What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2025-04-07 compared with 2024-04-01 · 101 added, 107 removed, 121 unchanged (63% of the section changed)

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”).

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.

(“NovelStem” or the “Company”) is a holding company whose principal assets are a 50% equity

interest in NetCo Partners (“NetCo”) and an approximately 31% interest in NewStem Ltd, an Israeli biotech company (“NewStem”).

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.

the purchase of NewStem, the Company expanded its business focus from media to cutting edge biotech.

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.

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.

as President.

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.

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,

Loeb serves as the de facto Chief Financial Officer and Chief Strategic Officer of NewStem.

depends entirely on earnings and cash from its investments in NewStem and our 50% equity interest in a legacy joint venture named NetCo

Partners (“NetCo”).

The Company’s principal operations coincide with those of NewStem.

We have not received any dividend

payments or other distributions from NewStem in the fiscal years ended December 31, 2023 and 2022.

We received distributions of earnings

from NetCo of $6,875 and $12,591, respectively, for the fiscal years ended December 31, 2023 and 2022.

is a development stage Israeli biotech limited liability company focused on human Pluripotent Stem Cells (hPSCs) in general, and

Haploid human Pluripotent Stem Cells (HhPSCs), in particular.

These cells have the potential to change the face of medical research

as they play a pivotal role in cancer research, regenerative medicine and disease therapy.

NewStem established a discovery

bio-platform based on haploid human embryonic stem cell technology for genome-wide screenings and is currently using this platform

for the discovery and development of oncology drugs based on synthetic lethal interaction and developing a personalized diagnostic

for early detection of chemotherapy resistance.

NewStem has incurred losses since inception and has generated minimal revenues from

a licensing agreement to date.

NewStem filed an FDA Pre-Submission and received a CE Mark from the European Medicines Agency (EMA)

for its in vitro diagnostic device (IVDD).

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.

the second quarter of 2024, the Company was a development stage biotechnology holding company focused on the stem cell-based technology

developed by Hebrew University under exclusive license to NewStem.

The Company signed an agreement (the “Purchase Agreement”) on June 20, 2024 to acquire the remainder

of NewStem in exchange for Company stock as well as funding for NewStem.

The Company was unable to obtain funding to proceed and the

Purchase Agreement was not fully consummated.

As such, no Company shares were issued to NewStem shareholders in exchange for NewStem

the third quarter of 2024, it became evident that NewStem would not be able to raise funds to continue operations consisting of research

and development and further development of the technology.

In October 2024, NewStem ceased operations and began the process of liquidation

under which the current state of the technology reverts back to the original licensor with the Company retaining a financial interest

in any future licensing.

depends entirely on earnings and cash from its investments in NewStem and the NewStem technology and our 50% equity interest in the NetCo

joint venture.

The Company’s principal operations coincided with those of NewStem.

We have not received any dividend payments or

other distributions from NewStem in the fiscal years ended December 31, 2024 and 2023.

We received distributions of earnings from NetCo

of $6,875 during the fiscal year ended December 31, 2023.

No such distributions of earnings were received during the fiscal year ended

December 31, 2024.

is a development stage Israeli biotech limited liability company that performed research focused on human Pluripotent Stem Cells (hPSCs)

in general, and Haploid human Pluripotent Stem Cells (HhPSCs), in particular.

These cells have the potential to change the face of medical

research as they play a pivotal role in cancer research, regenerative medicine and disease therapy.

NewStem established a discovery bio-platform

based on haploid human embryonic stem cell technology for genome-wide screenings and is currently using this platform for the discovery

and development of oncology drugs based on synthetic lethal interaction and developing a personalized diagnostic for early detection

of chemotherapy resistance.

NewStem has incurred losses since inception and has generated minimal revenues from a licensing agreement

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.

The NewStem Software Diagnostic Device (NSDD) is CE marked under

EU regulation as an “other” IVD under Directive 98/79/EC since March 2022.

performs genome-wide genetic screening to identify synthetic lethal interactions with common cancer-related mutations.

13 unchanged sentences

The validation process

requires additional experiments that corroborate the results in independent experiments

that are performed on haploid human embryonic stem cells and cancer models.

For validated targets, artificial intelligence (AI) based

drug discovery will be performed following by hit to lead process and ADMET that will support the transition to clinical trials.

requires additional experiments that corroborate the results in independent experiments that are performed on haploid human embryonic

stem cells and cancer models.

For validated targets, artificial intelligence (AI) based drug discovery will be performed following by

hit to lead process and ADMET that will support the transition to clinical trials.

reference to AI-based drug discovery, AI can assist in structure-based drug discovery by predicting the 3D protein structure and the

11 unchanged sentences

their genetic manipulation, immunogenicity, tumorigenicity and their unique capacity in disease modeling.

believe that NewStem is currently the only company worldwide to develop products based on this innovative proprietary technology.

products refer to the medical device platform that provides information to oncologists regarding the presence of mutations in the patient’s

believe that NewStem is 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

3 unchanged sentences

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,

The License provided 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”

grant of the License, NewStem was obligated to pay royalties of up to 3% of net sales and up to 12% of “Sublicense Consideration”

(as defined in the License Agreement).

As part of the ongoing liquidation of NewStem, the License reverts to the original holders and

NovelStem retains a significant financial interest in any future monetization of the License.

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.

6 unchanged sentences

Professor Benvenisty and a representative of Yissum occupy the other two Board seats.

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

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.

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.

such occurrence could have a material and adverse effect on NewStem’s and our business, results of operations and financial condition.

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

technologies underlying future monetization of the License 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 can be developed through the License.

Any such occurrence could have a material and adverse effect on our business, results of operations and financial condition.

plans to find new users for the technology based on the License.

The success of a future licensee to enhance and broaden its product

offerings in response to changing customer demands and competitive pressure and technologies will depend on numerous factors, including

the ability to:

identify and anticipate physician and patient needs;

14 unchanged sentences

Approval Process

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.

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.

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.

therapeutic product candidates were 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.

testing and approval process requires substantial time, effort and financial resources, and any future licensee’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 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.

any licensee to obtain, or any delay in obtaining, regulatory approvals or in complying with requirements could adversely affect the

commercialization of product candidates and the Company’s ability to receive licensing revenues.

Regulatory Requirements

3 unchanged sentences

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.

the United States, NewStem’s ability to market a product is contingent upon receiving marketing authorization from the appropriate

Failure by a licensee 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.

the United States, a licensee’s ability to market a product is contingent upon receiving marketing authorization from the appropriate

regulatory authorities.

27 unchanged sentences

to Net Force.

the time of this filing, the Company is in final negotiations to sell our interest in NetCo to our joint venture partner in exchange

for the settlement of related debt in the form of a litigation funding agreement.

in the publishing and video game industries is intense.

20 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business