What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-06-01 compared with 2025-04-15 · 41 added, 28 removed, 111 unchanged (38% of the section changed)

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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.

Our net losses were approximately $19.4 million and $17.4 million for the years ended December 31, 2025 and 2024, 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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and Development Expenses

and development expenses increased by $5,253,407, or approximately 68%, to $12,952,029 for the year ended December 31, 2024 from $7,698,622

for the year ended December 31, 2023.

The increase was primarily the result of increases in clinical expenses for the Phase III clinical

trial and the one-time upfront vesting of 25% of an options grant to employees, management and the board of directors.

Research and development expenses increased

by $1,740,184, or approximately 11%, to $17,220,401 for the year ended December 31, 2025 from $15,480,217 for the year ended December

The increase was primarily the result of increases in clinical expenses for the Phase III clinical trial.

and Administrative Expenses

and administrative expenses increased by $1,430,544, or approximately 88% to $3,059,788 for the year ended December 31, 2024 from $1,629,244

for the year ended December 31, 2023.

The increase was primarily the result of the one-time upfront vesting of 25% of an options grant to employees, management

and the board of directors.

General and administrative expenses increased by $70,507,

or approximately 3% to $2,227,517 for the year ended December 31, 2025 from $2,157,010 for the year ended December 31, 2024.

and Capital Resources

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be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

January 1, 2025 and April 11 , 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 120,810

shares of its common stock at an average offering price of $10.42 per share for gross proceeds of $1,259,198 and net proceeds of $1,232,026,

after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totaled $27,172.

Flow Activities for the Years Ended December 31, 2025 and 2024

incurred net losses of $15,788,809 and $8,891,803 during the years ended December 31, 2024 and 2023, respectively, and the increase was

primarily the result of increases in clinical expenses for the Phase III clinical trial and the one-time upfront vesting of 25% of an options grant to employees, management

and the board of directors.

Cash was $4,091,990 at December 31, 2024 and $6,989,424 at December 31, 2023 and decreased due to the following reasons:

incurred net losses of $ 19,358,218 and $17,414,219 during the years ended December 31, 2025 and 2024, respectively, and the increase

was primarily the result of increases in clinical expenses for the Phase III clinical trial.

Cash was $6,178,021 at December 31, 2025 and $4,091,990 at December

31, 2024 and increased due to the following reasons:

cash used in operating activities was $9,913,453 for the year ended December 31, 2025 and $7,266,543 for the year ended December 31,

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did not use or generate cash from investing activities during the year ended December 31, 2025 and December 31, 2024.

Net cash provided by financing activities was $4,369,109 during the year

ended December 31, 2024, attributable to the sale of common stock via the ATM program and a private placement.

was no net cash provided by or used in financing activities during the year ended December 31, 2023.

cash provided by financing activities was $11,999,484 during the year ended December 31, 2025, attributable to the sale of common

stock via the ATM program and the exercise of the remaining underwriter warrants.

Net cash provided by financing activities was

$4,369,109 during the year ended December 31, 2024, attributable to the sale of common stock via the ATM program and a private

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

Wainwright, in which it issued and sold a total of 1,125,543 shares of its common stock at an average offering price of $10.85

per share for gross proceeds of $12,210,213 and net proceeds of $11,854,484, after deducting underwriting discounts and commissions and

offering expenses borne by the Company, which totaled $355,729.

September 2025, the remaining underwriter warrants were exercised resulting in gross proceeds to the Company of $145,000.

January 1, 2024 and December 31, 2024, the Company sold shares of its common stock pursuant to its ATM agreement with Jefferies and H.C.

Wainwright, in which it issued and sold a total of 129,739 shares of its common stock at an average offering price of $15.92 per share

for gross proceeds of $2,065,366 and net proceeds of $1,869,111, after deducting underwriting discounts and commissions and offering

expenses borne by the Company, which totaled $196,257.

June 13, 2024, the Company completed a private placement offering resulting in net proceeds of $2,499,998.

Between January 1, 2026 and April 15, 2026, 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 379,762 shares of its common stock at an average offering

price of $25.36 per share for gross proceeds of $9,629,468 and net proceeds of $9,340,576, after deducting underwriting discounts and

commissions and offering expenses borne by the Company, which totaled $288,892.

Obligations and Commitments

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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 2024.

Adopted Accounting Pronouncements

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financial statements and related disclosures.

In 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,

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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the adoption of certain accounting standards until those standards would otherwise apply to private companies.

have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying

have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act, when available to the Company, for complying

with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.

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complying with new or revised accounting standards.

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

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

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

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provide the information required under this Item 7A.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

financial information required by this Item is attached hereto at the end of this report beginning on page F-1 and is hereby incorporated

by reference.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

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-K

Item 7. Management’s Discussion and Analysis