What changed in this filing

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Item 1. Business

2026-03-30 compared with 2025-03-27 · 126 added, 80 removed, 301 unchanged (41% of the section changed)

Business Description

Precipio, Inc., and its subsidiaries, (collectively, “we”, “us”, “our”, the “Company” or “Precipio”) is a healthcare biotechnology company focused on cancer diagnostics.

Our mission is to address the pervasive problem of cancer misdiagnoses by developing solutions in the form of diagnostic products and services.

Our products and services aim to deliver higher accuracy, improved laboratory workflow, and ultimately better patient outcomes, which reduce healthcare expenses.

We develop innovative technologies in our laboratory where we design, test, validate, and use these products clinically.

We believe these technologies improve diagnostic outcomes across various diseases within the hematologic field.

We then commercialize these technologies as proprietary products that serve the global laboratory community in furtherance of our mission to eliminate or greatly reduce the prevalence of misdiagnoses.

To deliver our strategy, we have structured our organization to develop diagnostic products, including our laboratory and research and development (“R&D”) facilities located in New Haven, Connecticut and Omaha, Nebraska, respectively, which house teams that collaborate on the development of new products and services.

We operate Clinical Laboratory Improvement Amendments (“CLIA”) compliant laboratories in both New Haven, Connecticut and Omaha, Nebraska, from which we provide essential blood cancer diagnostics to oncologists nationwide.

To deliver on our strategy of mitigating misdiagnoses, we rely heavily on our CLIA laboratories to support R&D beta-testing of the products we develop, in a clinical environment.

The development of laboratory products involves a qualified facility;

highly skilled laboratory staff;

and access to viable patient specimens to conduct development and testing.

Our CLIA laboratory in New Haven, which is operated by our pathology services division, encapsulates these components, and also generates revenue for us which covers costs associated with operating this laboratory.

This structure of utilizing our clinical lab to obtain samples and utilize the equipment and staffing to develop, test and validate our products, significantly reduces the development costs and timeline for our products.

This also enables us to accelerate the time to market of new product development and launch.

Furthermore, as a clinical laboratory, we are always the first user of every product we develop, which allows us to optimize important laboratory functions such as workflow, inventory management, regulatory and billing issues.

As a vendor, this enables us to serve as a reputable user of our own products, and we believe this provides us with significant credibility with existing and prospective customers.

Furthermore, because we use our products as part of our day-to-day operations, we can deliver a high level of hands-on, expert support to customers, improving their experience with our products.

Our Products Division commercial team generates direct sales and works with our key distributors.

Global healthcare distributors, such as ThermoFisher, McKesson, Medline and Cardinal Health, have partnered with us to form the backbone of our go-to-market strategy and enable us to access laboratories around the country that can benefit from using our diagnostic products.

Our operating structure promotes the harnessing of our proprietary technology and genetic diagnostic expertise to bring to market our robust pipeline of innovative solutions designed to address the root causes of misdiagnoses.

We are a healthcare biotechnology company with a mission to battle the systemic problem of disease misdiagnosis, by focusing on improving cancer diagnostics, particularly, hematologic malignancies.

Our objective is to enhance diagnostic accuracy and accessibility while building a sustainable business model that supports ongoing innovation.

We aim to achieve this through a combination of clinical laboratory services and proprietary diagnostic product development.

By integrating diagnostic services with product development, our service business doubles as a self-funded research and development (“R&D”) unit, enabling us to achieve rapid and cost-efficient innovation rather than being a major cost center for us.

This unique integrated operating structure is the foundation of our approach to research, development, and product commercialization.

Unlike other companies that rely primarily on stand-alone research facilities or external clinical validation programs, our clinical laboratory operations enables our R&D team to evaluate, refine, and validate diagnostic products in the course of routine clinical testing activities, and at incremental cost.

Through these activities, we generate clinical data, operational experience, and specimen access that support ongoing assay development and product improvement.

While these activities are initially conducted to provide diagnostic services to patients and their healthcare providers, they also contribute to product development and validation processes.

Our Structure (Two Divisions):

We have a single operating segment but operate two business divisions that are complementary to each other:

Pathology Services Division

Our pathology services division provides specialized cancer diagnostic testing services to physicians, hospitals, and laboratories.

This division generates revenue and supports the development of our expertise in oncology diagnostics.

The pathology services division delivers specialized diagnostic testing focused primarily on hematologic cancers.

Services include molecular diagnostics, cytogenetics, and related advanced laboratory analyses performed for healthcare providers and institutions.

We receive patient samples (blood and biopsies) sent in from clinics and hospitals, and conduct a diagnostic analysis, ultimately providing a pathology report that informs the physician about the nature of the disease the patient has.

The pathology services division operates two full laboratories that include all the equipment, personnel, and work processes required to receive patient samples daily, and deliver clinical results to the physicians under the proper compliance umbrella.

This division provides:

● An internal clinical environment to develop, test and validate all new products before going to market.

● Recurring diagnostic service revenue.

● Direct engagement with clinicians and patient testing needs.

● Operational experience that informs diagnostic development activities.

While reimbursement levels and testing volumes may vary, we view this division as an important foundation for both current operations and future product development.

Products Division

The products division develops and commercializes proprietary assays designed for use by clinical laboratories.

These products allow the Company to expand its reach by enabling other laboratories to benefit from the diagnostic products developed by the Company while building scalable diagnostic solutions.

We believe this dual structure provides a unique model for R&D development of clinically applicable products, while delivering operational stability and supporting innovation and future growth.

Furthermore, it provides us with substantial competitive advantages in terms of the economics of product development and time to market.

The products division focuses on developing proprietary diagnostic assays and kits intended for use by other clinical laboratories.

These products are designed to improve testing accessibility and laboratory workflow efficiency while enabling broader market reach without requiring us to perform all testing internally.

Key elements of this division include:

● Assay development and validation.

● Manufacturing and commercialization of diagnostic kits.

● Distribution through laboratory partners and commercial channels.

Product revenues may offer greater scalability than traditional laboratory services, although adoption depends on regulatory, reimbursement, and market factors.

Integrated R&D Model:

Relationship Between Pathology and Products Divisions

As described above, our pathology services division operates fully equipped clinical laboratories staffed with specialized personnel, as well as the infrastructure necessary to perform complex diagnostic testing.

These operations provide access to instrumentation, technical expertise, and clinical workflows that support the development, evaluation, and refinement of the diagnostic products.

In addition, our clinical testing activities provide access, where appropriate and consistent with regulatory and ethical requirements, to patient specimens that are critical for assay development, validation, and performance assessment.

Such specimens, particularly fresh clinical samples relevant to hematologic malignancies, are extremely difficult and costly for product-focused organizations to obtain in sufficient quantity or condition through external channels.

As a technology innovator, this model provides us with a significant set of competitive advantages.

First, the ongoing access to patient specimens removes a significant challenge faced by other manufacturers, both from a cost, as well as from an ability to even procure these samples.

Second, the immediate access to this entire infrastructure, coupled with daily feedback from clinicians, gives us time-to-market advantage in being able to respond to both new scientific publications, as well as market demand, in developing new products.

This integrated operating model allows us to leverage existing revenue-generating laboratory infrastructure to support research and development activities, which reduces development costs and timelines compared to approaches that rely solely on dedicated research facilities or external clinical partnerships.

It also enables us to respond quickly to emerging scientific developments by developing new assays or refining existing tests as clinically appropriate.

This becomes a key competitive advantage in a constantly-evolving field, by enabling the company to be the first to deliver to the market the most updated, clinically-relevant products.

This integrated approach allows us to:

● Evaluate clinical needs through direct laboratory operations.

● Validate assays using operational experience.

● Refine products based on clinician and laboratory feedback.

● Leverage clinical samples from the pathology services divisions to develop new assays at a lower cost and faster timeline to go to market.

We believe this model may improve alignment between product development and clinical market demand.

Growth Strategy

Our growth strategy includes several key components:

● Expansion of Proprietary Diagnostic Products:

Increasing commercialization of diagnostic assay kits through partnerships, distribution channels, and broader laboratory adoption.

● Sustained Pathology Services Operations:

Maintaining and expanding diagnostic testing services to support revenue generation, clinical engagement, and operational expertise.

● Regulatory and Reimbursement Progress:

Pursuing appropriate regulatory clearances and reimbursement coverage to support market adoption.

● Operational Efficiency and Scale:

Improving laboratory and manufacturing efficiencies while managing costs to support long-term financial performance.

Execution of this strategy is subject to various risks, including market competition, reimbursement dynamics, regulatory developments, and operational factors as further set out in the Risk Factors.

We believe there is a significant problem of misdiagnosis across numerous disease states (particularly in blood-related cancers) due to an inefficient and commoditized industry.

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Despite much publicity of the industry transitioning from fee-per-service to value-based payments, this transition has not yet occurred in diagnostics.

patient is misdiagnosed, physicians often end up administering incorrect treatments, creating adverse effects rather than improving outcomes.

When a patient is misdiagnosed, physicians often end up administering incorrect treatments, creating adverse effects rather than improving outcomes.

We believe that insurance providers, Medicare and Medicaid waste valuable dollars on the application of incorrect treatments and can incur substantial downstream costs.

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Our market is the United States domestic oncology market where we participate as a commercial diagnostic laboratory and market our products.

The oncology total available market, is currently estimated to exceed $20 billion, with an estimated compound annual growth rate exceeding 5%.

The oncology total available market, is currently estimated to exceed $116 billion by 2034, with an estimated compound annual growth rate exceeding 5%.

We also provide new technologies to the oncology diagnostic laboratory market in the form of HemeScreen and IV-Cell product offerings.

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A small panel targeted approach that operates on a single, low-cost, and easy-to-operate platform should be considered an attractive solution that provides the clinician with the answers they need while maintaining a simple, cost-effective workflow and economic model within the laboratory.

HemeScreen utilizes an inexpensive RT-PCR (reverse

transcription polymerase chain reaction).

HemeScreen utilizes an inexpensive RT-PCR (reverse transcription polymerase chain reaction).

HemeScreen is a set of disease-specific reagents that provide a simple workflow, is easy to use, and create attractive economics to the lab, resulting in their ability to reduce batches and provide faster test turnaround time.

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Faced with four different options of cell lineages for culturing – myeloid, B-cell, T-cell, and Plasma – current products on the market limit the laboratory to select only one cell lineage to culture.

This selection is typically based solely on the clinical suspicion provided;

This selection is typically based solely

on the clinical suspicion provided;

hence, if the clinical suspicion is incorrect, the laboratory will have cultured the wrong cell lineage, potentially arriving at a false negative result.

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These competitors also compete with us in recruiting and retaining qualified scientific and management personnel as well as in acquiring technologies complementary to, or necessary for, our programs.

Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Our competitors also may obtain Food and Drug Administration (“ FDA”) or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Single gene vs.

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Require very basic laboratory training and can be run by any lab tech with limited training;

Have attractive economics that provide attractive margins to laboratories who decide to use the RUO assays as an LDT.

Have attractive economics that provide attractive margins to laboratories who decide to use only RUO assays.

IV-Cell competition

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Competitors include Gibco, Irvine Scientific, Capricorn Scientific, Sigma-Aldrich, Euroclone and others.

Precipio’s IV-Cell is the only known media that has an all-in-one product that includes a base media plus all necessary mitogens, enabling the simultaneous culturing of all 4 cell lineages.

Precipio’s IV-Cell is, to our knowledge, based on publicly available information, the only known media that has an all-in-one product that includes a base media plus all necessary mitogens, enabling the simultaneous culturing of all 4 cell lineages.

Competitive Advantage

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The healthcare industry is subject to extensive regulation by a number of governmental entities at the federal, state and local level.

Laws and regulations in the healthcare industry are extremely complex and, in many instances, the industry does not have the benefit of significant regulatory or judicial interpretation.

Laws and regulations in the healthcare industry are extremely complex and, in many instances, the

industry does not have the benefit of significant regulatory or judicial interpretation.

For example, the U.S.

federal transparency requirements under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (“PPACA”) including the provision commonly referred to as the Physician Payments Sunshine Act, and its implementing regulations, which requires applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to CMS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other licensed health care practitioners, and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members.

federal transparency requirements under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (“PPACA”) including the provision commonly referred to as the Physician Payments Sunshine Act, and its implementing regulations, which requires applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to Center for Medicare and Medicaid Services (“CMS”), information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other licensed health care practitioners, and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members.

Our business is impacted not only by those laws and regulations that are directly applicable to us but also by certain laws and regulations that are applicable to our payers, vendors and referral sources.

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Further, to the extent we engage in new business initiatives, we must continue to evaluate whether new laws and regulations are applicable to us.

There can be no assurance that we will not be subject to scrutiny or challenge under one or more of these laws or that any enforcement

actions would not be successful.

There can be no assurance that we will not be subject to scrutiny or challenge under one or more of these laws or that any enforcement actions would not be successful.

Any such challenge, whether or not successful, could have a material adverse effect upon our business and consolidated financial statements.

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Non-Medicare patients are typically insured by private insurance companies who provide patient coverage and pay for patients’ health-related costs.

These private insurance companies will often adjust their rates according to the insurance rates annually published by the Center for Medicare and Medicaid Services, (“CMS”).

These private insurance companies will often adjust their rates according to the insurance rates annually published by the CMS.

We, and other providers, typically bill according to the codes relevant to the tests we conduct.

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furnishes economic incentives for measurable improvements in health care quality outcomes;

promotes a more integrated health care delivery system and

the creation of new health care delivery.

promotes a more integrated health care delivery system and the creation of new health care delivery.

It is unclear how other healthcare reform measures of the Trump administration or other efforts, if any, to challenge, repeal or replace the PPACA will impact our business.

Food and Drug Administration Regulation

Medical devices are subject to extensive regulation by the Food and Drug Administration (“FDA”).

Medical devices are subject to extensive regulation by the FDA.

The FDA regulates, among other things, the research, design, development, preclinical and clinical testing, manufacturing, safety, effectiveness, packaging, labeling, storage, recordkeeping, marketing authorization, adverse event reporting, marketing, promotion, sales, distribution and import and export of medical devices.

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● criminal prosecution.

Currently, we offer our products as research use only (“RUO”) products.

Currently, we offer our products as RUO products.

An RUO product is one that is not intended for clinical diagnostic use and must be labeled “For Research Use Only.

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The RUO Guidance further articulates the FDA’s position that any assistance offered in performing clinical validation or verification, or similar specialized technical support, to clinical laboratories, conflicts with RUO status.

Additionally, our CLIA laboratories offer testing utilizing our laboratory developed tests (“LDTs”).

Historically, the FDA has exercised enforcement discretion with respect to most LDTs and has not required laboratories that offer LDTs to comply with the FDA’s requirements for medical devices, such as the FDA’s requirements pertaining to marketing authorization, establishment registration, device listing, the Quality System Regulation, and other post-market controls.

However, at various points in recent years, the FDA has stated that it intends to end its policy of enforcement discretion and to actively regulate LDTs.

Most recently, on April 29, 2024, the FDA published a final rule on LDTs, in which FDA outlines its plans to end enforcement discretion for many LDTs in five stages over a four-year period:

● In Phase 1 (effective May 6, 2025), clinical laboratories would be required to comply with medical device reporting, correction/removal reporting, and certain quality systems complaint handling requirements.

● In Phase 2 (effective May 6, 2026), clinical laboratories would be required to comply with all other device requirements (e.g., establishment registration and device listing, labeling, investigational use requirements), except for remaining quality systems requirements and premarket review requirements.

● In Phase 3 (effective May 6, 2027), clinical laboratories would be required to comply with all remaining applicable quality systems requirements.

● In Phase 4 (effective November 6, 2027), clinical laboratories would be required to comply with premarket submission requirements for high-risk tests (i.e., tests subject to FDA’s premarket approval (PMA) requirement).

● In Phase 5 (effective May 6, 2028), clinical laboratories would be required to comply with premarket submission requirements for moderate- and low- risk tests (i.e., tests subject to de novo classification or the 510(k) requirement).

The final rule potentially extends enforcement discretion for certain tests, such as LDTs approved by the New York State Department of Health and LDTs first marketed prior to May 6, 2024 which are not modified or are modified in certain limited ways, from certain FDA regulatory requirements, provided certain important limitations have been met.

We are actively reviewing the final rule to evaluate its applicability to our operations, and the extent to which we may be required to modify our operations to comply with its requirements.

On May 29, 2024, the American Clinical Laboratory Association filed a lawsuit challenging the FDA’s authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act.

Subsequently, on August 19, 2024, the Association for Molecular Pathology filed a lawsuit similarly challenging FDA’s final rule on LDTs.

The outcome of these lawsuits are uncertain at this time.

If the FDA were to determine that certain tests offered by us as LDTs are no longer eligible for enforcement discretion for any reason, including new rules, policies or guidance, or due to changes in statute, our tests may become subject to extensive FDA requirements.

If required, the regulatory marketing authorization process required to bring our current or future LDTs into compliance may involve, among other things, successfully completing additional clinical validations and submitting to and obtaining clearance, authorization or approval from the FDA.

Furthermore, pending legislative proposals, if enacted, could create new or different regulatory and compliance burdens on us and could have a negative effect on our ability to keep products on the market or develop new products.

Additionally, our laboratories offer testing utilizing our LDTs.

Historically, it has been the FDA’s position that it has exercised enforcement discretion with respect to most LDTs and has not required laboratories that offer LDTs to comply with the FDA’s requirements for medical devices, such as the FDA’s requirements pertaining to marketing

authorization, establishment registration, device listing, the Quality System Regulation (as of February 2, 2026, the Quality Management System Regulation), and other post-market controls.

On April 29, 2024, FDA published a final rule that, if implemented, would have amended FDA’s regulatory definition of in vitro diagnostics to include LDTs and phased out the agency’s longstanding enforcement discretion for most LDTs over a planned multi-stage implementation period.

The rule would have subjected many LDTs to premarket review and device regulatory requirements.

Subsequently, in March 2025, a federal district court in American Clinical Laboratory Association v.

FDA and Association for Molecular Pathology v.

FDA vacated the April 29, 2024 final rule on the basis that FDA lacked statutory authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act.

In September 2025, FDA published a rule restoring the regulatory text governing LDTs to the pre-2024 status quo.

As a result, the April 2024 final rule is no longer in effect, and there are currently no FDA-imposed device-style premarket requirements or staged compliance deadlines applicable solely because a laboratory develops and uses an LDT.

Accordingly, LDTs continue to be regulated primarily under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and related CMS authorities as laboratory services, and FDA generally continues to exercise enforcement discretion with respect to LDTs.

The regulatory framework for LDT oversight remains uncertain, and future actions by FDA, CMS, or Congress or subsequent litigation could alter the applicable requirements or enforcement posture.

If FDA, CMS, or Congress adopts new requirements governing LDTs, compliance with such requirements could require significant additional investments in regulatory, quality, clinical validation, operational, and administrative infrastructure and could adversely affect our business, results of operations, financial condition, and prospects.

If the FDA were to determine that certain tests offered by us as LDTs or products offered by us as RUO products are subject to regulation as medical devices for any reason, including new rules, policies or guidance, or due to changes in statute, our tests or products may become subject to extensive FDA requirements.

If required, the regulatory marketing authorization process required to market our current or future tests or products as medical devices in the United States may involve, among other things, successfully completing additional clinical validations and submitting to and obtaining clearance, authorization or approval from the FDA.

Furthermore, any future legislative proposals, if enacted, could create new or different regulatory and compliance burdens on us and could have a negative effect on our ability to keep products on the market or develop new products.

We are actively monitoring developments, assessing the impact on our operations, and evaluating compliance strategies, including potential FDA submissions and resource allocation for regulatory changes.

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The IVDR introduced more stringent requirements than the previous In Vitro Diagnostics Directive 98/79/EC (“IVDD”), including enhanced clinical evidence, post-market surveillance, and increased scrutiny by notified bodies for most device classes.

For an in-vitro diagnostic device to be placed on the EU market, a CE mark demonstrating compliance with the IVDR is required.

While Class A, non-sterile devices can be self-certified, all other devices require conformity assessment by an independent notified body.

Under IVDR’s transitional provisions, devices placed on the EU market under IVDD before May 26, 2022, may continue to be supplied until deadlines ranging from December 2027 to December 2029, depending on risk classification, provided they comply with post-market surveillance, vigilance, and registration requirements.

The transition deadlines are subject to manufacturers submitting applications to notified bodies within specified timeframes.

There is no certainty regarding the final IVDR approval.

Under the IVDR’s transitional provisions, devices for which a declaration of conformity was drawn up prior to May 26, 2022 under the IVDD and which require Notified Body involvement the IVDR may continue to be placed on the EU and Northern Ireland markets until December 31, 2028, assuming a Class C risk classification.

This is contingent on the devices with post-market surveillance, vigilance, and registration requirements under the IVDR, and provided the manufacturer submits a formal application to an IVDR-designated notified body by May 26, 2026 and concludes a written agreement with that notified body by September 26, 2026.

Failure to meet either of these deadlines would result in the loss of transitional protection on that date.

HemeScreen qualifies for these transitional provisions by virtue of its registration and sale in Northern Ireland, which follows EU medical device rules under the Windsor Framework.

There is no certainty regarding the timing or outcome of notified body conformity assessments under the IVDR.

The transition to IVDR continues to present regulatory, operational, and financial challenges, including potential delays in obtaining notified body certification and increased compliance costs.

We are actively monitoring regulatory developments and have taken steps to transition our products to IVDR compliance, including engagement with notified bodies and implementation of enhanced post-market surveillance measures.

The UK formally left the EU on January 31, 2020.

In respect of medical devices, since the end of the Brexit transitional period on January 1, 2021, medical devices must be registered with the Medicines and Healthcare products Regulatory Agency, or MHRA (the UK medicines and medical devices regulator) before being placed on the Great Britain market.

If a manufacturer of a device placed on the market in Great Britain is based outside of the UK, the manufacturer must appoint a UK responsible person with a registered place of business in the UK to act on the manufacturer’s behalf in respect of certain activities (e.g.

device registration).

CE marks issued by EU notified bodies to place in-vitro diagnostic medical devices on the market in the EU will remain valid in the UK up until, at the latest, June 30, 2030, following which a UK Conformity Assessed, or UKCA, mark will be required to place a device on the Great Britain market.

Manufacturers may choose to use the UKCA mark on a voluntary basis prior to such dates.

UCKA marking will, however, not be recognized in the EU.

The EU regulatory framework on medical devices continues to apply in Northern Ireland under the Windsor Framework and medical devices in Northern Ireland may either carry an EU CE mark or a UK and Northern Ireland CE mark, or CE UK(NI), although devices bearing the CE UK(NI) marking will not be accepted on the EU market.

Following a public consultation, the UK government is implementing changes to the medical devices legislation.

The first piece of legislation will come into force on June 16, 2025, and implements changes to the post-market surveillance requirements for medical devices in Great Britain, with the aim of facilitating greater traceability of incidents.

Further legislation will be put in place in 2025 and 2026 to introduce new pre-market requirements, including an international reliance procedure for approval of certain medical devices for the Great Britain market.

We are actively monitoring regulatory developments and have taken steps to transition our products to IVDR compliance, including engagement with notified

bodies and implementation of enhanced post-market surveillance measures.

For more information about how the transitional provisions may impact our business, see “Risk Factors - Changes to the UK regulations may require additional review of our devices and there is a risk our devices may not be compliant with any revised UK regulations ” in Item 1A of this Annual Report.

The United Kingdom formally left the EU on January 31, 2020.

In respect of medical devices, since the end of the Brexit transition period on January 1, 2021, medical devices must be registered with the Medicines and Healthcare products Regulatory Agency, or MHRA, before being placed on the market in Great Britain.

If a manufacturer of a device placed on the market in Great Britain is established outside the United Kingdom, the manufacturer must appoint a UK Responsible Person with a registered place of business in the United Kingdom to act on the manufacturer’s behalf with respect to certain regulatory obligations, including device registration.

CE marked devices and in vitro diagnostic medical devices, or IVDs, that comply with applicable EU legislation may continue to be placed on the Great Britain market until June 30, 2030, at the latest, subject to compliance with applicable registration and post market requirements.

Thereafter, devices and IVDs placed on the Great Britain market will generally be required to bear a UK Conformity Assessed, or UKCA, mark, unless otherwise permitted under applicable reliance or transitional mechanisms.

Manufacturers may elect to use the UKCA mark on a voluntary basis prior to such date.

UKCA marking is not recognized in the EU.

The EU regulatory framework for medical devices continues to apply in Northern Ireland under the Windsor Framework.

Medical devices placed on the market in Northern Ireland may bear either a CE mark or a CE UK(NI) marking, although devices bearing the CE UK(NI) marking are not accepted on the EU market.

Following a public consultation, the UK government is implementing changes to UK medical devices legislation.

The first such legislation came into force on June 16, 2025 and introduced revised post market surveillance requirements for medical devices in Great Britain intended to improve traceability and incident monitoring.

The UK government has also indicated that further legislation is expected to revise pre-market requirements for devices and IVDs placed on the Great Britain market.

Proposed reforms include a potential international reliance framework that could facilitate market access for certain devices previously authorized by comparable regulators.

The scope, timing, and final requirements of these reforms remain subject to further legislation and regulatory guidance.

Research and Development Expenses

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Human Capital

As of March 1, 2025, Precipio employed fifty-four (54) employees on a full-time basis and six (6) employees as part-time.

Of the total full-time and part-time employees, nine (9) were in Finance, General and Administration, thirty-five (35) were in laboratory and production, eight (8) were in Sales and Marketing, three (3) were in Customer Service and Support and five (5) were in Research & Development.

As of March 9, 2026, Precipio employed sixty-one (61) employees on a full-time basis and ten (10) employees as part-time.

Of the total full-time and part-time employees, ten (10) were in Finance, General and Administration, forty-four (44) were in laboratory and production, ten (10) were in Sales and Marketing, two (2) were in Customer Service and Support and five (5) were in Research & Development.

All of our employees are based in the U.S.

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state laws also govern the privacy and security of personal information.

For example, California enacted the California Consumer Privacy Act, or CCPA, which, effective January 1, 2023, created new individual privacy rights for California consumers (as defined in the law) and placed increased privacy and security obligations on entities handling personal data of consumers or households.

handling personal data of consumers or households.

The CCPA requires covered companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California residents with ways to opt-out of certain sales or transfers of personal information.

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Other states have proposed new privacy laws which, if enacted, may add additional complexity, variation in requirements, restrictions and potential legal risk, require additional investment of resources in compliance programs, impact strategies and the availability of previously useful data and could result in increased compliance costs and/or changes in business practices and policies.

The existence of comprehensive

privacy laws in different states in the country would make our compliance obligations more complex and costly and may increase the likelihood that we may be subject to enforcement actions or otherwise incur liability for noncompliance.

The existence of comprehensive privacy laws in different states in the country would make our compliance obligations more complex and costly and may increase the likelihood that we may be subject to enforcement actions or otherwise incur liability for noncompliance.

There are also states that are specifically regulating health information.

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For example, a small number of states have passed laws that regulate biometric data specifically.

In Europe, with respect to the collection and processing of personal data relating to the European Union (“EU”), European Economic Area (“EEA”) and United kingdom (“UK”), we are subject to the EU General Data Protection Regulation (EU GDPR), the UK General Data Protection Regulation (UK GDPR), as well as applicable data protection laws in effect in the Member States of the EEA and in the UK (including the UK Data Protection Act 2018) which govern the processing of personal data in connection with (i) the marketing or offering of our goods or services to individuals in the UK and EEA;

In Europe, with respect to the collection and processing of personal data relating to the EU, European Economic Area (“EEA”) and United Kingdom (“UK”), we are subject to the EU General Data Protection Regulation (EU GDPR), the UK General Data Protection Regulation (UK GDPR), as well as applicable data protection laws in effect in the Member States of the EEA and in the UK (including the UK Data Protection Act 2018) which govern the processing of personal data in connection with (i) the marketing or offering of our goods or services to individuals in the UK and EEA;

(ii) the monitoring of their behavior so long as this takes place in the EEA/UK (for example, through cookies and other tracking tools), or (iii) the activities of any establishments we may set up in the UK or any EEA Member State (e.g.

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Information found on our website is not incorporated by reference into this report and should not be considered as part of this report.

We make available free of charge through our website our SEC filings, including exhibits and amendments to these reports, furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

We make available free of charge through our website

our SEC filings, including exhibits and amendments to these reports, furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

You can review our electronically filed reports and other information that we file with the SEC on the SEC’s website at http://www.sec.gov.

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

What changed 10-K

Item 1. Business