What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-04-15 compared with 2024-04-15 · 34 added, 34 removed, 105 unchanged (39% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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.

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

21 unchanged sentences

for the year ended December 31, 2023.

The increase was primarily the result of increases in clinical expenses for the

Phase III clinical trial.

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.

and Administrative Expenses

1 unchanged sentence

for the year ended December 31, 2023.

The increase was primarily the result of increases in stock-based compensation expense.

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.

and Capital Resources

15 unchanged sentences

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 .

January 1, 2025 and April 11 , 2025, the Company completed At The Market (“ATM”)

offerings pursuant to its ATM agreement with H.

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.

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

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 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

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:

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,

1 unchanged sentence

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

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.

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.

Obligations and Commitments

15 unchanged sentences

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.

June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326):

Measurement of Credit Losses on Financial

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.

Issued Accounting Pronouncements Not Yet Adopted

37 unchanged sentences

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