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Item 1A. Risk Factors
In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the risks and uncertainties relating to the Companys business disclosed in Part I, Item 1A, Risk Factors, in the Companys Annual Report on Form 10-K for the fiscal year ended September 30, 2025. There have been no material changes from the risk factors disclosed in Part I, Item 1A, Risk Factors, in the Companys Annual Report on Form 10-K for the fiscal year ended September 30, 2025.
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, except for the following additional risk factor. Additional risks that we do not yet know of or that we currently think are immaterial may also impair our business operations.
We will need to raise additional capital to fund our operations and development programs in the future, and the SEC baby shelf rule may limit our ability to raise sufficient capital when needed.
We are not profitable and have had negative cash flow from operations. We will need large amounts of capital to support our development and commercialization efforts for our drug candidates. Our existing cash, cash equivalents, and restricted cash as of the date of this report may not be sufficient to fund our working capital needs and operating expenses. To obtain the capital necessary to fund our operations, we expect to finance our cash needs through public or private equity offerings, debt financing and/or other capital sources. Additional capital may not be available at such times or amounts as needed by us.
Under current SEC regulations, because our public float is less than $75 million, and for so long as our public float remains less than $75 million, the amount we can raise through primary public offerings of securities in any 12-month period using shelf registration statements is limited to an aggregate of one-third of our public float (referred to as the baby shelf rule). As of April 7, 2026, the aggregate market value of our outstanding common shares held by non-affiliates, or public float, was approximately $38.5 million, which is calculated based on 14,480,292 shares of our outstanding common stock held by non-affiliates and a price of $2.66 per share, the closing price of our common stock on February 26, 2026, which is the highest closing price of our common stock on the Nasdaq Capital Market within the prior 60 days of April 7, 2026. If our public float decreases, the amount of securities we may sell under our shelf registration statement may also decrease.
If access to sufficient capital is not available as and when needed, our business will be materially impaired, and we may be required to cease operations, curtail one or more product development programs, scale back or eliminate the development of business opportunities, or significantly reduce expenses, sell assets, seek a merger or joint venture partner, file for protection from creditors or liquidate all of our assets. Any of these factors could harm our operating results.
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