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| PART I | FINANCIAL INFORMATION | 5 |
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| Item 1 | Financial Statements | 5 |
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| | Unaudited Condensed Balance Sheets as of June 30, 2025 and December 31, 2024 | 5 |
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| | Unaudited Condensed Statements of Operations for the Three and Six Months Ended June 30, 2025 and 2024 | 6 |
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| | Unaudited Condensed Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended June 30, 2025 and 2024 | 7 |
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| | Unaudited Condensed Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024 | 9 |
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| | Notes to Unaudited Condensed Financial Statements | 10 |
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| Item 2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 18 |
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| Item 3 | Quantitative and Qualitative Disclosures About Market Risk | 26 |
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| Item 4 | Controls and Procedures | 26 |
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| PART II | OTHER INFORMATION | 27 |
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| Item 1 | Legal Proceedings | 27 |
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| Item 1A | Risk Factors | 27 |
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| Item 2 | Unregistered Sales of Equity Securities and Use of Proceeds | 53 |
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| Item 3 | Defaults Upon Senior Securities | 54 |
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| Item 4 | Mine Safety Disclosures | 54 |
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| Item 5 | Other Information | 54 |
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| Item 6 | Exhibits | 55 |
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| | Signatures | 56 |
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SUMMARY OF RISK FACTORS
An investment in our common stock is subject to a broad range of risks and should only be made after a careful consideration of such risks. For a discussion of some of the risks you should consider before purchasing our common stock, you are urged to carefully review and consider the section entitled “Item 1A. Risk Factors.”
Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition, results of operations, cash flows and prospects that you should consider before making a decision to invest in our common stock. These risks are discussed more fully in the section titled “Risk factors” beginning on page 26 of this report, and include the following:
Risks Related to our Financial Condition and Capital Requirements
| ● | We have a limited operating history, have only initiated a limited number of clinical trials, and have only a limited number of patients currently enrolled in our ongoing trials and have not completed any clinical trials to date. We do not have any products approved for commercial sale and have not generated any revenue, which may make it difficult for investors to evaluate our current business and likelihood of success and viability. |
| ● | We have incurred losses since our inception and have not generated any revenue. We expect to incur continued losses for the foreseeable future and may never achieve or maintain profitability. |
| ● | Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery or identification, preclinical and clinical development, regulatory approval and commercialization of our current or future product candidates. |
| ● | Tariffs and other trade measures could adversely affect our business, results of operations, financial position and cash flows. |
| ● | We will require substantial additional capital to finance our operations and achieve our goals. If we are unable to raise capital when needed or on terms acceptable to us, we may be forced to delay, reduce or eliminate our research or product development programs, any future commercialization efforts or other operations. |
| ● | Policies implemented during the COVID-19 pandemic, which remain in place today, could adversely impact our business, including our preclinical development, clinical trials and clinical trial operations. |
Risks Related to the Development of our Product Candidates
| ● | We are substantially dependent on the success of our product candidates, NXP900 and NXP800. |
| ● | Clinical trials are very expensive, time consuming and difficult to design and implement, and involve uncertain safety, tolerability and efficacy outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials. Our current or future product candidates may not have favorable results in early or later clinical trials, if any, or receive regulatory approval. |
| ● | If we fail to demonstrate safety and/or efficacy for any or all of our product candidates, we may need to terminate development programs, which may harm our reputation and the business. |
| ● | The development and commercialization of pharmaceutical products are subject to extensive regulation, and we may not obtain regulatory approvals for NXP900, NXP800, or any future product candidate. |
| ● | If we are unable to obtain or maintain regulatory approval for our product candidates and ultimately cannot commercialize one or more of them, or experience significant delays in doing so, our business will be materially harmed. |
Risks Related to Government Regulation
| ● | Denial of or delay in our receipt of required regulatory approvals may prevent or delay commercialization of our current or future product candidates and our ability to generate revenue may be materially impaired. |
| ● | Even if we receive regulatory approval of our current or future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our current or future product candidates. |
Risks Related to our Intellectual Property
| ● | If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our products and technology may be adversely affected. |
Risks Related to our Reliance on Third Parties
| ● | The manufacturing of our current and any future product candidates is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to supply any of our current or future product candidates for clinical trials or, if approved, for commercial sale. |
Risks Related to Managing Growth and Employee Matters
| ● | Our future success depends on our ability to retain our executive officers and key employees and to attract, retain and motivate qualified personnel and manage our human capital. |
| ● | We currently have 13 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth. |
Risks Related to Commercial Activities
| ● | If any of our current or future product candidates do not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues from any such current or future product candidate may be limited. |
| ● | If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates. |
Risks Related to Ownership of our Common Stock
| ● | We do not know whether an active, liquid and orderly trading market will be maintained for our Common Stock or what the market price of our Common Stock will be and, as a result, it may be difficult for you to sell your shares of our Common Stock. |
| ● | We do not intend to pay dividends on our Common Stock in the foreseeable future, so any returns will be limited to the value of our stock, which may be volatile. |
