What changed in this filing

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Item 1A. Risk Factors

2026-07-09 compared with 2026-04-08 · 100 added, 86 removed, 1509 unchanged (11% of the section changed)

10 unchanged sentences

We expect to incur losses over at least the next several years and may never achieve or maintain profitability.

Our net loss was $264.5 million for the fiscal year ended November 30, 2025, and $87.2 million for the three months ended February 28, 2026.

As of February 28, 2026, we had an accumulated deficit of $1.1 billion.

Our net loss was $264.5 million for the fiscal year ended November 30, 2025, and $176.7 million for the six months ended May 31, 2026.

As of May 31, 2026, we had an accumulated deficit of $1.2 billion.

To date, we have not generated any revenue from product sales and have financed our operations primarily through our collaborations and sales of our equity interests.

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If we are unable to raise capital when needed or on attractive terms, we may be required to delay, limit, reduce or terminate our research, product development programs or any future commercialization efforts or grant rights to develop and market drug candidates that we otherwise would prefer to develop and market ourselves.

We had cash, cash equivalents and marketable securities of $540.7 million as of February 28, 2026.

We had cash, cash equivalents and marketable securities of $443.5 million as of May 31, 2026.

We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months.

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(Gilead), Sanofi S.A.

(Sanofi) and Seagen Inc.

(Sanofi), Seagen Inc.

(now a part of Pfizer Inc.

(Pfizer)) and any other collaborations we may establish;

(Pfizer)) and F.

Hoffmann-La Roche Ltd (Roche) and any other collaborations we may establish;

• the costs, timing and outcome of regulatory review of our drug candidates;

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Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements.

Although we may receive potential future milestone payments under our collaborations with Gilead, Sanofi and Pfizer, we do not currently have any committed external source of funds.

Although we may receive potential future milestone payments or royalty payments under our collaborations with Gilead, Sanofi, Pfizer and Roche, we do not currently have any committed external source of funds.

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 common stock.

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Our lead drug candidates, bexobrutideg (NX-5948), zelebrudomide (NX-2127) and NX-1607, are in the early stages of clinical development.

If we are unable to advance our drug candidates through clinical development or are unable to obtain regulatory approval for and commercialize our drug candidates or experience significant delays in doing so, our business may be materially harmed.

If we are unable to advance our drug candidates through clinical development or to obtain regulatory approval for them, or to secure an adequate reimbursement price for them, or to commercialize them or experience significant delays in doing so, our business may be materially harmed.

We are early in our development efforts.

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The Innovation Passport is the mandated entry point to the Innovative Licensing and Access Pathway (ILAP) in the UK to facilitate approval of and market access to an innovative medicine.

Grant of the Innovation Passport paves the way for enhanced engagement with key stakeholders such as the Medicines and Healthcare products Regulatory Agency (MHRA), health technology agencies in the UK such as the National Institute for Health and Care Excellence or the Scottish Medicines Consortium and NHS England.

However, although the goal of ILAP and the Innovation Passport is to reduce the time to market and enable earlier patient access, they do not accelerate conduct of clinical trials or mean that the regulatory requirements are less stringent, nor do they ensure that any NX-1607 marketing authorization application (MAA) will be approved or that any approval will be granted within any particular timeframe.

Grant of the Innovation Passport paves the way for enhanced engagement with key stakeholders such as the Medicines and Healthcare products Regulatory Agency (MHRA), health technology agencies in the UK such as the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium and NHS England.

However, although the goal of ILAP and the Innovation Passport is to reduce the time to market and enable earlier patient access, they do not accelerate the conduct of clinical trials or mean that the regulatory requirements are less stringent, nor do they ensure that any NX-1607 marketing authorization application (MAA) will be approved or that any approval will be granted within any particular timeframe, nor that an adequate reimbursement price will be obtained.

Despite receiving an Innovation Passport designation, we may decide to delay or forego the commercialization of NX-1607 in the UK or the development may otherwise not proceed.

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Our future success depends on the successful development of this novel therapeutic approach.

Very few small molecule drug candidates designed to control cellular protein levels, such as our BTK degraders, have been tested in humans, none have been approved in the United States or Europe, and the data underlying the feasibility of developing these therapeutic products is both preliminary and limited.

Although multiple companies are testing drug candidates that eliminate protein targets, such as BTK degraders, few drugs have been approved in the United States or Europe.

As such, the data underlying the long term safety and efficacy of these therapeutic products is both preliminary and limited.

Discovery and development of targeted protein degraders that harness ligases to degrade protein targets have been impeded largely by the complexities and limited understanding of the functions, biochemistry and structural biology of E3 ligases as well as by challenges of engineering compounds that promote protein-protein interactions.

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Additionally, the regulatory approval process for novel drug candidates such as ours can be more expensive and take longer than for other, better-known or extensively-studied drug candidates.

Although other companies are also developing therapeutics based on targeted protein degradation, no regulatory authority has granted approval for any such therapeutic.

Although multiple companies are also developing therapeutics based on targeted protein degradation, few such therapeutics have been approved in the United States and Europe.

As a result of these factors, it is more difficult for us to predict the time and cost of targeted protein degrader drug candidate development, and we cannot predict whether targeted protein degradation will result in the development and marketing approval of any products.

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• regulators may revise the requirements for approving our drug candidates, or such requirements may not be as we anticipate;

• any future collaborators that conduct clinical trials may face any of the above issues and may also conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us;

• our current collaborators or any future collaborators that conduct clinical trials may face any of the above issues and may also conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us;

• disruptions caused by macroeconomic, political and market conditions, including supply chain disruptions, may increase the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing clinical trials.

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From time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones.

These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings and may be associated with payments from third-party collaborators such as Gilead, Sanofi or Pfizer.

From time to time, we may publicly announce the expected timing of some of these milestones.

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On June 28, 2024, the U.S.

Supreme Court issued an opinion holding that courts reviewing agency action pursuant to the Administrative Procedure Act (APA) “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision will have a significant impact on how lower courts evaluate challenges to agency interpretations of law, including those by the FDA and other agencies with significant oversight of the biopharmaceutical industry.

The new framework may result in an increase in both the frequency of such challenges and their odds of success by eliminating one way in which the government previously prevailed in such cases.

Supreme Court issued an opinion in Loper Bright Enterprises v.

Raimondo holding that courts reviewing agency action pursuant to the Administrative Procedure Act (APA) “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision has and will have a significant impact on how lower courts evaluate challenges to agency interpretations of law, including those by the FDA and other agencies with significant oversight of the biopharmaceutical industry.

This framework may result in an increase in both the frequency of such challenges and their odds of success by eliminating one way in which the government previously prevailed in such cases.

As a result, significant regulatory policies may be subject to increased litigation and judicial scrutiny.

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in December 2019 we entered into a collaboration with Sanofi, which was subsequently expanded and amended in January 2021;

and in September 2023 we entered into a collaboration with Seagen Inc.

in September 2023 we entered into a collaboration with Seagen Inc.

(now a part of Pfizer);

Each of the foregoing collaborations requires us to conduct certain research activities.

and in June 2026 we entered into a collaboration with Roche which will become effective upon the expiration or termination of the applicable waiting period under the Hart-Scott-Roding Antitrust Improvements Act of 1976, as amended, and the expiration, termination or resolution of all other required waiting periods, clearance decision or outstanding inquiries under antitrust laws.

The foregoing collaborations require us to conduct certain research, development, manufacturing, co-promotion or other activities.

Our likely collaborators for any other collaboration arrangements include large and mid-size pharmaceutical companies, biotechnology companies and universities.

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We cannot predict the success of any collaboration that we enter into.

Collaborations involving our research programs or any drug candidates we may develop, including our collaborations with Gilead, Sanofi and Pfizer, pose risks to us, including:

Collaborations involving our research programs or any drug candidates we may develop, including our collaborations with Gilead, Sanofi, Pfizer and Roche, pose risks to us, including:

• Collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations with us.

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• Gilead and Sanofi have broad option rights to select up to five targets each, and Pfizer has option rights to multiple targets, for exclusive targeted protein degrader development, so long as not excluded by us under the terms of each collaboration, and may select targets we are considering but have not taken sufficient action to exclude under each collaboration.

In addition, Roche has an exclusive option right, during a specified option period, to expand its license to include one additional BTK degrader to the extent one is developed by us.

• Collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing.

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• Collaborators may not properly obtain, maintain, enforce or defend our intellectual property or proprietary rights or may use our proprietary information in such a way that could jeopardize or invalidate our proprietary information or expose us to potential litigation.

For example, Gilead, Sanofi and Pfizer have the first right to enforce or defend certain intellectual property rights under the applicable collaboration arrangement with respect to particular licensed programs, and although we may have the right to assume the enforcement and defense of such intellectual property rights if the collaborator does not, our ability to do so may be compromised by their actions.

For example, Gilead, Sanofi, Pfizer and Roche have the first right to enforce or defend certain intellectual property rights under the applicable collaboration arrangement with respect to particular licensed programs, and although we may have the right to assume the enforcement and defense of such intellectual property rights if the collaborator does not, our ability to do so may be compromised by their actions.

• Disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our products or drug candidates or that result in costly litigation or arbitration that diverts management attention and resources.

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• 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.

For example, each of Gilead, Sanofi and Pfizer can terminate its agreement with us in its entirety or with respect to a specific target for convenience upon written notice or in connection with a material breach of the agreement by us that remains uncured for a specified period of time.

For example, each of Gilead, Sanofi, Pfizer and Roche can terminate its agreement with us in its entirety (or, under our agreements with Gilead, Sanofi and Pfizer, with respect to a specific target) for convenience upon written notice or in connection with a material breach of the agreement by us that remains uncured for a specified period of time.

• Collaboration agreements may not lead to development or commercialization of drug candidates in the most efficient manner, or at all.

For instance, if a present or future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished or terminated.

If our collaborations do not result in the successful development and commercialization of products, or if one of our collaborators terminates its agreement with us, we may not receive any future research funding or milestone or royalty payments under the collaboration.

If we do not receive the funding we expect under these agreements, our development of drug candidates could be delayed, and we may need additional resources to develop drug candidates.

If our collaborations do not result in the successful development and commercialization of products, or if one of our collaborators terminates its agreement with us, we may not receive any future research funding, milestone payments, royalty payments or benefits under the collaboration.

If we do not receive the funding or economic benefits we expect under these agreements, our development of drug candidates could be delayed, and we may need additional resources to develop drug candidates.

In addition, if one of our collaborators terminates its agreement with us, we may find it more difficult to find a suitable replacement collaborator or attract new collaborators, and our development programs may be delayed or the perception of us in the business and financial communities could be adversely affected.

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If we license rights to any drug candidates we or our collaborators may develop, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture.

The Roche Collaboration Agreement is subject to closing conditions and may not close when expected or at all, and we may fail to realize all of the anticipated benefits.

In June 2026, we entered into the Roche Collaboration Agreement for the co-development and co-commercialization of bexobrutideg.

The closing of the Roche Collaboration Agreement is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the expiration, termination or resolution of all other required waiting periods, clearance decisions or outstanding inquiries under antitrust laws.

While we expect the Roche Collaboration Agreement to become effective in the third fiscal quarter of 2026, we cannot provide assurance that the collaboration will close when expected or at all.

A number of factors, including regulatory or governmental action, litigation, and macroeconomic or market conditions, may prevent, delay or otherwise materially and adversely affect the ability of the parties to complete the collaboration.

The failure to receive any required antitrust approvals in a timely manner could delay or prevent the closing of the Roche Collaboration Agreement.

If the closing of the Roche Collaboration Agreement is delayed, receipt of the $700 million upfront payment would be delayed, and if the closing does not occur, we would not receive the upfront payment or realize the other potential benefits of the collaboration, including payments of up to $2.3 billion in potential total payments, including the upfront payment.

In addition, the failure to close the Roche Collaboration Agreement may materially and adversely affect the market price of our common stock and could harm our reputation, business and operations if customers, investors or other parties react negatively to the failed transaction.

Furthermore, if the Roche Collaboration Agreement does not close, we may need to seek alternative sources of capital or collaboration partners to advance the development and commercialization of bexobrutideg, which may not be available on favorable terms, or at all, and may distract management’s attention and resources from other business activities.

We may seek to establish additional collaborations.

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We rely on third-party contract research organizations (CROs) to conduct our clinical trial programs for bexobrutideg, zelebrudomide and NX-1607 and we will rely on third-party CROs to conduct any clinical trials for other drug candidates.

Agreements with these CROs might terminate for a variety of reasons, including for such CRO’s failure to perform.

Agreements with these CROs might terminate for a variety of reasons, including due to a CRO’s failure to perform.

Entry into alternative arrangements, if necessary, could significantly delay our product development activities.

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• any restrictions on the use of our products together with other medications.

If we are unable to establish sales and marketing capabilities, we may not be successful in commercializing our drug candidates if and when they are approved.

If we or our collaborators are unable to establish sales and marketing capabilities, we may not be successful in commercializing our drug candidates if and when they are approved.

We do not have a sales or marketing infrastructure and have no experience in the sale, marketing or distribution of biopharmaceutical products.

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In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.

Patent and other types of the intellectual property litigation can involve complex factual and legal questions, and their outcome is uncertain.

Patent and other types of intellectual property litigation can involve complex factual and legal questions, and their outcome is uncertain.

If we are found, or believe there is a risk we may be found, by a court of competent jurisdiction to infringe, misappropriate or otherwise violate a third party’s intellectual property rights, we could be required or may choose to obtain a license from such third party to continue developing and marketing our products and technology.

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Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of our confidential information could be compromised by disclosure.

Uncertainties resulting from the litigation of patent litigation and other proceedings could delay our research and development efforts, adversely affect our ability to raise additional funds and could limit our ability to continue our operations.

Uncertainties resulting from patent litigation and other proceedings could delay our research and development efforts, adversely affect our ability to raise additional funds and could limit our ability to continue our operations.

Any of the foregoing could have a material adverse effect on our business.

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Fast Track designation may not lead to faster development or regulatory review or approval process, and it does not increase the likelihood that our drug candidates will receive marketing approval.

In January 2024, the FDA granted Fast Track designation for bexobrutideg in the United States for the treatment of adult patients with relapsed or refractory CLL or small lymphocytic lymphoma after at least two lines of therapy, including a BTK inhibitory and a B-cell lymphoma 2 inhibitor, and in December 2024, the FDA granted Fast Track designation for bexobrutideg in the United States for the treatment of adult patients with relapsed or refractory Waldenström macroglobulinemia after at least two lines of therapy, including a BTK inhibitor.

As part of our business strategy, we may also seek Fast Track designation for other of our drug candidates.

In January 2024, the FDA granted Fast Track designation for bexobrutideg in the United States for the treatment of adult patients with relapsed or refractory CLL or small lymphocytic lymphoma after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 inhibitor, and in December 2024, the FDA granted Fast Track designation for bexobrutideg in the United States for the treatment of adult patients with relapsed or refractory Waldenström macroglobulinemia after at least two lines of therapy, including a BTK inhibitor.

As part of our business strategy, we may also seek Fast Track designation for our other drug candidates.

Programs with Fast Track designation may be eligible for more frequent interactions with the FDA, and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

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If we are unable to obtain regulatory and marketing approval for our drug candidates or experience significant delays in our efforts to do so, our business could be substantially harmed.

Failure to obtain marketing approval in foreign jurisdictions would prevent our drug candidates from being marketed abroad and may limit our ability to generate revenue from product sales.

To market and sell our drug candidates in jurisdictions outside the United States, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

Failure by us or our collaborators to obtain marketing approval in foreign jurisdictions would prevent our drug candidates from being marketed abroad and may limit our ability to generate revenue from product sales.

To market and sell our drug candidates in jurisdictions outside the United States, we or any collaborators with rights in such jurisdictions must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and can involve additional testing.

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The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval.

In addition, in many countries outside the United States, we must secure product reimbursement approvals before regulatory authorities will approve the product for sale in that country.

Failure to obtain foreign regulatory approvals on a timely basis or non-compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our drug candidates in certain countries.

In addition, in many countries outside the United States, we or our collaborators must secure product reimbursement approvals before regulatory authorities will approve the product for sale in that country.

Failure to obtain foreign regulatory approvals on a timely basis or non-compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us or our collaborators and could delay or prevent the introduction of our drug candidates in certain countries.

Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any jurisdiction, which would materially impair our ability to generate revenue.

We or our collaborators may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any jurisdiction, which would materially impair our ability to generate revenue.

Due to the UK’s exit from the EU, the UK is now being treated as a “third country” by the EU.

Although UK legislation has retained existing EU law, new UK legislation is being drafted and the UK has not retained new EU law, including the Clinical Trials Regulation (EU) No 536/2014.

The UK has implemented separate clinical trial regulations, including the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which came into force on April 28, 2026.

This means that some regulatory activities, such as batch testing and Qualified Person certification, conducted in the UK are no longer recognized in the EU;

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In March 2025, the FDA granted Orphan Drug Designation to bexobrutideg for the treatment of Waldenström macroglobulinemia, and in June 2025, the EMA granted Orphan Drug Designation to bexobrutideg for the treatment of adult patients with lymphoplasmacytic lymphoma, of which Waldenström macroglobulinemia is the most common subtype.

As part of our business strategy, we may also seek Orphan Drug Designation or other designations from regulators for other of our current or future drug candidates.

As part of our business strategy, we may also seek Orphan Drug Designation or other designations from regulators for our other current or future drug candidates.

Regulatory authorities in some jurisdictions, including the United States, EU and European Economic Area (EEA), Switzerland and the UK, may designate drugs or biological products for relatively small patient populations as orphan drugs.

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Orphan Drug Designation does not convey any advantage in, or shorten the duration of, the regulatory review process.

If a product that has Orphan Drug Designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including an NDA or BLA, to market the same drug or biological product for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the biological product was designated.

If a product that has Orphan Drug Designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including an NDA or biologics license application, to market the same drug or biological product for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the biological product was designated.

As a result, even if one of our drug candidates receives orphan exclusivity, the FDA can still approve or license other drugs or biological products for use in treating the same indication or disease.

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In addition, although we may seek Orphan Drug Designation for other drug candidates, we may never receive these designations.

Under the current EU general pharmaceutical legislative framework, in order to obtain orphan designation in the EEA (the UK has a similar legislation), the product must fulfill certain criteria:

Under the current EU general pharmaceutical legislative framework, in order to obtain orphan designation in the EEA (similar legislation applies in the UK), the product must fulfill certain criteria:

(1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition;

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The revised periods of regulatory protection are reflected in the agreed compromise texts.

Under the proposed new framework, orphan medicinal products would benefit from a baseline period of 9 years of market exclusivity, which may be increased to 11 years for products qualifying as “breakthrough” orphan medicines.

Under the proposed new framework, orphan medicinal products would benefit from a baseline period of nine years of market exclusivity, which may be increased to 11 years for products qualifying as “breakthrough” orphan medicines.

In each case, this exclusivity period may be further extended by up to two additional one-year periods for new orphan indications.

While the legislation does not yet clearly define the criteria for “breakthrough” designation, the concept is expected to capture medicines addressing unmet medical needs.

In addition, the new framework would retain the existing six-month supplementary protection certificate (SPC) extension as a pediatric reward for the completion of studies in accordance with an agreed pediatric investigation plan (PIP).

In addition, the new framework would retain the existing six-month SPC extension as a pediatric reward for the completion of studies in accordance with an agreed pediatric investigation plan (PIP).

The compromise texts also introduce changes to the general regulatory exclusivity regime.

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Applicants may obtain waivers or deferrals to these requirements in certain circumstances (for example a waiver may be obtained if the condition only occurs in adult populations).

Where required, pediatric studies must cover all sub-sets of the pediatric population for both existing and new indications, pharmacological forms and route of administrations.

Where required, pediatric studies must cover all subsets of the pediatric population for both existing and new indications, pharmacological forms and routes of administration.

Limited further exclusions apply, including in relation to generic or biosimilar applications.

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Our operations and relationships with actual and potential customers, providers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to penalties including criminal sanctions, civil penalties, exclusions from government programs, contractual damages and reputational harm, and could diminish our future profits and earnings.

Our arrangements with third-party payors, physicians, and other potential customers will subject us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any drug candidates for which we obtain marketing approval.

The expected coverage and reimbursement of our products will subject us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any drug candidates for which we obtain marketing approval.

Applicable U.S.

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• federal criminal statutes created by the Health Insurance Portability and Accountability Act (HIPAA), which impose criminal liability for, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private insurance plans, or, in any matter involving a healthcare benefit program, for knowingly and willfully making materially false, fictitious or fraudulent statements in connection with the delivery of or payment for healthcare benefits;

• HIPAA, as amended by the Health Information Technology for Economic Clinical Health Act, and its implementing regulations, which also imposes obligations, including mandatory contractual terms, on certain types of people and entities with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and its implementing regulations, which also imposes obligations, including mandatory contractual terms, on certain types of people and entities with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

• the federal Food, Drug, and Cosmetic Act and Public Health Service Act, which, among other things, strictly regulates drug marketing, prohibits manufacturers from marketing such products for off-label use or misbranding or adulterating their products, and regulates the distribution of samples;

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Infringement of these laws may result in substantial fines and imprisonment.

EU Directive 2001/83/EC, which is the EU Directive governing medicinal products for human use, provides that, where medicinal products are being promoted to healthcare professionals, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such individuals unless they are inexpensive and relevant to the practice of medicine or pharmacy.

This provision was transposed into the Human Medicines Regulations 2012 and as such remains applicable in the UK.

EU pharmaceutical legislation provides that, where medicinal products are being promoted to healthcare professionals, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such individuals unless they are inexpensive and relevant to the practice of medicine or pharmacy.

These requirements also apply in the UK through the Human Medicines Regulations 2012.

Payments made to physicians in certain EU Member States must be publicly disclosed.

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congressional inquiries and proposed and enacted state and federal legislation and regulations designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient support programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products.

Most notably, the Inflation Reduction Act (IRA), which was signed into law on August 16, 2022, allows Medicare to:

beginning in 2026, establish a “maximum fair price” for a fixed number of pharmaceutical and biological products covered under Medicare Parts B and D following a price negotiation process with the Centers for Medicare and Medicaid Services (CMS);

and, as of 2023, penalize drug companies that raise prices for products covered under Medicare Parts B and D faster than inflation, among other reforms.

CMS has and continues to take steps to implement the IRA, including negotiating and publishing “maximum fair prices” for drugs selected under the IRA’s price negotiation framework and releasing quarterly lists of Medicare Part B products and annual lists of Medicare Part D products that are subject to adjusted coinsurance rates based on the inflationary rebate provisions of the IRA.

Most notably, the Inflation Reduction Act (IRA), which was signed into law on August 16, 2022, allows Medicare to establish a “maximum fair price” for a fixed number of pharmaceutical and biological products covered under Medicare Parts B and D following a price negotiation process with the Centers for Medicare & Medicaid Services (CMS);

and penalize drug companies that raise prices for products covered under Medicare Parts B and D faster than inflation, among other reforms.

CMS has taken and continues to take steps to implement the IRA, including negotiating and publishing “maximum fair prices” for drugs selected under the IRA’s price negotiation framework and releasing quarterly lists of Medicare Part B products and annual lists of Medicare Part D products that are subject to adjusted coinsurance rates based on the inflationary rebate provisions of the IRA.

Additionally, when originally enacted, the IRA explicitly excluded from price negotiation orphan drugs designated for only one rare disease or condition and for which the only active approved indication is for such disease or condition.

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The OBBBA also postpones the start of price negotiation requirements for drugs and biologics with orphan designations until the product receives approval for a non-orphan indication.

It is unclear how future regulatory actions to implement the IRA, as well as the outcome of pending litigation against the IRA, may affect our products and future profitability, and we cannot predict the likelihood, nature, or extent of other health reform initiatives that may arise from future legislation or administrative actions.

Moreover, recent healthcare regulatory developments indicate that prescription drug price reduction remains a key policy objective for the current presidential administration.

It is unclear how future regulatory actions to implement the IRA may affect our products and future profitability.

Although in May 2026 the Supreme Court declined to hear certain manufacturer challenges to the IRA price negotiation program, other litigation remains pending, the outcome of which could affect the scope and operation of the program.

We also cannot predict the likelihood, nature, or extent of other health reform initiatives that may arise from future legislation or administrative actions.

The current presidential administration has also signaled its intent to pursue additional healthcare reform measures, including those aimed at reducing prescription drug prices, through various means, including presidential executive orders and agency action.

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drug prices to the prices paid for drugs in other countries.

It remains to be seen how these drug pricing initiatives will affect the broader pharmaceutical industry .

Additionally, on April 2, 2026, President Trump issued a separate proclamation imposing tariffs on certain imported patented pharmaceuticals and pharmaceutical ingredients pursuant to Section 232 of the Trade Expansion Act of 1962 and linking certain tariff relief to “most-favored-nation” pricing commitments and domestic manufacturing initiatives.

Although implementation of the tariffs is subject to phased effective dates beginning in July 2026 for certain manufacturers, it remains to be seen how these drug pricing initiatives will affect the broader pharmaceutical industry.

In addition, on June 28, 2024, the U.S.

Supreme Court issued an opinion holding that courts reviewing agency action pursuant to the APA “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision will have a significant impact on how lower courts evaluate challenges to agency interpretations of law, including those by CMS and other agencies with significant oversight of the healthcare industry.

Supreme Court issued an opinion in Loper Bright Enterprises v.

Raimondo holding that courts reviewing agency action pursuant to the APA “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision has impacted how lower courts evaluate challenges to agency interpretations of law, including those by CMS and other agencies with significant oversight of the healthcare industry.

For additional information, see the risk factor above titled “The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subject to change, including due to judicial challenges.”

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These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.

Another emerging trend at the state level is the establishment of prescription drug affordability boards, some of which will prospectively permit certain states to establish upper payment limits for drugs that the state has determined to be “high-cost.” Prescription drug affordability boards in several states, including Colorado, Maryland, Oregon, and Washington, have begun identifying products for affordability reviews and issuing information requests to manufacturers to determine whether upper payment limits may be justified.

Another emerging trend at the state level is the establishment of prescription drug affordability boards, some of which will prospectively permit certain states to establish upper payment limits for drugs that the state has determined to be “high-cost.” Prescription drug affordability boards in several states, including Colorado, Maryland, Oregon, and Washington, have begun identifying products for affordability reviews, issuing information requests to manufacturers to determine whether upper payment limits may be justified, and, in the case of Colorado, implementing upper payment limits.

Legislative and regulatory proposals have also been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

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To obtain reimbursement or pricing approval in some countries, we, or our collaborators, may be required to conduct a clinical trial that compares the cost-effectiveness of our drug to other available therapies.

Furthermore, in some European countries, the authorities conduct an HTA to assess the cost-effectiveness of the product (in the UK that HTA assessment is conducted by the National Institute for Health and Care Excellence), which may significantly impact effective access to the market.

As of January 12, 2025, EU Health Technology Regulation No.

Furthermore, in some European countries, the authorities conduct an HTA to assess the cost-effectiveness of the product (in the UK that HTA assessment is conducted by NICE), which may significantly impact effective access to the market.

As of January 12, 2025, EU Health Technology Assessment Regulation No.

2021/2282 became applicable in respect of new oncology medicines.

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If reimbursement of our drugs is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be materially harmed.

In particular, following the executive order of the Trump Administration of May 12, 2025, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” there may be an unpredictable effect on prices of medicinal products in European countries.

The Executive Order directs federal agencies to implement policies that would align U.S.

prescription drug prices with the lowest prices paid by other comparable nations and mandates the Secretary of HHS to communicate “most-favored-nation” price targets to pharmaceutical manufacturers and, if significant progress is not achieved, to propose rulemaking to impose “most-favored nation” pricing across federal healthcare programs and potentially the private market.

In particular, the Trump Administration's continued efforts to implement "most-favored-nations" pricing in the United States may have unpredictable effects on prices of medicinal products in European countries.

For additional information, see the risk factor above titled “Current and future legislation may increase the difficulty and cost for us, and any collaborators, to obtain marketing approval of and commercialize our drug candidates and affect the prices we, or they, may obtain.” This policy may introduce significant risks to our future pricing strategies, revenue, and profitability in the U.S.

Additionally, the Executive Order instructs the Department of Commerce and the U.S.

Additionally, a May 2025 Executive Order instructs the Department of Commerce and the U.S.

Trade Representative to take action against foreign countries that engage in practices suppressing drug prices below fair market value, which could lead to increased pricing pressures or regulatory changes in international markets.

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In addition, the prevalent use of mobile devices and remote work applications that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential information or other intellectual property or unauthorized access to personal information.

More capable general-purpose AI models released by major providers that are or may soon become widely accessible to developers and end users have amplified, and will continue to amplify, the capabilities of attackers, enabling more targeted and convincing phishing and social engineering campaigns, automated identification and exploitation of software vulnerabilities, the generation of novel malware and attack vectors, prompt injection attacks, automated reconnaissance, and the ability to conduct attacks at greater speed and scale than previously possible.

Additionally, AI-enhanced threats may be more difficult to detect using traditional security measures and may require us to invest in additional defensive capabilities.

To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or those of our third-party vendors, CROs and other contractors and consultants, or inappropriate disclosure of confidential, personal or proprietary information, we could incur liability and reputational damage and the further development and commercialization of our drug candidates could be delayed.

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Each of these laws is subject to varying interpretations and the legislative landscape is constantly evolving.

In particular, laws and regulations governing the privacy of health information, such as HIPAA, establish privacy and security standards that limit the use and disclosure of individually identifiable health information, or protected health information, and require the implementation of administrative, physical and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity and availability of electronic protected health information.

In particular, laws and regulations governing the privacy of health information, such as state privacy laws or HIPAA, establish privacy and security standards that may apply to us or healthcare providers that we interact with.

These laws may limit the use and disclosure of individually identifiable health information, or protected health information, and require the implementation of administrative, physical and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity and availability of electronic protected health information.

Determining how protected health information may be used, shared or processed in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation.

Further, if we fail to comply with applicable privacy laws, we could face civil and criminal penalties, or claims for breach of contract.

The HHS has enforcement discretion for HIPAA, and any enforcement activity can result in financial liability and reputational harm, and responses to such enforcement activity can consume significant internal resources.

On April 22, 2024, HHS issued a Final Rule, the HIPAA Privacy Rule to Support Reproductive Health Care Privacy, which is intended to strengthen the HIPAA Privacy Rule by prohibiting the disclosure of protected health information related to lawful reproductive healthcare in certain circumstances.

HHS, as well as state Attorneys General have enforcement authority for HIPAA, and any enforcement activity can result in financial liability and reputational harm, and responses to such enforcement activity can consume significant internal resources.

On December 10, 2020, HHS issued proposed revisions to the HIPAA Privacy Rule aimed at reducing regulatory burdens that may exist in discouraging coordination of care, including creating an exception to the minimum necessary standard for healthcare coordination, and other proposals to increase patient access to their health information, among other changes.

Moreover, on December 27, 2024, HHS issued proposed revisions to the HIPAA Security Rule aimed at strengthening required cybersecurity protections for protected health information While a final rule has not yet been issued for either proposed rule, if adopted, these proposed changes may change standards for the processing, securing and sharing of health information in the industry, and impose additional risks and costs.

The Federal Trade Commission (FTC) has authority under Section 5 of the FTC Act to regulate unfair or deceptive practices, and has used this authority to initiate enforcement actions against companies that implement inadequate controls around privacy and information security in violation of their externally facing policies.

The FTC, as well as state attorneys general, have taken enforcement action against companies that do not abide by their representations to consumers regarding electronic security and privacy, including with respect to health information.

In addition, states have shown an increased interest in regulating the processing of personal information in general and specifically in the privacy of health data.

In addition, as referenced above, states have shown an increased interest in regulating the processing of personal information in general and specifically in the privacy of health data.

Washington state passed the My Health My Data Act, which took effect on March 31, 2024, and is focused on the collection of consumer health data.

The My Health My Data Act has a broader scope than HIPAA and includes a private right of action—depending on whether this law applies to us, there may be substantial regulatory action and litigation associated with this act.

Following Washington, Nevada enacted Senate Bill 370, which also took effect on March 31, 2024, and is similar to the My Health My Data Act and requires in-scope entities to comply with certain requirements regarding consumer health data.

Notably, Senate Bill 370 does not include a private right of action nor does it apply to entities that are subject to HIPAA.

Connecticut also amended its comprehensive privacy law in 2023, the Connecticut Data Privacy Act, to impose obligations aimed at “consumer health data.” Virginia also recently updated its Consumer Protection Act for certain health information and other states are considering health privacy legislation.

Furthermore, state attorneys general are authorized to bring civil actions seeking either injunctions or damages in response to violations that threaten the privacy of state residents pursuant to local state laws.

Following Washington, certain other states have enacted consumer health data protection laws.

We cannot be sure how these regulations will be interpreted, enforced or applied to our operations.

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Notably, following California’s lead, over a third of other U.S.

states enacted or proposed privacy laws that contain obligations similar to the CCPA that have taken effect or will take effect in coming years.

In addition, a comprehensive federal privacy bill, which includes a private right of action for violations, has been proposed and is under review by the U.S.

House of Representatives.

states enacted privacy laws that contain obligations similar to the CCPA that have taken effect or will take effect in coming years.

In addition, comprehensive federal privacy legislation continues to be considered.

While these new laws and proposals generally include exemptions for HIPAA-covered data and clinical trial data, they add layers of complexity to compliance in the U.S.

market and could increase our compliance costs and adversely affect our business.

Compliance with this new and evolving privacy legislation adds complexity and may require investment in additional resources for compliance programs, thus potentially result in additional costs and expense of resources to maintain compliance.

Compliance with evolving privacy legislation and regulation adds complexity and may require investment in additional resources for compliance programs, thus potentially result in additional costs and expense of resources to maintain compliance.

In the EU, the EU GDPR governs the collection, use, disclosure, transfer, or other processing of personal data.

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national security safeguards and redress.

Under the UK GDPR, companies not established in the UK but who process personal data in relation to the offering of goods or services to individuals in the UK, or to the monitoring of the behavior of individuals in the UK, will be subject to the UK GDPR.

On December 19, 2025, the European Commission adopted its most recent adequacy decision in favor of the UK, enabling data transfers from EU Member States to the UK without additional safeguards until December 27, 2031.

The UK GDPR also imposes similar restrictions on transfers of personal data from the UK to jurisdictions that the UK Government does not consider adequate, including the United States.

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data bridge through the UK extension to the DPF to organizations self-certified under the UK extension to the DPF.

However, the DPF in both the EU and UK may be subject to further legal challenge which could cause the legal requirements for personal data transfers from the EU and the UK to the United States to become uncertain once again.

However, the DPF for both the EU and UK may be subject to further legal challenge which could cause the legal requirements for personal data transfers from the EU and the UK to the United States to become uncertain once again.

EU and UK data protection authorities have and may again block the use of certain U.S.-based services that involve the transfer of personal data to the United States.

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We use artificial intelligence in our business, and challenges with properly managing its use could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operations.

We leverage artificial intelligence (AI) into certain aspects of our operations, including through our proprietary DEL-AI platform, which employs machine learning across all aspects of the discovery process.

However, our competitors and other third parties may incorporate AI into their operations and processes more quickly or more successfully than us, which could impair our ability to compete effectively and adversely affect our results of operations.

We leverage artificial intelligence (AI) in certain aspects of our operations, including through our proprietary DEL-AI platform, which employs machine learning across all aspects of the discovery process.

However, our competitors and other third parties may incorporate AI into their operations and processes more quickly or more successfully than we do, which could impair our ability to compete effectively and adversely affect our results of operations.

Additionally, if the output that AI applications assist in producing are or are alleged to be inaccurate, deficient, or biased, our business, financial condition, and results of operations may be adversely affected.

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AI also presents emerging ethical issues and if our use of AI becomes controversial, we may experience brand or reputational harm, competitive harm, or legal liability.

Legislation and regulations governing the development and use of AI have been passed or are under consideration in the United States at the state and local level, as well as internationally.

As a result, the ability to use artificial intelligence and machine learning may be constrained by current or future laws, regulatory or self-regulatory requirements.

The rapid evolution of AI, including regulation of AI and it various uses, will require significant resources to develop, test and maintain our platforms and AI operations to help us implement AI ethically in order to minimize unintended, harmful impact.

Legislation and regulations governing the development and use of AI, including specific AI legislation at the state level relating to AI in the life sciences and healthcare contexts, have been passed or are under consideration in the United States at the state and local level, as well as internationally.

As a result, the ability to use AI and machine learning may be constrained or complicated by current or future laws, regulatory or self-regulatory requirements, and further resources may be necessary to build compliance processes to respond to AI law developments.

The rapid evolution of AI, including regulation of AI and its various uses, will require significant resources to develop, test and maintain our platforms and AI operations to help us implement AI ethically in order to minimize unintended, harmful impact.

federal income tax reform and changes in other tax laws could adversely affect us.

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If we fail to comply with these laws, we could be subject to civil or criminal penalties, or other remedial measures and legal expenses, any of which could adversely affect our business, results of operations and financial condition.

Our operations are subject to anti-corruption laws, including the Foreign Corrupt Practices Act (FCPA), the Bribery Act and other anticorruption laws that apply in countries where we do business and may do business in the future.

Our operations are subject to anti-corruption laws, including the Foreign Corrupt Practices Act (FCPA), the Bribery Act and other anti-corruption laws that apply in countries where we do business and may do business in the future.

The FCPA, the Bribery Act and other anti-corruption or similar laws generally prohibit us, our officers and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage.

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economic sanctions, trade sanctions regulations administered by the U.S.

Department of the Treasury’s Office of Foreign Assets Controls, including restrictions or prohibitions on the sale or supply of certain products and services to U.S.-embargoed or sanctioned countries, governments, persons and entities, and other applicable export control regulations, customs requirements and currency exchange regulations, which we collectively refer to as Trade Control Laws.

Department of the Treasury’s Office of Foreign Assets Control, including restrictions or prohibitions on the sale or supply of certain products and services to U.S.-embargoed or sanctioned countries, governments, persons and entities, and other applicable export control regulations, customs requirements and currency exchange regulations, which we collectively refer to as Trade Control Laws.

There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the FCPA, the Bribery Act, or other legal requirements including Trade Control Laws.

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For example, the global financial crisis of 2007-2008 caused extreme volatility and disruptions in the capital and credit markets.

Similarly, the volatility associated with the COVID-19 pandemic caused significant instability and disruptions in the capital and credit markets and, more recently, the global economy has been impacted by interest rate fluctuations and inflation, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, as well as the possibility of a recession or further economic downturn.

and foreign trade policy, and uncertainty regarding the availability and cost of capital.

Moreover, there have been concerns in recent years with respect to the stability of the global banking system.

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dollar relative to other currencies, which may have the result of increasing the portions of our expenses which are realized in other currencies.

We currently do not engage in hedging transactions to protect against uncertainty in future exchange rates between particular foreign currencies and the U.S dollar.

We currently do not engage in hedging transactions to protect against uncertainty in future exchange rates between particular foreign currencies and the U.S.

We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our business, financial condition, results of operations and prospects.

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• regulatory developments affecting our drug candidates or those of our competitors;

• changes in general market and economic conditions, including interest rate fluctuations, inflation, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system and the possibility of a recession or further economic downturn.

• changes in general market and economic conditions, including interest rate fluctuations, inflation, tariffs, trade restrictions, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system, volatility in capital and credit markets, and the possibility of a recession or further economic downturn.

If our quarterly results of operations fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially.

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• natural disasters and other calamities;

• general economic, industry and market conditions, including interest rate fluctuations, inflation, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system and the possibility of a recession or further economic downturn.

• general economic, industry and market conditions, including interest rate fluctuations, inflation, tariffs, trade restrictions, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system, volatility in capital and credit markets, and the possibility of a recession or further economic downturn.

In addition, the stock market in general, and the markets for pharmaceutical, biopharmaceutical and biotechnology stocks in particular, have experienced extreme price and volume fluctuations that often have been unrelated or disproportionate to the operating performance of the issuer.

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however, any exercise would increase the number of shares eligible for future resale in the public market and result in substantial dilution to our stockholders.

As of February 28, 2026, we have issued pre-funded warrants to purchase a total of 8,315,020 shares of our common stock, of which 7,577,909 were outstanding as of February 28, 2026.

As of May 31, 2026, we have issued pre-funded warrants to purchase a total of 8,315,020 shares of our common stock, of which 7,577,909 were outstanding as of May 31, 2026.

Each pre-funded warrant is exercisable for $0.001 per share of common stock underlying such pre-funded warrant, which may be paid by way of a cashless exercise, meaning that the holder may not pay a cash purchase price upon exercise, but instead would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the pre-funded warrant.

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The impact of these requirements also could make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.

Moreover, these rules and regulations often are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.

Moreover, these rules and regulations continue to evolve and often are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.

This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors