What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-06-04 compared with 2025-11-14 · 79 added, 71 removed, 99 unchanged (60% of the section changed)

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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.

the Annual Report on Form 10-K for the year ended December 31, 2025.

Moreover, we operate in a very competitive

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

Our net losses were approximately $15.8 million and $8.9 million

for the years ended December 31, 2024 and 2023, respectively and $11.4 million and $7.7 million for the nine months ended September 30,

2025 and 2024, respectively.

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.

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, 2025 and 2024

and Development Expenses

and development expenses increased by $1,229,536 or 54%, to $3,521,576 for the three months ended September 30, 2025 from $2,292,040

for the three months ended September 30, 2024.

The increase was primarily the result of an options grant to employees and management working on research and development activities and

an increase in clinical expenses.

and Administrative Expenses

and administrative expenses increased by $216,055, or 49%, to $653,066 for the three months ended September 30, 2025 from $437,011 for

the three months ended September 30, 2024.

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

board of directors.

of Operations for the Nine Months Ended September 30, 2025 and 2024

of Operations for the Three Months Ended March 31, 2026 and 2025

and Development Expenses

and development expenses increased by $2,836,178, or 42%, to $9,630,604 for the nine months ended September 30, 2025 from $6,794,426

for the nine months ended September 30, 2024.

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

working on research and development activities and an increase in clinical 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 Administrative Expenses

and administrative expenses increased by $739,093, or 65%, to $1,872,323 for the nine months ended September 30, 2025 from $1,133,230

for the nine months ended September 30, 2024.

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

the board of directors.

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 Capital Resources

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may require us to raise additional capital.

As of September 30, 2025 and December 31, 2024, our principal source of liquidity was our

cash, which totaled $3,806,978 and $4,091,990, respectively, and additional loans and accrued unreimbursed expenses from related parties.

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

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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, 2025 and 2024

incurred net losses of $11,435,485 and $7,748,590 during the nine month periods ended September 30, 2025 and 2024, 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 $6,738,796 for the nine months ended September 30, 2025 and $5,414,337 for the nine months ended

September 30, 2024.

did not use or generate cash from investing activities during the nine months ended September 30, 2025 and 2024.

In September 2025, the remaining

underwriter warrants were exercised resulting in the issuance of 20,174 shares of common stock and gross proceeds to the Company of $145,000.

Between January 1, 2025 and September 30, 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 621,674 shares of its common stock at an average offering price

of $10.44 per share for gross proceeds of $6,492,994 and net proceeds of $6,308,784, after deducting underwriting discounts and commissions

and offering expenses borne by the Company, which totaled $184,210.

January 1, 2024 and September 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 121,663 shares of its common stock at an average offering price of $15.96 per share for gross proceeds

of $1,941,424 and net proceeds of $1,747,282, after deducting underwriting discounts and commissions and offering expenses borne by the

Company, which totaled $194,142.

Between October

1, 2025 and October 28, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with

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

per share for gross proceeds of $631,362 and net proceeds of $612,420, after deducting underwriting discounts and commissions and

offering expenses borne by the Company, which totaled $18,942.

$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

Wainwright, in which it issued and sold a total of 39,918 shares of its common stock at an average offering price of $12.52 per

share for gross proceeds of $499,936 and net proceeds of $492,423, after deducting underwriting discounts and commissions and offering

expenses borne by the Company, which totalled $7,513.

April 1, 2026 and April 15, 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 12,215 shares of its common stock at an average offering price of $26.22 per

share for gross proceeds of $320,279 and net proceeds of $310,664, after deducting underwriting discounts and commissions and offering

expenses borne by the Company, which totalled $9,615.

Obligations and Commitments

of September 30, 2025, we did not have any material contractual obligations, other than employment and shareholder agreements and the

license for GP2 from HJF.

of March 31, 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 September 30, 2025, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

of March 31, 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

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

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,

Adopted Accounting Pronouncements

June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326):

Measurement of Credit Losses on Financial

The main 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.

October 2024, the FASB issued ASU 2024-03, which requires public business entities to provide detailed disclosures of specific expense

categories—such as employee compensation, depreciation, and amortization—within the relevant expense captions on the income

statement (e.g., Cost of Sales, SG&A).

The standard is effective for fiscal years beginning after December 15, 2026, and interim

periods within fiscal years beginning after December 15, 2027, with early adoption permitted.

The Company is currently evaluating the

impact of this guidance on its financial statement disclosures.

As this guidance relates to disclosure only, it is not expected to have

a material impact on the Company’s financial position or results of operations.

Issued Accounting Pronouncements Not Yet Adopted

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to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,

including, without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial

reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public

Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s

report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis.

will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total

annual gross revenues of $1.07 billion or more;

(ii) the last day of our fiscal year following the fifth anniversary of the date of the

completion of our initial public offering;

(iii) the date on which we have issued more than $1 billion in nonconvertible debt during

the previous three years;

or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

when available to the Company, including, without limitation, (i) providing an auditor’s attestation report on our system of internal

controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may

be adopted by the Public Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement

to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion

and analysis.

We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which

we have total annual gross revenues of $1.07 billion or more;

(ii) the last day of our fiscal year following the fifth anniversary of

the date of the completion of our initial public offering;

(iii) the date on which we have issued more than $1 billion in nonconvertible

debt during the previous three years;

or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

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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