Greenwich LifeSciences, Inc. (GLSI)

ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We
are a clinical-stage biopharmaceutical company focused on our Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an
immunotherapy to prevent breast cancer recurrences. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface
receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate
(2+), and high (3+ or over-expressor) levels. The combination of GP2 + GM-CSF is called GLSI-100. We are currently expanding Flamingo-01
into Europe with plans to open up to 150 sites globally. Flamingo-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2/neu
positive patients with residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant
and postoperative adjuvant trastuzumab based treatment.

To
date, we have not generated any revenue and we have incurred net losses. Our net losses were approximately $15.8 million and $8.9 million
for the years ended December 31, 2024 and 2023, respectively.

Our
net losses have resulted from costs incurred in developing the drug in our pipeline, planning and preparing for clinical trials and general
and administrative activities associated with our operations. We expect to continue to incur significant expenses and corresponding increased
operating losses for the foreseeable future as we continue to develop our pipeline. Our costs may further increase as we conduct clinical
trials and seek regulatory approval for and prepare to commercialize our product candidate. We expect to incur significant expenses to
continue to build the infrastructure necessary to support our expanded operations, clinical trials, commercialization, including manufacturing,
marketing, sales and distribution functions. We will also experience increased costs associated with operating as a public company.

55

Table of Contents

Basis
of Presentation

The
accompanying financial statements are presented in conformity with accounting principles generally accepted in the U.S. (“GAAP”)
and pursuant to the rules and regulations of the SEC.

Results
of Operations For the Years Ended December 31, 2024 and 2023

Research
and Development Expenses

Research
and development expenses increased by $5,253,407, or approximately 68%, to $12,952,029 for the year ended December 31, 2024 from $7,698,622
for the year ended December 31, 2023. The increase was primarily the result of increases in clinical expenses for the Phase III clinical
trial and the one-time upfront vesting of 25% of an options grant to employees, management and the board of directors.

General
and Administrative Expenses

General
and administrative expenses increased by $1,430,544, or approximately 88% to $3,059,788 for the year ended December 31, 2024 from $1,629,244
for the year ended December 31, 2023. The increase was primarily the result of the one-time upfront vesting of 25% of an options grant to employees, management
and the board of directors.

Liquidity
and Capital Resources

Since
our inception in 2006, we have devoted most of our cash resources to research and development and general and administrative activities.
We have not yet achieved commercialization of our product and have a cumulative net loss from our operations. We will continue to incur
net losses for the foreseeable future.

We
will require additional capital to meet our long-term operating requirements. We expect to raise additional capital through the sale
of equity and/or debt securities; however, there is no assurance that we will be successful at raising additional capital in the future.
If our plans are not achieved and/or if significant unanticipated events occur, we may have to further modify our business plan, which
may require us to raise additional capital. As of December 31, 2024 and December 31, 2023, our principal source of liquidity was our
cash, which totaled $4,091,990 and $6,989,424, respectively, and additional loans and accrued unreimbursed expenses from related parties.
Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related party
loans. Our principal uses of cash have included cash used in operations. We expect that the principal uses of cash in the future will
be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

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

Cash
Flow Activities for the Years Ended December 31, 2024 and 2023

We
incurred net losses of $15,788,809 and $8,891,803 during the years ended December 31, 2024 and 2023, respectively, and the increase was
primarily the result of increases in clinical expenses for the Phase III clinical trial and the one-time upfront vesting of 25% of an options grant to employees, management
and the board of directors.
Cash was $4,091,990 at December 31, 2024 and $6,989,424 at December 31, 2023 and decreased due to the following reasons:

Operating
Activities

Net
cash used in operating activities was $7,266,543 for the year ended December 31, 2024 and $6,478,602 for the year ended December 31,
2023. The increase was primarily the result of increases in clinical expenses for the Phase III clinical trial.

Investing
Activities

We
did not use or generate cash from investing activities during the year ended December 31, 2024 and December 31, 2023.

Financing
Activities

Net cash provided by financing activities was $4,369,109 during the year
ended December 31, 2024, attributable to the sale of common stock via the ATM program and a private placement. There
was no net cash provided by or used in financing activities during the year ended December 31, 2023.

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Table of Contents

Contractual
Obligations and Commitments

As
of December 31, 2024, we did not have any material contractual obligations, other than employment and shareholder agreements and the
license for GP2 from HJF.

Off-Balance
Sheet Arrangements

As
of December 31, 2024, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

Critical
Accounting Policies and Estimates

Our
financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect
the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and
the reported amounts of expenses in the periods presented.

On
an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts
of expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the
significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control
responses.

Recent
Adopted Accounting Pronouncements

In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments. The main objective of the standard is to provide financial statement users with more decision-useful information about the
expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date.
To achieve this objective, the amendments in this standard replace the incurred loss impairment methodology in current GAAP with a methodology
that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform
credit loss estimates. The update is effective for the Company beginning January 1, 2023 with early adoption permitted. The Company adopted
the standard on January 1, 2023. The adoption of this standard did not have a material effect on the Company’s audited consolidated
financial statements and related disclosures.

Recently
Issued Accounting Pronouncements Not Yet Adopted

In
October 2023, the FASB issued ASU 2023-06—Codification Amendments in Response to the SEC’s Disclosure Update and Simplification
Initiative. The main objective of the amendment is to modify the disclosure or presentation requirements of various Topics in the Codification.
Certain amendments represent clarifications to or technical corrections of the current requirements. to eliminate disclosure requirements
that were redundant, duplicative, overlapping, outdated, or superseded. The effective date for each amendment will be when the SEC’s
removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. The Company
is still evaluating the impact of the adoption of this standard.

JOBS
Act

On
April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take
advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (“Securities
Act”) for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay
the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for
complying with new or revised accounting standards.

Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including, without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public
Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We
will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the
completion of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during
the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

57

Table of Contents

ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We are a clinical-stage biopharmaceutical company focused on our Phase
III clinical trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell
surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+),
intermediate (2+), and high (3+ or over-expressor) levels. We have commenced Flamingo-01, a Phase III clinical trial, with plans to expand
into Europe and to open up to 150 sites globally. Flamingo-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2/neu
positive patients with residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant
and postoperative adjuvant trastuzumab based treatment.

To
date, we have not generated any revenue and we have incurred net losses. Our net losses were approximately $8.9 million and $7.8 million
for the years ended December 31, 2023 and 2022, respectively.

Our
net losses have resulted from costs incurred in developing the drug in our pipeline, planning and preparing for clinical trials and general
and administrative activities associated with our operations. We expect to continue to incur significant expenses and corresponding increased
operating losses for the foreseeable future as we continue to develop our pipeline. Our costs may further increase as we conduct clinical
trials and seek regulatory approval for and prepare to commercialize our product candidate. We expect to incur significant expenses to
continue to build the infrastructure necessary to support our expanded operations, clinical trials, commercialization, including manufacturing,
marketing, sales and distribution functions. We will also experience increased costs associated with operating as a public company.

Table of Contents

Basis
of Presentation

The
accompanying financial statements are presented in conformity with accounting principles generally accepted in the U.S. (“GAAP”)
and pursuant to the rules and regulations of the SEC.

Results
of Operations For the Years Ended December 31, 2023 and 2022

Research
and Development Expenses

Research
and development expenses increased by $1,222,954, or approximately 19%, to $7,698,622 for the year ended December 31, 2023 from $6,475,668
for the year ended December 31, 2022. The increase was primarily the result of increases in clinical expenses for the
Phase III clinical trial.

General
and Administrative Expenses

General
and administrative expenses increased by $64,658, or approximately 4% to $1,629,244 for the year ended December 31, 2023 from $1,564,586
for the year ended December 31, 2022. The increase was primarily the result of increases in stock-based compensation expense.

Liquidity
and Capital Resources

Since
our inception in 2006, we have devoted most of our cash resources to research and development and general and administrative activities.
We have not yet achieved commercialization of our product and have a cumulative net loss from our operations. We will continue to incur
net losses for the foreseeable future.

We
will require additional capital to meet our long-term operating requirements. We expect to raise additional capital through the sale
of equity and/or debt securities; however, there is no assurance that we will be successful at raising additional capital in the future.
If our plans are not achieved and/or if significant unanticipated events occur, we may have to further modify our business plan, which
may require us to raise additional capital. As of December 31, 2023 and December 31, 2022, our principal source of liquidity was our
cash, which totaled $6,989,424 and $13,468,026, respectively, and additional loans and accrued unreimbursed expenses from related parties.
Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related party
loans. Our principal uses of cash have included cash used in operations. We expect that the principal uses of cash in the future will
be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

Between January 1, 2024 and April 10, 2024, 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.

Cash
Flow Activities for the Years Ended December 31, 2023 and 2022

We
incurred net losses of $8,891,803 and $7,825,237 during the years ended December 31, 2023 and 2022, respectively, and the increase was
primarily the result of increases in clinical expenses for the Phase III clinical trial and increases in stock-based
compensation expense. Cash was $6,989,424 at December 31, 2023 and $13,468,026 at December 31, 2022 and decreased due to the following
reasons:

Operating
Activities

Net
cash used in operating activities was $6,478,602 for the year ended December 31, 2023 and $6,200,027 for the year ended December 31,
2022. The increase was primarily the result of increases in clinical expenses for the Phase III clinical trial.

Investing
Activities

We
did not use or generate cash from investing activities during the year ended December 31, 2023 and December 31, 2022.

Financing
Activities

There
was no net cash provided by or used in financing activities during the year ended December 31, 2023. Net cash used in financing activities
was $7,536,216 during the year ended December 31, 2022, attributable to the repurchase of common stock pursuant to the Company’s
stock repurchase program.

Table of Contents

Contractual
Obligations and Commitments

As
of December 31, 2023, we did not have any material contractual obligations, other than employment and shareholder agreements and the
license for GP2 from HJF.

Off-Balance
Sheet Arrangements

As
of December 31, 2023, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

Critical
Accounting Policies and Estimates

Our
financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect
the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and
the reported amounts of expenses in the periods presented.

On
an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts
of expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the
significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control
responses.

Recent
Adopted Accounting Pronouncements

In June 2016, the FASB issued ASU 2016-13, Financial Instruments –
Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The main objective of the standard is to provide financial
statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments
to extend credit held by a reporting entity at each reporting date. To achieve this objective, the amendments in this standard replace
the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration
of a broader range of reasonable and supportable information to inform credit loss estimates. The update is effective for the Company
beginning January 1, 2023 with early adoption permitted. The Company adopted the standard on January 1, 2023. The adoption of this standard
did not have a material effect on the Company’s audited consolidated financial statements and related disclosures.

Recently
Issued Accounting Pronouncements Not Yet Adopted

In
October 2023, the FASB issued ASU 2023-06—Codification Amendments in Response to the SEC’s Disclosure Update and Simplification
Initiative. The main objective of the amendment is to modify the disclosure or presentation requirements of various Topics in the Codification.
Certain amendments represent clarifications to or technical corrections of the current requirements. to eliminate disclosure requirements
that were redundant, duplicative, overlapping, outdated, or superseded. The effective date for each amendment will be when the SEC’s
removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. The Company
is still evaluating the impact of the adoption of this standard.

JOBS
Act

On
April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take
advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (“Securities
Act”) for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay
the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for
complying with new or revised accounting standards.

Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including, without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public
Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We
will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the
completion of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during
the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

Table of Contents

ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We
are a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences
in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell
surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+),
intermediate (2+), and high (3+ or over-expressor) levels. The combination of GP2 + GM-CSF is called GLSI-100. In a completed randomized,
single-blinded, placebo-controlled, multi-center Phase IIb clinical trial led by MD Anderson Cancer Center, no recurrences were observed
in patients treated with GLSI-100 in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patients were
treated, followed, and remained disease free over the first 6 months, which is the time required to reach peak immunity and thus maximum
efficacy and protection (p = 0.0338). For the 146 patients who have been treated with GLSI-100 to date over 4 clinical trials, treatment
was well tolerated and no serious adverse events were observed related to the immunotherapy. We
have commenced Flamingo-01, a Phase III clinical trial with Baylor College of Medicine as the global primary investigator site. Flamingo-01
is designed to evaluate the safety and efficacy of GLSI-100 in HER2/neu positive patients with residual disease or high-risk pathologic
complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment.

To
date, we have not generated any revenue and we have incurred net losses. Our net losses were approximately $7.8 million and $4.6 million
for the years ended December 31, 2022 and 2021, respectively.

Our
net losses have resulted from costs incurred in developing the drug in our pipeline, planning and preparing for clinical trials and general
and administrative activities associated with our operations. We expect to continue to incur significant expenses and corresponding increased
operating losses for the foreseeable future as we continue to develop our pipeline. Our costs may further increase as we conduct clinical
trials and seek regulatory approval for and prepare to commercialize our product candidate. We expect to incur significant expenses to
continue to build the infrastructure necessary to support our expanded operations, clinical trials, commercialization, including manufacturing,
marketing, sales and distribution functions. We will also experience increased costs associated with operating as a public company.

51

Table of Contents

Basis
of Presentation

The
accompanying financial statements are presented in conformity with accounting principles generally accepted in the U.S. (“GAAP”)
and pursuant to the rules and regulations of the SEC.

Results
of Operations For the Years Ended December 31, 2022 and 2021

Research
and Development Expenses

Research
and development expenses increased by $2,916,153, or approximately 82%, to $6,475,668 for the year ended December 31, 2022 from
$3,559,515 for the year ended December 31, 2021. The increase was primarily the result of increases in manufacturing and clinical
expenses for the Phase III clinical trial.

General
and Administrative Expenses

General
and administrative expenses increased by $526,158, or approximately 51% to $1,564,586 for the year ended December 31, 2022 from
$1,038,428 for the year ended December 31, 2021. The increase was primarily the result of increases in cash and stock-based compensation expense.

Liquidity
and Capital Resources

Since
our inception in 2006, we have devoted most of our cash resources to research and development and general and administrative activities.
We have not yet achieved commercialization of our product and have a cumulative net loss from our operations. We will continue to incur
net losses for the foreseeable future.

We
will require additional capital to meet our long-term operating requirements. We expect to raise additional capital through the sale
of equity and/or debt securities; however, there is no assurance that we will be successful at raising additional capital in the future.
If our plans are not achieved and/or if significant unanticipated events occur, we may have to further modify our business plan, which
may require us to raise additional capital. As of December 31, 2022 and December 31, 2021, our principal source of liquidity was our
cash, which totaled $13,468,026 and $27,204,269, respectively, and additional loans and accrued unreimbursed expenses from related parties.
Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related party
loans. Our principal uses of cash have included cash used in operations. We expect that the principal uses of cash in the future will
be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

Cash
Flow Activities for the Years Ended December 31, 2022 and 2021

We
incurred net losses of $7,825,237 and $4,570,576 during the years ended December 31, 2022 and 2021, respectively, and the increase was primarily the result of increases in manufacturing and clinical expenses for the Phase III clinical trial and increases
in cash and stock-based compensation expense. Cash
was $13,468,026 at December 31, 2022 and $27,204,269 at December 31, 2021 and decreased due to the following reasons:

Operating
Activities

Net
cash used in operating activities was $6,200,027 for the year ended December 31, 2022 and $4,291,548 for the year ended December 31,
2021. The increase was primarily the result of increases in manufacturing and clinical expenses for the Phase III clinical trial and increases
in cash compensation expense.

Investing
Activities

We
did not use or generate cash from investing activities during the year ended December 31, 2022 and December 31, 2021.

Financing
Activities

Net
cash used in financing activities was $7,536,216 during the year ended December 31, 2022, attributable to the repurchase of common stock pursuant to the Company’s stock repurchase program. Net cash
provided by financing activities was $2,835,442 during the year ended December 31, 2021, attributable to the exercise of the
underwriter’s over-allotment option from our follow-on offering and the partial exercise of underwriter warrants.

52

Table of Contents

Contractual
Obligations and Commitments

As
of December 31, 2022, we did not have any material contractual obligations, other than employment and shareholder agreements, license
for GP2 from HJF, manufacturing and clinical trial obligations related to the Phase III clinical trial.

Off-Balance
Sheet Arrangements

As
of December 31, 2022, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

Critical
Accounting Policies and Estimates

Our
financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect
the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and
the reported amounts of expenses in the periods presented.

On
an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts
of expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the
significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control
responses.

Recent
Accounting Pronouncements

In
February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which provides guidance requiring lessees
to recognize a right-of-use asset and a lease liability on the balance sheet for substantially all leases, with the exception of short-term
leases. Leases will be classified as either financing or operating, with classification affecting the pattern of expense recognition
in the statement of income. The Company adopted Topic 842 effective October 1, 2019 and elected the package of transition practical expedients
for expired or existing contracts, which does not require reassessment of: (1) whether any of the Company’s contracts are or contain
leases, (2) lease classification and (3) initial direct costs. In July 2018, the FASB issued ASU No. 2018-11, “Targeted Improvements
- Leases (Topic 842).” The Company did not elect the hindsight practical expedient. This update provides an optional transition
method that allows entities to elect to apply the standard using the modified retrospective approach at its effective date, versus recasting
the prior years presented. If this adoption method is elected, an entity would recognize a cumulative-effect adjustment to the opening
balance of retained earnings in the year of adoption. The Company elected this adoption method on October 1, 2019 and the adoption did
not result in any cumulative impact to retained earnings.

Additionally,
the Company’s adoption of Topic 842 did not have a significant impact on the recognition, measurement, or presentation of lease
expenses within the statements of operations or the statements of cash flows. The Company’s adoption of Topic 842 did not have
a material impact on the timing or amount of the Company’s sublease agreement.

In
January 2021, the Company early adopted ASU 2020-06 Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging
— Contracts in Entity’s Own Equity (Subtopic 815-40). ASU 2020-06 simplifies the accounting for convertible debt instruments
and convertible preferred stock by reducing the number of accounting models and limiting the number of embedded conversion features separately
recognized from the primary contract. The guidance also includes targeted improvements to the disclosures for convertible instruments
and earnings per share. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within
those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The adoption of
ASU 2020-06 did not have a material impact on the Company’s financial statements.

JOBS
Act

On
April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take
advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (“Securities
Act”) for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay
the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for
complying with new or revised accounting standards.

Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including, without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public
Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We
will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the
completion of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during
the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

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ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We are a clinical-stage biopharmaceutical
company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously
undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface receptor protein that
is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high
(3+ or over-expressor) levels. The combination of GP2 + GM-CSF is called GLSI-100. In a completed randomized, single-blinded,
placebo-controlled, multi-center Phase IIb clinical trial led by MD Anderson Cancer Center, no recurrences were observed in patients
treated with GLSI-100 in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patients were treated,
followed, and remained disease free over the first 6 months, which is the time required to reach peak immunity and thus maximum
efficacy and protection (p = 0.0338). For the 146 patients who have been treated with GLSI-100 to date over 4 clinical trials,
treatment was well tolerated and no serious adverse events were observed related to the immunotherapy. We are planning to commence
Flamingo-01, a Phase III clinical trial with Baylor College of Medicine as the global primary investigator site. Flamingo-01 is
designed to evaluate the safety and efficacy of GLSI-100 in HER2/neu positive patients with residual disease or high-risk
pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based
treatment. The Phase III clinical trial protocol including the patient population, trial size, statistical analysis plan, interim
analysis, adaptive features, and manufacturing information are still under discussion with the FDA and therefore subject to change.
We are also currently completing the last steps to manufacture GP2 clinical drug product and to open clinical sites.

To
date, we have not generated any revenue and we have incurred net losses. Our net losses were approximately $4.6 million and $1.9 million
for the years ended December 31, 2021 and 2020, respectively.

Our
net losses have resulted from costs incurred in developing the drug in our pipeline, planning and preparing for clinical trials and general
and administrative activities associated with our operations. We expect to continue to incur significant expenses and corresponding increased
operating losses for the foreseeable future as we continue to develop our pipeline. Our costs may further increase as we conduct clinical
trials and seek regulatory approval for and prepare to commercialize our product candidate. We expect to incur significant expenses to
continue to build the infrastructure necessary to support our expanded operations, clinical trials, commercialization, including manufacturing,
marketing, sales and distribution functions. We will also experience increased costs associated with operating as a public company.

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Basis
of Presentation

The
accompanying financial statements are presented in conformity with accounting principles generally accepted in the U.S. (“GAAP”) and pursuant to the rules and regulations of the SEC.

Results
of Operations For the Years Ended December 31, 2021 and 2020

Research
and Development Expenses

Research
and development expenses increased by $2,501,909, or 237%, to $3,559,515 for the year ended December 31, 2021 from $1,057,606 for the
year ended December 31, 2020. The increase was primarily the result of preparation of manufacturing and clinical activities for the planned
Phase III clinical trial.

General
and Administrative Expenses

General
and administrative expenses increased by $232,240, or 29% to $1,038,428 for the year ended December 31, 2021 from $806,188 for the year
ended December 31, 2020. The increase was primarily due to increase in finance and corporate activities.

Liquidity
and Capital Resources

Since
our inception in 2006, we have devoted most of our cash resources to research and development and general and administrative activities.
We have not yet achieved commercialization of our product and have a cumulative net loss from our operations. We will continue to incur
net losses for the foreseeable future. Our financial statements have been prepared assuming that we will continue as a going concern.

We
will require additional capital to meet our long-term operating requirements. We expect to raise additional capital through the sale
of equity and/or debt securities; however, there is no assurance that we will be successful at raising additional capital in the future.
If our plans are not achieved and/or if significant unanticipated events occur, we may have to further modify our business plan, which
may require us to raise additional capital. As of December 31, 2021 and December 31, 2020, our principal source of liquidity was our
cash, which totaled $27,204,269 and $28,660,375, respectively, and additional loans and accrued unreimbursed expenses from related parties.
Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related party
loans. Our principal uses of cash have included cash used in operations. We expect that the principal uses of cash in the future will
be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

Cash
Flow Activities for the Years Ended December 31, 2021 and 2020

We
incurred net losses of $4,570,576 and $1,862,962 during the years ended December 31, 2021 and 2020, respectively, and the increase was
primarily due to an increase in compensation expense, license expenses, clinical trial expenses, and the GMP manufacturing of GP2. Cash
was $28,660,375 at December 31, 2020 and $27,204,269 at December 31, 2021 and decreased due to the following reasons:

Operating
Activities

Net
cash used in operating activities was $4,291,548 for the year ended December 31, 2021 and $1,152,962 for the year ended December 31,
2020. The increase was primarily due to an increase in compensation expense, license expenses, clinical trial expenses, and the GMP manufacturing
of GP2.

Investing
Activities

We
did not use or generate cash from investing activities during the year ended December 31, 2021 and December 31, 2020.

Financing
Activities

Net cash provided by financing activities was $2,835,442
during the year ended December 31, 2021, attributable to the exercise of the underwriter’s over-allotment option from our
follow-on offering and the partial exercise of underwriter warrants. Net cash provided by financing activities was $29,806,502 during
the year ended December 31, 2020, attributable to the completion of our initial public offering and a follow-on offering.

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Contractual Obligations and Commitments

As
of December 31, 2021, we did not have any material contractual obligations, other than employment and shareholder agreements, license
for GP2 from HJF, and manufacturing and clinical trial obligations related to the planned Phase III clinical trial.

Off-Balance
Sheet Arrangements

As
of December 31, 2021, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

Critical
Accounting Policies and Estimates

Our
financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect
the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and
the reported amounts of expenses in the periods presented.

On
an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts
of expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the
significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control
responses.

Recent
Accounting Pronouncements

As of December 31, 2021, there were no recent
accounting pronouncements applicable to our business.

JOBS
Act

On
April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take
advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (“Securities
Act”) for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay
the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for
complying with new or revised accounting standards.

Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including, without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public
Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We
will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the
completion of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during
the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

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