What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-10-19 compared with 2023-08-21 · 52 added, 58 removed, 112 unchanged (50% of the section changed)

12 unchanged sentences

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.

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, 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.

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

28 unchanged sentences

Our net losses were approximately $7.8 million and $4.6 million

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

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,

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 June 30, 2023 and 2022

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

and Development Expenses

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 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 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 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

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.

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

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,

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

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.

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 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.

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.

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.

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 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.

Obligations and Commitments

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.

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.

Sheet Arrangements

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

of September 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

In June 2016, the Financial Accounting

Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial Instruments - Credit Losses (Topic 326):

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”).

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.

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.

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