What changed in this filing

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Item 1. Business

2025-03-27 compared with 2024-03-29 · 156 added, 90 removed, 225 unchanged (52% of the section changed)

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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 misdiagnosis.

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 CLIA laboratories in both New Haven, Connecticut and Omaha, Nebraska where we provide essential blood cancer diagnostics to office-based oncologists in many states nationwide.

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

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;

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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 places us as a reputable user of our own products, and we believe gains us significant credibility with existing and prospective customers.

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

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, 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.

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.

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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.

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.

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.

According to a report by Pinnacle Health, the estimated cost of misdiagnosis within the healthcare system is $100 billion annually.

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The ongoing introduction of new, genetic-based targeted therapies have made molecular testing a mainstream and essential component of the diagnostic process.

WHO (World Health Organization) and NCCN (The National Comprehensive Cancer Network®) guidelines have delineated the testing requirements of several specific genetic markers that are required during the diagnostic workup based on the patient's disease state.

The current products on the market offer two solutions for genetic testing.

World Health Organization (WHO) and The National Comprehensive Cancer Network® (NCCN) guidelines have delineated the testing requirements of several specific genetic markers that are required during the diagnostic workup based on the patient's disease state.

The current products on the market largely offer two types of solutions for genetic testing.

One of those solutions is single-gene testing products via various testing modalities;

the other solution is broad, NGS (Next Generation Sequencing) panels that typically range from 50 to >500 genes in one panel.

the other solution is broad, next generation sequencing (“NGS”) panels that typically range from 50 to >500 genes in one panel.

There are benefits and drawbacks to both current product options.

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Poor economics of an assay require the laboratory to batch samples, resulting in lengthy turnaround time to provide results to patients, and impacting patient care.

Conversely, NGS, although providing broad gene coverage, is cumbersome and expensive to operate, thus resulting in lengthy test turnaround time;

and is costly to the payors who are reluctant to pay for the testing of 50 genes, when only 5 are defined as medically necessary.

Conversely, NGS, although providing broad gene coverage, is cumbersome and expensive to operate, thus resulting in lengthy test turnaround time, and is costly to the payors who are reluctant to pay for the testing of 50 genes, when only 5 are defined as medically necessary.

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 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.

HemeScreen utilizes an inexpensive RT-PCR (reverse

transcription polymerase chain reaction).

Our customers that utilize HemeScreen have demonstrated a reduction in test turnaround time of 2 weeks to 2 days, and have also improved their financial outcome through this cost-effective technology.

The first panel developed using HemeScreen technology was our Myeloproliferative Neoplasms panel.

We have since added Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Cytopenia, and BCR-ABL panels, evolving HemeScreen into a “suite” of robust genetic diagnostic panels, and we released a number of panels during 2023 and expect the release of additional diagnostic panels in the coming years.

We own an international patent application on our proprietary panels.

These assays provide lower limits of detection compared to their HemeScreen predecessors and provide quantitative results.

These assays were also released with complementary analysis software (BHAS) for rapid data analysis to further streamline laboratory workflows.

We own pending U.S.

and European patent applications on our proprietary panels.

Our technology enables testing to be completed in one rapid scanning process.

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When a laboratory receives a sample, the cytogenetics laboratory must immediately set up the sample for cell culturing.

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

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;

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These companies provide a high level of service focused on oncology and offer their services to oncologists and pathology departments within hospitals.

Competitors in this group include NeoGenomics Laboratories, Inc., also known as NeoGenomics or Neo,

GenPath Diagnostics and Inform Diagnostics.

Competitors in this group include NeoGenomics Laboratories, Inc., also known as NeoGenomics or Neo, GenPath Diagnostics and Inform Diagnostics.

The second group consists of large commercial companies that offer a wide variety of laboratory tests ranging from simple chemistry tests to complex genetic testing.

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Companies such as Life Technologies, Illumina, Roche, Natera, PerkinElmer, BioRad, Qiagen and many others have developed machines and assays that can test hundreds of genes simultaneously.

While this technology is extremely robust, there are a few challenges to NGS.

While this technology is extremely robust, there are a few challenges to NGS, including, but not limited to:

Operability – this is a complex technology that requires a high level of lab competency and an advanced level of staff sophistication and training;

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Typically range from 4-7 genes (matching the clinical requirements);

Are all run on one, inexpensive machine (a RT-PCR, which costs between $30-75k);

Are all run on one, inexpensive machine (an RT-PCR, which costs between $30-75k);

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

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and then commercialize the technology and bring it to market.

Our model gives us a unique capability to ensure that the product is relevant, reliable, and workable within the laboratory workflow.

Furthermore, given the hands-on experience we have as first-users of our own products, we have unparalleled experience and expertise required to support our customers and help them maximize the value of our technologies that they use.

Our model gives us a unique capability to ensure that the finished product is relevant, reliable, and workable within the laboratory workflow.

Furthermore, given the hands-on experience we have as first-users of our own products, we have unparalleled experience, insight, and expertise required to support our customers and help them maximize the value of our technologies that they use.

As cancer diagnostic testing continues to evolve, laboratory testing has become extremely complex, requiring even greater diagnostic precision, attention to process and a more appropriate evaluation.

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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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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.

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

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

We offer our products as research use only (“RUO”) products.

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

Not for use in diagnostic procedures.” Products that are intended for research use only and are properly labeled as RUO are exempt from compliance with the requirements of

Food and Drug Administration (FDA) applicable to medical devices.

A product labeled RUO but intended to be used diagnostically may be viewed by the FDA as adulterated or misbranded and is subject to FDA enforcement activities.

The FDA may consider the totality of the circumstances surrounding distribution and use of an RUO product, including how the product is marketed, when determining its intended use.

In November 2013, the FDA issued a guidance document entitled “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (RUO Guidance), which highlights the FDA’s interpretation that distribution of RUO products with any labeling, advertising or promotion that suggests that clinical laboratories can validate the test through their own procedures and subsequently offer it for clinical diagnostic use as a laboratory developed test is in conflict with RUO status.

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”).

LDTs are defined by the FDA to be tests that are designed, developed, and used within a single laboratory.

The FDA takes the position that it has authority to regulate LDTs as medical devices, and historically, 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.

However, the FDA has stated it intends to end its policy of enforcement discretion and to actively regulate LDTs.

For example, on October 3, 2014, the FDA issued two draft guidance documents, entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Regulatory Oversight of Laboratory Developed Tests (LDTs)”, that set forth a proposed risk-based regulatory framework that would apply varying levels of FDA oversight to LDTs.

The draft guidance documents have not been finalized.

In January 2017, the FDA issued a “Discussion Paper on Laboratory Developed Tests (LDTs),” which includes a possible approach to LDT oversight that is intended to advance public discussion on the topic.

Additionally, legislative proposals continue to be discussed.

Such proposals would implement differing approaches to the regulation of LDTs, including in certain instances to require marketing authorization from the FDA.

On October 3, 2023, the FDA published a proposed rule on LDTs, in which the FDA proposes to end enforcement discretion for virtually all LDTs in five stages over a four-year period from the date the FDA publishes a final rule.

In Phase 1 (effective one year post-finalization), laboratories would be required to comply with medical device (adverse event) reporting and correction/removal reporting requirements.

In Phase 2 (effective two years post-finalization), laboratories would be required to comply with all other device requirements (e.g., registration/listing, labeling, investigational use), except for quality systems and premarket review.

In Phase 3 (effective three years post-finalization), laboratories would be required to comply with quality systems requirements.

In Phase 4 (effective three and a half years post-finalization, but not before October 1, 2027), laboratories would be required to comply with premarket review requirements for high-risk tests (i.e., tests subject to the PMA requirement).

Finally, in Phase 5 (effective four years post-finalization, but not before April 1, 2028), laboratories would be required to comply with premarket review requirements for moderate- and low-risk tests (i.e., tests subject to de novo or the 510(k) requirement).

Unlike previous proposals, the proposed rule does not provisions that would allow for “grandfathering” of existing tests.

The content and timing of any final rule on LDTs is uncertain at this time.

Medical devices are subject to extensive regulation by the FDA.

Medical devices are subject to extensive regulation by the Food and Drug Administration (“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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● refusing or delaying requests for marketing authorization or new products or modified products;

or criminal prosecution.

● criminal prosecution.

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

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

Not for use in diagnostic procedures.” Products that are intended for research use only and are properly labeled as RUO are exempt from compliance with the requirements of the FDA applicable to medical devices.

A product labeled RUO but intended to be used diagnostically may be viewed by the FDA as adulterated or misbranded and is subject to FDA enforcement activities.

The FDA may consider the totality of the circumstances surrounding distribution and use of an RUO product, including how the product is marketed, when determining its intended use.

In November 2013, the FDA issued a guidance document entitled “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (“RUO Guidance”), which highlights the FDA’s interpretation that distribution of RUO products with any labeling, advertising or promotion that suggests that clinical laboratories can validate the test through their own procedures and subsequently offer it for clinical diagnostic use as a laboratory developed test is in conflict 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.

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.

European Union Regulation

Our products are regulated as in-vitro diagnostic devices in the European Union (EU) and will therefore be subject to the requirements of the In-Vitro Diagnostic Devices Regulation (EU) 2017/746, (“IVDR”).

The IVDR became fully applicable in all EU Member States on May 26, 2022 (therefore not including the UK).

The IVDR introduced more stringent requirements than the previous EU In Vitro Diagnostics Directive 98/79/EC, (“IVDD”).

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

The CE mark confirms that the device meets the general safety and performance requirements under the IVDR (or, previously, the essential requirements under the IVDD).

For the lowest risk class devices, the manufacturer can conduct a self-assessment of its device against the requirements and issue a declaration of conformity confirming that the device is compliant.

For all other devices, a conformity assessment procedure must be undertaken by an independent notified body to assess the compliance of the device with the applicable requirements.

In accordance with the transitional provisions in the IVDR, devices placed on the EU market prior to May 26, 2022 in accordance with the IVDD (except for Class A, non-sterile devices which must conform with the IVDR requirements since May 26, 2022) may continue to be supplied until a certain date (ranging from May 2025 to May 2027) which will depend on the risk class of the device, provided that manufacturers comply with the IVDR requirements relating to post-market surveillance, market surveillance, vigilance and registration of economic operators and devices.

After the applicable date, all devices must be certified under the IVDR in order to be marketed in the EU.

In January 2024, the European Commission published a proposal for a further extension to the transitional periods until December 2027 to December 2029, depending on the risk class of the device and subject to certain requirements (e.g.

for devices requiring notified body assessment, the manufacturer must submit an application to a notified body to transfer the device to the IVDR by a certain date (ranging from May 2025 to May 2027), depending on the risk class of the device).

The proposal will now be put forward to the European Parliament and European Council for adoption.

Our products are regulated as in-vitro diagnostic devices in the European Union (“EU”) and are subject to the In-Vitro Diagnostic Devices Regulation (EU) 2017/746 (“IVDR”), which became fully applicable in all EU Member States on May 26, 2022.

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.

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.

Research and Development Expenses

For the years ended December 31, 2023 and 2022, we recorded $1.7 million, respectively, of research and development expenses.

For the years ended December 31, 2024 and 2023, we recorded $1.3 million and $1.7 million, respectively, of research and development expenses.

More information regarding our research and development activities can be found in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” under Item 7 of this Annual Report.

Human Capital

As of March 1, 2024, Precipio employed fifty-one (51) employees on a full-time basis and six (6) employees as part-time.

Of the total, thirteen (13) were in Finance, General and Administration, twenty-four (24) were in laboratory and production, ten (10) were in Sales and Marketing, three (3) were in Customer Service and Support and seven (7) were in Research & Development.

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.

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

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Compensation and Benefits.

Our human capital strategies, initiatives, and outcomes are reviewed on a regular basis with our Board’s Governance Committee as well as Compensation Committee to help align with our overall business strategies.

Our human capital management strategies, initiatives, and outcomes are reviewed on a regular basis with our Board’s Governance Committee as well as Compensation Committee to help align with our overall business strategies.

Our competitive compensation programs are designed to align the compensation of our employees with our performance and to provide the proper incentives to attract, retain and motivate employees.

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medical insurance including prescription drug benefits, dental insurance, vision insurance, accident insurance, life insurance, disability insurance, health savings accounts, flexible spending accounts and access to mental health support.

We also enable our employees to take unlimited personal time off and have put in place enhanced parental leave abilities.

We also enable our employees to take unlimited personal time off and have put in place enhanced parental leave benefits.

Employee Engagement.

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We believe our management team has the experience necessary to effectively execute our strategy and advance our product and technology leadership.

Diversity & Inclusion (“D&I”).

Inclusion Efforts.

We strive to create a culture in which all employees feel heard, respected, and valued.

We are committed to creating and maintaining a diverse, inclusive and safe work environment.

As we grow and mature, we look forward to establishing programs that infuse D&I within the business, identify barriers that impact recruitment, development and retention of underrepresented employees, identify educational content, communicate the value and impact of D&I on goals and objectives, all while continuing to focus on hiring diverse talent at all levels of the Company.

We are committed to creating and maintaining an inclusive and safe work environment.

As we grow and mature, we look forward to establishing programs that infuse inclusivity within the business, identify barriers that impact recruitment, development and retention of underrepresented employees, identify educational content, communicate the value and impact of inclusivity on goals and objectives, all while continuing to focus on hiring diverse talent at all levels of the Company.

Our ability to innovate and meet people’s needs is strongest when all voices are heard and valued.

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We intend to satisfy any disclosure requirements under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of this Code of Business Conduct and Ethics by posting such information on our website, at the Internet address and location specified above.

Executive Officers of the Registrant

Information about our Executive Officers.

Our executive officers, their ages as of March 1, 2025 and their respective positions are as follows:

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Danieli assumed the role of Chief Executive Officer of Precipio, Inc.

at the time of a

June 2017 merger transaction with Transgenomic, Inc.

at the time of a June 2017 merger transaction with Transgenomic, Inc.

(the “Merger”).

With over 20 years managing small and medium-size companies, some of his previous experiences include COO of Osiris, a publicly-traded company based in New York City with operations in the US, Canada, Europe and Asia;

VP of Operations for Laurus Capital Management, a multi-billion dollar hedge fund;

and in various other entrepreneurial ventures.

With over 20 years managing small and medium- size companies, some of his previous experiences include serving as COO of Osiris, a publicly-traded company based in New York City with operations in the US, Canada, Europe and Asia, VP of Operations for Laurus Capital Management, a multi- billion dollar hedge fund, and in various other entrepreneurial ventures.

Ilan holds an MBA from the Darden School at the University of Virginia, and a BA in Economics from Bar-Ilan University in Israel.

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Gage was appointed Interim Chief Financial Officer of Precipio, Inc.

effective March 21, 2022 and promoted to Chief Financial Officer effective July 1, 2023 without any change to his compensation or any additional stock award.

Gage previously served as Director of Financial Reporting and Analysis of Precipio, Inc.

since joining the Company in June 2017 following its acquisition of Transgenomic Inc., where he was Director of Financial Reporting and Analysis since 2014.

Gage has over 30 years of experience in company finance, 25 years of which being with publicly traded companies.

effective March 21, 2022 and promoted to Chief Financial Officer effective July 1, 2023 without any change to his compensation or stock awards.

Gage previously served as Director of Financial Reporting and Analysis of Precipio, Inc., upon joining the Company in June 2017 following its acquisition of Transgenomic Inc., where he was Director of Financial Reporting and Analysis since 2014.

Gage has over 30 years of experience in corporate finance, 25 years of which being with publicly traded companies.

Gage holds a Bachelor of Science Degree in Business Administration from Bryant University.

Ahmed Zaki Sabet, Chief Operating Officer, age 40

Sabet has been with Precipio since co-founding the Company in 2011 and currently serves as the Chief Operating Officer.

Sabet holds over 17 years of experience in laboratory management spanning all fields of reference laboratory operations primarily focusing on cancer diagnostics.

Prior to Precipio, Mr.

Sabet has served as a consultant with the College of American Pathologists (CAP) and assisted several diagnostic companies in setting up their specialized cancer testing operations.

Sabet holds a Bachelor of Science degree in Biomedical Engineering from the New Jersey Institute of Technology.

Ayman Mohamed, Chief Technology Officer, age 41

Mohamed has been with Precipio since co-founding the Company in 2011, and currently serves as the Chief Technology Officer, as well as the laboratory’s Technical Director.

In this dual role, Dr.

Mohamed is responsible for the entire process from conceptualization and invention of proprietary technologies, through design and development, economic cost analysis and modeling, testing and validation;

and finally, the technical implementation of the technologies for clinical use in the Company’s laboratories.

Mohamed has been responsible for the development and introduction of ground-breaking products such as IV-Cell™ and HemeScreen.

Prior to joining the Company, Dr.

Mohamed served in various technical and research positions in both commercial diagnostic companies as well as academic centers such as Yale University.

Mohamed holds an MD and a Masters in Human Genetics from the University of Alexandria, Egypt.

Environmental, Social, and Governance

As our business continues to grow and develop, we recognize the importance of making responsible business decisions for the benefit of all of our stakeholders, including our stockholders, customers, employees, partners, the communities in which we work and live, as well as the planet.

To that end, we published our ESG Report in February 2023, which is available on our website, and expect to continue reporting on our progress to our various stakeholders.

To that end, we published our Environmental, Social, and Governance (ESG) Report in February 2023, which is available on our website, and expect to continue reporting on our progress to our various stakeholders.

As part of our commitment to responsible business practices, we integrate ESG principles into our corporate strategy.

Our ESG efforts focus on corporate governance, environmental responsibility, and human capital management.

Environmental:

We actively reduce waste by implementing office-wide recycling and minimizing paper usage.

We continue to explore further sustainability initiatives to reduce our environmental footprint.

Our workforce reflects a commitment to diversity, with a focus on gender, ethnicity, and cultural inclusion.

We invest in professional development through annual performance reviews and targeted training programs.

Additionally, we support community engagement through partnerships such as the Salvation Army’s "Adopt-A-Family” program.

Our Board of Directors maintains independence, with three key committees—Audit, Compensation, and Nominating & Corporate Governance—ensuring oversight and accountability.

Employees adhere to a robust Code of Business Conduct and Ethics, with an anonymous Ethics Hotline for reporting concerns.

Our ESG report, available on our website, details our commitments and progress.

We will continue evaluating and reporting on ESG risks and improvements over time.

Climate Change

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Intellectual Property

The Company has filed an international patent applications for its proprietary HemeScreen technology.

The Company has filed U.S.

and European patent applications for its proprietary HemeScreen technology, reinforcing our commitment to innovation in diagnostic solutions.

In addition to patent protection, we have also registered trademarks to safeguard our brand identity and ensure the distinctiveness of our products in the marketplace.

This combination of patent and trademark applications reflects our ongoing efforts to protect and commercialize our intellectual property, strengthen our market position, and drive long-term value.

We continue to invest in research and development to expand our portfolio of proprietary technologies.

We are subject to U.S.

federal, state, and foreign data protection laws and regulations, such as laws and regulations that address privacy and data security.

In the U.S., numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws, govern the collection, use, disclosure, and protection of health-related and other personal information.

For example, at the federal level, in addition to HIPAA, failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission (FTC) Act, 15 U.S.C § 45(a).

The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business and the cost of available tools to improve security and reduce vulnerabilities

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.

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.

While there is currently an exception for protected health information that is subject to HIPAA, as currently written, the CCPA may impact our business activities.

Further, the California Privacy Rights Act, or CPRA, took effect on January 1, 2023, and amended the CCPA by creating additional obligations with respect to processing and storing personal information.

These additional obligations have included expanding consumers’ rights with respect to certain categories of sensitive personal information and establishing the California Privacy Protection Agency to enforce the CCPA.

Similar laws have been passed in numerous other states.

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.

There are also states that are specifically regulating health information.

For example, Washington’s My Health My Data Act, which became effective on March 31, 2024, regulates the collection and sharing of health information and has a private right of action, which further increases the relevant compliance risk.

Connecticut and Nevada have also passed similar laws regulating consumer health data.

In addition, other states have proposed and/or passed legislation that regulates the privacy and/or security of certain specific types of information.

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;

(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.

branches, subsidiaries or any significant sales representative presence).

The UK’s data protection regime is independent from but aligned to the EU’s data protection regime.

In this Annual Report on Form 10-K, references to “GDPR” encompasses both the EU GDPR and UK GDPR, unless specified otherwise.

The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requiring additional disclosures to individuals regarding data processing activities, requiring that safeguards are implemented to protect the security and confidentiality of personal data, limiting retention periods for personal data, creating mandatory data breach notification requirements in certain circumstances, and requiring that certain measures (including contractual requirements) are put in place when engaging third-party service providers.

The GDPR also imposes strict rules on the transfer of personal data to countries outside of the UK and EEA that do not ensure an adequate level of protection, including the United States in certain circumstances, unless derogation exists or a valid GDPR transfer mechanism (for example, the European Commission approved Standard Contractual Clauses (SCCs) and the UK International Data Transfer Agreement or Addendum (UK IDTA) have been put in place, and transfer impact assessments conducted).

Failure to comply with the requirements of the GDPR and the related national data protection laws of the EEA Member States and the UK may result in fines up to €20 million (17.5 million for the UK GDPR) or 4% of a company’s global annual revenues for the preceding financial year, whichever is higher.

The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.

Corporate History

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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 Securities and Exchange Commission, (“SEC”), filings, including exhibits, 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 web site at http://www.sec.gov.

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.

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What changed 10-K

Item 1. Business