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What changed in OneMedNet Corp's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of OneMedNet Corp's 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+347 added−321 removedSource: 10-K (2025-04-15) vs 10-K (2024-04-09)

Top changes in OneMedNet Corp's 2024 10-K

347 paragraphs added · 321 removed · 199 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

99 edited+31 added−44 removed61 unchanged
Biggest changeWe believe that OneMedNet unlocks the value in imaging and electronic health records data in the following three principal ways: ● Regulatory Grade — Our imaging results serve as proof of effectiveness for regulatory agencies, meeting requirements for quality & diversity; ● On Demand — Our powerful indexing platform access and harmonizes complete patient profiles across fragmented data silos, delivering images and records on-demand; ● Expertly Curated — We curate to the most stringent multi-level stratified requirements, providing unmatched data accuracy and completeness. 2 OneMedNet’s data is fully de-identified using a multi-step quality control process and goes beyond PHI to include PII (personally identifiable information), SII (Site Identifiable Information), and more.
Biggest changeOur in-house clinical team performs intensive curation of the data so that results meet the specifications and requirements of life science Data Collection Protocol (“DCP”) - regardless of the complexity. 2 We believe that OneMedNet unlocks the value in imaging and EHR data in the following three principal ways: ● Regulatory Grade - Our imaging results serve as proof of effectiveness for regulatory agencies, meeting requirements for quality & diversity. ● On Demand - Our powerful indexing platform accesses and harmonizes complete patient profiles across fragmented data silos, delivering images and records on-demand. ● Expertly Curated - We curate to the most stringent multi-level stratified requirements, providing unmatched data accuracy and completeness.
And that registry study analyzed outcomes of 54 patients treated with Orencia for the prevention of graft versus host disease, in combination with standard immunosuppressive drugs, versus 162 patients treated with the standard immunosuppressive drugs alone, and showed efficacy in that indication.
That registry study analyzed outcomes of 54 patients treated with Orencia® for the prevention of graft versus host disease, in combination with standard immunosuppressive drugs, versus 162 patients treated with the standard immunosuppressive drugs alone, and showed efficacy in that indication.
Although clinical trials are incredibly important to determine the safety and efficacy of new technologies, when compared to real-world evidence they do have some limitations. For example, traditional clinical trials can have strict inclusion criteria that makes it challenging for providers to accurately extrapolate the results of a clinical trial to a broader population.
Although clinical trials are incredibly important to determine the safety and efficacy of new technologies, when compared to Real World Evidence, they do have some limitations. For example, a traditional clinical trial can have strict inclusion criteria that makes it challenging for providers to accurately extrapolate the results of a clinical trial to a broader population.
AI integrated analytics and automation provide access to crucial insights from historical clinical trial Real-World Data and Real World Evidence, expanding end-to-end clinical trial capabilities: ● Data ingestion — publicly/historical available Real-World Data ● Text extraction — NLP used to extract key entities from clinical trial documents ● Data transformation & standardization — data standardization using pre-built models ● AI model deployment — predicting trial design impacts on costs, feasibility, cycle times, and quality risk AI is driving ground-breaking leaps in protein structure identification, and advances in regulations are providing healthcare research organizations with access to real-world data to accelerate clinical trial processes.
AI-integrated analytics and automation provide access to crucial insights from historical clinical trial Real World Data and Real World Evidence, expanding end-to-end clinical trial capabilities: ● Data ingestion - publicly/historically available Real World Data ● Text extraction - NLP used to extract key entities from clinical trial documents ● Data transformation & standardization - data standardization using pre-built models ● AI model deployment - predicting trial design impacts on costs, feasibility, cycle times, and quality risk AI is driving ground-breaking leaps in protein structure identification, and advances in regulations are providing healthcare research organizations with access to Real World data to accelerate clinical trial processes.
This process includes several steps, which are summarized here: 1. Defining a study protocol answering relevant clinical questions. 2. Defining which data elements can be collected from which Real-World Data sources. 3. Establishing data capture arrangements and protocols with existing Real-World Data sources. 4. Blending disparate data sources through probabilistic record matching algorithms. 5.
This process includes several steps, which are summarized here: 1. Defining a study protocol answering relevant clinical questions. 7 2. Defining which data elements can be collected from which Real World Data sources. 3. Establishing data capture arrangements and protocols with existing Real World Data sources. 4. Blending disparate data sources through probabilistic record matching algorithms. 5.
The market growth is driven by rising demand for enhanced Real-World Evidence (RWE) capabilities within the life science industry, reflecting an increasing market shift from volume to value-based care. Advancements in data analytics and real-world evidence (RWE) contribute to supporting regulatory compliance, research, and solution development efforts in medical device and life sciences organizations.
The market growth is driven by rising demand for enhanced Real World Evidence capabilities within the life science industry, reflecting an increasing market shift from volume to value-based care. Advancements in data analytics and Real World Evidence contribute to supporting regulatory compliance, research, and solution development efforts in medical device and life sciences organizations.
A primary rationale for the FDA to use Real World Evidence E is to help support the approval of a new or extended use for a drug approved under the FD&C Act and to help support or satisfy post-approval study requirements always with the condition that the data quality is up to the standard required.
A primary rationale for the FDA to use Real World Evidence is to help support the approval of a new or extended use for a drug approved under the FD&C Act and to help support or satisfy post-approval study requirements always with the condition that the data quality is up to the standard required.
Data Privacy Certain of our operations are subject to regulation under the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA). Federal regulations related to HIPAA contain minimum standards for electronic transactions and code sets and for the privacy and security of protected health information.
Data Privacy Certain of our operations are subject to regulation under the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”). Federal regulations related to HIPAA contain minimum standards for electronic transactions and code sets and for the privacy and security of protected health information.
AI-enabled systems can help to improve patient cohort composition and aid with patient recruitment. AI technologies can help biopharma companies identify target locations, qualified investigators, and priority candidates and collect and collate evidence to satisfy regulators that the trial process complies with good clinical practice (“GMP”) requirements.
AI-enabled systems can help to improve patient cohort composition and aid with patient recruitment. AI technologies can help biopharma companies identify target locations, qualified investigators, and priority candidates and collect and collate evidence to satisfy regulators that the trial process complies with good clinical practice requirements.
Professor Alexander Wong, University of Waterloo Canada Research Chair in AI and Medical Imaging, points out that AI benefits include the potential to ease the burden on radiology departments in terms of assessing scans and predicting upcoming demand for general hospital and intensive care beds, and demand for equipment such as respirators and ventilators, medicines, masks, and ventilator mouthpieces, as well as aiding workforce planning. 5 Across a diverse set of imaging modalities, digital images typically include metadata and/or annotations that may include protected health information ( e.g., patient name, date of birth).
Professor Alexander Wong, University of Waterloo Canada Research Chair in AI and Medical Imaging, points out that AI benefits include the potential to ease the burden on radiology departments in terms of assessing scans and predicting upcoming demand for general hospital and intensive care beds, and demand for equipment such as respirators and ventilators, medicines, masks, and ventilator mouthpieces, as well as aiding workforce planning. 6 Across a diverse set of imaging modalities, digital images typically include metadata and/or annotations that may include protected health information ( e.g., patient name, date of birth).
Indeed, the FDA is soon expected to conduct its first full post-market safety approval using only Real World Evidence. Real World Evidence is now accepted as a reliable source of information for regulatory decision making in certain circumstances.
Indeed, the FDA is soon expected to conduct its first full post-market safety approval using only Real World Evidence. 8 Real World Evidence is now accepted as a reliable source of information for regulatory decision making in certain circumstances.
Support from regulatory bodies for using Real World Evidence solutions and an increase in research and development spending are anticipated to boost the market growth. The RWE solution providers are increasingly forming strategic partnerships with AI solution providers to offer integrated solutions.
Support from regulatory bodies for using Real World Evidence solutions and an increase in research and development spending are anticipated to boost the market growth. The Real World Evidence solution providers are increasingly forming strategic partnerships with AI solution providers to offer integrated solutions.
Meanwhile, a 2018 study from the Tufts Center noted that the timeline for new drug development ranged from 12.8 years for the average drug to 17.2 years for ultra-orphan drugs that only affect several hundred patients.
Meanwhile, a 2018 study from the Tufts Center for the Study of Drug Development noted that the timeline for new drug development ranged from 12.8 years for the average drug to 17.2 years for ultra-orphan drugs that only affect several hundred patients.
Today, life science companies, including pharmaceutical companies, artificial intelligence (AI) developers, medical device businesses, and clinical research organizations share the same widespread challenge in obtaining insight-rich, high-quality patient data that explicitly matches their precise cohort specifications. A substantial portion of patient diagnosis involves clinical imaging and approximately 90% of healthcare data, by size, is associated with imaging.
Today, life science companies, including pharmaceutical companies, artificial intelligence (“AI”) developers, medical device businesses, and clinical research organizations, share the same widespread challenge in obtaining insight-rich, high-quality patient data that explicitly matches their precise cohort specifications. A substantial portion of patient diagnosis involves clinical imaging, and approximately 90% of healthcare data, by size, is associated with imaging.
Doing so requires specialized expertise in AI/ML technology, data privacy/security, as well as expertise in clinical patient condition(s) and healthcare record keeping. Having, or achieving, expertise in all essential disciplines is a challenging achievement. OneMedNet had a significant head start with our clinical image exchange solution which served to launch the Company nearly a decade ago.
Doing so requires specialized expertise in AI/ML technology, data privacy/security, as well as expertise in clinical patient condition(s) and healthcare record keeping. Having, or achieving, expertise in all essential disciplines is a challenging achievement. OneMedNet had a significant head start with our clinical image exchange solution which served to launch the Company over a decade ago.
This presents a unique opportunity for NLP to perform the sophisticated analysis necessary to combine genomic data with electronic medical records (“EMRs”) and other patient data, present in various locations, owners, and formats — from handwritten paper copies to digital medical images — to surface biomarkers that lead to endpoints that can be more efficiently measured, and thereby identify and characterize appropriate patient subpopulations.
This presents a unique opportunity for NLP to perform the sophisticated analysis necessary to combine genomic data with electronic medical records (“EMR”) and other patient data, present in various locations, owners, and formats - from handwritten paper copies to digital medical images - to surface biomarkers that lead to endpoints that can be more efficiently measured, and thereby identify and characterize appropriate patient subpopulations.
These provisions include, but are not limited to: ● being permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus; ● not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”); ● reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and ● exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
These provisions include, but are not limited to: ● being permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure; ● not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”); ● reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and 16 ● exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
For instance, in April 2023, ConcertAI, a player in AI SaaS technology and RWE solutions for healthcare and life sciences, partnered with PathAI, an AI-powered pathology provider, to introduce a first-in-class quantitative histopathology and curated clinical Real-World Data solution. This collaboration integrates ConcertAI’s Patient360 and RWD360 products with PathAI’s PathExplore tumor microenvironment panel.
For instance, in April 2023, ConcertAI, a player in AI SaaS technology and Real World Evidence solutions for healthcare and life sciences, partnered with PathAI, an AI-powered pathology provider, to introduce a first-in-class quantitative histopathology and curated clinical Real World Data solution. This collaboration integrates ConcertAI’s Patient360 and RWD360 products with PathAI’s PathExplore tumor microenvironment panel.
As reliance on healthcare data grows exponentially, OneMedNet has observed that the reliance on information has increased coming from multiple additional sources including EHRs, claims, registries, clinical trials, patient and provider surveys, wearable devices and more. These additional sources include the internet of things (“IoT”), social media forums and blogs.
As reliance on healthcare data grows exponentially, OneMedNet has observed that the reliance on information has increased coming from multiple additional sources including EHR, claims, registries, clinical trials, patient and provider surveys, wearable devices and more. These additional sources include the internet of things (“IoT”), social media forums and blogs.
Second, Real-World Evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of Real-World Data. Real World Evidence provides clinically-rich insights into what actually happens in everyday practice and why.
Second, Real World Evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of Real World Data. Real World Evidence provides clinically-rich insights into what actually happens in everyday practice and why. The U.S.
Moreover, Life Sciences improve their product development and validation processes, which benefits all parties. Significant documentation exists that shows that Real-World Data can provide expanded insights across broader and more representative patient populations. For this reason, the Food and Drug Administration (“FDA”) has instituted Real-World Data guidelines for regulatory approvals.
Moreover, life sciences improve life science companies’ product development and validation processes, which benefits all parties. Significant documentation exists that shows that Real World Data can provide expanded insights across broader and more representative patient populations. For this reason, the Food and Drug Administration (“FDA”) has instituted Real World Data guidelines for regulatory approvals.
FDA’s press release announcing the approval noted that the approval was “significant because it reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data, when compared to a suitable control, can be considered adequate and well-controlled under FDA regulations.” An additional recent approval of note was the December 2021 approval of the supplemental BLA for Orencia to prevent graft versus host disease.
FDA’s press release announcing the approval noted that the approval was “significant because it reflects how a well-designed, non-interventional study relying on fit-for-purpose Real World data, when compared to a suitable control, can be considered adequate and well-controlled under FDA regulations.” 5 An additional recent approval of note was the FDA’s December 2021 approval of the supplemental BLA (Biological License Application) for Orencia® to prevent graft versus host disease.
All data remains “native” within the federated OneMedNet iRWD TM provider network – meaning all the data remains locally onsite until specific de-identified data is licensed for a particular Life Science research opportunity. OneMedNet’s Competitive Advantages We believe that OneMedNet iRWD TM offers the best of advanced technology, clinical expert curation, and service.
All data remains “native” within the federated OneMedNet iRWDTM provider network - meaning all the data remains locally onsite until specific de-identified data is licensed for a particular life science research opportunity. OneMedNet’s Competitive Advantages We believe that OneMedNet iRWDTM offers the best of advanced technology, clinical expert curation, and service.
This further facilities the inclusion of new therapies in the coverage of healthcare, which in turn creates major opportunities in the global market. ● Innovate Our Commercial Approach to Drive Incremental Market Share: We intend to rapidly expand our sales network across the globe, while simultaneously building out our sales infrastructure.
This further facilitates the inclusion of new therapies in the coverage of healthcare, which in turn creates major opportunities in the global market. ● Innovate Our Commercial Approach to Drive Incremental Market Share: We intend to expand our sales network across the globe, while simultaneously building out our sales infrastructure.
From Real-World Data to Real World Evidence The creation of Real World Evidence requires a combination of high-powered analytics, a validated approach and a robust knowledge of available Real-World Data sources ( e.g., what data is captured within existing quality registries, what data can be captured through electronic health records and case report forms or claims, which patient organizations capture data on relevant patient cohorts).
From Real World Data to Real World Evidence The creation of Real World Evidence requires a combination of high-powered analytics, a validated approach and a robust knowledge of available Real World Data sources ( e.g., what data is captured within existing quality registries, what data can be captured through EHR and case report forms or claims, and which patient organizations capture data on relevant patient cohorts).
OneMedNet maintains a rigorous and ongoing internal quality management system to enable the organization to produce the highest quality regulatory compliant clinical data for our clients and consumers.
OneMedNet maintains a rigorous and ongoing internal quality management system to enable the organization to produce high quality regulatory compliant clinical data for our clients and consumers.
Item 1. Business Company Overview OneMedNet is a global provider of clinical imaging innovation and curator of regulatory-grade Imaging Real-World Data or iRWD TM . OneMedNet’s innovative solutions connect healthcare providers and patients satisfying a crucial need within the Life Sciences field offering direct access to clinical images and the associated contextual patient record.
Item 1. Business Company Overview OneMedNet is a global provider of clinical imaging innovation and curator of regulatory-grade Imaging Real World Data (“iRWDTM”). OneMedNet’s innovative solutions connect healthcare providers and patients satisfying a crucial need within the life sciences field offering direct access to clinical images and the associated contextual patient record.
We employ a wide variety of methods to manage privacy requirements, including: ● governance, frameworks, models and training to promote good decision making and accountability; ● a layered approach to privacy and security management to avoid a single point of failure; ● ongoing evaluation of privacy and security practices to promote continuous improvement; ● use of technical, administrative, physical and organizational safeguards and controls; ● collaboration with data suppliers and trusted third parties for our syndicated market research and analytics offerings to remove identifiable information or employ effective encryption or other techniques to render information non-identified before data is delivered to us; and ● work with leading researchers, policy makers, thought leaders and others in a variety of fields relevant to the application of effective privacy and security practices, including statistical, epidemiological and cryptographic sciences, legal, information security and compliance, and privacy. 13 We have relied on expertise in the industry with de-identifying data.
We employ a wide variety of methods to manage privacy requirements, including: ● governance, frameworks, models and training to promote good decision making and accountability; ● a layered approach to privacy and security management to avoid a single point of failure; ● ongoing evaluation of privacy and security practices to promote continuous improvement; ● use of technical, administrative, physical and organizational safeguards and controls; ● collaboration with data suppliers and trusted third parties for our syndicated market research and analytics offerings to remove identifiable information or employ effective encryption or other techniques to render information non-identified before data is delivered to us; and ● work with leading researchers, policy makers, thought leaders and others in a variety of fields relevant to the application of effective privacy and security practices, including statistical, epidemiological and cryptographic sciences, legal, information security and compliance, and privacy.
We take pride in this ambitious achievement – while continually working to maintain state-of-the-art expertise. OneMedNet strictly adheres to the highest level of professional and ethical standards and applicable regulations throughout all interactions and activities. We believe there is a reason OneMedNet is the leader in an uncrowded field of regulatory-grade imaging RWD curators.
We take pride in this ambitious achievement - while continually working to maintain state-of-the-art expertise. OneMedNet strictly adheres to the highest level of professional and ethical standards and applicable regulations throughout all interactions and activities. We believe OneMedNet is a leader in the field of regulatory-grade imaging RWD curators.
First and foremost, OneMedNet’s iRWD TM offering plays a significant role in enabling Life Science companies to bring safer and more effective patient care to market sooner. Using our highly curated de-identified clinical data in our iRWD TM offering in Life Science product development, validation, and regulatory approval processes, they contribute to patient care advancements in more meaningful ways.
First and foremost, OneMedNet’s iRWDTM offering plays a significant role in enabling life science companies to bring safer and more effective patient care to market sooner. Using our highly curated de-identified clinical data in our iRWDTM offering in life science product development, validation, and regulatory approval processes, life science companies contribute to patient care advancements in more meaningful ways.
This program includes: ● Ongoing internal audits, policy reviews, and procedure testing to ensure validation, audit trails, legacy systems, and record handling and retention adhere to the latest regulatory guidelines and best practices. ● Regular third-party or client initiated external audits to assess the compliance of OneMedNet to ensure operations are in accordance with, but not limited to the applicable regulations, standards, policies, and standard operation procedures.
This program includes: ● Ongoing internal audits, policy reviews, and procedure testing to ensure validation, audit trails, legacy systems, and record handling and retention adhere to the latest regulatory guidelines and best practices; and ● Regular third-party or client-initiated external audits to assess the compliance of OneMedNet to ensure operations are in accordance with the applicable regulations, standards, policies, and standard operating procedures.
When data and in particular imaging data is submitted to the FDA the agency requires the following: ● Guard against biased — evidence must align with the patient population being study — expectations focus on the similar patient demographics, comorbidities, disease severity, etc.; ● Traceability — confirm the chain of custody, the source of the data is known and can be validated if required; and ● Go forward basis — regulatory agencies seek evidence that aligns with the trials timeframe and when possible collect evidence that mirrors the clinical trials timeline.
When data and, in particular, imaging data is submitted to the FDA, the agency requires the following: ● Guard against bias - evidence must align with the patient population being studied - expectations focus on the similar patient demographics, comorbidities, disease severity, etc.; ● Traceability - confirm the chain of custody, the source of the data is known and can be validated if required; and ● Go-forward basis - regulatory agencies seek evidence that aligns with the trial’s timeframe and, when possible, collect evidence that mirrors the clinical trial’s timeline.
The availability of medical imaging in Real-World Data such as that provided by OneMedNet is facilitated by the development of digital image analysis to increase the accuracy of diagnostics and conduct passive screening on large databases of medical images using artificial-intelligence (“AI”) algorithms such as those applied by OneMedNet.
The availability of medical imaging in Real World Data such as that provided by OneMedNet is facilitated by the development of digital image analysis to increase the accuracy of diagnostics and conduct passive screening on large databases of medical images using AI algorithms such as those applied by OneMedNet.
We were able to leverage internal technological competencies along with OneMedNet’s formidable healthcare provider installed base from its first product with BEAM TM to become the first RWD solution for Life Science companies with its launch of iRWD TM in 2019. OneMedNet provides innovative solutions that unlock the significant value contained within clinical image archives.
We were able to leverage internal technological competencies along with OneMedNet’s formidable healthcare provider installed base from its first product with BEAMTM to become the first RWD solution for life science companies with its launch of iRWDTM in 2019. OneMedNet provides innovative solutions that unlock the significant value contained within clinical image archives.
Algorithms can also help identify additional diagnostic tests of value from medical images with pathology. Real-World Evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real-World Data, as defined by the Food and Drug Administration.
Algorithms can also help identify additional diagnostic tests of value from medical images with pathology. Real World Evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real World Data, as defined by the FDA.
Often this insight is used to better understand a patient’s journey or a natural history of a disorder (how does a disease progress if left untreated.) 4 Real World Evidence in contrast builds upon many of these data sets and prepares them for submission, as part of regulatory review such as to the Food and Drug Administration or the European Medicines Agency, for example, in support of a customer’s clinical trial application.
Often this insight is used to better understand a patient’s journey or a natural history of a disorder (how does a disease progress if left untreated.) Real World Evidence in contrast builds upon many of these data sets and prepares them for submission, as part of regulatory review such as to the FDA or the European Medicines Agency (“EMA”), for example, in support of a customer’s clinical trial application.
With a growing federated network of 95+ healthcare facilities, OneMedNet has the immediate ability to quickly search and extensively curate multi-layer data from a Federated group of healthcare facilities. The term “healthcare facilities” refers specifically to the hospitals, integrated delivery networks (“IDNs”) and imaging centers that provide imaging to OneMedNet, which represent the core source of our data.
With a growing network of 1,400 healthcare sites, OneMedNet has the immediate ability to quickly search and extensively curate multi-layer data from a federated group of healthcare facilities. The term “healthcare sites” refers specifically to the hospitals, integrated delivery networks (“IDNs”) and imaging centers that provide imaging to OneMedNet, which represent the core source of our data.
Historically, much of imaging value has been derived from its initial review and further gains from the image archives have been very limited. 1 We help providers to “Unlock the Value in Imaging Archives”. TM By utilizing OneMedNet’s iRWD TM offering, providers can greatly improve their research efforts with streamlined data access.
Historically, much of imaging value has been derived from its initial review, and further gains from the image archives have been very limited. We help providers to “Unlock the Value in Imaging Archives.”TM By utilizing OneMedNet’s iRWDTM offering, providers can greatly improve their research efforts with streamlined data access.
There are many different types, sources and uses of Real-World Data, for example: ● Clinical Data — For example, clinical data from EHRs and case report forms (“eCRF”) including biopsies and other Pathology tests, diagnostic imaging, social determinants of health, cancer organoids, that provide patient demographics, family history, comorbidities, procedure and treatment history, and outcomes. ● Patient Generated Data — For example, patient-generated data from patient-reported outcome surveys, which data provide insights directly from the patient, and they help researchers understand what happens outside of clinic visits, procedures, and hospital stays. ● Cost and Utilization Data (Qualitative Studies) — For example, cost and utilization data from claims and public datasets, which data provides information regarding healthcare services utilization, population coverage, and prescribing patterns. ● Public Health Data — For example, public health data from various government data sources.
There are many different types, sources and uses of Real World Data, for example: ● Clinical Data - For example, clinical data from EHR and case report forms (“eCRF”) including biopsies and other pathology tests, diagnostic imaging, social determinants of health, cancer organoids, which provide patient demographics, family history, comorbidities, procedure and treatment history, and outcomes. 4 ● Patient Generated Data - For example, patient-generated data from patient-reported outcome surveys, which data provide insights directly from the patient and help researchers understand what happens outside of clinic visits, procedures, and hospital stays. ● Cost and Utilization Data (Qualitative Studies) - For example, cost and utilization data from claims and public datasets, which data provides information regarding healthcare services utilization, population coverage, and prescribing patterns. ● Public Health Data - For example, public health data from various government data sources, which add critical information to enable stakeholders to best serve the needs of the populations they serve.
The FD&C Act defines Real-World Evidence as “ data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials. ” In developing its Real-World Evidence program, FDA believes it is helpful to distinguish between the sources of Real-World Data and the evidence derived from that data.
Federal Food, Drug, and Cosmetic Act of 1938 (“FD&C Act”) defines Real World Evidence as “ data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials. ” In developing its Real World Evidence program, the FDA believes it is helpful to distinguish between the sources of Real World Data and the evidence derived from that data.
OneMedNet continued to innovate by responding to the demand for and utilization of Real-World Data and Real-World Evidence, specifically data that focused on clinical images with its associated contextual clinical record.
OneMedNet continued to innovate by responding to the demand for and utilization of Real World Data (as defined below) (“RWD”) and Real World Evidence (“RWE”), specifically data that focused on clinical images with its associated contextual clinical record.
For example, late last year, the FDA published proposed guidance related to data standards for product submissions with Real-World Data and also weighed in on the use of Real-World Data and Real World Evidence to support regulatory decision-making for drugs and biological products with specific advice for data from electronic health records and medical claims.
For example, in late 2022, the FDA published proposed guidance related to data standards for product submissions with Real World Data and also weighed in on the use of Real World Data and Real World Evidence to support regulatory decision-making for drugs and biological products with specific advice for data from EHR and medical claims.
Real-World Evidence can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective). The difference in Real World Evidence and Real World Data focuses on the end use case.
Real World Evidence can be generated by different study designs or analyses, including but not limited to randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective). The difference in Real World Evidence and Real World Data focuses on the end use case. Real World Data can take the form of claims, EHR, labs, data etc.
The OneMedNet Difference OneMedNet has been a leader in the business of extracting, securing, and transferring medical data for 12+ years.
The OneMedNet Difference We believe OneMedNet has been a leader in the business of extracting, securing, and transferring medical data for 10+ years.
One area where Real World Evidence has been relief on heavily relates to oncology approvals. Food and Drug Administration’s Oncology Center of Excellence actually presented an analysis of this at American Society of Clinical Oncology in 2021, looking at oncology applications containing Real-World Data and Real-World Evidence.
One area where Real World Evidence has been relied on heavily relates to oncology approvals. The FDA’s Oncology Center of Excellence presented an analysis of this at the American Society of Clinical Oncology in 2021, looking at oncology applications containing Real World Data and Real World Evidence.
At the same time, life sciences companies are facing tumultuous times. Industry globalization, the end of the blockbuster era, and an increasingly complex regulatory environment all add to the difficulty of bringing products to market. And across the board, companies are moving toward a patient-centric and outcome-focused model.
Industry globalization, the end of the blockbuster era, and an increasingly complex regulatory environment all add to the difficulty of bringing products to market. And across the board, companies are moving toward a patient-centric and outcome-focused model.
As a result, the demand for real world data solutions is increasing rapidly, which is further driving growth of the market. Regulatory agencies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are making use of real-world evidence in regulatory decision making processes.
As a result, the demand for Real World Data solutions is increasing rapidly, which is further driving the growth of the market. Regulatory agencies such as EMA and the FDA are making use of Real World Evidence in regulatory decision making processes.
Moreover, OneMedNet has the unique combination of knowledge, tools, and experience to: ● Access and harmonize complete patient profiles across fragmented data silos; ● Provide unmatched data accuracy and completeness; ● Ensure the security and privacy of patients’ Protected Health Information (PHI)Imaging RWD is our singular passion and focus and no one does it better.
Moreover, OneMedNet has the unique combination of knowledge, tools, and experience to: ● Access and harmonize complete patient profiles across fragmented data silos; ● Provide unmatched data accuracy and completeness; ● Ensure the security and privacy of patients’ PHI; ● Imaging RWD is our singular passion and focus and no one does it better. 3 Finally, OneMedNet has a team of highly experienced and clinically trained data curators.
Definitions of Real-World Data and Real-World Evidence Real-World Data has become a powerful tool in the life sciences industry. After decades of relying on clinical data as the gold standard for decision making, industry leaders now recognize how data collected in the real world adds valuable context and insight to their efforts.
After decades of relying on clinical data as the gold standard for decision making, industry leaders now recognize how data collected in the real world adds valuable context and insight to their efforts.
Real-world data is any data that is collected in the context of the routine delivery of care, in contrast to data collected within a clinical trial where study design controls variability in ways that are not representative of real-world care and outcomes.
The federated network allows OneMedNet to access the following data to provide to research as RWD. Real World Data is any data that is collected in the context of the routine delivery of care, in contrast to data collected within a clinical trial where study design controls variability in ways that are not representative of Real World care and outcomes.
We were originally incorporated in Delaware on February 8, 2021 under the name “Data Knights Acquisition Corp” as a special purpose acquisition company, formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. On May 11, 2021, we consummated an initial public offering.
Corporate Information Data Knights was originally incorporated in Delaware on February 8, 2021 under the name “Data Knights Acquisition Corp” as a special purpose acquisition company, formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses.
Doing so requires specialized expertise in: ● Compliancy (HIPAA, GDPR, 21 Part11) ● Advanced privacy & security measures ● Clinical patient condition(s) and hospital processes ● Radiology interpretation ● AI/ML technology Attaining in-house expertise in all essential elements is quite a challenge and deters many organizations from even attempting such a venture.
Doing so requires specialized expertise in: ● Compliance (HIPAA (as defined below), GDPR, 21 CFR Part11) ● Advanced privacy & security measures ● Clinical patient condition(s) and hospital processes ● Radiology interpretation ● AI/ML (Artificial Intelligence and Machine Learning) technology Attaining in-house expertise in all essential elements is a challenge and we believe deters many organizations from attempting such a venture.
This can help clinicians, researchers, and industry partners better understand their products and how they work. 7 Once a product is approved and marketed, Real-World Evidence assists pharmaceutical or medical device company understand their products’ relative safety, effectiveness, value, off-label use and more. This post-market surveillance, or post-marketing surveillance, is valuable to stakeholders across the healthcare industry.
This can help clinicians, researchers, and industry partners better understand their products and how they work. Once a product is approved and marketed, Real World Evidence assists pharmaceutical or medical device companies understand their products’ relative safety, effectiveness, value, off-label use and more.
With the growing need for evidence generated from Real-World Data, the increasing importance of epidemiological data in decision making, and a shift from volume to value-based care, there has been an increased focus on patient registries, a rise in the adoption of EMR in hospitals, and exponential growth in mobile health data and social media which have resulted in the generation of huge amounts of medical data.
The large share of this segment is primarily attributed to the increasing importance of Real World Evidence studies in drug development and approvals and the growing need to avoid costly drug recalls and assess drug performance in Real World settings. 11 With the growing need for evidence generated from Real World Data, the increasing importance of epidemiological data in decision making, and a shift from volume to value-based care, there has been an increased focus on patient registries, a rise in the adoption of EMR in hospitals, and exponential growth in mobile health data and social media, which have resulted in the generation of huge amounts of medical data.
Real World Evidence fill those gaps and documents the truth by establishing definitively what really happens when doctors treat a wide range of patients that do not look like the homogeneous patient groups in a clinical trial.
Real World Evidence fills those gaps and documents the truth by establishing definitively what really happens when doctors treat a wide range of patients that do not look like the homogeneous patient groups in a clinical trial. Because of this, Real World Evidence serves many uses and provides many benefits across the healthcare ecosystem.
Real-World Data is observational data typically gathered when an approved medical product is on the market and used by “real” patients in real life, as opposed to clinical trials or real world images for real patients.
Real World Data is observational data typically gathered when an approved medical product is on the market and used by “real” patients in real life, as opposed to clinical trials or real world images for real patients. The FDA cites several potential sources of Real World Data, including EHR, claims, and disease and product registries.
Outside of the oncology context, probably the most notable recent example of an approval relying on Real World Evidence is the July 2021 approval of a new indication for Astellas’ drug Program (or tacrolimus) for the prevention of organ rejection in lung transplant patients. The approval there was based on a non-interventional study providing Real-World Evidence of effectiveness.
Outside of the oncology context, probably the most notable recent example of an approval relying on Real World Evidence is the FDA’s July 2021 approval of a new indication for Astella Pharma Inc.’s’ drug program (or tacrolimus) for the prevention of organ rejection in lung transplant patients.
We operate in more than 100 countries around the world, many of which have data protection and privacy laws and regulations based on similar core principles ( e.g., openness, accountability, security safeguards, etc.). We apply those principles globally and augment our practices to address local laws, contractual obligations and other data privacy requirements.
We operate in more than 100 countries around the world, many of which have data protection and privacy laws and regulations based on similar core principles ( e.g., openness, accountability, security safeguards, etc.).
In addition, our Compliance team liaises with our Legal, IT, Information Security and other teams so that privacy requirements are addressed in technology, contracting, offerings and other business activities. The OneMedNet Privacy Policy (the “Privacy Policy”) is our foundational privacy policy.
The Compliance team provides subject matter expertise related to the proper management of all data types. In addition, our Compliance team liaises with our Legal, Information Technology, Information Security and other teams so that privacy requirements are addressed in technology, contracting, offerings and other business activities. The OneMedNet Privacy Policy (the “Privacy Policy”) is our foundational privacy policy.
The FDA cites several potential sources of Real-World Data, including electronic health records (“EHRs”), claims, disease and product registries, there are multiple types of data including structured and unstructured data, clinical and billing data, transactional and claims data, patient-generated data, and data gathered from additional sources that can shed light on a patient’s health status and more.
There are multiple types of data including structured and unstructured data, clinical and billing data, transactional and claims data, patient-generated data, and data gathered from additional sources that can shed light on a patient’s health status and more.
Our information management services relate to the processing of information regarding patient diagnosis and treatment of disease and are, therefore, subject to substantial governmental regulation. In addition, the confidentiality of patient-specific information and the circumstances under which such patient-specific records may be released for inclusion in our databases or used in other aspects of our business is heavily regulated.
In addition, the confidentiality of patient-specific information and the circumstances under which such patient-specific records may be released for inclusion in our databases or used in other aspects of our business is heavily regulated.
The human mind can possibly manage 4-5 variables, therefore, AI-enabled data mapping and integration and their normalization into a common data model according to disease pathway and workflow will likely be useful for both quality management in clinical trials and generating meaningful insight for human disease by providing a broader perspective based on real-world data. 8 Market Size The global real world evidence solutions market size was estimated at USD 2.6 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 8.4% from 2024 to 2030.
The human mind can possibly manage 4-5 variables; therefore, AI-enabled data mapping and integration and their normalization into a common data model according to disease pathway and workflow will likely be useful for both quality management in clinical trials and generating meaningful insight for human disease by providing a broader perspective based on Real World data.
In addition to salaries, these programs (which vary by location) include a 2024 Stock Option Plan, a 401(k) Plan, health care and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, family care resources, flexible work schedules, employee assistance programs, tuition and student loan assistance and on-site services, such as cafeterias and fitness centers, among many others.
In addition to salaries, these programs (which vary by location of the employee) include a 2022 Stock Option Plan, health care and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, family care resources, and employee assistance programs, among many others.
Real World Evidence can be generated by different study designs or analysis, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).
Real World Evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real World Data. Real World Evidence can be generated by different study designs or analysis, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).
The AI-enabled patient enrichment and recruitment process can improve suitable cohorts and increase clinical trial effectiveness, data management, analysis, and interpretation of multiple Real-World Data sources, including EHRs and medical imaging data.
This post-market surveillance, or post-marketing surveillance, is valuable to stakeholders across the healthcare industry. 9 The AI-enabled patient enrichment and recruitment process can improve suitable cohorts and increase clinical trial effectiveness, data management, analysis, and interpretation of multiple Real World Data sources, including EHR and medical imaging data.
According to Coherent Market Insights, the global Real-World Data market is estimated to be valued at $1.59 billion in 2023 and is expected to exhibit a CAGR of 14.4% during the forecast period (2023-2030). 9 Our Long-Term Growth Strategies Our long-term growth strategy is anchored on the following key pillars: ● Increase Global Reach to Meet Demand: Our strategy is to continue growing our global footprint into areas where we expect high demand growth in t he global real world evidence solutions market, which is projected to grow from $16.13 billion in 2023 to $36.24 billion by 2030, at a CAGR of 12.3%.
Our Long-Term Growth Strategies Our long-term growth strategy is anchored on the following key pillars: ● Increase Global Reach to Meet Demand: Our strategy is to continue growing our global footprint into areas where we expect high demand growth in t he global Real World Evidence solutions market, which is projected to grow from $2.62 billion in 2024 to $4.55 billion by 2030, at a CAGR of 8.2%.
Real-World Data has the potential to break down inefficiencies and fill gaps in information silos among stakeholders throughout the healthcare ecosystem of providers, payers, manufacturers, government entities and patients.
Real World Data has the potential to break down inefficiencies and fill gaps in information silos among stakeholders throughout the healthcare ecosystem of providers, payers, manufacturers, government entities and patients. This information sharing, in turn, enables all parties to derive new insights, support value-based care and deliver better health outcomes.
Our capabilities allow us to render data non-identified while still maintaining data utility, thus protecting privacy while still advancing innovation.
We have relied on expertise in the industry with de-identifying data. Our capabilities allow us to render data non-identified while still maintaining data utility, thus protecting privacy while still advancing innovation.
AI integrated clinical trial programs can help monitor and manage patients by automating real-world data capture, sharing data across systems, and digitalizing standard clinical assessments. AI technologies and wearable technologies can help enable continuous patient monitoring and generate real-time insights into the safety and effectiveness of treatment while predicting the possible risk of dropouts, thereby enhancing patient engagement and retention.
AI technologies and wearable technologies can help enable continuous patient monitoring and generate real-time insights into the safety and effectiveness of treatment while predicting the possible risk of dropouts, thereby enhancing patient engagement and retention.
Finally, OneMedNet has the most experienced and clinically trained data curators in the industry. This team appreciates the complexity and criticality of clinical data and can effectively communicate with both Provider and Life Science specialists.
This team appreciates the complexity and criticality of clinical data and can effectively communicate with both providers and life science specialists.
OneMedNet’s innovative technology proved the commercial and regulatory viability of imaging Real-World Data, an emerging market, and provides regulatory-grade image-centric iRWD TM that exactly matches OMN’s Life Science partners Case Selection Protocols and paves the way for Real World Evidence. OneMedNet was founded to solve a deficiency in how clinical images were shared between healthcare providers.
OneMedNet’s innovative technology proved the commercial and regulatory viability of imaging Real World Data (as defined below), an emerging market, and provides regulatory-grade image-centric iRWDTM that exactly matches OneMedNet’s life science partners case selection protocols and paves the way for Real World Evidence (as defined below).
This information sharing, in turn, enables all parties to derive new insights, support value-based care and deliver better health outcomes. 3 Commercializing a drug requires its developer to harness various sources of Real-World Data to identify patient populations and refine sales and marketing strategies for those populations among many other undertakings.
Commercializing a drug requires its developer to harness various sources of Real World Data to identify patient populations and refine sales and marketing strategies for those populations among many other undertakings.
This resulted in OMN’s initial product BEAM TM image exchange that enabled the successful sharing of images for more than a decade with OMN’s largest customer being the Country of Ireland.
OneMedNet was founded to solve a deficiency in how clinical images were shared between healthcare providers. This resulted in OMN’s initial product BEAMTM image exchange that enabled the successful sharing of images for more than a decade with OMN’s largest customer being the Republic of Ireland.
Preparing this data for analysis is both expensive and time-consuming thus many organizations would outsource the process to consultants or third-party vendors; moreover, the process of preparing this data for analysis by untrained consultants can yield a static analysis that is difficult to modify or rerun in response to follow-up questions or potential discrepancies.
Moreover, the process of preparing this data for analysis by untrained consultants can yield a static analysis that is difficult to modify or rerun in response to follow-up questions or potential discrepancies. Definitions of Real World Data and Real World Evidence Real World Data has become a powerful tool in the life sciences industry.
Because of this, Real World Evidence serves many uses and provides many benefits across the healthcare ecosystem. 6 As more countries battle to contain healthcare costs, and as the population ages and the number of patients with chronic diseases increases, the need to remove inefficiencies and upgrade the delivery of coordinated care that improves outcomes is more pressing.
As more countries battle to contain healthcare costs, and as the population ages and the number of patients with chronic diseases increases, the need to remove inefficiencies and upgrade the delivery of coordinated care that improves outcomes is more pressing. At the same time, life sciences companies are facing tumultuous times.
Real-World Evidence refers to evidence about the risks and benefits of a product derived from analysis of the Real-World Data. For example, the FDA has used Real-World Data and Real-World Evidence, derived from its Sentinel system for monitoring the safety of regulated products, in place of post-marketing studies.
For example, the FDA has used Real World Data and Real World Evidence, derived from its Sentinel System, the largest multisite distributed database in the world dedicated to medical product safety, for monitoring the safety of regulated products, in place of post-marketing studies. It has carried this out for nine potential safety issues involving five products.
Historically, this practice involved purchasing large amounts of data from data aggregators or data platforms, if not directly from the source itself, sometimes without much knowledge about the quality of the data.
Historically, this practice involved purchasing large amounts of data from data aggregators or data platforms, if not directly from the source itself, sometimes without much knowledge about the quality of the data. Preparing this data for analysis is both expensive and time-consuming; thus, many organizations would outsource the process to consultants or third-party vendors.
In addition, the FDA uses Real-World Data and Real World Evidence to monitor post-market safety and adverse events and to make regulatory decisions. The health care community is using these data to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.
In addition, the FDA uses Real World Data and Real World Evidence to monitor post-market safety and adverse events and to make regulatory decisions.
These regulatory authorities have frameworks and guidelines for using Real-World Evidence and Real-World Data in regulatory submissions, post-market surveillance, and drug approvals.
These regulatory authorities have frameworks and guidelines for using Real World Evidence and Real World Data in regulatory submissions, post-market surveillance, and drug approvals. As a result, the demand for Real World Data is rising, which in turn is expected to support growth of the market in the coming future.
Medical imaging and associated clinical data is indexed at each network site using state-of-the-art AI/ML technology. This typically includes electronic health records (“EHR”), radiology, cardiology, lab, path and more. Our in-house clinical team performs intensive curation of the data ensuring that results meet the exact specification and requirements of Life Science Data Collection Protocol (“DCP”) – regardless of the complexity.
Medical imaging and associated clinical data are indexed at each network site using state-of-the-art AI/ML technology. This typically includes electronic health records (“EHR”), radiology, cardiology, lab, pathology and more.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThe Nasdaq Notice received have no immediate effect on the Company’s continued listing on the Nasdaq Global Market or the trading of Company’s common stock, subject to the Company’s compliance with the other continued listing requirements. The Company is presently evaluating potential actions to regain compliance with all applicable requirements for continued listing on the Nasdaq Global Market.
Biggest changeThe Company is presently evaluating potential actions to regain compliance with all applicable requirements for continued listing on the Nasdaq Capital Market. There can be no assurance that the Company will be successful in maintaining the listing of its Common Stock on the Nasdaq Capital Market.
Investors seeking cash dividends should not purchase our shares. Any determination to pay dividends in the future will be made at the discretion of our board of directors and will depend on our results of operations, financial condition, contractual restrictions, restrictions imposed by applicable law and other factors our board deems relevant.
Investors seeking cash dividends should not purchase our shares. Any determination to pay dividends in the future will be made at the discretion of our Board of Directors and will depend on our results of operations, financial condition, contractual restrictions, restrictions imposed by applicable law and other factors our Board of Directors deems relevant.
To the extent we are unable to execute on our growth strategies in accordance with our expectations, this could have a material adverse effect on our business, financial condition, and future results of operations.
To the extent we are unable to execute our growth strategies in accordance with our expectations, this could have a material adverse effect on our business, financial condition, and future results of operations.
The real-world data and real-world evidence business market continues to evolve, is highly competitive, and we may not be successful in competing in this industry or establishing and maintaining confidence in our long-term business prospects among current and future partners and customers.
The Real World Data and Real World Evidence business market continues to evolve and is highly competitive, and we may not be successful in competing in this industry or establishing and maintaining confidence in our long-term business prospects among current and future partners and customers.
A decline in the market price of our securities also could adversely affect our ability to issue additional securities and our ability to obtain additional financing in the future. Following certain periods of volatility in the market price of our securities, we may become subject of securities litigation.
A decline in the market price of our securities also could adversely affect our ability to issue additional securities and our ability to obtain additional financing in the future. Following certain periods of volatility in the market price of our securities, we may become subject to securities litigation.
Our operations are subject to many hazards and operational risks inherent to our business, including: (a) general business risks; (b) warranty liability; and (c) damage to third parties (e.g., our vendors), our infrastructure or properties caused by fires, floods and other natural disasters, power losses, telecommunications failures, terrorist attacks, riots, cyberattacks, public health crises such as the current COVID-19 pandemic (and other future pandemics or epidemics), human errors and similar events.
Our operations are subject to many hazards and operational risks inherent to our business, including: (a) general business risks; (b) warranty liability; and (c) damage to third parties (e.g., our vendors), our infrastructure or properties caused by fires, floods and other natural disasters, power losses, telecommunications failures, terrorist attacks, riots, cyberattacks, public health crises such as the COVID-19 pandemic (and other future pandemics or epidemics), human errors and similar events.
Any one of these risks and uncertainties has the potential to cause material adverse effects on our business, prospects, financial condition and operating results which could cause actual results to differ materially from any forward-looking statements expressed by us and a significant decrease in the value of our Common Stock shares and warrants.
Any one of these risks and uncertainties has the potential to cause material adverse effects on our business, prospects, financial condition and operating results which could cause actual results to differ materially from any forward-looking statements expressed by us and a significant decrease in the value of our Common Stock and warrants.
The highly complex nature of our industry requires that we effectively execute and manage our business objectives and growth strategies, such as expanding our marketing and commercialization of our services in the U.S. and internationally, adding new customers, and increasing our service delivery capacity. However, we may not be able to execute on these strategies as effectively as anticipated.
The highly complex nature of our industry requires that we effectively execute and manage our business objectives and growth strategies, such as expanding our marketing and commercialization of our services in the U.S. and internationally, adding new customers, and increasing our service delivery capacity. However, we may not be able to execute these strategies as effectively as anticipated.
If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our share price may be more volatile. Anti-takeover provisions contained in our certificate of incorporation and bylaws as well as provisions of Delaware law, could impair a takeover attempt.
If some investors find our Common Stock less attractive as a result, there may be a less active trading market for our common stock and our share price may be more volatile. 25 Anti-takeover provisions contained in our certificate of incorporation and bylaws as well as provisions of Delaware law could impair a takeover attempt.
Factors affecting the trading price of our securities may include: ● announcements by us or our competitors regarding technical developments and levels of performance achieved by our or their real-world data and real-world evidence offering; ● announcements by us regarding developments in our relationship with existing and future key customers; ● our ability to bring our products and technologies to market on a timely basis, or at all; ● our operating results or development efforts failing to meet the expectation of securities analysts or investors in a particular period; ● Actual or anticipated fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to it; ● changes in the market’s expectations about our operating results or the real-world data and real-world evidence industry; ● success of competitors actual or perceived development efforts; ● changes in financial estimates and recommendations by securities analysts concerning the Company or the real-world data and real-world evidence industry in general; ● operating and share price performance of other companies that investors deem comparable to the Company; ● disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain intellectual property protection for our technologies; ● changes in laws and regulations affecting our business; ● our ability to meet compliance requirements; ● commencement of, or involvement in, litigation involving the Company; ● changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; ● the volume of shares of Common Stock available for public sale; ● the level of demand for our Common Stock, including the amount of short interest in our stock; ● any major change in our Board or management; ● sales of substantial amounts of the shares of Common Stock by our directors, executive officers or significant stockholders or the perception that such sales could occur; ● the expiration of contractual lock-up agreements with our executive officers, directors and stockholders, which we have entered into and may enter into in the future from time to time; and ● general economic and political conditions such as recessions, interest rates, fuel prices, international currency fluctuations and acts of war or terrorism. 21 Broad market and industry factors may materially harm the market price of our securities irrespective of our operating performance.
Factors affecting the trading price of our securities may include: ● announcements by us or our competitors regarding technical developments and levels of performance achieved by our or their Real World Data and Real World Evidence offering; ● announcements by us regarding developments in our relationship with existing and future key customers; ● our ability to bring our products and technologies to market on a timely basis, or at all; ● our operating results or development efforts failing to meet the expectation of securities analysts or investors in a particular period; ● Actual or anticipated fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to us; ● changes in the market’s expectations about our operating results or the Real World Data and Real World Evidence industry; ● success of competitors’ actual or perceived development efforts; ● changes in financial estimates and recommendations by securities analysts concerning the Company or the Real World Data and Real World Evidence industry in general; ● operating and share price performance of other companies that investors deem comparable to the Company; ● disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain intellectual property protection for our technologies; ● changes in laws and regulations affecting our business; ● our ability to meet compliance requirements; ● commencement of, or involvement in, litigation involving the Company; ● changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; ● the volume of shares of Common Stock available for public sale; ● the level of demand for our Common Stock, including the amount of short interest in our Common Stock; ● any major change in our Board of Directors or management; ● sales of substantial amounts of shares of our Common Stock by our directors, executive officers or significant stockholders or the perception that such sales could occur; ● the expiration of contractual lock-up agreements with our executive officers, directors and certain stockholders, which we have entered into and may enter into in the future from time to time; and ● general economic and political conditions such as recessions, interest rates, fuel prices, international currency fluctuations and acts of war or terrorism. 22 Broad market and industry factors may materially harm the market price of our securities irrespective of our operating performance.
We have the ability to redeem outstanding Warrants at any time prior to their expiration, at a price of $0.01 per Warrant, provided that the last reported sales price of Common Stock equals or exceeds $18.00 per share for any 20 trading days within a 30-trading day period ending on the third trading day prior to the date we send the notice of redemption to Warrantholders and provided certain other conditions are met.
We have the ability to redeem outstanding Warrants at any time prior to their expiration, at a price of $0.01 per Warrant, provided that the last reported sales price of Common Stock equals or exceeds $18.00 per share for any 20 trading days within a 30-trading day period ending on the third trading day prior to the date we send the notice of redemption to Warrant holders and provided certain other conditions are met.
Our operations could be adversely affected by events outside of our control, such as natural disasters, wars, health epidemics such as the ongoing COVID-19 pandemic, and other calamities .
Our operations could be adversely affected by events outside of our control, such as natural disasters, wars, health epidemics such as the COVID-19 pandemic, and other calamities .
It may also be more expensive to obtain director and officer liability insurance. Risks associated with our status as a public company may make it more difficult to attract and retain qualified persons to serve on our Board or as executive officers.
It may also be more expensive to obtain director and officer liability insurance. Risks associated with our status as a public company may make it more difficult to attract and retain qualified persons to serve on our Board of Directors or as executive officers.
Redemption of the outstanding Warrants could force Warrantholders (i) to exercise their Warrants and pay the exercise price therefor at a time when it may be disadvantageous for them to do so, (ii) to sell their Warrants at the then-current market price when they might otherwise wish to hold their Warrants or (iii) to accept the nominal redemption price which, at the time the outstanding Warrants are called for redemption, we expect would be substantially less than the market value of their Warrants.
Redemption of the outstanding Warrants could force Warrant holders (i) to exercise their Warrants and pay the exercise price therefor at a time when it may be disadvantageous for them to do so, (ii) to sell their Warrants at the then-current market price when they might otherwise wish to hold their Warrants or (iii) to accept the nominal redemption price which, at the time the outstanding Warrants are called for redemption, we expect would be substantially less than the market value of their Warrants.
Although our Common Stock is currently listed on The Nasdaq Global Market, we may not be able to continue to meet the exchange’s minimum listing requirements or those of any other national exchange.
Although our Common Stock is currently listed on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s minimum listing requirements or those of any other national exchange.
OneMedNet has the immediate ability to quickly search and extensively curate multi-layer data from a federated group of healthcare facilities and to provide fast access to curated medical images that has proved the commercial and regulatory viability of imaging RWD and covers the complete value chain in imaging RWD, validated by an increasing federated network of providers.
OneMedNet has the immediate ability to quickly search and extensively curate multi-layer data from a federated group of healthcare facilities and to provide fast access to curated medical images that has proved the commercial and regulatory viability of imaging Real World Data and covers the complete value chain in imaging Real World Data, validated by an increasing federated network of providers.
Furthermore, if any issues in complying with those requirements are identified (for example, if the auditors identify a material weakness or significant deficiency in the internal control over financial reporting), we could incur additional costs rectifying those issues, and the existence of those issues could adversely affect our reputation or investor perceptions of it.
Furthermore, if any issues in complying with those requirements are identified (the auditors identified a material weakness and significant deficiency in our internal control over financial reporting), we could incur additional costs rectifying those issues, and the existence of those issues could adversely affect our reputation or investor perceptions of it.
For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including exemption from compliance with the auditor attestation requirements of Section 404, reduced disclosure obligations regarding executive compensation and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including, among other things, exemption from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
The trading price of our Common Stock may be subject to extreme volatility. We cannot predict the magnitude of future fluctuations in the trading price of our Common Stock.
Risks Related to Our Common Stock Our Common Stock may be subject to extreme volatility. The trading price of our Common Stock may be subject to extreme volatility. We cannot predict the magnitude of future fluctuations in the trading price of our Common Stock.
On the global front, OneMedNet works with hospitals and life science companies around the world including Ireland, United Kingdom, Ghana, Denmark and South Korea and growing. We base these claims on our understanding of our competition in the United States and globally.
On the global front, OneMedNet works with hospitals and life science companies around the world including in Ireland, United Kingdom, , The Netherlands, Denmark, Germany, Canada and South Korea and growing. We base these claims on our understanding of our competition in the United States and globally.
If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business. 16 If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the market price for the shares and trading volume could decline.
If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business. 24 If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the market price for our Common Stock and trading volume could decline.
Our ability to execute on these strategies depends on a number of factors, including, without limitation: ● our ability to obtain adequate capital resources to complete execute our growth plans; ● our ability to hire, train and retain skilled managers and personnel, including quality and production personnel, and marketing and commercial specialists; ● our ability to protect our existing and new services by registering and defending our intellectual property rights; and ● our ability to successfully add new customers.
Our ability to execute on these strategies depends on a number of factors, including, without limitation: ● our ability to obtain adequate capital resources to execute our growth plans; ● our ability to hire, train and retain skilled managers and personnel, including quality and production personnel, and marketing and commercial specialists; ● our ability to protect our existing and new services by registering and defending our intellectual property rights; and ● Our ability to successfully continue to add provider partners to the platform; and ● our ability to successfully add new customers.
OneMedNet believes it has demonstrated its quality and responsiveness in clinical imaging and curation of Real-World Data based upon success in compiling one of the largest networks of imaging centers (comprised of hospitals, imaging centers and clinics) throughout the United States covering more than 15 million patients to date.
OneMedNet believes it has demonstrated its quality and responsiveness in clinical imaging and curation of Real-World Data based upon success in compiling one of the largest networks of imaging centers (comprised of hospitals, imaging centers and clinics) throughout the United States covering more than 31 million Patient Records to date.
We are an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (“the JOBS Act”).
We are an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make our Common Stock less attractive to investors. We are an “emerging growth company,” as defined in the JOBS Act.
The real-world data and real-world evidence business market in which we compete continues to evolve and is highly competitive. To date, we have focused our efforts on its expertise in clinical imaging innovation solutions that connects healthcare providers and patients and satisfies a crucial need with the life sciences.
The Real World Data and Real World Evidence business market in which we compete continues to evolve and is highly competitive. To date, we have focused our efforts on our expertise in clinical imaging innovation solutions that connect healthcare providers and patients and satisfy a crucial need for the life sciences.
Risks Related to Our Warrants We may redeem unexpired Warrants prior to their exercise at a time that is disadvantageous to Warrantholders. Our public Warrants are currently exercisable for one share of Common Stock at a price of $11.50 per share.
Risks Related to Our Warrants We may redeem unexpired Warrants prior to their exercise at a time that is disadvantageous to Warrant holders. Our Public Warrants (as defined below) are currently exercisable for one share of Common Stock at a price of $11.50 per share.
Our corporate governance documents include provisions: ● authorizing “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend, and other rights superior to our common stock; ● limiting the liability of, and providing indemnification to, our directors and officers; ● limiting the ability of our stockholders to call and bring business before special meetings; ● requiring advance notice of stockholder proposals for business to be conducted at meetings of our stockholders and for nominations of candidates for election to our board of directors; ● controlling the procedures for the conduct and scheduling of board of directors and stockholder meetings; and ● providing our board of directors with the express power to postpone previously scheduled annual meetings and to cancel previously scheduled special meetings. 17 These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.
Our corporate governance documents include provisions: ● authorizing “blank check” preferred stock, which could be issued by our Board of Directors without stockholder approval and may contain voting, liquidation, dividend, and other rights superior to our Common Stock; ● limiting the liability of, and providing indemnification to, our directors and officers; ● limiting the ability of our stockholders to call and bring business before special meetings; ● requiring advance notice of stockholder proposals for business to be conducted at meetings of our stockholders and for nominations of candidates for election to our Board of Directors; ● controlling the procedures for the conduct and scheduling of Board of Directors and stockholder meetings; and ● providing our Board of Directors with the express power to postpone previously scheduled annual meetings and to cancel previously scheduled special meetings.
The Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), including the requirements of Section 404, as well as rules and regulations subsequently implemented by the SEC, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 and the rules and regulations promulgated and to be promulgated thereunder, the PCAOB and the securities exchanges, impose additional reporting and other obligations on public companies.
The Sarbanes-Oxley Act, including the requirements of Section 404, as well as rules and regulations subsequently implemented by the SEC, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 and the rules and regulations promulgated and to be promulgated thereunder, the Public Company Accounting Oversight Board and the securities exchanges, impose additional reporting and other obligations on public companies.
Moreover, there is a substantial risk that we may not be able to successfully commercialize our iRWD TM services, which would make it unlikely that we would ever achieving profitability.
Moreover, there is a substantial risk that we may not be able to successfully commercialize our iRWDTM services, which would make it unlikely that we would ever achieve profitability.
As of December 31, 2023, we had accumulated losses of approximately $55.1 million. We expect to continue to incur significant losses in the development, marketing, sale and delivery of our services. If we do not grow our revenues or if we lose existing customers, we expect to continue to incur losses from operations for the foreseeable future.
As of December 31, 2024, we had an accumulated deficit of approximately $101.6 million. We expect to continue to incur significant losses in the development, marketing, sale and delivery of our services. If we do not grow our revenues or if we lose existing customers, we expect to continue to incur losses from operations for the foreseeable future.
The trading price of our Common Stock may be affected by a number of factors, including events described in the risk factors set forth in this prospectus and in our periodic reports filed with the SEC from time to time, as well as our operating results, financial condition and other events or factors.
The trading price of our Common Stock may be affected by a number of factors, including events described in this section entitled, “Risk Factors” and in our other periodic reports filed with the SEC from time to time, as well as our operating results, financial condition and other events or factors.
In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has a compliance period of 180 calendar days, or until August 5, 2024, to regain compliance with the Minimum MVLS Requirement.
In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has a compliance period of 180 calendar days, or until September 8, 2025, to regain compliance with the Minimum MVLS Requirement.
For example, we do not currently maintain cybersecurity insurance and our insurance providers may take the position that our coverage, under present circumstances, does not extend to business interruptions as they relate to the COVID-19 pandemic.
For example, we do not currently maintain cybersecurity insurance and our insurance providers may take the position that our coverage, under present circumstances, does not extend to business interruptions.
Compliance may be achieved if the Company’s MVLS closes at $50,000,000 or more for a minimum of ten consecutive business days at any time during the 180-day compliance period, in which case Nasdaq will notify the Company of its compliance and the matter will be closed.
Compliance could have been achieved if the Company’s MVLS closed at $35,000,000 or more for a minimum of ten consecutive business days at any time during the 180-day compliance period, in which case Nasdaq would notify the Company of its compliance and the matter would be closed.
Our ability to utilize our net operating loss and tax credit carryforwards to offset future taxable income may be subject to certain limitations. In general, under Section 382 of the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change net operating loss carryforwards (“NOLs”), to offset future taxable income.
In general, under Section 382 of the Internal Revenue Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change net operating loss carryforwards (“NOLs”) to offset future taxable income.
Compliance with public company requirements will increase costs and make certain activities more time-consuming. A number of those requirements will require us to carry out activities we have not done previously. For example, we have created new Board committees and adopted new internal controls and disclosure controls and procedures. In addition, expenses associated with SEC reporting requirements will be incurred.
Compliance with public company requirements has increased and will continue to increase costs and make certain activities more time-consuming. A number of those requirements will require us to carry out activities we have not done previously. For example, we have created new Board of Directors committees and adopted new internal controls and disclosure controls and procedures.
Because of the numerous risks and uncertainties associated with the development, marketing, sale and delivery of our imaging real world data (“iRWD TM ”) services, we may experience larger than expected future losses and may never become profitable.
Because of the numerous risks and uncertainties associated with the development, marketing, sale and delivery of our iRWDTM services, we may experience larger than expected future losses and may never become profitable.
As we expand, market, sell and deliver our service offerings, we anticipate that we will need to increase our service development, sales and marketing and administrative headcount. Such an evolution may impact our strategic focus and our deployment and allocation of resources.
We may encounter difficulties in managing our attempted growth of our business, which could negatively impact our operations. As we expand, market, sell and deliver our service offerings, we anticipate that we will need to increase our service development, sales and marketing and administrative headcount. Such an evolution may impact our strategic focus and our deployment and allocation of resources.
We offer direct access to clinical images and associated contextual patient record. OneMedNet proved the commercial and regulatory viability of imaging Regulatory Grade Real-World Data (“iRWD TM ”), a promising emerging market, that exactly matches OneMedNet’s life science partners’ case selection protocol.
We offer direct access to clinical images and associated contextual patient records. OneMedNet proved the commercial and regulatory viability of iRWDTM, a promising emerging market, that exactly matches OneMedNet’s life science partners’ case selection protocol.
The limitations apply if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period.
An “ownership change” is generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period.
The occurrence of a significant uninsured claim or a claim in excess of the insurance coverage limits maintained by us could have a material adverse effect on our business, financial condition and results of operations. Risks Related to Being a Public Company Our management has limited experience in operating a public company.
The occurrence of a significant uninsured claim or a claim in excess of the insurance coverage limits maintained by us could have a material adverse effect on our business, financial condition and results of operations.
None of the private placement Warrants will be redeemable by us so long as they are held by the Sponsor or its permitted transferees. Item 1b. Unresolved Staff Comments None.
None of the private placement warrants will be redeemable by us so long as they are held by Data Knights, LLC, a Delaware limited liability company (the “Sponsor”), or its permitted transferees. Item 1B. Unresolved Staff Comments None.
There is also a risk that changes in law or regulatory changes made in response to the need for some jurisdictions to raise additional revenue to help counter the fiscal impact from unforeseen reasons, including suspensions on the use of net operating losses or tax credits, possibly with retroactive effect, may result in our existing net operating losses or tax credits expiring or otherwise being unavailable to offset future income tax liabilities.
The Company has not yet conducted a formal study of whether, or to what extent, past changes in control of the Company impacts its ability to utilize NOL carryforwards because such NOL carryforwards cannot be utilized until the Company achieves profitability. 20 There is also a risk that changes in law or regulatory changes made in response to the need for some jurisdictions to raise additional revenue to help counter the fiscal impact from unforeseen reasons, including suspensions on the use of net operating losses or tax credits, possibly with retroactive effect, may result in our existing net operating losses or tax credits expiring or otherwise being unavailable to offset future income tax liabilities.
As previously reported on Form 8-K on February 9, 2024, the Company received written notice (the “Nasdaq Notice”), dated February 7, 2024, from Nasdaq indicating that for the preceding 30 consecutive business days, the market value of the Company’s listed securities (“MVLS”) did not maintain a minimum market value of $50,000,000 (the “Minimum MVLS Requirement”) as required by Nasdaq Listing Rule 5450(b)(2)(A).
On March 12, 2025, the Company received written notice (the “MVLS Nasdaq Notice”) from Nasdaq indicating that for the preceding 31 consecutive business days, the market value of the Company’s listed securities (“MVLS”) did not maintain a minimum market value of $35,000,000 (the “Minimum MVLS Requirement”) as required by Nasdaq Listing Rule 5550(b)(2).
There can be no assurance that our current management team or any new members of our management team will be able to successfully execute our business and operating strategies. Our operations could be damaged or adversely affected as a result of natural disasters and other catastrophic events.
There can be no assurance that our current management team or any new members of our management team will be able to successfully execute our business and operating strategies.
Our Business Risks We have a history of operating losses and may never achieve profitability in the future . We have experienced net losses in each annual period since inception. We generated net losses of $23.2 million and $6.2 million for the years ended December 31, 2023 and 2022, respectively.
Refer to “Cautionary Statement Regarding Forward-Looking Statements.” Risks Related to Our Business We have a history of operating losses and may never achieve profitability in the future . We have experienced net losses in each annual period since inception. We generated net losses of $10.1 million and $33.8 million for the years ended December 31, 2024 and 2023, respectively.
Any of the foregoing events may give rise to interruptions, breakdowns, system failures, technology platform failures or internet failures, which could cause the loss or corruption of data or malfunctions of software or hardware as well as adversely affect our ability to provide services. 19 Any financial or economic crisis, or perceived threat of such a crisis, including a significant decrease in consumer confidence, may materially and adversely affect our business, financial condition, and results of operations.
Any of the foregoing events may give rise to interruptions, breakdowns, system failures, technology platform failures or internet failures, which could cause the loss or corruption of data or malfunctions of software or hardware as well as adversely affect our ability to provide services.
Acquisitions involve many risks, any of which could materially harm our business, including the diversion of management’s attention from core business concerns, failure to effectively exploit acquired technologies, failure to successfully integrate the acquired business or realize expected synergies or the loss of key employees from either our business or the acquired businesses. 18 We may be unable to execute our business objectives and growth strategies successfully or sustain our growth and, as a result, this could have a material adverse effect on our operating results.
Acquisitions involve many risks, any of which could materially harm our business, including the diversion of management’s attention from core business concerns, failure to effectively exploit acquired technologies, failure to successfully integrate the acquired business or realize expected synergies or the loss of key employees from either our business or the acquired businesses.
Our executive officers have limited experience in the management of a publicly traded company. Our management team may not successfully or effectively manage our transition to a public company that will be subject to significant regulatory oversight and reporting obligations under federal securities laws.
Our management team may not successfully or effectively manage the significant regulatory oversight and reporting obligations under federal securities laws to which we are now subject now that we are a public company.
It is possible that we will be required to expand our employee base and hire additional employees to support our operations as a public company which will increase our operating costs in future periods.
It is possible that we will be required to expand our employee base and hire additional employees to support our operations as a public company, which will increase our operating costs in future periods. 26 We have incurred and will continue to incur significant increased expenses and administrative burdens as a public company, which could have an adverse effect on our business, financial condition and results of operations.
These competitors also may have greater access to customers and may be able to establish cooperative or strategic relationships amongst themselves or with third parties that may further enhance their resources and competitive positioning. Developments in improvements in real-world data and real-world evidence curation by competitors may materially adversely affect the sales, pricing and gross margins of our business.
These competitors also may have greater access to customers and may be able to establish cooperative or strategic relationships amongst themselves or with third parties that may further enhance their resources and competitive positioning.
However, if we were to lose these relationships with our network of imaging centers or lose our customers or our competitors’ technology surpasses ours, our competitors could claim a greater market share domestically or abroad, which could reduce our growth and our profits, which could harm our business, financial position, results of operations and prospects.
However, if we were to lose these relationships with our network of imaging centers or lose our customers or our competitors’ technology surpasses ours, our competitors could claim a greater market share domestically or abroad, which could reduce our growth and our profits, which could harm our business, financial position, results of operations and prospects. 17 The report of our independent registered public accounting firm for the fiscal years ended December 31, 2024 and 2023 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
There can be no assurance that the Company will be successful in maintaining the listing of its common stock on the Nasdaq Global Market. The listing rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange.
The listing rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange.
The additional reporting and other obligations imposed by these rules and regulations will increase legal and financial compliance costs and the costs of related legal, accounting and administrative activities. These increased costs will require us to divert a significant amount of money that could otherwise be used to expand the business and achieve strategic objectives.
The additional reporting and other obligations imposed by these rules and regulations has increased and will continue to increase legal and financial compliance costs and the costs of related legal, accounting and administrative activities.
Item 1A. Risk Factors An investment in our securities involves a high degree of risk. This prospectus contains a discussion of the risks applicable to an investment in our securities. The risks and uncertainties we have described are not the only ones we face.
Item 1A. Risk Factors An investment in our securities involves a high degree of risk. The risks and uncertainties we have described in this Annual Report are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business, financial condition, and results of operations.
We have experienced, and may in the future experience additional litigation following periods of volatility. This type of litigation may result in substantial costs and a diversion of management’s attention and resources. Our business model is capital-intensive, and we may not be able to raise additional capital on attractive terms, if at all, which could be dilutive to stockholders.
We have experienced, and may in the future experience, additional litigation following periods of volatility. This type of litigation may result in substantial costs and a diversion of management’s attention and resources. We are currently listed on The Nasdaq Capital Market.
You should carefully consider the following risks, as well as the other information contained in this prospectus, including our historical financial statements and related notes included elsewhere in this prospectus before you decide to purchase our securities.
We may not be successful in preventing the material adverse effects that any of the following risks and uncertainties may cause. You should carefully consider the following risks, as well as the other information contained in this Annual Report, including our historical financial statements and related notes included elsewhere in this Annual Report.
We will incur significant increased expenses and administrative burdens as a public company, which could have an adverse effect on our business, financial condition and results of operations. We will face increased legal, accounting, administrative and other costs and expenses as a public company that legacy OneMedNet Corporation did not incur as a private company.
We currently face and will continue to face increased legal, accounting, administrative and other costs and expenses as a public company that Legacy ONMD did not incur as a private company.
If a competing technology or process is developed that has superior operational or price performance, our business will be harmed.
Developments in improvements in Real World Data and Real World Evidence curation by competitors may materially adversely affect the sales, pricing and gross margins of our business. If a competing technology or process is developed that has superior operational or price performance, our business will be harmed.
If the Company does not regain compliance with the Minimum MVLS Requirement by August 5, 2024, Nasdaq will provide written notification to the Company that its common stock is subject to delisting. At that time, the Company may appeal the relevant delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules.
At that time, the Company could have appealed the relevant delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules.
Removed
Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our operations. The occurrence of any of these known or unknown risks might cause you to lose all or part of your investment in the offered securities.
Added
As stated above, we have experienced net losses in each annual period since inception. We generated net losses of $10.1 million and $33.8 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of approximately $101.6 million.
Removed
We may not be successful in preventing the material adverse effects that any of the following risks and uncertainties may cause. You could lose all or a significant portion of your investment due to any of these risks and uncertainties.
Added
In their audit report for the fiscal year ended December 31, 2024 included in this report, our auditors have expressed their concern as to our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate cashflows from operations and obtain financing.
Removed
Refer to “Cautionary Statement Regarding Forward-Looking Statements.” Risks Related to this Offering and Our Common Stock Our stock price may be volatile, and purchasers of our Common Stock could incur substantial losses.
Added
We intend to continue funding our operations through equity and debt financing arrangements, which may be insufficient to fund our capital expenditures, working capital and other cash requirements in the long term. There can be no assurance that the steps management is taking will be successful.
Removed
The stock market in general has experienced significant price and volume fluctuations that have often been unrelated or disproportionate to operating performance of individual companies, particularly following a public offering of a company with a small public float. There is the potential for rapid and substantial price volatility of our Common Stock following this offering.
Added
We may be unable to execute our business objectives and growth strategies successfully or sustain our growth and, as a result, this could have a material adverse effect on our operating results.
Removed
These broad market factors may seriously harm the market price of our Common Stock, regardless of our actual or expected operating performance and financial condition or prospects, which may make it difficult for investors to assess the rapidly changing value of our Common Stock. 15 We are currently listed on The Nasdaq Global Market.
Added
A material breach in security relating to the Company’s information systems and regulation related to such breaches, cyber-attacks, or other disruptions could adversely affect the Company, expose us to liability and affect our business and reputation.
Removed
However, there can be no assurance, if the Company does appeal the delisting determination by Nasdaq to the hearings panel, that such appeal would be successful. In such event, the Company may also seek to apply for a transfer to The Nasdaq Capital Market if it meets the requirements for continued listing thereon.
Added
Information security risks have generally increased in recent years, in part because of the proliferation of new technologies and the use of the Internet, and the increased sophistication and activity of organized crime, hackers, terrorists, activists, cybercriminals and other external parties, some of which may be linked to terrorist organizations or hostile foreign governments.
Removed
Two significant customers represented 53% and 52% of our revenues for 2022 and 2023 respectively, and is expected to continue to represent a significant portion of our forecasted revenue for 2024. Change Healthcare and Siemens Medical Solutions USA, collectively represented 53% and 52% of our revenues in 2023 and 2022, respectively.
Added
Cybersecurity attacks are becoming more sophisticated and include malicious software, ransomware, attempts to gain unauthorized access to data and other electronic security breaches that could lead to disruptions in critical systems, unauthorized release of confidential or otherwise protected information and corruption of data, substantially damaging the Company’s reputation.
Removed
Change Healthcare is expected to continue to represent a significant portion of our forecasted revenue for 2024. If we fail to maintain and grow our relationships with Change Healthcare, we could lose a significant portion of our revenue for 2023, which would materially adversely affect our results of operations and our business.
Added
Any person who circumvents the security measures could steal proprietary or confidential information or cause interruptions in the Company’s operations. We are increasingly dependent on our information technology systems and infrastructure for our business.
Removed
If OneMedNet were to lose one or more of its significant customers, its revenue may significantly decline. In addition, revenue from significant customers may vary from period to period depending on the timing of renewing existing agreements or entering into new agreements for additional OneMedNet products as well as other unforeseen risks and variables discussed in this proxy statement/prospectus.
Added
We, our collaborators and our service providers collect, store, and transmit sensitive information including intellectual property, proprietary business information, and personal information in connection with our business operations. The secure maintenance of this information is critical to our operations and business strategy.
Removed
The loss of one or more of OneMedNet’s significant customers could adversely affect its business, results of operations and financial condition. You should not rely on our historical relationship with these companies as an indication of our future performance. We may encounter difficulties in managing our attempted growth of our business, which could negatively impact our operations.
Added
Some of this information could be an attractive target of criminal attack by third parties with a wide range of motives and expertise, including organized criminal groups, “hacktivists,” disgruntled current or former employees, nation-state and nation-state supported actors, and others.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeNon-technical safeguards also play an important role in our cybersecurity program. We provide various training programs and tools to employees so they can avoid risky practices and help us promptly identify potential or actual issues.
Biggest changeWe provide various training programs and tools to employees so they can avoid risky practices and help us promptly identify potential or actual issues. We also have global incident response procedures, global service tools to log incidents and issues for investigation, and an ethics line to report concerns and follow up on matters already reported.
We developed, maintain and utilize a global integrated information security framework to guide our practices, based on relevant industry frameworks and laws, including, but not limited to NIST, GxP, HITRUST, the ISO 27000 family, COBIT, GDPR, and HIPAA. The framework consists of policies, standards, procedures, work Instructions and documentation.
We developed, maintained and utilized a global integrated information security framework to guide our practices, based on relevant industry frameworks and laws, including, but not limited to NIST, GxP, HITRUST, the ISO 27000 family, COBIT, GDPR, and HIPAA. The framework consists of policies, standards, procedures, work instructions and documentation.
As part of this process, the Audit receives regular updates from the Director Product Management, Head of Data on critical issues related to our information security risks, cybersecurity strategy, supplier risk and business continuity capabilities.
As part of this process, the Audit Committee receives regular updates from the Chief Technology Officer on critical issues related to our information security risks, cybersecurity strategy, supplier risk and business continuity capabilities .
Item 1c. Cybersecurity OneMedNet manages cybersecurity and data protection through a continuously evolving framework. The framework allows us to identify, assess and mitigate the risks we face, and assists us in establishing policies and safeguards to protect our systems and the information of those we serve. Our cybersecurity program is managed by our Director Product Management, Head of Data.
Item 1C. Cybersecurity OneMedNet manages cybersecurity and data protection through a continuously evolving framework, as described in further detail below. The framework allows us to identify, assess and mitigate the risks we face, and assists us in establishing policies and safeguards to protect our systems and the information of those we serve.
Pursuant to the Company’s incident response plan, any incidents are to be reported to the Audit Committee, appropriate government agencies and other authorities, as deemed necessary or appropriate, considering the actual or potential impact, significance and scope. 22 We employ an array of data security technologies, processes, and methods across our infrastructure to protect systems and sensitive information from unauthorized access.
Pursuant to the Company’s incident response plan, any incidents are to be reported by the Chief Technology Officer to the Audit Committee, appropriate government agencies and other authorities, as deemed necessary or appropriate, considering the actual or potential impact, significance and scope.
We also have global incident response procedures, global service tools to log incidents and issues for investigation, and an ethics line to report concerns and follow-up on matters already reported. The Compliance team, led by our Chief Compliance Officer, develops and implements our strategy, as well as monitors systems and devices for risks and threats.
The Compliance team, led by our Chief Technology Officer, develops and implements our strategy, as well as monitors systems and devices for risks and threats.
We draw on the knowledge and insight of external cybersecurity experts and vendors, and internally employ dedicated, certified, cybersecurity staff, such as but not limited to, CISSP, CISM, CISA, CSSP or other equivalent certifications, that leverage an array of third-party tools to secure OneMedNet information infrastructure and protect systems and information from unauthorized access.
We draw on the knowledge and insight of external cybersecurity experts and vendors, and our Chief Technology Officer’s experience in building solutions that are secure and compliant with our information security framework. OneMedNet leverages an array of security services and tools to secure OneMedNet information infrastructure and protect systems and information from unauthorized access.
Added
Our cybersecurity program is managed by James Wang, our Chief Technology Officer. James holds a degree in computer science from the University of Hawaii at Manoa and has 19 years of development experience focused on architecture and security. In his career, he has led initiatives for companies to attain SOC2 compliance and PCI compliance for their product solutions.
Added
The Company is no t aware of any cybersecurity incidents or threats that are reasonably likely to materially affect its business strategy, results of operations, or financial condition. 28 We employ an array of data security technologies, processes, and methods across our infrastructure to protect systems and sensitive information from unauthorized access.
Added
OneMedNet’s products and solutions, including 3 rd party software and services such as hosted cloud based platforms are monitored by a healthcare cloud, security and compliance organization that provides a real-time dashboard to monitor for potential threats and vulnerabilities. Non-technical safeguards also play an important role in our cybersecurity program.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeDue to the inherent uncertain nature of litigation, the ultimate outcome or actual cost of settlement may materially vary from estimates. See “Risk Factors—Other Risks—Any future litigation against us could be costly and time-consuming to defend.” Item 4. Mine Safety Disclosures Not applicable. 23 PART II
Biggest changeWe intend to recognize provisions for claims or pending litigation when we determine that an unfavorable outcome is probable, and the amount of loss can be reasonably estimated. Due to the inherent uncertain nature of litigation, the ultimate outcome or actual cost of settlement may materially vary from estimates. Item 4. Mine Safety Disclosures Not applicable. 29 PART II
Removed
We do not currently expect the results of any of these matters to have a material effect on our business, results of operations, financial condition or cash flows. We intend to recognize provisions for claims or pending litigation when we determine that an unfavorable outcome is probable, and the amount of loss can be reasonably estimated.
Added
We are not presently party to any legal proceedings that, in the opinion of management, if determined adversely to us, would individually or taken together have a material adverse effect on our business, operating results, financial condition, or cash flows.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeDividend Policy We have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends in the foreseeable future. 24 Issuer Purchases of Equity Securities There were no purchases of equity securities by the issuer or affiliated purchasers, as defined in Rule 10b-18(a)(3) the Securities Exchange Act of 1934, during the quarter ended December 31, 2023.
Biggest changePurchases of Securities by the Issuer and Affiliated Purchasers There were no purchases of equity securities by the issuer or affiliated purchasers, as defined in Rule 10b-18(a)(3) of the Exchange Act during the quarter ended December 31, 2024. Item 6. [Reserved]
Certain shares of our Common Stock are held in “street” name and, accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number. The number of holders of record also does not include beneficial owners of shares that are be held in trust by other entities.
Certain shares of our Common Stock are held in “street” name and, accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number. The number of holders of record also does not include beneficial owners of shares that are held in trust by other entities.
Performance Graph We are a “smaller reporting company,” as defined by Item 10(f)(1) of Regulation S-K, and therefore are not required to provide the information required by paragraph (e) of Item 201 of Regulation S-K.
Performance Graph We are a “smaller reporting company,” as defined by Item 10(f)(1) of Regulation S-K, and therefore are not required to provide the information required by paragraph (e) of Item 201 of Regulation S-K. Recent Sales of Unregistered Securities None.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information for Common Stock and Warrants Our Common Stock is traded on The Nasdaq Global Select Market under the symbol “ ONMD ”.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information for Common Stock and Warrants Our Common Stock is traded on The Nasdaq Capital Market under the symbol “ONMD”.
Our Public Warrants, each entitling the holder to purchase one share of our Common Stock are traded on traded on The Nasdaq Global Select Market under the symbol “ONMDW”. Holders of our Common Stock As of April 2, 2024, there were approximately 122 holders of record of our Common Stock.
Our Public Warrants, each entitling the holder to purchase one share of our Common Stock, are traded on The Nasdaq Capital Market under the symbol “ONMDW”. Holders of our Common Stock As of April 15, 2025, there were approximately 38 holders of record of our Common Stock.
Removed
Recent Sales of Unregistered Securities On June 28, 2023, the Company executed a Securities Purchase Agreement for PIPE financing in the aggregate original principal amount of $1,595,744.70 and a purchase price of $1.5 million. Pursuant to the Securities Purchase Agreement, the Company agreed to issue and sell to each of Thomas Kosasa, Dr.
Added
Dividend Policy We have never paid or declared any cash dividends on our Common Stock, and we do not anticipate paying any cash dividends in the foreseeable future.
Removed
Jeffrey Yu, Aaron Green and Steve Kester (the “PIPE Investors”), a new series of senior secured convertible notes (the “PIPE Notes”), which Notes shall be convertible into shares of Common Stock at the PIPE Investors election at the conversion price (rounded to the nearest 1/100th of one cent) which shall be computed as the lesser of: (a) with respect to a conversion pursuant to Section 4.1 of the Securities Purchase Agreement (discussed below), the lesser of: (i) a price per share equal to the product of (x) 100% less the Discount and (y) the lowest per share purchase price of the Equity Securities issued in the Next Equity Financing; and (ii) $2.50 per share; and (b) with respect to a conversion pursuant to Section 4.2 (discussed below), (relating to payment at maturity) or Section 4.3, $2.50 per share.
Removed
The Securities Purchase agreement provided that the PIPE Investors’ $1.5 million investment in the PIPE Notes would close and fund contemporaneous to the Closing of the Business Combination.
Removed
Section 4.1 of the Securities Purchase Agreement provides that the principal balance and unpaid accrued interest on each Note will automatically convert into the PIPE Conversion Shares upon the closing of the Next Equity Financing (“Next Equity Financing” means the next sale or series of related sales by the Company of its Common Stock in one or more offerings relying on Section 4(a)(2) of the Securities Act or Regulation D thereunder for exemption from the registration requirements of Section 5 of the Securities Act, from which the Company receives gross proceeds of not less than US$5,000,000 (excluding, for the avoidance of doubt, the aggregate principal amount of the Notes).
Removed
Section 4.2 of the Securities Purchase Agreement provides that in the event of a Corporate Transaction or the repayment of such Note, at the closing of a corporate transaction, the holder of each Note may elect that either: (a) the Company will pay the holder of such Note an amount equal to the sum of (x) the outstanding principal balance of such Note, and (y) a premium equal to 20% of the outstanding principal balance of such Note (which premium, is in lieu of all accrued and unpaid interest due on such Note); or (b) such Note will convert into that number of Conversion Shares equal to the quotient (rounded down to the nearest whole share) obtained by dividing (x) the outstanding principal balance and unpaid accrued interest of such Note on a date that is no more than five days prior to the closing of such corporate transaction by (y) the applicable Conversion Price.
Removed
Notwithstanding the foregoing, any sale (or series of related sales) of the Company’s Equity Securities to a special purpose acquisition company will not be deemed a “Next Equity Financing. Notwithstanding the foregoing, the Company may, at its option, pay any unpaid accrued interest on each Note in cash at the time of conversion.
Removed
The number of PIPE Conversion Shares the Company issues upon such conversion will equal the quotient (rounded down to the nearest whole share) obtained by dividing (x) the outstanding principal balance and unpaid accrued interest under each converting Note on a date that is no more than five days prior to the closing of the Next Equity Financing by (y) the applicable Conversion Price.
Removed
At least five days prior to the closing of the Next Equity Financing, the Company will notify the holder of each Note in writing of the terms of the Equity Securities that are expected to be issued in such financing.
Removed
The issuance of PIPE Conversion Shares pursuant to the conversion of each Note will be on, and subject to, the same terms and conditions applicable to the Equity Securities issued in the Next Equity Financing.
Removed
Securities Authorized for Issuance Under Equity Compensation Plans The information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report. Item 6. [Reserved] Not applicable.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

27 edited+49 added−50 removed8 unchanged
Biggest changeThe following table reconciles GAAP net loss to Adjusted EBITDA during the periods presented (in thousands): Year Ended December 31, 2023 Year Ended December 31, 2022 Net loss $ (23,205,456 ) $ (6,229,639 ) Interest Expense 749,213 403,307 Impairment 10,504,327 - Depreciation and amortization 27,983 24,807 Unit and Stock-based compensation 3,572,232 45,584 Business combination transaction expenses 1,427,73 900,152 Adjusted EBITDA $ (6,932,966 ) $ (4,855,789 ) Liquidity and Capital Resources As of December 31, 2023, our principal sources of liquidity were net proceeds received related to the Business Combination and cash received from customers. 29 The following table shows net cash and cash equivalents provided by (used in) operating activities, net cash and cash equivalents used in investing activities, and net cash and cash equivalents provided by financing activities during the periods presented: Year Ended December 31, 2023 December 31, 2022 Net cash provided by (used in) Operating activities $ 8,220,910 $ 87,239,622 Investing activities (43,757 ) (58,137 ) Financing Activities (8,431,875 ) (88,032,226 ) Operating Activities Our net cash and cash equivalents provided by (used in) operating activities consists of net loss adjusted for certain non-cash items, including depreciation and amortization, business combination cost, stock-based compensation expense, cash held in trust account, and as well as changes in operating assets and liabilities.
Biggest changeThe following table shows net cash and cash equivalents used in operating activities, net cash and cash equivalents used in investing activities, and net cash and cash equivalents provided by financing activities during the periods presented: For the year ended December 31, 2024 2023 Net cash provided by (used in) Operating activities $ (6,983 ) $ (4,791 ) Investing activities (1,982 ) (44 ) Financing activities 9,090 4,611 36 Operating Activities Our net cash and cash equivalents used in operating activities consists of net loss adjusted for certain non-cash items, including depreciation and amortization, stock-based compensation expense, changes in fair value of liability classified financial instruments, as well as changes in operating assets and liabilities.
At the Closing of the Business Combination, all shares of Data Knights owned by the Sponsor (consisting of shares of Common Stock and shares of Class B common stock, which we refer to as the founder shares), automatically converted into an equal number of shares of OneMedNet’s Common Stock, and the Private Placement Warrants held by the Sponsor, automatically converted into warrants to purchase one share of OneMedNet Common Stock with substantively identical terms.
At the closing of the Business Combination (the “Closing”), all shares of Data Knights owned by the Sponsor (consisting of shares of Common Stock and shares of Class B common stock, which we refer to as the founder shares), automatically converted into an equal number of shares of OneMedNet’s Common Stock, and the Private Placement Warrants held by the Sponsor automatically converted into warrants to purchase one share of OneMedNet Common Stock with substantively identical terms.
These estimates, assumptions, and judgments are necessary because future events and their effects on our results and the value of our assets cannot be determined with certainty and are made based on our historical experience and on other assumptions that we believe to be reasonable under the circumstances.
These estimates, assumptions, and judgments are necessary because future events and their effects on our results of operations and the value of our assets cannot be determined with certainty and are made based on our historical experience and on other assumptions that we believe to be reasonable under the circumstances.
Revenue is recognized when the data is delivered to the customer. Beam revenue is subscription-based revenue which is recognized ratably over the subscription period committed to by the customer. The Company invoices its Beam customers quarterly or annually in advance with the customer contracts automatically renewing unless the customer issues a cancellation notice.
Revenue is recognized when the data is delivered to the customer. BEAM revenue is subscription-based revenue that is recognized ratably over the subscription period committed to by the customer. The Company invoices its BEAM customers quarterly or annually in advance with the customer contracts automatically renewing unless the customer issues a cancellation notice.
Key Components of Consolidated Statements of Operations Revenue The Company generates revenue from two streams: (1) iRWD (imaging Real World Data) which provides regulatory grade imaging and clinical data in the Pharmaceutical, Device Manufacturing, CRO’s and AI markets and (2) BEAM which is a Medical Imaging Exchange platform between Hospital/Healthcare Systems, Imaging Centers, Physicians and Patients. iRWD is sold on a fixed fee basis based on the number of data units and the cost per data unit committed to in the customer contract.
Key Components of Consolidated Statements of Operations Revenue The Company generates revenue from two streams: (1) iRWD, which provides regulatory grade imaging and clinical data in the pharmaceutical, device manufacturing, contract research organizations, and AI markets and (2) BEAM, which is a medical imaging exchange platform between hospital/healthcare systems, imaging centers, physicians and patients. iRWD is sold on a fixed fee basis based on the number of data units and the cost per data unit committed to in the customer contract.
Effective November 7, 2023, Data Knights’ units ceased trading, and effective November 8, 2023, OneMedNet’s common stock began trading on the Nasdaq Global Market under the symbol “ONMD” and the warrants began trading on the Nasdaq Global Market under the symbol “ONMDW.” As a result of the Merger and the Business Combination, holders of Data Knights common stock automatically received common stock of OneMedNet, and holders of Data Knights warrants automatically received warrants of OneMedNet with substantively identical terms.
Effective November 7, 2023, Data Knights’ common stock, warrants and units ceased trading, and effective November 8, 2023, our Common Stock began trading on the Nasdaq Global Market under the symbol “ONMD” and the Public Warrants began trading on the Nasdaq Global Market under the symbol “ONMDW.” As a result of the Business Combination, holders of Data Knights common stock automatically received common stock of OneMedNet, and holders of Data Knights warrants automatically received warrants of OneMedNet with substantively identical terms.
Research and Development Costs incurred in the research and development of our products are expensed as incurred. Research and development costs include personnel, contracted services, materials, and indirect costs involved in the design and development of new products and services, as well as hosting expense. Sales & Marketing Our sales and marketing costs consist of labor and tradeshow costs.
Research and development costs include personnel, contracted services, materials, and indirect costs involved in the design and development of new products and services, as well as hosting expense. Sales and Marketing Our sales and marketing costs consist of labor and tradeshow costs.
Payment terms on invoiced amounts typically range from zero to 90 days, with typical terms of 30 days. Cost of Revenue Our cost of revenue is composed of our distinct performance obligations of hosting, labor, and data cost. 26 General, and Administrative General and administrative functions, includes finance, legal, human resources, and information technology support.
Payment terms on invoiced amounts typically range from zero to 90 days, with typical terms of 30 days. Cost of Revenue Our cost of revenue is composed of our distinct performance obligations of hosting, labor, and data cost. 31 General and Administrative General and administrative functions include finance, legal, operations, human resources, and information technology support.
In connection with the Special Meeting, certain public holders (the “Redeeming Stockholders”) holding 1,600,741 shares of Common Stock exercised their right to redeem such shares for a pro rata portion of the funds held by Continental Stock Transfer & Trust Company, as trustee (“Continental”) in the trust account established in connection with Data Knights’ initial public offering (the “Trust Account”).
In connection with the meeting of stockholders of Data Knights to approve the Business Combination (the “Special Meeting”), certain public holders (the “Redeeming Stockholders”) holding 1,600,741 shares of Common Stock exercised their right to redeem such shares for a pro rata portion of the funds held by Continental Stock Transfer & Trust Company, as trustee (“Continental”) in the trust account established in connection with Data Knights’ initial public offering (the “Trust Account”).
Our foreseeable cash needs, in addition to our recurring operating expenses, include our expected capital expenditures to support the expansion of our infrastructure and workforce, interest expense and minimum contractual obligations. Management hopes to raise cash either through a public offering or private debt and equity offering. Our inability to raise cash would cause to operate as a going concern.
Our foreseeable cash needs, in addition to our recurring operating expenses, include our expected capital expenditures to support the expansion of our infrastructure and workforce, interest expense and minimum contractual obligations. Management hopes to raise cash either through a public offering or private debt and equity offering.
Recently Issued Accounting Pronouncements See Note 2 to the accompanying consolidated financial statements included elsewhere in this Annual Report on Form 10-K for a description of certain recently issued accounting standards which may impact our financial statements in future reporting periods.
Recently Issued Accounting Pronouncements See Note 2, Summary of Significant Accounting Policies to the accompanying consolidated financial statements included elsewhere in this Annual Report for a description of certain recently issued accounting standards which may impact our financial statements in future reporting periods.
Contractual Obligations and Commitments and Liquidity Outlook Currently, management does not believe the cash and cash equivalents is sufficient to meet our foreseeable cash needs for at least the next 12 months.
Contractual Obligations and Commitments and Going Concern Outlook Currently, management does not believe that cash and cash equivalents are sufficient to meet our foreseeable cash needs for at least the next 12 months.
Investing Activities Our investing activities have consisted primarily of property and equipment purchases. Net cash and cash equivalents used in investing activities during the year ended December 31, 2023 consisted of $44 thousand of purchased property and equipment.
During the year ended December 31, 2023, net cash used in investing activities was $44 thousand, consisting of purchases of property and equipment.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis should be read in conjunction with our consolidated financial statements and notes thereto that appear elsewhere in this Annual Report on Form 10-K.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis should be read in conjunction with our consolidated financial statements and notes thereto that appear elsewhere in this Annual Report. See “Risk Factors” elsewhere in this Annual Report for a discussion of certain risks associated with our business.
This may result in an operating cash flow source or use for the period, depending on the timing of payments received as compared to the fulfillment of the performance obligation. Net cash used in operating activities was $8.2 million during the year ended December 31, 2023.
This may result in an operating cash flow source or use for the period, depending on the timing of payments received as compared to the fulfillment of the performance obligation.
We believe that the assumptions and estimates associated with the following critical accounting policies involve significant judgment and thus have the most significant potential impact on our Consolidated Financial Statements. Revenue Recognition We generate revenue from the sale of products and services.
We believe that the assumptions and estimates associated with the following critical accounting policies involve significant judgment and thus have the most significant potential impact on our Consolidated Financial Statements. Revenue Recognition Although most of our sales agreements contain standard terms and conditions, certain agreements contain multiple performance obligations.
See “Risk Factors” elsewhere in this Annual Report on Form 10-K for a discussion of certain risks associated with our business. The following discussion contains forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts.
The following discussion contains forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts.
In the event that additional financing is required from outside sources, we may be unable to raise the funds on acceptable terms, if at all. 30 The following table summarizes our current and long-term material cash requirements as of December 31, 2023: Payments due in: Total Less than 1 year 1-3 years Accounts payable and accrued expenses $ 4,184,398 $ 4,184,398 $ - Excise tax 113,353 113,353 - Income tax payable 120,017 120,017 - PIPE Notes, net of discount including interest 1,549,820 1,549,820 - Loan, related party of OMN including interest 465,023 - 465,023 $ 6,432,610 $ 5,967.587 $ 465,023 Critical Accounting Policies and Estimates Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements which have been prepared in accordance with accounting principles generally accepted in the United States of America.
In the event that additional financing is required from outside sources, we may be unable to raise the funds on acceptable terms, if at all. 37 The following table summarizes our current and long-term material cash requirements as of December 31, 2024: Payments due in: Total Less than 1 year 1-3 years Accounts payable & accrued expenses $ 6,371 $ 6,371 $ - Loan extensions 2,992 2,992 - Deferred underwriter fee payable 3,250 3,250 - Loan - related party 2,319 2,319 - PIPE Notes 1,734 1,734 - Yorkville Note 1,718 1,718 - $ 18,384 $ 18,384 $ - Critical Accounting Policies and Estimates Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements which have been prepared in accordance with GAAP.
These functions include costs for items such as salaries and benefits and other personnel-related costs, maintenance and supplies, professional fees for external legal, accounting, and other consulting services, and depreciation expense. Operation services Operations consists primarily of labor cost for our operations team who provides services to our customers.
These functions include costs for items such as salaries and benefits and other personnel-related costs, maintenance and supplies, professional fees for external legal, accounting, and other consulting services, and depreciation expense. Research and Development Costs incurred in the research and development of our products are expensed as incurred.
Pursuant to the terms of the Merger Agreement, the total consideration for the Business Combination and related transactions (the “Merger Consideration”) was approximately $200 million.
Following the Business Combination, Data Knights changed its name to “OneMedNet Corporation”. The total consideration for the Business Combination and related transactions (the “Merger Consideration”) was approximately $200 million.
Recently Adopted Accounting Pronouncements See Note 2 to the accompanying consolidated financial statements included elsewhere in this Annual Report on Form 10-K for a description of recently adopted accounting standards.
The discount rate was held constant over the valuation periods given the fact pattern associated with the Company and the stage of development. Recently Adopted Accounting Pronouncements See Note 2, Summary of Significant Accounting Policies to the accompanying consolidated financial statements included elsewhere in this Annual Report for a description of recently adopted accounting standards.
By comparison, the Company’s net cash and cash equivalents used in investing activities during the year ended December 31, 2022 consisted primarily of $58 thousand of purchased property and equipment.
Investing Activities Our investing activities have consisted primarily of property and equipment purchases and Bitcoin purchases and sales. During the year ended December 31, 2024, net cash used in investing activities was $2.0 million, consisting of $1.9 million in net purchases of Bitcoin and $0.1 million of purchases of property and equipment.
Employing our proven OneMedNet iRWD™ solution, we securely de-identifies, searches, and curates a data archive locally, bringing a wealth of internal and third-party research opportunities to providers. By leveraging this extensive federated provider network, together with industry leading technology and in-house clinical expertise, OneMedNet successfully meets the most rigorous RWD Life Science requirements.
Company Overview We provide innovative solutions that unlock the significant value contained within the clinical image archives of healthcare providers. Employing our OneMedNet iRWD™ solution, which securely de-identifies, searches, and curates a data archive locally, bringing a wealth of internal and third-party research opportunities to providers.
This decrease was primarily due to a decrease in headcount. Sales & Marketing Our sales & marketing expense increased by $0.15 million year over year from the year ended 2022 compared to the year ended 2023. The increase is due to the addition of an employee and consultant in 2023.
Sales and Marketing Sales and marketing expenses were $0.8 million for the year ended December 31, 2024, compared to $1.1 million for year ended December 31, 2023. The decrease in total sales and marketing expenses of $0.3 million in 2024 was primarily due to a decrease of $0.3 million in personnel costs driven by decreased headcount.
By comparison, the Company’s net cash flows from financing activities was ($88.0 million) for the year ended December 31, 2023, which primarily consisted of $5.5 million proceeds from convertible promissory notes payable, $88.5 million from common stock subject to redemption in connection with the Business Combination, $4.5 million decrease in warrant liability, $2.8 million additional paid in capital and $3.4 million retained earning adjustment.
During the year ended December 31, 2023, net cash provided by financing activities was $4.6 million, consisting of $4.2 million in proceeds from convertible notes, $1.5 million in proceeds from PIPE Notes, and $0.5 million in proceeds from shareholder loans, partially offset by $1.5 million in Business Combination costs paid.
In the year ended 2023 our Software cost, iRWD consultants and iRWD Data cost each decreased by $0.2 million. The decrease was partially offset by a $0.2 million increase in payroll expenses. General and Administrative Our general and administrative expense increased year over year by $1.8 million from the year ended 2022 compared to the year ended 2023.
These decreases are partially offset by an increase of $0.1 million in iRWD data charges as we shift our focus to the iRWD service line. 34 General and Administrative General and administrative expenses were $7.0 million for the year ended December 31, 2024, compared to $3.5 million for the year ended December 31, 2023.
For the year ended 2023, overall revenue was down by 11%. The primary driver for exchange revenue increase was delivery of revenue to a significant customer. The primary drive for the decrease in broker revenue was revenue deliveries pushed to Q1 of Fiscal 2024.
For the year ended December 31, 2024, overall revenue decreased by 37%. The primary driver for the decrease in subscription revenue was the planned discontinuation of the BEAM platform in 2025.
Removed
Unless the context otherwise requires, references in this Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” to “OneMedNet Corporation,” “we,” “us,” “our” and the “Company” are intended to mean the business and operations of OneMedNet Corporation. 25 Company Overview Founded in 2009, we provide innovative solutions that unlock the significant value contained within the clinical image archives of healthcare providers.
Added
By leveraging our extensive federated provider network, together with our technology and in-house clinical expertise, OneMedNet successfully meets the most rigorous Real World Data life science requirements. 30 Business Combination On November 7, 2023, we completed the Business Combination, whereby a subsidiary of Data Knights merged with and into Legacy ONMD, with Legacy ONMD surviving as a wholly-owned subsidiary of Data Knights.
Removed
Business Combination On November 7, 2023, we held the closing of the previously announced merger (the “Merger”) whereby Data Knights Merger Sub, Inc., merged with and into OneMedNet Solutions Corporation (formerly named OneMedNet Corporation), with OneMedNet Solutions Corporation continuing as the surviving entity, which resulted in all of the issued and outstanding capital stock of OneMedNet Solutions Corporation being exchanged for shares of the Company’s Common Stock upon the terms set forth in the Merger Agreement (collectively, the “the Business Combination”).
Added
Interest Expense Interest expense consists of interest incurred on our outstanding debt facilities, including loans with related parties, deferred underwriter fees, insurance premiums paid in exchange for a note payable, and our line of credit.
Removed
The Merger and other transactions that closed on November 7, 2023, pursuant to the Merger Agreement, led to Data Knights changing its name to “OneMedNet Corporation” and the business of the Company became the business of OneMedNet Solutions Corporation.
Added
Other (Income) Expenses, Net Other (income) expenses, net, primarily includes the changes in fair value of convertible debt, change in fair value of PIPE Notes and change in fair value of Yorkville Note (as defined below) for which we have elected the fair value option of accounting.
Removed
Interest Expense Interest incurred on convertible notes and shareholder loans. Other Expense Foreign exchange and tax expenses related to the Company’s operations and revenue outside of the United States.
Added
Convertible notes payable, which include convertible promissory notes and PIPE Notes issued to related parties, including accrued interest and contingently issuable warrants, contain embedded derivatives, including settlement of the contingent conversion features, which require bifurcation and separate accounting. Accordingly, we have elected to measure the entire contingently convertible debt instruments, including accrued interest, at fair value.
Removed
Results of Operations The following tables set forth our Consolidated Statements of Operations data for the periods presented: Year Ended December 31, 2023 2022 Revenue $ 1,021,651 $ 1,152,738 Cost of Revenue 1,149,551 1,513,428 Gross Margin (127,900 ) (360,690 ) Operating Expenses General and administrative 5,273,503 8,755,620 Operations 226,257 398,760 Sales & Marketing 1,114,977 957,690 Research and Development 1,631,613 952,701 Total Operating Expenses 8,246,350 11,064,771 Operating loss (8,374,250 ) (11,425,461 ) Other Expense (income) Impairment 10,504,327 - Income tax provision - 214,850 Interest expense 749,213 403,307 Other expense 52,256 46,820 Change in FV of Warrants (46,822 ) (4,489,110 ) Stock Expense 3,572,232 Unrealized gain or loss - (1,371,689 ) 14,831,206 $ (5,195,822 ) Net loss $ (23,205,456 ) $ (6,229,639 ) Year Ended December 31, 2023 Compared to the Year Ended December 31, 2022 Revenue Year Ended December 31, 2023 Year Ended December 31, 2022 % Percentage Change Data Exchange (Beam) $ 878,416 $ 678,138 30 % Data Broker (RWD) $ 143,235 $ 474,600 -70 % Master Reseller Agreement $ 1,021,651 $ 1,152,738 -11 % 27 Our revenue comprises of sales made from our data exchange (BEAM) and from data broker (RWD).
Added
These debt instruments were initially recorded at fair value as liabilities and are subsequently re-measured at fair value on our consolidated balance sheet at the end of each reporting period and at settlement, as applicable.
Removed
Cost of Revenue Year Ended December 31, 2023 Year Ended December 31, 2022 Cost of Revenue 1,149,551 1,513,428 As a percentage of Revenue 113 % 131 % In 2023 we were able to reduce our cost of revenue as a percentage of revenue by 24%.
Added
Other income or expenses, net, also includes changes in fair value of warrants which are treated as liability instruments measured at fair value for accounting purposes, initially recorded at fair value and subsequently re-measured to fair value on our consolidated balance sheets at the end of each reporting period.
Removed
The increase is primarily due to the additional cost incurred in connection with our Business Combination. We incurred an additional $1.0 million legal cost, $0.7 million on warrants issued to convertible note holders that were converted into share of commons stock, $0.4 million additional employees’ salaries, $0.3 million for investor relations cost, and $0.3 million in additional audit fees.
Added
The changes in the fair value of these debt and liability instruments are recorded in changes in fair value, included as a component of other (income) expenses, net, in the consolidated statements of operations.
Removed
The increase in general and administrative expenses were partially offset by $0.2 million decrease in both recruitment fees and bad debt expense. Operation Our operations expense includes payroll and consultant costs. Operations expense decreased year over year by $0.2 million from the year ended 2022 compared with the year ended 2023.
Added
At the Closing of the Business Combination, convertible promissory notes were converted into Common Stock immediately prior to the Closing and were no longer outstanding as of the Closing Date.
Removed
Research and development Our research and development expense increased by $0.7 million year over year from the year ended 2022 compared to the year ended 2023. The increase is primarily due to the additional cost in salaries for curators, consultants and increased hosting costs, which increased by $0.4 million, $0.2 million and $0.1 million, respectively.
Added
Other (income) expenses, net, also includes change in fair value of our Bitcoin holdings, as well as foreign exchange and tax expenses related to the Company’s operations and revenue outside of the United States. 32 Results of Operations The following tables set forth our consolidated statements of operations data for the periods presented: For the year ended December 31, Change 2024 2024 2023 $ % Revenue Subscription revenue $ 351 $ 878 $ (527 ) -60 % Web imaging revenue 292 143 149 104 % Total revenue 643 1,021 (378 ) -37 % Cost of revenue 924 1,150 (226 ) -20 % Gross margin (281 ) (129 ) (152 ) 118 % Operating expenses General and administrative 7,027 3,544 3,483 98 % Sales and marketing 830 1,115 (285 ) -26 % Research and development 1,467 2,065 (598 ) -29 % Total operating expenses 9,324 6,724 2,600 39 % Loss from operations (9,605 ) (6,853 ) (2,752 ) 40 % Other (income) expense, net Interest expense 147 11 136 1236 % Stock warrant expense 35 9,207 (9,172 ) -100 % Change in fair value of warrants (9 ) (129 ) 120 -93 % Change in fair value of PIPE notes 97 269 (172 ) -64 % Change in fair value of Yorkville Note 711 - 711 N/A Change in fair value of crypto assets – Bitcoin (798 ) - (798 ) N/A Realized gain on sale of crypto assets – Bitcoin (120 ) - (120 ) N/A Change in fair value of derivative liability 434 - 434 N/A Change in fair value of convertible promissory notes - 17,517 (17,517 ) -100 % Other expense 25 34 (9 ) -26 % Total other (income) expenses, net 522 26,909 (26,387 ) -98 % Loss before income taxes $ (10,127 ) $ (33,762 ) $ 23,635 -70 % Income tax (benefit) expense 2 18 (16 ) -89 % Net loss (10,129 ) (33,780 ) 23,651 -70 % 33 Revenue For the year ended December 31, Change 2024 2024 2023 $ % Subscription revenue (BEAM) $ 351 $ 878 $ (527 ) -60 % Web imaging revenue (Real-World Data) 292 143 149 104 % Total $ 643 $ 1,021 $ (378 ) -37 % Our revenue is comprised of sales made from our subscription revenue (BEAM) and from our web imaging (iRWD).
Removed
Impairment The Company recorded goodwill of $10.5 million in connection with the Business Combination. In December 2023, the Company concluded that the entire goodwill was impaired, as such the $10.5 million of goodwill was written-off. Income tax provision For the year ended 2023, the Company is in a significant loss, as such we did not record any income tax provision.
Added
As we move away from the BEAM platform to focus on iRWD sales, we have stopped renewals for most of our customers leading to a $0.5 million decrease for the year ended December 31, 2024, as compared to the prior year.
Removed
Interest Expense The Company incurred interest expense on Loan extensions associated with the Business Combination, convertible promissory notes, the Pipe Senior Secured Convertible Notes and Loans made from related parties (Management and Directors). Interest expense in the year ended 2023 increased by $0.3 million. The increase was mainly from the Pipe Senior Secured Convertible Notes issued in 2023.
Added
The primary driver for the increase in web imaging revenue was due to our enhanced focus on iRWD sales leading to increased customer deliveries during the year ended December 31, 2024, as compared to the prior year.
Removed
Change in Fair Value of Warrants The change in Warrant Fair Value was due to the closing of the Business Combination Agreement and the resulting fluctuations of the share market price . 28 Stock Expense The Company incurred approximately $3.5 million in common stock issuance expense for the Data Knight shares converted to OneMedNet Corporation shares.
Added
Cost of Revenue For the year ended December 31, 2024 2023 Cost of revenue 924 1,150 % of revenue 144 % 113 % The decrease in cost of revenue of $0.2 million was primarily attributable to a decrease of $0.1 million in software and hosting costs due to the planned shutdown of our BEAM platform and a decrease of $0.2 million in personnel costs driven by decreased headcount.
Removed
Non-GAAP Financial Measure In addition to providing financial measurements based on generally accepted accounting principles in the United States of America, or GAAP, we provide an additional financial metric that is not prepared in accordance with GAAP, or non-GAAP financial measure.
Added
The increase in total general and administrative expenses of $3.5 million was primarily due to an increase of $2.2 million in accounting, audit and tax related services, an increase of $0.8 million in legal fees, an increase of $0.4 million in insurance premiums and an increase of $0.1 million in other general and administrative expenses, each of which is attributable to enhanced public company reporting obligations and regulatory requirements after the Business Combination closed in the fourth quarter of 2023.
Removed
We use this non-GAAP financial measure, in addition to GAAP financial measures, to understand and compare operating results across accounting periods, for financial and operational decision making, for planning and forecasting purposes, to measure executive compensation, and to evaluate our financial performance. This non-GAAP financial measure is Adjusted EBITDA, as discussed below.
Added
Research and development Research and development expenses were $1.5 million for the year ended December 31, 2024, compared to $2.1 million for year ended December 31, 2023.
Removed
We believe that this non-GAAP financial measure reflects our ongoing business in a manner that allows for meaningful comparisons and analysis of trends in the business, as it facilitates comparing financial results across accounting periods and to those of peer companies.
Added
The decrease in total research and development expenses of $0.6 million in 2024 was primarily due to a decrease of $0.4 million in stock based compensation expense and a decrease of $0.2 million in third-party contractor costs.
Removed
We also believe that this non-GAAP financial measure enables investors to evaluate our operating results and future prospects in the same manner as we do. This non-GAAP financial measure may exclude expenses and gains that may be unusual in nature, infrequent, or not reflective of our ongoing operating results.
Added
Interest Expense During the year ended December 31, 2024, interest expense was primarily comprised of interest expense on loans made by related parties (Management and Directors) and interest expense on the remaining $0.4 million of deferred underwriter fees that are payable in cash.
Removed
The non-GAAP financial measure does not replace the presentation of our GAAP financial measures and should only be used as a supplement to, not as a substitute for, our financial results presented in accordance with GAAP.
Added
The increase of $0.1 million in 2024 is primarily due to receiving additional loans from related parties, as well as interest on deferred underwriter fees which did not accrue interest in 2023. During the year ended December 31, 2023, interest expense was only comprised of interest expense on loans made by related parties.
Removed
We consider Adjusted EBITDA to be an important indicator of the operational strength and performance of our business and a good measure of our historical operating trends. Adjusted EBITDA eliminates items that we do not consider to be part of our core operations.
Added
Change in Fair Value of Warrants At the closing of the Business Combination in 2023, we issued warrants in connection with the PIPE financing and separately assumed certain private warrants from Data Knights. We determined that these warrants should be accounted for as liabilities, which are adjusted to fair value at the end of each reporting period.
Removed
We define Adjusted EBITDA as GAAP net loss excluding the following items: interest income; income taxes; depreciation and amortization of tangible and intangible assets; unit and stock-based compensation; Business Combination transaction expenses; and other non-recurring items that may arise from time to time.
Added
The change in fair value is mainly due to the resulting fluctuations in the market price of shares of Common Stock . Change in Fair Value of PIPE Notes At the closing of the Business Combination in 2023, we issued PIPE Notes (as defined below) that are convertible into shares of Common Stock and carried at fair value.
Removed
The non-GAAP adjustments, and our basis for excluding them from our non-GAAP financial measure, are outlined below: ● Unit and Stock-based compensation – Although unit and stock-based compensation is an important aspect of the compensation paid to our employees, the grant date fair value varies based on the derived stock price at the time of grant, varying valuation methodologies, subjective assumptions, and the variety of award types.
Added
The change in fair value is mainly due to the resulting fluctuations in the market price of shares of Common Stock . Change in Fair Value of Yorkville Note In June 2024, we issued the Yorkville Note (as defined below) which is convertible into shares of Common Stock and carried at fair value.
Removed
This makes the comparison of our current financial results to previous and future periods difficult to interpret; therefore, we believe it is useful to exclude unit and stock-based compensation from our non-GAAP financial measures in order to highlight the performance of our business and to be consistent with the way many investors evaluate our performance and compare our operating results to peer companies. ● Business Combination transaction expenses – Business Combination transaction expenses represent the expenses incurred solely related to the Business Combination, which we completed on June 7, 2022.
Added
The change in fair value is mainly due to the resulting fluctuations in the market price of shares of Common Stock . 35 Change in Fair Value of Crypto Assets – Bitcoin The change in fair value of crypto assets – Bitcoin during the year ended December 31, 2024 reflects the increase in the price of Bitcoin, which we began strategically investing in using excess cash from our private placement transactions.
Removed
It primarily includes investment banker fees, legal fees, professional fees for accountants, transaction fees, advisory fees, due diligence costs, certain other professional fees, and other direct costs associated with strategic activities. These amounts are impacted by the timing of the Business Combination.
Added
During the year ended December 31, 2023, we did not have any Bitcoin holdings. Realized Gain on Sale of Crypto Assets – Bitcoin The realized gain on sale of crypto assets – Bitcoin during the year ended December 31, 2024 reflects the increase in the price of Bitcoin upon sale compared to its purchase price.
Removed
We exclude Business Combination transaction expenses from our non-GAAP financial measures to provide a useful comparison of our operating results to prior periods and to our peer companies because such amounts vary significantly based on the magnitude of the Business Combination transaction and do not reflect our core operations.
Added
During the year ended December 31, 2023, we did not have any Bitcoin holdings. Change in Fair Value of Derivative Liability The change in fair value of derivative liability during the year ended December 31, 2024 represents the issuance date fair value and remeasurement adjustment of the SEPA put option with Yorkville.
Removed
Net cash used in operating activities was due to our net loss of $23.2 million adjusted for non-cash items of $31.4 million, primarily consisting of the redemption of public shares in connection with the Business Combination causing the withdrawal of $29.0 million of cash held in the trust account, $0.9 million business combination cost, $0.4 million extension loan, and use of cash for operating assets and liabilities of $1.1million due to the timing of cash payments to vendors and cash receipts from customers.
Added
The fair value is primarily driven by expected sales of our Common Stock to Yorkville and projections on the future path of the Company’s stock price during the commitment period. During the year ended December 31, 2023, we did not have the SEPA arrangement.
Removed
By comparison, the Company’s net cash provided by operating activities was $87.2 million during the year ended December 31, 2022.
Added
Change in Fair Value of Convertible Promissory Notes There was no change in fair value of our Convertible Promissory Notes (as defined below) in 2024 because all previously outstanding principal and accrued interest was converted into shares of Common Stock at the closing of the Business Combination.
Removed
Net cash provided by operating activities was due to our net loss of $6.2 million adjusted for non-cash items of $93.5 million, primarily consisting of the redemption of public shares in connection with the Business Combination causing the withdrawal of $88.3 million of cash held in trust account $1.6 million of stock-based compensation expense, $2.5 million extension loan, less $0.5 million and use of cash for operating assets and liabilities of $.5 million due to the timing of cash payments to vendors and cash receipts from customers.
Added
As a result, no obligation remained on our Convertible Promissory Notes immediately after the Business Combination. The change in fair value in 2023 was due to the resulting fluctuations in the market price of shares of Common Stock .
Removed
Financing Activities Net cash flows from financing activities was ($8.4 million) for the year ended December 31, 2023, which primarily consisted of $10.7 million repayment on convertible promissory note payable, $1.5 million proceeds from issuance of PIPE Convertible Notes and Warrants, $0.5 proceeds from related loan, $28.8 million from Common Stock subject to redemption in connection with the Business Combination, $0.5 million underwriting fee related to the Business Combination, $0.3 million decrease in warrant liability, $18.2 million additional paid in capital and $11.6 million retained earning adjustment.

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