As filed with the U.S. Securities and Exchange Commission on September 21, 2026

Registration No. 333-

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S‑1

REGISTRATION STATEMENT

Under

The Securities Act of 1933

Iambic Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

5627 Oberlin Drive, Suite 120

San Diego, California 92121

(619) 330-5499

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Thomas Miller, Ph.D.

Chief Executive Officer

5627 Oberlin Drive, Suite 120

San Diego, California 92121

(619) 330-5499

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

Table of contents

Through and including , 2026 (the 25th day after the date of this prospectus), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to a dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.

Neither we nor any of the underwriters have authorized anyone to provide you with information that is different than the information contained in this prospectus and any free writing prospectus prepared by or on behalf of us or to which we have referred you. Neither we nor the underwriters take any responsibility for, and cannot provide any assurance as to the reliability of, any other information that others may give you. The information contained in this prospectus or in any applicable free writing prospectus is accurate only as of the date of this prospectus or such free writing prospectus, as applicable, regardless of the time of delivery of this prospectus or any such free writing prospectus or of any sale of the securities offered hereby. Our business, operating results, financial condition, and prospects may have changed since that date.

For investors outside the United States: Neither we nor any of the underwriters have taken any action that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons who have come into possession of this prospectus in a jurisdiction outside the United States are required to inform themselves about and to observe any restrictions relating to this offering and the distribution of this prospectus.

Risk factors

Investing in our common stock involves a high degree of risk. Before making an investment decision, you should consider carefully the risks and uncertainties described below, together with all of the other information in this prospectus, including the section titled “Management’s discussion and analysis of financial condition and results of operations” and our consolidated financial statements and related notes thereto included elsewhere in this prospectus. Our business, operating results, financial condition, and prospects could also be harmed by risks and uncertainties not currently known to us or that we currently do not believe are material. If any of the risks actually occur, our business, operating results, financial condition, and prospects could be adversely affected. In that event, the market price of our common stock could decline, and you could lose part or all of your investment. Our risk factors are not guarantees that no such conditions exist as of the date of this prospectus and should not be interpreted as an affirmative statement that such risks or conditions have not materialized, in whole or in part.

Risks related to our limited operating history, our financial position and need for additional capital

We are a technology and clinical-stage life sciences company with a limited operating history and no products approved for commercial sale, which may make it difficult to evaluate our current business prospects and predict our future success or viability.

We are a technology and clinical-stage life sciences company with a limited operating history. While we have generated revenue from our strategic partnerships and collaborations, we have no products approved for commercial sale and have not generated any revenue from product sales. Since our inception in October 2019, we have focused substantially all of our efforts and resources on building what we refer to as our molecular superintelligence platform, our proprietary platform that integrates advanced AI models with automated, high-throughput laboratory experimentation and is comprised of (i) Enchant, our multimodal AI model for predicting preclinical and clinical properties, (ii) NeuralPLexer, our flow-matching generative AI for biomolecular structure prediction, and (iii) robotic data generation at scale (collectively, our molecular superintelligence platform) as well as advancing our own platform-developed drug candidates and pipeline. All of our therapeutic assets are in the discovery, Investigational New Drug (IND)-enabling, or clinical stages, including our most advanced clinical program, IAM1363. Before we can commercialize our drug candidates, they require, among other steps, clinical success; development of internal or external manufacturing capacity and marketing expertise; and regulatory approval by the U.S. Food and Drug Administration (the FDA) and other applicable authorities in other jurisdictions. We do not expect to generate any revenue from drug product sales in the foreseeable future and we can provide no assurance that we will obtain regulatory approvals to market and sell any drug products in the future. Until we successfully develop and commercialize drug candidates, which may never occur, we expect to finance our operations through a combination of private and public equity offerings, debt financings, strategic partnerships and collaborations, or similar arrangements.

In addition, we may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown factors and risks frequently experienced by clinical-stage life sciences companies developing therapeutics, as well as by technology-enabled companies that perform drug discovery on behalf of partners. Although we have generated revenue from our partnerships, we have not generated any revenue from drug product sales, and, as we advance our wholly owned programs, we will need to transition from a company primarily focused on research and development and the performance of drug discovery on behalf of ourselves and our partners to a company that is also capable of commercializing its own drug products, while continuing to operate and scale our collaboration business. If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer.

Our limited operating history may make it difficult for investors and securities analysts to evaluate our current business prospects and predict our future success or viability. You should consider our business and prospects in light of the risks, uncertainties, and difficulties frequently encountered by early-stage clinical life sciences companies in rapidly evolving markets. We may not be able to successfully address any or all of these risks.

We have incurred significant losses and negative cash flows from operations since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

While we have generated revenue from our strategic partnerships and collaborations, we have no drug products approved for commercial sale, have not generated any revenue from drug product sales, and have incurred significant net losses since our formation. Furthermore, we may not generate revenue from drug product sales for many years, if ever. To date, we have funded our operations from venture capital financings and through partnerships. Our net losses were $77.3 million and $47.9 million for the years ended December 31, 2025 and 2024, respectively, and $50.1 million for the six month period ended June 30, 2026. As of June 30, 2026, we had an accumulated deficit of $245.3 million. Additionally, the net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indicator of our future performance. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Substantially all of our operating losses have resulted from costs incurred in connection with research and development efforts primarily related to the discovery and development of our preclinical and clinical therapeutic candidates and the advancement of our proprietary molecular superintelligence platform, and from general and administrative costs associated with our operations.

Our model takes a dual-track approach, tackling both the development of wholly owned internally developed therapeutic assets and partnerships with pharmaceutical and technology companies, including drug discovery and development for third-party pharmaceutical partners using our molecular superintelligence platform. Neither our internal pipeline nor our partnered programs have yet produced an approved drug product. We expect to continue incurring significant expenses and increasing operating losses for the foreseeable future. We expect that our expenses will increase substantially if and as we:

Our prior losses and expected future losses have had and will continue to have an adverse effect on our working capital and our ability to achieve and maintain profitability.

In addition, we may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown factors and risks frequently experienced by clinical-stage life sciences companies in rapidly evolving fields. See the risk titled “—We are a technology and clinical-stage life sciences company with a limited operating history…” above.

Even if this offering is successful, we expect that we will need substantial additional capital to complete the development and any commercialization of our current and any future drug candidates, which may cause dilution to our stockholders. If we are unable to raise this capital when needed, we may be forced to delay, reduce or eliminate at least some of our drug product development programs, platform development plans, business development plans, potential commercialization efforts and to possibly cease operations.

The development of drug candidates is capital-intensive. We have programs throughout the stages of drug development, including discovery, IND-enabling, and clinical stage. We expect to incur additional losses in connection with our ongoing activities as we continue the research and development of, initiate clinical trials of, and potentially seek marketing approval for, our current drug candidates, including IAM1363, and as we build out and diversify our pipeline. In particular, we expect expenses to increase substantially as we advance our programs through discovery and IND-enabling studies, submit IND applications, initiate and progress clinical trials, and continue investing in our molecular superintelligence platform. Drug development, particularly clinical stage development and trials, is expensive and can take many years, so we will need supplemental funding to complete these undertakings. If our drug candidates are eventually approved by regulators, we will require significant additional funding in order to launch and commercialize our products. Furthermore, upon the closing of this offering, we expect to incur additional costs associated with operating as a public company. We expect that we will require additional capital beyond the proceeds of this offering, which we may raise through private and public equity offerings, debt financings, technology enablement, and strategic partnerships and collaborations or similar arrangements.

As of June 30, 2026, we had cash and cash equivalents of $207.9 million. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this prospectus, together with the estimated net proceeds from this offering, will be sufficient to fund our operating expenses and capital expenditures through . However, this estimate is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Because the length of time and activities associated with successful clinical development of our drug candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any marketing and commercialization activities.

We will need substantial additional capital to develop our drug candidates and fund operations for the foreseeable future. Our future capital requirements will depend on many factors, including:

In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of our common stock. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional funds through partnerships and collaborations, strategic alliances, or marketing, distribution, or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or grant licenses on terms that may not be favorable to us.

Adequate additional financing may not be available to us when needed on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative effect on our financial condition and our ability to pursue our business strategy. In addition, attempting to secure additional financing may divert the time and attention of our management from day-to-day activities and harm our development efforts. If we are unable to raise capital when needed or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market drug products that we would otherwise prefer to develop and market ourselves.

Our quarterly and annual operating results may fluctuate significantly due to a variety of factors and could fall below our expectations or the expectations of investors or securities analysts, which may cause our stock price to fluctuate or decline.

The amount of our future losses, and when we might achieve profitability, is uncertain, and our quarterly and annual operating results may fluctuate significantly for various reasons, many of which are outside of our control and may be difficult to predict, including, but not limited to, the following:

The occurrence of one or more of these or other factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. This variability and unpredictability could also result in our failing to meet any

forecasts we provide to the market, or the expectations of industry or financial analysts or investors, for any period. If one or more of these events occur, the price of our common stock could decline substantially.

If we engage in future strategic transactions, this may increase our capital requirements, dilute our stockholders’ equity, cause us to incur debt or assume contingent liabilities, and subject us to other risks.

We may in the future pursue acquisitions of complementary businesses, products, or technologies, or enter into additional strategic partnerships, including by licensing or acquiring complementary intellectual property rights, technologies, or businesses. We have not completed any acquisitions to date, and we have limited experience in evaluating or integrating acquired businesses or assets. When we are pursuing additional strategic partnerships and if we pursue any acquisitions, we may not be able to identify suitable transaction candidates, and even if we do, we may be unable to complete a transaction on favorable terms, if at all. The competition for acquisition and partnership candidates may be intense and any such transaction may entail numerous risks whether or not any transaction is ultimately consummated, including increased operating expenses and cash requirements, the assumption of indebtedness or contingent liabilities, the issuance of equity securities that would dilute existing stockholders, the diversion of our management’s attention from our existing programs, advancement of our molecular superintelligence platform, and initiatives, and risks associated with entering into new business areas or geographies in which we have limited or no experience. If we undertake such a transaction, we may assume or incur debt obligations, incur large one-time expenses, or acquire goodwill and intangible assets, which could result in significant future amortization expenses and adversely impact our results of operations. A significant portion of the purchase price of any business we acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed for impairment at least annually. If our acquisitions do not yield the returns we expect, we may be required to take impairment or other charges to our results of operations, which could adversely affect our results of operations.

Risks related to our partnership strategy

We are engaged in strategic partnerships and we intend to seek to establish additional partnerships, including for the clinical development of drug candidates. If we are unable to establish these partnerships on commercially reasonable terms or at all, or if current and future partnerships are not successful, our business and operating results could be materially and adversely impacted.

The advancement of our programs, and the potential commercialization of our drug candidates, will require substantial additional capital. To date, our operating revenue has primarily been generated through our partnerships. See the section titled “Business—Collaboration agreements” for a description of our material partnership agreements with AbbVie Group Holdings Limited (AbbVie), Takeda Pharmaceuticals, U.S.A., Inc. (Takeda), and H. Lundbeck A/S (Lundbeck). We also have partnerships with leading pharmaceutical and technology companies, NVIDIA Corporation (NVIDIA), Lambda, Inc. (Lambda), Revolution Medicines, Inc. (RevMed), Jazz Pharmaceuticals Ireland Limited (Jazz Pharmaceuticals), and Bayer Healthcare LLC (Bayer). These partnerships cover a substantial number of programs and could represent a significant portion of our potential downstream value. We intend to seek additional partnerships, strategic collaborations, and licensing arrangements with technology, pharmaceutical and biotechnology companies. In the near term, the value of our Company will depend in part on the number and quality of the partnerships and similar arrangements that we negotiate, and we may not be able to reach definitive agreements on commercially reasonable terms, or at all. In addition, the significant number of business combinations among large pharmaceutical companies and consolidation in the biotechnology industry has reduced the number of potential future collaborators with whom we can partner.

Partnerships and similar arrangements can be complex and time consuming to negotiate and execute. We may have to relinquish valuable rights to our drug candidates, intellectual property, or future revenue streams, or grant licenses on terms that are not favorable to us. We may be restricted under collaboration agreements from entering into future agreements on certain terms with other potential partners or from conducting certain activities on our own. We face significant competition in seeking appropriate partners, including from established companies that may have a competitive advantage over us due to, among other factors, their size and/or financial resources, which may make it more challenging to achieve favorable terms in our partnership agreements, if at all. In addition, management of our relationships with partners requires (i) significant time and effort from our

management team; (ii) coordination of our research and development programs with the research and development priorities of our partners; and (iii) effective allocation of our resources across multiple projects.

We may not be able to establish additional strategic partnerships and similar arrangements on a timely basis, on acceptable terms, or at all, and to maintain and successfully conclude them. Collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return. If we are unable to establish or maintain partnerships and similar strategic arrangements on terms favorable to us and realize the intended benefits of those partnering arrangements, our research and development efforts and potential to generate revenue may be limited, we may have to alter our development and commercialization plans, and our business and operating results could be materially and adversely impacted.

For programs that are led by a partner, but for which we have downstream economic participation, success is dependent on the eventual approval and commercialization of drugs developed by our partners for which we have no control over the clinical development plan, regulatory strategy, or commercialization efforts.

Our business model is, in part, dependent on the eventual progression of drug candidates discovered or initially developed utilizing our discovery and development capabilities into clinical trials and commercialization. This requires us to find partners and enter into agreements with them that contain obligations for the partners to pay us milestone payments as well as royalties on sales of approved drugs for the drug candidates they develop that are generated utilizing our molecular superintelligence platform. Partners generally have significant discretion in determining the efforts and resources that they will apply to these partnerships, and they may not pursue or prioritize the development and commercialization of partnered drug candidates. In addition, given the nature of our relationships with our partners, we generally have limited control over the progression, clinical development, regulatory strategy, or eventual commercialization, if approved, of these drug candidates. As a result, our potential to receive milestones and royalties is dependent on our partners' efforts over which we have no control. Moreover, unless publicly disclosed by our partners, we may have limited information related to our partners' preclinical studies or clinical trial results, including serious adverse events, or ongoing communications with the relevant health authorities regarding our partners’ development strategy, which limits our visibility into how such programs may be progressing. In addition, because our partners have significant discretion in determining when to make announcements about the status of our partnerships, including about preclinical and clinical developments and timelines for advancing the partnered programs, any public announcement of unexpected results or developments in our partnerships, or any withholding of such information by our partners, may adversely impact our business. If our partners determine not to proceed with the development of a drug candidate discovered or initially developed utilizing our molecular superintelligence platform, or if they implement preclinical, clinical or regulatory strategies that ultimately do not result in the further development or approval of the drug candidate, we will not receive the benefits of our partnerships, which may have a material and adverse effect on our operations.

Additionally, we may have conflicts with our future partners, such as conflicts concerning the interpretation of preclinical or clinical data, the achievement of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership of intellectual property developed during our collaboration. If any conflicts arise with any of our partners, such partner may act in a manner that is adverse to our best interests. Any such disagreement could result in one or more of the following, each of which could delay or prevent the development or commercialization of our drug candidates, and in turn prevent us from generating revenue: disputes regarding milestone payments or royalties; uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations; unwillingness by the partner to cooperate in the development or manufacture of a drug candidate, including providing us with data or materials; unwillingness on the part of a partner to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities; initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or attempts by either party to terminate the agreement. Collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable drug candidates. Termination by our partner would adversely affect us financially and could harm our business reputation.

Our partnership model involves actively performing drug discovery on behalf of our partners, which requires substantial resources, and our ability to maintain and enter into new partnerships may suffer if we are unable to consistently deliver the necessary resources. Our failure to meet our commitments to perform under existing and future partnership could subject us to financial penalties and liability, impair our partner relationships, and adversely affect our business.

Our partnership model involves, in most cases, actively performing drug discovery on behalf of our partners using our molecular superintelligence platform, rather than simply licensing access to our technology. This model exposes us to risks distinct from a traditional technology licensing arrangement because our ability to deliver results under these partnerships depends on the continued availability and advancement of our molecular superintelligence platform, our computational infrastructure, and our specialized personnel, any of which may be constrained or competing for capacity with other partnerships as well as our wholly owned internal programs. If we are unable to allocate sufficient resources to our partnerships while also advancing our internal pipeline, or if partners are dissatisfied with the pace or quality of our work, our partnership revenue and our ability to maintain and enter into new partnerships could be materially and adversely affected. If we fail, or are alleged to fail, to meet our performance commitments, we may be subject to remedies that could include reduced or withheld fees, liquidated damages, indemnification obligations, or other damages, and partners may have the right to terminate the collaboration. Any such failure could also harm our reputation, reduce the likelihood that partners renew or expand their engagements with us, make it more difficult to enter into new partnerships, and expose us to disputes or litigation. The occurrence of any of these events could adversely affect our business, financial condition, results of operations, and prospects.

We deploy certain software products to partners under agreements that include service level and related performance commitments, and our failure to meet those commitments could subject us to financial penalties and liability, impair our partner relationships, and adversely affect our business.

In addition to performing drug discovery on behalf of certain partners using our molecular superintelligence platform, we deploy software products, primarily, but not exclusively, NeuralPLexer, to external parties for use in their own environments or workflows. These deployments are governed by agreements that, to varying degrees, specify service level commitments and related obligations, including with respect to availability, uptime, business continuity, disaster recovery, support, and error correction. These arrangements exist both as standalone software agreements and as components embedded within broader discovery-focused collaborations. As a result, our obligations with respect to deployed software may be interdependent with our other commitments to a partner, and a failure with respect to the software component of a partnership could have consequences that extend to the broader relationship.

Our ability to meet these service level and performance commitments depends on the continuous, effective, and reliable operation of our software, the underlying computational infrastructure, and third-party cloud and hardware providers on which that software depends, as well as on our ability to detect and remediate defects, errors, and disruptions in a timely manner. Software deployed into external environments may be subject to conditions, integrations, and usage patterns that we do not control and cannot fully anticipate, which can increase the likelihood of performance issues and complicate our ability to diagnose and resolve them. Defects or vulnerabilities in our software, outages or capacity constraints affecting our compute resources, interruptions in third-party services, security incidents affecting availability, and other events may cause us to fail to satisfy our commitments. Because we support both our internal pipeline and multiple external deployments from shared infrastructure and personnel, contention for these resources may further constrain our ability to meet all of our obligations concurrently.

If we fail, or are alleged to fail, to meet our service level or other performance commitments, we may be subject to remedies that could include service credits, refunds, reduced or withheld fees, liquidated damages, indemnification obligations, or other damages, and partners may have the right to terminate the applicable software agreement or, where the software is a component of a broader partnership, the partnership as a whole. Any such failure could also harm our reputation, reduce the likelihood that partners renew or expand their engagements with us, make it more difficult to enter into new partnerships, and expose us to disputes or litigation. The occurrence of any of these events could adversely affect our business, financial condition, results of operations, and prospects.

We host partner data that we do not own, both in connection with discovery partnerships and technology deployments, and the loss, corruption, unavailability, or unauthorized disclosure of that data could expose us to liability, damage our partner relationships, and adversely affect our business.

In the course of our business, we host and process data belonging to our partners that we do not own and to which our rights are limited to the purposes specified in the applicable agreement. This occurs in two principal contexts. First, in connection with discovery partnerships in which we perform research on behalf of a partner, the partner may supply datasets that it has obtained or generated, which we host and use to carry out the partnership. Second, in connection with our technology enablement and deployment activities, including deployments of software products such as NeuralPLexer, partners upload or otherwise provide data that we host on their behalf. In each case, we host this partner data in cloud environments that we commission and manage, primarily on Amazon Web Services (AWS).

Because we host but do not own this data, we act as a custodian of information that may be highly valuable and sensitive to our partners, including proprietary chemical, biological, and other research data, licensed third-party datasets, personal data, and confidential business information. Our obligations with respect to such data, including obligations relating to its security, confidentiality, integrity, availability, retention, and return or deletion, are typically specified by contract and may be more extensive than, or different from, the obligations imposed by generally applicable law. Where a partner has supplied data that it obtained from a third party under license, our permitted use of that data, and our exposure in the event of its loss or unauthorized disclosure, may also be governed or constrained by the terms of that upstream license, which we may not fully control or be party to.

The loss, corruption, destruction, unavailability, alteration, or unauthorized access to, use, or disclosure of partner data that we host, whether resulting from defects or failures in our software or infrastructure, outages or incidents affecting our cloud environments or the third-party providers on which they depend, human error, security breaches, or other causes, could constitute a breach of our contractual obligations and cause direct harm to our partners. We are subject to multiple separately negotiated security incident notification obligations with different timelines, and a single incident affecting shared infrastructure could trigger some of them concurrently. Our failure to meet any one could constitute a breach of the applicable agreement, exposing us to contractual liability. Data hosted in support of our partnerships and deployments may be difficult or impossible to reconstruct, and its loss could disrupt or delay the affected partnership or deployment, impair a partner’s own programs, and require costly efforts to recover or regenerate the data. Any such event could subject us to claims for breach of contract, indemnification obligations, liability to the partner or to third parties from whom the data was licensed, termination of the applicable collaboration or deployment agreement, and disputes or litigation, and could occur even where our broader systems have not been compromised.

Additionally, because our internal programs and our partner-facing activities rely on the same molecular superintelligence platform, the same computational infrastructure, and, in many cases, the same or overlapping personnel, we must establish and maintain organizational, technical, and contractual measures designed to segregate each partner’s confidential data, methods, and results from our internal programs and from the work we perform for other partners. If we fail, or are alleged or perceived to fail, to maintain barriers designed to separate each partner’s confidential data and direct it solely towards the benefit of each applicable partner, whether as a result of employee error or misconduct, defects in our technical controls, the practical difficulty of segregating shared infrastructure and personnel, or otherwise, our partners may lose confidence in our ability to protect their confidential information, may decline to share data with us or narrow the scope of their engagements, and may assert claims for breach of contract or misuse of their information.

Any of the foregoing could result in significant financial exposure, harm our reputation, reduce the likelihood that partners renew, expand, or enter into engagements with us, and adversely affect our business, financial condition, results of operations, and prospects. For related risks concerning our service level and performance commitments, and the security of our systems generally, see the risks titled “—We deploy certain software products to partners under agreements that include service level and related performance commitments...” and “—Our internal computer systems, or those of any of our CROs, manufacturers, other contractors, or consultants or potential future partners, may fail or suffer actual or suspected security or privacy breaches...”

The failure of our partners to meet their contractual obligations to us could adversely affect our business.

For partners who have contractual obligations to us, we bear the risk that they may not perform their contractual obligations to us to our standards, in compliance with applicable legal or contractual requirements, in a timely manner or at all, they may not maintain the confidentiality of our proprietary information, and disagreements or disputes could arise that could cause delays in, or termination of, the research, development, or commercialization of drugs using our drug candidates, technology or molecular superintelligence platform or result in litigation or arbitration. In addition, we are dependent on our partners’ ability to accurately track and make milestone payments to us pursuant to the terms of our agreements with them. Any failure by them to inform us when milestones are reached and make related payments to us could adversely affect our results of operations. Any of these factors could adversely impact their financial condition and results of operations, which could impair their ability to meet their contractual obligations to us, which may have a material adverse effect on our business, financial condition, and results of operations.

To the extent we decide to take equity or other interests in our partners as part of our evolving partnership model, we may never realize a return on such investments.

We may decide to take equity or other interests in our drug discovery partners as part of our partnership model. If we do so, we may never realize a return on such investments, and our partners may be dependent on the availability of capital on favorable terms to continue their operations. If partners in which we hold equity interests raise additional capital, our ownership interest in and degree of control over those partners could be diluted, unless we choose to invest further or successfully negotiate contractual anti-dilution protections. The financial success of any such equity investment would likely be dependent on a liquidity event, such as a public offering, acquisition, or other favorable market event reflecting appreciation in value. The capital markets for public offerings and acquisitions are dynamic, and the likelihood of liquidity events for companies in which we may hold equity interests could significantly worsen. In addition, to the extent any partner in which we hold equity is or becomes publicly traded, the fair value of that interest may fluctuate significantly from period to period based on the market price of the partner’s common stock, and those fluctuations would be reflected in our results of operations. Further, valuations of privately held companies are inherently complex due to the lack of readily available market data, and if we determine that any such investments have experienced a decline in value, we may be required to record an impairment, which could negatively impact our financial results. Any equity we hold in our drug discovery partners would be subject to a risk of partial or total loss.

To date, we have depended on a relatively small number of partners for a substantial portion of our revenue. The loss of any one of these partners could adversely impact our expected revenue and results of operations.

We have entered into partnerships with a relatively limited number of pharmaceutical and technology companies. To date, our revenue has primarily resulted from payments from certain of our partners, and we expect that a substantial portion of our revenue for the near future will continue to come from partnerships. The loss of any of our partners, the failure of our partners to perform their obligations under their agreements with us, including paying license or technology fees or reimbursements, milestone payments or royalties, could have a material adverse effect on our financial performance. Payments under our existing and future strategic partnerships are also subject to significant fluctuations in both timing and amount, which could adversely impact our results of operations.

Risks related to drug discovery and development and our lead programs

Our approach to drug discovery is novel and unproven and may not lead to successful drug products for various reasons, including, but not limited to, challenges identifying mechanisms of action for our drug candidates.

Our approach to drug discovery is based on novel AI, machine learning, and computational technologies, including our molecular superintelligence platform. The quality and sophistication of our molecular superintelligence platform is critical to our ability to conduct our research and discovery activities. Because AI-designed drug candidates are novel, there is greater uncertainty about our ability to develop, advance and commercialize drug candidates using our molecular superintelligence platform. We cannot be certain that our molecular

superintelligence platform will lead to the successful identification of drug candidates, lowering of the cost of drug discovery or the development of commercially viable drug products. We may encounter challenges that prevent us from demonstrating the utility of our molecular superintelligence platform, and the market may be skeptical of the viability of our approach. If we are unable to demonstrate the utility of our molecular superintelligence platform, we may be required to alter or abandon our current business model.

Such uncertainty could make it more difficult to form partnerships with larger pharmaceutical companies, as the expenses involved in late-phase clinical trials increase the level of risk related to potential efficacy and/or safety concerns and may pose challenges to IND and/or new drug application (NDA) approval by the FDA or other regulatory agencies.

Even if our molecular superintelligence platform successfully identifies promising drug candidates, those candidates may not advance successfully through preclinical and clinical development. No assurance can be given that our approach will result in the discovery or development of any approved product. As a result, these challenges could adversely affect our reputation and results of operations.

Our drug candidates are in preclinical or clinical development, which can be lengthy and expensive processes with uncertain outcomes and the potential for substantial delays.

Our most advanced drug candidate, IAM1363 (our HER2 Inhibitor Program), is currently in a Phase 1/1b clinical trial, with monotherapy expansion and combination cohorts actively enrolling. Our KIF18A Inhibitor Program (IAM217) and CDK2/4 Inhibitor Program (IAM-C1) are in preclinical development, and we anticipate submitting IND applications for these programs in the fourth quarter of 2026, followed in each case by initiation of a Phase 1/2 clinical trial, subject to regulatory clearance. Before we can bring any of these drug candidates to market, we must, among other things, successfully complete clinical development, have the candidates manufactured to appropriate specifications, conduct extensive clinical trials to demonstrate safety and efficacy in humans, and obtain marketing approval from the FDA and other applicable regulatory authorities, which we have not yet demonstrated our ability to do.

Our pipeline is currently led by three oncology programs—our HER2 Inhibitor Program (IAM1363, an oral, highly selective, pan-mutant, brain-penetrant Type II tyrosine kinase inhibitor (TKI) of wild-type and oncogenic mutant HER2), our KIF18A Inhibitor Program (IAM217, a brain-penetrant, allosteric KIF18A inhibitor), and our CDK2/4 Inhibitor Program (IAM-C1, a selective dual CDK2/4 inhibitor). We anticipate filing IND applications with the FDA or other regulators for clinical studies for our drug candidates. We may not be able to file such IND applications and begin such studies, on the timelines we expect, if at all, and any such delays could impact any additional product development timelines. Each of our programs employs a novel or differentiated mechanism of action whose clinical hypothesis may not bear out. See the section titled “Business—Our drug candidates and programs” for a description of our programs and their mechanisms of action.

Moreover, we cannot be sure that submission of an IND will result in the FDA or other regulators allowing clinical trials to begin or that, once begun, issues will not arise that require us to suspend or terminate these trials. Commencing each of these clinical trials is subject to finalizing the trial design based on discussions with the FDA and other regulatory authorities. The requirements imposed by these regulatory authorities, or their governing statutes, could change at any time, which may result in stricter approval conditions than we currently expect and/or necessitate completion of additional or longer clinical trials. Successful completion of our clinical trials is a prerequisite to submitting NDAs to the FDA, as well as Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for each drug candidate and, consequently, to the ultimate approval and commercial marketing of each drug candidate. We do not know whether any of our future clinical trials will begin on time or be completed on schedule, if at all.

We may experience delays in completing our preclinical development and initiating or completing clinical trials, or numerous unforeseen events during, or as a result of, any clinical trials, that could require us to incur additional costs or delay or prevent our ability to receive marketing approval or to commercialize our drug candidates, including but not limited to those related to one or more of the following:

Our product development costs will increase if we experience delays in testing or regulatory approvals. We do not know whether any of our future clinical trials will begin as planned, or whether any of our current or future clinical trials will need to be restructured or will be completed on schedule, if at all. If we decide or are required to suspend or terminate a clinical trial, we may elect to abandon product development for that program. Significant preclinical study or clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our drug candidates or could allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our drug candidates. Any delays in or unfavorable outcomes from our preclinical or clinical development programs may significantly harm our business, operating results, and prospects.

Interim, initial, “top-line”, and preliminary data from our clinical trials that we announce or publish from time to time may change as more participant data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time as we move through the stages of drug development, we have published, and expect to continue to publish, interim top-line or preliminary data from our clinical trials. Interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as enrollment of participants continues and more data becomes available. Preliminary or top-line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

For example, we presented preliminary monotherapy data from our ongoing IAM1363 Phase 1/1b trial at the European Society for Medical Oncology (ESMO) Congress in October 2025, including measures of anti-tumor activity, and we expect to present additional clinical data at future medical conferences as enrollment continues. Any differences between these preliminary results and final or later results, or any differences between results observed at the dose levels previously reported and results at the recommended monotherapy dose, could significantly affect perceptions of our IAM1363 program. Moreover, preliminary or interim data are subject to the risk that one or more of the clinical outcomes may materially change as participant enrollment continues and more participant data become available, and the results we have observed to date in earlier stages of our clinical trials may not be predictive of subsequent stages.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular drug candidate or drug product and our Company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the interim, top-line, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our drug candidates may be harmed, which could harm our business, operating results, financial condition, and prospects.

Conducting successful clinical trials requires the enrollment of a sufficient number of patients, and suitable patients may be difficult to identify and recruit.

Conducting successful clinical trials requires the enrollment of a sufficient number of patients, and suitable patients may be difficult to identify and recruit. Identifying and qualifying patients to participate in future clinical trials for any drug candidates we develop is critical to our success. Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the severity of disease; size of the patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability of clinical trial investigators with appropriate competencies and experience; support staff; the number of ongoing clinical trials in the same indication that compete for the same patients; proximity of patients to clinical sites; the number and availability of trial sites; the ability to comply with the eligibility and exclusion criteria for participation in the clinical trial; ability to obtain and maintain patient consents; patient compliance; the ability to monitor patients during and after treatment; and the impact of any health pandemic or epidemic. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our drug candidates. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products with competitors that have more clinical development experience than we do.

Our inability to locate and enroll a sufficient number of patients for our clinical trials would result in significant delays, could require us to abandon one or more clinical trials altogether and could delay or prevent our receipt of necessary regulatory approvals. Enrollment delays in our clinical trials may result in increased development costs for our drug candidates, which would cause the value of our Company to decline and limit our ability to obtain additional financing.

We may not be successful in our efforts to identify, discover or develop drug candidates and may fail to capitalize on programs, collaborations, or drug candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success.

Research and development programs to identify new drug candidates require substantial technical, financial, and human resources. We are advancing IAM1363, IAM217, and IAM-C1, although our KIF18A Inhibitor Program (IAM217) and CDK2/4 Inhibitor Program (IAM-C1) are both in IND-enabling development, and we may fail to identify additional drug candidates for development. Because we have limited resources, we focus our research programs on targets where we believe our molecular superintelligence platform can demonstrate utility, where we believe it is theoretically possible to discover a molecule with properties that are required for the molecule to become a drug, and where we believe there is a meaningful commercial opportunity, among other factors. We may

forego or delay pursuit of opportunities with certain programs, partnerships, or drug candidates or for indications that later prove to have greater commercial potential than our current and planned development programs and drug candidates. However, the development of any drug candidate we pursue may ultimately prove to be unsuccessful or less successful than other potential drug candidates that we might have chosen to pursue on a more aggressive basis with our capital resources. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and other future drug candidates for specific indications may not yield any future drug candidates that are commercially viable. If we do not accurately evaluate the commercial potential for a particular drug candidate, we may relinquish valuable rights to that drug candidate through partnership, strategic collaboration, licensing, or other arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such drug candidate. Alternatively, we may allocate internal resources to a drug candidate in a therapeutic area in which it would have been more advantageous to enter into a partnership.

We expect to submit IND applications for our KIF18A Inhibitor Program (IAM217) and our CDK2/4 Inhibitor Program (IAM-C1) in the fourth quarter of 2026, followed in each case by initiation of a Phase 1/2 clinical trial, subject to regulatory clearance. We may not be able to file such IND applications on the timelines we expect, if at all, and any delays could impact our pipeline diversification strategy and our ability to reduce concentration risk in our clinical portfolio.

Our research programs may show initial promise in identifying potential drug candidates internally or with partners, yet fail to yield drug candidates for clinical development for a number of reasons, including:

If any of these events occur, we may be forced to abandon our development efforts for a program or programs, which would have a material adverse effect on our business.

We may develop drug candidates for use in combination with other therapies, which exposes us to additional risks.

Investigating drug candidates for use in combination with one or more currently approved therapies can expose us to additional risks. If a drug candidate we develop were to receive marketing approval for use in combination with existing therapies, we would continue to bear the risks that the FDA or similar foreign regulatory authorities could revoke approval of the therapies used in combination with our drug candidate or that safety, efficacy, manufacturing, or supply issues could arise with such existing therapies. This could result in our own products being removed from the market or being less successful commercially. For example, pursuant to our research collaboration with Jazz Pharmaceuticals, we are studying IAM1363 in combination with other therapeutic agents, including agents supplied by our collaboration partner. Further, we are currently investigating IAM1363 for use in combination with other approved cancer therapeutics in four cohorts. If we are not able to negotiate favorable terms with the manufacturers of such approved therapeutics, we may not be able to advance our combination therapy trials as we had planned, if at all, or our clinical development plans for the proposed combination therapies may be materially delayed. Combination therapy trials may require more resources than monotherapy trials.

We may also potentially evaluate current or future drug candidates in combination with one or more other therapies that have not yet been approved for marketing by the FDA or similar foreign regulatory authorities. We will not be able to market and sell any drug candidate we develop in combination with any such therapies that do

not ultimately obtain marketing approval whether alone or in combination with our product. In addition, unapproved therapies face the same risks described with respect to our drug candidates currently in development and clinical trials, including the potential for serious adverse effects, delay in their clinical trials, and lack of FDA or similar foreign regulatory authorities’ approval. If safety, efficacy, manufacturing, or supply issues arise with the products we choose to evaluate in combination with our drug candidates, we may be unable to obtain approval of or market such combination.

It is difficult to establish with precision the incidence and prevalence for target patient populations of our drug candidates. If the market opportunities for our drug candidates are smaller than we estimate, or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected, possibly materially.

Even if approved for commercial sale, the total addressable market for our drug candidates will ultimately depend upon, among other things, (i) the indications and diagnostic criteria included in the final label; (ii) acceptance by the medical community; and (iii) patient access, product pricing, and reimbursement by third-party payors. The number of patients targeted by our drug candidates may turn out to be lower than expected, patients may not be amenable to treatment with our drug products, or new patients may become increasingly difficult to identify or access, all of which would adversely affect our results of operations and our business. Due to our limited resources and access to capital or for other reasons, we must prioritize development of certain drug candidates, which may prove to be less lucrative than alternative drug candidates and may adversely affect our business.

Risks related to our platform, technology and data

We have invested, and expect to continue to invest, in research and development efforts to further enhance our molecular superintelligence platform, which is central to our mission. If the return on these investments is lower or develops more slowly than we expect, our business and operating results may suffer.

Our molecular superintelligence platform is central to our mission to redefine drug discovery and deliver highly differentiated medicines to patients with urgent unmet needs. Our molecular superintelligence platform integrates AI models with automated, high-throughput laboratory experimentation and is comprised of (i) Enchant, our multimodal AI model for predicting preclinical and clinical properties, (ii) NeuralPLexer, our flow-matching generative AI for biomolecular structure prediction, and (iii) robotic data generation at scale. Our molecular superintelligence platform depends upon the continuous, effective, and reliable operation of our software, automated experimentation systems, databases, and related tools and functions, as well as the integrity of our data. Our ability to develop drug candidates and increase revenue depends in large part on our ability to enhance and improve our molecular superintelligence platform. The success of any enhancement to our molecular superintelligence platform depends on several factors, including (i) innovation in experimental solutions, (ii) increased computational storage and processing capacity, (iii) development of more advanced algorithms, and (iv) generation of additional biological and chemical data, such as that which is necessary to our ability to identify important and emerging use cases and quickly develop new and effective innovations to address those use cases.

We have invested, and expect to continue to invest, in research and development efforts and licensing agreements that further enhance our molecular superintelligence platform. These investments may involve significant time, risks, and uncertainties, including the risks that any new software or equipment enhancement or the integration of software or equipment from an acquired company or third party licensor may not be introduced in a timely or cost-effective manner, may not keep pace with technological developments, may not be able to secure all of the rights to use the data, algorithms or models disclosed by or generated with a third party in our future collaborations, or may not achieve the functionality necessary to generate significant revenue.

Our proprietary software tools, automated experimentation systems, and datasets are inherently complex. We have from time to time found defects, vulnerabilities, or other errors in our software and automated experimentation systems that produce the datasets we use to discover new drug candidates, and new errors with our software and systems may be detected in the future. The risk of errors is particularly significant when new software or systems are first introduced or when new versions or enhancements of our existing systems are

implemented. Errors may also result from the interface of our proprietary software and experimental tools with our data or with third-party systems and data.

If we are unable to successfully enhance our molecular superintelligence platform, or if there are any defects or disruptions in our molecular superintelligence platform that are not timely resolved, our ability to develop new innovations and ultimately gain market acceptance of our products and discoveries could be materially and adversely impacted, and our reputation, business, operating results, and prospects could be materially harmed.

Issues relating to the use of AI and machine learning in our offerings could adversely affect our business and operating results.

We incorporate AI and machine learning solutions into our molecular superintelligence platform, in applications that are important to our operations and our drug discovery processes. Our employees and personnel also use AI to perform their work. There are significant risks involved in utilizing AI. Issues relating to the use of new and evolving technologies such as AI and machine learning may cause us to experience brand or reputational harm, competitive harm, legal liability, and new or enhanced governmental or regulatory scrutiny, and we may incur additional costs to resolve such issues. Known risks of AI currently include, but are not limited to, inaccuracy, bias, toxicity, intellectual property infringement or misappropriation, privacy, data protection and cybersecurity issues, and data provenance disputes. Perceived or actual technical, legal, compliance, privacy, data protection, cybersecurity, ethical, or other issues relating to the use of AI may cause public confidence in AI to be undermined, which could slow adoption of our products and services that use AI. In addition, litigation or government regulation related to the use of AI may also adversely impact our and others’ abilities to develop and offer products that use AI, as well as increase the cost and complexity of doing so.

Developing, testing and deploying AI systems may also increase the cost profile of our product offerings due to the nature of the computing costs involved in such systems, which could impact our project margin and adversely affect our business and operating results. In addition, AI may have or produce errors or inadequacies that are not easily detectable. If the data used to train AI or the content, analyses, or recommendations that AI applications assist in producing are or are alleged to be deficient, inaccurate, incomplete, overbroad or biased, our business, financial condition, and results of operations may be adversely affected. The legal landscape and subsequent legal protection for the use of AI and the collection and use of data used to train AI models continues to evolve, and development of new law in this area could impact our ability to enforce our proprietary rights or protect against infringing uses. If we do not have sufficient rights to collect or use the data on which our AI relies or to the outputs produced by AI applications, we may incur liability through the alleged violation of certain laws, third-party privacy rights, online terms of service, or other contracts to which we or our data providers are a party. Our use of AI applications may also, in the future, result in security breaches or other incidents that implicate the personal data of customers or patients. Any such security breaches or other incidents related to our use of AI applications could adversely affect our reputation and results of operations.

We depend on continued access to certain third-party and licensed datasets that we may procure on a rolling or subscription basis, and any loss of, or material change to, that access could impair our ability to develop and operate our molecular superintelligence platform.

The development, training, validation, and ongoing operation of our molecular superintelligence platform depend in part on our continued access to external biological, chemical, and structure-activity datasets that we do not own and that we license or procure from third parties. We may obtain certain of these datasets under time-limited, subscription, or periodically renewed arrangements rather than through outright acquisition, and our access is contingent on maintaining those arrangements on acceptable terms. We cannot assure you that these datasets will remain available to us, that renewal or continued-access terms will not become materially more expensive or more restrictive, or that the applicable licensor will continue to maintain, update, or support the dataset. A licensor may discontinue a dataset, be acquired by or enter into an exclusive arrangement with a competitor, change its permitted-use or field-of-use terms (including terms governing use for model training or commercial purposes), or otherwise limit or terminate our access.

Certain of these datasets are available only from a limited number of sources and are not readily replaceable, and identifying, procuring, curating, and integrating a substitute could be time-consuming and costly and may not

yield data of comparable scope or quality. In addition, if the data we license is or is alleged to be inaccurate, incomplete, improperly sourced, or licensed on terms narrower than the uses we make of it, we could experience degraded model performance or become subject to claims of breach or infringement. Any loss of, interruption to, or adverse change in our access to these datasets could delay or impair our development and operation of the molecular superintelligence platform, degrade the performance of our models, require costly retraining or re-engineering, and adversely affect our business, financial condition, results of operations, and prospects.

Our current and future use of evolving technologies, such as AI, may present risks and challenges that can impact our business, including as a result of dependencies on specialized graphics processing units (GPUs) and other high-performance computing resources and by posing cybersecurity and other risks to our and our partners’ confidential and/or proprietary information, including personal information, and as a result we may be exposed to operational challenges, reputational harm and potential liability.

We incorporate AI and machine learning throughout our molecular superintelligence platform and our technology development activities depend on sophisticated AI algorithms and computational systems to conduct drug creation activities. These activities require and depend on substantial computational resources, including high-performance computing systems and cloud computing services, including substantial GPU-based high-performance computing capacity, whether owned or procured through cloud arrangements. This dependence is twofold: we require large-scale compute for the long-term research and development of leading-edge AI technologies, including training and deploying next-generation versions of Enchant and NeuralPLexer, and we also require reliable, continuous compute for the day-to-day operation of our discovery pipeline and the performance of our obligations under partner collaborations. Because we actively perform drug discovery on behalf of our partners using our molecular superintelligence platform, a disruption in compute availability could affect both our internal programs and our contractual deliverables at the same time. As a result, limited access to, or the inability to expand, these computational resources could pose significant risks to our business and operations in the following ways:

The market for advanced GPUs and associated networking equipment has at times been highly constrained, with demand far exceeding supply, and both cost and availability have been volatile and difficult to predict. We rely on a limited number of cloud computing providers, including Lambda and AWS, and we may face allocation constraints, lead-time delays, price increases, or contention for capacity between our internal pipeline and our collaboration work. Increases in the cost of compute could raise the cost profile of our programs and partnerships and compress our margins, particularly to the extent we are unable to pass such costs through to partners. A sustained inability to obtain compute on acceptable terms, or at all, could slow our research and development, delay program milestones, impair our ability to meet collaboration commitments, weaken our competitive position, and adversely affect our business, financial condition, results of operations, and prospects.

We continually assess our computational needs and strategically invest in our infrastructure, including access to compute through cloud computing arrangements, to mitigate these risks. However, there is no assurance that these measures will be sufficient to prevent the adverse effects associated with limited access to computational resources. Our failure to effectively manage and scale our computational resources could have a material adverse effect on our business, financial condition, and operational results.

If we enable or use AI solutions that draw controversy due to perceived or actual negative societal impact, we may experience brand or reputational harm, competitive harm or legal liability. A growing number of legislators and regulators are adopting laws and regulations and have focused enforcement efforts on the adoption of AI, and use of such technologies in compliance with ethical standards and societal expectations. These developments may increase our compliance burden and costs in connection with use of AI and lead to legal liability if we fail to meet evolving legal standards or if use of such technologies results in harms or other causes of action we did not predict. For further discussion on the regulatory impact of our use of AI, see the risk titled “—Regulatory and legislative developments related to the use of AI could adversely affect our use of such technologies in our products, services, and business.”

The rapid evolution of AI will require the application of significant resources to design, develop, test, and maintain such systems to help ensure that AI is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts. The use of certain AI technologies can also give rise to intellectual property risks, including by disclosing or otherwise compromising our confidential or proprietary intellectual property, or by undermining our ability to assert or defend ownership rights in intellectual property created with the assistance of AI tools. Our vendors may in turn incorporate AI tools into their offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and security. Further, bad actors around the world use increasingly sophisticated methods, including the use of AI, to engage in illegal activities and cyber-attacks, cyber espionage campaigns, exploitation of expanded attack surfaces, and other activities, including attacks that may result in the theft and misuse of our and our partners’ personal information, confidential information and intellectual property. In addition, the use of generative AI models in our internal or third-party systems may create new attack surfaces or methods for adversaries, which could impact us and our vendors. Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to be in violation of applicable laws and regulations, and adversely impact our business.

Our solutions utilize third-party open-source software (OSS), which presents risks that could adversely affect our business and subject us to possible litigation.

Our solutions include software that is licensed from third parties under open-source licenses, and we expect to continue to incorporate such OSS in our solutions in the future. While we monitor our use of OSS, we cannot ensure that we have effectively monitored our use, validated the quality or source of such software, or are in compliance with the terms of the applicable open-source licenses or our policies and procedures. Use of OSS may entail greater risks than use of third-party commercial software because open-source licensors generally do not provide support, updates, or warranties or other contractual protections regarding infringement claims or the quality of the code. OSS may also be more susceptible to security vulnerabilities. Third-party OSS providers could experience service outages, data loss, privacy breaches, cyber-attacks, and other events relating to the applications and services they provide, which could diminish the utility of these services and harm our business.

The terms of many open-source licenses have not been interpreted by U.S. courts, and there is a risk that these licenses could be construed in a way that could impose unanticipated conditions or restrictions on our ability to commercialize our solutions. From time to time, companies that use third-party open-source software have faced claims challenging the use of such open-source software and requesting compliance with the open-source software license terms. Accordingly, we could be subject to lawsuits by third parties claiming ownership of what we believe to be open-source software or claiming non-compliance with the applicable open-source licensing terms. If we were to receive a claim of non-compliance with the terms of any of these open-source licenses, we could be required to incur significant legal expenses defending against those allegations and could be subject to significant damages, enjoined from offering or selling our solutions that contained the open-source software, and required to comply with the foregoing conditions, and we may be required to publicly release certain portions of our

proprietary source code. If we inappropriately use open-source software, or if the license terms for open-source software that we use change, we may be required to re-engineer our solutions, incur additional costs, discontinue the sale of some or all of our solutions or take other remedial actions. In addition, some open-source software licenses require end users who use, distribute or make available across a network software and services that include open-source software to offer aspects of the technology that incorporates the open-source software for no cost. If we were to combine our proprietary software with open-source software in a certain manner, we could, under certain open-source licenses be required to make publicly available source code (which in some circumstances could include valuable proprietary code) for modifications or derivative works we create based upon, incorporating or using the open-source software and/or to license such modifications or derivative works under the terms of the particular open-source license, which could open security risks as well as risks to exposing some of our trade secrets. This would allow our competitors to create similar solutions with less development effort and time.

Although we believe that our molecular superintelligence platform has the potential to identify more promising molecules than traditional methods and to accelerate drug discovery, our focus on using our molecular superintelligence platform to discover and design molecules with therapeutic potential may not result in the discovery and development of commercially viable products for us or our partners.

Our scientific approach focuses on using our molecular superintelligence platform technology and leverages our deep understanding of physics-based modeling and theoretical chemistry to design molecules and predict their key properties without conducting time-consuming and expensive physical experiments. Our molecular superintelligence platform, together with our automated laboratory infrastructure, enables an integrated discovery process pairing computational prediction with high-throughput experimentation. While our internal pipeline suggests that our molecular superintelligence platform is capable of accelerating drug discovery and identifying high quality drug candidates, these results do not assure future success for our partners or for us with our proprietary drug discovery programs.

To date, our internal pipeline and the substantial majority of our molecular superintelligence platform-derived programs have focused on oncology targets. Our partnerships with AbbVie (oncology, immunology and neurologic indications), Takeda (oncology, gastrointestinal, and inflammatory diseases), and Lundbeck (neurological indications) represent our first significant application of our molecular superintelligence platform in therapeutic areas outside of oncology. The applicability of our computational models and discovery methodology to these new therapeutic areas is unproven, and we cannot assure you that our molecular superintelligence platform will perform as effectively in neurological, gastrointestinal, or inflammatory disease biology as it has in our oncology programs. If our molecular superintelligence platform does not translate effectively to these new areas, our ability to expand our partnership model and diversify our pipeline would be adversely affected.

Each of our current drug candidates is developed using our molecular superintelligence platform. As a result, we may be exposed to a number of unforeseen risks related to our molecular superintelligence platform, and these risks could impact each of our drug candidates using or derived from our molecular superintelligence platform. Even if we are successful in improving our molecular superintelligence platform or expanding our portfolio, the potential drug candidates that we identify may not be successful in clinical development. For example, harmful side effects associated with one drug candidate could raise similar concerns for other drug candidates developed using our molecular superintelligence platform. If we do not successfully develop and commercialize drug candidates, we will not be able to generate revenue, which will have a material adverse effect on our financial position and stock price.

We face significant competition, and if our competitors discover, develop and market products more rapidly than we do or that are more effective, safer or less expensive than the drug candidates we develop, our commercial opportunities will be negatively impacted. Our drug candidates may, if approved, also face competition from existing branded, generic and off-label products.

The development and commercialization of new drug products is highly competitive. We face competition with respect to our technology and our drug candidates from large and specialty pharmaceutical, biotechnology companies, academic research institutions and governmental agencies, and public and private research institutions. Any drug candidate we develop and commercialize will have to compete with existing therapies, as

well as therapies currently in development and that may be developed in the future. We believe that the key competitive factors affecting the success of any of our drug candidates will include efficacy, safety, speed to market, ease of use and reliability, acceptance by physicians, reimbursement and costs, level of devoted promotional activity and IP protection.

Many of the companies that we compete against, or which we may compete against in the future, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approval of products than we do. They may also compete with us in recruiting and retaining qualified scientific and management personnel, in establishing clinical trial sites and patient recruitment for clinical trials, as well as in acquiring technologies complementary to, or necessary for, developing our drug candidates. The current marketplace is primarily divided between companies focused solely on computational software and firms focused exclusively on high-throughput screening. See the section titled “Business—Competition” for a description of the competitive landscape in which we operate, including our representative competitors. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be strong competitors, particularly through collaborative arrangements with large and established companies.

We also face competition from biotechnology companies based in the People's Republic of China (China) that may develop, train, and deploy advanced computational models more rapidly or at lower cost given substantial government investment and access to large biological and clinical datasets. While we believe our models (Enchant and NeuralPLexer) achieve strong performance on public benchmarks relative to competing models, including third-party structure-prediction tools, benchmark comparisons are inherently point-in-time, and competing models, including open source and commercially available alternatives, are rapidly advancing. Our current benchmark positioning may not hold, and our differentiation could erode if competitors achieve comparable or superior performance on the metrics that matter to partners and drug discovery outcomes.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, or are easier to use, more reliable or less expensive than any of our drug candidates that are approved. Our competitors also may obtain FDA or other regulatory approval for their drug candidates more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Risks related to reliance on third parties and supply chain, regulatory approval and commercialization

We rely, and expect to continue to rely, on third parties, including independent clinical investigators and CROs, to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business could be substantially harmed.

We have relied upon and plan to continue to rely upon third parties, including independent clinical investigators and third-party CROs, to conduct certain aspects of our preclinical studies and clinical trials and to monitor and manage data for our ongoing preclinical and clinical programs. Given the nature of these relationships, we only control certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies and trials is conducted in accordance with the applicable protocol, scientific standards, and laws and regulations and our reliance on these third parties does not relieve us of our regulatory responsibilities. Material near-term value depends on AbbVie, Takeda, Lundbeck, and our other partners performing under their respective agreements and advancing the underlying programs. We and our third-party contractors and CROs are required to comply with good clinical practice (GCP) requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for all of our drug candidates in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of these third parties or our CROs fail to comply with applicable GCPs, the clinical data generated

in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations. In addition, our clinical trials must be conducted with product produced under current good manufacturing practice (cGMP) regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be adversely affected if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Further, these investigators and CROs are not our employees and we will not be able to control, other than by contract, the amount of resources, including time, which they devote to our drug candidates and clinical trials. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which could affect their performance on our behalf. If independent investigators or CROs fail to devote sufficient resources to the development of our drug candidates, or if CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our drug candidates. As a result, our results of operations and the commercial prospects for our drug candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed or precluded entirely.

Our CROs have the right to terminate their agreements with us in the event of an uncured material breach. In addition, some of our CROs have an ability to terminate their respective agreements with us if it can be reasonably demonstrated that the safety of the subjects participating in our clinical trials warrants such termination, if we make a general assignment for the benefit of our creditors or if we are liquidated.

Although we are not substantially dependent on any individual CRO arrangement, if any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs on commercially reasonable terms. Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Additionally, CROs may lack the capacity to absorb higher workloads or take on additional capacity to support our needs. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition, and prospects.

We contract with third parties for the manufacture of our drug candidates for preclinical studies and our ongoing clinical trials and expect to continue to do so for additional clinical trials and ultimately for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates for clinical development or such quantities at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts.

We do not own any manufacturing facilities and do not currently have the infrastructure or internal capability to manufacture supplies of our drug candidates for use in development and commercialization. We rely, and expect to continue to rely, on third party manufacturers for the production of our drug candidates for preclinical studies and clinical trials under the guidance of members of our organization. As a clinical-stage company running a multi-center IAM1363-01 trial, we depend on contract manufacturers, CROs, and clinical sites for supply and trial conduct. If we were to experience an unexpected loss of supply of any of our drug candidates or any of our future drug candidates for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, we could experience delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials.

We rely on third parties for the manufacture of our drug candidates, including IAM1363 drug substance and drug product, and on third-party CROs for the conduct of our clinical trials, including our ongoing IAM1363-01 Phase 1/1b trial. See the section titled “Business—Manufacturing, operations, and scalable infrastructure” for a description of our manufacturing and supply arrangements.

We expect to continue to rely on third-party manufacturers for the commercial supply of any of our drug candidates for which we obtain marketing approval. There are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing for us and willing to do so. We currently rely on a single contract manufacturer for the drug substance, and a limited number of contract manufacturers for the drug product, of IAM1363, and we may rely on single-source or sole-source third parties for our other drug candidates and for certain starting materials, reagents, and components. We do not currently have a qualified second-source supplier for our drug substance, and while we maintain more than one qualified drug product manufacturer for certain programs, we do not have redundant suppliers for all of our materials and programs, and establishing additional or redundant supply would require significant time, cost, and technology transfer and may require additional regulatory review, during which our development could be delayed. We may be unable to maintain or establish required agreements with third-party manufacturers or to do so on acceptable terms. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

If we were to need to find alternative manufacturing facilities it would significantly impact our ability to develop, obtain regulatory approval for or market our drug candidates, if approved. The commercial terms of any new arrangement could be less favorable than our existing arrangements and the expenses relating to the transfer of necessary technology and processes could be significant.

A significant portion of our third-party manufacturing is concentrated with contract manufacturers located in, or affiliated with entities based in, China. This geographic concentration exposes us to risks arising from changes in trade, tariff, import/export, sanctions, and national-security laws and policies, including legislative and regulatory proposals in the United States that would restrict or disincentivize biopharmaceutical companies from contracting with certain foreign, including China-based or China-affiliated, manufacturers and service providers. If such measures are enacted or expanded, or if geopolitical developments, trade restrictions, or actions by the U.S. or

other governments limit our ability to continue working with these manufacturers, we could be required to identify, qualify, and transfer our processes to alternative suppliers. Any such transition would require significant time, cost, technology transfer, and potential additional regulatory review, and could delay or disrupt our clinical development and supply, any of which could adversely affect our business, financial condition, results of operations, and prospects.

We do not have complete control over all aspects of the manufacturing process of, and are dependent on, our CMOs for compliance with cGMP regulations for manufacturing both active drug substances and finished drug products. Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside of the United States.

Any problems or delays we or our CMOs experience in preparing for commercial scale manufacturing of a drug candidate may result in a delay in the FDA approval of the drug candidate or may impair our ability to manufacture commercial quantities or such quantities at an acceptable cost, which could result in the delay, prevention or impairment of clinical development and commercialization of our drug candidates and could adversely affect our business. Furthermore, if any of our drug candidates are approved and we or our CMOs fail to deliver the required commercial quantities of such product on a timely basis and at reasonable costs, we would likely be unable to meet demand for our products and we would lose potential revenue, which would adversely affect our business, financial condition, results of operations, and prospects.

Our CMOs’ manufacturing facilities may also be unable to comply with our specifications, cGMP, or with other FDA, state, and foreign regulatory requirements. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of drug candidate that may not be detectable in final product testing. If we or our CMOs are unable to reliably produce drug candidates to specifications acceptable to the FDA or other regulatory authorities, or in accordance with the strict regulatory requirements, we may not obtain or maintain the approvals we need to commercialize such drug candidates. For example, manufacturing facilities generally must submit to FDA pre-approval inspections that will be conducted after we submit marketing applications, including our planned NDAs, to the FDA, and any inability on the part of our CMOs to successfully complete such pre-approval inspections could delay or prevent commercialization of our drug candidates. Even if we obtain regulatory approval for any of our drug candidates, there is no assurance that either we or our CMOs will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Deviations from manufacturing requirements may further require remedial measures that may be costly and/or time-consuming for us or a third party to implement and may include the temporary or permanent suspension of a clinical trial or, if approved, commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business, financial condition, results of operations, and prospects.

Even to the extent we use and continue to use CMOs, we are ultimately responsible for the manufacture of our products and drug candidates. A failure to comply with these requirements may result in regulatory enforcement actions against our manufacturers or us, including fines and civil and criminal penalties, which could result in imprisonment, suspension or restrictions of production, injunctions, delay or denial of product approval or supplements to any approved products, clinical holds or termination of clinical trials, warning or untitled letters, regulatory authority communications warning the public about safety issues, refusal to permit the import or export of such products, product seizure, detention, or recall, operating restrictions, suits under the civil False Claims Act, corporate integrity agreements, consent decrees, or withdrawal of product approval.

Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our drug candidate, impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations, and prospects.

Regulatory and legislative developments related to the use of AI could adversely affect our use of such technologies in our products, services, and business.

We use AI throughout our business, including in our drug discovery processes and technology. As the regulatory framework for AI (including generative AI) evolves, our business, financial condition, and results of operations may be adversely affected. The regulatory framework for AI and similar technologies is changing rapidly. It is possible that new laws and regulations will be adopted in the United States and in non-U.S. jurisdictions, or that existing laws and regulations may be interpreted in ways that would affect the operation of our molecular superintelligence platform and data analytics and the way in which we use AI and similar technologies. We may not be able to adequately anticipate or respond to these evolving laws and regulations, and we may need to expend additional resources to adjust our offerings in certain jurisdictions if applicable legal frameworks are inconsistent across jurisdictions. In addition, because these technologies are themselves highly complex and rapidly developing, it is not possible to predict all of the legal or regulatory risks that may arise relating to our use of such technologies. Further, the cost to comply with such laws or regulations could be significant and would increase our operating expenses, which could adversely affect our business, financial condition and results of operations.

For example, in the United States, the FDA issued draft guidance titled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products” in January 2025, which proposes a risk-based framework for assessing the credibility of AI models used to produce information or data intended to support regulatory decisions regarding the safety, effectiveness, or quality of a drug in the nonclinical, clinical, post-marketing, and manufacturing phases. Although this draft guidance does not address the use of AI in drug discovery, which is our primary use of AI models at this time, to the extent we use AI models in the future to generate data or analyses that we submit in support of any regulatory submissions, including an investigational or marketing application, or in the manufacture of our product candidates, we may be required to establish and document the credibility assessment and evidence of those models for particular context of use. This guidance is not final and may change, and we cannot predict the requirements that will ultimately apply to our operations and uses of AI, the resources that compliance will require, or whether the FDA or other regulators will accept AI-derived data or analyses that we may submit in the future. We will continue to monitor and adjust our processes in response to further developments. Any of these developments could delay or increase the cost of our development programs, or limit our use of AI, which could adversely affect our business.

Additionally, in Europe, the European Union’s Artificial Intelligence Act (AI Act) entered into force on August 1, 2024. The AI Act establishes a risk-based governance framework for regulating high-risk AI systems operating in or being used by the EU market. The AI Act could impact our products, business, and use of AI, even if we do not have a direct presence in the EU. This framework categorizes AI systems based on the risks associated with such AI systems’ intended purposes as creating “unacceptable”, “high” or “limited” risks. While the AI Act has not yet been enforced, there is a risk that our current or future AI-powered software or applications may be categorized as “high” risk or “limited” risk, obligating us to comply with the applicable requirements of the AI Act, which may impose additional costs on us, increase our risk of liability, or adversely affect our business. For example, “high” risk AI systems are required, amongst other things, to implement and maintain certain risk and quality management systems, conduct certain conformity and risk assessments, use appropriate data governance and management practices, including in development and training, and meet certain standards related to testing, technical robustness, transparency, human oversight, and cybersecurity. Even if our AI systems are not categorized as “high” risk we may be subject to additional transparency and other obligations for “low” risk AI system providers. The AI Act sets forth certain penalties, including fines of the greater of EUR 35 million or 7% of worldwide annual turnover (as defined in the AI Act) for the prior year for violations related to offering prohibited AI-systems or data governance, fines of the greater of EUR 15 million or 3% of worldwide annual turnover for the prior year for violations related to the requirements for “high” risk AI systems, and fines of the greater of EUR 7.5 million or 1.5% of worldwide annual turnover for the prior year for violations related to supplying incorrect, incomplete or misleading information to the EU and member state authorities. The AI Act’s regulatory framework is expected to have a material impact on the way AI is regulated in the EU and across the world. Other jurisdictions also have proposed, and in certain cases enacted, laws and regulations addressing the use and development of AI. For example, in the United States, numerous states have proposed or have enacted laws addressing these matters, and in the United Kingdom, the government has published a white paper calling for existing regulators to implement certain specific principles to guide and inform the responsible development and use of AI. The AI Act and other evolving laws and regulations addressing AI, together with developing guidance and/or decisions in this

area, may affect our use of AI and our ability to provide and to improve our services, require additional compliance measures and changes to our operations and processes, result in increased compliance costs and potential increases in civil claims against us, and could adversely affect our business, financial condition, and results of operations.

Changes in U.S. trade policy, including tariffs, could have a material adverse impact on our business, financial condition, and results of operations.

Changes in U.S. trade policy, including tariffs, could have a material adverse impact on our business, financial condition, and results of operations. There is currently significant uncertainty about the future relationship between the United States and various other countries, including China, with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations, collaboration, and investment. The U.S. government has and continues to make significant additional changes in U.S. trade policy and may continue to take future actions that could negatively impact U.S. trade.

For example, the National Defense Authorization Act of 2026 includes Section 851 regarding “[p]rohibition on contracting with certain biotechnology providers” (the BIOSECURE Act), which restricts federal government contracts, grants, and loans from being issued to companies that use biotechnology equipment or services from any designated “biotechnology company of concern,” as part of such companies’ performance of those agreements with the U.S. government. The Office of Management and Budget (OMB) will issue a list of “biotechnology companies of concern” no later than mid-December 2026, which will include (i) certain companies that are named in the Department of Defense’s List of Chinese Military Companies, also known as the 1260H List, (ii) companies that OMB designates as a “biotechnology company of concern” pursuant to certain criteria, and (iii) certain subsidiaries or parent or successor entities of the foregoing. There is a “safe harbor” provision in the BIOSECURE Act providing that the restrictions do not apply to equipment or services that were formerly but are no longer provided by a “biotechnology company of concern,” as well as a “grandfathering” provision providing that the prohibitions shall not apply for a five-year period to biotechnology equipment or services produced or provided under a contract or agreement entered into before the applicable effective date. Once fully implemented through regulations to be published, the BIOSECURE Act may ultimately limit certain U.S. biotechnology companies (such as ours) from using equipment or services produced or provided by certain designated Chinese biotechnology companies to the extent we would contract with, or otherwise receive funding from, the U.S. government. In addition, even if we do not seek any covered U.S. federal government contracts, grants, or loans, commercial partners, government agencies, or other third parties may view our business less favorably if we engage with entities that are or which become designated as biotechnology companies of concern. For example, we currently contract with WuXi AppTec for certain research and development services, which is at high risk of being designated a biotechnology company of concern due to its inclusion on the 1260H List. This association could affect the perception of our business among third parties, and could delay or impede clinical trials and commercialization of our candidates.

As another example, the U.S. Department of Justice’s Data Security Program (DSP) places limitations on U.S. companies’ ability to enter into (and in some cases prohibits) certain contracts involving transfers of sensitive personal data to business partners located in China, or with other specified links to China and other designated countries. The rule further requires U.S. persons to obtain from certain foreign counterparties contractual commitments to refrain from engaging in subsequent transfers of sensitive personal data to entities located in China or with other specified links to China and other designated countries. This new rule may impact our ability to contract not just with Chinese companies but also with foreign entities in general, potentially requiring us to extract promises related to compliance with this new rule.

Additionally, in September 2018, the USTR enacted a tariff on the import of other Chinese products, with a combined import value of approximately $200 billion; since that time USTR has modified these tariff rates and imposed tariffs on additional goods. In addition, since February 4, 2025, the U.S. government has imposed additional tariffs in amounts generally between 10% and 125% on the import of various foreign-origin goods, including Chinese-origin goods, under authorities provided in the Trade Act of 1974 and the Trade Expansion Act of 1962 and asserted under the International Emergency Economic Powers Act. Additional tariffs may in the future be implemented by the U.S. government, the implementation, scope, and duration of which remain uncertain. For

example, in July 2026, the U.S. government began imposing a tariff of up to 100% on the import of certain branded pharmaceutical drugs. Tariffs on imported starting materials used in our drug candidates as well as on drug candidates themselves, or retaliatory trade measures taken by China or other countries, which could potentially include restricted access to starting materials used in our drug candidates, could result in us needing to make changes to our suppliers or our drug candidates, or materially harm our business, financial condition and results of operations. Further, the implementation, escalation, or threat of tariffs, trade restrictions, and trade barriers could have a generally disruptive impact on the global economy and, therefore, negatively impact our company, including through impacts on our customers, vendors, suppliers, or other counterparties. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions or what actions may be taken by the other countries in retaliation.

If we are unable to obtain or use services from existing service providers, are restricted from sharing relevant data with such service providers or with others, or become unable to export or sell our products to any of our customers or service providers, our business, liquidity, financial condition, and/or results of operations would be materially and adversely affected.

The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our drug candidates, we will be unable to generate product revenue and our business will be substantially harmed.

We are not permitted to commercialize, market, promote, or sell any drug candidate in the United States without obtaining marketing approval from the FDA. Foreign regulatory authorities impose similar requirements. The time required to obtain approval by the FDA and other comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the drug candidates involved. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a drug candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other data. Even if we eventually complete clinical testing and receive approval of any marketing application for our drug candidates, the FDA and other comparable foreign regulatory authorities may approve our drug candidates for a more limited indication or a narrower patient population than we originally requested. We have not obtained regulatory approval for any drug candidate, and it is possible that none of our existing drug candidates or any drug candidates we may seek to develop in the future will ever obtain regulatory approval. Of the large number of drugs in development, only a small percentage successfully complete the applicable regulatory approval processes and are commercialized.

Prior to obtaining approval to commercialize a drug candidate in the United States or abroad, we must demonstrate with substantial evidence from adequate and well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such drug candidates are safe and effective for their intended uses. Results from preclinical studies and clinical trials can be interpreted in different ways. Even if we believe available preclinical or clinical data support the safety or efficacy of our drug candidates, such data may not be sufficient to obtain approval from the FDA and other comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authorities, as the case may be, may also require us to conduct additional preclinical studies or clinical trials for our drug candidates either prior to or post-approval, or may object to elements of our clinical development program.

Applications for our drug candidates may be delayed or limited or could fail to receive regulatory approval for many reasons, including the following:

With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional product testing, administrative review periods and agreements with pricing authorities.

Even if we obtain approval of our drug candidates, regulatory authorities may approve any of our drug candidates for fewer or more limited indications than we request, may impose significant limitations in the form of narrow indications, warnings, or a Risk Evaluation and Mitigation Strategy (REMS). Regulatory authorities may not approve the price we intend to charge for drug products we may develop, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a drug candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that drug candidate. Any of the foregoing scenarios could seriously harm our business.

The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.

The acceptance of study data by the FDA, EMA or other comparable foreign regulatory authority from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions. For example, our IAM1363-01 Phase 1/1b trial began at U.S. sites and has expanded into the EU, with planned expansion into the UK and APAC, and we run development operations primarily in the United States and Bristol, United Kingdom. In cases where data from United States clinical trials are intended to serve as the basis for marketing approval in the foreign countries outside the United States, the standards for clinical trials and approval may be different. There can be no assurance that any United States or foreign regulatory authority would accept data from trials conducted outside of its applicable jurisdiction. If the FDA, EMA or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our drug candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.

Uncertainty in the regulatory framework could also result in disruption to the supply and distribution as well as the import/export both of active pharmaceutical ingredients and finished product. Such a disruption could create supply difficulties for ongoing clinical trials. The cumulative effects of the disruption to the regulatory framework,

uncertainty in future regulation, and changes to existing regulations may increase our development lead time to marketing authorization and commercialization of products in the EU and/or the UK and increase our costs. We cannot predict the impact of such changes and future regulation on our business or the results of our operations.

Obtaining and maintaining regulatory approval of our drug candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our drug candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of our drug candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction. For example, even if the FDA grants marketing approval of a drug candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion and pricing of the drug candidate in those countries. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, the pricing of a prescription drug candidate is subject to regulatory approval before it can be sold in that jurisdiction. In some cases, the price that we intend to charge for our drug products, if approved, is also subject to approval.

We may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of drug candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products, if approved, in certain countries. If we or any future partner fails to comply with the regulatory requirements in international markets or fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our potential drug candidates will be harmed.

The clinical trials of our drug candidates may not demonstrate safety and efficacy to the satisfaction of the FDA or other comparable foreign regulatory authorities or otherwise produce positive results.

Before obtaining marketing approval from the FDA or other comparable foreign regulatory authorities for the sale of our drug candidates, we must complete preclinical development and extensive clinical trials to demonstrate the safety and efficacy of our drug candidates. Clinical testing is expensive, difficult to design and implement, can take many years to complete and its ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process. The outcome of preclinical studies and early stage clinical trials may not be predictive of the success of later clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their drug candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs.

We do not know whether our future clinical trials will begin on time or enroll participants on time, or whether our ongoing and/or future clinical trials will be completed on schedule or at all. Clinical trials can be delayed for a variety of reasons, including delays related to:

Clinical trials must be conducted in accordance with the FDA’s and other applicable regulatory authorities’ legal requirements, and remain subject to oversight by these governmental agencies and ethics committees or IRBs at the medical institutions where such clinical trials are conducted. We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or comparable foreign regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial.

Further, conducting clinical trials in foreign countries, as we may do for our drug candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our drug candidates.

If we experience delays in the completion of, or termination of, any clinical trial of our drug candidates, the commercial prospects of our drug candidates will be harmed, and our ability to generate product revenue from any of these drug candidates will be delayed. Moreover, any delays in completing our clinical trials will increase our costs, slow down our drug candidate development and approval process and jeopardize our ability to commence product sales and generate revenue.

In addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval of a drug candidate. Any delays to our clinical trials that occur as a result could shorten any period during which we may have the exclusive right to commercialize our drug candidates and our competitors may be able to bring products to market before we do, and the commercial viability of our drug candidates could be significantly reduced. Any of these occurrences may harm our business, financial condition, and prospects significantly.

If our drug candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials, we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

Participants in our ongoing and planned clinical trials may in the future suffer SAEs or other side effects not observed in our preclinical studies or previous clinical trials. For example, as of the August 31, 2026, data cutoff date, IAM1363 is generally well tolerated. The most common treatment-related AEs to date at the go-forward dose of 960 mg QD are diarrhea, nausea, vomiting, and fatigue. Grade 3 treatment-related AEs were reported in four of 68 subjects dosed with IAM1363 monotherapy at 960 mg QD, which included events of nausea, diarrhea, acute kidney injury with increased blood creatinine, and pneumonitis. No Grade 4 or Grade 5 events have been reported to date. Additional or more severe treatment-related adverse events, including at a rate or severity greater than what we have observed to date, may emerge as we continue to test our drug candidates in more patient populations, as a combination agent combined with other anticancer therapies, and in larger clinical trials or with longer follow-up. If SAEs or other side effects are observed in any of our ongoing or planned clinical trials, we may have difficulty recruiting participants to the clinical trials, participants may drop out of our trials, or we may be required to abandon the trials or our development efforts of that drug candidate altogether. We, the FDA, other comparable regulatory authorities, or an IRB may suspend clinical trials of a drug candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude the drug candidate from obtaining or maintaining regulatory approval, undesirable side effects may inhibit market acceptance due to tolerability concerns as compared to other available therapies. Any of these developments could materially harm our business, financial condition, and prospects.

Additionally, if any of our drug candidates receives regulatory approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result. For example, the FDA could require us to adopt a REMS, to ensure that the benefits of treatment with such drug candidate outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring, or distribution systems and processes that are highly controlled, restrictive and more costly than what is typical for the industry. We may also be required to adopt a REMS or engage in similar actions, such as patient education, certification of health care professionals or specific monitoring, if we or others later identify undesirable side effects caused by any product that we develop alone. Other potentially significant negative consequences associated with AEs include:

Any of these events could diminish the usage or otherwise limit the commercial success of our drug candidates and prevent us from achieving or maintaining market acceptance of our drug candidates, if approved by the FDA or other regulatory authorities.

Even if we receive regulatory approval of our drug candidates, we will be subject to ongoing regulatory obligations and continued regulatory oversight, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our drug candidates.

Even if we obtain any regulatory approval for one or more of our drug candidates, such drug candidates will be subject to ongoing regulatory requirements applicable to manufacturing, labeling, packaging, storage, advertising, promoting, sampling, record-keeping, and submission of safety or other post-market information, among other things. Any regulatory approvals that we receive for our drug candidates will require surveillance to monitor the safety and efficacy of the drug candidate, as well as ongoing compliance with cGMPs and GCPs for any clinical trials. The FDA may also require a REMS, limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or requirements that we conduct potentially costly post-market testing and surveillance studies, including post-marketing clinical trials and surveillance to monitor the quality, safety and efficacy of the drug. An unsuccessful post-marketing study or failure to complete such a study may require a REMS in order to approve our drug candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

In addition, drug manufacturers are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA or foreign marketing application. If we, the FDA or a comparable foreign regulatory authority, discover previously unknown problems with our drug candidates, such as AEs of unanticipated severity or frequency, or problems with the facility where the drug is manufactured or if a

regulatory authority disagrees with the promotion, marketing or labeling of that drug, a regulatory authority may impose restrictions relative to that drug, the manufacturing facility or us including requesting a recall or requiring withdrawal of the drug from the market or suspension of manufacturing.

Failure to comply with applicable regulatory requirements following approval of any drug candidates, may result in, among other things:

The occurrence of any event or penalty described above may inhibit our ability to commercialize our drug candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity.

The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our drug candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, we may be subject to enforcement action, and we may not achieve or sustain profitability. We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. It is difficult to predict how current and future legislation, executive actions, and litigation, including the executive orders, will be implemented, and the extent to which they will impact our business, our clinical development, and the FDA’s and other agencies’ ability to exercise their regulatory authority, including FDA’s pre-approval inspections and timely review of any regulatory filings or applications we submit to the FDA. To the extent any executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

If any of our drug candidates are approved and we are found to have improperly promoted off-label uses of those products, we may become subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, such as our drug candidates, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. While physicians in the United States may choose in their independent medical judgment to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, our ability to

promote any products will be narrowly limited to those indications that are specifically approved by the FDA. If we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of our drug candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

Breakthrough therapy designation and fast track designation by the FDA, even if granted for any of our drug candidates, may not lead to a faster development, regulatory review, or regulatory approval process, and each designation does not increase the likelihood that any of our drug candidates will receive marketing approval in the United States.

To the extent we submit a request for a breakthrough therapy designation for one or more of our drug candidates, the FDA may not grant the designation. Even if the designation is granted by the FDA, our clinical development and regulatory review process may not be faster. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the more efficient pathway for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as breakthrough therapies by the FDA may also be eligible for priority review and accelerated approval. Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our drug candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine to not grant such designation. The receipt of a breakthrough therapy designation for a drug candidate may not result in a faster development process, review or approval compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of our drug candidates qualify as breakthrough therapies, the FDA may later decide that such drug candidates no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

If a drug candidate is intended for the treatment of a serious or life-threatening condition and the drug candidate demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for fast track designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular drug candidate is eligible for this designation, we cannot provide any assurance that the FDA would decide to grant it. Even if we do receive fast track designation, we may not experience a faster development process, regulatory review or regulatory approval compared to conventional FDA procedures. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program. Fast track designation alone does not guarantee qualification for the FDA’s priority review procedures.

Disruptions at the FDA, the SEC, and other government agencies caused by funding shortages, global health concerns, staffing limitations, or otherwise could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, changes in FDA leadership and the ability to hire and retain key personnel and accept the payment of user fees, reduction in the federal workforce, and statutory, regulatory, and policy changes, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC

and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. For example, in recent years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, the current U.S. Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities.

Further, upon completion of this offering and in our operations as a public company, future government shutdowns or delays could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

We may face difficulties from changes to current regulations and future legislation.

Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our drug candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, we may be subject to enforcement action, and we may not achieve or sustain profitability.

In the United States, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system in ways that could affect our future revenue and profitability and the future revenue and profitability of our potential customers. Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, one of the most significant healthcare reform measures in decades, the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act (collectively, the ACA), was enacted in 2010. The ACA contained a number of provisions, including those governing enrollments in federal healthcare programs, reimbursement changes and fraud and abuse measures. Since its enactment, there have been judicial, executive, and Congressional challenges to certain aspects of the ACA.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. The Budget Control Act of 2011, among other things, reduced Medicare payments to providers, effective on April 1, 2013, and, due to subsequent legislative amendments to the statute, will remain in effect through 2032, unless additional Congressional action is taken.

There likely will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care. We cannot predict the initiatives that may be adopted in the future or their full impact. The continuing efforts of the government, insurance companies, managed care organizations, and other payors of healthcare services to contain or reduce costs of health care may adversely affect:

There has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted legislation designed, among other things, to bring more transparency to product pricing, to review the relationship between pricing and manufacturer patient programs, and to reform government program reimbursement methodologies for pharmaceutical products. For example, in August 2022, Congress passed the Inflation Reduction Act of 2022 (IRA), which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, the first year in which negotiated prices become effective, Centers for Medicare & Medicaid Services (CMS) selected 10 high-cost Medicare Part D drugs in 2023, negotiations began in 2024, and the negotiated maximum fair price for each drug has been announced. CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027. For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected. HHS has and will continue to issue and update guidance as these programs are implemented, although the Medicare drug price negotiation program is currently subject to legal challenges. Various industry stakeholders, including certain pharmaceutical companies and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional.

The current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States. If HHS begins to set most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or increases generic and biosimilar drug entry sooner than expected, that can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover research and development costs, ability to attract potential investors and potential buyers in the future. We cannot predict the full impact of the executive orders focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States. Such cost containment policies and executive orders could substantially and negatively impact the prices we may charge for any approved drug products, which could harm our valuation, ability to generate revenue and achieve and sustain profitability.

In addition, the One Big Beautiful Bill Act (OBBBA), which was signed into law in July 2025, includes provisions that will impact the U.S. healthcare system in various ways, including budget cuts to Medicaid and introducing new participant work and eligibility requirements for Medicaid coverage, which are expected to significantly change the administration and applicability of Medicaid coverage. The OBBBA also expanded exemptions for orphan designated drugs for Medicare drug price negotiations, which is expected to incentivize development of orphan designated drugs or increase competition for drug development in orphan diseases or conditions. Although the full impact of the OBBBA on the healthcare system and our business remains uncertain, the resulting changes may increase the cost and complexity of completing clinical development of and launching any drug candidates for which we may receive regulatory approval or increase our competition in the marketplace, any of which could adversely affect our business and prospects. The impact of ongoing and future judicial challenges, as well as future legislative, executive, and administrative actions and healthcare measures and agency rules implemented by the government on us and the pharmaceutical industry as a whole is unclear. To the extent changes lead to disruptions in federal agencies, greater uncertainty in the industry, or impose more constraints on drug pricing, such as the introduction of the most-favored nation pricing or international reference pricing, our business may be materially impacted. The implementation of cost containment measures or other healthcare reforms may negatively impact

the valuation of our company and/or prevent us from being able to generate revenue, attain profitability, or commercialize our drug candidates if approved.

In addition, individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures and, in some cases, mechanisms to encourage importation from other countries and bulk purchasing. A number of states are considering or have recently enacted state drug price transparency and reporting laws that could substantially increase our compliance burdens and expose us to greater liability under such state laws once we begin commercialization after obtaining regulatory approval for any of our drug candidates. Some states have also enacted legislation creating so-called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states, while some states are also seeking to implement general, across-the-board price caps for pharmaceuticals, or are seeking to regulate drug distribution. Further, in June 2026, the FDA approved Colorado’s Section 804 Importation Program proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this and Florida’s similar program, approved by the FDA in 2024, will be implemented and whether they will overcome potential legal, regulatory, or industry challenges in the United States and/or Canada. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products or drug candidates.

Further, changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols of ongoing studies to reflect these changes. Amendments may require us to resubmit our clinical trial protocols to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial. In light of widely publicized events concerning the safety risk of certain drug products, regulatory authorities, members of Congress, the Government Accountability Office, medical professionals, and the general public have raised concerns about potential drug safety issues. These events have resulted in the recall and withdrawal of drug products, revisions to drug labeling that further limit use of the drug products and establishment of risk management programs that may, for instance, restrict distribution of drug products or require safety surveillance or patient education. The increased attention to drug safety issues may result in a more cautious approach by the FDA to clinical trials and the drug approval process. Data from clinical trials may receive greater scrutiny with respect to safety, which may make the FDA or other regulatory authorities more likely to terminate or suspend clinical trials before completion or require longer or additional clinical trials that may result in substantial additional expense and a delay or failure in obtaining approval or approval for a more limited indication than originally sought.

Given the serious public health risks of certain AEs that may be associated with certain drug products, the FDA may require, as a condition of approval, costly REMS, which may include safety surveillance, restricted distribution and use, patient education, enhanced labeling, special packaging or labeling, expedited reporting of certain AEs, preapproval of promotional materials and restrictions on direct-to-consumer advertising.

Our relationships with healthcare professionals, clinical investigators, CROs, and third party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, and government price reporting, which could expose us to, among other things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens, and diminished profits and future earnings.

Healthcare providers and third-party payors play a primary role in the recommendation of any drug candidates for which we obtain marketing approval. Our current and future arrangements with healthcare providers, third-party payors, customers, and others may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which we research, as well as sell, market, and distribute any drug candidates for which we obtain marketing approval. The

applicable federal, state and foreign healthcare laws and regulations that may affect our ability to operate include, but are not limited to:

Pricing and rebate programs must also comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990 and more recent requirements in the ACA. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. Manufacturing, sales, promotion, and other activities also are potentially subject to federal and state consumer protection and unfair competition laws. In addition, the distribution of pharmaceutical, drug delivery and/or medical device products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage, and security requirements intended to prevent the unauthorized sale of pharmaceutical, drug delivery and/or medical device products. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act as well as other applicable consumer safety requirements.

Efforts to ensure that our current and future business arrangements with third parties will comply with applicable healthcare laws and regulations will involve on-going substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement,

individual imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of our operations. Defending against any such actions can be costly, time consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards, and other requirements could adversely affect our business, results of operations, and financial condition.

The global data protection landscape is rapidly evolving, and we are or may become subject to numerous state, federal and foreign laws, regulations, standards, and other requirements governing the collection, use, disclosure, retention, processing, and security of personal information, such as information collected or otherwise processed in connection with clinical trials. Implementation standards in connection with novel requirements and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards or other requirements, or perception of their respective obligations may have on our business. This may create uncertainty in our business, affect our ability to operate in certain jurisdictions or to collect, store, transfer, use, share, and otherwise process personal information, necessitate the acceptance of more onerous obligations in our contracts, result in liability or impose additional costs on us. The cost of compliance with these laws, regulations, standards, and other requirements is high and is likely to increase in the future. Any failure or perceived failure by us to comply with federal, state or foreign laws or regulations, our internal policies and procedures, our contracts, applicable standards, or other actual or asserted requirements governing our processing of personal information could result in negative publicity, government investigations and enforcement actions, claims by third parties and damage to our reputation, any of which could have a material adverse effect on our business, results of operation, and financial condition.

As our operations and business grow, we may become subject to or affected by new or additional laws, regulations, standards, and other requirements applicable to the processing of personal information and face increased scrutiny or attention from regulatory authorities. For example, outside the United States, numerous jurisdictions, including the European Union, United Kingdom, and other jurisdictions in which we operate our business, have enacted laws and regulations addressing privacy, data protection, security, and the collection, use, transfer, and other processing of personal information such as the EU General Data Protection Regulation and the United Kingdom General Data Protection Regulation, and UK Data Protection Act (collectively, the GDPR). We may be unable to transfer personal data from Europe and other jurisdictions to the United States or other countries due to data localization requirements or limitations on cross-border data flows. Europe and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer of personal data to other countries. In particular, the European Economic Area (EEA) and the United Kingdom (UK) have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it generally believes are inadequate.

Other jurisdictions may adopt similarly stringent interpretations of their data localization and cross-border data transfer laws. Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance with law, such as the EU’s standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S. Data Privacy Framework and the UK extension thereto (which allows for transfers by U.S.-based organizations who self-certify compliance and participate in the Framework), these mechanisms are subject to ongoing legal challenges and may be modified, suspended, or invalidated, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States. If there is no lawful manner for us to transfer personal data from the EEA, the UK, or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions (such as Europe) at significant expense, increased exposure to regulatory actions, substantial fines and penalties,

the inability to transfer data and work with partners, vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business. Additionally, companies that transfer personal data out of the EEA and UK to other jurisdictions, particularly to the United States, are subject to increased scrutiny from regulators, individual litigants, and activist groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers of personal data out of Europe for allegedly violating the GDPR’s cross-border data transfer limitations.

In the United States, HIPAA imposes, among other things, certain standards relating to the privacy, security, transmission, and breach reporting of individually identifiable health information. Certain states have also adopted other privacy and security laws and regulations that govern the privacy, processing and protection of health-related and other personal information. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. For example, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act (collectively, the CCPA) requires businesses that process the personal information of California residents to, among other things: (i) provide certain notices to California residents regarding the business’s collection, use and disclosure of their personal information; (ii) receive and respond to requests from California residents to access, delete and correct their personal information or to opt out of certain disclosures of their personal information; and (iii) enter into specific contractual provisions with service providers that process California resident personal information on the business’s behalf. Similar laws have been passed in other states and are continuing to be proposed at the state and federal level, and certain U.S. states also have enacted laws and regulations addressing specific categories of data, such as Washington’s My Health, My Data Act, which, among other things, provides for a private right of action. Collectively, these reflect a trend toward more stringent privacy legislation in the United States. The enactment of such laws could have potentially conflicting requirements that would make compliance challenging. Additional compliance investment and potential business process changes may be required.

As another example, the U.S. Department of Justice’s Data Security Program (DSP) places limitations on U.S. companies’ ability to enter into (and in some cases prohibits) certain contracts involving transfers of sensitive personal data to business partners located in China, or with other specified links to China and other designated countries. The rule further requires U.S. persons to obtain from certain foreign counterparties contractual commitments to refrain from engaging in subsequent transfers of sensitive personal data to entities located in China or with other specified links to China and other designated countries. If we fail to comply with these new regulations, we could be subject to civil and criminal penalties, harm to our reputation, and other adverse consequences. Additional compliance investment and potential business process changes may be required to address risks arising from the DSP.

Furthermore, the Federal Trade Commission (FTC) and many state Attorneys General continue to enforce federal and state consumer protection laws against companies for online collection, use, dissemination, and security practices that appear to be unfair or deceptive. For example, according to the FTC, failing to take appropriate steps to keep consumers’ personal information secure can constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act. The FTC expects a company’s security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Although we work to comply with applicable laws, regulations and standards, our contractual obligations, and other legal obligations, these and other actual or potentially asserted requirements are evolving and may be modified, interpreted and applied in an inconsistent manner from one jurisdiction to another, and may conflict with one another or other legal obligations. Any failure or perceived failure by us or our employees, representatives, contractors, consultants, partners, or other third parties to comply with such requirements or adequately address concerns relating to privacy, security or data protection, even if unfounded, could result in additional cost and liability to us, damage our reputation and adversely affect our business and results of operations.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment, and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of hazardous and flammable materials, including chemicals and biological materials. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Even if we are able to commercialize any drug candidates, if approved, those products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could harm our business. Coverage and reimbursement may be limited or unavailable in certain market segments for our drug candidates, if approved, which could make it difficult for us to sell any drug candidates profitably.

The success of our drug candidates, if approved, depends on the availability of coverage and adequate reimbursement from third-party payors. We cannot be certain that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our drug candidates or assure that coverage and reimbursement will continue to be available for any product that we may develop that receives coverage and adequate reimbursement from one or more third-party payors. Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Accordingly, coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance.

Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which treatments they will cover and the amount of reimbursement, which can impose price controls or measures to limit coverage and reimbursement for particular medications. In the United States, there is no uniform policy for coverage and reimbursement for drug products among third-party payors. As a result, obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our drug products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. Even if we obtain coverage for a given product, the resulting reimbursement payment rates may not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved drug products. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our drug candidates.

Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved drug products and, as a result, they may not cover or provide adequate payment for our drug candidates. The Inflation Reduction Act of 2022 included several prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements,

requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program, and potential negative pricing effects in other market channels, on a per unit basis. In June 2026, the CMS issued a proposed rule that would codify policies established in guidance documents for the Medicare Drug Price Negotiation Program for initial price applicability year 2029 and beyond. CMS plans to release guidance in 2026 to implement policies related to the effectuation of the maximum fair price (MFP) for the Medicare Drug Price Negotiation Program for 2028. Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of HHS to establish a mechanism through which U.S. patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States. Government agreements with pharmaceutical companies and other measures that use most-favored-nation pricing targets for prescription drugs or that increase generic and biosimilar drug entry sooner than expected can have a material adverse effect on our industry, our ability to set adequate pricing for new drugs to recover research and development costs, ability to attract potential investors and potential buyers in the future, or the pricing of our drug products, if approved, in the United States and in foreign countries. The impact of these and future measures implemented by the government on us and the pharmaceutical industry as a whole is unclear.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain drug access, marketing cost disclosure, transparency measures, and other measures designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, financial condition, results of operations, and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our drug products, if approved, or put pressure on our pricing, which could negatively affect our business, financial condition, results of operations, and prospects.

We expect to experience pricing pressures in connection with the sale of all of our drug candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, cost containment initiatives and additional legislative changes. Net prices for therapies may be reduced by mandatory discounts or rebates required by government healthcare programs or third-party payors and by any future relaxation of laws that presently restrict imports of therapies from countries where they may be sold at lower prices than in the United States. Our inability to promptly obtain coverage and profitable reimbursement rates from both government-funded and private payors for any approved drug products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any drug candidates we may develop, we may not be successful in commercializing those drug candidates, if and when they are approved.

We do not have a sales or marketing infrastructure and have little experience in the sale, marketing, or distribution of pharmaceutical products. To achieve commercial success for any approved drug product for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization, develop sales and marketing software solutions, or outsource these functions to third parties. In the future, we may choose to build a focused sales, marketing, and commercial support infrastructure to market and sell our drug candidates, if and when they are approved. We may also elect to enter into collaborations or strategic partnerships with third parties to engage in commercialization activities with respect to selected drug candidates,

indications, or geographic territories, including territories outside the United States, although there is no guarantee we will be able to enter into these arrangements.

There are risks involved with both establishing our own commercial capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force or reimbursement specialists is expensive and time-consuming and could delay any product launch. If the commercial launch of a drug candidate for which we recruit a sales force and establish marketing and other commercialization capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition commercialization personnel. Factors that may inhibit our efforts to commercialize any approved product on our own include but are not limited to the following:

If we enter into arrangements with third parties to perform sales, marketing, commercial support, and distribution services, they may also experience many of the above challenges. In addition, our product revenue or the profitability of product revenue may be lower than if we were to market and sell any products we may develop internally. We may not be successful in entering into such arrangements, or we may be unable to do so on terms that are favorable to us or them. We also may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our drug products effectively, or they may expose us to legal and regulatory risk by not adhering to regulatory requirements and restrictions governing the sale and promotion of prescription drug products, including those restricting off-label promotion. If we do not establish commercialization capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing any future approved drug candidates.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our drug candidates, if approved.

Our business exposes us to significant product liability risks inherent in the development, testing, manufacturing, and marketing of therapeutic treatments. Product liability claims could delay or prevent completion of our development programs. If any of our drug candidates are approved for marketing, such claims could still result in an FDA or other regulatory authority investigation of the safety and effectiveness of such products, our manufacturing processes and facilities or our marketing programs. These investigations could potentially lead to a recall of our products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in injury to our reputation, withdrawal of clinical trial participants, costs to defend the related litigation, a diversion of management’s time and our resources, initiation of investigations by regulators, substantial monetary awards to patients or other claimants, the inability to commercialize our drug candidates and decreased demand for our drug candidates, if approved for commercial sale.

We currently have product liability insurance that we believe is appropriate for our stage of development and may need to obtain higher levels prior to marketing any of our drug candidates, if approved. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business and cause our stock price to decline. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to maintain or obtain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses, including those caused by product liability claims.

A variety of risks associated with operating and marketing our drug candidates internationally could materially adversely affect our business.

We conduct a portion of our operations outside the United States through subsidiaries and offices located in the United Kingdom and Ireland and employees spanning several additional countries. Operating in more than one jurisdiction subjects us to risks that could adversely affect our business, financial condition, results of operations, and prospects, including the cost and complexity of complying with, and the potential for inconsistent application of, the employment, tax, anti-corruption, and other laws of multiple jurisdictions; exposure to additional anti-corruption and anti-bribery laws; exposure to non-U.S. tax laws and to taxation in more than one jurisdiction; and the added difficulty of managing geographically dispersed operations.

We may also seek to develop regulatory strategies for our drug candidates outside the United States and, if we do so, we expect that we or our partners would seek regulatory approval of our drug candidates outside of the United States. If we do seek to market our drug candidates outside the United States, we will be subject to additional risks related to operating in foreign countries if we or our partners obtain the necessary approvals, including:

These and other risks associated with our international operations or those of any applicable international partners may materially adversely affect our ability to attain or maintain profitable operations.

Our business could be affected by litigation, government investigations, and enforcement actions.

We currently operate in a number of jurisdictions in a highly regulated industry, and we could be subject to litigation, government investigation and enforcement actions on a variety of matters in the United States or foreign jurisdictions, including, without limitation, intellectual property, regulatory, product liability, environmental, whistleblower, false claims, data privacy and security, anti-kickback, anti-bribery, securities,

commercial, employment, and other claims and legal proceedings that may arise from conducting our business. Any determination that our operations or activities are not in compliance with existing laws or regulations could result in the imposition of fines, civil and criminal penalties, equitable remedies, including disgorgement, injunctive relief and/or other sanctions against us, and remediation of any such findings could have an adverse effect on our business operations.

Legal proceedings, government investigations and enforcement actions can be expensive and time-consuming. An adverse outcome resulting from any such proceedings, investigations or enforcement actions could result in significant damages awards, fines, penalties, exclusion from the federal healthcare programs, healthcare debarment, injunctive relief, product recalls, reputational damage, and modifications of our business practices, which could have a material adverse effect on our business and results of operations. Even if such a proceeding, investigation, or enforcement action is ultimately decided in our favor, the investigation and defense thereof could require substantial financial and management resources.

Risks related to intellectual property

If we are unable to obtain and maintain sufficient intellectual property protection for IAM1363, IAM217, IAM-C1, and any future drug candidates, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our drug candidates may be adversely affected.

Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to IAM1363, IAM217, IAM-C1, and any future drug candidates. We currently rely upon or intend to rely upon, a combination of patents, trademarks, trade secret protections, and confidentiality agreements to protect the intellectual property related to IAM1363, IAM217, IAM-C1, and any future drug candidates. If we are unable to obtain or maintain patent protection with respect to IAM1363, IAM217, IAM-C1, or any future drug candidates, and their uses, our business, financial condition, results of operations, and prospects could be materially harmed.

As of September 18, 2026, we own one issued U.S. patent covering drug candidate IAM1363. As of September 18, 2026, we do not own any issued patents with respect to drug candidates IAM217 or IAM-C1. These drug candidates are covered by pending U.S. patent applications and PCT patent applications. We cannot provide assurances that we will file one or more non-provisional patent applications claiming priority to the PCT applications. We cannot predict whether our patent applications will issue as granted patents in any particular jurisdiction or whether the claims of any granted patent will provide sufficient proprietary protection from competitors. Even if we obtain issued patents, those patents, as well as any patents we license from third parties in the future, may be challenged, circumvented, rendered unenforceable, or invalidated by third parties. In addition, the coverage claimed in a patent application can be significantly reduced before a patent is issued, and its scope can be reinterpreted and even challenged after issuance. As a result, we cannot guarantee that our drug candidates will be protected or remain protectable by enforceable patents.

Furthermore, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first nonprovisional U.S. filing. The natural expiration of a patent outside of the United States varies in accordance with provisions of applicable local law, but is generally 20 years from the earliest local filing date. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

Other parties have developed technologies that may be related or competitive to our own and such parties may have filed or may file patent applications, or may have received or may receive patents, claiming inventions that may overlap or conflict with those claimed in our own patent applications or issued patents. Publication of discoveries in the scientific literature lags behind the actual discoveries, and patent applications in the United States and in other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether the inventors of our patents and applications were the first to make the inventions claimed in those patents or pending patent applications, or that they were the first to file for

patent protection of such inventions. Further, we cannot assure that all of the potentially relevant prior art relating to our patents and patent applications has been found.

Third parties, including former employees, consultants, collaborators and competitors, may challenge the inventorship, scope, validity, or enforceability thereof, which may result in such patents being narrowed, invalidated or held unenforceable. If issued, our patents may be challenged in patent offices in the United States and abroad, or in court. For example, we may be subject to Post Grant Review or Inter Partes Review proceedings to the U.S. Patent Trial and Appeal Board (PTAB) challenging the validity of one or more claims of our patents, once issued. Such submissions may also be made prior to a patent's issuance, precluding the granting of a patent based on one of our patent applications. We may become involved in opposition, reexamination, inter partes review, post-grant review, derivation, or similar proceedings in the United States or abroad challenging the claims of our patents, once issued. Furthermore, patents may be challenged in court, once issued. Competitors may have filed patent applications before the inventors of our patents did. A competitor may also claim that we are infringing its patents and that we therefore cannot practice our technology as claimed under our patent applications and patents, if issued. As a result, one or more claims of our patents may be narrowed or invalidated. In litigation, a competitor could claim that our patents, if issued, are not valid for a number of reasons. If a court agrees, we would lose our rights to those challenged patents.

The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we will be successful in protecting our drug candidates by obtaining patents.

The patent prosecution process is expensive and time-consuming, and we may not be able to file, prosecute, obtain, enforce, or license all necessary or desirable patents or patent applications at a reasonable cost, in a timely manner, or in all jurisdictions where protection may be commercially advantageous. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. For example, we may not be able to obtain patents or maintain patent applications and patents due to the subject matter claimed being in disclosures in the public domain.

Our drug candidates IAM1363, IAM217, and IAM-C1 are covered in part by pending patent applications. The patent prosecution process is subject to numerous risks and uncertainties, including a patent examiner finding that the pursued claims satisfy the patentability requirements of the respective jurisdiction, and we cannot guarantee that future non-provisional patent applications will satisfy these requirements. Certain patentability requirements, such as novelty and non-obviousness, are a function of the state of art at the time of filing. Such art includes our own art, and the art of third parties. We may not be aware of all third-party art potentially relating to our research programs and drug candidates, or their intended uses, and as a result, the potential impact of such third-party art upon the patentability of our future patents or patent applications is highly uncertain.

Obtaining and maintaining our patent protection depends on compliance with various procedural processes, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance.

Periodic maintenance fees, renewal fees, annuity fees, and various other government fees will be due to the United States and foreign patent agencies over the lifetime of any patents or patent applications we may obtain or file. While an inadvertent lapse can in many cases be cured by payment of a late fee, there are situations in which noncompliance can result in abandonment or lapse, resulting in partial or complete loss of patent rights. Noncompliance events include failure to respond to official actions, non-payment of fees, and failure to properly submit formal documents.

It is possible that defects of form in the preparation or filing of current or future patents or patent applications may exist, or may arise in the future, including with respect to proper priority claims, inventorship listings, ownership, claim scope, timely filed responses, or timely requests for patent term adjustments. If there are material defects, an issued patent may be invalid and/or unenforceable.

We may not be able to protect our intellectual property rights throughout the world, which could impair our business.

Filing, prosecuting, and defending patents throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we do not pursue or obtain patent protection to develop their own products and may export infringing products to territories where we have patent protection, but enforcement is weak. Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. Many countries also limit the enforceability of patents against government agencies or contractors. Consequently, we may not be able to prevent third parties from practicing our inventions in certain countries.

The laws and regulations governing patents vary widely across jurisdictions. Patent claims that may be valid in the United States may not be eligible in another foreign jurisdiction. For example, our ability to obtain claims to medical methods is more limited in certain jurisdictions. Additionally, enforcement and recoverable damages based on medical method claims have limitations that may affect our ability to enforce our patents in certain jurisdictions.

The legal systems of certain developing countries do not favor the enforcement of patents, trade secrets and other intellectual property, which could make it difficult for us to stop infringement. We may need to share proprietary know-how with partners located in countries at heightened risk of theft, including through direct intrusion by private parties or foreign actors affiliated with or controlled by state actors.

Our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets.

Government actions in certain jurisdictions may allow exploitation of intellectual property without the patent owner’s consent. For example, government decrees may allow third parties to exploit patented inventions without authorization, effectively eliminating patent protection in those territories. These actions could result in abandonment or lapse of future patents in the affected jurisdictions. Geopolitical actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of future patent applications and the maintenance, enforcement, or defense of any future issued patents. For example, the United States and foreign government actions related to Russia’s invasion of Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia. Specifically, the Russian government issued Decree 299 stating that Russian companies and individuals can use patented inventions without the owner’s permission or compensation, if the patent is held by owners from “unfriendly countries,” which includes the United States. As a result, we would not be able to enforce our otherwise valid patent rights against an infringer in Russia. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights, if pursued, in Russia. Consequently, we may not be able to prevent third parties from practicing our inventions in Russia or from selling or importing products made using our inventions in and into Russia. Countries in addition to Russia have means by which they may allow exploitation of intellectual property, which include China and Brazil. As a result, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected in those countries.

The complex nature of our strategic partnerships may impact our ability to pursue and maintain valuable rights to our intellectual property.

Our ongoing and potential future partnerships involve complexities that may pose a number of risks to our intellectual property. For example, disagreements with collaborators over intellectual property or proprietary rights might cause delays or terminations of the research, development or commercialization of drug candidates, might lead to additional responsibilities for us with respect to drug candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive. Additionally, our collaborators may not properly obtain, maintain, enforce, defend or protect our intellectual property or proprietary rights or may use our proprietary information in such a way as to potentially lead to disputes or legal proceedings that could jeopardize

or invalidate our intellectual property or proprietary information or expose us to potential litigation. Disputes may arise with respect to the ownership of intellectual property developed pursuant to our collaborations. Our collaborators may infringe, misappropriate or otherwise violate the intellectual property or proprietary rights of third parties, which may expose us to litigation and potential liability.

If we are unable to obtain and maintain patent protection that is sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our drug candidates may be adversely affected.

Our pending and future patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless, and until, patents issue from such applications, and then only to the extent the issued claims cover the technology. The coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. We cannot offer assurances that any current non-provisional patent applications or future non-provisional patent applications claiming priority to the pending U.S. provisional patent applications covering our drug candidates IAM1363, IAM217, and IAM-C1 will issue as patents, and that the breadth of any issued patents will be sufficient to stop a competitor from developing, manufacturing, and commercializing products in a non-infringing manner that would be competitive with our products. If our competitors or other third parties are able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner, this could materially adversely affect our business, financial condition, results of operations, and prospects. In addition, any issued patent may be the subject of an adverse decision in proceedings before various patent offices or in courts that could result in loss of exclusivity or in patent claims being modified, revoked, invalidated, or held unenforceable, which could limit our ability to stop others from using or commercializing similar technologies and products. Therefore, the degree of future patent protection for our drug candidates is uncertain. The scope and coverage of future patents may be narrow enough that a third party could design around them and therefore not infringe. Others may independently develop similar or alternative technologies or duplicate our technologies without infringing our intellectual property rights. Therefore, only limited protection may be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage. The failure to obtain meaningful protection from the intellectual property rights relating to our drug candidates could have a material adverse effect on our financial condition and results of operations, including dissuading companies from collaborating with us to develop and commercialize our drug candidates.

Patent terms may be inadequate to protect our competitive position on IAM1363, IAM217, IAM-C1, or other drug candidates for an adequate amount of time.

Patent rights are of limited duration. In the United States, the natural expiration of a patent is generally 20 years after the non-provisional filing date, absent any terminal disclaimers, patent term adjustment, or patent term extension, and assuming timely payment is made of all appropriate maintenance, renewal, annuity, or other governmental fees. Given the amount of time required for development, testing and regulatory review, patents we obtain protecting drug candidates might expire before or shortly after commercialization. As a result, our patent portfolio may not provide sufficient rights to exclude others from commercializing similar products.

Patent term extension, supplementary protection certificates, and similar provisions are not guaranteed, and any award of patent term extension may be less than requested.

Depending upon the timing, duration, and specifics of FDA marketing approval of IAM1363, IAM217, and IAM-C1, or other drug candidates, one or more U.S. patents that we may obtain may be eligible for limited patent term extension (PTE) under the Drug Price Competition and Patent Term Restoration Act of 1984. This act permits PTE for a term of up to five years, but cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Patent Term Extension under 35 U.S.C. §156(f) is narrowly limited to the specific FDA-approved active ingredient and may therefore be limited in scope as compared to the entirety of the U.S. patent. The applicable authorities, including the FDA and the U.S. Patent and Trademark Office (USPTO), may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to patents we may obtain, or may grant more limited extensions than we request. We may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review

process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements.

PTE is only relevant after a patent has been issued. If the USPTO delays issuance of a patent, this can affect the number of days awarded that extend patent term. There could be delays at the USPTO caused by staffing cuts, budgetary constraints, or other government actions that could increase the timeline of patent prosecution or affect issuance of patents, which may shorten the number of patent term extension days eligible for award. Administrative changes may also lead to delays in review of regulatory submissions or requests for patent term extension. The PTE is awarded based upon the FDA’s regulatory review period, but the PTE evaluation stage involves cooperation between the USPTO and the FDA. Administrative changes (e.g., at the FDA or USPTO) may also lead to delays in review and analysis of regulatory submissions or requests for PTE.

If we are unable to obtain PTE, or the term of such extension is less than we request, the period during which we will have the right to exclude others from marketing our product in the U.S. will be shortened and our competitors may obtain approval of competing products following expiration of a patent we may obtain, and may take advantage of our investment in development and clinical trials by referencing our preclinical and clinical data to launch their product earlier than might otherwise be the case, and our revenue could be reduced, possibly materially.

Depending upon the timing, duration, and specifics of regulatory and marketing approval of IAM1363, IAM217, IAM-C1, or other drug candidates, one or more European patents that we may obtain may be eligible for Supplementary protection certificates (SPCs) under the Council Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009. An SPC can extend a patent right for a maximum of five years with an additional six-month extension available in accordance with Regulation (EC) No 1901/2006 if the SPC relates to a medicinal product for children for which data has been submitted according to a Paediatric Investigation Plan (PIP). Other countries in addition to the U.S. and Europe may have equivalent patent term extension mechanisms which may be available for one or more patents that we may obtain for IAM1363, IAM217, IAM-C1, or other drug candidates.

The Inflation Reduction Act of 2022, which, for example, enables the U.S. Department of Health and Human Services to negotiate prices for certain high-cost Medicare covered drugs, or other future U.S. legislation may impact our ability to receive revenue from any potential sale(s) of IAM1363, IAM217, IAM-C1, or other drug candidates, for instance, if patents we may obtain prevent entry of a generic to the market. Certain exceptions of the Inflation Reduction Act of 2022 may or may not be available to IAM1363, IAM217, IAM-C1, or other drug candidates.

The scope of patent exclusivity may be reduced when future composition of matter patents expires.

Upon the expiration of or the end of any period of exclusivity of any patents we may obtain, competitors may seek to develop and market generic versions of our products. Competitors may file abbreviated new drug applications (ANDAs) or 505(b)(2) applications referencing any of our future approved products. These manufacturers might only be required to conduct a relatively inexpensive study to show that their product is a generic, and thus could be significantly less costly than ours to bring to market and companies that produce such generics may be able to offer their products at lower prices. We may not be able to prevent such competition, which could significantly reduce our revenue. Accordingly, competition from generics of our drug candidate could materially adversely impact our ability to successfully commercialize our drug candidate.

Composition of matter patents are generally considered the strongest form of intellectual property protection because they provide protection without regard to any particular method of use or formulation. The composition of matter for our drug candidates IAM1363, IAM217, and IAM-C1 are covered in part by an issued U.S. patent for IAM1363, non-provisional applications for IAM217, and pending U.S. provisional patent applications for IAM-C1. The estimated expiration for these patent and patent applications if issued and absent any terminal disclaimers, patent term adjustments, or patent term extensions, and assuming timely payment is made of all appropriate maintenance, renewal, annuity, or other governmental fees, is from 2043 to 2046. New patent families may be filed covering new methods of use, formulations, dosage forms and dosing schedules, patient population(s), and methods of manufacture, that, if issued as granted patents, would be expected to expire after 2046 absent any

terminal disclaimers, patent term adjustments, or patent term extensions, and assuming timely payment is made of all appropriate maintenance, renewal, annuity, or other governmental fees.

Method of use patents protect only the use of a product for the specified method and do not prevent a competitor from making and marketing an identical product for an indication outside the scope of the patented method. Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label,” and although off-label prescriptions may infringe method of use patents, the practice is common and such infringement is difficult to prevent or prosecute. If the aforementioned non-provisional patent application(s) claiming IAM1363, IAM217, and IAM-C1 compositions of matter are filed and issue as granted patents, after expiration of such granted patents, competitors may use the same compositions for different methods, in different formulations, or via production from different manufacturing methods, without infringing one or more granted patents. Therefore, if IAM1363, IAM217, and IAM-C1 are approved and eventually become commercially available in generic products, remaining unexpired patents may only provide limited protection.

Future patents we may obtain may be challenged or the laws may change in a manner that could limit our ability to enforce against competitors.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and patents we may obtain may be challenged in the courts or patent offices in the United States and abroad. We may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review (PGR) and inter partes review (IPR), or other similar proceedings challenging our patent rights. There may be prior art of which we are not aware that may affect the validity or enforceability of our patent claims. Even prior art we believe does not affect validity may ultimately be found to do so. There is no assurance that all potentially relevant prior art has been identified. An adverse decision may result in loss of exclusivity or in patent claims being narrowed, invalidated, or held unenforceable, which could limit our ability to stop others from using or commercializing similar technologies and products and compete directly with us, without payment to us. The legal threshold for initiating such proceedings may be low, so that even proceedings with a low probability of success might be initiated. Even if they are unchallenged, our patent applications, if issued, may not provide us with any meaningful protection or prevent competitors from designing around our patent claims to circumvent our patent portfolio by developing similar or alternative drug candidates in a non-infringing manner.

The patent position of pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and is the subject of much litigation, resulting in court decisions, including U.S. Supreme Court decisions. Therefore, court decisions may be made that could alter our ability to enforce patent rights in the future. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States, or vice versa. There may also be pressure on the U.S. government and foreign governmental bodies to limit the scope of patent protection as a matter of public policy in response to health or access concerns.

Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.

We may conclude that even if a third party is infringing patents we may obtain in the future, the risk-adjusted cost of bringing and enforcing such a claim may be too high or not in the best interest of our company or stockholders. Our competitors may sustain the costs of complex patent litigation more effectively because of their greater financial resources. In such cases, we may decide to simply monitor the situation or seek a non-litigious resolution.

Litigation involves substantial uncertainty that could affect our business.

Our ability to enforce our intellectual property rights depends on the ability to detect infringement. It is difficult to detect infringers who do not advertise the components that are used in their products. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s product, particularly in litigation in countries that do not provide extensive discovery procedures.

Because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure. The initiation of a claim against a third party may cause the third party to bring counterclaims asserting that our patents are invalid or unenforceable. Grounds for such challenges could include lack of novelty, obviousness, non-enablement, insufficient written description, failure to claim patent-eligible subject matter, or inequitable conduct during prosecution.

If we were to initiate legal proceedings against a third party to enforce a patent covering one of our products or our technology, the defendant could counterclaim that our patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, for example, lack of novelty, lack of adequate written description, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that an individual connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity or unenforceability during patent litigation is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on one or more of our products or certain aspects of our platform technology. Such a loss of patent protection could have a material and adverse effect on our business, financial condition, results of operations and prospects. An adverse outcome in a litigation or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Derivation proceedings provoked by third parties or brought by us may be necessary to determine the inventorship of inventions with respect to our patents or patent applications. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain access to the same technology.

Even if we establish infringement, a court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may not be an adequate remedy. Furthermore, even if resolved in our favor, the monetary cost of litigation and the diversion of management attention could outweigh any benefit we receive. Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

During the course of intellectual property litigation, there could be public announcements of commencement, results of hearings, rulings on motions, and other developments. If securities analysts or investors perceive these results as negative, the perceived value of our products, drug candidates, or intellectual property could be diminished, and the market price of our common stock may decline. Such announcements could also harm our reputation or the market for our products.

The uncertainties associated with litigation could compromise our ability to raise funds necessary to continue clinical trials, internal research programs or enter into development partnerships.

Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future drug candidates.

Depending on actions by the U.S. Congress, federal courts, the USPTO, and authorities in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that may have a material adverse effect on our ability to obtain new patents and to defend and enforce existing patents. We cannot be sure our patent portfolio will not be negatively impacted by new court rulings, changes in guidance, or procedures issued by governments or patent offices around the world.

The Leahy-Smith America Invents Act of 2011 (the Leahy-Smith Act) made significant changes to U.S. patent law. These changes include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including PGR, IPR and derivation proceedings. Further, because of a lower evidentiary standard in these USPTO post-grant proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a patent claim invalid even though the same evidence would be insufficient to invalidate the patent claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate patent claims we may obtain that would not have been invalidated if first challenged by the third party as a defendant in a district court action. Thus, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our patents we may obtain, all of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

In addition, under the Leahy-Smith Act, the United States transitioned from a “first-to-invent” system to a “first-to-file” system in which, assuming that the other statutory requirements are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before we file an application covering the same invention, could therefore be awarded a patent covering an invention to which we have rights even if we made the invention before it was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we are the first to either (i) file any patent application related to our drug candidates and other proprietary technologies we may develop or (ii) invent any of the inventions claimed in our patent applications. Even if we obtain a valid and enforceable patent, we may not be able to exclude others from practicing the claimed invention where the other party can show that they used the invention in commerce before our filing date or the other party benefits from a compulsory license.

These and future changes in patent law could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any patents, if issued, all of which could have a negative effect on our business.

In addition, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. For example, in Amgen Inc. v. Sanofi, 598 US 594 (2023), the Supreme Court held that claims with functional language may pose high hurdles in fulfilling the enablement requirement. In 2023, the Federal Circuit issued a decision in In re Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023) involving the interaction of patent term adjustment, or PTA, terminal disclaimers, and obviousness-type double patenting which may affect the patent term of any issued patents that rely on any PTA and have a terminal disclaimer. Depending on actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain patents, to obtain patents having commercially relevant scope or patent term, or to enforce patents that we may obtain.

Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain patents or to enforce patents that we may obtain in the future. For example, the complexity and uncertainty of European patent laws have also increased in recent years. In Europe, a new unitary patent system took effect June 1, 2023, which has significantly impacted European patents, including those granted before June 1, 2023. Under the unitary patent system, European applications have the option, upon grant of a patent, of becoming a Unitary Patent which is subject to the jurisdiction of the Unified Patent Court (UPC). Additionally, certain non-Unitary Patents that are European patents may also be subject to the jurisdiction of the UPC. As the UPC is a new court system, there is only a limited established body of substantive and procedural precedents, which increases the uncertainty of any litigation. Proprietors of certain European patents

granted before the implementation of the UPC have the option of opting such patents out of the jurisdiction of the UPC and designating such patents as being subject to the jurisdiction of national courts. Patents that remain under the jurisdiction of the UPC will be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in all countries who are signatories to the UPC. We cannot predict with certainty the long-term effects of any potential changes.

We may become involved in third-party claims of intellectual property infringement, which may delay or prevent the development and commercialization of IAM1363, IAM217, IAM-C1, and any future drug candidates.

Our commercial success depends in part on our ability to develop, manufacture, market and sell IAM1363, IAM217, and IAM-C1, and any future drug candidates while avoiding infringement of third-party patents and proprietary rights. There is a substantial amount of litigation and other adverse proceedings, both within and outside the United States, involving patent and other intellectual property rights in the pharmaceutical industries, including patent infringement lawsuits, international trade commission (ITC)-related lawsuits that affect import of products that infringe third party patents (e.g., Section 337 of the U.S. Tariff Act of 1930), interferences, administrative law proceedings, ex parte re-examinations, PGR, IPR, before the USPTO, as well as oppositions and similar processes in foreign jurisdictions.

We may be exposed to future litigation by third parties alleging that our drug candidates infringe their intellectual property rights. If any third-party patents were held to cover the manufacturing process, methods of treatment, or any of our products themselves, the holders may be able to block our ability to commercialize such products unless we obtain a license or until such patents expire.

It is also possible that we have failed to identify relevant third-party patents or applications. Patent applications covering our products could have been filed by others without our knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our products or the use of our products. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our current or future therapeutic candidates may infringe. Third-party intellectual property right holders may also actively bring infringement claims against us. There may be issued patents of which we are not aware, held by third parties that, if found to be valid and enforceable, could be alleged to be infringed by our drug candidates or any future drug candidates. There also may be pending patent applications of which we are not aware that may result in issued patents, which could be alleged to be infringed by our drug candidates or any future drug candidates. There may be issued patents, held by third parties, which we do not believe we infringe, that, if found to be valid and enforceable, could be found to be infringed by our drug candidates or any future drug candidates.

Individuals and groups that are non-practicing entities may purchase patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. We may receive threatening letters, notices or “invitations to license,” or may be the subject of claims that our drug candidates and business operations infringe the intellectual property rights of such entities. Non-practicing entities have no relevant product revenue and our own patent portfolio may have no deterrent effect against them.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our drug candidates. Defense of these claims, regardless of merit, would involve substantial litigation expense and a substantial diversion of employee resources from our business.

In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain licenses from third parties, pay royalties, or redesign our affected drug candidates, which may be impossible or require substantial time and monetary expenditure. If a court decides that we willfully infringed a third party’s intellectual property rights, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees. Such damages could be substantial and have a material adverse effect on our financial condition. Furthermore, even if resolved in our favor, the monetary cost of such litigation and the diversion of the attention of our management could outweigh any benefit we receive as a result of the proceedings. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our business.

Our defense against an allegation of infringement, including willful infringement, may rely on opinion of patent counsel that the allegedly infringed patents are invalid or unenforceable. This opinion may be supported in part by the case law current as of the date of the opinion. Such case law may become overturned in a subsequent court proceeding or by legislation. For example, in the United States, we may rely on invalidity of a genus claim in a patent based on lack of enablement or written description, in view of Amgen Inc. v. Sanofi, 598 US 594 (2023); Regents of the Univ. of Minn. v. Gilead Scis., Inc., 61 F.4th 1350, 1356 (Fed. Cir. 2023); and Duke Univ. v. Sandoz, Inc., 2025 160 F.4th 1305, 1312 (Fed. Cir. 2025). The reliance on these cases for invalidity of genus claims defining a composition or method of treatment with the composition by the composition’s functional attributes is customary in the pharmaceutical industry. However, should one of these cases, or other decisions that may be relied upon, be overturned or overruled by legislation, the basis for our invalidity position, and thus defense to infringement, including willful infringement, may be obsolete, which could harm our ability to defend against a claim of patent infringement. The aforementioned cases relied upon for invalidity of an issued patent are specific to U.S. patent law, and are not applicable to other jurisdictions, and thus we may not be able to rely on the same invalidity positions outside of the U.S. For example, jurisdictions such as Europe may allow claims to compositions or methods of treatment with a composition defined by its function, such as inhibition or antagonism of a target, rather than its structure. If such patents are deemed valid, we may infringe such patents in jurisdictions outside the U.S., which could result in an injunction or monetary damages.

Our defense against an allegation of infringement may also rely on the “Safe Harbor” provision (35 U.S.C. § 271(e)(1)), established by the Hatch-Waxman Act, for allegedly infringing activities performed solely for uses reasonably related to FDA regulatory approval. Our evaluation of whether our activities are solely for uses reasonably related to FDA regulatory approval is based on statutory interpretation and current case law, and we cannot guarantee that our evaluation is correct. Our defense against an allegation of infringement may also rely on corresponding safe harbor provisions in jurisdictions outside the United States where we may perform clinical trials, including the Bolar exemptions in European countries. We cannot make assurances that all of our activities in a country, including those related to clinical trials, fall within that country’s safe harbor provisions. For instance, the provisions in certain European countries may not be provided for by statute, and thus the scope of defense against potentially infringing activities during clinical trials is specific to the patent and jurisdiction, and is thus uncertain. For instance, whether a patent has been validated in a European country versus via the Unitary Patent could affect the scope of any exemption. Our analysis of the safe harbor provisions may be drawn from legal texts and input from European patent counsel, which may require validation with litigators in each country to obtain a current status of exemptions. In addition, case law or legislation may overrule or amend the safe harbor provisions in the U.S. or other jurisdictions, in a manner that could prevent us from performing clinical trials in a given jurisdiction, or result in a finding of infringement due to clinical trial activities performed in that jurisdiction, either of which could have a material adverse effect on our business.

Litigation may result in publicity and disclosures that could be harmful to our business.

During the course of any intellectual property litigation, there could be public announcements of the litigation such as commencement of a litigation, results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, drug candidates, programs, or intellectual property could be diminished. Accordingly, the market price of shares of our common stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business. Because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation.

Numerous U.S. and foreign patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing drug candidates.

As the oncology market expands and more patents are issued, and as we gain greater visibility and market exposure as a public company, the risk increases that our IAM1363, IAM217, IAM-C1, or our other drug candidates or other business activities may be subject to claims of infringement of the patent and other proprietary rights of third parties in the U.S., Europe or other foreign countries. Third parties may assert that we are infringing their patents or employing their proprietary technology without authorization, regardless of the merit of such claims.

Even if we believe such claims are without merit, for example, due to invalidity of a third-party patent, a court of competent jurisdiction could hold that the third-party patent is valid, enforceable and infringed, which could have a negative impact on our ability to commercialize our current and any future drug candidates. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this is a high burden and requires us to present clear and convincing evidence as to invalidity, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. Other jurisdictions have similar presumptions, and thus we similarly can make no assurances that the claims of patents outside the U.S. in which we may be alleged to infringe will be held invalid.

We cannot guarantee that our patent searches or analyses are complete or thorough. Our interpretation of the relevance, scope, or validity of a third-party patent may be incorrect. We may incorrectly determine that our drug products are not covered by a third-party patent or may incorrectly predict whether a pending application will issue with claims of relevant scope. Our determination of the expiration date of any relevant patent may also be incorrect.

Further, we may not be aware of all third-party intellectual property rights potentially relating to our research programs and drug candidates, or their intended uses, and as a result the potential impact of such third-party intellectual property rights upon our freedom to operate is highly uncertain. Moreover, because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our drug candidates may infringe. Patent applications are not published until 18 months after their earliest claimed priority date and, in some instances, applications may not publish until after issuance as a patent. Thus, there may be pending patent applications relevant to drug candidates that we are unaware of due to this lag in publication. In addition, identification of third-party patent rights that may be relevant to our technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases, and the difficulty in assessing the meaning of patent claims. There may be patents or patent applications of which we are aware, but which we do not believe is relevant to our business, which may, nonetheless, ultimately be found to limit our ability to make, use, sell, offer for sale, or import our drug products that may be approved in the future, or impair our competitive position. There may be patents or patent applications of which we are aware, but which we do not believe are valid or patentable, which may, nonetheless, ultimately be found to be valid or patentable and thus limit our ability to make, use, sell, offer for sale, or import our drug products that may be approved in the future, or impair our competitive position. In addition, third parties may obtain patents in the future on uses of our technology that we may infringe. If we are found to infringe patent rights, the patent holders may be able to block our ability to commercialize such drug candidate unless we obtain a license or until such patents expire.

We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of their former or current employers.

We may employ individuals who were previously employed or are currently employed at other biotechnology companies or research institutions, including our competitors. Although we take steps to ensure compliance with ongoing obligations to former and current employers, we may be subject to claims that these individuals violated their contractual obligations, improperly retained proprietary information, or used or disclosed trade secrets. If we fail in defending any such claims, we may lose valuable intellectual property rights or personnel.

We may be subject to claims that current or former employees, contractors, or other third parties have an ownership interest in our patents or patent applications as an inventor or co-inventor. The failure to name proper inventors can result in patents being unenforceable. Inventorship disputes may arise from conflicting views regarding contributions, effects of foreign laws, or co-ownership of joint inventions.

Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing our drug candidates or as a result of questions regarding co-ownership of potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship or ownership. Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property. If we fail to defend any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive

ownership of, or right to use, valuable intellectual property. Such an outcome could adversely affect our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could adversely affect our business, financial condition, results of operations, and prospects.

The laws may limit the enforceability of non-compete provisions in employment agreements. If non-compete provisions are found unenforceable, former employees may be free to join competitors or form competing businesses, potentially using know-how gained during their employment.

We may depend on intellectual property rights granted under license agreement(s) with licensor(s). If we were to lose our current or future license(s), we may not be able to continue developing our drug candidates.

We license certain intellectual property that is important to our business and, in the future, we may enter into additional agreements that provide us with licenses to valuable intellectual property or technology. Our current license agreements impose, and we expect our future license agreements will impose, various development, diligence, commercialization, and other obligations on us in order to maintain the licenses.

If we were to fail to comply with our obligations, and fail to cure our breach within a specified period, the licensor may have the right to terminate the license. Termination could result in us being unable to develop, manufacture, or sell drug candidates covered by the licensed technology, or could enable competitors to gain access to the licensed technology. If in-licenses are terminated or the underlying patents fail to provide intended exclusivity, competitors may have the freedom to market products identical to ours.

The current agreement or future agreements under which we license IP from third parties may be complex, and certain provisions may be susceptible to multiple interpretations. The resolution of any interpretation disagreement could narrow the scope of our rights or increase our financial obligations. Disputes may arise regarding: scope of rights granted; financial obligations; whether our technology infringes on licensor IP not covered by the license; sublicensing rights; diligence obligations; right to transfer or assign the license; inventorship and ownership of jointly created inventions; and priority of invention.

We may enter into agreements under which we are a sublicensee. If our sublicensor fails to comply with its upstream license obligations, the licensor may terminate the upstream license, which may terminate our sublicense.

It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our platform or drug candidates, in which case we would be required to obtain a license from such third parties. The in-licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies may also be pursuing strategies to in-license or acquire third-party intellectual property rights that we may consider attractive or necessary to our business. These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities. Furthermore, companies that perceive us to be a competitor may be unwilling to sell, assign or license intellectual property rights to us. Moreover, we may be unable to negotiate a license within the specified time frame or under terms that are acceptable to us. In addition, we expect that competition for the in-licensing or acquisition of third-party intellectual property rights for drug candidates that are attractive to us may increase in the future, which may mean fewer suitable opportunities for us as well as higher acquisition or licensing costs. If we are unable to license such technology, or if we are forced to in-license such technology on unfavorable terms, such as substantial licensing fees or royalty payments, our business could be materially and adversely affected. If we are unable to obtain a necessary license, the third parties owning such intellectual property rights could seek an injunction prohibiting our manufacturing, use, and/or sales or we may be unable to

otherwise develop or commercialize the affected drug candidates, which could materially harm our business. If we are unable to obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may be required to expend significant time and resources to redesign any future drug candidates, or the methods for manufacturing them or to develop or license replacement intellectual property, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize the affected drug candidates, which could harm our business, financial condition, results of operations, and prospects significantly. Even if we are able to obtain a license from a third party, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. A non-exclusive license would not provide us with a competitive advantage with respect to the licensed technology.

We may rely on our research and development partners for know-how on design, manufacturing methods and formulation of our products. Our research and development partners may fail to properly protect their intellectual property, fail to comply with regulatory provisions, or fail to yield anticipated economic benefits. If we are unable to reach agreements with suitable partners on acceptable terms, we may have to curtail product development, reduce or delay development programs, or increase our expenditures to undertake development at our own expense.

Our research and development partners’ ability to protect their proprietary rights directly affects our ability to commercialize products developed through such partnerships. Any failure by our partners to maintain adequate IP protection could expose our jointly developed products to competition. Although we may enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, corporate partners, outside scientific partners, CROs, CMOs, consultants, independent contractors, advisors, and other third parties, any of these parties may breach these agreements and disclose such results before a patent application is filed, thereby jeopardizing our ability to seek adequate patent protection.

Rights to improvements to our drug candidates may be held by third parties.

In the course of testing and developing our current or future drug candidates, we may enter into agreements with third parties to conduct clinical testing, which may provide that improvements to our drug candidates may be owned solely by a third party or jointly between the parties. Third parties may independently develop improvements to our product, such as crystalline polymorphs or salts with beneficial properties, or alternative manufacturing techniques. If we determine that rights to such improvements are necessary to commercialize our drug candidates or maintain our competitive advantage, we may need to obtain a license from such third party. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain such a license, it could be granted on non-exclusive terms, potentially giving our competitors access to the same technologies. Failure to obtain a license could prevent us from commercializing our current or future drug candidates or force us to cease some of our business operations.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to patent protection, we seek to rely on trade secret protection for proprietary know-how that is not patentable, processes for which patents are difficult to enforce, and other elements of our product discovery and development processes. Although we require employees, consultants, advisors, and third parties to enter into confidentiality agreements, we cannot be certain that our trade secrets will not be disclosed or that competitors will not independently develop substantially equivalent information and techniques. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results, and financial condition.

Because we may rely on third parties in development and manufacture, we may be required to share trade secrets with them, increasing the possibility of misappropriation or disclosure. Any disclosure—intentional or unintentional, including through cybersecurity breach—could enable competitors to duplicate or surpass our technological achievements. Monitoring unauthorized disclosure is difficult, and enforcing trade secret claims is expensive, time-consuming, and unpredictable in outcome.

Moreover, third parties may still obtain this information or may come upon this or similar information independently, and we would have no right to prevent them from using that technology or information to compete with us. For example, competitors could purchase our products and attempt to replicate or improve some or all of the competitive advantages we derive from our development efforts, reverse engineer our proprietary technologies, and design their products around our protected technologies or develop their own competitive technologies that fall outside of our intellectual property rights.

If any of these events occurs or if we otherwise lose protection for our trade secrets, the value of this information may be greatly reduced, and our competitive position could be harmed. If we do not apply for patent protection prior to such publication or if we cannot otherwise maintain the confidentiality of our proprietary technology and other confidential information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized.

If our trademarks and trade names are not adequately protected, we may not be able to build brand recognition in our markets of interest and our business may be adversely affected.

Our trademarks or trade names may be challenged, infringed, circumvented, or declared generic. During registration proceedings, we may receive rejections by the USPTO or in foreign jurisdictions. Third parties may oppose pending applications or seek to cancel registered trademarks. Any proprietary name we propose to use with our drug candidates must be approved by the FDA, regardless of whether we have registered it as a trademark. If the FDA objects, we may need to expend significant resources to identify a suitable alternative. We may license our trademarks to third parties, and misuse by licensees may jeopardize our rights or diminish goodwill.

At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. If we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

Compounding pharmacies may produce formulations that are similar to or identical to our drug candidates using the same active ingredient. These formulations may create brand confusion among healthcare providers and patients, and may not be subject to the same regulatory standards as our approved drug products. Such competition may be difficult to prevent through trademark protection alone.

The use of new and evolving technologies, such as AI, in our operations may require us to expend material resources and may present risks and challenges that can impact our business, including by posing security and other risks to our confidential information, proprietary information and personal information, any of which may result in reputational harm and liability, or otherwise adversely affect our business.

We integrate AI, including generative artificial intelligence (Gen AI), machine learning, and automated decision-making technologies into our operations. The use of AI technology, including Gen AI, can give rise to intellectual property risks, including uncertainty regarding ownership of AI-generated inventions, compromises to proprietary IP, inaccuracy, bias, data privacy and cybersecurity issues, data provenance disputes, and infringement or misappropriation claims. The legal landscape for AI-generated inventions remains uncertain, and development of the law in the U.S. and abroad could impact our ability to enforce proprietary rights or protect against infringing uses. Depending on actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to

enforce patents. For example, on February 13, 2024, the USPTO issued AI Inventorship guidance entitled “Inventorship Guidance for AI-assisted Inventions” which indicated that the three-part test articulated in Pannu v. Iolab Corp. 155 F.3d 1344 (Fed. Cir. 1998) was relevant to the inventorship analysis of AI-assisted inventions. However, the USPTO rescinded the February 13, 2024, guidance and issued a new guidance document entitled “Revised Inventorship Guidance for AI-Assisted Inventions” on November 28, 2025, wherein it is stated that the Pannu factors only apply when determining whether multiple natural persons qualify as joint inventors. The determination of inventorship with respect to AI-assisted inventions is thus highly uncertain and subject to change based on USPTO guidance and law.

AI, including Gen AI, may have errors or inadequacies that are not easily detectable. If the data used to train AI or the content AI applications assist in producing are deficient, inaccurate, or biased, our business may be adversely affected. We expect increasing government regulation of AI use (including the EU’s AI Act which entered into force on August 1, 2024), which may significantly increase compliance costs. This legislation imposes significant obligations on providers and deployers of AI systems. The legal landscape for AI-related intellectual property remains uncertain, and development of the law could impact our ability to enforce proprietary rights.

The rapid evolution of AI (including Gen AI) may, to the extent we decide to integrate such technologies with our products and services, require the application of significant resources to design, develop, test and maintain such products and services to help ensure that any such AI is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts. We also may need to expend further resources to adjust our business practices, as these laws and regulations evolve, especially where requirements across jurisdictions are inconsistent. Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could materially and adversely affect our business, financial condition, results of operations, and prospects.

Our vendors may in turn incorporate AI tools (including Gen AI) into their own offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security. Further, bad actors around the world use increasingly sophisticated methods, including the use of Gen AI, to engage in illegal activities involving the theft and misuse of personal information, financial and other confidential information and intellectual property. Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, and adversely impact our business.

Any future proprietary technology platform may not yield protectable intellectual property. The components of such a platform, including proprietary hardware, software, and computational methods, may be difficult to protect through traditional patent means. Data rights and computational IP present unique challenges including potential for independent development by competitors using similar datasets or methodologies.

Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, reporting requirements and a preference for U.S.-based manufacturing.

We may conceive or reduce to practice an invention made using government funding. Pursuant to the Bayh-Dole Act, the U.S. government retains certain rights in inventions developed with government funding, including a non-exclusive, non-transferable, irrevocable worldwide license for governmental purposes. The government may also require a patentee to grant licenses to third parties if: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use (march-in rights).

The government requires that products embodying these inventions be manufactured substantially in the United States. This preference may limit our ability to contract with non-U.S. manufacturers for products covered by such IP.

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

Should any of these or similar events occur, they could significantly harm our business, financial condition, results of operations, and prospects.

Our internal computer systems, or those of any of our CROs, manufacturers, other contractors, or consultants or potential future partners, may fail or suffer actual or suspected security or privacy breaches or incidents or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations, and potentially significant delays in our delivery to market.

Despite the implementation of security measures in an effort to protect systems that store our information, given their size and complexity and the increasing amounts of information maintained on our internal information technology systems and external processing and storage systems (e.g., cloud), and those of our third-party CROs, other contractors (including sites performing our current or future clinical trials) and consultants and other third-party service providers, these systems are from time to time vulnerable to breakdown or other damage, disruption or interruption from service interruptions, system malfunction, power outages, natural disasters, global pandemics, terrorism, vandalism, war (such as the ongoing conflicts in the Middle East and between Ukraine and Russia) and telecommunication and electrical failures, as well as security breaches and incidents arising from or caused by inadvertent or intentional actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by malicious third parties (including the deployment of harmful malware, ransomware, denial-of-service attacks, viruses, phishing attacks, and other forms of social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information), which may compromise our system infrastructure or lead to unauthorized access to or disruption of our or third-party systems used in our business and unauthorized access to, misuse, disclosure, loss, destruction, alteration, dissemination or other processing of, or damage to, our data, including trade secrets or other confidential information, intellectual property, proprietary business information, and personal information. Several companies have also experienced an increase in phishing and social engineering attacks from third parties in recent years. Our employees primarily work from the corporate offices but also have the ability to work in a hybrid model in our offices and from home, and we may need to adjust our working model from time to time. As a result, we have increased security risks, due to increased use of home wi-fi networks and virtual private networks, as well as increased disbursement of physical machines. While we implement controls designed to reduce the risk of a resulting security breach or other security incident, we may experience security breaches and incidents, and there is no guarantee that the measures we have implemented will be adequate to safeguard all systems and data, especially with an increased number of employees working from home or in a hybrid model where it is more difficult for us to monitor our employees.

Any cyber-attack, disruption or other security breach or incident, including any such event resulting in any unauthorized, unlawful, or accidental access to, or acquisition, use, corruption, loss, destruction, unavailability, alteration or dissemination of, or damage to, our data (including confidential or personal information) or other data we or any of our CROs, other contractors, or consultants or potential future partners or other third-party service providers maintain or otherwise process, or our applications, or for it to be believed or reported that any of these occurred, could result in us incurring liability and reputational damage and delays in the development and commercialization of our drug candidates. For example, if a security incident were to result in interruptions in our operations, it could result in a material disruption of our programs and the development of our drug candidates could be delayed. In addition, the loss or unavailability of clinical trial data for our drug candidates could result in

delays in our marketing approval efforts and significantly increase our costs to recover or reproduce the data. Furthermore, disruptions of our internal information technology systems or those of third parties used in our business, or security breaches or incidents impacting us or any of our CROs, other contractors, or consultants or potential future partners or other third-party service providers, could result in the loss, misappropriation, and/or unauthorized access, use, or disclosure of, or the inability to access, data (including trade secrets or other confidential information, intellectual property, proprietary business information, and personal information), which could result in financial, legal, business, and reputational harm to us. Unauthorized access to, or use, disclosure or other processing of personal information, including personal information regarding our clinical trial subjects or employees, could harm our reputation directly, compel us to notify individuals or regulators under data breach notification laws, cause us to incur costs related to investigation of the incident (including legal expenses, forensic examination costs, and remediation costs), subject us to mandatory corrective action, and otherwise subject us to liability under laws and regulations that protect the privacy and security of personal information, which could result in significant legal and financial exposure and reputational damages that could potentially have an adverse effect on our business.

We expect to incur significant costs in our efforts to detect, prevent, and respond to security incidents. We also rely on third parties to manufacture our drug candidates, and similar events relating to their systems could also have a material adverse effect on our business. There have been and may continue to be significant supply chain attacks and operational technology attacks globally, and we cannot guarantee that our systems or those of third-party service providers or other third parties that support us or our operations have not been subject to security breaches or incidents or that they do not contain exploitable defects or bugs that could result in a security breach of, security incident impacting or other disruption to, our systems and the systems of third parties that support us and our operations. Any cyber-attack, disruption or other security breach or incident, including any such event resulting in any loss, unavailability, destruction or alteration of, or damage to, our data, or inappropriate acquisition, disclosure or other processing of confidential or proprietary information, could expose us to litigation and governmental investigations and other actions and proceedings, delay further development and commercialization of our drug candidates, and result in our being subject to significant fines, penalties or other liabilities. Litigation and governmental investigations or other actions or proceedings could require us to spend money in defense or settlement, divert management’s time and attention, increase our costs of doing business, and/or adversely affect our reputation. We could be required to fundamentally change our business activities and practices in response to such litigation or investigations or other actions or proceedings, which could have an adverse effect on our business. Any actual or perceived inability by ourselves or any of our CROs, other contractors, or consultants or potential future partners or other third-party service providers to adequately protect data could have a material adverse effect upon our reputation, business, operations, or financial condition.

Our insurance policies may not be adequate to compensate us for the potential losses arising from any such disruption in or, failure or security breach of, or incident impacting, our systems or third-party systems where information important to our business operations or commercial development is maintained or processed. In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, our insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.

Risks related to employee matters and managing growth

Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.

To succeed, we must recruit, retain, manage and motivate qualified executives as we build out the management team, and we face significant competition for experienced personnel. We are highly dependent on the principal members of our management and need to add executives with operational and commercialization experience as we plan for commercialization of our drug candidates and build out a leadership team that can manage our operations as a public company. If we do not succeed in attracting and retaining qualified personnel, particularly at the management level, it could adversely affect our ability to execute our business plan and harm our operating results. In particular, the loss of one or more of our executive officers could be detrimental to us. We are highly

dependent on our co-founder and Chief Executive Officer, Thomas (Tom) Miller, Ph.D., and our co-founder and Chief Technology Officer, Fred Manby, Ph.D., and if we cannot recruit suitable replacements in a timely manner, our ability to implement our business strategy could be seriously harmed. Although we have formal employment agreements with our executive officers, these agreements do not prevent them from terminating their employment with us at any time and, for certain of our executive officers, entitle them to receive severance payments in connection with their voluntary resignation of employment for good reason, as defined in the employment agreements. Additional details regarding these arrangements can be found in the section titled “Executive compensation—Named executive officer agreements.” If we lose one or more of our executive officers, our ability to implement our business strategy successfully could be seriously harmed. Furthermore, replacing executive officers may be difficult and may take an extended period of time. The competition for qualified personnel in the biotechnology field is intense and as a result, we may be unable to continue to attract and retain qualified personnel necessary for the future success of our business. We could in the future have difficulty attracting experienced personnel to our company and may be required to expend significant financial resources in our employee recruitment and retention efforts.

Our business requires an interdisciplinary workforce that bridges advanced machine learning, computational physics, and data science with medicinal chemistry, biology, and clinical drug development. Individuals who combine expertise across these domains are exceptionally scarce, and the loss of key personnel with this cross-functional capability could be particularly difficult to replace. Competition for such talent is intense, including from large technology companies, other AI-focused drug discovery companies, and traditional pharmaceutical companies that are increasingly building internal computational capabilities. If we are unable to attract and retain personnel with the specialized, interdisciplinary expertise our model requires, our ability to advance our molecular superintelligence platform, execute on our collaborations, and progress our internal pipeline could be materially impaired.

Many of the other biotechnology companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better prospects for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what we have to offer. If we are unable to continue to attract and retain high-quality personnel, the rate and success at which we can discover, develop and commercialize our drug candidates will be limited and the potential for successfully growing our business will be harmed.

We expect to significantly expand our organization, including creating additional infrastructure to support our operations as a public company, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

As of September 18, 2026, we had 171 full-time employees. We will need to expand our organization, and we may have difficulty identifying, hiring and integrating new personnel. Future growth would impose significant additional responsibilities on our management, including the need to identify, recruit, maintain, motivate, and integrate additional employees, consultants and contractors. Also, our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees, and reduced productivity among remaining employees. Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of drug candidates. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenue could be reduced, and we may not be able to implement our business strategy. Our future financial performance and our ability to commercialize our drug candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth. In addition, a portion of our workforce is located outside the United States, and our employees in the United Kingdom, Ireland, and other jurisdictions are subject to local labor and employment laws that differ from labor laws in the United States and that may make it more costly or time-consuming for us to adjust the size or composition of our non-U.S. workforce than would be the case in the United States. We may also incur costs to comply with differing labor and employment regimes and may be subject to claims by current or former non-U.S. employees.

Our employees, independent contractors, consultants, and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading laws, which could cause significant liability for us and harm our reputation.

We are exposed to the risk of fraud or other misconduct by our employees, independent contractors, consultants, and vendors. Misconduct by these partners could include intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory authorities, provide accurate information to the FDA or comparable foreign regulatory authorities, comply with manufacturing standards, comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable foreign regulatory authorities, report financial information or data accurately, or disclose unauthorized activities to us. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. This could include violations of U.S. federal and state law, and requirements of non-U.S. jurisdictions, including the European Union Data Protection Directive. We are also exposed to risks in connection with any insider trading violations by employees or others affiliated with us. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws, standards, regulations, guidance, or codes of conduct. Furthermore, our employees may, from time to time, bring lawsuits against us for employment issues, including injury, discrimination, wage and hour disputes, sexual harassment, hostile work environment, or other employment issues. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant fines or other sanctions.

Risks related to this offering and ownership of our common stock

There has been no public market for our common stock. An active, liquid and orderly market for our common stock may not develop, or we may in the future fail to satisfy the continued listing requirements of The Nasdaq Global Select Market, and, as a result, you may not be able to resell your shares of our common stock at or above the initial public offering price or at all.

Prior to this offering, there has been no public market for our common stock. Although we have applied to list our common stock on The Nasdaq Global Select Market (Nasdaq) under the symbol “IAM,” an active trading market for our common stock may never develop or, if developed, may not be sustained following this offering. We and the representatives of the underwriters intend to determine the initial public offering price of our common stock through negotiation. This price does not necessarily reflect the price at which investors in the market will be willing to buy and sell our shares following this offering. In addition, an active trading market may not develop following the completion of this offering or, if it is developed, may not be sustained. The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. An inactive market may also impair our ability to raise capital by selling shares and may impair our ability to acquire other businesses or technologies using our shares as consideration, which, in turn, could materially adversely affect our business.

If, after listing, we fail to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements, the minimum closing bid price requirement or the minimum stockholders’ equity requirement, Nasdaq may take steps to delist our common stock. Such a delisting would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with the listing requirements of Nasdaq.

The trading price of our common stock may be highly volatile, and you could lose all or part of your investment.

The trading price of our common stock following this offering is likely to be volatile and could be subject to fluctuations in response to various factors, some of which are beyond our control. The stock market in general and the market for stock of clinical-stage life sciences companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell their common stock at or above the initial public offering price. Factors that could cause fluctuations in the trading price of our common stock include those discussed in this “Risk factors” section and many others, including the following:

In addition, in the past, stockholders have initiated class action lawsuits against clinical-stage life sciences companies following periods of volatility in the market prices of these companies’ stock. This litigation, if instituted against us, could cause us to incur substantial costs, divert our management’s attention and resources and damage our reputation, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

We have broad discretion in the use of the net proceeds from this offering and may not use them effectively, or in ways that you and other stockholders would approve.

Our management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described in the section titled “Use of proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. Our management might not apply our net proceeds in ways that ultimately increases the value of your investment, and the failure by our management to apply these proceeds effectively could adversely affect our business, financial condition and results of operations. Pending their use, we may invest the net proceeds of this offering in short-term, interest-bearing, investment-grade instruments, certificates of deposit, or direct or guaranteed obligations of the U.S. government. These investments may not yield a favorable return to our stockholders. If we do not invest or apply the net proceeds from this offering in ways that enhance stockholder value, we may fail to achieve expected results, which could cause our stock price to decline.

You will suffer immediate and substantial dilution in the net tangible book value of the common stock you purchase in this offering.

The initial public offering price of our common stock is substantially higher than the pro forma as adjusted net tangible book value per share of our outstanding common stock immediately after the completion of this offering. In addition, in connection with the completion of this offering, our outstanding Convertible Notes will automatically convert into an aggregate of shares of our common stock, based on the assumed initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus. Because the Convertible Notes convert at a discount to the initial public offering price, they will convert into a greater number of shares than if they converted at the initial public offering price, further diluting investors purchasing shares in this offering, and a lower initial public offering price would increase the number of shares issued and the resulting dilution to you. Purchasers of our common stock in this offering will experience immediate dilution of approximately $ per share, based on the initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus. In the past, we granted options to acquire common stock at prices significantly below the initial public offering price and we granted restricted stock units to be issued common stock. To the extent common stock is ultimately issued under these outstanding options and/or restricted stock units, investors purchasing common stock in this offering will sustain further dilution. For a further description of the dilution that you will experience immediately after this offering, see the section titled “Dilution.”

Insiders will continue to have substantial influence over us after this offering, which could limit your ability to affect the outcome of key transactions, including a change in control.

After this offering, our directors, executive officers, holders of more than 5% of our common stock and their respective affiliates will beneficially own, in the aggregate, approximately % of the shares of our outstanding common stock, based on the number of shares outstanding as of June 30, 2026 (assuming the Notes Conversion, no exercise of the underwriters’ option to purchase additional shares of our common stock and no exercise of outstanding options, no vesting of outstanding performance-vesting restricted stock units and without giving effect to any potential purchases by such persons in this offering). As a result, these stockholders, if they act together, will be able to influence our management and affairs and all matters requiring stockholder approval, including the election of directors, amendments of our organizational documents and approval of significant corporate transactions. They may also have interests that differ from yours and may vote in a way with which you disagree, and which may be adverse to your interests. This concentration of ownership may have the effect of delaying, preventing or deterring a change in control of our company and might affect the market price of our common stock.

A significant portion of our total outstanding shares is restricted from immediate resale but may be sold into the market in the near future, which could cause the market price of our common stock to decline significantly, even if our business is doing well.

The market price of our common stock could decline as a result of sales of a large number of shares of our common stock in the market after this offering, or the perception that these sales could occur. Following the completion of this offering, based on the number of shares of our capital stock outstanding as of June 30, 2026, we will have a total of shares of our common stock outstanding (assuming the Notes Conversion and no exercise of the underwriters’ option to purchase additional shares of our common stock). We, our directors, our officers, and substantially all of the holders of our common stock or securities convertible into, exercisable for, or exchangeable for our common stock have entered into market standoff agreements with us and have entered or will enter into lock-up agreements under which we have agreed or will agree, subject to specific exceptions described in the section titled “Underwriting,” not to offer, sell, or transfer such securities for 180 days following the date of this prospectus. We refer to such period as the lock-up period. J.P. Morgan Securities LLC, Jefferies LLC, BofA Securities, Inc. and Citigroup Global Markets Inc. may, in their sole discretion and at any time or from time to time before the termination of the lock-up period release all or any portion of the securities subject to lock-up agreements. As a result of these agreements and subject to the provisions of Rule 144 or Rule 701 under the Securities Act of 1933, as amended (the Securities Act), the shares of our common stock will be available for sale in the public market following the completion of this offering as follows:

Upon completion of this offering, stockholders owning an aggregate of up to shares of our common stock will be entitled, under our investors’ rights agreement, to certain rights with respect to the registration of the offer and resale of those shares under the Securities Act. See the section titled “Description of capital stock—Registration rights.” Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares held by affiliates, as defined in Rule 144 under the Securities Act.

In addition, we intend to file a Form S-8 registration statement to register shares reserved for future issuance under our equity compensation plans. Upon effectiveness of that registration statement, subject to the satisfaction of applicable vesting restrictions and the expiration or waiver of the market standoff agreements and lock-up agreements referred to above, the shares issued upon exercise of outstanding stock options and settlement of restricted stock units will be available for immediate resale in the public market.

Sales of our common stock as restrictions end or pursuant to registration rights may make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate. These sales also could cause the trading price of our common stock to fall and make it more difficult for you to sell shares of our common stock at a time and price that you deem appropriate.

Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.

Until such time, if ever, as we can generate substantial revenue, we expect that we will need additional capital in the future to continue our planned operations, which include conducting clinical trials, pursuing commercialization efforts, expanding research and development activities, and operating as a public company. To raise capital, we may sell common stock, convertible securities, or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities, or other equity securities, investors may be materially diluted by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights, preferences, and privileges senior to the holders of our common stock, including shares of common stock sold in this offering. If we raise additional funds through up-front payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our drug candidates, or grant licenses on terms that are not favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

Pursuant to the 2026 Equity Incentive Plan (the 2026 Plan), which has been adopted and will become effective upon the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus is a part, our board of directors or its duly authorized committee is authorized to grant equity awards to our employees, directors, and consultants.

Initially, a total of shares of our common stock are reserved for issuance pursuant to our 2026 Plan, which number is inclusive of shares that remained available for grant under our Amended and Restated 2020 Equity Incentive Plan (the 2020 Plan) as of the effectiveness of the 2026 Plan. In addition, the shares reserved for issuance under our 2026 Plan will also include shares of our common stock subject to or issued pursuant to awards granted under our 2020 Plan that, after the date of stockholder approval of the 2026 Plan, expire or otherwise terminate without having been exercised in full or are forfeited to or repurchased by us due to failure to vest (provided that the maximum number of shares that may be added to the 2026 Plan pursuant to the foregoing is shares). The number of shares of our common stock reserved for issuance under the 2026 Plan shall be increased on the first day of each fiscal year, beginning with our 2027 fiscal year and ending on the 10 year anniversary of the date our board of directors approves the 2026 Plan equal to the least of shares, 5% of the total number of shares of our common stock outstanding as of the last day of the immediately preceding fiscal year, or a lesser number of shares determined by the administrator of the 2026 Plan. Unless the administrator of the 2026 Plan elects not to increase the number of shares available for future grant each year, our stockholders may experience additional dilution, which could cause our stock price to fall.

Further, we expect to adopt a 2026 Employee Stock Purchase Plan (ESPP), which will become effective upon the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus is a part, and pursuant to which our employees may receive the right to purchase shares of our common stock.

Initially, the aggregate number of shares of our common stock available for sale under our ESPP will be shares. The number of shares of our common stock available for sale under our ESPP shall be increased on the first day of each fiscal year, beginning with our 2027 fiscal year and ending on the 10 year anniversary of the date our board of directors approves the ESPP equal to the least of shares, 1% of the total number of shares of our common stock outstanding as of the last day of the immediately preceding fiscal year, or a lesser number of shares determined by the administrator of the ESPP. Unless the administrator of the ESPP elects not to increase the number of shares available for future grant each year, our stockholders may experience additional dilution, which could cause our stock price to fall.

In addition, as of June 30, 2026, we had options outstanding that, if fully exercised, would result in the issuance of 17,208,599 shares of our common stock, and warrants outstanding that, if fully exercised, would result in the issuance of 74,396 shares of our common stock, as well as 3,338,160 shares of our common stock issuable upon the vesting of RSUs for which the performance-based vesting condition was not satisfied as of June 30, 2026 and for which the liquidity-based vesting condition will be satisfied upon the completion of this offering. We intend to file one or more registration statements on Form S-8 under the Securities Act to register the shares of our common stock subject to outstanding stock options and RSUs as of the date following the effectiveness of the registration statement of which this prospectus forms a part and shares that will be issuable pursuant to future awards granted under our equity incentive plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to applicable vesting requirements, compliance by affiliates with Rule 144, and other restrictions provided under the terms of the applicable plan and/or the award agreements entered into with participants.

Our board of directors will be authorized to issue and designate shares of our preferred stock in additional series without stockholder approval.

Our amended and restated certificate of incorporation will authorize our board of directors, without the approval of our stockholders, to issue shares of our preferred stock, subject to limitations prescribed by applicable law, rules and regulations and the provisions of our amended and restated certificate of incorporation, as shares of preferred stock in series, to establish from time to time the number of shares to be included in each such series and to fix the designation, powers, preferences, and rights of the shares of each such series and the qualifications, limitations or restrictions thereof. The powers, preferences and rights of these additional series of preferred stock may be senior to or on parity with our common stock, which may reduce its value.

We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (JOBS Act). As a result of this status, we have taken advantage of reduced reporting requirements in this prospectus and, for as long as we continue to be an emerging growth company, we may continue to take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (Sarbanes-Oxley Act), reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements, and exemptions from the requirements of holding nonbinding advisory votes on executive compensation and stockholder approval of any golden parachute payments not previously approved. We will remain an emerging growth company until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the closing of this offering, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which requires, among other things, that the market value of our common stock that is held by non-affiliates to exceed $700.0 million as of the prior June 30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act (if we are also a non-accelerated filer at that time) and reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to use this extended transition period under the JOBS Act. As a result, our financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards

that are applicable to public companies, which may make comparison of our financials to those of other public companies more difficult. As a result, changes in rules of GAAP or their interpretation, the adoption of new guidance, or the application of existing guidance to changes in our business could significantly affect our financial position and results of operations.

We do not anticipate paying cash dividends for the foreseeable future, and therefore investors should not buy our stock if they wish to receive cash dividends. Investors in this offering may never obtain a return on their investment.

You should not rely on an investment in our common stock to provide dividend income. We have never declared or paid any cash dividends or distributions on our common stock. We currently intend to retain our future earnings to support operations and to finance expansion and, therefore, we do not anticipate paying any cash dividends on our common stock in the foreseeable future. In addition, any future credit facility may contain terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock. Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize any return on their investment. As a result, investors seeking cash dividends should not purchase our common stock.

Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws might delay, discourage or prevent a change in control of our company or changes in our management, thereby depressing the market price of our common stock.

Our status as a Delaware corporation and the anti-takeover provisions of Section 203 of the Delaware General Corporation Law (the DGCL) may discourage, delay or prevent a change in control by prohibiting us from engaging in a business combination with certain interested stockholders, as defined in Section 203, for a period of three years after the date of the transaction in which the person became an interested stockholder, even if a change in control would be beneficial to our existing stockholders, unless particular requirements are satisfied. In addition, our amended and restated certificate of incorporation and amended and restated bylaws will contain provisions that may make the acquisition of our company more difficult or delay or prevent changes in control of our management. Among other things, these provisions will:

These provisions, alone or together, could delay, discourage, or prevent a transaction involving a change in control of our company. These provisions could also discourage proxy contests and make it more difficult for stockholders to elect directors of their choosing and to cause us to take other corporate actions they desire, any of which, under certain circumstances, could limit the opportunity for our stockholders to receive a premium for their shares of our common stock, and could also affect the price that some investors are willing to pay for our common stock.

Our amended and restated bylaws will designate a state or federal court located within the state of Delaware as the exclusive forum for substantially all disputes between us and our stockholders, and also provide that the federal district courts will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, each of which could limit our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, stockholders or employees.

Our amended and restated bylaws will provide that, unless we consent in writing to the selection of an alternative forum, the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, stockholders, officers or other employees to us or our stockholders, (iii) any action arising pursuant to any provision of the DGCL, our amended and restated certificate of incorporation or our amended and restated bylaws or (iv) any other action asserting a claim that is governed by the internal affairs doctrine shall be the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, another State court in Delaware or the federal district court for the District of Delaware), except for any claim as to which such court determines that there is an indispensable party not subject to the jurisdiction of such court (and the indispensable party does not consent to the personal jurisdiction of such court within 10 days following such determination). This provision would not apply to any action brought to enforce a duty or liability created by the Securities Exchange Act of 1934, as amended (Exchange Act) and the rules and regulations thereunder.

Section 22 of the Securities Act establishes concurrent jurisdiction for federal and state courts over Securities Act claims. Accordingly, both state and federal courts have jurisdiction to hear such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated bylaws will also provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States will be the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act.

Any person or entity purchasing or otherwise acquiring or holding or owning (or continuing to hold or own) any interest in any of our securities shall be deemed to have notice of and consented to the foregoing bylaw provisions. Although we believe these exclusive forum provisions benefit us by providing increased consistency in the application of Delaware law and federal securities laws in the types of lawsuits to which each applies, the exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum of its choosing for disputes with us or our current or former directors, officers, stockholders or other employees, or could result in increased costs for a stockholder to bring a claim, particularly if the stockholder does not reside in or near Delaware, both of which may discourage such lawsuits against us and our current and former directors, officers, stockholders and other employees. Our stockholders will not be deemed to have waived our compliance with the federal securities laws and the rules and regulations thereunder as a result of our exclusive forum provisions.

Further, the enforceability of similar exclusive forum provisions in other companies’ organizational documents have been challenged in legal proceedings, and it is possible that a court of law could rule that these types of provisions are inapplicable or unenforceable if they are challenged in a proceeding or otherwise. If a court were to find either exclusive forum provision contained in our amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur significant additional costs associated with resolving such action in other jurisdictions, all of which could harm our results of operations.

Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

Our amended and restated certificate of incorporation provides that we will indemnify our directors, and our amended and restated bylaws provide that we will indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law. In addition, as permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws and our indemnification agreements that we have entered into with our directors and officers provide that:

We will indemnify our directors and officers for serving us in those capacities or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.

To the extent that a claim for indemnification is brought by any of our directors or officers, it would reduce the amount of funds available for use in our business.

Participation in this offering by our existing stockholders and/or their affiliated entities may reduce the public float for our common stock.

To the extent certain of our existing stockholders and their affiliated entities participate in this offering, such purchases would reduce the non-affiliate public float of our shares of common stock, meaning the number of shares of our common stock that are not held by officers, directors, and controlling stockholders. A reduction in the public float could reduce the number of shares that are available to be traded at any given time, thereby adversely impacting the liquidity of our common stock and depressing the price at which you may be able to sell shares of common stock purchased in this offering.

General risk factors

Our operations are predominantly concentrated in one location, and we or the third parties upon whom we depend may be adversely affected by a wildfire and earthquake or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Our current operations are predominantly located in California. Any unplanned event, such as a flood, wildfire, explosion, earthquake, extreme weather condition, epidemic or pandemic, power outage, telecommunications failure or other natural or manmade accidents or incidents that result in us being unable to fully utilize our facilities may have a material and adverse effect on our ability to operate our business, particularly on a daily basis, and have significant negative consequences on our financial and operating conditions. Any similar impacts of natural or manmade disasters on our third-party CMOs and CROs could cause delays in our clinical trials and may have a material and adverse effect on our ability to operate our business and have significant negative consequences on our financial and operating conditions. If a natural disaster, power outage or other event occurred that prevented us from using our clinical sites, impacted clinical supply or the conduct of our clinical trials, that damaged critical infrastructure, such as the manufacturing facilities of our third-party CMOs, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we and our CMOs and CROs have in place may prove inadequate in the event of a serious disaster or similar event. In the event of an accident or incident at these facilities, we cannot assure you that the amounts of insurance we currently carry will be sufficient to satisfy any damages and losses. If our facilities, or the manufacturing facilities of our CMOs or CROs, are unable to operate because of an accident or incident or for any other reason, even for a short period of time,

any or all of our development programs may be harmed. Any business interruption could adversely affect our business, financial condition, results of operations, and prospects.

We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. We could face criminal liability and other serious consequences for violations, which could harm our business.

We are subject to U.S. and foreign anti-corruption, anti-money laundering, export controls, trade sanctions, and import laws and regulations. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, CROs, contractors and other partners and collaborators from authorizing, promising, offering, providing, soliciting or receiving, directly or indirectly, improper payments or anything else of value to or from recipients in the public or private sector. We may engage third parties for clinical trials outside of the United States, to sell our products abroad if they are approved and we enter a commercialization phase, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We or our agents, CROs, contractors and other partners and collaborators have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, CROs, contractors and other partners and collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. These laws also require that we keep accurate books and records and maintain internal controls and compliance procedures designed to prevent any such actions. While we have policies and procedures to address compliance with such laws, we cannot assure you that none of our employees, agents, CROs, contractors and other partners and collaborators will take actions in violation of our policies and applicable law, for which we may be ultimately held responsible.

Governmental regulation of the import or export of our products, or our failure to obtain any required import or export authorization for our products, when applicable, could harm our international sales and adversely affect our revenue. Compliance with applicable regulatory requirements regarding the export of our products may create delays in the introduction of our products in international markets or, in some cases, prevent the export of our products to some countries altogether. Furthermore, U.S. export control laws and economic sanctions prohibit the shipment of certain products and services to countries, governments, and persons targeted by U.S. sanctions. U.S. sanctions that have been or may be imposed may impact our ability to continue activities at future clinical trial sites within regions covered by such sanctions. Moreover, any new export or import restrictions, new legislation or shifting approaches in the enforcement or scope of existing regulations, or in the countries, persons, or products targeted by such regulations, could result in decreased use of our products by, or in our decreased ability to export our products to, existing or potential customers with international operations. Any decreased use of our products or limitation on our ability to export or sell our products would likely adversely affect our business. If we fail to comply with export and import regulations and such economic sanctions, penalties could be imposed, including fines and/or denial of certain export privileges. These export and import controls and economic sanctions could also adversely affect our supply chain.

Furthermore, U.S. export control laws and economic sanctions prohibit the provision of certain products and services to countries, governments, and persons targeted by U.S. sanctions. U.S. sanctions that have been or may be imposed may impact our ability to continue activities at future clinical trial sites within regions covered by such sanctions. If we fail to comply with export and import regulations and such economic sanctions, penalties could be imposed, including fines and/or denial of certain export privileges. These export and import controls and economic sanctions could also adversely affect our supply chain.

Any allegations or violation of the FCPA or other applicable anti-bribery and anti-corruption laws, anti-money laundering laws, and trade controls could result in whistleblower complaints, sanctions, settlements, prosecution, enforcement actions, fines, damages, adverse media coverage, investigations, severe criminal or civil sanctions, or suspension or debarment from government contracts, all of which may have an adverse effect on our reputation, business, results of operations, and prospects. Responding to any investigation or action will likely result in a materially significant diversion of management’s attention and resources and significant defense costs and other professional fees.

We will incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could adversely affect our business, results of operations and financial condition.

As a public company, we will incur substantial legal, accounting and other expenses that we did not incur as a private company, and these expenses may increase even more after we are no longer an “emerging growth company.” For example, we will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, the rules and regulations of the SEC and the listing standards of Nasdaq. Our management and other personnel will need to devote a substantial amount of time to compliance with these requirements and we expect these rules and regulations to substantially increase our legal and financial compliance costs. For example, we expect these rules and regulations to make it more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to maintain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified individuals to serve on our board of directors, particularly to serve on our audit committee and compensation committee, or as our executive officers. In addition, we have expended, and anticipate that we will continue to expend, significant resources in order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over financial reporting. In addition, as a public company, we may be subject to stockholder activism, which can lead to substantial costs, distract management and impact the manner in which we operate our business in ways we cannot currently anticipate. As a result of disclosure of information in this prospectus and in filings required of a public company, our business and financial condition will become more visible, which may result in threatened or actual litigation, including by competitors and other third parties. If such claims are successful, our business and results of operations could be adversely affected, and even if the claims do not result in litigation or are resolved in our favor, these claims, and the time and resources necessary to resolve them, could divert the resources of our management and adversely affect our business and results of operations. These increased costs and demands upon management could adversely affect our business, results of operations and financial condition.

If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.

Pursuant to Section 404 of Sarbanes-Oxley, our management will be required to report upon the effectiveness of our internal control over financial reporting beginning with the second annual report following the completion of this offering. When we lose our status as an “emerging growth company” and do not otherwise qualify as a non-accelerated filer, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting. Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate financial statements on a timely basis is a costly and time-consuming effort that needs to be evaluated frequently. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP. In connection with this offering, we intend to begin the process of documenting, reviewing, and improving our internal controls and procedures for compliance with Section 404 of the Sarbanes-Oxley Act, which will require annual management assessment of the effectiveness of our internal control over financial reporting.

Implementing any appropriate changes to our internal controls entails substantial costs to modify our existing processes and take significant time to complete. These changes may not, however, be effective in maintaining the adequacy of our internal controls, and any failure to maintain that adequacy, or consequent inability to produce accurate financial statements on a timely basis, could increase our operating costs and harm our business. We may discover significant deficiencies in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

For example, a material weakness in internal control over financial reporting was identified in 2023 and was remediated as of December 31, 2024. There can be no assurance, however, that the remediation will prevent

similar determinations in the future or that we will not identify other material weaknesses in the future. If we are unable to successfully remediate a material weakness in our internal control over financial reporting, or if we identify any other material weaknesses, the accuracy and timing of our financial reporting may be adversely affected. If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to maintain proper and effective internal controls over financial reporting, we may not be able to produce timely and accurate financial statements. If that were to happen, our investors could lose confidence in our reported financial information, the market price of our stock could decline, and we could be subject to sanctions or investigations by the SEC or other regulatory authorities. In addition, investors’ perceptions that our internal controls are inadequate or that we are unable to produce accurate financial statements on a timely basis may harm our stock price and make it more difficult for us to effectively market and sell our service to new and existing customers.

If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operations could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in our audited consolidated financial statements and unaudited condensed consolidated financial statements and accompanying notes. We base our estimates on historical experience and estimates and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, and expenses that are not readily apparent from other sources. If our assumptions underlying our estimates and judgments relating to our critical accounting policies change or if actual circumstances differ from our assumptions, estimates or judgments, our operating results may be adversely affected and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.

If we are unable to maintain effective disclosure controls and procedures, our business, financial position, and results of operations could be adversely affected.

Upon the closing of this offering, we will become subject to the periodic reporting requirements of the Exchange Act. We designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or other internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

These inherent limitations include the facts that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

If securities or industry analysts either do not publish research about us or publish inaccurate or unfavorable research about us, our business or our market, or if they adversely change their recommendations regarding our common stock, the trading price or trading volume of our common stock could decline.

The trading market for our common stock will be influenced in part by the research and reports that securities or industry analysts may publish about us, our business, our market, or our competitors. If one or more securities analysts initiate research with an unfavorable rating or downgrade our common stock, provide a more favorable recommendation about our competitors or publish inaccurate or unfavorable research about our business, our common stock price would likely decline. If few securities analysts commence coverage of us, or if one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets and demand for our securities could decrease, which in turn could cause the price and trading volume of our common stock to decline.

Our insurance policies may be inadequate, may not cover all of our potential liabilities and may potentially expose us to unrecoverable risks.

We do not carry insurance for all categories of risk that our business may encounter. Some of the policies we currently maintain include property, general liability, employee benefits liability, business automobile, workers’ compensation, clinical trials/products liability, cybersecurity liability, directors’ and officers’, and employment practices insurance. We do not know, however, if we will be able to maintain insurance with adequate levels of coverage. No assurance can be given that an insurance carrier will not seek to cancel or deny coverage after a claim has occurred. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our financial position and results of operations. For example, although we maintain product liability insurance coverage that also covers our clinical trials, this insurance may not be adequate to cover all liabilities that we may incur, and we may be required to increase our product liability insurance coverage. We anticipate that we will need to increase our insurance coverage each time we commence a clinical trial and if we successfully commercialize any drug candidate. Insurance availability, coverage terms and pricing continue to vary with market conditions. We endeavor to obtain appropriate insurance coverage for insurable risks that we identify. However, we may fail to correctly anticipate or quantify insurable risks, we may not be able to obtain appropriate insurance coverage and insurers may not respond as we intend to cover insurable events that may occur. Any significant uninsured liability may require us to pay substantial amounts, which would materially adversely affect our business, financial condition, results of operations, and growth.

In addition, although we are dependent on certain key personnel, we do not have key person life insurance policies on any such individuals. Therefore, if any of our key personnel die or become disabled, the loss of such person could materially adversely affect our business, financial condition, results of operations, and growth prospects.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

As of December 31, 2025, we had U.S. federal and state net operating loss (NOL) carryforwards of $157.0 million and $149.9 million, respectively, which may be available to offset future taxable income for U.S. income tax purposes. The U.S. federal NOL carryforwards of $157.0 million may be carried forward indefinitely. State NOL carryforwards totaling $148.4 million begin to expire in 2039 unless previously utilized. In addition, we had federal and state general business credit carryforwards totaling $6.1 million and $3.3 million, respectively. The federal general business credit carryforwards will begin to expire in 2041 unless previously utilized. State general business credit carryforwards totaling $3.0 million may be carried forward indefinitely, while $0.3 million begin to expire in 2036 unless previously utilized.

U.S. federal NOLs generated in taxable periods beginning after December 31, 2017, will not expire and may be carried forward indefinitely, but the deductibility of such NOL carryforwards in a taxable year is limited to 80% of current year taxable income (with certain adjustments). Many state jurisdictions conform to federal law for this purpose or have other provisions that limit the deductibility of state NOL carryforwards in a taxable period. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Code), U.S. federal NOL carryforwards and other tax attributes may become subject to an annual limitation in the event of certain cumulative changes in ownership. An “ownership change” pursuant to Section 382 of the Code generally occurs if one or more stockholders or groups of stockholders who own at least 5% of a company’s stock increase their ownership of equity by more than 50 percentage points (by value) within a rolling three-year period. To the extent we have experienced or will experience an ownership change(s), including potentially as a result of this offering, our ability to utilize our NOL carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited. If we earn taxable income, such limitations could result in increased future income tax liability to us, and our future cash flows could be adversely affected.

We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.

We are or may become subject to income and non-income taxes in the jurisdictions in which we may operate. The rules governing U.S. federal, state, and local and non-U.S. income and non-income taxation are constantly under review by persons involved in the legislative process and by various tax authorities. Changes to tax laws (which changes may have retroactive application) or in their implementation or interpretation could adversely affect us or our stockholders. We continually assess the impact of various tax reform proposals in all jurisdictions where we

have operations to determine the potential effect on our business and any assumptions we will make about our future taxable income. We cannot predict whether any specific proposals will be enacted, the terms of any such proposals or what effect, if any, such proposals would have on our business if they were to be enacted. Any such changes, among others, may adversely affect our effective tax rate, results of operation, and general business condition.

The amount of taxes we pay in different jurisdictions depends on the application of the tax laws of various jurisdictions, and our ability to operate our business in a manner consistent with our corporate structure and intercompany arrangements. The taxing authorities of the jurisdictions in which we operate may challenge our methodologies for pricing intercompany transactions pursuant to our intercompany arrangements or disagree with our determinations as to the income and expenses attributable to specific jurisdictions. If such a challenge or disagreement were to occur, and our position was not sustained, we could be required to pay additional taxes, interest, and penalties, which could result in one-time tax charges, higher effective tax rates, reduced cash flows, and lower overall profitability of our operations.

We could be subject to securities class action litigation, which is expensive and could divert management attention.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because pharmaceutical companies have experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business, operating results, or financial condition.

Special note regarding forward-looking statements

This prospectus contains forward-looking statements within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seek,” “objective,” “forecast,” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements contained in this prospectus include statements about:

We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus.

You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this prospectus primarily on our current expectations and projections about future events and trends that we believe may affect our business, operating results, financial condition, and prospects. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors, including those described in the section titled “Risk factors” and elsewhere in this prospectus. Moreover, we operate in a very 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 prospectus. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this prospectus relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this prospectus to reflect events or circumstances after the date of this prospectus or to reflect new information or the occurrence of unanticipated events, except as required by law. You should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may make.

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 prospectus, and while 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 an exhaustive 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.

Market, industry and other data

This prospectus contains estimates, projections and information concerning our industry, business and the markets in which we operate, including our expectations about our drug candidates, market size, position and opportunity, and the incidence of certain medical conditions, that is based on or derived from publicly available information released by industry analysts and third-party sources, independent market research, industry and general publications and surveys, governmental agencies, our internal research, and our industry experience. In some cases, we do not expressly refer to the sources from which the data is derived. Any industry forecasts are based on data (including third-party data), models, and experience of various professionals and are based on assumptions, all of which are subject to change without further notice. In addition, information that is based on estimates, forecasts, projections, market research, or similar methodologies is inherently subject to a high degree of uncertainty and other risks, including those described in the section titled “Risk factors.” These and other factors could cause actual results to differ materially from those expressed in these sources, publications and reports and actual events and circumstances may differ materially from events and circumstances that are assumed in this information.

Use of proceeds

We estimate that the net proceeds to us from this offering will be approximately $ million (or approximately $ million if the underwriters exercise in full their option to purchase additional shares), based upon the assumed initial public offering price of $ per share, the midpoint of the range set forth on the cover page of this prospectus, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase or decrease in the assumed initial public offering price of $ per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the net proceeds to us from this offering by $ million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each increase or decrease of 1.0 million shares in the number of shares offered by us would increase or decrease, as applicable, the net proceeds to us from this offering by $ million, assuming that the assumed initial public offering price remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We do not expect that a change in the initial public offering price or the number of shares by these amounts would have a material effect on our use of the proceeds from this offering, although it may accelerate the time when we need to seek additional capital.

The principal purposes of this offering are to increase our capitalization and financial flexibility, create a public market for our common stock, facilitate future access to the public equity markets by us, our employees and our stockholders, and increase our visibility in the marketplace. We currently intend to use the net proceeds from this offering, together with our existing cash and cash equivalents, as follows:

Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this prospectus, together with the estimated net proceeds from this offering, will be sufficient to fund our operating expenses and capital expenditures through . However, this estimate is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect.

The expected use of net proceeds from this offering represents our intentions based upon our current plans, business condition and financial condition. The amounts and timing of our actual expenditures may vary significantly and will depend on numerous factors, including the progress, costs, timing and results of our clinical trials and other research and development activities; the status of and results from preclinical studies; any collaborations that we may enter into with third parties; and any unforeseen delays, cash needs or opportunities. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of these proceeds.

Pending the uses described above, we intend to invest the net proceeds from this offering in short-term, investment-grade, interest-bearing instruments.

Dividend policy

We have never declared or paid any cash dividends on our capital stock, and we do not currently intend to pay any cash dividends on our capital stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to support operations and to finance the growth and development of our business. Any future determination to pay dividends will be made at the discretion of our board of directors subject to applicable laws and will depend upon, among other factors, our operating results, financial condition, contractual restrictions, and capital requirements. Our future ability to pay cash dividends on our capital stock may be limited by any future debt instruments or preferred securities.

Capitalization

The following table summarizes our cash and cash equivalents, as well as our capitalization, as of June 30, 2026:

You should read this table together with our unaudited condensed consolidated financial statements and the related notes included elsewhere in this prospectus and the section titled “Management’s discussion and analysis of financial condition and results of operations.”

The number of shares of common stock in the table above is based on shares of our common stock outstanding as of June 30, 2026, after giving effect to the automatic conversion of all outstanding shares of our convertible preferred stock into an aggregate of 150,004,272 shares of common stock immediately prior to the completion of this offering and the Notes Conversion, which will occur in connection with the completion of this offering, and excludes:

The 2026 Plan and the ESPP each provide for annual automatic increases in the number of shares of our common stock reserved thereunder, and the 2026 Plan also provides for increases to the number of shares of our common stock that may be granted thereunder based on shares under the 2020 Plan that expire, are forfeited or are repurchased by us, as more fully described in the section titled “Executive compensation—Employee benefit and stock plans.”

Dilution

If you invest in our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share of our common stock and the pro forma as adjusted net tangible book value per share of our common stock immediately after this offering. Net tangible book value dilution per share to new investors represents the difference between the amount per share paid by purchasers of shares of our common stock in this offering and the pro forma as adjusted net tangible book value per share of our common stock immediately after completion of this offering.

Net tangible book value (deficit) per share is determined by dividing our total tangible assets (which excludes deferred offering costs) less our total liabilities by the number of shares of our common stock outstanding. Our historical net tangible book value (deficit) as of June 30, 2026 was $ million, or $ per share. Our pro forma net tangible book value as of June 30, 2026 was $ million, or $ per share, based on the total number of shares of our common stock outstanding as of June 30, 2026, after giving effect to the automatic conversion of all outstanding shares of convertible preferred stock into an aggregate of 150,004,272 shares of common stock. The pro forma as adjusted information above also gives effect to the Notes Conversion, in which our outstanding Convertible Notes will convert into an aggregate of shares of our common stock, based on the assumed initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus. Because the Convertible Notes convert at a discount to the initial public offering price, a lower initial public offering price would increase the number of shares issued in the Notes Conversion and the resulting dilution to investors participating in this offering.

After giving effect to the sale by us of shares of our common stock in this offering at the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of June 30, 2026 would have been $ million, or $ per share. This represents an immediate increase in pro forma net tangible book value of $ per share to our existing stockholders and an immediate dilution in pro forma as adjusted net tangible book value of $ per share to investors purchasing shares of our common stock in this offering at the assumed initial public offering price. The following table illustrates this dilution:

Each $1.00 increase or decrease in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, our pro forma as adjusted net tangible book value per share by approximately $ , and would increase or decrease, as applicable, dilution per share to new investors purchasing shares of common stock in this offering by $ , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares in the number of shares of our common

stock offered by us would increase or decrease, as applicable, our pro forma as adjusted net tangible book value by approximately $ per share and increase or decrease, as applicable, the dilution to new investors purchasing shares of common stock in this offering by $ per share, assuming the assumed initial public offering price remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

If the underwriters exercise their option in full to purchase additional shares of common stock in this offering, the pro forma as adjusted net tangible book value per share after the offering would be $ per share, the increase in the pro forma net tangible book value per share to existing stockholders would be $ per share and the pro forma as adjusted dilution to new investors purchasing common stock in this offering would be $ per share.

The following table presents, on a pro forma as adjusted basis to give effect to this offering, as of June 30, 2026, the differences between the existing stockholders and the new investors purchasing shares of our common stock in this offering with respect to the number of shares purchased from us, the total consideration paid or to be paid to us and the average price per share paid or to be paid to us at the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us:

Each $1.00 increase or decrease in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the total consideration paid by new investors and the total consideration paid by all stockholders by approximately $ million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million in the number of shares offered by us would increase or decrease, as applicable, total consideration paid by new investors and total consideration paid by all stockholders, by approximately $ million, assuming that the assumed initial public offering price remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The table above assumes no exercise of the underwriters’ option to purchase additional shares in this offering. If the underwriters’ option to purchase additional shares is exercised in full, the total number of shares of our common stock held by existing stockholders would be reduced to % of the total number of shares of our common stock outstanding after this offering, and the total number of shares of common stock held by investors purchasing shares of common stock in the offering would be increased to % of the total number of shares outstanding after this offering.

The foregoing tables and calculations (other than historical net tangible book value) are based on shares of our common stock outstanding as of June 30, 2026, after giving effect to (i) the automatic conversion of all outstanding shares of our convertible preferred stock into an aggregate of 150,004,272 shares of common stock immediately prior to the completion of this offering and (ii) the Notes Conversion, which will occur in connection with the completion of this offering, as if it had occurred as of June 30, 2026, and excludes:

The 2026 Plan and the ESPP each provide for annual automatic increases in the number of shares of our common stock reserved thereunder, and the 2026 Plan also provides for increases to the number of shares of our common stock that may be granted thereunder based on shares under the 2020 Plan that expire, are forfeited or are repurchased by us, as more fully described in the section titled “Executive compensation—Employee benefit and stock plans.”

To the extent that any outstanding options to purchase our common stock are exercised or new awards are granted under our equity compensation plans, or additional shares of our common stock are issued, there will be further dilution to investors participating in this offering.

Management’s discussion and analysis of financial condition and results of operations

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and the related notes appearing elsewhere in this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should read the sections titled “Risk factors” and “Special note regarding forward-looking statements” for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a technology and clinical-stage life sciences company pursuing a fundamental shift in the biopharmaceutical industry. Our mission is to make better technology for better medicines. We do this by integrating leading proprietary, large-scale AI with automated, scalable chemistry and biology experimentation. We call this approach molecular superintelligence.

The Iambic molecular superintelligence platform is designed to disrupt legacy drug discovery paradigms. Instead of treating each stage of drug discovery as a distinct technological challenge, we have developed a unified, intelligent platform designed to address the full journey of drug discovery and development—from hit identification to multiparameter lead optimization to clinical developability.

Crucially, the molecular superintelligence platform learns from its own laboratory-generated data: reinforcement learning based on a continuous stream of experiments sharpens predictions and search strategy, tightening the design-make-test (DMT) loop with every cycle. Although our approach is novel and unproven, in that it has not yet led to an approved drug product to date, we designed our molecular superintelligence platform to navigate chemical and biological spaces with the goal of improving the probability of success at every stage. There is no guarantee that our platform will lead to the successful completion of clinical trials or the approval of our product candidates, or the product candidates of partners and collaborators using our platform. However, Iambic aims to systematically expand the boundaries of what is druggable, and to redefine how novel therapeutics are conceived, optimized, and advanced to address unmet patient need.

Our molecular superintelligence platform integrates three tightly coupled elements that work together in drug discovery, each described in more detail below: (i) Enchant, our multimodal AI model for predicting how potential drug molecules will behave in preclinical testing and in the clinic; (ii) NeuralPLexer, our flow-matching generative AI model for predicting three-dimensional structure of biological molecules; and (iii) robotic data generation at scale, generating new chemical and biological data in tightly orchestrated weekly cycles.

These three elements can work independently, but complement one another rather than act as substitutes: each performs a distinct function, and we use them together in our discovery programs. All three elements operate together as a closed-loop DMT framework, in which our team uses AI predictions and AI agents to guide wet-lab experiments, with resulting data continuously fed back to retrain our models. Within each cycle, the output of one element can inform the others, and one element may use data generated by another. As an example, a therapeutic molecule generally must attach to a specific biological target, often a disease-associated protein, to have a therapeutic effect. NeuralPLexer is used to predict structures and protein-ligand affinities, meaning how a molecule would fit and bind that target, and to enable generation of hypotheses. Its predicted structures and binding characteristics may inform which molecules Enchant evaluates for preclinical and clinical properties. Enchant's predictions may in turn guide which molecules our robotic workflows synthesize and test; and the resulting laboratory data are then used to fine-tune both Enchant and NeuralPLexer for the next cycle. We use the platform both to advance our pipeline of wholly owned drug candidates and to power collaborations with technology, biotechnology, and pharmaceutical development partners.

Our most advanced drug candidate, IAM1363, is an oral, highly selective, pan-mutant, and brain-penetrant small molecule inhibitor of human epidermal growth factor receptor 2 (HER2) that is being evaluated in an ongoing Phase 1/1b clinical trial, and we anticipate initiating a registrational trial as early as 2027, subject to regulatory feedback. Our development candidates IAM217, a brain-penetrant allosteric inhibitor for KIF18A, and IAM-C1, a selective dual inhibitor of CDK2/4, are in preclinical development and we anticipate submitting IND applications for these programs in the fourth quarter of 2026, followed in each case by initiation of a Phase 1/2 clinical trial, subject to regulatory clearance. We are also advancing additional wholly owned and partnered programs across multiple targets and disease areas.

The physical foundation of our drug discovery platform relies on our proprietary, highly automated internal laboratory infrastructure, which is custom-engineered to operate as an integrated, closed-loop data engine with its computational core. As our proprietary therapeutic assets transition from early-stage discovery into formal, regulatory-enabling development, we deploy a capital-efficient, scalable manufacturing strategy that integrates our automated internal discovery operations with a global network of premier Contract Development and Manufacturing Organizations (CDMOs). While internal automated laboratories maintain complete ownership of early-stage, milligram-scale synthesis to drive the computational DMT framework, we intentionally leverage audited, world-class third-party CDMOs to execute large-scale, clinical-grade Good Manufacturing Practice (GMP) synthesis. This operational segregation allows us to avoid the massive capital expenditure and long-term asset depreciation associated with building and maintaining commercial-scale physical manufacturing plants.

We actively manage this diversified CDMO network to establish secure, redundant, and highly compliant supply chains across our entire pipeline portfolio. This external infrastructure supports the ongoing active clinical supply requirements for the IAM1363 Phase 1/1b trial, ensuring robust substance and product availability for both the monotherapy expansion cohorts and active combination studies. Furthermore, our CDMO partners have successfully initiated scale-up chemistry, formulation development, and analytical validation campaigns to support upcoming regulatory filings. This includes securing the critical GMP batches required to maintain the IND readiness timelines for both the dual CDK2/4 inhibitor program, IAM-C1, and the allosteric KIF18A inhibitor program, IAM217. This tech-transfer and supply-chain framework ensures that we can scale our asset portfolio seamlessly from digital inception to advanced clinical testing while adhering strictly to international regulatory and quality control standards.

We have generated revenue from collaboration agreements under which we apply our platform for our partners or together with them. These arrangements generally provide for some combination of upfront payments, research funding and cost reimbursement, preclinical, clinical, regulatory, and commercial milestone payments, and, in certain cases, royalties on future product sales. We use cash received under these arrangements both to fund our operations, including a portion of the costs of our wholly owned programs, and to deepen the proprietary data and technology that underpin our platform and pipeline. We have no products approved for commercial sale and have not generated any revenue from product sales.

From inception through September 18, 2026, we have primarily raised capital through the sale of convertible preferred stock and payments from our collaboration partners. As of September 18, 2026, we have received aggregate gross cash proceeds of $536.5 million, including $461.8 million from sales of our convertible preferred stock, convertible promissory notes and simple agreements for future equity (SAFE), and $74.7 million in payments from our collaboration partners.

We have incurred significant operating losses since our inception and expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance our drug candidates through clinical development, continue to invest in our platform and data-generation infrastructure, expand our pipeline, and incur the additional costs associated with operating as a public company. Our net losses were $50.1 million and $33.2 million for the six months ended June 30, 2026 and 2025, respectively. Our net losses were $77.3 million and $47.9 million for the years ended December 31, 2025 and 2024, respectively. As of June 30, 2026, we had an accumulated deficit of $245.3 million.

We do not expect to generate revenue from product sales unless and until we or our collaboration partners successfully complete the clinical development or future clinical development of, and obtain regulatory approval for, one or more of our current or future drug candidates, including any jointly-developed drug candidates, which will not be for several years, if ever. If we obtain regulatory approval for any of our drug candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, manufacturing, marketing, market access, and distribution.

Our net losses may fluctuate significantly from period to period, depending on the timing of our current and potential future clinical trials and expenditures related to our research and developmental activities, platform, and automated laboratory infrastructure. Furthermore, following the closing of this offering, we expect to incur additional costs associated with operating as a public company, including significant audit, legal, and regulatory expenses, as well as director and officer insurance premiums and investor relations costs that we did not incur as a private company. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such a time when we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of private and public equity offerings, debt financings, strategic partnerships and collaborations, or similar arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. Our failure to raise capital or enter into such agreements or arrangements, as and when needed, could have a material adverse effect on our business, results of operations, and financial condition, including potentially requiring us to delay, limit, reduce, or eliminate product development or future commercialization efforts, or grant rights to develop and market current or future development drug candidates that we would otherwise prefer to develop and market ourselves.

As there are numerous risks and uncertainties associated with product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. As of June 30, 2026, we had cash and cash equivalents of $207.9 million. After that date, in one or more closings through September 11, 2026 and therefore not reflected in that amount, we issued subordinated convertible promissory notes for aggregate gross proceeds to us of $66.5 million. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this prospectus, together with the estimated net proceeds from this offering, will be sufficient to fund our operating expenses and capital expenditures through . However, this estimate is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. See the subsection titled “Liquidity and capital resources” below and Note 1 of our audited consolidated financial statements and unaudited condensed consolidated financial statements included elsewhere in this prospectus.

License and collaboration agreements

Below is a summary of the key terms for certain of our license and collaboration agreements. See the section titled “Business—Collaboration agreements” for a more detailed description of certain agreements.

Agreement with AbbVie

In September 2026, we entered into a Collaboration and Option to License Agreement with AbbVie (AbbVie Agreement), pursuant to which we apply our proprietary molecular superintelligence platform, together with our integrated high-throughput experimental capabilities and certain AbbVie-specific instances of our superintelligence platform, to identify, generate and optimize compounds directed to two initial targets selected by AbbVie.

Under the AbbVie Agreement, we will receive an upfront payment from AbbVie in consideration for the rights and licenses to be granted to AbbVie under the AbbVie Agreement and our performance of research activities thereunder. AbbVie has an exclusive option, exercisable during a defined option period, to obtain an exclusive, worldwide, royalty-bearing, sublicensable license under certain of our patents and know-how to develop, manufacture, commercialize and otherwise exploit certain compounds and products directed to that collaboration target. We are eligible to receive (i) additional payments upon the extension of option periods, delivery of final option exercise data packages, and exercise of license options for each collaboration target and (ii) success-based development and sales-based milestone payments upon the achievement of specified regulatory, development and commercial events with respect to each collaboration target, and, for a term specified in the agreement, tiered royalties on net sales of licensed products with rates from within the mid-single digits to the low-teens range, subject to customary offsets and reductions in specified circumstances.

Agreement with Takeda

In February 2026, we entered into a Research Collaboration and License Agreement with Takeda (Takeda Agreement), pursuant to which we will utilize our proprietary molecular superintelligence platform to identify, generate, and optimize small molecule drug candidates directed to three initial collaboration targets. Contemporaneously, we and Takeda entered into a separate master services agreement pursuant to which we licensed to Takeda access to certain proprietary AI platform technology (Technology Enablement Agreement).

Under the Takeda Agreement, we received an upfront payment and Takeda agreed to reimburse our research costs incurred in performing activities under the research program. Reimbursable costs incurred under the research program are subject to an initial research budget, which may be further amended by the parties. Takeda will have the right to develop, manufacture, and commercialize resulting qualifying compounds and products worldwide. In addition, under the Technology Enablement Agreement, we granted Takeda access to our NeuralPLexer model in exchange for specified annual fees. We are eligible to receive success-based research and development milestone payments upon the achievement of specified events with respect to each collaboration target, as well as commercial milestone payments and escalating royalties on net sales of qualifying products with rates from within the mid-single digits to the low-teens range, subject to customary offsets and reductions in specified circumstances. Takeda also has the right to designate up to three additional collaboration targets upon payment of a specified fee per target.

For the six months ended June 30, 2026, we recognized $6.2 million in revenue related to the Takeda Agreement. As of June 30, 2026, the remaining transaction price of $28.0 million is expected to be recognized by us as revenue through 2028.

Agreement with Revolution Medicines

In May 2025, we entered into a Collaboration and License Agreement with RevMed (RevMed Agreement), pursuant to which we develop optimized machine learning models through fine tuning and training using RevMed’s training data (Optimized Models) to conduct certain related research and development activities, and license to RevMed the Optimized Models.

Under the RevMed Agreement, we received an upfront payment and RevMed agreed to reimburse our research costs incurred in performing activities under the research plan. Reimbursable costs incurred under the research plan are subject to an initial research budget, which may be further amended by the parties. We are also eligible to receive success-based milestone and annual update payments. During the six months ended June 30, 2026, one success-based research milestone had been achieved.

For the six months ended June 30, 2026 and 2025, we recognized $2.4 million and zero, respectively, in revenue related to the RevMed Agreement. For the year ended December 31, 2025, we recognized $2.7 million in revenue related to the RevMed Agreement. As of June 30, 2026, the remaining transaction price of $17.6 million is expected to be recognized by us as revenue through 2030.

Agreement with Lundbeck

In September 2024, we entered into a Collaboration and Option Agreement with Lundbeck (Lundbeck Agreement). The Lundbeck Agreement establishes a 36-month research collaboration pursuant to which we apply our molecular superintelligence platform, together with our integrated high-throughput experimental capabilities, to identify, design, characterize, and optimize compounds directed to a target selected by Lundbeck.

Under the Lundbeck Agreement, we received an upfront payment and Lundbeck agreed to reimburse our research costs incurred in performing activities under the research plan. Reimbursable costs incurred under the research plan are subject to an initial research budget, which may be further amended by the parties. Upon completion of the research program, Lundbeck will have the right, exercisable during a specified option period, to obtain an exclusive license to develop, manufacture, and commercialize certain resulting compounds and products worldwide. We are also eligible to receive success-based milestone payments upon the achievement of specified research milestones, regardless of whether Lundbeck exercises the option. If Lundbeck exercises the option, Lundbeck is required to pay us an option exercise fee as well as success-based development and commercial milestone payments upon the achievement of specified events with respect to licensed products and escalating royalties on net sales of licensed products with rates from within the mid-single digits to the low-teens range, subject to customary offsets and reductions in specified circumstances.

For the six months ended June 30, 2026 and 2025, we recognized $4.2 million and $3.9 million respectively, in revenue related to the Lundbeck Agreement. For the years ended December 31, 2025 and 2024, we recognized $6.7 million and $1.2 million, respectively, in revenue related to the Lundbeck Agreement. As of June 30, 2026, the remaining transaction price of $3.8 million is expected to be recognized by us as revenue through 2027.

Components of results of operations

Collaboration revenue

We have not generated any revenue from the sale of products to date and do not expect to generate any revenue from the sale of products for the next several years, if at all. If our development efforts for our current or future drug candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales. For the foreseeable future, we expect substantially all of our revenue to be generated from our current collaboration arrangements. For more information on our collaboration agreements, see the subsection titled “License and collaboration agreements” above and Note 5 and Note 11 to our audited consolidated financial statements and unaudited condensed consolidated financial statements included elsewhere in this prospectus.

Our collaboration arrangements provide for one or more of the following: upfront fees; reimbursement of research and development costs; development, regulatory, commercial and success-based milestone payments; and royalties on net sales of licensed products, if any. The amount and timing of these payments are uncertain and may cause our revenue to fluctuate significantly from period to period.

Operating expenses

Our operating expenses consist of research and development expenses and general and administrative expenses.

Research and development

Research and development expenses represent the largest component of our operating expenses and primarily consist of costs incurred in connection with the discovery and development of our preclinical and clinical drug candidates and the advancement of our proprietary molecular superintelligence platform. These expenses include:

We utilize our personnel and infrastructure resources for our research and development efforts, including the advancement of our internal drug candidates, platform technology, and external research and development activities with collaboration partners. A significant portion of our research and development costs have been, and will continue to be, external costs. External expenses that are specific to a program are tracked upon filing an IND application and on a program-by-program basis for collaboration partners. Due to the fact that we use internal resources across multiple programs, we do not allocate personnel-related costs, other internal research and development costs, and facilities-related and overhead costs by program.

We expense research and development costs as incurred. Nonrefundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered.

We record accruals for estimated ongoing research costs and receive updated estimates of costs and amounts from our third-party service providers. When evaluating the adequacy of the prepaid expenses and accrued liabilities, we analyze progress of the studies, including the phase or completion of events, invoices received, and contracted cost estimates from our third-party service providers. Estimates are made in determining the balances at the end of any reporting period.

We expect that our research and development expenses will increase substantially for the foreseeable future as we continue to expand and advance our clinical HER2 program, IAM1363, and other early discovery programs into and through preclinical studies and clinical development, invest in the continued development of our proprietary molecular superintelligence platform, and support our existing and potential future collaboration activities with partners. The timing and amount of these expenses will depend on, among other things, the progress of our ongoing and planned clinical trials, the results of our preclinical studies, regulatory feedback, and the extent to which we enter into additional collaboration agreements.

Due to the inherent uncertainties of clinical development, we cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete the development of our therapeutic candidates. We also cannot predict the outcome of clinical trials or when, if ever, material net cash inflows may commence from any of our drug candidates.

General and administrative

General and administrative expenses primarily consist of personnel-related costs, including salaries, employee benefits, travel and business expenses, and stock-based compensation for our employees engaged in general and administrative functions; professional fees, including legal fees relating to corporate and intellectual property matters, consulting and insurance fees, and accounting, audit, and tax services; software and information technology costs; allocated costs related to office facilities, including rent, maintenance, and utilities, and overhead costs for software and information technology; and other general operating expenses not otherwise classified as research and development expenses.

We expect that our general and administrative expenses will increase substantially for the foreseeable future as we increase our headcount to support our continued research and development activities and the growth of our business. We anticipate incurring additional legal fees related to corporate and intellectual property matters as we

explore additional collaboration opportunities with potential partners and file patent applications to protect innovations arising from our research and development activities. Additionally, we expect to incur increased expenses associated with being a public company, including increased costs related to accounting, audit, and tax-related services, maintaining compliance with exchange listing and the SEC’s requirements, director and officer insurance costs, and investor and public relations costs.

Other income (expense), net

Interest income

Interest income consists of interest earned on cash and cash equivalents. We expect interest income to vary each reporting period depending on our average money market fund balances during the period and market interest rates.

Interest expense

Interest expense primarily consists of interest associated with our finance lease of property and equipment.

Other expense

Other expense primarily consists of realized and unrealized gains and losses on foreign currency transactions and loss on disposal of property and equipment.

Income taxes

Income tax expense consists of U.S. state and foreign taxes in jurisdictions in which we conduct business. Since our inception, we have not recorded any income tax benefits for the net losses we have incurred or for our earned research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized. As of June 30, 2026 and December 31, 2025, we have recorded a full valuation allowance against our net deferred tax assets.

Results of operations

Comparison of the six months ended June 30, 2026 and 2025

The following table summarizes our results of operations for the periods presented (in thousands, except percentages):