Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2026
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| PART I—FINANCIAL INFORMATION | 1 | |
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| Item 1. | Financial Statements (Unaudited) | 1 |
| Condensed Consolidated Balance Sheets | 1 |
| Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | 2 |
| Condensed Consolidated Statements of Stockholders’ Deficit | 3 |
| Condensed Consolidated Statements of Cash Flows | 4 |
| Notes to Condensed Consolidated Financial Statements | 5 |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 28 |
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 41 |
| Item 4. | Controls and Procedures | 41 |
| PART II—OTHER INFORMATION | 43 | |
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| Item 1. | Legal Proceedings | 43 |
| Item 1A. | Risk Factors | 43 |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 43 |
| Item 3. | Defaults Upon Senior Securities | 43 |
| Item 4. | Mine Safety Disclosures | 43 |
| Item 5. | Other Information | 43 |
| Item 6. | Exhibits | 44 |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements in this Quarterly Report on Form 10-Q (“Quarterly Report”) may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this Quarterly Report may include, for example, statements about:
| ● | our future financial performance, including our ability to continue as a going concern; |
| ● | our plans and strategies to raise additional funding; |
| ● | the clinical results of our drug candidates; |
| ● | the likelihood of commercial success for our drug candidates; |
| ● | our plans and strategies to obtain and maintain regulatory approvals of our drug candidates; |
| ● | the size and growth potential of the markets for our drug candidates, and our ability to serve those markets, either alone or in combination with others; |
| ● | changes in the market for our drug candidates; |
| ● | expansion plans and opportunities; and |
| ● | any other statements that address events or developments that we intend or believe will or may occur in the future. |
These forward-looking statements represent our views as of the date of this Quarterly Report and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date.
As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include:
| ● | our substantial dependence on the successful commercialization of our drug candidates, if approved, in the future; |
| ● | our significant net losses and net operating cash outflows; |
| ● | our ability to demonstrate the efficacy and safety of our drug candidates; |
| ● | the clinical results for our drug candidates, which may not support further development or marketing approval; |
| ● | actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; |
| ● | our ability to achieve commercial success for our drug candidates, if approved; |
| ● | our ability to obtain and maintain protection of intellectual property for our technology and drug candidates; |
| ● | our reliance on third parties to conduct research, drug development, and other services; |
| ● | our limited operating history and our ability to obtain additional funding for operations and to complete the licensing or development and commercialization of our drug candidates; |
| ● | the impact of any future epidemics, pandemics, or conflicts; |
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| ● | changes in applicable laws or regulations; |
| ● | the effects of inflation; |
| ● | the effects of staffing and materials shortages; |
| ● | the possibility that we may be adversely affected by other economic, business, and/or competitive factors; and |
| ● | other risks and uncertainties set forth in the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. |
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements.
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