What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-11 compared with 2026-06-04 · 53 added, 49 removed, 129 unchanged (44% of the section changed)

14 unchanged sentences

the Annual Report on Form 10-K for the year ended December 31, 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.

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.

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

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date, we have not generated any revenue and we have incurred net losses.

Our net losses were approximately $19.4 million and $17.4

million for the years ended December 31, 2025 and 2024, respectively and $5.7 million and $2.7 million for the three months ended

March 31, 2026 and 2025, respectively.

Our net losses were approximately $19.4 million and $17.4 million

for the years ended December 31, 2025 and 2024, respectively and $9.6 million and $6.5 million for the six months ended June 30, 2026

and 2025, 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, 2026 and 2025

of Operations for the Three Months Ended June 30, 2026 and 2025

and Development Expenses

and development expenses increased by $2,936,416, or 129%, to $5,207,564 for the three months ended March 31, 2026 from $2,271,148 for

the three months ended March 31, 2025.

The increase was primarily the result of an increase in accounts payable for clinical trial expenses.

and development expenses increased by $142,237 or 4%, to $3,558,714 for the three months ended June 30, 2026 from $3,416,477 for the

three months ended June 30, 2025.

The increase was primarily the result of an increase in clinical expenses.

and Administrative Expenses

and administrative expenses increased by $20,588, or 4%, to $518,190 for the three months ended March 31, 2026 from $497,602 for the

three months ended March 31, 2025.

and administrative expenses increased by $110,093, or 31%, to $462,931 for the three months ended June 30, 2026 from $352,838 for the

three months ended June 30, 2025.

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

of Operations for the Six Months Ended June 30, 2026 and 2025

and Development Expenses

and development expenses increased by $3,078,653, or 54%, to $8,766,278 for the six months ended June 30, 2026 from $5,687,625 for the

six months ended June 30, 2025.

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

directors and an increase in clinical expenses.

and Administrative Expenses

and administrative expenses increased by $130,681, or 15%, to $981,121 for the six months ended June 30, 2026 from $850,440 for the

six months ended June 30, 2025.

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

and Capital Resources

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may require us to raise additional capital.

As of March 31, 2026 and December 31, 2025, our principal source of liquidity was our cash,

which totalled $10,505,435 and $6,178,021, 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 Three Months Ended March 31, 2026 and 2025

incurred net losses of $5,657,137 and $2,744,780 during the three month periods ended March 31, 2026 and 2025, respectively.

increase was primarily the result of an increase in accounts payable for clinical

trial expenses.

cash used in operating activities was $4,702,498 for the three months ended March 31, 2026 and $1,834,454 for the three months ended

March 31, 2025.

The increase was primarily the result of an increase in clinical trial expenses.

did not use or generate cash from investing activities during the three months ended March 31, 2026 and 2025.

January 1, 2026 and March 31, 2026, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement

Wainwright, in which it issued and sold a total of 367,547 shares of its common stock at an average offering price of

$25.33 per share for gross proceeds of $9,309,189 and net proceeds of $9,029,912, after deducting underwriting discounts and

commissions and offering expenses borne by the Company, which totalled $279,277.

January 1, 2025 and March 31, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with

As of June 30, 2026 and December 31, 2025, our principal source of liquidity was our cash,

which totaled $8,876,353 and $6,178,021, 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 Six Months Ended June 30, 2026 and 2025

incurred net losses of $9,605,812 and $6,493,420 during the six month periods ended June 30, 2026 and 2025, respectively.

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

cash used in operating activities was $6,642,244 for the six months ended June 30, 2026 and $4,067,557 for the six months ended June

did not use or generate cash from investing activities during the six months ended June 30, 2026 and 2025.

January 1, 2026 and June 30, 2026, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with

Wainwright, in which it issued and sold a total of 379,762 shares of its common stock at an average offering price of $25.36 per

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expenses borne by the Company, which totalled $288,892.

April 1, 2026 and April 15, 2026, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with

January 1, 2025 and June 30, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with

Wainwright, 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 totalled $9,615.

expenses borne by the Company, which totaled $84,993.

Obligations and Commitments

of March 31, 2026, we did not have any material contractual obligations, other than employment and shareholder agreements and the license

of June 30, 2026, we did not have any material contractual obligations, other than employment and shareholder agreements and the license

for GP2 from HJF.

Sheet Arrangements

of March 31, 2026, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

of June 30, 2026, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

Accounting Policies and Estimates

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 of assets and liabilities, the disclosure of contingent liabilities at the date of the

financial statements, and the reported amounts of expenses in the periods presented.

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based

compensation.

We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the

circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported

amounts of expenses that are not readily apparent from other sources.

Actual results could differ from those estimates, particularly given

the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control

There are no critical accounting policies or estimates for the year ended December 31, 2025 and three months ended March 31,

financial statements are prepared in conformity with U.S.

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

the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and

the reported amounts of expenses in the periods presented.

an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation.

We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,

the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts

of expenses that are not readily apparent from other sources.

Actual results could differ from those estimates, particularly given the

significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control

There are no critical accounting policies or estimates for the year ended December 31, 2025 and three months ended June 30,

Adopted Accounting Pronouncements

56 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