Correspondence 0001493152-23-023145 from Vascular Biogenics Ltd. (NTBL) (CIK 0001603207)
Vascular Biogenics Ltd. (NTBL) (CIK 0001603207)
Date: June 30, 2023 · CIK: 0001603207 · Accession: 0001493152-23-023145
AI Filing Summary & Sentiment
File numbers found in text: 333-271826
Referenced dates: June 15, 2023
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Goodwin
Procter LLP
Three
Embarcadero Center, 28th Floor
San
Francisco, CA 94111
goodwinlaw.com
+1
(415) 733-6000
June
30, 2023
VIA
EDGAR
Office
of Life Sciences
Division
of Corporation Finance
U.S.
Securities and Exchange Commission
100
F Street NE
Washington,
DC 20549
Attention:
Li Xiao
Vanessa Robertson
Arzhang Navai
Joe McCann
Re: Vascular
Biogenics Ltd.
Registration
Statement on Form S-4
Filed
May 11, 2023
File
No. 333-271826
Ladies
and Gentlemen:
This
letter is submitted on behalf of Vascular Biogenics Ltd. (“VBL”) in response to the comments of the staff of the Division
of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”)
with respect to VBL’s Registration Statement on Form S-4 (File No: 333-271826), initially filed on May 11, 2023 (the “Registration
Statement”), as set forth in the Staff’s letter dated June 15, 2023 (the “Comment Letter”). VBL is
concurrently submitting Amendment No. 1 to the Registration Statement (“Amendment No. 1”), which includes changes
to reflect responses to the Staff’s comments and other updates.
For
reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience,
we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions
of the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment No. 1. All
capitalized terms used and not otherwise defined herein shall have the meanings set forth in Amendment No. 1.
Registration
Statement on Form S-4
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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 1 of Amendment No. 1 to reflect the Staff’s
comment. VBL has also updated the disclosure regarding VB-601 throughout Amendment No. 1 (see, e.g., pages 18, 113 and 163).
U.S.
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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 the regulatory approval of a drug candidate
or do so with greater speed, value or success.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 1 of Amendment No. 1 to reflect the Staff’s
comment.
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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on pages 1 and 195 of Amendment No. 1 to reflect the Staff’s
comment.
The
pre-Merger net operating loss carryforwards..., page 93
4. Please
revise the last sentence of the risk factor to quantify the loss carryforwards.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 93 of Amendment No. 1 to reflect the loss carryforwards
of VBL and Notable as of December 31, 2022 in response to the Staff’s comment. VBL has also updated the disclosure on page 220
of Amendment No. 1 in response to the Staff’s comment.
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).
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 166 of Amendment No. 1 to reflect the Staff’s
comment and has filed the opinion of Goodwin Procter LLP as Exhibit 8.1 accordingly. VBL respectfully advises the Staff that counsel
cannot opine on the status of any entity under the PFIC rules and has updated the disclosure on pages 44 and 168 of Amendment No. 1 accordingly.
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).
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on pages 164-168 and 170 of Amendment No. 1 to reflect
the Staff’s comment.
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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 191 of Amendment No. 1 to reflect the Staff’s
comment.
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Securities and Exchange Commission
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8. Revise
to clarify whether the predicted response is binary (i.e., predicted responder or predicted
non-responder).
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 191 of Amendment No. 1 to reflect the Staff’s
comment.
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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 192 of Amendment No. 1 to reflect the Staff’s
comment.
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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure with respect to each study on pages 193-194 of Amendment
No. 1 to reflect the Staff’s comment.
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 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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on pages 60 and 196 of Amendment No. 1 to reflect
the Staff’s comment.
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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 196 of Amendment No. 1 to reflect the Staff’s
comment.
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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on pages 194-195 of Amendment No. 1 to reflect the
Staff’s comment.
14. Please
revise to explain the term “ex vivo avatar trial.”
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 195 of Amendment No. 1 to reflect the Staff’s
comment.
U.S.
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June
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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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the introductory disclosure on page 195 to the chart on page 196
of Amendment No. 1 to reflect the Staff’s comment.
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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 223 of Amendment No. 1 to reflect the Staff’s
comment.
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 current liabilities
or expand your disclosure in Note D adjustment (b) to clarify that the estimated transaction
costs are included as an adjustment to the accrued liabilities line item.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 257 of Amendment No. 1 to reflect the Staff’s
comment.
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.
RESPONSE:
VBL acknowledges the Staff’s comment and has revised the disclosure on page 258 of Amendment No. 1 to reflect the Staff’s
comment. VBL has also included such disclosure under “Unaudited Pro Forma Condensed Combined Statement of Operations –
For The Three Months Ended March 31, 2023” on page 257 of Amendment No. 1.
***
U.S.
Securities and Exchange Commission
June
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If
you should have any questions or comments with respect to the foregoing, please contact me at (415) 733-6134 or via e-mail at msarrazin@goodwinlaw.com.
Very truly yours,
/s/
Marianne Sarrazin
Marianne Sarrazin
Cc:
Sam Backenroth, Vascular Biogenics
Ltd.
Thomas Bock, Notable Labs,
Inc.
Mitchell S. Bloom, Goodwin
Procter LLP
Andrew H. Goodman, Goodwin
Procter LLP
Tevia K. Pollard, Goodwin
Procter LLP
Evan Kipperman, Wiggin and
Dana LLP
Michael Grundei, Wiggin and
Dana LLP
Elishama Rudolph, Wiggin and
Dana LLP
Yuval Horn, Horn & Co.
– Law Offices
Shimrit Roznek, Horn &
Co. – Law Offices