What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-08-15 compared with 2022-05-20 · 43 added, 41 removed, 114 unchanged (42% of the section changed)

44 unchanged sentences

was well tolerated and no serious adverse events were observed related to the immunotherapy.

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

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.

have completed the last steps of manufacturing GP2 and released 3 clinical lots of GP2 drug product that we believe have met all release

specifications and are awaiting review of the manufacturing data by the FDA.

The third lot was manufactured in a commercial facility

on an automated filling line.

We are also scheduling site initiation visits to do the final training of the clinicians, nurses, coordinators,

and pharmacists to activate and open clinical sites.

The FDA previously informally asked us not to start the Phase III trial until we

submitted updated manufacturing information as our manufacturing information for the final drug product was incomplete and lots were

being tested for the first time.

The FDA formally asked us through a clinical hold letter not to start the trial until we provided such

manufacturing information.

As soon as the information was available, we provided it to the FDA and we are currently awaiting comments.

All hold issues were associated with manufacturing.

We along with our CRO continue to actively recruit and prepare sites for site initiation.

Please refer to related risk factors disclosed in our Form 10-K for the year ended December 31, 2021.

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 $1.9 million and $0.6 million for the three months ended March 31, 2022

and 2021, respectively.

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.

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 and $2.7 million and $1.3 million for the six months ended June 30, 2022 and 2021, 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 March 31, 2022 and 2021

of Operations for the Three Months Ended June 30, 2022 and 2021

and Development Expenses

and development expenses increased by $1,378,844, or 489%, to $1,660,821 for the three months ended March 31, 2022 from $281,977 for

the three months ended March 31, 2021.

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

Research and development expenses

increased by $76,716 or 14%, to $633,250 for the three months ended June 30, 2022 from $556,534 for the three months ended June 30, 2021.

The increase was primarily the result of an increase in cash compensation.

General and Administrative Expenses

General and administrative expenses decreased by $56,854, or 29%, to $140,057

for the three months ended June 30, 2022 from $196,911 for the three months ended June 30, 2021.

The decrease was primarily the result

of a decrease in financing and corporate costs.

Results of Operations for the Six Months Ended

June 30, 2022 and 2021

Research and Development Expenses

Research and development expenses increased by $1,455,560, or 174%, to

$2,294,071 for the six months ended June 30, 2022 from $838,511 for the six months ended June 30, 2021.

The increase was primarily the

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

and Administrative Expenses

and administrative expenses increased by $9,753, or 3%, to $328,382 for the three months ended March 31, 2022 from $318,629 for

the three months ended March 31, 2021.

General and administrative expenses decreased by $47,101, or 9%, to $468,439

for the six months ended June 30, 2022 from $515,540 for the six months ended June 30, 2021.

The decrease was primarily the result of

a decrease in financing and corporate costs.

and Capital Resources

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may require us to raise additional capital.

As of March 31, 2022 and December 31, 2021, our principal source of liquidity was our cash,

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

which totaled $17,187,890 and $27,204,269, respectively, and additional loans and accrued unreimbursed expenses from related parties.

3 unchanged sentences

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, 2022 and 2021

incurred net losses of $1,969,628 and $597,008 during the three month periods ended March 31, 2022 and 2021, respectively.

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

cash used in operating activities was $1,947,462 for the three months ended March 31, 2022 and $528,270 for the three months ended March

did not use or generate cash from investing activities during the three months ended March 31, 2022 and March 31, 2021.

used a total of $5,513,711 cash for the stock buy back program, net of costs, during the three months ended March 31, 2022 and

used and generated cash netting a total of $2,272,846 from financing activities during the three months ended March 31, 2021.

Flow Activities for the Six Months Ended June 30, 2022 and 2021

We incurred net losses of $2,715,701 and $1,346,753 during the six month

periods ended June 30, 2022 and 2021, respectively.

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

and manufacturing expenses.

Net cash used in operating activities

was $2,480,163 for the six months ended June 30, 2022 and $1,132,589 for the six months ended June 30, 2021.

We did not use or generate cash

from investing activities during the six months ended June 30, 2022 and June, 2021.

We used a total of $7,536,216

cash for the stock buy back program, net of costs, during the six months ended June 30, 2022 and used and generated cash netting a total

of $2,272,846 from financing activities during the six months ended June 30, 2021.

Obligations and Commitments

of March 31, 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 related to the planned Phase III clinical trial.

GP2 from HJF, and manufacturing and clinical trial obligations.

Sheet Arrangements

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

of June 30, 2022, 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 December 31, 2021, there were no recent accounting pronouncements applicable to our business.

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

April 5, 2012, the JOBS Act was enacted.

24 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