What changed in this filing

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Item 1. Financial Statements

2022-05-12 compared with 2021-11-12 · 391 added, 372 removed, 398 unchanged (66% of the section changed)

FINANCIAL STATEMENTS

Therapeutics, Inc.

thousands, except for share and per share amounts)

September 30,

Unicycive Therapeutics, Inc.

Balance Sheets

(In thousands, except for share and per share amounts)

Current assets:

Prepaid related party service fee

Deferred offering costs

Prepaid expenses and other current assets

Total current assets

Right of use asset, net

Property, plant and equipment, net

Liabilities and stockholders’ (deficit) equity

1 unchanged sentence

Accounts payable

Related party service fee payable

Accrued liabilities

Convertible notes

Loan from stockholder

Government loan

Operating lease liability - current

Total current liabilities

Operating lease liability – long term

Total liabilities

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Preferred stock:

$ 0.001 par value per share— 10,000,000 shares authorized at December 31, 2020 and September 30, 2021 (unaudited);

no shares issued and outstanding at December 31, 2020 and September 30, 2021 (unaudited)

Common stock, $ 0.001 par value per share – 200,000,000 shares authorized at December 31, 2020 and September 30, 2021 (unaudited);

8,514,070 shares issued and outstanding at December 31, 2020, and 14,972,552 shares issued and outstanding at September 30, 2021 (unaudited)

$ 0.001 par value per share— 10,000,000 shares authorized at December 31, 2021 and March 31, 2022;

no shares issued and outstanding at December 31, 2021 and March 31, 2022

Common stock, $ 0.001 par value per share – 200,000,000 shares authorized at December 31, 2021 and March 31, 2022;

14,996,534 shares issued and outstanding at December 31, 2021, and 15,020,517 shares issued and outstanding at March 31, 2022

Additional paid-in capital

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Total liabilities and stockholders’ (deficit) equity

accompanying notes to the financial statements

Therapeutics, Inc.

of Operations

thousands, except for share and per share amounts)

See accompanying notes to the financial statements

Unicycive Therapeutics, Inc.

Statements of Operations

(In thousands, except for share and per share amounts)

Three Months Ended

September 30,

Nine Months Ended

September 30,

Operating expenses:

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Interest expense

Loss on debt conversion

Gain on extinguishment of debt

2 unchanged sentences

Weighted-average shares outstanding used in computing net loss per share, basic and diluted

accompanying notes to the financial statements

Therapeutics, Inc.

of Stockholders’ (Deficit) Equity

thousands, except share amounts)

Stockholders’

See accompanying notes to the financial statements

Unicycive Therapeutics, Inc.

Statements of Stockholders’ (Deficit)

(In thousands, except share amounts)

Preferred Stock

Balance at December 31, 2019

Net loss (unaudited)

Issuance of common stock for cash (unaudited)

Issuance of common stock for anti-dilution clause (unaudited)

Stock-based compensation expense (unaudited)

Balance at March 31, 2020 (unaudited)

Net loss (unaudited)

Issuance of common stock for cash (unaudited)

Issuance of common stock for anti-dilution clause (unaudited)

Stock-based compensation expense (unaudited)

Balance at June 30, 2020 (unaudited)

Net loss (unaudited)

Issuance of common stock for anti-dilution clause (unaudited)

Stock-based compensation expense (unaudited)

Balance at September 30, 2020 (unaudited)

Stockholders’

Balance at December 31, 2020

Issuance of common stock for exercise of options

Stock-based compensation expense

Balance at March 31, 2021

Preferred Stock

Stockholders’

Balance at December 31, 2021

Net loss (unaudited)

Issuance of common stock for exercise of options (unaudited)

Stock-based compensation expense (unaudited)

Balance at March 31, 2021 (unaudited)

Net loss (unaudited)

Issuance of common stock for exercise of options (unaudited)

Stock-based compensation expense (unaudited)

Balance at June 30, 2021 (unaudited)

Net loss (unaudited)

Issuance of common stock for cash, net of $ 2.7 million offering costs (unaudited)

Conversion of convertible notes into common stock (unaudited)

Issuance of common stock for exercise of options (unaudited)

Issuance of common stock for anti-dilution clause (unaudited)

Stock-based compensation expense (unaudited)

Balance at September 30, 2021 (unaudited)

accompanying notes to the financial statements

Therapeutics, Inc.

of Cash Flows

September 30,

Issuance of common stock for exercise of options

Stock-based compensation expense

Balance at March 31, 2022

See accompanying notes to the financial statements

Unicycive Therapeutics, Inc.

Statements of Cash Flows

(In thousands)

Three Months Ended

Cash flows from operating activities

Adjustments to reconcile net loss to net cash used in operating activities:

R&D Expense for issuance of common stock for anti-dilution clause

Depreciation expense

Stock-based compensation expense

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Convertible debt non-cash interest

Amortization of operating lease right of use asset

Gain on extinguishment of debt

Deferred compensation to CEO

Loss on debt conversion

Changes in assets and liabilities:

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Accounts payable and accrued liabilities

Operating lease liability

Related party service fee payable

Net cash used in operating activities

Cash flows from investing activities

Purchases of property, plant, and equipment

Net cash used in investing activities

Cash flows from financing activities

Net proceeds from initial public offering

Issuance of common stock for cash

Proceeds from loan from stockholder

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Repayment of loan from stockholder

Deferred offering costs

Proceeds from exercise of options

Proceeds from government loan

Net cash provided by financing activities

Net increase in cash

Net increase (decrease) in cash

Cash at the beginning of the period

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Deferred offering costs included in accrued liabilities

Deferred preclinical charges included in prepaid expenses and other current assets

Cash paid for income taxes

accompanying notes to the financial statements

See accompanying notes to the financial statements

Unicycive Therapeutics, Inc.

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As the Company increases its research and development activities, the operating losses are expected to increase.

has historically relied on private equity offerings, debt financings and loans from a stockholder to fund its operations.

As of September

30, 2021 and December 31, 2020, the Company had an accumulated deficit of $ 13.2 million and $ 5.9 million, respectively.

The Company has

historically relied on private equity offerings, debt financings and loans from a stockholder to fund its operations.

As of December 31,

2021 and March 31, 2022, the Company had an accumulated deficit of $ 15.9 million and $ 19.5 million, respectively.

As a result of its initial public offering (“IPO”),

on July 13, 2021 the Company began trading on the Nasdaq Capital Market under the symbol “UNCY”, and on July 15, 2021 received

approximately $ 22,271,000 in net proceeds after deducting the underwriting discounts, commissions and other offering expenses.

approximately $ 22.3 million in net proceeds after deducting the underwriting discounts, commissions and other offering expenses.

intends to use the net proceeds from the IPO to complete pre-clinical and clinical studies, submit regulatory filings to the FDA, and

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These funds were

used primarily to settle outstanding accounts payable as well as $ 460,000 of the loan outstanding from the chief executive officer and

principal stockholder.

In addition, the Company received approximately $ 22,271,000 in net proceeds from its IPO.

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 current level of expenditures, and given the Company’s cash balance of $ 18,011,000 as

of September 30, 2021, the Company believes that it has sufficient resources to continue operations for at least one year after the date

that these financial statements are available to be issued.

used primarily to settle outstanding accounts payable as well as to make payments on the loan outstanding from the chief executive officer

and principal stockholder.

In addition, the Company received approximately $ 22.3 million in net proceeds from its IPO.

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 obligations.

Based on the Company’s current level of expenditures, and, given the Company’s cash balance of $ 13.6

million as of March 31, 2022, the Company believes that it will need funding before the end of the second quarter 2023 to continue operations,

satisfy its obligations and fund the future expenditures that will be required to conduct the clinical and regulatory work to develop

its product candidates.

The accompanying financial statements have been

prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of

liabilities and commitments in the normal course of business.

There is substantial doubt about the Company’s ability to continue

as a going concern for one year after the date that these financial statements are available to be issued.

The financial statements do

not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary from

the outcome of this uncertainty.

Summary of Significant Accounting Policies

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have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).

The accompanying unaudited financial statements of

the Company as of March 31, 2022 have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X

and, accordingly, they do not include all information and footnote disclosures required by accounting principles generally accepted in

The Company believes the footnotes and other disclosures made in the financial statements are adequate

for a fair presentation of the results of the interim periods presented.

The financial statements include all adjustments (solely of a

normal recurring nature) which are, in the opinion of management, necessary to make the information presented not misleading.

read these financial statements and the accompanying notes in conjunction with the financial statements and notes thereto included in

the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the U.S.

Securities and Exchange

Commission (“SEC”) on March 31, 2022.

All common share amounts and per share amounts

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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 deferred tax asset valuation allowance, unrecognized tax benefits, stock-based compensation and fair value of Company’s

common stock.

Significant items subject to such estimates and assumptions

include progress estimates for material third party research and development contracts, stock-based compensation and fair value of the

Company’s common stock prior to the Company’s IPO.

Actual results may materially differ from those estimates.

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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 purposes of allocating resources and evaluating financial performance.

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

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

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.

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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

its employees, consultants and other third parties.

Deferred Offering Costs

Deferred offering costs, consisting of legal,

accounting and other fees and costs relating to the Company’s Initial Public Offering (“IPO”) are capitalized and recorded

as a current asset on the balance sheets.

There were $ 0.2 million of deferred offering costs capitalized as of December 31, 2020.

September 30, 2021, all previously deferred offering costs, totaling approximately $ 0.9 million, were netted against the proceeds received

upon the closing of the IPO, which occurred on July 15, 2021.

Property, Plant and Equipment

Property, plant, and equipment are recorded at

cost less accumulated depreciation.

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.

Depreciation is computed using the straight-line

method over the estimated useful lives of the related assets, which range from three to seven years.

Leasehold improvements are amortized

on a straight-line basis over the shorter of their estimated useful lives or the remaining lease term.

Management assesses the carrying value of property

and equipment whenever events or changes in circumstances indicate that the carrying value may not be recoverable.

If there is indication

of impairment, management prepares an estimate of future cash flows expected to result from the use of the asset and its eventual disposition.

If these cash flows are less than the carrying amount of the asset, an impairment loss is recognized to write down the asset to its estimated

fair value at that time.

At March 31, 2022, management determined there were no impairments of the Company’s property and equipment.

The Company determines whether a contract is,

or contains, a lease at inception.

Right-of-use assets represent the Company’s right to use an underlying asset during the lease

term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease.

Right-of-use assets

and lease liabilities are recognized at lease commencement based upon the estimated present value of unpaid lease payments over the lease

The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present

value of unpaid lease payments.

Fair Value of Financial Instruments

The Company’s financial instruments include

cash, prepaid expenses, accounts payable, convertible notes and a loan from the Chief Executive Officer and stockholder of the Company.

The carrying amounts of these items approximate fair value as of December 31, 2020 and September 30, 2021 due to their short-term nature.

cash, prepaid expenses, and accounts payable.

The carrying amounts of these items approximate fair value as of December 31, 2021 and March

31, 2022 due to their short-term nature.

Concentration of Credit Risk

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and development expenses consist of expenses incurred in connection with the development of the Company’s product candidates.

expenses include fees paid to third parties to conduct certain research and development activities on the Company’s behalf, consulting

costs, costs for laboratory supplies, product acquisition and license costs, certain payroll and personnel-related expenses, including

salaries and bonuses, employee benefit costs and stock-based compensation expenses for the Company’s research and product development

employees and allocated overheads, including information technology costs and utilities and expenses for issuance of shares pursuant

to the anti-dilution clause in the purchase of IPR&D technology.

The Company expenses both internal and external research and development

expenses as they are incurred.

expenses include fees paid to third parties to conduct certain research and development activities on the Company’s behalf and related

progress estimates for those activities, consulting costs, costs for laboratory supplies, product acquisition and license costs, certain

payroll and personnel-related expenses, including salaries and bonuses, employee benefit costs and stock-based compensation expenses for

the Company’s research and product development employees and allocated overheads, including information technology costs and utilities.

The Company expenses both internal and external research and development expenses as they are incurred.

General and Administrative Expenses

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

Common Stock Valuations

The Company is required to periodically estimate

the fair value of common stock when issuing stock options and computing their estimated stock-based compensation expense.

The fair value

of common stock prior to the Company’s initial public offering was determined on a periodic basis, with the assistance of an independent

third-party valuation expert.

The assumptions underlying these valuations represented Management’s best estimates, which involved

inherent uncertainties and the application of significant levels of Management judgment.

In order to determine the fair value, the Company

considered, among other things, contemporaneous transactions involving the sale of the Company’s common stock to unrelated third

the lack of marketability of the Company’s common stock;

and the market performance of comparable publicly traded companies.

Prior to the Company’s IPO, the fair value

of common stock was estimated with the assistance of an independent third-party valuation expert when issuing stock options and computing

their estimated stock-based compensation expense.

The assumptions underlying these valuations represented management’s best estimates,

which involved inherent uncertainties and the application of significant levels of management judgment.

In order to determine the fair

value, the Company considered, among other things, contemporaneous transactions involving the sale of common stock to unrelated third

parties, the lack of marketability of the common stock and the market performance of comparable publicly traded companies.

Subsequent to the IPO, the Company determines the fair value of common

stock from closing prices as quoted on the NASDAQ exchange.

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 relate 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 relate 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,

We are monitoring legislation for any further changes to Section 174 and the impact, if any, to the financial statements in 2022.

Comprehensive Loss

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dilutive securities.

Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares

and potentially dilutive securities outstanding for the period.

For purposes of the diluted net loss per share calculation, common stock

options and warrants are considered to be potentially dilutive securities.

Basic and diluted net loss per share is presented in conformity

with the two-class method required for participating securities.

The Company has no participating securities and as such, the

net loss was attributed entirely to common stockholders.

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

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

All common share amounts and per share amounts

have been adjusted to reflect a 1-for-4.

3 reverse stock split of the Company’s common stock that was effectuated on June 21, 2021.

Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and

potentially dilutive securities outstanding for the period.

For purposes of the diluted net loss per share calculation, common stock options

and warrants are considered to be potentially dilutive securities.

Basic and diluted net loss per share is presented in conformity with

the two-class method required for participating securities.

The Company has no participating securities and as such, the net

loss was attributed entirely to common stockholders.

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

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

All common share amounts and per share amounts have

been adjusted to reflect a 1-for-4.3 reverse stock split of the Company’s common stock that was effectuated on June 21, 2021.

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.

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

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 instruments.

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

Additionally, among other changes,

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

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.

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

The Company is currently evaluating the impact this guidance will have on its financial statements.

The Company adopted the standard on January 1, 2022, and the adoption did not have a material effect on the Company’s

financial statements.

In February 2016, the FASB issued ASU 2016-02,

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The Company has adopted this standard effective as of January 1, 2019.

The Company chose to adopt the package of practical expedients

available from the FASB.

As a policy election, the Company chose to expense and amortize, on a straight line, the leases with terms less

than 12 months.

The Company chose to adopt certain practical expedients available

from the FASB.

As a policy election, the Company chose to expense and amortize, on a straight line, the leases with terms less than 12

In addition, the Company chose not to separate certain lease and non-lease components when evaluating the fair value of a lease.

The adoption of this standard did not have a material effect on the Company’s financial statements.

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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 rather 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.

At the time the FDA accepts a NDA application submitted by

the Company for the product, the Company will pay Sphaera $1.65 million.

Upon commercialization and sale of the drug product, royalty

payments will also be payable quarterly to Sphaera equal to 2% of net sales on the preceding quarter.

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.

payments were made upon execution of the agreement but rather 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.

At the time the FDA accepts a NDA application submitted by the Company

for the product, the Company will pay Sphaera $1.65 million.

Upon commercialization and sale of the drug product, royalty payments will

also be payable quarterly to Sphaera equal to 2% of net sales on the preceding quarter.

In September 2018, the Company entered into an

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capitalization of at least $ 50 million.

As part of the anti-dilution clause, the Company issued 149,762 and 105,897 shares of common stock

during the years ended December 31, 2019 and 2020, respectively.

The Company recognized $ 145,000 and $ 104,000 for the years ended December

31, 2019 and 2020, respectively, as research and development expenses as cost to issue those shares.

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 represents 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 three and nine months ended September 30, 2021.

The Company is also required to pay Spectrum 40% of all of 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 Renazorb Purchase 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 Renazorb Purchase Agreement.

On February 8, 2021, the Company entered into

a Master Services Agreement (the “Renazorb Development Agreement”) with Ascent Development Services, Inc.

pursuant to which Ascent will provide strategic services related to the development of Renazorb or other investigational products (the

“Compounds”) for clinical use and regulatory approval in Japan and other Asian countries.

The Renazorb Development Agreement

anticipates services to be provided by Ascent will include market research, facilitation of informal and formal meetings with Japan’s

Pharmaceutical and Medical Devices Agency (“PMDA”), management of contract research organizations and clinical trials, and

government applications and regulatory filings related to the Asian development of the Compounds.

Unicycive will supply the Compounds

or other materials necessary for Ascent to perform the development services.

The initial Statement of Work (“SOW”) under

the Renazorb Development Agreement encompasses the development of clinical strategy as well as both informal and formal meetings with

The budget for the initial SOW is approximately 24,000,000 Japanese Yen, and an upfront payment of approximately $87,000, was

paid to Ascent upon the execution of the Renazorb Development Agreement and was recorded to prepaid expenses and other current assets

in accompanying balance sheets.

Deliverables for the initial SOW are expected to be completed by December 31, 2021.

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.

The Company is also required to pay Spectrum 40% of all of 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 Renazorb Purchase 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 Renazorb Purchase Agreement.

On February 8, 2021, the Company entered into a Master

Services Agreement (the “Renazorb Development Agreement”) with Ascent Development Services, Inc.

(“Ascent”) pursuant

to which Ascent will provide strategic services related to the development of Renazorb or other investigational products (the “Compounds”)

for clinical use and regulatory approval in Japan and other Asian countries.

The Renazorb Development Agreement anticipates services to

be provided by Ascent will include market research, facilitation of informal and formal meetings with Japan’s Pharmaceutical and

Medical Devices Agency (“PMDA”), management of contract research organizations and clinical trials, and government applications

and regulatory filings related to the Asian development of the Compounds.

Unicycive will supply the Compounds or other materials necessary

for Ascent to perform the development services.

The initial Statement of Work (“SOW”) under the Renazorb Development Agreement

encompasses the development of clinical strategy as well as both informal and formal meetings with the PMDA.

The budget for the initial

SOW is approximately 24,000,000 Japanese Yen, and an upfront payment of approximately $87,000, was paid to Ascent upon the execution of

the Renazorb Development Agreement and deliverables for the initial SOW were completed by December 31, 2021.

On July 19, 2021, the Company entered into an agreement

with Syneos Health LLC (“Syneos”) pursuant to which Syneos will provide preclinical research and analysis services related

to the development of UNI-494.

The budget for the initial study, which will also include clinical pharmacology, translational sciences,

and bioanalytical services, is approximately $ 1.9 million.

Related payments totaling approximately $ 883,000 have been paid to Syneos as

of March 31, 2022, and approximately $ 738,000 of this amount is recorded as prepaid expense in the accompanying balance sheet as of March

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 budget for the initial study is approximately

$ 3.2 million.

Related payments totaling approximately $ 321,000 have been paid to Quotient as of March 31, 2022, and approximately $ 306,000

of this amount is recorded as prepaid expense in the accompanying balance sheet as of March 31, 2022.

On February 9, 2022, the Company entered into a Master

Services Agreement with CBCC Global Research Inc.

(“CBCC”), a California based company that provides clinical trial and related

service, for the purpose of performing clinical research in support of Renazorb.

The budget for the initial study is approximately $ 1.4

Related payments totaling approximately $ 94,000 have been paid to CBCC as of March 31, 2022, and approximately $ 58,000 of this

amount is recorded as prepaid expense in the accompanying balance sheet as of March 31, 2022.

Balance Sheet Components

Accounts payable as of December 31, 2020 and

September 30, 2021 consisted of the following (in thousands):

September 30,

Prepaid expenses and other current assets as of

December 31, 2021 and March 31, 2022 consisted of the following (in thousands):

Prepaid directors and officers liability insurance premiums

Prepaid preclinical services

Property, plant and equipment as of December 31,

2021 and March 31, 2022 consisted of the following (in thousands):

Leasehold improvements

Furniture and fixtures

Less accumulated depreciation

Accounts payable as of December 31, 2021 and March

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

Trade accounts payable

Credit card liability

Accrued liabilities as of December 31, 2021 and

March 31, 2022 consisted of the following (in thousands):

Accrued labor costs

Accrued drug development costs

Operating Lease

The Company leases office space under an operating

In December 2021, the Company entered into a lease agreement for 2,367 square feet of office space commencing December 1, 2021.

The initial lease term is for two years, and there is an option to extend the lease for an additional year.

In accounting for the leases, the Company adopted

ASC 842 Leases on January 1, 2019, which requires a lessee to record a right-of-use asset and a corresponding lease liability at the inception

of the lease initially measured at the present value of the lease payments.

The Company classified the lease as an operating lease and,

at December 1, 2021, determined that the present value of the lease was approximately $ 318,000 using a discount rate of 8.0 %.

In accordance

with ASC 842, the right-of-use asset will be amortized over the life of the underlying lease.

The Company determined that the option to

extend the lease for an additional year was not considered reasonably certain at December 31, 2021or March 31, 2022.

During the three

months ended March 31, 2022, the Company reflected amortization of right-of-use asset of approximately $ 37,000 , resulting in a right of

use asset balance of $ 268,000 .

During the three months ended March 31, 2022,

the Company made cash payments on the lease of $ 42,000 towards the lease liabilities.

As of March 31, 2022, the total lease liability

was $ 269,000 .

ASC 842 requires recognition in the statement of operations of a single lease cost, calculated so that the cost of the lease

is allocated over the lease term, generally on a straight-line basis.

Rent expense for the lease for the three months ended March 31,

2022 was approximately $ 43,000 .

As of March 31, 2022, maturities of the Company’s

lease liabilities are as follows (in thousands, unaudited):

Operating Lease

Year ending December 31, 2022

Year ending December 31, 2023

Total lease payments

Less imputed interest rate / present value discount

Present value of lease liability

Less current portion

Long term portion

Convertible Notes

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“Conversion Price”

means (i) in the event of a Qualified Financing, 70 % of the price per share (or conversion price, as applicable) of common stock (or

securities convertible into common stock, as applicable) sold in such financing or (ii) in the event of a change of control, the price

per share reflected in such transaction.

The Company has accounted for the 2021 Notes

as stock-settled debt and was accreting the carrying amount of the 2021 Notes to the settlement amount through maturity.

means (i) in the event of a Qualified Financing, 70% of the price per share (or conversion price, as applicable) of common stock (or securities

convertible into common stock, as applicable) sold in such financing or (ii) in the event of a change of control, the price per share

reflected in such transaction.

The Company accounted for the 2021 Notes as stock-settled

debt and was accreting the carrying amount of the 2021 Notes to the settlement amount through maturity.

In July through November 2020, the Company issued

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$500,000 (a “Qualified Financing”) or upon a change of control.

The 2020 Notes shall convert into such numbers of shares

of the Company’s common stock equal to the conversion amount divided by the Conversion Price.

The 2020 Notes shall convert into such numbers of shares of

the Company’s common stock equal to the conversion amount divided by the Conversion Price.

“Conversion Price” means

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reflected in such transaction.

The Company has accounted for the 2020 Notes

as stock-settled debt and is accreting the carrying amount of the 2020 Notes to the settlement amount through maturity.

As of December

31, 2020, unpaid and accrued interest of $ 53,000 as well as debt discount accretion expense of approximately $ 186,000 was included with

the convertible notes on the balance sheet.

The Company accounted for the 2020 Notes as stock-settled

debt and was accreting the carrying amount of the 2020 Notes to the settlement amount through maturity.

As of December 31, 2020, unpaid

and accrued interest of $ 53,000 as well as debt discount accretion expense of approximately $ 186,000 was included with the convertible

notes on the balance sheet.

As a result of the Company’s initial public

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Additionally the noteholders were granted warrants equal to 25 % of the conversion shares

The conversion resulted in a loss of $ 431,000 that is included as loss on debt conversion in the accompanying statements of operations

for the three and nine months ended September 30, 2021.

In 2017 and 2018, the Company raised $550,000

from the issuance of twelve convertible promissory notes (the “2018 Notes”).

The 2018 Notes bear interest at 10% per annum

which was payable at maturity.

The 2018 Notes’ principal and interest were due and payable on written demand by the majority of

the 2018 Note holders on the two-year anniversary of the first 2018 Note issued.

The first 2018 Note was issued on October 5, 2017 and,

accordingly, all 2018 Notes would have matured on October 5, 2019.

In the event the Company consummated an equity financing with an aggregate

sales price of not less than $500,000, then the aggregate outstanding principal and unpaid interest would automatically convert into

shares of the Company’s common stock.

The per-share price of the conversion would be equal to 75% of the price per share paid by

the cash purchasers of the common stock sold in the financing.

The Company accounted for the 2018 Notes as stock-settled

debt and accreted the carrying amount of the 2018 Notes to the settlement amount through maturity.

On July 31, 2019, all 2018 Notes principal

and accrued interest were converted into 1,159,065 shares of common stock upon the consummation of a 2019 equity financing in excess

of $ 500,000 .

The Company recorded, as part of the conversion of the debt, a loss on conversion of $ 63,000 included in other expenses.

The conversion resulted in a loss of $ 431,000 that was included as loss on debt conversion in the statement of operations for

the three months ended September 30, 2021.

Paycheck Protection Program Loan

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The Company classified the loans as a current liability, has applied for and received loan forgiveness

in February 2021, and recorded a gain on extinguishment of debt in the statement of operations for the nine months ended September 30,

in February 2021, and recorded a gain on extinguishment of debt in the statement of operations for the three months ended March 31, 2021.

Related Party Transactions

1 unchanged sentence

The Company received advances from the stockholder

of $ 248,000 during the nine months ended September 30, 2021.

The Company repaid amounts owed to the stockholder of $ 1,361,000 during the

nine months ended September 30, 2021.

As of September 30, 2021 and December 31, 2020, the current liability loan from a stockholder of

approximately $ 103,000 and $ 967,000 , respectively, represents primarily the accumulation of deferred compensation due to the chief executive

officer and stockholder.

This amount bears no interest and is repayable on demand.

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

the Company’s drug development program.

The Service Agreement provides Globavir the right to receive $ 50,000 per month for such

services through December 31, 2019 and $ 10,000 per month commencing on January 1, 2020.

As of December 31, 2020, $ 9,000 was payable to

Globavir for such service fees.

As of September 30, 2021, $ 58,000 was prepaid to Globavir for such service fees.

Amounts incurred by

the Company under the Service Agreement were $ 30,000 , $ 30,000 , $ 90,000 and $ 90,000 for the three and nine months ended September 30,

2020 and September 30, 2021, respectively, and are included in operating expenses in the statements of operations.

The initial amended

term of the agreement ended on December 31, 2020, and unless terminated, the Service Agreement automatically renews for successive one

month periods after the initial termination date.

Common stock purchase agreement and services

of $ 150,000 during the three months ended March 31, 2021.

The Company repaid amounts owed to the stockholder of $ 144,000 during the three

months ended March 31, 2021.

The Company repaid all amounts owed to the stockholder during the year ended December 31, 2021.

Common Stock Purchase Agreement and Service

Agreement with Globavir

On July 1, 2017, the Company entered into a Common

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the Company in 2017, which were issued in 2018.

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 provides 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 renews 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 three months ended March 31, 2022,

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

plans to amend the Service Agreement to reflect the consulting services and a reduced service fee of $ 6,000 per month.

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 September 2020, the Company signed an engagement

letter (the “Benchmark Agreement”) with The Benchmark Company LLC (“Benchmark”) to act as the lead or managing

underwriter in connection with the Company’s planned initial public offering.

In connection with this agreement the Company agreed

to pay a nonaccountable expense allowance to Benchmark equal to 1.0 % of the gross proceeds received in the Company’s planned initial

public offering.

In addition to the non-accountable expense allowance, the Company has also agreed to pay or reimburse the underwriters

for certain of the underwriters’ out-of-pocket expenses relating to the offering, including all reasonable fees and expenses of

the underwriters’ outside legal counsel, and background checks, which shall not exceed in the aggregate $ 132,500 .

In March 2021, the Benchmark Agreement was terminated.

Concurrent with the termination, the Company signed an advisory services agreement pursuant to which the Company will pay Benchmark $ 150,000

upon the closing of the planned initial public offering, and Benchmark will provide advisory services with respect to the planned public

In March 2021, the Company signed an advisory

services agreement with The Benchmark Company LLC (“Benchmark”) pursuant to which the Company would pay Benchmark a $ 150,000

advisory fee upon the closing of the initial public offering, and Benchmark would provide advisory services with respect to the public

The Company paid the advisory fee in July 2021.

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

Employee Benefit Plan

In December 2021, the Company implemented a 401K

Plan which covers all eligible employees of the Company (the “401K Plan”).

Employer matching contributions are immediately

100 % vested.

The Company’s 401K Plan provides that the Company match each participant's contribution at 100 % up to 4 % of the employee’s

eligible compensation.

Company contributions to the 401K Plan totaled approximately $ 0 and $ 19,000 for the three months ended March 31,

2021 and 2022, respectively.

Stockholders’ (Deficit) Equity

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Issuance of Common Stock and Warrants

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 per

During July 2021, as a result of its IPO, 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

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 IPO, the Company’s outstanding

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

Additionally, in accordance with the

original terms of the warrant agreements 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 following table summarizes activity for warrants

for the nine months ended September 30, 2021:

for the three months ended March 31, 2022:

(in thousands)

2 unchanged sentences

Warrants exercised

Outstanding, September 30, 2021

During July 2021, 438,374 shares of common stock

were allocated to Spectrum Pharmaceuticals, Inc.

in accordance with the anti-dilution provisions of the Company’s Assignment and

Asset Purchase Agreement with Spectrum.

During the nine months ended September 30, 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, 2021, 100,388 of the options remained unvested.

Proceeds received

related to the unvested options of $68,000 at September 30, 2021 were recorded in accrued liabilities on the accompanying balance sheets

and will be reclassified to equity as vesting occurs, provided the employees and consultants continue to provide services to the Company.

The vested portion of the exercises was 283,335 shares at September 30, 2021.

During the nine months ended September 30, 2020,

the Company issued 33,263 shares to investors in exchange of cash at $ 4.21 per share.

During the year ended December 31, 2020, the

Company issued 33,263 shares to investors in exchange of cash at $ 4.21 per share and 24,627 shares to Spectrum following its anti-dilution

provision (Note 3).

Outstanding, March 31, 2022

During the three months ended March 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 March 31, 2022, 52,414 of the options remained unvested.

Proceeds received related to the

unvested options of $53,000 at March 31, 2022 were recorded in accrued liabilities on the accompanying balance sheets and will be reclassified

to equity as vesting occurs, provided the employees and consultants continue to provide services to the Company.

Proceeds received related

to the vested portion of options of $ 31,000 and $ 7,000 were reclassified to equity at March 31, 2021 and March 31, 2022, respectively.

The vested portion of the exercises was 331,300 shares at March 31, 2022.

Voting Rights of Common Stock

2 unchanged sentences

Preferred Stock

As of December 31, 2020 and September 30, 2021,

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.

As of December 31, 2021 and March 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.

Stock-based Compensation

18 unchanged sentences

2019, 232,558 shares were authorized for issuance and 75,581 shares were available for future grant under the 2019 Plan.

On April 6, 2020

the Company increased the shares authorized for issuance to 348,837 shares total.

On February 17, 2021, the Company increased the

shares authorized for issuance to 1,767,442 shares total.

As of September 30, 2021, no further awards may be issued under the 2019 Plan.

In 2018, the Company adopted the 2018 Equity

Incentive Plan (“2018 Plan”) which allowed for the granting of incentive stock options (“ISO”), non-qualified

stock options (“NSO”), stock appreciation rights, restricted stock and restricted stock units to the employees, members of

the board of directors and consultants of the Company.

In 2018, the Company granted ISOs and NSOs to consultants and directors from this

As of December 31, 2020, 465,116 shares were authorized for issuance and 17,442 shares were available for future grant under the

As of September 30, 2021, no further awards may be issued under the 2018 Plan.

During July 2021, in connection with the appointment

Brigitte Schiller to the Company’s board of directors, the Company granted Dr.

Schiller 17,882 stock options with a ten year

term, an exercise price of $5.00 per option, and a total fair value of $50,000 on the date of grant.

Additionally, the Company granted

Schiller 26,738 restricted stock units with a grant date fair value of $100,000.

Subject to Dr.

Schiller’s continued service,

such options and restricted stock units shall vest upon the one-year anniversary of the date of grant.

As of September 30, 2021, the unrecognized

compensation cost related to outstanding restricted stock units was $0.1 million, which is expected to be recognized as expense over approximately

On February 17, 2021, the Company increased the shares

authorized for issuance to 1,767,442 shares total.

As of July 15, 2021, no further awards may be issued under the 2019 Plan due to the

adoption of the Company’s 2021 Plan.

In 2018, the Company adopted the 2018 Equity Incentive

Plan (“2018 Plan”) which allowed for the granting of incentive stock options (“ISO”), non-qualified stock options

(“NSO”), stock appreciation rights, restricted stock and restricted stock units to the employees, members of the board of

directors and consultants of the Company.

In 2018, the Company granted ISOs and NSOs to consultants and directors from this plan.

December 31, 2020, 465,116 shares were authorized for issuance and 17,442 shares were available for future grant under the 2018 Plan.

As of July 15, 2021, no further awards may be issued under the 2018 Plan due to the adoption of the Company’s 2021 Plan.

The following table summarizes activity for stock

options under all plans for the nine months ended September 30, 2021:

options under all plans for the three months ended March 31, 2022:

(in thousands)

1 unchanged sentence

Options granted

Options forfeited

Options exercised

Outstanding, September 30, 2021

Shares vested and exercisable as of September 30, 2021

The grant date fair value of options granted during

the nine months ended September 30, 2021 was $ 1.3 million.

As of September 30, 2021, the unrecognized compensation

Outstanding, March 31, 2022

Options vested and exercisable as of March 31, 2022

As of March 31, 2022, the unrecognized compensation

cost related to outstanding stock options was $ 1.8 million, which is expected to be recognized as expense over approximately 2.3 years.

The Company has recorded stock-based compensation

expense, which includes expense related to restricted stock units, allocated by functional cost as follows for the three and nine months

ended September 30, 2020 and 2021 (in thousands):

expense, which includes expense related to restricted stock units, allocated by functional cost as follows for the three months ended

March 31, 2021 and 2022 (in thousands):

Three Months Ended

Nine Months Ended

September 30,

Research and development

13 unchanged sentences

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.

The assumptions underlying these valuations represented

management’s best estimates, which involved inherent uncertainties and the application of significant levels of management judgment.

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.

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

3 unchanged sentences

risk-free interest rate is based on median U.S.

Treasury zero coupon issues with remaining terms similar to the expected term on the

Treasury zero coupon issues with remaining terms similar to the expected term on the options.

Expected Dividend - The Company

1 unchanged sentence

an expected dividend yield of zero .

The following averaged assumptions were used

to calculate the fair value of awards granted to employees, directors and non-employees for the nine months ended September 30, 2020

Nine Months Ended

September 30,

The following averaged assumptions were used to

calculate the fair value of awards granted to employees, directors and non-employees for the three months ended March 31, 2021 and 2022:

Three Months Ended

Expected volatility

1 unchanged sentence

Risk-free interest rate

0.44 - 0.51 %

0.61 - 0.92 %

Dividend yield

5 unchanged sentences

Three Months Ended

September 30,

Nine Months Ended

September 30,

Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted

4 unchanged sentences

Three Months Ended

September 30,

Nine Months Ended

September 30,

Options to purchase common stock

1 unchanged sentence

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-Q

Item 1. Financial Statements