United States securities and exchange commission logo
June 15, 2023
Sam Backenroth
Chief Financial Officer
Vascular Biogenics Ltd.
1 Blue Hill Plaza , Suite 1509
Pearl River, NY 10965
Re: Vascular Biogenics
Ltd.
Registration
Statement on Form S-4
Filed May 11, 2023
File No. 333-271826
Dear Sam Backenroth:
We have reviewed your 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.
Form S-4 filed May 11, 2023
Summary, page 1
1. With references to
disclosures on pages 170 and 173, please revise the Summary
disclosure on page 1
regarding VB-601 to explain that VBL s goal is to monetize this
asset prior to or
concurrent with the Merger and that VBL does not anticipate further
development of this
asset if the Merger is completed.
2. Please revise the
Summary discussion to provide context and balance to the discussion of
the Predictive
Precision Medicines Platform (PPMP). To the extent you highlight the
predictive capabilities
of the platform and Notable's belief that it can deliver a drug
product s medical
impact and commercial value faster, higher, and with a greater
likelihood of success,
please also explain and highlight that Notable has limited
experience in drug
discovery and development and that the platform may never result in
Sam Backenroth
FirstName LastNameSam
Vascular Biogenics Ltd. Backenroth
Comapany
June NameVascular Biogenics Ltd.
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the regulatory approval of a drug candidate or do so with greater
speed, value or success.
3. Further to the above comment, please revise the Summary and the
Business section to
explain that evidence of clinical activity and/or clinical response
does not mean that the
product candidate has or will demonstrate clinical efficacy or that it
will prove to be safe
as required to receive regulatory approval.
The pre-Merger net operating loss carryforwards..., page 93
4. Please revise the last sentence of the risk factor to quantify the
loss carryforwards.
U.S. Federal Income Taxation of U.S. Holders of VBL Securities, page 165
5. Please revise to indicate that the disclosure in this section
concerning the tax
consequences to VBL holders constitutes the opinion of tax counsel and
also file the
opinion as an exhibit to the registration statement. Also, have
counsel opine on whether
VBL is or has been a PFIC in prior tax years. Refer to Staff Legal
Bulletin No. 19 (Oct.
14, 2011).
6. We note statements that shareholders should rely solely upon
their tax advisors
regarding certain tax consequences. Please remove these disclaimers.
In this regard,
investors are entitled to rely on the opinion expressed by counsel.
Refer to Staff Legal
Bulletin No. 19 (Oct. 14, 2011).
Predictive Precision Medicines Platform (PPMP) , page 190
7. Please revise to discuss the development history of the platform. For
instance, discuss
whether it was developed internally and whether current employees were
responsible for
such development. Clarify whether the platform is fully developed.
8. Revise to clarify whether the predicted response is binary (i.e.,
predicted responder or
predicted non-responder).
9. Discuss how the data repository was built and how it grows. For
instance, explain whether
lines of data are added through third-party data sets or libraries.
Clinical Validation, page 191
10. Please revise to clarify whether the patients referenced in each of
the four studies were
administered FDA approved drug treatments for the condition or whether
they were
administered drug candidates pursuant to active INDs. Disclose the
dates for these
studies. Clarify how clinical response was measured and, if
applicable, whether patients
were cured of the disease.
Complementary and Companion Diagnostics, page 193
11. Please revise to clarify your current plans with respect to seeking or
not seeking FDA
approval for the PPMP. In this regard, the graphic on page 195
depicting the clinical
Sam Backenroth
Vascular Biogenics Ltd.
June 15, 2023
Page 3
development path for Volasertib appears to indicate that you will file
a companion
diagnostics (CD) application and seek FDA approval for the diagnostic.
In contrast, your
disclosure on page 60 indicates that it is too early to make such a
determination.
Volasertib, page 193
12. Disclose whether Notable has filed an IND relating to the Phase 2b
trial that it expects to
initiate in the fourth quarter.
13. Please revise to present the clinical safety and toxicity results for
the past clinical trials
where Volasertib was administered or advise. Also, reconcile your
disclosure concerning
these trials with the disclosure on page 54 indicating that Volasertib
has not yet been
administered in patients.
14. Please revise to explain the term ex vivo avatar trial.
15. We refer to the graphic and chart presented at the top of page 195.
Please revise to
clarify/highlight that the graphic and chart do not reflect actual
results from patient
testing.
Liquidity and Capital Resources, page 221
16. We note your disclosure that Notable anticipates that its expenses
will increase
substantially in 2023 as it advances the clinical development of
Volasertib and
Fosciclopirox. We also note the disclosure concerning substantial
doubt about the ability
of the combined company to continue as a going concern. Please revise
to disclose how
the funds available to the post-combination company will be allocated.
In particular,
discuss whether there is funding available to complete the planned
Phase 2a AML trial for
the Volasertib candidate and whether you presently have funds to
conduct ongoing and/or
future trials involving Fosciclopirox. Clarify whether the funding is
sufficient to operate
the business for twelve months following the closing of the merger.
Unaudited Pro Forma Condensed Combined Financial Information
Note 3. Pro Forma Adjustments
Unaudited Pro Forma Condensed Combined Balance Sheet As of December 31,
2022, page
254
17. We note that one of the closing conditions is that the expected
aggregate net cash proceeds
from the Notable Pre-Closing Financing must be greater than $5,000,000
after deducting
all unpaid Transaction Costs applicable to and incurred by Notable, or
for which Notable
is liable. Therefore, for Note D adjustment (e), either revise to adjust
the $6.3 million
transaction costs against cash and cash equivalent rather than accrued
expenses and other
FirstName LastNameSam Backenroth
current liabilities or expand your disclosure in Note D adjustment (b)
to clarify that the
Comapany NameVascular
estimated Biogenics
transaction costs areLtd.
included as an adjustment to the
accrued liabilities line
item.
June 15, 2023 Page 3
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Sam Backenroth
FirstName LastNameSam
Vascular Biogenics Ltd. Backenroth
Comapany
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June 15,
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Unaudited Pro Forma Condensed Combined Statement of Operations - For The Year
Ended
December 31, 2022, page 254
18. Please revise to provide a table showing the components of all equity
shares included for
the pro forma EPS calculation. Also disclose the equity shares
excluded from that table
(e.g. stock options, warrants, and etc.) In your revised disclosure,
please clarify how you
have treated the pre-funded warrants and restricted stock units, and
their respective shares
if included, in the EPS share calculation.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
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 Arzhang Navai at (202) 551-4676 or Joe McCann at (202) 551-6262 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Marianne Sarrazin