UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
☒
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31 , 2023
or
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ___ to ___
Commission
File Number: 001-40386
ONEMEDNET
CORPORATION
(Exact
name of registrant as specified in its charter)
Delaware
86-2076743
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
6385
Old Shady Oak Road , Suite 250
Eden
Prairie , MN
55344
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code: ( 800 )
918-7189
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol
Name
of each exchange on which registered
Common
stock, par value $0.0001 per share
ONMD
The
Nasdaq Stock Market LLC
Redeemable
Warrants, each exercisable for one share of Common Stock at an exercise price of $11.50 per share
ONMDW
The
Nasdaq Stock Market LLC
Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. Yes ☐ No ☒
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).
Yes ☐ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company”
in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
Smaller
reporting company ☒
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☒ No ☐
As
of April 2, 2024, the aggregate market value of the common equity of the registrant held by non-affiliates was $ 88,480
(based on the closing sales price of the shares of common stock on April 2, 2024 of $0.79.
As
of April 2, 2024, there were there were 23,850,010 shares of common stock, par value $0.0001 per share, issued and outstanding, and
0 shares of preferred stock, par value $0.0001 per share, of the registrant issued and outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
The
registrant intends to file a definitive proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended
December 31, 2023. Portions of such proxy statement are incorporated by reference into Items 10, 11, 12, 13, and 14 of Part III of this
Annual Report on Form 10-K.
As
used in this Annual Report on Form 10-K, unless otherwise indicated or the context otherwise requires, references to “we,”
“us,” “our,” “OneMedNet” and the “Company” refer OneMedNet Corporation (f/k/a Data Knights
Acquisition Corp.), a Delaware corporation, and its consolidated subsidiaries following the effective time of the business combination
between Data Knights Acquisition Corp. and OneMedNet (the “Business Combination”) pursuant to an agreement and plan of merger,
dated April 25, 2022 (the “Merger Agreement”), by and among Company, Data Knights Merger Sub, Inc., a Delaware corporation
and a wholly-owned subsidiary of the Company (“Merger Sub”), OneMedNet, Data Knights, LLC, a Delaware limited liability company
(“Sponsor” or “Purchaser Representative”) that closed on November 7, 2023.
ONEMEDNET
CORPORATION
ANNUAL
REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2023
INDEX
Page
PART I
Item
1.
Business
1
Item
1A.
Risk Factors
15
Item
1B.
Unresolved Staff Comments
22
Item
1C.
Cybersecurity
22
Item
2.
Properties
23
Item
3.
Legal Proceedings
23
Item
4.
Mine Safety Disclosures
23
PART II
Item
5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
24
Item
6.
[Reserved]
25
Item
7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
25
Item
7A.
Quantitative and Qualitative Disclosures About Market Risk
32
Item
8.
Financial Statements and Supplementary Data
34
Item
9.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosures
35
Item
9A.
Controls and Procedures
35
Item
9B.
Other Information
35
Item
9C.
Disclosure Regarding Foreign Jurisdiction that Prevent Inspections.
35
PART III
Item
10.
Directors, Executive Officers and Corporate Governance
36
Item
11.
Executive Compensation
36
Item
12.
Security Ownership of Certain Beneficial Owner and Management and Related Stockholder Matters
36
Item
13.
Certain Relationships and Related Transactions, and Director Independence
36
Item
14.
Principal Accounting Fees and Services
36
PART IV
Item
15.
Exhibits, Financial Statement Schedules
37
Item
16.
Form 10-K Summary
38
Signatures
39
i
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
statements that we make from time to time, including statements contained in this Annual Report on Form 10-K constitute “forward-looking
statements” within the meaning Private Securities Litigation Reform Act of 1995, and of Section 27A of the Securities Act of 1933,
as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements
other than statements of historical facts contained in this Annual Report on Form 10-K are forward-looking statements. The forward-looking
statements in this Annual Report on Form 10-K are only predictions. We have based these forward-looking statements largely on our current
expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and
results of operations. In some cases, you can identify these forward-looking statements by terms such as “anticipate,” “believe,”
“continue,” “could,” “depends,” “estimate,” “expects,” “intend,”
“may,” “ongoing,” “plan,” “potential,” “predict,” “project,”
“should,” “will,” “would” or the negative of those terms or other similar expressions, although not
all forward-looking statements contain those words. We have based these forward-looking statements on our current expectations and projections
about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term
business operations and objectives, and financial needs.
Our
operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could
materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. We have based
these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may
affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives,
and financial needs. Forward-looking statements in this Annual Report on Form 10-K include, without limitation, statements reflecting
management’s expectations for future financial performance and operating expenditures (including our ability to continue as a going
concern, to raise additional capital and to succeed in our future operations), expected growth, profitability and business outlook, and
operating expenses.
Forward-looking
statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our
actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements.
These factors include, among other things, the unknown risks and uncertainties that we believe could cause actual results to differ from
these forward looking statements as set forth under the heading, “Risk Factors” and elsewhere in this Annual Report on Form
10-K. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all of the risks and uncertainties
that could have an impact on the forward-looking statements, including without limitation, risks and uncertainties relating to:
●
our
projected financial position and estimated cash burn rate;
●
our
estimates regarding expenses, future revenues and capital requirements;
●
our
ability to continue as a going concern;
●
our
ability to raise substantial additional capital in sufficient amounts or on acceptable terms to fund our operations and our business
plan;
●
our
ability to reverse the recent decline in our revenue and resume growing our revenue;
●
our
ability to compete in the global space industry;
●
our
ability to obtain and maintain intellectual property protection for our current products and services;
●
our
ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce or
protect our intellectual property rights;
●
the
possibility that a third party may claim we have infringed, misappropriated or otherwise violated their intellectual property rights
and that we may incur substantial costs and be required to devote substantial time defending against
these
claims;
●
our
reliance on third-party suppliers and manufacturers;
●
the
success of competing products or services that are or become available;
●
our
ability to expand our organization to accommodate potential growth and our ability to retain and attract key personnel;
and
●
the
potential for us to incur substantial costs resulting from lawsuits against us and the potential for these lawsuits to cause us to
limit our commercialization of our products and services.
ii
These
forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk
Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is
not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which
any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements
we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus
may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
You
should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected
in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events
and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither
we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation
to update publicly any forward-looking statements for any reason after the date of this prospectus to conform these statements to actual
results or to changes in our expectations.
You
should read this prospectus and the documents that we reference in this prospectus and have filed with the SEC as exhibits to the registration
statement of which this prospectus is a part with the understanding that our actual future results, levels of activity, performance and
events and circumstances may be materially different from what we expect. As a result of a number of known and unknown risks and uncertainties,
our actual results or performance may be materially different from those expressed or implied by these forward-looking statements including
those described in the “Risk Factors” section beginning on page 31 and elsewhere in this prospectus.
iii
PART
I
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. 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. 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
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. 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. 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. At
present, OneMedNet works with more than 95 facilities who provide regulatory grade imaging to us. OneMedNet has access to these more
than 95 facilities because these 95+ contracted facilities have more than 200 locations among them including offices and clinics, which
in total generates regulatory grade imaging from more than 200 customers. Among these customers, all are data providers and some are
data purchasers.
OneMedNet
is ahead of the curve when it comes to providing fast and secure access to curated medical images. Initially, it was all about solving
the diverse access needs of patient care providers. This focus systematically evolved to addressing the rapidly growing needs of image
analysis and researchers, clinicians, regulators, scientists and more.
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.
A
key component driving its mission is that OneMedNet believes we have a unique opportunity to affect a material positive impact on the
lives of tens of millions of people while improving our customers’ business productivity. 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. 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.
Utilization of highly reliable and quality Real-World Data that strictly adheres to all of the very specific data stratification requirements
can supplement or supplant clinical trials.
OneMedNet
covers the complete value chain in imaging Real-World Data; it begins with our 10+ year federated network of providers and is supported
by a multi-faceted data curation process managed by an expert in-house clinical team. Additionally, we work hand-in-hand with our Life
Science partners regarding the Case Selection Protocol and when required producing Case Report Forms for regulatory clearance. We are
focused on delivering value by supporting Life Science Advancements with OneMedNet’s iRWD TM which holds the key to unlocking
boundless patient care advances. We unleash the power of research-grade image-centric iRWD TM that is highly curated to painstakingly
meet every cohort requirement and stand up to all of the rigors of prospective clinical trials.
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. 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. Health care providers such as hospitals, clinics,
and imaging centers can also accelerate life science patient care innovations by sharing de-identified data in a well-defined and de-identified
and secure manner. In return for doing so, income is generated and applied to critical and possibly unfunded provider projects.
The
OneMedNet Difference
OneMedNet
has been a leader in the business of extracting, securing, and transferring medical data for 12+ years. 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.
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. 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. 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. 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.
We
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. Importantly, Life Science users receive the data in the exact format that they require.
No data sifting or manipulation is needed. The data is simply ready for use. 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.
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.
Industry
Background
A
2016 analysis published in the Journal of Health Economics and authored by the Tufts Center for the Study of Drug Development placed
the cost of bringing a drug to market, including post-approval research and development, at a staggering $2.87 billion. 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. This places the onus on life science organizations to find ways
to deliver treatments to patients faster — especially those who cannot wait 17 years for a potentially life-saving
treatment. Knowing how a medicinal product is actually used by patients can help stakeholders across the healthcare ecosystem make important
and potentially life-saving real-time decisions.
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 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. 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. 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.
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. 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; 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. 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. From
identifying unmet medical needs and defining the patient journey, to supporting regulatory submissions, proving value to payers, and
shaping market strategies, Real-World Data adds value at every stage of the drug development lifecycle. Real-World Data also sets the
foundation for Real World Evidence, and while the terms are often used interchangeably, they are distinct and they are changing health
care. Here’s how it happens:
1.
First,
Real-World Data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of
sources. Real-World Data is aggregated and transformed such as through OneMedNet’s robust analytics. Real-World Data are the
data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. 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. These add critical information
to enable stakeholders to best serve the needs of the populations they serve.
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. 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. 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, electronic health records, labs, data etc. 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.
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.
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. That analysis looked at 94 applications that were submitted from 2011-2020 and showed
that inclusion of Real-World Data to support regulatory decision-making has increased dramatically over that period. In 2020 alone, there
were 28 submissions for oncology products that contained Real-World Data. 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. 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.
The application included data from a randomized clinical trial, with additional evidence of effectiveness provided by a registry-based
clinical study that was conducted using real-world data from the Center for International Blood and Marrow Transplant Research. 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.
AI
is employed in Real-World Data to enhance data anomaly detection, standardization, and quality checking at the pre-processing stage.
AI is expected to offer pharma and biotech companies the ability to increase meaningful Real World Evidence output, decrease time to
insights, and make the most of the available vast data sources. A Real World Evidence technology platform that delivers smart data processing,
analysis, and outcomes offers an unparalleled opportunity to capitalize on these computing advancements.
When
used as part of an overall comprehensive Real World Evidence strategy, AI innovations can enhance drug development, improve patient treatment
and access, and drive valuable new business opportunities.
In
post-marketing studies, adverse events reporting is an area where AI is used, creating greater automation and efficiency in historical
data sets. Techniques like natural language processing (“NLP”) enable AI to scan tens of thousands of records and quickly
find adverse event details. 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. We believe that AI-enabled technologies have unparalleled potential
to offer innovative trial design and collection, organizing, and analyzing the increasing amount of data generated by clinical trials.
AI has many applications in clinical trials, both short and long-term. AI technologies make possible innovations crucial for transforming
clinical trials, such as seamlessly combining Phases I and II, developing novel patient-centered endpoints, and collecting and analyzing
Real-World Data.
OneMedNet
believes that AI tools also have wider benefits for hospitals and health systems. 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). Although diagnostic images generally do not warrant the same level of privacy concerns as
genomic data, researchers must also remove facial characteristics or other features that could identify a patient.
Digital
image analysis can be used to support research and development by analyzing large volumes of tissue specimens or other medical images
to run molecular screens that model biomarkers and treatment responses by transplanting a portion of a patient’s tumor into humanized
mice or 3D tissue cultures derived from stem cells that resemble miniature organs. These models allow researchers to conduct controlled
laboratory experiments that can inform treatment approaches and link predicted treatment response to actual clinical outcomes by linking
this data to EHR, claims, and other sources of Real-World Data. Similarly, preclinical studies can be informed by safety assessments
conducted in animal models or studies of animal molecular biomarkers or anatomic abnormalities to minimize the burden on human study
participants. Findings can also inform clinical trial optimization by stratifying participants according to predicted response and determining
appropriate eligibility criteria.
2.
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
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.
Evaluating
Real-World Evidence in the context of regulatory decision-making depends not only on the evaluation of the methodologies used to generate
the evidence but also on the reliability and relevance of the underlying Real-World Data; these constructs may raise different types
of considerations. 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. It has carried this out for nine potential safety issues involving five products.
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).
Unlike
traditional clinical trials, where necessary data elements can be curated and collection mandated, the creation of Real World Evidence
requires assessing, validating and aggregating various, often disparate, sources of data available through routine clinical practice.
Real-world evidence is used by different stakeholders in many different ways.
●
It
gives life sciences companies insight into how their drugs are being used.
●
It
helps providers improve the delivery of care.
●
It
enables regulatory authorities to monitor post-market safety and adverse events.
●
It
helps payers assess outcomes from treatments.
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). 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.
Validating
and supplementing blended data through editable eCRFs.
6.
Defining
and calculating clinically relevant outcomes and measures.
7.
Appropriately
assessing and controlling for variability in data quality, availability and confounding patient factors affecting measured
outcomes.
8.
Real
World Evidence can provide a holistic view of patients that in many cases cannot be studied through traditional clinical trials.
Real
World Evidence has been proven to fill a gap between research (what we learn) and everyday practice (what we do) in healthcare, and it
creates a difference between what is expected to happen and what really happens. Driving measurable improvements in healthcare requires
us all to be rooted in the reality of what actually happens before, during, and after clinical procedures, interventions, and office
visits. 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. 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. 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. In this environment, Real World Evidence can be transformative for the industry when Real-World
Data is combined with the right technology framework and the regulatory intelligence to make sense of it. As data is consumed across
life sciences in different ways and by different stakeholders, it can provide valuable insights and “evidence” across the
product life cycle. In addition, stakeholders across the healthcare ecosystem use this new knowledge to support decision-making and improve
safety and effectiveness, and ultimately, patient outcomes.
Uses
of Real World Evidence in Life Sciences, Among Regulators, Clinicians, Researchers and Healthcare Systems
According
to repeated studies by Deloitte, the importance of Real World Evidence continues to rise as it promises to accelerate regulatory decision-making
and support the approval of new indications for drugs already on the market. Life Sciences, pharmaceutical and medical device companies
are significant consumers of Real World Evidence because it can provide value across the entire product lifecycle from pre-trial design
to clinical studies and trials to post-market surveillance. Medical product developers are using Real World Evidence to support clinical
trial designs ( e.g., large simple trials, pragmatic clinical trials) and observational studies to generate innovative, new treatment
approaches.
Real
World Evidence can be used to make clinical trials more effective and efficient, for example in patient recruitment or label extension,
Real World Evidence gathered from other studies or from currently marketed products in a similar category, for example, can have a positive
effect on the product portfolio by exposing positive side effects as new potential indications. The most famous example is Viagra, which
was initially studied as a drug to lower blood pressure, but an unexpected side effect led to the drug ultimately being approved for
erectile dysfunction.
The
benefits of Real World Evidence derived from Real-World Data are increasingly being recognized by regulatory authorities. The FDA released
a framework for using Real World Evidence to support the process of drug regulation and submission. This is a major step toward recognizing
that clinical trials, while still relevant, are not the only way to assess the efficacy and safety of a product. 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. 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. In a recent statement, the FDA even noted how new tools for capturing data in the post-market period, including
more sophisticated use of Real-World Data and Real-World Evidence are providing new approaches to address important questions about the
safety and benefits of new drugs in real world settings and that these approaches have the potential to do to so more rapidly and with
greater efficiency than traditional methods.
Why
Do We Need Real-World Evidence?
There
is a gap between research (what we learn) and everyday practice (what we do) in healthcare, and it creates a difference between what
is expected to happen and what really happens. But it is what really happens that matters. Driving measurable improvements in healthcare
requires us all to be rooted in the reality of what actually happens before, during, and after clinical procedures, interventions, and
office visits. Real-World Evidence is here to fill those gaps and root us in truth. It tells us what really happens when doctors treat
a wide range of patients that don’t 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.
Uses
of Real-World Evidence in Pharmaceutical and Device Companies
Pharmaceutical
and medical device companies are major consumers of Real-World Evidence, as it can provide value across the entire product lifecycle.
Real-World Evidence plays an important role for research across the product lifecycle for both pharmaceutical and device companies. It
can inform pre-trial study design by helping researchers identify potential patients and create proper inclusion criteria for clinical
trials. Much of medical innovation is driven by traditional clinical trials, where new pharmaceuticals and devices are rigorously studied
and tracked before they can be sold and widely distributed.
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. Clinical trial participation is often
limited by who the study administrators are able to recruit, and various demographics are often not able to participate. This again challenges
the generalizability of clinical trial results across patient populations. Real-world evidence can help overcome the limitations of clinical
trials by providing information about a broader cross-section of society. 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.
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 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. 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.
One of the most important elements of a clinical trial is a selection of high-functioning investigator sites. Site qualities such as
resource availability, administrative procedures, and experienced clinicians with in-depth knowledge and understanding of the disease
can shape study timelines and data quality, accuracy, completeness, and consistency.
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. To comply with trial adherence criteria, patients must keep detailed records of their medication
intake and other data points related to their bodily functions, response to medication, and daily protocols. This can be an overwhelming
and tedious task, leading to 40% of patients becoming non-adherent after 150 days into a clinical trial. Wearable devices/sensors and
video monitoring are used to collect patient data automatically and continuously, thereby relieving the patient of this task. In combination
with wearable technology, AI techniques offer new approaches to developing real-time, power-efficient, mobile, and personalized patient
monitoring systems.
Among
regulators, clinicians, academic researchers and healthcare systems, the reliance on curated Real World Evidence has grown significantly
because of the value it can provide, which is unique relative to each parties’ objectives and mandates. It also helps that the
FDA has also sharpened its focus on Real-World Data and Real World Evidence. 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. 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.
AI
with deep-learning capability is also helpful in organizing and translating a vast amount of structured and unstructured data to RWE.
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 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. For instance, the increased demand for Real-World
Evidence solutions is prompting players to introduce new products, fostering market growth. In October 2023, Maxis Clinical Sciences
launched Real-World Evidence Solutions, providing diverse real-world data capture and analysis to improve clinical research and care.
Government
initiatives supporting Real-World Evidence programs, evolving regulations, and actionable Real-World Data enable organizations to conduct
outcomes-based analyses, contributing to the overall market expansion. For instance, in December 2022, the FDA launched the Real-World
Evidence Program. This program aims to raise awareness that Real-World Evidence can support regulatory decisions, identify approaches
for generating Real-World Evidence to meet post-approval study requirements or effectiveness labeling and develop agency processes that
foster consistent decision-making and shared learning regarding Real-World Evidence.
The
COVID-19 pandemic further accelerated the adoption of Real-World Evidence solutions, with governments collaborating with market players
to implement these solutions. For instance, in June 2021, ConcertAI and the FDA initiated a five-year collaborative research program,
Evaluation of Real-World Outcomes and Safety in the Treatment of Cancer . The partnership leverages ConcertAI’s oncology
Real-World Data and advanced AI technology solutions to generate Real-World Evidence for various clinical and regulatory use cases.
The
global real world evidence solutions market is projected to grow from $16.13 billion in 2023 to $36.24 billion by 2030, at a CAGR of
12.3%. The drug development and approvals segment accounted for the highest revenue share of around 28.9% in 2020. Real-world evidence
solutions services allow pharmaceutical companies and healthcare providers as well as payers for efficient management of operations and
accelerate the process of drug development and its approval, which fuels market growth. 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. 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. Based on end user, the global Real World Evidence solutions market is
segmented into pharmaceutical, biotechnology, and medical device companies; healthcare payers; healthcare providers; and other end-users
(academic research institutions, patient advocacy groups, regulators, and health technology assessment agencies). 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.
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.
In 2021, the real-world datasets segment is estimated to account for the larger share of 51.2% of the global real-world evidence solutions
market. 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%. There
is a rise in emphasis on evidence-based medicine that relies on Real-World Evidence, which comes from Real-World Data. Market players
in healthcare industries, including regulators, healthcare providers, and payers are becoming more aware of the importance of using
Real-World Data for making informed decisions regarding comparative effectiveness, treatment effectiveness, cost-effectiveness, and
safety. 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. 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. 17 The
use of Real-World Evidence derived from Real-World Data demonstrates value and cost-effectiveness of medical devices and drugs for
healthcare technology assessment agencies and payers. With this Real-World Evidence, market access becomes easier and it also enables
reimbursement negotiations. 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. We intend to focus on our target markets, which include (i) Imaging AI;
(ii) medical device companies; and (iii) pharmaceutical companies, as summarized here:
●
Enhance
and Refine Our Service Offering: Building on our customer-centric mindset throughout our development, curation and commercial
processes, we plan to continue expanding and improving our service offering. As we continue to expand into additional geographies
globally, we plan to build upon these three pillars
●
Expand
Our Product Offering: We plan to continually evaluate the benefits of expanding our portfolio into other high-growth, high-demand
Real-World Data and Real-World Evidence solutions in the future.
10
Corporate
Information
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 November 7, 2023, we held the Closing of the previously
announced Merger whereby Merger Sub 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.
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. We are
located at 6385 Old Shady Oak Road, Suite 250, Eden Prairie, MN 55344 and reachable by telephone on 800-918-7189.
The
information contained on our website is not incorporated by reference into this prospectus, and you should not consider any information
contained on, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our Common Stock.
OneMedNet
Corporation a Delaware corporation (the “Company,” “we,” “us,” or “OneMedNet”) together
with its wholly-owned subsidiary OneMedNet Solutions Corporation, a Delaware corporation, founded on October 13, 2009 in the State of
Hawaii and later incorporated in the State of Delaware on November 20, 2015 and its wholly-owned subsidiary, OneMedNet Technologies (Canada)
Inc., incorporated on October 16, 2015 under the provisions of the Business Corporations Act of British Columbia whose functional currency
is the Canadian dollar. All refences in this prospectus to the “Company,” “we,” “us,” or “OneMedNet”
include OneMedNet Solutions Corporation and its wholly-owned subsidiary, OneMedNet Technologies (Canada) Inc., incorporated on October
16, 2015 under the provisions of the Business Corporations Act of British Columbia whose functional currency is the Canadian dollar.
Recent
Developments
Closing
of Business Combination
OneMedNet
Corporation, a Delaware corporation (the “Company,” “we,” “us” or “OneMedNet”) together
with its wholly-owned subsidiary, OneMedNet Solutions Corporation, a Delaware corporation, and its wholly-owned subsidiary, OneMedNet
Technologies (Canada) Inc., incorporated under the provisions of the Business Corporations Act of British Columbia whose functional currency
is the Canadian dollar. All references in this prospectus to the “Company,” “we,” “us,” or “OneMedNet”
include OneMedNet Corporation and both OneMedNet Solutions Corporation and OneMedNet Technologies (Canada) Inc., except that references
to the “Company” “we,” “us,” or “Data Knights” in this Item 7 refer to OneMedNet Corporation
f/k/a Data Knights Acquisition Corp.
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.
On
November 7, 2023, following the approval at the special meeting of the shareholders of Data Knights Acquisition Corp., a Delaware corporation
held on October 17, 2023 (the “Special Meeting”), Data Knights Merger Sub, Inc., a Delaware corporation (“Merger Sub”)
and a wholly-owned subsidiary of Data Knights Acquisition Corp., a Delaware corporation (“Data Knights”), consummated a merger
(the “Merger”) with and into OneMedNet Solutions Corporation (formerly named OneMedNet Corporation), a Delaware corporation
(“OneMedNet”) pursuant to an agreement and plan of merger, dated as of April 25, 2022 (the “Merger Agreement”),
by and among Data Knights, Merger Sub, OneMedNet, Data Knights, LLC, a Delaware limited liability company (“Sponsor” or “Purchaser
Representative”) in its capacity as the representative of the stockholders of Data Knights, and Paul Casey in his capacity as the
representative of the stockholders of OneMedNet (“Seller Representative”). Accordingly, the Merger Agreement was adopted,
and the Merger and other transactions contemplated thereby (collectively, the “Business Combination”) were approved and completed.
At
the closing, on November 7, 2023, of the Business Combination pursuant to the Merger Agreement, Merger Sub merged with and into OneMedNet
with OneMedNet surviving the Merger, as a wholly-owned subsidiary of Data Knights, and Data Knights changed its name to “OneMedNet
Corporation.”
The
Business Combination was accounted for as a reverse recapitalization in accordance with U.S. GAAP. Under this method of accounting, Data
Knights was treated as the acquired company and OneMedNet Corporation was treated as the acquirer for financial statement reporting purposes.
Lock-up
Agreements
Effective
April 25, 2022, in connection with the execution of the Merger Agreement, certain stockholders of OneMedNet and certain of OneMedNet’s
officers and directors (such stockholders, the “Company Holders”) entered into a lock-up agreement (the “Lock-up Agreement”)
pursuant to which the Company Holders will be contractually restricted, during the Lock-up Period (as defined below), from selling or
transferring any of (i) their shares of OneMedNet common stock held immediately following the Closing and (ii) any of their shares of
OneMedNet common stock that result from converting securities held immediately following the Closing (the “Lock-up Shares”).
Effective November 7, 2023, the newly appointed officers and directors of OneMedNet Corporation have entered into a Lock-Up Agreement.
11
The
“Lock-up Period” means the period commencing at Closing and end the earliest of: (a) six months from the Closing, and (b)
the date after the Closing on which the Purchaser consummates a liquidation, merger, capital stock exchange, reorganization, or other
similar transaction with an unaffiliated third party that results in all of the Purchaser’s stockholders having the right to exchange
their shares of the Purchaser Common Stock for cash, securities, or other property: (i) lend, offer, pledge, hypothecate, encumber, donate,
assign, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right
or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any Restricted Securities, (ii) enter into any swap
or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Restricted
Securities, or (iii) publicly disclose the intention to do any of the foregoing, whether any such transaction described in clauses (i),
(ii), or (iii) above is to be settled by delivery of Restricted Securities or other securities, in cash or otherwise (any of the foregoing
described in clauses (i), (ii), or (iii), a “Prohibited Transfer”).
In
addition, the Sponsor is subject to a lock-up pursuant to a letter agreement (the “Sponsor Lock-up Agreement”), entered into
on May 6, 2021, at the time of the IPO (as defined below), among Data Knights, the Sponsor and each of the individuals who were a member
of Data Knights’ board of directors and/or management team (each, an “Insider” and collectively, the “Insiders”),
who agreed that it, he or she shall not transfer any founder shares which means the 2,875,000 shares of Data Knights Class B common stock,
par value $0.0001 per share, initially held by the Sponsor, or shares of OneMedNet’s Common Stock issuable upon conversion thereof)
until the earlier of (A) six months after the date of Data Knights’ initial Business Combination or (B) subsequent to the initial
Business Combination, (x) if the reported last sale price of the Common Stock equals or exceeds $12.00 per share (as adjusted for stock
splits, stock dividends, right issuances, reorganizations, recapitalizations and the like) for any 20 trading days within any 30-trading
day period commencing at least 150 days after the Company’s initial Business Combination, or (y) the date on which the Company
completes a liquidation, merger, capital stock exchange, reorganization or other similar transaction that results in all of our stockholders
having the right to exchange their shares of common stock for cash, securities or other property. Further, the Sponsor and each of the
Insiders agreed further in the Sponsor Lock-Up Agreement that he, she or it shall not transfer any private placement units, the private
placement shares, the private placement warrants or shares of Common Stock issued or issuable upon the exercise of the private placement
warrants, until 30 days after the completion of the initial Business Combination.
Registration
Rights Agreements
At
the Closing of the Business Combination and funding of the PIPE, the PIPE Investors each executed a PIPE Note and a PIPE Warrant in the
amount corresponding to each PIPE Investor’s investment amount and in accordance with the terms set forth in the PIPE SPA as well
as a registration rights agreement (the “PIPE Registration Rights Agreement”). We are registering the offer and sale of these
securities to satisfy the registration rights we have granted in the PIPE Registration Rights Agreement. At the Closing of the Business
Combination, OneMedNet, Data Knights and the Sponsor entered into a registration rights agreement (the “Registration Rights Agreement”),
pursuant to which, among other things, the Company is obligated to file a registration statement to register the resale of certain securities
of the Company held by the holders, as defined in the Registration Rights Agreement and the Sponsor. The Registration Rights Agreement
also provides the holders and the Sponsor with “piggy-back” registration rights, subject to certain requirements and customary
conditions.
Voting
Agreement and Sponsor Support Agreement
In
connection with entry into the Merger Agreement, the Company entered into voting agreements (the “Voting Agreements”) with
certain stockholders of OneMedNet representing approximately 55% of the outstanding voting power of OneMedNet’s equity securities
(the “OneMedNet Stockholders”) pursuant to which OneMedNet Stockholders agreed to vote their securities in favor of the approval
of the Merger Agreement and the Business Combination, be bound by certain covenants and agreements related to the Business Combination
and to take other customary actions to cause the Business Combination to occur.
In
connection with entry into the Merger Agreement, the Company, the Sponsor and OneMedNet entered into a sponsor support agreement (the
“Sponsor Support Agreement”) pursuant to which the Sponsor agreed to vote its Data Knights securities in favor of the approval
of the Merger Agreement and the Business Combination and to take other customary actions to cause the Business Combination to occur.
Executive
Employment Agreements
In
connection with the Closing of the Business Combination, the Company has entered into employment agreements (the “Employment Agreements”)
with executive officers: Aaron Green (President), Lisa Embree (Chief Financial Officer), and Paul Casey (Chief Executive Officer). The
Employment Agreements provide for at-will employment that may be terminated by the Company with or without cause, by the executive with
or without good reason, or mutually terminated by the parties.
The
Employment Agreement for Mr. Green provides for $350,000 annual salary, eligibility to receive an annual cash performance bonus of $175,000
upon his achievement of the performance goals set by the Company’s CEO and Board of Directors, and eligibility to receive 600,000
of the Company’s outstanding shares at closing, as part of the Company’s Restricted Stock Unit Plan, subject to the approval
of the Company’s Board of Directors. In the event that his employment is terminated by the Company without Cause (as defined in
the Employment Agreement), or is terminated by Mr. Green for Good Reason (as defined in the Employment Agreement), after six months of
employment, and he signs and does not revoke a standard release of claims with the Company in a form reasonably satisfactory to the Company’s
Board of Directors (a “Release”), which Release becomes irrevocable no later than sixty (60) days (the “Release Deadline”),
after the date of his termination of employment (the “Termination Date”) he will be entitled to the following severance payment,
as follows: (a) if the Termination Date is after six (6) months’ of employment, but before he has completed 12 months’ of
employment, he will receive three (3) months’ salary; and (b) if the Termination Date is after 12 months’ employment he will
receive six (6) months’ salary. If the Release does not become effective and irrevocable by the Release Deadline, he will forfeit
any right to severance.
12
The
Employment Agreement for Ms. Embree provides for $225,000 annual salary, eligibility to receive an annual cash performance bonus of twenty-five
percent (25%) of her annual salary upon her achievement of the performance goals set by the Company’s CEO and Board of Directors,
and eligibility to receive 260,000 of the Company’s outstanding shares, as part of the Company’s Restricted Stock Unit Plan,
subject to the approval of the Company’s Board of Directors. In the event that her employment with the Company is terminated by
the Company without Cause (as defined in the Employment Agreement) or is terminated by Ms. Embree for Good Reason (as defined in the
Employment Agreement) she will receive six (6) months’ salary as a Severance Payment.
The
Employment Agreement for Mr. Casey provides for $144,000 annual salary, eligible to receive 147,000 shares of stock upon the successful
fundraising of an amount equal to or greater than $5,000,000 and, as part of the Company’s Restricted Stock Unit Plan, further
equity will be rewarded to Mr. Casey subject to the approval of the Company’s Board of Directors. In the event that his employment
with the Company is terminated by the Company without Cause (as defined in the Employment Agreement) or is terminated by Mr. Casey for
Good Reason (as defined in the Employment Agreement) he will receive six (6) months’ salary as a Severance Payment.
Stock
Purchase Agreement
On
June 28, 2023, the Company and Data Knights entered into a Securities Purchase Agreement (the “PIPE SPA”) with certain investors
(collectively referred to herein as the “Purchasers”) for PIPE financing in the aggregate original principal amount of $1,595,744.70
and the purchase price of $1.5 million. Pursuant to the Securities Purchase Agreement, Data Knights will issue and sell to each of the
Purchasers, a new series of senior secured convertible notes (the “PIPE Notes”), which are convertible into shares of Common
Stock at the Purchasers election at a conversion price equal to the lower of (i) $10.00 per share, and (ii) 92.5% of the lowest volume
weighted average trading price for the ten (10) Trading Days immediately preceding the Conversion Date. The Purchasers’ $1.5 million
investment in the PIPE Notes closed and funded contemporaneous to the Closing of the Business Combination. Effective immediately prior
to the Closing, Data Knights issued the PIPE Notes to the Purchasers pursuant to the private offering rules under the Securities Act
of 1933, as amended (the “Securities Act”).
Government
Regulation
Many
aspects of our businesses are regulated by federal and state laws, rules and regulations. Accordingly, we maintain a robust compliance
program aimed at ensuring we operate our business in compliance with all existing legal requirements material to the operation of our
businesses. There are, however, occasionally uncertainties involving the application of various legal requirements, the violation of
which could result in, among other things, fines or other sanctions. See “Risk Factors” for additional detail.
Regulation
of Patient Information. 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. Federal, state and foreign governments are contemplating or have proposed or adopted
additional legislation governing the possession, use and dissemination of personal data, such as personal health information and personal
financial data, as well as security breach notification rules for loss or theft of such data. Additional legislation or regulation of
this type might, among other things, require us to implement additional security measures and processes or bring within the legislation
or regulation deidentified health or other data, each of which may require substantial expenditures or limit our ability to offer some
of our services.
In
particular, personal health information is recognized as a special, sensitive category of personal information, subject to additional
mandatory protections. Violations of data protection regulations are subject to administrative penalties, civil money penalties and criminal
prosecution, including corporate fines and personal liability.
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. Patient health information is among the most sensitive
of personal information, and it is critically important that information about an individual’s healthcare is properly protected
from inappropriate access, use and disclosure. Real world evidence — information that allows us to examine actual
practices and outcomes — is essential to increase access to care, improve outcomes, and lower costs.
OneMedNet
uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information
on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed
for better outcomes. 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. Our capabilities allow us to render data non-identified while still
maintaining data utility, thus protecting privacy while still advancing innovation. Not only do we make use of de-identification techniques
with respect to the data we hold, but we also share our expertise in this area with policymakers, regulators and others to help them
understand de-identification methodologies and practical considerations to avoid re-identification risk. 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.
Our
Compliance team, led by our Chief Compliance Officer, is comprised of privacy professionals and privacy law experts who drive our strategy
and develop and manage our policies and standards. 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, 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. It explains how, when applicable, we
collect, hold, use and disclose personal information, including that of our personnel, consumers, healthcare professionals, patients,
medical research subjects, clinical investigators, customers, suppliers, vendors, business partners and investors.
Regulatory
Quality Compliance (FDA 21 CFR Part 11)
OneMedNet
provides high-quality, de-identified, regulatory-grade imaging and clinical data; as such OneMedNet adheres to all applicable local and
Federal regulatory quality requirements, including but not limited to FDA 21 CFR Part 11. 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. 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.
Organizational
Structure
The
following is a current organizational chart of our Company:
Human
Capital Resources
Our
workforce is comprised of approximately 20 employees (as of December 31, 2023), including approximately 0 part-time employees
(references herein to “employees” include to the employees of our subsidiaries). Our Board of Directors and its committees
oversee human capital matters through regular reporting from management and advisors.
14
Diversity,
Equity and Inclusion
We
are committed to fostering a culture of inclusion that embraces and supports our patients, colleagues, partners, physicians and communities.
Our policies prohibit discrimination on the basis of age, gender, disability, race, color, ancestry, citizenship, religion, pregnancy,
sexual orientation, gender identity or expression, national origin, medical condition, marital status, veteran status, payment source
or ability, or any other basis prohibited by federal, state or local law.
Compensation
and Benefits
We
provide competitive compensation and benefits programs to help meet the needs of our employees. 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.
Facilities
Prior
to the closing of the Business Combination, the Company’s executive offices were located at Unit G6, Frome Business Park, Manor
Road, Frome, United Kingdom, BA11 4FN and its telephone number was +44 203 833 4000. The Company agreed to pay ARC Group Ltd., an affiliate
of the Sponsor, up to an amount of $10,000 per month for office space, secretarial and administrative support. For the nine months ended
September 30, 2023 and 2022, we had incurred $60,000 in fees under this agreement, respectively. Upon completion of our Business Combination,
the Company ceased paying these monthly fees.
After
the closing of the Business Combination, our headquarters is located at 6385 Old Shady Oak Road, Suite 250, Eden Prairie, MN 55344 and
our telephone number is (800) 918-7189, where we lease and occupy our office space with an aggregate floor area of approximately 67 square
feet from unrelated third parties under operating lease agreements. We believe the current office space is adequate for our current operations
and are adequate for our anticipated future needs.
Implications
of Being an Emerging Growth Company
As
a company with less than $1.235 billion in revenues during our last fiscal year, we qualify as an emerging growth company as defined
in the Jumpstart Our Business Startups Act (“JOBS Act”) enacted in 2012. As an emerging growth company, we expect to take
advantage of reduced reporting requirements that are otherwise applicable to public companies. 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.
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. 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. 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.
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. 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. 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.
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. 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. If we are unable to maintain listing of our securities on Nasdaq or any stock exchange,
our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and
it may be more difficult for our stockholders to sell their securities.
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. If we are unable to maintain listing on Nasdaq or if a liquid market for
our Common Stock does not develop or is sustained, our Common Stock may remain thinly traded.
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). 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. 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.
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. 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.
The
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. 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. If, for any
reason, we should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from trading on its
exchange and we are unable to obtain listing on another national securities exchange, a reduction in some or all of the following may
occur, each of which could have a material adverse effect on our stockholders:
●
the
liquidity of our Common Stock;
●
the
market price of our Common Stock;
●
our
ability to obtain financing for the continuation of our operations;
●
the
number of institutional and general investors that will consider investing in our Common Stock;
●
the
number of investors in general that will consider investing in our Common Stock;
●
the
number of market makers in our Common Stock;
●
the
availability of information concerning the trading prices and volume of our Common Stock; and
●
the
number of broker-dealers willing to execute trades in shares of our Common Stock.
Our
principal stockholders will continue to have significant influence over the election of our board of directors and approval of any significant
corporate actions, including any sale of the Company.
Our
founders, executive officers, directors, and other principal stockholders, in the aggregate, beneficially own a majority of our outstanding
stock. These stockholders currently have, and likely will continue to have, significant influence with respect to the election of our
board of directors and approval or disapproval of all significant corporate actions. The concentrated voting power of these stockholders
could have the effect of delaying or preventing an acquisition of the Company or another significant corporate transaction.
We
could be subject to securities class action litigation.
In
the past, securities class action litigation has often been brought against companies following a decline in the market price of their
securities. In 2020, 22% of securities class action litigation filings
were against defendants in the health technology and services sector, which accounted for 22% of new filings . 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.
The
trading market for our Common Stock will depend in part on the research and reports that securities or industry analysts publish about
us or our business. If research analysts do not establish and maintain adequate research coverage or if one or more of the analysts who
covers us downgrades our Common Stock or publishes inaccurate or unfavorable research about our business, the market price for our Common
Stock would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly,
we could lose visibility in the financial markets, which, in turn, could cause the market price or trading volume for our common stock
to decline.
We
do not expect to pay dividends in the foreseeable future, and you must rely on price appreciation of your shares of Common Stock for
return on your investment.
We
have paid no cash dividends on any class of our stock to date, and we do not anticipate paying cash dividends in the near term. For the
foreseeable future, we intend to retain any earnings to finance the development and expansion of our business, and we do not anticipate
paying any cash dividends on our stock. Accordingly, investors must be prepared to rely on sales of their shares after price appreciation
to earn an investment return, which may never occur. 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.
Future
sales of substantial amounts of our Common Stock or securities convertible into or exchangeable or exercisable for shares of Common Stock,
either by us or by our existing stockholders, or the possibility that such sales could occur, could adversely affect the market price
of our Common Stock.
Future
sales in the public market of shares of our Common Stock or securities convertible into or exchangeable or exercisable for shares of
Common Stock, shares held by our existing stockholders or shares issued upon exercise of our outstanding stock options or warrants, or
the perception by the market that these sales could occur, could lower the market price of our Common Stock or make it difficult for
us to raise additional capital.
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”). 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. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth
anniversary of the closing of our initial public offering, (b) in which we have total annual gross revenue of at least $1.235 billion
or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock held by non-affiliates
exceeds $700 million as of the end of our prior second fiscal quarter, and (2) the date on which we have issued more than $1 billion
in non-convertible debt during the prior three-year period.
In
addition, under the JOBS Act, emerging growth companies may delay adopting new or revised accounting standards until such time as those
standards apply to private companies. We may elect not to avail ourselves of this exemption from new or revised accounting standards
and, therefore, may be subject to the same new or revised accounting standards as other public companies that are not emerging growth
companies. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. 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.
Our
certificate of incorporation, bylaws and Delaware law contain provisions which could have the effect of rendering more difficult, delaying
or preventing an acquisition deemed undesirable by our board of directors. 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. As a Delaware
corporation, we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation law, which
prevents some stockholders holding more than 15% of our outstanding common stock from engaging in certain business combinations without
approval of the holders of substantially all of our outstanding common stock.
Any
provision of our certificate of incorporation, bylaws or Delaware law that has the effect of delaying or deterring a change in control
could limit the opportunity for our stockholders to receive a premium for their shares of our Common Stock and could also affect the
price that some investors are willing to pay for our Common Stock.
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. 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. 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. 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.
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. 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. 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.
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. 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. 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. 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.
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.
Our ability to manage our operations and growth effectively depends upon the continual improvement of our procedures, reporting systems
and operational, financial and management controls. We may not be able to implement administrative and operational improvements in an
efficient or timely manner and may discover deficiencies in existing systems and controls. If we do not meet these challenges, we may
be unable to execute our business strategies and may be forced to expend more resources than anticipated addressing these issues.
We
may acquire additional technology and complementary businesses in the future. 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.
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. 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.
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.
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 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. 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. 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. However, real-world data and real-world evidence
has been increasingly adopted and our current competitors have, and future competitors may have, greater resources than we do and may
also be able to devote greater resources to the development of their current and future technologies. 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. If a competing technology or process is developed that has superior operational or price performance,
our business will be harmed. Similarly, if we fail to accurately predict and ensure that our real-world data and real-world evidence
offering can address customers’ changing needs or emerging technological trends, or if our customers fail to achieve the benefits
expected from our real-world data and real-world evidence offering, our business will be harmed.
We
must continue to commit resources to develop our real-world data and real-world evidence technology in order to establish a competitive
position, and these commitments will be made without knowing whether such investments will result in products potential customers will
accept. There is no assurance we will successfully identify new customer requirements, develop and bring our real-world data and real-world
evidence to market on a timely basis, or that products and technologies developed by others will not render our real-world data and real-world
evidence obsolete or noncompetitive, any of which would adversely affect our business and operating results.
If
we are unable to attract and retain key employees and qualified personnel, our ability to compete could be harmed.
We
depend on the talents and continued efforts of our senior management and key employees. The loss of members of our management or key
employees may disrupt our business and harm our results of operations. Further, our ability to manage further expansion will require
us to continue to attract, motivate and retain additional qualified personnel. Competition for this type of personnel is intense, and
we may not be successful in attracting, integrating and retaining the personnel required to grow and operate our business effectively.
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.
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 . We cannot assure you that any backup systems will be adequate to protect us from
the effects of fire, floods, typhoons, earthquakes, power loss, telecommunications failures, break-ins, war, riots, terrorist attacks
or similar events. 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.
In
recent years, the United States and global economies suffered dramatic downturns as the result of the COVID-19 pandemic, a deterioration
in the credit markets and related financial crisis as well as a variety of other factors including, among other things, extreme volatility
in security prices, severely diminished liquidity and credit availability, ratings downgrades of certain investments and declining valuations
of others. The United States and certain foreign governments have taken unprecedented actions in an attempt to address and rectify these
extreme market and economic conditions by providing liquidity and stability to the financial markets. If the actions taken by these governments
are not successful, the return of adverse economic conditions may negatively impact the demand for iRWD TM offering and may
negatively impact our ability to raise capital, if needed, on a timely basis and on acceptable terms or at all.
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. 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. If we have experienced an ownership change
at any time since our incorporation, we may already be subject to limitations on our ability to utilize our existing NOLs and other tax
attributes to offset taxable income or tax liability. In addition, the Business Combination and future changes in our stock ownership,
which may be outside of our control, may trigger an ownership change. Similar provisions of state tax law may also apply to limit our
use of accumulated state tax attributes. As a result, even if we earn net taxable income in the future, our ability to use these or our
pre-change NOL carryforwards and other tax attributes to offset such taxable income or tax liability may be subject to limitations, which
could potentially result in increased future income tax liability to us.
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.
We
are subject to many hazards and operational risks that can disrupt our business, some of which may not be insured or fully covered by
insurance.
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. As a result of the COVID-19 outbreak, or
similar pandemics, we have and may in the future experience disruptions that could severely impact our business and the business of our
customers.
Our
insurance coverage may be inadequate to cover our liabilities related to such hazards or operational risks. 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. In addition, we may not be able to maintain adequate insurance
in the future at rates we consider reasonable and commercially justifiable, and insurance may not continue to be available on terms as
favorable as our current arrangements. 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.
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. Their limited experience in dealing with the increasingly complex laws pertaining to public companies
could be a significant disadvantage in that it is likely that an increasing amount of their time may be devoted to these activities which
will result in less time being devoted to the management and growth of our Company. We may not have adequate personnel with the appropriate
level of knowledge, experience, and training in the accounting policies, practices or internal controls over financial reporting required
of public companies in the United States. The development and implementation of the standards and controls necessary for us to achieve
the level of accounting standards required of a public company in the United States may require costs greater than expected. 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.
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. 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. 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. 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. 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. 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. Advocacy
efforts by stockholders and third parties may also prompt additional changes in governance and reporting requirements, which could further
increase costs.
20
If
securities or industry analysts do not publish or cease publishing research or reports about us, our business, or the market in which
we operate, or if they change their recommendations regarding our securities adversely, the price and trading volume of our securities
could decline.
The
trading market for our securities will be influenced by the research and reports that industry or securities analysts may publish about
us, our business, market or competitors. Securities and industry analysts do not currently, and may never, publish research on us. If
no securities or industry analysts commence coverage of us, our share price and trading volume would likely be negatively impacted. If
any of the analysts who may cover us change their recommendation regarding our shares of Common Stock adversely, or provide more favorable
relative recommendations about our competitors, the price of our shares of Common Stock would likely decline. If any analyst who may
cover us were to cease our coverage of us or fail to regularly publish reports on it, we could lose visibility in the financial markets,
which in turn could cause our share price or trading volume to decline.
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. 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. Any of the factors listed below could have a material adverse effect on your
investment in our securities. 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. The stock
market in general, and the Nasdaq in particular, have experienced price and volume fluctuations that have often been unrelated or disproportionate
to the operating performance of the particular companies affected. The trading prices and valuations of these stocks, and of our securities,
may not be predictable. A loss of investor confidence in the market for retail stocks or the stocks of other companies which investors
perceive to be similar to the Company could depress our share price regardless of our business, prospects, financial conditions or results
of operations. 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. 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. If we cannot raise additional capital when needed, our operations and prospects could be materially and adversely
affected.
We
can be expected to continue to sustain substantial operating expenses without generating sufficient revenues to cover expenditures. Over
time, we expect that we will need to raise additional funds, including through the issuance of equity, equity-related or debt securities
or through obtaining credit from financial institutions to fund, together with our principal sources of liquidity, ongoing costs, any
significant unplanned or accelerated expenses, and new strategic investments. We cannot be certain that additional capital will be available
on attractive terms, if at all, when needed, which could be dilutive to stockholders, and our financial condition, results of operations,
business and prospects could be materially and adversely affected.
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. 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. If and when the
Warrants become redeemable by us, we may exercise our redemption rights even if we are unable to register or qualify the underlying securities
for sale under all applicable state securities laws. As a result, we may redeem the Warrants, as set forth above even if the holders
are otherwise unable to exercise the Warrants.
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. 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.
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. The Audit Committee of the Board of
Directors has oversight of our cybersecurity program and is responsible for reviewing and assessing the Company’s cybersecurity
and data protection policies, procedures and resource commitment, including key risk areas and mitigation strategies. 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. The Company’s framework includes an
incident management and response program that continuously monitors the Company’s information systems for vulnerabilities, threats
and incidents; manages and takes action to contain incidents that occur; remediates vulnerabilities; and communicates the details of
threats and incidents to management, including the Director Product Management, Head of Data, as deemed necessary or appropriate. 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. OneMedNet maintains comprehensive identity and access management practices ( e.g., roles and access privileges
for each user; multi-factor authentication, privileged user accounts, single sign-on, user lifecycle management) and employs a variety
of security information and event management tools. 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. Information is classified into four categories
to help individuals apply the right level of controls and safeguards to information, applications and systems. Our cybersecurity program
focuses on all areas of our business, including cloud-based environments, data centers, devices used by employees and contractors, facilities,
networks, applications, vendors, disaster recovery / business continuity and controls and safeguards enabled through business processes
and tools. We continuously monitor for threats and unauthorized access.
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. Non-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. 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.
Item
2. Properties
Our
corporate headquarters is in Eden Prairie, Minnesota is leased on a month-to-month basis.
Item
3. Legal Proceedings
We
may be subject from time to time to various claims, lawsuits and other legal and administrative proceedings arising in the ordinary course
of business. Some of these claims, lawsuits and other proceedings may involve highly complex issues that are subject to substantial uncertainties,
and could result in damages, fines, penalties, non-monetary sanctions or relief.
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. Due 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
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 ”.
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. 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.
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.
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.
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
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. 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.
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.
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).
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.
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. 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. 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. 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.
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 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. 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 use of words such as “anticipate,” “estimate,” “expect,” “project,”
“intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with any
discussion of future operating or financial performance. From time to time, we also may provide forward-looking statements in other materials
we release to the public. 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. 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.
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”). 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.
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. 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”). 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. 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.
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. 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.
The
Company excludes from revenue taxes collected from a customer that are assessed by a governmental authority and imposed on and concurrent
with a specific revenue-producing transaction. The transaction price for the products is the invoiced amount. Advanced billings from
contracts are deferred and recognized as revenue when earned. Deferred revenue consists of payments received in advance of performance
under the contract. Such amounts are generally recognized as revenue over the contractual period. The Company receives payments from
customers based upon contractual billing schedules. Accounts receivable is recorded when the right to consideration becomes unconditional.
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. 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.
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.
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.
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). 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.
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%. 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.
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. 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. 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.
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.
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.
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.
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.
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. 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.
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. 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.
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.
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. 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.
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. 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. 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. 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.
The
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. The primary changes in working capital items, such as the changes in accounts receivable
and deferred revenue, result from the difference in timing of payments from our customers related to contract performance obligation.
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. 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.
By
comparison, the Company’s net cash provided by operating activities was $87.2 million during the year ended December 31, 2022.
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.
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.
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.
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.
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.
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.
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
future capital requirements will depend on many factors, including our growth rate, the timing and extent of spending to support research
and development efforts, the expansion of sales and marketing activities, the introduction of new and enhanced product and service offerings,
and the cost of any future acquisitions of technology or businesses. 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 preparing our
financial statements, we make estimates, assumptions, and judgments that can have a significant impact on our reported revenue, results
of operations, and net income or loss, as well as on the value of certain assets and liabilities on our balance sheet during and as of
the reporting periods. 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 may change as new events occur or additional information is
obtained, and we may periodically be faced with uncertainties, the outcomes of which are not within our control and may not be known
for a prolonged period of time. Because the use of estimates is inherent in the financial reporting process, actual results could differ
from those estimates.
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. A description of our revenue recognition policies is included in Note 2,
Summary of Significant Accounting Policies in the Notes to the Consolidated Financial Statements included elsewhere in this Annual
Report on Form 10-K.
Although
most of our sales agreements contain standard terms and conditions, certain agreements contain multiple performance obligations or non-standard
terms and conditions. For customer contracts that contain more than one performance obligation, we allocate the total transaction consideration
to each performance obligation based on the relative stand-alone selling price of each performance obligation within the contract. We
rely on either observable standalone sales or an expected cost plus a margin approach to determine the standalone selling price of offerings,
depending on the nature of the performance obligation.
As
we further discuss in Note 2, Summary of Significant Accounting Policies in the Notes to the Consolidated Financial Statements
included elsewhere in this Annual Report on Form 10-K, for contracts with customers entered into during fiscal years 2023 and 2022, revenue
from the sales of our iRWD and BEAM are recognized over time as the asset created by our performance does not have alternative use to
us and an enforceable right to payment for performance completed to date is present. We recognize revenue as work progresses, using costs
incurred to date relative to total estimated costs at completion. Incurred costs represent work performed, which correspond with and
best depict transfer of control to the customer. Contract costs are incurred over a period of time, which can span periods, and the estimation
of these costs requires management’s judgment. Due to the nature of the work required to be performed on the iRWD and BEAM and
our reliance on the availability the estimation of total revenue and cost at completion is complex, subject to many variables, and requires
significant judgment on a contract-by-contract basis. As part of this process, we review information including, but not limited to, any
outstanding key contract matters, progress towards completion and the related program schedule, identified risks and opportunities and
the related changes in estimates of revenue and costs. The risks and opportunities relate to our judgment about the delays that may or
may not be within our control. Risks and opportunities may also relate to supply chain trends and commodity pricing, as well as changes
in foreign currencies. Changes in estimates of net sales, cost of sales, and the related impact to operating profit are recognized on
a cumulative catch-up basis, which recognizes the cumulative effect of the profit changes on current and prior periods based on a performance
obligation’s percentage of completion in the current period. A significant change in one or more of these estimates could affect
the profitability of one of more of our performance obligations and could have a material impact on our financial condition and results
of operations.
Stock-based
Compensation
Prior
to the Business Combination, OneMedNet Corporation (now OneMedNet Solutions Corporation) had five authorized classes of membership interests,
consisting of a class of common units known as the Class A Common Units (the “Class A Units”), a class of preferred units
known as the Series A-2 Preferred Units (the “A-2 Preferred Units”), a class of preferred units known as the Series A-1 Preferred
Units (the “A-1 Preferred Units”), Convertible Notes, Stock Options units, known as the Options and Warrants units granted
to employees, officers, and directors pursuant to an incentive plan.
31
Following
the Business Combination, the Company has authorized 101,000,000 shares of common stock, including 100,000,000 shares of Common Stock
and 1,000,000 shares of Preferred Stock. In addition, the Company has three classes of warrants ( i.e. , Public Warrants, Private
Warrants and PIPE Warrants) issued and outstanding.
As
the Business Combination is accounted for as a reverse recapitalization, all periods prior to the Business Combination have been retroactively
adjusted using the Exchange Ratio as stipulated by the Merger Agreement for the equivalent number of shares outstanding immediately after
the Merger to effect the reverse recapitalization. The Class A Units, A-2 Preferred Units, A-1 Preferred Units, Options and Warrants
were converted into Common Stock using an exchange ratio of 1:1, the Convertible Notes were converted into Common Stock using an exchange
ratio of 2.5 per share. This is presented within the consolidated statements of changes in redeemable preferred and common units and
equity (deficit).
We
typically issue restricted stock units (“RSUs”) as stock-based compensation. For RSUs, the fair value is the closing market
price of the stock on the date immediately preceding the grant. We recognize compensation expense over the requisite service period for
awards expected to vest. We account for forfeitures as they occur, rather than applying an estimated forfeiture rate. The graded-vesting
method of expense recognition is applied to all awards with service-only conditions.
Certain
RSUs involve stock to be issued upon the achievement of certain performance conditions. Such RSUs become available, subject to time-based
vesting conditions if, and to the extent that, financial performance criteria for the applicable period are achieved. Accordingly, the
number of RSUs earned will vary based on the level of achievement of financial performance objectives for the applicable period. Until
such time that our financial performance can ultimately be determined, each quarter we estimate the number of RSUs to be earned based
on an evaluation of the probability of achieving the financial performance objectives. Such estimates are revised, if necessary, in subsequent
periods when the underlying factors change our evaluation of the probability of achieving the financial performance objectives. Accordingly,
stock-based compensation expense associated with performance-based RSUs may differ significantly from the amount recorded in the current
period.
The
assumptions used in calculating the fair value of stock-based compensation awards represent management’s best estimates, but these
estimates involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and we use
different assumptions, our stock-based compensation expense could be materially different in the future.
Warrant
transactions
PIPE
Warrants to purchase our shares of Common Stock may be accounted for as either liability or equity instruments depending on the terms
of the warrant agreements. The warrants issued by us are accounted for as equity instruments due to our ability to settle the warrants
through the issuance of units and the absence of terms which would require liability classification, including the rights of the grantee
to require cash settlement. We classify these equity instruments within additional paid-in capital on the consolidated balance sheets.
Private
Warrants to purchase units accounted for as liability instruments represent the warrants issued to significant shareholders and related
parties.
In
order to calculate warrant charges, we used the Black-Scholes pricing model, which required key inputs including volatility and risk-free
interest rate and certain unobservable inputs for which there is little or no market data, requiring us to develop our own assumptions.
We estimated the fair value of unvested warrants, considered to be probable of vesting, at the time. Based on that estimated fair value,
we determined warrant charges, which were recorded as a reduction of the transaction price.
Off-Balance
Sheet Arrangements:
As
of December 31, 2023, we had no off-balance sheet arrangements as defined in Instruction 8 to Item 303(b) of Regulation S-K.
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.
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.
Item
7A. Quantitative and Qualitative Disclosures About Market Risk
We
are exposed to market risk, including changes to interest rates and foreign currency exchange rates.
32
Interest
Rate Sensitivity
We
had cash and cash equivalents totaling $0.05 million and $0.30 million as of December 31, 2023, and December 31, 2022, respectively.
Cash and cash equivalents include cash on hand and investments with original maturities of three months or less, are stated at cost,
and approximate fair value. Our investment policy and strategy are focused on preservation of capital, supporting our liquidity requirements,
and delivering competitive returns subject to prevailing market conditions. We were not exposed to material risks due to changes in market
interest rates given the liquidity of the cash and investments with original maturities of three months.
Foreign
Currency Risk
Although
we are exposed to foreign currency risk from our international operations, we do not consider it to have a material impact. Certain transactions
of the Company and its subsidiaries are denominated in currencies other than the functional currency. Foreign currency transaction losses
totaled $23,109 for the year ended December 31, 2023, which is up from $13,066 for the year ended December 31, 2022, each of which were
recorded within other income, net on the consolidated statements of operations.
Credit
Risk
Financial
instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts
receivable.
The
Company’s cash and cash equivalents are generally held with large financial institutions. Although the Company’s deposits
may exceed federally insured limits, the financial institutions that the Company uses have high investment-grade credit ratings and,
as a result, the Company believes that, as of December 31, 2023, its risk relating to deposits exceeding federally insured limits was
not significant.
The
Company has no significant off-balance sheet risk such as foreign exchange contracts, options contracts, or other hedging arrangements.
The
Company believes its credit policies are prudent and reflect normal industry terms and business risk. The Company generally does not
require collateral from its customers and generally requires payment from zero to 90 days from the invoice date with typical terms of
30 days. As of December 31, 2023, three customers accounted for over 10% of the Company’s accounts receivable balance, and one
customer accounted for more than 10% of the Company’s accounts receivable balance as of December 31, 2022.
33
Item
8. Financial Statements and Supplementary Data
ONEMEDNET
CORPORATION
INDEX
TO THE CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 5041 )
F-1
Consolidated Balance Sheets
F-2
Consolidated Statements of Operations
F- 3
Consolidated Statements of Changes in Redeemable Preferred and Common Units and Equity (Deficit)
F- 4
Consolidated Statements of Cash Flows
F- 5
Notes to the Consolidated Financial Statements
F- 6
34
Report
of Independent Registered Public Accounting Firm
To
the shareholders and the board of directors of OneMedNet Corporation
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of OneMedNet Corporation as of December 31, 2023 and 2022, the related statements
of operations, stockholders' equity (deficit), and cash flows for the years then ended, and the related notes (collectively referred
to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial
position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for the years then ended,
in conformity with accounting principles generally accepted in the United States.
Substantial
Doubt about the Company’s Ability to Continue as a Going Concern
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note
2 to the financial statements, the Company has suffered recurring losses from operations and has a significant accumulated deficit. In
addition, the Company continues to experience negative cash flows from operations. These factors raise substantial doubt about the Company's
ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The financial statements
do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These
financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's
financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or
fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides
a reasonable basis for our opinion.
/s/
BF Borgers CPA PC
BF
Borgers CPA PC (PCAOB ID 5041)
We
have served as the Company’s auditor since 2022
Lakewood,
CO
April
9, 2024
F- 1
ONEMEDNET
CORPORATION
CONSOLIDATED
BALANCE SHEETS
December 31, 2023
December 31, 2022
Current Assets
Cash and cash equivalents
$ 47,008
301,730
Investments held in Trust
-
29,029,415
Accounts receivable, net of allowance
151,640
18,975
Prepaid expenses and other assets
165,538
100,945
Receivable from SPAC
900,152
Total current assets
364,186
30,351,217
Property and Equipment, Net
98,871
83,097
Total assets
$ 463,057
$ 30,434,314
Current Liabilities
Accounts payable & accrued expenses
4,184,398
2,814,570
Loan Amount due to related parties
11,200
11,500
Excise tax
113,353
-
Loan Extensions
2,991,679
-
Deferred revenues
253,997
183,683
Loan Payable
38,921
-
Convertible promissory notes
-
8,490,000
Canada Emergency Business Loan Act
44,673
-
Income tax payable
120,017
214,850
Franchise tax payable
-
69,966
Pipe Notes, net of discount including interest
1,549,820
-
Deferred underwriter fee payable
3,525,000
-
Total current liabilities
12,833,058
11,784,569
Long Term Liabilities
Convertible promissory note
1,500,000
Canada Emergency Business Loan Act
44,144
Accrued interest
690,772
Loan, related party of OMN
465,023
-
Warrant liabilities
24,582
362,558
Deferred underwriter fee payable
-
4,025,000
Working capital Loan
-
207,081
Extension loans
-
2,545,839
Total liabilities
13,322,663
21,159,963
Stockholders’ Equity (Deficit)
Preferred Series A-2, par value $ 0.0001 , 4,200,000 shares authorized and, 0 and 3,853,797 shares issued and outstanding as of December 31, 2023 and December 31, 2022
-
385
Preferred Shares A-1, par value $ 0.0001 , 4,400,000 shares authorized and, 0 and 3,204,000 shares issued and outstanding as of December 31, 2023 and December 31, 2022
-
320
Preferred value
-
320
Common Stock, par value $ 0.0001 , 30,000,000 shares authorized and 23,572,232 and 4,550,166 shares issued and outstanding as of December 31, 2023 and December 31, 2022
2,357
455
Data Knights Acquisition Corp. Class A Common Stock, par value $ 0.0001 , 4,200,000 shares authorized and, 0 and 3,853,797 shares issued and outstanding as of December 31, 2023 and December 31, 2022
-
59
Data Knights Acquisition Corp. Class A Common Stock, par value $ 0.0001 , 4,200,000 shares authorized and, 0 and 3,853,797 shares issued and outstanding as of December 31, 2023 and December 31, 2022
-
425
Common stock value
-
425
Commitments and contingencies
-
28,750,110
Additional paid in capital
42,220,714
24,032,561
Accumulated deficit
( 55,082,677 )
( 43,509,964 )
Total stockholders’ equity (deficit)
( 12,859,606 )
9,274,351
Total liabilities and stockholders’ equity (deficit)
$ 463,057
$ 30,434,314
The
accompanying notes are an integral part of these consolidated financial statements.
F- 2
ONEMEDNET
CORPORATION
CONSOLIDATED
STATEMENTS OF OPERATIONS
2023
2022
Year Ended
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 )
Other Expense (income)
14,831,206
( 5,195,822 )
Net loss
$ ( 23,205,456 )
$ ( 6,229,639 )
Loss per share of Common
Stock :(1)
Basic and Diluted
$ ( 0.98 )
N/M
Weighted-average shares of Common Stock outstanding:
Basic and Diluted
23,572,232
N/M
(1)
Loss
per share information has not been presented for periods prior to the Business Combination (as defined in Note 3, Business Combination ),
as it resulted in values that would not be meaningful to the users of these consolidated financial statements. Refer to Note 3, Business
Combination for further information. This has been indicated on these statements of operations as “N/M”.
The
accompanying notes are an integral part of these consolidated financial statements
F- 3
ONEMEDNET
CORPORATION
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
Data
Knights Acquisition Corp.
Data Knights Acquisition Corp.
Series
A-2 Preferred Stock
Series
A-1 Preferred Stock
Class
A-Common Stock
Class
B-Common Stock
Class
A-Common Stock
Additional
Paid-in
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Commitments
Capital
Deficit
Equity
Balances,
December 31, 2021
3,853,797
$ 385
3,204,000
$ 320
585,275
$ 59
2,875,000
$ 288
4,342,666
$ 434
$ 28,750,110
$ 19,607,173
$ ( 33,920,734 )
$ 14,438,035
Issuance
of common shares in exchange for services
-
200,000
20
-
199,980
200,000
Issuance
of common shares in exchange for cash at $ 1.00 per share
7,500
1
-
7,499
7,500
Issuance
of Data Knights Acquisition Corp. Class B Common Stock
1,378,517
137
-
2,825,823
2,825,960
Re-Measurement
of Data Knights Acquisition Corp. Class A Common Stock Subject to Possible Redemption
-
( 3,359,591 )
( 3,359,591 )
Stock-based
compensation expense
-
1,392,086
1,392,086
2022
net loss
-
-
-
-
-
( 6,229,639 )
( 6,229,639 )
Balances,
December 31, 2022
3,853,797
$ 385
3,204,000
$ 320
585,275
$ 59
4,253,517
$ 425
4,550,166
$ 455
$ 28,750,110
$ 24,032,561
$ ( 43,509,964 )
$ 9,274,351
Beginning
balance
3,853,797
$ 385
3,204,000
$ 320
585,275
$ 59
4,253,517
$ 425
4,550,166
$ 455
$ 28,750,110
$ 24,032,561
$ ( 43,509,964 )
$ 9,274,351
Stock-based
compensation expense
1,892,741
1,892,741
Preferred
Stock to Common Stock
( 3,853,797 )
( 385 )
( 3,204,000 )
( 320 )
-
-
7,057,797
706
-
7,057,091
7,057,092
Convertible
Notes to Common Stock
-
-
-
-
6,177,229
618
-
6,176,611
6,177,229
Stock
Options to Common Stock
-
-
-
-
612,670
61
-
612,609
612,670
Converting
of Warrants to Common Stock
-
-
-
-
3,859,464
386
-
3,859,078
3,859,464
Private
OneMedNet to ONMD Public Shares
-
-
-
-
( 2,257,326 )
( 226 )
-
( 2,257,100 )
( 2,257,326 )
Issuance
of PIPE Warrants
-
-
-
-
-
-
101,071
101,071
Converting
Data Knights Common Shares (A and B) to ONMD Public Shares
-
-
( 585,275 )
( 59 )
( 4,253,517 )
( 425 )
3,460,275
346
-
634,106
633,968
Common
stock redemption
-
-
-
-
-
( 28,750,110 )
( 28,750,110 )
Issuance
Public Shares
-
-
-
-
111,957
11
-
111,946
111,957
Retained
earnings adjustment
-
-
-
-
-
-
11,632,743
11,632,743
2023
net loss
-
-
-
( 23,205,456 )
( 23,205,456 )
Net loss
-
-
-
( 23,205,456 )
( 23,205,456 )
Balances,
December 31, 2023
0
$ 0
0
$ 0
0
$ 0
0
$ 0
23,572,232
$ 2,357
$ 0
$ 42,220,714
$ ( 55,082,677 )
$ ( 12,859,606 )
Ending
Balance
0
$ 0
0
$ 0
0
$ 0
0
$ 0
23,572,232
$ 2,357
$ 0
$ 42,220,714
$ ( 55,082,677 )
$ ( 12,859,606 )
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
ONEMEDNET
CORPORATION
CONSOLIDATED
STATEMENTS OF CASH FLOWS
December 31, 2023
December 31, 2022
Year Ended
December 31, 2023
December 31, 2022
Cash flow from Operating Activities
Net Loss
$ ( 23,205,456 )
$ ( 6,229,639 )
Adjustments to reconcile net loss to net cash flows from operating activities:
Depreciation and amortization
27,983
24,807
Business combination cost
900,152
-
Stock-based compensation expense
-
1,599,586
Cash Held in Trust Account
29,029,416
88,291,558
Prepaid Expenses
( 64,594 )
Other current assets
-
( 875,803 )
Accounts payable and accrued Expenses
1,369,825
1,929,787
Accounts receivable, net of allowance
( 132,665 )
72,767
Deferred Revenue & Customer Deposits
70,314
( 458,667 )
Amount due to related party
( 300 )
11,500
Exercise tax liability
113,353
Extension loan
445,840
2,545,838
Franchise tax payable
( 69,966 )
( 94,043 )
Income Tax Payable
( 94,833 )
214,850
Working capital loan
( 168,159 )
207,081
Net cash flows used in operating activities
$ 8,220,910
$ 87,239,622
Cash used for Investing Activities
Purchase of property and equipment
$ ( 43,757 )
$ ( 58,137 )
Cash flow from Financing Activities
Class B Common Stock
-
137
Proceeds (repayment) from issuance of convertible promissory note payable
( 10,680,772 )
5,543,162
Proceeds from issuance of PIPE Convertible Notes and Warrants
1,549,820
Proceed from related party loan
465,024
-
Proceeds from Canada Emergency Business Loan Act
529
( 2,754 )
Common Stock Subject to Redemption
( 28,750,109 )
( 88,549,890 )
Deferred underwriting fee
( 500,000 )
-
Warrant liability
( 337,976 )
( 4,489,110 )
Additional Paid-in Capital
18,189,350
2,825,823
Class A Common Stock
( 59 )
-
Class B Common Stock
( 425 )
-
Retained Earnings adjustment
11,632,743
( 3,359,594 )
Net cash flows from financing activities
( 8,431,875 )
( 88,032,226 )
Net change in cash and cash equivalents
( 254,722 )
( 850,741 )
Cash and Cash Equivalents, Beginning
301,730
1,152,471
Cash and Cash Equivalents, Ending
47,008
301,730
The
accompanying notes are an integral part of these consolidated financial statements.
F- 5
ONEMEDNET
CORPORATION
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
1.
Organization and Operations
OneMedNet
Corporation (the “Company”) is a healthcare software company with solutions focused on digital medical image management,
exchange, and sharing. The Company was incorporated in Delaware on September 20, 2006. The Company has been solely focused on creating
solutions that simplify digital medical image management, exchange, and sharing. The Company has one wholly-owned subsidiary, OneMedNet
Technologies (Canada) Inc., incorporated on October 16, 2015 under the provisions of the Business Corporations Act of British Columbia
whose functional currency is the Canadian dollar. The Company’s headquarters location is Eden Prairie, Minnesota.
On
November 7, 2023, as contemplated by the Company, Data Knights Merger Sub, Inc., a Delaware corporation (“Merger Sub”), and
Data Knights, LLC, the Merger Sub’s sponsor merged with and into OneMedNet Corporation, with OneMedNet Corporation surviving the
merger. The Business Combination is further described in Note 3, Business Combination.
Data
Knights Acquisition Corp Merger
On
November 7, 2023, we consummated a merger (the “Merger”) following
the approval at the special meeting of the shareholders of Data Knights Acquisition Corp., a Delaware corporation held on October 17,
2023 (the “Special Meeting”), Data Knights Merger Sub, Inc., a Delaware corporation (“Merger Sub”) and a wholly-owned
subsidiary of Data Knights Acquisition Corp., a Delaware corporation (“Data Knights”), consummated a merger (the “Merger”)
with and into OneMedNet Solutions Corporation (formerly named OneMedNet Corporation), a Delaware corporation (“OneMedNet”)
pursuant to an agreement and plan of merger, dated as of April 25, 2022 (the “Merger Agreement”), by and among Data Knights,
Merger Sub, OneMedNet, Data Knights, LLC, a Delaware limited liability company (“Sponsor” or “Purchaser Representative”)
in its capacity as the representative of the stockholders of Data Knights, and Paul Casey in his capacity as the representative of the
stockholders of OneMedNet (“Seller Representative”). Accordingly, the Merger Agreement was adopted, and the Merger and other
transactions contemplated thereby (collectively, the “Business Combination”) were approved and completed.
The
Business Combination was accounted for as a as a reverse
recapitalization with OneMedNet as the accounting acquirer under the accounting principles generally
accepted in the United States of America (“U.S. GAAP”). Accordingly, the financial statements of the combined company represent
a continuation of the financial statements of OneMedNet.
On
June 28, 2023, the Company and Data Knights entered into a Securities Purchase Agreement (the “SPA”) with certain investors
(collectively referred to herein as the “Purchasers”) for PIPE financing in the aggregate original principal amount of $ 1,595,744.70
and the purchase price of $ 1.5 million. Pursuant to the Securities Purchase Agreement, Data Knights will issue and sell to each of the
Purchasers, a new series of senior secured convertible notes (the “PIPE Notes”), which are convertible into shares of Common
Stock at the Purchasers election at a conversion price equal to the lower of (i) $10.00 per share, and (ii) 92.5% of the lowest volume
weighted average trading price for the ten (10) Trading Days immediately preceding the Conversion Date. The Purchasers’ $ 1.5 million
investment in the PIPE Notes closed and funded contemporaneous to the Closing of the Business Combination.
Effective
immediately prior to the Closing, OneMedNet, Inc. issued the PIPE Notes to the Purchasers under the private offering exemptions under
Securities Act of 1933, as amended (the “Securities Act”).
Risks
and Uncertainties
The
Company is subject to risks common to companies in the markets it serves, including, but not limited to, global economic and financial
market conditions, fluctuations in customer demand, acceptance of new products, development by its competitors of new technological innovations,
dependence on key personnel, and protection of proprietary technology.
As
previously reported on Form 8-K on February 9, 2024, the Company received written notice (the “Nasdaq Notice”), dated February
7, 2024, from the Nasdaq Stock Market (“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). 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.
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.
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. 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 Global Market if it meets the requirements for continued listing
thereon. The 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. There can be no assurance that the Company will be successful in maintaining the listing of its common stock
on the Nasdaq Global Market.
F- 6
2.
Summary of Significant Accounting Policies
Basis
of Presentation and Foreign Currency Translation
The
consolidated financial statements have been prepared in U.S. dollars, in accordance with accounting principles generally accepted in
the United States of America (“GAAP”). The accompanying consolidated financial statements include the accounts of the Company
and its wholly owned subsidiaries. The consolidated financial statements include 100% of the accounts of wholly-owned subsidiaries. All
intercompany balances and transactions have been eliminated in consolidation.
Business
Combination
We
account for business acquisitions under ASC Topic 805, Business Combinations (“ASC Topic 805”). The total purchase consideration
for an acquisition is measured as the fair value of the assets given, equity instruments issued, and liabilities assumed at the acquisition
date. Costs that are directly attributable to the acquisition are expensed as incurred. Identifiable assets (including intangible assets)
and liabilities assumed (including contingent liabilities) are measured initially at their fair values at the acquisition date. We recognize
goodwill if the fair value of the total purchase consideration is in excess of the net fair value of the identifiable assets acquired
and the liabilities assumed. We recognize a bargain purchase gain within Other income (expense), net, in the consolidated statement of
operations if the net fair value of the identifiable assets acquired and the liabilities assumed is in excess of the fair value of the
total purchase consideration. We include the results of operations of the acquired business in the consolidated financial statements
beginning on the acquisition date.
Use
of Estimates
The
preparation of consolidated financial statements in conformity with GAAP requires management to make estimates, judgments, and assumptions
that affect the reported amounts of assets, liabilities, revenue, and expenses, and the amounts disclosed in the related notes to the
consolidated financial statements. Actual results and outcomes may differ materially from management’s estimates, judgments, and
assumptions. Significant estimates, judgments, and assumptions used in these financial statements include, but are not limited to, those
related to revenue, useful lives and realizability of long-lived assets, accounting for income taxes and related valuation allowances,
and unit and stock-based compensation. Estimates are periodically reviewed in light of changes in circumstances, facts, and experience.
Operating
Segments
The
Company operates as one operating segment. Operating segments are defined as components of an enterprise for which separate financial
information is regularly evaluated by the chief operating decision maker (“CODM”), which is the Company’s Chief Executive
Officer, in deciding how to allocate resources and assess performance. The Company’s CODM evaluates the Company’s financial
information and resources and assesses the performance of these resources on a consolidated basis. The Company is not organized by market
and is managed and operated as one business. A single management team that reports to the chief executive officer comprehensively manages
the entire business. Accordingly, the Company does not accumulate discrete financial information with respect to separate divisions and
does not have separate operating or reportable segments. Since the Company operates in one operating segment, all required financial
segment information can be found in the consolidated financial statements.
Cash
and Cash Equivalents
Cash
and cash equivalents consist of highly liquid, short-term investments with a maturity of three months or less when purchased. Cash equivalents
consist of money market funds and are carried at cost, which approximates fair value. The balances, at times, may exceed FDIC Insured
limits. The Company believes that, as of December 31, 2023, its risk relating to deposits exceeding federally insured limits was not
significant.
Accounts
Receivable
Accounts
receivable are unsecured, recorded at net realizable value, and do not bear interest. Accounts receivable are considered past due if
not paid within the terms established between the Company and the customer. Amounts are only written off after all attempts at collections
have been exhausted. The Company determines the need for an allowance for doubtful accounts based upon factors surrounding the credit
risk of specific customers, historical trends and other information. As of December 31, 2023 and 2022, the Company established allowances
of $ 0 and $ 102,700 respectively. The net receivable balances outstanding are fully collectible.
The
Company believes its credit policies are prudent and reflect normal industry terms and business risk. The Company generally does not
require collateral from its customers and generally requires payment from 0 to 90 days from the invoice date. For the year ended December
31, 2023, there was 1 customer that accounted for 10 % or more of total revenue, and there were 2 customers that accounted for 10 % or
more of total revenue for the years ended December 31, 2022 . The following table represents these customers’ aggregate percent
of total revenue:
Schedule
Of Aggregate Percentage Revenue and Accounts Receivable
December 31, 2023
December 31, 2022
Year Ended
December 31, 2023
December 31, 2022
Customer 1
52 %
31 %
Customer 2
-
22 %
Aggregate Percent of Total Revenue
52 %
53 %
F- 7
As
of December 31, 2023, three customers accounted for more than 10 % of the Company’s accounts receivable balance, and two customers
accounted for over 10 % of the Company’s accounts receivable balance at December 31, 2022. The following table represents these
customers’ aggregate percent of total accounts receivable:
December 31, 2023
December 31, 2022
Year Ended
December 31, 2023
December 31, 2022
Customer 1
-
40 %
Customer 2
36 %
-
Customer 3
33 %
-
Customer 4
-
32 %
Customer 5
27 %
-
Aggregate Percent of Total Accounts Receivable
96 %
72 %
Aggregate Percent of Revenue and Accounts Receivable
96 %
72 %
Property
and Equipment
Property
and equipment are recorded at cost. The straight-line method is used for computing depreciation and amortization. Assets are depreciated
over their estimated useful lives ranging from three to five years. Cost of maintenance and repairs are charged to expense when incurred.
Impairment
of Long-Lived Assets
The
Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances
indicate that the carrying amount of an asset may not be fully recoverable. An impairment loss would be recognized when the estimated
future undiscounted net cash flows from the use of the asset are less than the carrying amount of that asset. There have been no losses
during the years ended December 31, 2023 or December 31, 2022.
Fair
Value of Financial Instruments
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes
the inputs to valuation methodologies used to measure fair value:
Level
1 — Valuations based on quoted prices for identical assets and liabilities in active markets.
Level
2 — Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets
and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other
inputs that are observable or can be corroborated by observable market data.
Level
3 — Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions
made by other market participants. These valuations require significant judgment.
We
measure the fair value of money market funds and certain marketable equity securities based on quoted prices in active markets for identical
assets or liabilities. Other marketable securities were valued either based on recent trades of securities in inactive markets or based
on quoted market prices of similar instruments and other significant inputs derived from or corroborated by observable market data. We
did not hold significant amounts of marketable securities categorized as Level 3 assets as of the years ended December 31, 2022 and December
31, 2023.
The
Company’s financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable, convertible notes
payable and certain privately issued warrants. The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable
financial instruments approximate their fair value due to their short-term nature. The Company’s Private Warrants estimated fair
values are provided by a third party pricing vendor and are reviewed by the Company’s management. The Private Warrants valuations
are based on unobservable inputs reflecting the vendor’s assumptions, consistent with reasonably available assumptions made by
other market participants and thus are classified as Level 3.
Revenue
Recognition
Revenue
is recognized in accordance with the five-step model set forth by Accounting Standards Update (“ASU”) 2014-09, Revenue from
Contracts with Customers (“Topic 606”), which involves identification of the contract, identification of performance obligations
in the contract, determination of the transaction price, allocation of the transaction price to the previously identified performance
obligations, and revenue recognition as the performance obligations are satisfied.
Revenue
from all customers is recognized when a performance obligation is satisfied by transferring control of a distinct good or service to
a customer. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit
of account under Topic 606. A contract’s transaction price is allocated to each distinct performance obligation in proportion to
the standalone selling price for each and recognized as revenue when, or as, the performance obligation is satisfied.
F- 8
Individual
promised goods and services in a contract are considered a performance obligation and accounted for separately if the good or service
is distinct. A good or service is considered distinct if the customer can benefit from the good or service on its own or with other resources
that are readily available to the customer and the good or service is separately identifiable from other promises in the arrangement.
The
transaction price for the products is the invoiced amount. Advanced billings from contracts are deferred and recognized as revenue when
earned. Revenue is recognized only to the extent that it is probable that a significant reversal of revenue will not occur and when collection
is considered probable The Company excludes from revenue taxes collected from a customer that are assessed by a governmental authority
and imposed on and concurrent with a specific revenue-producing transaction. Deferred revenue consists of payments received in advance
of performance under the contract. Such amounts are generally recognized as revenue over the contractual period. The Company receives
payments from customers based upon contractual billing schedules. Accounts receivable is recorded when the right to consideration becomes
unconditional. Payment terms on invoiced amounts typically range from zero to 90 days, with typical terms of 30 days.
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. 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.
Income
Taxes
The
Company is subject to U.S. federal, state and local income taxes. The Company accounts for income taxes in accordance with ASC Topic
740, Accounting for Income Taxes (“ASC Topic 740”), which requires the recognition of tax benefits or expenses on temporary
differences between the financial reporting and tax bases of its assets and liabilities by applying the enacted tax rates in effect for
the year in which the differences are expected to reverse. Such net tax effects on temporary differences are reflected on the Company’s
consolidated balance sheets as deferred tax assets and liabilities.
ASC
Topic 740 prescribes a two-step approach for the recognition and measurement of tax benefits associated with the positions taken or expected
to be taken in a tax return that affects amounts reported in the financial statements. The Company has reviewed and will continue to
review the conclusions reached regarding uncertain tax positions, which may be subject to review and adjustment at a later date based
on ongoing analyses of tax laws, regulations and interpretations thereof. To the extent that the Company’s assessment of the conclusions
reached regarding uncertain tax positions changes as a result of the evaluation of new information, such change in estimate will be recorded
in the period in which such determination is made. The Company reports income tax-related interest and penalties relating to uncertain
tax positions, if applicable, as a component of income tax expense
Deferred
tax assets are reduced by a valuation allowance when the Company believes that it is more-likely-than-not that some portion or all of
the deferred tax assets will not be realized. The Company provides deferred taxes at the enacted tax rate that is expected to apply when
the temporary differences reverse. The Company has recorded a full valuation allowance against the net deferred tax asset due to the
uncertainty of realizing the related benefits.
Patents
and Trademarks
Costs
associated with the submission of a patent application are expensed as incurred given the uncertainty of the patents resulting in probable
future economic benefits to the Company and are included in research and development expenses on the consolidated statements of operations.
Research
and Development
The
Company account for its research and development cost in accordance with ASC Topic 730, Research and Development (“ASC Topic 730”).
ASC Topic 730 requires that all R&D costs be recognized as an expense as incurred. However, some costs associated with R&D activities
that have an alternative future use (e.g., materials, equipment, facilities) may be capitalizable. For the years ended December 31, 2023
and December 31, 2022 research and development expenditures were charged to operating expense as incurred..
Stock-based
Compensation
The
Company has a stock-based compensation plan, which is described in more detail in Note 8. The fair value of stock option and warrant
grants are determined on the date of grant using the Black Scholes valuation model. Forfeitures of stock based awards are recorded as
the actual forfeitures occur. Stock based compensation expense is recognized over the service period, net of estimated forfeitures, using
the straight-line method. The Company converted all unvested stock based compensation awards to common shares in the year ended December
31, 2023.
F- 9
General,
and Administrative Expenses
General
and administrative expenses include all costs that are not directly related to satisfaction of customer contracts. General, and administrative
expenses include items for the Company’s selling and administrative functions, such as sales, finance, legal, human resources,
and information technology support. 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, intangible asset amortization,
and depreciation expense.
Emerging
Growth Company
The
Company is an emerging growth company, as defined in Section 2(a) of the Securities Act of 1933, as amended (the “Securities Act”),
as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Section 102(b)(1) of the JOBS Act exempts
emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that
is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are required to comply with the new or revised
financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply
with the requirements that apply to non-emerging growth companies but any such an election to opt out is irrevocable. The Company has
not elected to opt out of such extended transition period which means that when a standard is issued or revised and it has different
application dates for public or private companies, the Company, as an emerging growth company , can adopt the new or revised standard
at the time private companies adopt the new or revised standard.
Accounting
Pronouncements Not Yet Adopted
In
November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2023-07, Improvements to Reportable Segment
Disclosures (Topic 280). This ASU updates reportable segment disclosure requirements by requiring disclosures of significant reportable
segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and included within each reported
measure of a segment’s profit or loss. This ASU also requires disclosure of the title and position of the individual identified
as the CODM and an explanation of how the CODM uses the reported measures of a segment’s profit or loss in assessing segment performance
and deciding how to allocate resources. The ASU is effective for annual periods beginning after December 15, 2023, and interim periods
within fiscal years beginning after December 15, 2024. Adoption of the ASU should be applied retrospectively to all prior periods presented
in the financial statements. Early adoption is also permitted. This ASU will likely result in us including the additional required disclosures
when adopted. We are currently evaluating the provisions of this ASU and expect to adopt them for the year ending December 31, 2024.
In
December 2023, the Financial Accounting Standards Board issued an Accounting Standards Update (“ASU”) amending existing income
tax disclosure guidance, primarily requiring more detailed disclosure for income taxes paid and the effective tax rate reconciliation.
The ASU is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted and can be applied
on either a prospective or retroactive basis. We are currently evaluating the ASU to determine its impact on our income tax disclosures.
Recently
adopted accounting pronouncements
In
October 2021, the FASB issued ASU No. 2021-08, Accounting for Contract Assets and Contract Liabilities from Contracts with Customers
(ASC Topic 805). This ASU requires an acquirer in a business combination to recognize and measure contract assets and contract liabilities
(deferred revenue) from acquired contracts using the revenue recognition guidance in Topic 606. At the acquisition date, the acquirer
applies the revenue model as if it had originated the acquired contracts. The ASU is effective for annual periods beginning after December
15, 2022, including interim periods within those fiscal years. We adopted this ASU prospectively on January 1, 2023. This ASU has not
and is currently not expected to have a material impact on our consolidated financial statements.
3.
Business Combination
The
Business Combination was accounted for as a reverse recapitalization as OneMedNet Corporation was determined to be the accounting acquirer
under Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) Topic 805,
Business Combinations. This determination was primarily based on OneMedNet Corporation comprising the ongoing operations of the combined
entity, OneMedNet Corporation’s senior management comprising of all the senior management of the combined company, and the prior
shareholders of OneMedNet owning a majority of the voting power of the combined entity. Accordingly, for accounting purposes, the financial
statements of the combined entity upon consummation of the Business Combination represented a continuation of the financial statements
of OneMedNet Corporation with the merger being treated as the equivalent of OneMedNet issuing stock for the net assets of Data Knights
Inc., accompanied by a recapitalization. Operations prior to the Business Combination are presented as those of OneMedNet Corporation
in future reports of the combined entity.
4.
Going Concern
The
accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets
and satisfaction of liabilities and commitments in the normal course of business. The Company does not have adequate liquidity to fund
its operations through at least twelve months from the date these financial statements were available for issuance. The Company has an
accumulated deficit 55,082,677 as of year-end December 31, 2023 and $ 43,509,964 , as of year-end December 31, 2022 and has had negative
cash flows from operating activities for the year ended December 31, 2023. These conditions raise substantial doubt about the Company’s
ability to continue as a going concern. To continue in existence and expand its operations, the Company will be required to, and management
plans to, raise additional working capital through an equity or debt offering and ultimately attain profitable operations. If the Company
is not able to raise additional working capital, it would have a material adverse effect on the operations of the Company and continuing
research and development of its product. The consolidated financial statements do not include any adjustments relating to the recoverability
and classification of assets and liabilities that might be necessary should the Company be unable to continue as a going concern. The
Company’s continuation as a going concern is dependent upon its ability to continue receiving working capital cash payments and
generating cash flow from operations.
F- 10
5.
Property and Equipment
Property
and equipment are summarized as of December 31:
Schedule
of Property And Equipment
2023
2022
Computers
$ 246,578
$ 259,207
Furniture and equipment
35,708
3,785
Total Property and Equipment
282,286
262,992
Less: accumulated depreciation
( 183,415 )
( 179,895 )
Net Property and Equipment
$ 98,871
$ 83,097
Depreciation
and amortization expense was $ 27,983 and $ 24,807 for the years ended December 31, 2023 and 2022, respectively.
6.
Income Taxes
The
Company has generated both federal and state net operating losses (NOL) of approximately $ 21
million and $ 23 million, respectively, which if not used, will begin to expire in 2030 .
The Company believes that its ability to fully utilize the existing NOL carryforwards could be restricted on a portion of the NOL by
changes in control that may have occurred or may occur in the future and by its ability to generate net income. The Company has not yet
conducted a formal study of whether, or to what extent, past changes in control of the Company impairs its NOL carryforwards because
such NOL carryforwards cannot be utilized until the Company achieves profitability.
Components
of deferred income taxes are as follows as of December 31:
Schedule
of Deferred Income Taxes
2023
2022
Deferred Tax Assets
Net operating loss carry forward
$ 6,823,785
$ 6,973,587
Stock Compensation
1,035,947
481,144
Other
-
53,268
Gross deferred tax assets
7,859,732
7,507,999
Less valuation allowance
( 7,859,732 )
( 7,507,999 )
Net deferred tax assets
-
-
The
change in the valuation allowance was $ 351,734 and $ 1,384,220 for the years ended December 31, 2023 and 2022, respectively. The effective
tax rate for the years ended December 31, 2023 and 2022 differs from the federal and state statutory rates due to the full valuation
allowance. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority
would more likely than not sustain the position following an audit. The tax years from inception through December 31, 2023 remain subject
to examination by all major taxing authorities due to the net operating loss carryovers. The Company is not currently under examination
by any taxing jurisdiction. The Company did not incur any interest or penalties during the years ended December 31, 2023 or 2022.
As
a result of the Business Combination, the Company was appointed as the sole managing member of Data Knights. The Company is subject to
U.S. federal income taxes, in addition to state and local income taxes. The Company accounts for income taxes using the asset and liability
method, which requires the recognition of deferred tax assets and liabilities for the estimated future tax consequences attributable
to temporary differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective
tax base. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements
and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the temporary differences are expected
to be settled or recovered. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. In assessing
the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred
tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income
during the periods in which those temporary differences become deductible. The Company considers the scheduled reversal of deferred tax
liabilities, projected future income, and tax planning strategies in making this assessment.
The
Company has established a valuation allowance related deferred tax assets on deductible temporary differences, tax losses, and tax credit
carryforwards. The valuation allowance as of December 31, 2023 was $ 168.3 . The increase
in the valuation allowance in fiscal year 2023 of $ 155.7 million primarily relates to the
Company’s investment in Data Knights, and tax carryforward attributes.
F- 11
As
of December 31, 2023, the Company had a U.S. federal net operating loss carryforwards of $ 10.3
million and gross state net operating loss carryforwards of $ 8.9 million.
7.
Convertible Promissory Notes held by Related Party
During
2023, the Company entered various Convertible Promissory Notes (“Note”) with related party investors totaling $ 2,300,000
(2022 - $ 4,700,000 ) and unrelated party investors of $ 1,875,000 (2022 - $ 440,000 ). The Notes issued are unsecured and bear an interest
rate of six percent annually from the date of issuance until the outstanding principal is paid or converted. On November 11, 2022 the
Convertible note agreement was amended and restated in order to (i) provide for the sale and issuance to Purchasers from the effective
date of January 1, 2022 and after the date of this Agreement of up to an additional $ 5,000,000 aggregate principal amount of Notes and
warrants to purchase shares of the Company’s capital stock, (ii) provide for the sale and issuance to Purchasers who purchased
Notes under the Prior Agreement between the Effective Date and the date of this Agreement of warrants to purchase shares of the Company’s
common stock at an exercise price of $ 1.00 per share; (iii) extend the maturity date of all outstanding Notes from December 31, 2022
to November 7, 2023.
The
principal and unpaid accrued interest on each Note will convert: (i) automatically, upon the Company’s issuance of equity securities
(the “Next Equity Financing”) in a single transaction, or series of related transactions, with aggregate gross proceeds to
the Company of at least $ 5,000,000 , into shares of the Company’s capital stock issued to investors in the Next Equity Financing,
at a conversion price equal to the lesser of (A) a 20% discount to the lowest price per share of shares sold in the Next Equity Financing,
or (B) $2.50 per share; (ii) at the noteholder’s option, in the event of a defined Corporate Transaction while such Note remains
outstanding, into shares of the Company’s Series A-2 Preferred Stock at a conversion price equal to $ 2.50 per share; and (iii)
at the noteholder’s option, on or after the Maturity Date while such Note remains outstanding, into shares of the Company’s
Series A-2 Preferred Stock at a conversion price equal to $ 2.50 per share.
If
a Corporate Transaction occurs before the repayment or conversion of the Notes, the Company will pay at the closing of the Corporate
Transaction to each noteholder that elects not to convert its Notes in connection with such Corporate Transaction an amount equal to
the outstanding principal amount of such noteholder’s Note plus a 20% premium. “Corporate Transaction” means (a) a
sale by the Company of all or substantially all of its assets, (b) a merger of the Company with or into another entity (if after such
merger the holders of a majority of the Company’s voting securities immediately prior to the transaction do not hold a majority
of the voting securities of the successor entity) or (c) the transfer of more than 50% of the Company’s voting securities to a
person or group.
During
November 2019, the Company entered into a Convertible Promissory Note (“Note”) agreement with a related party investor. The
total amount of the Note is $ 1,500,000 . The Note is unsecured and bears interest at a rate of four percent annually from the date of
issuance until the outstanding principal is paid or converted. The Note matures on January 1, 2025. The Note shall automatically convert
into the next offering of preferred stock upon closing of such next equity financing. The number of shares of preferred stock to be issued
upon conversion shall be equal to the number obtained by dividing the outstanding principal and unpaid accrued interest owed on the date
of conversion, by the conversion price. The conversion price is 100 percent of the lowest price per share paid for the next equity preferred
stock by other investors in the next equity financing. In the event that prior to the conversion or repayment of amounts owed, the Company
completes a financing transaction in which the Company sells equity securities but such transaction does not qualify as next equity financing
(i.e., an “alternative financing”), then the principal and unpaid accrued interest may (upon written election of the purchaser
holding the Note) convert into the securities issued by the Company in the alternative financing. The number of alternative financing
equity securities to be issued upon such conversion shall be equal to the number obtained by dividing the outstanding principal and unpaid
accrued interest owed by an amount equal to 100 percent multiplied by the lowest price per share at which the alternative financing equity
securities are sold and issued for cash in the alternative financing.
As
of December 31, 2022 there was $ 9.9 million outstanding principal balance on the Notes and $ 690,771 in accrued interest, all included
in long-term liabilities on the balance sheet. There were no payments of principal or interest during 2022. In connection with the $ 5,140,000
in convertible notes issued in 2022, 2,056,000 in warrants were issued.
In
November 2023, the Business Combination between Data Knights and the Company triggered the Notes’ conversion to common stock. Approximately
$ 15.4 million of the total outstanding Notes plus accrued interest were converted at $ 2.50 per share of common stock.
8.
Canadian Emergency Business Loan Act (CEBA)
During
December 2020, the Company applied for and received a $ 44,673 USD CEBA loan. The loan was provided by the Government of Canada to provide
capital to organizations to see them through the current challenges and better position them to return to providing services and creating
employment. The loan is unsecured. The loan was interest free through December 31, 2023. If the loan is paid back by January 18, 2024,
$ 14,742 of the loan will be forgiven. If the loan is not paid back by January 18, 2023, the full $ 44,673 loan will be converted to loan
repayable over three years with a 5 % interest rate. The loan was paid back prior January 18, 2024. At December 31, 2023 the loans is
classified as Canada Emergency Business Loan Act under Current Liabilities on the Consolidated Balance Sheet.
The
Company accounted for the loan as debt in accordance with FASB Accounting Standards Codification 470 Debt and accrued interest in accordance
with the interest method under FASB ASC 835-30.
F- 12
9.
Shareholders’ Equity
Series
A-2 Preferred Stock
The
Company’s previously issued and outstanding Series A-2 preferred stock included a $ 0.15 per share annual noncumulative dividend
when and if declared by the board of directors. No dividends were declared in the years ended December 31, 2023 or December 31 2022.
The Series A-2 preferred stock also includes a liquidation preference of 1.25 times the original issue price plus any declared but unpaid
dividends upon the liquidation, dissolution, merger or sale of substantially all the assets of the Company and have a preference upon
liquidation over Series A-1 preferred stock and common stock. Each share of Series A-2 preferred stock may be converted into equal shares
of common stock at the option of the holder at any time. In addition, the Series A-2 preferred stock shares are automatically convertible
into common shares upon the sale of shares of common stock to the public at the then applicable conversion price in a firm commitment
underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, resulting
in at least $ 20 million in proceeds, net of underwriting discounts and commissions. Each share of Series A-2 preferred stock has voting
rights equal to the number of shares of common stock then issuable upon conversion of such share of preferred stock. The Company is obligated
to redeem shares of Series A-2 Preferred Stock in the occurrence of a Deemed Liquidation Event unless a majority of the holders of Series
A-2 Preferred Stock and a majority of the Series A-1 Preferred Stock consent otherwise.
In
November 2023, the Business Combination between Data Knights and the Company triggered the Series A-2 Preferred Stock and Series A-1
Preferred Stock convert 1-1 to commons stock .
Series
A-1 Preferred Stock
The
Company’s previously issued and outstanding Series A-1 preferred stock included a $ 0.15 per share annual noncumulative dividend
when and if declared by the board of directors. No dividends were declared in the years ended December 31, 2023 or December 31 2022.
The Series A-1 preferred stock also includes a liquidation preference of 1.25 times the original issue price plus any declared but unpaid
dividends upon the liquidation, dissolution, merger or sale of substantially all the assets of the Company and have a preference upon
liquidation over common stock. Each share of Series A-1 preferred stock may be converted into equal shares of common stock at the option
of the holder at any time. In addition, the Series A-1 preferred stock shares are automatically convertible into common shares upon the
sale of shares of common stock to the public at the then applicable conversion price in a firm commitment underwritten public offering
pursuant to an effective registration statement under the Securities Act of 1933, as amended, resulting in at least $ 20 million in proceeds,
net of underwriting discounts and commissions. Each share of Series A-1 preferred stock has voting rights equal to the number of shares
of common stock then issuable upon conversion of such share of preferred stock. The Company is obligated to redeem shares of Series A-1
Preferred Stock in the occurrence of a Deemed Liquidation Event unless a majority of the holders of Series A-1 Preferred Stock consent
otherwise.
In
November 2023, the Business Combination between Data Knights and the Company triggered the Series A-2 Preferred Stock and Series A-1
Preferred Stock convert 1-1 to commons stock .
Common
Stock
In
2023, in connection with services performed by the Board of Directors common shares of 100,000 ( 100,000 - 2022) were issued at $ 1.00 per
share. These were expensed as general and administrative expenses in the Statement of Operations.
The
table below summarizes the Common Stock activities during the year ended December 31, 2023.
Schedule of Common Stock Activities
Common Shares
Balances, December 31, 2022
4,550,166
Balance
4,550,166
Preferred Stock to Common Stock
7,057,797
Convertible Notes to Common Stock
6,177,229
Stock Options to Common Stock
612,670
Converting of Warrants to Common Stock
3,859,464
Private OneMedNet to ONMD Public Shares
( 2,257,326 )
Converting Data Knights Common Shares (A and B) to ONMD Public Shares
3,460,275
Issuance Public Shares
111,957
Balances, December 31, 2023
23,572,232
Balance
23,572,232
10.
Stock Options
During
2020, the Company adopted a new equity incentive plan (the Plan), which provides for the granting of incentive and nonqualified stock
options to employees, directors, and consultants. As of December 31, 2020, the Company has reserved 3,000,000 shares of common stock
under the Plan. The Company believes that such awards better align the interests of its employees with those of its stockholders. Option
awards are generally granted with an exercise price equal to the fair market value of the Company’s stock at the date of grant;
those option awards generally vest with a range of one to four years of continuous service and have ten-year contractual terms. As there
is no public data available for the share price valuation, the Company considers the Fair Market Value of $ 1 to be on the conservative
side and similar to the exercise price. Certain option awards provide for accelerated vesting if there is a change in control, as defined
in the Plan. The Plan also permits the granting of restricted stock and other stock-based awards. Unexercised options are cancelled upon
termination of employment and become available under the Plan.
F- 13
Information
with respect to options outstanding is summarized as follows:
Schedule of Options Outstanding
Options Outstanding
Weighted- Average Exercise Price
Aggregate Intrinsic Value
Outstanding as of December 31, 2020
1,995,000
$ 1.00
$ 1,995,000
Granted - under the Plan
25,000
Exercised
-
Cancelled
( 1,072,816 )
Outstanding as of December 31, 2021
947,184
$ 1.00
$ 947,184
Granted - under the Plan
577,000
Exercised
( 7,500 )
Cancelled
( 485,684 )
Outstanding as of December 31, 2022
1,031,000
$ 1.00
$ 1,031,000
Options exercisable as of December 31, 2022
567,581
$ 1.00
$ 567,581
As
of December 31, 2022 and 2021, there were 1,031,000 and 947,184 common stock options outstanding with a weighted average remaining contractual
life of 7.11 years and 6.01 years, respectively.
As
of December 31, 2022 and 2021, there were 567,581 and 723,431 common stock options exercisable at a weighted average remaining contractual
life of 5.56 years and 5.27 years, respectively.
On
November 7, 2023, the Company issued shares of common stock for 692,153 vested options less an exercise price of $ 1.00 .
At
the Special Meeting held on October 17, 2023 ,
Data Knights shareholders considered and approved the OneMedNet Corporation 2022 Equity Incentive Plan (the “Plan”) and reserved
an amount of shares of common stock equal to 10% of the number of shares of common stock of OneMedNet following the Business Combination
for issuance thereunder . The Plan was approved by the OneMedNet pre-Closing board of directors on October 17, 2023. The Plan became effective
immediately upon the Closing of the Business Combination.
Black
Scholes Assumptions
The
determination of the fair value of stock options using an option valuation model is affected by the Company’s stock price valuation,
as well as assumptions regarding a number of complex and subjective variables. The volatility assumption is based on volatilities of
similar companies over a period of time equal to the expected term of the stock options. The volatilities of similar companies are used
in conjunction with the Company’s historical volatility because of the lack of sufficient relevant history for the Company’s
common stock equal to the expected term. The expected term of the employee stock options represents the weighted average period for which
the stock options are expected to remain outstanding. The expected term assumption is estimated based primarily on the options’
vesting terms and remaining contractual life and employees’ expected exercise and post- vesting employment termination behavior.
The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time
of grant. The dividend yield assumption is based on the expectation of no future dividend payouts by the Company.
The
fair value of the Company’s previous stock options was estimated assuming no expected dividends and the following weighted average
assumptions:
Schedule
of Fair Value of Stock Options
2022
2021
Expected life in years
5.89
6.08
Risk-free interest rate
0.55 %
0.49 %
Expected dividend yield
0.00 %
0.00 %
Expected volatility
32 %
60 %
The
total expense recognized for share-based payments was $ 45,584 and $ 47,071 for the years ended December 31, 2022 and 2021, respectively.
These costs are included in the statements of operations. As of December 31, 2022, there was $ 75,987 of unrecognized compensation costs
related to stock option grants which will be recognized over the next four years.
During
2023, the Company issued common stock to employees and extinguished all outstanding stock options. The 612,720 shares outstanding were
recorded as stock expense in the Consolidated Statement of Operations.
F- 14
11.
Stock Warrants
In
2021, there were 174,102 OneMedNet Corporation outstanding common stock warrants issued for service at a weighted average exercise price
of $ 0.10 . In 2022 for the exercise price of $ 1.00 , the OneMedNet Corporation issued 145,746 warrants for 2021 service and 294,000 warrants
for 2022 service, 2,056,000 in warrants were issued attached to convertible notes. The Company expensed $ 1,346,288 in 2022 in relation
to the issuance of the Warrants. In 2023 for the exercise price of $ 1.00 , the OneMedNet issued 1,670,000 in warrants attached to convertible
notes. OneMedNet Corporation converted 4,165,746 warrants outstanding to common stock at an exercise price of $ 1.00 and converted 174,102
warrants outstanding to common stock at an exercise price of $ 0.10 .
As
of December 31, 2023 and December 31, 2022, the Company had 11,500,000
of publicly traded warrants. The warrants trade on the Nasdaq had closing price of $ .0149
and $ .0400
at December 31, 2023 and December 31, 2022 respectively.
As
of December 31, 2023 and December 31, 2022, the Company had 681,019 and 585,275
of private warrants outstanding. These warrants are classified as liability on the Consolidated Balance Sheet. Changes in the
warrant liabilities are recorded in the Statement of Operations. As of December 31, 2023 and December 31, 2022, the warrant
liabilities were $ 0.6
million and $ 0.4
respectively.
12.
Fair Value Measures
The
fair value measurement accounting standards establish a framework for measuring fair value and expand disclosures about fair value measurements.
The standard does not require any new fair value measurements; rather, it applies to other accounting pronouncements that require or
permit fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability
in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. This pronouncement
also establishes a three-level hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable
inputs when measuring fair value.
The
valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability on the measurement date. The three
levels are defined as follows:
Level
1—inputs to the valuation methodology are quoted prices (unadjusted) for an identical asset or liability in an active market
Level
2—inputs to the valuation methodology include quoted prices for a similar asset or liability in an active market or model-derived
valuations in which all significant inputs are observable for substantially the full term of the asset or liability
Level
3—inputs to the valuation methodology are unobservable and significant to the fair value measurement of the asset or liability
The
following table presents the Company’s financial assets measured and recorded at fair value on a recurring basis using the above
input categories as of December 31, 2023 and December 31, 2022 (in thousands):
Schedule of Financial Assets
Year Ended
December 31, 2023
December 31, 2022
Level 1
Level 2
Level 3
Total
Level 1
Level 2
Level 3
Total
Assets:
Investments held in Trust
$ —
$ —
$ —
$ —
$ 29,029,416
$ —
$ —
$ 29,029,416
Total Assets
$ —
$ —
$ —
$ —
$ 29,029,416
$ —
$ —
$ 29,029,416
13.
Related Party Transactions
Loan
Extensions
F- 15
Data
Knights closed its initial public offering in May 2021 and had 12 months to complete a business combination. Alternatively, the Data
Knight could extend the period up to two times for an additional three months each time with an extension costing $ 1.2 million. Data
Knights received a total of $ 300,000 from members of the Company’s Management and Directors. As of December 31, 2023 and December
31, 2022 the total extension loan including interest outstanding was $ 3.0 million and $ 2.5 million, respectively.
PIPE
Convertible Notes and Warrants
In
November 2023, the Company entered into a Securities Purchase Agreement (SPA) in which the Company was required to sell senior secured
convertible notes and warrants to Directors of the Company. The SPA stipulates a collateral security agreement between the Company and
the Directors for punctual payment and performance by the Company on its Obligations to the Directors. The Intellectual Property of the
Company serves as the collateral for the Directors. The senior secured convertible notes and warrants were issued through a private issuance
of a public entity (PIPE) transaction, which is a form of debt and equity offering under an exception in the securities law for qualifying
private placements by issuers of publicly traded securities. The Company received a total of $ 1.5 million from the director in exchange
for senior convertible notes of $ 1.6 million (plus accrued interest of $ 0.1 million) and 95,745 warrants to acquire common stock. The
senior secured notes are convertible to the conversion rate of $ 10.00 per share, and 92.5% of the lowest VWAP for the ten (10) trading
days immediately preceding the conversion Date, subject to the floor price of $1.14 (representing 20% of the closing price on the last
trading day before the closing of the Business Combination), or the alternative conversion ratio the greater of the floor price and the
lesser of 80% of the VWAP of the common stock as of the trading day and 80% of the price computed as the quotient of the sum of the VWAP
of the Common Stock for each of the three Trading Days with the lowest VWAP of the Common Stock during the fifteen consecutive trading
day period ending and including the trading day immediately preceding the delivery or deemed delivery of the applicable Conversion Notice,
divided by three . All such determinations to be appropriately adjusted for any stock dividend, stock split, stock combination, reclassification
or similar transaction that proportionately decreases or increases the common stock.
The
warrants are classified as equity and the total proceeds received from the Directors are allocated based on the relative fair values
of the convertible notes and the warrants at the issued date. The portion allocable to warrants is accounted for as paid-in capital.
The senior secured convertible notes are classified as long term debt in the Consolidated Balance Sheet. The estimate fair value of the
senior secured convertible notes at December 31, 2023 was $ 1.2 million.
14.
Commitments, Contingencies, and Concentrations Operating lease
The
Company has a month-to-month lease for a suite at a cost of $ 575 per month. The Company incurred $ 7,695 and $ 7,694 of rent expense, including
common tenant costs and cancellation costs, during the years ended December 31, 2023 and 2022, respectively.
15.
Subsequent Events
The
Company has evaluated subsequent events occurring through April 9, 2024, the date the financial statements were available for issuance,
for events requiring recording or disclosure in the Company’s financial statements.
During
2024, through to the date of this report, the Company issued 256,944
and 20,834
shares of Common Stock to EF Hutton LLC and Kingwood Capital Partners, LLC, respectively, as consideration for $ 3.0
million owed by the Company for underwriting commission due at the closing of the Business Combination.
During
2024, through to the date of this report, the Company bought back 187,745 shares of Common Stock from a convertible note holder.
During
2024, through to the date of this report, the Company received $ 1,000,000
from a majority shareholder for the purchase
of shares, and an additional $ 300,000
treated as a shareholder loan.
During
2024, through to the date of this report, the Company entered into a definitive securities purchase agreement with an institutional investor
providing up to $ 4.54 million in funding through a private placement for the issuance of senior convertible notes.
As previously announced on Form
8-K, on March 28, 2024, OneMedNet Corporation (the “Company”) entered into a definitive
securities purchase agreement (the “Securities Purchase Agreement”) with Helena Global Investment Opportunities 1 Ltd., an
affiliate of Helena Partners Inc., a Cayman-Islands based advisor and investor providing for up to USD$ 4.54 million in
funding through a private placement for the issuance of senior secured convertible notes (the “Notes”).
As previously
announced on Form 8-K, on March 27, 2024, Paul J. Casey, Chief, Chief Executive Officer of the Company, notified the Company of his intention
to retire as Chief Executive Officer of the Company effective March 29, 2024. Mr. Casey will continue to serve as a member of the Board
of Directors (the “Board”) of the Company. In connection with Mr. Casey’s service on the Advisory Board of the Company,
the Board approved a Stock Option Grant (the “Option Grant”) providing for the grant of 147,000 five-year options exercisable
at $ 1.00 per share adviser to Mr. Casey. Also on March 27, 2024, Scott Holbrook, a member of the Board of the Company and a member of
the Company’s Audit Committee, notified the Company of his intention to retire from the Company’s Board effective March 29,
2024.
Effective
March 29, 2024, the Board (i) appointed Mr. Aaron Green, to serve as Chief Executive Officer of the Company to fill the vacancy created
by the retirement of Paul Casey; (ii) appointed Mr. Aaron Green, to serve as a member of the Board to fill the vacancy created by the
retirement of Scott Holbrook; and (iii) appointed Board member, Dr. Thomas Kosasa, to serve on the Company’s Audit Committee, also
to fill the vacancy created by the retirement of Scott Holbrook.
F- 16
Item
9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
None.
Item
9A. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the
design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange
Act of 1934, as amended (the “Exchange Act”)), as of the end of the period covered by this Annual Report on Form 10-K. Based
on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of December 31, 2023, our disclosure
controls and procedures were effective at the reasonable assurance level.
Management’s
Report on Internal Control Over Financial Reporting
As
disclosed elsewhere in this Annual Report on Form 10-K, we completed the Business Combination on November 7, 2023. Prior to the Business
Combination Data Knights, our predecessor, was a special purpose acquisition company formed for the purpose of effecting a merger, capital
stock exchange, asset acquisition, stock purchase, recapitalization or similar business combination with one or more businesses. As a
result, previously existing internal controls are no longer applicable or comprehensive enough as of the assessment date, because Data
Knights’ operations prior to the Business Combination were insignificant compared to those of the consolidated entity post-Business
Combination. As a result, management was unable, without incurring unreasonable effort or expense, to complete an assessment of our internal
control over financial reporting as of December 31, 2023. Accordingly, we are excluding management’s report on internal control
over financial reporting pursuant to Section 215.02 of the SEC Division of Corporate Finance’s Regulation S-K Compliance and Disclosure
Interpretations.
Changes
in Internal Control Over Financial Reporting
No
change in our internal control over financial reporting occurred during the quarter ended December 31, 2023 that has materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.
Item
9B. Other Information
None.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not
applicable.
35
PART
III
Item
10. Directors, Executive Officers and Corporate Governance
The
information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to
Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close
of the Company’s fiscal year ended December 31, 2023.
Item
11. Executive Compensation
The
information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to
Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close
of the Company’s fiscal year ended December 31, 2023.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The
information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to
Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close
of the Company’s fiscal year ended December 31, 2023.
Item
13. Certain Relationships and Related Transactions, and Director Independence
The
information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to
Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close
of the Company’s fiscal year ended December 31, 2023.
Item
14. Principal Accounting Fees and Services
The
information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to
Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close
of the Company’s fiscal year ended December 31, 2023.
36
PART
IV
Item
15. Exhibits, Financial Statement Schedules
The
following documents are filed as a part of this Form 10-K:
(a)(1)
Financial Statements
Index
to Financial Statements
Page
Consolidated Balance Sheets
F-2
Consolidated Statements of Operations and Comprehensive Income (Loss)
F-3
Consolidated Statements of Changes in Shareholders ’ Equity
F-4
Consolidated Statements of Cash Flows
F-5
Notes to Consolidated Financial Statements
F-6
(a)(2)
Financial Statement Schedules
None.
(a)(3)
Exhibits.
These
exhibits listed below are filed or incorporated by reference into this Report.
Exhibit
Number
Description
2.1†
Agreement and Plan of Merger, dated April 25, 2022, by and among Data Knights, Merger Sub, Sponsor, OneMedNet, and Paul Casey (incorporated by reference to Exhibit 2.1 to the Company’s Form 8-K, filed with the SEC on April 25, 2022).
3.1
Third Amended and Restated Certificate of Incorporation of OneMedNet Corporation (incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K, filed with the SEC on November 13, 2023).
3.2
Amended and Restated Bylaws of OneMedNet Corporation (incorporated by reference as Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on November 13, 2023).
4.1
Description of the Registrant’s securities.
4.2
Specimen Warrant Certificate (incorporated by reference to Exhibit 4.3 to the Company’s Form S-1/A, filed with the SEC on April 7, 2021).
4.3
Warrant Agreement, dated May 6, 2021, by and between Continental Stock Transfer & Trust Company and the Company (incorporated by reference to Exhibit 4.3 to the Company’s Form S-1/A, filed with the SEC on April 7, 2021).
10.1
Securities Purchase Agreement dated June 28, 2023 with OneMedNet Corporation (incorporated by reference as Exhibit 10.11 to the Registrant’s Current Report on Form 8-K filed with the SEC on November 13, 2023).
10.2
Letter Agreement, dated May 6, 2021, by and between Data Knights, the initial security holders and the officers and directors of the Data Knights (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K, filed with the SEC on May 11, 2021).
10.3
Form of OneMedNet Corporation 2022 Equity Incentive Plan (incorporated by reference to Annex D to the proxy statement/prospectus which is part of the Registration Statement on Form S-4 declared effective by the SEC on September 22, 2023).
10.4
Form of Registration Rights Agreement by certain OneMedNet equity holders (included as Exhibit G to Annex B to the proxy statement/prospectus).
10.5
Lockup Agreement by certain OneMedNet equity holders (included as Exhibit C to Annex B to the proxy statement/prospectus).
10.6+
Employment Agreement between OneMedNet Corporation and Aaron Green, President (incorporated by reference as Exhibit 10.8 to the Registrant’s Current Report on Form 8-K filed with the SEC on November 13, 2023).
10.7+
Employment Agreement between OneMedNet Corporation and Lisa Embree, Chief Financial Officer (incorporated by reference as Exhibit 10.09 to the Registrant’s Current Report on Form 8-K filed with the SEC on November 13, 2023).
10.8+
Employment Agreement between OneMedNet Corporation and Paul Casey, Chief Executive Officer (incorporated by reference as Exhibit 10.10 to the Registrant’s Current Report on Form 8-K filed with the SEC on November 13, 2023).
37
21
Subsidiaries of the Registrant.
23.1
Consent of Independent Registered Public Accounting Firm.
31.1
Certification of Chief Executive Officer (Principal Executive Officer) Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification of Chief Financial Officer (Principal Financial Officer) Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*
Certification of Chief Executive Officer (Principal Executive Officer) Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*
Certification of Chief Financial Officer (Principal Financial Officer) Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.SCH
Inline
XBRL Taxonomy Extension Schema Document
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover
Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
†Schedules
and exhibits to this Exhibit omitted pursuant to Regulation S-K Item 601(b)(2). The Registrant agrees to furnish supplementally a copy
of any omitted schedule of exhibit to the SEC upon request.
+
Management or compensatory agreement or arrangement.
*
The certifications furnished in Exhibit 32.1 and Exhibit 32.2 hereto are deemed to accompany this Annual Report on Form 10-K and will
not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent
that the registrant specifically incorporates it by reference.
Item
16. Form 10-K Summary
None.
38
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report
to be signed on its behalf by the undersigned, thereunto duly authorized.
April
9, 2024
OneMedNet
Corporation
/s/ Aaron
Green
Name:
Aaron Green
Title:
Chief
Executive Officer
(Principal
Executive Officer)
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/
Jeffrey Yu, MD
Director
and Chairman of the Board
April
9, 2024
Jeffrey
Yu, MD
/s/
Aaron Green
Chief
Executive Officer and Director
April
9, 2024
Aaron Green
(Principal
Executive Officer)
/s/
Paul J. Casey
Director
April
9, 2024
Paul J. Casey
/s/
Lisa Embree
Chief
Financial Officer and VP of Finance
April
9, 2024
Lisa
Embree
(Principal
Accounting Officer)
/s/
Erkan Akyuz
Director
April
9, 2024
Erkan
Akyuz
/s/
Thomas Kosasa
Director
April
9, 2024
Thomas
Kosasa
/s/
Eric Casaburi
Director
April
9, 2024
Eric
Casaburi
/s/
Sun Joo Huh
Director
April
9, 2024
Dr.
Julianne ( Sun Joo) Huh
39
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