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Item 1. Business

2026-02-11 compared with 2025-02-25 · 98 added, 137 removed, 162 unchanged (59% of the section changed)

We are a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology.

We seek to develop drug candidates in the precision medicine space, and our processes for selection and clinical development of drug candidates are based on scientific insights into cancer-promoting factors, as well as our understanding of the clinical landscape and regulatory requirements.

We seek to develop drug candidates in the precision medicine space, and our processes for selection and clinical development of drug candidates are based on scientific data into cancer-promoting factors, as well as our understanding of the clinical landscape and regulatory requirements.

CORPORATE INFORMATION

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PRODUCTS UNDER DEVELOPMENT

In May 2021, we licensed exclusive worldwide commercial rights to NXP800, a novel small molecule that exerts its biologic activity through activation of the kinase general control nonderepressible 2 (“GCN2”), and which was discovered at the Institute for Cancer Research (“ICR”) in London, England.

Our license agreement with the ICR is subject to certain milestone and royalty payments.

For additional information see section “NXP800 License Agreement.” The U.S.

Food and Drug Administration (“FDA”) granted the NXP800 development program in platinum resistant, adenine-thymine (“AT”)-rich interaction domain (“ARID1a”)-mutated ovarian carcinoma Fast Track Designation in 2022, and Orphan Drug Designations for the treatment of cholangiocarcinoma in 2023 and ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers in 2024.

Scientific Background

NXP800 activates the GCN2 kinase inducing inhibition of cap-dependent protein translation and activation of the integrated stress response leading to cancer cell death.

In preclinical studies, treatment with NXP800 inhibited tumor growth in xenografts of ovarian cancer that harbored a loss of function mutation in the ARID1a gene.

Based on this work, we are currently evaluating the safety and efficacy of NXP800 in platinum-resistant ARID1a-mutated ovarian carcinoma, which is a cancer type comprised primarily of two histologies:

ovarian clear cell carcinoma (“OCCC”) and endometrioid ovarian carcinoma (“EOC”), and investigating the use of ARID1a mutations as a potential patient selection marker for additional types of cancer.

In addition, in preclinical studies, treatment with NXP800 inhibited tumor growth in patient-derived xenograft ("PDX") models of cholangiocarcinoma.

The safety and efficacy of NXP800 in this indication is currently being evaluated through an investigator-sponsored study conducted in collaboration with the Mayo Clinic.

The genetic screening for mutations in the ARID1a gene is included in commercially available next generation sequencing kits.

NXP800 Clinical Development

A comprehensive preclinical data package supported the approval of the Clinical Trial Application (“CTA”) by the Medicines and Healthcare Regulatory Agency (“MHRA”) in the United Kingdom, and the Investigational New Drug (“IND”) Application submission by the FDA.

In December 2021, we announced the commencement of the Phase 1 study for NXP800.

The Phase 1 study is comprised of two parts:

dose-escalation Phase 1a, which was completed in April 2023, and an expansion Phase 1b.

In the Phase 1a, we evaluated the safety, tolerability and pharmacokinetic properties of NXP800 in patients with advanced solid tumors to identify potential doses and dosing schedules for the Phase 1b.

In April 2023, we announced the commencement of the Phase 1b, in which the safety and preliminary anti-tumor activity of NXP800 is being evaluated in women with platinum-resistant, ARID1a-mutated ovarian carcinoma.

In January 2023, we announced that the European Network of Gynecological Oncology Trial Groups and the GOG Foundation, Inc., the world's premier gynecology oncology clinical trials consortia, will lead the Phase 1b clinical trial in ARID1a-mutated ovarian carcinoma.

In December 2023, we announced a collaboration with Mayo Clinic to conduct an investigator-sponsored clinical trial in patients with cholangiocarcinoma.

In December 2022, we announced that the FDA granted Fast Track Designation status to NXP800 for the treatment of

patients with platinum-resistant, ARIDA1a-mutated ovarian carcinoma.

In August 2023, we announced that the FDA granted Orphan Drug Designation to NXP800 for the treatment of patients with cholangiocarcinoma.

In August 2024, we announced that the FDA granted Orphan Drug Designation to NXP800 for the treatment of ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers.

Addressing an Unmet Need in Clear Cell Ovarian Cancer and Advanced-stage Endometrioid Ovarian Carcinoma

We are investigating NXP800 as a potential treatment for platinum-resistant, ARID1a-mutated ovarian carcinoma, which is a cancer type comprised primarily of two histologies:

OCCC and EOC.

It is estimated that approximately 66% and 40% of the patients with OCCC and EOC have the ARID1a mutation, respectively.

OCCC is highly malignant, difficult to treat, and has a very poor survival rate due to frequent recurrence after surgery and first-line treatment.

First-line treatment consists of platinum-based chemotherapy, for which the reported response rate in relapse/refractory, platinum resistant patients has been observed to be 1%, demonstrating a clear and dire need for a new treatment option for women with OCCC.

OCCC represents approximately 10% of all ovarian cancer cases in the United States, with an annual incidence of approximately 2,200 patients.

EOC also represents approximately 10% of all diagnosed ovarian cancer cases.

If diagnosed at an early-stage, EOC can often be resected.

However, if diagnosed at later stages, these tumors have a substantially worse prognosis.

Advanced, platinum-refractory, endometrioid cancer in the United States represents approximately 30% of the endometrioid ovarian cancer segment.

In this ovarian subset, the progression-free survival at three years for women diagnosed with stage III/IV disease is a dismal 20% for stage III and 0% for stage IV, representing a clear unmet medical need.

OCCC and EOC are subtypes of epithelial ovarian carcinoma, which have clinical characteristics distinct from those of high-grade serous ovarian carcinoma.

They exhibit a unique biological profile that is markedly different from those of other histologic types.

The relative prevalence of OCCC and EOC among women with ovarian cancer is higher in East Asia (for example, approximately 25% and 19% in Japan for OCCC and EOC, respectively) than in Europe and the United States (approximately 10% for each indication).

Market Potential/Addressable Patient Population in Additional Solid Tumor Types

In preclinical trials, NXP800 has also demonstrated anti-tumor activity in in-vivo xenograft models of gastric, and endometrial cancer bearing ARID1a mutation, and in PDX models of cholangiocarcinoma, which provide several development opportunities for NXP800.

In August 2021, we licensed worldwide commercial rights to NXP900 from the University of Edinburgh in Scotland.

NXP900 is a targeted-therapy, small molecule drug candidate that inhibits the proto-oncogene c-Src ( “SRC”) and YES1 kinases, the key members of the SRC kinase family.

In May 2023, we announced the IND was cleared by the FDA which included a Phase 1 protocol and comprised of two parts:

In May 2023, we announced the Investigational New Drug application (“IND”) was cleared by the U.S.

Food and Drug Administration (“FDA”) which included a Phase 1 protocol and comprised of two parts:

a dose-escalation Phase 1a and an expansion Phase 1b.

In September 2023, we announced the initiation of the Phase 1a portion of the clinical trial where we are evaluating the safety, tolerability and pharmacokinetic properties of NXP900 in patients with advanced solid tumors to identify potential doses and dosing schedules for the Phase 1b.

In the Phase 1b portion of the trial, we plan to investigate NXP900 in solid tumors where the SRC and/or YES1 pathways are overactivated and involved in the disease etiology.

In July 2025, we announced the completion of the Phase 1a part of the clinical trial in which we evaluated the safety, tolerability and pharmacokinetic properties of NXP900 in patients with advanced solid tumors to identify potential doses and dosing schedules for the Phase 1b.

In this Phase 1a portion of the study, a dose range of 20 to 300 mg/day was evaluated, and the dose-limiting toxicity level was not reached in that dose range.

The most common treatment emergent adverse events were primarily gastrointestinal-related and were mild to moderate in intensity.

Systemic exposure to NXP900 increased with higher doses, and a robust pharmacodynamic response of approximately 90% inhibition of SRC kinase phosphorylation was elicited at doses of 150 mg/day and higher, suggesting a potentially wide therapeutic window.

The results of the Phase 1a study support once-daily oral dosing of NXP900.

In August 2025, we announced the initiation of the Phase 1b expansion portion of the study.

The ongoing Phase 1b study will evaluate the safety, tolerability and preliminary efficacy of NXP900 both as a single agent targeting specific tumor types and in combination with market-leading epidermal growth factor receptor (“EGFR”) and anaplastic lymphoma kinase (“ALK”) inhibitors.

In July 2025, in advance of exploring combinations of NXP900 with EGFR and ALK inhibitors, we announced the completion and topline results from our clinical drug-drug interaction (“DDI”) study in healthy volunteers.

The NXP900 DDI study was conducted to evaluate the potential of NXP900 to induce the activity of cytochrome P450 enzyme CYP3A, which showed NXP900’s effect on the CYP3A enzyme is classified as a weak inhibitor according to the International Council for Harmonization M12 guidelines.

There were no serious or severe adverse events reported in the DDI study.

Diarrhea and non-infection related increases in white blood cell counts were the most common adverse events reported, all mild to moderate in intensity.

Scientific Background

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YES1 is amplified and overexpressed in many tumor types, where it promotes cell proliferation, survival, and invasiveness .

In addition, YES1 directly phosphorylates and activates the yes-associated protein 1 (“YAP1”), the main effector of the Hippo pathway, which has been identified as a promoter of drug resistance, cancer progression, and metastasis in several cancer types, including squamous cell, mesothelioma and papillary kidney cancers.

In addition, YES1 directly phosphorylates and activates yes-associated protein 1 (“YAP1”), the main effector of the Hippo pathway, which has been identified as a promoter of drug resistance, cancer progression, and metastasis in several cancer types, including squamous cell, mesothelioma and papillary kidney cancers.

NXP900’s Novel Mechanism of Action

SRC pathway activation is regulated by a switch between inactive and active conformations.

The inactive conformation of SRC family kinases is associated with lack of membrane binding, lack of phosphorylation of the activation loop, and characterized by a “closed conformation.” The active “open” conformation allows for the binding of SRC to signaling partners and enables full activation of the pathway via SRC’s kinase catalytic activity and the scaffolding property.

The inactive conformation of SRC family kinases is associated with the lack of membrane binding, the lack of phosphorylation of the activation loop, and is characterized by a “closed conformation.” The active “open” conformation allows for the binding of SRC to signaling partners and enables full activation of the pathway via SRC’s kinase catalytic activity and the scaffolding property.

NXP900 is a targeted therapy that inhibits the SRC and YES1 kinases.

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In vivo, treatment with NXP900 inhibited primary and metastatic tumor growth in xenograft models of breast, esophageal, head and neck cancers and medulloblastoma, and demonstrated on-target pharmacodynamic effects.

Moreover, publications in the scientific literature outlined opportunities to potentially reverse resistance to osimertinib (active ingredient of Tagrisso®) in non-small cell lung cancer and enzalutamide (active ingredient of Xtandi®) in metastatic, castration resistant prostate cancer, in combination with these agents, validating the potential importance of NXP900’s key targets, YES1 and SRC kinases, in these disease settings.

Moreover, publications in the scientific literature have outlined opportunities to potentially reverse resistance to osimertinib (active ingredient of Tagrisso®) in non-small cell lung cancer and enzalutamide (active ingredient of Xtandi®) in metastatic, castration resistant prostate cancer, in combination with these agents, further validating the potential importance of NXP900’s key targets, YES1 and SRC kinases, in these disease settings.

Gene amplification of the site containing the YES1 gene has been reported in clinical samples in several tumors including lung, head and neck, bladder and esophageal cancers.

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The transforming ability of YES1 has been demonstrated via several experimental methods, for example down-regulating YES1 by short hairpin RNA (shRNA) significantly inhibited cell growth in several malignancies, including colon carcinoma, rhabdomyosarcoma, and basal-like breast cancer suggesting YES1 may play a key role in these solid tumors.

Furthermore, it has been found that YES1 gene amplification is a mechanism of resistance to epidermal growth factor receptor (“EGFR”), Anaplastic lymphoma kinase (“ALK”) and human epidermal growth factor receptor 2 (“HER2”) inhibitors.

There are no YES1 inhibitors that are FDA approved or currently in clinical development.

Furthermore, it has been found that YES1 gene amplification is a mechanism of resistance to EGFR, ALK and human epidermal growth factor receptor 2 (“HER2”) inhibitors.

There are no FDA-approved selective YES1 inhibitors.

We plan to conduct additional in vivo studies to better understand the effects of YES1 inhibition in solid tumors driven by YES1 overexpression or gene amplification.

We have a mission-driven strategy to build a global biopharmaceutical company through the identification, licensing, development, and commercialization of therapeutics intended to address unmet medical needs in oncology, with an initial focus on platinum-resistant, ARID1a-mutated ovarian carcinoma.

The key elements driving our business strategy include:

● advancing our lead product candidate, NXP800, through clinical development towards regulatory approval in platinum-resistant, ARID1a mutated ovarian carcinoma and cholangiocarcinoma;

● maximizing the therapeutic potential for NXP800 in additional tumor types, both as a monotherapy and possibly in combination with other approved therapies;

● developing NXP900 as a potential differentiated YES1/SRC kinase inhibitor with improved therapeutic activity in solid tumors and advancing it through clinical development towards regulatory approval;

● maximizing the therapeutic potential of NXP900 by generating additional preclinical data in single agent and combination settings to highlight the benefits of YES1 inhibition and advancing NXP900 through applicable clinical trials towards regulatory approval in such settings;

● deploying our differentiated and proven business development expertise to further expand our targeted oncology pipeline for patients with unmet medical needs;

● deploying our differentiated and proven business development expertise to further expand our product candidate pipeline for patients with unmet medical needs;

● evaluating opportunities to accelerate development timelines and enhance the commercial potential of our programs in collaboration with third parties, including potential ex-U.S.

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In addition, because of the extensive time required for clinical development and regulatory review of any current or future product candidates we may develop, it is possible that, before any current or future product candidates can be commercialized, any related patent may expire or remain in force for only a short period following commercialization, thereby limiting the protection such patent would afford the respective product and any competitive advantage such patent may provide.

In May 2021, we licensed one patent family covering the composition of matter for NXP800, which includes three issued U.S.

patents as well as methods of using and making NXP800.

Composition of matter patents in this family have also been issued in other major markets, including Australia, Brazil, Canada, China, India, Israel, Mexico, Russia, Singapore, South Korea, the United Kingdom, the European Union and Japan.

The statutory expiration for patents in this family is October 2034, without taking into account any possible patent term extension, where applicable.

We have also licensed a patent family directed to additional compounds, structurally distinct from NXP800, that modulate HSF1.

This patent family is granted in the U.S.

and in the European Union, and patents in this family have a statutory expiration of April 2036.

We have also licensed a patent family directed to deuterated compounds that modulate HSF1.

This patent family is pending in the U.S.

and is granted in the European Union, patents in this family have a statutory expiration of October 2037.

We intend to pursue additional patent protection for NXP800 relating to methods of use and related technologies that we consider important to our business.

In August 2021, we licensed one patent family covering the composition of matter for NXP900, which includes one U.S.

patent covering the composition of matter for NXP900, as well as patents and patent applications issued in major markets, including the European Union, China and Japan, and one patent application pending in Canada.

patent covering the composition of matter for NXP900, as well as patents and patent applications issued or pending issuance in additional major markets, including the European Union, China and Japan, and one patent application pending in Canada.

The statutory expiration for patents in this patent family is April 2036, without taking into account any possible patent term extension, where applicable.

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In most countries in which we file, the patent term is 20 years from the earliest date of filing a non-provisional patent application.

In the United States, the term of a patent covering an FDA-approved drug may, in certain cases, be eligible for a patent term extension under the Hatch-Waxman Act as compensation for patent term lost during the FDA regulatory review process.

The period of extension may be up to five years but cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval by the FDA.

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It is possible that issued U.S.

patents covering NXP800 and NXP900, may or will be entitled to patent term extensions.

patents covering NXP900, may or will be entitled to patent term extensions.

If our current or future product candidates receive FDA approval, we intend to apply for patent term extensions, if available, to extend the term of patents that cover any approved product candidates.

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however, there is no guarantee that the applicable authorities, including the FDA, will agree with our assessment of whether such extensions should be granted, and even if granted, the length of such extensions.

In addition to patent protection, we also rely on trade secret protection for our proprietary information that is not amenable to, or that we do not consider appropriate for, patent protection, including certain aspect of our manufacturing processes.

However, trade secrets can be difficult to protect.

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NXP900 License Agreement

In May 2021, we entered into a worldwide, exclusive license agreement with the CRT Pioneer Fund (“CRT”) for NXP800 and any of its derivatives (collectively, the “NXP800 Program”).

NXP800 is a small molecule product candidate that we believe can be applied to a broad range of cancers.

Pursuant to the license agreement, we have an obligation to pay success-based milestones and royalties to CRT, as follows:

● pre-approval milestone payments of up to approximately $26.5 million including an upfront payment of $3.5 million and patient enrollment milestone payment of $1.0 million which have already been paid;

● regulatory approval and commercial sales milestones of up $178 million;

● mid-single digit to 10% royalties on a tiered basis based on net sales.

In addition, in connection with the license agreement, we provided ICR with additional research and development support totaling approximately $0.9 million to conduct additional scientific research and preclinical testing for certain indications that we select in connection with the NXP800 Program.

We own an exclusive license to intellectual property rights developed in the collaboration, to research, develop and commercialize products resulting from the collaboration.

The license will remain in effect in each territory subject to the license and will continue until our obligation to pay royalties in such territory has expired.

The royalty term for each licensed product in each country commences with the first commercial sale of the applicable licensed product in the applicable country and ending on the expiration of the last to expire of any patent specified by the license (with the key composition of matters patent expiring October 2034) or the expiration of any extended exclusivity period in the relevant country.

CRT may earlier terminate the license if we, or any of our affiliates or sub-licensees, challenge or seek to challenge the validity of any of the licensed patents or upon certain change of control provisions.

Either party may terminate the license upon material breach by the other party, and upon the appointment of a receiver or upon a winding-up order or similar or equivalent action.

NXP900 License Agreement

In August 2021, we entered into a worldwide, exclusive license agreement with the University of Edinburgh (“UoE”) for NXP900 and any of its derivatives (collectively, the “NXP900 Program”).

In August 2021, we entered into a worldwide, exclusive license agreement (the “License Agreement”) with the University of Edinburgh (“UoE”) for NXP900 and any of its derivatives (collectively, the “NXP900 Program”).

Discovered at the UoE, NXP900 is a targeted therapy, small molecule SRC and YES1 kinase inhibitor product candidate that we believe can be applied to a broad range of cancers.

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● pre-approval milestone payments of up to approximately $49.5 million including an upfront payment of $3.5 million and an anniversary milestone payment of $0.5 million which have already been paid;

● regulatory approval and commercial sales milestones of up $279.5 million;

● regulatory approval and commercial sales milestones of up to $279.5 million;

● mid-single digit to 8% royalties on a tiered basis based on net sales;

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In addition, in connection with the License Agreement, we expect to provide the UoE with up to an additional £580,000 in research and development support over the next 18 months to conduct additional scientific research and preclinical testing for certain indications that we select in connection with the NXP900 Program.

We own an exclusive license to intellectual property rights developed in the collaboration, to research, develop and commercialize products resulting from the collaboration.

The royalty term for each licensed product in each country is the period commencing with first commercial sale of the applicable licensed product in the applicable country and ending on the expiration of the last to expire of any patent specified by the license (statutory expiration for the NXP900 patent family is April 2036), or the expiration of any extended exclusivity period in the relevant country.

We may terminate the license if we determine that it is not scientifically or commercially viable to research, develop, or commercialize the licensed products which are the subject of the license agreement.

UoE may terminate the agreement if we:

We own an exclusive license to intellectual property rights developed in the collaboration, allowing us to research, develop and commercialize products resulting from the collaboration.

The royalty term for each licensed product in each country is the period commencing with the first commercial sale of the applicable licensed product in the applicable country and ending on the expiration of the last to expire of any patent specified by the license (statutory expiration for the NXP900 patent family is April 2036), or the expiration of any extended exclusivity period in the relevant country.

We may terminate the License Agreement if we determine that it is not scientifically or commercially viable to research, develop, or commercialize the licensed products which are the subject of the License Agreement.

UoE may terminate the License Agreement if we:

(i) cease to carry on the business regarding the treatment, prevention and/or diagnosis of human diseases;

(ii) discontinue the development of the licensed products which are the subject of the license;

(ii) discontinue the development of the licensed products which are the subject of the License Agreement;

(iii) dispose of our assets or business in whole or in material part;

(iv) challenge the validity, ownership, or enforceability of the exclusively licensed technology;

(v) contest the secret or substantial nature of certain know-how subject to the license;

or (vi) breach certain diligence obligations or fail to pay any amount due under the license within a specified time frame.

The parties may terminate the NXP900 license agreement immediately by written notice upon material breach by the other party, if such breach (if capable of cure) is not so cured within thirty (30) business days following the notice of breach.

(v) contest the secret or substantial nature of certain know-how subject to the License Agreement;

or (vi) breach certain diligence obligations or fail to pay any amount due under the License Agreement within a specified time frame.

The parties may terminate the License Agreement immediately by written notice upon material breach by the other party, if such breach (if capable of cure) is not so cured within thirty (30) business days following the notice of breach.

NXP800 License Agreement

In May 2021, we entered into a worldwide, exclusive license agreement with the CRT Pioneer Fund (“CRT”) for NXP800 and any of its derivatives (collectively, the “NXP800 Program”).

NXP800 is a small molecule product candidate that we believe can be applied to a broad range of cancers.

In July 2025, following the completion of a Phase 1b clinical study, we decided to cease clinical development of NXP800 and assess possible next steps, if any, in the development of the compound.

Pursuant to the license agreement, we have an obligation to pay success-based milestones and royalties to CRT, as follows:

● pre-approval milestone payments of up to approximately $26.5 million including an upfront payment of $3.5 million and a patient enrollment milestone payment of $1.0 million, both of which have already been paid;

● regulatory approval and commercial sales milestones of up to $178 million;

● mid-single digit to 10% royalties on a tiered basis based on net sales.

We own an exclusive license to intellectual property rights developed in the collaboration, allowing us to research, develop and commercialize products resulting from the collaboration.

The license will remain in effect in each territory subject to the license and will continue until our obligation to pay royalties in such territory has expired.

The royalty term for each licensed product in each country commences with the first commercial sale of the applicable licensed product in the applicable country and end on the expiration of the last to expire of any patent specified by the license (with the key composition of matters patent expiring October 2034)

or the expiration of any extended exclusivity period in the relevant country.

CRT may terminate the license earlier if we, or any of our affiliates or sub-licensees, challenge or seek to challenge the validity of any of the licensed patents or upon certain change of control provisions.

Either party may terminate the license upon material breach by the other party, and upon the appointment of a receiver or upon a winding-up order or similar or equivalent action.

Our industry is intensely competitive and subject to rapid and significant technological changes.

We face competition with respect to our current product candidates, and will face competition with respect to future product candidates, from segments of the pharmaceutical, biotechnology and other related markets.

There are several companies that are developing or have recently obtained approval for drugs for various types of ovarian cancer, including ImmunoGen, Inc.

(acquired by Abbvie Inc.

for $10.1 billion 2024) and MorphoSys AG (acquired by Novartis for $2.9 billion in 2024).

In the GCN2 activation space, HiberCell is developing HC-7366, an orally bioavailable GCN2 modulator.

HC-7366 is under investigation in a phase 1b clinical trial as monotherapy and in combination with a HIF-2 a inhibitor in clear cell renal carcinoma patients.

In the SRC/YES1 space, Dasatinib (SPRYCEL ® ) and bosutinib (BOSULIF ® ) are multi-kinase inhibitors that potently inhibit the catalytic activity of SRC/YES1, as well as a multitude of other kinases, including Abl, and are approved in Philadelphia chromosome-positive chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, both hematological malignancies.

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Our competitors may also develop drugs that are more effective, more convenient, more widely used and less costly, or have a better safety profile than our products;

and these competitors may also be more successful than us in manufacturing and marketing their products.

and these competitors may also be more successful than we are in manufacturing and marketing their products.

In addition, we may need to develop our current or future product candidates in collaboration with diagnostic companies, and we will face competition from other companies in establishing these collaborations.

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We do not lease or own any manufacturing facilities.

We currently rely, and expect to continue to rely, on third-party manufacturers for the production of drug substance and drug product for clinical trials in accordance with current Good Manufacturing Practices ("cGMPs"), including a single, sole source manufacturer to make the NXP800 drug substance and finished drug product, each performed at a different manufacturing facility, and a single, sole source manufacturer to make the NXP900 drug substance and another single, sole source manufacturer to make the NXP900 finished drug product.

There is no assurance that we will be able to successfully manufacture drug substance and/or drug product for NXP800 and/or NXP900.

We currently rely, and expect to continue to rely, on third-party manufacturers for the production of drug substance and drug product for clinical trials in accordance with current Good Manufacturing Practices ("cGMPs"), including a single, sole source manufacturer to make the NXP900 drug substance and another single, sole source manufacturer to make the NXP900 finished drug product.

There is no assurance that we will be able to successfully manufacture drug substance and/or drug product for NXP900.

As with any supply program, obtaining raw materials of the correct quality cannot be guaranteed and we cannot ensure that we will be successful in these endeavors.

We plan to continue to rely on third-party manufacturers for the supply of NXP800 and NXP900, for manufacture of future additional product candidates, for preclinical testing as well as for clinical trials and commercial manufacture if our current or future product candidates receive marketing approval.

We plan to continue to rely on third-party manufacturers for the supply of NXP900, and any future additional product candidates we may acquire or license, for preclinical testing, clinical trials and commercialization if our current or future product candidates receive marketing approval.

GOVERNMENT REGULATION

Numerous governmental authorities, principally the FDA, as well as other state and foreign regulatory agencies impose substantial regulatory requirements upon the clinical development, manufacture and marketing of our product candidates, as well as our ongoing research and development activities.

Before marketing in the U.S., any drug that we develop must undergo rigorous preclinical testing and clinical trials and an evaluation under an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug and Cosmetic Act of 1930.

Numerous governmental authorities, principally the FDA, as well as other state and foreign regulatory agencies, impose substantial regulatory requirements upon the clinical development, manufacture, and commercializing, marketing and sale of our product candidates, as well as our ongoing research and development activities.

Before marketing in the U.S., any drug that we develop must undergo rigorous preclinical testing and clinical trials and be evaluated under an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug and Cosmetic Act.

The FDA regulates, among other things, the pre-clinical and clinical testing, safety, efficacy, approval, manufacturing, record keeping, adverse event reporting, packaging, labeling, storage, advertising, promotion, export, sale and distribution of biopharmaceutical products.

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The clinical testing and approval processes require substantial time, effort, and financial resources, and we cannot be certain that any approvals for our current or future product candidates will be granted on a timely basis, if at all.

with our vendors, contract research organizations and contract manufacturers, will be required to navigate the various preclinical, clinical, manufacturing and commercial requirements of the FDA, as well as those of any other governing regulatory agency of the countries in which we wish to conduct studies or seek approval of our current or future product candidates.

We, along with our vendors, contract research organizations and contract manufacturers, will be required to navigate the various preclinical, clinical, manufacturing and commercial requirements of the FDA, as well as those of any other governing regulatory agency of the countries in which we wish to conduct studies or seek approval of our current or future product candidates.

The process of obtaining regulatory approvals of drugs and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

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Preclinical studies include laboratory evaluations of drug chemistry, formulation and stability, as well as in vitro and animal studies to assess safety and address use concerns.

The conduct of preclinical studies is subject to federal and state regulations and requirements, including good clinical practice (“GCP”) requirements for safety/toxicology studies.

The conduct of preclinical studies is subject to federal and state regulations and requirements, including good clinical practice (“GCP”) and good laboratory practice (“GLP”) requirements for safety/toxicology studies.

The results of the preclinical studies, together with manufacturing information and analytical data must be submitted to the FDA as part of an IND application.

An IND application is a request for authorization from the FDA to administer an investigational product to humans and must become effective before clinical trials may begin.

An IND application is a request for authorization from the FDA to administer an investigational product to humans, and to ship such products in interstate commerce for use in investigational clinical trials, and must become effective before clinical trials may begin.

Some long-term preclinical testing may continue after the IND application is submitted.

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Submission of an IND application may result in the FDA not allowing clinical trials to commence or not allowing clinical trials to commence on the terms originally specified in the IND application.

A separate submission to an existing IND application must also be made for each successive clinical trial conducted during product development of a product candidate, and the FDA must grant permission, either explicitly or implicitly by not objecting, before each clinical trial can begin.

Clinical development of product candidates to support New Drug Applications (“NDAs”) are typically conducted in accordance with the following sequential phases, which may overlap:

The investigational product is initially introduced into healthy human volunteers.

These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism, excretion and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence of efficacy.

In the case of some products for severe or life-threatening diseases, such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

This phase typically involves administration of the investigational product to a limited patient population with a specified disease or condition to determine optimal dosages, dosage tolerance and dosing schedule, to identify possible adverse side effects and safety risks, and to preliminarily evaluate the efficacy of the product candidate for specific targeted diseases.

This phase typically involves administration of the investigational product to an expanded patient population to provide significant evidence of clinical efficacy and to further test for safety, generally at multiple and often geographically dispersed clinical trial sites.

These clinical trials are intended to provide the primary basis for the overall risk/benefit ratio of the investigational product and to enable regulatory decision-making of product approval and physician labeling.

These trials may include comparisons with placebo and/or other comparator treatments.

The duration of treatment is often extended to mimic the actual use of a product during marketing.

A separate submission to an existing IND application must also be made for each successive clinical trial conducted during product development of a product candidate, and the FDA must grant authorization, either explicitly or implicitly by not objecting, before each clinical trial can begin.

Clinical development of product candidates to support New Drug Applications (“NDAs”) is typically conducted in accordance with the following phases, which may overlap (see Code of Federal Regulations Title 21 § 312.21 Phases of an investigation for definitions):

An IND may be submitted for one or more phases of an investigation.

The clinical investigation of a previously untested drug is generally divided into three phases.

Although in general the phases are conducted sequentially, they may overlap, goals and objectives of each phase may vary:

● Phase 1 includes the initial introduction of an investigational new drug into humans.

Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects.

These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side

effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.

Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.

● Phase 2 includes the clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.

● Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

Post-approval trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval.

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Fast Track Designation provides increased opportunities for sponsor interactions with the FDA during preclinical and clinical development, in addition to the potential for rolling review of a marketing application once a marketing application is filed, meaning that the agency may review portions of the application before the sponsor submits the complete application, as well as priority review, discussed below.

In December 2022, we announced that the FDA granted Fast Track Designation status to NXP800 for the treatment of patients with platinum-resistant, ARIDA1a-mutated ovarian carcinoma.

In August 2023, we announced that the FDA granted Orphan Drug Designation for NXP800 for the treatment of cholangiocarcinoma.

In August 2024, we announced that the FDA granted Orphan Drug Designation for NXP800 for the treatment of ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers.

The FDA granted the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma Fast Track Designation (2022), and Orphan Drug Designations for the treatment of cholangiocarcinoma (2023) and ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers (2024).

Under another pathway, a new drug may be eligible for breakthrough therapy designation if it is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

Under another pathway, a new drug may be eligible for breakthrough therapy designation if it is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

Breakthrough therapy designation provides all the features of Fast Track Designation in addition to intensive guidance on an efficient drug development program beginning as early as Phase 1, and FDA organizational commitment to expedited development, including involvement of senior managers and experienced review staff in a cross-disciplinary review, where appropriate.

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The accelerated approval pathway has been used primarily in settings in which the disease course is long and an extended period of time would be required to measure the intended clinical benefit of a drug.

FDA may require a sponsor to perform post-marketing studies to verify the outcome and the product may be subject to withdrawal procedures.

In addition, FDA requires premarket review of promotional materials as a condition of granting accelerated approval, which could adversely impact the timing of the commercial launch of the product.

Finally, the FDA may designate a product for priority review if it is a drug or biologic that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.

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Other regulatory matters

Manufacturing, sales, promotion and other activities of product candidates following product approval, where applicable, or commercialization are also subject to regulation by numerous regulatory authorities in the United States in addition to the FDA, which may include the Centers for Medicare & Medicaid Services (“CMS”) an agency within the U.S.

Department of Health and Human Services (“HSS”), other divisions of the Department of Health and Human Services, the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local governments and governmental agencies.

Manufacturing, marketing, sales, advertising, promotion and other activities of product candidates following product approval, where applicable, or commercialization are also subject to regulation by numerous regulatory authorities in the United States in addition to the FDA, which may include the Centers for Medicare & Medicaid Services (“CMS”) an agency within the U.S.

Department of Health and Human Services (“DHHS”), other divisions of the DHHS, the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local governments and governmental agencies.

Other healthcare laws

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For a description of these risks, please see the section entitled “Risk Factors.”

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (the “Act”), which, among other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms.

Specifically, the Act authorizes and directs the Department of Health and Human Services (the “DHHS”) to set drug price caps for certain high-cost Medicare Part B and Part D qualified drugs, with the initial list of drugs to be selected by September 1, 2023, and the first year of maximum price applicability to begin in 2026.

On October 3, 2023,

the Centers for Medicare & Medicaid Services announced that all manufacturers of the initially selected drugs opted to

On January 15, 2025, the Biden Administration issued 15 additional drugs selected for Medicare Drug Price

Negotiations.

While negotiations are still in progress, the Trump Administration has stated that lowering the cost of

prescription drugs for Americans is a top priority and it will continue to pursue drug price negotiations.

On August 16, 2022, former President Biden signed into law the Inflation Reduction Act of 2022 (the “Act”), which, among other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms.

Specifically, the Act authorizes and directs DHHS to set drug price caps for certain high-cost Medicare Part B and Part D drugs.

The program began with the initial list of drugs identified in 2023 for initial price applicability year (“IPAY”) 2026.

The Trump Administration has continued to advance this program, as it negotiated prices with manufacturers for IPAY 2027 and announced the selection of drugs for IPAY 2028, which includes, for the first time, drugs provided under Medicare Part B.

The Trump Administration stated that lowering the cost of prescription drugs for Americans is a top priority and it will continue to pursue drug price negotiations.

The Act further authorizes the DHHS to penalize pharmaceutical manufacturers that increase the price of certain Medicare Part B and Part D drugs faster than the rate of inflation.

Finally, the Act creates significant changes to the Medicare Part D benefit design by capping Part D beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025.

We cannot be sure whether additional or related legislation or rulemaking will be issued or enacted, or what impact, if any, such changes will have on the profitability of any of our drug candidates, if approved for commercial use, in the future.

The Trump Administration has aggressively sought to pursue a most favored nation (“MFN”) pricing scheme for prescription drugs.

On May 12, 2025, the President signed an Executive Order that directs DHHS to propose a rulemaking plan to impose MFN prices for prescription drugs (absent “significant progress” to lower their cost) and to facilitate direct-to-consumer purchasing programs for manufacturers.

Following this announcement, DHHS announced that it “expects each [drug] manufacturer to commit to aligning [U.S.] pricing for all brand products

across all markets that do not currently have generic or biosimilar competition with the lowest price of a set of economic peer countries.”

Accordingly, throughout the last few months of 2025, the Trump Administration announced deals with major drug manufacturers to offer at least some of their drugs at MFN prices to state Medicaid programs, while also offering drugs at a discount when selling directly to consumers, via the TrumpRx.gov website.

To effectuate these deals, in part, CMS announced a Center for Medicare and Medicaid Innovation (“CMMI”) model called the GENErating cost Reductions fOr U.S.

Medicaid (GENEROUS Model).

Under this voluntary model, drug manufacturers will provide supplemental rebates to participating states for drugs included in the model to align Medicaid net prices with what certain other countries pay.

The supplemental rebates would be based on CMS-led negotiations with manufacturers.

The model is set to last five years, beginning in January 2026.

While we have described the current policy landscape above, we cannot be sure whether additional or related legislation or rulemaking will be issued or enacted, or what impact, if any, such changes will have on the profitability of any of our drug candidates, if approved for commercial use, in the future.

Current and future healthcare reform legislation

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If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

In recent years, there has been heightened governmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products.

As described above, in recent years there has been heightened governmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products.

Such scrutiny has resulted in several recent U.S.

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

Congressional inquiries, administrative action, and the enactment of federal and state legislation designed to, among other things, increase transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for pharmaceutical products.

Administrative activity and ongoing legislative activity continue to drive changes in drug pricing, competition, and reimbursement, particularly for oncology and specialty drugs.

Congress and the executive branch have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs, making this area subject to ongoing uncertainty.

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We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

We maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees, but this insurance may not provide adequate coverage against potential liabilities.

We maintain workers’ compensation insurance to cover costs and expenses we may incur due to injuries to our employees, but this insurance may not provide adequate coverage against potential liabilities.

However, we do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us.

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In addition to regulations in the United States, there are a variety of foreign regulations governing clinical trials and commercial sales and distribution of any product candidates.

The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval.

The approval process varies from country to country, and the time required may be longer or shorter than that required for FDA approval.

EMPLOYEES AND HUMAN CAPITAL MANAGEMENT

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What changed 10-K

Item 1. Business