What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-05-22 compared with 2022-11-14 · 43 added, 42 removed, 110 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 $4.6 million and $1.9

million for the years ended December 31, 2021 and 2020, respectively and $5.0 million and $2.2 million for the nine months ended

September 30, 2022 and 2021, respectively.

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,

2023 and 2022, respectively.

net losses have resulted from costs incurred in developing the drug in our pipeline, planning and preparing for clinical trials and general

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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, 2022 and 2021

and Development Expenses

and development expenses increased by $1,066,397, or 162%, to $1,723,493 for the three months ended September 30, 2022 from $657,096

for the three months ended September 30, 2021.

The increase was primarily the result of an increase in stock

compensation, clinical, and manufacturing expenses.

and Administrative Expenses

and administrative expenses increased by $449,978, or 215%, to $659,568 for the three months ended September 30, 2022 from $209,590

for the three months ended September 30, 2021.

The increase was primarily the result of an increase in stock compensation and

financing expenses.

of Operations for the Nine Months Ended September 30, 2022 and 2021

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

and Development Expenses

and development expenses increased by $2,521,957, or 169%, to $4,017,564 for the nine months ended September 30, 2022 from $1,495,607

for the nine months ended September 30, 2021.

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

manufacturing 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 Administrative Expenses

and administrative expenses increased by $402,877, or 56%, to $1,128,007 for the nine months ended September 30, 2022 from $725,130 for

the nine months ended September 30, 2021.

The increase was primarily the result of an increase in stock compensation and financing 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 Capital Resources

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may require us to raise additional capital.

As of September 30, 2022 and December 31, 2021, our principal source of liquidity was our

cash, which totaled $15,638,087 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

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 Nine Months Ended September 30, 2022 and 2021

incurred net losses of $5,034,725 and $2,209,871 during the nine month periods ended September 30, 2022 and 2021, respectively.

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

cash used in operating activities was $4,029,966 for the nine months ended September 30, 2022 and $2,027,228 for the nine months ended

September 30, 2021.

did not use or generate cash from investing activities during the nine months ended September 30, 2022 and September 30, 2021.

used a total of $7,536,216 cash for the stock buy back program, net of costs, during the nine months ended September 30, 2022 and used

and generated cash netting a total of $2,272,846 from financing activities during the nine months ended September 30, 2021.

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.

Obligations and Commitments

of September 30, 2022, 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, 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 September 30, 2022, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

of March 31, 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

of September 30, 2022, there were no recent accounting pronouncements applicable to our business.

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.

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