What changed in this filing

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Item 1. Business

2025-02-25 compared with 2024-03-05 · 39 added, 39 removed, 260 unchanged (23% 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 is based on scientific insights into cancer-promoting factors, as well as on 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 insights 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 was discovered at the Institute for Cancer Research (“ICR”) in London, England.

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.” In December 2022, NXP800 received Fast Track Designation from the U.S.

Food and Drug Administration (“FDA”) for the treatment of platinum resistant, adenine-thymine (“AT”)-rich interaction domain (“ARID1a”)-mutated ovarian carcinoma.

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

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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 ARID1a-mutated ovarian carcinoma, which is a cancer type comprised primarily of two histologies:

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.

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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

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

The Phase 1 study is comprised of two parts:

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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 will be evaluated in women with platinum-resistant, ARID1a-mutated ovarian carcinoma.

In December 2022, we announced that the FDA granted Fast Track Designation status to NXP800 for the treatment of patients with platinum-resistant, ARID1a-mutated ovarian carcinoma.

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

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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.

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:

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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, 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 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.

NXP900’s Novel Mechanism of Action

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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.

YES1-dependent oncogenic transformation has also been reported, suggesting that YES1 plays a key role in these solid tumors.

YES1-dependent oncogenic transformation has also been reported, suggesting that YES1 may play a key role in these solid tumors.

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.

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● 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;

● 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;

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Any issued patents that we may own or in-license in the future may be challenged, invalidated, circumvented, or have the scope of their claims narrowed.

Furthermore, the coverage claimed in a patent

application can be significantly reduced before a patent is issued, and its scope can be reinterpreted and even challenged after issuance.

Furthermore, the coverage claimed in a patent application can be significantly reduced before a patent is issued, and its scope can be reinterpreted and even challenged after issuance.

Moreover, many jurisdictions permit third parties to challenge issued patents in administrative proceedings, which may result in further narrowing or even cancellation of patent claims.

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However, trade secrets can be difficult to protect.

(“CROs”), hospitals, independent treatment centers, suppliers, collaborators and other third parties, such parties may breach such agreements and disclose our proprietary information including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

Although we take steps to protect our proprietary information, including restricting access to our confidential information, as well as entering into non-disclosure and confidentiality agreements with our employees, consultants, independent contractors, advisors, contract manufacturers, clinical research organizations (“CROs”), hospitals, independent treatment centers, suppliers, collaborators and other third parties, such parties may breach such agreements and disclose our proprietary information including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

In addition, third parties may independently develop the same or similar proprietary information or may otherwise gain access to our proprietary information.

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

In addition, in connection with the license agreement, we expect to provide ICR with up to an additional approximately $865,000 in research and development support over the next nine months to conduct additional scientific research and preclinical testing for certain indications that we select in connection with the NXP800 Program.

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.

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

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

● 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;

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

● 2.5% of the gross amount of each Nuvectis capital raising transaction, including our initial public offering, up to an aggregate total of $3.0 million, of which $0.8 million has already been paid.

● 2.5% of the gross amount of each Nuvectis capital raising transaction, including our initial public offering (“IPO”), up to an aggregate total of $3.0 million, of which $0.8 million has already been paid.

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.

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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 drugs for various types of ovarian cancer, including ImmunoGen, Inc.

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 $10.1B in February 2024) and MorphoSys AG (acquisition by Novartis AG pending).

MorphoSys AG disclosed patient recruitment commenced in May 2021 in a phase 2 expansion cohort for CPI-0209 in patients with relapsed urothelial carcinoma, relapsed OCCC, and relapsed endometrial carcinoma, all with known ARID1a mutations.

Preliminary data was presented at the EORTC/NCI/AACR conference (October 26, 2022) with 4 unconfirmed partial responses in ten OCCC evaluable patients as of a cut-off date of July 16 th , one of which was reported to have been confirmed after the cut-off date.

In the SRC/YES1 space Dasatinib (SPRYCEL ® ) and bosutinib (BOSULIF ® ) are multikinase inhibitors that also target Abl and SRC and are approved in Philadelphia chromosome-positive chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, both hematological malignancies.

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.

These two compounds have been extensively tested in solid tumors demonstrating only minor clinical activity.

Sarcatinib is an inhibitor of the SRC/ABl family of kinases.

It was originally developed by AstraZeneca for various types of cancer, but discontinued in Phase 2 for lack of sufficient efficacy.

Turning Point Therapeutics, Inc.

(“Turning Point”) (acquired by BMS in 4Q 2022 for $4.1 billion) is developing a MET/SRC/CSF1R inhibitor which is currently being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring Mesenchymal–Epithelial Transition kinase (“MET”) genetic alterations.

The simultaneous inhibition of MET, SRC and CSF1R kinases has been reported by Turning Point as a key component of the target product profile, and Turning Point has described the program as a strategy for the treatment of MET-driven solid tumors, an area that does not overlap with our development strategy.

Turning Point is also developing enbezotinib (TPX-0046), a Rearranged during Transfection (“RET”) kinase inhibitor that can also inhibit other kinases including SRC family members, YES1, ABl,

TRK and JAK2.

TPX-0046 is being evaluated in an ongoing Phase 1/2 clinical trial for the treatment of advanced solid tumors with RET gene alterations, an area that does not overlap with our development strategy.

Saracatinib is an inhibitor of the SRC/ABl kinases originally developed by AstraZeneca for various types of cancer, but was discontinued in Phase 2.

Our competitors may obtain regulatory approval of their products more rapidly than us or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our current or future product candidates.

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If we fail to comply with applicable FDA or other legal requirements, we may become subject to administrative or judicial sanctions or other legal consequences.

These sanctions or consequences may include, among other things, the

FDA’s denial of our pending applications, the issuance of clinical holds for ongoing studies, suspension or revocation of approved applications, warning or untitled letters, product withdrawals or recalls, product seizures, relabeling or repackaging, total or partial suspensions of manufacturing or distribution, injunctions, fines, civil penalties or criminal prosecution.

These sanctions or consequences may include, among other things, the FDA’s denial of our pending applications, the issuance of clinical holds for ongoing studies, suspension or revocation of approved applications, warning or untitled letters, product withdrawals or recalls, product seizures, relabeling or repackaging, total or partial suspensions of manufacturing or distribution, injunctions, fines, civil penalties or criminal prosecution.

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.

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.

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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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.

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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.

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.

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We may be subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes.

From time to time and in the future, our operations may involve the use of hazardous and flammable materials, including chemicals

and biological materials, and may also produce hazardous waste products.

From time to time and in the future, our operations may involve the use of hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste products.

Even if we contract with third parties for the disposal of these materials and waste products, we cannot completely eliminate the risk of contamination or injury resulting from these materials.

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EMPLOYEES AND HUMAN CAPITAL MANAGEMENT

As of March 1, 2024, we had 13 full-time employees.

Additionally, we have retained and may retain in the future, a number of expert consultants and vendors that help navigate us through and execute the different aspects of our business.

As of February 21, 2025, we had 13 full-time employees.

Additionally, we have retained and may retain in the future, a number of expert consultants and vendors that help execute different aspects of our business.

We consider our relationship with our employees to be good and have not experienced any work stoppages, slowdowns or other serious labor problems that have materially impeded our business operations.

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

What changed 10-K

Item 1. Business