, and A-5 Preferred Stock have the following rights, has the

following terms:

At all times following the Issuance Date, while shares of

Series A Preferred Stock are issued and outstanding, holders of Series A Preferred Stock shall be entitled to receive, and the Company

shall pay, dividends on shares of Series A Preferred Stock equal (on an as-if-converted-to-Common-Stock basis and without regard to any

limitations on conversion set forth herein or otherwise) to and in the same form as dividends (other than dividends in the form of Common

Stock, which shall be made in accordance with the terms of the Amended Certificate of Designation) actually paid on shares of the Common

Stock when, as and if such dividends (other than dividends in the form of Common Stock, which shall be made in accordance with the terms

of the Amended Certificate of Designation) are paid on shares of the Common Stock.

Voting Rights.

Subject to certain limitations described in the Amended

Certificate of Designation, the Series A Preferred Stock is voting stock.

Holders of the Series A Preferred Stock are entitled to vote

together with the Common Stock on an as-if-converted-to-Common-Stock basis.

Holders of Common Stock are entitled to one vote for each

share of Common Stock held on all matters submitted to a vote of stockholders.

Accordingly, holders of Series A Preferred Stock will be

entitled to one vote for each whole share of Common Stock into which their Series A Preferred Stock is then-convertible on all matters

submitted to a vote of stockholders.

Upon any Liquidation, the assets of the Company available

for distribution to its stockholders shall be distributed among the holders of the shares of Series A Preferred Stock and Common Stock,

pro rata based on the number of shares held by each such holder, treating for this purpose all shares of Series A Preferred Stock as if

they had been converted to Common Stock pursuant to the terms of the Amended Certificate of Designation immediately prior to such Liquidation,

without regard to any limitations on conversion set forth in the Amended Certificate of Designation or otherwise.

Subject to the limitations set forth in the Amended Certificate

of Designation, at the option of the holder, each share of Series A-2 Prime Preferred Stock, Series A-3 Convertible Preferred Stock, Series

A-4 Convertible Preferred Stock or Series A-5 Convertible Preferred Stock shall be convertible into a number of shares of Common Stock

obtained by dividing the Original Per Share Price ($ 1,000 ) of each such share of Series A-2 Prime Convertible Preferred Stock, Series

A-3Convertible Preferred Stock, Series A-4 Convertible Preferred Stock or Series A-5 Convertible Preferred Stock by the applicable conversion

price of $ 0.49 , $ 0.54 ,$ 0.59 and $ 0.74 for the Series A-2 Prime Convertible Preferred Stock, Series A-3 Convertible Preferred Stock, Series

A-4 Convertible Preferred Stock or Series A-5 Convertible Preferred Stock, respectively.

Issuance of Series B-1 Preferred Stock and Series B-2 Preferred

On March 13, 2024, the Company signed a securities

purchase agreement with certain healthcare-focused institutional investors that provided $ 50 million in gross proceeds through a private

Pursuant to the securities purchase agreement, the Company issued to institutional investors $ 50.0 million in shares of Series

B-1 Convertible Preferred Stock.

50,000 Shares of Series B-1 Convertible Preferred Stock were issued at a price of $ 1,000.00 per share

and each share is convertible into shares of common stock at a rate equal to the initial $ 1,000 purchase price divided by the initial

conversion price of $ 1.00 per share.

Pursuant to the Certificate of Designation of Preferences, Rights and

Limitations of the Series B Convertible Preferred Stock filed with the Delaware Secretary of State on March 14, 2024, as corrected by

the Certificate of Correction to Series B Certificate of Designation filed with the Delaware Secretary of State on November 8, 2024 (the

“Series B Certificate of Designation”), each share of Series B-1 Preferred Stock is, subject to approval of the Company’s

stockholders, convertible into shares of common stock of the Company and, if applicable, shares of Series B-2 Convertible Preferred Stock

(the “Series B-2 Preferred Stock”), in lieu of common stock.

The Company has designated 50,000 shares of Series A-1 Preferred Stock

and 50,000 shares of Series B-2 Preferred Stock.

The Series B Certificate of Designation states that, to the extent that the conversion

of the Series B-1 preferred stock results in a beneficial ownership interest in excess of the maximum percentage of common stock upon

conversion, the holders will receive them as converted equivalent for the remaining shares in preferred stock.

On June 20, 2024, The Company held its annual

stockholder meeting, and as a result, stockholder approval for the conversion of the Series B-1 Convertible Preferred Stock was obtained.

On July 5, 2024, pursuant to the Certificate of Designation of Preferences, Rights and Limitations of the Series B Convertible Preferred

Stock, the Company issued 42,118,000 shares of common stock and 7,882 shares of Series B-2 preferred stock in settlement of the automatic

conversion of the Series B-1Convertible Preferred Stock.

The Series B-1 Preferred Stock have the following rights:

Prior to the receiving Stockholder Approval, dividends will

accrue, on all issued and outstanding shares of Series A-1 Preferred Stock, prior to and in preference to all other shares of capital

stock of the Company, at an annual rate of eight percent ( 8 %) compounded annually on the original per share price (plus any such accreted

compounded amounts);

provided that such annual dividend rate shall increase to fourteen percent ( 14 %) if Stockholder Approval is not obtained

at the first meeting of stockholders following the date of the Preferred Stock offering.

If such dividends are not declared and paid in

cash, the dividend amounts will be added to the aggregate liquidation preference then outstanding of the Series B-1 Preferred Stock.

all times following the Issuance Date, while shares of Series B-1 Preferred Stock are issued and outstanding, holders of Series B Preferred

Stock shall be entitled to receive, and the Company shall pay, dividends on shares of Series B-1 Preferred Stock equal (on an as-if-converted-to-Common-Stock

basis and without regard to any limitations on conversion set forth herein or otherwise)to and in the same form as dividends (other than

dividends in the form of Common Stock, which shall be made in accordance with the terms of the Series B Certificate of Designation) actually

paid on shares of the Common Stock when, as and if such dividends (other than dividends in the form of Common Stock, which shall be made

in accordance with the terms of the Series B Certificate of Designation) are paid on shares of the Common Stock.

Stockholder approval

was received on June 20, 2024.

Subject to certain limitations described in the Series B

Certificate of Designation holders of the Series B-1 Preferred Stock are entitled to vote together with the common stock on an as-if-converted-to-common-stock

basis as determined by dividing the liquidation preference with respect to such shares of Series B-1Preferred Stock by the conversion

Holders of common stock are entitled to one vote for each share of common stock held on all matters submitted to a vote of stockholders.

Unless and until the Company has obtained the Stockholder Approval, the number of shares of Common Stock that shall be deemed issued upon

conversion of the Series B Preferred Stock (for purposes of calculating the number of aggregate votes that the holders of Series B Preferred

Stock are entitled to on an as-converted basis) will be equal to that number of shares equal to 19.9 % of the Company’s outstanding

Common Stock as of the Signing Date (excluding for purposes of the calculation, any securities issued on the Signing Date) (the “Cap”),

which each such holder being able to vote the number of shares of Series B Preferred Stock held by it relative to the total number of

shares of Series B Preferred Stock then outstanding multiplied by the Cap.

Notwithstanding the foregoing, the holders of the Series B

Preferred Stock are not entitled to vote together with the Common Stock on an as-if-converted-to-Common-Stock-basis with regard to the

approval of the issuance of Common Stock upon conversion of the Series B Preferred Stock.

On the tenth trading day following the announcement of the Stockholder

Approval, each share of Series B-1 Preferred Stock shall automatically convert into a unit consisting of:

(1) the number of shares of

common stock equal to the quotient of (A) the liquidation preference with respect to such share of Series B-1 Preferred Stock, divided

by (B) the conversion price, provided that, to the extent the share conversion would cause such Holder’s beneficial ownership to

exceed 9.99 %, such holder shall receive shares of Series B-2 Preferred Stock in lieu of common stock, on a one-for-one basis, with respect

to the number of shares of common stock that exceed 9.99 % ownership divided by 1,000 .

Liquidation Preference:

The Series A-1 Preferred

Stock shall have a liquidation preference of one-times the original per share price of $ 1,000 per share, plus any accrued but unpaid

dividends thereon, whether or not declared, subject to certain customary anti-dilution adjustments.

The Series A-2, A-3, A-4, and A-5 Preferred Stock

have the following rights:

While shares of Series A Preferred

Stock are issued and outstanding, holders of Series A Preferred Stock shall be entitled to receive, and the Corporation shall pay, dividends

on shares of Series A Preferred Stock equal (on an as-if-converted-to-Common-Stock basis) and in the same form as dividends (other than

dividends in the form of Common Stock) actually paid on shares of the Common Stock when, as and if such dividends are paid on shares

of the Common Stock.

Holders of the Series A-2, A-3, A-4,

and A-5 Preferred Stock are entitled to vote together with the common stock on an as-if-converted-to-common-stock basis as determined

by dividing the liquidation preference with respect to such shares of Preferred Stock by the conversion price.

Holders of common stock

are entitled to one vote for each share of common stock held on all matters submitted to a vote of stockholders.

Accordingly, holders

of Series A Preferred Stock will be entitled to one vote for each whole share of Common Stock into which their Series A Preferred Stock

is then-convertible on all matters submitted to a vote of stockholders.

At the option of the holder thereof, each share

of Series A-2 Preferred Stock, Series A-3 Preferred Stock, Series A-4 Preferred Stock, or Series A-5 Preferred Stock shall be convertible

into one share of common stock.

The Series B-1 Preferred Stock had a liquidation

preference of one-times the original per share price of $ 1,000 per share, plus any accrued but unpaid dividends thereon, whether or not

declared, subject to certain customary anti-dilution adjustments.

The Series B-2 Preferred Stock has the following rights:

Dividends will accrue, on all issued and outstanding shares

of Series B-2 Preferred Stock, prior to and in preference to all other shares of capital stock of the Company, at an annual rate of eight

percent ( 8 %) compounded annually on the original per share price (plus any such accreted compounded amounts).

If such dividends are not

declared and paid in cash, the dividend amounts will be added to the aggregate liquidation preference then outstanding.

Subject to certain limitations described in the Series B Certificate

of Designation, the Series B-2 Preferred Stock is voting stock.

Holders of the Series B-2 Preferred Stock are entitled to vote together

with the common stock on an as-if-converted-to-common-stock basis.

Holders of common stock are entitled to one vote for each share of

common stock held on all matters submitted to a vote of stockholders.

Accordingly, holders of Series B-2 Preferred Stock will be entitled

to one vote for each whole share of common stock into which their Series B-2 Preferred Stock is then-convertible on all matters submitted

to a vote of stockholders.

Upon any Liquidation, the assets of the Company available

for distribution to its stockholders shall be distributed among the holders of the shares of Series B Preferred Stock and common stock,

pro rata based on the number of shares held by each such holder, treating for this purpose all shares of Series B Preferred Stock as if

they had been converted to common stock pursuant to the terms of the Certificate of Designation immediately prior to such Liquidation,

without regard to any limitations on conversion set forth in the Series B Certificate of Designation or otherwise.

Subject to the limitations set forth in the Series B Certificate

of Designation, at the option of the holder thereof, each share of Series B-2 Preferred Stock, is convertible into the number of shares

of common stock equal to the quotient of (A) the stated value ($ 1,000 ), divided by (B) the conversion price of $ 1.00 .

Warrant Liability

In connection with the Preferred Stock Offering

(see Note 10), the Company issued the Warrants.

After the Warrants were legally issued as a result

of the automatic conversion of the Series A-1 Preferred Stock upon shareholder approval, they became immediately exercisable at the option

of the holder.

The Company determined that the Warrants, while still contingently issuable, qualified as derivative instruments pursuant

to ASC 815-40, Contracts in an Entity’s Own Equity and that the Warrants were considered issued for accounting purposes

concurrently with the Series A-1 Preferred Stock.

On June 26, 2023, the Company held its annual

shareholder meeting, and as a result, shareholder approval for the conversion of the Series A-1 Preferred Stock was obtained.

11, 2023, pursuant to the Certificate of Designation, the Company issued, in addition to common stock and Series A-2 Preferred Stock,

(i) a Tranche A Warrant to acquire 47,852,430 shares of Series A-3 Preferred Stock, (ii) a Tranche B Warrant to acquire 43,502,206 shares

of Series A-4 Preferred Stock, and (iii) a Tranche C Warrant to acquire 69,603,531 shares of Series A-5 Preferred Stock.

The Warrants are recognized as liabilities in

the balance sheets and were initially recognized at fair value at the time of issuance.

The Warrants are also subject to remeasurement

at each balance sheet date after issuance.

Any change in fair value is recognized as a component of other income (expense) in the statements

of operations in the period of change.

The valuation of the Warrants contains unobservable

inputs that reflect the Company’s own assumptions for which there is little market data.

Accordingly, the Warrants are measured

at fair value on a recurring basis using unobservable inputs and are classified as Level 3 inputs.

The significant unobservable inputs

used in the fair value measurement of the Company’s Warrants include, but are not limited to, probability of obtaining certain

shareholder approvals, probability of reaching certain technical milestones related to the development of Oxylanthanum Carbonate, and

the estimated term of the Warrants.

Significant increases (decreases) in any of those inputs in isolation would result in a significantly

higher (lower) fair value measurement.

Generally, a change in the assumption used for the probability of obtaining certain shareholder

approvals is not correlated to a change in the probability of reaching certain technical milestones.

However, a change to the assumption

used for the probability of obtaining certain shareholder approvals or a change in the probability of reaching certain technical milestones

would have been accompanied by a directionally opposite change and a directionally similar change, respectively, in the assumption used

for the estimated term.

The fair value of the contingently issuable Warrants

associated with the Company’s March 2023 private placement transaction was determined as of March 3, 2023, and March 31, 2023,

by using a Monte Carlo simulation technique (“MCS”) to value the embedded derivatives associated with the Warrants.

methodology calculates the theoretical value of a warrant based on certain parameters, including:

(i) the threshold of exercising the

warrant, (ii) the price of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the

underlying security, (v) the risk-free rate, (vi) the number of paths, (vii) estimated probability assumptions surrounding shareholder

approval as well as the achievement by the Company of technical milestones associated with regulatory and commercial progress, and (viii)

an estimated discount for lack of marketability.

The MCS valuation model was used for the valuation

performed as of the transaction inception on March 3, 2023, and on March 31, 2023, due to uncertainty in the timing of shareholder approval

and the potential variability in the Warrant exercise price.

On June 26, 2023, the Company held its annual shareholder meeting, and as

a result, shareholder approval for the issuance of common shares upon the conversion of the Series A-1 Preferred Stock was obtained and

the exercise price for the Warrants became fixed.

Therefore, as of December 31, 2023, the fair value of the Warrants was determined using

In connection with the Series A-1 Preferred Stock Offering (see Note

10), the Company issued the Warrants.

After the Warrants were legally issued as a result of the automatic

conversion of the Series A-1 Preferred Stock upon shareholder approval, they became immediately exercisable at the option of the holder.

The Company determined that the Warrants, while still contingently issuable, qualified as derivative instruments pursuant to ASC 815-40,

Contracts in an Entity’s Own Equity and that the Warrants were considered issued for accounting purposes concurrently with

the Series A-1 Preferred Stock.

On June 26, 2023, the Company held its annual shareholder meeting,

and as a result, shareholder approval for the conversion of the Series A-1 Preferred Stock was obtained.

On July 11, 2023, pursuant to

the Certificate of Designation, the Company issued, in addition to common stock and Series A-2 Preferred Stock, (i) Tranche A Warrants

to acquire 47,852,430 shares of Series A-3 Preferred Stock, (ii) Tranche B Warrants to acquire 43,502,206 shares of Series A-4 Preferred

Stock, and (iii) Tranche C Warrants to acquire 69,603,531 shares of Series A-5 Preferred Stock.

On March 13, 2024 the Company and each Investor

amended and restated the following warrants:

(i) tranche A warrants to acquire an aggregate of 47,852,430 shares of Series A-3 Convertible

Preferred Stock of the Company convertible into 47,852,430 shares of common stock that were issued on July 11 2023 (the “Original

Tranche A Warrants”) have been amended and restated to acquire an aggregate of 25,840.3122 shares of Series A-3 Convertible Preferred

Stock (as amended, the “Amended Tranche A Warrants”) convertible into 47,852,430 shares of common stock;

(ii) tranche B warrants

to acquire an aggregate of 43,502,206 shares of Series A-4 Convertible Preferred Stock of the Company convertible into 43,502,206 shares

of common stock that were issued on July 11, 2023 (the “Original Tranche B Warrants”) have been amended and restated to acquire

an aggregate of 25,666.30154 shares of Series A-4 Convertible Preferred Stock (as amended, the “Amended Tranche B Warrants”)

convertible into 43,502,206 shares of common stock and (iii) tranche C warrants to acquire an aggregate of 69,603,531 shares of Series

A-5 Convertible Preferred Stock of the Company convertible into 69,603,531 shares of common stock that were issued on July 11, 2023 (the

“Original Tranche C Warrants”, and together with the Original Tranche A Warrants and Tranche B Warrants, the “Original

Warrants”) have been amended and restated to acquire 51,506.61294 shares of Series A-5 Convertible Preferred Stock (as amended,

the “Amended Tranche C Warrants,” together with the Amended Tranche A Warrants and the Amended Tranche B Warrants, the “Amended

Warrants”) convertible into 69,603,351 shares of common stock.

The Amended Warrants have the same terms and conditions as the original

warrants except that such Amended Warrants:

(i) reduced the amount of shares of Series A-3 Convertible Preferred Stock, Series A-4 Convertible

Preferred Stock and Series A-5 Convertible Preferred Stock into which such Amended Warrants are convertible as described above;

for the issuance of fractional shares of Series A-3 Preferred Stock, Series A-4 Preferred Stock and Series A-5 Preferred Stock, as applicable

upon exercise of such Amended Warrants and (ii) revised the exercise price to be $ 1,000 per share of Series A-3 Preferred Stock, Series

A-4 Preferred Stock and Series A-5 Preferred Stock, as applicable in such Amended Warrants.

The aggregate exercise price, the amount of

shares of Common Stock upon conversion of the Series A-3 Preferred Stock, the Series A-4 Preferred Stock and the Series A-5 Preferred

Stock and exercise period in the Amended Warrants did not change from the Original Warrants.

The Warrants are recognized as liabilities in the balance sheets and

were initially recognized at fair value at the time of issuance.

The Warrants are also subject to remeasurement at each balance sheet

date after issuance.

Any change in fair value is recognized as a component of other income (expense) in the statements of operations in

the period of change.

The valuation of the Warrants contains unobservable inputs that reflect

the Company’s own assumptions for which there is little market data.

Accordingly, the Warrants are measured at fair value on a recurring

basis using unobservable inputs and are classified as Level 3 inputs.

The significant unobservable inputs used in the fair value measurement

of the Company’s Warrants include, but are not limited to, probability of obtaining certain shareholder approvals, probability of

reaching certain technical milestones related to the development of Oxylanthanum Carbonate, and the estimated term of the Warrants.

increases (decreases) in any of those inputs in isolation would result in a significantly higher (lower) fair value measurement.

a change in the assumption used for the probability of obtaining certain shareholder approvals is not correlated to a change in the probability

of reaching certain technical milestones.

However, a change to the assumption used for the probability of obtaining certain shareholder

approvals or a change in the probability of reaching certain technical milestones would have been accompanied by a directionally opposite

change and a directionally similar change, respectively, in the assumption used for the estimated term.

The fair value of the contingently issuable Warrants associated with

the Company’s March 2023 private placement transaction was determined as of March 3, 2023, and March 31, 2023, by using a Monte

Carlo simulation technique (“MCS”) to value the embedded derivatives associated with the Warrants.

The MCS methodology calculates

the theoretical value of a warrant based on certain parameters, including:

(i) the threshold of exercising the warrant, (ii) the price

of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying security, (v)

the risk-free rate, (vi) the number of paths, (vii) estimated probability assumptions surrounding shareholder approval as well as the

achievement by the Company of technical milestones associated with regulatory and commercial progress, and (viii) an estimated discount

for lack of marketability.

The MCS valuation model was used for the valuation performed as of

the transaction inception on March 3, 2023, and on March 31, 2023, due to uncertainty in the timing of shareholder approval and the potential

variability in the Warrant exercise price.

On June 26, 2023, the Company held its annual shareholder meeting, and as a result, shareholder

approval for the issuance of common shares upon the conversion of the Series A-1 Preferred Stock was obtained and the exercise price for

the Warrants became fixed.

Therefore, as of December 31, 2023 and December 31, 2024, the fair value of the Warrants was determined using

a Black Scholes model using parameters including (i) the exercise price of the warrant, (ii) the price of the underlying security, (iii)

the time to expiration, or expected term, (iv) the expected volatility of the underlying security, (v) the risk-free rate, and (vi) estimated

probability assumptions surrounding the achievement by the Company of technical milestones associated with regulatory and commercial

These valuation techniques involve management’s

estimates and judgment based on unobservable inputs and are classified in Level 3.

The fair value estimates may not be indicative of

the amounts that would be realized in a market exchange.

Additionally, there may be inherent uncertainties or changes in the underlying

assumptions used, which could significantly affect the current or future fair value estimates.

Generally, a significant increase (decrease)

in the probabilities of shareholder approval and the achievement of technical milestones would have resulted in a significantly higher

(lower) fair value measurement;

however, changes in other inputs such as expected term and price of the underlying common stock will

have a directionally opposite impact on fair value measurement.

The Company uses a third-party valuation expert

to assist in the determination of the fair value of the Warrants.

The tables below summarize the valuation inputs into the Black Scholes

model for the liability associated with the three tranches of Warrants at December 31, 2023.

probability assumptions surrounding the achievement by the Company of technical milestones associated with regulatory and commercial progress.

These valuation techniques involve management’s estimates and

judgment based on unobservable inputs and are classified in Level 3.

The fair value estimates may not be indicative of the amounts that

would be realized in a market exchange.

Additionally, there may be inherent uncertainties or changes in the underlying assumptions used,

which could significantly affect the current or future fair value estimates.

Generally, a significant increase (decrease) in the probabilities

of shareholder approval and the achievement of technical milestones would have resulted in a significantly higher (lower) fair value measurement;

however, changes in other inputs such as expected term and price of the underlying common stock will have a directionally opposite impact

on fair value measurement.

The Company uses a third-party valuation expert to assist in the determination

of the fair value of the Warrants.

The tables below summarize the valuation inputs into the Black Scholes model for the liability associated

with the three tranches of Warrants at December 31, 2023, and December 31, 2024.

Tranche A Warrant

At December 31,

Fair value of underlying stock

1 unchanged sentence

96.5 % – 139.2 %

105.4 % – 111.3 %

Risk free rate

4.6 % – 5.3 %

Dividend yield

2 unchanged sentences

Probability for FDA approval

38.48 % - 39.29 %

Tranche B Warrant

At December 31,

Fair value of underlying stock

1 unchanged sentence

114.6 % – 139.2 %

105.4 % – 125.2 %

Risk free rate

4.4 % – 4.8 %

Dividend yield

2 unchanged sentences

Probability for FDA approval

Tranche C Warrant

At December 31,

Fair value of underlying stock

1 unchanged sentence

107.8 % – 114.6 %

105.4 % – 125.2 %

Risk free rate

4.0 % – 4.4 %

Dividend yield

2 unchanged sentences

Probability for FDA approval

As of the issuance date (March 3, 2023), the

Company estimated the fair value of the Warrants to be $ 2.8 million.

As of December 31, 2023, the Company estimated the fair value of

the Warrants to be $ 13.1 million.

The following table summarizes activity for the

Company’s Warrants for the year ended December 31, 2023 (includes the conversion effect in the liquidation preference of accrued

(in thousands)

4.3 % - 12.5 %

As of the issuance date March 3, 2023, the Company estimated the fair

value of the Warrants to be $ 2.8 million.

As of December 31, 2023, the Company estimated the fair value of the Warrants to be $ 13.1 million.

As of December 31, 2024, the Company estimated the fair value of the Warrants to be $ 18.9 million.

The following table summarizes activity for the Company’s Warrants

for the year ended December 31, 2024 (includes the conversion effect in the liquidation preference of accrued dividends):

Number of Average

Shares Weighted- Remaining Aggregate

Underlying Average Contractual Intrinsic

Outstanding Exercise Term Value

Warrants Price (in Years) (in thousands)

Outstanding, December 31, 2023 -

3 unchanged sentences

Stock-based Compensation

On July 15, 2021, in connection with the completion

of the Company’s IPO, the Company adopted a new comprehensive equity incentive plan, the 2021 Omnibus Equity Incentive Plan (the

“2021 Plan”).

Following the effective date of the 2021 Plan, no further awards may be issued under the 2018 Plan or the 2019

Plan (collectively, the “Prior Plans”).

However, all awards under the Prior Plans that are outstanding as of the effective

date of the 2021 Plan will continue to be governed by the terms, conditions and procedures set forth in the Prior Plans and any applicable

award agreements.

A total of 1,302,326 shares of common stock were reserved for issuance pursuant to the 2021 Plan prior to our annual

meeting on June 26, 2023.

Shareholders approved an increase to the number of shares reserved on June 26, 2023, and accordingly, at December

31, 2023, approximately 12,775,996 shares are reserved for issuance.

The 2021 Plan provides for the issuance of incentive stock options,

non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock-based awards.

December 31, 2022, approximately 389,676 shares of common stock were available under the 2021 Plan.

As of December 31, 2023, there are

approximately 2,815,503 shares of common stock available under the 2021 Plan.

The following table summarizes activity for stock

options under all plans for the year ended December 31, 2023:

(in thousands)

On July 15, 2021, in connection with the completion of the Company’s

IPO, the Company adopted a new comprehensive equity incentive plan, the 2021 Omnibus Equity Incentive Plan (the “2021 Plan”).

Following the effective date of the 2021 Plan, no further awards may be issued under the 2018 Plan or the 2019 Plan (collectively, the

“Prior Plans”).

However, all awards under the Prior Plans that are outstanding as of the effective date of the 2021 Plan will

continue to be governed by the terms, conditions and procedures set forth in the Prior Plans and any applicable award agreements.

of 1,302,326 shares of common stock were reserved for issuance pursuant to the 2021 Plan prior to our annual meeting on June 26, 2023.

Shareholders approved an increase to the number of shares reserved on June 26, 2023, and accordingly, at December 31, 2023, approximately

12,775,996 shares were reserved for issuance.

On June 20, 2024, shareholders approved a further increase of 8,000,000 shares, to the number

of shares reserved, for a total of 20,775,996 shares.

The 2021 Plan provides for the issuance of incentive stock options, non-statutory

stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock-based awards.

As of December 31, 2023,

approximately 2,815,503 shares of common stock were available under the 2021 Plan.

As of December 31, 2024, there are approximately 7,433,327

shares of common stock available under the 2021 Plan.

The following table summarizes activity for stock options under all

plans for the year ended December 31, 2024:

Number of Average

Shares Weighted- Remaining Aggregate

Underlying Average Contractual Intrinsic

Outstanding Exercise Term Value

Options Price (in Years) (in thousands)

Outstanding, December 31, 2023 10,302,086 $ 1.00 9.34 $ 1,196

4 unchanged sentences

Options vested and exercisable as of December 31, 2024 5,231,799 $ 1.23 8.11 $ 243

The grant date fair value of options granted

during the year ended December 31, 2023 was $ 5.7 million.

As of December 31, 2023, the unrecognized compensation

cost related to outstanding stock options was $ 5 million, which is expected to be recognized as expense over approximately 2.9 years.

During August 2023, the Company granted a consultant

10,000 restricted stock units with a grant date fair value of $ 7,500 , resulting in a fair value per share of $ 0.75 .

Subject to the consultant’s

continued service, the restricted stock units shall vest upon the two-year anniversary of the date of grant.

As of December 31, 2023,

the unrecognized compensation cost related to the grant was approximately $ 4,000 , which is expected to be recognized as expense over

approximately 15 months.

During the year ended December 31, 2021, employees

and consultants exercised a total of 383,721 stock options and the Company received $ 119,000 in proceeds.

A portion of these options

were exercised early (prior to vesting), and as of December 31, 2023, 1,357 of the options remained unvested.

Proceeds received related

to the unvested options of approximately $ 4,000 at December 31, 2023 were included in accrued liabilities on the accompanying balance

sheet and will be reclassified to equity as vesting occurs, provided the employees and consultants continue to provide services to the

Proceeds received related to the vested portion of options of $ 27,000 were reclassified to equity during the year ended December

The vested portion of the exercises was 382,364 shares at December 31, 2023.

During May 2022, the Company granted a consultant

10,000 restricted stock units with a grant date fair value of $ 7,200 , resulting in a fair value per share of $ 0.72 .

Subject to the consultant’s

continued service, the restricted stock units shall vest upon the two-year anniversary of the date of grant.

As of December 31, 2023,

the unrecognized compensation cost related to the grant was approximately $ 1,000 , which is expected to be recognized as expense over

approximately 5 months.

During July 2021, the Company granted a director

26,738 restricted stock units with a grant date fair value of $ 100,000 , resulting in a fair value per share of $ 3.74 .

The restricted

stock units vested in July 2022.

The grant date fair value of options granted during the year ended

December 31, 2024, was $ 2.8 million.

As of December 31, 2024, the unrecognized compensation cost related

to outstanding stock options was $ 5.5 million, which is expected to be recognized as expense over approximately 4.0 years.

During the year ended December 31, 2021, employees and consultants

exercised a total of 383,721 stock options and the Company received $ 119,000 in proceeds.

A portion of these options were exercised early

(prior to vesting), and as of September 30, 2024, none of the options remained unvested.

Proceeds received related to the vested portion

of options of $ 2,500 were reclassified to equity during the year ended December 31, 2024.

During May 2022, the Company granted a consultant 10,000 restricted

stock units with a grant date fair value of $ 7,200 , resulting in a fair value per share of $ 0.72 .

The restricted stock units vested in

During August 2023, the Company granted a consultant 10,000 restricted

stock units with a grant date fair value of $ 7,500 , resulting in a fair value per share of $ 0.75 .

The restricted stock units will vest

in March 2025.

During August 2024, the Company granted a consultant 11,765 restricted

stock units with a grant date fair value of $ 4,000 , resulting in a fair value per share of $ 0.34 .

The restricted stock units will vest

in August 2026.

The Company has recorded stock-based compensation

5 unchanged sentences

Fair Value of Stock Options

The assumptions are based on the following for

each of the periods presented:

Expected Term - The expected

term is calculated using the simplified method which is used when there is insufficient historical data about exercise patterns and post-vesting

employment termination behavior.

The simplified method is based on the vesting period and the contractual term for each grant, or for

each vesting-tranche for awards with graded vesting.

The mid-point between the vesting date and the maximum contractual expiration

date is used as the expected term under this method.

Common Stock Fair Value - The

fair value of the common stock underlying the Company’s stock options prior to the initial public offering was estimated at each

grant date and was determined on a periodic basis and based either on transactions with third parties in which common stock was sold

for cash or with the assistance of an independent third-party valuation expert.

Subsequent to our initial public offering, the fair value

underlying the Company’s common stock is determined based on the public market closing price on each date of grant.

The assumptions

underlying these valuations represented management’s best estimates, which involved inherent uncertainties and the application

of significant levels of management judgment.

Volatility - The expected volatility

being used is derived from the historical stock volatilities of a representative industry peer group of comparable publicly listed companies

over a period approximately equal to the expected term of the options.

Risk-free Interest Rate - The

risk-free interest rate is based on median U.S.

Treasury zero coupon issues with remaining terms similar to the expected term on the

Expected Dividend – Through

December 31, 2023, the Company has never declared nor paid any cash dividends.

The Company shall modify its dividend policy to state

that the Company intends to pay dividends to all stockholders, including holders of Series A Preferred Stock on an as-if-converted-to-common-stock

basis, on a quarterly basis in an amount of which the aggregate of all quarterly dividends shall equal at least seventy-five percent

( 75 %) of its annual net cash flow from operations following the approval of Oxylanthanum Carbonate by the FDA if obtained, and the commencement

of commercial sales.

The following averaged assumptions were used

to calculate the fair value of awards granted to employees, directors and non-employees for the years ended December 31, 2022 and 2023:

The assumptions are based on the following for each of the periods

Expected Term - The expected term is calculated using the simplified

method which is used when there is insufficient historical data about exercise patterns and post-vesting employment termination behavior.

The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting-tranche for awards with

graded vesting.

The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term

under this method.

Common Stock Fair Value - The fair value of the common stock

underlying the Company’s stock options prior to the initial public offering was estimated at each grant date and was determined

on a periodic basis and based either on transactions with third parties in which common stock was sold for cash or with the assistance

of an independent third-party valuation expert.

Subsequent to our initial public offering, the fair value underlying the Company’s

common stock is determined based on the public market closing price on each date of grant.

The assumptions underlying these valuations

represented management’s best estimates, which involved inherent uncertainties and the application of significant levels of management

Volatility - The expected volatility being used is derived from

the historical stock volatilities of a representative industry peer group of comparable publicly listed companies over a period approximately

equal to the expected term of the options.

Risk-free Interest Rate - The risk-free interest rate is based

on median U.S.

Treasury zero coupon issues with remaining terms similar to the expected term on the options.

Expected Dividend – Through December 31, 2024, the Company

has never declared nor paid any cash dividends.

The Company shall modify its dividend policy to state that the Company intends to pay

dividends to all stockholders, including holders of Series A Preferred Stock on an as-if-converted-to-common-stock basis, on a quarterly

basis in an amount of which the aggregate of all quarterly dividends shall equal at least seventy-five percent ( 75 %) of its annual net

cash flow from operations following the approval of Oxylanthanum Carbonate by the FDA if obtained, and the commencement of commercial

The following average assumptions were used to

calculate the fair value of awards granted to employees, directors and non-employees for the years ended December 31, 2023, and 2024:

Ended December 31,

Expected volatility

104.00 – 108.00 %

104.00 – 108.00

Risk-free interest rate

4.35 – 4.37 %

3.78 – 4.65 %

Dividend yield

1 unchanged sentence

5.50 - 6.25 years

A reconciliation of the provision for income

taxes to the amount computed by applying the statutory income tax rate of 21 % to the net loss is summarized for the years ended December

A reconciliation of the provision for income taxes

to the amount computed by applying the statutory income tax rate of 21 % to the net loss is summarized for the years ended December 31,

2023, and 2024 is as follows:

December 31, 2023

December 31, 2024

Income taxes (benefit) at statutory rates

3 unchanged sentences

Effective income tax rate

For the years ended December 31, 2022 and 2023,

the Company did not record a deferred income tax expense or benefit.

Income tax expense has been nominal for the years ended December

31, 2022 and 2023.

Deferred tax assets and liabilities are recognized

for the expected tax consequences attributable to the differences between financial reporting and the tax basis of existing assets and

liabilities and operating loss carryforward, and they are measured using enacted tax rates expected to be in effect when differences

are expected to reverse.

A valuation allowance is recorded for loss carryforwards and other deferred tax assets where it is more likely

than not that such loss carryforward and deferred tax asset will not be realized.

Significant components of the Company’s deferred

tax assets at December 31, 2022 and 2023 are shown below (in thousands):

For the years ended December 31, 2023 and 2024, the Company did not

record a deferred income tax expense or benefit.

Income tax expense has been nominal for the years ended December 31, 2023 and 2024.

Deferred tax assets and liabilities are recognized for the expected

tax consequences attributable to the differences between financial reporting and the tax basis of existing assets and liabilities and

operating loss carryforward, and they are measured using enacted tax rates expected to be in effect when differences are expected to reverse.

A valuation allowance is recorded for loss carryforwards and other deferred tax assets where it is more likely than not that such loss

carryforward and deferred tax asset will not be realized.

Significant components of the Company’s deferred tax assets at December

31, 2023 and 2024 are shown below (in thousands):

Deferred tax assets:

16 unchanged sentences

has established a full valuation allowance against its Federal and state deferred tax assets.

As of December 31, 2023, the Company had available

Federal and state net operating loss carryforwards of approximately $ 24.7 million and $ 11.6 million, respectively, to reduce future taxable

income, if any.

Federal net operating losses generated prior to 2018 and all state net operating losses generated expire in varying amounts

beginning in 2037.

The net operating losses generated after 2017 do not expire and will be able to offset 80 % of taxable income generated

in the future.

As of December 31, 2023, the Company had research

and development credit carryforwards of approximately $ 629,000 and $ 398,000 available to reduce future taxable income, if any, for federal

and state income tax purposes, respectively.

As of December 31, 2024, the Company had available Federal and state

net operating loss carryforwards of approximately $ 39.2 million and $ 40.0 million, respectively, to reduce future taxable income, if any.

Federal net operating losses generated prior to 2018 and all state net operating losses generated expire in varying amounts beginning

The net operating losses generated after 2017 do not expire and will be able to offset 80 % of taxable income generated in the

As of December 31, 2024, the Company had research and development credit

carryforwards of approximately $ 1,353,000 and $ 631,000 available to reduce future taxable income, if any, for federal and state income

tax purposes, respectively.

These credits have been provided a full reserve under ASC 740-10.

The federal credit carryforwards

begin to expire in 2037, and the state credit carryforwards can be carried forward indefinitely.

Utilization of net operating losses and tax credits

may be subject to an annual limitation due to ownership change limitations provided in the Internal Revenue Code of 1986, as amended

(the “Code”), and similar state provisions.

The effect of an ownership change would be the imposition of annual limitation

on the use of net operating loss (“NOL”) carryforwards attributable to periods before the change in ownership.

An assessment

of such ownership changes under Section 382 of the Code was not completed through December 31, 2023, and as such the Company is not able

to determine the impact on the NOLs and tax credit carryforwards, if any, as of the date of the financial statements.

To the extent that

an assessment is completed in the future, the Company’s ability to utilize tax attributes could be restricted on a year-by-year

basis and certain attributes could expire before they are utilized.

The Company applies the guidance under ASC 740,

subtopic 10-50-15, Unrecognized Tax Benefit Related Disclosures (formerly FASB Interpretation 48, Accounting for Uncertainty in Income

For benefits to be realized, a tax position must be more likely than not to be sustained upon examination by tax authorities.

The amount recognized is measured as the largest amount of benefit that is greater than 50 % likely of being realized upon settlement.

This interpretation also provides guidance on measurement, de-recognition, classification, interest and penalties.

The following table summarizes the changes to

the Company’s gross unrecognized tax benefits for the years ended December 31, 2022 and 2023 (in thousands):

The federal credit carryforwards begin to

expire in 2037, and the state credit carryforwards can be carried forward indefinitely.

Utilization of net operating losses and tax credits may be subject

to an annual limitation due to ownership change limitations provided in the Internal Revenue Code of 1986, as amended (the “Code”),

and similar state provisions.

The effect of an ownership change would be the imposition of annual limitation on the use of net operating

loss (“NOL”) carryforwards attributable to periods before the change in ownership.

An assessment of such ownership changes

under Section 382 of the Code was not completed through December 31, 2024, and as such the Company is not able to determine the impact

on the NOLs and tax credit carryforwards, if any, as of the date of the financial statements.

To the extent that an assessment is completed

in the future, the Company’s ability to utilize tax attributes could be restricted on a year-by-year basis and certain attributes

could expire before they are utilized.

The Company applies the guidance under ASC 740, subtopic 10-50-15,

Unrecognized Tax Benefit Related Disclosures (formerly FASB Interpretation 48, Accounting for Uncertainty in Income Taxes).

to be realized, a tax position must be more likely than not to be sustained upon examination by tax authorities.

The amount recognized

is measured as the largest amount of benefit that is greater than 50 % likely of being realized upon settlement.

This interpretation also

provides guidance on measurement, de-recognition, classification, interest and penalties.

The following table summarizes the changes to the Company’s gross

unrecognized tax benefits for the years ended December 31, 2023 and 2024 (in thousands):

Beginning balance

2 unchanged sentences

Ending balance

As of December 31, 2022 and 2023, the total unrecognized

tax benefit was approximately $ 0.7 million and $ 1.0 million, respectively.

The Company does not expect any material changes to the estimated

amount of liability associated with its uncertain tax positions within the next 12 months.

The Company’s policy is to recognize

interest and penalties related to uncertain tax positions in income tax expense.

As of December 31, 2023, the Company had no accrued

interest and penalties related to uncertain tax positions.

As of December 31, 2023 and 2024, the total unrecognized tax benefit

was approximately $ 1.0 million and $ 2.0 million, respectively.

The Company does not expect any material changes to the estimated amount

of liability associated with its uncertain tax positions within the next 12 months.

The Company’s policy is to recognize interest

and penalties related to uncertain tax positions in income tax expense.

As of December 31, 2024, the Company had no accrued interest and

penalties related to uncertain tax positions.

The Company files U.S.

and state income tax returns

with varying statutes of limitations.

and state income tax returns with varying statutes

of limitations.

Tax years 2018 and forward remain open to examination due to the carryover of NOL carryforwards.

There are no ongoing examinations by taxing authorities at this time.

There are no ongoing

examinations by taxing authorities at this time.

Net loss per share

The Company computes net loss per share using

the two-class method.

The two-class method uses an earnings allocation formula that determines net loss per share for common stock and

any participating securities according to dividends declared and participation rights in undistributed earnings.

Diluted net loss per share includes the potential

dilutive effect of common stock equivalents as if such securities were converted or exercised during the period, when the effect is dilutive.

Common stock equivalents include:

The Company computes net loss per share using the two-class method.

The two-class method uses an earnings allocation formula that determines net loss per share for common stock and any participating securities

according to dividends declared and participation rights in undistributed earnings.

Diluted net loss per share includes the potential dilutive effect of

common stock equivalents as if such securities were converted or exercised during the period, when the effect is dilutive.

equivalents include:

(i) outstanding stock options and restricted stock units;

(ii) common stock to be issued upon the assumed

exercise of the Company’s common stock warrants;

and (iii) prior to issuance, the issuable warrants related to the Company’s

March private placement financing.

Because the impact of these items is generally anti-dilutive during periods of net loss, there is

no difference between basic and diluted income (loss) per common share for periods with net losses.

The following table sets forth the computation

of basic and diluted net loss per share of common and preferred stock (in thousands, except share and per share data):

(ii) common stock to be issued upon the assumed exercise

of the Company’s common stock warrants;

and (iii) prior to issuance, the issuable warrants related to the Company’s March

private placement financing.

Because the impact of these items is generally anti-dilutive during periods of net loss, there is no difference

between basic and diluted income (loss) per common share for periods with net losses.

The following table sets forth the computation of basic and diluted

net loss per share of common and preferred stock (in thousands, except share and per share data):

Deemed dividends on Series A-1 Preferred Stock

Dividends on Series B-1 Preferred Stock

Net loss attributable to common shares, basic and diluted

1 unchanged sentence

Net loss per share attributable to common stockholders, basic and diluted

The following outstanding shares of potentially

dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them

would have been antidilutive:

The following outstanding shares of potentially dilutive securities

were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive:

Options to purchase common stock

2 unchanged sentences

Subsequent Events

On March 13, 2024, the Company signed a securities purchase agreement

with certain healthcare-focused institutional investors that will provide $ 50 million in gross proceeds to Unicycive through a private

Pursuant to the securities purchase agreement,

the Company issued to institutional purchasers $ 50 million in shares of the Company’s Series B Convertible Preferred Stock.

50,000 Shares of Series B Convertible Preferred

Stock were issued at a price of $ 1,000.00 per share with an initial conversion price of $ 1.00 per common share.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON

ACCOUNTING AND FINANCIAL DISCLOSURE

On February 18, 2025, the Company issued 1,400,000 shares of common

stock, upon conversion of 686 shares of the Company’s Series A-2 Prime Preferred Stock.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING

AND FINANCIAL DISCLOSURE

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 8. Financial Statements and Supplementary Data