What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-03-31 compared with 2024-03-28 · 195 added, 213 removed, 243 unchanged (63% of the section changed)

MANAGEMENT’S DISCUSSION AND

ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and

analysis of our financial condition and plan of operations together with our accompanying financial statements and the related notes

appearing elsewhere in this Annual Report on Form 10-K.

In addition to historical information, this discussion and analysis contains

forward-looking statements that involve risks, uncertainties, and assumptions.

Our actual results may differ materially from those discussed

Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those

discussed in the section titled “Risk Factors” included elsewhere in this Annual Report on Form 10-K.

All amounts in this

report are in U.S.

analysis of our financial condition and plan of operations together with our accompanying financial statements and the related notes appearing

elsewhere in this Annual Report on Form 10-K.

In addition to historical information, this discussion and analysis contains forward-looking

statements that involve risks, uncertainties, and assumptions.

Our actual results may differ materially from those discussed below.

that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the

section titled “Risk Factors” included elsewhere in this Annual Report on Form 10-K.

All amounts in this report are in U.S.

dollars, unless otherwise noted.

We are a biotechnology company dedicated to developing treatments for certain medical conditions.

Currently, two of our programs are focused

on kidney disease, an area we believe we have the potential to offer medical benefit.

As we grow the company and build our team, we intend

to focus on identifying medical conditions within and outside of kidney disease.

Our current development programs are focused on two novel

Oxylanthanum Carbonate, for treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis, and UNI 494,

for treatment of acute kidney injury (AKI).

Oxylanthanum Carbonate and UNI 494 were initially developed by and licensed to us from Spectrum

Pharmaceuticals (“Spectrum”) and Sphaera Pharma, respectively.

Spectrum conducted a Phase 1 clinical trial with Oxylanthanum

Carbonate in 2012, prior to the grant of our license in 2018.

Sphaera conceived and performed initial characterization of various potential

pro-drug linkers, including the initial patent application, and performed some initial physiochemical characterization and preliminary

animal pharmacokinetic studies.

As discussed herein, after completing IND enabling preclinical studies, we have conducted a Phase I clinical

study in healthy volunteers with UNI 494 in 2023.

Chronic kidney disease (CKD) is the gradual loss of kidney (renal) function that can get worse over time leading to lasting damage and

possibly Stage 5 or end-stage renal disease (ESRD).

Our initial focus is on developing drugs and getting them approved in the U.S., and

then to partner with global biopharmaceutical companies in the rest of the world.

According to the United States Renal Data System (USRDS)

2022 Annual Data Report, 30 million (14%) of adults in the United States are estimated to have CKD and, of these, approximately 13 million

patients have advanced CKD (stage 3-5).

Approximately 550,000 patients (ESRD) are on dialysis and of those, approximately 450,000 patients

(~80%) take phosphate binders to control hyperphosphatemia hyperphosphatemia (too much phosphorus in their blood).

The number of patients

with ESRD in the U.S.

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

AKI is a sudden episode of kidney failure or kidney damage (within the first 90 days of injury).

After 90 days, the patient is considered

to have progressed into CKD.

AKI affects more than 2 million U.S.

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

We are a clinical-stage biotechnology company

focused on identifying, developing, and commercializing innovative therapies to address significant unmet medical needs, with an initial

focus on kidney disease.

Founded in 2016, Unicycive was established to create a streamlined and efficient drug development platform capable

of accelerating the advancement of promising therapies from discovery to commercialization.

Currently, our two programs are focused on

kidney disease, an area we believe we have the potential to offer medical benefit.

Our initial focus is on developing drugs and getting

them approved in the U.S., and then to partner with global biopharmaceutical companies in the rest of the world.

As we grow the company

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

Our business model is to

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

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

however, that our management team’s broad network, expertise in the biopharmaceutical industry, and successful track record gives

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

Our current development programs are focused on

two novel therapies:

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

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

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

Pharma, respectively.

Spectrum conducted a Phase 1 clinical trial with Oxylanthanum Carbonate in 2012, prior to the grant of our license

Sphaera conceived and performed initial characterization of various potential pro-drug linkers, including the initial patent

As discussed herein, after completing IND enabling preclinical studies, we have completed a Phase I clinical study in healthy

volunteers with UNI-494 in 2024.

Chronic kidney disease (CKD) is the gradual loss

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

CKD affects nearly 36 million Americans;

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

Hyperphosphatemia

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

For an estimated

75% of people in the U.S.

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

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

To address this significant and growing challenge, Unicycive

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

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

it is swallowed, not chewed.

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

AKI is a sudden episode of kidney failure or kidney

damage (within the first 90 days of injury).

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

AKI affects more than

2 million U.S.

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

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

die due to AKI that has many causes.

Our business model is to license technologies and drugs in order to pursue development, regulatory approval, and commercialization of

those products in global markets.

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

We believe, however, that our management team’s broad network, expertise in the biopharmaceutical industry, and successful

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

die due to AKI.

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

Treatment options for AKI include continuous renal

replacement therapy, renal transplant, and dialysis.

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

have a renal transplant or be on dialysis for life.

Therefore, there is a high unmet medical need.

If approved, UNI-494 has the potential

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

Our business model is to license technologies

and drugs in order to pursue development, regulatory approval, and commercialization of those products in global markets.

Many biotechnology

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

We believe, however, that our management

team’s broad network, expertise in the biopharmaceutical industry, and successful track record gives us an advantage in identifying

and bringing these assets into our company.

Since our formation we have devoted substantially

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Our net losses were

$18.1 million and $30.5 million for the years ended December 31, 2022 and 2023.

As of December 31, 2023, we had an accumulated deficit

of $64.5 million.

We expect that our operating expenses will increase significantly as we advance our product candidates through pre-clinical

and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization;

acquire, discover,

validate, and develop additional product candidates;

$30.5 million and $36.7 million for the years ended December 31, 2023 and 2024 respectively.

As of December 31, 2024, we had an accumulated

deficit of $101.3 million.

We expect that our operating expenses will increase significantly as we advance our product candidates through

pre-clinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization;

discover, validate, and develop additional product candidates;

obtain, maintain, protect and enforce our intellectual property portfolio;

additional personnel.

We have funded our operations primarily from

the sale and issuance of common stock, convertible promissory notes and from a loan, including cash and deferred salary from our Chief

Executive Officer and principal stockholder.

and hire additional personnel.

We have funded our operations primarily from the

sale and issuance of common stock, convertible promissory notes and from a loan, including cash and deferred salary from our Chief Executive

Officer and principal stockholder.

Our ability to generate

product revenue will depend on the successful development, regulatory approval and eventual commercialization of our current product

candidates and future product candidates.

Until such time as we can generate significant revenue from product sales, if ever, we expect

to finance our operations through private or public equity or debt financings, collaborative or other arrangements with corporate sources,

or through other sources of financing.

product revenue will depend on the successful development, regulatory approval and eventual commercialization of our current product candidates

and future product candidates.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance

our operations through private or public equity or debt financings, collaborative or other arrangements with corporate sources, or through

other sources of financing.

Adequate funding may not be available to us on acceptable terms, or at all.

If we fail to raise

capital or enter into agreements to raise capital as and when needed, we may have to significantly delay, scale back or discontinue the

development and commercialization of our current product candidates and future product candidates.

If we fail to raise capital or

enter into agreements to raise capital as and when needed, we may have to significantly delay, scale back or discontinue the development

and commercialization of our current product candidates and future product candidates.

We plan to continue to use third-party service

providers, including contract manufacturing organizations, to carry out our pre-clinical and clinical development and to manufacture

and supply the materials to be used during the development and commercialization of our product candidates.

providers, including contract manufacturing organizations, to carry out our pre-clinical and clinical development and to manufacture and

supply the materials to be used during the development and commercialization of our product candidates.

Recent Developments

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 us through a private placement.

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 and are convertible into common stock at $1.00 per share.

On March 3, 2023, we entered into a securities

purchase agreement (the “Purchase Agreement”) with certain accredited investors (the “Investors”), pursuant to

which we agreed to issue and sell, in a private placement (the “Offering”), 30,190 shares of Series A-1 Convertible Preferred

Stock, par value $0.001 per share (the “Series A-1 Preferred Stock”), with initial upfront funding of $30 million and an

additional $100 million possible if warrants issued in the Offering are exercised.

Pursuant to the Certificate of Designation of

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

each share of Series A-1 Preferred Stock is, subject to the Stockholder Approval (as defined below), convertible into a unit (“Unit”)

consisting of (i) shares of common stock, par value $0.001 per share (the “Common Stock”) and, if applicable, shares of Series

A-2 Convertible Preferred Stock, par value $0.001 per share (the “Series A-2 Preferred Stock”), in lieu of Common Stock,

(ii) a tranche A warrant to acquire shares of Series A-3 Convertible Preferred Stock (the “Tranche A Warrant”), (iii) a tranche

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

to acquire shares of Series A-5 Convertible Preferred Stock (the “Tranche C Warrant”, together with the Tranche A Warrant

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

The shares of Series A-3 Convertible Preferred Stock, Series A-4 Convertible

Preferred Stock and Series A-5 Convertible Preferred Stock issuable upon exercise of the Warrants collectively are referred to herein

as the “Preferred Warrant Shares”.

The Tranche A warrants for an aggregate exercise price of approximately $25 million are

exercisable until 21 days following our announcement of receipt of FDA approval for Oxylanthanum Carbonate, the Tranche B warrants for

an aggregate exercise price of approximately $25 million are exercisable until 21 days following our 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 are exercisable until 21 days following four quarters of commercial sales of Oxylanthanum

Carbonate following receipt of TDAPA approval.

On June 26, 2023, we held our 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.

On the tenth (10th) Trading Day (as defined in the Certificate of Designation) following the announcement of the stockholder

approval, each share of Series A-1 Preferred Stock automatically converted into a Unit.

Subject to the limitations set forth in the Certificate

of Designation, at the option of the holder, shares of Series A-2 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 Common Stock.

In addition, in connection with the Offering,

we agreed to modify our dividend policy to state that we intend 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 our annual net cash flow from operations following approval of Oxylanthanum Carbonate

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

The COVID-19 Pandemic and its Impacts on Our

In March 2020, the World Health Organization

declared the outbreak of COVID-19 a global pandemic.

This pandemic could result in difficulty securing clinical trial site locations,

CROs, and/or trial monitors and other critical vendors and consultants supporting our trial.

These situations, or others associated with

COVID-19, could cause delays in our clinical trial plans and could increase expected costs, all of which could have a material adverse

effect on our business and financial condition.

At the current time, we are unable to quantify the potential effects of this pandemic

on our future financial statements.

Extension of Nasdaq Compliance Period

On July 9, 2024, the Company received written

notice (the “ Notice ”) from the Nasdaq Stock Market, LLC (“ Nasdaq ”) indicating that the bid price

its common stock, for the last 30 consecutive business days, had closed below the minimum $1.00 per share and, as a result, the Company

was not in compliance with the $1.00 minimum bid price requirement for the continued listing on the Nasdaq Capital Market, as set forth

in Nasdaq Listing Rule 5550(a)(2).

In accordance with the Nasdaq Listing Rule 5810(c)(3)(A),

the Company had a period of 180 calendar days, or until January 6, 2025, to regain compliance with the minimum bid price requirement.

As of January 6, 2025, the Company has not regained

compliance with the minimum bid price requirement.

On January 7, 2025, Nasdaq notified the Company that it would have an additional 180

calendar days, or until July 7, 2025, to regain compliance.

Issuance of Common Stock Upon Conversion of

Series A-2 Prime Preferred

On February 18, 2025, the Company issued 1,400,000

shares (the “Shares”) of common stock, upon conversion of 686.00 shares of the Company’s Series A-2 Prime Preferred.

Components of Results of Operations

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Research and Development Expenses

Substantially all of our research and development expenses consist

of expenses incurred in connection with the development of our product candidates.

These expenses include fees paid to third parties to

conduct certain research and development activities on our 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 our research and product development employees and allocated overheads, including information technology costs

and utilities and expenses for the issuance of shares pursuant to the anti-dilution clause in the purchase of in process research and

development technology.

Substantially all of our research and development

expenses consist of expenses incurred in connection with the development of our product candidates.

These expenses include fees paid to

third parties to conduct certain research and development activities on our 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 our research and product development employees and allocated overheads, including information

technology costs and utilities and expenses for the issuance of shares pursuant to the anti-dilution clause in the purchase of in process

research and development technology.

We expense both internal and external research and development expenses as they are incurred.

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General and administrative expenses consist principally

of payroll and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees

for legal, consulting, accounting and tax services, including information technology costs and utilities, and other general operating

expenses not otherwise classified as research and development expenses.

of payroll and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for

legal, consulting, accounting and tax services, including information technology costs and utilities, and other general operating expenses

not otherwise classified as research and development expenses.

We anticipate that our general and administrative

expenses will increase as a result of increased personnel costs, expanded infrastructure and higher consulting, legal and accounting

services costs associated with complying with the applicable stock exchange and the SEC requirements, investor relations costs and director

and officer insurance premiums associated with being a public company.

expenses will increase as a result of increased personnel costs, expanded infrastructure and higher consulting, legal and accounting services

costs associated with complying with the applicable stock exchange and the SEC requirements, investor relations costs and director and

officer insurance premiums associated with being a public company.

Other Expenses

Other expenses consist primarily of interest

expense related to convertible notes and a loss on conversion of convertible notes.

Other expenses consist of the change in fair value

of our warrant liability, interest income and interest expense.

Results of Operations

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Licensing revenues decreased approximately $0.7

million or 29% from 2022 due to a smaller upfront payment of approximately $0.7 million associated with a licensing agreement entered

into with Lotus International PTE Ltd in February 2023.

We received an upfront payment of approximately $1.0 million associated with

a licensing agreement entered into with Lee’s Pharmaceutical (HK) Limited in July 2022.

We may earn additional licensing revenue

in the future if we negotiate business development arrangements with third parties.

million, or 100%, from the year December 30, 2023 due to an upfront payment of approximately $0.7 million associated with a licensing

agreement entered into with Lotus International Pte Ltd.

in February 2023.

There was no comparable revenue earned in the current period.

We may earn additional licensing revenue in the future if we negotiate business development arrangements with third parties.

Research and Development Expenses

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approximately $7.1 million, or 55% from $12.9 million for the year ended December 31, 2023 to $20.0 million for the year ended December

The increase in research and development expenses was primarily due to a $662,000 increase in labor costs.

Non-cash stock compensation

increased $465,000.

The increases were partially offset by a decrease in drug development costs of $671,000.

The increase in research and development expenses was primarily due to an increase in drug development costs of $6.1 million.

There was $750,000 increase in labor costs.

Non-cash stock compensation increased $211,000.

General and Administrative Expenses

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Labor costs increased $319,000 due to

hiring of new employees, and rent, travel, supplies and other costs increased $353,000.

hiring of new employees, and rent, travel, supplies and other costs increased $2.7 million.

Non-cash stock compensation costs increased

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Other Income (Expenses)

Other income (expenses) increased by approximately

$9.8 million, or 162,733% from $6,000 for the year ended December 31, 2022 to approximately $9.8 million for the year ended December

Other income (expenses) decreased by approximately

$5.2 million, or 53% from $9.8 million for the year ended December 31, 2023 to approximately $4.6 million for the year ended December

The increase was due primarily to the change in fair value of our warrant liability.

We earned interest income of $615,000

on our cash balance during the year that was partially offset by a $76,000 increase in interest expense.

We earned interest income of $1.3 million

on our cash balance during the year that was partially offset by $71,000 in interest expense.

Liquidity and Capital Resources

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for the commercial launch of Oxylanthanum Carbonate in the U.S.

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

with certain accredited investors pursuant to which we agreed to issue and sell, in a private placement 50,000 shares of our Series B

Convertible Preferred Stock, par value $0.001 per share at a purchase price of $1,000 per share with an initial conversion price of $1.00

per share, subject to adjustment for an aggregate purchase price of $50 million.

On March 13, 2024, the Company entered into a

securities purchase agreement with certain accredited investors pursuant to which we agreed to issue and sell, in a private placement,

50,000 shares of our Series B Convertible Preferred Stock, par value $0.001 per share at a purchase price of $1,000 per share with an

initial conversion price of $1.00 per share, subject to adjustment for an aggregate purchase price of $50 million.

In addition, on November 13, 2024, we entered

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

aggregate offering price of up to $50 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 we have 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.

Future Funding Requirements

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Based on our currently anticipated

level of expenditures, and after receiving the proceeds from the private placement in March 2024, we believe that we have 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.

level of expenditures, and after receiving the proceeds from the private placement in March 2024 and at-the-market public offering in

November 2024, we believe that we have 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.

We anticipate that we will need to raise substantial

additional capital, the requirements for which will depend on many factors, including:

the scope, timing, rate

of progress and costs of our drug discovery efforts, pre-clinical development activities, laboratory testing and clinical trials

for our current product candidates and future product candidates;

the number and scope of

clinical programs we decide to pursue;

the cost, timing, and outcome

of preparing for and undergoing regulatory review of our current product candidates and future product candidates;

the scope and costs of

development and commercial manufacturing activities;

the cost and timing associated

with commercializing our current product candidates and future product candidates, if they receive marketing approval;

the extent to which we

acquire or in-license other product candidates and technologies;

the costs of preparing,

filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual

property-related claims;

our ability to establish

and maintain collaborations on favorable terms, if at all;

our efforts to enhance

operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development

of our current product candidates and future product candidates and, ultimately, the sale of our products, following FDA approval;

the impact, if any, of

the coronavirus pandemic on our business operations;

the scope, timing, rate of progress and costs of our drug discovery efforts, pre-clinical

development activities, laboratory testing and clinical trials for our current product candidates and future product candidates;

the number and scope of clinical programs we decide to pursue;

the cost, timing, and outcome of preparing for and undergoing regulatory review of our current product

candidates and future product candidates;

the scope and costs of development and commercial manufacturing activities;

the cost and timing associated with commercializing our current product candidates and future product

candidates, if they receive marketing approval;

the extent to which we acquire or in-license other product candidates and technologies;

the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our

intellectual property rights and defending intellectual property-related claims;

our ability to establish and maintain collaborations on favorable terms, if at all;

our efforts to enhance operational systems and our ability to attract, hire and retain qualified

personnel, including personnel to support the development of our current product candidates and future product candidates and, ultimately,

the sale of our products, following FDA approval;

the impact, if any, of the coronavirus pandemic on our business operations;

our ability to access capital;

our implementation of operational,

financial and management systems;

the costs associated with

being a public company.

our implementation of operational, financial and management systems;

the costs associated with being a public company.

A change in the outcome of any of these or other

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Related Party Payable

We entered into a Service Agreement with Globavir

Biosciences, Inc.

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

Globavir provides administrative and

consulting services and shared office space and other costs in connection with the Company’s drug development programs.

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.

During the 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 30, 2022.

We have not entered into any additional agreements

with Globavir during the year ended December 31, 2023.

The Company received advances from the stockholder

of $210,000 during February 2023.

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

Summary of Cash Flows

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million for the year ended December 31, 2023.

Cash used in operating activities was primarily due to the use of funds for director

and officer insurance premiums, development costs associated with our drug candidates, labor costs, consulting and accounting services,

and other corporate expenditures for investor relations, compliance, and legal services.

We incurred a net loss of $18.1 million after

including the effect of non-cash adjustments for stock compensation.

Cash used in operating activities was primarily due to the use of funds for development

costs associated with our drug candidates, labor costs, consulting services, and other corporate expenditures for investor relations,

compliance, and legal services.

We incurred a net loss of $30.5 million after including the effect of non-cash adjustments for stock

compensation and change in fair value of our warrant liability.”.

Cash Flows from Investing Activities

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$45.1 million for the year ended December 31, 2024 and was due primarily to the private placement financing agreement we closed on March

Net cash used by financing activities was $471,000

for the year ended December 31, 2022 and was primarily due to payments made pursuant to our financed director and officer insurance

13, 2024 and the public offering sales agreement we closed on November 13, 2024 , partially offset by dividends paid to preferred stockholders.

Net cash provided by financing activities was

$27.5 million for the year ended December 31, 2023 and was primarily due to the private placement financing agreement we closed

on March 3, 2023.

Critical Accounting Policies, Significant

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a performance obligation.

Debt and Equity Classification

In conjunction with the issuance of Series A-1

Preferred Stock in March 2023, and in conjunction with the issuance of Series B-1 Preferred Stock in March 2024, we initially account

for the preferred stock as temporary, or mezzanine, equity.

The Series A-1 and Series B-1 Preferred Stock do not fall within the scope

of ASC 480, Distinguishing Liabilities from Equity , do not contain any embedded derivatives that require bifurcation, and are

not classified as liabilities.

However, as the Series A-1 and Series B-1 Preferred Stock, at issuance, are contingently redeemable upon

the occurrence of an event that is not solely within our control, they are required to be initially classified as mezzanine equity and

measured at the amount of net proceeds received.

As the Series A-1 and Series B-1 Preferred Stock are not currently redeemable or probable

of becoming redeemable, no subsequent remeasurement is required.

Warrant Liabilities

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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 7. Management’s Discussion and Analysis