United States securities and exchange commission logo
July 19, 2023
Sam Backenroth
Chief Financial Officer
Vascular Biogenics Ltd.
1 Blue Hill Plaza , Suite 1509
Pearl River, NY 10965
Re: Vascular Biogenics
Ltd.
Amendment No. 1 to
Registration Statement on Form S-4
Filed June 30, 2023
File No. 333-271826
Dear Sam Backenroth:
We have reviewed your amended registration statement and have the
following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe our comments apply 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 these comments, we may have additional comments.
Unless we note
otherwise, our references to prior comments are to comments in our June
15, 2023 letter.
Amendment No. 1 to Registration Statement on Form S-4 filed June 30,
2023
Q: Why am I being asked to approve the Proposed VB-601 Asset Sale?, page
viii
1. Consistent with your
disclosure on page 163, please revise pages viii and 102 to explain
the reasons why the VBL
Board determined that a non-binding offer for the VB-601 Asset
received prior to
execution of the letter of intent with Wellbeing was "not actionable."
2. Please revise to
clarify why it is important from the perspective of VBL shareholders that
VBL execute the asset
sale agreement prior to closing the Merger. In this regard it is
unclear what
consideration VBL shareholders stand to receive pre-Merger that they won't
receive post-Merger.
Also, clarify the value of the referenced consideration.
Sam Backenroth
FirstName LastNameSam
Vascular Biogenics Ltd. Backenroth
Comapany
July NameVascular Biogenics Ltd.
19, 2023
July 19,
Page 2 2023 Page 2
FirstName LastName
What is the Quorum Requirement?, page x
3. Please revise to clarify (i) the quorum required to hold the VBL
special meeting and (ii)
the quorum requirement under Nasdaq rules. In this regard, your
disclosures on pages x
and 99 indicate that VBL s existing quorum is two shareholders
holding at least 33 1/3%
of the outstanding VBL Ordinary Shares whereas your disclosure on page
273 indicates
that VBL s quorum is two shareholders holding 25%. Also, your
disclosure on page x
indicates that the Nasdaq quorum requirement is two shareholders
holding at least 33
1/3% whereas Proposal 4, if enacted, would set the quorum at only one
shareholder
holding 33 1/3%. In light of the above, please tell us whether VBL s
existing and
proposed quorum provisions satisfy Nasdaq s requirements.
Background of the Merger, page 101
4. Your disclosure on page 102 appears to indicate that Wellbeing
submitted a non-binding
offer to purchase the VB-601 Asset during the August 15, 2022 to
December 15, 2022
timeframe. If so, please revise to disclose the material terms of this
offer and any other
offers made by Wellbeing during 2022 and 2023.
Related Party Transactions, page 163
5. We note your disclosure that Wellbeing intends to recruit Prof.
Harats, Dr. Feige, and Mr.
Backenroth as investors and partners to manage the new company and
develop the VB-
601 Asset. Please revise this section, as well as the Background and
Q&A sections, as
applicable, to describe the contacts and negotiations involving
Wellbeing and the three
VBL executive officers relating to the VB-601 Asset and/or the new
company. Discuss
the substance of these negotiations. Identify the person who initiated
the contacts or
negotiations. Disclose the timing of these contacts and negotiations
relative to Wellbeing's
initial offer and its Asset Sale negotiations with Mr. Kozin. Also,
clarify the status of the
recruitment negotiations.
VB-601 Offer, page 163
6. We note your disclosures describing the differences between the VB-601
Initial Offer and
the VB-601 Offer. Please revise to explain which party sought these
revised terms and the
reason(s) they did so. Also clarify whether the parties negotiated the
upfront payment
amount.
7. Please revise to explain whether the parties continue to negotiate the
Asset Sale agreement
and whether they intend to execute such an agreement in advance of the
Special Meeting.
As applicable, disclose whether Israeli law requires shareholder
approval for a sale
agreement or whether approval of a non-binding term sheet is
sufficient.
U.S. Federal Income Taxation of U.S. Holders of VBL Securities, page 166
8. We note your revised disclosure in response to prior comment 5 and
reissue in part. Please
Sam Backenroth
Vascular Biogenics Ltd.
July 19, 2023
Page 3
have counsel revise its opinion so that it does not assume VBL's past
and current PFIC
status. Alternatively, to the extent that there is significant doubt
about the tax
consequences of the transaction because the PFIC principles and
methodologies are
unclear and/or subject to varying interpretation, then counsel may
issue a should or
more likely than not opinion to make clear that the opinion is
subject to a degree of
uncertainty. If so, then please have counsel substantially revise the
tax opinion and also
revise the Q&A, Summary risk factor, and risk factor sections to set
forth the risks to VBL
holders of the uncertain tax treatment. For guidance, refer to Staff
Legal Bulletin No. 19
(Oct. 14, 2011).
Clinical Validation of PPMP, page 192
9. We note your revisions made in response to prior comment 10. Please
revise the
disclosure on page 192 to clarify that clinical response rates do not
indicate that patients
were cured of the condition.
10. Please provide a brief explanation of the terms "bootstrapping" and
"confidence interval."
Therapeutic Product Development
Volasertib, page 194
11. We note that your revisions to this section in response to prior
comment 11 appear to be
inconsistent with disclosure on page 60 indicating that FDA has
generally required
companion diagnostics to obtain "Premarket Approval" for the
diagnostic. Please revise
page 196 to reconcile your disclosures and highlight the risk that the
FDA will require the
approval of a companion diagnostic in order for you to market
volasertib.
12. We note your revisions in response to prior comment 13. With reference
to your
discussion of toxicity, please address the following:
define medical terms such as "febrile neutropenia," "neutropenia,"
and "infections
and infestations;"
briefly explain references to "CTCA grades" and clarify, if true,
that treatment-related
events classified as grades 3-5 are serious adverse events; and
with respect to the seven early-stage trials you reference on page
195, confirm that
you have disclosed all treatment-related serious adverse events
and quantified the
number of incidents (or lack thereof), as opposed to the "most
commonly observed"
categories.
Liquidity and Capital Resources Overview, page 223
13. We note your revised disclosures in response to prior comment 16. With
reference to the
FirstName LastNameSam Backenroth
pro forma presentation on page 252, we note that the revised disclosures
on page 223 only
Comapany NameVascular
address Biogenics
a small portion Ltd.
of the proceeds that will be available to
pursue Notable's business.
Accordingly,
July 19, 2023 Page 3please revise to disclose Notable's plan for the cash
that will be available.
FirstName LastName
Sam Backenroth
FirstName LastNameSam
Vascular Biogenics Ltd. Backenroth
Comapany
July NameVascular Biogenics Ltd.
19, 2023
July 19,
Page 4 2023 Page 4
FirstName LastName
Unaudited Pro Forma Condensed Combined Financial Information
Notable Pre-Closing Financing, page 250
14. You disclose on page 257 that investors under Notable pre-closing
financings will
receive 188,831,813 VBL Ordinary Shares upon merger. Given the
exchange ratio of
2.2482, this would equate to approximately 83,992,444 shares of
Notable equity. Please
include a reconciliation to the total 188,831,813 VBL Ordinary Shares
that includes the
6,118,198 shares of Series D-1 Preferred Stock and the 5,891,911
shares of Series D-2
Preferred Stock disclosed on page F-67 and include the conversion
ratio for the Notable
preferred stock to Notable common stock. In addition, explain why
there is not a pro
forma adjustment to eliminate the fair value change for the SAFEs in
your interim March
31, 2023 pro forma statement of operations similar to the elimination
of the gain on
change in fair value of Notable preferred stock warrant liability.
Unaudited Pro Forma Condensed Combined Statement of Operations - For The Three
Months
Ended March 31, 2023, page 257
15. We note your response to our prior comment 18 and the revisions made.
Please further
expand to disclose the Notable equity grants (e.g. warrants and
options) outstanding that
were excluded from the pro forma EPS presentation so investors have a
full picture of
their potential dilutive impact.
Exhibits
16. Please file the exclusive term sheet for the asset sale of the VB-601
Asset.
You may contact Li Xiao at 202-551-4391 or Vanessa Robertson at
202-551-3649 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Lauren Hamill at 303-844-1008 or Joe McCann at 202-551-6262 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Marianne Sarrazin