−Removed: Company is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development and developing and
−Removed: commercializing cancer therapies.
−Removed: The Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A,
−Removed: which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies.
−Removed: The Company believes that
−Removed: inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers.
−Removed: The Company is focusing on the
−Removed: clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer
+Added: Company is a clinical-stage biopharmaceutical and proton cancer therapy company focused on identifying new targets for cancer drug development
+Added: and developing and commercializing cancer therapies.
+Added: The Company’s drug product pipeline is primarily focused on inhibitors of
+Added: protein phosphatase 2A, which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies.
+Added: The Company believes that inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers.
+Added: Company is focusing on the clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown
+Added: to have clinical anti-cancer activity.
+Added: Company is the majority shareholder of Liora Technologies Europe Ltd., which is pioneering the development of electronically controlled
+Added: proton therapy systems for treating tumors in various types of cancers.
+Added: Liora’s proprietary technology, known as LiGHT System (Linac
+Added: for Image Guided Hadron Therapy), has significant advantages over currently available technologies for treating tumors with proton therapy.
+Added: Liora is an excellent complement to the pharmaceutical side of the Company’s business and ongoing clinical trials with LB-100 for
+Added: Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer,
Company believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved for
23 unchanged sentences
operating requirements.
+Added: of LB-100 Business
cancer patients are treated with either chemotherapy or immunotherapy or both.
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these preclinical and clinical observations, it is likely that LB-100 may be a general way to enhance immunotherapy responses.
−Removed: research on the LB-100 series was initiated in 2006 under a Cooperative Research and Development Agreement (“CRADA”) with
−Removed: the National Institute of Neurologic Disorders and Stroke or NINDS of the National Institutes of Health or NIH dated March 22, 2006 that
−Removed: was subsequently extended through a series of amendments until it terminated on April 1, 2013.
+Added: research on the LB-100 series was initiated in 2006 under a Cooperative Research and Development
+Added: Agreement (“CRADA”) with the National Institute of Neurologic Disorders and Stroke
+Added: or NINDS of the National Institutes of Health or NIH dated March 22, 2006 that was subsequently
+Added: extended through a series of amendments until it terminated on April 1, 2013.
have also designed and developed the LB-200 series, which consists of histone deacetylase inhibitors (HDACi).
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We expect to have data on toxicity and preliminary efficacy from this portion
−Removed: of the clinical trial during the quarter ending December 31, 2025.
+Added: of the clinical trial during the quarter ending March 31, 2026.
the focus on the combination of LB-100 with immunotherapy in ovarian clear cell carcinoma and colorectal cancer and the availability
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Agreement of approximately $3,095,000.
−Removed: As a result, it is uncertain as to whether the Phase 2 portion of this clinical trial will proceed.
+Added: As a result, the Phase 2 portion of this clinical trial will not proceed and the trial will be
+Added: closed after completion of the first phase in Q1 2026.
Research Support Agreement Relating to Small Cell Lung Cancer
−Removed: had executed a Clinical Research Support Agreement with the City of Hope National Medical Center to carry out a Phase 1b clinical trial
−Removed: of LB-100 combined with an FDA-approved standard regiment for treatment of untreated extensive-stage disease small cell lung cancer.
−Removed: The clinical trial was initiated on March 9, 2021.
−Removed: However, due to the lack of patient accrual, the Company provided notice to the City
−Removed: of Hope National Medical Center of the Company’s intent to terminate the Clinical Research Support Agreement effective as of July
+Added: had executed a Clinical Research Support Agreement with the City of Hope National Medical
+Added: Center to carry out a Phase 1b clinical trial of LB-100 combined with an FDA-approved standard
+Added: regiment for treatment of untreated extensive-stage disease small cell lung cancer.
+Added: trial was initiated on March 9, 2021.
+Added: However, due to the lack of patient accrual, the Company
+Added: provided notice to the City of Hope National Medical Center of the Company’s intent
+Added: to terminate the Clinical Research Support Agreement effective as of July 8, 2024.
Anderson Cancer Center Clinical Trial
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Patient recruitment is underway, and the first patient has been dosed.
+Added: December 23, 2025 we announced that we are going to expand the enrollment of the trial from 21 to 42 patients in collaboration with GSK,
+Added: MD Anderson and Northwestern University.
+Added: We completed the enrollment of the first 21 patients in Q4, 2025 and expect patient 22 to be
+Added: enrolled in Q1 2026.
Cancer Institute Clinical Trial
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The Investigational Review Board
−Removed: (IRB) of the Netherlands Cancer Institute has requested additional information with respect to these SAEs and the study has been paused
−Removed: for enrollment until the IRB’s questions have been, as more fully discussed at “Item 7.
+Added: (IRB) of the Netherlands Cancer Institute requested additional information with respect to these SAEs and the study has been paused for
+Added: enrollment until the IRB’s questions were addressed, as more fully discussed at “Item 7.
Management’s Discussion and
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– Serious Adverse Events”.
−Removed: Cancer Institute Pharmacologic Clinical Trial
−Removed: May 2019, the National Cancer Institute (NCI) initiated a glioblastoma (GBM) pharmacologic clinical trial.
−Removed: This study was being conducted
−Removed: and funded by the NCI under a Cooperative Research and Development Agreement, with the Company being required to provide the LB-100 clinical
−Removed: malignant brain tumors (gliomas) are very challenging to treat.
−Removed: Radiation combined with the chemotherapeutic drug temozolomide has been
−Removed: the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with little further benefit gained
−Removed: by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients.
−Removed: models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation,
−Removed: temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment
−Removed: in the clinic.
−Removed: Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human
−Removed: cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain was not known.
−Removed: Many drugs potentially
−Removed: useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.
−Removed: NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas.
−Removed: Patients having surgery to remove
−Removed: one or more tumors received one dose of LB-100 prior to surgery and had blood and tumor tissue analyzed to determine the amount of LB-100
−Removed: present and to determine whether the cells in the tumors showed the biochemical changes expected to be present if LB-100 reached its
−Removed: molecular target.
−Removed: As a result of the innovative design of the NCI study, it was believed that data from a few patients would be sufficient
−Removed: to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment
−Removed: regimen for GBMs.
−Removed: Blood and brain tumor tissue were analyzed from seven patients after intravenous infusion of a single dose of LB-100.
−Removed: Results of the investigation demonstrated that there was virtually no entry of LB-100 into the brain tumor tissue.
−Removed: Accordingly, alternative
−Removed: methods of drug delivery will be required to determine if LB-100 has meaningful clinical anti-cancer activity against glioblastoma multiforme
−Removed: and other aggressive brain tumors.
+Added: As of Q4 2025 the questions of the IRB have been sufficiently addressed, and the trial opened
+Added: for enrollment again.
and License Agreements
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of 100,000 Euros.
+Added: March 31, 2025 we announced we will conduct a new pre-clinical study in collaboration with the NKI to test whether “initiated”
+Added: cells that carry mutations found in cancer cells can be eliminated by treatment with LIXTE’s proprietary compound LB-100.
as of June 15, 2022, Dr.
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in the field of molecular carcinogenesis and is employed by NKI.
+Added: On August 18, 2025, Dr.
+Added: Bernards resigned from the board and was appointed
+Added: Chairman of the Scientific Advisory Board.
intellectual property includes proprietary know-how, proprietary methodologies and extensive clinical validation data and publications.
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Lixte has also filed joint patent applications with the NIH and the Netherlands Cancer Institute for
−Removed: the treatment of cancer using LB-100 in combination with other drugs like immune checkpoint inhibitors and WEE1 inhibitors (a class of
−Removed: drugs that target and inhibit the WEE1 kinase enzyme that plays a crucial role in regulating cell division).
−Removed: applications for the LB-100 series (oxabicycloheptanes and oxabicycloheptenes) have been filed in the United States and internationally
−Removed: under the Patent Cooperation Treaty.
−Removed: Patents for composition of matter and for several uses of the LB-100 series have been issued in
−Removed: the United States, Mexico, Australia, Japan, China, Hong Kong, Canada, and by the European Patent Office
+Added: the treatment of cancer using LB-100 in combination with other drugs like immune checkpoint inhibitors and WEE1 inhibitors.
+Added: applications for the LB-100 series have been filed in the United States and internationally under the Patent Cooperation Treaty.
+Added: for composition of matter and for several uses of the LB-100 series have been issued in the United States, Mexico, Australia, Japan,
+Added: China, Hong Kong, Canada, and by the European Patent Office
Company strives to protect and enhance the proprietary technology, inventions, and improvements that are commercially important to the
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patent portfolios for the Company’s most important programs involving the development of the LB-100 series are summarized and presented
−Removed: below, along with related information, as of March 10, 2025, followed by a detailed listing of U.S.
−Removed: patents that have been
−Removed: The projected patent expiration dates noted below assume that that all required maintenance or annuity fees for the patents are
−Removed: timely paid and that a court or agency does not determine that the patents are invalid or unenforceable.
+Added: below, along with related information, as of January 12, 2026, followed by a detailed listing of U.S.
+Added: patents that have
+Added: The projected patent expiration dates noted below assume that that all required maintenance or annuity fees for the patents
+Added: are timely paid and that a court or agency does not determine that the patents are invalid or unenforceable.
The Company’s lead compound LB-100 is covered by U.S.
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to expire in 2037, exclusive of any patent term extension.
−Removed: Combination Therapy with Carboplatin, Etoposide and Atezolizumab .
−Removed: LB-100 combination therapy with carboplatin, etoposide and
−Removed: atezolizumab for treating small-cell lung cancer is covered by pending U.S.
−Removed: patent applications that are solely owned by
−Removed: Lixte Biotechnology, Inc.
−Removed: Patents issuing from these patent applications are projected to expire in 2041, exclusive of any patent term
+Added: Combination Therapy with Doxorubicin .
+Added: LB-100 combination therapy with doxorubicin for treating soft tissue sarcoma is covered
+Added: 12,343,342, which is solely owned by Lixte Biotechnology, Inc.
+Added: This patent is projected to expire in 2034, exclusive
+Added: of any patent term extension.
Combination Therapy with Another Investigational Compound .
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and Oxabicycloheptenes, Their Preparation and Use
−Removed: 2124550 validated and pending in Germany, Spain, France, United Kingdom and Italy
+Added: EP 2124550 validated and pending in Germany, Spain, France, United Kingdom and Italy
of Oxabicycloheptanes and Oxabicycloheptenes
−Removed: 2983661 validated and pending as Unitary Patent, and in Spain, United Kingdom and Switzerland
+Added: EP 2983661 validated and pending as Unitary Patent, and in Spain, United Kingdom and Switzerland
of Synthesizing 3-(4-Methylpiperazine-1-Carbonyl)-7-Oxabicyclo [2.2.1] Heptane-2-Carboxylic Acid
−Removed: Oxabicycloheptane
−Removed: 3294287 validated and pending in Austria, Switzerland, Czechia, Germany, Denmark, Spain, France, United Kingdom, Hungary, Ireland, Italy,
−Removed: Netherlands, and Sweden
−Removed: 3736275 validated and pending as Unitary Patent, and in Spain, United Kingdom and Switzerland
+Added: Oxabicycloheptane Prodrugs
+Added: EP 3294287 validated and pending in Austria, Switzerland, Czechia, Germany, Denmark, Spain, France, United Kingdom, Hungary, Ireland,
+Added: Italy, Netherlands, and Sweden
+Added: EP 3736275 validated and pending as Unitary Patent, and in Spain, United Kingdom and Switzerland
Oxabicycloheptanes
for Modulation of Immune Response
−Removed: 3551629 validated and pending in Belgium, Germany, Denmark, Spain, France, United Kingdom, Ireland, Iceland, Italy, Netherlands, Norway,
+Added: EP 3551629 validated and pending in Belgium, Germany, Denmark, Spain, France, United Kingdom, Ireland, Iceland, Italy, Netherlands, Norway,
Sweden and Switzerland
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The Company is the only company that has a drug in clinical trials with demonstrated capacity to over-activate oncogenic
−Removed: The pre-clinical data obtained with LB-100 were recently posted online in a paper titled “Paradoxical Activation of
−Removed: Oncogenic Signaling as a Cancer Treatment Strategy” in the scientific journal Cancer Discovery , and were published in the
−Removed: July 2024 issue of Cancer Discovery .
+Added: The pre-clinical data obtained with LB-100 were recently posted online in a paper titled “Paradoxical Activation
+Added: of Oncogenic Signaling as a Cancer Treatment Strategy” in the scientific journal Cancer Discovery , and were published in
+Added: the July 2024 issue of Cancer Discovery .
This study showed that LB-100 triggers hyper-activation of the signals that are responsible
44 unchanged sentences
ability to compete successfully is based on numerous factors, including:
−Removed: cost-effectiveness of any product that we ultimately commercialize relative to competing products;
+Added: cost-effectiveness of any product that we ultimately commercialize relative to competing
ease of use and ready availability of any product that we bring to market;
−Removed: relative speed with which we are able to bring any product resulting from its research to market in our target markets.
+Added: relative speed with which we are able to bring any product resulting from its research to
+Added: market in our target markets.
we are unable to distinguish our products from competing products, or if competing products reach the market first, we may be unable
to compete successfully with current or future competitors.
−Removed: and Human Capital Resources
−Removed: of March 14, 2025, we had two officer/employees, our Chief Executive Officer and our Chief Financial Officer, and one consultant, our
−Removed: Chief Medical Officer.
−Removed: The Company relies to a significant extent on outside consultants and advisors with various technical skills and
−Removed: expertise that the Company can draw on as necessary to conduct its research and development and clinical trial programs.
−Removed: our relationship with our employees to be good.
−Removed: Our future performance depends significantly upon the continued service of our key personnel
−Removed: and our ability to attract highly skilled employees.
−Removed: We provide our officer/employees and consultants with opportunities for equity ownership.
−Removed: of March 14, 2025, we do not operate or lease any facilities.
−Removed: We contract out research and development activities, drug production, and
−Removed: drug storage to various commercial laboratories, drug manufacturers and storage facilities.
+Added: of March 31, 2026, the Company does not operate or lease any facilities for LB-100.
+Added: We contract out research and development activities,
+Added: drug production, and drug storage to various commercial laboratories, drug manufacturers and storage facilities.
business is subject to the regulations of the FDA as it conducts clinical trials.
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in any market.
−Removed: Company may be subject to legal claims and actions from time to time as part of its business activities.
−Removed: We are not currently subject
−Removed: to any threatened or pending lawsuits, legal claims or legal proceedings.
+Added: TECHNOLOGIES EUROPE LTD.
+Added: primary aim of radiation therapy is to irradiate the cancer cells and minimize radiation to healthy cells.
+Added: X-rays radiate all
+Added: cells along their trajectory, the healthy cells in front of, and behind the tumor.
+Added: Protons are subatomic particles with a positive
+Added: electric charge .
+Added: Due to an effect called the Bragg peak, a proton radiates a small volume at a depth (d) given by the incident
+Added: energy of the proton.
+Added: The radiation at depths greater than d is zero.
+Added: required range of depths, dictated by the location of the tumor is controlled by variation of the proton beam energy.
+Added: Since the proton
+Added: is charged, the radiation deposition can be controlled in the horizontal and vertical dimensions by electromagnets.
+Added: are fixed-energy accelerators.
+Added: For proton therapy, the required beam energy is achieved in cyclotrons by placing an object (“absorber”)
+Added: in the beam path.
+Added: The mechanical absorber not only reduces the beam energy but also greatly reduces the beam intensity and produces a
+Added: large amount of unwanted radiation.
+Added: The unwanted radiation must be shielded by large concrete blocks.
+Added: Liora’s LiGHT machine is a proton linear accelerator that electronically controls the beam energy and does not need absorbers.
+Added: The LiGHT machine is superior to existing cyclotrons both from treatment efficiency and overall cost considerations.
+Added: linear accelerator concept originated from research conducted at CERN and the TERA Foundation, and was further developed by ADAM SA,
+Added: which was a spin-off from CERN.
+Added: The accelerator chain consists of:
+Added: Radio Frequency Quadrupole (RFQ),
+Added: ● Side-Coupled
+Added: Drift Tube Linac (SCDTL) modules, and
+Added: Cavity Linac (CCL) modules, together designed to accelerate protons to therapeutic energies
+Added: of up to approximately 230 MeV.
+Added: combination of proton therapy and immune checkpoint inhibition acts at several stages of the antitumor response, suggesting a mechanism
+Added: of synergy between the two modalities.
+Added: The possibility of reducing the side-effects of oncology therapy and reversing the spread of metastatic
+Added: disease has created tremendous global demand for this type of treatment.
+Added: However, widespread use of the combination therapies is limited
+Added: by the availability of proton therapy centers.
+Added: As of early 2026, there are only 47 centers in the U.S.
+Added: irradiation with hadron beams, a method to which CERN contributed by advancing carbon ion therapy of radioresistant tumors into the medical
+Added: world some thirty years ago, has treated more than 300,000 patients to date.
+Added: Unfortunately, present proton and ion therapy centers are
+Added: large and very demanding on the design of accelerators and guiding systems.
+Added: highly adaptable Linac Image-Guided Hadron Technology ( LiGHT ) accelerator developed by Liora provides a proton beam allowing the
+Added: delivery of ultra-high dose rates to deep-seated tumors.
+Added: LiGHT, the first linear accelerator used for proton cancer treatment worldwide,
+Added: operates with components and designs developed by CERN, the linac design reduces beam losses, stray radiation and, consequently, the
+Added: volume of shielding material required.
+Added: This will allow not only large tertiary care centers to provide proton therapy.
+Added: unique biologic effects of ultra-high-dose-rate radiotherapy delivered at more than 40 Gy/sec, now known as FLASH therapy, were first
+Added: reported more than 50 years ago.
+Added: Interest in this modality began re-emerging recently.
+Added: animal experiments have demonstrated that FLASH can increase the therapeutic ratio of radiotherapy by decreasing normal tissue injury
+Added: while maintaining the tumoricidal effects of conventional-dose-rate radiotherapy (conventional radiotherapy) or by allowing for dose
+Added: escalation and improved tumor control probability without increasing normal tissue injury.
+Added: such, FLASH is the holy grail in the industry.
+Added: As its name sounds, this consists of delivering radiation in a “flash”.
+Added: doing so, the opportunity is to treat a cancer patient in a single visit as opposed to 25/35 visits.
+Added: Typically, radiation (measured in
+Added: Grays (Gy)) is delivered at a rate of 2Gy per minute.
+Added: With FLASH, radiation must be delivered at … 40-60Gy per … second.
+Added: The higher the number of Gy is, the higher the number of protons in a pulse.
+Added: This means that the delivery of a FLASH treatment requires
+Added: a fast delivery of radiation and a high level of radiation (i.e.
+Added: number of protons per pulse).
+Added: LiGHT – because
+Added: of its design and the electronic (i.e.
+Added: without a slow mechanical) control of the proton beam – can deliver pulses of proton at
+Added: a frequency of 200 times per second as opposed to conventional systems which deliver radiation at a frequency of only 2-3 times per second.
+Added: This means the property of protons (i.e.
+Added: its high precision) is leveraged for the benefits of patients in the case of FLASH when using
+Added: our LiGHT system:
+Added: Within a second, LiGHT can hit various points (voxels) of the tumour.
+Added: The LiGHT system is highly efficient.
+Added: In other words, up to 98/99% of the protons which are accelerated and energised
+Added: reach their targets, i.e.
+Added: With circular accelerators, that % is as low as 1/2% when treating superficial tumours, the rest
+Added: of the accelerated and energised protons being “lost” and creating neutrons, which must be shielded to protect operators
+Added: and patients.
+Added: This advantage of LiGHT is therefore compounded in the case of FLASH whereby the dose rate (40-60Gys per second) is high,
+Added: and a high number of protons must be accelerated.
+Added: LiGHT machine is a physically complete linear accelerator, with all components manufactured and assembled, that has demonstrated the
+Added: ability to generate a 230 MeV proton beam, which is widely recognized as the clinical gold standard for proton therapy.
+Added: Unlike conventional
+Added: proton therapy systems, which typically rely on large cyclotrons or synchrotrons, the LIGHT Machine is based on a modular, high-frequency
+Added: linear accelerator architecture.
+Added: The design enables a more compact footprint for precise control of the treatment dose delivery, rapid
+Added: energy modulation, and ultimately lower installation and operating costs for single-room proton therapy facilities.
+Added: Proton energy can
+Added: be modulated up to 200Hz in a range from 70 to 230 MeV by varying the gradient of the accelerating structures.
+Added: Achieving a stable 230
+Added: MeV beam is the point at which proton accelerators can be clinically used.
+Added: LiGHT system’s main aspects are complete, and no substantive research and development is needed.
+Added: It is currently a non-clinical
+Added: prototype system.
+Added: However, the system was powered down for an extended period prior to the acquisition by the Company.
+Added: The system will
+Added: be subject to a safety assessment to be done before switching on the equipment.
+Added: This will require updating all computers, screens, and
+Added: software in the control rooms, beamline integration, safety checks, and regulatory clearance.
+Added: The timeline to make the LiGHT machine
+Added: operational is estimated to take twenty-four months and cost approximately two million dollars.
+Added: is no resolving scientific uncertainty, inventing new technology, or proving that the LIGHT system can do what physics already has shown
+Added: Liora is not planning incremental research and development beyond commissioning.
+Added: LiGHT System is the first Linac system in the market, as all other proton therapy systems are based on cyclotron technology.
+Added: the LiGHT system a disruptive technology offering applications that are not possible with the current cyclotron technology and offers
+Added: a much increased capacity of patient throughput.
+Added: the LiGHT system beam is directed at a brain tumor, a prostate tumor, or another tissue does not change the fundamental nature of the
+Added: The LiGHT machine produces a proton beam with defined energy, stability, and modulation.
+Added: How the beam is clinically applied
+Added: is a decision that does not fundamentally alter the machine.
+Added: The LiGHT system is not tied to a single experiment, a single protocol,
+Added: or a single disease.
+Added: It is inherently capable of supporting multiple clinical uses over a long period of time.
+Added: does not plan to make the LiGHT system saleable as a clinical system.
+Added: To become operational for clinical use would require tens of millions
+Added: of dollars in additional funding for key elements, including but not limited to integrated patient positioning and imaging, clinical
+Added: commissioning and dosimetry validation, certified safety interlock systems, extensive reliability, endurance testing, and site-specific
+Added: installation, shielding, and licensing.
+Added: Company’s marketing plan for the LiGHT system is to position it as a functional prototype asset (rather than a turnkey clinical
+Added: system), valued primarily for its intellectual property, accelerator hardware configuration, and accumulated engineering work, without
+Added: immediate clinical operability.
+Added: It will be saleable as a functional unlicensed prototype to be copied and licensed at locations closer
+Added: to large patient populations.
+Added: LiGHT machine offers cost advantages over competitors in the proton therapy market.
+Added: These advantages include:
+Added: unwanted radiation levels:
+Added: reduction in radiation shielding,
+Added: replacement rate of electronics and components,
+Added: lower radiation levels allow rapid human access for repair of technical faults
+Added: inside the accelerator.
+Added: depth modulation with higher intensity spots also allows ‘hypofractionation’,
+Added: which substantially reduces the patient treatment time and increases throughput.
+Added: ● Construction
+Added: in reasonable-sized modules allows reduced infrastructure and installation costs
+Added: beam cross-section allows smaller and cheaper magnets for beam transfer to the treatment
+Added: market for proton therapy products is still developing and is characterized by rapidly evolving technology and pricing pressure.
+Added: primary competitors in the proton therapy market are IBA Worldwide, Varian Medical Systems (Siemens Healthineers), Hitachi, Mevion
+Added: Medical Systems , ProNova Solutions, P-Cure, and Sumitomo Heavy Industries .
+Added: These companies dominate the market by providing
+Added: advanced, high-energy particle accelerators for pencil beam scanning and intensity-modulated proton therapy.
+Added: These manufacturers primarily
+Added: focus on improving tumor-targeting precision while minimizing damage to healthy tissues, particularly using Pencil Beam Scanning (PBS)
+Added: Company’s ability to compete successfully depends, in part, on their ability to lower product costs, and develop and provide a
+Added: technically superior, proven product that delivers precise, cost-effective, high-quality capabilities.
+Added: Because of the large footprint
+Added: and high price of many proton therapy systems, there is increasing demand for the development of smaller, more compact proton therapy
+Added: equipment and operations are located in part of the Tower at Daresbury Laboratory, Daresbury Cheshire, United Kingdom, pursuant to a
+Added: lease agreement with the United Kingdom Research and Innovation.
+Added: The annual rent is £590,384.79, which is approximately $787,278,
+Added: The annual Rent and any VAT are payable in quarterly instalments on April 1, June 1, September 1, and December 1.
+Added: Company intends to pursue regulatory clearance based on substantial equivalence to existing proton therapy systems.
+Added: This regulatory pathway
+Added: does not require the development of new scientific principles, novel mechanisms of action, or experimental validation beyond standard
+Added: safety and performance testing.
+Added: The Company’s regulatory activities are not indicative of substantive research and development.
+Added: The Company is looking at substantial equivalence versus existing technology.
+Added: That means that if the LIGHT machine does the same (shooting
+Added: 230 MeV protons out of a beam) as existing proton therapy machines, Liora will achieve regulatory clearance for the effectiveness proven
+Added: by the so-called “predicate device”.
+Added: Liora utilizes a different way to get to the same result.
+Added: The LIGHT system accelerates
+Added: linear, while other companies in proton beam radiotherapy accelerate circular.
+Added: and Human Capital Resources
+Added: of March 31, 2026, we had three officer/employees, our Chief Executive Officer, our Chief Financial Officer, our Chief Scientific Officer,
+Added: and our Director of Administration.
+Added: The Company relies to a significant extent on outside consultants and advisors with various technical
+Added: skills and expertise that the Company can draw on as necessary to conduct its research and development and clinical trial programs.
+Added: consider our relationship with our employees to be good.
+Added: Our future performance depends significantly upon the continued service of our
+Added: key personnel and our ability to attract highly skilled employees.
+Added: We provide our officer/employees and consultants with opportunities
+Added: for equity ownership.
+Added: On November 19, 2025, the Company
+Added: received a written demand from FX Group Inc.
+Added: and certain related parties (“FX”), asserting that FX was entitled to consulting
+Added: fees in connection with capital offerings completed by the Company during June and July 2025.
+Added: The Company denied the allegations, and
+Added: negotiations continued after year-end.
+Added: On January 22, 2026, the Company entered into a settlement agreement, under which the Company agreed
+Added: to pay a one-time settlement amount of $100,000 to FX in exchange for mutual releases of all claims.
+Added: As of December 31, 2025, management
+Added: recorded an accrual of $100,000 for the settlement expense.
+Added: The Company may be subject to
+Added: legal claims and actions from time to time as part of its business activities.
+Added: As of December 31, 2025 and 2024, the Company was not subject
+Added: to any other threatened or pending lawsuits, legal claims or legal proceedings.
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.