Allarity Therapeutics, Inc.
For the period ended Dec 31, 2024. Filed Mar 31, 2025.
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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 31, 2025
Contents
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSii
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Annual Report”) contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements, other than statements of historical fact, contained in this Annual Report, including statements regarding our strategy, future preclinical studies and clinical trials, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. If one or more of these risk factors or uncertainties materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements. Furthermore, we operate in a competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Annual Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements relating to Allarity in this Annual Report include, but are not limited to, statements about:
| ● | our ability to secure immediate substantial funding for our operations, working capital and to pursue our clinical trials. If we are unable to raise capital when needed or on favorable terms, we could be forced to delay, reduce or terminate our operations, product development, other operations or commercialization efforts; |
| ● | our ability to indemnify third parties pursuant to contractual agreements; |
| ● | our ability to satisfy the Nasdaq Capital Market continued listing requirements; |
| ● | our ability to maintain effective internal control over financial reporting, disclosures and procedures. If we do not maintain effective internal controls, our ability to record, process and report financial information timely and accurately could be adversely affected and could result in a material misstatement in our financial statements, which could subject us to litigation or investigations, require management resources, increase our expenses, negatively affect investor confidence in our financial statements and adversely impact the trading price of our common stock; |
| ● | our plans to develop and commercialize stenoparib; |
| ● | our ability to generate any revenue or become profitable; |
| ● | the impact of adjustments to our outstanding warrants because of future dilutive financings resulting in the decrease of exercise price and increase the number of shares of issuable under outstanding warrants, adjustment and exercise of such warrants would result in the material dilution of the percentage ownership of our stockholders and increase the number of shares of common stock in the public markets. The perception that such sales could occur could cause our stock price to fall; |
| ● | the initiation, cost, timing, progress and results of our current and future preclinical studies and clinical trials, as well as our research and development programs; |
| ● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
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| ● | our ability to successfully acquire or in-license additional product candidates on reasonable terms; |
| ● | our ability to maintain and establish collaborations or obtain additional funding; |
| ● | our ability to obtain regulatory approval of stenoparib; |
| ● | our expectations regarding the potential market size and the rate and degree of market acceptance of stenoparib; |
| ● | our expectations regarding our ability to fund operating expenses and capital expenditure requirements with our existing cash and cash equivalents, and future expenses and expenditures; |
| ● | our ability to enroll patients in our clinical trials, our clinical development activities; |
| ● | our ability to retain key employees, consultants and advisors; |
| ● | our ability to retain reliable third parties to perform the chemistry work associated with our drug discovery, preclinical activities and to conduct our preclinical studies and clinical trials in a satisfactory manner; |
| ● | our ability to secure reliable third party manufacturers to produce clinical and commercial supplies of API for stenoparib; |
| ● | our ability to obtain, maintain, protect and enforce sufficient patent and other intellectual property rights for stenoparib; |
| ● | our anticipated strategies and our ability to manage our business operations effectively; |
| ● | the impact of governmental laws and regulations; |
| ● | the possibility that we may be adversely impacted by other economic, business, and/or competitive factors; |
| ● | any future currency exchange and interest rates; and |
| ● | other risks and uncertainties indicated in this Annual Report, including those set forth in the section titled “Risk Factors” as set forth in this Annual Report, which is incorporated herein by reference. |
These forward-looking statements are based on information available as of the date of this Annual Report, and current expectations, forecasts and assumptions, and involve a number of risks and uncertainties. We do not assume any obligation to update any forward-looking statements, Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any 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.
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