What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-05-20 compared with 2023-10-19 · 66 added, 68 removed, 96 unchanged (58% of the section changed)

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These forward-looking statements are subject to a number of risks, uncertainties and assumptions.

addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors”

in the Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 31, 2023 and updated in Item 1A below.

Moreover, we operate in a very

competitive and rapidly changing environment.

New risk factors emerge from time to time and it is not possible for us to predict all

risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of

factors, may cause actual results to differ materially from those contained in any forward-looking statements.

addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in

the Annual Report on Form 10-K for the year ended December 31, 2023, filed on April 15, 2024.

Moreover, we operate in a very competitive

and rapidly changing environment.

New risk factors emerge from time to time and it is not possible for us to predict all risk factors,

nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual

results to differ materially from those contained in any forward-looking statements.

should not rely upon forward-looking statements as predictions of future events.

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assessment of our management.

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.

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.

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.

have commenced Flamingo-01, a Phase III clinical trial with Baylor College of Medicine as the global primary investigator site.

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.

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.

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, 2022 and 2021, respectively and $6.1 million and $5.0 million for the nine months ended September 30,

for the years ended December 31, 2023 and 2022, respectively and $2.5 million and $2.1 million for the three months ended March 31, 2024

and 2023, respectively.

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We will also experience increased costs associated with operating as a public company.

of Operations for the Three Months Ended September 30, 2023 and 2022

and Development Expenses

and development expenses increased by $434,674, or 25%, to $2,158,167 for the three months ended September 30, 2023 from $1,723,493 for

the three months ended September 30, 2022.

The increase was primarily the result of an increase in clinical expenses.

and Administrative Expenses

and administrative expenses decreased by $314,810, or 48%, to $344,758 for the three months ended September 30, 2023 from $659,568 for

the three months ended September 30, 2022.

The decrease was primarily the result of a decrease in compensation, financing, and corporate

of Operations for the Nine Months Ended September 30, 2023 and 2022

of Operations for the Three Months Ended March 31, 2024 and 2023

and Development Expenses

Research and development expenses

increased by $1,348,077, or 34%, to $5,365,641 for the nine months ended September 30, 2023 from $4,017,564 for the nine months ended

September 30, 2022.

The increase was primarily the result of an increase in clinical expenses.

General and Administrative Expenses

increased by $ 366,606 , or 20 %,

to $ 2,194,513 for the three months ended March 31, 2024 from $1,827,907 for the three months ended March 31, 2023.

was primarily the result of an increase in clinical expenses.

and Administrative Expenses

General and administrative expenses

decreased by $1,815 to $1,126,192 for the nine months ended September 30, 2023 from $1,128,007 for the nine months ended September 30,

decreased by $ 70,487 , or 17%, to $ 342,688

for the three months ended March 31, 2024 from $413,175 for the three months ended March 31, 2023.

and Capital Resources

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may require us to raise additional capital.

As of September 30, 2023 and December 31, 2022, our principal source of liquidity was our

cash, which totaled $9,143,619 and $13,468,026, respectively, and additional loans and accrued unreimbursed expenses from related parties.

As of March 31, 2024 and December 31, 2023, our principal source of liquidity was our cash,

which totalled $5,505,975 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

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be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

The Company’s existing cash resources are expected to provide sufficient funds to carry the Company’s planned operations

over the next 12 months from the date these financial statements were issued.

Flow Activities for the Nine Months Ended September 30, 2023 and 2022

incurred net losses of $6,145,064 and $5,034,725 during the nine month periods ended September 30, 2023 and 2022, respectively.

was primarily the result of an increase in clinical expenses.

cash used in operating activities was $4,324,407 for the nine months ended September 30, 2023 and $4,029,966 for the nine months ended

September 30, 2022.

did not use or generate cash from investing activities during the nine months ended September 30, 2023 and September 30, 2022.

used a total of $0 and $7,536,216 cash for the stock buy back program, net of costs, during the nine months ended September 30, 2023

and September 30, 2022, respectively.

Flow Activities for the Three Months Ended March 31, 2024 and 2023

We incurred net losses of $ 2,473,195

and $2,124,902 during the three month periods ended March 31, 2024 and 2023, respectively.

The increase was primarily the result of an

increase in cash compensation, clinical, and manufacturing expenses.

cash used in operating activities was $1,782,565 for the three months ended March 31, 2024 and $1,556,807 for the three months ended

March 31, 2023.

did not use or generate cash from investing activities during the three months ended March 31, 2024 and 2023.

January 1, 2024 and March 31, 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 27,117 shares of its common stock at an average offering price of $ 12.

per share for gross proceeds of $ 332,351 and net proceeds of $ 299,116,

after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totalled $ 33,235 .

April 1, 2024 and May 8, 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 4,713 shares of its common stock at an average offering price of $17.08 per share for gross proceeds

of $ 80,482 and net proceeds of $ 72,434, after

deducting underwriting discounts and commissions and offering expenses borne by the Company, which totalled $ 8,049 .

Obligations and Commitments

of September 30, 2023, 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.

of March 31, 2024, we did not have any material contractual obligations, other than employment and shareholder agreements and the license

for GP2 from HJF.

Sheet Arrangements

of September 30, 2023, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

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

Accounting Policies and Estimates

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significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control

Accounting Pronouncements

June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial

Instruments - Credit Losses (Topic 326):

Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”).

2016-13 requires companies to measure credit losses utilizing a methodology that reflects expected credit losses and requires a consideration

of a broader range of reasonable and supportable information to inform credit loss estimates.

ASU 2016-13 is effective for fiscal years

beginning after December 15, 2022, including interim periods within those fiscal years.

The Company adopted ASU 2016-13 effective January

The Company determined that the update applied to trade receivables, but that there was no material impact to the consolidated

financial statements from the adoption of ASU 2016-13.

time to time, new accounting pronouncements are issued by the Financial Accounting Standard Board or other standard setting bodies that

the Company adopts as of the specified effective date.

The Company does not believe that the impact of recently issued standards that

are not yet effective will have a material impact on the Company’s financial position or results of operations upon adoption.

Adopted Accounting Pronouncements

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 financial statements and related disclosures.

Issued Accounting Pronouncements Not Yet Adopted

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

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.

is still evaluating the impact of the adoption of this standard.

April 5, 2012, the JOBS Act was enacted.

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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-Q

Item 2. Management’s Discussion and Analysis