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Item 9A. Controls and Procedures

2026-03-12 compared with 2025-03-17 · 213 added, 150 removed, 842 unchanged (30% of the section changed)

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Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

Our management recognizes that any controls and procedures, no matter how

well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

As required by Rules 13a-15(e) and 15d-15(e) of the Exchange Act, our management, including our principal executive officer and our principal financial officer, conducted an evaluation as of the end of the period covered by this Form 10-K of the effectiveness of the design and operation of our disclosure controls and procedures.

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Our board of directors currently consists of seven (7) members, classified into three (3) classes as follows:

DeLuccia, Mr.

Scodari and Mr.

James Donohue constitute Class III, with a term ending at the 2024 annual meeting;

Sailer and Mr.

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Dean constitute Class II, with a term ending at the 2026 annual meeting;

DeLuccia, Mr.

Scodari and Mr.

James Donohue constitute Class III, with a term ending at the 2027 annual meeting.

The following table provides information regarding our directors as of March 12, 2026:

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Luci served as a member of the board of directors of Access, where he also served as Chairman of the Audit Committee and Chairman of the Compensation Committee as well as serving in a consulting capacity following the acquisition of MacroChem.

December 2007 through February 2009, Mr.

From December 2007 through February 2009, Mr.

Luci served as a member of the board of directors and President of MacroChem.

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He later practiced corporate law at Paul Hastings LLP in New York, where his practice encompassed all aspects of public and private mergers and acquisitions, corporate finance, restructurings and private equity transactions, with a core focus in the healthcare industry.

Luci graduated from Bucknell University with a degree as a Bachelor of Science in Business Administration with a concentration in Accounting and graduated from Albany Law School of Union University where he served as Managing Editor of the Journal of Science & Technology.

Luci graduated from Bucknell University with a Bachelor of Science in Business Administration with a concentration in Accounting and graduated from Albany Law School of Union University where he served as Managing Editor of the Journal of Science & Technology.

Luci became a certified public accountant in the State of Pennsylvania in 1990 (inactive) and is a member of the New York State Bar Association.

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Previously, from 2004 to 2009, Mr.

DeLuccia served in several capacities at MacroChem, a development-stage, publicly traded pharmaceutical company using topical drug delivery technology for products in dermatology, podiatry, urology and cancer, including as Chairman of the board of directors, President and Chief Executive Officer.

DeLuccia served in several capacities at MacroChem, a development-stage, publicly traded pharmaceutical company using topical drug delivery technology for products in

dermatology, podiatry, urology and cancer, including as Chairman of the board of directors, President and Chief Executive Officer.

Prior to joining MacroChem, Mr.

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Since May 2019, Mr.

Sailer has served as VP, Global Account Lead for Syneos Health (Nasdaq:

Sailer has served as VP, Global Account Lead for Syneos Health.

Previously, Mr.

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Donohue has more than 30 years of experience in valuation, damages, and forensic accounting.

Donohue is a Certified Public Accountant (CPA) in Maryland and has a Bachelor of Science

degree in Accountancy from Villanova University.

Donohue is a Certified Public Accountant (CPA) in Maryland and has a Bachelor of Science degree in Accountancy from Villanova University.

He is also a Certified Valuation Analyst (CVA) and is Accredited in Business Valuation (ABV).

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Meeting Attendance

During the fiscal year ended December 31, 2024, there were ten meetings of our board of directors, and the various committees of our board of directors met a total of five times.

During the fiscal year ended December 31, 2025, there were thirteen meetings of our board of directors, and the various committees of our board of directors met a total of seven times.

No director attended fewer than 75% of the total number of meetings of our board of directors and of committees of our board of directors on which he or she served during the fiscal year ended December 31, 2025.

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Compensation Committee

Our Compensation Committee met one time during the year ended December 31, 2024.

Our Compensation Committee met three times during the year ended December 31, 2025.

This committee currently has three members, Joseph C.

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Chief Financial Officer

(1) Other compensation represents health care insurance.

Luci’s base annual salary was $475,000 for the year ended December 31, 2023 and was increased to $550,000 effective March 2024.

Luci received a stock option grant in 2024 with an exercise price of $3.15.

(1) Other compensation includes payments for healthcare insurance premiums for Mr.

DeLuccia and payments for accrued but unused vacation time for Mr.

DeLuccia and Mr.

Luci’s base annual salary was $550,000 for the year ended December 31, 2025.

Luci received a stock option grant in settlement of his previously accrued 2024 bonus with an exercise price of $15.96 per share.

The options were valued using the Black Scholes option valuation model.

The options had no intrinsic value at March 1 2 , 2026.

DeLuccia’s base salary was $485,000 for the year ended December 31, 2023 and was increased to $550,000 effective March 2024.

DeLuccia received a stock option grant in 2024 with an exercise price of $3.15.

DeLuccia’s base salary was $550,000 for the year ended December 31, 2025.

DeLuccia received a stock option grant in settlement of his previously accrued 2024 bonus with an exercise price of $15.96 per share.

The options were valued using the Black Scholes option valuation model.

The options had no intrinsic value at March 1 2 , 2026.

Shawah’s base salary was $375,000 for the year ended December 31, 2023 and was increased to $400,000 effective March 2024.

Shawah received a stock option grant in 2024 with an exercise price of $3.15.

Shawah’s base salary was $400,000 for the year ended December 31, 2025.

Shawah received a stock option grant in settlement of his previously accrued 2024 bonus with an exercise price of $15.96 per share.

The options were valued using the Black Scholes option valuation model.

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Luci was granted stock options to purchase 6,500 shares of common stock in connection with his service as President and Chief Executive Officer pursuant to his employment agreement, and such stock options shall become vested and exercisable pro-rata on a monthly basis over 36 months, such that all stock options shall be fully vested and exercisable by February 13, 2026.

On February 23, 2024,

(the “February Grant Date”), Mr.

Luci was granted stock options to purchase 250,000 shares of common stock in connection with his service as President and Chief Executive Officer pursuant to his employment agreement, and such stock options shall become vested and exercisable pro-rata on a monthly basis over 36 months, such that all stock options shall be fully vested and exercisable by February 23, 2027.

On February 23, 2024, (the “February Grant Date”), Mr.

Luci was granted stock options to purchase 12,500 shares of common stock in connection with his service as President and Chief Executive Officer pursuant to his employment agreement, and such stock options shall

become vested and exercisable pro-rata on a monthly basis over 36 months, such that all stock options shall be fully vested and exercisable by February 23, 2027.

On February 5, 2025, (the “February Grant Date”), Mr.

Luci was granted stock options to purchase 12,500 shares of common stock in lieu of cash bonus payment, and the options were fully vested and exercisable on the grant date.

(2) On the June Grant Date, Mr.

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DeLuccia was granted stock options to purchase 12,500 shares of common stock in connection with his service as Executive Chairman pursuant to his employment agreement, and such stock options shall become vested and exercisable pro-rata on a monthly basis over 36 months, such that all stock options shall be fully vested and exercisable by February 23, 2027.

On February 5, 2025, (the “February Grant Date”), Mr.

DeLuccia was granted stock options to purchase 12,500 shares of common stock in lieu of cash bonus payment, and the options were fully vested and exercisable on the grant date.

(3) On the June Grant Date, Mr.

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Shawah was granted stock options to purchase 7,250 shares of common stock in connection with his service as Chief Financial Officer pursuant to his employment agreement, and such stock options shall become vested and exercisable pro-rata on a monthly basis over 36 months, such that all stock options shall be fully vested and exercisable by February 23, 2027.

On February 5, 2025, (the “February Grant Date”), Mr.

Shawah was granted stock options to purchase 7,275 shares of common stock in lieu of cash bonus payment, and the options were fully vested and exercisable on the grant date.

Director Compensation

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James Donohue (5)

(1) These amounts represent the aggregate grant date fair value of options granted to each director on June 15, 2024 computed in accordance with FASB ASC Topic 718.

A discussion of the assumptions used in determining grant date fair value may be found in Note 5 to our financial statements included in this Form 10-K.

Such options vest on the one-year anniversary of the grant date.

Sailer had 3,600 option awards outstanding at December 31, 2025.

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We deem shares of common stock that may be acquired by an individual or group within 60 days of March 12, 2026, pursuant to the exercise of options or warrants to be outstanding for the purpose of computing the percentage ownership of such individual or group, but those shares are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table.

indicated in footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power with respect to all shares of common stock shown to be beneficially owned by them based on information provided to us by these stockholders.

Except as indicated in footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power with respect to all shares of common stock shown to be beneficially owned by them based on information

provided to us by these stockholders.

Percentage of ownership is based on 2,855,025 shares of common stock outstanding on March 12, 2026.

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Certificate of Incorporation of Acurx Pharmaceuticals, Inc.

Certificate of Amendment No.

1 to the Certificate of Incorporation of Acurx Pharmaceuticals, Inc.

Certificate of Amendment No.

2 to the Certificate of Incorporation of Acurx Pharmaceuticals, Inc.

Bylaws of Acurx Pharmaceuticals, Inc.

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Form of Series A Warrant .

Form of Series B Warrant .

Form of Placement Agent Warrant.

Form of Series C Warrant .

Form of Series D Warrant .

Form of 2023 Pre-Funded Warrant.

Form of Series E Warrant

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Form of Series F Warrant

Form of Pre-Funded Warrant

Form of March 2025 Wainwright Warrant

Form of G-1 Warrant.

Form of G-2 Warrant.

Form of June 2025 Wainwright Warrant.

Description of Securities.

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Form of Stock Option Agreement under the 2021 Equity Incentive Plan.

Exhibit Description

Form of Restricted Stock Agreement under the 2021 Equity Incentive Plan.

Form of Recapitalization Exchange Option Agreement.

Exhibit Description

Amended and Restated Employment Agreement, by and between Acurx Pharmaceuticals, Inc.

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and the purchaser party thereto.

Exhibit Description

Purchase Agreement, dated as of May 8, 2025, between Acurx Pharmaceuticals, Inc.

and Lincoln Park Capital Fund, LLC.

Registration Rights Agreement, dated as of May 8, 2025, between Acurx Pharmaceuticals, Inc.

and Lincoln Park Capital Fund, LLC.

Form of Letter Agreement

Acurx Pharmaceuticals, Inc.

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Consent of CohnReznick LLP.

Exhibit Description

Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

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Inline XBRL Taxonomy Extension Presentation Linkbase Document.

Exhibit Description

Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit).

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SHAREHOLDERS' EQUITY

Preferred Stock;

$ 0.001 par value, 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2025 and 2024

Common Stock;

$ .001 par value, 200,000,000 shares authorized, 17,030,686 and 14,468,229 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively

$ 0.001 par value, 250,000,000 shares authorized, 2,348,113 shares issued and outstanding at December 31, 2025 and 200,000,000 shares authorized, 851,534 shares issued and outstanding at December 31, 2024

Additional Paid-In Capital

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TOTAL OPERATING EXPENSES

OPERATING LOSS

( 8,091,983 )

( 14,123,227 )

Interest Income

( 7,966,538 )

( 14,103,103 )

LOSS PER SHARE

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Share-Based Payments to Vendors

Issuance of shares of common stock and pre-funded warrants in registered direct offering, net of $ 456,314 cash issuance costs

Issuance of shares of common stock in At-the-Market sales agreement, net of $ 209,305 cash issuance costs

Warrant Exercise

Cashless Warrant Exercise

Pre-funded Warrant Exercise

( 14,103,103 )

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( 67,321,956 )

Reverse Stock Split fractional share adjustment

Share-Based Compensation

Share-Based Compensation to settle accrued compensation

Share-Based Payments to Vendors

Issuance of shares of common stock in At-the-Market sales agreement, net of $ 209,305 cash issuance costs

Issuance of shares of common stock in January Registered Direct Offering, net of $ 400,750 cash issuance costs

Issuance of shares of common stock and pre-funded warrants in March Registered Direct Offering, net of $ 208,580 cash issuance costs

Pre-funded Warrant Exercise

Issuance of shares of common stock related to equity line of credit purchase agreement, net of $ 144,991 cash issuance costs

Issuance of shares of common stock related to warrant inducement, net of $ 186,708 cash issuance costs

Warrant Exercise

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Cash Flow from Financing Activities:

Reverse Stock Split fractional share adjustment

Proceeds from Warrant Inducement, net of issuance costs

Proceeds from Warrant Exercise

Proceeds from issuance of common stock in connection with equity line of credit purchase agreement, net of issuance costs

Proceeds from 2025 March Registered Direct Offering, net of issuance costs

Proceeds from 2025 January Registered Direct Offering, net of issuance costs

Proceeds from At-the-Market Offering, net of issuance costs

Pre-funded Warrant Exercise

Warrant Exercise

Proceeds from 2023 Registered Direct Offering, net of issuance costs

Net Cash Provided by Financing Activities

Net Decrease in Cash

( 3,767,475 )

Net Increase/(Decrease) in Cash

( 3,767,475 )

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Cash at End of Year

SUPPLEMENTAL DISCLOSURE OF NON-CASH OPERATING ACTIVITIES

Share-Based Compensation to settle accrued compensation (Note 5)

SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES

2023 Registered Direct Offering costs (Note 4)

2025 Equity Line of Credit Purchase Agreement costs (Commitment shares)(Note 4)

2025 Warrant Inducement Financing costs (Note 4)

2025 January Registered Direct Offering costs (Note 4)

2025 March Registered Direct Offering costs (Note 4)

See accompanying notes to financial statements.

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Under the ATM Program, the Company sold a total of 141,516 shares of common stock for gross proceeds of approximately $ 9.2 million.

As of December 31, 2024, the Company had a cash balance of approximately $ 3.7 million, which based on

current estimates will not be sufficient to meet its anticipated cash requirements for at least 12 months from the issuance of the financial statements for the year ended December 31, 2024.

As of January 6, 2025, the Company suspended the ATM program.

In January 2025, the Company completed a registered

direct offering and concurrent private placement, issuing 123,153 shares of common stock for gross proceeds of $ 2.5 million.

In March 2025, the Company completed a registered direct offering and concurrent private placement, issuing 107,500 shares of common stock for gross proceeds of $ 1.1 million.

On May 8, 2025, the Company entered into an equity line of credit purchase agreement (the “ELOC”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $ 12.0 million in shares of our common stock, $ 0.001 par value per share.

Under the ELOC, the Company sold 751,397 shares of common stock for gross proceeds of approximately $ 4.0 million as of December 31, 2025.

On June 17, 2025, the Company entered into a warrant inducement agreement with a certain holder of existing warrants, receiving gross proceeds of approximately $ 2.7 million.

As of December 31, 2025, the Company had a cash balance of approximately $ 7.6 million, which based on current estimates will not be sufficient to meet its anticipated cash requirements for at least 12 months from the issuance of the financial statements for the year ended December 31, 2025.

Management believes that the Company will continue to incur losses for the foreseeable future and will need additional resources to sustain its operations until it can achieve profitability and positive cash flows, if ever.

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NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Reverse Stock Split

On August 4, 2025, the Company effected a 1-for-20 reverse stock split of its issued and outstanding shares of common stock.

The Company accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share.

All issued and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted in these financial statements, on a retrospective basis, to reflect the reverse stock split for all year s presented.

Authorized common stock was not adjusted as result of the reverse stock split.

Authorized shares of common stock

At the special meeting of stockholders of the Company held on September 16, 2025, the Company’s stockholders approved an amendment (the “Amendment”) to the Company’s Certificate of Incorporation to increase the total number of authorized shares of the Company’s common stock from 200,000,000 to 250,000,000 .

On September 22, 2025, the Company filed the Amendment with the Secretary of State of the State of Delaware with immediate effect.

Reclassification of Prior Presentation

Certain amounts in the prior year have been reclassified to conform to the current year presentation.

Specifically, interest income, which was previously recorded within general and administrative expense, was reclassified to other income.

This reclassification had no effect on the reported results of operations or cash flows.

Use of Estimates

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Should the Company’s assessment change, tax benefits associated with the historic net operating loss carryforwards could be limited due to future ownership changes.

During the second quarter of 2024, the Company applied for a qualified small business payroll tax credit for increasing research activities in the amount of $ 51,127 and it is disclosed on the accompanying balance sheet as of December 31, 2024.

The Company applied for a qualified small business payroll tax credit for increasing research activities, resulting in “other receivable” on the accompanying balance sheets in the amount of $ 48,417 and $ 51,127 as of December 31, 2025 and 2024, respectively.

Recent Accounting Pronouncements

In November 2023, the FASB issued ASU No.

2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures which requires public entities to disclose significant segment expenses regularly provided to the chief operating decision-maker.

Public entities with a single reporting segment have to provide all disclosures required by ASC 280, including the significant segment expense disclosures.

For public business entities, the guidance is effective for annual periods beginning after December 15, 2024.

The adoption of ASU 2023-07 did not have a significant impact on the Company’s financial accounting measurements or disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

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The amendment should be applied on a prospective basis while retrospective application is permitted.

The Company is currently evaluating the effect of this pronouncement on its disclosures.

As an emerging growth company, the Company has elected to use the extended transition period for complying with new or revised accounting standards, and therefore the guidance will be effective for the Company for fiscal years beginning after December 15, 2025.

The amendments are required to be applied on a prospective basis, with retrospective application permitted.

The Company is currently evaluating the impact of the adoption of this guidance on its financial statements and related disclosures and currently believes that it will not have a material impact on its disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, to improve transparency in financial reporting by requiring entities to present more detailed information about the nature of expenses included within the Income Statement.

The guidance will first be effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027.

Early adoption is permitted.

The Company currently believes that it will not have a material impact on its disclosures.

Segment Information

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To date, the Company has not generated any product revenue.

The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval.

Concentration of Credit Risk

Cash and Concentration of Credit Risk

The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents.

The Company maintains the majority of its cash balance in one financial institution.

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Share-Based Compensation

The Company accounts for the cost of services performed by officers and directors received in exchange for an award of Company membership interests, common stock or stock options, based on the grant-date fair value of the award.

The Company accounts for the cost of services performed by employees, directors and consultants received in exchange for an award of Company’s common stock or stock options, based on the grant-date fair value of the award.

The Company recognizes compensation expense based on the requisite service period.

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The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value computation using the Black-Scholes option pricing model.

Because there is no public market for the Company’s stock options and very little historical experience with the

Company’s stock, similar public companies were used for the comparison of volatility and the dividend yield.

Because there is no public market for the Company’s stock options and very little historical experience with the Company’s stock, similar public companies were used for the comparison of volatility and the dividend yield.

The risk-free rate of return was derived from U.S.

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The Company recognizes the expense in the same period and in the same manner as if the Company had paid cash for the services.

The Company had two major vendors that accounted for approximately 35 % of the research and development expenditures for the year ended December 31, 2024, and a major vendor that accounted for approximately 63 % of the research and development expenditures for the year ended December 31, 2023.

As of December 31, 2024, the two major vendors accounted for approximately 2 % of the total accounts payable and accrued expenses and as of December 31, 2023, the major vendor accounted for 53 % of the total accounts payable and accrued expenses.

The Company had three major vendors that accounted for approximately 41 % of the research and development expenditures for the year ended December 31, 2025, and two major vendors that accounted for approximately 35 % of the research and development expenditures for the year ended December 31, 2024.

As of December 31, 2025, the three major vendors accounted for approximately 6 % of the total accounts payable and accrued expenses and as of December 31, 2024, the two major vendors accounted for 2 % of the total accounts payable and accrued expenses.

NOTE 3 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES

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NOTE 4 – ISSUANCE OF EQUITY INTERESTS

On August, 4, 2025, the Company effected a 1-for-20 reverse stock split of its issued and outstanding shares of common stock.

The Company accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share.

All issued and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted in these condensed interim financial statements, on a retrospective basis, to reflect the reverse stock split for all years presented.

Authorized common stock was not adjusted as result of the reverse stock split.

On June 23, 2021, Acurx Pharmaceuticals, LLC was converted into a corporation and renamed Acurx Pharmaceuticals, Inc.

The Company’s certificate of incorporation authorizes 200,000,000 shares of common stock, of which 17,030,686 were issued and outstanding as of December 31, 2024.

On May 16, 2023, the Company entered into a securities purchase agreement with a single healthcare-focused U.S.

institutional investor named therein (the “2023 Investor”), pursuant to which the Company issued and sold, in a registered direct offering by the Company directly to the 2023 Investor (the “2023 Registered Offering”), an aggregate of 601,851 shares of common stock at an offering price of $ 3.00 per share and an aggregate of 731,482 pre-funded warrants exercisable for shares of common stock at an offering price of $ 2.9999 per pre-funded warrant.

The pre-funded warrants sold to the Investor have an exercise price of $ 0.0001 and were immediately exercisable.

As of December 31, 2024, all of the pre-funded warrants were exercised.

The gross proceeds to the Company from the 2023 Registered Direct Offering were approximately $ 4.0 million and net proceeds after deducting the placement agent’s fees and other offering expenses payable by the Company were approximately $ 3.5 million.

In a concurrent private placement (the “2023 Private Placement” and together with the 2023 Registered Offering, the “2023 Offerings”), the Company issued to the Investor Series C warrants exercisable for an aggregate of 1,333,333 shares of common stock at an exercise price of $ 3.26 per share and Series D warrants exercisable for an aggregate of

1,333,333 shares of common stock at an exercise price of $ 3.26 per share.

The Series C Warrants were exercisable commencing on November 18, 2023 and will expire on November 18, 2025.

The Series D Warrants were exercisable commencing on November 18, 2023 and will expire on November 19, 2029.

In connection with the 2023 Offerings, the Company also entered into a Warrant Amendment Agreement with the 2023 Investor.

Under the Warrant Amendment Agreement, the Company amended its existing Series A warrants to purchase up to an aggregate of 1,230,769 shares of the Company's common stock and Series B warrants to purchase up to an aggregate of 1,230,769 shares of the Company's common stock (collectively, the “Existing Warrants”) that were previously issued in July 2022, such that effective upon the closing of the offering, the amended Existing Warrants have a termination date of May 18, 2029.

The Company used the Black-Scholes model to calculate the change in the value of the aforementioned Series A and Series B warrants attributable to the change in the termination date, with an estimated increase in fair value of approximately $ 2.0 million.

This amount was recorded as both an increase to additional paid-in capital and as a non-cash issuance cost of the offerings.

The Company’s certificate of incorporation authorizes 250,000,000 shares of common stock, $ 0.001 par value per share, of which 2,348,113 were issued and outstanding and 10,000,000 shares of preferred stock, $ 0.001 par value per share, of which no shares were outstanding as of December 31, 2025.

On November 15, 2023, the Company entered into a Sales Agreement and established the ATM Program, pursuant to which the Company may offer and sell, from time to time through A.G.P./Alliance Global Partners, as sales agent, shares of its common stock having an aggregate offering price of up to $ 17.0 million.

Under the Sales Agreement, the sales agent is entitled to compensation of 3.0 % of the gross offering proceeds of all shares sold through it pursuant to the Sales Agreement.

The Company sold 106,610 shares of its common stock under the ATM Program at a weighted-average price of $ 62.00 per share, raising $ 6.6 million of gross proceeds and net proceeds of $ 6.4 million, after deducting commissions to the sales agent for the year ended December 31, 2024.

In addition, 894 shares sold under the ATM Program in 2023 remained unsettled as of December 31, 2023 and were settled on January 2, 2024.

As of December 31, 2024, the Company had $ 7.8 million available under the ATM Program.

The ATM Program was suspended on January 6, 2025 and the Company did not have any ATM program sales for the year ended December 31, 2025.

In January 2024, the Affiliate Investors exercised 2,961 of Series B Warrants which generated approximately $ 0.2 million in proceeds for the Company.

On January 6, 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors and Affiliate Investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “January Registered Offering”) by the Company, directly to the certain investors and to certain Affiliate Investors, an aggregate of 123,153 shares of common stock (consisting of an aggregate of 114,779 shares of common stock purchased by the investors and an aggregate of 8,374 shares of common stock purchased by certain Affiliate Investors), at an offering price of $ 20.30 per share, for aggregate gross proceeds from the offering of approximately $ 2.5 million.

The net proceeds after deducting the placement agent’s fees and other offering expenses payable by the Company were approximately $ 2.1 million.

The Company intends to use the net proceeds from the January Registered Offering for working capital and other general corporate purposes.

In a concurrent private placement (the “January Private Placement” and, together with the January Registered Offering, the “January Offering”), the Company agreed to issue to the investors and to certain Affiliate Investors Series E common warrants (the “Series E Warrants”) to purchase up to an aggregate of 123,153 shares of common stock (consisting of Series E Warrants to purchase up to 114,779 shares of common stock issued to the Investors and Series E Warrants to purchase up to 8,374 shares of common stock issued to certain Affiliate Investors) at an exercise price of $ 18.00 per share.

Each Series E Warrant was immediately exercisable upon the issuance date and will expire five years from the issuance date.

The Series E Warrants and the shares of common stock issuable upon the exercise of the Series E Warrants were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act, and Rule 506(b) promulgated thereunder.

In connection with the January Offering, the Company issued 7,389 warrants to the placement agent.

Such warrants have an exercise price of $ 25.38 per share and will expire on January 6, 2030.

The Company used the Black-Scholes model to calculate the estimated fair value of the warrants of $ 85,419 .

The inputs utilized in the calculation were as follows:

5 -year term, 4.46 % risk-free rate, stock price at grant date of $ 16.20 and 102 % volatility utilizing comparable companies.

This amount was recorded as both an increase to additional paid-in capital and as a non-cash issuance cost of the offering.

The January Offering closed on January 7, 2025.

On March 6, 2025, the Company entered into a Securities Purchase Agreement with an institutional investor, pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “March Registered Offering”) by the Company directly to the investor (i) 107,500 shares of common stock at a purchase price of $ 8.00 per share and (ii) pre-funded common stock purchase warrants (the “March Pre-Funded Warrants”) to purchase up to 29,750 shares of common stock at a purchase price of $ 7.998 per March Pre-Funded Warrant for aggregate gross proceeds of approximately $ 1.1 million, before deducting the placement agent’s fees and related offering expenses.

The net proceeds after deducting the placement agent’s fees and other offering expenses payable by the Company were approximately $ 0.9 million.

The Company intends to use the net proceeds from the March Registered Offering for working capital and other general corporate purposes.

As of December 31, 2025, all of the March Pre-Funded Warrants were exercised.

In a concurrent private placement (the “March Private Placement” and together with the March Registered Offering, the “March Offering”), the Company agreed to issue to the investor series F common warrants (the “Series F Warrants”) to purchase up to an aggregate of 411,750 shares of common stock.

The Series F Warrants have an exercise price of $ 8.00 per share and were exercisable commencing on July 17, 2025 and will expire on July 19, 2027 .

The Series F Warrants and the shares of common stock issuable upon the exercise of the Series F Warrants were not registered under the Securities Act and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act, and Rule 506(b) promulgated thereunder.

In connection with the March Offering, the Company issued 8,235 warrants to the placement agent.

Such warrants have an exercise price of $ 10.00 per share and will expire on July 19, 2027.

The Company used the Black-Scholes model to calculate the estimated fair value of the warrants of $ 56,163 .

The inputs utilized in the calculation were as follows:

5 -year term, 3.98 % risk-free rate, stock price at grant date of $ 9.00 and a 102 % volatility utilizing comparable companies.

This amount was recorded as both an increase to additional paid-in capital and as a non-cash issuance cost of the offering.

The March Offering closed on March 10, 2025.

The Company expects that any proceeds it receives from such sales will be used for working capital and general corporate purposes.

The Company sold 751,397 shares of its common stock under the ELOC at a weighted-average price of $ 5.26 per share, raising $ 3,953,430 of gross proceeds and net proceeds of $ 3,808,439 after deducting related fees and expenses for the year ended December 31, 2025.

In connection with the ELOC, the Company issued 44,963 shares of common stock to Lincoln Park in consideration for its commitment to purchase shares under the ELOC and recorded $ 360,000 as both an increase to additional paid-in capital and as a non-cash issuance cost of the ELOC.

On June 17, 2025, the Company entered into a warrant inducement agreement (the “Letter Agreement”) with certain of its existing warrant holders for the exercise of warrants to purchase an aggregate of 222,272 shares of its common stock having a current exercise price of (i) Series A warrants to purchase 61,538 shares of common stock at $ 65.00 per share (ii) Series B warrants to purchase 27,400 shares of common stock at $ 65.00 per share (iii) Series C warrants to purchase 66,667 shares of common stock at $ 65.20 per share and (iv) Series D warrants to purchase 66,667 shares of common stock at $ 65.20 per share, originally issued in July 2022 and May 2023, (collectively, the “Existing Warrants”) at a reduced exercise price of $ 12.00 per share, in consideration for the issuance of (i) Series G-1 warrants to purchase up to an aggregate of 311,180 shares of common stock with a term of five years and (ii) Series G-2 warrants to purchase up to an aggregate of 133,363 shares of common stock with a term of five years from September 16, 2025, each at an exercise price of $ 8.50 per share (collectively, the “Series G Warrants”).

The Company received gross proceeds from the exercise of the Existing Warrants of approximately $ 2.7 million and net proceeds of $ 2.5 million after deducting fees and transaction expenses payable by the Company.

The reduction of the exercise price represented a modification to the Existing Warrants.

This modification of Existing Warrants, together with the issuance of the Series G-1 and G-2 warrants, resulted in a total non-cash equity issuance cost of $ 4,527,245 .

This amount was recorded as both an increase to additional paid-in capital and as a non-cash issuance cost of the financing.

The warrant inducement transaction closed on June 20, 2025.

The Company expects to use the net proceeds of these transactions for general corporate and working capital purposes.

Pursuant to the engagement letter entered into with H.C.

Wainwright & Co., LLC (“Wainwright”) in connection with prior financings by the Company and as previously disclosed in the Company’s prior filings with the U.S.

Securities and Exchange Commission, the Company paid a fee to Wainwright equal to 7.0 % of the gross proceeds from the transactions contemplated by the Letter Agreement and issued to Wainwright and its designees warrants to purchase up to an aggregate of 13,336 shares of common stock, which have the same terms as the Series G Warrants, except that they have an exercise price of $ 15.00 per share.

The Company used the Black-Scholes model to calculate the estimated fair value of the warrants of $ 109,624 .

The inputs utilized in the calculation were as follows;

5 -year term, 3.96 % risk-free rate, stock price at grant date of $ 11.00 and a 105 % volatility utilizing comparable companies.

This amount was recorded as both an increase to additional paid-in capital and as a non-cash issuance cost of the offering.

The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2025:

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The weighted average contractual life of the outstanding warrants is 3.48 years.

Under the Sales Agreement, the sales agent is entitled to compensation of 3.0 % of the gross offering proceeds of all shares sold through it pursuant to the Sales Agreement.

The Company sold 698,121 shares of its common stock under the ATM Program at a weighted-average price of $ 3.76 per share, raising $ 2.6 million of gross proceeds and net proceeds of $ 2.4 million, after deducting commissions to the sales agent and other ATM Program related expenses for the year ended December 31, 2023.

The Company recorded a receivable of $ 129,159 for 34,116 shares sold under the ATM Program yet to settle as of December 31, 2023, of which 17,869 shares had yet to be issued by the transfer agent as of the year-end.

The receivable for the unsettled shares as of December 31, 2023 is included within the “Other Receivable” balance in the accompanying balance sheets.

The receivable was collected on January 3, 2024 and 17,869 shares were settled and transferred on January 2, 2024.

The Company sold 2,132,207 shares of its common stock under the ATM Program at a weighted-average price of $ 3.10 per share, raising $ 6.6 million of gross proceeds and net proceeds of $ 6.4 million, after deducting commissions to the sales agent for the year ended December 31, 2024.

As of December 31, 2024, the Company had $ 7.8 million available under the ATM Program.

NOTE 5 – SHARE-BASED COMPENSATION

In April 2021, the board of directors approved the creation of the 2021 Equity Incentive Plan (the “Plan”).

The Plan became effective as of the completion of the corporate conversion.

The Plan originally reserved an aggregate of 2,000,000 shares of common stock, subject to annual adjustments as provided in the Plan, which was 580,852 shares for the year ended December 31, 2024.

The Plan currently has 171,720 shares available for issuance as of December 31, 2024.

The Plan became effective as of the completion of the corporate conversion, with an annual evergreen provision pursuant to the Plan.

In July 2025, the Company’s stockholders approved an amendment to add an additional 125,000 shares of common stock to the Plan.

The Plan currently reserves an aggregate of 331,807 shares of common stock, subject to adjustments as provided in the Plan, of which 133,872 are currently still available for issuance as of December 31, 2025.

The purpose of the Plan is to attract, retain and incentivize directors, officers, employees, and consultants.

In June 2021, the Company granted stock options to purchase a total of 807,500 shares of common stock to its three executives and three non-employee management team members to replace the Class B Membership Interests that were cancelled in March 2021.

The options were issued at an exercise price of $ 6.26 , with the employee options vesting 40 % upon issuance and the balance over 36 months , and the non-employee options vesting at grant date.

The Company recorded general and administrative expenses of $ 363,440 and $ 726,880 for the years ended December 31, 2024 and 2023, respectively, related to compensation expenses for these options.

In July 2021, the Company granted stock options to purchase a total of 1,550,000 shares of common stock to its three executives pursuant to their respective employment agreements, the independent directors, and one consultant, pursuant to the Plan.

The options were issued at an exercise price of $ 6.18 , the grant date fair value, with one -quarter of the executive’s options vesting upon issuance and the balance over 36 months , and the options granted to the directors and consultants vesting over 36 months .

The Company recorded general and administrative expenses of $ 981,834 and $ 1,963,667 for the years ended December 31, 2024 and 2023, respectively, related to compensation expenses for these options.

In January 2022, the Company granted stock options to purchase a total of 80,000 shares of common stock to seven consultants pursuant to the Plan.

The options were issued at an exercise price of $ 4.44 , the grant date fair value, with one -quarter of the options vesting upon issuance and the balance over 36 months .

The Company recorded general and administrative expenses of $ 75,800 for the each of the years ended December 31, 2024 and 2023, related to compensation expenses for these options.

In April 2022, the Company granted stock options to purchase a total of 30,000 shares of common stock to a new employee pursuant to the Plan.

The options were issued at an exercise price of $ 3.79 , the grant date fair value, with one -quarter of the options vesting upon issuance and the balance over 36 months .

The Company recorded general and administrative expenses of $ 21,510 for the each of the years ended December 31, 2024 and 2023, related to compensation expenses for these options.

In February 2023, the Company granted stock options to purchase a total of 467,500 shares of common stock to its four employees and seven consultants pursuant to the Plan.

The options were issued at an exercise price of $ 3.41 , the grant date fair value, with the options vesting monthly over 36 months .

The Company recorded general and administrative expenses of $ 438,084 and $ 365,070 for the years ended December 31, 2024 and 2023, respectively, related to compensation expense for these options.

In June 2023, the Company granted stock options to purchase a total of 50,000 shares of common stock to its five independent board of directors pursuant to the Plan.

The options were issued at an exercise price of $ 2.75 , the grant date fair value, with the options vesting on the one -year anniversary of the grant date.

The Company recorded general and administrative expenses of $ 53,600 for the each of the years ended December 31, 2024 and 2023, related to compensation expenses for these options.

In February 2024, the Company granted stock options to purchase a total of 41,750 shares of common stock to its four employees and a number of consultants pursuant to the Plan.

The options were issued at an exercise price of $ 3.15 , the grant date fair value, with the options vesting monthly over 36 months .

The Company recorded general and administrative expenses of $ 612,375 for the year ended December 31, 2024, related to compensation expense for these options.

The options were issued at an exercise price of $ 63.00 , which was the grant date fair value, with the options vesting monthly over 36 months .

In June 2024, the Company granted stock options to purchase a total of 3,000 shares of common stock to its five independent board of directors pursuant to the Plan.

The options were issued at an exercise price of $ 2.38 , the grant date fair value, with the options vesting on the one -year anniversary of the grant date.

The Company recorded $ 55,260 for the year ended December 31, 2024, related to compensation expense for these options.

The options were issued at an exercise price of $ 47.60 , which was the grant date fair value, with the options vesting on the one-year anniversary of the grant date.

In January 2025, the Company granted stock options to purchase a total of 1,500 shares of common stock to one of its employees pursuant to the Plan.

The options were issued at an exercise price of $ 15.54 , which was the grant date fair value of the common stock, with the options vesting monthly over 36 months .

In February 2025, the Company granted stock options to purchase a total of 32,275 shares of common stock to its three employees to settle the 2024 executive bonus of $ 413,120 in lieu of cash payment.

The options were issued at an exercise price of $ 15.96 , which was the grant date fair value of the common stock, with the options vesting immediately.

A summary of the Company’s stock option issuances and associated general and administrative expenses are as follows:

Issuance Date

February 2023

February 2024

February 2025

Compensation expense associated with these awards is recognized over the vesting period based on the fair value of the option at the grant date determined based on the Black-Scholes option pricing model.

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NOTE 6 – SHARE-BASED PAYMENTS TO VENDORS

In the fourth quarter of 2022, the Company entered into a number of agreements with vendors pursuant to which the Company made grants of a total of 43,186 share of common stock with grant date fair values ranging from $ 3.30 to $ 3.67 , up to 10,096 of warrants, and cash payments.

These contracts had six-months terms with various contractual vesting periods.

The cash payments were expensed over the service period and the equity components were expensed consistent with the various contractual vesting periods.

The Company recorded general and administrative expenses of $ 0 and $ 46,742 for the years ended December 31, 2024 and 2023, respectively.

In the first quarter of 2023, the Company entered into an agreement with a consultant to provide investor relation services for a six-month term.

The Company granted 36,000 shares of common stock at a grant date fair value of $ 3.31 , pursuant to the agreement and recorded general and administrative expenses of $ 0 and $ 119,160 for the years ended December 31, 2024 and 2023, respectively.

In the fourth quarter of 2023, the Company entered into a number of agreements with vendors pursuant to which the Company made grants of a total of 5,800 share of common stock with grant date fair values ranging from $ 30.00 to $ 103.60 and cash payments.

These contracts had four to six-months terms with various contractual vesting periods.

These contracts had four to six-month terms with various contractual vesting periods.

The cash payments were expensed over the service period and the equity components were expensed consistent with the various contractual vesting periods.

The Company recorded general and administrative expenses of $ 0 and $ 76,600 for the years ended December 31, 2025 and 2024, respectively.

In the first quarter of 2024, the Company entered into a number of agreements with consultants to provide investor relation services for four-month terms.

In the first quarter of 2024, the Company entered into a number of agreements with consultants to provide investor relations services for four-month terms.

The cash payments were expensed over the service period and the equity components were expensed consistent with the various contractual vesting periods.

Per the agreements, the Company issued a total of 6,000 shares of common stock evenly over the four-month service period with grant date fair values ranging from $ 37.40 to $ 96.20 .

The Company recorded general and administrative expenses of $ 329,700 for the year ended December 31, 2024.

The Company recorded general and administrative expenses of $ 0 and $ 329,700 for the years ended December 31, 2025 and 2024, respectively.

In the second quarter of 2024, the Company entered into a number of agreements with consultants to provide investor relation services for six-month terms.

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Per the agreements, the Company issued a total of 7,800 shares of common stock evenly over the six-month service period with grant date fair values ranging from $ 36.00 to $ 48.00 .

The Company recorded general and administrative expenses of $ 312,600 for the year ended December 31, 2024.

In the fourth quarter of 2024, the Company entered into a number of agreements with vendors pursuant to which the Company will make grants of a total of 76,000 shares of common stock.

These contracts have six to twelve-months terms with various contractual vesting periods and they are expensed consistently with the various contractual vesting periods.

The Company issued 46,000 shares of common stock with grant date fair values ranging from $ 1.89 to $ 2.08 .

The Company recorded general and administrative expenses of $ 93,780 for the year ended December 31, 2024.

In addition, in the fourth quarter of 2024, the Company entered into a 12-month agreement with a vendor pursuant to which the Company will make quarterly grants equal to $ 21,000 worth of common stock and certain cash payments.

The share-based payments will be expensed consistently over the contractual vesting period.

The Company recorded general and administrative expenses of $ 21,000 for the year ended December 31, 2024.

The Company recorded general and administrative expenses of $ 0 and $ 312,600 for the years ended December 31, 2025 and 2024, respectively.

In the fourth quarter of 2024, the Company entered into a number of agreements with vendors pursuant to which the Company made grants of a total of 3,800 shares of common stock with grant date fair values ranging from $ 8.12 to $ 41.60 .

These contracts had six to twelve-months terms with various contractual vesting periods and were expensed consistently with the various contractual vesting periods.

The Company recorded general and administrative expenses of $ 16,559 and $ 93,780 for the years ended December 31, 2025 and 2024, respectively.

In addition, in the fourth quarter of 2024, the Company entered into a 12-month agreement with a vendor pursuant to which the Company made quarterly grants equal to $ 21,000 worth of common stock and certain cash payments.

The share-based payments were expensed consistently over the contractual vesting period.

The Company granted total of 7,660 shares of common stock with grant date fair values ranging from $ 6.52 to $ 37.60 .

The Company recorded general and administrative expenses of $ 63,000 and $ 21,000 for the years ended December 31, 2025 and 2024, respectively.

This agreement was extended in the fourth quarter of 2025 for additional 12-month term and pursuant to the agreement, the Company issued 5,426 shares of common stock with grant date fair value of $ 3.87 and recorded general and administrative expense of $ 21,000 for the year ended December 31, 2025.

In the first quarter of 2025, the Company entered into an agreement with a vendor to provide investor relations services for a six-month term.

Pursuant to the agreement, the Company issued a total of 12,000 shares of common stock and made a certain cash payment.

The cash payment and the equity components were expensed consistently over the contractual vesting period.

The Company issued 12,000 shares of common stock with grant date fair values ranging from $ 6.80 to $ 16.20 and recorded general and administrative expense of $ 124,280 for the year ended December 31, 2025.

In the second quarter of 2025, the Company entered into an agreement with a vendor to provide investor relations services for a six-month term.

Pursuant to the agreement, the Company issued 2,300 shares of common stock with a grant date fair value of $ 7.60 and recorded general and administrative expenses of $ 17,480 for the year ended December 31, 2025.

This agreement was amended in the third quarter of 2025 for an additional six-month term and pursuant to the agreement, the Company will make quarterly grants equal to $ 20,000 worth of common stock and certain cash payments.

The cash payments and the equity components will be expensed consistently over the contractual vesting

Pursuant to the agreement, the Company issued 19,316 shares of common stock with grant date fair values ranging from $ 3.37 to $ 4.95 and recorded general and administrative expenses of $ 80,000 for the year ended December 31, 2025.

NOTE 7 – INCOME TAXES

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These costs are required to be amortized over five years if the R&D activities are performed in the U.S., or over 15 years if the activities were performed outside the U.S.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law.

OBBBA introduces significant changes to U.S.

income-tax legislation .

The Company has evaluated the current legislation at this time and prepared the provision by following the treatment of research and development expenditures for tax purposes under Section 174.

The Company capitalized approximately $ 2.2 million and $ 5.7 million of R&D expenses for the years ended December 31, 2025 and 2024, respectively.

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Basic and diluted net loss per share of common stock for the years ended December 31, 2025 and 2024 was determined by dividing net loss by the weighted average shares of common stock outstanding during the period.

The Company’s

potentially dilutive securities, consisting of 6,136,245 , warrants, and 3,880,000 stock options, have not been included in the computation of diluted net loss per share for all periods as the result would be antidilutive.

The Company’s potentially dilutive securities, consisting of 922,879 warrants and 227,775 stock options, have not been included in the computation of diluted net loss per share for all periods as the result would be antidilutive.

NOTE 9 – COMMITMENTS AND CONTINGENCIES

In conjunction with the Asset purchase in February 2018, the Company is required to make certain milestone payments related to the ongoing development of ACX-362E totaling $ 700,000 in the aggregate if certain milestones are achieved (which includes $ 200,000 already paid after the acquisition in February 2018).

During the fourth quarter of 2023, the Company achieved the Phase 2 clinical trial milestone and included $ 150,000 as a part of accounts payable and accrued expenses as of December 31, 2023, and this amount was paid in 2024.

During the fourth quarter of 2023, the Company achieved the Phase 2 clinical trial milestone and paid $ 150,000 in 2024.

The Company is also obligated to make royalty payments equal to 4 % of net sales of ACX-362E for a period of time equal to the last to expire of any applicable patents, as defined in the purchase agreement.

NOTE 10 – SUBSEQUENT EVENTS

On January 6, 2025, the Company suspended the existing ATM program.

On January 6, 2025, the Company, entered into a Securities Purchase Agreement with certain institutional investors and Affiliate Investors, pursuant to which the Company agreed to issue and sell, in a 2025 January Registered Direct Offering by the Company directly to the Investors and to the Affiliate Investors, an aggregate of 2,463,058 shares of common stock, par value $ 0.001 per share, of the Company (consisting of an aggregate of 2,295,570 Shares purchased by the Investors and an aggregate of 167,488 Shares purchased by the Affiliate Investors), at an offering price of $ 1.015 per share, for aggregate gross proceeds from the Registered Offering of approximately $ 2.5 million.

The net proceeds after deducting the placement agent’s fees and other offering expenses payable by the Company were approximately $ 2.1 million.

The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

In a concurrent private placement (the “2025 January Private Placement” and together with the January Registered Offering, the “Offering”), the Company agreed to issue to the Investors and to the Affiliate Investors Series E common warrants (the “Series E Warrants”) to purchase up to an aggregate of 2,463,058 shares of Common Stock (consisting of Series E Warrants to purchase up to 2,295,570 shares of Common Stock issued to the Investors and Series E Warrants to purchase up to 167,488 shares of Common Stock issued to the Affiliate Investors) at an exercise price of $ 0.90 per share.

Each Series E Warrant will be immediately exercisable upon the issuance date and will expire five years from the initial exercise date.

The Series E Warrants and the shares of the Company’s Common Stock issuable upon the exercise of the Series E Warrants were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act, and Rule 506(b) promulgated thereunder.

In connection with the January Registered Offering, the Company issued 147,783 warrants to the placement agent at an exercise price of $ 1.2688 per share.

The Offering closed on January 7, 2025.

On March 6, 2025, the Company entered into a Securities Purchase Agreement with an institutional investor, pursuant to which the Company agreed to issue and sell, in a Registered Direct Offering (the March Registered Offering”) by the Company directly to the investor (i) 2,150,000 shares (the “Shares”) of common stock (the “Common Stock”), par value $ 0.001 per share, of the Company, at a purchase price of $ 0.40 per share and (ii) pre-funded common stock purchase warrants (the “March Pre-Funded Warrants”) to purchase up to 595,000 shares of Common Stock at a purchase price of $ 0.3999 per March Pre-Funded Warrant for aggregate gross proceeds of approximately $ 1.1 million, before deducting the placement agent fees and related offering expenses.

The net proceeds after deducting the placement agent’s fees and other offering expenses payable by the Company were approximately $ 0.9 million.

The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

As of March 17, 2025, 240,000 of the pre-funded warrants were exercised.

The Series F Warrants will have an exercise price of

$ 0.40 per share and will be exercisable commencing on the effective date of stockholder approval of the issuance of the shares of Common Stock issuable upon exercise of the Series F Warrants (the “Stockholder Approval”) and will expire twenty-four months following the date of Stockholder Approval.

The Company will be obligated to obtain Stockholder Approval at the Company's annual meeting of stockholders on or prior to the date that is 150 days following the Closing Date (the “Stockholder Meeting Deadline”).

If Stockholder Approval is not obtained on or prior to the Stockholder Meeting Deadline, the Company is required to cause an additional stockholder meeting to be held every 60 days after the Stockholder Meeting Deadline until Stockholder Approval is obtained or the Series F Warrants are no longer outstanding.

The Series F Warrants and the shares of our Common Stock issuable upon the exercise of the Series F Warrants were not registered under the Securities Act of 1933, as amended (the “Securities Act”), were not offered pursuant to the Registration Statement and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act, and Rule 506(b) promulgated thereunder.

In connection with the March Registered Offering, the Company issued 164,700 warrants to the placement agent at an exercise price of $ 0.50 per share.

The March Offering closed on March 10, 2025.

Under the ELOC, the Company sold an additional 482,038 shares of its common stock for approximately $ 1.0 million subsequent to year end, bringing the cumulative total to 1,233,434 shares of common stock, with gross proceeds of approximately $ 4.9 million through March 12, 2026.

On March 9, 2026, the Company announced a new clinical development initiative to expand the ibezapolstat program into recurrent C.

difficile infection (rCDI).

The initiative includes an open label pilot trial in multiply recurrent CDI that will enroll up to 20 patients who have experienced at least two recurrences within the past 12 months.

Trial start up activities are scheduled to begin later this month, and first patient enrollment is expected in the fourth quarter of this year.

The Company intends to use data from this 20 patient study to inform the design of a planned active controlled Phase 3 registration trial in rCDI.

Following a successful pivotal Phase 3 study, the Company plans to seek the United States Food and Drug Administration’s approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for treatment and prevention of rCDI.

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 9A. Controls and Procedures