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What changed in Nurix Therapeutics, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Nurix Therapeutics, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+516 added−493 removedSource: 10-K (2026-01-28) vs 10-K (2025-01-28)

Top changes in Nurix Therapeutics, Inc.'s 2025 10-K

516 paragraphs added · 493 removed · 402 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

144 edited+40 added−55 removed415 unchanged
Biggest changeCMS has also taken steps to implement the IRA, including: on August 29, 2023, releasing the initial list of ten drugs subject to price negotiations; on August 15, 2024 releasing the negotiated maximum prices for such drugs that will be effective beginning in 2026; on October 2, 2024, releasing final guidance outlining the process for the second round of price negotiations for products subject to the “maximum fair price” provision; and on December 20, 2024, releasing a list of 64 Medicare Part B products that had an adjusted coinsurance rate based on the inflationary rebate provisions of the IRA for the time period of January 1, 2025, to March 31, 2025.
Biggest changeCMS has also taken steps to implement the IRA, including releasing the negotiated maximum prices, which are effective in 2026 for the first ten drugs that were subject to the IRA’s negotiation process, as well as the negotiated maximum prices for fifteen additional drugs to be effective in 2027, and releasing quarterly lists of Medicare Part B products that are subject to adjusted coinsurance rates based on the inflationary rebate provisions of the IRA.
The EU GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the EU GDPR. Reimbursement of medicines in Europe In the EU, pricing and reimbursement methods can differ in each Member State.
The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR. Reimbursement of medicines in Europe In the EU, pricing and reimbursement methods can differ in each Member State.
By employing advanced machine learning models informed by empirical degrader assay datasets we amassed, which include a compendium of in vitro and in vivo pharmacokinetic and pharmacodynamic readouts from tens of thousands of targeted protein degrader compounds, we have the ability to reduce the number of design-make-test cycles in our optimization campaigns, eliminate optimization bottlenecks, and shorten the overall project timelines required to achieve desired TPD target product profiles.
By employing advanced machine learning models informed by empirical degrader assay datasets that we have amassed, which include a compendium of in vitro and in vivo pharmacokinetic and pharmacodynamic readouts from tens of thousands of targeted protein degrader compounds, we have the ability to reduce the number of design-make-test cycles in our optimization campaigns, eliminate optimization bottlenecks, and shorten the overall project timelines required to achieve desired TPD target product profiles.
It is possible that the distinction between a biosimilar and interchangeable could be eliminated in the future; the FDA in its Fiscal Year 2025 budget proposal for the first time included a request that Congress “eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products.” 40 In the EU and the UK, an abridged procedure is available for the regulatory approval of biosimilars, on the basis of comparability studies to the reference biological medicine to substantiate the safety and efficacy profile of the biosimilar product.
It is possible that the distinction between a biosimilar and interchangeable could be eliminated in the future; the FDA in its Fiscal Year 2025 budget proposal for the first time included a request that Congress “eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products.” In the EU and the UK, an abridged procedure is available for the regulatory approval of biosimilars, on the basis of comparability studies to the reference biological medicine to substantiate the safety and efficacy profile of the biosimilar product.
For more information, please see the sections titled “Risk Factors—Risks Related to Our Intellectual Property” and “Risk Factors—Risks Related to Regulatory Approval and Marketing of Our Drug Candidates.” Government Regulation The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.
For more information, please see the sections titled “Risk Factors—Risks Related to Our Intellectual Property” and “Risk Factors—Risks Related to Regulatory Approval and Marketing of Our Drug Candidates.” 30 Government Regulation The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.
These fees are typically increased annually. Sponsors of applications for drugs granted Orphan Drug Designation are exempt from these user fees. 32 The FDA has 60 days from its receipt of an NDA or BLA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review.
These fees are typically increased annually. Sponsors of applications for drugs granted Orphan Drug Designation are exempt from these user fees. The FDA has 60 days from its receipt of an NDA or BLA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review.
Conversely, the 10-year exclusivity period can be further extended by two years, when pediatric studies are conducted in accordance with an agreed pediatric investigation plan and in completion of all the legal requirements. It is noted that the general pharmaceutical legislative framework, as well as the framework applicable to orphan and pediatric medicinal products in the EU, is under review.
Conversely, the 10-year exclusivity period can be further extended by two years, when pediatric studies are conducted in accordance with an agreed pediatric investigation plan and in completion of all the legal requirements. 37 It is noted that the general pharmaceutical legislative framework, as well as the framework applicable to orphan and pediatric medicinal products in the EU, is under review.
The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug or biological product is manufactured.
The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. 33 Before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug or biological product is manufactured.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance. 37 Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance. Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
On March 11, 2021, Congress enacted the American Rescue Plan Act of 2021, which included among its provisions a sunset of the ACA’s cap on pharmaceutical manufacturers’ rebate liability under the Medicaid Drug Rebate Program. Under the ACA, manufacturers’ rebate liability was capped at 100% of the average manufacturer price for a covered outpatient drug.
For example, on March 11, 2021, Congress enacted the American Rescue Plan Act of 2021, which included among its provisions a sunset of the ACA’s cap on pharmaceutical manufacturers’ rebate liability under the Medicaid Drug Rebate Program. Under the ACA, manufacturers’ rebate liability was capped at 100% of the average manufacturer price for a covered outpatient drug.
We are also aware of clinical-staged BTK degraders currently in development by multiple companies, and we are aware of at least once company currently developing a clinical-staged CBL-B inhibitor. Our lead drug candidates target hematologic cancers and immune-mediated diseases.
We are also aware of clinical-staged BTK degraders currently in development by multiple companies, and we are aware of at least once company currently developing a clinical-staged CBL-B inhibitor. 28 Our lead drug candidates target hematologic cancers and immune-mediated diseases.
Our wholly owned, clinical stage pipeline includes three investigational drug candidates designed with the goal to be first-in-class or best-in-class therapeutics: NX-5948, a highly selective degrader of Bruton’s tyrosine kinase (BTK); NX-2127, a dual degrader of BTK and transcription factors IKZF1(Ikaros) and IKZF3 (Aiolos); and NX-1607, an inhibitor of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells.
Our wholly owned, clinical stage pipeline includes three investigational drug candidates designed with the goal to be first-in-class or best-in-class therapeutics: bexobrutideg (NX-5948), a highly selective degrader of Bruton’s tyrosine kinase (BTK); zelebrudomide (NX-2127), a dual degrader of BTK and transcription factors IKZF1(Ikaros) and IKZF3 (Aiolos); and NX-1607, an inhibitor of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells.
These changes include the Budget Control Act of 2011, which, among other things, led to aggregate reductions of Medicare payments to providers of up to 2% per fiscal year that started in 2013 and, due to subsequent statutory amendments, will remain in effect through the first eight months of the fiscal year 2032 sequestration order unless additional congressional action is taken, with the exception of a temporary suspension, and later a temporary reduction instituted during the COVID-19 pandemic that expired on July 1, 2022.
These changes include the Budget Control Act of 2011, which, among other things, led to aggregate reductions of Medicare payments to providers of up to 2% per fiscal year that started in 2013 and, due to subsequent statutory amendments, will remain in effect through the first eleven months of the fiscal year 2032 sequestration order unless additional congressional action is taken, with the exception of a temporary suspension, and later a temporary reduction instituted during the COVID-19 pandemic that expired on July 1, 2022.
For risks related to our intellectual property, please see “Risk Factors—Risks Related to Our Intellectual Property.” We believe that we have a strong global intellectual property position and substantial know how and trade secrets relating to our DEL-AI platform and drug candidates.
For risks related to our intellectual property, please see “Risk Factors—Risks Related to Our Intellectual Property.” 29 We believe that we have a strong global intellectual property position and substantial know how and trade secrets relating to our DEL-AI platform and drug candidates.
NX-2127 Phase 1 Study Design a Planned number of evaluable patients (i.e., meeting DLT evaluability criteria); b Planned number of evaluable patients (i.e., meeting efficacy evaluability criteria) CLL , chronic lymphocytic leukemia; DLBCL , diffuse large B-cell lymphoma; DLT , dose-limiting toxicity; FL , follicular lymphoma; MCL , mantle cell lymphoma; MTD , maximum tolerated dose; MZL , marginal zone lymphoma; PD , pharmacodynamics; PK , pharmacokinetics; PCNSL , primary central nervous system lymphoma; SLL , small lymphocytic lymphoma; WM , Waldenstrom's macroglobulinemia NX-2127 Clinical findings Positive data from the NX-2127 clinical study was presented at the 65th ASH annual meeting in December 2023 (ASH 2023) and ASH 2024, in patients with NHL and CLL, confirming a manageable safety profile that is consistent with previous reports for BTK-targeted and immunomodulatory therapies.
Zelebrudomide Phase 1 Study Design a Planned number of evaluable patients (i.e., meeting DLT evaluability criteria); b Planned number of evaluable patients (i.e., meeting efficacy evaluability criteria) CLL , chronic lymphocytic leukemia; DLBCL , diffuse large B-cell lymphoma; DLT , dose-limiting toxicity; FL , follicular lymphoma; MCL , mantle cell lymphoma; MTD , maximum tolerated dose; MZL , marginal zone lymphoma; PD , pharmacodynamics; PK , pharmacokinetics; PCNSL , primary central nervous system lymphoma; SLL , small lymphocytic lymphoma; WM , Waldenstrom's macroglobulinemia Zelebrudomide Clinical findings Positive data from the zelebrudomide clinical study was presented at the 65th ASH annual meeting in December 2023 (ASH 2023) and ASH 2024, in patients with NHL and CLL, confirming a manageable safety profile that is consistent with previous reports for BTK-targeted and immunomodulatory therapies.
NX-1607 is an orally bioavailable inhibitor of CBL-B that has the potential to relieve T cell anergy and promote anti-cancer immune cell activity. NX-1607 is currently being explored in a variety of solid tumor indications. Status of NX-1607: We are currently conducting a Phase 1a/1b dose-escalation and cohort expansion study of NX-1607 in patients with a range of oncology indications.
NX-1607 is an orally bioavailable inhibitor of CBL-B that has the potential to reduce T cell anergy and promote anti-cancer immune cell activity. NX-1607 is currently being explored in a variety of solid tumor indications. Status of NX-1607: We are currently conducting a Phase 1a/1b dose-escalation and cohort expansion study of NX-1607 in patients with a range of oncology indications.
Among other reforms, the IRA imposes inflation rebates on drug and biological product manufacturers for products reimbursed under Medicare Parts B and D if the prices of those products increase faster than inflation beginning in 2023; implements changes to the Medicare Part D benefit that, beginning in 2025, will cap benefit annual out-of-pocket spending at $2,000, with new discount obligations for pharmaceutical manufacturers; and, beginning in 2026, establishes 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 CMS.
Among other reforms, the IRA imposes inflation rebates on drug and biological product manufacturers for products reimbursed under Medicare Parts B and D if the prices of those products increase faster than inflation beginning in 2023; implements changes to the Medicare Part D benefit that, beginning in 2025, caps benefit annual out-of-pocket spending at $2,000, with new discount obligations for pharmaceutical manufacturers; and, beginning in 2026, establishes 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 CMS.
Clinical development of NX-1607 We are studying the pharmacology, safety and clinical activity of single-agent NX-1607 and the combination of NX-1607 with taxane chemotherapy in multiple solid tumor indications. The solid tumors selected for this initial assessment include three different immune phenotypes: checkpoint-resistant tumors, tumors with an immunosuppressive microenvironment and tumors that are poorly immunogenic.
Clinical development of NX-1607 We are studying the pharmacology, safety and clinical activity of single-agent NX-1607 and have studied the combination of NX-1607 with taxane chemotherapy in multiple solid tumor indications. The solid tumors selected for this initial assessment include three different immune phenotypes: checkpoint-resistant tumors, tumors with an immunosuppressive microenvironment and tumors that are poorly immunogenic.
Under our Gilead, Sanofi and Pfizer collaborations, we have the potential to receive up to $7.1 billion in future fees and milestone payments, as well as royalties on future sales, and we retain certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates.
Under our Gilead, Sanofi and Pfizer collaborations, we have the potential to receive up to $6.1 billion in future fees and milestone payments, as well as royalties on future sales, and we retain certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates.
Some of these cost-savings pilots and projects, such as the Enhancing Oncology Model, are directed specifically at oncology. The ACA and certain of its provisions have been subject to judicial challenges as well as legislative and regulatory efforts to repeal or replace them or to alter their interpretation or implementation.
Some of these cost-savings pilots and projects, such as the Enhancing Oncology Model, are directed specifically at oncology. The ACA and certain of its provisions have been subject to judicial challenges as well as legislative and regulatory efforts to repeal or replace them, to alter their interpretation, or to otherwise impact the implementation of the ACA.
Minor changes in the amino acid sequence of a target protein, as a consequence of somatic or inhibitor-induced resistance mutations, do not necessarily preclude degrader activity, even in cases where the mutations occur within the degrader binding site.
Minor changes in the amino acid sequence of a target protein, as a consequence of somatic or inhibitor-selected resistance mutations, do not necessarily preclude degrader activity, even in cases where the mutations occur within the degrader binding site.
As of November 30, 2024, we are eligible to receive up to approximately $1.8 billion in total additional payments based on certain additional fees, payments and the successful completion of certain preclinical, clinical, development and sales milestones.
As of November 30, 2025, we are eligible to receive up to approximately $1.8 billion in total additional payments based on certain additional fees, payments and the successful completion of certain preclinical, clinical, development and sales milestones.
We previously initiated Phase 1b expansion cohorts for patients with relapsed CLL, diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). Enrollment was paused in 2023 due to a partial clinical hold stemming from a manufacturing change designed to produce a chirally controlled form of NX-2127.
We previously initiated Phase 1b expansion cohorts for patients with relapsed CLL, diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). Enrollment was paused in 2023 due to a partial clinical hold stemming from a manufacturing change designed to produce a chirally controlled form of zelebrudomide.
Patients enrolled in the clinical study who are deriving clinical benefit on the original drug product may continue to receive treatment in accordance with the ongoing study protocol, but all new patients are being treated with the new drug product.
Patients enrolled in the clinical study who are deriving clinical benefit on the original drug product may continue to receive treatment in accordance with the ongoing study protocol, however all new patients are being treated with the new drug product.
Our focus on culture comes from our Board and flows throughout our company. In evaluating our Chief Executive Officer and management team, significant emphasis is place on their contributions to our overall culture.
Our focus on culture comes from our Board and flows throughout our company. In evaluating our Chief Executive Officer and management team, significant emphasis is placed on their contributions to our overall culture.
According to the Windsor Framework, medicinal products intended for the UK market including Northern Ireland will be authorized by the MHRA and will bear a “UK only” label. This means that medicinal products placed on the market in Northern Ireland no longer need to be compliant with EU law. These new measures have been implemented as of January 1, 2025.
According to the Windsor Framework, medicinal products intended for the UK market including Northern Ireland are now authorized by the MHRA and must bear a “UK only” label. This means that medicinal products placed on the market in Northern Ireland no longer need to be compliant with EU law. These new measures have been implemented as of January 1, 2025.
The following chart summarizes our clinical and preclinical pipelines and ongoing clinical studies: 4 Clinical Pipeline Our portfolio of targeted protein degraders of the B‑cell signaling protein BTK comprises NX‑5948, an investigational, orally bioavailable, highly selective BTK degrader for the treatment of relapsed or refractory B-cell malignancies and potentially autoimmune diseases, and NX‑2127, an investigational, orally bioavailable degrader that simultaneously degrades BTK and two well-characterized cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) that are clinically validated transcription factor targets for relapsed or refractory B‑cell malignancies.
The following chart summarizes our clinical and preclinical pipelines and ongoing clinical studies: 4 Clinical Pipeline Our portfolio of targeted protein degraders of the B‑cell signaling protein BTK comprises bexobrutideg, an investigational, orally bioavailable, highly selective BTK degrader for the treatment of relapsed or refractory B-cell malignancies and potentially autoimmune diseases, and zelebrudomide, an investigational, orally bioavailable degrader that simultaneously degrades BTK and two well-characterized cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) that are clinically validated transcription factor targets for relapsed or refractory B‑cell malignancies.
We expect to earn multiple additional preclinical and clinical milestones across our three active partnerships in 2025, which may allow us to secure additional license and development candidate events in subsequent years. 6 • Advance our proprietary portfolio of preclinical programs toward additional INDs.
We expect to earn multiple additional preclinical and clinical milestones across our three active partnerships in 2026, which may allow us to secure additional license and development candidate events in 2026 and subsequent years. • Advance our proprietary portfolio of preclinical programs toward additional INDs.
Enrollment was paused in the fourth quarter of 2023 due to a partial clinical hold stemming from a manufacturing change designed to produce a chirally controlled form of NX-2127. Enrollment of new patients in the NX-2127 clinical trial recommenced in August 2024, following resolution of the partial hold by the FDA.
Enrollment was paused in the fourth quarter of 2023 due to a partial clinical hold stemming from a manufacturing change designed to produce a chirally controlled form of zelebrudomide. Enrollment of new patients in the zelebrudomide clinical trial recommenced in August 2024, following resolution of the partial hold by the FDA.
For patients with CLL, despite a median of five prior lines of treatment and BTK mutations present in 36% of patients, NX-2127 treatment resulted in an objective overall response rate of 40.7%, including partial responses in 11 patients, with treatment ongoing in 13 patients.
For patients with CLL, despite a median of five prior lines of treatment and BTK mutations present in 36% of patients, zelebrudomide treatment resulted in an objective overall response rate of 40.7%, including partial responses in 11 patients, with treatment ongoing in 13 patients.
In 2025, we intend to commence enrollment of a suite of additional trials designed to support the potential future registration of the drug in multiple regulatory jurisdictions.
In 2026, we intend to commence enrollment of a suite of additional trials designed to support the potential future registration of the drug in multiple regulatory jurisdictions.
We believe that NX-5948 may offer unique advantages over currently available BTK inhibitors in these disease indications by addressing both the enzymatic and scaffold activities of BTK, which are key to its function.
We believe that bexobrutideg may offer unique advantages over currently available BTK inhibitors in these disease indications by addressing both the enzymatic and scaffold activities of BTK, which are key to its function.
Enrollment of new patients in our Phase 1a/1b clinical trial of NX-2127 has resumed in adults with relapsed or refractory B-cell malignancies. In 2025, we expect to define doses to enable a Phase 1b cohort expansion. • Continue development of NX-1607 through dose escalation in a range of solid tumor indications.
Enrollment of new patients in our Phase 1a/1b clinical trial of NX-2127 has continued in adults with relapsed or refractory B-cell malignancies. In 2026, we expect to define doses to enable a Phase 1b cohort expansion. • Continue development of NX-1607 through dose escalation in a range of solid tumor indications.
We have personnel or engaged consultants with extensive technical, manufacturing, analytical and quality experience and good project management to oversee contract manufacturing and testing activities. We have engaged third-party manufacturers to supply the drug substances for NX-5948, NX-2127 and NX-1607 and to develop and manufacture finished drug products for use in our clinical trials.
We have personnel or engaged consultants with extensive technical, manufacturing, analytical and quality experience and good project management to oversee contract manufacturing and testing activities. We have engaged third-party manufacturers to supply the drug substances for bexobrutideg, zelebrudomide, and NX-1607 and to develop and manufacture finished drug products for use in our clinical trials.
We will also be subject to certain ex-U.S. privacy laws in connection with our clinical trial activities outside the United States such as the EU General Data Protection Regulation (EU GDPR), non-compliance with which could result in administrative fines of up to the greater of €20.0 million or 4% of global annual revenues.
We will also be subject to certain ex-U.S. privacy laws in connection with our clinical trial activities outside the United States such as the EU and UK General Data Protection Regulation (GDPR), non-compliance with which could result in administrative fines of up to the greater of 4% of global annual revenues or €20.0 million (under the EU GDPR) or £17.5m (under the UK GDPR).
In 2025, we plan to expand the current Phase 1b trial in patients with CLL to include patients who are also suffering from immune-mediated cytopenias such as anemia, a common co-morbidity associated with CLL.
In 2025, we expanded the current Phase 1b trial in patients with CLL to include patients who are also suffering from immune-mediated cytopenias such as anemia, a common co-morbidity associated with CLL.
In December 2024, the FDA granted Fast Track designation for NX-5948 for the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM) after at least two lines of therapy, including a BTK inhibitor. Status of NX‑2127: We are currently conducting a Phase 1a/1b dose-escalation and cohort expansion study of NX-2127 in patients with relapsed or refractory B-cell malignancies.
In December 2024, the FDA granted Fast Track designation for bexobrutideg for the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM) after at least two lines of therapy, including a BTK inhibitor. Status of Zelebrudomide: We are currently conducting a Phase 1a/1b dose-escalation and cohort expansion study of zelebrudomide in patients with relapsed or refractory B-cell malignancies.
Tumor shrinkage and clinical responses were observed in patients regardless of prior lines of therapy or baseline BTK mutations. 14 NX-2127 NHL efficacy NX-2127 CLL efficacy Source: Danilov et al, ASH 2023, Poster #4463 Background on CBL-B as a regulator of T-cell activation T cells are central to the cell-mediated adaptive immune response.
Tumor shrinkage and clinical responses were observed in patients regardless of prior lines of therapy or baseline BTK mutations. Zelebrudomide NHL efficacy Zelebrudomide CLL efficacy Source: Danilov et al, ASH 2023, Poster #4463 16 Background on CBL-B as a regulator of T-cell activation T cells are central to the cell-mediated adaptive immune response.
The expected expirations for issued patents and patents that may issue from pending applications covering our clinical candidates are between the years 2039 and 2044 for NX-5948; 2039 and 2042 for NX-2127; and 2040 and 2043 for NX-1607. The term of individual patents depends upon the laws of the countries in which they are obtained.
The expected expirations for issued patents and patents that may issue from pending applications covering our clinical candidates are between the years 2039 and 2044 for bexobrutideg; 2039 and 2042 for zelebrudomide; and 2040 and 2043 for NX-1607. The term of individual patents depends upon the laws of the countries in which they are obtained.
In November 2024, the European Medicines Agency (EMA) granted Priority Medicine (PRIME) designation for NX-5948 in CLL or SLL after at least a BTK inhibitor and a BCL-2 inhibitor.
In November 2024, the European Medicines Agency (EMA) granted Priority Medicine (PRIME) designation for bexobrutideg in CLL or SLL after at least a BTK inhibitor and a BCL-2 inhibitor.
Enrollment is ongoing in our Phase 1a/1b trial for NX-1607 in adults with multiple solid tumor types. In 2025, we expect to define doses and potential indications to enable a Phase 1b cohort expansion. • Advance our portfolio of preclinical programs to generate development candidates and license agreements for our partnered pipeline.
Enrollment is ongoing in our Phase 1a/1b trial for NX-1607 in adults with multiple solid tumor types. In 2025, we continued dose escalation and expect to define doses and potential indications to enable a Phase 1b cohort expansion in 2026. 6 • Advance our portfolio of preclinical programs to generate development candidates and license agreements for our partnered pipeline.
Our partnership efforts are focused on the advancement of a robust and sustainable pipeline in collaboration with our partners Gilead, Sanofi, and Pfizer. In our more mature partnerships with Gilead and Sanofi, multiple disclosed and undisclosed programs are advancing through lead optimization and IND-enablement.
Our partnership efforts are focused on the advancement of a robust and sustainable pipeline in collaboration with our partners Gilead, Sanofi, and Pfizer. In our more mature partnerships with Gilead and Sanofi, multiple disclosed and undisclosed programs are advancing through lead optimization, IND-enablement and Phase 1 clinical studies.
However, TPDs are increasingly cited for their ability to penetrate and show pharmacology in the CNS, in part due to the minimal plasma exposure required for these catalytic agents to exhibit target coverage. • Inhibiting E3 ligases to control pathway activation.
However, TPDs are increasingly cited for their ability to penetrate and show pharmacology in the CNS, in part due to the minimal plasma and cerebral spinal fluid (CSF) exposure required for these catalytic agents to exhibit target coverage. • Inhibiting E3 ligases to control pathway activation.
Potential advantages of BTK degraders We have conducted extensive preclinical studies of our two clinical stage BTK degraders. We have demonstrated that both NX-5948 and NX-2127 can induce BTK degradation and inhibit tumor growth with oral administration in xenograft mouse models implanted with both wild-type and ibrutinib-resistant lymphoma cell lines.
Potential advantages of BTK degraders We have conducted extensive preclinical studies of our two clinical stage BTK degraders. We have demonstrated that both bexobrutideg and zelebrudomide can induce BTK degradation and inhibit tumor growth with oral administration in xenograft mouse models implanted with both wild-type and ibrutinib-resistant lymphoma cell lines.
We believe that targeted protein degradation of BTK may be a superior approach to existing covalent or noncovalent BTK inhibitors, particularly in the relapsed and refractory setting, and in the setting of resistance mutations to both covalent and noncovalent inhibitors. Immunomodulatory drugs, including Revlimid, or lenalidomide, and Pomalyst, or pomalidomide, are analogs of Thalomid, or thalidomide.
We believe that targeted protein degradation of BTK may be a superior approach to existing covalent or noncovalent BTK inhibitors as well as in the setting of resistance mutations to both covalent and noncovalent inhibitors. Immunomodulatory drugs, including Revlimid, or lenalidomide, and Pomalyst, or pomalidomide, are analogs of Thalomid, or thalidomide.
Of our vice president-level and above employees, 33% were self-reported as ethnic or racial minorities in the United States, with 21% Asian and 8% Black or African American. Employee development and training We focus on attracting, retaining and cultivating talented individuals.
Of our vice president-level and above employees, approximately 33% were self-reported as ethnic or racial minorities in the United States, with approximately 30% Asian and 3% Black or African American. Employee development and training We focus on attracting, retaining and cultivating talented individuals.
As of November 30, 2024, we have received a total of $435.0 million in non-dilutive funding from our collaborations, which has enabled us to invest in our own research and development activities.
As of November 30, 2025, we have received a total of $482.0 million in non-dilutive funding from our collaborations, which has enabled us to invest in our own research and development activities.
Removing a protein from the cell by targeting it for proteasomal destruction eliminates all of a protein’s functionality, in contrast to small molecule inhibitors that only block enzymatic function. • Degraders can access an expanded range of target space.
Removing a protein from the cell by targeting it for proteasomal destruction eliminates all of a protein’s functionality, including scaffolding or structural functions, in contrast to small molecule inhibitors that only block enzymatic function. • Degraders can access an expanded range of target space.
In our partnership with Pfizer, which was announced in September 2023 under an agreement with Seagen, Inc., we have achieved two preclinical milestones to date, qualifying for $10.0 million in milestone payments.
In our partnership with Pfizer, which was announced in September 2023 under an agreement with Seagen, Inc., we have achieved three preclinical milestones to date, qualifying for $15.0 million in milestone payments.
These laws include anti-kickback statutes, false claims statutes and other healthcare laws and regulations. 42 The federal Anti-Kickback Statute is a broad criminal statute that prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, in cash or in kind, to induce, or in return for, purchasing, leasing, ordering or arranging for, referring, or recommending the purchase, lease or order of any healthcare item or service that may be reimbursable, in whole or in part, under Medicare, Medicaid, or other federal healthcare programs.
The federal Anti-Kickback Statute is a broad criminal statute that prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, in cash or in kind, to induce, or in return for, purchasing, leasing, ordering or arranging for, referring, or recommending the purchase, lease or order of any healthcare item or service that may be reimbursable, in whole or in part, under Medicare, Medicaid, or other federal healthcare programs.
The key elements of our strategy are to: • Advance our lead program, NX-5948, into late-stage clinical development in CLL and potentially other B-cell malignancies. Enrollment is ongoing in our Phase 1b clinical trial of NX-5948 in adults with relapsed or refractory B-cell malignancies.
The key elements of our strategy are to: • Advance our lead program, bexobrutideg, into late-stage clinical development in CLL and potentially other B-cell malignancies. Enrollment is ongoing in our Phase 2 clinical trial of bexobrutideg in adults with relapsed or refractory CLL.
In addition, from the signing of the Gilead Agreement to November 30, 2024, we received payments of $47.0 million for research milestones and additional payments, $20.0 million for a license option exercise payment and $15.0 million in research term extension fees.
In addition, from the signing of the Gilead Agreement to November 30, 2025, we received payments of $47.0 million for research milestones and additional payments, $20.0 million for a license option exercise payment, $15.0 million in research term extension fees and $5.0 million for a clinical milestone payment.
In a Phase 3 trial, the drug or biological product is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy or potency and purity, and safety, of the product for approval or licensure, to establish the overall risk benefit profile of the product, and to provide adequate information for the labeling of the product.
In a Phase 3 trial, the drug or biological product is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy or potency and purity, and safety, of the product for approval or licensure, to establish the overall risk benefit profile of the product, and to provide adequate information for the labeling of the product. 32 In most cases the FDA requires at least two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy or potency of the drug.
As of November 30, 2024, we have received a total of $435.0 million in non-dilutive financing from our collaborators, and we are eligible to receive up to $7.1 billion in potential future fees and milestone payments, as well as royalties on future product sales.
As of November 30, 2025, we have received a total of $482.0 million in non-dilutive financing from our collaborators, and we are eligible to receive up to $6.1 billion in potential future fees and milestone payments, as well as royalties on future product sales.
To attract qualified applicants, we offer a total rewards package consisting of a base salary and cash target bonus, a comprehensive benefits package and equity compensation for all full-time and part-time employees. Bonus opportunity and equity compensation increase as a percentage of total compensation based on level of responsibility.
To attract qualified applicants, we offer a total rewards package consisting of a base salary and cash target bonus, a comprehensive benefits package and equity compensation for all full-time and part-time employees. Bonus opportunity and equity compensation increase as a percentage of total compensation based on level of responsibility. Actual bonus payout is based on company and individual performance.
Pursuant to the Northern Ireland Protocol, the EU pharmaceutical legal framework acquis continues to apply in Northern Ireland and medicines can only be placed in the Northern Ireland market if they comply with EU law. The UK government reached a new agreement with the EU, the “Windsor Framework,” which has replaced the Northern Ireland protocol.
Pursuant to the Northern Ireland Protocol, the EU pharmaceutical legal framework acquis continued to apply in Northern Ireland and medicines could only be placed in the Northern Ireland market if they complied with EU law. The UK government reached a new agreement with the EU, the “Windsor Framework,” which has replaced the Northern Ireland protocol.
We plan to focus development in indications where NX-2127 shows evidence of compelling clinical activity and where there is high unmet need. 12 The Phase 1a/1b dose escalation and cohort expansion study was initiated in 2021.
We plan to focus development in NHL indications where zelebrudomide shows evidence of compelling clinical activity and where there is high unmet need. 14 The Phase 1a/1b dose escalation and cohort expansion study was initiated in 2021.
We plan to leverage the Fast Track designation from the FDA in CLL and WM as well as the PRIME designation from the EMA to accelerate the clinical development and registrational path for NX-5948 in oncology. • Explore the therapeutic applications of our lead BTK degrader, NX-5948, for the treatment of patients with diseases caused by inflammation and autoimmunity.
We plan to leverage the Fast Track designation from the FDA in CLL and WM as well as the PRIME designation from the EMA to accelerate the clinical development and registrational path for bexobrutideg in oncology. • Explore the therapeutic applications of bexobrutideg, for the treatment of patients with diseases caused by inflammation and autoimmunity.
In 2025, we may further explore the utility of NX-5948 in autoimmune and inflammatory diseases with a separate clinical program which will require an IND with a separate division at the FDA. • Continue development of NX-2127 through dose escalation with a focus on aggressive lymphomas including MCL and DLBCL.
In 2026, we may further explore the utility of bexobrutideg in autoimmune and inflammatory diseases with a separate clinical program which will require an IND with a separate division at the FDA. • Continue development of zelebrudomide through dose escalation with a focus on aggressive lymphomas including MCL and DLBCL.
Our DEL-AI Platform and Research Engine In disease settings where existing treatments are limited by suboptimal efficacy, safety, or rapid mutational resistance, or in settings that lack treatment options because the relevant disease drivers are not druggable by conventional means, we believe targeted protein degradation represents a promising treatment paradigm with the potential to greatly expand the number of pharmaceutically tractable biological disease targets and thereby significantly improve patient care.
NX-1607 Demonstrates a Disease Control Rate of 49.3% Across Doses and Tumor Types 18 Our DEL-AI Platform and Research Engine In disease settings where existing treatments are limited by suboptimal efficacy, safety, or rapid mutational resistance, or in settings that lack treatment options because the relevant disease drivers are not druggable by conventional means, we believe targeted protein degradation represents a promising treatment paradigm with the potential to greatly expand the number of pharmaceutically tractable biological disease targets and thereby significantly improve patient care.
Moreover, there have been several recent U.S. Congressional inquiries and proposed federal legislation designed to, among other things, bring more transparency to drug and biological product pricing, review the relationship between pricing and manufacturer patient support programs, reduce the cost of prescription drugs and biological products under Medicare and reform government program reimbursement methodologies for drug and biological products.
Congressional inquiries and proposed federal legislation designed to, among other things, bring more transparency to drug and biological product pricing, review the relationship between pricing and manufacturer patient support programs, reduce the cost of prescription drugs and biological products under Medicare and reform government program reimbursement methodologies for drug and biological products.
Corporate Strategy Our strategy is to discover and develop breakthrough therapies for patients with significant unmet clinical need by developing highly differentiated targeted protein degrader drugs that eliminate disease-causing or disease-associated biological targets that to date have been ineffectively drugged or have been considered undruggable with existing modalities.
Corporate Strategy Our strategy is to discover and develop breakthrough therapies for patients with significant unmet clinical need by developing highly differentiated degrader-based medicines that alter or remove disease-causing or disease-associated biological targets that to date have been ineffectively drugged or have been considered undruggable with existing modalities.
The figure below shows a heat map of the relative activity of NX-5948 and NX-2127 compared to a panel of both covalent and non-covalent BTK inhibitors.
The figure below shows a heat map of the relative activity of bexobrutideg compared to a panel of both covalent and non-covalent BTK inhibitors.
This is in strong contrast to the propensity of amino acid point mutations to disrupt the in vivo activity and efficacy of inhibitor drugs. 20 • Degraders can penetrate the CNS. Small molecule drugs and, most prominently beyond-the-rule-of-five compounds rarely achieve potent CNS exposure or activity.
This desirable property relates to the event-driven pharmacology of degraders and is in stark contrast to the propensity of amino acid point mutations to disrupt the in vivo activity and efficacy of inhibitor drugs. 20 • Degraders can penetrate the CNS. Small molecule drugs and, most prominently beyond-the-rule-of-five compounds rarely achieve potent CNS exposure or activity.
Actual bonus payout is based on company and individual performance. 47 Diversity and inclusion We are committed to creating and maintaining a workplace free from discrimination or harassment on the basis of color, race, sex, national origin, ethnicity, religion, age, disability, sexual orientation, gender identification or expression or any other status protected by applicable law.
Diversity and inclusion We are committed to creating and maintaining a workplace free from discrimination or harassment on the basis of color, race, sex, national origin, ethnicity, religion, age, disability, sexual orientation, gender identification or expression or any other status protected by applicable law.
By combining Nurix’s experience in machine learning, automated chemistry and targeted protein degraders with Pfizer’s expertise in antibody conjugate design, optimization and development, we believe we can achieve technical synergies that could allow us to redefine the application of antibody conjugates for not only oncology but also non-oncology indications.
By combining Nurix’s experience in machine learning, automated chemistry and targeted protein degraders with Pfizer’s expertise in antibody conjugate design, optimization and development, we believe we can achieve technical synergies that could allow us to redefine the application of antibody conjugates for not only oncology but also non-oncology indications. 7 • Grow our proprietary pipeline by expanding the capabilities of our DEL-AI platform.
Human Capital As of November 30, 2024, we had 286 full-time or part-time employees, of which approximately 43% have earned an M.D. or a Ph.D. As of November 30, 2024, 256 of our full-time or part-time employees are engaged in research and development. From time to time, we retain independent contractors to support our organization.
Human Capital As of November 30, 2025, we had 317 full-time or part-time employees, of which approximately 38% have earned an M.D. or a Ph.D. As of November 30, 2025, 257 of our full-time or part-time employees are engaged in research and development. From time to time, we retain independent contractors to support our organization.
When an ANDA applicant files its application with the FDA, the applicant is required to certify to the FDA concerning any patents listed for the reference product in the Orange Book, except for patents covering methods of use for which the ANDA applicant is not seeking approval.
Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Orange Book. 39 When an ANDA applicant files its application with the FDA, the applicant is required to certify to the FDA concerning any patents listed for the reference product in the Orange Book, except for patents covering methods of use for which the ANDA applicant is not seeking approval.
Food and Drug Administration (FDA) granted Fast Track designation for NX-5948 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor.
In January 2024, the FDA granted Fast Track designation for bexobrutideg for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor.
Recruitment, hiring, development, training, compensation and advancement at our company is based on qualifications, performance, skills and experience without regard to gender, race and ethnicity. As of November 30, 2024, approximately 51% of our full-time and part-time employees were self-reported as female. Of our vice president-level and above employees, approximately 42% were self-reported as female.
Recruitment, hiring, development, training, compensation and advancement at our company is based on qualifications, performance, skills and experience without regard to gender, race and ethnicity. As of November 30, 2025, approximately 55% of our full-time and part-time employees were self-reported as female.
Within these collaborations, we retain certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates.
(Gilead), Sanofi S.A. (Sanofi) and Pfizer Inc. (Pfizer). Within these collaborations, we retain certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates.
At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological 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, to encourage importation from other countries and bulk purchasing.
It remains to be seen how these drug pricing initiatives will affect the broader pharmaceutical industry. 46 At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological 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, to encourage importation from other countries and bulk purchasing.
We will provide any of the foregoing information without charge upon written request to our Corporate Secretary, Nurix Therapeutics, Inc., 1700 Owens Street, Suite 205, San Francisco, California 94158. We use our Investor Relations website (http://ir.nurixtx.com) as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD promulgated by the SEC.
We will provide any of the foregoing information without charge upon written request to our Corporate Secretary, Nurix Therapeutics, Inc., 1600 Sierra Point Parkway, Brisbane, California 94005. We use our Investor Relations website (http://ir.nurixtx.com) as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD promulgated by the SEC.
The EU and UK operate accelerated evaluation and assessment schemes, which include, at EU level, Priority Medicines (PRIME) scheme and, at UK level, the Early Access to Medicines Scheme (EAMS), which may be granted in exceptional cases, often when there is unmet medical need for a life-threatening or serious debilitating condition and existing data show a positive benefit/risk balance that means the medicinal product is of a major public health interest.
In addition, all promotional materials for drugs and biological products approved under accelerated regulations are subject to prior review by the FDA. 36 The EU and UK operate accelerated evaluation and assessment schemes, which include, at EU level, Priority Medicines (PRIME) scheme and, at UK level, the Early Access to Medicines Scheme (EAMS), which may be granted in exceptional cases, often when there is unmet medical need for a life-threatening or serious debilitating condition and existing data show a positive benefit/risk balance that means the medicinal product is of a major public health interest.
If a Member State does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding. Since the UK has left the EU, Great Britain is no longer covered by centralized marketing authorizations.
If a Member State does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding. 34 Since the UK has left the EU, it is no longer covered by centralized marketing authorizations. A separate marketing authorization application is required in respect of the UK.
The Inflation Reduction Act of 2022 (IRA) extended this increased tax credit assistance and removal of the 400% federal poverty limit through 2025. In the future, there may be additional challenges and/or amendments to the ACA.
The Inflation Reduction Act of 2022 (IRA) extended this increased tax credit assistance and removal of the 400% federal poverty limit through 2025. This tax credit assistance expired on December 31, 2025, and additional action from Congress would be needed to restore such assistance in the future. In the future, there may be additional challenges and/or amendments to the ACA.
Some patients also have mutations associated with BTK inhibitor resistance and other high risk molecular and clinical features. The study is currently enrolling in the United States, the UK, and in selected sites in Europe.
The patients in the study represent a heavily pre-treated population with a variety of previous treatments. Some patients also have mutations associated with BTK inhibitor resistance and other high risk molecular and clinical features. The study is currently enrolling in the United States, the UK, and in selected sites in Europe.
Hatch-Waxman patent certification and the 30-month stay In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims cover the applicant’s product. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Orange Book.
Hatch-Waxman patent certification and the 30-month stay In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims cover the applicant’s product.
We are also advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in our preclinical pipeline. Our partnered drug discovery pipeline consists of preclinical stage degraders of IRAK4, STAT6 and multiple currently undisclosed targets under collaboration agreements with Gilead Sciences, Inc. (Gilead), Sanofi S.A. (Sanofi) and Pfizer Inc. (Pfizer).
We are also advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in our preclinical pipeline. Our partnered drug discovery pipeline consists of a clinical stage degrader of IRAK4 (NX-0479/GS-6791), a preclinical stage degrader of STAT6, currently in investigational new drug application (IND), enabling studies, and multiple currently undisclosed targets under collaboration agreements with Gilead Sciences, Inc.
NX-5948 Phase 1 Clinical Study Design 11 NX-5948 Phase 1 clinical findings in chronic lymphocytic leukemia Clinical findings from the NX-5948 Phase 1 trial were presented at the 66th American Society of Hematology annual meeting in December 2024 (ASH 2024).
Bexobrutideg Phase 1 Clinical Study Design Bexobrutideg Phase 1a clinical findings in chronic lymphocytic leukemia Clinical findings from the bexobrutideg Phase 1a trial were presented at the 67th American Society of Hematology annual meeting in December 2025 (ASH 2025).

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf one or more of our drug candidates receives marketing approval and we, or others, discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, a number of potentially significant negative consequences could result, including: • regulatory authorities may withdraw their approval of the drug or seize the drug; • we, or any future collaborators, may be required to recall the drug, change the way the drug is administered or conduct additional clinical trials; • additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular drug; • we may be subject to fines, injunctions or the imposition of civil or criminal penalties; • regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication; • we, or any future collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients; • we, or any future collaborators, could be sued and held liable for harm caused to patients; • the drug may become less competitive in the marketplace; and • our reputation may suffer.
Biggest changeIf one or more of our drug candidates receives marketing approval and we, or others, later discover that the drug is less effective than previously believed, or causes undesirable side effects that were not previously identified, or if issues with the manufacturing process or manufacturers arise, or if we fail to comply with regulatory requirements, a number of potentially significant negative consequences could result, including: • regulatory authorities may withdraw their approval of the drug or seize the drug; • we, or any future collaborators, may be required to recall the drug, change the way the drug is administered, conduct post-marketing studies or additional clinical trials, or withdraw the drug from the market; • additional restrictions may be imposed on the marketing, manufacturing processes, distribution, import or export, or use of the particular drug; • we may be subject to litigation, fines, restitution, disgorgement of profits or revenues, injunctions or the imposition of civil or criminal penalties; • we may receive warning letters or untitled letters from regulatory authorities; • regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication, or impose other restrictions or warnings on the labeling or marketing of the drug; • we, or any future collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients; • regulatory authorities may refuse to approve pending applications or supplements to approved applications that we submit; • any ongoing clinical trials may be suspended; • we, or any future collaborators, could be sued and held liable for harm caused to patients; • relationships with any potential collaborators may be damaged; • the drug may become less competitive in the marketplace; • we may receive unfavorable press coverage; and • our reputation may suffer.
If any of the following risks occur, our business, financial condition, results of operations, and future prospects could be materially and adversely affected. In that event, the trading price of our common stock could decline, and you could lose part or all of your investment.
If any of the following risks occur, our business, financial condition, results of operations, and future prospects could be materially and adversely affected. In that event, the trading price of our common stock could decline, and you could lose all or part of your investment.
The degree of market acceptance of our drug candidates, if approved for commercial sale, will depend on a number of factors, including: • the efficacy and potential advantages compared to alternative treatments; • the prevalence and severity of any side effects, in particular compared to alternative treatments; • our ability to offer our products for sale at competitive prices; • the convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; • the strength of our marketing, sales and distribution support; • the availability of third-party payor coverage and adequate reimbursement; 64 • the ability to secure a positive HTA recommendation for the product to be prescribed and reimbursed under the national health system; • the timing of any marketing approval in relation to other product approvals; and • any restrictions on the use of our products together with other medications.
The degree of market acceptance of our drug candidates, if approved for commercial sale, will depend on a number of factors, including: • the efficacy and potential advantages compared to alternative treatments; 64 • the prevalence and severity of any side effects, in particular compared to alternative treatments; • our ability to offer our products for sale at competitive prices; • the convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; • the strength of our marketing, sales and distribution support; • the availability of third-party payor coverage and adequate reimbursement; • the ability to secure a positive HTA recommendation for the product to be prescribed and reimbursed under the national health system; • the timing of any marketing approval in relation to other product approvals; and • any restrictions on the use of our products together with other medications.
The risks we face in connection with acquisitions include: • diversion of management time and focus from operating our business to addressing acquisition integration challenges; • coordination of research and development efforts; • retention of key employees from the acquired company; • changes in relationships with strategic partners as a result of product acquisitions or strategic positioning resulting from the acquisition; • cultural challenges associated with integrating employees from the acquired company into our organization; • the need to implement or improve controls, procedures and policies at a business that prior to the acquisition may have lacked sufficiently effective controls, procedures and policies; • liability for activities of the acquired company before the acquisition, including intellectual property infringement claims, violation of laws, commercial disputes, tax liabilities and other known liabilities; • unanticipated write-offs or charges; and • litigation or other claims in connection with the acquired company, including claims from terminated employees, customers, former stockholders or other third parties.
The risks we face in connection with acquisitions include: • diversion of management time and focus from operating our business to addressing acquisition integration challenges; • coordination of research and development efforts; 99 • retention of key employees from the acquired company; • changes in relationships with strategic partners as a result of product acquisitions or strategic positioning resulting from the acquisition; • cultural challenges associated with integrating employees from the acquired company into our organization; • the need to implement or improve controls, procedures and policies at a business that prior to the acquisition may have lacked sufficiently effective controls, procedures and policies; • liability for activities of the acquired company before the acquisition, including intellectual property infringement claims, violation of laws, commercial disputes, tax liabilities and other known liabilities; • unanticipated write-offs or charges; and • litigation or other claims in connection with the acquired company, including claims from terminated employees, customers, former stockholders or other third parties.
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, beginning in 2023, penalize drug companies that raise prices for products covered under Medicare Parts B and D faster than inflation, among other reforms.
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.
You should carefully consider the risks and uncertainties described below, together with all of the other information in this Annual Report on Form 10-K, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the accompanying notes and the information contained in our other public filings before deciding whether to invest in shares of our common stock.
You should carefully consider the risks and uncertainties described below, together with all of the other information in this Annual Report on Form 10-K, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the accompanying notes and the information contained in our other public filings before deciding whether to invest in shares of our common stock.
Consequently, the types of claims in issued patents of our patent portfolio may fail to afford strong protection against third-party infringement. 67 The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation, resulting in court decisions, including U.S.
Consequently, the types of claims in issued patents of our patent portfolio may fail to afford strong protection against third-party infringement. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation, resulting in court decisions, including U.S.
Our inability to successfully manage our growth and expand our operations could have a material and adverse effect on our business, financial condition, results of operations and prospects. 91 Our employees, independent contractors, vendors, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading laws.
Our inability to successfully manage our growth and expand our operations could have a material and adverse effect on our business, financial condition, results of operations and prospects. Our employees, independent contractors, vendors, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading laws.
We may experience numerous unforeseen events during, or as a result of, clinical trials, that could delay or prevent our ability to receive marketing approval or commercialize our drug candidates, including: • we may experience delays in reaching, or may fail to reach, a consensus with regulators on trial design; • the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate, including as a result of delays in the testing, validation, manufacturing and delivery of drug candidates to the clinical sites by us or by third parties with whom we have contracted to perform certain of those functions; • we may experience delays in reaching, or may fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites; • regulators or institutional review boards (IRBs) may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may receive feedback from regulatory authorities that requires us to modify the design of our clinical trials; • we may face delays under human tissue act legislation and restrictions across various jurisdictions; • we may experience difficulty in designing clinical trials and in selecting endpoints for diseases that have not been well-studied and for which the natural history and course of the disease is poorly understood; • the selection of certain clinical endpoints may require prolonged periods of clinical observation or analysis of the resulting data; • the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; • our drug candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or IRBs to suspend or terminate the trials; • we may have to suspend or terminate clinical trials of our drug candidates for various reasons, including a partial or full clinical hold based on a finding that our drug candidates have undesirable side effects or other unexpected characteristics, or that the participants are being exposed to unacceptable health risks; • our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; • regulators or IRBs may require that we or our investigators suspend or terminate clinical trials for various reasons, including noncompliance with regulatory requirements; • clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; • the cost of clinical trials of our drug candidates may be greater than we anticipate; • the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate; • 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; and 55 • 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.
We may experience numerous unforeseen events during, or as a result of, clinical trials, that could delay or prevent our ability to receive marketing approval or commercialize our drug candidates, including: • we may experience delays in corresponding with the FDA or a foreign regulatory authority regarding regulatory issues; • we may experience delays in reaching, or may fail to reach, a consensus with regulators on trial design; • the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate, including as a result of delays in the testing, validation, manufacturing and delivery of drug candidates to the clinical sites by us or by third parties with whom we have contracted to perform certain of those functions; • we may experience delays in reaching, or may fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites; • regulators or institutional review boards (IRBs) may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may receive feedback from regulatory authorities that requires us to modify the design of our clinical trials; • we may face delays under human tissue act legislation and restrictions across various jurisdictions; • we may experience difficulty in designing clinical trials and in selecting endpoints for diseases that have not been well-studied and for which the natural history and course of the disease is poorly understood; • the selection of certain clinical endpoints may require prolonged periods of clinical observation or analysis of the resulting data; • the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; • our drug candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or IRBs to suspend or terminate the trials; • we may have to suspend or terminate clinical trials of our drug candidates for various reasons, including a partial or full clinical hold based on a finding that our drug candidates have undesirable side effects or other unexpected characteristics, or that the participants are being exposed to unacceptable health risks; • our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; • regulators or IRBs may require that we or our investigators suspend or terminate clinical trials for various reasons, including noncompliance with regulatory requirements; • clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; • the cost of clinical trials of our drug candidates may be greater than we anticipate; • the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate; • regulators may revise the requirements for approving our drug candidates, or such requirements may not be as we anticipate; 55 • 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; and • 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.
We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq and other applicable securities rules and regulations which impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq and other applicable securities rules and regulations which impose various requirements on public companies, including maintenance of effective disclosure and financial controls and corporate governance practices.
In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions. 99 Unfavorable global economic conditions could adversely affect our business, financial condition, stock price and results of operations. Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets.
In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions. Unfavorable global economic conditions could adversely affect our business, financial condition, stock price and results of operations. Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets.
Any business interruption could have a material and adverse effect on our business, financial condition, results of operations and prospects. 100 Risks Related to Our Common Stock Our quarterly results of operations may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
Any business interruption could have a material and adverse effect on our business, financial condition, results of operations and prospects. Risks Related to Our Common Stock Our quarterly results of operations may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
The UK’s regulatory legal framework provides for similar periods of protection (namely regulatory data protection, marketing protection and market exclusivity). 85 It is important to note that the regulatory protection afforded to medicinal products such as data exclusivity, marketing protection, market exclusivity for orphan indications and pediatric extension are currently under review at the EU level.
The UK’s regulatory legal framework provides for similar periods of protection (namely regulatory data protection, marketing protection and market exclusivity). It is important to note that the regulatory protection afforded to medicinal products such as data exclusivity, marketing protection, market exclusivity for orphan indications and pediatric extension are currently under review at the EU level.
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. In the EU, the EU GDPR governs the collection, use, disclosure, transfer, or other processing of personal data.
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. 96 In the EU, the EU GDPR governs the collection, use, disclosure, transfer, or other processing of personal data.
If we decide to seek Orphan Drug Designation or other designations from regulators for any of our current or future drug candidates, we may be unsuccessful or may be unable to maintain the benefits associated with these designations, including the potential for supplemental market exclusivity associated with an Orphan Drug Designation.
If we decide to seek Orphan Drug Designation or other designations from regulators for any of our other or future drug candidates, we may be unsuccessful or may be unable to maintain the benefits associated with these designations, including the potential for supplemental market exclusivity associated with an Orphan Drug Designation.
In addition, our advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with ours. We will need to grow our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
In addition, our advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with ours. 92 We will need to grow our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance. Our stock price may be volatile and you could lose all or part of your investment.
We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance. 102 Our stock price may be volatile and you could lose all or part of your investment.
Many companies have filed, and continue to file, patent applications related to novel protein degradation therapies that target disease-causing proteins and many companies have filed and continue to file patent applications related to ACT. Some of these patent applications have already been allowed or issued and others may issue in the future.
Many companies have filed, and continue to file, patent applications related to novel protein degradation therapies that target disease-causing proteins. Some of these patent applications have already been allowed or issued and others may issue in the future.
If we are unable to advance our drug candidates through clinical development, develop, obtain regulatory approval for and commercialize our drug candidates or experience significant delays in doing so, our business may be materially harmed. We are early in our development efforts.
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. We are early in our development efforts.
In addition, although we may seek Orphan Drug Designation for other drug candidates, we may never receive these designations. In order to obtain orphan designation in the EEA (the UK has a similar legislation), the product must fulfill certain criteria.
In addition, although we may seek Orphan Drug Designation for other drug candidates, we may never receive these designations. 84 In order to obtain orphan designation in the EEA (the UK has a similar legislation), the product must fulfill certain criteria.
In addition, we may be subject to changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements. We obtain and process a large amount of proprietary and sensitive data.
In addition, we may be subject to changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements. 94 We obtain and process a large amount of proprietary and sensitive data.
Any of the foregoing scenarios could materially harm the commercial prospects for our drug candidates. We have received Fast Track designation for NX-5948 and may seek Fast Track designation for other drug candidates in the future.
Any of the foregoing scenarios could materially harm the commercial prospects for our drug candidates. We have received Fast Track designation for bexobrutideg (NX-5948) and may seek Fast Track designation for other drug candidates in the future.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. 105 If we fail to maintain effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, which could harm our results of operations, investors’ views of us and, as a result, the value of our common stock.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. 106 If we fail to maintain effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, which could harm our results of operations, investors’ views of us and, as a result, the value of our common stock.
Any of these outcomes could impair our ability to prevent competition from third parties. Method of use patents protect the use of a product for the specified method.
Any of these outcomes could impair our ability to prevent competition from third parties. 67 Method of use patents protect the use of a product for the specified method.
We anticipate that our operating expenses and capital expenditure requirements will increase substantially if and as we: • increase enrollment in and further develop our drug candidates NX-5948, NX-2127 and NX-1607 through Phase 1 clinical trials; • submit investigational new drug applications (INDs) and initiate clinical trials of our other drug candidates; • enter advanced clinical development and scale up external manufacturing capabilities to supply clinical trials; • expand the capabilities of our DEL-AI platform and apply our DEL-AI platform to advance additional drug candidates into preclinical and clinical development; • conduct process development for manufacturing of our drug candidates; • seek marketing approvals for any drug candidates that successfully complete clinical trials; • prepare for negotiations with the pricing authorities and submission to the health technology appraisal (HTA) bodies; • ultimately establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain marketing approval; • expand, maintain and protect our intellectual property portfolio; • hire additional clinical, regulatory, manufacturing, quality assurance and scientific personnel; and • add operational, financial and management information systems and personnel to support our research, product development and future commercialization efforts and support our operations as a public company.
We anticipate that our operating expenses and capital expenditure requirements will increase substantially if and as we: • increase enrollment in and further develop our drug candidates bexobrutideg, zelebrudomide and NX-1607 through Phase 1 and Phase 2 clinical trials; • submit investigational new drug applications (INDs) and initiate clinical trials of our other drug candidates; • enter advanced clinical development and scale up external manufacturing capabilities to supply clinical trials; • expand the capabilities of our DEL-AI platform and apply our DEL-AI platform to advance additional drug candidates into preclinical and clinical development; • conduct process development for manufacturing of our drug candidates; • seek marketing approvals for any drug candidates that successfully complete clinical trials; • prepare for negotiations with the pricing authorities and submission to the health technology appraisal (HTA) bodies; • ultimately establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain marketing approval; • expand, maintain and protect our intellectual property portfolio; • hire additional clinical, regulatory, manufacturing, quality assurance and scientific personnel; and • add operational, financial and management information systems and personnel to support our research, product development and future commercialization efforts and support our operations as a public company.
Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operating performance. 52 Risks Related to the Discovery and Development of Our Drug Candidates We are early in our development efforts. Our lead drug candidates, NX-5948, NX-2127 and NX-1607, are in the early stages of clinical development.
Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operating performance. 52 Risks Related to the Discovery and Development of Our Drug Candidates We are early in our development efforts. Our lead drug candidates, bexobrutideg (NX-5948), zelebrudomide (NX-2127) and NX-1607, are in the early stages of clinical development.
Moreover, the FDA and other foreign regulators such as the EMA and the MHRA require compliance with good clinical practice standards, commonly referred to as GCPs, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.
Moreover, the FDA and other foreign regulators such as the EMA and the MHRA require compliance with good clinical practice standards (GCPs), for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.
Additionally, the SEC adopted a new cybersecurity rule requiring companies subject to SEC reporting requirements to formally report material cybersecurity incidents, where failure to report may result in regulatory investigations leading to consent orders that may require additional compliance obligations and/or injunctions, fines and other penalties.
Additionally, the SEC adopted a cybersecurity disclosure rule requiring companies subject to SEC reporting requirements to formally report material cybersecurity incidents, where failure to report may result in regulatory investigations leading to consent orders that may require additional compliance obligations and/or injunctions, fines and other penalties.
Personal data may now be transferred from the UK under the UK-U.S. data bridge through the UK extension to the DPF to organizations self-certified under the UK extension to the DPF.
Personal data may be transferred from the UK under the UK-U.S. data bridge through the UK extension to the DPF to organizations self-certified under the UK extension to the DPF.
As a result, we may forego or delay pursuit of opportunities with other drug candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
As a result, we may forgo or delay pursuit of opportunities with other drug candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
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.
House of Representatives. 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.
As a company, we have invested, and expect to continue to invest, significant time and resources in our GDPR compliance program. This is necessary to ensure we can initiate and maintain GDPR-compliant clinical trials in the EU or UK (as applicable).
As a company, we have invested, and expect to continue to invest, significant time and resources in our DPF certification and GDPR compliance program. This is necessary to ensure we can initiate and maintain GDPR-compliant clinical trials in the EU or UK (as applicable).
Our lead drug candidates, NX-5948, NX-2127 and NX-1607, are in the early stages of clinical development. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
Our lead drug candidates, bexobrutideg (NX-5948), zelebrudomide (NX-2127) and NX-1607, are in the early stages of clinical development. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
In certain cases, including when transfers are made in reliance on standard contractual clauses (EU SCCs), including a requirement for companies to carry out a transfer impact assessment (TIA)—which (among other things) assesses laws governing access to personal data in the recipient country and considers whether supplementary measures that provide privacy protections additional to those provided under EU SCCs—will need to be implemented to ensure an ‘essentially equivalent’ level of data protection to that afforded in the EEA.
In certain cases, for example, when transfers are made in reliance on standard contractual clauses (EU SCCs), there is a requirement for companies to carry out a transfer impact assessment (TIA)—which (among other things) assesses laws governing access to personal data in the recipient country and considers whether supplementary measures that provide privacy protections additional to those provided under EU SCCs—will need to be implemented to ensure an ‘essentially equivalent’ level of data protection to that afforded in the EEA.
As of November 30, 2024, 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 November 30, 2024.
As of November 30, 2025, 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 November 30, 2025.
The market price for our common stock may be influenced by many factors, including the other risks described in this “Risk Factors” section and the following: • results of preclinical studies and clinical trials of our drug candidates, or those of our competitors or our existing or future collaborators; • regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our drug candidates; • the success of competitive products or technologies; • introductions and announcements of new products by us, our collaboration partners, or our competitors, and the timing of these introductions or announcements; • actions taken by regulatory agencies with respect to our drug candidates, clinical trials, manufacturing process or sales and marketing terms; • actual or anticipated variations in our financial results or in those of companies that are perceived to be similar to us; • the success of our efforts to acquire or in-license additional technologies, products or drug candidates; • developments concerning our current or future collaborations, including but not limited to those with our sources of manufacturing supply and our commercialization partners; • market conditions in the pharmaceutical and biotechnology sectors; 101 • announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures or capital commitments; • developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our drug candidates and products; • our ability or inability to raise additional capital and the terms on which any additional capital is raised; • the recruitment or departure of key personnel; • changes in the structure of healthcare payment systems; • actual or anticipated changes in earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally; • our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may provide to the market; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • announcement and expectation of additional financing efforts; • speculation in the press or investment community; • trading volume of our common stock; • sales of our common stock by us or our stockholders; • the concentrated ownership of our common stock; • changes in accounting principles; • cybersecurity events; • terrorist acts, acts of war or periods of widespread civil unrest, including the increasingly volatile global economic conditions resulting from regional conflicts around the world; • effects of public health crises, pandemics and epidemics; • natural disasters and other calamities; and • 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.
The market price for our common stock may be influenced by many factors, including the other risks described in this “Risk Factors” section and the following: • results of preclinical studies and clinical trials of our drug candidates, or those of our competitors or our existing or future collaborators; • regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our drug candidates; • the success of competitive products or technologies; • introductions and announcements of new products by us, our collaboration partners, or our competitors, and the timing of these introductions or announcements; • actions taken by regulatory agencies with respect to our drug candidates, clinical trials, manufacturing process or sales and marketing terms; • actual or anticipated variations in our financial results or in those of companies that are perceived to be similar to us; • the success of our efforts to acquire or in-license additional technologies, products or drug candidates; • developments concerning our current or future collaborations, including but not limited to those with our sources of manufacturing supply and our commercialization partners; • market conditions in the pharmaceutical and biotechnology sectors; • announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures or capital commitments; • developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our drug candidates and products; • our ability or inability to raise additional capital and the terms on which any additional capital is raised; • the recruitment or departure of key personnel; • changes in the structure of healthcare payment systems; • actual or anticipated changes in earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally; • our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may provide to the market; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • announcement and expectation of additional financing efforts; • speculation in the press or investment community; • trading volume of our common stock; • sales of our common stock by us or our stockholders; • the concentrated ownership of our common stock; • changes in accounting principles; • cybersecurity events; • terrorist acts, acts of war or periods of widespread civil unrest, including the increasingly volatile global economic conditions resulting from regional conflicts around the world; • effects of public health crises, pandemics and epidemics; • natural disasters and other calamities; and • 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. 103 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.
We, as a company, have limited experience in filing for and obtaining regulatory approval to initiate a clinical trial, and we do not have experience completing any clinical trials, including large-scale, pivotal clinical trials or in manufacturing or in quality assurance in order to market a new drug in the United States or in any other jurisdiction.
We, as a company, have limited experience in filing for and obtaining regulatory approval to initiate a clinical trial, and we do not have experience completing any pivotal clinical trials or in manufacturing or in quality assurance in order to market a new drug in the United States or in any other jurisdiction.
We currently expect that we may build our own focused, specialized sales and marketing organization to support the commercialization in the United States of drug candidates for which we receive marketing approval and which can be commercialized with such capabilities. There are risks involved with establishing our own sales and marketing capabilities.
We may build our own focused, specialized sales and marketing organization to support the commercialization in the United States of drug candidates for which we receive marketing approval and which can be commercialized with such capabilities. There are risks involved with establishing our own sales and marketing capabilities.
A decline in the value of our company could also cause you to lose all or part of your investment. 50 We have never generated revenue from product sales and may never be profitable. We are in the early stages of clinical development of our lead drug candidates NX-5948, NX-2127 and NX-1607.
A decline in the value of our company could also cause you to lose all or part of your investment. 50 We have never generated revenue from product sales and may never be profitable. We are in the early stages of clinical development of our lead drug candidates bexobrutideg, zelebrudomide and NX-1607.
As a company, we have limited experience in filing for or obtaining regulatory approval to initiate clinical trials, we do not have experience completing any clinical trials, including large-scale, pivotal clinical trials and we rely on third parties to conduct our clinical trials.
As a company, we have limited experience in filing for or obtaining regulatory approval to initiate clinical trials, we do not have experience completing any pivotal clinical trials and we rely on third parties to conduct our clinical trials.
For example, in October 2023, following our communication to the FDA of our intention to transition to an improved manufacturing process for NX-2127, the FDA placed a partial clinical hold on our ongoing Phase 1 clinical trial evaluating NX-2127.
For example, in October 2023, following our communication to the FDA of our intention to transition to an improved manufacturing process for zelebrudomide, the FDA placed a partial clinical hold on our ongoing Phase 1 clinical trial evaluating zelebrudomide.
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we conduct our Phase 1 clinical trials of NX-5948, NX-2127 and NX-1607 and any future development of our drug candidates, grow our pipeline of drug candidates, expand the breadth of our DEL-AI platform, continue research and development and initiate additional clinical trials of and potentially seek marketing approval for our lead programs and other drug candidates.
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we conduct our Phase 1 and Phase 2 clinical trials of bexobrutideg, zelebrudomide and NX-1607 and any future development of our drug candidates, grow our pipeline of drug candidates, expand the breadth of our DEL-AI platform, continue research and development and initiate additional clinical trials of and potentially seek marketing approval for our lead programs and other drug candidates.
Our future capital requirements will depend on many factors, including: • the progress, costs and results of our Phase 1 clinical trials for NX-5948, NX-2127 and NX-1607 and any future clinical development of such drug candidates; • the scope, progress, costs and results of preclinical and clinical development for our other drug candidates and development programs; • the number and development requirements of other drug candidates that we pursue; • the scope of, and costs associated with, future advancements to our DEL-AI platform; • the success of our collaborations with Gilead Sciences, Inc.
Our future capital requirements will depend on many factors, including: • the progress, costs and results of our Phase 1 and Phase 2 clinical trials for bexobrutideg, zelebrudomide and NX-1607 and any future clinical development of such drug candidates; • the scope, progress, costs and results of preclinical and clinical development for our other drug candidates and development programs; • the number and development requirements of other drug candidates that we pursue; • the scope of, and costs associated with, future advancements to our DEL-AI platform; • the success of our collaborations with Gilead Sciences, Inc.
For example, data breaches frequently result in regulatory actions and commercial and class action litigation based on a variety of laws and legal duties, such as the California Consumer Privacy Act (CCPA), which provides for a private right of action in the event of certain data security breaches.
For example, data breaches frequently result in regulatory actions and commercial and class action litigation based on a variety of laws and legal duties, such as the California Consumer Privacy Act, as later amended by the California Privacy Rights Act (CCPA), which provides for a private right of action in the event of certain data security breaches.
We may not be successful in our efforts to identify or discover additional potential drug candidates. A key element of our strategy is to apply our DEL-AI platform to address a broad array of targets and new therapeutic areas.
We may not be successful in our efforts to identify or discover additional potential drug candidates, or in further efforts to expand the breadth of our DEL-AI platform. A key element of our strategy is to apply our DEL-AI platform to address a broad array of targets and new therapeutic areas.
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 governing the development and use of AI has been passed or is under consideration in the United States at the state and local level, as well as internationally.
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.
The period of regulatory data protection and marketing protection applies in the UK (running from the date of the first authorization in Great Britain).
The period of regulatory data protection and marketing protection applies in the UK (running from the date of the first UK marketing authorization).
Risks Related to Our Financial Position and Need for Additional Capital We have incurred significant losses since our inception. We expect to incur losses over at least the next several years and may never achieve or maintain profitability. Our net loss was $193.6 million and $143.9 million for the fiscal years ended November 30, 2024 and 2023, respectively.
Risks Related to Our Financial Position and Need for Additional Capital We have incurred significant losses since our inception. 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 and $193.6 million for the fiscal years ended November 30, 2025 and 2024, respectively.
Orphan Drug Designation does not convey any advantage in, or shorten the duration of, the regulatory review process. 84 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 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.
The new framework is likely to increase 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 will be subject to increased litigation and judicial scrutiny.
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. As a result, significant regulatory policies may be subject to increased litigation and judicial scrutiny.
We may seek Orphan Drug Designation or other designations from regulators for one or more of our 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.
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. 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.
Additionally, the CCPA requires companies that process personal information of California residents to make disclosures to consumers about their data collection, use and sharing practices, allow consumers to opt out of certain data sharing with third parties, complete certain audits and assessments when processing higher risk data and provide a private right of action for data breaches, as described above.
Additionally, the CCPA requires companies that process personal information of California residents to make disclosures to consumers about their data collection, use and sharing practices, complete certain audits and assessments when processing higher risk data and provide a private right of action for data breaches, as described above.
We cannot anticipate all of the ways in which the foregoing, and the current economic climate and financial market conditions generally, could adversely impact our business. Furthermore, our stock price may decline due in part to the volatility of the stock market and any general economic downturn.
We cannot anticipate all of the ways in which the foregoing, and the current economic climate and financial market conditions generally, could adversely impact our business. Furthermore, our stock price may decline due in part to the volatility of the stock market and any general economic downturn. We may be exposed to foreign exchange risk.
In January 2024, the FDA granted Fast Track designation for NX-5948 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 NX-5948 in the United States for the treatment of adult patients with relapsed or refractory Waldenstrom’s macroglobulinemia after at least two lines of therapy, including a BTK inhibitor.
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.
However, any inherent primary or acquired secondary resistance to our BTK degraders in patients would prevent or diminish their clinical benefit. We are in the early stages of clinical development of NX-5948 and NX-2127 and we currently have limited safety data of NX-5948 and NX-2127 in humans.
However, any inherent primary or acquired secondary resistance to our BTK degraders in patients would prevent or diminish their clinical benefit. We are in the early stages of clinical development of bexobrutideg and zelebrudomide and we currently have limited safety data of bexobrutideg and zelebrudomide in humans.
We rely on third-party contract research organizations (CROs) to conduct our Phase 1 clinical trial programs for NX-5948, NX-2127 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.
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.
This patent may be alleged to cover one or more of our targeted protein degrader drug candidates, including our NX-5948 and NX-2127 drug candidates. While we believe that we have valid defenses against any assertion of such patent against us, such defenses may be unsuccessful.
This patent may be alleged to cover one or more of our targeted protein degrader drug candidates, including our bexobrutideg and zelebrudomide drug candidates. While we believe that we have valid defenses against any assertion of such patent against us, such defenses may be unsuccessful.
Complying with these new disclosure obligations once applicable to our company, or any or any additional new disclosure requirements that may apply to us in the future, could cause us to incur substantial costs and could increase negative publicity surrounding any incident that we are required to disclose.
Complying with these disclosure obligations or any new disclosure requirements that may apply to us in the future, could cause us to incur substantial costs and could increase negative publicity surrounding any incident that we are required to disclose.
Therefore, our ability to identify and enroll eligible patients for our NX-5948, NX-2127 and NX-1607 clinical trials may be limited or may result in slower enrollment than we anticipate.
Therefore, our ability to identify and enroll eligible patients for our bexobrutideg, zelebrudomide and NX-1607 clinical trials may be limited or may result in slower enrollment than we anticipate.
Our current and planned clinical trials for our drug candidates NX-5948, NX-2127 and NX-1607 are and will be with patients who have received one or more prior treatments.
Our current and planned clinical trials for our drug candidates bexobrutideg, zelebrudomide and NX-1607 are and will be with patients who have received one or more prior treatments.
We had cash, cash equivalents and marketable securities of $609.6 million as of November 30, 2024. 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.
We had cash, cash equivalents and marketable securities of $592.9 million as of November 30, 2025. 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.
From time to time, we may publish interim top-line or preliminary data from our planned clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
We have published and may continue to publish interim top-line or preliminary data from our current and planned clinical trials. Interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
Despite the implementation of security measures, our internal information technology systems and infrastructure, and those of our current and any future CROs, collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to breach, breakdown or other damage or interruption from service interruptions, system malfunction, computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet (including harmful attachments to emails, ransomware, distributed denial-of-service attacks, social engineering, and other means to affect service reliability and threaten the confidentiality, integrity, and availability of information), persons inside our organization, or persons with access to systems inside our organization.
We have also outsourced elements of our information technology infrastructure, resulting in a number of third-party vendors that may or could have access to our information. 93 Despite the implementation of security measures, our internal information technology systems and infrastructure, and those of our current and any future CROs, collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to breach, breakdown or other damage or interruption from service interruptions, system malfunction, computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet (including harmful attachments to emails, ransomware, distributed denial-of-service attacks, social engineering, and other means to affect service reliability and threaten the confidentiality, integrity, and availability of information), persons inside our organization, or persons with access to systems inside our organization.
As of November 30, 2024, we had an accumulated deficit of $738.8 million. 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. We are in the early stages of development of our drug candidates.
As of November 30, 2025, we had an accumulated deficit of $1,003.2 million. 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. We are in the early stages of development of our drug candidates.
Regardless of merit or eventual outcome, liability claims may result in: • decreased demand for any drug candidates or products that we may develop; • termination of clinical trials; • withdrawal of marketing approval, recall, restriction on the approval or a “black box” warning or contraindication for an approved drug; • withdrawal of clinical trial participants; • significant costs to defend the related litigation; • substantial monetary awards to trial participants or patients; • loss of revenue; • injury to our reputation and significant negative media attention; • reduced resources of our management to pursue our business strategy; and • the inability to commercialize any products that we may develop. 66 Although we maintain product liability insurance coverage, it may not be adequate to cover all liabilities that we may incur.
Regardless of merit or eventual outcome, liability claims may result in: • decreased demand for any drug candidates or products that we may develop; • termination of clinical trials; 66 • withdrawal of marketing approval, recall, restriction on the approval or a “black box” warning or contraindication for an approved drug; • withdrawal of clinical trial participants; • significant costs to defend the related litigation; • substantial monetary awards to trial participants or patients; • loss of revenue; • injury to our reputation and significant negative media attention; • reduced resources of our management to pursue our business strategy; and • the inability to commercialize any products that we may develop.
Moreover, these rules and regulations have increased our legal and financial compliance costs and have made some activities more time-consuming and costly. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements.
Moreover, these rules and regulations result in high legal and financial compliance costs and have made some activities time-consuming and costly. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements.
In particular, we are currently conducting Phase 1 clinical trials for each of our lead drug candidates NX-5948, NX-2127 and NX-1607, and we expect to initiate a Phase 2 clinical trial of NX-5948 in 2025. We cannot predict how difficult it will be to enroll patients for these trials.
In particular, we are currently conducting Phase 1 clinical trials for each of our lead drug candidates, bexobrutideg, zelebrudomide and NX-1607, and a Phase 2 clinical trial for bexobrutideg, and we expect to initiate a Phase 3 clinical trial for bexobrutideg in 2026. We cannot predict how difficult it will be to enroll patients for these trials.
Our lead drug candidates, NX-5948, NX-2127 and NX-1607, are in the early stages of clinical development and their risk of failure is high.
Our lead drug candidates, bexobrutideg, zelebrudomide and NX-1607, are in the early stages of clinical development and their risk of failure is high.
If the FDA, the EMA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our drug candidates or if such regulatory authority withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain marketing approval for or market our drug candidates, if approved.
If the FDA, the EMA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our drug candidates or if such regulatory authority withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain marketing approval for or market our drug candidates, if approved. 63 Our drug candidates and any products that we may develop may compete with other drug candidates and products for access to suitable manufacturing facilities.
The GDPR imposes compliance obligations on controllers (and in more limited cases, on processors), including granting certain privacy rights to individuals to control how companies collect, use, disclose, retain and otherwise process their personal data as well as specific requirements for obtaining valid consent where consent is the legal basis for processing, requirements around accountability and transparency, the obligation to consider data protection when any new products or services are developed, the obligation to appoint data protection officers in certain circumstances, the obligation to notify relevant data protection supervisory authorities of notifiable personal data breaches without undue delay (and no later than 72 hours) after becoming aware of the personal data breach, and the requirement to provide more detailed notices for clinical trial subjects and investigators.
The GDPR imposes compliance obligations on controllers (and in more limited cases, on processors), including (among others) granting certain privacy rights to individuals to control how companies collect, use, disclose, retain and otherwise process their personal data as well as specific requirements for obtaining valid consent where consent is the legal basis for processing, requirements around accountability and transparency, the obligation to consider data protection when any new products or services are developed, the obligation to appoint data protection officers in certain circumstances, the obligation to notify (i) relevant data protection supervisory authorities of personal data breaches without undue delay (and no later than 72 hours) after becoming aware of the personal data breach, unless the personal data breach is unlikely to result in a risk to the data subjects’ rights and freedoms; and (ii) affected individuals, where the personal data breach is likely to result in a high risk to their rights and freedoms, whereas processors are required to notify the controller without undue delay after becoming aware of a personal data breach, and the requirement to provide more detailed notices for clinical trial subjects and investigators.
A key element of our strategy is to expand the capabilities of our DEL-AI platform and leverage our platform to discover, develop and potentially commercialize additional drug candidates beyond our current portfolio to target diseases in a wide range of organ systems and tissues and treat various disease states.
We also intend to expand the capabilities of our DEL-AI platform and leverage our platform to discover, develop and potentially commercialize additional drug candidates beyond our current portfolio to target diseases in a wide range of organ systems and tissues and treat various disease states.
Our state NOLs can be carried forward 20 years and begin expiring in 2029. 97 Under Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes (such as R&D credit carryovers) to offset its post-change income or post-change income tax may be limited.
Under Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes (such as R&D credit carryovers) to offset its post-change income or post-change income tax may be limited.
Such pre-funded warrants are immediately exercisable, have an exercise price of $0.001 and may be exercised at any time after the date of issuance.
The pre-funded warrants sold in April 2024 are immediately exercisable, have an exercise price of $0.001 and may be exercised at any time after the date of issuance.
Under current law, NOLs arising in tax years beginning after December 31, 2017, may be carried forward indefinitely, but are limited to no more than 80% of the excess, if any, of current year taxable income (without regard to certain deductions).
Under current law, NOLs arising in tax years beginning after December 31, 2017, may be carried forward indefinitely, but are limited to no more than 80% of the excess, if any, of current year taxable income (without regard to certain deductions). Our state NOLs can be carried forward 20 years and begin expiring in 2029.
We will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices. As a public company, we incur significant legal, accounting and other expenses.
We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives and corporate governance practices. As a public company, we incur significant legal, accounting and other expenses.
Both NX-5948 and NX-2127 degrade BTK with mutations that confer resistance to currently marketed BTK inhibitors, and we believe that preliminary data from our ongoing Phase 1 trials of NX-5948 and NX-2127 may provide evidence of clinical benefit to patients with such resistance mutations.
Both bexobrutideg and zelebrudomide degrade BTK with mutations that confer resistance to currently marketed BTK inhibitors, and we believe that preliminary data from our ongoing Phase 1 and Phase 2 trials of bexobrutideg and our Phase 1 trial of zelebrudomide may provide evidence of clinical benefit to patients with such resistance mutations.
Non-compliance with EU and UK requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population (as explained further under “—If any of our drug candidates are not considered to be a new active substance or are deemed to fall within the “global marketing authorization” of an existing medicinal product or if pediatric studies are not adequately completed, this may result in lack of regulatory data protection or failure to obtain an extension to existing regulatory data protection,” below), also can result in significant financial penalties, and non-compliance with pediatric requirements may prevent regulatory approvals from being granted.
Other jurisdictions, including European countries, have similar provisions which may lead to investigations and enforcement actions by national authorities. 83 Non-compliance with EU and UK requirements regarding safety monitoring or pharmacovigilance, or with requirements related to the development of products for the pediatric population (as explained further under “—If any of our drug candidates are not considered to be a new active substance or are deemed to fall within the “global marketing authorization” of an existing medicinal product or if pediatric studies are not adequately completed, this may result in lack of regulatory data protection or failure to obtain an extension to existing regulatory data protection,” below), also can result in significant financial penalties, and non-compliance with pediatric requirements may prevent regulatory approvals from being granted.
Without an active market, the liquidity of the pre-funded warrants will be limited, and the value of the pre-funded warrants may be adversely impacted. 103 Additionally, each holder of pre-funded warrants will not be entitled to exercise any portion of any pre-funded warrant, which, upon giving effect to such exercise, would cause (i) the aggregate number of shares of our common stock beneficially owned by the holder (together with its affiliates) to exceed 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, or (ii) the combined voting power of our securities beneficially owned by the holder (together with its affiliates) to exceed 9.99% of the combined voting power of all of our securities then outstanding immediately after giving effect to the exercise.
Additionally, each holder of pre-funded warrants will not be entitled to exercise any portion of any pre-funded warrant, which, upon giving effect to such exercise, would cause (i) the aggregate number of shares of our common stock beneficially owned by the holder (together with its affiliates) to exceed 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, or (ii) the combined voting power of our securities beneficially owned by the holder (together with its affiliates) to exceed 9.99% of the combined voting power of all of our securities then outstanding immediately after giving effect to the exercise.
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. 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.
Further, in connection with new initiatives, 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.
Although we believe that there are several potential alternative manufacturers who could manufacture our drug candidates, we may incur added costs and delays in identifying and qualifying any such replacement manufacturer or may not be able to reach agreement with any alternative manufacturer.
If our current CMOs cannot perform as agreed, we may be required to replace such manufacturers. Although we believe that there are several potential alternative manufacturers who could manufacture our drug candidates, we may incur added costs and delays in identifying and qualifying any such replacement manufacturer or may not be able to reach agreement with any alternative manufacturer.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeCybersecurity Governance Our cybersecurity and data privacy programs are implemented and overseen by our Chief Information Security Officer (CISO), our Senior Vice President (SVP) of Information Technology, and members of our executive management team. 107 Our SVP of Information Technology has over 20 years of information technology experience, with over 15 years of experience leading technology and cybersecurity programs in biopharmaceutical companies.
Biggest changeThe assessment methodology is based on risk and relies on the data, access, connectivity, and criticality of the services that the third-party offers. Cybersecurity Governance Our cybersecurity and data privacy programs are implemented and overseen by our Chief Information Security Officer (CISO), our Senior Vice President (SVP) of Information Technology, and members of our executive management team.
Risk and Issues Disclosure As of November 30, 2024, and through the date of this filing, we are not aware of any material cybersecurity incidents that have impacted the Company, nor do we believe that there are currently any known risks from cybersecurity threats that are reasonably likely to materially affect us or our business strategy, results of operations or financial condition.
Risk and Issues Disclosure As of November 30, 2025, and through the date of this filing, we are not aware of any material cybersecurity incidents that have impacted the Company, nor do we believe that there are currently any known risks from cybersecurity threats that are reasonably likely to materially affect us or our business strategy, results of operations or financial condition.
He holds industry-recognized certifications, including CISSP. He earned his MBA with a focus on Finance and Strategy and a B.E. in Electronics and Communication. Our SVP of Information Technology and our CISO regularly provide cyber threat intelligence briefings to management on the status of the Company’s security measures and our efforts to identify and mitigate risks from cybersecurity threats.
He earned his MBA with a focus on Finance and Strategy and a B.E. in Electronics and Communication. Our SVP of Information Technology and our CISO regularly provide cyber threat intelligence briefings to management on the status of the Company’s security measures and our efforts to identify and mitigate risks from cybersecurity threats.
He holds industry cybersecurity certifications and is undertaking advanced studies in IT Management and Cybersecurity. Our CISO has over 20 years of experience in information security, including more than 15 years of experience leading large-scale cybersecurity and privacy programs across various industries. He currently leads all aspects of our enterprise cybersecurity strategy, risk governance, and privacy effort.
Our CISO has over 20 years of experience in information security, including more than 15 years of experience leading large-scale cybersecurity and privacy programs across various industries. He currently leads all aspects of our enterprise cybersecurity strategy, risk governance, and privacy effort. He holds industry-recognized certifications, including CISSP.
Our SVP of Information Technology and CISO also work closely with our Chief Financial Officer and Chief Legal Officer to further enhance incident response procedures and to assess and manage risks from cybersecurity threats.
Our SVP of Information Technology and CISO also work closely with our Chief Financial Officer and Chief Legal Officer to further enhance incident response procedures and to assess and manage risks from cybersecurity threats. 108 The Audit Committee of our Board of Directors (Audit Committee) oversees the Company’s overall enterprise risk assessment and risk management policies and guidelines, including risks related to cybersecurity matters.
Since joining Nurix in 2021, our SVP of Information Technology has led all information technology strategy and operations, including our cybersecurity program. Previously, he served as Chief Technology Advisor focused on cybersecurity incident response and strategic security consulting, and held senior IT leadership roles at multiple clinical-stage biotechnology companies.
Previously, he served as Chief Technology Advisor focused on cybersecurity incident response and strategic security consulting, and held senior IT leadership roles at multiple clinical-stage biotechnology companies. He holds industry cybersecurity certifications and is undertaking advanced studies in IT Management and Cybersecurity.
Members of the Board of Directors also participate in table-top exercises involving simulated data security incidents and the Company’s responses to those incidents.
The Audit Committee provides periodic reports to the Board of Directors regarding its oversight of cybersecurity, information technology, data protection and related matters. Members of the Board of Directors also have participated in table-top exercises involving simulated data security incidents and the Company’s responses to those incidents.
Removed
The assessment methodology is based on risk and relies on the data, access, connectivity, and criticality of the services that the third-party offers.
Added
Our SVP of Information Technology has over 20 years of information technology experience, with over 15 years of experience leading technology and cybersecurity programs in biopharmaceutical companies. Since joining Nurix in 2021, our SVP of Information Technology has led all information technology strategy and operations, including our cybersecurity program.
Removed
The Audit Committee of our Board of Directors (Audit Committee) oversees the Company’s overall enterprise risk assessment and risk management policies and guidelines, including risks related to cybersecurity matters. The Audit Committee provides periodic reports to the Board of Directors regarding its oversight of cybersecurity, information technology, data protection and related matters.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties and Facilities Our principal executive office is located in San Francisco, California, where we lease a total of 77,222 square feet of office and laboratory spaces that we use for our administrative, research and development and other activities. The lease expires in October 2025.
Biggest changeItem 2. Properties and Facilities Our principal executive office is located in Brisbane, California, where we lease a total of 195,888 square feet of office and laboratory spaces that we use for our administrative, research and development and other activities. The lease expires in September 2031.
Additionally, we lease a total of 50,094 square feet of office and laboratory space in The Woodlands, Texas that expires in February 2035. We believe that our existing facilities are suitable and adequate for our current requirements and operations. 108
Additionally, we lease a total of 50,094 square feet of office and laboratory space in The Woodlands, Texas that expires in February 2035. We believe that our existing facilities are suitable and adequate for our current requirements and operations.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on our business or consolidated financial statements.
Biggest changeItem 3. Legal Proceedings From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on our business or financial statements.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe comparisons shown in the graph below are based upon historical data and are not necessarily indicative of, nor intended to forecast, the potential future performance of our common stock. 110 $100 investment in stock or index 7/24/2020 11/30/2020 11/30/2021 11/30/2022 11/30/2023 11/30/2024 Nurix Therapeutics, Inc. $ 100.00 $ 224.20 $ 151.60 $ 65.18 $ 32.72 $ 116.31 NASDAQ Composite Index $ 100.00 $ 118.08 $ 151.38 $ 112.65 $ 140.95 $ 191.77 NASDAQ Biotechnology Index $ 100.00 $ 106.48 $ 112.76 $ 103.13 $ 92.73 $ 112.08 Use of Proceeds from Registered Securities None.
Biggest changeThe comparisons shown in the graph below are based upon historical data and are not necessarily indicative of, nor intended to forecast, the potential future performance of our common stock. 110 $100 investment in stock or index 11/30/2020 11/30/2021 11/30/2022 11/30/2023 11/30/2024 11/30/2025 Nurix Therapeutics, Inc. $ 100.00 $ 67.62 $ 29.07 $ 14.59 $ 51.88 $ 41.48 NASDAQ Composite Index $ 100.00 $ 128.20 $ 95.40 $ 119.37 $ 162.41 $ 198.75 NASDAQ Biotechnology Index $ 100.00 $ 105.90 $ 96.85 $ 87.09 $ 105.26 $ 132.93 Use of Proceeds from Registered Securities None.
Holders of Record As of close of business on January 24, 2025, there were 8 holders of record of our common stock. The actual number of stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees.
Holders of Record As of close of business on January 23, 2026, there were 7 holders of record of our common stock. The actual number of stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees.
The graph below compares the cumulative total stockholder return on $100 invested in our common stock with the cumulative total return of $100 invested in the Nasdaq Composite Index and the Nasdaq Biotechnology Index from the close of market on July 24, 2020, which was our initial trading day, through November 30, 2024, assuming the reinvestment of dividends, if any.
The graph below compares the cumulative total stockholder return on $100 invested in our common stock with the cumulative total return of $100 invested in the Nasdaq Composite Index and the Nasdaq Biotechnology Index from the close of market on November 30, 2020, through November 30, 2025, assuming the reinvestment of dividends, if any.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeWe did not have during the periods presented, and we do not currently have, any commitments or obligations, including contingent obligations, arising from arrangements with unconsolidated entities or persons that have or are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, cash requirements or capital resources. 123 Cash flows Our cash flows for the years ended November 30, 2024, 2023 and 2022 are summarized as follows (in thousands): Year ended November 30, 2024 2023 2022 Cash used in operating activities $ (172,584) $ (81,365) $ (159,807) Cash (used in) provided by investing activities (257,713) 68,301 27,198 Cash provided by financing activities 485,667 3,217 117,192 Net increase (decrease) in cash, cash equivalents and restricted cash $ 55,370 $ (9,847) $ (15,417) Operating activities Net cash used in operating activities was $172.6 million for the year ended November 30, 2024, and consisted of our net loss of $193.6 million and an increase in net assets of $18.4 million, offset by non-cash adjustments of $39.4 million.
Biggest changeCash flows Our cash flows for the years ended November 30, 2025, 2024 and 2023 are summarized as follows (in thousands): Year ended November 30, 2025 2024 2023 Cash used in operating activities $ (249,465) $ (172,584) $ (81,365) Cash provided (used in) by investing activities 147,853 (257,713) 68,301 Cash provided by financing activities 238,642 485,667 3,217 Net increase (decrease) in cash, cash equivalents and restricted cash $ 137,030 $ 55,370 $ (9,847) Operating activities Net cash used in operating activities was $249.5 million for the year ended November 30, 2025, and consisted of our net loss of $264.5 million and an increase in net assets of $31.6 million, offset by non-cash adjustments of $46.6 million.
In August 2019 and September 2022, we and Gilead entered into the First Amendment and the Second Amendment, respectively, to the Gilead Agreement to clarify certain language of the Gilead Agreement. These amendments had no impact on revenue recognition.
In August 2019 and September 2022, we entered into the First Amendment and the Second Amendment, respectively, to the Gilead Agreement to clarify certain language of the Gilead Agreement. These amendments had no impact on revenue recognition.
In August 2022 and November 2023, we and Sanofi entered into the Fourth Amendment and Fifth Amendment, respectively, to the Sanofi Agreement to modify the research plan for certain targets, which had no impact on revenue recognition.
In August 2022 and November 2023, we entered into the Fourth Amendment and Fifth Amendment, respectively, to the Sanofi Agreement to modify the research plan for certain targets, which had no impact on revenue recognition.
In March 2024, we and Sanofi entered into the Sixth Amendment to the Sanofi Agreement to extend the research term for the collaboration target STAT6 (signal transducer and activator of transcription 6), a key drug target in type 2 inflammation, by two years, which is expected to increase overall forecasted costs and have an impact on revenue recognition.
In March 2024, we entered into the Sixth Amendment to the Sanofi Agreement to extend the research term for the collaboration target STAT6 (signal transducer and activator of transcription 6), a key drug target in type 2 inflammation, by two years, which is expected to increase overall forecasted costs and have an impact on revenue recognition.
We closely monitor the impact of these factors on all aspects of our business, including the impacts on our clinical trial patients, employees, partner, suppliers, and vendors. The ultimate impact of global economic conditions on our business remains highly uncertain and will depend on future developments and factors that continue to evolve.
We closely monitor the impact of these factors on all aspects of our business, including the impacts on our clinical trial patients, employees, partner, suppliers, and vendors. The ultimate impact of global and domestic economic conditions on our business remains highly uncertain and will depend on future developments and factors that continue to evolve.
In January 2021, as part of the existing Sanofi Agreement, Sanofi paid us $22.0 million to exercise its option to expand the number of targets in the Sanofi Agreement from three to a total of five targets. In January 2021, we and Sanofi entered into the First Amendment to the Sanofi Agreement to modify the research term on all targets.
In January 2021, as part of the existing Sanofi Agreement, Sanofi paid us $22.0 million to exercise its option to expand the number of targets in the Sanofi Agreement from three to a total of five targets. In January 2021, we entered into the First Amendment to the Sanofi Agreement to modify the research term on all targets.
The net proceeds from this offering were approximately $188.7 million, after deducting underwriting discounts and commissions and offering expenses. As of November 30, 2024, a total of 1,480,349 of the 2024 Pre-Funded Warrants remained available for exercise.
The net proceeds from this offering were approximately $188.7 million, after deducting underwriting discounts and commissions and offering expenses. As of November 30, 2025, a total of 1,480,349 of the 2024 Pre-Funded Warrants remained available for exercise.
In December 2021, we and Sanofi entered into the Second Amendment to the Sanofi Agreement to extend the substitution deadline on certain targets. In July 2022, we and Sanofi entered into the Third Amendment to the Sanofi Agreement to further extend the substitution deadline on certain targets. The extensions of the substitution deadline had no impact on revenue recognition.
In December 2021, we entered into the Second Amendment to the Sanofi Agreement to extend the substitution deadline on certain targets. In July 2022, we entered into the Third Amendment to the Sanofi Agreement to further extend the substitution deadline on certain targets. The extensions of the substitution deadline had no impact on revenue recognition.
In the long term, our ability to support our working capital and capital expenditure requirements will depend on many factors, including the following: • the progress, costs and results of our ongoing Phase 1 clinical trials for our lead drug candidates NX-5948, NX-2127 and NX-1607, and any future clinical development of such drug candidates; • the scope, progress, costs and results of preclinical and clinical development for our other drug candidates and development programs; • the number and development requirements of other drug candidates that we pursue; • the scope of, and costs associated with, future advancements to our DEL-AI platform; • the success of our collaborations with Gilead, Sanofi, Pfizer and any other collaborations we may establish; • the costs, timing and outcome of regulatory review of our drug candidates; • the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our drug candidates for which we receive marketing approval; • the revenue, if any, received from commercial sales of our drug candidates for which we receive marketing approval; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and • our ability to establish additional collaboration arrangements with other biotechnology or pharmaceutical companies on favorable terms, if at all, for the development or commercialization of our drug candidates.
In the long term, our ability to support our working capital and capital expenditure requirements will depend on many factors, including the following: • the progress, costs and results of our ongoing Phase 1 clinical trials for our lead drug candidates bexobrutideg, zelebrudomide and NX-1607, and any future clinical development of such drug candidates; • the scope, progress, costs and results of preclinical and clinical development for our other drug candidates and development programs; • the number and development requirements of other drug candidates that we pursue; • the scope of, and costs associated with, future advancements to our DEL-AI platform; • the success of our collaborations with Gilead, Sanofi, Pfizer and any other collaborations we may establish; • the costs, timing and outcome of regulatory review of our drug candidates; • the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our drug candidates for which we receive marketing approval; • the revenue, if any, received from commercial sales of our drug candidates for which we receive marketing approval; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and • our ability to establish additional collaboration arrangements with other biotechnology or pharmaceutical companies on favorable terms, if at all, for the development or commercialization of our drug candidates.
Critical Accounting Policies and Estimates Our accounting policies are more fully described in Note 2 of the consolidated financial statements to this Annual Report on Form 10-K.
Critical Accounting Policies and Estimates Our accounting policies are more fully described in Note 2 of the financial statements to this Annual Report on Form 10-K.
In February and March 2024, as part of the existing collaboration agreement, Gilead elected to extend the five-year initial research term by two years for certain drug targets (Gilead Research Term Extension). The Gilead Research Term Extension triggered a $15.0 million payment that we received in the second quarter of fiscal year 2024.
In February and March 2024, as part of the existing collaboration agreement, Gilead elected to extend the five-year initial research term by two years for certain drug targets (Gilead Research Term Extension). The Gilead Research Term Extension triggered a $15.0 million payment, which we received in the second quarter of fiscal year 2024.
We expect that our existing cash, cash equivalents and marketable securities are sufficient to meet our cash requirements and continue operating activities, including the clinical trials of our drug candidates NX-5948, NX-2127 and NX-1607 and the expansion of our intellectual property portfolio and infrastructure, for at least the next 12 months.
We expect that our existing cash, cash equivalents and marketable securities are sufficient to meet our cash requirements and continue operating activities, including the clinical trials of our drug candidates bexobrutideg (NX-5948), zelebrudomide (NX-2127) and NX-1607 and the expansion of our intellectual property portfolio and infrastructure, for at least the next 12 months.
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. Impact of Current Global Business, Political and Macroeconomic Conditions Uncertainty in the global business, political and macroeconomic environments present significant risks to our business.
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. 116 Impact of Current Business, Political and Macroeconomic Conditions Uncertainty in the business, political and macroeconomic environments present significant risks to our business.
Forecasted total expenditures are driven primarily by the number of full-time employees, and the assumptions over the number of full-time employees require significant management judgement. The number of full-time employees may change based on the progress and timing of our product development, and may be influenced by resource allocation decisions on internal programs and overall constraint on resources.
Forecasted total expenditures are driven primarily by the number of full-time employees, and the assumptions over the number of full-time employees require significant management judgment. The number of full-time employees may change based on the progress and timing of our product development, and may be influenced by resource allocation decisions on internal programs and overall constraint on resources.
Net proceeds from the RDOs were $94.8 million, after deducting offering expenses of $0.2 million. As of November 30, 2024, a total of 6,097,560 of the 2022 Pre-Funded Warrants remained available for exercise.
Net proceeds from the RDOs were $94.8 million, after deducting offering expenses of $0.2 million. As of November 30, 2025, a total of 6,097,560 of the 2022 Pre-Funded Warrants remained available for exercise.
This study also includes a cohort within the Phase 1a dose escalation study testing NX-1607 in combination with paclitaxel, a taxane chemotherapy commonly used across a range of relapsed and refractory solid tumor indications.
This study also included a cohort within the Phase 1a dose escalation study testing NX-1607 in combination with paclitaxel, a taxane chemotherapy commonly used across a range of relapsed and refractory solid tumor indications.
As of November 30, 2024, we are eligible to receive up to approximately $1.8 billion in total additional payments based on certain additional fees, payments and the successful completion of certain preclinical, clinical, development and sales milestones.
As of November 30, 2025, we are eligible to receive up to approximately $1.8 billion in total additional payments based on certain additional fees, payments and the successful completion of certain preclinical, clinical, development and sales milestones.
If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Our contractual obligations mostly consist of our operating lease obligations for facilities in San Francisco, California and The Woodlands, Texas.
If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Our contractual obligations mostly consist of our operating lease obligations for facilities in The Woodlands, Texas and Brisbane, California.
Our partnered drug discovery pipeline consists of multiple programs under collaboration agreements with Gilead Sciences, Inc. (Gilead), Sanofi S.A. (Sanofi) and Seagen Inc. (now a part of Pfizer Inc. (Pfizer)), within which we retain certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates.
Our partnered drug discovery pipeline consists of multiple programs under collaboration agreements with Gilead Sciences, Inc. (Gilead), Sanofi S.A. (Sanofi) and Pfizer Inc. (Pfizer), within which we retain certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates.
Overview We are a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of medicines based on targeted protein degradation, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and autoimmune diseases.
Overview We are a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.
As of November 30, 2024, we had $204.6 million of common stock remaining available for sale under the Second Amended Equity Distribution Agreement.
As of November 30, 2025, we had $204.6 million of common stock remaining available for sale under the Second Amended Equity Distribution Agreement.
Pfizer will be responsible for conjugating these degraders to antibodies to make degrader antibody conjugates (DACs), a new class of medicines for use in cancer treatment, and advancing these DAC drug candidates through preclinical and clinical development and commercialization.
Pfizer will be responsible for conjugating these degraders to antibodies to make DACs, a new class of medicines for use in cancer treatment, and advancing these DAC drug candidates through preclinical and clinical development and commercialization.
We are subject to continuing risks and uncertainties, including increasing financial market volatility and uncertainty, inflation, interest rate fluctuations, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system, cybersecurity events, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics.
We are subject to continuing risks and uncertainties, including increasing financial market volatility and uncertainty, inflation, interest rate fluctuations, changing tariff policies and trade restrictions, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system, cybersecurity events, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics.
Provision for Income Taxes The provision for income taxes primarily consists of reserves for unrecognized tax benefits and state taxes. We have generated NOLs since inception and have established a full valuation allowance against our deferred tax assets due to the uncertainty surrounding the realization of such assets.
Provision for Income Taxes The provision for income taxes primarily consists of reserves for unrecognized tax benefits and state taxes. We have generated net operating losses since inception and have established a full valuation allowance against our deferred tax assets due to the uncertainty surrounding the realization of such assets.
We expect that any collaboration revenue we generate from our current collaboration and license agreements, and from any future collaboration partners, will fluctuate in the future as a result of the timing and amount of upfront, milestones and other collaboration agreement payments and other factors.
We expect that any collaboration revenue we generate from our current collaboration and license agreements, and from any future collaboration partners, will fluctuate in the future as a result of the timing and amount of upfront, milestones and other collaboration agreement payments and other factors. License Revenue Our license revenue consists of payments received from the Sanofi License Extensions.
The increase in net assets consisted of a decrease in deferred revenue of $28.5 million as we increased effort in our programs and recognized revenue, a decrease in operating lease liabilities of $6.4 million due to lease payments made during the period, offset by an increase in accrued expenses and other liabilities of $11.8 million primarily related to the accrual of annual incentive compensation, an increase in accounts payable of $5.2 million from outstanding payments to vendors, an increase in prepaid expenses and other assets of $0.5 million primarily due to the recognition of expenses for prepaid services.
The increase in net assets consisted of a decrease in deferred revenue of $28.5 million as we increased effort in our programs and recognized revenue, a decrease in operating lease liabilities of $6.4 million due to lease payments made during the period and an increase in prepaid expenses and other assets of $0.5 million primarily related to increased prepaid contract manufacturing costs and software license costs, offset by an increase in accrued expenses and other liabilities of $11.8 million primarily related to the accrual of annual incentive compensation, an increase in accounts payable of $5.2 million from outstanding payments to vendors.
As of November 30, 2024, we had $609.6 million in cash, cash equivalents and marketable securities. We expect that our existing cash, cash equivalents and marketable securities are sufficient to fund our operations for at least the next 12 months. See the section titled “—Liquidity and Capital Resources” for more information.
As of November 30, 2025, we had $592.9 million in cash, cash equivalents and marketable securities. We expect that our existing cash, cash equivalents and marketable securities are sufficient to fund our operations for at least the next 12 months. See the section titled “—Liquidity and Capital Resources” for more information.
In aggregate, we have received $440.0 million in non-dilutive financing from our collaborators to date and, as of November 30, 2024, we are eligible to receive up to $7.1 billion in potential future fees and milestone payments, as well as royalties on future product sales.
In aggregate, we have received $482.0 million in non-dilutive financing from our collaborators to date and, as of November 30, 2025, we are eligible to receive up to $6.1 billion in potential future fees and milestone payments, as well as royalties on future product sales.
Interest and Other Income, Net Our interest and other income, net increased by $8.6 million during the year ended November 30, 2024, compared to the year ended November 30, 2023, primarily attributable to higher interest rates earning higher interest income on our deposits, money market funds and marketable securities.
Interest and Other Income, Net Our interest and other income, net increased by $2.2 million during the year ended November 30, 2025, compared to the year ended November 30, 2024, primarily attributable to higher interest rates earning higher interest income on our deposits, money market funds and marketable securities.
Comparison of the Years Ended November 30, 2023 and 2022 Discussion and analysis of the results of operations for the year ended November 30, 2023, compared to the year ended November 30, 2022, is included under the heading “Comparison of the years ended November 30, 2023 and 2022” in Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, in our Annual Report on Form 10-K as filed with the SEC on February 15, 2024, and incorporated by reference into this Annual Report on Form 10-K.
Comparison of the Years Ended November 30, 2024 and 2023 Discussion and analysis of the results of operations for the year ended November 30, 2024, compared to the year ended November 30, 2023, is included under the heading “Comparison of the years ended November 30, 2024 and 2023” in Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, in our Annual Report on Form 10-K as filed with the SEC on January 28, 2025, and incorporated by reference into this Annual Report on Form 10-K.
In addition, from the signing of the Gilead Agreement to November 30, 2024, we received payments of $47.0 million for research milestones and additional payments, $20.0 million for a license option exercise payment and $15.0 million in research term extension fees.
In addition, from the signing of the Gilead Agreement to November 30, 2025, we have received payments of $47.0 million for research milestones and additional payments, $20.0 million for a license option exercise payment, $15.0 million in research term extension fees and $5.0 million for a clinical milestone payment.
Food and Drug Administration (FDA) granted Fast Track designation for NX-5948 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two lines of therapy, including a BTK inhibitor (BTKi) and a B-cell lymphoma 2 (BCL2) inhibitor.
In January 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for bexobrutideg for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor.
We do not have any products approved for sale, and we have not generated any revenue from product sales. As of November 30, 2024, we had $609.6 million in cash, cash equivalents and marketable securities.
We do not have any products approved for sale, and we have not generated any revenue from product sales. As of November 30, 2025, we had $592.9 million in cash, cash equivalents and marketable securities.
External research and development expenses consist primarily of costs incurred for the development of our drug candidates and may include: • fees paid to third parties such as consultants, contractors and contract research organizations to conduct our clinical trials, discovery programs and preclinical studies; • costs to acquire, develop and manufacture supplies for clinical trials and preclinical studies, including fees paid to third parties such as contract manufacturing organizations; and • expenses related to laboratory supplies and services.
External expenses for clinical development programs and other research and development expenses include: • fees paid to third parties such as consultants, contractors and contract research organizations to conduct our clinical trials, discovery programs and preclinical studies; 117 • costs to acquire, develop and manufacture supplies for clinical trials and preclinical studies, including fees paid to third parties such as contract manufacturing organizations; and • expenses related to laboratory supplies and services.
We recognized collaboration revenue from the Gilead Agreement of $14.0 million and $29.9 million during the years ended November 30, 2024 and 2023, respectively. As of November 30, 2024 and 2023, there was $11.0 million and $10.0 million, respectively, of deferred revenue related to payments received by us under the Gilead Agreement.
We recognized collaboration revenue from the Gilead Agreement of $7.1 million and $14.0 million during the years ended November 30, 2025 and 2024, respectively. As of November 30, 2025 and 2024, there was $3.8 million and $11.0 million, respectively, of deferred revenue related to payments received by us under the Gilead Agreement.
During the years ended November 30, 2024 and 2023, we incurred net losses of $193.6 million and $143.9 million, respectively. As of November 30, 2024, we had an accumulated deficit of $738.8 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations.
During the years ended November 30, 2025 and 2024, we incurred net losses of $264.5 million and $193.6 million, respectively. As of November 30, 2025, we had an accumulated deficit of $1.0 billion These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations.
Investing activities Net cash used in investing activities was $257.7 million for the year ended November 30, 2024, and consisted of purchases of marketable securities of $707.9 million and purchases of property and equipment of $9.3 million, offset by the maturity of marketable securities of $459.5 million.
Net cash used in investing activities was $257.7 million for the year ended November 30, 2024, and consisted of purchases of marketable securities of $707.9 million and purchases of property and equipment of $9.3 million, offset by the maturity of marketable securities of $459.5 million. 124 Net cash provided by investing activities was $68.3 million for the year ended November 30, 2023, and consisted of the maturity of marketable securities of $323.0 million, offset by the purchase of marketable securities of $246.3 million and purchases of property and equipment of $8.4 million.
Our total operating lease commitments as of November 30, 2024, were approximately $38.5 million, of which $8.2 million is expected to be paid within the next 12 months.
Our total operating lease commitments as of November 30, 2025, were approximately $82.5 million, of which $6.3 million is expected to be paid within the next 12 months.
Net cash used in operating activities was $159.8 million for the year ended November 30, 2022, and consisted of our net loss of $180.4 million and an increase in net assets of $19.0 million, offset by non-cash adjustments of $39.6 million.
Net cash used in operating activities was $172.6 million for the year ended November 30, 2024, and consisted of our net loss of $193.6 million and an increase in net assets of $18.4 million, offset by non-cash adjustments of $39.4 million.
Net cash provided by financing activities was $3.2 million for the year ended November 30, 2023, and consisted primarily of proceeds from the issuance of common stock under our Employee Stock Purchase Plan.
Net cash provided by financing activities was $3.2 million for the year ended November 30, 2023, and consisted primarily of proceeds from the issuance of common stock under our Employee Stock Purchase Plan. Information About Segments We currently operate in a single business segment.
As a result of these variables, we are unable to determine when and to what extent we will generate revenue from the commercialization and sale of our drug candidates.
As a result of these variables, we are unable to determine when and to what extent we will generate revenue from the commercialization and sale of our drug candidates. We may never succeed in achieving regulatory approval for any of our drug candidates.
Pfizer In September 2023, we entered into a strategic collaboration with Seagen Inc. (now a part of Pfizer Inc.) (the Pfizer Agreement) to develop a suite of targeted protein degraders against multiple targets nominated by Pfizer that are suitable for antibody conjugation.
(now a part of Pfizer Inc.) (the Pfizer Agreement) to develop a suite of targeted protein degraders against multiple targets nominated by Pfizer that are suitable for antibody conjugation.
Targeted Protein Degradation Our portfolio of targeted protein degraders of BTK, a B‑cell signaling protein, comprises NX‑5948, an investigational, orally bioavailable degrader of BTK for the treatment of relapsed or refractory B-cell malignancies and potentially autoimmune diseases, and NX‑2127, an investigational orally bioavailable degrader of BTK that also degrades cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) for the treatment of relapsed or refractory B‑cell malignancies.
Targeted Protein Degradation Our portfolio of targeted protein degraders of the B‑cell signaling protein BTK comprises bexobrutideg (NX‑5948), an investigational, orally bioavailable, highly selective BTK degrader for the treatment of relapsed or refractory B-cell malignancies and potentially autoimmune diseases, and zelebrudomide (NX‑2127), an investigational orally bioavailable degrader that simultaneously degrades BTK and two well-characterized cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) that are clinically validated transcription factor targets for relapsed or refractory B‑cell malignancies.
If the license is the predominant promise, and it is determined that the license represents functional intellectual property, revenue is recognized at the point in time when control of the license is transferred.
If the license is the predominant promise, and it is determined that the license represents functional intellectual property, revenue is recognized at the point in time when control of the license is transferred. If it is determined that the license does not represent functional intellectual property, revenue is recognized over time using an appropriate method of measuring progress.
Powered by our prolific DEL-AI discovery engine and leading ligase expertise, capable of tackling any protein class, we have built a significant advantage in translating the science of degradation into clinical advancements. We aim to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with leading ligase expertise, we have built a significant advantage in translating the science of protein degradation into clinical advancements with the aim of establishing degrader-based treatments at the forefront of patient care.
These existing and future programs may have the potential to address diseases with significant unmet need, including cancer, autoimmunity, inflammation, and other challenging diseases. We have entered into several revenue generating collaborations with large biopharmaceutical companies, including with Gilead, Sanofi and Seagen (now a part of Pfizer), to leverage our DEL-AI platform for drug discovery.
These existing and future programs have the potential to provide patients with better options in the therapeutic indications with significant unmet needs, including cancer, inflammation, autoimmunity and other challenging therapeutic areas We have entered into several revenue generating collaborations with large biopharmaceutical companies, including Gilead, Sanofi and Pfizer, to leverage our DEL-AI platform for drug discovery.
We recognized collaboration revenue from the Sanofi Agreement of $21.7 million and $25.4 million during the years ended November 30, 2024 and 2023, respectively. As of November 30, 2024 and 2023, there was $9.1 million and $24.9 million, respectively, of deferred revenue related to payments received by us under the Sanofi Agreement.
We recognized collaboration revenue from the Pfizer Agreement of $25.7 million and $18.8 million during the years ended November 30, 2025 and 2024, respectively. As of November 30, 2025 and 2024, there was $23.8 million and $44.5 million, respectively, of deferred revenue related to payments received by us under the Pfizer Agreement.
In addition, from the signing of the Sanofi Agreement to November 30, 2024, we have received payments of $13.0 million for research milestones. As of November 30, 2024, we are eligible to receive up to approximately $1.9 billion in total additional payments based on certain additional fees, payments and the successful completion of certain research development, regulatory and sales milestones.
As of November 30, 2025, we are eligible to receive up to approximately $930.0 million in total additional payments based on certain additional fees, payments and the successful completion of certain research development, regulatory and sales milestones.
The capitalized amounts are then expensed as the related goods are delivered and as services are performed. We track the external research and development costs incurred for each of our drug candidates.
Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and as services are performed. We track the external research and development costs incurred for each of our drug candidates.
Information About Segments We currently operate in a single business segment. See additional information in our consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K.
See additional information in our financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K.
Internal research and development costs include: • payroll and personnel expenses, including benefits, stock-based compensation and travel expenses, for our research and development functions; and • depreciation of research and development equipment, allocated overhead and facilities-related expenses.
Internal research and development costs include: • payroll and personnel expenses, including benefits, stock-based compensation and travel expenses, for our research and development functions; • costs associated with our research and development platform used across programs, process development, manufacturing and preclinical research and development for earlier stage programs and new technologies; and • depreciation of research and development equipment, allocated overhead and facilities-related expenses.
The collaboration excludes our current internal protein degradation programs for which we retain all rights, and also excludes our future internal programs, provided that we distinguished future programs as excluded from the scope of the collaboration. 114 For drug targets that are subject to the collaboration, we have primary responsibility for conducting preclinical research activities (including target validation, drug discovery, identification or synthesis) in accordance with the applicable research plan agreed to by the parties and established on a target-by-target basis.
For drug targets that are subject to the collaboration, we have primary responsibility for conducting preclinical research activities (including target validation, drug discovery, identification or synthesis) in accordance with the applicable research plan agreed to by the parties and established on a target-by-target basis.
Net cash provided by investing activities was $27.2 million for the year ended November 30, 2022, and consisted of the maturity of marketable securities of $278.8 million, offset by the purchase of marketable securities of $239.4 million and purchases of property and equipment of $12.2 million. 124 Financing activities Net cash provided by financing activities was $485.7 million for the year ended November 30, 2024, and consisted primarily of net proceeds from our 2024 Public Offering, the May 2024 ATM Financing, the August 2024 ATM Financing, the October 2024 ATM Financing and the November 2024 ATM Financing.
Net cash provided by financing activities was $485.7 million for the year ended November 30, 2024, and consisted primarily of net proceeds from our 2024 Public Offering, the May 2024 ATM Financing, the August 2024 ATM Financing, the October 2024 ATM Financing and the November 2024 ATM Financing.
Net cash provided by investing activities was $68.3 million for the year ended November 30, 2023, and consisted of the maturity of marketable securities of $323.0 million, offset by the purchase of marketable securities of $246.3 million and purchases of property and equipment of $8.4 million.
Investing activities Net cash provided by investing activities was $147.9 million for the year ended November 30, 2025, and consisted of purchases of marketable securities of $455.7 million and purchases of property and equipment of $14.0 million, offset by the maturity of marketable securities of $617.5 million.
For more information regarding these risks and uncertainties, see the section titled “Risk Factors” in this Annual Report on Form 10-K. 116 Components of Results of Operations Collaboration Revenue We have no products approved for commercial sale and to date have not generated any revenue from the sale of products and do not expect to generate any revenue from the sale of products in the near future.
Components of Results of Operations Collaboration Revenue We have no products approved for commercial sale and to date have not generated any revenue from the sale of products and do not expect to generate any revenue from the sale of products in the near future.
As of November 30, 2024 and 2023, there was $44.5 million and $58.3 million, respectively, of deferred revenue related to payments received by us under the Pfizer Agreement. 115 Financial Overview Since the commencement of our operations, we have devoted substantially all of our resources to conducting research and development activities, establishing and maintaining our intellectual property portfolio, establishing our corporate infrastructure, raising capital and providing general and administrative support for these operations.
Financial Overview Since the commencement of our operations, we have devoted substantially all of our resources to conducting research and development activities, establishing and maintaining our intellectual property portfolio, establishing our corporate infrastructure, raising capital and providing general and administrative support for these operations.
The increase in net assets consisted primarily of a decrease in deferred revenue of $26.6 million as we increased effort in our programs and recognized revenue, a decrease in operating lease liabilities of $4.9 million due to payments made on operating leases and an increase in prepaid expenses and other assets of $1.1 million primarily related to increased prepaid clinical and contract manufacturing costs and software license costs, offset by an increase in accrued expenses and other liabilities of $7.5 million primarily related to the accrual of contract research, laboratory supplies and annual incentive compensation and a decrease in accounts receivable of $6.0 million related to payments received under the Gilead Agreement.
The increase in net assets consisted of a decrease in deferred revenue of $37.0 million as we increased effort in our programs and recognized revenue, a decrease in operating lease liabilities of $5.1 million due to lease payments made during the period, an increase in prepaid expenses and other assets of $6.2 million primarily due to security deposit payments related to the Brisbane Lease and a decrease in accounts payable of $0.6 million from payments to vendors, offset by an increase in accrued expenses and other liabilities of $17.3 million primarily related to the accrual of annual incentive compensation.
Non-cash adjustments primarily consisted of stock-based compensation expenses of $28.1 million, amortization of operating lease ROU assets of $5.5 million and depreciation and amortization expenses of $5.3 million.
Non-cash adjustments primarily consisted of stock-based compensation expenses of $38.0 million, depreciation and amortization expenses of $8.7 million and amortization of operating lease ROU assets of $10.1 million, offset by net accretion of discount on marketable securities of $10.3 million.
The collaboration excludes our current internal protein degradation programs for which we retain all rights, and also excludes our future internal programs, provided that we have distinguished future programs as excluded from the scope of the collaboration.
The collaboration excludes our current internal protein degradation programs for which we retain all rights, and also excludes our future internal programs, provided that we distinguished future programs as excluded from the scope of the collaboration. 114 In March 2025, Sanofi exercised its right to exclusively license one target (the First Sanofi License Extension), the first development candidate resulting from the Sanofi Agreement.
Forecasted total expenditures also include other direct costs related to product development, including third-party contract costs, and may also require management’s estimate of costs and market conditions that may impact costs. 119 Results of Operations Comparison of the Years Ended November 30, 2024 and 2023 Our results of operations for the years ended November 30, 2024 and 2023 are summarized as follows (in thousands): Year ended November 30, 2024 2023 Change Revenue: Collaboration revenue $ 54,549 $ 56,987 $ (2,438) License revenue — 20,000 (20,000) Total revenue 54,549 76,987 (22,438) Operating expenses: Research and development 221,632 189,148 32,484 General and administrative 45,944 42,902 3,042 Total operating expenses 267,576 232,050 35,526 Loss from operations (213,027) (155,063) (57,964) Interest and other income, net 19,728 11,115 8,613 Loss before income taxes (193,299) (143,948) (49,351) Provision for income taxes 270 — 270 Net loss $ (193,569) $ (143,948) $ (49,621) Collaboration Revenue Our collaboration revenue for the years ended November 30, 2024 and 2023 is summarized as follows (in thousands): Year ended November 30, 2024 2023 Change Gilead $ 13,996 $ 29,947 $ (15,951) Sanofi 21,706 25,350 (3,644) Pfizer 18,847 1,690 17,157 Total collaboration revenue $ 54,549 $ 56,987 $ (2,438) Our collaboration revenue decreased by $2.4 million during the year ended November 30, 2024, compared to the year ended November 30, 2023, primarily due to a decrease in revenue from our collaboration with Gilead as we concluded the initial research term for certain drug targets and due to fewer milestone payments being achieved.
Forecasted total expenditures also include other direct costs related to product development, including third-party contract costs, and may also require management’s estimate of costs and market conditions that may impact costs. 119 Results of Operations Comparison of the Years Ended November 30, 2025 and 2024 Our results of operations for the years ended November 30, 2025 and 2024 are summarized as follows (in thousands): Year ended November 30, 2025 2024 Change Revenue: Collaboration revenue $ 53,980 $ 54,549 $ (569) License revenue 30,000 — 30,000 Total revenue 83,980 54,549 29,431 Operating expenses: Research and development 316,903 221,632 95,271 General and administrative 52,743 45,944 6,799 Total operating expenses 369,646 267,576 102,070 Loss from operations (285,666) (213,027) (72,639) Interest and other income, net 21,969 19,728 2,241 Loss before income taxes (263,697) (193,299) (70,398) Provision for income taxes 760 270 490 Net loss $ (264,457) $ (193,569) $ (70,888) Collaboration Revenue Our collaboration revenue for the years ended November 30, 2025 and 2024 is summarized as follows (in thousands): Year ended November 30, 2025 2024 Change Gilead $ 12,148 $ 13,996 $ (1,848) Sanofi 16,148 21,706 (5,558) Pfizer 25,684 18,847 6,837 Total collaboration revenue $ 53,980 $ 54,549 $ (569) Our collaboration revenue decreased by $0.6 million during the year ended November 30, 2025, compared to the year ended November 30, 2024, primarily due to a decrease in revenue from our collaborations with Sanofi and Gilead as we concluded the initial research term for certain drug targets.
Actual results could differ significantly from those estimates. We believe that the following discussion addresses our most critical accounting policies and estimates, which are those that are most important to the portrayal of our financial condition and results of operations and require management’s most difficult, subjective and complex judgments.
We believe that the following discussion addresses our most critical accounting policies and estimates, which are those that are most important to the portrayal of our financial condition and results of operations and require management’s most difficult, subjective and complex judgments. 118 Revenue Recognition We recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services.
We recognized collaboration revenue from the Pfizer Agreement of $18.8 million and $1.7 million during the years ended November 30, 2024 and 2023, respectively.
We recognized collaboration revenue from the Sanofi Agreement of $16.1 million and $21.7 million during the years ended November 30, 2025 and 2024, respectively. We also recognized $30 million in license revenue received pursuant to the Sanofi License Extensions during the year ended November 30, 2025.
We expect our general and administrative expenses to increase for the foreseeable future as we continue to improve our infrastructure and operate as a public company.
General and Administrative Expenses General and administrative expenses consist primarily of payroll and personnel expenses, including benefits and stock-based compensation, facilities-related expenses and professional fees for legal, consulting and audit and tax services. We expect our general and administrative expenses to increase for the foreseeable future as we continue to improve our infrastructure and operate as a public company.
For the profit-share products, the parties will share net profits and net losses and global development costs, and we will be eligible to receive royalty and milestone payments on such optioned products. Under the terms of the Pfizer Agreement, we received an upfront payment of $60.0 million.
Development of licensed degraders, with the exception of licensed products for which we exercise our profit-share options, will be at Pfizer’s sole cost and expense. For the profit-share products, the parties will share net profits and net losses and global development costs, and we will be eligible to receive royalty and milestone payments on such optioned products.
Our license revenue was $20.0 million for the year ended November 30, 2023 and is related to the Gilead License Option Exercise. 120 Research and Development Expenses Our research and development expenses for the years ended November 30, 2024 and 2023 are summarized as follows (in thousands): Year ended November 30, 2024 2023 Change Compensation and related personnel costs $ 72,965 $ 72,876 $ 89 Stock-based compensation 17,763 18,709 (946) Supplies and contract research 47,879 43,943 3,936 Preclinical activities 3,050 1,652 1,398 Contract manufacturing 17,046 7,770 9,276 Clinical costs 29,750 17,500 12,250 Facility and other costs 33,179 26,698 6,481 Total research and development expenses $ 221,632 $ 189,148 $ 32,484 Our research and development expense increased by $32.5 million during the year ended November 30, 2024, compared to the year ended November 30, 2023.
There was no license revenue for the year ended November 30, 2024. 120 Research and Development Expenses Our research and development expenses for the years ended November 30, 2025 and 2024 are summarized as follows (in thousands): Year ended November 30, 2025 2024 Change Compensation and related personnel costs $ 98,441 $ 72,965 $ 25,476 Stock-based compensation 21,562 17,763 3,799 Supplies and contract research 53,749 47,879 5,870 Preclinical activities 6,351 3,050 3,301 Contract manufacturing 36,887 17,046 19,841 Clinical costs 57,878 29,750 28,128 Facility and other costs 42,035 33,179 8,856 Total research and development expenses $ 316,903 $ 221,632 $ 95,271 Our research and development expenses increased by $95.3 million during the year ended November 30, 2025, compared to the year ended November 30, 2024.
In November 2024, the European Medicines Agency granted PRIME designation for NX-5948 in CLL or SLL after at least a BTKi and a BCL-2 inhibitor. In December 2024, the FDA granted Fast Track designation for NX-5948 for the treatment of adult patients with Waldenstrom’s macroglobulinemia after at least two lines of therapy, including a BTKi.
In November 2024, the European Medicines Agency (EMA) granted Priority Medicine (PRIME) designation for bexobrutideg in CLL or SLL after at least a BTK inhibitor and a BCL-2 inhibitor.
There was an increase in clinical, contract manufacturing, and consulting costs primarily driven by our continued efforts to accelerate enrollment for NX-5948. The increase was also attributable to increased supplies and contract research costs in connection with supporting our collaborations with Pfizer and Sanofi.
There was an increase in clinical, contract manufacturing, and consulting costs as we continued to accelerate the enrollment of patients in the ongoing clinical trials of bexobrutideg (NX-5948) and prepare for the initiation of pivotal trials, and an increase in contract research costs to support our ongoing collaborations.
For the targets nominated by Pfizer under the collaboration, we shall use commercially reasonable efforts to identify, synthesize, characterize and deliver targeted protein degraders that selectively bind to and degrade such targets. Development of licensed degraders, with the exception of licensed products for which we exercise our profit-share options, will be at Pfizer’s sole cost and expense.
The collaboration excludes our current internal protein degradation programs for which we retain all rights, and also excludes our future internal programs, provided that we have distinguished future programs as excluded from the scope of the collaboration. 115 For the targets nominated by Pfizer under the collaboration, we shall use commercially reasonable efforts to identify, synthesize, characterize and deliver targeted protein degraders that selectively bind to and degrade such targets.
Net cash provided by financing activities was $117.2 million for the year ended November 30, 2022, and consisted primarily of net proceeds from the issuance of the 2022 Pre-Funded Warrants in the RDOs of $94.8 million and from the issuance of common stock in the June 2022 ATM Offering of $19.4 million.
Financing activities Net cash provided by financing activities was $238.6 million for the year ended November 30, 2025, and consisted primarily of net proceeds from the 2025 RDO.
We expense both internal and external research and development expenses to operations in the periods in which they are incurred. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized.
Research and Development Expenses Research and development expenses consist primarily of costs incurred for the discovery and development of our drug candidates. We expense both internal and external research and development expenses to operations in the periods in which they are incurred.
We are also eligible for mid-single to low double digit percentage tiered royalties on future sales.
We are eligible to receive up to approximately $3.4 billion in contingent payments based on specified research, development, regulatory and commercial milestones across multiple programs. We are also eligible for mid-single to low double digit percentage tiered royalties on future sales.
NX‑2127: We are currently conducting a Phase 1a/1b dose-escalation and cohort expansion study of NX-2127 in patients with relapsed or refractory B-cell malignancies. We have initiated Phase 1b expansion cohorts for patients with relapsed CLL, diffuse large B-cell lymphoma and mantle cell lymphoma. In March 2024, the FDA lifted the partial clinical hold on the U.S.
In December 2024, the FDA granted Fast Track designation for bexobrutideg for the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM) after at least two lines of therapy, including a BTK inhibitor. Zelebrudomide (NX-2127): We are currently conducting a Phase 1a/1b dose-escalation and cohort expansion study of zelebrudomide in patients with relapsed or refractory B-cell malignancies.
In addition, we enter into agreements in the normal course of business with contract research organizations for clinical trials and with vendors for preclinical studies and other services and products for operating purposes, which are generally cancelable upon written notice.
In addition, we enter into agreements in the normal course of business with contract research organizations for clinical trials and with vendors for preclinical studies and other services and products for operating purposes, which are generally cancelable upon written notice. 123 We did not have during the periods presented, and we do not currently have, any commitments or obligations, including contingent obligations, arising from arrangements with unconsolidated entities or persons that have or are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, cash requirements or capital resources.
Drug Discovery Pipeline In addition to our clinical stage drug candidates, we are extending our protein degrader and ligase inhibitor portfolio, both on our own and with partners, by developing new targeted protein degraders and ligase inhibitors for a number of targets for which we believe these modalities can be clinically advantageous over existing therapies.
Drug Discovery Pipeline In addition to our clinical stage drug candidates, we are advancing multiple preclinical-stage programs within our degradation portfolio, both on our own and with partners, by developing new targeted protein degraders and degrader antibody conjugates for several therapeutic indications that currently lack treatment options or where current therapies are ineffective.
There was also an increase in facility costs primarily driven by lease expense and equipment costs related to our lease in The Woodlands, Texas, which commenced in September 2023. There was a decrease in non-cash stock-based compensation expense primarily due to the departures of certain executives.
There was an increase in compensation and related personnel costs and non-cash stock-based compensation expense due to an increase in headcount.
General and Administrative Expenses Our general and administrative expenses increased by $3.0 million during the year ended November 30, 2024, compared to the year ended November 30, 2023.
There was also an increase in facility and other costs primarily driven by lease expense and equipment costs related to our lease in Brisbane, California, which commenced in March 2025. General and Administrative Expenses Our general and administrative expenses increased by $6.8 million during the year ended November 30, 2025, compared to the year ended November 30, 2024.
A holder of the pre-funded warrants may increase or decrease this percentage not in excess of 19.99% by providing us at least 61 days’ prior notice. 122 Funding Requirements As of November 30, 2024, our operations have primarily been funded through the net proceeds from equity offerings of $1.1 billion and proceeds from collaborations of $435.0 million.
A holder of the pre-funded warrants may increase or decrease this percentage not in excess of 19.99% by providing us at least 61 days’ prior notice. 122 In October 2025, we completed an underwritten registered direct offering (the 2025 RDO) and issued 24,485,799 shares of common stock at a price of $10.21 per share.
The decrease in collaboration revenue was mainly offset by the recognition of revenue from our collaboration agreement with Pfizer that we entered into in September 2023. License Revenue There was no license revenue for the year ended November 30, 2024.
As of November 30, 2025 and 2024, there was zero and $9.1 million, respectively, of deferred revenue related to payments received by us under the Sanofi Agreement. Pfizer In September 2023, we entered into a strategic collaboration with Seagen Inc.
In addition, from the signing of the Pfizer Agreement to November 30, 2024, we have received a payment of $5.0 million in connection with the achievement of a research milestone. We are eligible to receive up to approximately $3.4 billion in contingent payments based on specified research, development, regulatory and commercial milestones across multiple programs.
Under the terms of the Pfizer Agreement, we received an upfront payment of $60.0 million. In addition, from the signing of the Pfizer Agreement to November 30, 2025, we have received payments of $10.0 million for research milestones.
If it is determined that the license does not represent functional intellectual property, revenue is recognized over time using an appropriate method of measuring progress. 118 Research and collaboration licenses : Collaboration agreements may include research licenses and research and development services to be performed by us.
Research and collaboration licenses : Collaboration agreements may include research licenses and research and development services to be performed by us.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeAs of November 30, 2024 and 2023, we have estimated that a hypothetical 100 basis point increase in interest rates would decrease the fair market value of our investment portfolio by $2.4 million and $0.9 million, respectively. Such losses would only be realized if we sold the investments prior to maturity. 125
Biggest changeAs of November 30, 2025 and 2024, we have estimated that a hypothetical 100 basis point increase in interest rates would decrease the fair market value of our investment portfolio by $1.3 million and $2.4 million, respectively. Such losses would only be realized if we sold the investments prior to maturity. 125
Our interest income is sensitive to changes in the general level of interest rates, primarily U.S. interest rates. As of November 30, 2024, our cash equivalents consisted of bank deposits and money market funds and our marketable securities included interest-earning securities. Such interest-earning instruments carry a degree of interest rate risk.
Our interest income is sensitive to changes in the general level of interest rates, primarily U.S. interest rates. As of November 30, 2025, our cash equivalents consisted of bank deposits and money market funds and our marketable securities included interest-earning securities. Such interest-earning instruments carry a degree of interest rate risk.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk We are exposed to market risks in the ordinary course of our business. Our primary exposure to market risk is interest rate sensitivity. Our interest-earning assets consist of cash, cash equivalents, restricted cash and marketable securities. Interest income earned on these assets totaled $19.2 million in fiscal year 2024.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk We are exposed to market risks in the ordinary course of our business. Our primary exposure to market risk is interest rate sensitivity. Our interest-earning assets consist of cash, cash equivalents, restricted cash and marketable securities. Interest income earned on these assets totaled $22.0 million in fiscal year 2025.

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