SEC Comment Letter 0000000000-24-006448 to Silexion Therapeutics Corp (SLXN)
Silexion Therapeutics Corp
Date: June 5, 2024 · CIK: 0002022416 · Accession: 0000000000-24-006448
AI Filing Summary & Sentiment
File numbers found in text: 333-279281
Show Raw Text
United States securities and exchange commission logo
June 5, 2024
Ilan Levin
Chief Executive Officer
Biomotion Sciences
250 Park Avenue, 7th Floor
New York, NY 10177
Re:Biomotion Sciences
Registration Statement on Form S-4
Filed May 9, 2024
File No. 333-279281
Dear Ilan Levin:
We have reviewed your registration statement and have the following comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments.
Registration Statement on Form S-4
Cover Page
1.Please revise your Cover Page and where else you disclose Moringa's securities are listed
on Nasdaq to disclose Moringa received notice from Nasdaq that it is in non-compliance
with Nasdaq IM-5101-2 and the potential ramifications if the Panel does not grant
Moringa's requested six-month extension as discussed on page 74. Revise where you
discuss the factors considered by the Moringa Board in recommending the Business
Combination to disclose whether it considered the potential de-listing of Moringa
securities in recommending the Business Combination.
Frequently Used Terms, page 1
2.We note that the Condition Precedent Proposals means each of the Business Combination
Proposal, the Articles Amendment Proposal, the Share Incentive Plan Proposal and the
Director Election Proposal. Please tell us where the Articles Amendment Proposal, the
Share Incentive Plan Proposal and the Director Election Proposal are presented or revise
FirstName LastNameIlan Levin
Comapany NameBiomotion Sciences
June 5, 2024 Page 2
FirstName LastNameIlan Levin
Biomotion Sciences
June 5, 2024
Page 2
throughout as appropriate.
Questions and Answers About the Proposals
Q: What voting interests will our current shareholders, the Sponsor, and Silexion
shareholders...?, page 11
3.Please disclose the sponsor and its affiliates' total potential ownership interest in the
combined company, assuming exercise and conversion of all securities. Please revise to
disclose all possible sources and extent of dilution that shareholders who elect not to
redeem their shares may experience in connection with the business combination. Provide
disclosure of the impact of each significant source of dilution, including the amount of
equity held by founders, convertible securities, including warrants retained by redeeming
shareholders, at each of the redemption levels detailed in your sensitivity analysis,
including any needed assumptions.
4.Revise your disclosure to show the potential impact of redemptions on the per share value
of the shares owned by non-redeeming shareholders by including a sensitivity analysis
showing a range of redemption scenarios, including minimum, maximum and interim
redemption levels.
Q: What interests do our Sponsor, current officers, directors and advisors have in the Business
Combination?, page 12
5.Please quantify the aggregate dollar amount and describe the nature of what the sponsor
and its affiliates have at risk that depends on completion of a business combination.
Include the current value of securities held, loans extended, fees due, and out-of-pocket
expenses for which the sponsor and its affiliates are awaiting reimbursement. Provide
similar disclosure for the company's officers and directors, if material.
6.Please revise under this heading and where else you discuss the interests of the Sponsor,
current officers, directors and advisors in the Business Combination to highlight the risk
that the sponsor will benefit from the completion of a business combination and may be
incentivized to complete an acquisition of a less favorable target company or on terms less
favorable to shareholders rather than liquidate.
7.Please clarify here and elsewhere as appropriate if the sponsor and its affiliates can earn a
positive rate of return on their investment, even if other SPAC shareholders experience a
negative rate of return in the post-business combination company.
8.We note your disclosure on page 12 and elsewhere that amounts may be paid to EarlyBird
from the Trust Account pursuant to the Marketing Agreement. Please revise here and
elsewhere as appropriate to quantify the amount that is owed to EarlyBird pursuant to the
Marketing Agreement. Revise your disclosure to disclose the effective underwriting fee
on a percentage basis for shares at each redemption level presented in your sensitivity
analysis related to dilution.
FirstName LastNameIlan Levin
Comapany NameBiomotion Sciences
June 5, 2024 Page 3
FirstName LastName
Ilan Levin
Biomotion Sciences
June 5, 2024
Page 3
What conditions must be satisfied to complete the Business Combination?, page 14
9.We note that a condition to closing, unless waived, is Silexion's receipt of the Silexion
Equity Financing in an amount of at least $3.5 million by April 30, 2024 and that the
financing has, to date, not taken place, and the parties are working towards completion of
a financing prior to, or upon, Closing. Please update this disclosure when appropriate.
What are the U.S. federal income tax consequences of the SPAC Merger?, page 17
10.We note your disclosure that the Mergers, taken together, are intended to qualify for tax-
deferred treatment under Section 351(a) of the Code. Please revise your disclosure here
and throughout, including in the section beginning on page 210, to provide counsel's firm
opinion for each material tax consequence, including whether the Mergers will qualify as
an integrated transaction, or explains why such opinion cannot be given. Please also
clearly disclose that this is the opinion of tax counsel and identify counsel. If the opinion
is subject to uncertainty, please provide disclosure that reflects the degree of uncertainty
(e.g., "should" or "more likely than not") and explains the facts or circumstances giving
rise to the uncertainty, and provide disclosure of the possible alternative tax consequences
including risk factor and/or other appropriate disclosure setting forth the risks of uncertain
tax treatment to investors. For guidance, refer to Staff Legal Bulletin No. 19, Sections
III.C.1 and 4.
Silexion, page 22
11.Please revise your disclosure here to remove the disclosure that Silexion's phase 2 clinical
trial showed "positive efficacy results" as efficacy determinations are within the sole
discretion of the FDA or comparable foreign regulators.
12.Revise under this heading to disclose Silexion's current stage of development and future
development plans for its first-generation product and its new formulated product. If
Silexion is still in pre-clinical development for its second-generation product, please make
that clear.
Risk Factors
If we are deemed to be an investment company for purposes of the Investment Company Act...,
page 82
13.Please revise your disclosure under this heading regarding the potential safe harbor and to
otherwise update for the guidance the SEC provided for SPACs to consider when
analyzing their status under the Investment Company Act of 1940. See SEC Release No.
33-11265, Special Purpose Acquisition Companies, Shell Companies, and Projections,
adopted on January 24, 2024. Please ensure any outdated disclosure is removed.
FirstName LastNameIlan Levin
Comapany NameBiomotion Sciences
June 5, 2024 Page 4
FirstName LastName
Ilan Levin
Biomotion Sciences
June 5, 2024
Page 4
Risks Relating to Owning New Pubco Ordinary Shares Following the Business Combination and
the Company Operating as a Public Company, page 83
14.Disclose the material risks to unaffiliated investors presented by taking the company
public through a merger rather than an underwritten offering. These risks could include
the absence of due diligence conducted by an underwriter that would be subject to liability
for any material misstatements or omissions in a registration statement.
Proposal No. 1. The Business Combination Proposal
Background of the Business Combination, page 102
15.We note your disclosure on page 130 that EarlyBird performed additional services after
the IPO and part of the IPO underwriting fee was deferred and conditioned on completion
of a business combination. Please quantify the aggregate fees payable to EarlyBird that
are contingent on completion of the business combination and describe the extent of
EarlyBird's role.
16.Please revise this section to discuss the negotiations leading to Ilan Levin becoming a
director of the combined company.
Certain Financial Analyses
Comparable Company Analysis, page 106
17.Please revise to describe and quantify the factors that you considered in determining
Silexion's pre-transaction equity value of $62.5 million, specifically addressing how you
evaluated lead clinical programs for the 25 comparable companies, how you related
enterprise value to the status of each comparable company's lead program, and how you
compared these lead clinical programs to Silexion's lead clinical program.
18.Please revise to state who created the comparable company analysis relied on by
Moringa's management and board.
19.Please revise to disclose whether any companies that met the selection criteria were not
included in the analysis and if so, explain why. Revise to describe the standard the
company used to identify whether a company's drug development was "innovative."
Proposal No. 2. The Merger Proposal, page 117
20.Please revise to unbundle Proposal No. 2 so that shareholders may vote on the proposal to
eliminate the $5,000,001 net tangible assets requirement separately. Alternatively, provide
us an analysis supporting why this provision may be presented along with the other
provisions in Proposal No. 2. Refer to Rule 14a-4(a)(3) and Exchange Act Rule 14a-
4(a)(3) Compliance and Disclosure Interpretations 101.01 and 101.02 Regarding
Unbundling under Rule 14a-4(a)(3) Generally, and 201.01 and 201.02 Regarding
Unbundling under Rule 14a-4(a)(3) in the M&A Context.
FirstName LastNameIlan Levin
Comapany NameBiomotion Sciences
June 5, 2024 Page 5
FirstName LastName
Ilan Levin
Biomotion Sciences
June 5, 2024
Page 5
Information About Silexion
Business Overview, page 148
21.We note the disclosure throughout this section appears to indicate that Silexion is no
longer developing the first-generation of Loder as a clinical-stage product candidate and is
now developing a new product candidate, SIL-204B, which appears yet to undergo
toxicology studies per the disclosure on page 154. To the extent this is true, it appears the
company is not currently in a clinical development stage, but instead a pre-clinical
development stage. If so, please revise throughout to reflect that Silexion is in a
preclinical stage of development, or otherwise advise.
Our Technology, page 151
22.We note Silexion makes various performance claims about its product candidates. Please
revise to provide and discuss the preclinical data and other sources relied on for these
claims. As a non-exhaustive list, we note the following statments:
•Silexion "synthetically produc[es] a chain of molecules, called nucleotides (NT),
which mimic the natural process and bind to the specific messenger [it] want[s]
destroyed, inducing the natural protection mechanism of the cell;"
•Silexion's inhibitors "prevent the production of the protein;"
•Silexion's "sequence of [its] NTs is chosen for their specificity to bind and induce the
destruction process;"
•Silexion "include[s] modification to the NT to prevent enzymatic breakdown of [its]
siRNA, before they reach the mRNA target;" and
•Silexion adds "a lipid which increases the ability of our product to enter the tumor
cells."
23.We note that Silexion's first-generation product candidate was originally designed to
combat the KRAS G12D mutation, and showed improvement in overall survival in
patients with the KRAS G12D or G12V mutations, and from the disclosure on page 153,
that Silexion intends to broaden the KRAS silencing activity to additional KRAS
mutations such as G12C. Please indicate whether the Silexion siRNA has shown
complementary binding to all types of G12x mutations or only to an individual mutation
type. If the Silexion siRNA only targets individual mutation types, indicate whether
clinical trials would need to be conducted for the other mutation types. In this regard,
please make clear which mutation type or mutation range SIL-204B intends to target.
Our First-Generation Development - Loder, page 152
24.Please revise to discuss the primary and any secondary endpoints, whether the trial met
the endpoints, and whether there were any adverse events attributable to the treatment.
25.We note your references to a Phase 2a and a Phase 2 multinational clinical trial. Please
revise to clarify if these were separate trials or the same trial and indicate the regulatory
jurisdictions in which the studies were conducted. If there were separate trials, please
FirstName LastNameIlan Levin
Comapany NameBiomotion Sciences
June 5, 2024 Page 6
FirstName LastNameIlan Levin
Biomotion Sciences
June 5, 2024
Page 6
revise the discussion of the second trial to disclose the primary and secondary endpoints,
whether the trial met its endpoints, the inclusion/exclusion criteria, and whether the results
of the second trial were statistically significant.
26.Please revise to discuss future clinical development plans for the first-generation of Loder.
To the extent Silexion discontinued clinical development of that product candidate, state
this and the reasons why.
27.We note your disclosure that the Phase 2a clinical trial results "provided evidence of an
improvement in overall survival in patients with the KRAS G12D or G12V mutations
(G12D/V) as well." However, we note your disclosure on page 153 that the trial was
relatively small and statistical significance was not achieved. As such, please clarify why
Silexion's believes that the Phase 2a clinical trial provided evidence of improvement.
28.We note your disclosure in the last paragraph of this section that it was concluded that
intratumor administration via EUS is an effective and safe approach. In addition, we note
the statement on page 153 that the conjugated lipid Silexion is using in SIL-204B provides
twice the efficacy as compared to the non-lipid conjugated siRNA. Rather than making
efficacy and safety conclusions that are within the sole discretion of the FDA or
comparable foreign regulators, revise your disclosure throughout to avoid using these
terms and to present the data underlying these conclusions.
Our Second-Generation Development SIL-204B, page 153
29.Please revise page 153 to provide the preclinical and other data supporting the
performance claims for SIL-204B's siRNA advances and extended-release formulation
advancements. Disclose the current stage of development of the product candidate.
30.We note your reference to Phase 1 trials. Please disclose all material outcomes observed in
that trial including adverse events.
Manufacturing, page 154
31.We note Silexion's disclosure on page 154 that it "has an agreement with LGC/Axolab for
the manufacturing of [its] product for the Phase 3 trial." Please revise where appropriate to
discuss the details of this trial or otherwise advise.
Our Commercialization Plans, page 154
32.We note the disclosure under this heading assumes SIL-204B will be approved by the
FDA or comparable foreign regulators, which is speculative given that SIL-204B does not
appear to have been studied in any clinical trial. Please revise to state that Silexion's
product candidates must be approved by the FDA or a comparable foreign regulator
before they may be commercialized.
33.Please revise your reference to Orphan Drug Designation to clarify that such a designation
neither shortens the devel