Correspondence 0001493152-22-034598 from NovelStem International Corp. (NSTM) (CIK 0000912544) (NSTM)
NovelStem International Corp. (NSTM) (CIK 0000912544)
Date: Dec. 6, 2022 · CIK: 0000912544 · Accession: 0001493152-22-034598
AI Filing Summary & Sentiment
File numbers found in text: 000-22908
Referenced dates: November 2, 2022
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NovelStem
International Corp.
2255
Glades Road Suite 221A
Boca
Raton, Florida 33431
December
6, 2022
VIA
EDGAR
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
DC 20549-7010
Attn:
Re:
NovelStem International Corp.
Amendment
No. 1 to Registration Statement on Form 10-12G
Filed
October 12, 2022
File
No. 000-22908
Ladies
and Gentlemen:
The
following responses address the comments of the reviewing Staff of the Commission as set forth in a comment letter dated November 2,
2022, relating to the draft registration statement on Form 10-12G (the “Registration Statement”) of NovelStem International
Corp. (the “Company” or “NovelStem”). The numbered paragraphs below correspond to the numbered comments in the
Staff’s letter and the Staff’s comments are presented in bold.
We
are filing herewith Amendment No. 2 to the Registration Statement (“Amendment No. 2”).
Amendment
1 to Form 10-12G Filed October 12, 2022
Item
1. Business, page 2
1.
We
note your response to comment 6 and reissue in part. Please clarify what is meant by the reference to “products” in the
statement “[w]e believe that NewStem is currently the only company worldwide to develop products...” Namely, please describe
whether there are particular product(s) or whether it is the screening in its entirety that is the product. Explain what it means
that a target is “validated,” and explain the meaning of the terms AI-based drug discovery, hit to lead process, and
ADMET so that investors can understand their significance. Please also clearly state that NewStem does not have any FDA- or EMA-approved
medical devices or products.
Response:
The
Company notes the Staff’s Comment #1 and has revised the disclosure in Amendment No. 2. Please see page 2 of Amendment No.
2. Our reference to NewStem’s products is intended to comprise:
●
A
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
●
Anticancer
drugs that target tumors with specific mutations, based on synthetic-lethal interaction approach.
2. We
reissue comment 8. Please tell us whether the products that will be developed will be considered
medical devices. If so, please revise to discuss the relevant approval process.
Response:
The
diagnostic product will be considered a medical device. A Pre-Submission regarding the NSDD was submitted to the 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.
The
Company has revised the disclosure in Amendment No. 2 in accordance with the Staff’s Comment 2. Please see page 4 of Amendment
No. 2.
Item
5. Directors and Executive Officers, page 18
3. We
note your response to comment 13 and reissue in part. We note in your response that Jan Loeb
is now an “Executive Chairman” and that no Vice President has been appointed.
Please tell us how this is consistent with Article Four of your bylaws which state that the
officers shall include a President and one or more Vice Presidents.
Response:
The
Company notes the Staff’s Comment #3. Presently, and as disclosed in Amendment No. 2, the Company is a development stage company
which has generated no revenue to date. As the Company and NewStem continue to grow and their product candidates advance in the regulatory
approval process, the Company anticipates appointing additional officers in accordance with the terms of its bylaws to manage the Company’s
growth.
4. We
note that Jan Loeb was appointed as Executive Chairman in September. Please explain how this
differs from his role as Chairman of the Board, as it appears that he continues to serve
only on the Board and not in a policy making function such that he would be an executive
officer under the Rule 3b-7 of the Exchange Act. We also note that he is the Chairman of
NewStem. Please advise and disclose Mr. Loeb’s duties with respect to the day-to-day
operations of NewStem given that he does not appear to be in a policy-making position for
either NovelStem or NewStem.
Response:
Jan
Loeb has served as the Company’s Chairman since July 2018. Rule 3b-7 of the Exchange Act defines the term “executive officer”
in part as an “officer who performs a policy making function or any other person who performs similar policy making functions for
the registrant”. 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 factco leadership role. In September 2022, the Board appointed Mr. Loeb as Executive Chairman in order to ratify
Mr. Loeb’s position and clarify his executive role. 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.
Item
8. Legal Proceedings., page 22
5. We
note your response to comment 15 and reissue in part. Please expand on your disclosure to
better illustrate the factual basis alleged to underlie the arbitration. Namely, please describe
what disagreement caused you to initiate an arbitration proceeding against your partner in
Netco Partners and what is meant when you say that you hope to “maximize” the
potential value of the NetForce intellectual property. We also note that you have until mid-October
2022 to negotiate a settlement with C.P. Group before arbitration proceedings resume, please
update this disclosure if arbitration proceedings have resumed.
Response:
The Company has revised the disclosure in Amendment No. 2 in accordance with the Staff’s Comment 5. Please see page 21
of Amendment No. 2.
Item
10. Recent Sales of Unregistered Securities, page 23
6. We
note your response to comment 16 and reissue in part. With reference to the transaction dated
December 11, 2019, please provide the name of the person or identify the class of the person
who bought the 2,500,000 shares of common stock.
Response:
The
Company has revised the disclosure in Amendment No. 2 in accordance with the Staff’s Comment #6. Please see page 23
of Amendment No. 2.
Novelstem
International Corp.
Note
1 - Nature of Operations, page F-7
7.
We
note your response to comment 1 and reissue in part. Please clarify or update the Company’s holding interest in NewStem Ltd.
as it currently still states “31.5%” in this section.
Response:
The
Company notes the Staff’s Comment #7. In Note 1 – Nature of Operations, page F-7 in our financial statements as of and for
the years ended December 31, 2021 and 2020, we correctly state that as of December 31, 2021, our ownership percentage in NewStem was
31.5%. The Company’s ownership percentage decreased to 30.99% in April 2022 due to the issuance of shares of common stock to
a new investor in NewStem at that time, resulting in a slight decrease of NovelStem’s ownership percentage.
The
Company has revised the disclosure in Amendment No. 2 in accordance with the Staff’s Comment #7. Please see page 2 of Amendment
No. 2.
General
8. We
reissue our request that you provide us with the calculation of the Company’s investment
securities as a percentage of its total assets (on an unconsolidated basis) pursuant to Section
3(a)(1)(C) of the Investment Company Act of 1940 (the “1940 Act”). If you are
taking the position that the Company’s interests in NetCo and/or NewStem are not “investment
securities” under Section 3(a)(1)(C) and 3(a)(2) of the 1940 Act, please provide a
comprehensive legal analysis supporting your position.
Response:
The
following analysis is being provided in response to the Staff’s Comment #8 and a request from the reviewing Staff of the Commission
as discussed with Nicholas Nalbantian on November 17, 2022. In particular, the Staff is requesting a more comprehensive analysis as to
why the Company should not be classified as an “investment company” as defined in the 1940 Act.
As
noted in the Company’s prior responses to the Staff’s Comments with respect to the Registration Statement, the Company again
respectfully submits that the Company is not an investment company based on the definition set forth in Section 3 of the 1940 Act based
on the analysis provided below.
Objectives
of the Act
The
policy and purposes of the 1940 Act, as set forth in Section l(b) of the 1940 Act, are “to mitigate and, so far as is feasible,
to eliminate” certain conditions, enumerated in that section, which adversely affect the public interest and interest of investors.
The “findings and declaration of policy” set forth in Section 1(a) of the 1940 Act notes that “the
principal activities of such companies” are “investing, reinvesting, and trading in securities.” A typical investment
company would hold multiple investments as a means of diversifying its portfolio with the goal of maximizing returns for its investors.
A typical investment strategy of an investment company would also consist of an exit strategy.
By
contrast, the Company’s its ownership interest in NewStem is a relatively illiquid and restricted investment and constitutes its
only material equity ownership in an operating entity. The Company is actively engaged in the management, financial activities and strategic
planning of NewStem and is focused almost entirely on the continuing growth of NewStem. There is no intention to engage in “trading”
in such securities or any other investments.
Definition
of Investment Company
In
broad terms, an investment company is any arrangement by which a number of persons invest funds in a “company” that is
itself engaged in investing in securities. In view of this, Section 3(a)(1) of the Act defines an “investment company”
as an issuer which:
A.
Is or holds itself out as being engaged primarily,
or proposes to engage primarily, in the business of investing, reinvesting or trading in securities.
B.
Is engaged or proposes to
engage in the business of issuing face-amount certificates of the installment type, or has been engaged in such business and has
any such certificate outstanding; or
C.
Is engaged or proposes to
engage in the business of investing, reinvesting, owning, holding, or trading in securities, and owns or proposes to acquire investment
securities having a value exceeding 40 per cent of the value of such issuer’s total assets (exclusive of Government securities
and cash items) on an unconsolidated basis.
We
respectfully submit that the Company does not fall within the scope of the criteria enumerated in any of the foregoing tests for defining
an “investment company”.
First,
the Company is not and does not propose to engage in the business of issuing “face-amount certificates of the installment type”
and, therefore, does not fall within Section 3(a)(1)(B)’s definition.
Moreover,
the Company is not, nor holds itself out as, nor proposes to engage primarily in, the business of investing, reinvesting or trading in
securities as required to meet the definition in Section 3(a)(1)(A). Rather, the Company has consistently described itself to investors
and the business world as a biotechnology company engaged through NewStem in the development and commercialization of stem-cell-based
diagnostic technology. For example, in shareholder updates and other press releases dated December 16, 2019, April 21, 2020 and December
1, 2020, NovelStem consistently described itself, respectively as:
● “a
biotechnology company focused on stem-cell-based diagnostic technology to aid the selection
of cancer therapeutic agents being developed by its Israel-based affiliate, NewStem Ltd.”
● “a
biotechnology company focused on its stem-cell-based technology platform, developed by Israel-based
affiliate, NewStem Ltd.”
● “a
biotechnology company focused on the stem cell-based technology platform developed by 30%-owned,
Israel-based NewStem, Ltd.”
Later
press releases consistently describe NovelStem in a similar fashion. For example, on October 13, 2022, the Company issued a press release
announcing that it had become an SEC-reporting company as a result of the effectiveness of the Registration Statement. In that release,
NovelStem described itself as:
a
development-stage company focused on the stem cell-based technology platform developed by 30%-owned, Israel-based NewStem Ltd.
As
previously disclosed, the Company was formed in 1993 and until December 15, 2010, comprised various businesses focusing primarily on
online ticket sales, deriving revenue primarily from Broadway, Off-Broadway and London’s West End ticket sales to individuals and
groups, as well as advertising and book development license fees and royalties. The Company divested its ticketing division in 2010 and
remained focused on its advertising sales and intellectual properties divisions.
In
July 2018 the Company acquired its initial ownership interest in NewStem, a research and development company focused on human Pluripotent
Stem Cells (hPSCs) in general, and Haploid human Pluripotent Stem Cells (HhPSCs), in particular. In that respect, the Company also changed
its name to NovelStem to further reinforce its identity with NewStem.
Substantially
all of NovelStem’s assets, operations and management resources are committed to NewStem’s business and strategic growth.
NovelStem’s Executive Chairman and its other Directors, most of whom have pharmaceutical and life science backgrounds, are actively
involved in, and d