Acurx Pharmaceuticals, Inc.
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| PART I - | | FINANCIAL INFORMATION | 5 | |
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| | Item 1. | | Condensed Interim Financial Statements | 5 |
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| | | | Condensed Interim Balance Sheets as of September 30, 2024 (unaudited) and December 31, 2023 | 5 |
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| | | | Condensed Interim Statements of Operations for the Three and Nine Months Ended September 30, 2024 and 2023 (unaudited) | 6 |
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| | | | Condensed Interim Statements of Changes in Shareholders’ Equity for the Three and Nine Months Ended September 30, 2024 and 2023 (unaudited) | 7 |
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| | | | Condensed Interim Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 (unaudited) | 8 |
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| | | | Notes to the Condensed Interim Financial Statements (unaudited) | 9 |
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| | Item 2. | | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 16 |
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| | Item 3. | | Quantitative and Qualitative Disclosures about Market Risk | 25 |
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| | Item 4. | | Controls and Procedures | 25 |
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| PART II - | | OTHER INFORMATION | 26 | |
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| | Item 1. | | Legal Proceedings | 26 |
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| | Item 1A. | | Risk Factors | 26 |
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| | Item 2. | | Unregistered Sales of Equity Securities and Use of Proceeds | 59 |
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| | Item 3. | | Defaults Upon Senior Securities | 59 |
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| | Item 4. | | Mine Safety Disclosure | 59 |
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| | Item 5. | | Other Information | 59 |
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| | Item 6. | | Exhibits | 60 |
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| | | | Signatures | 61 |
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| | | | Certificates | |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (“Quarterly Report”) and certain information incorporated herein by reference contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In this Quarterly Report, we refer to Acurx Pharmaceuticals, Inc., together with its subsidiary, as the “Company,” “we,” “our” or “us.” All statements other than statements of historical facts contained herein, including statements regarding our future results of operations and financial position, strategy and plans, and our expectations for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect” or the negative version of these words and similar expressions are intended to identify forward-looking statements.
We have based these forward-looking statements on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A “Risk Factors.” In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances included herein may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. 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; and |
| ● | other risks and uncertainties, including those listed in “Risk Factors.” |
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. In addition, neither we nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking statements. Any forward-looking statement made by us in this Quarterly Report speaks only as of the date on which it is made. We disclaim any duty to update any of these forward-looking statements after the date of this Quarterly Report to conform these statements to actual results or revised expectations.
Other risks may be described from time to time in our filings made under applicable securities laws. New risks emerge from time to time. It is not possible for our management to predict all risks. All forward-looking statements in this Quarterly Report speak only as of the date made and are based on our current beliefs and expectations. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
