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| PART I | | 6 |
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| Item 1. Business | | 6 |
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| Item 1A. Risk Factors | | 43 |
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| Item 1B. Unresolved Staff Comments | | 100 |
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| Item 1C. Cybersecurity | | 100 |
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| Item 2. Properties | | 101 |
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| Item 3. Legal Proceedings | | 102 |
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| Item 4. Mine Safety Disclosures | | 102 |
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| PART II | | 103 |
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| Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | 103 |
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| Item 6. [Reserved] | | 103 |
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| Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 104 |
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| Item 7A. Quantitative and Qualitative Disclosures About Market Risk | | 116 |
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| Item 8. Financial Statements and Supplementary Data | | 116 |
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| Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | | 116 |
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| Item 9A. Controls and Procedures | | 117 |
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| Item 9B. Other Information | | 118 |
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| Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | | 118 |
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| PART III | | 119 |
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| Item 10. Directors, Executive Officers and Corporate Governance | | 119 |
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| Item 11. Executive Compensation | | 119 |
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| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | 119 |
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| Item 13. Certain Relationships and Related Transactions, and Director Independence | | 119 |
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| Item 14. Principal Accountant Fees and Services | | 119 |
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| PART IV | | 120 |
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| Item 15. Exhibits and Financial Statement Schedules | | 120 |
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| Financial Statements | | 126 |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Statements made in this Annual Report on Form 10-K for the fiscal year ended December 31, 2024, or this Annual Report, may include “forward-looking statements” within the meaning of the federal securities laws, which statements are subject to considerable risks and uncertainties. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this Annual Report, other than statements of historical fact, are forward-looking statements. You can identify forward-looking statements by the use of words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “ongoing,” “plan,” “predict,” “project,” “positioned,” “potential,” “seek,” “should,” “suggest,” “target,” “will,” “would” and similar statements of a future or forward-looking nature and identify forward-looking statements. In particular, forward-looking statements contained in this Annual Report relate to, among other things, the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around these medicines. We caution you that the foregoing may not encompass all the forward-looking statements made in this Annual Report. 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 Annual Report on Form 10-K, and while we believe such information forms a reasonable basis for these statements, this 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.
Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. There are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We undertake no obligation to update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.
This Annual Report also contains estimates, projections and other information concerning our industry, our business, and the markets for our product candidates. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. Information that is based on data, estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and involve a number of assumptions and limitations, and actual events or circumstances may differ materially from events and circumstances reflected in this information. Accordingly, you are cautioned not to give undue weight to such information. While we believe such information is reliable, there can be no assurance as to the accuracy or completeness of the indicated information.
You should read the following together with the more detailed information regarding our company, our common stock and our consolidated financial statements and notes to those statements appearing elsewhere in this Annual Report or incorporated by reference. The Securities and Exchange Commission, or SEC, allows us to “incorporate by reference” information that we file with the SEC, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this Annual Report.
Risk Factor Summary
The risks described in the section titled “Risk Factors” in Part I of this Annual Report could impact our ability to realize the full benefits of our strengths or execute all or part of our strategy. Some of the more significant risks described in “Risk Factors” include the following:
| ● | We are a biopharmaceutical company with a history of losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability. |
| ● | We have a limited operating history, which may make it difficult to evaluate our drug development capabilities and predict our future performance. |
| ● | We have not yet demonstrated successful completion of clinical development, submitted a New Drug Application, or NDA, or Biologics License Application, or BLA, obtained U.S. Food & Drug Administration, or FDA, approval for marketing, or successfully commercialized a product, and we may be unable to do so. Furthermore, varegacestat, which we recently acquired, is currently in Phase 3 clinical development, but such acquisition and prior clinical success is not indicative of our ability to obtain NDA approval or successfully commercialize varegacestat. |
| ● | We may be unable to advance any of our product candidates into and through clinical development, obtain regulatory approvals and ultimately commercialize them, or we could experience significant delays in doing so. |
| ● | We may not be successful in our efforts to use and expand our ADC platform to build and progress a pipeline. |
| ● | We may pursue particular programs or product candidates over others; these decisions may prove to be wrong and may adversely impact our business. |
| ● | We may fail to realize the business benefits anticipated as a result of completed or future strategic transactions. |
| ● | As a targeted radioligand therapy, our IM-3050 program may face additional and potentially unpredictable challenges. |
| ● | Clinical trials are expensive, time-consuming and difficult to design and implement. |
| ● | Preliminary results from our preclinical studies and clinical trials that we announce or publish from time to time may change as more data become available and as the data undergo audit and verification procedures. Furthermore, clinical development has an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results and generally could be impacted by other factors beyond our reasonable control. |
| ● | If we encounter difficulties enrolling participants in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. |
| ● | We may experience delays in completion of our clinical trials based on study design. |
| ● | We face substantial competition, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. If their product candidates are shown to be safer or more effective than ours, then our commercial opportunity will be reduced or eliminated. |
| ● | If we or others identify undesirable side effects caused by a product candidate undergoing clinical trials, our ability to market and derive revenue from the product candidate could be compromised. |
| ● | If third parties on which we rely to conduct our current and future preclinical and clinical studies do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our programs could be delayed with material and adverse impacts on our business and financial condition. |
| ● | Because we rely on third parties for manufacturing, supply and testing, some of which may be sole source vendors, for preclinical and clinical development materials and commercial supplies, our supply may become limited or interrupted or may not be of satisfactory quantity or quality. |
| ● | It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection. |
| ● | If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. |
| ● | Any inability to attract and retain qualified key management, technical personnel and employees would impair our ability to implement our business plan. In addition, prior successes of our personnel may not be indicative of our future success. |
| ● | The market price of our common stock is expected to be volatile, and purchasers of our common stock could incur substantial losses. |
| ● | Unfavorable global economic and political conditions could adversely affect our business, financial condition or results of operations. |
