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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, 2022 |
|
Commission
file number: 000-22908 |
☐
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) 654-3315
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 2022, the aggregate market value of the registrant’s common stock held by non-affiliates
of the registrant was approximately $8,907,480 based on the closing sale price on that date as reported on the OTCQB marketplace. As
of March 31, 2023 there were 46,881,475 shares of Common Stock, $0.01 par value per share, outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
None
TABLE
OF CONTENTS
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.”
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, 2022 and 2021.
We received distributions of earnings from NetCo of $12,591 and $21,290, respectively, for the fiscal years ended December 31, 2022 and
2021.
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 not generated any revenues 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 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.
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 30.58% equity interest in NewStem. The remaining equity interests in NewStem are owned by Yissum and Professor Benvenisty,
each of whom owns a 30.58% equity interest, Illumina Cambridge LTD, which owns a 5.32% equity interest, and management and a number of
other shareholders who own collectively approximately 2.93%. 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.
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.
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.
NewStem
has a collaboration with Memorial Sloan Kettering Cancer Center (“MSK”) Innovation Hub to further optimize and validate NewStem’s
bioinformatics-based software as a medical device diagnostic platform. The NewStem Software Diagnostic Device (“NSDD”) provides
information to oncologists regarding the presence of mutations in a patient’s tumor profile which may confer resistance to certain
anti-cancer drugs. Armed with NSDD-based intelligence, oncologists can make more informed treatment decisions. The collaboration is focused
on triple-negative breast cancer patients and non-small cell lung cancer patients treated with Paclitaxel and/or Carboplatin. NewStem
expects to receive genomic data from the MSK Innovation Hub within the next few months. That data will be analyzed and compared to the
data that the NSDD generates for that particular patient.
The
MSK Innovation Hub brings together innovative, digitally focused companies with MSK’s community of researchers, clinicians, and
digital health professionals through a program designed to establish innovative collaborations that can have a tangible impact on treatment
or management of cancer.
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.
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 8 – 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.
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 30.58% 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, are able to exert significant influence over this entity and its operations.
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 no 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, 2022 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.
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 are currently in arbitration as to ongoing scope and the operation of NetCo. If we are unable
to resolve such dispute 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.
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.
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 will 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.
As
a public company, we will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Act of
2010 and other applicable securities rules and regulations. Despite recent reforms made possible by the JOBS Act, compliance with these
rules and regulations will nonetheless increase our legal and financial compliance costs, make some activities more difficult, time-consuming
or costly and increase demand on our systems and resources, particularly after we are no longer an “emerging growth company.”
The Exchange Act requires, among other things, that we file annual, quarterly, and current reports with respect to our business and operating
results.
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;
personnel, such as a chief financial officer familiar with the obligations of public company reporting; 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.
In
addition, being a public company could make it more difficult or more costly for us to obtain certain types of insurance, including directors’
and officers’ liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher
costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract and retain
qualified persons to serve on our board of directors, our board committees or as executive officers.
The
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.
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. It is unknown as to how long the arbitrator will take to render his decision.
To
fund efforts to maximize the value of NetCo, NovelStem has secured non-recourse litigation funding.
Item
4. Mine Safety Disclosures.
Not
applicable
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 2023 | |
| | | |
| | |
Quarter ended 3/31/2023 (through
March 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 January 25, 2023 there were 46,881,475 shares of common stock outstanding held by approximately 90 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]
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 $766,000 and $1,346,000 for the years ended December 31,
2022 and 2021, respectively. We had current assets of approximately $59,000 and current liabilities of approximately $65,000 as of
December 31, 2022. As of December 31, 2021, our current assets and current liabilities were approximately $37,000 and $193,000,
respectively. We have prepared our financial statements for the years ended December 31, 2022 and 2021 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 entered into long term finance agreements with two related party
individuals to fund current operating expenses.
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 condensed 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 policy for stock-based compensation as a critical accounting policy.
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 2022 was based on the historical volatility of the market price of our common
stock over a period equal to the expected term of the options. 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, 2022 and 2021, we incurred stock compensation expense with respect to options of approximately $283,000
and $273,000, respectively.
See
Note 5 to the financial statements for the assumptions used to calculate the fair value of stock-based compensation.
Results
of Operations.
The
selected statement of operations data for the years ended December 31, 2022 and 2021 and balance sheet data as of December 31, 2022 and
2021 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, | | |
| |
| |
2022 | | |
2021 | | |
Change | |
Administrative fee income | |
$ | 12,000 | | |
$ | - | | |
$ | 12,000 | |
Operating expenses: | |
| | | |
| | | |
| | |
General and administrative expenses | |
| 744,434 | | |
| 495,535 | | |
| 248,899 | |
Contra expenses - legal fees | |
| (310,000 | ) | |
| - | | |
| (310,000 | ) |
Total operating expenses | |
| 434,434 | | |
| 495,535 | | |
| (61,101 | ) |
Loss from operations | |
| (422,434 | ) | |
| (495,535 | ) | |
| 73,101 | |
Interest expense | |
| 11,018 | | |
| 6,825 | | |
| 4,193 | |
Net loss before equity in net loss of equity method investees | |
| (433,452 | ) | |
| (502,360 | ) | |
| 68,908 | |
Equity in net loss of equity method investees | |
| (719,802 | ) | |
| (843,268 | ) | |
| 123,466 | |
Gain on dilution of equity method investment | |
| 387,524 | | |
| - | | |
| 387,524 | |
Net loss | |
$ | (765,730 | ) | |
$ | (1,345,628 | ) | |
$ | 579,898 | |
2022
Compared to 2021
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. During the year ended December 31, 2022, we began charging annual administrative
fees to an affiliated entity.
The
Company incurs general and administrative (“G&A”) expenses primarily related to professional fees and insurance. We
incurred G&A expenses of approximately $744,000 and $496,000 for the years ended December 31, 2022 and 2021, respectively. Our
increase 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, 2021 and 2020, preparation of our quarterly reports for 2022, and, in the
preparation, and filing of our Form 10 registration statement which was filed in August 2022. Specifically, professional fees
increased by $199,000 in the year ended December 31, 2022 as compared to the year ended December 31, 2021. Insurance costs increased
by $31,000 in the year ended December 31, 2022 as compared to the year ended December 31, 2021. The remaining increase in G&A
expenses of approximately $9,000 during the year ended December 31, 2022 consists primarily of increases in expenses related to
investor relations and information technology.
Stock-based
compensation expense increased by approximately $10,000 in the year ended December 31, 2022 as compared to the year ended December
31, 2021. This is primarily due to certain options issued in 2022 having a shorter vesting period.
During
the year ended December 31, 2022, we recorded a contra expense of $310,000 which is comprised of funds from a 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 has no obligation to repay any funds received under the agreement.
In the event of a favorable outcome, Omni Bridgeway would recover disbursed funding as part of their investment return.
As
part of that funding arrangement, Omni Bridgeway agreed to reimburse NovelStem $310,000 which was comprised of $140,000 for reimbursement
of previously incurred legal expenses and $170,000 for working capital needs including previously incurred general and administrative
costs. There was no contra expense in the year ended December 31, 2021.
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, 2022 and 2021. The 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. Net losses reported for the year ended December 31, 2021 included net income of approximately $21,000 from
NetCo which was offset by net loss of approximately $864,000 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 $388,000
during the year ended December 31, 2022.
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 or enter into strategic partnerships. We also
expect our G&A expenses to increase as we expand our finance and administrative staff, add infrastructure, and incur additional costs
related to being a reporting act company, including directors’ and officers’ insurance and increased professional fees.
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.
In
May 2022, the Company entered into an agreement with Jan Loeb, our Executive Chairman and Jerry Wolasky, a member of the Board, which
was amended in July 2022, to borrow up to an aggregate of $600,000 for working capital needs. This agreement provides for funding through
January 31, 2024, provides for interest at a rate of 8% per annum, increased to 10% per annum for advances subsequent to November 11,
2022, and matures the earlier of January 31, 2024 or twenty months from the date of the first funded amount unless the lenders agree
to extend the due date at that time. As of the date of this Form 10-K, the Company has borrowed $292,000 pursuant to the agreement.
Net
Cash Provided By (Used In) Operating Activities.
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, 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.
For the year ended December 31, 2021, net cash used in operating activities
was approximately $181,000, which consisted primarily of a net loss of approximately $1,345,000, offset by noncash equity in loss of equity
method investees of approximately $865,000 and stock-based compensation of approximately $273,000 and an increase in accrued liabilities
and other payables of approximately $24,000.
Net
Cash Used In Investing Activities.
For
the years ended December 31, 2022 and 2021, no net cash was used in investing activities.
Net
Cash Provided By Financing Activities.
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.
For
the year ended December 31, 2021, net cash provided by financing activities was $100,000 consisting of short-term borrowings from a significant
stockholder.
Off-Balance
Sheet Arrangements
We
are not party to any off-balance sheet transactions. 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, 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.
As
of December 31, 2021, we did not have contractual obligations and commercial commitments.
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.
None
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, 2022 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.
The
material weaknesses identified included insufficient resources to employ proper segregation of duties over the processing of transactions
and financial reporting.
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.
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 – 64 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 – 59 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 – 68 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 -61
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 – 62 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 – 64 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 -54 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. |
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 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 2021 our executive officers and directors complied
with the filing requirements of Section 16(a).
Code
of Ethics
To
be added
Changes
in control
There
are no arrangements which may at a subsequent date result in a change in control of the Company
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 | |
2022 | |
| - | | |
| - | | |
| 27,170 | (1) | |
| - | | |
| 27,170 | |
President and Executive Chairman | |
2021 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Christine Jenkins | |
2022 | |
| 58,725 | (2) | |
| - | | |
| - | | |
| - | | |
| 58,725 | |
Vice President and Chief Financial Officer | |
2021 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Mitchell Rubenstein | |
2022 | |
| - | | |
| - | | |
| 27,170 | (1) | |
| - | | |
| 27,170 | |
Director | |
2021 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Eric Richman | |
2022 | |
| - | | |
| - | | |
| 27,170 | (1) | |
| - | | |
| 27,170 | |
Director | |
2021 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | |
David Seltzer | |
2022 | |
| - | | |
| - | | |
| 27,170 | (1) | |
| - | | |
| 27,170 | |
Director | |
2021 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Jerry Wolasky | |
2022 | |
| - | | |
| - | | |
| 27,170 | (1) | |
| - | | |
| 27,170 | |
Director | |
2021 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Tracy Clifford | |
2022 | |
| - | | |
| - | | |
| 27,170 | (1) | |
| - | | |
| 27,170 | |
Director | |
2021 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| (1) | 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. |
| (2) | Represents
hourly fees paid to Ms. Jenkins for the provision of services as Chief Financial Officer
of the Company. |
Executive
Compensation for 2021 and 2022
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.
Outstanding
Equity Awards at 2022 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, 2022.
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
Christine Jenkins | |
| - | | |
| - | | |
| - | | |
| - | |
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, 2023 | |
Mitchell Rubenstein | |
| 750,000 | | |
| - | | |
| 0.10 | | |
| June 28, 2023 | |
Eric Richman | |
| - | | |
| - | | |
| - | | |
| - | |
David Seltzer | |
| - | | |
| - | | |
| - | | |
| - | |
Jerry Wolasky | |
| - | | |
| - | | |
| - | | |
| - | |
Tracy Clifford | |
| - | | |
| - | | |
| - | | |
| - | |
Christine Jenkins | |
| - | | |
| - | | |
| - | | |
| - | |
Option
and Warrant Exercises
None
Non-qualified
Deferred Compensation
The
Company has no deferred compensation plan in place during the years ended December 31, 2022 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, 2022.
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 January 25, 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 |
|
|
|
5.9 |
% |
Stephen
Gans |
|
|
5,537,978 |
|
|
|
11.8 |
% |
Jan
Loeb |
|
|
7,570,673 |
(2)(3)(4) |
|
|
15.1 |
% |
Jerry
Wolasky |
|
|
10,122,973 |
(3)(4) |
|
|
21.5 |
% |
Tracy
Clifford |
|
|
1,100,000 |
(4) |
|
|
2.3 |
% |
Eric
Richman |
|
|
754,054 |
(3)(4) |
|
|
1.5 |
% |
Mitchell
Rubenstein |
|
|
2,958,108 |
(4)(5) |
|
|
6.1 |
% |
David
Seltzer |
|
|
4,028,378 |
(3)(4) |
|
|
8.6 |
% |
All
directors and officers as a group (seven persons) |
|
|
26,484,186 |
|
|
|
49.4 |
% |
(1)
Applicable percentage ownership is based on 46,881,475 shares of common stock outstanding as of January 25, 2023, together with securities
exercisable or convertible into shares of common stock within 60 days of January 25, 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 January 25, 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 and options to purchase 1.10 million shares of common stock at an exercise
price of $0.10 per share.
(3)
Includes options to purchase 150,000 shares of common stock at an exercise price of $0.10 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.
(6)
The address of each person is c/o NovelStem International Corp. 2255 Glades Road, Suite 221A, Boca Raton, FL 33431.
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 | |
| 8,400,000 | | |
$ | 0.13 | | |
| 1,600,000 | |
Total | |
| 8,400,000 | | |
$ | 0.13 | | |
| 1,600,000 | |
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.
On
November 15, 2021, in connection with previous, the Company issued 1,729,729 shares of common stock to directors as a result of certain
contingent assets not being realized, as required by the governing financing documents. A summary of the shares issued follows:
| |
Shares | |
Jan Loeb | |
| 270,270 | |
Mitchell Rubenstein | |
| 108,108 | |
Jerry Wolasky | |
| 972,973 | |
David Seltzer | |
| 324,324 | |
Eric Richman | |
| 54,054 | |
Total | |
| 1,729,729 | |
On
April 12, 2021, the Company entered into a promissory note (the “Note”) with Stephen Gans 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 this this Note was $5,752 for the year ended December
31, 2021. The Note and all accrued interest were paid in full on February 16, 2022.
In May 2022, the Company entered into a
finance agreement with Jan Loeb and Jerry Wolasky, shareholders and Board members, which was amended in July 2022, to borrow up to an
aggregate of $600,000 for working capital needs. This agreement provides for funding through January 31, 2024, provides 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 agreement matures the earlier of January 31, 2024 or 20 months from the date of the first funded amount
unless the lenders agree to extend the due date at that time. As of the date of this Annual Report, the Company has received advances
of $342,000 under the aforementioned agreement.
Except
as disclosed herein, no director, executive officer, shareholder 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.
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, 2022 and 2021.
| |
2022 | | |
2021 | |
Audit fees | |
$ | 60,800 | | |
$ | 68,000 | |
Tax Fees | |
| 3,500 | | |
| 11,100 | |
All other fees | |
| 13,050 | | |
| - | |
Total | |
$ | 77,350 | | |
$ | 79,100 | |
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 2022 and 2021.
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, 2022 and 2021
Index
to Audited Financial Statements
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 sheets of NovelStem International Corp. (the “Company”) as of December 31, 2022 and
2021, and the related statements of operations, shareholders’ equity, and cash flows for each of the years in the two-year period
ended December 31, 2022, 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 2021, and the
results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2022, 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 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. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits,
we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
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.
/s/ Cherry Bekaert LLP |
|
|
We have served as the Company’s auditor
since 2021. |
|
|
Fort Lauderdale, Florida |
March 31, 2023 |
|
NOVELSTEM
INTERNATIONAL CORP.
BALANCE
SHEETS
The
accompanying notes are an integral part of these financial statements.
NOVELSTEM
INTERNATIONAL CORP.
STATEMENTS
OF OPERATIONS
The
accompanying notes are an integral part of these financial statements.
NOVELSTEM
INTERNATIONAL CORP.
STATEMENTS
OF SHAREHOLDERS’ EQUITY
The
accompanying notes are an integral part of these financial statements.
NOVELSTEM
INTERNATIONAL CORP.
STATEMENTS
OF CASH FLOWS
The
accompanying notes are an integral part of these financial statements.
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.
Liquidity
and Management’s Plans
Since
inception, the Company has accumulated a deficit of approximately $289,000,000.
The accumulated deficit of the Company subsequent to its business focus shift and name change in September 2018 is approximately $2,260,000 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 become profitable (see Note 3).
In
May 2022, the Company entered into a finance agreement with two individuals who are shareholders and directors, which was amended in
July 2022, to borrow up to $600,000 for working capital needs (see Note 4). Following this financing, the Company believes that its cash
resources are sufficient for the operations of the next 12 months.
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.
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 presented.
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 recognizes a gain or loss on dilution when the equity method
Investee company issues stock to third parties.
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.
Treasury
Stock
Shares
of common stock repurchased are recorded at cost as treasury stock.
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 over 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.
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.
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
Basic
and Diluted Net Loss Per Share
Basic
net loss per share is computed by dividing the net loss by the weighted average number of shares outstanding during the year, excluding
treasury stock. Diluted net loss per share is computed by dividing the net loss 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
| |
2022 | | |
2021 | |
| |
Year
Ended December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Net loss available to common shareholders | |
$ | (765,730 | ) | |
$ | (1,345,628 | ) |
| |
| | | |
| | |
Weighted average shares outstanding: | |
| | | |
| | |
-Basic | |
| 46,881,475 | | |
| 44,259,559 | |
Add: Warrants | |
| - | | |
| - | |
Add: Stock options | |
| - | | |
| - | |
-Diluted | |
| 46,881,475 | | |
| 44,259,559 | |
| |
| | | |
| | |
Basic and diluted net loss per share | |
$ | (0.02 | ) | |
$ | (0.03 | ) |
Warrants and stock options excluded
from the above calculations are as follows:
SCHEDULE OF WARRANTS AND
STOCK OPTIONS
|
|
2022 |
|
|
2021 |
|
|
|
Year Ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
Warrants |
|
|
3,000,000 |
|
|
|
3,000,000 |
|
Stock options |
|
|
5,400,000 |
|
|
|
4,300,000 |
|
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. NewStem sold and issued shares to third party investors in 2021 and 2022 resulting in the Company recognizing
a gain on dilution of equity method investment. These transactions resulted in the Company having an ownership interest of 30.58%
and 31.51%,
respectively, as of December 31, 2022 and 2021.
The
Company accounts for its investment in NewStem under the equity method. At December 31, 2022 and 2021, the carrying value of the investment
in NewStem exceeded the underlying net assets of NewStem by $2,090,286 and $2,435,155, 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.
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
The
Company assesses its investment in NewStem for impairment on an annual basis.
NewStem
is in the development stage and has incurred losses since its inception and has yet to generate any revenues. 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 of products or financing
on terms acceptable to the Company. NewStem obtained additional funding of approximately $1,450,000 in 2022 through the sale of
shares or ordinary stock.
The
following table represents the Company’s investment in NewStem:
SCHEDULE OF INVESTMENTS
| |
2022 | | |
2021 | |
| |
Year
Ended December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Investment in NewStem, beginning | |
$ | 2,435,155 | | |
$ | 3,299,713 | |
Allocation of net loss from NewStem | |
| (732,393 | ) | |
| (864,558 | ) |
Gain on dilution of equity method investment | |
| 387,524 | | |
| - | |
Purchase of NewStem shares | |
| - | | |
| - | |
Investment in NewStem, ending | |
$ | 2,090,286 | | |
$ | 2,435,155 | |
The
results of operations and financial position of the Company’s investment in NewStem are summarized below:
SCHEDULE
OF OPERATIONS AND FINANCIAL POSITION INVESTMENT
| |
2022 | | |
2021 | |
| |
Year
Ended December 31, | |
| |
2022 | | |
2021 | |
Condensed income statement information: | |
| | | |
| | |
Net sales | |
$ | - | | |
$ | - | |
Gross margin | |
$ | - | | |
$ | - | |
Net loss | |
$ | (2,341,000 | ) | |
$ | (2,630,000 | ) |
Company’s allocation
of net loss from NewStem | |
$ | (732,393 | ) | |
$ | (864,558 | ) |
| |
2022 | | |
2021 | |
| |
As
of December 31, | |
| |
2022 | | |
2021 | |
Condensed balance sheet information: | |
| | | |
| | |
Current
assets | |
$ | 911,000 | | |
$ | 1,425,000 | |
Non-current assets | |
$ | 23,000 | | |
$ | 41,000 | |
Current liabilities | |
$ | 97,000 | | |
$ | 227,000 | |
Non-current liabilities | |
$ | 121,000 | | |
$ | 134,000 | |
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 from this arrangement. The Company assesses its investment in NetCo for
impairment on an annual basis.
The
following table represents the Company’s investment in NetCo:
SCHEDULE OF INVESTMENTS
| |
2022 | | |
2021 | |
| |
Year
Ended December 31, | |
| |
2022 | | |
2021 | |
Investment in NetCo, beginning | |
$ | 137,011 | | |
$ | 137,011 | |
Allocation of net income from Netco | |
| 12,591 | | |
| 21,290 | |
Distribution from NetCo
| |
| (12,591 | ) | |
| (21,290 | ) |
Investment in NetCo, ending | |
$ | 137,011 | | |
$ | 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
| |
2022 | | |
2021 | |
| |
Year
Ended December 31, | |
| |
2022 | | |
2021 | |
Condensed income statement information: | |
| | | |
| | |
Net sales | |
$ | 25,182 | | |
$ | 42,580 | |
Gross margin | |
$ | - | | |
$ | - | |
Net income | |
$ | 25,182 | | |
$ | 42,580 | |
Net income (loss) | |
$ | 25,182 | | |
$ | 42,580 | |
Company’s allocation
of net income from NetCo | |
$ | 12,591 | | |
$ | 21,290 | |
| |
2022 | | |
2021 | |
| |
As
of December 31, | |
| |
2022 | | |
2021 | |
Condensed balance sheet information: | |
| | | |
| | |
Current
assets | |
$ | 13,473 | | |
$ | 13,475 | |
Non-current assets | |
$ | 272,799 | | |
$ | 272,799 | |
Current liabilities | |
$ | 12,250 | | |
$ | 12,252 | |
Non-current liabilities | |
$ | - | | |
$ | - | |
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
NOTE
4—NOTES PAYABLE
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 this this Note was $5,752 for the year
ended December 31, 2021. The Note and all accrued interest, totaling $6,752, were paid in full on February 16, 2022.
In
May 2022, the Company entered into a finance agreement (the “Agreement”) with two individuals who are shareholders and directors,
which was amended in July 2022, to borrow up to $600,000 for working capital needs. This Agreement provides for funding through January
31, 2024 and provides 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 Agreement matures the earlier of January 31, 2024 or 20 months from the date of the first
funded amount unless the shareholders agree to extend the due date at that time. The Company received advances of $280,000 pursuant to
this agreement through December 31, 2022.
NOTE
5—EQUITY
(a)
General
At
December 31, 2022 and 2021 the Company had issued and outstanding 46,881,475 shares of its common stock, par value $0.01 per share. Holders
of outstanding common stock are entitled to receive dividends when, as 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.
On
November 15, 2021, in a noncash transaction, the Company issued approximately 3,000,000 shares of common stock to existing holders of
subscription agreements dated June 2020. These subscription agreements provided for the issuance of additional shares if certain contingent
assets were not realized. It was determined during the year ended December 31, 2021 that the contingent asset would not be realized and
the shares were issued.
(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 5,400,000 options have been issued to directors and investor relations professionals.
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
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, | |
| |
2022 | | |
2021 | |
Risk-free interest rate | |
| 1.5 | % | |
| 1.6 | % |
Expected term, in years | |
| 3.82 | | |
| 6 | |
Expected volatility | |
| 183.7 | % | |
| 140.2 | % |
Expected dividend yield | |
| 0 | % | |
| 0 | % |
Determined weighted average grant date fair value per option | |
$ | 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 7 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 expected term of the option. 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.
(c)
Summary Option Information
A
summary of the Company’s option plans as of December 31, 2022 and 2021, as well as changes during each of the years then ended,
is presented below:
SCHEDULE OF STOCK OPTION ACTIVITIES
| |
Year
Ended December 31, | |
| |
2022 | | |
2021 | |
| |
Number | | |
Weighted | | |
Number | | |
Weighted | |
| |
of | | |
Average | | |
of | | |
Average | |
| |
Options | | |
Exercise | | |
Options | | |
Exercise | |
| |
(in
shares) | | |
Price | | |
(in
shares) | | |
Price | |
Outstanding at beginning of year | |
| 4,300,000 | | |
| 0.10 | | |
| 4,300,000 | | |
| 0.10 | |
Granted | |
| 1,100,000 | | |
| 0.29 | | |
| - | | |
| - | |
Outstanding at end of
year | |
| 5,400,000 | | |
| 0.14 | | |
| 4,300,000 | | |
| 0.10 | |
Exercisable at end of
year | |
| 4,800,000 | | |
| 0.12 | | |
| 4,300,000 | | |
| 0.10 | |
Stock-based
compensation expense was approximately $283,000 and $273,000 in the years ending December 31, 2022 and 2021, respectively.
The
total compensation cost related to non-vested awards not yet recognized was approximately $13,000 as of December 31, 2022. An award of 500,000 options granted on January 31, 2022 had special vesting provisions whereby the awards fully vested
in 2022. All awards
outstanding as of December 31, 2021 were vested.
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
(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, | |
| |
2022 | | |
2021 | |
| |
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
warrants outstanding at December 31, 2022 have a weighted average remaining contractual life of approximately six months.
NOTE
6—INCOME TAXES
For
the years ended December 31, 2022 and 2021, 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, 2022 and 2021, the Company had approximately $61,000,000 and $118,000,000, respectively, of net operating losses subject
to IRC Section 382 limitations, of which $6,400,000 and $6,200,000, 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
federal and state net operating losses expire beginning in 2021. Approximately $55,000,000 and $25,000,000, respectively of federal and
state losses expired in December 2022, and approximately $23,000,000 and $3,000,000, respectively, of federal and state losses expired
in December 2021. The Company has approximately $1,775,000 in federal and state losses that do not expire. The remaining losses expire
from 2023 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.
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
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
| |
2022 | | |
2021 | |
| |
Year
Ended December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Computed tax at the federal statutory
rate of 21% | |
$ | (160,803 | ) | |
$ | (282,582 | ) |
State income taxes, net of federal income tax
benefit | |
| (33,271 | ) | |
| (58,468 | ) |
Foreign rate differential | |
| (171,089 | ) | |
| (106,409 | ) |
Change in federal valuation
allowance | |
| 365,163 | | |
| 447,459 | |
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, 2022 and 2021 consist of the
following:
SCHEDULE OF DEFERRED TAX
ASSETS
| |
2022 | | |
2021 | |
| |
As
of December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
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 | |
| 1,686,708 | | |
| 1,676,585 | |
General business credit | |
| 41,551 | | |
| 41,551 | |
Stock compensation | |
| 174,009 | | |
| 99,103 | |
Net operating losses | |
| | | |
| | |
Research and development credit carried forward | |
| | | |
| | |
Other | |
| | | |
| | |
Total deferred tax assets | |
| 3,602,268 | | |
| 3,517,239 | |
Federal and state net operating loss carryforwards
subject to IRC Section 382 limitations | |
| 15,465,570 | | |
| 28,425,763 | |
Less valuation allowance for net operating
loss limitations | |
| (15,465,570 | ) | |
| (28,425,763 | ) |
Valuation allowance | |
| (2,971,573 | ) | |
| (2,482,298 | ) |
Subtotal deferred tax assets | |
| 630,695 | | |
| 1,034,941 | |
Deferred tax liability,
equity method basis difference | |
| (630,695 | ) | |
| (1,034,941 | ) |
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, 2022 and 2021.
NOVELSTEM
INTERNATIONAL CORP.
Notes
to Financial Statements
NOTE
7—COMMITMENTS AND CONTINGENCIES
The
Company is 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 proceedings for the joint owners of NetCo concluded
during 2022 with final briefs being filed in January 2023. The arbitrator has not rendered a decision as of the date of these financial
statements.
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 this arbitration proceeding. 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.
NOTE
8 – RESTATEMENTS OF PREVIOUSLY ISSUED INTERIM FINANCIAL STATEMENTS (UNAUDITED)
Previously
issued unaudited financial statements have been restated to reflect gains on dilution from the Company’s equity method
investment in NewStem. The previously issued financial statements as of and for the three and six months ended June 30, 2022 and as
of and for the nine months ended September 30, 2022 contained an error whereby the Company did not recognize gains on the dilution
of its equity method investment in NewStem due to the issuance of stock to third parties.
The
following is a summary of the restatement:
SCHEDULE
OF ERROR CORRECTIONS AND PRIOR PERIOD ADJUSTMENTS
Balance
Sheet:
| |
Originally Reported | | |
Adjustment | | |
Restated | |
| |
September 30, 2022 | |
| |
Originally Reported | | |
Adjustment | | |
Restated | |
Total current assets | |
$ | 65,832 | | |
$ | - | | |
$ | 65,832 | |
Investment in NewStem, Ltd | |
| 1,828,419 | | |
| 194,948 | | |
| 2,023,367 | |
Total assets | |
| 2,031,262 | | |
| 194,948 | | |
| 2,226,210 | |
Total current liabilities | |
| 125,632 | | |
| - | | |
| 125,632 | |
Stockholders’ equity | |
| 1,737,421 | | |
| 194,948 | | |
| 1,932,369 | |
Statements
of Operations:
| |
Originally Reported | | |
Adjustment | | |
Restated | |
| |
Nine Months Ended September 30, 2022 | |
| |
Originally Reported | | |
Adjustment | | |
Restated | |
Provision for income tax | |
| - | | |
| - | | |
| - | |
Net loss before equity in net loss of equity method investees | |
| (270,283 | ) | |
| - | | |
| (270,283 | ) |
Equity in net income (loss) of equity method investees | |
| (606,736 | ) | |
| 194,948 | | |
| (411,788 | ) |
Net loss | |
| (877,019 | ) | |
| 194,948 | | |
| (682,071 | ) |
Balance Sheet:
| |
Originally Reported | | |
Adjustment | | |
Restated | |
| |
June 30, 2022 | |
| |
Originally Reported | | |
Adjustment | | |
Restated | |
Total current assets | |
$ | 108,634 | | |
$ | - | | |
$ | 108,634 | |
Investment in NewStem, Ltd | |
| 1,913,951 | | |
| 194,948 | | |
| 2,108,899 | |
Total assets | |
| 2,159,596 | | |
| 194,948 | | |
| 2,354,544 | |
Total current liabilities | |
| 102,053 | | |
| - | | |
| 102,053 | |
Stockholders’ equity | |
| 1,957,543 | | |
| 194,948 | | |
| 2,152,491 | |
Statements of Operations:
| |
Originally Reported | | |
Adjustment | | |
Restated | |
| |
Six Months Ended June 30, 2022 | |
| |
Originally Reported | | |
Adjustment | | |
Restated | |
Provision for income tax | |
| - | | |
| - | | |
| - | |
Net loss before equity in net loss of equity method investees | |
| (60,543 | ) | |
| - | | |
| (60,543 | ) |
Equity in net income (loss) of equity method investees | |
| (521,204 | ) | |
| 194,948 | | |
| (326,256 | ) |
Net loss | |
| (581,747 | ) | |
| 194,948 | | |
| (386,799 | ) |
| |
| | | |
| | | |
| | |
Statements of Operations:
| |
Originally Reported | | |
Adjustment | | |
Restated | |
| |
Three Months Ended June 30, 2022 | |
| |
Originally Reported | | |
Adjustment | | |
Restated | |
Provision for income tax | |
| - | | |
| - | | |
| - | |
Net loss before equity in net loss of equity method investees | |
| (229,982 | ) | |
| - | | |
| (229,982 | ) |
Equity in net income (loss) of equity method investees | |
| (134,301 | ) | |
| 194,948 | | |
| 60,647 | |
Net loss | |
| (364,283 | ) | |
| 194,948 | | |
| (169,335 | ) |
NOTE 9—SUBSEQUENT
EVENTS
The
Company evaluated subsequent events through the date these financial statements were available to be issued and filed with the SEC.
On March 23, 2023, the board
approved the grant of 360,000 stock options to directors and officers.
|
(c) |
Financial statements of
fifty percent or less owned subsidiaries. |
NewStem
Ltd.
Financial Statements
As of December 31, 2022
Financial Statements as of December 31, 2022 |
NewStem Ltd. |
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, 2022 and 2021, 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, 2022, 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, 2022 and 2021, and the results of its operations and its cash flows for each of
the years in the two-year period ended December 31, 2022, in conformity with U.S. generally accepted accounting principles.
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.
Somekh
Chaikin
Member
Firm of KPMG International
We
have served as the Company’s auditor since 2021.
Tel
Aviv, Israel
March
22, 2023
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
NewStem
Ltd.
Balance
Sheets as of December 31,
|
Ayelet
Dilion Mashiah |
CEO
|
Date
of approval of the financial statements: March 22, 2023.
* | Represents an amount
less than $1 thousands. |
The
accompanying notes are an integral part of the financial statements.
NewStem
Ltd.
Statements
of Operations for the Year Ended December 31
The
accompanying notes are an integral part of the financial statements.
NewStem
Ltd.
Statements
of Changes in Shareholders’ Equity
* | Represents an amount
less than $1 thousands. |
The
accompanying notes are an integral part of the financial statements.
NewStem
Ltd.
Statements
of Cash Flows for the year ended December 31
The
accompanying notes are an integral part of the financial statements.
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
1 - General
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. | Since
inception, the Company has accumulated a deficit of $7,970 thousand. |
| | |
| | The
Company will need to obtain additional funds to continue its operations. 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. The Company’s management has approved a contingent cost reductions in order to
adjust future operation expenses to its cash balance. Following the fund-raising mentioned in Note 7D, and Note 12, and the Company’s
adjustment of its future operation expenses, the Company believes that its cash resources are sufficient for the operations of the next
12 months. |
|
D. |
Definitions |
|
|
|
|
|
In
these financial statements – |
| 1. | The
Company – NewStem Ltd. |
| 2. | Related
Party – Within its meaning in ASC 850, “Related Party Transactions”. |
Note
2 - Significant Accounting Policies
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
significant accounting policies applied on a consistent basis are as follows:
The
financial statements are prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”).
|
B. |
Presentation of financial information |
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. 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.
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.
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
2 - Significant Accounting Policies (cont’d)
|
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 2022 or 2021.
|
F. |
Concentrations
of credit risk |
Financial
instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, and
marketable securities.
Cash
and cash equivalents are invested in a major bank in Israel. Management believes that the financial institution that hold the Company’s
investments are 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.
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. As of December 31, 2022
and 2021, all of the Company’s employees are included under Section 14.
Marketable
securities are recorded at fair value. Changes in fair value of the securities are reported as financial income or expenses in the statement
of operations.
|
I. |
Research
and development costs |
Research
and development expenses consist mainly of labor costs. Costs are expensed as incurred.
A
grant received is presented as an offset from research and development expenses. See also Note 2M.
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
2 - Significant Accounting Policies (cont’d)
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.
|
K. |
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.
|
L. |
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 agreement 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.
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
2 - Significant Accounting Policies (cont’d)
|
M. |
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 records prepaid share-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.
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.
In
February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which requires lessees to recognize leases on-balance sheet and disclose
key information about leasing arrangements. Topic 842 establishes a ROU model that requires a lessee to recognize a ROU asset and lease
liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as finance or operating, with
classification affecting the pattern and classification of expense recognition in the income statement.
The
Company adopted the ASU effective January 1, 2022 using a modified retrospective transition approach. As a result, the Company was not
required to adjust its comparative period financial information for effects of the standard or make the new required lease disclosures
for periods before the date of adoption. The Company elected to adopt the package of transition practical expedients and, therefore,
has not reassessed (1) whether existing or expired contracts contain a lease, (2) lease classification for existing or expired leases
or (3) the accounting for initial direct costs that were previously capitalized. The Company did not elect the practical expedient to
use hindsight for leases existing at the adoption date.
The
Company is a lessee in two agreements.
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. Therefor the lease is not under the
scope of ASC-842.
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
2 - Significant Accounting Policies (cont’d)
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.
Note
3 - Cash and Cash Equivalents
CASH AND CASH EQUIVALENTS
The
Company’s cash and cash equivalents balance as of December 31, 2022 and 2021, is denominated in the following currencies:
SCHEDULE OF CASH AND CASH EQUIVALENTS
| |
2022 | | |
2021 | |
| |
December 31 | |
| |
2022 | | |
2021 | |
| |
US$ thousands | | |
US$ thousands | |
US Dollars | |
| 811 | | |
| 371 | |
New Israeli Shekels | |
| 57 | | |
| 97 | |
Euro | |
| 9 | | |
| - | |
Great British Pound | |
| 1 | | |
| 133 | |
| |
| | | |
| | |
Cash
and cash equivalents | |
| 878 | | |
| 601 | |
Note
4 - Other Current Assets
OTHER
CURRENT ASSETS
SCHEDULE OF OTHER CURRENT ASSETS
| |
2022 | | |
2021 | |
| |
December 31 | |
| |
2022 | | |
2021 | |
| |
US$ thousands | | |
US$ thousands | |
Government institutions | |
| 29 | | |
| 52 | |
Prepaid expenses | |
| 4 | | |
| 1 | |
| |
| | | |
| | |
Other
current assets | |
| 33 | | |
| 53 | |
Note
5 - Property and Equipment, net
PROPERTY
AND EQUIPMENT, NET
SCHEDULE
OF PROPERTY AND EQUIPMENT, NET
| |
2022 | | |
2021 | |
| |
December 31 | |
| |
2022 | | |
2021 | |
| |
US$ thousands | | |
US$ thousands | |
Cost: | |
| | |
| |
Software and Computers | |
| 62 | | |
| 62 | |
| |
| | | |
| | |
Accumulated depreciation: | |
| | | |
| | |
Software and Computers | |
| 39 | | |
| 21 | |
| |
| | | |
| | |
Depreciated cost | |
| 23 | | |
| 41 | |
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
6 - Accounts payable
ACCOUNTS
PAYABLE
SCHEDULE OF ACCOUNTS PAYABLE
| |
2022 | | |
2021 | |
| |
December 31 | |
| |
2022 | | |
2021 | |
| |
US$ thousands | | |
US$ thousands | |
Employees and payroll accruals | |
| 53 | | |
| 104 | |
Accrued expenses and other payables | |
| 44 | | |
| 23 | |
| |
| | | |
| | |
Accounts
payable | |
| 97 | | |
| 127 | |
Note
7 - Share Capital
EQUITY
SCHEDULE
OF SHARE CAPITAL COMPOSITION
Composition: | |
As of December 31, 2022 | |
| |
| | |
Issued and | |
| |
Authorized | | |
fully paid | |
| |
Number of shares | |
| |
| | | |
| | |
Ordinary shares NIS 0.01 par value (“Ordinary Shares”) | |
| 1,000,000 | | |
| 163,494 | |
Ordinary shares NIS 0.01 par value (“Ordinary Shares”) | |
| 1,000,000 | | |
| 163,494 | |
| |
As of December 31, 2021 | |
| |
| | |
Issued and | |
| |
Authorized | | |
fully paid | |
| |
Number of shares | |
| |
| | | |
| | |
Ordinary shares | |
| 1,000,000 | | |
| 158,696 | |
| 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. The remaining
services were rendered in 2022. Accordingly, the Prepaid share-based payment balance of US$771
thousands, was fully recognized in the Statement of Operations in 2022. |
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
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. |
| | |
| | Based
on the Company’s agreement with one of its other shareholders, the Company is entitled in certain circumstances to a matching investment
(“the matching investment”) which could bring the total funding to US$2,900 thousands. As of December 31, 2022, the matching
investment has not yet been approved by the shareholder. |
| E. | Stock
option plan: |
| | |
| | In
2018 the Company adopted a stock option plan for its employees, service providers and officers, pursuant to which, and to a resolution
of the Company’s board of directors dated October 31, 2018, the Company reserved for issuance 6,250 Ordinary Shares. |
| | |
| | In
June 2021, the Company increased its reserved stock option plan to 13,654 Ordinary Shares. |
| | |
| | The
contractual life of the share option is 10 years from the respective date of grant. |
| | |
| | Share
options to employees, service providers and officers granted under the stock option plan shall be vesting in installments, gradually
over a period of 4 years from the grant date. |
| | |
| | Below
is a summary of employee option activity under the Company’s equity incentive plan during the current year: |
SUMMARY OF EMPLOYEE OPTION ACTIVITY
| |
Year ended December 31, 2022 | |
| |
| | |
Weighted | | |
Weighted | | |
Aggregate | |
| |
| | |
average | | |
average | | |
intrinsic | |
| |
| | |
exercise | | |
remaining | | |
value | |
| |
Number of | | |
price | | |
contractual | | |
US$ | |
| |
options | | |
US$ | | |
term (years) | | |
thousands | |
| |
| | | |
| | | |
| | | |
| | |
Outstanding at the beginning of the
year | |
| 13,145 | | |
| 146.63 | | |
| 8.25 | | |
| 1,475 | |
Granted | |
| - | | |
| - | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Outstanding at the end of the year | |
| 13,145 | | |
| 146.63 | | |
| 7.25 | | |
| 2,045 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at the end of the year | |
| 8,862 | | |
| 101.90 | | |
| 6.8 | | |
| 1,775 | |
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
7 - Share Capital (cont’d)
| E. | Stock
option plan (cont’d) |
| 1. | The
aggregate intrinsic value represents the total intrinsic value (the difference between the
Company’s stock fair value on December 31, 2022 and the exercise price, multiplied
by the number of in-the-money options) that would have been received by the option holders
had all option holders exercised their options on December 31, 2022. |
| 2. | Fair
value measurement: |
| | |
| | The
fair value of each option granted during 2021 was estimated on the date of grant, using the Binomial model taking into account the following
assumptions: |
SCHEDULE OF FAIR VALUE OF OPTION USING VALUATION ASSUMPTIONS
| |
2021 | |
Dividend yield | |
| 0 | % |
Expected volatility | |
| 76 | % |
Weighted average risk-free interest | |
| 1.5 | % |
Expected life | |
| 10 years | |
Expected
volatility was calculated based on market benchmarks.
Since
the Company’s shares are not publicly traded and its shares are rarely traded privately, expected volatility is estimated based
on the average historical volatility of similar entities with publicly traded shares.
The
expected option term represents the period that the Company’s share options are expected to be outstanding. Since
the options were granted to executives, the assumption is that the option will be exercised close to the expiration date. The
risk-free interest rate is based on the yield from U.S. Federal Reserve rates. The Company has historically not paid dividends and has
no plans to pay dividends in the foreseeable future.
There
were no option grants during 2022.
| 3. | 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
| |
2022 | | |
2021 | |
| |
December 31 | |
| |
2022 | | |
2021 | |
| |
US$ thousands | | |
US$ thousands | |
Research and development | |
| 321 | | |
| 185 | |
General and administrative | |
| 181 | | |
| 54 | |
| |
| | | |
| | |
Total stock-based compensation expense | |
| 502 | | |
| 239 | |
|
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$134 thousands). According to the agreement, the SAFE does not bear interest
and is convertible to the Company’s ordinary shares, as follows:
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
7 - Share Capital (cont’d)
|
F. |
Convertible Financial Instruments (cont’d) |
| (a) | In
the event of a financing round of at least 1 million GBP, the SAFE will be automatically
converted into ordinary shares at the price determined in such round; |
| (b) | In
the event that the financing round is below 1 million GBP, the SAFE may be converted into
ordinary shares at the price determined in such round, at the discretion of the investor; |
| (c) | If
no financing round occurs, the SAFE amount shall automatically be converted into ordinary
shares at the earlier of: (a) an M&A transaction – using the price per share |
determined
in such transaction, or (b) 36 months after the date of the agreement, at the fair market value of an ordinary share at that time.
The
SAFE was treated for accounting purposes as a liability, since this arrangement is settled in a variable amount of shares and the investor
is not exposed to the changes in the fair value of the shares during the period from the transfer of funds until conversion.
The
convertible financial instrument is presented at fair value. The convertible financial instrument is considered a Level 3 fair value
measurement.
The
changes in the liability measured at fair value for which the Company has used Level 3 inputs to determine fair value are as follows:
SCHEDULE OF CHANGE IN LIABILITY
MEASURED AT FAIR VALUE
| |
2022 | | |
2021 | |
| |
2022 | | |
2021 | |
| |
US$ thousands | | |
US$ thousands | |
Balance as of January 1, | |
| 134 | | |
| - | |
Convertible financial instrument received | |
| - | | |
| 134 | |
Change in fair value | |
| (13 | ) | |
| - | |
| |
| | | |
| | |
Balance as of December 31, | |
| 121 | | |
| 134 | |
Note
8 - Commitments and Contingent Liabilities
COMMITMENTS AND CONTINGENCIES
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,
2022, the Company has yet to incur revenues, therefore no provision was recorded for these commitments in the financial statements.
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
8 - Commitments and Contingent Liabilities (cont’d)
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.
| 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, 2022, 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.
On
November 10, 2022, the Company entered into a lease agreement (hereinafter – “The Agreement”. (According to the agreement,
the Company will rent a vehicle for 12 months from December 10, 2022, at a monthly rent cost of approximately NIS 3 thousand (approximately
US$1 thousand)
Future
minimum commitments under the agreement as of December 31, 2022, are as follows:
SCHEDULE OF FUTURE MINIMUM COMMITMENTS
During
2022, the Company recognized lease expenses in the amount of US$6 thousand in General and administrative expenses.
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
9 - Financial (Income) Expenses, net
FINANCIAL (INCOME) EXPENSES, NET
SCHEDULE
OF FINANCIAL EXPENSE (INCOME), NET
| |
2022 | | |
2021 | |
| |
December 31 | |
| |
2022 | | |
2021 | |
| |
US$ thousands | | |
US$ thousands | |
Bank commissions | |
| 2 | | |
| 1 | |
Revaluation of marketable securities to market value | |
| - | | |
| 4 | |
Revaluation of convertible financial instrument | |
| (13 | ) | |
| - | |
Interest from government authorities | |
| (3 | ) | |
| - | |
Currency exchange differences | |
| 11 | | |
| - | |
| |
| | | |
| | |
Financial
(income) expenses, net | |
| (3 | ) | |
| 5 | |
Note
10 - Related Parties
RELATED PARTIES
The
Company engaged with its shareholders to receive consulting services and lab renting.
SCHEDULE OF RELATED PARTY TRANSACTIONS
Transactions | |
Year ended | | |
Year ended | |
| |
December 31 | | |
December 31 | |
| |
2022 | | |
2021 | |
| |
US$ thousands | | |
US$ thousands | |
Research and development expenses | |
| 353 | | |
| 309 | |
Note
11 - Taxes on Income
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 2022 and 2021. |
| | |
| | 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, 2022, the Company has net operating tax losses carried forward indefinitely of approximately $3.8 million, (December
31, 2021 - $3.1 million).
The
tax effects of temporary differences that give rise to significant components of the Company’s deferred tax assets and liabilities
are as follows:
NewStem
Ltd.
Notes
to the Financial Statements for the year ended December 31, 2022
Note
11 - Taxes on Income (cont’d)
|
D. |
Deferred income taxes (cont’d) |
SCHEDULE OF DEFERRED TAX ASSETS
| |
2022 | | |
2021 | |
| |
December 31, | |
| |
2022 | | |
2021 | |
| |
US$ thousands | | |
US$ thousands | |
Deferred tax assets: | |
| | | |
| | |
Net operating losses | |
| 885 | | |
| 719 | |
Research and development credit carried forward | |
| 229 | | |
| 230 | |
Other | |
| 26 | | |
| 4 | |
Total
deferred tax assets | |
| 1,140 | | |
| 953 | |
| |
| | | |
| | |
Less valuation allowance | |
| (1,140 | ) | |
| (953 | ) |
| |
| | | |
| | |
Net deferred tax assets | |
| - | | |
| - | |
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.
Note
12 – Subsequent Events
SUBSEQUENT EVENTS
On
March 20, 2023, The Company signed a Convertible Loan Agreement (“the Loan”) of US$200 thousands, maturing after two years.
The Loan shall bear simple interest at the rate of 12.5% per annum, paid in kind, with a conversion price per share reflecting 75% of
the lowest price per share paid by the investors participating in the Company’s next financing. In an Event of liquidation only,
the Interest rate shall increase to 20% per annum.
Item
16. Form 10–K Summary.
Not
applicable
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 March XX, 2023.
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 |
|
March
31, 2023 |
Jan
H. Loeb |
|
|
|
|
|
|
|
|
|
/s/
Christine Jenkins |
|
Vice
President and Chief Financial Officer |
|
March
31, 2023 |
Christine
Jenkins |
|
|
|
|
|
|
|
|
|
/s/
Mitchell Rubenstein |
|
Director |
|
March
31, 2023 |
Mitchell
Rubenstein |
|
|
|
|
|
|
|
|
|
/s/
Eric Richman |
|
Director |
|
March
31, 2023 |
Eric
Richman |
|
|
|
|
|
|
|
|
|
/s/
David Seltzer |
|
Director |
|
March
31, 2023 |
David
Seltzer |
|
|
|
|
|
|
|
|
|
/s/
Jerry Wolasky |
|
Director |
|
March
31, 2023 |
Jerry
Wolasky |
|
|
|
|
|
|
|
|
|
/s/
Tracy Clifford |
|
Director |
|
March
31, 2023 |
Tracy
Clifford |
|
|
|
|
Grafico Azioni NovelStem (PK) (USOTC:NSTM)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni NovelStem (PK) (USOTC:NSTM)
Storico
Da Dic 2023 a Dic 2024