UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31 , 2023
Commission
file number: 001-14332
☐
TRANSITION REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
NOVELSTEM
INTERNATIONAL CORP.
(Exact
name of registrant as specified in its charter)
Florida
65-0385686
State
or other jurisdiction of
(I.R.S.
Employer
incorporation
or organization
Identification
No.)
2255
Glades Road , Suite 221A , Boca Raton , FL
33431
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code (410) 598-9024
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
None
Securities
registered pursuant to section 12(g) of the Act:
Common
Stock, par value $0.01 per share
(Title
of Class)
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 ☒
Note
– Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Exchange
Act from their obligations under those Sections.
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 ☐
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, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth 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 Ex- change Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
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. ☐
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). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
As
of the last day of the second fiscal quarter of 2023, the aggregate market value of the registrant’s common stock held by non-affiliates
of the registrant was approximately $ 3,282,000 based on the closing sale price on that date as reported on the OTCQB marketplace. As
of April 1, 2024 there were 46,881,475 shares of Common Stock, $0.01 par value per share, outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
None
TABLE
OF CONTENTS
PAGE
PART
I
Item
1.
BUSINESS
3
Item
1A.
RISK
FACTORS
8
Item
1B.
UNRESOLVED
STAFF COMMENTS
12
Item
2.
PROPERTIES
12
Item
3.
LEGAL
PROCEEDINGS
12
Item
4.
MINE
SAFETY DISCLOSURES
12
PART
II
Item
5.
MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
13
Item
6.
[RESERVED]
13
Item
7.
MANAGEMEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
14
Item
7A.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
17
Item
8.
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA
17
Item
9.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
17
Item
9A.
CONTROLS
AND PROCEDURES
18
Item
9B.
OTHER
INFORMATION
18
Item
9C.
DISCLOSURE
REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
18
PART
III
Item
10.
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
19
Item
11.
EXECUTIVE
COMPENSATION
21
Item
12.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
24
Item
13.
CERTAIN
RELATIONSHIPS, RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
25
Item
14.
PRINCIPAL
ACCOUNTING FEES AND SERVICES
26
PART
IV
Item
15.
EXHIBITS
AND FINANCIAL STATEMENT SCHEDULES
27
Item
16.
FORM
10-K SUMMARY
29
Certain
statements contained in this report are forward-looking in nature. These statements can be identified by the use of forward-looking terminology
such as “believes”, “expects”, “may”, “will”, “should” or “anticipates”,
or the negatives thereof, or comparable terminology, or by discussions of strategy. You are cautioned that our business and operations
are subject to a variety of risks and uncertainties and, consequently, our actual results may materially differ from those projected
by any forward-looking statements. Certain of such risks and uncertainties are discussed below under the heading “Item 1A. Risk
Factors.”
2
PART
I
Item
1. Business.
NovelStem
International Corp. (“NovelStem” or the “Company”) is a development stage biotechnology holding company focused
on the stem cell-based technology developed by its affiliate, NewStem Ltd, an Israeli biotech company (“NewStem”), in which
the Company owns an approximate 31% equity interest. NovelStem was formed in January 1993 as Big Entertainment, Inc. Thereafter, the
Company changed its name to Hollywood.Com Inc. and, later to Hollywood Media Corp. (“Hollywood Media”).
In
2018, the Company shifted its business focus from media to cutting edge biotech when it acquired a substantial ownership interest in
NewStem and changed its name to NovelStem. As a significant shareholder in NewStem, and the substantial commitment of our management
and financial resources to NewStem, including the fact that our Executive Chairman, Jan Loeb, is also the Chairman of NewStem, we have
the ability to exert significant influence over the management and operations of NewStem resulting in NewStem functioning as a minority
operating subsidiary of the Company. Since his appointment in July 2018, Mr. Loeb has acted in an executive capacity on behalf of the
Company and has served in a de facto leadership role. In September 2022, the Board appointed Mr. Loeb as Executive Chairman of
NovelStem in order to ratify Mr. Loeb’s position and clarify his executive role. On January 13, 2023, the Board appointed Mr. Loeb
as President. With respect to NewStem, Mr. Loeb, as the Chairman, calls and presides over the meetings of NewStem’s Board of Directors.
Additionally, Mr. Loeb leverages his financial expertise by guiding NewStem’s financial and strategic planning, including the raising
and deployment of capital, developing and modifying NewStem’s business plan and budget and by participating in the negotiation
of NewStem’s material contracts as required. NewStem does not currently have an appointed Chief Financial Officer and, as such,
Mr. Loeb serves as the de facto Chief Financial Officer and Chief Strategic Officer of NewStem.
NovelStem
depends entirely on earnings and cash from its investments in NewStem and our 50% equity interest in a legacy joint venture named NetCo
Partners (“NetCo”). The Company’s principal operations coincide with those of NewStem. We have not received any dividend
payments or other distributions from NewStem in the fiscal years ended December 31, 2023 and 2022. We received distributions of earnings
from NetCo of $6,875 and $12,591, respectively, for the fiscal years ended December 31, 2023 and 2022.
NewStem
NewStem
is a development stage Israeli biotech limited liability company focused on human Pluripotent Stem Cells (hPSCs) in general, and
Haploid human Pluripotent Stem Cells (HhPSCs), in particular. These cells have the potential to change the face of medical research
as they play a pivotal role in cancer research, regenerative medicine and disease therapy. NewStem established a discovery
bio-platform based on haploid human embryonic stem cell technology for genome-wide screenings and is currently using this platform
for the discovery and development of oncology drugs based on synthetic lethal interaction and developing a personalized diagnostic
for early detection of chemotherapy resistance. NewStem has incurred losses since inception and has generated minimal revenues from
a licensing agreement to date. NewStem filed an FDA Pre-Submission and received a CE Mark from the European Medicines Agency (EMA)
for its in vitro diagnostic device (IVDD). NewStem does not have an FDA approved medical device. The NewStem Software Diagnostic
Device (NSDD) is CE marked under EU regulation as an “other” IVD under Directive 98/79/EC since March 2022.
NewStem
performs genome-wide genetic screening to identify synthetic lethal interactions with common cancer-related mutations. The first step
in the process is to create a model with relevant cancer-related mutations in HhPSCs, where, subsequently, a library targeting approximately
18,000 coding genes is induced. At the end of this step, each cell has two mutations, one in the cancer related gene and the other in
a coding gene. A genome-wide genetic screening is performed, both on normal HhPSCs and genomic modified HhPSCs to which a cancer-related
mutation was inserted. The goal of such screens is to identify mutations that in combination with a cancer-related mutation will kill
the cells. Following bioinformatic analysis of the genetic screening results, novel targets are identified and validated, first in HhPSCs
and then cancer models (tumor organoids and PDX). NewStem has validated several targets in HhPSCs and will move next to validation in
cancer models. To identify novel targets for drug development, NewStem performs genome-wide genetic screening. The validation process
requires additional experiments that corroborate the results in independent experiments
that are performed on haploid human embryonic stem cells and cancer models. For validated targets, artificial intelligence (AI) based
drug discovery will be performed following by hit to lead process and ADMET that will support the transition to clinical trials.
3
In
reference to AI-based drug discovery, AI can assist in structure-based drug discovery by predicting the 3D protein structure and the
chemical environment of the target protein site, thus helping to predict the effect of a compound on the target along with safety considerations
before their synthesis or production and, accordingly, accelerates the drug development process.
In
reference to the hit to lead process- this is the iterative process of lead improvement. It is the stage where a hit, typically a small
molecule identified in a high throughput screen, is chemically modified into a lead molecule following improvements in activity against
the target.
In
reference to ADMET, this is the five-letter acronym for absorption, distribution, metabolism, excretion, and toxicity that describes
pharmacokinetics. ADMET plays key roles in drug discovery and development. A high-quality drug candidate should not only have sufficient
efficacy against the therapeutic target, but also show appropriate ADMET properties at a therapeutic dose.
NewStem
possesses pioneering intellectual property, reagents and experience related to the isolation and differentiation of HhPSCs and hPSCs,
their genetic manipulation, immunogenicity, tumorigenicity and their unique capacity in disease modeling.
We
believe that NewStem is currently the only company worldwide to develop products based on this innovative proprietary technology. These
products refer to the medical device platform that provides information to oncologists regarding the presence of mutations in the patient’s
tumor profile which may confer resistance to different anti-cancer drugs and to anticancer drugs that target tumors with specific mutations
based on a synthetic-lethal interaction approach.
NewStem’s
technology solutions are derived from an exclusive, worldwide license from Yissum Research Development Company, Hebrew University’s
technology transfer company (“Yissum”) and The New York Stem Cells Foundation, based on the findings and inventions of Prof.
Nissim Benvenisty, Director of the Azrieli Center for Stem Cells and Genetic Research, The Hebrew University of Jerusalem (the “License”).
The License provides NewStem an exclusive worldwide license to make commercial use of the License and to develop, manufacture, market,
distribute or sell a product in the field of therapeutics, diagnostics, screening, development and testing. In consideration for the
grant of the License, NewStem is obligated to pay royalties of up to 3% of net sales and up to 12% of “Sublicense Consideration”
(as defined in the License Agreement).
NovelStem
was the original seed investor in NewStem providing $2 million in July 2018 and another $2 million over the next two and a half years.
We currently own a 30.51% equity interest in NewStem. The remaining equity interests in NewStem are owned by Yissum and Professor Benvenisty,
each of whom owns a 30.51% equity interest, Illumina Cambridge LTD, which owns a 5.31% equity interest, and management and a number of
other shareholders who own collectively approximately 3.18%. Currently, our President and Executive Chairman, Jan Loeb, is also the Chairman
of the Board of NewStem. Professor Benvenisty and a representative of Yissum occupy the other two Board seats.
Pursuant
to NewStem’s Articles of Association, investors (including NovelStem) are granted certain rights and are subject to certain restrictions
with respect to their equity interests in NewStem. NovelStem has preemptive rights to purchase additional shares issued by NewStem up
to its pro-rata share of all outstanding shares of NewStem held by all shareholders of NewStem, until the consummation of either an initial
public offering or a liquidation event. Such pro-rata share may be increased into an over-allotment if other shareholders decline to
exercise their preemptive rights. The Board of Directors of NewStem may make capital calls on NovelStem and the other shareholders, in
respect of any sum unpaid in respect of shares held by such shareholder. All shareholders holding at least 10% of the outstanding shares,
including NovelStem, may exercise a right of first refusal on all sales of shares of NewStem other than transfers to certain permitted
transferees. NovelStem and other shareholders have a co-sale right to sell their shares in place of those that would be issued and sold
by NewStem’s founder. The shares of NewStem are subject to a drag-along right, compelling all shares to be sold in the event that
a transaction meant to sell all shares of NewStem is approved by shareholders holding at least 65% of the vote of all shares of NewStem.
4
Competition
The
technologies underlying NewStem’s products are subject to rapid and profound technological change. Competition intensifies as technical
advances in each field are made and become more widely known. We can give no assurance that others will not develop services, products,
or processes with significant advantages over the products, services, and processes that NewStem offers or is seeking to develop. Any
such occurrence could have a material and adverse effect on NewStem’s and our business, results of operations and financial condition.
NewStem
plans to enhance and broaden its product offerings in response to changing customer demands and competitive pressure and technologies.
The success of any new product offering or enhancement to an existing product will depend on numerous factors, including the ability
to:
-
Properly
identify and anticipate physician and patient needs;
-
Develop
and introduce new products or product enhancements in a timely manner;
-
Adequately
protect intellectual property and avoid infringing upon the intellectual property rights of third parties;
-
Demonstrate
the safety and efficacy of new products; and
-
Obtain
the necessary regulatory clearances or approvals for new products or product enhancements.
Government
Regulation
In
the United States, pharmaceutical products are subject to extensive regulation by the Federal Food and Drug Administration and Cosmetic
Act or the FDA. The FDA and other federal and state statutes and regulations, govern, among other things, the research, development,
testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and
reporting, sampling, and import and export of pharmaceutical products. The FDA has very broad enforcement authority and failure to abide
by applicable regulatory requirements can result in administrative or judicial sanctions being imposed on NewStem, including warning
letters, refusals of government contracts, clinical holds, civil penalties, injunctions, restitution, disgorgement of profits, recall
or seizure of products, total or partial suspension of production or distribution, withdrawal of approval, refusal to approve pending
applications, and criminal prosecution.
FDA
Approval Process
NewStem’s
therapeutic product candidates are expected to be regulated by the FDA as drugs. No manufacturer may market a new drug until it has submitted
a New Drug Application, or NDA, to the FDA, and the FDA has approved it.
The
testing and approval process requires substantial time, effort and financial resources, and NewStem’s product candidates may not
be approved on a timely basis, if at all. The time and expense required to perform the clinical testing necessary to obtain FDA approval
for regulated products can frequently exceed the time and expense of the research and development initially required to create the product.
The results of preclinical studies and initial clinical trials of NewStem’s product candidates are not necessarily predictive of
the results from large-scale clinical trials, and clinical trials may be subject to additional costs, delays or modifications due to
a number of factors, including difficulty in obtaining enough patients, investigators or product candidate supply. Failure by NewStem
to obtain, or any delay in obtaining, regulatory approvals or in complying with requirements could adversely affect the commercialization
of product candidates and NewStem’s (and, therefore, the Company’s) ability to receive product or royalty revenues.
5
The
diagnostic product (NSDD) will be considered a medical device. A Pre-Submission (Pre-Sub) regarding the NSDD was submitted to FDA in
March 2022, and the FDA’s written feedback was received in May 2022. The FDA requested that the presented intended use and pivotal
clinical testing design be modified. NewStem still needs to present to the FDA a Supplement to the Pre-Sub, presenting such modifications,
and asking it to confirm that the de novo route is indeed applicable to the device. Once an agreement is reached with the FDA, the device
will be subjected to a retrospective pivotal clinical testing that will be followed by the de novo submission to the FDA.
Other
Regulatory Requirements
After
approval, drug products are subject to extensive continuing regulation by the FDA, which include obligations to manufacture products
in accordance with Good Manufacturing Practice, or GMP, maintain and provide to the FDA updated safety and efficacy information, report
adverse experiences with the product, keep certain records and submit periodic reports, obtain FDA approval of certain manufacturing
or labeling changes, and comply with FDA promotion and advertising requirements and restrictions. Failure by NewStem to meet these obligations
can result in various adverse consequences, both voluntary and FDA-imposed, including product recalls, withdrawal of approval, restrictions
on marketing, and the imposition of civil fines and criminal penalties against the NDA holder. In addition, later discovery of previously
unknown safety or efficacy issues may result in restrictions on the product, manufacturer or NDA holder.
Outside
the United States, NewStem’s ability to market a product is contingent upon receiving marketing authorization from the appropriate
regulatory authorities. The requirements governing marketing authorization, pricing and reimbursement vary widely from jurisdiction to
jurisdiction. At present, foreign marketing authorizations are applied for at a national level, although within the European Union registration
procedures are available to companies wishing to market a product in more than one European Union member state.
NewStem
is also subject to various environmental, health and safety regulations including those governing laboratory procedures and the handling,
use, storage, treatment, and disposal of hazardous materials. From time to time, and in the future, NewStem’s operations may involve
the use of hazardous materials.
6
NetCo
In
June 1995, we and C.P. Group Inc. (“C.P. Group”), formed the joint venture, NetCo. NetCo owns the entertainment property,
“Net Force”, about a division of the FBI investigating crimes and adventures involving the internet and the digital world.
NovelStem
and C.P. Group each own 50% of the ownership interest in NetCo. NetCo owns all rights in all media to the Net Force property including
film, television, and video games.
In
1997, NetCo licensed to Putnam Berkley the rights to publish the first six Net Force books in North America, which books were written
and published. This agreement was subsequently renewed in December 2001 for four more books that were created and published. There was
also a series of books targeted to the young adult market, Net Force Explorer, also published by Putnam Berkley. Net Force books have
so far been published in mass market paperback format. The first book in the series was adapted as a four-hour mini-series on the ABC
television network.
In
2019, NetCo entered into a new publishing agreement with HarperCollins. Three novels and two Net Force novellas have been published under
that agreement. Through its interest in NetCo, NovelStem receives distributions of its 50% share of proceeds generated from the rights
to Net Force.
Competition
Competition
in the publishing and video game industries is intense. Many new products and services are regularly introduced in each major industry
segment (console, mobile and PC), but only a relatively small number of “hit” titles account for a significant portion of
total revenue in each segment. NetCo’s competitors range from established interactive entertainment companies and diversified media
companies to emerging start-ups, and we expect new competitors to continue to emerge throughout the world.
See
Item 3 – Legal Proceedings for information concerning proceedings related to NetCo.
Employees
We
do not currently have any employees; however, the Company relies on consultants to perform the duties that would be performed by employees.
Additional
Financial Information
For
additional financial information regarding our operations, see “Item 7. Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and our Financial Statements included in this Annual Report.
Available
Information
We
file annual, quarterly and current reports and other information with the U.S. Securities and Exchange Commission (the “SEC”).
These filings are available to the public over the internet at the SEC’s website at http://www.sec.gov. You may also read and copy
any document we file at the SEC’s public reference room located at 100 F Street, NE, Washington, DC 20549. Please call the SEC
at 1-800-SEC-0330 for further information on the public reference room.
Our
website can be found at http://novelstem.com.
7
Item
1A. Risk Factors.
Our
business is subject to certain risks, including those described below. If any of the events described in the following risk factors actually
occurs then our business, results of operations and financial condition could be materially adversely affected. More detailed information
concerning these risks is contained in other sections of this registration statement, including “Business” and “Management’s
Discussion and Analysis of Financial Condition and Results of Operations.”
Risks
Relating to our Business
We
are a holding company the principal assets of which are illiquid, ownership interests in NewStem and NetCo.
Our
Company’s primary assets are equity interests in NewStem and NetCo. Our President and Executive Chairman, Jan Loeb, is also the
Chairman of NewStem and through this shared management structure along with our 30.51% ownership interest in NewStem, we are able to
exert significant influence over the operations of NewStem. Additionally, we are a 50% partner in NetCo and through our ownership interest.
We
conduct no other business and, as a result, we depend entirely upon earnings and cash flow from NewStem and NetCo. If we decide in the
future to pay dividends, as a holding company, our ability to pay dividends and meet other obligations depends upon the receipt of dividends
or other payments from our operating subsidiaries.
Our
investments in NewStem and NetCo are illiquid.
Our
shares in NewStem and our ownership interest in NetCo are illiquid and have extremely limited liquidity rights. The transferability of
these interests is restricted under federal and state securities laws and the governing documents of each of NewStem and NetCo.
We
depend on our executive officers and consultants and other key individuals along with the executive officers and key individuals of NewStem
to continue the implementation of our long-term business strategy and could be harmed by the loss of their services and our inability
to make up for such loss with qualified replacements.
We
believe that our continued growth and future success will depend in large part on the skills of our management team and the management
teams of NewStem and NetCo, and our partners’ respective abilities to motivate and retain these individuals and other key individuals.
Jan Loeb, our President and Executive Chairman, is also the Chairman of NewStem, and therefore has the shared responsibility of growing
the business and operations of NewStem. The loss of any of their service could reduce our ability to successfully implement our long-term
business strategy which may result in a loss of revenue, and the value of our common stock could be materially adversely affected. Leadership
changes will occur from time to time and we cannot predict whether significant resignations will occur or whether NewStem will be able
to recruit additional qualified personnel. We believe these management teams possess valuable knowledge about our, NewStem’s and
NetCo’s respective industries and that their knowledge and relationships would be very difficult to replicate. The loss of key
personnel, or the inability to recruit and retain qualified and talented personnel in the future, could have an adverse effect on the
respective businesses of NewStem and NetCo, and, consequently, our business, financial condition and/or operating results.
We
and NewStem have limited operating histories and have generated minimal revenue to date.
We
and NewStem have a limited operating history and do not have a meaningful historical record of sales and revenues, nor do we or NewStem
have an established business track record. While we believe that we have the opportunity to be successful, there can be no assurance
that we will be successful in accomplishing our business initiatives, or that we will be able to achieve any significant levels of revenues
or net income.
We
have identified material weaknesses in our internal control and procedures and internal control over financial reporting. If not remediated,
our failure to establish and maintain effective disclosure controls and procedures and internal control over financial reporting could
result in material misstatements in our financial statements and a failure to meet our reporting and financial obligations, each of which
could have a material adverse effect on our financial condition and the trading price of our common stock.
Maintaining
effective internal control over financial reporting and effective disclosure controls and procedures are necessary for us to produce
reliable financial statements. We have re-evaluated our internal control over financial reporting and our disclosure controls and procedures
and concluded that they were not effective as of December 31, 2023 and we concluded there was a material weakness in the design of our
internal control over financial reporting.
A
material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting such that
there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or
detected on a timely basis.
8
Rapid
technological change could cause products to become obsolete, and if NewStem does not enhance its product offerings through research
and development efforts, it may be unable to effectively compete.
NewStem’s
future business success will depend upon its ability to maintain and enhance its product portfolio with respect to advances in technological
improvements for certain products that meet customer needs and market conditions in a cost-effective and timely manner. NewStem may not
be successful in gaining access to new products that successfully compete or are able to anticipate customer needs and preferences, and
customers may not accept one or more of its products. If NewStem fails to keep pace with evolving technological innovations or fails
to modify its products and services in response to customers’ needs or preferences, then NewStem’s and our business, financial
condition and results of operations could be adversely affected.
The
technologies underlying NewStem’s products are subject to rapid and profound technological change. Competition intensifies as technical
advances in each field are made and become more widely known. We can give no assurance that others will not develop services, products,
or processes with significant advantages over the products, services, and processes that NewStem offers or is seeking to develop. Any
such occurrence could have a material and adverse effect on NewStem’s and our business, results of operations and financial condition.
NewStem
plans to enhance and broaden its product offerings in response to changing customer demands and competitive pressure and technologies.
The success of any new product offering or enhancement to an existing product will depend on numerous factors, including the ability
to:
-
Properly
identify and anticipate physician and patient needs;
-
Develop
and introduce new products or product enhancements in a timely manner;
-
Adequately
protect intellectual property and avoid infringing upon the intellectual property rights of third parties;
-
Demonstrate
the safety and efficacy of new products; and
-
Obtain
the necessary regulatory clearances or approvals for new products or product enhancements.
If
NewStem does not develop and, when necessary, obtain regulatory clearance or approval for new products or product enhancements in time
to meet market demand, or if there is insufficient demand for these products or enhancements, its results of operations will suffer.
NewStem’s research and development efforts may require a substantial investment of time and resources before it is adequately able
to determine the commercial viability of a new product, technology, material or other innovation. In addition, even if NewStem is able
to successfully develop enhancements or new generations of its products, these enhancements or new generations of products may not produce
sales in excess of the costs of development, and they may be quickly rendered obsolete by changing customer preferences or the introduction
by competitors of products embodying new technologies or features.
Our
ongoing viability as a company depends on NewStem’s ability to successfully develop and commercialize its products.
NewStem
is principally focused on utilizing proprietary hPSCs and HhPSCs in the development of diagnostic and therapeutic products in oncology.
NewStem must develop diagnostics and therapeutics successfully test them for safety and efficacy in the targeted patient population and
manufacture the finished drugs on a commercial scale to meet regulatory standards and receive regulatory approvals. The development and
commercialization process is both time-consuming and costly, and involves a high degree of business risk. The results of pre-clinical
and clinical testing of product candidates are uncertain, and there can be no assurance that NewStem will be able to obtain regulatory
approvals of its product candidates. If obtained, regulatory approval may take longer or be more expensive than anticipated. Furthermore,
even if regulatory approvals are obtained, NewStem’s products may not perform as we expect and NewStem may not be able to successfully
and profitably produce and market any products. Delays in any part of the process or our inability to obtain regulatory approval of such
products could adversely affect NewStem’s and, therefore, NovelStem’s future operating results by restricting (or even prohibiting)
the introduction and sale of such products.
The
value of our investment in NetCo and our ability to receive distributions may be affected by disputes between the Company and C.P. Group,
our partner in NetCo.
The
Company and C.P. Group each own a 50% interest in NetCo. The joint venture agreement governing NetCo provides for mutual decision
making among the Company and C.P. Group generally (subject to exceptions) and arbitration in the event any controversy or
disagreement arises. The Company and C.P. Group were previously in arbitration as to ongoing scope and the operation of NetCo. This
arbitration was concluded in July 2023. The arbitrator ruled against the Company on certain key issues of the arbitration and in the
Company’s favor on two key issues of the arbitration. However, if we are unable proceed in successful utilization of the joint
venture assets in a manner favorable to the Company, our investment in NetCo and our ability to continue to receive distributions
from our interest in NetCo could have an adverse effect on our business, financial condition or operating results.
9
NetCo’s
business is intensely competitive and “hit” driven. NetCo may not deliver “hit” products and services, or consumers
may prefer a competitors’ products or services over NetCo.
Competition
in the publishing and video game industries is intense. Many new products and services are regularly introduced in each major industry
segment (console, mobile and PC), but only a relatively small number of “hit” titles account for a significant portion of
total revenue in each segment. NetCo’s competitors range from established interactive entertainment companies and diversified media
companies to emerging start-ups, and we expect new competitors to continue to emerge throughout the world. If NetCo’s competitors
develop and market more successful and engaging products or services, offer competitive products or services at lower price points, or
if NetCo does not develop high-quality, well-received and engaging products and services, NetCo and our revenue, margins, and profitability
will decline.
If
NetCo fails to develop relationships with new creative talent, its business could be adversely affected.
NetCo’s
business, in particular the trade publishing and media portions of the business, is highly dependent on maintaining strong relationships
with the authors, illustrators and other creative talent who produce the products and services that are sold to its customers. Any overall
weakening of these relationships, or the failure to develop successful new relationships, could have an adverse impact on NetCo and the
Company’s business and financial performance.
Risks
relating to our common stock
Because
our holding company structure creates restrictions on the payment of dividends, our ability to pay dividends is limited.
We
are a holding company whose primary assets are our ownership of equity interests in NewStem and NetCo. We conduct no other business and,
as a result, we depend entirely upon NewStem’s and NetCo’s earnings and cash flow. If we decide in the future to pay dividends,
as a holding company, our ability to pay dividends and meet other obligations depends upon the receipt of dividends or other payments
from NewStem or NetCo. NewStem and/or NetCo may be restricted in their ability to pay dividends, make distributions or otherwise transfer
funds to us prior to the satisfaction of other obligations, including the payment of operating expenses or debt service, appropriation
to reserves prescribed by laws and regulations, covering losses in previous years, restrictions on the conversion of local currency into
U.S. dollars or other hard currency, completion of relevant procedures with governmental authorities or banks and other regulatory restrictions.
We do not presently have any intention to declare or pay dividends in the future. You should not purchase shares of our common stock
in anticipation of receiving dividends in future periods.
Because
we do not intend to pay any cash dividends on our common stock, our shareholders will not be able to receive a return on their shares
unless they sell them.
We
intend to retain any future earnings to finance the development and expansion of our business. We do not anticipate paying any cash dividends
on our common stock in the foreseeable future. Unless we pay dividends, our shareholders will not be able to receive a return on their
shares unless they sell them. Shareholders may never be able to sell shares when desired. Before you invest in our securities, you should
be aware that there are various risks. You should consider carefully these risk factors, together with all of the other information included
in this annual report before you decide to purchase our securities. If any of the following risks and uncertainties develop into actual
events, our business, financial condition or results of operations could be materially adversely affected.
We
are an emerging growth company and the reduced disclosure requirements applicable to emerging growth companies could make our common
stock less attractive to investors.
We
are an emerging growth company. Under the JOBS Act, emerging growth companies can take advantage of certain exemptions from various reporting
requirements that are applicable to other public companies including, without limitation, reduced disclosure obligations regarding executive
compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a non-binding advisory shareholder
vote on executive compensation and golden parachute payments, exemption from the requirement of auditor attestation in the assessment
of our internal control over financial reporting and exemption from any requirement that may be adopted by the Public Company Accounting
Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information
about our audit and the financial statements (auditor discussion and analysis). As a result of the foregoing, the information that we
provide shareholders may be different than what is available with respect to other public companies.
In
addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period
provided in Section 7(a)(2)(B) of the Securities Act of 1933 for complying with new or revised accounting standards. We plan to elect
to use the extended period for compliance and, as a result, our financial statements may not be comparable to companies that comply with
public company effective dates.
10
Reporting
requirement under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and compliance with the Sarbanes-Oxley
Act of 2002 (the “Sarbanes-Oxley Act”), including establishing and maintaining acceptable internal controls over financial
reporting, are costly and may increase substantially.
The
rules and regulations of the SEC require a public company to prepare and file periodic reports under the Exchange Act, which require
that the Company engage legal, accounting, auditing and other professional services. The engagement of such services is costly. Additionally,
the Sarbanes-Oxley Act requires, among other things, that we design, implement and maintain adequate internal controls and procedures
over financial reporting. The costs of complying with the Sarbanes-Oxley Act and the limited technically qualified personnel we have
may make it difficult for us to design, implement and maintain adequate internal controls over financial reporting. In the event that
we fail to maintain an effective system of internal controls or discover material weaknesses in our internal controls, we may not be
able to produce reliable financial reports or report fraud, which may harm our overall financial condition and result in loss of investor
confidence and a decline in our share price.
We
are working with our legal, accounting and financial advisors to identify those areas in which changes should be made to our financial
and management control systems to manage our growth and our obligations as a public company. These areas include corporate governance,
corporate control, disclosure controls and procedures and financial reporting and accounting systems. We have made, and will continue
to make, changes in these and other areas. However, we anticipate that the expenses that will be required in order to adequately prepare
for being a public company could be material. We estimate that the aggregate cost of increased legal services; accounting and audit functions;
consultants to design and implement internal controls; and financial printing alone will be a few hundred thousand dollars per year and
could be several hundred thousand dollars per year. In addition, we may incur additional expenses related to director compensation and/or
premiums for directors’ and officers’ liability insurance, the costs of which we cannot estimate at this time. We may also
incur additional expenses associated with investor relations and similar functions, the cost of which we also cannot estimate at this
time. However, these additional expenses individually, or in the aggregate, may also be material.
The
continued increased costs associated with operating as a public company may decrease our net income or increase our net loss and may
cause us to reduce costs in other areas of our business or increase the prices of our products or services to offset the effect of
such increased costs. Additionally, if these requirements divert our management’s attention from other business concerns, they
could have a material adverse effect on our business, financial condition and results of operations.
There
is a very limited trading market for our common stock and investors are not assured of the opportunity to sell their stock, should they
desire to do so.
Our
common stock is currently quoted on the OTC Pink Market. However, our stock has traded in very limited quantities in the past. We believe
a significant factor in the limited market is our limited capitalization and liquidity, results of operations and the characterization
of our stock as a “penny stock.” We hope to remedy our financial condition and results of operation in the future. This,
in turn, may assist us in obtaining listing of our stock on other exchanges. However, there is no assurance that any of these objectives
will be met or that the market will ever increase to a point where investors could sell their stock at a desirable price, should they
desire to do so.
The
price of our common stock could be highly volatile.
Our
shares of common stock are quoted on the OTC Pink Market. It is likely that our common stock will be subject to price volatility, low
volumes of trades and large spreads in bid and ask prices quoted by market makers. Due to the low volume of shares traded on any trading
day, persons buying or selling in relatively small quantities may easily influence prices of our common stock. This low volume of trades
could also cause the price of our stock to fluctuate greatly, with large percentage changes in price occurring in any trading day session.
Holders of our common stock may also not be able to readily liquidate their investment or may be forced to sell at depressed prices due
to low volume trading. If high spreads between the bid and ask prices of our common stock exist at the time of a purchase, the stock
would have to appreciate substantially on a relative percentage basis for an investor to recoup their investment. Broad market fluctuations
and general economic and political conditions may also adversely affect the market price of our common stock. No assurance can be given
that an active market in our common stock will be sustained. If an active market does not continue, holders of our common stock may be
unable to readily sell the shares they hold or may not be able to sell their shares at all.
11
We
may be deemed an investment company, which could impose on us burdensome compliance requirements.
The
Investment Company Act of 1940, as amended (the “Investment Company Act”), requires companies to register as an investment
company if they are engaged primarily in the business of investing, reinvesting, owning, holding, or trading securities. Generally, companies
may be deemed investment companies under the Investment Company Act if they are viewed as engaging in the business of investing in securities
or they own investment securities having a value exceeding 40% of certain assets. We are not in the business of investing, reinvesting,
owning, holding or trading securities. However, if the Securities and Exchange Commission deems us to be an investment company, we may
have imposed upon us additional burdensome requirements, including having to register as an investment company, adopting a specific form
of corporation structure and having to comply with certain reporting, record keeping, voting, proxy, and disclosure requirements. Such
additional requirements would require us to incur additional costs and have an adverse effect on our results of operations and our ability
to effectively carry out our business plan.
Item
1B. Unresolved Staff Comments.
None
Item
2. Properties .
Our
corporate office is located at 2255 Glades Road, Boca Raton, FL 33431. We believe that our facilities are adequate for current operations.
Item
3. Legal Proceedings.
As
noted above, NetCo owns all rights to the “Tom Clancy’s Net Force” intellectual property in all media, including film,
television, and video games. As part of the joint venture, NetCo has published more than a dozen books and had an ABC miniseries.
After
Tom Clancy passed away in 2013, his estate and business partners refused to cooperate in exploiting the intellectual property. After
trying to amicably resolve the dispute, the Company initiated arbitration proceedings with the American Arbitration Association. The
Company’s arbitration demand asserts claims for breach of the joint venture agreement and breach of fiduciary duty. Both claims
arise from C.P. Group’s failure to make reasonable, good faith efforts to exploit the full array of media rights relating to Net
Force. The Company’s goal is to maximize the total potential value of the NetCo intellectual property across video games, streaming,
digital media, merchandising and other ancillary markets. The Company believes that the value of the intellectual property is significant.
The
arbitration evidentiary hearing concluded on October 20, 2022, and the arbitrator ordered the parties to submit post-hearing briefs.
Final briefs were filed in January 2023. The Arbitrator ruled in the Company’s favor on two key issues of the arbitration
and ruled against the Company in other key issues.
The
Arbitrator ruled in NovelStem’s favor on the issue of contract interpretation of the Netco Partners JV Agreement. The Arbitrator
also found that the Company’s joint venture partner failed to use “reasonable, good faith efforts” to license and exploit
the Net Force concept, in breach of its contractual obligations under the Netco Partners’ Joint Venture Agreement. The Arbitrator
confirmed NovelStem’s contractual right to use Tom Clancy’s name as a possessory credit in the Net Force title (Tom Clancy’s
Net Force). However, the arbitrator did not award any damages to the Company and did not cede operating control of the joint
venture to the Company as requested. As such, the Company continues to struggle to maximize the potential of the NetCo asset.
To
fund efforts to maximize the value of NetCo, NovelStem has secured non-recourse litigation funding. As a result of this ruling, the costs
related to the litigation funding agreement were recognized. Total costs related to the litigation and the related litigation funding
agreement of $2,819,196 were recorded by the Company.
Item
4. Mine Safety Disclosures.
Not
applicable
12
PART
II
[See
General Instruction G2]
Item
5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market
information
There
is no established public trading market in our common stock, and a regular trading market may not develop, or if developed, may not be
sustained. Our securities are currently quoted on the OTC Markets Pink under the symbol “NSTM”. The following reflect inter-dealer
prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.
High
Low
Fiscal 2024
Quarter ended 3/31/2024 (through March 29, 2024)
$ 0.08
$ 0.06
Fiscal 2023
Quarter ended 12/31/2023
$ 0.18
$ 0.06
Quarter ended 9/30/2023
$ 0.25
$ 0.13
Quarter ended 6/30/2023
$ 0.28
$ 0.14
Quarter ended 3/31/2023
$ 0.20
$ 0.15
Fiscal 2022
Quarter ended 12/31/2022
$ 0.21
$ 0.11
Quarter ended 9/30/2022
$ 0.28
$ 0.12
Quarter ended 6/30/2022
$ 0.33
$ 0.06
Quarter ended 3/31/2022
$ 0.30
$ 0.13
Fiscal 2021
Quarter ended 12/31/2021
$ 0.31
$ 0.20
Quarter ended 9/30/2021
$ 0.35
$ 0.19
Quarter ended 6/30/2021
$ 0.35
$ 0.23
Quarter ended 3/31/2021
$ 0.30
$ 0.16
Fiscal 2020
Quarter ended 12/31/2020
$ 0.20
$ 0.05
Quarter ended 9/30/2020
$ 0.09
$ 0.05
Quarter ended 6/30/2020
$ 0.13
$ 0.07
Quarter ended 3/31/2020
$ 0.13
$ 0.08
Holders
As
of April 1, 2024 there were 46,881,475 shares of common stock outstanding held by approximately 80 record holders.
Dividends
We
have not paid cash dividends on any of our capital stock since our name change and business focus shift in 2018 and currently intend
to retain our future earnings, if any, to fund the development and growth of our business. We do not expect to pay any dividends on any
of our capital stock in the foreseeable future.
Item
6. [Reserved]
13
Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion includes statements that are forward-looking in nature. Whether such statements ultimately prove to be accurate
depends on a variety of factors that may affect our business and operations. Certain of these factors are discussed in “Item 1A.
Risk Factors.”
The
following discussion of our financial condition and results of operations should be read in conjunction with our financial statements
and the related notes thereto and other financial information appearing elsewhere in this report.
Overview
We
are a development stage company and reported net losses of approximately $4,187,000 and $766,000 for the years ended December 31, 2023
and 2022, respectively. We had current assets of approximately $87,000 and current liabilities of approximately $346,000 as of December
31, 2023. As of December 31, 2022, our current assets and current liabilities were approximately $59,000 and $65,000, respectively. We
have prepared our financial statements for the years ended December 31, 2023 and 2022 assuming that we will continue as a going concern.
Our continuation as a going concern is dependent upon improving our profitability and the continuing financial support from our shareholders
as well as NewStem’s ability to successfully develop and commercialize its products. Our sources of capital in the past have included
the sale of equity securities, which include common stock sold in private transactions, and short-term debt. During the current year,
we continued to borrow on existing finance agreements with two related party individuals and entered into a long term finance agreement
with a shareholder to fund current operating expenses. Additionally, we entered into two short term notes to fund advances to NewStem.
NewStem
is a development stage Israeli biotech limited liability company focused on pioneering intellectual property related to haploid human
embryonic stem cells for the development of personalized diagnostics and therapeutics for genetic and epigenetic diseases. NewStem has
incurred losses related to in process research and development since inception and the Company records our percentage allocation of these
net losses as incurred. We have included the financial statements of NewStem as an exhibit to this Annual Report. In many cases, the
accounting treatment of a particular transaction is specifically dictated by generally accepted accounting principles, with no need for
management’s judgement in their application. There are also areas in which the selection of an available alternative policy would
not produce a materially different result.
Critical
Accounting Policies
The
SEC defines “critical accounting policies” as those that require application of management’s most difficult, subjective
or complex judgements, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and
my change in subsequent periods.
The
following discussion of critical accounting policies represents our attempt to report on these accounting policies which we believe are
critical to our financial statements and other financial disclosure. It is not intended to be a comprehensive list of all of our significant
accounting policies, which are more fully described in Note 2 of the Notes to the Financial Statements included in this Annual Report.
We
have identified our accounting policies for stock-based compensation and accounting for derivative liabilities as critical
accounting policies.
We
recognize stock-based compensation expense based on the fair value recognition provision of applicable accounting principles, using the
Black-Scholes option valuation method. Accordingly, we are required to measure the cost of services received in exchange for an award
of equity instruments based on the grant-date fair value of the award and to recognize that cost over the period during which services
are provided in exchange for the award. Under the Black-Scholes method, we make assumptions with respect to the expected lives of the
options that have been granted and are outstanding, the expected volatility, the dividend yield percentage of our common stock and the
risk-free interest rate at the respective dates of grant.
The
expected volatility factor used to value stock options in 2023 was based on the historical volatility of the market price of our common
stock over the period from our change to a biotechnology company, September 2018, through December
2023. For the expected term of the option, we used an estimate of the expected
option life based on historical experience. The risk-free interest rate used is based upon U.S. Treasury yields for a period consistent
with the expected term of the options. We assumed no quarterly dividend rate. Due to the numerous assumptions involved in calculating
stock-based compensation expense, the expense recognized in our financial statements may differ significantly from the value realized
by option holders on exercise of the share-based instruments. In accordance with the prescribed methodology, we do not adjust our recognized
compensation expense to reflect these differences.
For
the years ended December 31, 2023 and 2022, we incurred stock compensation expense with respect to options and warrants of
approximately $303,000 and $283,000, respectively.
See
Note 5 to the financial statements for the assumptions used to calculate the fair value of stock-based compensation.
In accordance with Accounting Standards Codification (“ASC”) 815, Derivatives
and Hedging, we identify and, if
applicable, bifurcate embedded derivatives in financial instrument instruments. Those embedded features that are identified, bifurcated
and accounted for separately are measured at fair value continuously at each financial statement reporting date. If the fair value of
a financial liability (the derivative) exceeds the proceeds received for the issuance of a hybrid instrument in an arms length transaction
with no rights or privileges that require separate accounting recognition as an asset identified, then we record the embedded derivative
at fair value with the excess of fair value over proceeds recognized as a loss in earnings.
14
Results
of Operations.
The
selected statement of operations data for the years ended December 31, 2023 and 2022 and balance sheet data as of December 31, 2023 and
2022 has been derived from our audited financial statements included in this Annual Report.
This
data should be read in conjunction with our financial statements and related notes included herein.
Selected
Statement of Operations Data:
Years
Ended December 31,
2023
2022
Change
Administrative
fee income
$ 12,000
$ 12,000
$ -
Operating expenses:
G&A expenses
$ 665,277
$ 744,434
$ (79,157 )
Litigation
expenses (contra expenses)
2,872,522
(310,000 )
3,182,522
Total
operating expenses
3,537,799
434,434
3,103,365
Loss
from operations
(3,525,799 )
(422,434 )
(3,103,365 )
Other expenses:
Loss on derivative instrument
260,000
-
260,000
Interest
expense
99,023
11,018
88,005
Total
other expenses
359,023
11,018
348,005
Net
loss before equity in net loss of equity method investees
(3,884,822 )
(433,452 )
(3,451,370 )
Equity in net loss of equity method investees
(338,618 )
(719,802 )
381,184
Gain on dilution of
equity method investment
36,139
387,524
(351,385 )
Net
loss
$ (4,187,301 )
$ (765,730 )
$ (3,421,571 )
2023
Compared to 2022
We
are a holding company whose primary assets are our ownership of equity interests in NewStem and NetCo. We conduct no other business and
as a result, we have no operating revenue or cost of revenue. We do charge annual administrative
fees to an affiliated entity.
The
Company incurs general and administrative (“G&A”) expenses primarily related to professional fees, insurance and
stock based compensation. We incurred G&A expenses of approximately $665,000 and $744,000 for the years ended December 31, 2023
and 2022, respectively. Our decrease in G&A expenses relates primarily to stock-based compensation and professional fees
incurred in the audit of our financial statements for the years ended December 31, 2023 and 2022, preparation of our quarterly
reports for 2023 and 2022, and, in the preparation, and filing of our Form 10 registration statement which was filed in August 2022.
Specifically, professional fees decreased by approximately $93,000 in the year ended December 31, 2023 as compared to the year ended
December 31, 2022. Insurance costs decreased by approximately $9,000 in the year ended December 31, 2023 as compared to the year
ended December 31, 2022. The remaining increase in G&A expenses of approximately $3,000 during the year ended December 31, 2023
consists primarily of increases in expenses related to investor relations and information
technology.
Total
stock compensation expense, included in G&A expenses, increased by approximately $20,000 in the year ended December 31, 2023 as compared
to the year ended December 31, 2022 due to a smaller number of options awarded in the current period as compared to the prior period
offset by the recognition of $243,000 in stock compensation expense related to the increased value of our outstanding warrants due to
the amendment of the agreements to extend the due date by two years.
We
incurred costs related to litigation and the related litigation funding agreement involving our arbitration with our NetCo joint venture
partner of approximately $2,873,000 for year ended December 31, 2023. We recognized contra expenses of $310,000 during the year ended
December 31, 2022 in relation to the same litigation and related litigation funding agreement. Specifically, the increase of approximately
$3,183,000 for the year ended December 31, 2023 as compared to 2022 is comprised of legal fees related to our NetCo arbitration including
litigation funding fees due to Omni Bridgeway pursuant to the litigation funding agreement combined with the reversal of the contra expenses
recognized in the previous period. These expenses and contra expenses were funded by the litigation funding agreement. This agreement
was signed during the first quarter of 2022 with Omni Bridgeway to fund our arbitration against our 50% joint venture partner, C.P. Group.
This is a nonrecourse agreement, and the Company had no obligation to repay any funds received under the agreement unless the NetCo arbitration
resulted in a favorable outcome. These amounts are included in the note payable to Omni Bridgeway which was recorded in June 2023 as
a result of the arbitration ruling.
15
The
Company has recorded a loss on derivative instrument of approximately $260,000 for the year ended December 31, 2023 related to a guarantee
included in the note payable shareholder entered into in May 2023. No such instrument was in effect in the year ended December 31, 2022.
Interest
expense increased by approximately $88,000 in the year ended December 31, 2023 as compared to the year ended December 31, 2022. The increases
in interest expense are related to increased debt incurred for operations and the funding of NewStem.
The
Company has recorded no income tax expense as we have incurred operating losses and all deferred tax assets are fully offset by an income
tax valuation allowance.
We
reported net losses from equity method investees during the years ended December 31, 2023 and 2022. The net losses reported for the year
ended December 31, 2023 included net income of approximately $3,000 from NetCo which was offset by net loss of approximately $342,000
from NewStem. Net losses reported for the year ended December 31, 2022 included net income of approximately $13,000 from NetCo which
was offset by net loss of approximately $733,000 from NewStem.
We
reported a gain on dilution of our equity method investment related to stock issuances made to third parties by NewStem. The gain was
approximately $36,000 and $388,000 during the years ended December 31, 2023 and 2022, respectively.
Liquidity
and Capital Resources
We
have not paid dividends on our common stock since our name change and business focus shift in 2018. Our present policy is to apply cash
to investments in product development at NewStem, acquisitions or expansion; consequently, we do not expect to pay dividends on common
stock in the foreseeable future.
We
expect to continue to incur greater expenses in the near future as we expand our business, including funding NewStem, or enter into strategic partnerships. We also
expect our G&A expenses to increase as we expand our administrative staff and add infrastructure.
The
Company will need to obtain additional funds to continue its operations. Management’s plans with regard to these matters include
additional financing and fundraising until our equity investment in NewStem is profitable. Although management continues to pursue these
plans, there is no assurance that the Company will be successful in obtaining sufficient cash from financing on terms acceptable to the
Company, or that NewStem will become profitable.
During
the year ended December 31, 2022, the Company entered into note agreements with Jan Loeb, our Executive Chairman and Jerry Wolasky, a
member of the Board, to borrow up to an aggregate of $600,000 for working capital needs. The note agreements were amended in March 2024
to increase the total borrowing to $650,000 and extend the maturity date. The agreements provide for interest at a rate of 8% per annum,
increased to 10% per annum for advances subsequent to November 11, 2022, and mature September 1, 2025. As of the date of this Annual
Report, the full amount of $650,000 has been funded pursuant to these agreements.
During the year ended December
31, 2023, the Company entered into a note agreement with a shareholder to borrow $300,000 for continued working capital. This note bears
interest at zero percent (0%) and matures on May 5, 2025. The note includes a guarantee which has been identified as an embedded derivative
with a fair value of a liability of $535,000 at December 31, 2023.
In December 2023, the Company entered into two short term notes payable with unrelated parties for a total of $250,000
in borrowings utilized for the funding of NewStem. The notes bear interest at 12% per annum and mature December 21, 2024, at which time
all principal and accrued interest are due and payable. The note agreements include a provision whereby, in the event of a capital raise
transaction by the Company, the note holders would be entitled to participate in the transaction in an amount equal to 133% of the amounts
owed on the note agreements at the closing of the transaction.
Net
Cash Used In Operating Activities.
For
the year ended December 31, 2023, net cash used in operating activities was approximately $348,000, which consisted primarily of a
net loss of approximately $4,187,000, offset by noncash equity in loss of equity method investees of approximately $339,000 and
distributions from equity method investees of $7,000, netted with gain on dilution of approximately $36,000 and stock-based
compensation of approximately $303,000. Further offset by approximately $2,819,000 in cumulative noncash litigation expenses funded
directly by the litigation funding agreement, loss on derivative instrument of $260,000, accretion of discount on notes payable of
$62,000 and interest added to related party notes payable of $35,138. Additionally, cash was used in operations related to a decrease in current assets of approximately $19,000 and an increase
in accrued liabilities and other payables of approximately $31,000.
For
the year ended December 31, 2022, net cash used in operating activities was approximately $182,000, which consisted primarily of a net
loss of approximately $776,000, offset by noncash equity in loss of equity method investees of approximately $720,000 and distributions
from equity method investees of approximately $13,000, netted with gain on dilution of approximately $388,000 and stock-based compensation
of approximately $283,000. Additionally, cash was used in operations related to an increase in current assets of approximately $24,000
and a decrease in accrued liabilities and other payables of approximately $28,000.
Net
Cash Used In Investing Activities.
For
the year ended December 31, 2023, $250,000 was loaned to NewStem in an investing activity. For the year ended December 31, 2022, no net
cash was used in investing activities.
Net
Cash Provided By Financing Activities.
For
the year ended December 31, 2023, net cash provided by financing activities was $645,000, consisting of long-term borrowings from two
directors and a stockholder totaling $395,000 and short term borrowings from unrelated parties of $250,000.
For
the year ended December 31, 2022, net cash provided by financing activities was $180,000, consisting of long-term borrowings from two
directors of $280,000 and repayment of $100,000 in short-term borrowings from a significant stockholder.
16
Off-Balance
Sheet Arrangements
We
are not party to any off-balance sheet transactions. With the exception of a guarantee related to long term borrowings from a stockholder
which is accounted for as a derivative, we have no guarantees or obligations other than those which arise out of normal business operations.
Contractual
Obligations and Commercial Commitments
As
of December 31, 2023, we had a contractual obligation related to our directors’ and officers’ insurance providing for 10
monthly installments of $4,943 payable through June 2024.
As
of December 31, 2022, we had a contractual obligation related to our directors’ and officers’ insurance providing for 10
monthly installments of $5,184 payable through June 2023.
Item
7A. Quantitative and Qualitative Disclosures About Market Risk.
This
section is not applicable.
Item
8. Financial Statements and Supplementary Data.
Furnished
at the end of this Annual Report, commencing on page F-1.
Item
9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
On
December 15, 2023, the Board of Directors of Novelstem International Corp. (the “Company”) received formal notice that our
independent auditors, Cherry Bekaert LLP (“CB”), had made the decision to resign as our independent accountants effective
December 15, 2023.
CB
audited the financial statements of the Company for the years ended December 31, 2020, 2021 and 2022. The reports of CB on such financial
statements dated August 1, 2022, October 11, 2022 and March 31, 2023 did not contain an adverse opinion or disclaimer of opinion and
were not modified as to uncertainty, audit scope or accounting principles.
For
the past three fiscal years and subsequent interim periods through the date of resignation, there have been no disagreements with the
former accountants on any matter of accounting principles or practices, financial statement disclosures or auditing scope or procedure,
which disagreement, if not resolved to the satisfaction of Cherry Bekaert LLP, would have caused them to make reference thereto in their
report on the financial statements.
During
the Company’s three most recent fiscal years, and since then, CB has not advised the Company that any of the following exist or
are applicable:
(1)
That
the internal controls necessary for the Company to develop reliable financial statements do not exist, that information has come
to their attention that has led them to no longer be able to rely on management’s representations, or that has made them unwilling
to be associated with the financial statements prepared by management.
(2)
That
the Company needs to expand significantly the scope of its audit, or that information has come to their attention that if further
investigated may material impact the fairness or reliability of a previously issued audit report or the underlying financial statements
or any other financial presentation, or cause them to be unwilling to rely on management’s representations or be associated
with the Company’s financial statements for the foregoing reasons or any other reason, or
(3)
That
they have advised the Company that information has come to their attention that they have concluded materially impacts the fairness
or reliability of either a previously issued audit report or the underlying financial statements for the foregoing reasons or any
other reason.
On
January 22, 2024, the Board of Directors of Novelstem International Corp. (the “Company”) approved the appointment of Kreit
& Chiu CPA LLP (“K&C”) as the Company’s new independent registered public accounting firm, effective immediately,
to perform independent audit services for the fiscal year ending December 31, 2023. During the fiscal years ended December 31, 2023,
2022 and 2021 and through January 22, 2024, neither the Company, nor anyone on its behalf, consulted K&C regarding either (i) the
application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might
be rendered on the Company’s financial statements, and no written report or oral advice was provided to the Company by K&C
that was an important factor considered by the Company in reaching a decision as to any accounting, auditing or financial reporting issue;
or (ii) any matter that was the subject of a “disagreement” (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related
instructions) or a “reportable event” (as that term is defined in Item 304(a)(1)(v) of Regulation S-K).
17
Item
9A. Controls and Procedures.
Our
Principal Executive Officer and Chief Financial Officer conducted an evaluation of our controls and procedures. We have identified material
weaknesses in our internal control and procedures and internal control over financial reporting. If not remediated, our failure to establish
and maintain effective disclosure controls and procedures and internal control over financial reporting could result in material misstatements
in our financial statements and a failure to meet our reporting and financial obligations, each of which could have a material adverse
effect on our financial condition and the trading price of our common stock.
Maintaining
effective internal control over financial reporting and effective disclosure controls and procedures are necessary for us to produce
reliable financial statements. We have re-evaluated our internal control over financial reporting and our disclosure controls and procedures
and concluded that they were not effective as of December 31, 2023 and we concluded there was a material weakness in the design of our
internal control over financial reporting as it relates to insufficient resources to employ proper segregation of duties over the processing of transactions
and financial reporting.
A
material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting such that
there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or
detected on a timely basis.
Remediation
Actions
Management
intends to focus on strengthening the Company’s internal controls. Management expects to make progress towards reducing the risk
that the material weakness could result in a material misstatement of the Company’s annual or interim financial statements. As
resources permit, management will continue to systematically build the necessary capabilities and infrastructure to implement corrective
action.
Changes
in Internal Control Over Financial Reporting
There
was no change in our internal control over financial reporting (as such term is defined in Rule 13a-15(f) under the Exchange Act) during
the period covered by this report 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.
18
PART
III
Item
10. Directors, Executive Officers and Corporate Governance.
Biographical
and certain other information concerning the Company’s officers and directors is set forth below. There are no familial relationships
among any of our officers or directors. Except as indicated below, none of our directors is a director in any other reporting companies.
None of our officers or directors has been affiliated with any company that has filed for bankruptcy within the last ten years except
that Jan Loeb has previously been affiliated with Kid Brands, Inc., which filed for bankruptcy in June 2014. We are not aware of any
proceedings to which any of our officers or directors, or any associate of any such officer or director is a party adverse to us or any
of our subsidiaries or has a material interest adverse to us or any of our subsidiaries. Unless otherwise indicated, there are no arrangements
or understandings between any officer and any other person pursuant to which such person was selected as an officer.
Jan
Loeb – President and Executive Chairman – 65 Mr. Loeb has more than 40 years of business, money management and investment
banking experience. He has served as Chairman of our Board since July 2018 and on September 29, 2022 was appointed as Executive Chairman.
On January 13, 2023, Mr. Loeb was appointed President of the Company. He has been the Managing Member of Leap Tide Capital Management
LLC since 2007 and has served as President and CEO of Acorn Energy, Inc. since January 2016 and as a Director since August 2015.
He has been a Director of Keweenaw Land Association, Ltd. From 2005 to 2007, Mr. Loeb was President of Leap Tide’s predecessor,
formerly known as AmTrust Capital Management Inc. He served as a Portfolio Manager of Chesapeake Partners from February 2004 to January
2005 and as Managing Director at Jefferies & Company, Inc. from 2002 to 2004. From 1994 to 2001, he served as Managing Director
at Dresdner Kleinwort Wasserstein, Inc. (formerly Wasserstein Perella & Co., Inc.). Mr. Loeb was a Lead Director of American
Pacific Corporation from 2013 to 2014 and a Director from 1997 to 2014. He also served as an Independent Director of Pernix Therapeutics
Holdings Inc. (formerly, Golf Trust of America, Inc.) from 2006 to 2011 and as a Director of TAT Technologies, Ltd. from 2009 to
2016.
Christine
Jenkins – Vice President and Chief Financial Officer – 60 Ms. Jenkins has over thirty-five years of experience in
public accounting, including audit, consulting and corporate tax. Ms. Jenkins is currently serving as a consultant providing audit
and accounting consultation to publicly-traded and large privately held companies. From 2010 to 2018 Ms. Jenkins was an audit partner
with Cherry Bekaert, LLP. Prior to Cherry Bekaert, from 1995 to 2010, Ms. Jenkins was a partner in a local accounting firm in Atlanta,
GA. Prior experience included audit and tax positions in public accounting firms.
Mitchell
Rubenstein – Director – 69 Mr. Rubenstein co-founded and served as Chairman of HMC from its inception to June 2018,
during which period the company returned approximately $37 million to shareholders in the form of dividends and share repurchases,
including a tender offer. He founded Syfy Channel and numerous other media and digital businesses.
Eric
Richman – Director -62 Mr. Richman is a life science executive with significant leadership, operational and strategic experience
from over 25 years in the field. He is currently The CEO of Gain Therapeutics and was a Venture Partner at Brace Pharma Capital and
serves on the boards of LabConnect, F2G (board observer) and previously ADMA Biologics (NASDAQ: ADMA). Previously he served as President
& CEO of PharmAthene and prior to that was part of the founding team at MedImmune, responsible for the U.S. launch of its first
commercial product and an integral part of the global launch teams for other products. He began his career at HealthCare Ventures,
a life-sciences focused VC firm and formerly was a Director of Lev Pharmaceuticals (sold to Viropharma) and American Bank (sold to
Congressional Bancshares) and served as CEO of Tyrogenex (sold to Betta Pharma).
David
Seltzer – Director – 63 Mr. Seltzer is the CEO and Founder of Reliable 1 Laboratories LLC, a distributor of OTC medications
and nutritional supplements to independent pharmacies, long-term care pharmacies, hospitals and government organizations. He is also
a minority owner and Director at Leading Pharma LLC, a generic manufacturer of prescription drugs, having previously served as President
and CEO and later Chairman of Hi-Tech Pharmacal Co., Inc., which was acquired by Akorn, Inc. for $640 million in 2014.
Jerry
Wolasky – Director – 63 Mr. Wolasky has over 35 years’ experience in the wholesale pharmaceutical business,
most recently for the past 15 years in his current role as President of HealthSource Distributors LLC. He previously served in executive
positions of increasing responsibility for AmerisourceBergen, and its predecessor company, Bergen Brunswig.
Tracy
Clifford – Director -55 Ms. Clifford has over twenty years of experience in accounting and finance, including mergers and
acquisitions of public companies. Ms. Clifford is the CFO of Acorn Energy, Inc. and COO of its operating subsidiary Omnimetrix Inc.
and since 2015 she has served as a contract CFO and COO for several clients, participated on advisory boards and worked on numerous
project engagements. Ms. Clifford previously served as CFO, Principal Accounting Officer, Corporate Controller and Secretary for
a publicly traded pharmaceutical company and a publicly-traded REIT from 1999 to 2015. Ms. Clifford’s prior experience included
accounting leadership positions at United Healthcare, the North Broward Hospital District and the audit team of Deloitte & Touche.
19
Audit
Committee; Audit Committee Financial Expert
The
Company’s full board is functioning as our audit committee at the time of this Annual Report.
Compensation
Committee
We
do not have a compensation committee or persons participating in deliberations concerning executive officer compensation as there
was no executive officer compensation paid other than hourly payments for Chief Financial Officer services during 2023 and
2022.
Nominating
Committee
We
do not have a nominating committee. All directors participate in the nomination and election of directors.
Section
16(a) Beneficial Ownership Reporting Compliance; Delinquent Section 16(a) Reports
Section
16(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) requires our executive officers and directors, and persons
who own more than 10% of a registered class of our equity securities to file reports of ownership and changes in ownership with the SEC.
These persons are also required by SEC regulation to furnish us with copies of all Section 16(a) forms they file. Further, we have implemented
measures to assure timely filing of Section 16(a) reports by our executive officers and directors. Based solely on our review of such
forms or written representations from certain reporting persons, we believe that during 2023 our executive officers and directors complied
with the filing requirements of Section 16(a).
Code
of Ethics
We
have adopted a Code of Business Conduct and Ethics that applies to all our directors, officers and employees. This code of ethics is
designed to comply with the NASDAQ marketplace rules related to codes of conduct.
Changes
in control
There
are no arrangements which may at a subsequent date result in a change in control of the Company.
20
Item
11. Executive Compensation.
Executive
and Director Compensation
Summary
Compensation Table
Option
All
Other
Salary
Bonus
Awards
Compensation
Total
Name
and Principal Position
Year
($)
($)
($)
($)
($)
Jan H. Loeb
2023
-
-
16,573 (1)
-
16,573
President and Executive
Chairman
2022
-
-
27,170 (2)
-
27,170
Christine Jenkins
2023
54,000 (3)
-
1,657 (1)
-
55,657
Vice President and Chief
Financial Officer
2022
58,725 (3)
-
-
-
58,725
Mitchell Rubenstein
2023
-
-
8,286 (1)
-
8,286
Director
2022
-
-
27,170 (2)
-
27,170
Eric Richman
2023
-
-
8,286 (1)
-
8,286
Director
2022
-
-
27,170 (2)
-
27,170
David Seltzer
2023
-
-
8,286 (1)
-
8,286
Director
2022
-
-
27,170 (2)
-
27,170
Jerry Wolasky
2023
-
-
8,286 (1)
-
8,286
Director
2022
-
-
27,170 (2)
-
27,170
Tracy Clifford
2023
-
-
8,286 (1)
-
8,286
Director
2022
-
-
27,170 (2)
-
27,170
(1)
Represents
the grant date fair value calculated in accordance with applicable accounting principles with respect to 50,000 options granted per
Director, 100,000 options granted to the President and Executive Chairman and 10,000 options granted to the Vice President and Chief
Financial Officer on March 23, 2023 with an exercise price of $0.20. The fair value of the options was determined using the Black-Scholes
option pricing model using the following assumptions: (i) a risk-free interest rate of 3.39% (ii) an expected term of 4.98 years
(iii) an assumed volatility of 118.3067% and (iv) no dividends.
(2)
Represents
the grant date fair value calculated in accordance with applicable accounting principles with respect to 100,000 options granted
per Executive/Director on January 31, 2022 with an exercise price of $0.29. The fair value of the options was determined using the
Black-Scholes option pricing model using the following assumptions: (i) a risk-free interest rate of 1.505% (ii) an expected term
of 4 years (iii) an assumed volatility of 184.74% and (iv) no dividends.
(3)
Represents
hourly fees paid to Ms. Jenkins for the provision of services as Chief Financial Officer of the Company.
21
Executive
Compensation for 2022 and 2023
Prior
to being appointed as our Chief Financial Officer on September 29, 2022 and Vice President on January 13, 2023, beginning in March 2022,
Ms. Jenkins served as our outside consultant providing certain financial services. Ms. Jenkins is paid on an hourly basis. Mr. Loeb was
appointed as Executive Chairman on September 29, 2022 and President on January 13, 2023 and does not receive any compensation for his
role as an officer of the Company.
The
Company pays compensation to its directors pursuant to the NovelStem International Corp. Equity Incentive Plan (the “Plan”).
The
Plan provides for the grant to officers, directors, third party contractors and other future key employees of options to purchase shares
of common stock. Under the Plan, the Company is authorized to issue up to 7,000,000 shares of common stock as equity awards under the
Plan. Awards may be made in the form of options, stock appreciation rights (“SARs”), restricted stock or restricted stock
units, or stock bonus awards in respect of the Company’s common stock of the Company. Grants to any single participant or non-executive
director during any calendar year may not exceed 1,000,000 shares.
The
purchase price may be paid in cash or at the end of the option term, if the option is “in-the-money”, it is automatically
exercised “net”. In a net exercise of an option, the Company does not require a payment of the exercise price of the option
from the optionee but reduces the number of shares of common stock issued upon the exercise of the option by the smallest number of whole
shares that has an aggregate fair market value equal to or in excess of the aggregate exercise price for the option shares covered by
the option exercised. Each option is exercisable to one share of the Company’s common stock.
Options
awarded under the Plan shall be awarded at an exercise price of not less than the fair market value of a share of our common stock as
of the grant date and shall vest and become exercisable after a period not to exceed seven (7) years. SARs awarded under the Plan shall
have a strike price per share of common stock of not less than the fair market value of a share of our common stock, provided that, in
the case of a SAR granted in tandem with an option, the strike price shall not be less than the exercise price of the related option.
A SAR granted in tandem with an option shall become exercisable and shall expire according to the same vesting schedule and expiration
provisions as the corresponding option, such date not to exceed seven (7) years of the grant date.
In
the event of the termination of an employee, third party service provider, officer or Director’s service on the Board of the Company
for any reason other than for cause, all of the options which are then vested may be exercised within 18 months of such termination,
provided that, in no event shall this extension period continue beyond the expiration of the term of the option(s). In addition, any
such extension shall be applicable only to the extent that such option or options are vested and exercisable according to the terms of
the Plan and any applicable option agreement. Any unvested options are immediately terminated on the effective date of the termination.
In the event of termination of an employee, third party service provider, officer or Director’s service for cause, all options
are forfeited and deemed cancelled and no longer exercisable as of the date of termination.
22
Outstanding
Equity Awards at 2023 Fiscal Year End
The
following tables set forth all outstanding equity awards made to each of the Executives and Directors that were outstanding at December
31, 2023.
Options
to Purchase NovelStem International Corp. Stock
Name
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
Option Exercise
Price ($)
Option
Expiration Date
Jan H. Loeb
50,000
0.10
November
12, 2025
50,000
0.10
November
26, 2026
1,000,000
0.10
November
24, 2027
100,000
0.29
January
31, 2029
100,000
0.20
March
23, 2030
Mitchell Rubenstein
50,000
0.10
November
12, 2025
50,000
0.10
November
26, 2026
1,000,000
0.10
November
24, 2027
100,000
0.29
January
31, 2029
50,000
0.20
March
23, 2030
Eric Richman
50,000
0.10
November
12, 2025
50,000
0.10
November
26, 2026
50,000
0.10
November
24, 2027
100,000
0.29
January
31, 2029
50,000
0.20
March
23, 2030
David Seltzer
50,000
0.10
November
12, 2025
50,000
0.10
November
26, 2026
50,000
0.10
November
24, 2027
100.000
0.29
January
31, 2029
50,000
0.20
March
23, 2030
Jerry Wolasky
50,000
0.10
November
12, 2025
50,000
0.10
November
26, 2026
50,000
0.10
November
24, 2027
100,000
0.29
January
31, 2029
50,000
0.20
March
23, 2030
Tracy Clifford
50,000
0.10
November
12, 2025
50,000
0.10
November
26, 2026
1,000,000
0.10
November
24, 2027
100,000
0.29
January
31, 2029
50,000
0.20
March
23, 2030
Christine Jenkins
10,000
0.20
March
23, 2030
Warrants
to Purchase NovelStem International Corp. Stock
Name
Number of
Securities
Underlying
Unexercised
Warrants (#)
Exercisable
Number of
Securities
Underlying
Unexercised
Warrants (#)
Unexercisable
Warrant Exercise Price ($)
Warrant
Expiration Date
Jan H. Loeb
2,250,000
-
0.13
June
28, 2025
Mitchell Rubenstein
750,000
-
0.10
June
28, 2025
Eric Richman
-
-
-
-
David Seltzer
-
-
-
-
Jerry Wolasky
-
-
-
-
Tracy Clifford
-
-
-
-
Christine Jenkins
-
-
-
-
23
Option
and Warrant Exercises
None
Non-qualified
Deferred Compensation
The
Company has no deferred compensation plan in place during the years ended December 31, 2023 and 2021.
Payments
and Benefits Upon Termination or Change in Control
There
are no agreements in place with any Executive or Director that would provide for any amounts due under any termination scenario at December
31, 2023.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
following table sets forth certain information with respect to the beneficial ownership of our common stock, as of December 31, 2023,
for each person known by us to be the beneficial owner of more than 5% of our outstanding shares of common stock, each of our directors
and all directors as a group. The Company has no executive officers. Except as indicated in footnotes to this table, we believe that
the shareholders named in this table will have sole voting and investment power with respect to all shares of common stock shown to be
beneficially owned by them, based on information provided to us by such shareholders.
Security
Ownership of Certain Beneficial Owners and Management
Name
and Address of beneficial owner (6)
Amount
and nature of beneficial ownership
Percent of
total common
equity (1)
Christine Jenkins
—
—
Michael Sosnowik
2,770,270
5.0 %
Stephen Gans
7,034,172
12.7 %
Jan Loeb
7,670,673 (2)(3)(4)
13.9 %
Jerry Wolasky
10,222,973 (3)(4)
18.5 %
Tracy Clifford
1,200,000 (4)
2.2 %
Eric Richman
804,054 (3)(4)
1.5 %
Mitchell Rubenstein
3,058,108 (4)(5)
5.5 %
David Seltzer
3,574,324 (3)(4)
6.5 %
All directors and officers as a group (seven
persons)
26,530,132
48.0 %
(1)
Applicable percentage ownership is based on 46,881,475 shares of common stock outstanding as of December 31, 2023, together with securities
exercisable or convertible into shares of common stock within 60 days of December 31, 2023. Beneficial ownership is determined in accordance
with the rules of the Securities and Exchange Commission and generally includes voting or investment power with respect to securities.
Shares of common stock that a person has the right to acquire beneficial ownership of upon the exercise or conversion of options, convertible
stock, warrants or other securities that are currently exercisable or convertible or that will become exercisable or convertible within
60 days of December 31, 2023, are deemed to be beneficially owned by the person holding such securities for the purpose of computing the
number of shares beneficially owned and percentage of ownership of such person, but are not treated as outstanding for the purpose of
computing the percentage ownership of any other person.
(2)
Includes 1,108,108 held in an IRA and 874,528 held as Trustee for the Steinberg Family Trust. Includes warrants to purchase 2.25 million
shares of common stock at an exercise price of $0.13 per share, options to purchase 1.10 million shares of common stock at an exercise
price of $0.10 per share and options to purchase 100,000 shares of common stock at an exercise price of $0.29 per share.
(3)
Includes options to purchase 150,000 shares of common stock at an exercise price of $0.10 per share and options to purchase 100,000 shares of common stock at an exercise price of $0.29 per share.
(4)
Director.
(5)
Includes options and warrants to purchase 1,850,000 shares of common stock at an exercise price of $0.10 per share and options to purchase 100,000 shares of common stock at an exercise price of $0.29 per share.
(6)
The address of each person is c/o NovelStem International Corp. 2255 Glades Road, Suite 221A, Boca Raton, FL 33431.
24
Securities
authorized for issuance under equity compensation plans.
Equity
Compensation Plan Information
Plan category
Number
of securities to be issued upon exercise of outstanding options, warrants and rights
Weighted-average
exercise price of outstanding options, warrants and rights
Number
of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
(a)
(b)
(c)
Equity compensation plans approved by security
holders
Equity compensation plans not approved
by security holders
8,760,000
$ 0.14
1,240,000
Total
8,760,000
$ 0.14
1,240,000
Item
13. Certain Relationships and Related Transactions, and Director Independence.
Jan
Loeb, our President and Executive Chairman of the Board, is also the Chairman of the Board of NewStem.
During
the year ended December 31, 2022, the Company entered into note agreements with Jan Loeb, our Executive Chairman and Jerry Wolasky, a
shareholder and member of the Board, to borrow up to an aggregate of $600,000 for working capital needs. The note agreements were amended
in March 2024 to increase the total borrowing to $650,000 and extend the maturity date. The agreements provide for interest at a rate
of 8% per annum, increased to 10% per annum for advances subsequent to November 11, 2022, and mature September 1, 2025. As of the date
of this Annual Report, the full amount of $650,000 has been funded pursuant to these agreements.
On
May 5, 2023, the Company entered into a long term note payable with a shareholder for $300,000 in financing to be funded $150,000 at
inception and $150,000 in October 2023. This note bears interest at zero percent (0%) and matures on May 5, 2025. The note includes a
guarantee which has been identified as an embedded derivative with a fair value of a liability of $535,000 at December 31, 2023.
Except
as disclosed herein, no director, executive officer, stockholder holding at least 5% of shares of our common stock, or any family member
thereof, had any material interest, direct or indirect, in any transaction, or proposed transaction since January 1, 2019, in which the
amount involved in the transaction exceeds the lesser of $120,000 or one percent of the average of our total assets at the year-end for
the last two completed fiscal years.
25
Review,
Approval or Ratification of Transactions with Related Persons
The
Board conducts an appropriate review of and oversees all related party transactions on a continuing basis and reviews potential conflict
of interest situations where appropriate. The Board has adopted formal standards to apply when it reviews, approves or ratifies any related
party transaction. In addition, the Board applies the following standards to such reviews: (i) all related party transactions must be
fair and reasonable and on terms comparable to those reasonably expected to be agreed to with independent third parties for the same
goods and/or services at the time they are authorized by the Board and (ii) all related party transactions should be authorized, approved
or ratified by the affirmative vote of a majority of the directors who have no interest, either directly or indirectly, in any such related
party transaction.
Director
Independence.
We
have determined that, under the criteria established by NASDAQ and by our board of directors, Tracy Clifford, Eric Richman, Mitchell
Rubenstein and David Seltzer are independent.
Item
14. Principal Accountant Fees and Services.
Accounting
Fees
Cherry
Bekaert LLP
The
following table summarizes the fees accrued and paid by NovelStem for professional services rendered by Cherry Bekaert LLP for the years
ended December 31, 2023 and 2022.
2023
2022
Audit fees
$ 111,605
$ 60,800
Tax Fees
6,400
3,500
All other fees
-
13,050
Total
$ 118,005
$ 77,350
Pre-Approval
Policies and Procedures
The
Audit Committee’s current policy is to pre-approve all audit and non-audit services that are to be performed and fees to be charged
by our independent auditor to assure that the provision of these services does not impair the independence of the auditor. The Audit
Committee pre-approved all audit and non-audit services rendered by our principal accountant in 2023 and 2022.
26
PART
IV
Item
15. Exhibit and Financial Statement Schedules.
(a)
Financial
Statements.
The
following financial statements are filed as part of this registration statement:
NOVELSTEM
INTERNATIONAL CORP.
Years
Ended December 31, 2023 and 2022
Index
to Audited Financial Statements
Page
Audited
Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID 6651 )
F-1
Report of Predecessor Auditor (PCAOB ID 677 )
F-2
Balance Sheets
F-3
Statements of Operations
F-4
Statements
of Changes in Shareholders’ Equity (Deficit)
F-5
Statements of Cash Flows
F-6
Notes to Financial Statements
F-7
27
Report
of Independent Registered Public Accounting Firm
Board
of Directors and Shareholders of
NovelStem
International Corp.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheet of NovelStem International Corp. as of December 31, 2023, and the related statements of operations,
shareholders’ equity (deficit) and cash flows for the year 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 NovelStem
International Corp. as of December 31, 2023, and the results of its operations and its cash flows for each of the years then ended, in
conformity with accounting principles generally accepted in the United States of America.
Going
Concern
The
accompanying financial statements have been prepared assuming that the entity will continue as a going concern. As discussed in Note
1 to the financial statements, the entity has suffered losses from operations that raise substantial doubt about its ability to continue
as a going concern. Management’s plans in regard to these matters are also described in Note 1. 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 entity’s management. Our responsibility is to express an opinion on these 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 NovelStem International Corp. 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. NovelStem
International Corp. is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
As part of our audit 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 entity’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/
Kreit & Chiu CPA LLP
We
have served as NovelStem International Corp.’s auditor since 2024.
New
York , New York
April
1, 2024
F- 1
Report
of Independent Registered Public Accounting Firm
To
the Board of Directors and Stockholders
NovelStem
International Corp.
Boca
Raton, Florida
Opinion
on the Financial Statements
We
have audited the accompanying balance sheet of NovelStem International Corp. (the “Company”) as of December 31, 2022, and
the related statements of operations, shareholders’ equity, and cash flows for the year 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, 2022, and the results of its operations and its cash flows for the year
then ended, in conformity with accounting principles generally accepted in the United States of America.
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 audit,
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/
Cherry Bekaert LLP
We
have served as the Company’s auditor from 2021 through 2022.
Fort
Lauderdale, Florida
March
31, 2023
F- 2
NOVELSTEM
INTERNATIONAL CORP.
BALANCE
SHEETS
As
of December 31,
2023
2022
ASSETS
Current assets:
Cash
$ 53,063
$ 6,346
Cash and cash equivalents
Accounts receivable, administrative fees
-
12,000
Prepaid expenses
33,540
40,561
Other
current assets
Total current assets
86,603
58,907
Non-current
assets
Property
and equipment, net
Investment in Netco
133,709
137,011
Note receivable, NewStem
250,000
-
Investment in NewStem
1,784,234
2,090,286
Total assets
$ 2,254,546
$ 2,286,204
LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable
$ 54,257
$ 21,203
Related party
Note payable
250,000
-
Accrued expenses
42,223
43,673
Total current liabilities
346,480
64,876
Long-term liabilities:
Long-term notes payable, including accrued interest
3,324,599
288,450
Convertible
financial instrument
-
-
Derivative liability, guarantee
535,000
-
Total long-term liabilities
3,859,599
288,450
Total liabilities
4,206,079
353,326
Commitments and contingencies (see Note 7)
-
-
Shareholders’ equity (deficit):
Common stock, $ .01 par value, 100,000,000 shares authorized, 50,316,672 shares issued at December 31, 2023 and 2022 and
46,881,475 shares outstanding at December 31, 2023 and 2022
468,815
468,815
Additional paid-in capital
290,907,217
290,604,327
Accumulated deficit
( 293,127,811 )
( 288,940,510 )
Treasury stock, at cost, 3,435,197 shares at December 31, 2023 and 2022
( 199,754 )
( 199,754 )
Total shareholders’ equity (deficit)
( 1,951,533 )
1,932,878
Total liabilities and shareholders’ equity (deficit)
$ 2,254,546
$ 2,286,204
The
accompanying notes are an integral part of these financial statements.
F- 3
NOVELSTEM
INTERNATIONAL CORP.
STATEMENTS
OF OPERATIONS
Years
Ended December 31,
2023
2022
Revenues
Cost
of revenues
Gross
profit
Administrative fee income
$ 12,000
$ 12,000
Operating expenses:
Research and development expenses
-
-
Less
– grants and participations received
-
-
Research
and development expenses, net
-
-
General and administrative expenses
665,277
744,434
Litigation expenses (contra expenses) (Note 7)
2,872,522
( 310,000 )
Total operating expenses
3,537,799
434,434
Loss from operations
( 3,525,799 )
( 422,434 )
Other expenses:
Loss on derivative instrument
260,000
-
Interest expense
99,023
11,018
Total other expenses
359,023
11,018
Financial income, net
Loss before income taxes
( 3,884,822 )
( 433,452 )
Provision for income tax
-
-
Net loss before equity in net loss of equity method investees
( 3,884,822 )
( 433,452 )
Equity in net loss of equity method investees
( 338,618 )
( 719,802 )
Gain on dilution of equity method investment
36,139
387,524
Net loss
$ ( 4,187,301 )
$ ( 765,730 )
Basic and diluted net loss per share:
Net loss per share - basic and diluted
$ ( 0.09 )
$ ( 0.02 )
Weighted average number of shares outstanding – basic
46,881,475
46,881,475
Weighted average number of shares outstanding – diluted
46,881,475
46,881,475
The
accompanying notes are an integral part of these financial statements.
F- 4
NOVELSTEM
INTERNATIONAL CORP.
STATEMENTS
OF SHAREHOLDERS’ EQUITY (DEFICIT)
Number
Total
Additional
of
Shareholders’
Number of
Common
Paid-In
Accumulated
Treasury
Treasury
Equity
Shares
Stock
Capital
Deficit
Shares
Stock
(Deficit)
Balance, December 31, 2021
46,881,475
$ 468,815
$ 290,321,665
$ ( 288,174,780 )
3,435,197
$ ( 199,754 )
$ 2,415,946
Net loss
-
-
-
( 765,730 )
-
-
( 765,730 )
Stock issued
-
-
-
-
-
-
-
Stock-based compensation
-
-
282,662
-
282,662
Balance, December 31, 2022
46,881,475
468,815
290,604,327
( 288,940,510 )
3,435,197
( 199,754 )
1,932,878
Balance
46,881,475
468,815
290,604,327
( 288,940,510 )
3,435,197
( 199,754 )
1,932,878
Net loss
-
-
-
( 4,187,301 )
-
-
( 4,187,301 )
Stock-based compensation
-
-
302,890
-
-
-
302,890
Balance, December 31, 2023
46,881,475
$ 468,815
$ 290,907,217
$ ( 293,127,811 )
3,435,197
$ ( 199,754 )
$ ( 1,951,533 )
Balance
46,881,475
$ 468,815
$ 290,907,217
$ ( 293,127,811 )
3,435,197
$ ( 199,754 )
$ ( 1,951,533 )
The
accompanying notes are an integral part of these financial statements.
F- 5
NOVELSTEM
INTERNATIONAL CORP.
STATEMENTS
OF CASH FLOWS
Years
Ended December 31,
2023
2022
Cash flows from operating activities:
Net loss
$ ( 4,187,301 )
$ ( 765,730 )
Adjustments
required to reconcile loss to net cash used in operating activities:
Depreciation
-
-
Revaluation
of convertible financial instrument
-
-
Equity in net loss of equity method investees
338,618
719,802
Gain on dilution of equity method investment
( 36,139 )
( 387,524 )
Distribution from NetCo
6,875
12,591
Accretion of discount on note payable
61,815
-
Loss on derivative instrument
260,000
-
Legal fees and litigation funding fees funded by litigation funding agreement
2,819,196
-
Accrued interest added to long-term note payable
35,138
8,450
Stock-based compensation
302,890
282,662
Change in operating assets and liabilities:
Decrease
in other current assets
-
-
Decrease in other liabilities
-
-
Accounts receivable, administrative fees
12,000
( 12,000 )
Prepaid expenses
7,021
( 12,245 )
Accounts payable
33,054
( 28,574 )
Accrued expenses
( 1,450 )
248
Net cash used in operating activities
( 348,283 )
( 182,320 )
Cash flows from investing activities:
Loans made
( 250,000 )
-
Net cash used in investing activities
( 250,000 )
-
Cash flows from financing activities:
Proceeds from (repayment of) note payable, current
250,000
( 100,000 )
Proceeds from long-term note payable
395,000
280,000
Funds
received from a related party
-
-
Issuance
of ordinary shares, net
-
-
Net cash from financing activities
645,000
180,000
Net change in cash
46,717
( 2,320 )
Cash at the beginning of the year
6,346
8,666
Cash at the end of the year
$ 53,063
$ 6,346
Supplemental cash flow information:
Cash paid during the year for:
Interest
$ 1,248
$ 8,320
The
accompanying notes are an integral part of these financial statements.
F- 6
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
NOTE
1— NATURE OF OPERATIONS
Description
of Business
NovelStem
International Corp. (“NovelStem” or the “Company”) is a holding company whose principal assets are an approximate
31 % equity interest in NewStem Ltd, an Israeli biotech company (“NewStem”), and a 50 % equity interest in NetCo Partners (“NetCo”).
NovelStem was formerly known as Hollywood Media Corp. The Company was incorporated in the State of Florida on January 22, 1993 and changed
its name to NovelStem International Corp. in September 2018 as a result of its business focus shift from a media business to cutting
edge biotech.
NewStem
focuses on the development and commercialization of diagnostic technology that can predict patients’ anti-cancer drug resistance,
allowing for targeted cancer treatments and the potential to reduce resistance to chemotherapy.
NetCo
is a legacy media business interest which owns “Net Force”, a book publishing franchise.
Going
Concern, Liquidity and Management’s Plans
Since
inception, the Company has accumulated a deficit of approximately $ 293,000,000 . The accumulated deficit of the Company subsequent to
its business focus shift and name change in September 2018 is approximately $ 6,447,000 which is comprised primarily of allocated losses
from equity method investments and general and administrative costs incurred by the Company.
The
Company will need to obtain additional funds to continue its operations. Management’s plans with regard to these matters include
additional financing and fundraising until its equity investment in NewStem is profitable. Although management continues to pursue these
plans, there is no assurance that the Company will be successful in obtaining sufficient cash from financing on terms acceptable to the
Company, or that NewStem will be able to continue as a going concern and become profitable (see Note 3).
The
Company has in place a finance agreement with two individuals who are shareholders and directors to borrow $ 650,000 for working capital
needs (see Note 4). Additionally, the Company entered into an additional finance agreement with a shareholder in 2023 to borrow $ 300,000
for working capital needs (see Note 4). As of the date of these financial statements, these borrowings have been fully utilized and the
Company will need to obtain additional funds to continue operations for the next 12 months.
In
view of the matters described above, the Company’s ability to meet financing requirements is dependent upon the ability to complete
additional fundraising or obtain additional financing, and/or monetize its investment in NetCo, along with NewStem continuing as a going
concern. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The financial
statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and
classification of liabilities that might be necessary should the Company be unable to continue in existence.
NOTE
2— SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
The Financial Accounting Standards Board (“FASB”) has established the FASB Accounting Standards Codification (“ASC”)
as the single source of authoritative GAAP.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain
reported amounts and disclosures. Accordingly, actual results could differ from those estimates.
F- 7
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
Cash
and Cash Equivalents
Cash
and cash equivalents include certain investments in highly liquid debt instruments with original maturities of three months or less at
the date of purchase. The Company had no cash equivalents as of either year end.
Equity
Investments
Investee
companies that are not consolidated, but over which the Company exercises significant influence, are accounted for under the equity method
of accounting. Whether or not the Company exercises significant influence with respect to an Investee depends on an evaluation of several
factors, including, among others, representation on the Investee company’s board of directors and ownership level, which is generally
a 20% to 50% interest in the voting securities of the Investee company. Under the equity method of accounting, an Investee company’s
accounts are not reflected within the Company’s Balance Sheets or Statements of Operations; however, the Company’s share
of the earnings or losses of the Investee company is reflected in the caption “Equity in net income (loss) of equity method investees”
in the Statements of Operations. The Company’s carrying value in an equity method Investee company is reflected in the caption
“Investment in Investee company” in the Company’s Balance Sheets.
When
the Company’s carrying value in an equity method Investee company is reduced to zero, no further losses are recorded in the Company’s
financial statements unless the Company guarantied obligations of the Investee company or has committed additional funding. When the
Investee company subsequently reports income, the Company will not record its share of such income until it equals the amount of its
share of losses not previously recognized.
The
Company reviews equity investments for impairment on an annual basis, or earlier if events or changes in circumstances indicate that
the carrying amounts might not be recoverable.
The
Company holds a minority investment in an entity, NewStem, which is accounted for pursuant to the equity method of accounting. Additionally,
the Company is a 50 % joint venture partner in NetCo which is accounted for pursuant to the equity method of accounting. See Note 3.
Derivative Financial Instruments
The Company has in place a financial
instrument, in the form of a note payable, with an identified embedded derivative in the form of a guarantee. The identified embedded
derivative has been bifurcated and accounted for separately. Such derivative financial instruments are measured at fair value at each
financial statement reporting date. If the fair value of a financial liability (the derivative) exceeds the proceeds received for the
issuance of a hybrid instrument in an arms length transaction with no rights or privileges that require separate accounting recognition
as an asset identified, then the embedded derivative is recorded at fair value with the excess of fair value over proceeds recognized
as a loss in earnings. During the year ended December 31, 2023, the Company recognized a loss on derivative financial instruments of $ 260,000 .
Proceeds from the note payable are shown as cash from financing instruments and the loss on derivative instrument is included as an adjustment
to reconcile loss to net cash used in operating activities in the statements of cash flows for the year ended December 31, 2023.
Treasury
Stock
Shares
of common stock repurchased are recorded at cost as treasury stock.
F- 8
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
Stock-Based
Compensation
The
Company accounts for stock-based awards in accordance with applicable accounting principles, which requires compensation expense related
to share-based transactions to be measured and recognized in the financial statements based on a determination of the fair value of the
stock options. The grant date fair value is determined using the Black-Scholes-Merton (“Black-Scholes”) pricing model. For
all stock options, the Company recognizes expense on an accelerated basis over the requisite service period (generally the vesting
period of the equity grant). The Company’s option pricing model requires the input of highly subjective assumptions, including
the expected stock price volatility, expected term, and forfeiture rate. Any changes in these highly subjective assumptions significantly
impact stock-based compensation expense.
Options
awarded to purchase shares of common stock issued to non-employees in exchange for services are accounted for as variable awards in accordance
with applicable accounting principles. Such options are valued using the Black-Scholes option pricing model.
In
the event of the termination of an employee, third party service provider, officer or Director’s service on the Board of the Company
for any reason other than for cause, all of the options which are then vested may be exercised within 18 months of such termination,
provided that, in no event shall this extension period continue beyond the expiration of the term of the option(s). In addition, any
such extension shall be applicable only to the extent that such option or options are vested and exercisable according to the terms of
the Plan and this Agreement. Any unvested options are immediately terminated on the effective date of the termination. In the event of
termination of an employee, third party service provider, officer or Director’s service for cause, all options are forfeited and
deemed cancelled and no longer exercisable on the date of termination.
See
Note 5 for the assumptions used to calculate the fair value of stock-based compensation. Upon the exercise of options, it is the Company’s
policy to issue new shares rather than utilizing treasury shares.
Income
Taxes
Deferred
income taxes are determined using the asset and liability method in accordance with Accounting Standards Codification (“ASC”)
Topic 740. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred income taxes are measured
using enacted tax rates expected to apply to taxable income in years in which such temporary differences are expected to be recovered
or settled. The effect of a change in tax rates on deferred income taxes is recognized in the statement of operations of the period that
includes the enactment date. In addition, a valuation allowance is established to reduce any deferred tax asset for which it is determined
that it is more likely than not that some portion of the deferred tax asset will not be realized.
F- 9
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
Basic
and Diluted Net Loss Per Share
Basic
net income per share is computed by dividing the net income by the weighted average number of shares outstanding during the year, excluding
treasury stock. Diluted net income per share is computed by dividing the net income by the weighted average number of shares outstanding
plus the dilutive potential of common shares which would result from the exercise of stock options and warrants. The dilutive effects
of stock options and warrants are excluded from the computation of diluted net income per share if the effect of doing so would be antidilutive.
The
following data represents the amounts used in computing earnings per share and the effect on net income (loss) and the weighted average
number of shares of dilutive potential common stock:
SCHEDULE OF WEIGHTED AVERAGE NUMBER OF SHARES OF DILUTIVE
Year Ended December 31,
2023
2022
Net loss available to common shareholders
$ ( 4,187,301 )
$ ( 765,730 )
Weighted average shares outstanding:
-Basic
46,881,475
46,881,475
Add: Warrants
-
-
Add: Stock options
-
-
-Diluted
46,881,475
46,881,475
Basic and diluted net loss per share
$ ( 0.09 )
$ ( 0.02 )
NOTE
3— EQUITY METHOD INVESTMENTS
Investment
in NewStem
In
2018, the Company entered into a Share Purchase Agreement with NewStem and other related parties to provide aggregate funding of up to
$ 4,000,000 to NewStem. This funding was to be provided through the sale of up to 50,000 common shares of NewStem to the Company representing
33 % of New Stem’s outstanding shares. In 2018, the Company purchased 25,000 shares of NewStem for $ 2,000,000 acquiring an ownership
interest of 20 % . The Company made additional investments in 2019 and 2020 purchasing 12,500 shares each year for a $ 1,000,000 investment
each year resulting in an ownership interest of 30.51 % and 30.58 % , respectively, as of December 31, 2023 and 2022.
The
Company accounts for its investment in NewStem under the equity method. At December 31, 2023 and 2022, the carrying value of the investment
in NewStem exceeded its portion of the underlying net assets of NewStem by approximately $ 1,800,000 and $ 1,900,000 , respectively. The
excess relates to identified intangible assets including license agreements, specialized work force (goodwill) and two separate projects
of in process research and development (“IPR&D”) related to stem cell-based diagnostics and therapeutics for cancer chemotherapies.
During the years ended December
31, 2023 and 2022, the Company reimbursed NewStem for audit and audit related costs of approximately $ 58,000 and $ 105,000 , respectively.
As disclosed in Note 8, the Company
is in negotiations to acquire the remainder of NewStem in exchange for shares of Company stock. In anticipation of this transaction, the
Company advanced $ 250,000 to NewStem in December 2023 and an additional $ 250,000 in March 2024. The related note agreement bears no interest
and is payable on December 30, 2024. The agreement provides for discharge of the note upon the closing of the anticipated acquisition
transaction. This note receivable has been presented as a noncurrent asset along with the investment in NewStem in the balance
sheets.
The
Company assesses its investment in NewStem for impairment on an annual basis or more frequently if indicators of impairment exist.
F- 10
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
NewStem
is in the development stage and has incurred losses since its inception and has generated only minimal revenues related to a licensing agreement. NewStem will need
to obtain additional funds to continue its operations. NewStem management’s plans with regard to these matters include
continued development, marketing and licensing of its products, as well as seeking additional financing arrangements. Although
management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient cash
from sales, licensing or financing on terms acceptable to the Company. NewStem obtained additional funding of approximately $ 1,450,000
in April 2022 through the sale of shares of ordinary stock. NewStem’s management has adopted a cost reduction plan in order to
adjust future operation expenses to its cash balance. In October 2023, the NewStem board of directors unanimously resolved to
dismiss most employees which occurred in December 2023.
The
aforementioned events indicate significant difficulties to continue as a concern. Additionally, Israel declared a state of war in October
2023 which resulted in a decrease in Israel’s economic and business activity. The security situation in Israel led to a disruption
in the chain of supply and production, a decrease in the volume of national transportation, and a shortage in manpower as well as a decrease
in the value of financial assets. As a result of the movement and work restrictions, NewStem began operating on a limited scale. Additionally,
the situation has brought further difficulties in management’s efforts to seek additional financing.
The
following table represents the Company’s investment in NewStem:
SCHEDULE
OF INVESTMENTS
2023
2022
Year Ended December 31,
2023
2022
Investment in NewStem, beginning
$ 2,090,286
$ 2,435,155
Allocation of net loss from NewStem
( 342,191 )
( 732,393 )
Gain on dilution of equity method investment
36,139
387,524
Investment in NewStem, ending
$ 1,784,234
$ 2,090,286
The
results of operations and financial position of the Company’s investment in NewStem are summarized below:
SCHEDULE
OF OPERATIONS AND FINANCIAL POSITION INVESTMENT
2023
2022
Year Ended December 31,
2023
2022
Condensed income statement information:
License fees
$ 95,000
$ -
Gross profit
$ 84,000
$ -
Net loss
$ ( 1,119,000 )
$ ( 2,341,000 )
Company’s allocation of net loss from NewStem
$ ( 342,191 )
$ ( 732,393 )
2023
2022
As of December 31,
2023
2022
Condensed balance sheet information:
Current assets
$ 353,000
$ 911,000
Non-current assets
$ 9,000
$ 23,000
Current liabilities
$ 284,000
$ 97,000
Non-current liabilities
$ -
$ 121,000
F- 11
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
Investment
in NetCo
NovelStem
owns a 50 %
interest in NetCo, a joint venture that owns the Net Force publishing franchise. The Company accounts for its investment in NetCo
under the equity method and recognizes nominal royalties and administrative fees from this arrangement. The Company assesses its
investment in NetCo for impairment on an annual basis or more frequently if indicators of impairment exist.
The
following table represents the Company’s investment in NetCo:
SCHEDULE
OF INVESTMENTS
2023
2022
Year Ended December 31,
2023
2022
Investment in NetCo, beginning
$ 137,011
$ 137,011
Allocation of net income from Netco
3,573
12,591
Distribution from NetCo
( 6,875 )
( 12,591 )
Investment in NetCo, ending
$ 133,709
$ 137,011
The
results of operations and financial position of the Company’s investment in NetCo are summarized below:
SCHEDULE
OF OPERATIONS AND FINANCIAL POSITION INVESTMENT
2023
2022
Year Ended December 31,
2023
2022
Condensed income statement information:
Net sales
$ 25,789
$ 25,182
Gross profit
$ 19,422
$ 25,182
Net income
$ 7,146
$ 25,182
Company’s allocation of net income from NetCo
$ 3,573
$ 12,591
2023
2022
As of December 31,
2023
2022
Condensed balance sheet information:
Current assets
$ 1,820
$ 13,473
Non-current assets
$ 272,799
$ 272,799
Current liabilities
$ 325
$ 12,250
Non-current liabilities
$ -
$ -
F- 12
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
NOTE
4— NOTES PAYABLE
In December 2023, the Company
entered into two short term notes payable with unrelated parties, Hewlett Fund and AIGH Investment Partners, LLC. The notes are for $ 125,000
each, for a total of $ 250,000 in borrowings utilized for the funding of NewStem. The notes bear interest at 12 % per annum and mature December
21, 2024 , at which time all principal and accrued interest are due and payable. The note agreements include a provision whereby, in the
event of a capital raise transaction by the Company, the note holders would be entitled to participate in the transaction in an amount
equal to 133% of the amounts owed on the note agreements at the closing of the transaction . Interest expense related to these notes was
$ 822 for the year ended December 31, 2023.
Long-term notes
payable are summarized as follows:
SCHEDULE
OF LONG TERM NOTES PAYABLE
As of December 31,
2023
2022
Notes payable related parties:
Notes payable director and Executive Chairman
$ 400,000
$ 280,000
Accrued interest added to note balance
43,588
8,450
Total notes payable director and Executive Chairman
443,588
288,450
Note payable shareholder, principal amount
275,000
-
Less unamortized discount
( 213,185 )
-
Total note payable shareholder
61,815
-
Note payable, litigation funding agreement:
Note payable Omni Bridgeway (Fund 4) Invt. 3 L.P.
2,819,196
-
Total notes payable
3,324,599
288,450
Less current portion
-
-
Long-term notes payable
$ 3,324,599
$ 288,450
On
April 12, 2021, the Company entered into a promissory note (the “Note”) with a related party (individual) for $ 100,000 . The
Note accrued interest at 8 % per annum and matured on April 12, 2022 . The proceeds of this Note were used to pay operating expenses of
the Company including directors and officer insurance premiums. Interest expense accrued related to this Note was $ 1,198 for the year
ended December 31, 2022. The Note and all accrued interest, totaling $ 6,752 , were paid in full on February 16, 2022.
In
May 2022, the Company entered into note agreements with two individuals who are related parties to borrow up to $ 600,000 for working
capital needs. The agreements were amended in March 2024 to increase the total borrowing to $ 650,000 and extend the maturity date. The
agreements provide for interest at a rate of 8 % per annum through November 11, 2022, at which time the interest rate increased to 10 %
per annum for subsequent advances. The agreements mature September 1, 2025 . The Company received advances of $ 400,000 and $ 280,000 , respectively,
pursuant to these agreements through December 31, 2023 and 2022.
On
May 5, 2023, the Company entered into a long term note payable with a shareholder for $ 300,000 in financing to be funded $ 150,000 at
inception and $ 150,000 in October 2023. This note bears interest at zero percent ( 0 % ) and matures on May 5, 2025 . The note includes a
guarantee which has been identified as an embedded derivative with a fair value of a liability of $ 535,000 at December 31, 2023 which
is reported separately on the balance sheet. The fair value of the note exceeds the proceeds, and the note has been discounted
at inception so that the net liability is the fair value of the derivative. Accretion of the note discount of $ 61,815 has been reflected
as part of interest expense in the statement of operations for year ended December 31, 2023.
Note
Payable, Litigation Funding Agreement
On
February 11, 2022, the Company entered into a nonrecourse litigation funding agreement (the “Agreement”) with Omni Bridgeway
(Fund 4) Invt. 3 L.P. (“Omni”) related to an arbitration proceeding disclosed in Note 7. The Agreement provides for Omni
to fund all costs related to the arbitration up to $ 1,000,000 in exchange for an assignment of a certain portion of rights to and interest
in claims related to this arbitration. The agreement provides for specific calculations of the portion of any claims collected to be
received by Omni with the remainder collectible by the Company. Additionally, the agreement provides for repayment of funded costs pursuant
to the same multiple calculations in the event of a favorable outcome that does not include the collection of claims. During the year
ended December 31, 2022, the Company received $ 310,000 pursuant to this agreement for the reimbursement of legal costs and working capital
expenditures, including previously incurred general and administrative costs.
F- 13
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
During
July 2023, the arbitration was settled with a favorable outcome for the Company. As a result of the ruling disclosed in Note 7, the
liability became probable and reasonably estimable, and the Company has recorded the full liability due to Omni as of December 31,
2023. This liability consists of expenses funded by Omni of $ 933,065 ,
including $ 310,000
advanced for working capital, and related fees or investment return to Omni calculated as contractual multiples of funding totaling
$ 1,886,131
as of December 31, 2023 for a total liability of $ 2,819,196 .
This agreement bears interest at 5 %
per annum beginning January 2024 and on January 10, 2025.
NOTE
5— EQUITY
(a)
General
At December 31, 2023 and 2022 the Company had issued 50,316,672 and outstanding
46,881,475 shares of its common stock, par value $ 0.01 per share. The Company held 3,435,197 shares of its common stock, $ .01 par value,
in treasury at December 31, 2023 and 2022. Holders of outstanding common stock are entitled to receive dividends when, and if declared
by the Board and to share ratably in the assets of the Company legally available for distribution in the event of a liquidation, dissolution
or winding up of the Company.
(b)
Summary Employee Option Information
The
Company’s stock option plans provide for the grant to officers, directors, third party contractors and other future key employees
of options to purchase shares of common stock. The purchase price may be paid in cash or at the end of the option term, if the option
is “in-the-money”, it is automatically exercised “net”. In a net exercise of an option, the Company does not
require a payment of the exercise price of the option from the optionee but reduces the number of shares of common stock issued upon
the exercise of the option by the smallest number of whole shares that has an aggregate fair market value equal to or in excess of the
aggregate exercise price for the option shares covered by the option exercised. Each option is exercisable to one share of the Company’s
common stock. Most options expire within six years from the date of the grant and generally vest on the first anniversary date of their
issuance. Pursuant to the Equity Incentive Plan approved by the Company’s board of directors on November 12, 2018, an aggregate
of 5,760,000 options have been issued to directors and investor relations professionals.
The
Company utilized the Black-Scholes option-pricing model to estimate fair value, utilizing the following assumptions for the respective
years (all in weighted averages):
SCHEDULE
OF FAIR VALUE OF OPTION USING VALUATION ASSUMPTIONS
Year Ended December 31,
2023
2022
Risk-free interest rate
3.4 %
1.5 %
Expected term, in years
3.91
3.82
Expected volatility
118.3 %
183.7 %
Expected dividend yield
0 %
0 %
Determined weighted average grant date fair value per option
$ 0.17
$ 0.27
The
expected term of the options represents an estimate of the length of time until the expected date of exercising the options. Options
granted have a maximum life of 6 years. With respect to determining expected exercise behavior, the Company has grouped its option grants
into certain groups in order to track exercise behavior and establish historical rates. The Company estimated volatility by considering
historical stock volatility over the period since the Company’s business focus shift to biotech. The risk-free interest rates are
based on the U.S. Treasury yields for a period consistent with the expected term. The dividend yield of 0 % is based on the Company’s
history and expectation of dividend payout. The Company has not paid and does not anticipate paying of dividends in the near future.
F- 14
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
(c)
Summary Option Information
A
summary of the Company’s option plans as of December 31, 2023 and 2022, as well as changes during each of the years then ended,
is presented below:
SCHEDULE
OF STOCK OPTION ACTIVITIES
Year Ended December 31,
2023
2022
Number
Weighted
Number
Weighted
of
Average
of
Average
Options
Exercise
Options
Exercise
(in shares)
Price
(in shares)
Price
Outstanding at beginning of year
5,400,000
0.14
4,300,000
0.10
Granted
360,000
0.20
1,100,000
0.29
Outstanding at end of year
5,760,000
0.14
5,400,000
0.14
Exercisable at end of year
5,400,000
0.14
4,800,000
0.12
Stock-based
compensation expense was approximately $ 303,000 and $ 283,000 in the years ending December 31, 2023 and 2022, respectively.
The
total compensation cost related to non-vested awards not yet recognized was approximately $ 13,000 and $ 13,000 , respectively, as of December
31, 2023 and 2022. An award of 500,000 options granted on January 31, 2022 had special vesting provisions whereby the awards fully vested
in 2022.
(d)
Warrants
The
Company has issued warrants at exercise prices equal to or greater than market value of the Company’s common stock at the date
of issuance. A summary of warrant activity follows:
SUMMARY
OF WARRANTS ACTIVITY
Year Ended December 31,
2023
2022
Number of
Weighted
Number
Weighted
shares
Average
of
Average
underlying
Exercise
Options
Exercise
warrants
Price
(in shares)
Price
Outstanding at beginning of year
3,000,000
0.12
3,000,000
0.12
Granted
-
-
-
-
Exercised
-
-
-
-
Forfeited or expired
-
-
-
-
Outstanding at end of year
3,000,000
0.12
3,000,000
0.12
The
warrant agreements were amended on May 12, 2023 to extend the expiration date to June 28, 2025 . The warrants outstanding at December
31, 2023 have a weighted average remaining contractual life of approximately one and a half years . The Company recognized $ 243,000 in
stock-based compensation expense related to the increase in fair value of warrants pursuant to the modification of the warrant term during
the year ended December 31, 2023. No such expense was recognized related to the warrants during the year ended December 31, 2022.
F- 15
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
NOTE
6— INCOME TAXES
For
the years ended December 31, 2023 and 2022, the Company incurred net operating losses and, accordingly, no provision for income
taxes has been recorded. In addition, no benefit for income taxes has been recorded due to the uncertainty of the realization of any
tax assets. At December 31, 2023 and 2022, the Company had approximately $ 54,000,000
and $ 61,000,000 ,
respectively of net operating losses subject to IRC Section 382 limitations, of which $ 9,900,000
and $ 6,400,000 ,
respectively, were available for carryforward after the consideration of IRC Section 382 limitations. State of Florida net operating
losses available for carryforward approximate the federal net operating loss carryforward amounts.
The
Company’s federal and state net operating losses began expiring in 2021. Approximately $ 8,000,000
and $ 4,000,000 ,
respectively of federal and state losses expired in December 2023, and approximately $ 55,000,000
and $ 25,000,000 ,
respectively, of federal and state losses expired in December 2022. The Company has approximately $ 5,331,000
in federal and state losses that do not expire. The remaining losses expire from 2024 through 2036. The majority of these expiring
losses are further limited by IRC section 382 as shown in the deferred tax table below. All such deferred tax assets have been
offset with a full valuation allowance.
The
Company’s income tax provision differs from the expense that would result from applying statutory rates to income before taxes.
A reconciliation of the provision (benefit) for income taxes with amounts determined by applying the statutory U.S. federal income tax
rate to income before income taxes is as follows:
SCHEDULE
OF INCOME BEFORE INCOME TAX
2023
2022
Year Ended December 31,
2023
2022
Computed tax at the federal statutory rate of 21 %
$ ( 879,333 )
$ ( 160,803 )
State income taxes, net of federal income tax benefit
( 181,938 )
( 33,271 )
Foreign rate differential
( 48,968 )
( 171,089 )
Change in federal valuation allowance
1,110,239
365,163
Total provision for income tax
$ -
$ -
Deferred
income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes. Deferred tax assets as of December 31, 2023 and 2022 consist of the
following:
SCHEDULE OF DEFERRED TAX
ASSETS
2023
2022
As of December 31,
2023
2022
Outside tax basis difference in equity investments
$ 1,700,000
$ 1,700,000
Federal and state net operating loss carryforwards available after consideration of IRC Section 382 limitations
2,540,308
1,686,708
General business credit
41,551
41,551
Related party
interest and accretion of note discount
25,691
-
Loss on derivative instrument
68,900
Stock compensation
252,275
174,009
Total deferred tax assets
4,630,725
3,602,268
Federal and state net operating loss carryforwards subject to IRC Section 382 limitations
13,644,005
15,465,570
Less valuation allowance for net operating loss limitations
( 13,644,005 )
( 15,465,570 )
Valuation allowance
( 4,130,103 )
( 2,971,573 )
Subtotal deferred tax assets
500,622
630,695
Deferred tax liability, equity method basis difference
( 500,622 )
( 630,695 )
Net deferred tax assets
$ -
$ -
Management
has evaluated all tax positions that could have a significant effect on the combined financial statements and determined the Companies
had no significant uncertain income tax positions at December 31, 2023 and 2022.
F- 16
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
NOTE
7— COMMITMENTS AND CONTINGENCIES
The
Company was the claimant in an arbitration proceeding against their 50 % partner in NetCo. The Company initiated the arbitration proceeding
in an effort to maximize the total potential value to be derived from fully utilizing the NetCo intellectual property across publishing,
entertainment, digital media, merchandising and other ancillary markets. Arbitration hearings were held at the end of July 2022. Arbitration
proceedings for the joint owners of NetCo concluded during 2022 and the arbitrator rendered a decision in July 2023. The arbitrator ruled against the Company on certain key issues of the arbitration and in the Company’s favor on two key issues of the arbitration.
The
Arbitrator ruled in NovelStem’s favor on the issue of contract interpretation of the Netco Partners JV Agreement. The Arbitrator
also found that the Company’s joint venture partner failed to use “reasonable, good faith efforts” to license and exploit
the Net Force concept, in breach of its contractual obligations under the Netco Partners’ Joint Venture Agreement. The Arbitrator
confirmed NovelStem’s contractual right to use Tom Clancy’s name as a possessory credit in the Net Force title (Tom Clancy’s
Net Force).
As
a result of this ruling, the costs related to the litigation funding agreement disclosed in Note 4 were recognized. Total costs related
to the litigation and the related litigation funding agreement of $ 2,819,196 , including a reversal of the prior period contra expenses,
were recorded during the December 31, 2023 and were separately stated in the statement of operations.
NOTE
8— SUBSEQUENT EVENTS
The Company evaluated subsequent events through the date these financial statements were available
to be issued and filed with the SEC.
During the fourth quarter of 2023,
the Company entered into negotiations with NewStem stockholders for the acquisition of the shares not held by the Company. The negotiations
are ongoing for the transaction in which the Company would acquire all outstanding shares in exchange for shares of NovelStem stock. Company
management anticipates the transaction to conclude in the second quarter of 2024. In anticipation of the Company acquiring the remaining
ownership of NewStem, the Company has loaned $ 500,000 to NewStem to ensure continuing operations. The Company advanced $ 250,000 of this
loan to NewStem in December 2023 and the remainder in March 2024. See Note 3.
As disclosed in Note 4, related
party loan agreements were amended in March 2024 to increase the total borrowing to $ 650,000 and extend the maturity date to September
1, 2025 . The Company received an advances of $ 250,000 on these agreements which was utilized to fund NewStem in March 2024 fully utilizing
available borrowings.
F- 17
(b)
Exhibits.
Exhibit
Number
Description
3.1
Third
Amended and Restated Articles of Incorporation December 1999 (1)
3.2
Articles
of Amendment to Articles of Incorporation 2004 (1)
3.3
Articles
of Amendment to Articles of Incorporation 2018 (1)
3.4
Bylaws
(1)
3.5
Articles
of Association of NewStem (1)
10.1
Equity
Incentive Plan (1)
10.2
Joint
Venture Agreement by and between the Company and NetCo (1)
10.3
Financing Agreement dated May 2022 (1)
10.4
Amendment
to Financing Agreement dated July 2022 (1)
10.5
Promissory Note issued to Jan Loeb (1)
10.6
Promissory
Note issued to Jerry Wolasky (1)
10.7
Form
of NovelStem Subscription Agreement (1)
10.8
NewStem
Share Purchase Agreement (1)
10.9
Redacted
Litigation Funding Agreement with Omni Bridgeway (1)
10.10
Promissory Note issued to Stephen Gans
10.11
1 st Amendment to Promissory Note issued to Jan Loeb
10.12
1 st Amendment to Promissory Note issued to Jerry Wolasky
10.13
Certification of Principal Executive Officer and Executive Chairman pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
10.14
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
10.15
Certification of Principal Executive Officer and Executive Chairman pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
10.16
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
Inline
XBRL Instance Document
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 (embedded within the Inline XBRL document)
(1)
Previously
filed.
28
(c)
Financial
statements of fifty percent or less owned subsidiaries.
NewStem
Ltd.
Financial
Statements
As
of December 31, 2023
NewStem
Ltd.
Financial
Statements as of December 31, 2023
Contents
Page
Report
of Independent Registered Public Accounting Firm
F- 2
Balance
Sheets
F- 3
Statements
of Operations
F- 4
Statements
of Changes in Shareholders’ Equity
F- 5
Statements
of Cash Flows
F- 6
Notes
to the Financial Statements
F- 7- F-18
F- 1
Somekh
Chaikin
KPMG
Millennium Tower
17
Ha’arba’a Street, PO Box 609
Tel
Aviv 61006, Israel
+972
3 684 8000
Report
of Independent Registered Public Accounting Firm
To
the Shareholders and the Board of Directors of NewStem Ltd.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheets of NewStem Ltd. as of December 31, 2023 and 2022, the related statements of operations,
changes in shareholders’ equity and cash flows for each of the years in the two-year period ended December 31, 2023, and the related
notes (collectively, 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 each of
the years in the two-year period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.
Going
Concern
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note
1C to the financial statements, the Company has suffered recurring losses from operations and has an accumulated deficit that raise substantial
doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note
1C. 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 these financial
statements based on our audits. 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 audits 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.
Our
audits 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 audits 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 audits
provide a reasonable basis for our opinion.
Critical
Audit Matters
Critical
audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and
(2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Somekh Chaikin
Somekh
Chaikin
Member
Firm of KPMG International
We
have served as the Company’s auditor since 2021.
Tel
Aviv, Israel
March
20, 2024
KPMG
Somekh Chaikin, an Israeli partnership and a member firm of the KPMG global organization of independent member
firms affiliated with
KPMG International Limited, a private English company limited by guarantee
F- 2
NewStem
Ltd.
Balance
Sheets as of December 31,
2023
2022
Note
US$
thousands
US$
thousands
Assets
Current
assets
Cash
and cash equivalents
3
324
878
Other
current assets
4
29
33
Total
current assets
353
911
Non-current
assets
Property
and equipment, net
5
9
23
Total
assets
362
934
Liabilities
and shareholders’ equity
Current
liabilities
Accounts
payable
6
34
97
Related
party
10
250
-
Total
current liabilities
284
97
Non-current
liabilities
Convertible
financial instrument
7F
-
121
Total
liabilities
284
218
Commitments
and contingent liabilities
9
-
-
Shareholders’
equity
7
Ordinary
shares
- *
- *
Additional
paid-in capital
9,167
8,686
Accumulated
deficit
( 9,089 )
( 7,970 )
Total
shareholders’ equity
78
716
Total
liabilities and shareholders’ equity
362
934
/s/
Jan Loeb
Jan
Loeb
Chairperson
of the Board
Date
of approval of the financial statements: March 20, 2024
* Represents an amount
less than $1 thousand.
The
accompanying notes are an integral part of the financial statements.
F- 3
NewStem
Ltd.
Statements
of Operations for the Year Ended December 31,
2023
2022
Note
US$
thousands
US$
thousands
Revenues
8
95
-
Cost
of revenues
9A
11
-
Gross
profit
84
-
Operating
expenses:
Research
and development expenses
2H
965
2,299
Less
– grants and participations received
9B
-
( 200 )
Research
and development expenses, net
965
2,099
General
and administrative expenses, net
240
245
Operating
loss
1,121
2,344
Financial
income, net
( 2 )
( 3 )
Loss
for the year
1,119
2,341
The
accompanying notes are an integral part of the financial statements.
F- 4
NewStem
Ltd.
Statements
of Changes in Shareholders’ Equity
Additional
paid-in
Accumulated
Ordinary
shares
capital
Deficit
Total
Number
of
shares
US$
thousands
US$
thousands
US$
thousands
US$
thousands
Balance
as of January 1, 2022
158,696
- *
6,734
( 5,629 )
1,105
Issuance
of ordinary shares, net
4,798
- *
1,450
-
1,450
Stock
based compensation
-
-
502
-
502
Loss
for the year
-
-
-
( 2,341 )
( 2,341 )
Balance
as of December 31, 2022
163,494
- *
8,686
( 7,970 )
716
Balance
163,494
- *
8,686
( 7,970 )
716
Conversion
of convertible financial instrument
412
-
125
-
125
Stock
based compensation
-
-
356
-
356
Loss
for the year
-
-
-
( 1,119 )
( 1,119 )
Balance
as of December 31, 2023
163,906
- *
9,167
( 9,089 )
78
Balance
163,906
- *
9,167
( 9,089 )
78
* Represents an amount
less than $1 thousand.
The
accompanying notes are an integral part of the financial statements.
F- 5
NewStem
Ltd.
Statements
of Cash Flows for the year ended December 31
2023
2022
US$
thousands
US$
thousands
Cash
flows from operating activities
Loss
for the year
( 1,119 )
( 2,341 )
Adjustments
required to reconcile loss to net cash used in operating activities:
Depreciation
14
18
Revaluation
of convertible financial instrument
4
( 13 )
Stock
based compensation
356
1,273
Decrease
in other current assets
4
20
Decrease
in other liabilities
-
( 100 )
Decrease
in accounts payable
( 63 )
( 30 )
Net
cash used in operating activities
( 804 )
( 1,173 )
Cash
flows from financing activities
Funds
received from a related party
250
-
Issuance
of ordinary shares, net
-
1,450
Net
cash provided by financing activities
250
1,450
Net
increase (decrease) in cash and cash equivalents
( 554 )
277
Cash
and cash equivalents at the beginning of the year
878
601
Cash
and cash equivalents at the end of the year
324
878
Non-cash
financing activities
Conversion
of convertible financial instrument
125
-
The
accompanying notes are an integral part of the financial statements.
F- 6
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
1 - General
NOTE
1— NATURE OF OPERATIONS
A. NewStem
Ltd. (“the Company”) was incorporated in September 2016 under the laws of the
State of Israel and commenced its business operations in July 2018.
B. The
Company is a development stage company utilizing its pioneering intellectual property related
to haploid human embryonic stem cells for the development of personalized diagnostics and
therapeutics for genetic and epigenetic diseases.
C. Going
Concern
Since
inception, the Company has accumulated losses of US$ 9,089 thousand. During the year ended December 31, 2023, the Company has incurred
losses of US$ 1,119 thousand. As of December 31, 2023, the Company’s cash and cash equivalents balance is US$ 324 thousand, and the
net cash used in operating activities during 2023, is US$ 804 thousand.
The
Company will need to obtain additional funds to continue its operations over the next 12 months. Management’s plans with regard
to these matters include continued development, marketing and licensing of its products, as well as seeking additional financing arrangements.
Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient
cash from sales, licensing or financing on terms acceptable to the Company (see also Note 1D). The Company’s management has adopted
a cost reduction plan in order to adjust future operation expenses to its cash balance. On October 23, 2023, the board of directors of
the Company unanimously resolved, due to the financial status of the Company, to hold a hearing for most of the Company’s employees
to be followed by a dismissal notice, which occurred on December 31, 2023.
The
above-mentioned events incur significant difficulties to continue to operate the Company’s business and there is a substantial
doubt about its ability to continue as a going concern during the look-forward period. The financial statements do not include any adjustments
to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable
to continue as a going concern.
D.
“Iron
Swords” war
Following
the brutal attacks on Israel, the mobilization of army reserves, and the Government declaring a state of war (“Iron Swords”
war) in October 2023, there was a decrease in Israel’s economic and business activity. The security situation has led, inter alia,
to a disruption in the chain of supply and production, a decrease in the volume of national transportation, a shortage in manpower as
well as a decrease in the value of financial assets and a rise in the exchange rate of foreign currencies in relation to the shekel.
As
a result of the movement and work restrictions, the Company began operating on a limited scale, and most of the employees were instructed
to work from home. In addition, the situation has brought further difficulties in management’s efforts to seek additional financing
arrangements.
E.
Definitions
In
these financial statements –
1. The
Company – NewStem Ltd.
2. Related
Party – Within its meaning in ASC 850, “Related Party Transactions”.
F- 7
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
2 - Significant Accounting Policies
NOTE
2— SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
significant accounting policies applied on a consistent basis are as follows:
A. Basis of Presentation
The
financial statements are prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”).
B. Functional currency
The
currency of the primary economic environment in which the Company conducts its operations is the U.S. dollar. The Company raises funds
in US dollars and manages its budget in US dollars. Initial revenues recorded in 2023 were generated in US dollars, and future revenues
are also expected to be generated in US dollars. Accordingly, the Company uses the U.S. dollar as its functional and reporting currency.
C. Use of estimates
The
preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions regarding transactions
or matters the final effect of which on the financial statements cannot be accurately determined at the time of their preparation. Even
though the estimates and assumptions are based on management’s best judgment, the final effect of such transactions or matters
may be different from the estimates and assumptions made in their respect.
As
applicable to these financial statements, the most significant estimates and assumptions relate to stock-based compensation.
D. Cash and cash equivalents
Cash
and cash equivalents include short-term bank deposits with an original maturity not exceeding three months, that is not restricted for
use.
E. Property and equipment
Property
and equipment are stated at cost. Depreciation is computed by using the straight-line method, over the assets’ estimated useful
life.
The
annual depreciation rate for Software and Computers is 33 %.
Estimates
of the depreciation method, useful life and residual value are reviewed at least at the end of each reporting year and adjusted as necessary.
Long-lived
assets held and used by the Company, are reviewed for impairment whenever events or changes in circumstance indicate that the carrying
amount of the assets may not be recoverable. No such impairment was recorded in 2023 or 2022.
F- 8
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
2 - Significant Accounting Policies (cont’d)
F. Concentrations of credit risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents.
Cash
and cash equivalents are invested in a major bank in Israel. Management believes that the financial institution that holds the Company’s
investments is financially sound and, accordingly, a minimal credit risk exists with respect to these investments.
The
Company has no off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other foreign hedging
arrangements.
G. Severance pays
Pursuant
to Section 14 of the Severance Compensation Law, 1963 (“Section 14”), the Company’s employees, covered by this section,
are entitled only to monthly deposits, at a rate of 8.33% of their monthly salary, made in their name with insurance companies and/or
pension funds. Payments in accordance with Section 14 release the Company from any liability for future severance payments in respect
of those employees. Deposits under Section 14 are not recorded as an asset in the Company’s balance sheet. All of the Company’s
employees are included under Section 14.
H. Research and development costs
Research
and development expenses consist mainly of labor costs. Costs are expensed as incurred.
A
grant received is offset from research and development expenses. See also Note 2M.
I. Income taxes
Deferred
income taxes are determined using the asset and liability method in accordance with Accounting Standards Codification (“ASC”)
Topic 740. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred income taxes are measured
using enacted tax rates expected to apply to taxable income in years in which such temporary differences are expected to be recovered
or settled. The effect of a change in tax rates on deferred income taxes is recognized in the statement of operations of the period that
includes the enactment date. In addition, a valuation allowance is established to reduce any deferred tax asset for which it is determined
that it is more likely than not that some portion of the deferred tax asset will not be realized.
F- 9
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
2 - Significant Accounting Policies (cont’d)
J. Fair value of financial instruments
The
following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments:
The
carrying amounts of cash and cash equivalents, trade receivables, other accounts receivable, trade payables and other liabilities approximate
their fair value due to the short-term maturity of such instruments.
The
Company adopted ASC 820 Fair Value Measurements (“ASC 820”) which clarifies that fair value is an exit price, representing
the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants.
As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in
pricing an asset or a liability. As a basis for considering such assumptions, ASC 820 establishes a three-tier value hierarchy, which
prioritizes the inputs used in the valuation methodologies in measuring fair value:
Level
1
-
Observable
inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level
2
-
Other
inputs that are directly or indirectly observable in the marketplace.
Level
3
-
Unobservable
inputs which are supported by little or no market activity.
The
fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when
measuring fair value.
K. Collaborative arrangement
The
Company may enter into collaborative agreement with a third party. According to such agreement, the Company further develops its intellectual
property to meet the needs of the third party and is entitled to royalties from any future sales that include its IP. The Company also
receives reimbursement for the R&D costs it incurred as part of such agreement. Such agreements are considered to be within the scope
of ASC 808 Collaborative Arrangements (“ASC 808”), as the parties are active participants and exposed to the risks and rewards
of the collaborative activity. Performing R&D services for reimbursement is considered to be a collaborative activity under the scope
of ASC 808. The Company records reimbursement payments received from the collaboration partner as reductions to R&D expense.
L. Stock-based compensation
The
Company accounts for its stock options grants under the fair value recognition provisions of ASC Topic 718. The Company currently uses
the straight-line amortization method for recognizing share option compensation costs. The Company recognizes compensation cost for an
award with only service conditions that has a graded vesting schedule on a straight-line basis over the requisite service period for
the entire award, provided that the cumulative amount of compensation cost recognized at any date at least equals the portion of the
grant-date value of such award that is vested at that date. The Company has elected to account for forfeitures as they occur; any compensation
cost previously recognized for an award that is forfeited because of a failure to satisfy the service condition is reversed in the period
of the forfeiture.
The
Company records prepaid stock-based payment as an asset in cases where a fully vested equity award was granted but the services have
not been fully received, as required by ASC 718-10 Stock compensation . See also note 7C.
F- 10
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
2 - Significant Accounting Policies (cont’d)
M. Grants received
The
Company receives from time-to-time grants from various sources to fund certain research and development activities. To date, the grants’
terms have stated that if such research and development activities are not successful, the Company would not be obligated to refund any
payment previously received. Given such terms, since the financial risk associated with the research and development remains with the
grantor, the Company does not recognize a liability associated with such funding.
Grants
that do not include a specific deliverable in the terms are offset from research and development expenses.
N. Leases
The
Company is a lessee in two agreements.
1.
Laboratory
The
Company leases a certain portion of a laboratory space for its use from a related party.
The
leased space of the laboratory is not considered to be an identified asset as the agreement does not explicitly specify a distinct space
for the Company’s use, nor implicitly specify a distinct space as it does not represent a substantial portion of the laboratory’s
capacity. Furthermore, other parties may also use the laboratory and have access to the laboratory. Therefore, the lease is not under
the scope of ASC-842. (see also Note 9D).
2.
Vehicle lease
The
lease agreement is for a period of 12 months. The Company has elected not to recognize Right of Use assets and lease liabilities for
short-term leases of transportation equipment that have a lease term of 12 months or less. The Company recognizes the lease payments
associated with its short-term transportation equipment lease as an expense on a straight-line basis over the lease term.
O. Revenue recognition
The
Company views granting of licenses and sublicenses as outputs of its ordinary business activities, and recipients of such licenses as
customers. Thus, the Company considered such licenses agreements to be in the scope of ASC 606 Revenue from Contracts with Customers
(“ASC 606”) . The Company has a sublicense agreement with one customer (the “Agreement”). The Company determined
that the customer has received rights of use of the IP, which are functional in nature, since the Company will not perform any activities
to change functionality of the IP during the terms of the sub-license. As prescribed by ASC 606, revenue from right to use IP is recognized
at a point in time, when the customer receives access to the IP. The Company did not identify a promise to provide future services in
the Agreement, and hence the rights to use the IP are the only performance obligations in the Agreement. Sales-based royalties and milestone
payments dependent of future sales will be recognized upon the occurrence of applicable future sales, under the royalty exception. Other
milestone payments are currently fully constrained under the variable consideration guidance.
F- 11
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
3 - Cash and Cash Equivalents
The
Company’s cash and cash equivalents balance as of December 31, 2023, and 2022, is denominated in the following currencies:
Schedule of Cash and Cash Equivalents
2023
2022
December
31
2023
2022
US$
thousands
US$
thousands
US
Dollars
257
811
New
Israeli Shekels
67
57
Euro
-
9
Great
British Pound
-
1
Cash
and cash equivalents
324
878
Note
4 - Other Current Assets
Schedule of Other Current Assets
2023
2022
December
31
2023
2022
US$
thousands
US$
thousands
Government
institutions
3
29
Prepaid
expenses
12
4
Related
parties
14
-
Other
current assets
29
33
Note
5 - Property and Equipment, net
Schedule
of Property and Equipment, Net
2023
2022
December
31
2023
2022
US$
thousands
US$
thousands
Cost:
Software
and Computers
62
62
Accumulated
depreciation:
Software
and Computers
53
39
Depreciated
cost
9
23
F- 12
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
6 - Accounts payable
Schedule of Accounts Payable
2023
2022
December
31
2023
2022
US$
thousands
US$
thousands
Employees
and payroll accruals
21
53
Accrued
expenses and other payables
13
44
Accounts
payable
34
97
Note
7 - Share Capital
NOTE
5— EQUITY
Schedule of Share Capital Composition
Composition:
As
of December 31, 2023
Authorized
Issued
and
fully
paid
Number
of shares
Ordinary
shares NIS 0.01 par value ( “ Ordinary Shares ” )
1,000,000
163,906
Ordinary
shares NIS 0.01 par value ( “ Ordinary Shares ” )
1,000,000
163,906
As
of December 31, 2022
Issued
and
Authorized
fully
paid
Number
of shares
Ordinary
shares
1,000,000
163,494
A . In
2016, the Company issued to its founders 100,000 Ordinary Shares.
B. In
June 2018, the Company entered into an investment agreement for the issuance of 50,000 Ordinary
Shares, representing 33 % of the Company’s issued and outstanding shares for a total
consideration of $ 4,000 thousands. In 2018, the Company issued to its investors 25,000 Ordinary
Shares for a total amount of $ 2,000 thousands. The remainder of the investment in the amount
of $ 2,000 thousands was subject to two equal tranches milestones. During 2019 the Company
issued additional 12,500 Ordinary Shares for a total amount of $ 1,000 thousands.
In
2020, the Company met all milestones set in the investment agreement. As such, the 3rd and last investment tranche of $ 1,000 thousands
was paid during 2020 and an additional 12,500 Ordinary Shares were issued.
C. In
September 2021, the Company signed an agreement with a third-party in which such third party
committed to provide the Company certain services in exchange to 5 % (fully diluted) of the
Company’s Ordinary Shares amounting to 8,696 Ordinary Shares. The Company recognized
the transaction based on the fair value of the shares at $ 1,952 thousands.
F- 13
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
7 - Share Capital (cont’d)
D. On
April 30, 2022, the Company signed a share purchase agreement with two investors for the
purchase of 2,647 Ordinary Shares of the Company (par value ILS 0.01 ) for a total consideration
of US$ 800 thousands. On December 23, 2022, the Company signed a Share Purchase Agreement
with another investor for the purchase of 2,151 Ordinary Shares of the Company (par value
ILS 0.01 ) for a total consideration of US$ 650 thousands.
According
to those agreements, if the Company provides favorable terms to other investors in this round, then it shall adjust the existing agreements
and provide substantially equivalent rights to all the Investors.
E. Stock
option plan:
In
2018 the Company adopted a stock option plan for its employees, service providers and officers, pursuant to which, and to a resolution
of the Company’s board of directors dated October 31, 2018, the Company reserved for issuance 6,250 Ordinary Shares.
In
June 2021, the Company increased its reserved stock option plan to 13,654 Ordinary Shares.
The
contractual life of the share option is 10 years from the respective date of grant.
Share
options to employees, service providers and officers granted under the stock option plan shall be vesting in installments, gradually
over a period of 4 years from the grant date.
Below
is a summary of employee option activity under the Company’s equity incentive plan during the current year:
Summary of Employee Option Activity
Year
ended December 31, 2023
Weighted
Weighted
average
average
remaining
Number
of
exercise
price
contractual
options
US$
term
(years)
Outstanding
at the beginning of the year
13,145
146.63
Forfeited
( 6 )
80
Outstanding
at the end of the year
13,139
146.66
1.80
Exercisable
at the end of the year
12,598
144.38
1.58
The
following table sets forth the total stock-based compensation expense resulting from stock options included in the statements of operations.
Schedule of Stock-based Compensation Expense
2023
2022
Year
ended December 31
2023
2022
US$
thousands
US$
thousands
Research
and development
212
321
General
and administrative
144
181
Total
stock-based compensation expense
356
502
F- 14
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
7 - Share Capital (cont’d)
F. Convertible Financial Instruments
In
November 2021, the Company signed a Simple Agreement for Future Equity (“SAFE”) with an investor in the amount of 100 thousand
Great British Pound (“GBP”) (approximately US$ 134 thousands). According to the agreement, the SAFE does not bear interest
and is convertible to the Company’s ordinary shares, as follows:
(a) In
the event of a financing round of at least 1 million GBP, the SAFE will be automatically
converted at the end of the round into ordinary shares at the price determined in such round.
(b) In
the event that the financing round is below 1 million GBP, the SAFE may be converted into
ordinary shares at the price determined in such round, at the discretion of the investor.
(c) If
no financing round occurs, the SAFE amount shall automatically be converted into ordinary
shares at the earlier of: (a) an M&A transaction – using the price per share determined
in such transaction, or (b) 36 months after the date of the agreement, at the fair market
value of an ordinary share at that time.
The
SAFE was treated for accounting purposes as a liability, since this arrangement is settled in a variable amount of shares and the investor
is not exposed to the changes in the fair value of the shares during the period from the transfer of funds until conversion.
The
convertible financial instrument was presented at fair value. The convertible financial instrument is considered a Level 3 fair value
measurement.
In
November 2023, upon closing of the round (see also Note 7D), the SAFE was converted to 412 Ordinary Shares, according to scenario (a).
The
changes in the liability measured at fair value for which the Company has used Level 3 inputs to determine fair value are as follows:
Schedule of Change in Liability Measured at Fair Value
2023
2022
US$
thousands
US$
thousands
Balance as of January 1,
121
134
Change in fair value
4
( 13 )
Conversion
of a convertible financial instrument
( 125 )
-
Balance as of December 31,
-
121
Note
8 - Revenues
On
December 23, 2022, The Company signed a Sub-License Agreement (the “Agreement”), which entered into effect in January 2023,
for a sub-license of the Company’s intellectual property related to Fragile X Syndrome (“IP”).
In
consideration for the grant of each period of the sub-license, the Company will be entitled to license fees of a lump sum of US$ 95 thousands
for years 1-5 (“First License Period”), US$ 50 thousand per year for years 6-7, US$ 100 thousand per year for year 8 and onwards.
The Company is also entitled for reimbursement of patent costs that were incurred in the past relating the intellectual property, of
approximately $ 24 thousand and will be entitled for reimbursement of future patent costs. These reimbursements will be accounted for
as reduction of General and administrative expenses.
F- 15
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
8 - Revenues (cont’d)
In
addition, the Company will be entitled to royalties upon future sales of products that are based on the Company’s licensed intellectual
property at a rate of 3.5 % of the net sales or 50 % of sales-based sub-license income, sublicense fees at a rate of up to 13.2 % - 22.0 %
of sublicense consideration, subject to certain terms, as outlined in the Agreement. Moreover, the Company is entitled to certain future
milestones payments, partly based on sales and partly based on reaching Phase III clinical trials. The Company also received a right
to receive a fee equal to 0.5 % of the customer’s exit consideration (“Exit Fee”), which will be received upon an exit
event of the customer, as defined in the Agreement. Based on the estimated date of the customer’s exit event and the discount rate
used to calculate the current value of the Exit Fee, the fair value of the Exit Fee as of the inception date of the Agreement was considered
to be immaterial.
The
Company determined that the customer has received rights of use of the IP, which are functional in nature, since the Company will not
perform any activities to change functionality of the IP during the terms of the sub-license. The Company did not identify a promise
to provide future services in the Agreement, and hence the rights to use the IP are the only performance obligations in the Agreement.
Therefore, the Company recognized revenues of $ 95 thousand in 2023, for the First License Period.
Sales-based
royalties and milestone payments dependent of future sales will be recognized upon the occurrence of applicable future sales, under the
royalty exception. Other milestone payments are currently fully constrained under the variable consideration guidance.
Note
9 - Commitments and Contingent Liabilities
NOTE
7— COMMITMENTS AND CONTINGENCIES
A. Royalties
As
part of the Company’s research and development efforts, the Company received licenses to use intellectual property developed by
Yissum Research and Development Company of the Hebrew University of Jerusalem (“Yissum”) and New York Stem Cell Foundation
(“NYSCF”). During 2017, Yissum and NYSCF granted the Company an exclusive license to make commercial use of that intellectual
property, in order to develop, manufacture, market, distribute or sell products, subject to certain terms and events. In consideration
for the grant of the license, the Company shall pay Yissum and NYSCF royalties at a rate of up to 3 % of the net sales and sublicense
fees at a rate of up to 12 % of sublicense consideration, subject to certain terms, as set forth in the agreement. As of December 31,
2023, a provision in the amount of US$ 11 thousands was recorded for these commitments in the financial statements.
B. Research
Agreement
During
2021 and 2022, the Company received payments of US$ 200 thousand as part of a research agreement with a third-party, which was finalized
in 2022. The Company recognized the payments in the statement of operations of 2022, as participation in the R&D activities which
is offset from development expenses.
The
research agreement determines that the Company will use its intellectual property to further develop know-how that will allow the third
party to use such developed know-how for its commercial purposes. The third party shall pay the Company royalties of up to 3.5 % from
any sales that include the Company’s developed know-how, and additional royalties for any sublicense, as set forth in the research
agreement.
F- 16
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
9 - Commitments and Contingent Liabilities (cont’d)
C. Master
Innovation Hub Agreement
On
October 31, 2022, the Company entered into an agreement with a third party, according to the agreement the Company will develop an IP
using the third party’s research data in exchange for 1.5 % royalties from future sales and 10 % royalties from future licenses.
In addition, the Company will issue the third-party shares on the earliest of the following milestones:
a. The
FDA approval of the Product.
b. A
Change in Control of the Company provided that the collaboration is completed as described
in the Development Plan.
c. The
execution of a Memorandum of Understanding (or equivalent) between the Company and the third
party for the investment of funds from the third party into the Company.
As
of December 31, 2023, the Company does not expect any future sales or licenses nor does the Company considers an FDA approval or change
in control of the company as events that are probable to occur. Therefore, no balances were recorded for these commitments in the financial
statements .
D. Laboratory
Renting Agreement
The
Company rents a laboratory from Yissum starting July 1, 2018. The rent is for an initial three-year term expiring on June 30, 2021. The
Company extended the lease until December 31, 2023, and it has an option to further extend the term for an additional one-year period.
Each party shall be entitled to terminate the agreement within 30 days’ notice. The company shall pay NIS 3,000 per company employee
per month.
Total
rent cost associated with this lease for the year ended December 31, 2023, and 2022 was US$ 21 thousand and US$ 43 thousand, respectively.
Note
1 0 - Related Parties
The
Company engaged with its shareholders to receive consulting services and laboratory renting (see also Note 9D).
In
addition, the Company is required to pay a shareholder sublicense fees at a rate of up to 12 % of sublicense (see also Note 9A).
Schedule of Related Party Transactions
A. Transactions
Year
ended
Year
ended
December 31
2023
December 31
2022
US$
thousands
US$
thousands
Cost
of revenues
11
-
Research
and development expenses
176
353
F- 17
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2023
Note
1 0 - Related Parties (cont’d)
B.
Balances
December 31,
2023
December 31,
2022
US$
thousands
US$
thousands
Other
current assets
14
-
Accounts
payable
11
-
Related
party (*)
250
-
(*) The
Company negotiates with a related party to make an additional investment in the Company. In December 2023, as part of this
negotiation, the Company received funds from the related party in the amount of US$ 250
thousand. Due to the fact that no binding agreement was signed as of December 31, 2023, the funds received were classified as a
current liability.
Note
11 - Taxes on Income
NOTE
6— INCOME TAXES
A. The
Company is incorporated in Israel and is subject to Israeli taxation.
B.
The
Israeli corporate income tax rate was 23 % in 2023 and 2022.
The
main reconciling items from the statutory tax rate of the Company to the effective tax rate ( 0 %) is the change in valuation allowance
(see note 11D) and non-deductible expenses.
C.
Net
operating loss carried forward
As
of December 31, 2023, the Company has net operating tax losses carried forward indefinitely of approximately US$ 4.4 million, (December
31, 2022 - US$ 3.8 million).
D.
Deferred
income taxes
The
tax effects of temporary differences that give rise to significant components of the Company’s deferred tax assets and liabilities
are as follows:
Schedule of Deferred Tax Assets
2023
2022
December
31,
2023
2022
US$
thousands
US$
thousands
Deferred
tax assets:
Net
operating losses
1,024
885
Research
and development credit carried forward
188
229
Other
12
26
Total
deferred tax assets
1,224
1,140
Less
valuation allowance
( 1,224 )
( 1,140 )
Net
deferred tax assets
-
-
The
net change in the total valuation allowance was an increase of US $ 84 thousand in 2023 and an increase of US $ 187 thousand in 2022.
The
Company has provided a full valuation allowance in respect of deferred tax assets resulting from the tax loss carried forward. Management
currently believes that, since the Company has a history of losses, it is more likely than not that the deferred tax assets related to
the loss carried forward and other temporary differences will not be realized in the foreseeable future.
F- 18
Item
16. Form 10–K Summary.
Not
applicable
29
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized on April 1, 2024.
NovelStem
International Corp.
By:
/s/
Jan H Loeb
Jan
H. Loeb
President
and Executive Chairman
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/
Jan H. Loeb
President
and Executive Chairman
April 1, 2024
Jan
H. Loeb
/s/
Christine Jenkins
Vice
President and Chief Financial Officer
April 1, 2024
Christine
Jenkins
/s/
Mitchell Rubenstein
Director
April 1, 2024
Mitchell
Rubenstein
/s/
Eric Richman
Director
April 1, 2024
Eric
Richman
/s/
David Seltzer
Director
April 1, 2024
David
Seltzer
/s/
Jerry Wolasky
Director
April 1, 2024
Jerry
Wolasky
/s/
Tracy Clifford
Director
April 1, 2024
Tracy
Clifford
30
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