What changed in this filing

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Item 9A. Controls and Procedures

2025-03-17 compared with 2024-03-15 · 161 added, 122 removed, 831 unchanged (25% 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.

In designing and evaluating our disclosure 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 the desired control

Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of the end of the period covered by this Form 10-K.

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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.

From December 2007 through February 2009, Mr.

December 2007 through February 2009, Mr.

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

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Luci began his career with Ernst & Whinney LLP (now Ernst &Young LLP) in New York as a certified public accountant working in the Healthcare Practice Group.

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.

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.

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(or Sterling Winthrop) (as an independent corporation and then as subsidiary of Eastman Kodak), and subsequently, upon acquisition, the U.S.

subsidiary of Sanofi-Aventis (or Sanofi) and currently serves as a member of the board of directors of IBEX Technologies Inc., which manufactures and markets proprietary enzymes (heparinases and chondroitinases) for use in pharmaceutical research and Heparinase I, used in many leading hemostasis monitoring devices.

subsidiary of Sanofi-Aventis (or Sanofi) and had served as a member of the board of directors of IBEX Technologies Inc., which manufactures and markets proprietary enzymes (heparinases and chondroitinases) for use in pharmaceutical research and Heparinase I, used in many leading hemostasis monitoring devices until the sale of IBEX to BBI Solutions OEM Limited in 2024.

DeLuccia began his career as a pharmaceutical sales representative for Pfizer, Inc.

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With over 5000 worldwide clients, the DAS division under Mr.

Harrison had annual revenues of over $6.0

billion and became the largest business unit within Omnicom Group.

Harrison had annual revenues of over $6.0 billion and became the largest business unit within Omnicom Group.

Harrison’s leadership, the DAS division grew from Omnicom’s smallest to its largest division and accounted for over 50% of Omnicom’s total revenues.

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Scodari began his career in 1974 in sales for Winthrop Laboratories, Division of Sterling Drug.

He progressed through various management positions, eventually leading the Diagnostic

Imaging Division for Winthrop and later Strategic Marketing at the corporate level for the Imaging business.

He progressed through various management positions, eventually leading the Diagnostic Imaging Division for Winthrop and later Strategic Marketing at the corporate level for the Imaging business.

Scodari joined Rorer Pharmaceuticals (shortly thereafter, Rhône-Poulenc Rorer) in 1989 as Vice President of Marketing and Business Development.

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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, 2023, there were nine meetings of our board of directors, and the various committees of our board of directors met a total of five 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, 2023.

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.

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, 2024.

Our board of directors has adopted a policy under which each member of our board of directors makes every effort to attend each annual meeting of our stockholders.

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Shawah graduated from Bucknell University with a degree as a Bachelor of Science in Business Administration with a concentration in Accounting.

Delinquent Section 16(a) Reports

Section 16(a) of the Exchange Act requires our directors, officers and beneficial owners of more than 10% of our common stock to file with the SEC initial reports of ownership and reports of changes in the ownership of our common stock and other equity securities.

Such persons are required to furnish us copies of all Section 16(a) filings.

Our records reflect that all reports which were required to be filed with the SEC pursuant to Section 16(a) of the Securities Exchange Act of 1934, as amended, were filed on a timely basis, except that Form 4 reports, covering an aggregate of four (4) transactions, were filed late by Robert J.

DeLuccia, Robert G.

Shawah and David P.

Code of Conduct and Ethics

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(1) Other compensation represents health care insurance.

Luci’s base annual salary was $475,000 for the years ended December 31, 2023 and 2022.

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.

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The options had no intrinsic value at March 14, 2025.

DeLuccia’s base salary was $485,000 for the year ended December 31, 2023 and $475,000 for the year ended December 31, 2022.

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.

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The options had no intrinsic value at March 14, 2025.

Shawah’s base salary was $375,000 for the year ended December 31, 2023 and $300,000 for the year ended December 31, 2022.

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.

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Luci entered into an Amended and Restated Employment Agreement, dated as of May 25, 2021, and effective June 29, 2021 (the “Luci Amended and Restated Employment Agreement”).

Amended and Restated Employment Agreement provides for a base salary of $450,000 per year and a potential incentive award bonus of up to 40% (or a higher or lower amount if so determined by the Board) of his base salary on an annualized basis (which amount shall be fixed for the first 12 months of the term).

The Luci Amended and Restated Employment Agreement provides for a base salary of $450,000 per year and a potential incentive award bonus of up to 40% (or a higher or lower amount if so determined by the Board) of his base salary on an annualized basis (which amount shall be fixed for the first 12 months of the term).

Effective January 13, 2022, Mr.

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Additionally, it is our policy that directors, executive officers and designated insiders are not permitted to hedge their ownership of Company securities, including (a) trading in publicly-traded options, (b) selling any security of the Company “short” and (c) purchasing any financial instruments (including straddles, collars or other similar risk reduction or hedging devices) or otherwise engaging in transactions that are designed to or have the effect of offsetting any decrease in the market value of our securities.

A copy of our Insider Trading Policy is attached hereto as exhibit 19.1.

Outstanding Equity Awards at 2024 Fiscal Year-End

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Luci was granted stock options to purchase 130,000 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 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.

(2) On the June Grant Date, Mr.

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DeLuccia was granted stock options to purchase 130,000 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 13, 2026.

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

DeLuccia was granted stock options to purchase 250,000 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.

(3) On the June Grant Date, Mr.

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Shawah was granted stock options to purchase 75,000 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 13, 2026.

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

Shawah was granted stock options to purchase 145,000 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.

Director Compensation

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We deem shares of common stock that may be acquired by an individual or group within 60 days of March 17, 2025, 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.

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.

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 22,042,511 shares of common stock outstanding on March 17, 2025.

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(3) Consists of 1,014,043 shares of our common stock, 92,957 shares of our common stock underlying warrants to purchase shares of our common stock and 1,294,722 shares of our common stock issuable upon exercise of stock options within 60 days of March 17, 2024, held of record by Mr.

(4) Consists of 3,077 shares of our common stock and 47,222 shares of our common stock issuable upon exercise of stock options within 60 days of March 15, 2024.

(4) Consists of 27,708 shares of our common stock, 24,631 shares of our common stock underlying warrants to purchase shares of our common stock and 60,000 shares of our common stock issuable upon exercise of stock options within 60 days of March 17, 2025.

(5) Consists of 27,546 shares of our common stock, 14,852 shares of our common stock underlying warrants to purchase shares of our common stock and 60,000 shares of our common stock issuable upon exercise of stock options within 60 days of March 17, 2025, held by Dr.

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In approving or rejecting any such proposal, our Audit Committee is to consider all available information deemed relevant by the Audit Committee, including, but not limited to, the extent of the related person’s interest in the transaction and whether the transaction is on terms no less favorable to us than terms we could have generally obtained from an unaffiliated third party under the same or similar circumstances.

During the fiscal years ended December 31, 2023 and 2022, we have engaged in the following transactions:

Investor Rights Agreements

We have entered into investor rights agreements with the investors who participated in our private placement financings between March 2018 and October 2019, including Messrs.

DeLuccia, Luci, Sailer, Scodari, Harrison and Dean.

Each such investor rights agreement imposes certain affirmative obligations on us and also grants certain rights to such investors, including certain registration rights with respect to the securities held by them and certain additional rights.

Since the beginning of our last fiscal year and during the fiscal years ended December 31, 2024 and 2023, we have engaged in the following transactions:

Indemnification Agreements

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The Indemnification Agreements set forth procedures for making and responding to requests for indemnification or advancement of expenses, as well as dispute resolution procedures that will apply to any dispute between us and an indemnitee arising under the Indemnification Agreements.

Participation in Our July 2022 Registered Direct Offering and Concurrent Private Placement

In July 2022, we issued and sold in a registered direct offering (i) an aggregate of 1,159,211 shares of our common stock (“Shares”) (consisting of 1,100,000 shares for single healthcare-focused U.S.

institutional investor (the “Investor”) and an aggregate of 59,211 for David P.

Participation in Our January 2025 Registered Direct Offering

On January 6, 2025, we entered into the Purchase Agreement with the institutional investors, and with each of David P.

Luci, our President and Chief Executive Officer, Robert J.

DeLuccia, our Executive Chairman and Carl V.

Sailer, a member of our board of directors (collectively, the “Affiliate Investors”)) at an offering price of $3.25 per share for the Investor and $3.80 per share for the Affiliate Investors and (ii) an aggregate of 130,769 pre-funded warrants exercisable for shares of common stock (the “Pre-Funded Warrants”) to the Investor at an offering price of $3.2499 per Pre-Funded Warrant, for aggregate gross proceeds from the Registered Offering of approximately $4.225 million before deducting the placement agent fee and related offering expenses.

In a concurrent private placement (the “Private Placement” and together with the Registered Offering, the “Offerings”), we issued to the Investor and to the Affiliate Investors (i) series A warrants (the “Series A Warrants”) exercisable for an aggregate of 1,289,980 shares of common stock (consisting of Series A Warrants (the “Investor Series A Warrants”) to purchase up to 1,230,769 shares of common stock for the Investor and Series A Warrants (the “Affiliate Series A Warrants”) to purchase up to 59,211 shares of common stock for the Affiliate Investors) at an exercise price of $3.25 per share for the Investor Series A Warrants and $3.55 per share for the Affiliate Series A Warrants and (ii) series B warrants (the “Series B Warrants” and together with the Series A Warrants, the “Warrants” and collectively with the Shares and the Pre-Funded Warrants, the “Securities”) exercisable for an aggregate of 1,289,980 shares of common stock (consisting of Series B Warrants (the “Investor Series B Warrants”) to purchase up to 1,230,769 shares of common stock for the Investor and Series B Warrants (the “Affiliate Series B Warrants”) to purchase up to an aggregate of 59,211 shares of common stock for the Affiliate Investors) at an exercise price of $3.25 per share for the Investor Series B Warrants and $3.55 per share for the Affiliate Series B Warrants.

The table below sets forth the aggregate number of Securities issued to our directors, executive officers or holders of more than 5% of our capital stock, or an affiliate or immediate family member thereof, at the time of the Offerings:

Purchase Price

DeLuccia, our Executive Chairman, Carl V.

Sailer, Jack H.

Dean, James Donohue, and Joseph Scodari, each members of our Board of Directors pursuant to which we issued and sold to the affiliate investors (i) an aggregate of 167,488 shares of common stock in a registered direct offering and (ii) the affiliate warrants at an exercise price of $0.90 per share in a concurrent private placement.

Each share of common stock was sold at a purchase price of $1.015 per share.

Director Independence

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Form of 2023 Pre-Funded Warrant.

Form of Series E Warrant

Form of January 2025 Wainwright Warrant

Form of Series F Warrant

Form of Pre-Funded Warrant

Form of March 2025 Wainwright Warrant

Description of Securities.

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Form of Recapitalization Exchange Option Agreement.

Exhibit Description

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

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Luci, dated May 25, 2021.

Exhibit Description

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

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and A.G.P/Alliance Global Partners .

Form of S ecurities Purchase Agreement, dated as of January 6, 2025, by and among Acurx Pharmaceuticals, Inc.

and the purchasers party thereto.

Form of Securities Purchase Agreement, dated as of March 6, 2025, by and between Acurx Pharmaceuticals, Inc.

and the purchaser party thereto.

Acurx Pharmaceuticals, Inc.

Insider Trading Policy.

Subsidiaries .

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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Clawback Policy.

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Exhibit Description

the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

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Inline XBRL Taxonomy Extension Schema Document.

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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 $ 222,161 cash issuance costs

Warrant Exercise

Cashless Warrant Exercise

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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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Cash Flow from Financing Activities:

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

Proceeds from 2023 Registered Direct Offering, net of issuance costs

Net Cash Provided by Financing Activities

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2023 Registered Direct Offering costs (Note 4)

Warrants issued in connection with 2022 offerings (Note 4)

See accompanying notes to financial statements.

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This outbreak caused major disruptions to businesses and markets worldwide as the virus continued to spread.

The COVID-19 pandemic has disrupted, and the Company expects it will continue to disrupt, its operations.

Previously, the Company’s clinical trial operations were directly and indirectly adversely impacted, and could continue to be directly and indirectly adversely impacted by the COVID-19 pandemic.

The extent of the effect on the Company’s operational and financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, and governmental, regulatory and private sector responses, direct and indirect economic effects as a result of inflation, supply chain disruptions and labor shortages all of which are uncertain and difficult to predict.

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On November 15, 2023, the Company entered into a Sales Agreement and established an “At-the-Market” offering (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 ATM Program, the Company sold 698,121 shares of common stock for gross proceeds of approximately $ 2.6 million.

As of December 31, 2023, the Company had a cash balance of approximately $ 7.5 million, which based on current estimates will not be sufficient to meet our anticipated cash requirements for at least 12 months from the issuance of the

financial statements for the year ended December 31, 2023.

Under the ATM Program, the Company sold a total of 2,830,328 , 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.

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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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.

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):

Improvements to Income Tax Disclosures , which expands the disclosures required for income taxes.

This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted.

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.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, in deciding how to allocate resources in assessing performance.

The Company views its operations and manages its business in one segment and the Company’s chief operating decision maker (“CODM”) is the President/Chief Executive Officer.

The Company’s segment consists of the development of clinical and preclinical product candidates for the development of the Company’s proprietary new therapies.

The CODM assesses performance of the segment based on net loss, which is reported on the statement of operations, assets as reported on the balance sheet, and cash utilization forecasts in deciding how to invest in the Company’s development and assesses the entity-wide operating results and performance.

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

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Costs for certain research and development activities, such as the provision of services for clinical trial activity, are estimated based on an evaluation of the progress to completion of specific tasks which may use data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred.

Payments for these activities are based on the terms of the individual arrangements, which may differ

from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be.

Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as applicable.

The estimates are adjusted to reflect the best information available at the time of the financial statement issuance.

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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 a major vendor that accounted for approximately 63 % and 55 % of the research and development expenditures for the years ended December 31, 2023 and 2022, respectively.

The same vendor also accounted for approximately 53 % and 56 % of the total accounts payable and accrued expenses as of December 31, 2023 and 2022, respectively.

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.

NOTE 3 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES

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December 31, 2023

Accrued compensation expenses

Accrued research and development

Accrued compensation expenses

Accrued professional fees

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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 June 29, 2021, the Company completed an IPO issuing 2,875,000 shares of common stock at a price of $ 6.00 per share, resulting in net cash proceeds of approximately $ 14.8 million, with cash issuance costs of approximately $ 2.4 million.

The outstanding Class A and Class B Membership Interests were converted to shares of common stock pursuant to a conversion ratio of one -for-two of the Membership Interests outstanding, resulting in the conversion of 14,082,318 Class A and Class B Membership Interests into 7,041,208 shares of common stock.

Warrants to purchase Class A Membership Interests were converted to warrants to purchase common stock at the same one -for two conversion ratio, resulting in 1,437,577 warrants to purchase common stock with a weighted average exercise price of $ 2.88 .

In connection with the IPO, the Company issued 150,000 warrants to the underwriter.

Each warrant is exercisable for 4.5 years from December 21, 2021 at an exercise price of $ 7.50 per share.

The Company used the Black-Scholes model to calculate the value of the warrants with an estimated fair value of $ 618,000 .

The inputs utilized in the calculation were as follows:

four and a half-year term, 0.79 % risk-free rate, stock price at grant date of $ 6.26 , and a 94 % 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.

On July 25, 2022, the Company entered into securities purchase agreements (the “Purchase Agreements”) with two of the Company’s executives and a member of the Company’s board of directors (collectively, the “Affiliate Investors”), and a single U.S.

institutional investor (the “Investor”) pursuant to which the Company issued and sold in a registered direct offering an aggregate of 1,159,211 shares of common stock, par value $ 0.001 per share and pre-funded warrants to purchase an aggregate of 130,769 shares of common stock.

The Affiliate Investors purchased an aggregate of 59,211 shares of common stock at a purchase price of $ 3.80 per share.

The Investor purchased an aggregate of 1,100,000 shares of common stock at a purchase price of $ 3.25 per share and an aggregate of 130,769 pre-funded warrants at a purchase price of $ 3.2499 per pre-funded warrant.

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

As of December 31, 2022, all of the pre-funded warrants were exercised.

The Company also issued to the Affiliate Investors and the Investor, series A warrants to purchase 1,289,980 shares of common stock and series B warrants to purchase 1,289,980 shares of common stock, all of which are deemed equity classified.

These warrants included 59,211 series A warrants and an aggregate of 59,211 series B warrants to the Affiliate Investors with an exercise price per share of $ 3.55 and an aggregate of 1,230,769 series A warrants and an aggregate of 1,230,769 series B warrants to the Investor with an exercise price per share of $ 3.25 .

The series A warrants were exercisable commencing on January 27, 2023 and will expire on May 18, 2029 for the Investor and January 27, 2028 for the Affiliates.

The series B warrants were exercisable commencing on January 27, 2023 and will expire on May 18, 2029 for the Investor and January 27, 2024 for the Affiliates.

The registered direct offering closed on July 27, 2022.

As of December 31, 2023, 682,769 of series B warrants were exercised and the Company received approximately $ 2.2 million in proceeds from these warrant exercises.

The gross proceeds to the Company from the registered direct offering were $ 4.2 million and net proceeds after deducting the placement agents’ fees and other offering expenses payable by the Company were approximately $ 3.7 million.

On July 25, 2022, the Company entered into a co-placement agent agreement (the “Placement Agent Agreement”), with two placement agents in connection with the registered direct offering pursuant to which the Company paid the Placement Agents a cash fee of $ 287,874 and issued to the Placement Agents an aggregate of 63,018 warrants to purchase shares of common stock.

The warrants have an exercise price of $ 3.60 per share (representing 110 % of the weighted average public offering price of the aggregate number of shares of common stock sold in the registered direct offering to the Investor and Affiliate Investors) and expire on July 27, 2027.

The Company used the Black-Scholes model to calculate the value of the warrants with an estimated fair value of $ 171,409 .

The inputs utilized in the calculation were as follows:

five -year term, 2.82 % risk free rate, stock price at grant date of $ 3.70 and a 95 % 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.

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

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

The gross proceeds to the Company from the registered direct offering were approximately $ 4.0 million and net proceeds after deducting the placements 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 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.

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

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 % of the gross offering proceeds of all shares sold through it pursuant to the Sales Agreement.

During the year ended December 31, 2023, 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.

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 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 receivables were collected on January 3, 2024 and 17,869 shares were settled and transferred on January 2, 2024.

As of December 31, 2023, the Company has $ 14.4 million available under the ATM Program.

In January 2024, the Affiliate Investors exercised 59,211 of Series B Warrants which generated approximately $ 0.2 million in proceeds for the Company.

The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2024:

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Balance at December 31, 2023

( 1,420,501 )

Balance at December 31, 2024

The weighted average contractual life of the outstanding warrants is 3.50 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 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

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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 $ 726,880 for each of the years ended December 31, 2023 and 2022, related to compensation expenses for these options.

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 $ 1,963,667 for each of the years ended December 31, 2023 and 2022, related to compensation expenses for these options.

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 and $ 145,283 for the years ended December 31, 2023 and 2022, respectively, related to compensation expenses for these options.

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 and $ 35,850 for the years ended December 31, 2023 and 2022, respectively, related to compensation expenses for these options.

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 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 835,000 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.

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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 general and administrative expenses of $ 53,600 for the year ended December 31, 2023, related to compensation expenses for these options.

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

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 2021, the Company entered into an agreement with a consultant to provide financial advisory services for a six-month term.

Pursuant to the agreement, the Company granted $ 150,000 of common stock over the term

The Company granted total of 27,778 shares of common stock at grant date fair value and recorded general and administrative expenses of $ 0 and $ 75,000 for the years ended December 31, 2023 and 2022, respectively.

In the first quarter of 2022, the Company entered into an agreement with a consultant to provide investor relation services for a six-month term.

Pursuant to the agreement, the Company granted 30,000 shares of common stock with a grant date fair value of $ 3.77 and paid $ 25,000 of cash compensation.

The cash component was expensed over the service period and the equity component was expensed consistent with the contractual vesting.

The Company recorded general and administrative expenses of $ 0 and $ 113,100 for the years ended December 31, 2023 and 2022, respectively.

In the third quarter of 2022, the Company entered into an agreement with a company to provide consulting services for a six-month term.

Pursuant to the agreement, the Company granted 36,000 shares of common stock with a grant date fair value of $ 3.53 , which was expensed consistent with the contractual vesting.

The Company recorded general and administrative expenses of $ 0 and $ 127,080 for the years ended December 31, 2023 and 2022, respectively.

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 a grant date fair values ranging from $ 3.30 to $ 3.67 , up to 10,096 of warrants, and cash payments.

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

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

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 $ 119,160 for the year ended December 31, 2023.

In the fourth quarter of 2023, the Company entered into a number of agreements with vendors pursuant to which the Company will make grants of a total of 116,000 share of common stock and cash payments, of which 96,000 shares of common stock were issued as of December 31, 2023 with grant date fair values ranging from $ 1.50 to $ 5.07 .

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

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

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 116,000 share of common stock with grant date fair values ranging from $ 1.50 to $ 5.18 and cash payments.

These contracts had four to 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 $ 76,600 and $ 393,681 for the years ended December 31, 2024 and 2023, 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.

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 120,000 shares of common stock evenly over the four-month service period with grant date fair values ranging from $ 1.87 to $ 4.81 .

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

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.

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 156,000 shares of common stock evenly over the six-month service period with grant date fair values ranging from $ 1.80 to $ 2.40 .

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.

NOTE 7 – INCOME TAXES

The Company has $ 25.7 million of net operating loss carryforwards and $ 0.3 million of research tax credit carryforwards as of December 31, 2024.

The net operating loss carryforwards are indefinite lived and research tax credit carryforwards will expire in 2043.

The federal net operating loss carryforwards are indefinite lived, and research tax credit carryforwards will begin to expire in 2041.

State and city net operating loss carryforwards will begin to expire in 2041.

Net operating loss and tax credit carryforwards may become subject to annual limitations in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined by Sections 382 and 383 of the Internal Revenue Code as well as similar state provisions.

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After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against their net deferred tax assets at December 31, 2024 because the Company has concluded that it is more-likely-than-not that these assets will not be realized.

A reconciliation of income tax expense (benefit) at the statutory Federal income tax rate and income taxes as reflected in the financial statements for both years ended December 31, 2023 and 2022 is as follows:

December 31, 2024

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NOTE 8 – NET LOSS PER SHARE

Basic and diluted net loss per share of common stock for the year ended December 31, 2023 and 2022 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 6,195,456 warrants, and 2,985,000 stock options, have not been included in the computation of diluted net loss per share for all periods as the result would be antidilutive.

Basic and diluted net loss per share of common stock for the years ended December 31, 2024 and 2023 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.

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.

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.

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

As a part of the ATM Program, the Company sold a total of 1,819,914 shares of its common stock pursuant to the Sales Agreement at an average price of $ 3.88 for aggregate net proceeds of approximately $ 6.7 million as of March 15, 2024.

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.

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 8,235,000 shares of Common Stock.

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.

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