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United States securities and exchange commission logo
December 22, 2020
Adrian Murray
General Counsel
4D Pharma PLC
5th Floor, 9 Bond Court
Leeds
LS1 2JZ
United Kingdom
Re: 4D Pharma PLC
Registration
Statement on Form F-4
Filed on November
25, 2020
File No. 333-250986
Dear Mr. Murray:
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.
Registration Statement on Form F-4, Filed on November 25, 2020
Cover Page
1. Please revise the cover
page to clarify that the price per ADS will be determined based on
the market price of 4D
Pharma's ordinary shares on AIM, and provide the market price as
of the latest
practicable date. See Item 501(b)(3) of Regulation S-K.
Questions about the Merger, page 20
2. Please add a question
and answer explaining to Longevity shareholders why Longevity is
diverging from the
structural approach to a combination outlined in its IPO prospectus,
which stated: We
anticipate structuring our initial business combination so that the post-
Adrian Murray
4D Pharma PLC
December 22, 2020
Page 2
transaction company in which our public shareholders own shares will
own or acquire
substantially all of the equity interests or assets of the target
business or businesses.
Please also note that Longevity initially intended to focus on
businesses in China, and that
4D Pharma is headquartered in the UK.
How will the Longevity Initial Insiders vote in connection with the Longevity
Proposals?, page
21
3. We note your statement on page 21 and elsewhere that the SPAC Sponsor
owns
approximately 47.6% of Longevity s outstanding common shares. We
also note your
disclosure in footnote 2 on page 225 that this amount excludes shares
underlying units
received by the SPAC Sponsor in the private placement consummated
simultaneously
with the Longevity IPO. Please advise us whether the shares underlying
the private
placement units may be voted in connection with the merger, and if so,
revise your
disclosure to state the total percentage of shares the SPAC Sponsor
will vote in favor of
the transaction pursuant to the Voting Agreement. If the shares
underlying the units may
not be voted, please clarify.
In addition, we note your disclosure on page 21 that the Longevity
Initial Insiders, defined
as the former and existing directors and officers of Longevity at the
consummation of the
IPO, have agreed to vote all shares owned by them in favor of the
business combination.
We also note your statement at the bottom of page 24 that the
Longevity Initial Insiders
own 47.6% of the outstanding shares; however, this is the same amount
purportedly held
by the SPAC Sponsor, Whale Management Corporation. Please revise to
clarify the
percentage of outstanding shares held by the Longevity Initial
Insiders, then provide the
total held by both the Longevity Initial Insiders and the SPAC Sponsor
together which are
to be voted in favor of the transaction. If this amount is more than
the 50% vote required
to approve the transaction, please clearly state this throughout the
document where the
required vote is discussed.
What happens if a substantial number of Longevity Public Shareholders vote in
favor of the
Longevity Merger Proposal..., page 23
4. We note the following statement on page 23: "Such backstop commitment,
if executed,
may prevent substantial redemption, or at least reduce the number of
redeemed Longevity
Public Shares." Please explain how the backstop commitment will actually
prevent
FirstName LastNameAdrian Murray
shareholders from exercising their redemption rights. If this is not the
case and the
Comapany Name4D
backstop Pharma
investors willPLC
merely replace any funds used to pay
shareholders requesting
redemption, please
December 22, 2020 Page 2 clarify.
FirstName LastName
Adrian Murray
FirstName
4D PharmaLastNameAdrian Murray
PLC
Comapany22,
December Name4D
2020 Pharma PLC
December
Page 3 22, 2020 Page 3
FirstName LastName
After the Merger, how much equity interest of 4D Pharma will Longevity
Shareholders own?,
page 25
5. We note your statement that Longevity shareholders are expected to own
approximately
17.7% of 4D Pharma, and 4D Pharma existing shareholders are expected
to own
approximately 82.3% of 4D Pharma immediately prior to the effective
time, prior to the
issuance of shares as financial advisor fees and 4D Pharma Shares that
may be issuable to
the backstop investors after closing relating to the exercise of
existing Longevity warrants.
Please revise to also provide the amount and recipient of the
financial advisor fees and to
provide the number of shares that existing Longevity warrants may
convert into,
disclosing the ownership split after these share issuances.
Summary, page 31
6. We note that much of your Summary provides only cross-references to
other sections of
the document and does not actually summarize the information provided
in those sections.
Please revise the following to provide a substantive summary of the
applicable material
information: Material U.S. Tax Considerations; Comparison of Rights of
Longevity
Shareholders and 4D Pharma Shareholders; Selected Financial Data of
Longevity; Selected Historic Financial Data of 4D Pharma; and
Unaudited Pro Forma
Condensed Combined Financial Information.
7. With respect to the description of the Backstop Agreement on page 33,
please revise page
33 and elsewhere, as appropriate, to state the consideration payable
under the Backstop
Agreement, briefly describe the registration rights provided
thereunder, and identify the
Buyers, including whether such Buyers are current shareholders of
either Longevity or 4D
Pharma.
8. We note the following statement on page 35 in relation to the Nasdaq
notice of listing
compliance deficiency: "Longevity was granted additional time until
November 30, 2020
to further supplement its plan of compliance to regain compliance with
Minimum Public
Holders Rule." Please update this disclosure to provide the current
status.
Comparative Market Price and Dividend Information, page 36
9. Please provide the market value of Longevity's securities pursuant to
Item 3(g) of Form F-
4.
Unaudited Pro Forma Condensed Combined Financial Information, page 97
10. You disclose that the merger will be accounted for as a
recapitalization through an asset
acquisition. Please revise Note 1 to the pro forma information on page
101 to clarify
who will be treated as the accounting acquirer and to explain your
accounting basis for
that conclusion. Refer to the guidance outlined in ASC 805-10-55-11
through ASC 805-
10-55-15.
Adrian Murray
4D Pharma PLC
December 22, 2020
Page 4
11. Regarding your discussion of the backstop agreement on pages 97 and
98, please disclose,
if true, that the pro forma combined financial information would not
change in the event
of redemptions and related purchases by the backstop investors.
Alternatively, please
provide alternate pro forma financial information for this scenario.
Longevity Proposal 1: The Merger, page 109
12. On page 111 you state In October 2018, Longevity engaged several
consultants in China
with strong professional backgrounds in audit, investment banking and
capital markets to
support its management team. Please provide the names of these
consultants as well as
the names of the financial advisors referenced for each of Company C
and Company D.
13. On page 111 you state that Longevity provided an initial non-binding
indication of interest
to 12 potential acquisition targets. Please briefly provide more
detail concerning these
companies aside from the four companies described on pages 111-112,
including the
industry such targets operate in and reason for terminating the
negotiations.
14. Please revise page 113 to provide additional detail concerning why the
negotiations with
Party 3 were terminated. Additionally, you disclose on page 113 that
the Takeover Panel
informed you that it consented to your approach of five potential
reverse merger
candidates but you only mention three candidates in your discussion.
Please provide
details for the other two candidates.
15. Please revise your disclosure regarding the negations between 4D
Pharma and Longevity
on page 117 to provide greater detail as to the material issues
discussed and key
negotiated terms, including how the minimum cash condition and merger
consideration
were determined. We also note your statement on page 117 that 4D
Pharma verbally
agreed with Chardan to revise the existing terms of arrangement such
that in lieu of cash
and equity payments under the existing engagement letters with each of
Longevity and 4D
Pharma that Chardan would instead receive shares of the combined
company as its sole
advisory fee (with a total current value that is less than the
aggregate that would have been
payable under the two prior engagement letters) in connection with the
transaction." Please also revise to state the amount of shares Chardan
will receive for its
services and whether Chardan will be locked up.
Background of the Merger, page 110
16. Please clarify whether the boards of directors obtained fairness
opinions in connection
with the business combination. If not, please expand your disclosure,
where applicable, to
include the processes employed by the boards of directors of both 4D
Pharma and
Longevity to assess the value of the potential transactions outlined in
this section,
FirstName LastNameAdrian Murray
including how each board determined that the final valuation, and
consideration to be
Comapany Name4D
received in thePharma PLC was fair. In addition, if no fairness
opinion was obtained
transaction,
please
December 22,include a risk
2020 Page 4 factor to this effect.
FirstName LastName
Adrian Murray
FirstName
4D PharmaLastNameAdrian Murray
PLC
Comapany22,
December Name4D
2020 Pharma PLC
December
Page 5 22, 2020 Page 5
FirstName LastName
Material Tax Consequences, page 137
17. We note your disclosure that the transaction should qualify as a
"reorganization" within
the meaning of Section 368 and no gain or loss generally should be
recognized by U.S.
Holders. A tax opinion must be filed whenever the tax consequences of
a transaction are
material to an investor and a representation as to tax consequences is
set forth in the filing.
Please file a tax opinion as an exhibit to the filing or provide us
your analysis as to why
you do not believe such an opinion is required. Refer to Item
601(b)(8) of Regulation S-
K and, for guidance, Section III.A.2 of Staff Legal Bulletin No. 19.
If there is uncertainty
regarding the tax treatment of the share exchange and merger, counsel
s opinion should
discuss the degree of uncertainty.
Business of 4D Pharma
Overview, page 157
18. We note your statements on page 157 and elsewhere comparing your LBP
candidates to
small molecules or biologics. Please revise to clarify how your
product candidates are
distinguishable from biologics.
19. We note the following statement on page 157: Over recent months,
our approach has
been validated by our demonstration of signals of clinical efficacy of
our therapeutic
candidates in both oncology and gastrointestinal disease. Please
revise this statement and
all similar statements throughout your proxy statement/prospectus to
remove implication
that your product candidates are safe or effective, as these
determinations are solely within
the authority of the FDA and comparable regulatory bodies.
As a non-exhaustive list for illustrative purposes only, we note the
following disclosures:
These factors, deriving from the inherent safety of LBPs,
significantly reduce the
cost and time to generating meaningful in-patient clinical data
for our therapeutic
candidates.
The Phase 1b clinical trial demonstrated that Thetanix was safe
and well tolerated
and indicated preliminary signals of clinical activity.
Distinct safety advantages of LBPs . we have observed highly
attractive safety
profiles in all of our clinical studies conducted to date.
MRx0518 is now being assessed in three separate clinical
trials, and has delivered
the first positive proof-of-concept data showing preliminary
efficacy of a Live
Biotherapeutic in a cancer setting.
To the best of our knowledge, we, through this data, delivered
the first ever clinical
signals of efficacy in the treatment of cancer using LBPs.
During Part A of this clinical trial, MRx0518 demonstrated a
highly favorable safety
profile .
Highly encouraged by the excellent safety profile and signals
of clinical activity
observed so far with MRx0518
The clinical trial demonstrated that Blautix was safe and well
tolerated....
Adrian Murray
FirstName
4D PharmaLastNameAdrian Murray
PLC
Comapany22,
December Name4D
2020 Pharma PLC
December
Page 6 22, 2020 Page 6
FirstName LastName
We have demonstrated the efficacy of Thetanix in multiple
pre-clinical models of
IBD. The data, published in the journal Inflammatory Bowel
Diseases, showed that
Thetanix demonstrated strong efficacy on the primary readouts in
two different
preclinical models with relevance to Crohn s disease
Studies in a murine model of severe neutrophilic asthma show
that MRx-4DP0004
was highly effective at protecting mice against lung
inflammation.
Figure 1 4D Pharma s pipeline of LBP therapeutic candidates, page 158
20. We note your statement on page 158 that the MRx0518 Phase I/II trial
is in combination
with Keytruda, please indicate such in the pipeline table on pages 158
and 165 given the
arrow shown for MRx0518 extends to Phase II and your other trials for
MRx0518 are
Phase I.
Immuno-oncology Portfolio, page 165
21. Please state the number of subjects in your Phase I clinical trial of
MRx0518 as a
neoadjuvant monotherapy in patients undergoing surgical resection of
solid tumors.
22. We note the p-values shown in Figure 5 on page 167. Please revise to
provide a brief
explanation of the p-values shown, how p-values are used to measure
statistical
significance and how statistical significance relates to FDA approval.
23. We note your references to first-, and best-in-class LBPs on
page 160. This term
suggests that 4D Pharma s product candidates are effective and
likely to be approved.
Accordingly, please revise to balance these statements and provide
context concerning the
development and regulatory status of your product candidates and
uncertainties
concerning approval and whether it will be first in class in the
future. Alternatively, please
revise to delete these references throughout your registration
statement.
Gastrointestinal Disease Portfolio, page 175
24. Please provide additional details concerning the Phase 1b trial of
Blautix on page 175,
including the number of subjects, duration of the trial and p-values.
25. Please provide p-values for the Thetanix Phase 1b trial mentioned on
page 176.
Respiratory Disease Portfolio, page 177
26. Please replace the graphics on page 178, which are stretched
horizontally, and generally
ensure all graphics throughout the proxy statement/prospectus have a
legible font size. See
for instance Figure 18 on page 180.
27. Please provide additional details concerning the Phase I/II trial of
MRx-4DP0004 in
patients with partly controlled asthma on page 178, including the
number of subjects and
duration of the trial, and, with respect to the UK Phase II trial for
patients with COVID-
19, also include the endpoints of the study.
Adrian Murray
FirstName
4D PharmaLastNameAdrian Murray
PLC
Comapany22,
December Name4D
2020 Pharma PLC
December
Page 7 22, 2020 Page 7
FirstName LastName
Intellectual Property, page 185
28. Please revise page 186 to provide the number of patents in your patent
portfolio, the
specific products, product groups and technologies to which such
patents relate, whether
the patents are owned or licensed, the type of patent protection,
expiration dates for such
patents on an individual basis and the jurisdiction covered by each
patent.
Collaborations, page 186
29. Please revise page 186 to state the amount of funding provided to date
and the total you
are committed to provide to MD Anderson under your collaboration
agreement. With
respect to the research collaboration and option to license agreement
with Merck, please
state the term of the research collaboration period and the royalty
term if Merck exercises
an option under the agreement.
Results of Operations, page 206
30. Please disclose the research and development costs incurred during
each period presented
for each of your key candidates. If you do not track your research and
development costs
by candidate, please disclose that fact and explain why you do not
maintain and evaluate
research and development costs by candidate.
Beneficial Ownership of Securities and Certain Relationships and Related Peron
Transactions,
page 225
31. Please revise the beneficial ownership table for 4D Pharma on page 226
to identify the
natural person or persons who have voting and/or investment control of
the shares held by
Hargreaves Lansdown Asset Management and Interactive Investor Trading.
32. We note the SPAC Sponsor promissory note mentioned on page 228 and
your discussions
of various promissory notes and other debt instruments involving the
SPAC Sponsor on
pages 147 and 153-154. Please revise page 228 to clearly state the
aggregate amount of
debt currently held by the SPAC Sponsor, whether promissory notes,
convertible notes or
loans, how much cash will be payable upon Closing in repayment of such
debt and how
many shares any such obligations could convert into.
Description of 4D Pharma American Depositary Shares, page 241
33. We note that the forum selection provision in the deposit agreement
identifies state and
federal courts in New York, New York as the exclusive forum for "any
legal suit, action
or proceeding against or involving us or the depositary, arising out
of or based upon the
deposit agreement, the ADSs or the transaction contemplated thereby."
Please disclose
whether this provision applies to actions arising under the Securities
Act or Exchange Act.
If so, please also state that there is uncertainty as to whether a
court would enforce such
provision. If the provision applies to Securities Act claims, please
also state that investors
cannot waive compliance with the federal securities laws and the rules
and regulations
Adrian Murray
4D Pharma PLC
December 22, 2020
Page 8
thereunder. In that regard, we note that Section 22 of the Securities Act
creates concurrent
jurisdiction for federal and state courts over all suits brought to
enforce any duty or
liability created by the Securities Act or the rules and regulations
thereunder. If this
provision does not apply to actions arising under the Securities Act or
Exchange Act,
please also ensure that the exclusive forum provision in the governing
documents states
this clearly, or tell us how you will inform investors in future filings
that the provision
does not apply to any actions arising under the Securities Act or
Exchange Act.
Please also include a risk factor discussing any uncertainty regarding
enforceability and
clearly describe any risks or other impacts on investors. Risks may
include, but are not
limited to, increased costs to bring a claim and that these provisions
can discourage claims
or limit investors ability to bring a claim in a judicial forum that
they find favorable.
Exhibits
34. Please file the Longevity Insider Letter Agreement, dated August 28,
2018, as an exhibit
pursuant to Item 601(b)(10) of Regulation S-K.
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 Kristin Lochhead at 202-551-3664 or Terence O'Brien at
202-551-3355
if you have questions regarding comments on the financial statements and
related
matters. Please contact Margaret Schwartz at 202-551-7153 or Laura Crotty at
202-551-
7614 with any other questions.
Sincerely,
FirstName LastNameAdrian Murray
Division of
Corporation Finance
Comapany Name4D Pharma PLC
Office of Life
Sciences
December 22, 2020 Page 8
cc: Bradley Finkelstein, Esq.
FirstName LastName