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| PART I |
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| Item 1. Business | | 7 |
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| Item 1A. Risk Factors | | 31 |
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| Item 1B. Unresolved Staff Comments | | 94 |
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| Item 1C. Cybersecurity | | 94 |
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| Item 2. Properties | | 95 |
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| Item 3. Legal Proceedings | | 95 |
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| Item 4. Mine Safety Disclosures | | 96 |
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| PART II |
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| Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | 96 |
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| Item 6. [Reserved] | | 97 |
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| Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 98 |
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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 | | 118 |
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| Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | | 161 |
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| Item 9A. Controls and Procedures | | 161 |
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| Item 9B. Other Information | | 162 |
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| Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | | 162 |
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| PART III |
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| Item 10. Directors, Executive Officers and Corporate Governance | | 163 |
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| Item 11. Executive Compensation | | 170 |
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| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | 179 |
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| Item 13. Certain Relationships and Related Transactions, and Director Independence | | 182 |
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| Item 14. Principal Accountant Fees and Services | | 185 |
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| PART IV |
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| Item 15. Exhibits and Financial Statement Schedules | | 187 |
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| Signatures | | 189 |
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In this Annual Report on Form 10-K, unless otherwise stated or as the context otherwise requires, references to “Alumis,” “the Company,” “we,” “us,” “our” and similar references refer to Alumis Inc.
This Annual Report on Form 10-K also contains registered marks, trademarks and trade names of other companies. All other trademarks, registered marks and trade names appearing in this report are the property of their respective holders. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, these other companies.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve substantial risks and uncertainties. All statements, other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
These forward-looking statements involve risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report on Form 10-K, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements about:
| ● | our plans to submit an NDA for envu in PsO (each as defined herein) in the second half of 2026; |
| ● | the potential for our product candidate envu to transform the treatment landscape for IL-23/IL-17—driven diseases as well as those driven by Type I interferon; |
| ● | the potential for envu to meaningfully elevate care for and effectively reduce the full burden of disease for patients with PsO; |
| ● | the timing of our topline readout in our LUMUS Phase 2b trial; |
| ● | our ability to obtain funding for our operations, including funding necessary to complete further development and any commercialization of our product candidates; |
| ● | our expectations regarding the potential benefits of our strategy, including with respect to the integration of operations, technologies and personnel associated with the ACELYRIN Merger (as defined herein); |
| ● | our plans relating to the research and development of our product candidates; |
| ● | developments related to our competitors and our industry, including the success of competing product candidates and therapies that are, or may become, available; |
| ● | details regarding our strategic vision and planned product candidate pipeline; |
| ● | our beliefs regarding the success, cost and timing of our product candidate development activities and current and future clinical trials and studies, including study design; |
| ● | the timing or likelihood of regulatory filings or other actions and related regulatory authority responses; |
| ● | the ability and willingness of various third parties to engage in research and development activities involving our product candidates, and our ability to leverage those activities; |
| ● | our expectations regarding the potential benefits from any existing or future license or collaboration agreements, including the receipt of potential co-development, milestone and royalty payments; |
| ● | our expectations regarding the ease of administration associated with our product candidates; |
| ● | our expectations regarding the patient compatibility associated with our product candidates; |
| ● | our beliefs regarding the potential markets for our product candidates and our ability to serve those markets; |
| ● | our beliefs regarding the potential of our product candidates to demonstrate differentiation from other approved therapies or therapies in development; |
| ● | the ability to obtain and, if approved, maintain regulatory approval of any of our product candidates, and any related restrictions, limitations and/or warnings in the label of any approved product candidate; |
| ● | our ability to commercialize any approved products; |
| ● | the rate and degree of market acceptance of any approved products; |
| ● | our ability to attract and retain key personnel; |
| ● | the accuracy of our estimates regarding our future revenue, as well as our future operating expenses, capital requirements and needs for additional financing; |
| ● | our ability to obtain, maintain, protect and enforce intellectual property protection for our product candidates and technology and not infringe, misappropriate or otherwise violate the intellectual property of others; |
| ● | regulatory developments in the United States and foreign countries; |
| ● | our expectations regarding the period during which we qualify as an “emerging growth company” under the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”), and a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act; and |
| ● | statements of belief and any statement of assumptions underlying any of the foregoing. |
You should refer to the section titled “Risk Factors” in Part I, Item 1A. of this Annual Report on Form 10-K for a discussion of other important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report on Form 10-K will prove to be accurate.
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 although 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 a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.
Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
RISK FACTORS SUMMARY
Below is a summary of the material factors that make an investment in our securities speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this Risk Factors Summary, and other risks that we face, can be found below under the heading “Risk Factors” under Part I, Item 1A of this Annual Report on Form 10-K and should be carefully considered, together with other information in this Annual Report on Form 10-K, before making investment decisions regarding our securities.
| ● | We are a clinical stage biopharmaceutical company with a limited operating history and no products approved for commercial sale, and have incurred substantial losses since our inception and anticipate incurring substantial and increasing losses for the foreseeable future. |
| ● | Enrollment and retention of participants in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, including difficulties in identifying patients, the availability of competitive products and significant competition for recruiting participants in clinical trials. |
| ● | We will require substantial additional financing to achieve our goals, and failure to obtain additional capital when needed, or on acceptable terms to us, could cause us to delay, limit, reduce or terminate our product development or future commercialization efforts. |
| ● | Preclinical and clinical development involves a lengthy and expensive process, with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our current product candidates or any future product candidates. |
| ● | Our clinical trials may reveal serious adverse events (“SAEs”) and significant adverse events (“AEs”) not seen in our preclinical studies or prior clinical trials and may result in a safety or tolerability profile that could delay or prevent regulatory approval or market acceptance of envudeucitinib (or “envu”), formerly known as ESK-001, A-005 or any future product candidates. |
| ● | We face competition from entities that have made substantial investments into the rapid development of competitor treatments for immunological indications, including large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies and/or candidates under development in our current indications. |
| ● | We are subject to various risks related to the acquisition and integration of ACELYRIN (as defined herein). |
| ● | Our business is highly dependent on the success of our most advanced product candidate, envu, and we cannot guarantee that envu will successfully complete development, receive regulatory approval or be successfully commercialized. If we are unable to develop, receive regulatory approval for and ultimately successfully commercialize our product candidates, or if we experience significant delays in doing so, our business will be materially harmed. |
| ● | The regulatory approval processes of the U.S. Food and Drug Administration (the “FDA”) and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed. |
| ● | We are dependent on the services of our management team and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer. |
| ● | If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates and any future product candidates we may develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and commercialize our product candidates may be adversely affected. |
| ● | We cannot ensure that patent rights relating to inventions described and claimed in our or any current or future licensors and licensees pending patent applications will issue or that patents based on our or any current or future licensors and licensees patent applications will not be challenged and rendered invalid and/or unenforceable. |
| ● | We have and may continue to form or seek collaborations or strategic alliances or enter into licensing arrangements in the future, and we may neither enter into, nor realize the benefits of, such alliances or licensing arrangements. |
| ● | Even if we receive regulatory approval for our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal. We may also be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates. |
| ● | Failure or perceived failure to comply with existing or future laws, regulations, contracts, self-regulatory schemes, standards, and other obligations related to data privacy or security (including security incidents) could harm our business. Compliance or the actual or perceived failure to comply with such obligations could increase our costs and otherwise negatively affect our operating results and business. |
| ● | We may have conflicts with any current or future licensors, licensees, collaborators or strategic partners that could delay or prevent the development or commercialization of our product candidates. |
PART I
