| PART I |
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| Item 1. Business | 3 |
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| Item 1A. Risk Factors | 24 |
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| Item 1B. Unresolved Staff Comments | 45 |
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| Item 1C. Cybersecurity | 45 |
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| Item 2. Properties | 46 |
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| Item 3. Legal Proceedings | 46 |
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| Item 4. Mine Safety Disclosure | 46 |
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| PART II |
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| Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 46 |
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| Item 6. [Reserved] | 47 |
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| Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations | 47 |
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| Item 7A. Quantitative and Qualitative Disclosures About Market Risk | 53 |
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| Item 8. Financial Statements and Supplementary Data | 53 |
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| Item 9. Change in and Disagreements with Accountants on Accounting and Financial Disclosures | 53 |
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| Item 9A. Controls and Procedures | 53 |
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| Item 9B. Other Information | 54 |
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| Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. | 54 |
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| PART III |
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| Item 10. Directors, Executive Officers and Corporate Governance | 54 |
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| Item 11. Executive Compensation | 54 |
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| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 54 |
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| Item 13. Certain Relationships and Related Transactions and Director Independence | 54 |
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| Item 14. Principal Accountant Fees and Services | 54 |
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| PART IV |
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| Item 15. Exhibits and Financial Statement Schedules | 54 |
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| Signatures | 58 |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
The Securities and Exchange Commission, referred to herein as the SEC, encourages companies to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment decisions. Certain statements that we may make from time to time, including, without limitation, statements contained in this report constitute “forward- looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.
We make forward-looking statements under the “Risk Factors,” “Business,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in other sections of this report. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “should,” “would,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or “continue,” and the negative of these terms and other comparable terminology. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the numerous risks and uncertainties described under “Risk Factors.”
While we believe we have identified material risks, these risks and uncertainties are not exhaustive. Other sections of this report describe additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very highly regulated, competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this report to conform our prior statements to actual results or revised expectations, and we do not intend to do so.
Forward-looking statements include, but are not limited to, statements about:
| • | Our ability to continue our relationship with MD Anderson, including, but not limited to, our ability to maintain current licenses and license future intellectual property resulting from our sponsored research agreements with MD Anderson; |
| • | The success or the lack thereof, including the ability to recruit subjects on a timely basis, for a variety of reasons, of our clinical trials through all phases of clinical development; |
| • | Our ability to satisfy any requirements imposed by the United States (US) Food and Drug Administration (FDA) (or its foreign equivalents) as a condition of our clinical trials proceeding or beginning as planned; |
| • | World-wide events including the wars in Ukraine and in the Middle East, and the general supply chain shortages effects on our clinical trials, clinical drug candidate supplies, preclinical activities and our ability to raise future financing; |
| • | Our ability to obtain additional funding on a timely basis to commence or continue our clinical trials, fund operations and develop our product candidates; |
| • | The need to obtain and retain regulatory approval of our drug candidates, both in the United States and in Europe, and in countries deemed necessary for future trials; |
| • | Our ability to complete our clinical trials in a timely fashion in line with our stated milestones and within our expected budget and resources; |
| • | Our ability to maintain compliance with the continued listing requirements of the Nasdaq Capital Market; |
| • | Our ability to source our drug products at reasonable prices; |
| • | Compliance with obligations under intellectual property licenses with third parties; |
| • | Any delays in regulatory review and approval of drug candidates in clinical development; |
| • | Potential efficacy of our drug candidates; |
| • | Our ability to commercialize our drug candidates; |
| • | Market acceptance of our drug candidates; |
| • | Competition from existing therapies or new therapies that may emerge; |
| • | Potential product liability claims; |
| • | Our dependency on third-party manufacturers to successfully, and timely, supply or manufacture our drug candidates for our preclinical work and our clinical trials; |
| • | Our ability to establish or maintain collaborations, licensing or other arrangements; |
| • | Our ability and third parties’ abilities to protect intellectual property rights; |
| • | Our ability to adequately support future growth; and |
| • | Our ability to attract and retain key personnel to manage our business effectively. |
We caution you not to place undue reliance on the forward-looking statements, which speak only as of the date of this Form 10-K in the case of forward-looking statements contained in this Form 10-K.
