14 unchanged sentences
research methodology used might not be successful in identifying potential product candidates;
−Removed: candidates for drugs might on further study be shown to have harmful side effects or other characteristics that indicate they are
−Removed: unlikely to be effective drugs.
+Added: candidates for drugs might on further study be shown to have harmful side effects or other
+Added: characteristics that indicate they are unlikely to be effective drugs.
we are unable to discover suitable potential product candidates, develop additional delivery technologies through internal research programs
28 unchanged sentences
or acquire rights to, and pursue development of, other products, product candidates or technologies;
−Removed: additional clinical, administrative, manufacturing, quality control, quality assurance and scientific personnel;
+Added: additional clinical, administrative, manufacturing, quality control, quality assurance and
+Added: scientific personnel;
marketing approval for any product candidates that successfully complete clinical trials;
−Removed: our outsourced manufacturing and commercial activities and establish sales, marketing and distribution capabilities, if we receive,
−Removed: or expect to receive, marketing approval for any product candidates;
+Added: our outsourced manufacturing and commercial activities and establish sales, marketing and
+Added: distribution capabilities, if we receive, or expect to receive, marketing approval for any
+Added: product candidates;
expand and protect our intellectual property portfolio;
operational, financial and management information systems and personnel.
−Removed: independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.
−Removed: Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates
−Removed: the realization of assets and satisfaction of liabilities in the normal course of business.
−Removed: The Company has no recurring source of revenue
−Removed: and has experienced negative operating cash flows since inception, and management has determined that substantial doubt exists about
−Removed: the Company’s ability to continue as a going concern.
−Removed: As a result, our independent registered public accounting firm has included
−Removed: an explanatory paragraph in their report with respect to this uncertainty that accompanies our audited consolidated financial statements
−Removed: as of and for the year ended December 31, 2024.
−Removed: This going concern opinion could materially limit our ability to raise additional funds
−Removed: through the sale of equity securities in the future, and subsequent reports by our independent registered public accounting firm on our
−Removed: consolidated financial statements may also include an explanatory paragraph with respect to our ability to continue as a going concern.
+Added: is substantial doubt about our ability to continue as a going concern.
+Added: Company has no recurring source of revenue and has used cash in operating activities since inception.
+Added: As a result, management has concluded,
+Added: and our independent registered public accounting firm has agreed with our conclusion, that there is a substantial doubt regarding the
+Added: Company’s ability to continue as a going concern for a period of at least 12 months beyond the filing of this Annual Report on
+Added: As a result, the report of our independent registered public accounting firm on our financial statements for the year ended
+Added: December 31, 2025, includes an explanatory paragraph regarding the existence of substantial doubt about our ability to continue as a
+Added: going concern.
need significant additional financing to fund our operations and complete the development and, if approved, the commercialization of
our lead product candidate, LB- 100.
−Removed: If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our
−Removed: product development programs or commercialization efforts.
+Added: If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate
+Added: our product development programs or commercialization efforts.
expect that our existing cash resources as of December 31, 2025 will provide sufficient working capital resources to fund our operations,
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and future capital requirements depend on many factors, including:
−Removed: scope, progress, results and costs of our ongoing and planned development programs for our lead product candidate, as well as any additional
−Removed: clinical trials we undertake to obtain data sufficient to seek marketing approval for our lead product candidate;
−Removed: timing of, and the costs involved in, obtaining regulatory approvals for our lead drug candidate if our clinical trials are successful;
−Removed: cost of commercialization activities for our lead product candidate, if it is approved for sale, including marketing, sales and distribution
−Removed: cost of manufacturing our lead product candidate for clinical trials in preparation for regulatory approval, including the cost and timing
−Removed: of process development, manufacturing scale-up and validation activities;
−Removed: ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;
+Added: scope, progress, results and costs of our ongoing and planned development programs for our
+Added: lead product candidate, as well as any additional clinical trials we undertake to obtain
+Added: data sufficient to seek marketing approval for our lead product candidate;
+Added: timing of, and the costs involved in, obtaining regulatory approvals for our lead drug candidate
+Added: if our clinical trials are successful;
+Added: cost of commercialization activities for our lead product candidate, if it is approved for
+Added: sale, including marketing, sales and distribution costs;
+Added: cost of manufacturing our lead product candidate for clinical trials in preparation for regulatory
+Added: approval, including the cost and timing of process development, manufacturing scale-up and
+Added: validation activities;
+Added: ability to establish and maintain strategic licensing or other arrangements and the financial
+Added: terms of such agreements;
costs to in-license future product candidates or technologies;
−Removed: costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation
−Removed: costs and the outcome of such litigation;
+Added: costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing
+Added: patent claims, including litigation costs and the outcome of such litigation;
costs in defending and resolving future derivative and securities class action litigation;
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revenues and achieve profitability also depends on a number of additional factors, including our ability to:
+Added: ● successfully
complete development activities, including the necessary clinical trials;
and submit a New Drug Application (“NDA”) to the FDA and obtain U.S.
−Removed: regulatory approval for an indication for which
−Removed: there is a commercial market;
+Added: approval for an indication for which there is a commercial market;
and submit applications to foreign regulatory authorities;
regulatory approval in territories with viable market sizes;
−Removed: coverage and adequate reimbursement from third parties, including government and private payors;
+Added: coverage and adequate reimbursement from third parties, including government and private
commercially viable prices for our intended product, if any;
−Removed: and maintain supply and manufacturing relationships with reliable third parties and/or build our own manufacturing facility and ensure
−Removed: adequate, legally and globally compliant manufacturing of bulk drug substances and drug products to maintain that supply;
+Added: and maintain supply and manufacturing relationships with reliable third parties and/or build
+Added: our own manufacturing facility and ensure adequate, legally and globally compliant manufacturing
+Added: of bulk drug substances and drug products to maintain that supply;
distribution processes for our lead product candidate;
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additional funding, if required to develop and commercialize our lead product candidate;
−Removed: a commercial organization capable of sales, marketing and distribution for any products we intend to sell ourselves, in the markets
−Removed: in which we choose to commercialize on our own;
+Added: a commercial organization capable of sales, marketing and distribution for any products we
+Added: intend to sell ourselves, in the markets in which we choose to commercialize on our own;
market acceptance of one or more of our intended products;
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unable to continue our operations at planned levels and might be forced to reduce our operations.
+Added: efforts to integrate acquired businesses may not be successful, and this may adversely affect our financial results.
+Added: success of business acquisitions may depend on our ability to successfully integrate the operations of the acquired business.
+Added: the operations of acquired businesses requires significant efforts, including the coordination of operations, manufacturing, personnel,
+Added: information technologies, research and development, sales and marketing and finance.
+Added: These efforts can be compounded when the acquisitions
+Added: are in new geographies or business lines.
+Added: If these integration efforts are not successful, the anticipated benefits and synergies of
+Added: the acquisition may not be realized fully, may take longer to realize than expected, or may not be realized at all.
+Added: Our efforts to successfully
+Added: integrate acquisitions may also result in additional expenses and divert significant amounts of management’s time from other projects.
+Added: or implementing new business lines or offering new products and services may subject us to additional risks.
+Added: time to time, we may acquire or implement new business lines or offer new products and services within existing lines of business.
+Added: example, with our November 2025 acquisition of Liora Technologies Europe Ltd., we entered the radiotherapy segment of cancer care treatment
+Added: There are substantial risks and uncertainties associated with these efforts.
+Added: We may invest significant time and resources in developing,
+Added: marketing, or acquiring new lines of business and/or offering new products and services.
+Added: Initial timetables for the introduction and
+Added: development or acquisition of new lines of business and/or the offering of new products or services may not be achieved, and price and
+Added: profitability targets may prove to be unachievable.
+Added: Our lack of experience or knowledge, as well as external factors, such as compliance
+Added: with regulations, competitive alternatives and shifting market preferences, may also impact the success of an acquisition or the implementation
+Added: or of a new line of business or a new product or service.
+Added: Entry into a new line of business and/or offering a new product or service
+Added: may also subject us to new laws and regulations with which we are not familiar and may lead to increased litigation or regulatory risk.
+Added: Furthermore, any new business line and/or new product or service could have an adverse impact on the effectiveness of our system of internal
+Added: New business lines or new products and services within existing lines of business could affect the sales and profitability
+Added: of existing lines of business or products and services, including as a result of sales channel conflicts.
+Added: Other risks include:
+Added: (i) potential
+Added: diversion of management’s attention, available cash, and other resources from our existing businesses;
+Added: (ii) unanticipated liabilities
+Added: or contingencies;
+Added: (iii) the need for additional capital and other resources to expand into or acquire the new line of business;
+Added: potential damage to existing customer relationships, lack of customer acceptance or inability to attract new customers;
+Added: and (v) the inability
+Added: to compete effectively.
+Added: These risks would be magnified to the extent that any new business line would result in a significant increase
+Added: in operations in developing markets.
+Added: Failure to successfully manage these risks in the implementation or acquisition of new lines of
+Added: business or the offering of new products or services could have a material adverse effect on our reputation, business, results of operations,
+Added: and financial condition.
+Added: compete in highly competitive markets, and we may lose market share to companies with greater resources or more effective technologies or be forced to reduce our prices.
+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 Varian Medical Systems, Ion Beam Applications S.A.
+Added: (IBA) and Hitachi Ltd.
+Added: to compete successfully depends, in part, on our ability to lower our product costs, and develop and provide technically superior, proven
+Added: products that deliver precise, cost-effective, high-quality capabilities.
ability to use net operating losses to offset future taxable income might be subject to limitations.
−Removed: December 31, 2024, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately
−Removed: $31,067,000 and $35,836,000, respectively.
−Removed: Federal net operating losses from tax years preceding 2018, if not utilized earlier, expire
−Removed: through 2038.
−Removed: Federal net operating losses generated in a tax year beginning after 2017 have an indefinite carryforward period.
−Removed: The utilization
−Removed: of federal net operating loss carryforwards is subject to various limitations.
−Removed: state net operating loss carryovers include approximately $19,141,000 that were incurred in the State of New York and approximately $16,695,000
−Removed: that were incurred in the State of California, which are subject to various restrictions and limitations.
−Removed: addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions of state law, if a
−Removed: corporation undergoes an “ownership change”, which is generally defined as a greater than 50% change, by value, in the ownership
−Removed: of its equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change
−Removed: tax attributes to offset its post-change income might be limited.
+Added: the period ended 12/31/2025, the Company had federal and states net operating loss carryforwards of approximately $34.8M and $36.8M respectively.
+Added: Of the federal amount, $14.0 have a limited carryforward period and will begin to expire in 2029 the remaining $20.8M will have an indefinite
+Added: carryforward period.
+Added: Of the state post-apportioned amount, $14.1M have a limited carryforward period and will begin to expire in 2038;
+Added: the remaining $22.7 will have an indefinite carryforward period.
+Added: Company has $732,880 of Federal, R&D ax credit carryforwards as of December 31, 2025.
+Added: accordance with Section 382 and Section 383, utilization of the NOL and tax credit carryforwards may be subject to limitations based
+Added: on prior or future ownership changes.
+Added: Additionally,
+Added: after weighing up all available positive and negative evidence for the period ending 12/31/2025, the Company has recorded a full valuation
+Added: July 4th, 2025, the President signed into law significant federal tax legislation, H.R.1 (the “Tax Reform Act of 2025”).
+Added: The legislation includes numerous changes to U.S.
+Added: corporate income tax law, including but not limited to permanent 100% bonus depreciation
+Added: for qualified property, immediate expensing of domestic research and experimental expenditures, modifications to the limitation on business
+Added: interest expense, increased Section 179 expensing limits, changes to the international tax regime, and expanded limitations on the deductibility
+Added: of executive compensation under IRC Section 162(m).
+Added: Most provisions are effective for tax years beginning after December 31, 2024, with
+Added: certain transition rules and exceptions.
+Added: Company has not recognized any signifcnt impact from the change in the tax law.
Related to the Development and Regulatory Approval of Our Product Candidates
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candidate will depend on several factors, including the following:
−Removed: conducting and successfully completing preclinical development activities, including preclinical efficacy and IND-enabling studies,
−Removed: for our lead product candidate or product candidates that we might, in the future, in-license or acquire;
+Added: conducting and successfully completing preclinical development activities, including preclinical
+Added: efficacy and IND-enabling studies, for our lead product candidate or product candidates that
+Added: we might, in the future, in-license or acquire;
conducting and completing clinical trials with positive results for our lead product candidate;
of regulatory approvals from applicable authorities;
−Removed: and maintaining patent and trade secret protection and regulatory exclusivity for our lead product candidate;
−Removed: arrangements with third party manufacturers, receiving regulatory approval of our manufacturing processes and our third party manufacturers’
−Removed: facilities from applicable regulatory authorities and ensuring adequate supply of drug product;
+Added: and maintaining patent and trade secret protection and regulatory exclusivity for our lead
+Added: product candidate;
+Added: arrangements with third party manufacturers, receiving regulatory approval of our manufacturing
+Added: processes and our third-party manufacturers’ facilities from applicable regulatory
+Added: authorities and ensuring adequate supply of drug product;
● manufacturing
our lead product candidate at an acceptable cost;
−Removed: launching commercial sales of our lead product candidate, if approved, whether alone or in collaboration with others;
−Removed: acceptance of our lead product candidate, if approved, by patients, the medical community and third party payors;
+Added: ● effectively
+Added: launching commercial sales of our lead product candidate, if approved, whether alone or in
+Added: collaboration with others;
+Added: acceptance of our lead product candidate, if approved, by patients, the medical community
+Added: and third-party payors;
+Added: ● effectively
competing with other therapies;
−Removed: our lead product candidate is approved, obtaining and maintaining coverage and adequate reimbursement by third party payors, including
−Removed: government payors, for our lead product candidate;
−Removed: with all applicable regulatory requirements, including FDA current Good Clinical Practices (“GCP”), Current Good Manufacturing
−Removed: Practices (“CGMP”), and standards, rules and regulations governing promotional and other marketing activities;
−Removed: a continued acceptable safety profile of the lead product candidate during development and following approval.
+Added: our lead product candidate is approved, obtaining and maintaining coverage and adequate reimbursement
+Added: by third party payors, including government payors, for our lead product candidate;
+Added: with all applicable regulatory requirements, including FDA current Good Clinical Practices
+Added: (“GCP”), Current Good Manufacturing Practices (“CGMP”), and standards,
+Added: rules and regulations governing promotional and other marketing activities;
+Added: ● maintaining
+Added: a continued acceptable safety profile of the lead product candidate during development and
+Added: following approval.
we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to
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factors might affect our ability to identify, enroll and maintain qualified patients, including the following:
−Removed: criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials;
+Added: ● eligibility
+Added: criteria of our ongoing and planned clinical trials with specific characteristics appropriate
+Added: for inclusion in our clinical trials;
of the clinical trial;
and nature of the patient population;
−Removed: perceptions as to risks and benefits of the lead product candidate under study and the participation in a clinical trial generally
−Removed: in relation to other available therapies, including any new drugs that might be approved for the indications we are investigating;
+Added: perceptions as to risks and benefits of the lead product candidate under study and the participation
+Added: in a clinical trial generally in relation to other available therapies, including any new
+Added: drugs that might be approved for the indications we are investigating;
availability and efficacy of competing therapies and clinical trials;
of other trials underway in the same patient population;
+Added: ● willingness
of physicians to participate in our planned clinical trials;
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who are noncompliant or do not otherwise complete the trials;
−Removed: with a contract research organization (a “CRO”) and/or with other vendors that are involved with our clinical trials.
+Added: with a contract research organization (a “CRO”) and/or with other vendors that
+Added: are involved with our clinical trials.
might not be able to initiate or continue to support clinical trials of LB-100, our lead product candidate, for one or more indications,
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to demonstrate a benefit from using a product candidate;
−Removed: in manufacturing, obtaining, from one or more third parties, or qualifying sufficient quantities of a product candidate to start
−Removed: or to use in clinical trials;
−Removed: of adequate funding to continue a trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct
−Removed: additional studies or increased expenses associated with the services of our CROs and other third parties;
−Removed: in governmental regulations or administrative actions or lack of adequate funding to continue a clinical trial.
+Added: ● difficulties
+Added: in manufacturing, obtaining, from one or more third parties, or qualifying sufficient quantities
+Added: of a product candidate to start or to use in clinical trials;
+Added: of adequate funding to continue a trial, including the incurrence of unforeseen costs due
+Added: to enrollment delays, requirements to conduct additional studies or increased expenses associated
+Added: with the services of our CROs and other third parties;
+Added: in governmental regulations or administrative actions or lack of adequate funding to continue
+Added: a clinical trial.
we experience delays in the completion or termination of any clinical trial of our lead product candidate, the approval and commercial
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regulatory requirements for drug approvals and regulation of approved drugs in foreign countries;
−Removed: stringent privacy requirements for data to be supplied to our operations in the United States, but generated outside of the United
−Removed: States, e.g., General Data Protection Regulation in the European Union;
+Added: stringent privacy requirements for data to be supplied to our operations in the United States,
+Added: but generated outside of the United States, e.g., General Data Protection Regulation in the
+Added: European Union;
changes in tariffs, trade barriers and regulatory requirements;
−Removed: weakness, including inflation, or political instability in particular foreign countries, economies or markets;
+Added: weakness, including inflation, or political instability in particular foreign countries,
+Added: economies or markets;
with tax, employment, immigration and labor laws for employees living or traveling abroad;
1 unchanged sentence
payor reimbursement regimes, governmental payors or patient self-pay systems and price controls;
−Removed: currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to
−Removed: doing business or operating in another country;
+Added: currency fluctuations, which could result in increased operating expenses or reduced revenues,
+Added: and other obligations incident to doing business or operating in another country;
uncertainty in countries where labor unrest is more common than in the United States;
−Removed: shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
−Removed: interruptions resulting from geopolitical actions or events, including civil or political unrest (such as the ongoing conflict between
−Removed: Ukraine and Russia), sanctions, war and terrorism.
+Added: shortages resulting from any events affecting raw material supply or manufacturing capabilities
+Added: interruptions resulting from geopolitical actions or events, including civil or political
+Added: unrest (such as the ongoing conflict between Ukraine and Russia), sanctions, war and terrorism.
current and future product candidates, the methods used to deliver them or their dosage levels may cause undesirable side effects or
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authorities might withdraw their approvals of such product;
−Removed: authorities might require additional warnings on the label that could diminish the usage or otherwise limit the commercial success
−Removed: of such product;
+Added: authorities might require additional warnings on the label that could diminish the usage
+Added: or otherwise limit the commercial success of such product;
may be required to conduct post-marketing studies;
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product candidates will not obtain regulatory approval, for many reasons, including:
−Removed: with the regulatory authorities regarding the scope, design or implementation of our clinical trials;
−Removed: to demonstrate that a product candidate is safe and effective for our proposed indication;
−Removed: of clinical trials to meet the level of statistical significance required for approval;
−Removed: to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
−Removed: with our interpretation of data from preclinical studies or clinical trials;
−Removed: insufficiency of data collected from clinical trials of our lead product candidate to support the submission and filing of an NDA
−Removed: or other submission or to obtain regulatory approval;
−Removed: to obtain approval of our manufacturing processes or facilities of third party manufacturers with whom we contract for clinical and
−Removed: commercial supplies or our own manufacturing facility;
−Removed: in the approval policies or regulations that render our preclinical and clinical data insufficient for approval.
+Added: disagreement with the regulatory authorities
+Added: regarding the scope, design or implementation of our clinical trials;
+Added: failure to demonstrate that a product candidate
+Added: is safe and effective for our proposed indication;
+Added: failure of clinical trials to meet the level
+Added: of statistical significance required for approval;
+Added: failure to demonstrate that a product candidate’s
+Added: clinical and other benefits outweigh its safety risks;
+Added: disagreement with our interpretation of data
+Added: from preclinical studies or clinical trials;
+Added: the insufficiency of data collected from clinical
+Added: trials of our lead product candidate to support the submission and filing of an NDA or other submission or to obtain regulatory approval;
+Added: failure to obtain approval of our manufacturing
+Added: processes or facilities of third party manufacturers with whom we contract for clinical and commercial supplies or our own manufacturing
+Added: changes in the approval policies or regulations
+Added: that render our preclinical and clinical data insufficient for approval.
FDA or a foreign regulatory authority might require more information, including additional preclinical or clinical data, to support approval
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manufacturing facilities for our lead product candidate fail to comply with applicable regulatory requirements, a regulatory agency might:
−Removed: warning letters or untitled letters;
−Removed: modifications to promotional materials or require us to provide corrective information to healthcare practitioners;
−Removed: us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due
−Removed: dates for specific actions and penalties for noncompliance;
−Removed: an injunction or impose civil or criminal penalties or monetary fines;
−Removed: or withdraw regulatory approval;
−Removed: any ongoing clinical trials;
−Removed: to approve pending applications or supplements to applications filed by us or a collaborator;
−Removed: or impose restrictions on operations, including costly new manufacturing requirements;
−Removed: or detain products, refuse to permit the import or export of products, or require us to initiate a product recall.
+Added: issue warning letters or untitled letters;
+Added: mandate modifications to promotional materials
+Added: or require us to provide corrective information to healthcare practitioners;
+Added: require us to enter into a consent decree,
+Added: which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties
+Added: for noncompliance;
+Added: seek an injunction or impose civil or criminal
+Added: penalties or monetary fines;
+Added: suspend or withdraw regulatory approval;
+Added: suspend any ongoing clinical trials;
+Added: refuse to approve pending applications or
+Added: supplements to applications filed by us or a collaborator;
+Added: suspend or impose restrictions on operations,
+Added: including costly new manufacturing requirements;
+Added: seize or detain products, refuse to permit
+Added: the import or export of products, or require us to initiate a product recall.
occurrence of any event or penalty described above might inhibit our ability to successfully commercialize our intended product and generate
12 unchanged sentences
depend on certain key scientific personnel for our success who do not work full time for us.
−Removed: The loss of any such personnel could adversely
+Added: The loss of any such personnel could a dversely
affect our business, financial condition and results of operations.
−Removed: September 26, 2023, Bas van der Baan, a director of the Company since June 17, 2022, replaced the Company’s founder, Dr.
+Added: September 26, 2023, Bastiaan van der Baan, who had served as a director of the Company since June 17, 2022, replaced our founder, John
Kovach, as President and Chief Executive Officer.
1 unchanged sentence
Effective October 6, 2023, Mr.
−Removed: was appointed as Chairman of the Board of Directors.
−Removed: Kovach was also the Company’s Chief Scientific Officer.
+Added: Baan was appointed Chairman of the Board of Directors.
+Added: June 16, 2025, Mr.
+Added: van der Baan resigned as Chairman of the Board and Chief Executive Officer.
+Added: van der Baan remained President and
+Added: a member of the Board of Directors and also assumed the role of Chief Scientific Officer.
+Added: At that time, Geordan Pursglove was appointed
+Added: Chairman of the Board of Directors and Chief Executive Officer.
+Added: September 1, 2025, Mr.
+Added: van der Baan resigned from the Board of Directors and resigned as President of the Company.
our success depended, in part, on the continued availability and contributions of Dr.
1 unchanged sentence
timely basis with a qualified replacement in Mr.
−Removed: van der Baan.
−Removed: Furthermore, recruiting and retaining qualified scientific personnel to
−Removed: perform future research and development work is critical to our success.
−Removed: Our inability to attract or retain qualified personnel or advisors
−Removed: in the future could significantly weaken our management, harm our ability to compete effectively, and harm our business.
−Removed: The competition
−Removed: for qualified personnel in the pharmaceutical field is intense and, as a result, we might be unable to attract and retain qualified personnel
−Removed: necessary for the development of our business.
+Added: van der Baan and subsequently Mr.
+Added: Furthermore, recruiting and retaining qualified
+Added: scientific personnel to perform future research and development work is critical to our success.
+Added: Our inability to attract or retain qualified
+Added: personnel or advisors in the future could significantly weaken our management, harm our ability to compete effectively, and harm our
+Added: The competition for qualified personnel in the pharmaceutical field is intense and, as a result, we might be unable to attract
+Added: and retain qualified personnel necessary for the development of our business.
Additionally,
1 unchanged sentence
Miser, with Dr.
−Removed: Jan Schellens during 2024, and we have reallocated the responsibilities
+Added: Jan Schellens during 2024, and we reallocated the
+Added: responsibilities of Eric J.
Forman, our Vice President and Chief Operating Officer, who resigned on December 31, 2024.
−Removed: We believe that Mr.
−Removed: Schellens are capable of managing the Company’s research and clinical activities.
+Added: Effective as of July 31, 2025, the Company agreed to accept the resignation of Dr.
+Added: Schellens and to terminate his consulting agreement
+Added: Schellens to pursue employment opportunities.
+Added: Van der Baan is capable of managing the Company’s research and clinical activities.
+Added: business may suffer if we are not able to hire and retain qualified personnel.
+Added: future success depends, to a great degree, on our ability to retain, attract, expand, integrate and train our management team and other
+Added: key personnel, such as qualified engineering, service, sales, marketing and other staff.
+Added: We compete for key personnel with other clinical-stage
+Added: pharmaceutical and med-tech companies, as well as universities and research institutions.
+Added: As we continue to grow our software revenues,
+Added: we face intense competition for personnel from software and technology companies.
+Added: Because this competition is intense, compensation-related
+Added: costs could increase significantly if the supply of qualified personnel decreases or demand increases.
+Added: If we are unable to hire and train
+Added: qualified personnel, we may not be able to maintain or expand our business.
+Added: In addition, some of our executive officers have had long
+Added: careers at our company.
+Added: If these executives retire or leave, and we are unable to locate qualified or suitable replacements in a timely
+Added: manner, our business could be adversely affected.
expect to rely heavily on third parties for the conduct of clinical trials of our product candidates.
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our product candidates are safe and effective.
−Removed: Miser is experienced in the design and conduct of early stage clinical trials.
−Removed: However, we expect to rely on collaborative partners and
−Removed: CROs for their performance and management of clinical trials of our product candidates.
+Added: expect to rely on collaborative partners and CROs for their performance and management of clinical trials of our product candidates.
intended products under development might not be effective in treating any of our targeted disorders or might prove to have undesirable
64 unchanged sentences
Third party collaborators may assist us in:
−Removed: research, preclinical development, clinical trials and manufacturing;
−Removed: and obtaining regulatory approvals;
−Removed: commercializing any future product candidates.
+Added: funding research, preclinical development,
+Added: clinical trials and manufacturing;
+Added: seeking and obtaining regulatory approvals;
+Added: successfully commercializing any future product
we are not able to establish further collaboration agreements, we might be required to undertake product development and commercialization
40 unchanged sentences
might bring against us, to determine the ownership of what we regard as our intellectual property.
+Added: The financial results of our Liora LiGHT
+Added: system business may be unpredictable and if our proton therapy customers are unsuccessful, our financial results
+Added: will be adversely affected.
+Added: The success of our Liora LiGHT system business will depend upon widespread awareness, acceptance and adoption by the oncology market of
+Added: proton therapy systems for the treatment of cancer.
+Added: This technology is expensive and has not been widely adopted.
+Added: Future developments
+Added: may not be adopted as quickly as technological developments in more traditional areas of radiation therapy.
+Added: estimates as to future operating results include certain assumptions about the future results of Liora LiGHT system’ business.
+Added: we are incorrect in our assumptions, our financial results could be materially and adversely affected.
+Added: It is possible that Liora LiGHT system
+Added: could perform significantly below our expectations due to a number of factors that cannot be predicted with certainty, including future
+Added: market conditions, market acceptance of proton therapy and reimbursement rates.
+Added: These factors could adversely impact Liora LiGHT system’s
+Added: ability to meet its projected results.
+Added: Liora LiGHT system business may subject us to increased liability.
+Added: Liora LiGHT system’s business may subject us to increased liability.
+Added: For example, because proton therapy projects are large in scale
+Added: and require detailed project planning, failure to deliver or delays in delivering on our commitments could result in greater than expected
+Added: liabilities, as we could be required to indemnify business partners and customers for losses suffered or incurred if we are unable to
+Added: deliver our products in accordance with the terms of customer contracts.
+Added: Additionally, customers have in the past requested and may in
+Added: the future request that the systems vendor, as the primary technology provider, provide guarantees for and suffer penalties in relation
+Added: to the overall construction project.
+Added: Since the cost of a proton therapy center project is typically between
+Added: $25 million and $200 million, the amount of
+Added: potential liability and potential for financial loss would likely be higher than the levels historically assumed by us for our traditional
+Added: radiation therapy business and may also exceed the project’s value.
+Added: Insurance covering these contingencies may be unobtainable
+Added: or expensive.
+Added: If we cannot reasonably mitigate or eliminate these contingencies or risks, our ability to competitively bid upon proton
+Added: center projects will be negatively impacted or we may be required to assume material amounts of potential liability, all of which may
+Added: have adverse consequences to us.
Related to Our Intellectual Property
38 unchanged sentences
The degree of future protection for our proprietary rights is uncertain.
−Removed: solely or jointly with our collaborators, might not have been the first to make the inventions covered by our pending or future patent
−Removed: applications;
−Removed: solely or jointly with our collaborators, might not have been the first to file patent applications for these inventions;
−Removed: might independently develop identical, similar or alternative technologies;
−Removed: is possible that our patent applications will not result in an issued patent or patents, or that the scope of protection granted by any
−Removed: patents arising from our patent applications will be significantly narrower than expected;
−Removed: might be unaware of prior art that renders one or more of our patent applications unpatentable or one or more of our patents invalid;
−Removed: court might determine that we failed to disclose to a patent office prior art that we were aware of and that is material to patentability
−Removed: and, therefore, conclude that one or more of our patents are unenforceable;
−Removed: patents under which we hold rights might not cover commercially viable products, might not provide us with any competitive advantages
−Removed: or might be challenged by one or more third parties as being not infringed, being invalid, or being unenforceable under United States
−Removed: or foreign laws;
−Removed: court or patent office might determine that two or more of our patents claim patentably indistinct subject matter, which could adversely
−Removed: affect one or more of the patents’ term, validity or enforceability;
−Removed: court or patent office might determine that one or more patents issued to us in the future or under which we hold rights are invalid
−Removed: or unenforceable;
−Removed: might develop additional proprietary technologies that are not patentable and which might not be adequately protected through trade
−Removed: secrets or know-how.
+Added: we, solely or jointly with our collaborators,
+Added: might not have been the first to make the inventions covered by our pending or future patent applications;
+Added: we, solely or jointly with our collaborators,
+Added: might not have been the first to file patent applications for these inventions;
+Added: others might independently develop identical,
+Added: similar or alternative technologies;
+Added: it is possible that our patent applications
+Added: will not result in an issued patent or patents, or that the scope of protection granted by any patents arising from our patent applications
+Added: will be significantly narrower than expected;
+Added: we might be unaware of prior art that renders
+Added: one or more of our patent applications unpatentable or one or more of our patents invalid;
+Added: a court might determine that we failed to
+Added: disclose to a patent office prior art that we were aware of and that is material to patentability and, therefore, conclude that one
+Added: or more of our patents are unenforceable;
+Added: any patents under which we hold rights might
+Added: not cover commercially viable products, might not provide us with any competitive advantages or might be challenged by one or more
+Added: third parties as being not infringed, being invalid, or being unenforceable under United States or foreign laws;
+Added: a court or patent office might determine that
+Added: two or more of our patents claim patentably indistinct subject matter, which could adversely affect one or more of the patents’
+Added: term, validity or enforceability;
+Added: a court or patent office might determine that
+Added: one or more patents issued to us in the future or under which we hold rights are invalid or unenforceable;
+Added: we might develop additional proprietary technologies
+Added: that are not patentable and which might not be adequately protected through trade secrets or know-how.
addition, we solely or jointly own patents or patent applications in jurisdictions having, or that might in the future have, geopolitical
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addition, disputes might arise regarding intellectual property subject to a license agreement, including:
−Removed: scope of rights granted under the license agreement and other interpretation-related issues;
−Removed: our technology, product candidates or processes infringe intellectual property rights that are owned by the licensor, but that are
−Removed: not subject to the licensing agreement;
−Removed: diligence obligations under the license agreement and the activities that satisfy those obligations;
−Removed: we are required to sublicense to a third party rights that the license grants to us, but that we do not commercially pursue;
−Removed: ownership of inventions, data and know-how resulting from joint creation or use of intellectual property by our licensors and us.
+Added: the scope of rights granted under the license
+Added: agreement and other interpretation-related issues;
+Added: whether our technology, product candidates
+Added: or processes infringe intellectual property rights that are owned by the licensor, but that are not subject to the licensing agreement;
+Added: our diligence obligations under the license
+Added: agreement and the activities that satisfy those obligations;
+Added: whether we are required to sublicense to a
+Added: third-party rights that the license grants to us, but that we do not commercially pursue;
+Added: the ownership of inventions, data and know-how
+Added: resulting from joint creation or use of intellectual property by our licensors and us.
disputes over intellectual property that we have licensed, or might in the future license, prevent or impair our ability to maintain
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might infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from
−Removed: commercializing or increase the costs of commercializing our product candidates.
+Added: commercializing or increasing the costs of commercializing our product candidates.
success will depend in part on our ability to operate without infringing the proprietary rights of third parties.
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first to invent the technology or that we were the first to file patent applications covering our technology, because:
−Removed: patent applications in the United States are maintained in secrecy until the patents are issued;
−Removed: applications in the United States are typically not published until 18 months after their earliest claimed priority date;
−Removed: in the scientific literature often lag behind actual discoveries.
+Added: some patent applications in the United States
+Added: are maintained in secrecy until the patents are issued;
+Added: patent applications in the United States are
+Added: typically not published until 18 months after their earliest claimed priority date;
+Added: publications in scientific literature
+Added: often lag behind actual discoveries.
competitors might have filed, and might in the future file, patent applications covering technology similar or identical to ours.
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we do not prevail in either type of litigation, we might be subject to:
−Removed: monetary damages related to the legal expenses of the third party;
−Removed: additional competition that might have a significant adverse effect on our intended-product pricing, market share, business operations,
−Removed: financial condition, and the commercial viability of our intended products;
−Removed: restructuring
−Removed: our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical
−Removed: trials, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.
+Added: paying monetary damages related to the legal
+Added: expenses of the third party;
+Added: facing additional competition that might have
+Added: a significant adverse effect on our intended-product pricing, market share, business operations, financial condition, and the commercial
+Added: viability of our intended products;
+Added: restructuring our company or delaying or terminating
+Added: select business opportunities, including, but not limited to, research and development, clinical trials, and commercialization activities,
+Added: due to a potential deterioration of our financial condition or market competitiveness.
third party might also challenge the validity, enforceability or scope of the intellectual property rights that we license or own, and
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This might invite or encourage third parties to develop their products or technologies in jurisdictions where we abandon patent applications
−Removed: we are not able to protect and control our unpatented trade secrets, know-how and other technological innovation, we might suffer competitive
+Added: we are not able to protect and control our unpatented trade secrets, know-how and other technological innovations, we might suffer competitive
also rely on proprietary trade secrets and unpatented know-how to protect our research and development activities, particularly when
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financial resources.
−Removed: If a patent or other proceeding is resolved against us, we might be enjoined from researching, developing, manufacturing
+Added: If a patent or other proceeding is resolved against us, we might be encouraged by researching, developing, manufacturing
or commercializing our intended products or our product candidates without a license from the other party and we might be held liable
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following factors are important to our success:
−Removed: patent protection for our product candidates;
−Removed: others from infringing our intellectual property rights;
−Removed: our patent rights and trade secrets.
+Added: receiving patent protection for our product
+Added: preventing others from infringing our intellectual
+Added: property rights;
+Added: maintaining our patent rights and trade secrets.
will be able to protect our intellectual property rights in patents and trade secrets from unauthorized use by third parties only to
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of any product candidates for which we receive approval depends on a number of factors, including:
−Removed: efficacy and safety of such product candidates as demonstrated in clinical trials;
+Added: the efficacy and safety of such product candidates as demonstrated in
+Added: clinical trials;
clinical indications and patient populations for which the product candidate is approved;
−Removed: by physicians, major cancer treatment centers and patients of the drug as a safe and effective treatment;
+Added: by physicians, major cancer treatment centers and patients of the drug as safe and effective treatment;
adoption of novel immunotherapies by physicians, hospitals and third-party payors;
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costs of healthcare and/or impose price controls might adversely affect:
−Removed: demand for our lead product candidate, if we obtain regulatory approval;
−Removed: ability to receive or set a price that we believe is fair for our intended product;
−Removed: ability to generate revenue and achieve or maintain profitability;
−Removed: level of taxes that we are required to pay;
−Removed: availability of capital.
+Added: the demand for our lead product candidate,
+Added: if we obtain regulatory approval;
+Added: our ability to receive or set a price that
+Added: we believe is fair for our intended product;
+Added: our ability to generate revenue and achieve
+Added: or maintain profitability;
+Added: the level of taxes that we are required to
+Added: the availability of capital.
expect that the ACA, as well as other healthcare reform measures that might be adopted in the future, might result in additional reductions
21 unchanged sentences
is set at unsatisfactory levels, our business could be adversely affected.
+Added: performance depends on successful improvements to our existing products and services, commercialization of new products and services
+Added: and increasingly on our ability to anticipate emerging trends in oncology diagnosis, treatment and management.
+Added: Liora LiGHT system products require intensive planning, design, development, testing and capital commitment.
+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: Although we have introduced our Liora Light machine proton therapy solution, other companies have more experience
+Added: offering smaller, less expensive proton therapy systems.
+Added: Our competitiveness will depend on our ability to continue to timely develop
+Added: new technologies to reduce the size and price of our system or provide additional features and functionality that our competitors do
+Added: may need to spend more time and money than anticipated to develop and introduce new products, product enhancements or services.
+Added: not be able to recover all or a meaningful part of our investments.
+Added: New products may adversely impact orders and sales of our existing
+Added: products or make them less desirable or even obsolete.
+Added: In addition, certain costs, including installation and warranty costs, associated
+Added: with new products may be disproportionately greater than the costs associated with existing products, and if we are unable to lower these
+Added: costs over time, our operating results could be adversely affected.
Related to Healthcare Compliance Regulations
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that might affect our ability to operate include the following:
−Removed: federal healthcare Anti-Kickback Statute which prohibits, among other things, individuals and entities from knowingly and willfully
−Removed: soliciting, offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce
−Removed: or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service,
−Removed: for which payment might be made under a federal healthcare program such as Medicare and Medicaid;
−Removed: civil and criminal false claims laws, including the federal False Claims Act that can be enforced through civil whistleblower or
−Removed: qui tam actions, and civil monetary penalty laws, prohibit individuals or entities from knowingly presenting, or causing to be presented,
−Removed: to the federal government, including the Medicare and Medicaid programs, claims for payment or approval that are false or fraudulent
−Removed: or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
−Removed: federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which imposes criminal and civil liability
−Removed: for executing a scheme to defraud any healthcare benefit program and also created federal criminal laws that prohibit knowingly and
−Removed: willfully falsifying, concealing or covering up a material fact or making any materially false statements in connection with the
−Removed: delivery of or payment for healthcare benefits, items or services, as amended by the Health Information Technology for Economic and
−Removed: Clinical Health Act of 2009 (“HITECH”) which imposes obligations, including mandatory contractual terms, with respect
−Removed: to safeguarding the privacy, security and transmission of individually identifiable health information on entities subject to the
−Removed: law, such as certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, and their respective
−Removed: business associates that perform services for them that involve the creation, use, maintenance or disclosure of, individually identifiable
−Removed: health information;
−Removed: federal physician sunshine requirements under the ACA which requires certain manufacturers of drugs, devices, biologics and medical
−Removed: supplies, with certain exceptions, to report annually to HHS information related to payments and other transfers of value to physicians,
−Removed: other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare
−Removed: providers and their immediate family members and applicable group purchasing organizations;
−Removed: state and foreign laws and regulations, such as state anti-kickback and false claims laws, which might apply to sales or marketing
−Removed: arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private
−Removed: some state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance
−Removed: guidelines and the relevant compliance guidance promulgated by the federal government and might require drug manufacturers to report
−Removed: information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures
−Removed: or pricing information;
−Removed: and certain state and local laws which require the registration of pharmaceutical sales representatives;
−Removed: and foreign laws govern the privacy and security of health information in specified circumstances, many of which differ from each
−Removed: other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.
+Added: the federal healthcare Anti-Kickback Statute
+Added: which prohibits, among other things, individuals and entities from knowingly and willfully soliciting, offering, receiving or providing
+Added: remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral
+Added: of an individual for, or the purchase, order or recommendation of, any good or service, for which payment might be made under a federal
+Added: healthcare program such as Medicare and Medicaid;
+Added: federal civil and criminal false claims laws,
+Added: including the federal False Claims Act that can be enforced through civil whistleblower or qui tam actions, and civil monetary penalty
+Added: laws, prohibit individuals or entities from knowingly presenting, or causing to be presented, to the federal government, including
+Added: the Medicare and Medicaid programs, claims for payment or approval that are false or fraudulent or making a false statement to avoid,
+Added: decrease or conceal an obligation to pay money to the federal government;
+Added: the federal Health Insurance Portability and
+Added: Accountability Act of 1996 (“HIPAA”) which imposes criminal and civil liability for executing a scheme to defraud any healthcare
+Added: benefit program and also created federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up
+Added: a material fact or making any materially false statements in connection with the delivery of or payment for healthcare benefits, items
+Added: or services, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) which
+Added: imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of
+Added: individually identifiable health information on entities subject to the law, such as certain healthcare providers, health plans, and
+Added: healthcare clearinghouses, known as covered entities, and their respective business associates that perform services for them that
+Added: involve the creation, use, maintenance or disclosure of, individually identifiable health information;
+Added: the federal physician sunshine requirements
+Added: under the ACA which requires certain manufacturers of drugs, devices, biologics and medical supplies, with certain exceptions, to report
+Added: annually to HHS information related to payments and other transfers of value to physicians, other healthcare providers, and teaching
+Added: hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members
+Added: and applicable group purchasing organizations;
+Added: analogous state and foreign laws and regulations,
+Added: such as state anti-kickback and false claims laws, which might apply to sales or marketing arrangements and claims involving healthcare
+Added: items or services reimbursed by non-governmental third party payors, including private insurers;
+Added: some state laws which require pharmaceutical
+Added: companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated
+Added: by the federal government and might require drug manufacturers to report information related to payments and other transfers of value
+Added: to physicians and other healthcare providers, marketing expenditures or pricing information;
+Added: and certain state and local laws which
+Added: require the registration of pharmaceutical sales representatives;
+Added: state and foreign laws govern the privacy
+Added: and security of health information in specified circumstances, many of which differ from each other in significant ways and often are
+Added: not pre-empted by HIPAA, thus complicating compliance efforts.
to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve
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Regardless of merit or eventual outcome, liability claims might result in:
−Removed: demand for any product candidates or products that we might develop;
−Removed: of clinical trial sites or entire clinical trial programs;
−Removed: to our reputation and significant negative media attention;
−Removed: of clinical trial participants;
−Removed: costs to defend the related litigation;
−Removed: monetary awards to trial subjects or patients;
−Removed: of management and scientific resources from our business operations;
−Removed: inability to commercialize any products that we might develop.
+Added: decreased demand for any product candidates
+Added: or products that we might develop;
+Added: termination of clinical trial sites or entire
+Added: clinical trial programs;
+Added: injury to our reputation and significant negative
+Added: media attention;
+Added: withdrawal of clinical trial participants;
+Added: significant costs to defend the related litigation;
+Added: substantial monetary awards to trial subjects
+Added: loss of revenue;
+Added: diversion of management and scientific resources
+Added: from our business operations;
+Added: the inability to commercialize any products
+Added: that we might develop.
to engaging in clinical trials, we obtain product liability insurance coverage at a level that we believe is customary for similarly
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before we can recover the expenses of development and commercialization.
−Removed: business might be adversely affected by the coronavirus or other pandemics.
−Removed: global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout the world
−Removed: as businesses and governments implemented broad actions to mitigate this public health crisis.
−Removed: Although the Covid-19 outbreak has subsided,
−Removed: the extent to which the coronavirus pandemic may reappear and impact the Company’s clinical trial programs and capital raising
−Removed: efforts in the future is uncertain and cannot be predicted.
disruptions of information technology systems, computer system failures or breaches of information and cyber security could adversely
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might need to grow the size of our organization in the future, and we might experience difficulties in managing this growth.
−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: We might need
−Removed: to grow the size of our organization in order to support our continued development and potential commercialization of our lead product
−Removed: As our development and commercialization plans and strategies continue to develop, our need for additional managerial, operational,
−Removed: manufacturing, sales, marketing, financial and other resources might increase.
−Removed: Our management, personnel and systems currently in place
−Removed: might not be adequate to support this future growth.
−Removed: Future growth would impose significant added responsibilities on members of management,
−Removed: our clinical trials effectively;
−Removed: recruiting, maintaining, motivating and integrating additional employees;
−Removed: our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors
−Removed: and other third parties;
−Removed: our managerial, development, operational, information technology, and finance systems;
−Removed: our facilities.
+Added: of March 31, 2026, we had three officer/employees, our Chief Executive Officer, our Chief Financial Officer, and our Chief Scientific
+Added: The Company relies to a significant extent on outside consultants and advisors with
+Added: various technical skills and expertise that the Company can draw on as necessary to conduct its research and development and
+Added: clinical trial programs.
+Added: We might need to grow the size of our organization in order to support our continued development and
+Added: potential commercialization of our lead product candidate.
+Added: As our development and commercialization plans and strategies continue to
+Added: develop, our need for additional managerial, operational, manufacturing, sales, marketing, financial and other resources might
+Added: Our management, personnel and systems currently in place might not be adequate to support this future growth.
+Added: growth would impose significant added responsibilities on members of management, including:
+Added: managing our clinical trials effectively;
+Added: identifying, recruiting, maintaining, motivating
+Added: and integrating additional employees;
+Added: managing our internal development efforts
+Added: effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;
+Added: improving our managerial, development, operational,
+Added: information technology, and finance systems;
+Added: expanding our facilities.
our operations expand, we will likely also need to manage additional relationships with various strategic partners, suppliers and other
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The failure to accomplish any of these tasks could prevent us from successfully growing our company.
+Added: Pursglove’s simultaneous service as our Chief Executive Officer and member of our Board of Directors, and as Chief Executive Officer
+Added: and member of the Board of Directors of Powell Max Ltd., may create conflicts of interest and may adversely affect management attention,
+Added: financial reporting and decision-making.
+Added: Pursglove currently serves as our Chief Executive Officer and as a member of our Board of Directors, while also serving as Chief Executive
+Added: Officer and a director of Powell Max Ltd.
+Added: These dual roles may from time to time create actual or potential conflicts
+Added: of interest, including with respect to the allocation of Mr.
+Added: Pursglove’s time and attention, the evaluation of strategic, commercial
+Added: or financing opportunities, relationships with counterparties, the handling of confidential information, compliance with blackout and
+Added: other securities-law restrictions, and the timing and content of public disclosures.
+Added: Pursglove serves as our Chief Executive
+Added: Officer, any reduction in his availability or any required recusal from deliberations involving PMAX could also adversely affect financial
+Added: management, internal-control oversight, capital-markets activities and the speed of management decision-making.
+Added: If actual or perceived
+Added: conflicts of interest are not resolved effectively, or if Mr.
+Added: Pursglove is unable to devote sufficient time to our business, our business,
+Added: financial condition, results of operations and stock price could be materially adversely affected.
funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel,
44 unchanged sentences
Related to Owning our Securities
−Removed: are a “smaller reporting company” and we have elected to comply with certain reduced reporting and disclosure requirements
−Removed: which could make its common stock less attractive to investors.
−Removed: are a “smaller reporting company,” as defined in the Regulation S-K of the Securities Act of 1933, as amended (the “Securities
−Removed: Act”), which allows us to take advantage of certain exemptions from various reporting requirements that are applicable to other
−Removed: public companies that are not smaller reporting companies, including (1) not being required to comply with the auditor attestation requirements
−Removed: of Section 404 of the Sarbanes-Oxley Act of 2002, and (2) reduced disclosure obligations regarding executive compensation in our periodic
−Removed: reports and proxy statements.
−Removed: In addition, as an emerging growth company, we are only required to provide two years of audited financial
−Removed: statements in this document.
−Removed: As a result of these reduced reporting and disclosure requirements our financial statements might not be
−Removed: comparable to SEC registrants not classified as emerging growth companies.
−Removed: cannot predict if investors will find our common stock less attractive because we might rely on these exemptions.
−Removed: If some investors find
−Removed: our common stock less attractive as a result, there might be a less active trading market for our common stock and our stock price might
−Removed: be more volatile.
−Removed: independent registered public accounting firm is not required to formally attest to the effectiveness of our internal control over financial
−Removed: reporting until we are no longer a “smaller reporting company”.
−Removed: We cannot assure you that there will not be material weaknesses
−Removed: or significant deficiencies in our internal controls in the future.
−Removed: might find our common stock less attractive as a result of our election to utilize these exemptions, which could result in a less active
−Removed: trading market for our common stock and/or the market price of our common stock might be more volatile.
−Removed: publicly-traded warrants that we issued in our November 2020 public offering are speculative in nature.
−Removed: warrants issued in our November 2020 public offering do not confer any rights of common stock ownership on their holders, such as voting
−Removed: rights or the right to receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price.
−Removed: Specifically,
−Removed: holders of the warrants may exercise their right to acquire the common stock and pay an effective exercise price of $57.00 per share,
−Removed: which is substantially in excess of the current market price of the Company’s common stock.
−Removed: Furthermore, each warrant will expire
−Removed: five years from the original issuance date, which is November 20, 2025.
−Removed: In the event our common stock price does not exceed the exercise
−Removed: price of the warrants during the period when the warrants are exercisable, the warrants may not have any value.
−Removed: of the warrants have no rights as a common stockholder until they acquire our common stock.
−Removed: the acquisition of shares of our common stock upon exercise of the warrants, a holder has no rights with respect to shares of our common
−Removed: stock issuable upon exercise of the warrant.
−Removed: Upon exercise of a warrant, a holder will be entitled to exercise the rights of a common
−Removed: stockholder as to the security exercised only as to matters for which the record date occurs after the exercise.
−Removed: is a limited market for the warrants to purchase shares of our common stock.
−Removed: the warrants are currently trading on The Nasdaq Capital Market, there can be no assurance that an active trading market for the warrants
−Removed: will develop.
−Removed: Without an active trading market, the liquidity of the warrants will continue to be limited.
of certain warrants could discourage a change-in control transaction involving a third party.
6 unchanged sentences
even where the acquisition could be beneficial to you.
−Removed: 20, 2023 sale of common stock and warrants.
−Removed: July 20, 2023, we sold 583,334 shares of common stock at a price of $6.00 per share to an institutional investor and raised gross proceeds
−Removed: of approximately $3,500,000.
−Removed: As part of this financing, the Company sold warrants to the institutional investor to purchase 583,334 shares
−Removed: of common stock.
−Removed: The common warrants had an initial exercise price of $6.00 per share, were immediately exercisable upon issuance, and
−Removed: expire five years thereafter on July 20, 2028.
−Removed: The Company also issued warrants to the placement agent to purchase 35,000 shares of common
−Removed: stock at an exercise price of $6.60 per share and expiring on July 20, 2028.
−Removed: exercise prices of the warrants issued to the institutional investor and to the placement agent are subject to customary adjustments
−Removed: for stock splits, stock dividends, stock combinations, reclassifications, reorganizations, or similar events affecting the Company’s
−Removed: common stock.
−Removed: In addition, the warrants issued to the institutional investor contain a “fundamental transaction” provision
−Removed: whereby in the event of a fundamental transaction (including a sale or transfer of assets or ownership of the Company as defined in the
−Removed: warrant agreement) within the Company’s control, the holder of the unexercised common stock warrants would be entitled to receive,
−Removed: in exchange for extinguishment of the warrants, cash consideration equal to a Black-Scholes valuation, as defined in the warrant agreement.
−Removed: If such fundamental transaction is not within the Company’s control, the warrant holder would only be entitled to receive the same
−Removed: form of consideration (and in the same proportion) as the holders of the Company’s common stock.
−Removed: in the event of a change in control of the Company or a sale or transfer of all or substantially all of the Company’s assets, as
−Removed: defined in the warrants, to the extent that the warrants issued to the institutional investor are outstanding at the effective date that
−Removed: such a transaction is closed, this “fundamental transaction” provision would entitle the holder to substantial cash consideration,
−Removed: thus reducing the amounts to be retained by the Company or potentially distributable to the Company’s stockholders.
−Removed: 13, 2025 sale of common stock and warrants.
−Removed: February 13, 2025, we sold 434,784 shares of common stock at a price of $2.415 per share to two institutional investors and raised gross
−Removed: proceeds of approximately $1,050,000.
−Removed: As part of this financing, the Company sold warrants to the institutional investors to purchase
−Removed: 434,784 shares of common stock.
−Removed: The common warrants had an initial exercise price of $2.29 per share, were immediately exercisable upon
−Removed: issuance, and expire five years thereafter on February 13, 2030.
−Removed: The Company also issued warrants to the placement agent to purchase
−Removed: 32,609 shares of common stock at an exercise price of $3.0188 per share and expiring on February 13, 2030.
−Removed: exercise prices of the warrants issued to the institutional investors and to the placement agent are subject to customary adjustments
−Removed: for stock splits, stock dividends, stock combinations, reclassifications, reorganizations, or similar events affecting the Company’s
+Added: following warrants issued by the Company and outstanding at December 31, 2025, contain a “fundamental transaction”
+Added: provision whereby in the event of a fundamental transaction (including a sale or transfer of assets or ownership of the Company as
+Added: defined in the warrant agreement) within the Company’s control, the holder of the unexercised common stock warrants would be
+Added: entitled to receive, in exchange for extinguishment of the warrants, cash consideration equal to a Black-Scholes valuation, as
+Added: defined in the warrant agreement.
+Added: If such fundamental transaction is not within the Company’s control, the warrant holder
+Added: would only be entitled to receive the same form of consideration (and in the same proportion) as the holders of the Company’s
common stock.
−Removed: In addition, the warrants issued to the institutional investors contain a “fundamental transaction” provision
−Removed: whereby in the event of a fundamental transaction (including a sale or transfer of assets or ownership of the Company as defined in the
−Removed: warrant agreement) within the Company’s control, the holders of the unexercised common stock warrants would be entitled to receive,
−Removed: in exchange for extinguishment of the warrants, cash consideration equal to a Black-Scholes valuation, as defined in the warrant agreement.
−Removed: If such fundamental transaction is not within the Company’s control, the warrant holders would only be entitled to receive the
−Removed: same form of consideration (and in the same proportion) as the holders of the Company’s common stock.
−Removed: in the event of a change in control of the Company or a sale or transfer of all or substantially all of the Company’s assets, as
−Removed: defined in the warrants, to the extent that the warrants issued to the institutional investors are outstanding at the effective date
−Removed: that such a transaction is closed, this “fundamental transaction” provision would entitle the holders to substantial cash
−Removed: consideration, thus reducing the amounts to be retained by the Company or potentially distributable to the Company’s stockholders.
+Added: Number of warrants
+Added: February 2025
+Added: February 2025
+Added: December 22, 2025
+Added: the event of a change in control of the Company or a sale or transfer of all or substantially all of the Company’s assets, as defined,
+Added: to the extent that the warrants are outstanding at the effective date that such a transaction is closed, this “fundamental transaction”
+Added: provision would entitle the holder to substantial cash consideration, thus reducing the amounts to be retained by the Company or potentially
+Added: distributable to the Company’s stockholders.
management has broad discretion over the use of the proceeds from any stock offerings we may conduct in the future and we may apply it
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the near future, we may need to curtail or cease operations, which could result in a total loss of stockholders’ investment.
−Removed: price of our common stock or warrants might fluctuate substantially.
−Removed: should consider an investment in our common stock and warrants to be risky.
−Removed: Some factors that might cause the market price of our common
−Removed: stock or warrants to fluctuate, in addition to the other risks mentioned in this “Risk Factors,” are:
−Removed: of our common stock by our stockholders, executives, and directors and our stockholders;
+Added: price of our common stock might fluctuate substantially.
+Added: should consider an investment in our common stock to be risky.
+Added: Some factors that might cause the market price of our common stock to
+Added: fluctuate, in addition to the other risks mentioned in this “Risk Factors,” are:
+Added: sale of our common stock by our stockholders,
+Added: executives, and directors and our stockholders;
and limitations in trading volumes of our shares of common stock;
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research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;
−Removed: and additions of key personnel;
−Removed: and litigations related to intellectual properties, proprietary rights, and contractual obligations;
−Removed: in applicable laws, rules, regulations, or accounting practices and other dynamics;
−Removed: events or factors, many of which might be out of our control.
+Added: departures and additions of key personnel;
+Added: disputes and litigations related to intellectual
+Added: properties, proprietary rights, and contractual obligations;
+Added: changes in applicable laws, rules, regulations,
+Added: or accounting practices and other dynamics;
+Added: other events or factors, many of which might
+Added: be out of our control.
addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences
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Related to the Company’s Common Stock
−Removed: Company’s common stock and the warrants are traded on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”,
−Removed: respectively.
+Added: Company’s common stock are traded on The Nasdaq Capital Market under the symbols “LIXT”.
June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock in order to remain in compliance
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because it did not complete its proposed financing initiatives to regain compliance.
−Removed: Company timely filed an appeal and requested a Hearing before a Nasdaq Hearings Panel (the “Panel”), which has been granted.
−Removed: The Hearing request automatically stayed Nasdaq’s delisting of the Company’s common shares and warrants pending the Panel’s
−Removed: Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension through no
−Removed: later than August 18, 2025.
−Removed: At the upcoming hearing, the Company will present its plan for regaining and sustaining compliance with the
−Removed: Stockholders’ Equity Requirement for continued listing.
−Removed: However, there can be no assurances that the Hearings Panel will grant
−Removed: the Company an extension of time to regain compliance, or that the Company will be able to regain compliance during any extension period.
−Removed: During the appeal process the Company’s common shares and warrants will continue to trade on The Nasdaq Capital Market.
−Removed: Company intends to take reasonable measures available to regain compliance under Nasdaq’s listing rules and to remain listed on
−Removed: However, there can be no assurances that the Company will ultimately regain compliance with the Stockholders’ Equity Rule,
−Removed: or be able to maintain compliance with all other applicable requirements for continued listing on Nasdaq.
−Removed: If the Company does not regain
−Removed: compliance with Nasdaq’s continued listing requirements within the time period permitted by Nasdaq, then the Company’s securities
−Removed: will be delisted from Nasdaq.
−Removed: the Company were to be delisted from Nasdaq, its common stock and warrants may be eligible for trading on an over-the-counter market.
−Removed: If the Company is not able to obtain a listing on another stock exchange or quotation service for its common stock and warrants, it may
−Removed: be extremely difficult or impossible for stockholders to sell their shares of common stock and warrants.
−Removed: Moreover, if the Company is
−Removed: delisted from Nasdaq, but obtains a substitute listing for its common stock and warrants, it will likely be on a market with less liquidity,
−Removed: and therefore experience potentially more price volatility than experienced on Nasdaq.
−Removed: Stockholders may not be able to sell their shares
−Removed: of common stock and warrants on any such substitute market in the quantities, at the times, or at the prices that could potentially be
−Removed: available on a more liquid trading market.
−Removed: As a result of these factors, if the Company’s common stock is delisted from Nasdaq,
−Removed: the value and liquidity of the Company’s common stock and warrants would likely be significantly adversely affected.
−Removed: of the Company’s common stock from Nasdaq could also adversely affect the Company’s ability to obtain financing for its operations
−Removed: and/or could result in a loss of confidence by investors, employees and/or business partners.
+Added: Company did not meet the terms of the extension and, on February 19, 2025, received a Staff determination letter.
+Added: The Company timely
+Added: requested a hearing before the Nasdaq Hearings Panel, staying any suspension or delisting pending the Panel’s decision.
+Added: an April 3, 2025 hearing, the Panel granted the Company a further extension through July 3, 2025 to regain compliance.
+Added: July 2, 2025, the Company closed a $5.05 million private placement and, on July 8, 2025, completed a $1.5 million registered
+Added: direct offering (see Note 6).
+Added: On July 15, 2025, Nasdaq notified the Company that it had regained compliance with the stockholders’
+Added: equity requirement.
+Added: Company remains subject to a Panel Monitor under Nasdaq Listing Rule 5815(d)(4)(B) through July 15, 2026.
+Added: During this period, any future
+Added: deficiency in stockholders’ equity would require the Company to request a hearing before the Panel rather than submit a new compliance
sale or perceived sale of a substantial number of shares of our common stock might cause the price of our common stock to decline.
10 unchanged sentences
economy and expectations of slower global economic growth, increased unemployment rates, and increased credit defaults in recent years.
−Removed: Our general business strategy might be adversely affected by any such economic downturns (including the impact related to the recent
−Removed: COVID-19 pandemic), volatile business environments and continued unstable or unpredictable economic and market conditions.
+Added: Our general business strategy might be adversely affected by any such economic downturns, volatile business environments and continued unstable or unpredictable economic and market conditions.
If these conditions
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rights and sinking fund provisions.
−Removed: We have designated 350,000 shares of preferred stock as Series A Convertible Preferred Stock, all
−Removed: of which are issued and outstanding.
The issuance of any preferred stock could materially adversely affect the rights of the holders
10 unchanged sentences
limitations on the removal of directors;
−Removed: advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted upon
−Removed: at stockholder meetings;
−Removed: that vacancies on the Board of Directors might be filled by a majority of directors in office, although less than a quorum.
+Added: ● establishing
+Added: advance notice requirements for nominations for election to the Board of Directors or for
+Added: proposing matters that can be acted upon at stockholder meetings;
+Added: that vacancies on the Board of Directors might be filled by a majority of directors in office,
+Added: although less than a quorum.
reporting obligations of being a public company in the United States are expensive and time-consuming, and our management will be required
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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.