What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-08-21 compared with 2023-05-22 · 54 added, 37 removed, 116 unchanged (44% of the section changed)

45 unchanged sentences

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.

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 $7.8 million and $4.6 million

for the years ended December 31, 2022 and 2021, respectively and $2.1 million and $1.9 million for the three months ended March 31,

for the years ended December 31, 2022 and 2021, respectively and $3.8 million and $2.7 million for the six months ended June 30, 2023

and 2022, respectively.

9 unchanged sentences

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

of Operations for the Three Months Ended March 31, 2023 and 2022

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

and Development Expenses

and development expenses increased by $167,086, or 10%, to $1,827,907 for the three months ended March 31, 2023 from $1,660,821 for the

three months ended March 31, 2022.

The increase was primarily the result of an increase in cash compensation, clinical, and manufacturing

and development expenses increased by $746,317 or 118%, to $1,379,567 for the three months ended June 30, 2023 from $633,250 for the three

months ended June 30, 2022.

The increase was primarily the result of an increase in compensation, clinical, and manufacturing expenses.

and Administrative Expenses

and administrative expenses increased by $84,793, or 26%, to $413,175 for the three months ended March 31, 2023 from $328,382 for the

three months ended March 31, 2022.

and administrative expenses in creased by $228,202, or 163%, to $368,259 for the three months ended June 30, 2023 from

$140,057 for the three months ended June 30, 2022.

The increase was primarily the result of an in crease

in compensation, financing, and corporate expenses.

of Operations for the Six Months Ended June 30, 2023 and 2022

and Development Expenses

and development expenses increased by $913,403, or 40%, to $3,207,474 for the six months ended June 30, 2023 from $2,294,071 for the

six months ended June 30, 2022.

The increase was primarily the result of an increase in compensation, clinical, and manufacturing

and Administrative Expenses

and administrative expenses increased by $312,995, or 67%, to $781,434 for the six months ended June 30, 2023 from $468,439 for the six

months ended June 30, 2022.

The increase was primarily the result of an increase in compensation, financing, and corporate expenses.

and Capital Resources

7 unchanged sentences

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 March 31, 2023 and December 31, 2022, our principal source of liquidity was our cash,

which totaled $11,911,219 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.

Flow Activities for the Three Months Ended March 31, 2023 and 2022

incurred net losses of $2,124,902 and $1,969,628 during the three month periods ended March 31, 2023 and 2022, respectively.

was primarily the result of an increase in cash compensation, clinical, and manufacturing expenses.

cash used in operating activities was $1,556,807 for the three months ended March 31, 2023 and $1,947,462 for the three months ended March

did not use or generate cash from investing activities during the three months ended March 31, 2023 and March 31, 2022.

used a total of $0 and $5,513,711 cash for the stock buy back program, net of costs, during the three months ended March 31, 2023

and March 31, 2022, respectively.

however, there is no assurance that we will be successful at raising additional capital in the

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 June 30, 2023 and December 31, 2022, our principal source of liquidity

was our cash, which totaled $10,944,242 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.

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 Six Months Ended June 30, 2023 and 2022

incurred net losses of $3,753,275 and $2,715,701 during the six month periods ended June 30, 2023 and 2022, respectively.

increase was primarily the result of an increase in compensation, clinical, manufacturing, financing, and corporate expenses.

cash used in operating activities was $2,523,784 for the six months ended June 30, 2023 and $2,480,163 for the six months ended June

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

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

30, 2022, respectively.

Obligations and Commitments

of March 31, 2023, we did not have any material contractual obligations, other than employment and shareholder agreements, license for

of June 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 related to the planned Phase III clinical trial.

Sheet Arrangements

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

of June 30, 2023, 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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Accounting Pronouncements

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

Instruments - Credit Losses (Topic 326):

In 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.

ASU 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 1, 2023.

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.

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

28 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-Q

Item 2. Management’s Discussion and Analysis