What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-08-14 compared with 2025-05-20 · 93 added, 93 removed, 102 unchanged (65% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT’S DISCUSSION AND

ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

This Quarterly Report on Form

10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities

This Quarterly Report on

Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities

Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

9 unchanged sentences

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

In 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, 2024, filed on April 15, 2025.

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.

You should not rely upon forward-looking

statements as predictions of future events.

We cannot assure you that the events and circumstances reflected in the forward-looking statements

will be achieved or occur.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot

guarantee future results, levels of activity, performance or achievements.

The following discussion and

analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the financial

statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q.

This discussion should not be construed to

imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily

In 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, 2024, filed on April 15, 2025.

Moreover, we operate in a very competitive and rapidly changing

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.

You should not rely upon

forward-looking statements as predictions of future events.

We cannot assure you that the events and circumstances reflected in the forward-looking

statements will be achieved or occur.

Although we believe that the expectations reflected in the forward-looking statements are reasonable,

we cannot guarantee future results, levels of activity, performance or achievements.

The following discussion

and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the

financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q.

This discussion should not be construed

to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily

be indicative of actual operating results in the future.

13 unchanged sentences

Our net losses were approximately $15.8 million and $8.9 million for the years ended December

31, 2024 and 2023, respectively and $3.3 million and $2.5 million for the three months ended March 31, 2025 and 2024, respectively.

31, 2024 and 2023, respectively and $7.3 million and $5.1 million for the six months ended June 30, 2025 and 2024, respectively.

Our net losses have resulted

9 unchanged sentences

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

Results of Operations for the Three Months Ended

March 31, 2025 and 2024

Research and Development Expenses

Results of Operations for the Three Months

Ended June 30, 2025 and 2024

Research and Development Expenses

increased by $406,609, or 19%, to $2,601,122 for the three months ended March 31, 2025 from $2,194,513 for the three months ended March

The increase was primarily the result of an options grant

to employees, management and the board of directors.

Research and development

expenses increased by $1,200,033 or 52%, to $3,507,906 for the three months ended June 30, 2025 from $2,307,873 for the three months

ended June 30, 2024.

The increase was primarily the result of an options grant to employees, management, and the board of directors

and an increase in clinical expenses.

General and Administrative Expenses

administrative expenses in creased by $184,516, or

52%, to $538,047 for the three months ended June 30, 2025 from $353,531 for the three months ended June 30, 2024.

The increase was primarily the result of an options grant to employees, management, and the board of directors.

Results of Operations for the Six Months Ended

June 30, 2025 and 2024

Research and Development Expenses

Research and development

expenses increased by $1,606,642, or 36%, to $6,109,028 for the six months ended June 30, 2025 from $4,502,386 for the six months ended

June 30, 2024.

The increase was primarily the result of an options grant to employees, management, and the board of directors and an

increase in clinical expenses.

General and Administrative Expenses

in creased by $338,522, or 99%, to $681,210 for the three months ended March 31, 2025 from $342,688 for the three months ended March 31,

General and administrative

expenses increased by $523,038, or 75%, to $1,219,257 for the six months ended June 30, 2025 from $696,219 for the six months ended June

The increase was primarily the result of an options grant to employees, management, and the board of directors.

6 unchanged sentences

Our financial statements have been prepared assuming that we will continue as a going concern.

We will require additional capital

to meet our long-term operating requirements.

We will require additional

capital to meet our long-term operating requirements.

We expect to raise additional capital through the sale of equity and/or debt securities;

2 unchanged sentences

and/or if significant unanticipated events occur, we may have to further modify our business plan, which may require us to raise additional

As of March 31, 2025 and December 31, 2024, our principal source of liquidity was our cash, which totalled $2,749,959 and $4,091,990,

As of June 30, 2025 and December 31, 2024, our principal source of liquidity was our cash, which totaled $3,125,101 and $4,091,990,

respectively, and additional loans and accrued unreimbursed expenses from related parties.

5 unchanged sentences

and development, including our clinical trials, and general working capital requirements.

Cash Flow Activities for the Three Months Ended

March 31, 2025 and 2024

Cash Flow Activities for the Six Months

Ended June 30, 2025 and 2024

We incurred net losses of

and $2,473,195 during the three month periods ended March 31, 2025 and 2024, respectively.

The increase was primarily the result of an options grant to employees, management and the board of directors.

$7,283,640 and $5,079,877 during the six month periods ended June 30, 2025 and 2024, respectively.

The increase was primarily the result

of an options grant to employees, management, and the board of directors and an increase in clinical expenses.

Operating Activities

Net cash used in operating activities

was $1,834,454 for the three months ended March 31, 2025 and $1,782,565 for the three months ended March 31, 2024.

Net cash used in operating

activities was $4,067,557 for the six months ended June 30, 2025 and $2,830,405 for the six months ended June 30, 2024.

Investing Activities

We did not use or generate cash

from investing activities during the three months ended March 31, 2025 and 2024.

We did not use or generate

cash from investing activities during the six months ended June 30, 2025 and 2024.

Financing Activities

Between January 1, 2025 and March 31, 2025, the Company

completed At The Market (“ATM”) offerings pursuant to its ATM agreement with H.

Wainwright, in which it issued and sold

Between January 1, 2025 and

June 30, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with H.

in which it issued and sold a total of 320,210 shares of its common stock at an average offering price of $9.95 per share for gross proceeds

of $3,185,661 and net proceeds of $3,100,668, after deducting underwriting discounts and commissions and offering expenses borne by the

Company, which totaled $84,993.

Between January 1, 2024 and

June 30, 2024, the Company sold shares of its common stock pursuant to its ATM agreement with Jefferies, in which it issued and sold

a total of 44,697 shares of its common stock at an average offering price of $14.07 per share for gross proceeds of $628,732 and net

proceeds of $492,423, after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totalled

Between 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 $12.26 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, 2025 and May 9, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with H.

Wainwright, in which it issued and sold a total of 175,657 shares of its common stock at an average offering price of $9.58 per share

for gross proceeds of $1,682,893 and net proceeds of $1,635,498, after deducting underwriting discounts and commissions and offering

expenses borne by the Company, which totalled $47,395.

proceeds of $565,858, after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totaled

Between July 1, 2025 and

July 28, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with H.

in which it issued and sold a total of 157,318 shares of its common stock at an average offering price of $10.49 per share for gross

proceeds of $1,650,575 and net proceeds of $1,601,059, after deducting underwriting discounts and commissions and offering expenses borne

by the Company, which totaled $49,516.

Contractual Obligations and Commitments

As of March 31, 2025, we did

As of June 30, 2025, we did

not have any material contractual obligations, other than employment and shareholder agreements and the license for GP2 from HJF.

Off-Balance Sheet Arrangements

As of March 31, 2025, we did

As of June 30, 2025, we did

not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

Critical Accounting Policies and Estimates

Our financial statements are

prepared in conformity with U.S.

Our financial statements

are prepared in conformity with U.S.

GAAP, which require the use of estimates, judgments and assumptions that affect the reported amounts

10 unchanged sentences

Recent Adopted Accounting Pronouncements

In June 2016, the FASB issued

ASU 2016-13, Financial Instruments – Credit Losses (Topic 326):

Measurement of Credit Losses on Financial Instruments.

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.

Recently Issued Accounting Pronouncements Not

In October 2023, the FASB issued

ASU 2023-06—Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative.

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.

The Company is still evaluating the impact of

the adoption of this standard.

On April 5, 2012, the JOBS Act

Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition

period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (“Securities Act”) for complying with new

or revised accounting standards.

In other words, an “emerging growth company” can delay the adoption of certain accounting

standards until those standards would otherwise apply to private companies.

Recently Issued Accounting Pronouncements

Not Yet Adopted

In October 2023, the FASB

issued ASU 2023-06—Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative.

main objective of the amendment is to modify the disclosure or presentation requirements of various Topics in the Codification.

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.

On April 5, 2012, the JOBS

Act was enacted.

Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended

transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (“Securities Act”) for complying

with new or revised accounting standards.

In other words, an “emerging growth company” can delay the adoption of certain

accounting standards until those standards would otherwise apply to private companies.

We have chosen to take advantage

18 unchanged sentences

ABOUT MARKET RISK

We are a smaller reporting company,

as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information required

under this Item 3.

We are a smaller reporting

company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information

required under this Item 3.

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