What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2025-04-15 compared with 2024-04-15 · 200 added, 149 removed, 904 unchanged (28% of the section changed)

283 unchanged sentences

following table presents the compensation awarded to, earned by or paid to each of our named executive officers for the year ended December

and Principal Position

Patel, Chief Executive Officer

Name and Principal Position

Snehal Patel,

Chief Executive Officer

2024 fiscal year, Mr.

Patel received options to purchase 262,181 shares of common stock for services rendered and as incentive for

services to be rendered.

Patel received deferred bonus compensation of $306,281 and options to purchase 630,000 shares of common stock for

services rendered and as incentive for services to be rendered.

For 2023 fiscal year, Mr.

Patel received 163,863 shares of our common stock and options to purchase 137,645

Patel received options to purchase 262,181

shares of common stock for services rendered and as incentive for services to be rendered.

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Option Awards

Number of Securities Underlying Unexercised Options (#) Exercisable

Number of Securities Underlying Unexercised Options (#) Unexercisable

Number of Securities Underlying

Unexercisable

Option Exercise Price ($)

Option Expiration Date

Snehal Patel (1)

June 21, 2032

Patel options to purchase shares of common stock on June 22, 2022 for compensation and incentives to be earned in equal

installments over 48 months.

Between the 18 month period, June, 22, 2022 to December 31, 2023, Mr.

Patel earned 399,826 options

which may or may not vest based on certain additional performance milestones and of which 20% is currently vested and exercisable,

totaling 79,966 shares, and the balance, or 968,757 options, may or may not vest over the 30 month period commencing on January 1,

2024 or thereafter.

December 23, 2034

Patel options to purchase shares of common stock on June 22, 2022 for compensation

and incentives to be earned in equal installments over 48 months.

Between the 30 month period,

June, 22, 2022 to December 31, 2024, Mr.

Patel earned 662,006 options which may or may not

vest based on certain additional performance milestones and of which 20% is currently vested

and exercisable, totaling 132,403 shares, and the balance, or 916,320 options, may or may

not vest over the 18 month period commencing on January 1, 2025 or thereafter.

Patel 100,000 options to purchase shares of common stock on December 24, 2024 for compensation and incentives which vest

We granted Mr.

Patel an additional 1,048,723 options to purchase shares of common stock on December 24, 2024 for compensation

and incentives of which 25% are earned immediately and the remainder are to be earned in equal installments over 36 months.

December 24, 2024 to December 31, 2024, Mr.

Patel earned 367,819 options which may or may not vest based on certain additional time

based milestones of which 100,000 options are currently vested and exercisable, and the balance, or 1,048,723 options, may or may

not vest over the 36 month period commencing on January 1, 2025 or thereafter.

Director Compensation

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members of our board in 2024.

Fees Earned or

Stock and Option Awards

and Option Awards

David McWilliams (1)

1 unchanged sentence

Kenneth Hallock (3)

McWilliams options to purchase shares of common stock on June 22, 2022 for compensation and incentives to be earned in

equal installments over 48 months of which 15,496 options vested between January 1, 2023 and December 31, 2023 over the 12 month

McWilliams options to purchase shares of common stock on June 22, 2022 for compensation

and incentives to be earned in equal installments over 48 months of which 15,496 options

vested between January 1, 2024 and December 31, 2024 over the 12 month period, and the balance,

or 22,856 options, vest over 18 equal monthly installments commencing on January 1, 2025.

McWilliams options to purchase shares of common stock on December 24, 2024 for compensation and incentives to be earned

in equal installments over 36 months of which 15,829 options vested between January 1, 2024 and December 31, 2024 over the 12 month

period, and the balance, or 46,155 options, vest over 36 equal monthly installments commencing on January 1, 2025.

Rothe options to purchase shares of common stock on June 22, 2022 for compensation and incentives to be earned in equal

installments over 48 months of which 10,337 options vested between January 1, 2023 and December 31, 2023 over the 12 month period,

and the balance, or 25,585 options, vest over 30 equal monthly installments commencing on January 1, 2024.

Hallock options to purchase shares of common stock on June 22, 2022 for compensation and incentives to be earned in

Rothe options to purchase shares of common stock on June 22, 2022 for compensation

and incentives to be earned in equal installments over 48 months of which 10,337 options

vested between January 1, 2024 and December 31, 2024 over the 12 month period, and the balance,

or 15,247 options, vest over 18 equal monthly installments commencing on January 1, 2025.

Rothe options to purchase shares of common stock on December 24, 2024 for compensation and incentives to be earned in

equal installments over 48 months of which 10,559 options vested between January 1, 2024 and December 31, 2024 over the 12 month

period, and the balance, or 30,790 options, vest over 3 6 equal monthly installments commencing on January 1, 2025.

Hallock options to purchase shares of common stock on June 22, 2022 for compensation

and incentives to be earned in equal installments over 48 months of which 10,337 options

vested between January 1, 2024 and December 31, 2024 over the 12 month period, and the balance,

or 15,247 options, vest over 18 equal monthly installments commencing on January 1, 2025.

Hallock options to purchase shares of common stock on December 24, 2024 for compensation and incentives to be earned

in equal installments over 48 months of which 10,559 options vested between January 1, 2024 and December 31, 2024 over the 12 month

period, and the balance, or 30,790 options, vest over 36 equal monthly installments commencing on January 1, 2025.

Patel Employment Agreement

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Dr, Building 14, Stafford, TX 77477.

Name of Beneficial Owner

Shares of Common Stock

Beneficially Owned

Executive officers and directors:

of Beneficial Owner

of Common Stock Beneficially Owned

officers and directors:

5,848,646 (1)

Joseph Daugherty

David McWilliams

Kenneth Hallock

All current named executive officers and directors as a group (5) persons

current named executive officers and directors as a group (5) persons

beneficial ownership of less than 1%

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fees consist of fees for professional services performed by MaloneBailey and RBSM for the audit and review of our financial statements.

preparation and filing of our registration statements, including issuance of comfort letters.

Audit-related fees consist of fees for professional services performed by MaloneBailey and RBSM related to the filing of our registration

statements, including issuance of comfort letters.

on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditors

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financial statements required by this item are submitted in a separate section beginning on page F-1 of this Annual Report on Form

Open Market Sale Agreement, dated July 12, 2022 by and between the Company and Jefferies LLC (incorporated by reference to Exhibit 1.1 to Form 8-K filed on July 12, 2022)

Second Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Form 8-K filed on October 1, 2020)

Second Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to Form 8-K filed on October 1, 2020)

Form of Underwriter Warrant (incorporated by reference to Exhibit 4.2 to Amendment No.

Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Form 8-K filed on October 1, 2020)

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to Form 8-K filed on October 1, 2020)

of Underwriter Warrant (incorporated by reference to Exhibit 4.2 to Amendment No.

1 to Form S-1 filed on June 23, 2020)

Description of the Registrant’s securities registered pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to Exhibit 4.2 to Form 10-K filed on March 31, 2021).

of the Registrant’s securities registered pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by reference

to Exhibit 4.2 to Form 10-K filed on March 31, 2021).

Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to Form S-1 filed on May 29, 2020)

Form of Indemnification Agreement with directors and executive officers (incorporated by reference to Exhibit 10.1 to Form S-1 filed on May 29, 2020)

Exclusive License Agreement between The Henry M.

of Indemnification Agreement with directors and executive officers (incorporated by reference to Exhibit 10.1 to Form S-1 filed on

May 29, 2020)

License Agreement between The Henry M.

Jackson Foundation for the Advancement of Military Medicine, Inc.

and the Company (incorporated by reference to Exhibit 10.3 to Amendment No.

and the Company (incorporated

by reference to Exhibit 10.3 to Amendment No.

1 to Form S-1 filed on June 23, 2020)

First Amendment to Exclusive License Agreement between The Henry M.

Amendment to Exclusive License Agreement between The Henry M.

Jackson Foundation for the Advancement of Military Medicine, Inc.

and the Company (incorporated by reference to Exhibit 10.4 to Amendment No.

the Company (incorporated by reference to Exhibit 10.4 to Amendment No.

1 to Form S-1 filed on June 23, 2020)

Second Amendment to Exclusive License Agreement between The Henry M.

Amendment to Exclusive License Agreement between The Henry M.

Jackson Foundation for the Advancement of Military Medicine, Inc.

and the Company (incorporated by reference to Exhibit 10.5 to Amendment No.

the Company (incorporated by reference to Exhibit 10.5 to Amendment No.

1 to Form S-1 filed on June 23, 2020)

American Arbitration Association Award of Arbitrators (incorporated by reference to Exhibit 10.6 to Amendment No.

Arbitration Association Award of Arbitrators (incorporated by reference to Exhibit 10.6 to Amendment No.

1 to Form S-1 filed on June

Employment Agreement between the Company and Snehal Patel dated September 29, 2020 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on October 1, 2020)

Registration Rights Agreement (incorporated by reference to Exhibit 10.8 to Amendment No.

Agreement between the Company and Snehal Patel dated September 29, 2020 (incorporated by reference to Exhibit 10.1 to Form 8-K filed

on October 1, 2020)

Rights Agreement (incorporated by reference to Exhibit 10.8 to Amendment No.

1 to Form S-1 filed on June 23, 2020)

Greenwich LifeSciences, Inc.

Insider Trading Policy

Consent of RBSM LLP

Consent of MaloneBailey LLP

Power of Attorney (included on signature page hereto).

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Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Clawback Policy

Clawback Policy (incorporated by reference to Exhibit 97.1 to Form 10-K filed on April 15, 2024).

XBRL Instance Document.

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LIFESCIENCES, INC.

April 15, 2024

Executive Officer (Principal Executive Officer and Principal Accounting and Financial Officer)

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Executive Officer and Director

April 15, 2024

Executive Officer and Principal Accounting and Financial Officer)

1 unchanged sentence

Medical Officer and Director

April 15, 2024

Joseph Daugherty

David McWilliams

April 15, 2024

Kenneth Hallock

April 15, 2024

LIFESCIENCES, INC.

to Financial Statements

of Independent Registered Public Accounting Firm

of Independent Registered Public Accounting Firm (PCAOB ID:

Report of Independent Registered Public Accounting Firm

Balance Sheets

3 unchanged sentences

Notes to Financial Statements

Business Park Dr

Houston, TX 77070

www.rbsmllp.com

3 unchanged sentences

on the Financial Statements

have audited the accompanying balance sheet of Greenwich LifeSciences, Inc.

have audited the accompanying balance sheets of Greenwich LifeSciences, Inc.

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

the related statements of operations, stockholders’ equity and cash flows for the year then ended, and the related notes (collectively

and the related statements of operations, stockholders’ equity and cash flows for the years then ended, and the related notes (collectively

referred to as the financial statements).

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

position of the Company as of December 31, 2023, and the results of its operations and its cash flows for the year then ended December

31, 2023, in conformity with accounting principles generally accepted in the United States of America.

position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended

December 31, 2024 and 2023, in conformity with accounting principles generally accepted in the United States of America.

accompanying financial statements have been prepared assuming that the Company will continue as a going concern.

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have served as the Company’s auditor since 2024.

April 15, 2024

York, NY Washington DC Mumbai & Pune, India Boca Raton, FL

Francisco, CA Las Vegas, NV Beijing, China Athens, Greece

Francisco, CA Houston, TX Las Vegas, NV Beijing, China Athens, Greece

ANTEA International with affiliated offices worldwide

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

the Shareholders and Board of Directors of

LIFESCIENCES, INC.

on the Financial Statements

have audited the accompanying balance sheet of Greenwich LifeSciences, Inc.

(the “Company”) as of December 31, 2022, and

the related statements of operations, stockholders’ equity, and cash flows for the year then ended, and the related notes (collectively

referred to as the “financial statements”).

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

the financial position of the Company as of December 31, 2022, and the results of its operations and its cash flows for the year then

ended, in conformity with accounting principles generally accepted in the United States of America.

financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s

financial statements based on our audit.

We are a public accounting firm registered with the Public Company Accounting Oversight Board

(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.

securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain

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

is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

As part of our audit

we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion

on the effectiveness of the Company’s internal control over financial reporting.

Accordingly, we express no such opinion.

audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or

fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding

the amounts and disclosures in the financial statements.

Our audit also included evaluating the accounting principles used and significant

estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audit provides

a reasonable basis for our opinion.

/s/ MaloneBailey,

www.malonebailey.com

have served as the Company’s auditor since 2019.

Houston, Texas

March 31, 2023

LIFESCIENCES, INC.

OF DECEMBER 31, 2024 AND 2023

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Accounts payable & accrued interest

Deferred compensation

Unreimbursed expenses

4 unchanged sentences

100,000,000 shares authorized;

12,848,165 shares issued and outstanding as of December 31, 2023 and 2022

13,152,729 and 12,848,165 shares issued and outstanding as of

December 31, 2024 and December 31, 2023, respectively

Additional paid-in capital

31 unchanged sentences

Stock-based compensation

Repurchase of common stock via stock repurchase program, net of costs

( 8,891,803 )

( 7,825,237 )

Balances, December 31, 2023

2 unchanged sentences

Stock-based compensation

Sale of common stock via ATM program, net of costs

Sale of common stock via Private Placement, net of costs

( 15,788,809 )

Balances, December 31, 2024

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Accounts payable

Deferred compensation

Unreimbursed expenses (accrued)

3 unchanged sentences

Financing activities:

Repurchase of common stock via stock repurchase program, net of costs

( 7,536,216 )

Sale of common stock via ATM program, net of costs

Sale of common stock via Private Placement, net of costs

Net cash provided by (used in) financing activities

( 7,536,216 )

Net increase (decrease) in cash

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consists primarily of deposits with commercial banks and financial institutions.

These cash deposits exceed the insured

limits at individual banks and financial institutions.

These cash deposits exceed the insured limits at individual

banks and financial institutions.

of Long-Lived Assets

18 unchanged sentences

rent is approximately $ 2,819 .

The month-to-month sub-lease is from a related party and the underlying lease expires in May of 2024.

Any right of use asset and liability is deemed to be nominal as of December 31, 2023 and 2022.

expense related to warrants and stock granted to employees and non-employees is measured at the grant date based on the estimated fair

value of the award and is recognized on a straight-line basis over the requisite service period.

Forfeitures are recognized as a reduction

of stock-based compensation expense as they occur.

Stock-based compensation expense for an award with a performance condition is recognized

when the achievement of such performance condition is determined to be probable.

If the outcome of such performance condition is not

determined to be probable or is not met, no compensation expense is recognized and any previously recognized compensation expense is

The month-to-month sub-lease is from a related party and the underlying lease expires in July of 2026.

The Company has elected the practical expedient to not record right of use asset and lease obligation liability for leases with terms

of less than 12 months.

expense related to warrants and stock granted to employees and non-employees is measured at the grant date based on the estimated

fair value of the award and is recognized on a straight-line basis over the requisite service period in the Company’s statements of income.

Forfeitures are recognized as

a reduction of stock-based compensation expense as they occur.

Accounting guidance requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent

periods if actual forfeitures differ from those estimates.

The Company has limited historical experience with forfeitures and were based

on management’s estimates.

Stock-based compensation expense for an award with a performance

condition is recognized when the achievement of such performance condition is determined to be probable.

If the outcome of such

performance condition is not determined to be probable or is not met, no compensation expense is recognized and any previously

recognized compensation expense is reversed.

LIFESCIENCES, INC.

21 unchanged sentences

Company’s common stock.

As of December 31, 2023 and 2022, the

Company had common stock equivalents related to options outstanding to acquire 1,498,128

shares of the Company’s common stock.

of December 31, 2024 and 2023, the Company had common stock equivalents related to options outstanding to acquire 3,126,065 and 1,498,128

shares of the Company’s common stock, respectively.

of December 31, 2024 and 2023, the Company has no common stock equivalents related to convertible preferred stock issued and outstanding.

26 unchanged sentences

Issued Accounting Pronouncements Not Yet Adopted

2023, the FASB issued ASU No 2023 - 03, “Presentation of Financial Statements (Topic 205 ),

Income Statement—Reporting Comprehensive Income (Topic 220 ), Distinguishing Liabilities from Equity (Topic 480 ),

Equity (Topic 505 ), and Compensation—Stock Compensation (Topic 718 )” pursuant to

SEC Staff Accounting Bulletin No.

120, which adds interpretive guidance for public companies to consider

when entering into share-based payment transactions while in possession of material non-public information.

The effective date of this

update is for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years.

Company does not expect the adoption to have a material impact on our consolidated financial statements.

July 2023, the FASB issued ASU No 2023 - 03, “Presentation of Financial Statements (Topic 205 ), Income

Statement—Reporting Comprehensive Income (Topic 220 ), Distinguishing Liabilities from Equity (Topic 480 ), Equity

(Topic 505 ), and Compensation—Stock Compensation (Topic 718 )” pursuant to SEC Staff Accounting Bulletin No.

120, which adds interpretive guidance for public companies to consider when entering into share-based payment transactions while

in possession of material non-public information.

The effective date of this update is for fiscal years beginning after December 15,

2023, including interim periods within those fiscal years.

The Company does not expect the adoption to have a material impact

on our consolidated financial statements.

October 2023, the FASB issued ASU 2023-06—Codification Amendments in Response to the SEC’s Disclosure Update and Simplification

8 unchanged sentences

expenses have been accrued and incurred by management, which total $ 75,916 as of December 31, 2024 and $ 38,089 as of December 31, 2023.

compensation of $ 306,281 for senior management for services provided in 2024 has been deferred.

June 13, 2024, the Company completed a private placement offering pursuant to which it issued and sold 174,825 shares of its common stock

at a price of $ 14.30 per share to Snehal Patel, the Company’s Chief Executive Officer and director, for net proceeds of $ 2,499,998 .

Patel agreed to a one year lock-up agreement with respect to his shares of common stock acquired in the offering.

LIFESCIENCES, INC.

18 unchanged sentences

realizing the benefits of the net deferred tax asset.

Company’s issuances of common and preferred stock may have resulted in ownership changes as defined by Section 382

Company’s issuances of common and preferred stock may have resulted in ownership changes as defined by Section 382 of the Code.

The Company has not conducted a Section 382 study to date.

It is possible that a future analysis may result in the conclusion

that a portion of the Company’s NOL carryforwards and R&D tax credit carryforwards will be limited due to Sections 382 and 383

It is possible that a future analysis may result in the conclusion that a

portion of the Company’s NOL carryforwards and R&D tax credit carryforwards will be limited due to Sections 382 and 383 of

Company is subject to U.S.

17 unchanged sentences

TO FINANCIAL STATEMENTS

Bonus compensation of $ 306,281 for senior management for services provided

in 2024 has been deferred.

time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal

11 unchanged sentences

Stockholders’ Equity

September 30, 2019, the board of directors (the “Board”) and stockholders of the Company adopted the Greenwich LifeSciences,

2019 Equity Incentive Plan setting aside and reserving 1,498,128 shares of common stock without any issuance of common stock or

September 30, 2019, the board of directors and stockholders of the Company adopted the Greenwich LifeSciences,

2019 Equity Incentive Plan setting aside and reserving 1.5 million shares of common stock without any issuance of common stock or

options under the plan.

On December 19, 2024, the board of directors and stockholders of the Company amended

the Greenwich LifeSciences, Inc.

2019 Equity Incentive Plan setting aside and reserving an additional 2.5 million shares of common stock

for a total of 4 million shares of common stock (the “2024 Amended Equity Incentive Plan”).

of December 31, 2024 and 2023, 893,181 shares of the 908,362 shares of the common stock grant, which includes an additional grant of

1 unchanged sentence

15,181 shares remain unvested and unrecognized at approximately $ 34,157 value.

In 2023, no shares of common stock grant vested.

220,164 shares of common stock grant vested at approximately $ 495,369 value.

In 2024 and 2023, no shares of common stock grant vested.

January 23, 2022, the board of directors authorized the Company’s management to implement a stock repurchase program for up to

6 unchanged sentences

at an aggregate purchase price, including all transactions costs, of approximately $ 7,536,216 .

January 23, 2022, November 30, 2022, and November 17, 2023, the Board of Directors sequentially extended the lock-up of the shares owned

by the Company’s directors, officers, and existing pre-IPO investors to December 31, 2024 (approximately 51 months from date of

the Company’s IPO).

During this period, current officers, directors and certain shareholders will not be able to sell their shares

of the Company’s common stock unless otherwise modified by the Board of Directors.

January 23, 2022, November 30, 2022, November 17, 2023, and March 12, 2024, the board of directors sequentially extended the lock-up

of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to June 30, 2025 (approximately 57 months

from date of the Company’s IPO).

During this period, current officers, directors and certain shareholders will not be able to sell

their shares of the Company’s common stock unless otherwise modified by the board of directors.

After June 30, 2025, leak-out provisions

will become effective unless otherwise modified by the board of directors.

January 1, 2024 and December 31, 2024, the Company sold shares of its common stock pursuant to its ATM agreement with Jefferies and H.C.

Wainwright, in which it issued and sold a total of 129,739 shares of its common stock at an average offering price of $ 15.92 per share

for gross proceeds of $ 2,065,366 and net proceeds of $ 1,869,111 , after deducting underwriting discounts and commissions and offering

expenses borne by the Company, which totaled $ 196,257 .

June 22, 2020, the Company filed an amendment to its Amended and Restated Certificate of Incorporation, as amended (the “Certificate

54 unchanged sentences

Schedule of Outstanding Warrants

Shares Underlying

September 24, 2025

warrants are exercisable at any time and from time to time, in whole or in part, during a period commencing March 24, 2021 and expiring

10 unchanged sentences

year period and certain additional performance milestones for senior management, primarily related to the Phase III clinical trial.

December 24, 2024, prior to the close of the Nasdaq market, 1,627,937

shares of common stock were granted to employees, consultants, and directors issuable upon exercise of outstanding stock options

under the Company’s Amended 2024 Equity Incentive Plan at an exercise price of $ 12.16

per share, which was the most recent prior closing share price on December 23, 2024.

The options had a fair value on the grant date

of $ 16,190,565 ,

based on a risk-free rate of 4.5 %

and an annualized volatility of 103 %,

of which $ 4,875,239

was expensed through December 31, 2024 and $ 11,315,326

will be expensed in the future if and as vesting occurs.

Vesting will consist of 100,000

shares vesting upfront on December 24, 2024 and of the remaining shares, 25 %

vesting upfront on December 24, 2024 and 75 %

vesting based on time of service over a three

year period with certain additional retention milestones for senior management.

June 13, 2024, prior to the close of the Nasdaq market, the Company completed a private placement offering pursuant to which it issued

and sold 174,825 shares of its common stock at a price of $ 14.30 per share, which was the most recent prior closing share price on June

12, 2024, to Snehal Patel, the Company’s Chief Executive Officer and director, for net proceeds of $ 2,499,998 .

No investment banking

fees were paid in connection with the offering.

Patel agreed to a one year lock-up agreement with respect to his shares of common

stock acquired in the offering.

Segment Information

segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief

operating decision maker ("CODM") in deciding how to allocate resources and in assessing performance.

The Company's CODM is

the Chief Executive Officer.

The Company views its operations and manages its business as one operating segment, which includes all activities

related to its clinical development programs.

The determination of a single reportable segment is consistent with the financial information

provided to the CODM.

The CODM views and manages the Company's clinical development programs as a single reportable segment for which

all operations are centralized and does not evaluate any other discrete financial information.

The accounting policies of the Company's

single reportable segment are the same as those for the financial statements.

loss is measured as the Company's net loss as reported on the statement of operations, which includes segment expenses such as research

and development and general and administrative expenses and other segment items such as interest expense.

As the Company does not currently

generate revenues or profit, the CODM evaluates performance, makes decisions, allocates resources, and plans future activities through

analysis of segment expense information.

The CODM also monitors the Company's cash and cash equivalents and net cash used in operations

as reported on the balance sheet and the statement of cash flows, respectively.

The measure of total segment assets is reported on the

balance sheet as total assets.

Subsequent Events

Company has evaluated events through, April 15, 2025, the filing date of this Annual Report on Form 10-K, and determined that there have

been no subsequent events that occurred that would require adjustments to our disclosures in the financial statements, other than the

January 1, 2025 and April 11, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with

Jefferies, in which it issued and sold a total of 30,244 shares of its common stock at an average offering price of $ 12.81 per share

for gross proceeds of $ 387,490 and net proceeds of $ 348,741 , after deducting underwriting discounts and commissions and

offering expenses borne by the Company, which totaled $ 38,749 .

Wainwright, in which it issued and sold a total of 120,810 shares of its common stock at an average offering price of $ 10.42 per

share for gross proceeds of $ 1,259,198 and net proceeds of $ 1,232,026 , after deducting underwriting discounts and commissions and offering

expenses borne by the Company, which totaled $ 27,172 .

March 2, 2025, the board of directors further extended the lock-up of the shares owned by the Company’s directors, officers, and

existing pre-IPO investors to June 30, 2025 (approximately 57 months from date of the Company’s IPO).

existing pre-IPO investors to March 31, 2026 (approximately 66 months from date of the Company’s IPO).

During this period, current

1 unchanged sentence

modified by the board of directors.

After March 31, 2026, the quantity of these locked-up shares that can be

sold daily and over various periods of time will be restricted unless otherwise modified by the board of directors.

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 9A. Controls and Procedures