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Acurx Pharmaceuticals, Inc.

For the period ended Dec 31, 2024. Filed Mar 17, 2025.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 17, 2025

ACXP$1.060.0%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits

Table of Contents

PART I3
Item 1. Business.3
Item 1A. Risk Factors.35
Item 1B. Unresolved Staff Comments.69
Item 1C. Cybersecurity69
Item 2. Properties.72
Item 3. Legal Proceedings.72
Item 4. Mine Safety Disclosures.72
PART II73
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.73
Item 6. Selected Financial Data.73
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.73
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.85
Item 8. Financial Statements and Supplementary Data.85
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.85
Item 9A. Controls and Procedures.85
Item 9B. Other Information.86
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.87
PART III87
Item 10. Directors, Executive Officers and Corporate Governance.87
Item 11. Executive Compensation.94
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.99
Item 13. Certain Relationships and Related Transactions, and Director Independence.101
Item 14. Principal Accounting Fees and Services.102
PART IV104
Item 15. Exhibits, Financial Statement Schedules.104

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K (this “Form 10-K”) contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Form 10-K are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

●our ability to obtain and maintain regulatory approval of ibezapolstat and/or our other product candidates;
●our ability to successfully commercialize and market ibezapolstat and/or our other product candidates, if approved;
●our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately;
●the potential market size, opportunity and growth potential for ibezapolstat and/or our other product candidates, if approved;
●our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize ibezapolstat and/or our other product candidates, if approved;
●our ability to obtain funding for our operations;
●the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs;
●the timing of anticipated regulatory filings;
●the timing of availability of data from our clinical trials;
●the impact of the ongoing COVID-19 pandemic and our response to it;
●the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;
●our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
●our ability to advance product candidates into, and successfully complete, clinical trials;
●our ability to recruit and enroll suitable patients in our clinical trials and the timing of enrollment;
●the timing or likelihood of the accomplishment of various scientific, clinical, regulatory and other product development objectives;
●the pricing and reimbursement of our product candidates, if approved;
●the rate and degree of market acceptance of our product candidates, if approved;
●the implementation of our business model and strategic plans for our business, product candidates and technology;
●the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
●developments relating to our competitors and our industry;
●the development of major public health concerns, including the novel coronavirus outbreak or other pandemics arising globally, and the future impact of it and COVID-19 on our clinical trials, business operations and funding requirements;
●the effects of the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide from the conflict between Russia and Ukraine as well as the conflict in the Middle East between Israel and Hamas;
●the volatility of the price of our common stock;
●our financial performance;
●our ability to comply with the listing requirements of The Nasdaq Capital Market and any delisting or potential delisting of shares of our common stock; and
●other risks and uncertainties, including those listed in “Risk Factors.”

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the “Risk Factors” section and elsewhere in this Form 10-K. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Form 10-K may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable as of the date of this Form 10-K, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Form 10-K to conform these statements to new information, actual results or to changes in our expectations, except as required by law.

You should read this Form 10-K and the documents that we reference in this Form 10-K and have filed with the Securities and Exchange Commission (“SEC”) as exhibits to this Form 10-K with the understanding that our actual future results, levels of activity, performance, and events and circumstances may be materially different from what we expect.

This Form 10-K includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Such data involves a number of assumptions and limitations and contains projections and estimates of the future performance of the markets in which we operate and intend to operate that are subject to a high degree of uncertainty. We caution you not to give undue weight to such projections, assumptions and estimates.

This Form 10-K contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Form 10-K, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.